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ONC

BeOne MedicinesC
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-13
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Earnings documents stored for ONC.

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Investor releaseQuarter not tagged2026-08-13

BeOne Medicines Ltd (ONC) (Q2 2026) Earnings Call Highlights: Revenue Surges 30% to $1. ...

GuruFocus.com
This article first appeared on GuruFocus. Total Revenue: $1.7 billion, representing 30% growth year over year. GAAP Earnings per ADS: $2.05, up 144% compared to the prior year. BRUKINSA Global Revenue: Over $1.2 billion, representing 31% year-over-year growth. US BRUKINSA Sales: $893 million, representing 31% growth. TEVIMBRA Global Sales: $229 million, representing 18% growth versus the prior period. Amgen In-Licensed Portfolio Revenue: $157 million, growing 25% year over year. US Revenue: Approximately $899 million, growing 31% year over year. China Revenue: Approximately $500 million, growing 17% year over year. Europe Revenue: Approximately $208 million, growing 37% year over year. Rest of World Revenue: Approximately $73 million, more than doubled year over year. Gross Profit: $1.5 billion with gross margin of just under 90%. Operating Expenses: $1.2 billion, representing 13% growth. Income from Operations: $325 million. Net Income: $237 million, including an approximate $60 million impact from a tax audit settlement. Adjusted Income from Operations: $503 million, representing growth of more than 80% year over year. Adjusted Net Income: $444 million. Adjusted Diluted EPS: $3.84, compared with $2.25 a year ago. Free Cash Flow: $435 million, doubling from the prior year period. 2026 Revenue Guidance: Raised by $300 million to a range of $6.6 billion to $6.8 billion. 2026 GAAP Operating Income Guidance: Raised by $250 million to a range of $1 billion to $1.1 billion. 2026 Non-GAAP Operating Income Guidance: $1.7 billion to $1.8 billion. Warning! GuruFocus has detected 5 Warning Sign with ONC. Is ONC fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BeOne Medicines Ltd (NASDAQ:ONC) delivered a strong Q2 2026 with total revenues of $1.7 billion, up 30% year-over-year, and GAAP EPS of $2.05, up 144%. BRUKINSA continues to outperform, with global revenues exceeding $1.2 billion (31% growth) and the highest level of sustained new patient starts since launch. The company raised its 2026 revenue guidance by $300 million to $6.6-$6.8 billion and operating income guidance by $250 million to $1.0-$1.1 billion. The Phase 3 MANGROVE study showed BRUKINSA plus rituximab as the first chemo-free regimen for frontline mantle cell l…Read full document

This article first appeared on GuruFocus. Total Revenue: $1.7 billion, representing 30% growth year over year. GAAP Earnings per ADS: $2.05, up 144% compared to the prior year. BRUKINSA Global Revenue: Over $1.2 billion, representing 31% year-over-year growth. US BRUKINSA Sales: $893 million, representing 31% growth. TEVIMBRA Global Sales: $229 million, representing 18% growth versus the prior period. Amgen In-Licensed Portfolio Revenue: $157 million, growing 25% year over year. US Revenue: Approximately $899 million, growing 31% year over year. China Revenue: Approximately $500 million, growing 17% year over year. Europe Revenue: Approximately $208 million, growing 37% year over year. Rest of World Revenue: Approximately $73 million, more than doubled year over year. Gross Profit: $1.5 billion with gross margin of just under 90%. Operating Expenses: $1.2 billion, representing 13% growth. Income from Operations: $325 million. Net Income: $237 million, including an approximate $60 million impact from a tax audit settlement. Adjusted Income from Operations: $503 million, representing growth of more than 80% year over year. Adjusted Net Income: $444 million. Adjusted Diluted EPS: $3.84, compared with $2.25 a year ago. Free Cash Flow: $435 million, doubling from the prior year period. 2026 Revenue Guidance: Raised by $300 million to a range of $6.6 billion to $6.8 billion. 2026 GAAP Operating Income Guidance: Raised by $250 million to a range of $1 billion to $1.1 billion. 2026 Non-GAAP Operating Income Guidance: $1.7 billion to $1.8 billion. Warning! GuruFocus has detected 5 Warning Sign with ONC. Is ONC fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BeOne Medicines Ltd (NASDAQ:ONC) delivered a strong Q2 2026 with total revenues of $1.7 billion, up 30% year-over-year, and GAAP EPS of $2.05, up 144%. BRUKINSA continues to outperform, with global revenues exceeding $1.2 billion (31% growth) and the highest level of sustained new patient starts since launch. The company raised its 2026 revenue guidance by $300 million to $6.6-$6.8 billion and operating income guidance by $250 million to $1.0-$1.1 billion. The Phase 3 MANGROVE study showed BRUKINSA plus rituximab as the first chemo-free regimen for frontline mantle cell lymphoma, with a hazard ratio of 0.57 versus standard of care. The pipeline is advancing rapidly, with five solid tumor programs achieving proof of concept and moving to pivotal trials, including CDK4, B7-H4 ADC, and GPC3 x 4-1BB. Real-world data from over 10,500 Medicare patients showed BRUKINSA significantly reduced risk of death by 24% vs acalabrutinib and 36% vs ibrutinib. The company achieved FDA approval for BEQALZI, the first BCL-2 inhibitor for mantle cell lymphoma, expanding its hematology franchise. Free cash flow doubled year-over-year to $435 million, demonstrating strong cash generation and financial health. The CELESTIAL-301 study of zanubrutinib plus sonrotoclax did not meet the uMRD superiority endpoint versus venetoclax plus obinutuzumab, raising questions about the regimen's comparative efficacy. The company remains unblinded to the hazard ratio data from CELESTIAL-301, creating uncertainty about the PFS endpoint. Competition from fixed-duration regimens like acalabrutinib plus venetoclax (AV) is emerging, though the company downplays its near-term impact. The company faces potential biosimilar competition for XGEVA from its Amgen in-licensed portfolio, which could impact future revenue. Operating expenses are expected to grow at a similar year-over-year rate in 2027, indicating continued high investment levels that may pressure margins. The company's narrative on BRUKINSA's safety and efficacy is challenged by cross-trial comparisons, which may not fully account for differences in patient populations and study designs. The tax audit settlement had a $60 million impact on net income, reducing reported profitability. Q: Can you provide more color on the growth of BRUKINSA sales, specifically quantifying growth from indications outside CLL versus CLL itself, and the impact of the Acala-ven (AV) launch? Also, any color on the hazard ratio from the CELESTIAL-301 study? A: Aaron Rosenberg (CFO) noted that BRUKINSA growth was driven by strong demand across all regions, with the highest level of sustained new patient starts since launch. Growth is broad-based across CLL and non-CLL indications, with the company "punching a little bit above our weight" in non-CLL indications where it holds strong share. Duration of therapy continues to be highly constructive yet immature, reinforced by real-world data showing meaningful long-term benefits on discontinuation versus acalabrutinib and ibrutinib. John Oyler (CEO) stated they are not seeing much impact from the AV AMPLIFY launch in the US yet. Amit Agarwal (CMO, Hematology) added that AV only has three-year data, which shows the lowest rate of uMRD and landmark PFS among Ven-based regimens, and highlighted that in unmutated IGHV patients, BRUKINSA shows 70% PFS at six years versus low 40s for Ven-based regimens. On CELESTIAL-301, the company remains blinded to the data and does not have details on the hazard ratio, but remains confident in achieving the PFS superiority endpoint. Q: Can you provide early physician feedback regarding the MANGROVE study results, thoughts on the study not including a rituximab maintenance arm, and how physicians interpret the data relative to the approved ECHO regimen? A: Amit Agarwal (CMO, Hematology) explained that MANGROVE was designed to test a chemo-free regimen in frontline MCL and show it is better than standard-of-care chemotherapy regimens, unlike other BTK inhibitor studies like ECHO which added the BTK inhibitor to chemotherapy. The ZR regimen showed a hazard ratio of 0.57 versus BR, which is "really unprecedented" for a chemo-free regimen. While OS data is immature, the results have generated significant excitement among physicians and KOLs who treat MCL, who understand the impact of avoiding chemotherapy toxicities. There is also high interest in understanding the rituximab maintenance-free regimen. Q: How are you tracking towards completing the first registration study for the BTK degrader (tacabrutideg) in relapsed/refractory CLL, and how do you see the program positioned relative to competitors like Nurix/Roche? A: Amit Agarwal (CMO, Hematology) confirmed the company remains on track for a potential accelerated approval submission in Q4 2026, supported by Fast Track designation from the FDA. Phase 1 data has shown encouraging response rates and durability across different patient populations, which the company believes supports accelerated approval. The Phase 3 head-to-head study of tacabrutideg versus pirtobrutinib is enrolling very well, and a tacabrutideg + sonrotoclax relapsed/refractory study is planned to initiate early next year. This reflects growing confidence in tacabrutideg becoming a foundational asset in CLL. Q: When could we see an additional data cut from MANGROVE, and what are the design elements for the KAT6 program to overcome safety limitations and combine with the CDK4 selective program? A: Amit Agarwal (CMO, Hematology) stated the company is excited to present the MANGROVE data at an upcoming congress and will share details soon. Lai Wang (President, Global Head of R&D) explained that the KAT6 molecule was designed to be more selective for KAT6 while sparing KAT7, which is the main differentiation versus Pfizer's program and could lead to less hematological toxicities. The first Phase 1 study in breast cancer is designed to combine with the CDK4 inhibitor, and a second Phase 1 study in AML was initiated last month based on interesting preclinical translational data. Q: What can we expect to see from the PRMT5 inhibitor data at ESMO, and is pancreatic cancer moving to Phase 3 next year as well? A: Mark Lanasa (CMO, Solid Tumors) stated the ESMO disclosure will be the initial disclosure for the PRMT5 program, which entered the clinic in Q1 2025. It will include monotherapy Phase 1a dose escalation data plus a significant number of expansion patients, with an emphasis on non-small cell lung cancer due to the molecule's CNS-penetrant design. The data will show early evidence of clinically meaningful CNS coverage and will include data across tumor types including NSCLC, pancreatic cancer, and others. The company intends to have a broad development plan for the molecule. Q: What changed most materially relative to your expectations when you last updated guidance, and can you talk in broad strokes about the Phase 3 you envision for the CEA ADC in lung cancer next year? A: Aaron Rosenberg (CFO) cited areas of strength for BRUKINSA including the level of new patient starts, strength across all indications, and improvements in understanding duration of therapy, all of which were ahead of expectations at the beginning of the year. Mark Lanasa (CMO, Solid Tumors) stated the CEA ADC will have its initial data disclosure at ESMO, including Phase 1 dose escalation and expansion data, showing first-in-class proof of concept in NSCLC that compares favorably to other investigational ADCs. The initial registration opportunities will be in a later line setting, but the company is actively working to generate evidence in an earlier line setting given the strength of emerging data. Q: Can you provide more detail on the PRMT5 and RAS strategy, including whether the Phase 3 for PRMT5 in lung cancer would be a combo or monotherapy, and details on the RAS-ON inhibitor? A: Mark Lanasa (CMO, Solid Tumors) stated the company is deeply committed to innovation in RAS inhibition. A highly potent RAS-ON inhibitor will enter the clinic before the end of this year and was designed to be CNS penetrant, making it particularly exciting for NSCLC. The company is aware of and excited about data combining RAS-ON inhibitors with PRMT5 inhibitors in MTAP-deleted pancreatic cancer and will look to generate evidence in that regard swiftly. Additional RAS targeting molecules are being advanced, including a KRAS targeting degrader and a RAS-ON ADC where the RAS-ON inhibitor serves as the payload. Q: How should we think about the Amgen in-licensed portfolio's contribution, given it continues to outperform expectations with 25% growth? A For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-07

Is BeOne Medicines (ONC) Undervalued Following Its Earnings Beat And Raised Outlook?

Simply Wall St.
Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. BeOne Medicines (ONC) is back in focus after reporting second quarter 2026 results on 5 August, with revenue and earnings surpassing analyst expectations and the company lifting its full year 2026 outlook. See our latest analysis for BeOne Medicines. These results sit against a share price that has gained 6.8% over the past month and 6.0% year to date, while the 3 year total shareholder return of 66.6% points to sustained investor confidence in BeOne Medicines. If BeOne Medicines caught your eye after these numbers, it can help to see what else is moving in healthcare. Take a look at 42 healthcare AI stocks After a strong run on the back of upbeat guidance and earnings, BeOne Medicines now asks a practical question of investors: Is it worth adding exposure at this price, or does it make more sense to wait for a pullback before reassessing value? At a last close of $329.80 against a widely followed fair value narrative of about $412 per share, BeOne Medicines is framed as trading at a material discount while still pricing in ambitious growth and profitability targets. Read the complete narrative. Readers may want to understand why this narrative still points to a premium earnings multiple years from now. The story rests on strong revenue expectations, rising margins and a specific path for future cash flows that must line up almost perfectly. Result: Fair Value of $412.35 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, the BeOne Medicines story can change quickly if BRUKINSA or sonrotoclax underperform against rivals, or if pricing and regulatory pressure squeeze margins. Find out about the key risks to this BeOne Medicines narrative. While the fair value narrative presents BeOne Medicines as materially undervalued, the P/E snapshot looks far less generous. ONC trades on a P/E of 57.2x, compared with a fair ratio of 34.4x, the US Biotechs industry at 17.1x and peers at 26.5x. That gap suggests investors are already paying a steep premium for future execution. The question is whether you agree that this premium is justified. See what the numbers say about this price — find out in our valuation breakdown. Sentiment on BeOne Medicines is mixed right now, so it helps to move quickly, review the…Read full document

Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. BeOne Medicines (ONC) is back in focus after reporting second quarter 2026 results on 5 August, with revenue and earnings surpassing analyst expectations and the company lifting its full year 2026 outlook. See our latest analysis for BeOne Medicines. These results sit against a share price that has gained 6.8% over the past month and 6.0% year to date, while the 3 year total shareholder return of 66.6% points to sustained investor confidence in BeOne Medicines. If BeOne Medicines caught your eye after these numbers, it can help to see what else is moving in healthcare. Take a look at 42 healthcare AI stocks After a strong run on the back of upbeat guidance and earnings, BeOne Medicines now asks a practical question of investors: Is it worth adding exposure at this price, or does it make more sense to wait for a pullback before reassessing value? At a last close of $329.80 against a widely followed fair value narrative of about $412 per share, BeOne Medicines is framed as trading at a material discount while still pricing in ambitious growth and profitability targets. Read the complete narrative. Readers may want to understand why this narrative still points to a premium earnings multiple years from now. The story rests on strong revenue expectations, rising margins and a specific path for future cash flows that must line up almost perfectly. Result: Fair Value of $412.35 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, the BeOne Medicines story can change quickly if BRUKINSA or sonrotoclax underperform against rivals, or if pricing and regulatory pressure squeeze margins. Find out about the key risks to this BeOne Medicines narrative. While the fair value narrative presents BeOne Medicines as materially undervalued, the P/E snapshot looks far less generous. ONC trades on a P/E of 57.2x, compared with a fair ratio of 34.4x, the US Biotechs industry at 17.1x and peers at 26.5x. That gap suggests investors are already paying a steep premium for future execution. The question is whether you agree that this premium is justified. See what the numbers say about this price — find out in our valuation breakdown. Sentiment on BeOne Medicines is mixed right now, so it helps to move quickly, review the underlying data, and weigh both the concerns and potential upside for yourself. To see both sides in one place, start with 4 key rewards and 1 important warning sign If you are reassessing BeOne Medicines after these results, it makes sense to broaden your watchlist with other clear, data driven ideas on Simply Wall St. Spot potential value early by reviewing companies in the screener containing 19 high quality undiscovered gems that stand out on quality and fundamentals. Strengthen your core holdings by checking out the solid balance sheet and fundamentals stocks screener (49 results) that can help anchor a portfolio through different market conditions. Reduce portfolio swings by assessing the 77 resilient stocks with low risk scores that score well on stability and financial health. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ONC. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Investor releaseQuarter not tagged2026-08-05

BeOne Medicines Q2 Earnings Call Highlights

MarketBeat
Interested in BeOne Medicines Ltd. - Sponsored ADR? Here are five stocks we like better. Strong second-quarter performance: BeOne Medicines reported revenue of $1.7 billion, up 30% year over year, while GAAP earnings per ADS rose 144% to $2.05. BRUKINSA sales increased 31% to more than $1.2 billion globally, driving the company’s commercial growth. Raised full-year outlook: The company lifted its 2026 revenue guidance to CNY 6.6 billion–CNY 6.8 billion and expects GAAP operating income of CNY 1 billion–CNY 1.1 billion. Free cash flow doubled year over year to CNY 435 million. Pipeline expansion continues: BeOne received FDA approval for Beqalzi in relapsed or refractory mantle cell lymphoma and reported positive Phase III results for a chemotherapy-free BRUKINSA regimen. Solid-tumor programs also advanced, including Phase III development for BGB-43395 and planned pivotal trials for additional oncology candidates. 4 Stocks With Huge Cash Holdings at Silicon Valley Bank BeOne Medicines (NASDAQ:ONC) reported second-quarter revenue of $1.7 billion, up 30% from a year earlier, and GAAP earnings per ADS of $2.05, up 144%, as sales of its BTK inhibitor BRUKINSA continued to expand across approved indications and global markets. Chief Executive Officer John Oyler said the company raised its 2026 guidance for revenue and GAAP operating income, citing stronger-than-expected commercial performance and continued progress across its hematology and solid-tumor pipeline. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control BRUKINSA generated more than $1.2 billion in global revenue during the quarter, an increase of 31% year over year. U.S. BRUKINSA sales totaled $893 million, also up 31%. Oyler said the drug recorded its highest sustained level of new patient starts since launch, more than six years after its initial introduction. Chief Financial Officer Aaron Rosenberg said growth was supported by demand in chronic lymphocytic leukemia, or CLL, as well as the drug’s non-CLL indications. BRUKINSA is approved in five B-cell malignancies, including mantle cell lymphoma, Waldenstrom’s macroglobulinemia, marginal zone lymphoma and follicular lymphoma. → 3 Drone Stocks That Should Soar After the Summer Slump Rosenberg said non-CLL indications represent about one-third of the total prevalence across BRUKINSA’s five approved uses and that the compan…Read full document

Interested in BeOne Medicines Ltd. - Sponsored ADR? Here are five stocks we like better. Strong second-quarter performance: BeOne Medicines reported revenue of $1.7 billion, up 30% year over year, while GAAP earnings per ADS rose 144% to $2.05. BRUKINSA sales increased 31% to more than $1.2 billion globally, driving the company’s commercial growth. Raised full-year outlook: The company lifted its 2026 revenue guidance to CNY 6.6 billion–CNY 6.8 billion and expects GAAP operating income of CNY 1 billion–CNY 1.1 billion. Free cash flow doubled year over year to CNY 435 million. Pipeline expansion continues: BeOne received FDA approval for Beqalzi in relapsed or refractory mantle cell lymphoma and reported positive Phase III results for a chemotherapy-free BRUKINSA regimen. Solid-tumor programs also advanced, including Phase III development for BGB-43395 and planned pivotal trials for additional oncology candidates. 4 Stocks With Huge Cash Holdings at Silicon Valley Bank BeOne Medicines (NASDAQ:ONC) reported second-quarter revenue of $1.7 billion, up 30% from a year earlier, and GAAP earnings per ADS of $2.05, up 144%, as sales of its BTK inhibitor BRUKINSA continued to expand across approved indications and global markets. Chief Executive Officer John Oyler said the company raised its 2026 guidance for revenue and GAAP operating income, citing stronger-than-expected commercial performance and continued progress across its hematology and solid-tumor pipeline. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control BRUKINSA generated more than $1.2 billion in global revenue during the quarter, an increase of 31% year over year. U.S. BRUKINSA sales totaled $893 million, also up 31%. Oyler said the drug recorded its highest sustained level of new patient starts since launch, more than six years after its initial introduction. Chief Financial Officer Aaron Rosenberg said growth was supported by demand in chronic lymphocytic leukemia, or CLL, as well as the drug’s non-CLL indications. BRUKINSA is approved in five B-cell malignancies, including mantle cell lymphoma, Waldenstrom’s macroglobulinemia, marginal zone lymphoma and follicular lymphoma. → 3 Drone Stocks That Should Soar After the Summer Slump Rosenberg said non-CLL indications represent about one-third of the total prevalence across BRUKINSA’s five approved uses and that the company has strong share in those settings. He also cited potentially favorable treatment duration, real-world evidence on treatment discontinuation and improved patient adherence following the launch of a tablet formulation late last year. The company said it was not yet seeing a meaningful impact in the U.S. from the launch of acalabrutinib plus venetoclax. Oyler said it was still early to determine how the competitive situation could evolve. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure BRUKINSA has treated more than 300,000 patients in more than 80 markets, according to the company. Oyler said BeOne believes the medicine’s clinical and real-world evidence supports its position as the leading BTK inhibitor. BeOne reported gross profit of CNY 1.5 billion and a gross margin of just under 90%, benefiting from product mix and productivity improvements for BRUKINSA and TEVIMBRA. Operating expenses were CNY 1.2 billion, up 13%, reflecting clinical-development and commercial investments. GAAP income from operations was CNY 325 million, while net income was CNY 237 million. Net income included an approximately CNY 60 million impact from a previously disclosed tax audit settlement. Adjusted income from operations rose more than 80% year over year to CNY 503 million, while adjusted diluted earnings per ADS increased to $3.84 from $2.25. Free cash flow doubled from the prior-year period to CNY 435 million, Rosenberg said. The company increased its full-year revenue outlook by CNY 300 million to a range of CNY 6.6 billion to CNY 6.8 billion. It now expects GAAP operating income of CNY 1 billion to CNY 1.1 billion and non-GAAP operating income of CNY 1.7 billion to CNY 1.8 billion, representing a CNY 250 million increase in operating-income guidance across the range. BeOne expects gross margin to remain in the high-80% range and operating expenses to total CNY 4.8 billion to CNY 5 billion for the year. Rosenberg said expenses could continue growing year over year in 2027 at a rate similar to the past two years as key pipeline assets progress. During the quarter, the FDA approved Beqalzi for relapsed or refractory mantle cell lymphoma, making it the first approved BCL-2 inhibitor in that disease, according to the company. BeOne also highlighted positive results from its Phase III MANGROVE trial evaluating BRUKINSA plus rituximab in previously untreated mantle cell lymphoma. Chief Medical Officer of Hematology Amit Agarwal said the chemotherapy-free regimen was superior to bendamustine plus rituximab, with a hazard ratio of 0.57 favoring the BRUKINSA-based regimen. The company plans global regulatory submissions for the MANGROVE regimen in the second half of 2026 and expects to present full data at an upcoming medical meeting. Agarwal said physician and key opinion leader feedback on the findings has been positive, particularly because the regimen could reduce exposure to chemotherapy and rituximab infusions. BeOne’s CELESTIMO-301 study of zanubrutinib plus sonrotoclax did not achieve statistical superiority over venetoclax plus obinutuzumab in an undetectable minimal residual disease analysis. However, President and Global Head of Research and Development Lai Wang said the independent data monitoring committee recommended continuing the trial toward its primary progression-free survival endpoint. The company also said its BTK degrader tacabrutideg remains on track for a potential accelerated-approval submission in relapsed or refractory CLL by the end of 2026, if data support filing. A Phase III trial comparing tacabrutideg with pirtobrutinib is ongoing, and BeOne plans to begin a tacabrutideg-sonrotoclax Phase III combination study in relapsed or refractory CLL in 2027. TEVIMBRA generated $229 million in global sales, up 18% year over year. The FDA accepted and granted priority review to BeOne’s application for TEVIMBRA in combination with ZIIHERA and chemotherapy for first-line HER2-positive gastroesophageal adenocarcinoma. China’s drug regulator also accepted submissions involving TEVIMBRA and ZIIHERA. In development, BeOne said its CDK4 inhibitor BGB-43395 has entered Phase III development in breast cancer. At the Phase III dose, the drug combined with letrozole produced an objective response rate of about 70% in first-line HR-positive, HER2-negative metastatic breast cancer, according to Wang. At 400 milligrams, overall neutropenia was 21%, with no grade 3 or higher events reported. The company expects to begin pivotal trials by year-end for its GPC3 4-1BB bispecific antibody in second-line hepatocellular carcinoma and its B7-H4 antibody-drug conjugate in first-line maintenance ovarian cancer. BeOne also plans to present initial proof-of-concept data at ESMO for its PRMT5 inhibitor and CEA-targeting antibody-drug conjugate. Oyler also said BeOne plans a $300 million expansion of its U.S. manufacturing site in Hopewell, New Jersey. BeOne Medicines Ltd. is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. The firm portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The company was founded by Xiao Dong Wang and John V. Oyler on October 28, 2010 and is headquartered in Basel, Switzerland. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "BeOne Medicines Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-05

BeOne Medicines Ltd. - Sponsored ADR (ONC) Q2 Earnings: How Key Metrics Compare to Wall Street Estimates

Zacks
BeOne Medicines Ltd. - Sponsored ADR (ONC) reported $1.71 billion in revenue for the quarter ended June 2026, representing a year-over-year increase of 29.6%. EPS of $2.05 for the same period compares to $0.84 a year ago. The reported revenue represents a surprise of +2.99% over the Zacks Consensus Estimate of $1.66 billion. With the consensus EPS estimate being $1.40, the EPS surprise was +46.43%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how BeOne Medicines Ltd. - Sponsored ADR performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Net product revenues: $1.68 billion versus the two-analyst average estimate of $1.65 billion. The reported number represents a year-over-year change of +29%. Revenues- Product Revenue- Other: $37.82 million versus $18.45 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a +78.8% change. Revenues- Product Revenue- BRUKINSA(Zanubrutinib): $1.25 billion compared to the $1.27 billion average estimate based on two analysts. The reported number represents a change of +31.4% year over year. Revenues- Product Revenue- TEVIMBRA: $228.52 million versus $221.7 million estimated by two analysts on average. Revenues- Product Revenue- POBEVCY: $9.63 million versus the two-analyst average estimate of $11.24 million. The reported number represents a year-over-year change of -14.3%. Revenues- Product Revenue- BLINCYTO: $36.54 million compared to the $29.76 million average estimate based on two analysts. The reported number represents a change of +42.8% year over year. Revenues- Product Revenue- KYPROLIS: $15.15 million compared to the $18.24 million average estimate based on two analysts. The reported number represents a change of -22% year over year. Revenues- Product Revenue- XGEVA: $104.5 million versus $69.33 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a +28.5…Read full document

BeOne Medicines Ltd. - Sponsored ADR (ONC) reported $1.71 billion in revenue for the quarter ended June 2026, representing a year-over-year increase of 29.6%. EPS of $2.05 for the same period compares to $0.84 a year ago. The reported revenue represents a surprise of +2.99% over the Zacks Consensus Estimate of $1.66 billion. With the consensus EPS estimate being $1.40, the EPS surprise was +46.43%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how BeOne Medicines Ltd. - Sponsored ADR performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Net product revenues: $1.68 billion versus the two-analyst average estimate of $1.65 billion. The reported number represents a year-over-year change of +29%. Revenues- Product Revenue- Other: $37.82 million versus $18.45 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a +78.8% change. Revenues- Product Revenue- BRUKINSA(Zanubrutinib): $1.25 billion compared to the $1.27 billion average estimate based on two analysts. The reported number represents a change of +31.4% year over year. Revenues- Product Revenue- TEVIMBRA: $228.52 million versus $221.7 million estimated by two analysts on average. Revenues- Product Revenue- POBEVCY: $9.63 million versus the two-analyst average estimate of $11.24 million. The reported number represents a year-over-year change of -14.3%. Revenues- Product Revenue- BLINCYTO: $36.54 million compared to the $29.76 million average estimate based on two analysts. The reported number represents a change of +42.8% year over year. Revenues- Product Revenue- KYPROLIS: $15.15 million compared to the $18.24 million average estimate based on two analysts. The reported number represents a change of -22% year over year. Revenues- Product Revenue- XGEVA: $104.5 million versus $69.33 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a +28.5% change. View all Key Company Metrics for BeOne Medicines Ltd. - Sponsored ADR here>>> Shares of BeOne Medicines Ltd. - Sponsored ADR have returned +4.6% over the past month versus the Zacks S&P 500 composite's +3.5% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BeOne Medicines Ltd. - Sponsored ADR (ONC) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-05

BeOne Medicines Announces Second Quarter 2026 Financial Results and Business Updates

Business Wire
Total global revenues of $1.7 billion for the second quarter, an increase of 30% from the prior year BRUKINSA (zanubrutinib) global revenues of $1.2 billion for the second quarter, an increase of 31% from the prior year Diluted GAAP Earnings per American Depository Share (ADS) of $2.05 for the second quarter; non-GAAP diluted Earnings per ADS of $3.84 for the second quarter Raised 2026 total revenue guidance to $6.6 to $6.8 billion; GAAP operating income of $1 to $1.1 billion, non-GAAP operating income of $1.7 to $1.8 billion SAN CARLOS, Calif., August 05, 2026--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the second quarter of 2026. John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said: "These strong second-quarter results underscore our continued growth as a global oncology leader. Our foundational hematology franchise, led by BRUKINSA, continues to gain momentum as we advance one of the industry’s deepest and most diverse pipelines. With differentiated capabilities spanning drug discovery, clinical development, manufacturing, and commercialization, we are well positioned for our next phase of global growth." Second Quarter 2026 Financial Results Product Revenue totaled $1.7 billion for the second quarter of 2026, representing growth of 29% compared to the prior-year period. BRUKINSA: Global sales totaled $1.2 billion for the second quarter of 2026, representing growth of 31% compared to the prior-year period; U.S. sales of BRUKINSA totaled $893 million in the second quarter of 2026, representing growth of 31% compared to the prior-year period. TEVIMBRA (tislelizumab): Global sales totaled $229 million in the second quarter of 2026, representing growth of 18% compared to the prior-year period. Amgen in-licensed products: Global sales totaled $157 million in the second quarter of 2026, representing growth of 25% compared to the prior-year period. Gross Margin as a percentage of global product sales for the second quarter of 2026 was 90%, compared to 87% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in the Company’s portfolio. Gross margin also benefited from productivity improvements resulting in lower costs for bo…Read full document

Total global revenues of $1.7 billion for the second quarter, an increase of 30% from the prior year BRUKINSA (zanubrutinib) global revenues of $1.2 billion for the second quarter, an increase of 31% from the prior year Diluted GAAP Earnings per American Depository Share (ADS) of $2.05 for the second quarter; non-GAAP diluted Earnings per ADS of $3.84 for the second quarter Raised 2026 total revenue guidance to $6.6 to $6.8 billion; GAAP operating income of $1 to $1.1 billion, non-GAAP operating income of $1.7 to $1.8 billion SAN CARLOS, Calif., August 05, 2026--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the second quarter of 2026. John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said: "These strong second-quarter results underscore our continued growth as a global oncology leader. Our foundational hematology franchise, led by BRUKINSA, continues to gain momentum as we advance one of the industry’s deepest and most diverse pipelines. With differentiated capabilities spanning drug discovery, clinical development, manufacturing, and commercialization, we are well positioned for our next phase of global growth." Second Quarter 2026 Financial Results Product Revenue totaled $1.7 billion for the second quarter of 2026, representing growth of 29% compared to the prior-year period. BRUKINSA: Global sales totaled $1.2 billion for the second quarter of 2026, representing growth of 31% compared to the prior-year period; U.S. sales of BRUKINSA totaled $893 million in the second quarter of 2026, representing growth of 31% compared to the prior-year period. TEVIMBRA (tislelizumab): Global sales totaled $229 million in the second quarter of 2026, representing growth of 18% compared to the prior-year period. Amgen in-licensed products: Global sales totaled $157 million in the second quarter of 2026, representing growth of 25% compared to the prior-year period. Gross Margin as a percentage of global product sales for the second quarter of 2026 was 90%, compared to 87% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in the Company’s portfolio. Gross margin also benefited from productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA. Operating Expenses The following table summarizes operating expenses for the second quarter of 2026: The following table summarizes operating expenses for the first half of 2026: Research and Development (R&D) Expenses increased for the second quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to advancing early clinical programs into late stage and preclinical programs into the clinic. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $23.3 million and $0.5 million in the second quarter of 2026 and 2025, respectively. Selling, General and Administrative (SG&A) Expenses increased for the second quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support commercial growth. SG&A expenses as a percentage of product sales were 35% for the second quarter of 2026, compared to 41% in the prior-year period. Net Income and Basic/Diluted Earnings Per Share GAAP net income for the second quarter of 2026 was $237 million, an increase of $143 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage. Adjusted net income was $444 million, an increase of $192 million over the prior-year period. For the second quarter of 2026, basic and diluted earnings per share were both $0.16 per share and $2.12 and $2.05 per American Depositary Share (ADS), respectively, compared to basic and diluted earnings per share of $0.07 and $0.06 per share and $0.87 and $0.84 per ADS in the prior-year period. On an adjusted basis, basic and diluted earnings per share was $0.31 and $0.30 per share and $3.98 and $3.84 per ADS, respectively, compared to $0.18 and $0.17 per share and $2.33 and $2.25 per ADS in the prior-year period. Free Cash Flow for the second quarter of 2026 was $435 million, representing an increase of $216 million over the prior-year period. For further details on BeOne’s Second Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the second quarter of 2026 filed with the U.S. Securities and Exchange Commission. Updated Full Year 2026 Guidance BeOne’s financial guidance is summarized below: BeOne’s total revenue guidance for full year 2026 of $6.6 billion to $6.8 billion includes expectations for strong revenue growth driven by BRUKINSA’s leadership position in the U.S. and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and a full year of 2026 productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth. The Company is providing the following additional guidance on items impacting net income and earnings per ADS: Other income (expense): Estimated range of $25 million to $50 million in expense, includes interest amortization from Royalty Pharma arrangement. Income tax outlook: Earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized; the timing and magnitude of a potential reversal is uncertain; prior to reversal, income tax expense should trend with earnings per historical relationship. See Form 10-Q for additional updates on income tax uncertainties. Diluted ADS outstanding: The Company expects diluted ADSs outstanding of approximately 118 million. Second Quarter 2026 Business Highlights Core Marketed Products BRUKINSA (zanubrutinib) Achieved positive topline results from the Phase 3 MANGROVE study in combination with rituximab demonstrating unprecedented progression-free survival (PFS) superiority versus bendamustine plus rituximab in adult patients with previously untreated mantle cell lymphoma (MCL). Reported long-term 78-month follow-up data from the Phase 3 SEQUOIA study, which continue to demonstrate sustained PFS benefit for the treatment of adult patients with treatment-naïve chronic lymphocytic leukemia (CLL), at the American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) annual meetings. BEQALZI (sonrotoclax) Received U.S. Food and Drug Administration (FDA) accelerated approval for the treatment of adult patients with relapsed or refractory (R/R) MCL, after at least two lines of systemic therapy, including a BTK inhibitor. TEVIMBRA (tislelizumab) Achieved Japan regulatory approval for the treatment of adult patients with first-line gastric cancer. ZIIHERA (zanidatamab) Announced New England Journal of Medicine publication of full results from the Phase 3 HERIZON-GEA-01 study plus chemotherapy, with and without TEVIMBRA, versus trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ gastroesophageal adenocarcinoma (GEA). Select Clinical-Stage Programs Hosted an investor event at ASCO highlighting proof-of-concept data for three solid tumor programs, including BGB-43395 (CDK4 inhibitor), BGB-B2033 (GPC3x4-1BB bispecific antibody), and BG-C9074 (B7-H4 antibody-drug conjugate). Hematology Tacabrutideg (BTK CDAC): Achieved last patient enrolled for Phase 3 CaDAnCe-303 (China-only) study (BGB-16673-303) in post-BTKi R/R CLL. BG-75202 (KAT6 A/B inhibitor): Achieved first patient enrolled into monotherapy cohort for Phase 1 study for the treatment of adult patients with acute myeloid leukemia. Breast and Gynecological Cancers BGB-43395 (CDK4 inhibitor): Initiated Phase 3 study in combination with letrozole for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer. Gastrointestinal Cancers BGB-58067 (MTA-cooperative PRMT5 inhibitor): Received U.S. FDA Orphan Drug Designation for the treatment of adult patients with pancreatic ductal adenocarcinoma. Lung Cancer BON-110 (PD-1xVEGF-AxCTLA-4 trispecific antibody)1: Initiated first-in-human study. Anticipated R&D Milestones Corporate Updates Announced a $300 million expansion of the Company’s flagship clinical and commercial-stage manufacturing and research and development center at the Princeton West Innovation Campus in Hopewell, New Jersey, to add small molecule manufacturing capabilities. Appointed Felix J. Baker, Ph.D.; Elizabeth F. Mooney; and Charles L. Sawyers, M.D., to the Company’s Board of Directors. BeOne’s Earnings Results Webcast The Company’s earnings conference call for the second quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, August 5, 2026, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available. About BeOne BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding: BeOne’s continued growth as a global oncology leader; BeOne’s pipeline catalysts; BeOne’s full year 2026 guidance; BeOne’s expectations regarding continued global expansion and investment to support growth; upcoming R&D milestones to be achieved by BeOne; the timing of clinical and regulatory developments and data readouts; and BeOne’s plans, commitments, aspirations and goals under the caption "About BeOne." Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled "Risk Factors" in BeOne’s most recent periodic report filed with the U.S. Securities and Exchange Commission ("SEC"), as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Note Regarding Use of Non-GAAP Financial Measures BeOne provides certain non-GAAP financial measures, including Adjusted Operating Expenses, Adjusted Operating Loss, Adjusted Net Income, Adjusted Earnings Per Share, Free Cash Flow and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeOne’s operating performance. Adjustments to BeOne’s GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Non-GAAP adjustments are tax effected to the extent there is U.S. GAAP current tax expense. The Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects. BeOne maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeOne believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeOne’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of BeOne’s historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators BeOne’s management uses for planning and forecasting purposes and measuring BeOne’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by BeOne may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. View source version on businesswire.com: https://www.businesswire.com/news/home/20260805570642/en/ Contacts Investor Contact Liza Heapes+1 [email protected] Media Contact Kyle Blankenship+1 [email protected]

TranscriptFY2026 Q22026-08-05

FY2026 Q2 earnings call transcript

Earnings source - 94 paragraphs
Operator

Good day, everyone. Welcome to BeOne Medicines Q2 2026 earnings call webcast. All lines have been placed on mute to prevent any background noise. After the speakers remark, there will be a question-and-answer session. At this time, I would like to turn the call over to the company.

Dan Maller

Hello and welcome. Thank you for joining us today. I'm Dan Maller, Head of Investor Relations at BeOne Medicines. Before we begin, please note that you can find additional materials, including a replay of today's webcast and presentation, on the investor relations section of our website, ir.beonemedicines.com. I would like to remind all participants that during this call, we may make forward-looking statements regarding, among other things, the company's future prospects and business strategy. Actual results may differ materially from those indicated in the forward-looking statements as a result of various factors, including those risks discussed in our most recent periodic report filed with the SEC.

Dan Maller

Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation. Reconciliations between GAAP and non-GAAP financial measures discussed on this call are provided in the appendix to our presentation, which is posted to our investor relations website, along with our earnings release. All information in this presentation is as of the date of this presentation, and we undertake no duty to update such information unless required by law. Now turning to today's call as outlined on slide three. John Oyler, our Co-Founder, Chairman, and CEO, will provide a business update.

Dan Maller

Aaron Rosenberg, our CFO, will provide an update on our second quarter financial results and 2026 financial guidance. Lai Wang, President and Global Head of R&D, will discuss our R&D and pipeline progress. We will open the call to questions. Joining the team for the Q&A portion of the call will be Dr. Wu, President and Chief Operating Officer, Matt Shaulis, General Manager of North America, Mark Lanasa, Chief Medical Officer for Solid Tumors, Amit Agarwal, Chief Medical Officer for Hematology. I'll now pass the call over to John. John?

John Oyler

Thank you, Dan, and welcome everyone. Q2 was a very strong quarter across every dimension of our business. From a financial perspective, we achieved $1.7 billion in total revenues and $2.05 in GAAP earnings per ADS. This represents growth of 30% and 144% compared to the prior year, respectively. BRUKINSA, our foundational BTK inhibitor, continues to exceed our high expectations in the marketplace. More than six and a half years after its initial launch, BRUKINSA is seeing its highest level of sustained new patient starts, showing favorable early trends in duration of therapy, and it is showing strong growth across all five approved indications. On the back of these strong results, we are raising our 2026 guidance ranges for revenue and GAAP operating income by $300 million and $250 million respectively. Aaron will detail this later.

John Oyler

As impressive as our financial performance was in the quarter, our pipeline progress was equally significant. This is highlighted by the FDA approval of Beqalzi as the first and only BCL-2 inhibitor in mantle cell lymphoma, the success of the phase III MANGROVE study of BRUKINSA, which is so exciting that it warrants the entire next slide. We also announced a $300 million expansion of our flagship U.S. manufacturing site in Hopewell, New Jersey. MANGROVE is yet another example of the growing body of evidence supporting BRUKINSA as the foundational BTK inhibitor. We are excited about MANGROVE for two key reasons. The first is because it represents the first chemo-free treatment option for patients with frontline mantle cell. Secondly, because when you see the data, we belive the efficacy will speak for itself.

John Oyler

We are confident that this BRUKINSA-based chemo-free regimen has the potential to become the future standard of care for the roughly 21,000 new patients diagnosed with MCL each year in the major markets. Global submissions are planned for the second half of 2026. We are looking forward to sharing the full data at an upcoming medical meeting. Let's now turn to BRUKINSA's commercial performance. In Q2, BRUKINSA's global revenues reached over $1.2 billion, representing growth of 31% year-over-year. BRUKINSA is the number one BTK inhibitor, both in the U.S. and globally. It has the broadest label of any BTKI, with approvals in five B-cell malignancies. We often talk about BRUKINSA in the context of CLL, and with good reason but it is important to remember that BRUKINSA is a very important option for patients with other B-cell malignancies, including MCL, Waldenstrom's, marginal zone, and follicular lymphoma.

John Oyler

BRUKINSA has now treated more than 300,000 patients across 80+ markets. Market share alone doesn't tell the full story. The reason we are winning is scientific and that story has three chapters. Differentiated design, differentiated clinical outcomes, differentiated real-world evidence. At BeOne, we are committed to generating and sharing the evidence needed to fully characterize our medicines for the patients and physicians that we serve. On the left side of this slide, you can see the highlights of the breadth of phase III data generated for BRUKINSA as a single agent. Here you can see BRUKINSA has reported the most phase III data of any single agent BTK. The right side illustrates the substantial body of data currently being generated in combination, where you can see that BRUKINSA has the most reported and ongoing phase III data of any BTKI agent.

John Oyler

This slide demonstrates the scale of BRUKINSA's development plan compared to the more curated efforts of our peers. In addition to MANGROVE, BRUKINSA has four more potentially market-expanding phase III readouts in the next three years. A major wave of data is coming that will extend BRUKINSA's evidence base and its label well into the future. One quick reminder of why BRUKINSA performs the way it does. From day one, BRUKINSA was designed to deliver complete and sustained BTK inhibition through its potency and its PK profile. Our hypothesis was simple. Continuous BTK coverage would translate into a superior therapeutic profile, and over a decade of clinical and real-world evidence has really borne that out, and that's what the next few slides show.

John Oyler

Let me remind you now that BRUKINSA is the only BTK inhibitor that has demonstrated PFS superiority versus ibrutinib in a head-to-head randomized trial. In ALPINE, BRUKINSA delivered a hazard ratio of 0.69, that separation has been sustained to a median follow-up of 42.5 months. In ELEVATE-RR, Acala showed early separation from ibrutinib, that separation was not sustained. The curves crossed, the final hazard ratio was one. In BRUIN 3.1.4, pirto reported a hazard ratio of 0.845. Put simply, there was very little differentiation between the two arms, with 48 PFS events reported for pirto versus 50 for ibrutinib. With respect to tolerability, pirto showed numerically more discontinuations due to AEs than ibrutinib, whereas both BRUKINSA and Acala each showed markedly fewer discontinuations than ibrutinib in their respective head-to-head trials.

John Oyler

When comparing AFib rates of next generation BTK inhibitors across studies, it's important to understand the protocol differences that may affect patient selection and event reporting. As you can see on the left, both BRUKINSA and Acala studies in frontline CLL used highly similar eligibility criteria and AFib reporting. In contrast, the pirto studies utilized more restrictive eligibility criteria that may have resulted in a fitter study population, they also incorporated sponsor adjudication of AFib events. As a reminder, AFib events and rates are known to rise substantially with age. In a large study of more than 17,000 adults in U.S. primary care clinics, the absolute prevalence of AFib was nearly 4% higher among those aged 70-74 as compared to 65-69 so factoring for this level of age difference in studies really matters.

John Oyler

Despite the differences in inclusion criteria, which may have led to roughly half the percentage of patients above the age of 75 in BRUIN 3.1.3, a four-year lower median age in the pirto studies, despite the differences in AFib reporting methods, AFib rates were generally similar in the active treatment arms across studies. Interestingly, if we appLaid the more restrictive BRUIN 3.1.3 and 3.1.4 eligibility criteria to the SEQUOIA population, 15 of the highest risk patients would have been excluded from the BRUKINSA arm. In fact, those 15 patients had roughly twice the rate of serious grade 3 or higher infections and more than twice the rate of deaths due to AEs compared to the overall study. This analysis underscores the extent to which differences in protocol inclusion criteria may play a key role in the clinical narrative.

John Oyler

Although some have suggested that pirto may be well-suited for use in older patients due to lower AFib risk and improved tolerability, it is the least studied BTK inhibitor in that population. It lacks relevant long-term data with only 28 months of follow-up, and the narrative about being more tolerable and having less AFib are not supported by the data. The totality of evidence continues to support BRUKINSA's best-in-class profile. One of the key lessons we've recently learned in CLL trials is that long-term follow-up matters. Many regimens can appear highly effective in the first three years, but that's not enough time to understand their true durability. This slide shows the reported landmark PFS at years three through six across the respective frontline CLL phase III trials for the frontline treatment regimens.

John Oyler

Recognizing the limitations of cross-trial comparisons, a few items jump out. One, the landmark PFS rates for BRUKINSA are higher and continue to diverge over time compared to the other two continuous BTKIs. In fact, in year six, the delta between the landmark PFS rates reaches 12%, which is equivalent of one in eight patients not progressing. Two, there's an even more pronounced delta between BRUKINSA's landmark PFS and that of VEN-O. In year six, there's a delta of 21%, or roughly one in five patients. While the all-comer story is compelling, the high-risk story is even more striking. It raises important questions about the use of the current fixed duration regimens in high-risk patients, which I want to point out represent the majority of CLL patients.

John Oyler

This is not a small patient subgroup. This slide shows how the current fixed duration treatments perform relative to the foundational BRUKINSA in unmutated IGHV patients, those with the highest unmet medical need. BRUKINSA remains durable, 84% landmark PFS at year three and 70% at year six. In contrast, VEN-O drops from 82% at year three to just 42% at year six, a 40-point collapse. AV Amplify, based on the limited data disclosed to date, shows just 69% at year three, which is of course lower than VEN-O at a similar time point. There's a few important takeaways from this slide. First, while we're big belivers in the promise of fixed duration, the existing VEN-based treatments are not compelling option for higher risk patients, where foundational BRUKINSA has generated the best-in-class data.

John Oyler

Second, long-term follow-up is critical in CLL. As you can see on this slide, many regimens look promising at three years, but by six years, the outcomes can diverge meaningfully, especially in high-risk patients. That's why we've consistently prioritized long-term follow-up in our studies, and that's why we belive six-year data provide a more complete picture of treatment durability. It's also why we're concerned when conclusions reached on regimens based on only three years of data or less are made. We've been very surprised that some studies have not continued to report longer-term follow-up data, because years three to six are critical to evaluate the true long-term benefit of any CLL therapy. Patient outcomes are at stake.

John Oyler

The durability advantage that we're seeing in the clinical data for foundational BRUKINSA is increasingly being reinforced in the real world. It's both consistent and it's compelling. At ASCO 2026, we published an analysis of over 10,500 Medicare free service patients with previously untreated CLL. This is the largest real-world data set ever assembled in this setting. In this patient population, BRUKINSA reported statistically significant 24% and 36% reduction in the risk of death compared to those treated with acala and ibrutinib respectively, 24% and 36%. As you can imagine, this data set generated significant interest from physicians at ASCO, given both its size and the importance of these findings to the real-world U.S. Medicare population. The study has since been published in a peer-reviewed journal.

John Oyler

Importantly, this is now one of several large real-world analyses showing a consistent advantage for BRUKINSA, including a recent study of claims data from 17,000 frontline CLL patients, which also reported improved survival and treatment durability for BRUKINSA versus acala. Stepping back, BeOne is the only company in the world with foundational medicines across the three mechanisms of action for B-cell malignancies. BRUKINSA, our foundational BTK inhibitor, Beqalzi, our recently approved next generation, potentially best-in-class BCL-2 inhibitor, and tacabrutideg, our potentially first and best-in-class BTK degrader.

John Oyler

Only BeOne is equipped to provide the best-in-class therapies as monotherapy or in combination for every CLL patient and other lymphomas, regardless of their stage of disease, risk status or treatment preference. I've spoken about how 2026 is an inflection year for our solid tumor pipeline, and we presented data this quarter that supports our confidence in moving our CDK4 inhibitor, our B7-H4 ADC, and our GPC3-41BB bispecific antibody into registrational trials. Looking forward, ESMO will be sharing similar proof of concept data sets for two more potentially best-in-class medicines, our PRMT5 inhibitor and our CEA ADC. It's an incredibly exciting time for our company, for our portfolio and for our pipeline. With that, I'll hand it over to Aaron for the financial results.

Aaron Rosenberg

Thanks, John. Our second quarter financial results reflect strong execution and a durable and healthy underlying business as we invest with discipline to support growth over the long term. Starting with our commercial performance, we delivered another strong quarter across the portfolio with continued broad-based growth. Total revenue for the quarter was $1.7 billion, representing 30% growth compared to the prior year. U.S. BRUKINSA sales totaled $893 million, representing growth of 31%, which exceeded expectations due to several underlying factors. Despite the competitive environment, in Q2, we saw the highest level of sustained new patient starts since BRUKINSA's launch. Prescribers increasingly selected BRUKINSA for their patients, given the totality of evidence for efficacy and durability, supported by the clinical data and their real-world experience.

Aaron Rosenberg

We also continue to see meaningful growth from indications beyond CLL, which speaks to the breadth of the BRUKINSA label and the diversification of the franchise. While duration of therapy remains immature for BRUKINSA, the data suggests favorable duration relative to historical benchmarks. This makes sense given the unprecedented long-term data seen with SEQUOIA, as well as recently published real-world studies that reinforce statistically significant advantages for BRUKINSA in time to discontinuation relative to both acalabrutinib and ibrutinib. Finally, patient adherence has also improved, potentially linked to the launch of the tablet formulation late last year, which reduced both pill size and burden.

Aaron Rosenberg

High adherence rates are important for patient outcomes, and we are pleased to see this progress. These factors are not unique to the U.S., and we expect they will support durable long-term global demand growth for BRUKINSA. Beyond BRUKINSA, TEVIMBRA generated $229 million in global sales, representing 18% growth versus the prior period. TEVIMBRA maintained its market leadership in China in the face of steep competition. Our global launches are also gaining traction. This is ahead of the potential catalyst associated with the approval of TEVIMBRA in combination with ZIIHERA and chemotherapy for patients with first-line HER2-positive GEA.

Aaron Rosenberg

Our Amgen in-licensed portfolio also delivered CNY 157 million in revenue, growing 25% year-over-year. I'd like to highlight the broad-based nature of growth across geographies. The U.S. remained our largest market, contributing approximately $899 million in revenue during the quarter and growing 31% year-over-year. China contributed approximately CNY 500 million in revenue and grew 17% year-over-year, demonstrating continued strength across our commercial portfolio while maintaining market leadership for both TEVIMBRA and BRUKINSA. Note that foreign exchange contributed 7% of reported growth given year-over-year renminbi strengthening. Europe continues to be important growth driver for the company, generating approximately CNY 208 million in revenue and growing 37% year-over-year.

Aaron Rosenberg

We also continue to see strong momentum across our rest of world markets, where revenue more than doubled to approximately CNY 73 million. Key markets such as Japan and Brazil are making contributions that are increasingly meaningful at the enterprise level. Turning to the GAAP P&L. Gross profit was CNY 1.5 billion with gross margin of just under 90%, benefiting from mix as well as productivity improvements for both BRUKINSA and TEVIMBRA. Operating expenses totaled CNY 1.2 billion, representing 13% growth, reflecting advancement of key clinical programs and continued investment to support commercial growth. We continue to demonstrate the scalability of our model in the quarter with income from operations growing to CNY 325 million. Finally, net income totaled CNY 237 million.

Aaron Rosenberg

This includes the previously disclosed tax audit settlement, which had an approximate CNY 60 million impact. GAAP diluted earnings per ADS were $2.05 compared with $0.84 in the prior period. Turning to our adjusted results with a full reconciliation provided in the appendix of our results presentation. Adjusted income from operations increased to CNY 503 million, representing growth of more than 80% year-over-year. Adjusted net income increased to CNY 444 million while adjusted diluted earnings per ADS increased to $3.84 compared with $2.25 a year ago. Cash generation continues to build momentum with free cash flow doubling from the prior year period to CNY 435 million. Turning to our updated full-year outlook, which reflects the strong first half performance and confidence in the trajectory of our business.

Aaron Rosenberg

We are raising our revenue outlook by CNY 300 million to a range of CNY 6.6 billion-CNY 6.8 billion. This increase reflects the continued strength we are seeing across the portfolio led by BRUKINSA's performance in the U.S., ongoing global expansion and continued contributions from the broader commercial portfolio. We continue to expect gross margin to remain in the high 80% range. We're investing in both commercial execution and pipeline advancement with a modest increase in operating expenses to an updated range of CNY 4.8 billion-CNY 5 billion. Including those investments, the strength of the business translates to the bottom line, with a guidance raise in 2026 operating income by CNY 250 million across the range. We now expect GAAP operating income of CNY 1 billion-CNY 1.1 billion and non-GAAP operating income of CNY 1.7 billion-CNY 1.8 billion.

Aaron Rosenberg

Other underlying assumptions remain unchanged. Overall, this updated outlook reflects the strong performance we've delivered year to date and our confidence in continued execution for the remainder of the year. As we have now rounded the first half of the year, and while staying away from providing detailed guidance, I'd like to provide some perspectives as you update your models and begin thinking beyond this year. Our 2026 outlook provides confidence in the durability of our commercial business, including the prospects for continued BRUKINSA growth despite the competitive environment. As you see in our impLaid operating expense guidance for the second half of the year, we are investing to realize the full potential of our pipeline that we belive will drive sustainable long-term value for shareholders and the potential to address multiple unmet need for patients.

Aaron Rosenberg

We remain committed to our dual objectives of growth with measured margin expansion in the near term. Operating expenses will continue to be prioritized against our high hurdle rates, but can be expected to grow at a year-over-year rate in 2027, similar to what we've seen over the recent two years, given the positive progression of key pipeline assets. We look forward to providing our next financial update in November with Q3 results. With that, I'll now pass the presentation over to Lai.

Lai Wang

Thank you, Aaron. Hello, everyone. Thank you for joining us today. Across our portfolio, we'll continue to deliver meaningful progress. Starting with Hematology, John already highlighted the positive readout from the MANGROVE study in treatment-naïve mantle cell lymphoma. BRUKINSA plus rituximab has the potential to redefine frontline treatment and become the first chemo-free regimen for these patients. For Beqalzi, we achieved our first FDA approval in relapsed refractory mantle cell lymphoma. Moving on to the CELESTIMO 301 study update. The zanu-sonro regimen did not reach statistical superiority in the uMRD analysis versus the VO regimen. The IDMC recommended that the study continue toward its primary regulatory endpoint of progression-free survival. While the uMRD comparison was an interesting scientific question, uMRD superiority represented a very high bar given the historical high uMRD rates associated with VO regimen.

Lai Wang

Importantly, uMRD rates do not consistently predict PFS outcomes when comparing different MOAs, such as BTK inhibitor versus anti-CD20 antibody. For example, in CLL17, despite 26% lower uMRD rates than VO, the ibrutinib venetoclax regimen demonstrated comparable PFS outcomes as VO. As a result, if a BTK inhibitor plus BCL-2 inhibitor combination achieves similar uMRD rates as VO, it should translate into better PFS than VO. Given the high uMRD rates and exceptional durability observed with the zanu-sonro regimen in study 101, we remain highly confident in achieving the PFS endpoint. Next, our BTK degrader, tacabrutideg, continues to advance through potentially registrational phase II studies. While our phase III CaDAnCe-304 study against the proto remains on track. Together, these programs support our ambition to lead the next generation of therapy in B-cell malignancies.

Lai Wang

In Solid Tumors, TEVIMBRA reached another important milestone with FDA acceptance and the priority review of our HER2-positive GEA application. We also made regulatory progress in China with the CDE accepting submissions for both TEVIMBRA and ZIIHERA. Beyond TEVIMBRA, we continue to advance a diversified and increasingly innovative pipeline. Our CDK4 inhibitor has begun phase III development in breast cancer. Our GPC3 4-1BB bispecific recently completed enrollment in a potentially China registration-enabling HCC cohort. We also remain on track to initiate a phase III study in second-line HCC before year-end. In addition, our PRMT5 inhibitor received FDA orphan drug designation for pancreatic cancer, and we initiated clinical development of our PD-1 VEGF CTLA-4 trispecific. The milestones from the last quarter are a reflection of more than strong execution. They demonstrate the power of focused R&D strategy.

Lai Wang

We concentrate our investments in disease areas where we can establish leadership, building disease franchises rather than standalone products. Supporting that strategy is a growing technology toolkit from degraders and novel payload ADCs to cell therapies and T-cell engagers. Because we're not tied to any single modality, we can pair the right biology with the right therapeutic approach. The result is a pipeline designed not just to be broad, but to be sustainable. As our innovation engine matures, we are creating depth within each priority disease area, with multiple assets and mechanisms working together. That depth opens the door to proprietary combinations from within our own portfolio, driving differentiation and maximizing the value of our innovation investments. As we discussed on the previous slide, our innovation engine is generating a growing number of high-quality opportunity across the portfolio. Historically, our solid tumor pipeline was heavily weighted toward immuno-oncology.

Lai Wang

The CDK4 inhibitor marked the beginning of a new chapter, one defined by more diversified mechanisms, broader modalities, and a sharper focus on specific tumor types. Today, that evolution is clearly visible. We now have five solid tumor programs that have achieved clinical proof of concept and are advancing toward pivotal development. Remarkably, each is on track to progress from first in-human studies to pivotal stage in approximately two and a half years. Our CDK4 inhibitor is already enrolling in phase III. The B7-H4 ADC is expected to enter a pivotal study in ovarian cancer by year-end. For GPC3 4-1BB, we completed enrollment of the China registration intended expansion cohort with approximately 100 patients in just two and a half months. You heard it right. It's only two and a half months, underscoring our ability to execute at an exceptional speed.

Lai Wang

Based on this momentum, we also expect to initiate a phase III study in second-line HCC by year-end. In parallel, our CEA ADC and PRMT5 inhibitor have achieved proof of concept and are advancing toward registration-enabling development. Taken together, these programs demonstrate a repeatable model built on differentiated science, disciplined portfolio strategy, and strong clinical execution. As multiple internal discovered assets advance into late-stage development, we are creating a growing number of value inflection points. Now, let's take a closer look at some of the assets we highlighted at ASCO. Starting with our CDK4 inhibitor, the data continue to be highly encouraging and are consistent with our scientific hypothesis. At ASCO, we report a potentially best-in-class profile, combining promising efficacy with differentiated hematological safety.

Lai Wang

At the phase III dose, BGB-43395 achieved an objective response rate of around 70% in combination with letrozole in first-line HR-positive, HER2 negative metastatic breast cancer. Safety remains a key point of differentiation. At 400 mg, the overall neutropenia rate was just 21%, with no grade 3 or higher events. This compares favorably with both atirmociclib and approved CDK4/6 inhibitors, where severe neutropenia remains a meaningful clinical challenge. Together, these findings provides strong support for our ongoing phase III program, which is enrolling rapidly. They also create opportunities for novel combinations across our portfolio, including with our CDK2 degrader, BCL-2 inhibitor, and the Cas6 inhibitor. Turning to our GPC3 4-1BB program, BGB-B2033 continues to demonstrate what could be a breakthrough profile in HCC, combining strong monotherapy activity with a highly favorable safety profile.

Lai Wang

At ASCO, we reported objective response rate of over 30% in second-line plus HCC, comparable to current first-line combination regimens and well above what was reported with available TKIs in the post-IO setting. Safety remains a key differentiator enabled by our unique 4-1BB approach. This profile supports development in earLair lines, where approximately 70 patients have already been enrolled in combination with TEVIMBRA and bevacizumab. Development momentum also remains strong. We completed enrollment in a potentially China registration-enabling expansion cohort in post-IO, post-TKI HCC.

Lai Wang

In parallel, we're engaging with global regulatory authorities to explore accelerated approval pathways in second-line plus HCC based on the compelling efficacy and the safety profile observed to date. Turning to our B7-H4 ADC, BGB-C9074. At ASCO, we presented data that supports its potential to become a leading program in ovarian cancer. The key differentiator is safety. At a 6 mg/kg, treatment-related grade 3 or higher adverse events were approximately 26%, less than half the rates reported for other ADCs in development for first-line ovarian cancer without biomarker selection. This profile is particularly attractive in the maintenance setting, where long-term tolerability is critical. We also reported encouraging efficacy, including activity that appears independent of B7-H4 expression, supporting an all-comer development strategy.

Lai Wang

Based on this data, we plan to initiate a phase III study in first-line maintenance ovarian cancer before the end of 2026, while continuing to expand that opportunity to endometrial cancer and TNBC. Taken together, C9074 combines competitive efficacy with potentially best-in-class tolerability, positioning it as a leading B7-H4 ADC. We're excited for ESMO, where we have 12 abstracts accepted, including one rapid oral presentation and nine posters. Highlights include our GPC3 4-1BB bispecific phase I dose optimization data, the first disclosure of phase I proof of concept data for our PRMT5 inhibitor, with a focus on non-small cell lung cancer and the initial evidence of clinical meaningful brain activity, and the initial proof of concept data for CEA ADC that underscores its compelling first-in-class potential in non-small cell lung cancer.

Lai Wang

Together, these presentations highlight the strengths and breadth of our innovation engine. We have covered most of the milestones already. I will just call out a few items on this slide. We remain on track for potential accelerated approval submission of taca in relapsed/refractory CLL by the end of this year, further expanding our CLL franchise in B-cell malignancies. In addition, we plan to start taca-sonro fixed generation combination phase III development in relapsed/refractory CLL in 2027.

Lai Wang

In Solid Tumors, we expect to initiate pivotal studies for both our GPC3 4-1BB bispecific in second-line plus HCC and our B7-H4 ADC in first-line maintenance ovarian cancer before year-end. Looking further ahead, both our PRMT5 inhibitor and the CEA ADC are positioned to enter phase III development in 2027. I will now turn it back to John.

John Oyler

Thanks so much, Lai. We'll now open the call to Q&A. Please limit the number of questions to ensure we have time to hear from as many attendees as possible. Operator, please go ahead.

Operator

If you would like to ask a question, please use the raise hand icon, which can be found at the bottom of the webinar application. When you are called upon, please unmute your line and ask your question. We will now take a minute for the queue to assemble. Your first question comes from the line of Yanan Zhu with Wells Fargo. Please unmute your audio and ask your question.

Yanan Zhu

Great. Thanks for taking our questions, congrats on a beat and raise quarter. Could you provide more color on the growth of BRUKINSA sales? Specifically, was wondering if you can quantify how much of the growth is coming from indications outside CLL versus CLL itself. Within CLL, do you see any impact from the acala ven launch? How do you think the dynamics could evolve in the next couple of quarters from that perspective? Also very quickly on CELESTIMO 301, any color on the HR of the two arms? Sounds like it could be similar at this stage, but any color would be helpful. Thank you.

John Oyler

Thanks. I think we got three sub-questions in there. Maybe I will start and give a quick answer related to your question on acala plus ven. We can jump to Aaron Rosenberg and he can answer your general BRUKINSA question, and we can come to CELESTIMO with Amit Agarwal. Let me just start. I think right now we're not seeing much impact from the AV Amplify in the U.S. It's early, it's hard to say how it'll evolve, and if Amit Agarwal has extra detail on that, he can add it when he jumps to CELESTIMO. With that, Aaron, do you want to talk more broadly about where growth's coming from?

Aaron Rosenberg

Thank you. We really saw BRUKINSA growth and really for the rest of our portfolio, driven by strong growth and demand across all of our regions. We spent some time talking about our U.S. business, and at the last quarter, we talked about the strength that we saw coming out of April and May, and obviously that's continued into our second quarter performance. I highlighted in my prepared remarks three core areas. The first, we are achieving our highest level of new patient starts since launch, so we're really pleased to see the uptake in the marketplace. This is driven by strength in CLL as well as our non-CLL indications, so we really do see that durable growth across all indications. You talked a bit about context.

Aaron Rosenberg

If you look at just prevalence across the five approved indications, there's about 1/3 of the total prevalence in those non-CLL indications, and we're punching a little bit above our weight in those areas because we actually have really strong share in those indications. The other piece that we had talked about was duration of therapy, and that continues to be highly constructive, yet immature. This is reinforced by real-world data. We talked about the study in 10,000 Medicare patients that were recently published. This was really noteworthy with BRUKINSA showing meaningful long-term benefits on discontinuation of therapy versus acalabrutinib and ibrutinib.

Aaron Rosenberg

In fact, BRUKINSA did not meet the median time to discontinuation in this data cut. What we're really pleased about is how this relates directly to patient outcomes and experience, and this is what you see in our overall demand growth. As a result of data such as this, we have updated our internal planning assumptions to reflect longer duration of therapy, and overall, the business is just performing exceptionally well.

John Oyler

Amit, will you take the next question?

Amit Agarwal

Yeah. Thank you, Aaron. I think the question was about AMPLIFY, and I think John mentioned this in his remarks, long-term outcomes are very important in CLL. As we've seen, there is a huge difference between what happens with patients between years three and six. For AV, we only have the three-year data. We don't have long-term data. What we've seen from that data is the lowest rate of uMRD as well as landmark PFS, even among the VEN-based regimens. While it is hard to say what will happen with this data set in six years, we do have other data sets that look better than AV at the three-year mark with the longer follow-up, including VEN-O and VEN-I.

Amit Agarwal

When we look at these data, they really highlight some of the challenges that are seen with the current VEN-based fixed duration regimens. Now, In particular, when we look at that unmutated IGHV patient population, which represents a majority of the frontline CLL patients, there's a clear distinction between the results from BRUKINSA and other VEN-based combinations. For example, at six years, BRUKINSA shows a 70% PFS, whereas the fixed duration VEN-based regimens show PFS in the low 40s. We're talking about a 30% difference in the PFS. This really matters. When we couple this with the fact that there are safety issues and some of the VEN-based regimens have serious infection rates of 20%-30%, including fatal infections, and the fact that almost half of the progression events are deaths, not even allowing patients an opportunity for retreatment, it is clear that these patients are really not being served well with VEN-based regimens.

Amit Agarwal

The fact that BRUKINSA is the treatment of choice makes a lot of sense. Maybe I'll quickly address the CELESTIMO question around the hazard ratio. As Lai mentioned in his prepared remarks, this was an IDMC event where the IDMC reviewed the data for the uMRD, and B1 remains unblinded to the data, we do not have the details of the hazard ratio. Having said that, again, we remain very confident in the PFS endpoint and our ability to show superiority for ZS over VO and for the primary regulatory endpoint, which is PFS. With that, I'll turn it back to John.

John Oyler

Thank you so much, Amit, can we have another question, please, Operator?

Operator

Your next question comes from the line of Reni Benjamin with Citizens. Please unmute your audio and ask your question.

Reni Benjamin

Hey, good morning, guys. Thanks for taking the questions and congratulations on an outstanding quarter. I guess my question mainly has to do with the MANGROVE study. Can you maybe provide some early physician feedback regarding the results you've disclosed? Any sort of thoughts on the study not including a rituximab maintenance arm, and kind of how they're viewing the data, and how do the physicians kind of interpret this relative to the ECHO regimen, which has already been approved? Thanks.

John Oyler

Sure. Thank you so much for the question. Again, we haven't disclosed that much data on this yet, but I think, Amit, this is back in your wheelhouse.

Amit Agarwal

Thank you, John, and thank you for the question, Reni. Really I think we're all very excited about the MANGROVE results. Really what MANGROVE has let us do is it's another great example of how BRUKINSA's differentiated profile leads to really meaningful advantage for patients. From a design perspective, one of the important differences for MANGROVE compared to some of the other studies is that MANGROVE was designed to test a chemo-free regimen in that frontline MCL setting and show for the first time that it actually is better than the standard of care chemotherapy regimens. The other BTK inhibitors, as you mentioned, ECHO being one example, have really added the BTK inhibitor to that chemotherapy regimen, and they're more add-on rather than replacement designs.

Amit Agarwal

MANGROVE, for the first time, showed that a chemo-free regimen of ZR was superior to BR with a hazard ratio of 0.57 in favor of the ZR arm. These results themselves are really unprecedented in terms of thinking about that chemo-free regimen. We've talked about the OS data being immature, I think when you see that data, it will really sort of tell an important story there. When we've shared these results with physicians, KOLs, experts who treat MCL, they're really excited about this data.

Amit Agarwal

I think they really understand the impact that this can have. The fact that the chemo-free regimen really is going to allow for patients to avoid some of the toxicities that are seen with chemotherapy, avoid the rituximab infusion. Actually, there is a high level of interest in understanding what this rituximab maintenance-free regimen would also look like. Overall, we've received very positive feedback from the MCL community so far.

John Oyler

Thanks, Amit. I just want to reiterate that the response I've had is wonderful. Thank you so much. Operator, could we have the next question, please?

Operator

Your next question comes from the line of Michael Schmidt with Guggenheim. Please unmute your audio and ask your question.

Michael Schmidt

Hey, good morning. Thanks for taking my questions. I had one on the BTK degrader programs, sticking with Hematology. Maybe comment a bit about how you're tracking towards completing the first registration study in relapsed/refractory CLL. What is the efficacy bar in this setting, especially in the context of a single arm study? Longer term, how do you see the degrader program position relative to other programs, specifically the Nurix/Roche program? Thanks so much.

John Oyler

Thanks, Michael. Nice to hear your voice. I think that Amit is very popular this morning, please can you jump into that?

Amit Agarwal

Yes. Thank you, John. As Lai mentioned in his remarks, if we remain on track and if the data supports this, we're looking forward to that EA submission in Q4 of this year. Now I'll remind folks that the FDA has previously granted Fast Track designation for tacabrutideg for adult patients with relapsed/refractory CLL who have received at least two prior lines of therapy, including a BTK and BCL-2 inhibitor. In the context of what we've seen so far from our phase I data, across different patient populations, we've seen very encouraging both response rates as well as the durability of those responses. We think that this is a profile which is compelling, and when we think about previous accelerated approvals, we think that the profile really supports accelerated approval in that context.

Amit Agarwal

In addition to this, we also have important phase III studies which are executing very well. Particularly, I would call out our head-to-head comparison of tacabrutideg versus pirtobrutinib, the non-covalent BTK inhibitor. This study is enrolling very well, and we are very excited to share those results when they're available. In addition to this, Lai mentioned the tacabrutideg plus sonrotoclax relapsed/refractory study that we also plan to initiate early next year. Overall, I think this really reflects our growing confidence in the program and our ability to execute on a sort of profile which is going to allow tacabrutideg to become a foundational asset in CLL, along with the rest of our portfolio.

John Oyler

Thanks, Amit. Operator, we're ready for another question.

Operator

Your next question comes from the line of Etzer Darout with Barclays. Please unmute your audio and ask your question.

Etzer Darout

Great. Thanks for taking the question and congrats on the update today. Maybe another one on MANGROVE, if you can maybe talk about when we could see an additional data cut here and any sort of potential presentations we may see around that. Secondly, maybe one for Lai around the pipeline, just curious around the Cas6 design elements, and the potential to combine maybe with the CDK4 selective program or other programs in the pipeline, just given sort of some of the other efficacies we've seen with that and the intriguing profile that that could have. Again, the safety being limited, just curious around sort of your design elements there to maybe overcome some of those limitations would be great. Thank you.

John Oyler

Thanks so much for the question. Let's start with Amit and jump to Lai.

Amit Agarwal

Yeah, I think the question about MANGROVE was really just when are we presenting the data, and I think, as you mentioned, John, we are very excited to present this at an upcoming congress. We'll hopefully share the details very soon. Lai?

Lai Wang

Yeah. In term for the Cas6, this molecule was designed to be more selective for Cas6, trying to spare in the Cas7. This is the main differentiation versus Pfizer's Cas6 program. We belive this can potentially leading to less hematological toxicities. So far, we certainly, starting from last year, we had this program entering CONNECT to initiated first in human study in breast cancer. While the design there used to be combined with our CDK4 inhibitor, but certainly in our pipeline, there are many other potential molecules which we can combine with Cas6 in the breast cancer.

Lai Wang

In addition to that, I think it was just last month, we also initiated our second phase I study. This one is to exploring this Cas6 molecule in AML. We have seen quite a bit interesting preclinical translational data about Cas6 in AML, and we're certainly looking forward to seeing this molecule, how it does in AML.

John Oyler

Thanks so much, gentlemen. Back to the operator for another question.

Operator

Your next question comes from the line of Yaron Werber with TD Cowen. You may unmute your mic and ask your question.

Yaron Werber

Great. Congrats on a really nice quarter. Question, PRMT5 is a really important target and you're the lead essentially with the brain penetrant molecule. It sounds like you're going to have data in lung cancer at ESMO. Can you give us a sense what we might be able to see, because you're moving that into phase III next year? I think also pancreatic cancer achieved POC. Is there any chance we might see some of that data at ESMO, or is that going to be in the next meeting, and is that moving to phase III next year as well? Thank you.

John Oyler

Hi, Yaron. Thanks for the great question. Mark, why don't you speak to that since you're closest to the detail?

Mark Lanasa

Thank you, Yaron. We are very excited about our PRMT5 program and look forward to the initial disclosure that is upcoming at ESMO. Our molecule entered the clinic in the first quarter of 2025. This is our initial disclosure and therefore will include the monotherapy phase I-A dose escalation data, but will also include a significant number of patients who have been enrolled in expansion phases. Because our molecule is designed to be CNS penetrant, we have had an emphasis on enrolling patients with non-small cell lung cancer. As you heard from Lai, we will share some data showing that we have early evidence of clinically meaningful CNS coverage, but we will share data across tumor types inclusive of non-small cell lung cancer, pancreatic cancer, and other tumor types. Again, while we have an emphasis on lung cancer, we intend to have a broad development plan for this molecule.

John Oyler

Thanks so much, Mark. Back for another question, please.

Operator

Your next question comes from the line of Jessica Fye with JPMorgan. Please unmute your audio and ask your question.

Jessica Fye

Hey, guys. Good morning. Thanks for taking my question. Maybe one for Aaron and one for Mark. On the guidance increase, can you just walk through what changed most materially relative to your expectations when you last updated guidance last quarter? For Mark, on the CEA-ADC for lung cancer, can you talk in broad strokes about the phase III you envision running for that product next year? Thank you.

John Oyler

Thanks, Jessica. Please, Aaron and Mark.

Aaron Rosenberg

Sure, I'll be fairly brief, thanks for the question, Jess. I covered, I think, many of the factors that were driving performance for the quarter. The ones I highlighted are all areas of strength for BRUKINSA, whether it be the level of new patient starts we're seeing, the strength across all indications, and certainly improvements in our understanding of duration of therapy and how that's manifest in demand. All these are areas of strength for the business candidly ahead of our expectations at the beginning of the year. We're really pleased to see this. Ultimately, this means impact for patients, we look forward to continuing to growing the franchise as we move forward.

Mark Lanasa

Thanks, Jess. Regarding the CEA ADC, as I mentioned for PRMT5, again, we're very excited to make our initial data disclosure at the upcoming ESMO. Because this is the first disclosure, this will include the phase I dose escalation data as well as the expansion data. We do have a first-in-class proof of concept in non-small cell lung cancer, and we think that these data compare favorably to other investigational ADCs in the non-small cell lung cancer space. Based on these data, we want to leverage our lead mover advantage, the initial registration opportunities will be in a later line setting. We're actively working to generate evidence in an earlier-line setting given the strength of data that's emerging.

John Oyler

Thanks so much. Another question, please.

Operator

Your next question comes from the line of Faisal Khurshid with Jefferies. Please unmute your audio and ask your question.

Anand Shah

Hello, this is Anand Shah for Faisal. Could you just give a little more detail on your PRMT5 and RAS strategy? Would the phase III for the PRMT5 lung cancer study be a combo or mono? Could you provide any further details on your RAS(ON) inhibitor? Thank you.

John Oyler

Mark, I think that's back to you.

Mark Lanasa

Thank you very much for the question. RAS inhibition has proven itself to be a very important therapeutic modality, not only in pancreatic cancer, but also in non-small cell lung cancer. We're deeply committed to innovation in that space. We have a highly potent RAS(ON) inhibitor that will enter the clinic prior to the end of this year. Similar to our PRMT5 molecule, this molecule was designed to be CNS penetrant, and therefore we're particularly excited about the opportunities for that molecule in non-small cell lung cancer.

Mark Lanasa

We are certainly aware and excited about the data when a RAS(ON) inhibitor is combined with a PRMT5 inhibitor in MTAP-deleted pancreatic cancer. We will be looking to generate evidence in that regard as swiftly as possible. Going back to RAS, we have additional RAS-targeting molecules that we're advancing, including a KRAS targeting degrader, as well as a RAS(ON) ADC, where our RAS(ON) inhibitor will be the payload for the molecule.

John Oyler

Thanks so much. Back to the operator for one more question.

Operator

Your last question comes from the line of Gregory Renza with Truist Securities. Please unmute your audio and ask your question.

Gregory Renza

Great. Thank you. Good morning, John and team. Congrats on the quarter. Thanks for taking my question. John, maybe one for Aaron. Just as we look across the portfolio, when it comes to the Amgen portfolio, Aaron mentioned the growth of 25% or so. Just curious how we should be thinking about its contribution. It continuously outperforms expectations. Certainly some nice growth there. Where do you see the portfolio going, and how should we be framing the contributor to the top line? Thanks so much.

John Oyler

Thanks for the question. Aaron, why don't you wrap up Q&A, we'll close.

Aaron Rosenberg

Sure. Thanks for the question. We're obviously very pleased with the performance of our Amgen portfolio this year and really since the inception of this important collaboration. This is a franchise with great assets. We're on the verge of launching our opportunity with IMDELLTRA in the marketplace. I did touch on the last quarter biosimilar competition that's coming for XGEVA. We'll share more on that evolution as our understanding of the situation evolves. That's not a near-term impact, it's certainly something that could influence performance as we move beyond this year, we'll share more details of that as our understanding of the situation comes to light. Thank you.

John Oyler

Thanks so much, Aaron. In closing, I just want to share that we belive the company has never been better positioned. The commercial engine is really delivering. The pipeline's at an inflection point. The global organization is executing at a very high level. That said, there's a lot of cancer out there, and it's tough, there's still a lot of work ahead. We're really excited about the opportunity in front of us, we do want to just take a moment to thank the patients, their families that we're serving, the physicians, our partners, and our more than 12,000 colleagues and their families who focus with urgency every day to make this progress possible. Thank you all for joining us and being part of things. Have a wonderful rest of the day. Thank you

Investor releaseQuarter not tagged2026-08-04

Countdown to BeOne Medicines Ltd. - Sponsored ADR (ONC) Q2 Earnings: A Look at Estimates Beyond Revenue and EPS

Zacks
Wall Street analysts expect BeOne Medicines Ltd. - Sponsored ADR (ONC) to post quarterly earnings of $1.40 per share in its upcoming report, which indicates a year-over-year increase of 66.7%. Revenues are expected to be $1.66 billion, up 25.9% from the year-ago quarter. Over the past 30 days, the consensus EPS estimate for the quarter has remained unchanged. This demonstrates the covering analysts' collective reassessment of their initial projections during this period. Before a company announces its earnings, it is essential to take into account any changes made to earnings estimates. This is a valuable factor in predicting the potential reactions of investors toward the stock. Empirical research has consistently shown a strong correlation between trends in earnings estimate revisions and the short-term price performance of a stock. While investors usually depend on consensus earnings and revenue estimates to assess the business performance for the quarter, delving into analysts' forecasts for certain key metrics often provides a more comprehensive understanding. With that in mind, let's delve into the average projections of some BeOne Medicines Ltd. - Sponsored ADR metrics that are commonly tracked and projected by analysts on Wall Street. Analysts forecast 'Revenues- Net product revenues' to reach $1.65 billion. The estimate points to a change of +26.4% from the year-ago quarter. It is projected by analysts that the 'Revenues- Product Revenue- Other' will reach $18.45 million. The estimate suggests a change of -12.8% year over year. The combined assessment of analysts suggests that 'Revenues- Product Revenue- BRUKINSA(Zanubrutinib)' will likely reach $1.27 billion. The estimate indicates a change of +33.4% from the prior-year quarter. The consensus among analysts is that 'Revenues- Product Revenue- XGEVA' will reach $69.33 million. The estimate indicates a year-over-year change of -14.7%. Based on the collective assessment of analysts, 'Revenues- Net revenue from collaborations' should arrive at $10.28 million. The estimate points to a change of -22.3% from the year-ago quarter. Analysts expect 'Revenues- Product Revenue- BLINCYTO' to come in at $29.76 million. The estimate points to a change of +16.3% from the year-ago quarter. According to the collective judgment of analysts, 'Revenues- Product Revenue- KYPROLIS' should come in at $18.24 million. The e…Read full document

Wall Street analysts expect BeOne Medicines Ltd. - Sponsored ADR (ONC) to post quarterly earnings of $1.40 per share in its upcoming report, which indicates a year-over-year increase of 66.7%. Revenues are expected to be $1.66 billion, up 25.9% from the year-ago quarter. Over the past 30 days, the consensus EPS estimate for the quarter has remained unchanged. This demonstrates the covering analysts' collective reassessment of their initial projections during this period. Before a company announces its earnings, it is essential to take into account any changes made to earnings estimates. This is a valuable factor in predicting the potential reactions of investors toward the stock. Empirical research has consistently shown a strong correlation between trends in earnings estimate revisions and the short-term price performance of a stock. While investors usually depend on consensus earnings and revenue estimates to assess the business performance for the quarter, delving into analysts' forecasts for certain key metrics often provides a more comprehensive understanding. With that in mind, let's delve into the average projections of some BeOne Medicines Ltd. - Sponsored ADR metrics that are commonly tracked and projected by analysts on Wall Street. Analysts forecast 'Revenues- Net product revenues' to reach $1.65 billion. The estimate points to a change of +26.4% from the year-ago quarter. It is projected by analysts that the 'Revenues- Product Revenue- Other' will reach $18.45 million. The estimate suggests a change of -12.8% year over year. The combined assessment of analysts suggests that 'Revenues- Product Revenue- BRUKINSA(Zanubrutinib)' will likely reach $1.27 billion. The estimate indicates a change of +33.4% from the prior-year quarter. The consensus among analysts is that 'Revenues- Product Revenue- XGEVA' will reach $69.33 million. The estimate indicates a year-over-year change of -14.7%. Based on the collective assessment of analysts, 'Revenues- Net revenue from collaborations' should arrive at $10.28 million. The estimate points to a change of -22.3% from the year-ago quarter. Analysts expect 'Revenues- Product Revenue- BLINCYTO' to come in at $29.76 million. The estimate points to a change of +16.3% from the year-ago quarter. According to the collective judgment of analysts, 'Revenues- Product Revenue- KYPROLIS' should come in at $18.24 million. The estimate points to a change of -6.1% from the year-ago quarter. The average prediction of analysts places 'Revenues- Product Revenue- POBEVCY' at $11.24 million. The estimate indicates a year-over-year change of 0%. View all Key Company Metrics for BeOne Medicines Ltd. - Sponsored ADR here>>> BeOne Medicines Ltd. - Sponsored ADR shares have witnessed a change of +1.4% in the past month, in contrast to the Zacks S&P 500 composite's +1.7% move. With a Zacks Rank #3 (Hold), ONC is expected closely follow the overall market performance in the near term. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> . Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BeOne Medicines Ltd. - Sponsored ADR (ONC) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-07-17

BeOne Medicines to Announce Second Quarter 2026 Financial Results on August 5

Business Wire
SAN CARLOS, Calif., July 17, 2026--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will report its second quarter 2026 financial results on Wednesday, August 5, 2026 before the financial markets open. Following the release of the financials, the Company will host a live webcast with management at 8:00 a.m. ET. The live webcast of this event can be accessed from the investors section of the Company’s website at https://ir.beonemedicines.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the Company’s website. About BeOne Medicines BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne’s plans, commitments, aspirations and goals related to BeOne’s medicines and drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors which are discussed in the section entitled "Risk Factors" in BeOne’s most recent periodic report filed with the U.S. Securities and Exchange Commission ("SEC") as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this press release is as of the date hereof, and BeOne undertakes no duty to update such information unless required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260717984937/en/ Contacts Investor Contact: Liza HeapesTel:+1 [email protected] Media Contact:…Read full document

SAN CARLOS, Calif., July 17, 2026--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will report its second quarter 2026 financial results on Wednesday, August 5, 2026 before the financial markets open. Following the release of the financials, the Company will host a live webcast with management at 8:00 a.m. ET. The live webcast of this event can be accessed from the investors section of the Company’s website at https://ir.beonemedicines.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the Company’s website. About BeOne Medicines BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne’s plans, commitments, aspirations and goals related to BeOne’s medicines and drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors which are discussed in the section entitled "Risk Factors" in BeOne’s most recent periodic report filed with the U.S. Securities and Exchange Commission ("SEC") as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this press release is as of the date hereof, and BeOne undertakes no duty to update such information unless required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260717984937/en/ Contacts Investor Contact: Liza HeapesTel:+1 [email protected] Media Contact: Kyle BlankenshipTel:+1 [email protected]

Investor releaseQuarter not tagged2026-06-30

BeOne Medicines Announces Positive Phase 3 Results for BRUKINSA in Frontline Mantle Cell Lymphoma

Business Wire
Foundational BTKi BRUKINSA plus rituximab reduced the risk of progression or death by 43% versus bendamustine plus rituximab (HR=0.57; p MANGROVE is the first Phase 3 trial to advance a new chemotherapy-free standard in frontline MCL, potentially allowing patients freedom from the burden of years of infusions Full results from MANGROVE, including efficacy and safety, will be presented at an upcoming medical meeting; global regulatory submissions are planned for 2H 2026 SAN CARLOS, Calif., June 30, 2026--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced positive topline results from the Phase 3 MANGROVE study (BGB-3111-306; NCT04002297) evaluating foundational BTK inhibitor BRUKINSA® (zanubrutinib) plus rituximab versus bendamustine plus rituximab (BR) in adult patients with previously untreated mantle cell lymphoma (MCL). MANGROVE is the first Phase 3, global, randomized trial to evaluate a BTK inhibitor-based chemotherapy-free regimen against standard chemoimmunotherapy in this setting. This pivotal Phase 3 trial builds on the established clinical evidence for BRUKINSA in MCL. Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:"For patients with newly diagnosed MCL, chemotherapy is currently the default. MANGROVE demonstrates for the first time that BRUKINSA plus rituximab, a chemotherapy-free regimen, can deliver unprecedented improvements in progression-free survival, potentially redefining the treatment paradigm globally. We believe it would be very meaningful for patients to be free from the burden of frequent infusions. This is what it means to state that BRUKINSA is foundational: another study where it anchors frontline therapy and extends its leadership across B-cell malignancies." Topline results with practice-changing potential For this prespecified interim analysis, MANGROVE met its primary endpoint of progression-free survival (PFS), demonstrating a highly statistically significant and clinically meaningful improvement for BRUKINSA plus rituximab versus BR, as assessed by an independent review committee (IRC). This is the first Phase 3 study of its kind to employ a chemotherapy-free, rituximab maintenance-free approach in first-line MCL, sparing patients approximately two years of infusions. This BRUKINSA-based, chemotherapy-free regimen led t…Read full document

Foundational BTKi BRUKINSA plus rituximab reduced the risk of progression or death by 43% versus bendamustine plus rituximab (HR=0.57; p MANGROVE is the first Phase 3 trial to advance a new chemotherapy-free standard in frontline MCL, potentially allowing patients freedom from the burden of years of infusions Full results from MANGROVE, including efficacy and safety, will be presented at an upcoming medical meeting; global regulatory submissions are planned for 2H 2026 SAN CARLOS, Calif., June 30, 2026--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced positive topline results from the Phase 3 MANGROVE study (BGB-3111-306; NCT04002297) evaluating foundational BTK inhibitor BRUKINSA® (zanubrutinib) plus rituximab versus bendamustine plus rituximab (BR) in adult patients with previously untreated mantle cell lymphoma (MCL). MANGROVE is the first Phase 3, global, randomized trial to evaluate a BTK inhibitor-based chemotherapy-free regimen against standard chemoimmunotherapy in this setting. This pivotal Phase 3 trial builds on the established clinical evidence for BRUKINSA in MCL. Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:"For patients with newly diagnosed MCL, chemotherapy is currently the default. MANGROVE demonstrates for the first time that BRUKINSA plus rituximab, a chemotherapy-free regimen, can deliver unprecedented improvements in progression-free survival, potentially redefining the treatment paradigm globally. We believe it would be very meaningful for patients to be free from the burden of frequent infusions. This is what it means to state that BRUKINSA is foundational: another study where it anchors frontline therapy and extends its leadership across B-cell malignancies." Topline results with practice-changing potential For this prespecified interim analysis, MANGROVE met its primary endpoint of progression-free survival (PFS), demonstrating a highly statistically significant and clinically meaningful improvement for BRUKINSA plus rituximab versus BR, as assessed by an independent review committee (IRC). This is the first Phase 3 study of its kind to employ a chemotherapy-free, rituximab maintenance-free approach in first-line MCL, sparing patients approximately two years of infusions. This BRUKINSA-based, chemotherapy-free regimen led to a 43% reduction in the risk of progression or death (HR=0.57; [95% CI, 0.43, 0.76]; p<0.0001). The safety profile of BRUKINSA plus rituximab was consistent with the known safety profile of both medicines, with no new safety signals identified. Overall survival (OS), a key secondary endpoint, was immature at the time of this analysis; however, a strong trend in favor of BRUKINSA plus rituximab was observed. OS will be tested as part of the final analysis. Full results from MANGROVE will be shared at an upcoming medical meeting. The Company is in discussions with global regulatory authorities with planned submissions in 2H 2026. Why a chemotherapy-free approach is needed in MCL Mantle cell lymphoma is a rare and typically aggressive (fast-growing) type of B-cell non-Hodgkin lymphoma.1 It predominantly affects older adults, who often have comorbidities that can influence treatment decisions and how well they can tolerate therapies.2 Frontline care has long relied on chemoimmunotherapy such as BR.3 Chemoimmunotherapy carries well-documented burdens, including myelosuppression, prolonged immune suppression and heightened infection risk, and cumulative toxicity that can be especially difficult for older patients.4 Efforts to improve frontline outcomes in MCL with BTK inhibitors have largely focused on adding them to chemotherapy rather than replacing it.5 MANGROVE takes a different approach, by evaluating whether a chemotherapy-free regimen of BRUKINSA plus rituximab can deliver durable disease control while sparing patients the burden of upfront chemotherapy. This approach seeks to advance longstanding efficacy and tolerability limitations of first-line care. About MANGROVE MANGROVE is a global, randomized, open-label Phase 3 trial evaluating BRUKINSA plus rituximab versus bendamustine plus rituximab in adult patients with previously untreated mantle cell lymphoma. The trial enrolled 510 patients across 176 sites worldwide. In the experimental arm, patients received BRUKINSA at 160 mg orally twice daily plus rituximab during the initial treatment period, followed by BRUKINSA monotherapy until disease progression or intolerance. In the control arm, patients received bendamustine plus rituximab for six cycles. The primary endpoint is PFS assessed by IRC. Overall survival is a key secondary endpoint for the study. Other secondary endpoints include investigator-assessed PFS, overall response rate (ORR), duration of response (DOR), patient-reported outcomes, and safety. About BRUKINSA® (zanubrutinib) BRUKINSA is a next-generation Bruton tyrosine kinase (BTK) inhibitor designed to deliver complete and sustained BTK inhibition, enabled by optimized pharmacokinetics, including bioavailability, half-life, and selectivity, resulting in consistent target coverage in disease-relevant tissues. BRUKINSA is the foundational BTK inhibitor and the first and only to demonstrate progression-free survival superiority over another BTK inhibitor in a Phase 3 study, setting a new benchmark for efficacy in the class. With the broadest label globally, it is also the only BTK inhibitor that offers the convenience of once- or twice-daily dosing to support individualized treatment. The global BRUKINSA clinical development program spans more than 8,000 patients across over 45 trials in 30+ countries and regions. Approved in more than 80 markets, BRUKINSA has been used to treat over 290,000 patients worldwide, reflecting its rapidly expanding role as a standard of care across B-cell malignancies. Select Important Safety Information for BRUKINSA Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury). In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Please see full U.S. Prescribing Information including U.S. Patient Information. About BeOne BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential benefits of BRUKINSA plus rituximab as a chemotherapy-free regimen in adult patients with previously untreated MCL; the foundational potential of BRUKINSA to anchor frontline therapy on its own and extend its leadership across B-cell malignancies; the timing of clinical and regulatory developments and data readouts; and BeOne’s plans, commitments, aspirations, and goals under the heading "About BeOne." Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled "Risk Factors" in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom. View source version on businesswire.com: https://www.businesswire.com/news/home/20260630413578/en/ Contacts Investor Contact Liza Heapes+1 [email protected] Media Contact Kyle Blankenship+1 [email protected]

Investor releaseQuarter not tagged2026-05-13

BeOne Medicines' (NASDAQ:ONC) Performance Is Even Better Than Its Earnings Suggest

Simply Wall St.
BeOne Medicines AG (NASDAQ:ONC) just reported healthy earnings but the stock price didn't move much. Our analysis suggests that investors might be missing some promising details. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Many investors haven't heard of the accrual ratio from cashflow, but it is actually a useful measure of how well a company's profit is backed up by free cash flow (FCF) during a given period. In plain english, this ratio subtracts FCF from net profit, and divides that number by the company's average operating assets over that period. You could think of the accrual ratio from cashflow as the 'non-FCF profit ratio'. As a result, a negative accrual ratio is a positive for the company, and a positive accrual ratio is a negative. While it's not a problem to have a positive accrual ratio, indicating a certain level of non-cash profits, a high accrual ratio is arguably a bad thing, because it indicates paper profits are not matched by cash flow. That's because some academic studies have suggested that high accruals ratios tend to lead to lower profit or less profit growth. Over the twelve months to March 2026, BeOne Medicines recorded an accrual ratio of -0.39. That implies it has very good cash conversion, and that its earnings in the last year actually significantly understate its free cash flow. In fact, it had free cash flow of US$1.1b in the last year, which was a lot more than its statutory profit of US$513.0m. Given that BeOne Medicines had negative free cash flow in the prior corresponding period, the trailing twelve month resul of US$1.1b would seem to be a step in the right direction. That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. As we discussed above, BeOne Medicines' accrual ratio indicates strong conversion of profit to free cash flow, which is a positive for the company. Because of this, we think BeOne Medicines' underlying earnings potential is as good as, or possibly even better, than the statutory profit makes it seem! And it's also positive that the company showed enough improvement to book a profit this year, after losing money last year. Of course, we've only just scratched the surface when…Read full document

BeOne Medicines AG (NASDAQ:ONC) just reported healthy earnings but the stock price didn't move much. Our analysis suggests that investors might be missing some promising details. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Many investors haven't heard of the accrual ratio from cashflow, but it is actually a useful measure of how well a company's profit is backed up by free cash flow (FCF) during a given period. In plain english, this ratio subtracts FCF from net profit, and divides that number by the company's average operating assets over that period. You could think of the accrual ratio from cashflow as the 'non-FCF profit ratio'. As a result, a negative accrual ratio is a positive for the company, and a positive accrual ratio is a negative. While it's not a problem to have a positive accrual ratio, indicating a certain level of non-cash profits, a high accrual ratio is arguably a bad thing, because it indicates paper profits are not matched by cash flow. That's because some academic studies have suggested that high accruals ratios tend to lead to lower profit or less profit growth. Over the twelve months to March 2026, BeOne Medicines recorded an accrual ratio of -0.39. That implies it has very good cash conversion, and that its earnings in the last year actually significantly understate its free cash flow. In fact, it had free cash flow of US$1.1b in the last year, which was a lot more than its statutory profit of US$513.0m. Given that BeOne Medicines had negative free cash flow in the prior corresponding period, the trailing twelve month resul of US$1.1b would seem to be a step in the right direction. That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. As we discussed above, BeOne Medicines' accrual ratio indicates strong conversion of profit to free cash flow, which is a positive for the company. Because of this, we think BeOne Medicines' underlying earnings potential is as good as, or possibly even better, than the statutory profit makes it seem! And it's also positive that the company showed enough improvement to book a profit this year, after losing money last year. Of course, we've only just scratched the surface when it comes to analysing its earnings; one could also consider margins, forecast growth, and return on investment, among other factors. Obviously, we love to consider the historical data to inform our opinion of a company. But it can be really valuable to consider what other analysts are forecasting. At Simply Wall St, we have analyst estimates which you can view by clicking here. This note has only looked at a single factor that sheds light on the nature of BeOne Medicines' profit. But there are plenty of other ways to inform your opinion of a company. For example, many people consider a high return on equity as an indication of favorable business economics, while others like to 'follow the money' and search out stocks that insiders are buying. So you may wish to see this free collection of companies boasting high return on equity, or this list of stocks with high insider ownership. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2026-05-08

Earnings Beat: BeOne Medicines AG Just Beat Analyst Forecasts, And Analysts Have Been Updating Their Models

Simply Wall St.
BeOne Medicines AG (NASDAQ:ONC) defied analyst predictions to release its first-quarter results, which were ahead of market expectations. The company beat forecasts, with revenue of US$1.5b, some 5.4% above estimates, and statutory earnings per share (EPS) coming in at US$1.96, 156% ahead of expectations. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on BeOne Medicines after the latest results. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. Taking into account the latest results, the current consensus from BeOne Medicines' 33 analysts is for revenues of US$6.47b in 2026. This would reflect a meaningful 13% increase on its revenue over the past 12 months. Statutory earnings per share are predicted to soar 43% to US$6.60. Yet prior to the latest earnings, the analysts had been anticipated revenues of US$6.38b and earnings per share (EPS) of US$5.47 in 2026. There was no real change to the revenue estimates, but the analysts do seem more bullish on earnings, given the massive increase in earnings per share expectations following these results. Check out our latest analysis for BeOne Medicines There's been no major changes to the consensus price target of US$411, suggesting that the improved earnings per share outlook is not enough to have a long-term positive impact on the stock's valuation. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. Currently, the most bullish analyst values BeOne Medicines at US$501 per share, while the most bearish prices it at US$333. These price targets show that analysts do have some differing views on the business, but the estimates do not vary enough to suggest to us that some are betting on wild success or utter failure. These estimates are interesti…Read full document

BeOne Medicines AG (NASDAQ:ONC) defied analyst predictions to release its first-quarter results, which were ahead of market expectations. The company beat forecasts, with revenue of US$1.5b, some 5.4% above estimates, and statutory earnings per share (EPS) coming in at US$1.96, 156% ahead of expectations. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on BeOne Medicines after the latest results. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. Taking into account the latest results, the current consensus from BeOne Medicines' 33 analysts is for revenues of US$6.47b in 2026. This would reflect a meaningful 13% increase on its revenue over the past 12 months. Statutory earnings per share are predicted to soar 43% to US$6.60. Yet prior to the latest earnings, the analysts had been anticipated revenues of US$6.38b and earnings per share (EPS) of US$5.47 in 2026. There was no real change to the revenue estimates, but the analysts do seem more bullish on earnings, given the massive increase in earnings per share expectations following these results. Check out our latest analysis for BeOne Medicines There's been no major changes to the consensus price target of US$411, suggesting that the improved earnings per share outlook is not enough to have a long-term positive impact on the stock's valuation. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. Currently, the most bullish analyst values BeOne Medicines at US$501 per share, while the most bearish prices it at US$333. These price targets show that analysts do have some differing views on the business, but the estimates do not vary enough to suggest to us that some are betting on wild success or utter failure. These estimates are interesting, but it can be useful to paint some more broad strokes when seeing how forecasts compare, both to the BeOne Medicines' past performance and to peers in the same industry. We would highlight that BeOne Medicines' revenue growth is expected to slow, with the forecast 17% annualised growth rate until the end of 2026 being well below the historical 39% p.a. growth over the last five years. Compare this against other companies (with analyst forecasts) in the industry, which are in aggregate expected to see revenue growth of 21% annually. Factoring in the forecast slowdown in growth, it seems obvious that BeOne Medicines is also expected to grow slower than other industry participants. The biggest takeaway for us is the consensus earnings per share upgrade, which suggests a clear improvement in sentiment around BeOne Medicines' earnings potential next year. Fortunately, the analysts also reconfirmed their revenue estimates, suggesting that it's tracking in line with expectations. Although our data does suggest that BeOne Medicines' revenue is expected to perform worse than the wider industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates. With that said, the long-term trajectory of the company's earnings is a lot more important than next year. We have forecasts for BeOne Medicines going out to 2028, and you can see them free on our platform here. We also provide an overview of the BeOne Medicines Board and CEO remuneration and length of tenure at the company, and whether insiders have been buying the stock, here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2026-05-07

BeOne Medicines Q1 Earnings Call Highlights

MarketBeat
Strong Q1 results and raised guidance: Product revenue was $1.5 billion (up 34% YoY) with BRUKINSA sales of $1.1 billion, GAAP diluted EPS of $1.96, and management raised 2026 revenue guidance by $100 million to a range of $6.3–$6.5 billion. BRUKINSA commercial and clinical leadership: Management called BRUKINSA the foundational BTK inhibitor after Q1 sales up 38% and cited head-to-head superiority versus ibrutinib (ALPINE), while positioning data and IRC-reviewed endpoints to defend its competitive claims. Pipeline inflection with hematology and solid-tumor progress: BeOne has >60 upcoming ASCO/EHA abstracts, is advancing sonrotoclax (designed as more potent/selective than venetoclax) in combination with BRUKINSA, and reported a BTK CDAC showing a 94.4% ORR at the recommended dose with a potential accelerated-approval filing in H2 2026, alongside late-stage momentum in multiple solid-tumor programs. Interested in BeOne Medicines Ltd. - Sponsored ADR? Here are five stocks we like better. 4 Stocks With Huge Cash Holdings at Silicon Valley Bank BeOne Medicines (NASDAQ:ONC) reported first-quarter 2026 results that management said reflected “strong execution across the business” and prompted the company to raise its full-year revenue outlook. Co-founder, Chairman and CEO John Oyler said the company entered 2026 with “tremendous momentum,” citing product revenue growth, GAAP earnings per ADS, and continued progress across its hematology franchise and solid tumor pipeline. The company highlighted a large upcoming data slate, noting more than 60 abstract acceptances across ASCO and EHA, including proof-of-concept data from three solid tumor programs moving into late-stage clinical trials. → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries Oyler emphasized the commercial and clinical trajectory of BRUKINSA, which he described as having “firmly established itself as the foundational BTK inhibitor.” BRUKINSA posted first-quarter sales of $1.1 billion, representing 38% growth, and the company said it is seeing strong performance “in all markets and all indications.” Discussing clinical evidence, Oyler pointed to data presented at ASH 2025 in frontline chronic lymphocytic leukemia (CLL), including six-year progression-free survival of 74% and overall survival of 84%, with adjusted figures of 77% and 87%, respectively, when accounting for COVID. H…Read full document

Strong Q1 results and raised guidance: Product revenue was $1.5 billion (up 34% YoY) with BRUKINSA sales of $1.1 billion, GAAP diluted EPS of $1.96, and management raised 2026 revenue guidance by $100 million to a range of $6.3–$6.5 billion. BRUKINSA commercial and clinical leadership: Management called BRUKINSA the foundational BTK inhibitor after Q1 sales up 38% and cited head-to-head superiority versus ibrutinib (ALPINE), while positioning data and IRC-reviewed endpoints to defend its competitive claims. Pipeline inflection with hematology and solid-tumor progress: BeOne has >60 upcoming ASCO/EHA abstracts, is advancing sonrotoclax (designed as more potent/selective than venetoclax) in combination with BRUKINSA, and reported a BTK CDAC showing a 94.4% ORR at the recommended dose with a potential accelerated-approval filing in H2 2026, alongside late-stage momentum in multiple solid-tumor programs. Interested in BeOne Medicines Ltd. - Sponsored ADR? Here are five stocks we like better. 4 Stocks With Huge Cash Holdings at Silicon Valley Bank BeOne Medicines (NASDAQ:ONC) reported first-quarter 2026 results that management said reflected “strong execution across the business” and prompted the company to raise its full-year revenue outlook. Co-founder, Chairman and CEO John Oyler said the company entered 2026 with “tremendous momentum,” citing product revenue growth, GAAP earnings per ADS, and continued progress across its hematology franchise and solid tumor pipeline. The company highlighted a large upcoming data slate, noting more than 60 abstract acceptances across ASCO and EHA, including proof-of-concept data from three solid tumor programs moving into late-stage clinical trials. → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries Oyler emphasized the commercial and clinical trajectory of BRUKINSA, which he described as having “firmly established itself as the foundational BTK inhibitor.” BRUKINSA posted first-quarter sales of $1.1 billion, representing 38% growth, and the company said it is seeing strong performance “in all markets and all indications.” Discussing clinical evidence, Oyler pointed to data presented at ASH 2025 in frontline chronic lymphocytic leukemia (CLL), including six-year progression-free survival of 74% and overall survival of 84%, with adjusted figures of 77% and 87%, respectively, when accounting for COVID. He also highlighted long-term landmark progression-free survival comparisons across trials, while noting cross-trial limitations. → The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches Oyler said BRUKINSA is “the only BTK inhibitor that has demonstrated superiority on efficacy versus ibrutinib in a head-to-head trial,” referencing ALPINE results with a hazard ratio of 0.69 and a P value of 0.001. During Q&A, Chief Medical Officer for Hematology Amit Aggarwal addressed competitor claims around pirtobrutinib, arguing that head-to-head superiority has not been demonstrated and stressing the importance of independent review committee (IRC) assessments in open-label studies. Aggarwal said BRUKINSA “remains the only BTK inhibitor to have shown clear superiority.” BeOne also detailed its next-generation BCL-2 inhibitor, sonrotoclax (referred to as “Sonro”), which Oyler said was designed to be “14x more potent and 6x more selective than venetoclax,” with a shorter half-life intended to minimize drug accumulation. Oyler said sonrotoclax’s “true transformative potential lies in combination with BRUKINSA,” and the company plans to share updated combination data at ASCO. → Tyson Foods' Total Returns: Tasty Treats for Income Investors? In Q&A, Aggarwal discussed the CELESTIAL-301 study design, describing “dual primary endpoints” of undetectable minimal residual disease (uMRD) at end of treatment and progression-free survival (PFS). He said PFS is the “traditional regulatory endpoint” and “base case” for filing, while uMRD is not currently accepted as a regulatory endpoint. Aggarwal said an IDMC review of uMRD across arms is expected in Q3, with disclosure planned “at the next proximate opportunity,” and that the study would continue to the PFS readout without changes to conduct regardless of uMRD outcome. The company also highlighted progress for its BTK CDAC (a degrader), which Oyler described as “first in class” with “complete BTK degradation” and broad BTK mutation coverage. He said data presented at ASH 2025 showed efficacy in heavily pretreated patients, including those with resistance mutations to covalent and non-covalent BTK inhibitors, and cited a 94.4% overall response rate at a recommended 200 mg dose in a phase I-II study. Management reiterated guidance toward a potential accelerated approval submission in the U.S. for relapsed/refractory CLL in the second half of 2026. Asked about an accelerated approval efficacy hurdle, Aggarwal said the benchmark is evolving and that the company is “looking at a benchmark of somewhere between 50%-70%, depending on the population.” General Manager of North America Matt Shaulis said the company expects a “relatively robust” launch ramp with a “typical S-shaped uptake curve,” noting a “well-prepared market.” Oyler added that the CDAC and sonrotoclax launches would largely leverage BeOne’s existing commercial infrastructure. CFO Aaron Rosenberg reported product revenue of $1.5 billion in the quarter, up 34% year over year. BRUKINSA global revenues were $1.1 billion, while U.S. BRUKINSA sales were $761 million, “principally driven by volume growth of approximately 28% versus Q1 2025.” Rosenberg said U.S. results included a mid-single-digit pricing benefit year over year and “non-recurring gross to net favorability of approximately $20 million,” while the company continues to expect “relatively stable pricing in 2026.” He also noted typical first-quarter seasonality in the BTK inhibitor class, including inventory dynamics and one fewer shipping week. Rosenberg said demand signals improved in March and carried into April, supporting confidence in U.S. performance for the year. TEVIMBRA revenue increased 20%, with management citing sustained market leadership in China and growth contributions from launch markets outside of China. In-license and other products grew 27% year over year, including what Rosenberg called robust performance from the company’s Amgen in-license portfolio. XGEVA contributed $90 million, though Rosenberg noted several biosimilar entrants filed for approval in April, which “could lead to enhanced competition.” By geography, the company said: United States: $766 million revenue, up 36% year over year China: $465 million revenue, up 17% (including 5% driven by foreign exchange) Europe: $91 million revenue, up 64% (with foreign exchange contributing about 11% of growth) Rest of world: up 104%, driven by expansions and launches including Japan and Brazil Gross margin improved to 89% from about 85% a year ago, which Rosenberg attributed to product mix, price, and cost efficiencies. Operating expenses rose 16% to $1.1 billion as the company invested in commercial growth and pipeline advancement. Income from operations was $250 million, up from $11 million in the prior-year period. Net income totaled $227 million, with GAAP diluted earnings per ADS of $1.96. On a non-GAAP basis, operating income was $414 million and non-GAAP net income was $375 million, or $3.24 per diluted ADS. Free cash flow was $161 million. Based on first-quarter performance and recent trends, BeOne raised its 2026 revenue guidance by $100 million to a range of $6.3 billion to $6.5 billion. GAAP operating expense guidance was unchanged at $4.7 billion to $4.9 billion, while GAAP operating income guidance was updated to $750 million to $850 million. Rosenberg said the company anticipates “modest full-year initial contributions” from launches of zanidatamab and sonrotoclax. President and Global Head of R&D Wang Lai said 2026 “marks a true inflection year” for BeOne’s solid tumor portfolio, with several programs moving toward registration. He cited progress including TEVIMBRA receiving U.S. priority review in HER2-positive gastric cancer, activation of phase III sites for the company’s CDK4 inhibitor, and a potentially pivotal hepatocellular carcinoma (HCC) study enrolling for its GPC3x4-1BB bispecific. Lai said the GPC3x4-1BB program moved from first-in-human dosing to enrolling the first patient in a potentially registrational study in 19 months. He said the company has enrolled more than 200 patients in 20 months and that the program has received FDA Fast Track and Orphan Drug Designations. In response to questions on the pivotal HCC study, Lai said BeOne is discussing the efficacy “bar” with health authorities and will present phase I data at ASCO, with additional updates at an oral presentation and an investor event. For the CDK4 inhibitor, Chief Medical Officer for Solid Tumors Mark Lanasa said BeOne will present updated data at ASCO from about 60 frontline stage 4 breast cancer patients treated in combination with letrozole. Lanasa said the company plans to show a strong response rate across doses tested for phase III dose selection, along with early data suggesting food may improve gastrointestinal tolerability. He added that PFS maturity remains low given expected frontline PFS exceeding two years. Lai also discussed an external innovation move: an exclusive option to license a PD-1/VEGF/CTLA-4 trispecific (BON-110, previously HH-160), expected to enter the clinic in June. He said the addition of a CTLA-4 arm could differentiate it from PD-1/VEGF bispecifics, and that engineering to reduce Fc function is intended to mitigate toxicity while “still retain largely the efficacy by removing some of the safety liabilities,” based on preclinical data. In closing remarks, Oyler said the company delivered “a very strong first quarter,” raised its full-year outlook, and sees the pipeline entering “a really critical phase of execution,” with hematology strength and an emerging solid tumor inflection point as programs advance into late-stage development. BeOne Medicines Ltd. is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. The firm portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The company was founded by Xiao Dong Wang and John V. Oyler on October 28, 2010 and is headquartered in Basel, Switzerland. The article "BeOne Medicines Q1 Earnings Call Highlights" was originally published by MarketBeat.

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook