Q2 2026 BeOne Medicines AG Earnings Call

August 5, 2026

Speaker #1: At any background noise. After the speaker's remark, there will be a question-and-answer session. At this time, I would like to attend the call over to the company.

Speaker #2: Hello and welcome. Thank you for joining us today. I'm Dan Maller, Head of Investor Relations at B1 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.b1medicines.com.

Speaker #2: I would like to remain 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: All information in this presentation is as of the date of this presentation. We undertake no duty to update such information unless required by law.

Speaker #2: Now, turning to today's call, as outlined on slide 3, John Oyler, our co-founder/chairman and CEO, will provide a business update. Aaron Rosenberg, our CFO, will provide an update on our second quarter financial results and 2026 financial guidance.

Speaker #2: And Lai Wang, president and global head of R&D, will discuss our R&D and pipeline progress. We will then 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.

Speaker #2: Matt Shaulis, general manager of North America. Mark Lanasa, chief medical officer for Solid Tumors. And Amit Agarwal, chief medical officer for hematology. I'll now pass the call over to John.

Speaker #2: John?

Speaker #3: 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.

Speaker #3: This represents growth of 30% and 144% compared to the prior year, respectively. For Kinza, our foundational BTK inhibitor, continues to exceed our high expectations in the marketplace.

Speaker #3: More than 6.5 years after its initial launch, Brook Kinza is seeing its highest level of sustained new patient starts, showing favorable early trends in duration of therapy, and it's showing strong growth across all 5 approved indications.

Speaker #3: On the back of these strong results, we're raising our 2026 guidance ranges for revenue and GAAP operating income by $300 million and $250 million respectively.

Speaker #3: And Aaron will detail this later. As impressive as our financial performance was in the quarter, our pipeline progress was equally significant. This is highlighted by the FDA approval of Bacalzi, as the first and only BCL2 inhibitor in mantle cell lymphoma, and the success of the phase 3 mangrove study of Brook Kinza, which is so exciting that it warrants the entire next slide.

Speaker #3: 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 Brook Kinza as the foundational BTK inhibitor.

Speaker #3: We're 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.

Speaker #3: And secondly, because when you see the data, we believe the efficacy will speak for itself. We're confident that this Brook Kinza-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.

John V. Oyler: Operating income by $300 million and $250 million respectively. Aaron will detail this later. 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, and 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 US 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're 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 believe the efficacy will speak for itself.

John Oyler: Operating income by $300 million and $250 million respectively. Aaron will detail this later. 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, and 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 US 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're 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 believe the efficacy will speak for itself.

Speaker #1: Operating income by $300 million, and $250 million respectively. And Aaron will detail this later. As impressive as our financial performance was in the quarter, our pipeline progress was equally significant.

Speaker #1: This is highlighted by the FDA approval of Bacalzi, as the first and only BCL-2 inhibitor in mantle cell lymphoma, and the success of the Phase III MANGROVE study of Brukenza.

Speaker #3: Global submissions are planned for the second half of 2026, and we're looking forward to sharing the full data at an upcoming medical meeting. Let's now turn to Brook Kinza's commercial performance.

Speaker #1: 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.

Speaker #3: In Q2, Brook Kinza's global revenues reached over $1.2 billion, representing growth of 31% year over year. Brook Kinza's the number 1 BTK inhibitor both in the U.S.

Speaker #1: Mangrove is yet another example of the growing body of evidence supporting Bruchenza as the foundational BTK inhibitor. We're excited about mangrove for two key reasons.

Speaker #3: and globally, and it has the broadest label of any BTKI, with approvals in 5 B-cell malignancies. We often talk about Brook Kinza in the context of CLL and with good reason.

Speaker #1: The first is because it represents the first chemo-free treatment option for patients with frontline mantle cell. And secondly, because when you see the data, we believe the efficacy will speak for itself.

Speaker #3: But it is important to remember that Brook Kinza is a very important option for patients with other B-cell malignancies, including MCL, Waldenstrom's, marginal zone, and follicular lymphoma.

Speaker #1: We're confident that this Bruchenza-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.

John V. Oyler: We're 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 H2 2026. We're looking forward to sharing the full data at an upcoming medical meeting. Let us 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 US and globally, and it has the broadest label of any BTKI with approvals in 5 B-cell malignancies. We often talk about BRUKINSA in the context of CLL, with good reason.

John Oyler: We're 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 H2 2026. We're looking forward to sharing the full data at an upcoming medical meeting. Let us 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 US and globally, and it has the broadest label of any BTKI with approvals in 5 B-cell malignancies. We often talk about BRUKINSA in the context of CLL, with good reason.

Speaker #3: Brook Kinza is now treated more than 300,000 patients across 80-plus markets. But market share alone doesn't tell the full story. The reason we're winning is scientific.

Speaker #1: Global submissions are planned for the second half of 2026, and we're looking forward to sharing the full data at an upcoming meeting. Let us move on to commercial performance.

Speaker #3: And that story has 3 chapters. Differentiated design, differentiated clinical outcomes, and differentiated real-world evidence. At B1, we're committed to generating and sharing the evidence needed to fully characterize our medicines for the patients and physicians that we serve.

Speaker #1: 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.

Speaker #3: On the left side of this slide, you can see the highlights of the breadth of phase 3 data generated for Brook Kinza as a single agent.

Speaker #1: ...and globally, and 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.

Speaker #3: Here you can see Brook Kinza has reported the most phase 3 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 Brook Kinza has the most reported and ongoing phase 3 data of any BTKI agent.

Speaker #1: But it is important to remember that Brukinsa is a very important option for patients with other B-cell malignancies, including MCL, Waldenström’s, and marginal zone, and is now treating more than 300,000 patients across 80-plus markets.

John V. Oyler: 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 has now treated more than 300,000 patients across 80+ markets. Market share alone doesn't tell the whole story. The reason we're winning is scientific, and that story has three chapters: differentiated design, differentiated clinical outcomes, and differentiated real-world evidence. At BeOne, we're 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.

John Oyler: 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 has now treated more than 300,000 patients across 80+ markets. Market share alone doesn't tell the whole story. The reason we're winning is scientific, and that story has three chapters: differentiated design, differentiated clinical outcomes, and differentiated real-world evidence. At BeOne, we're 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.

Speaker #3: This slide demonstrates the scale of Brook Kinza's development plan compared to the more curated efforts of our peers. In addition to potentially market-expanding phase 3 readouts, in the next 3 years.

Speaker #1: But market share alone doesn't tell the full story. The reason we're winning is scientific. And that story has three chapters: differentiated design, differentiated clinical outcomes, and differentiated real-world evidence.

Speaker #3: A major wave of data is coming, that will extend Brook Kinza's evidence base and its label well into the future. One quick reminder of why Brook Kinza performs the way it does.

Speaker #1: At B1, we're 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 Bruchenza, as a single agent.

Speaker #3: From day 1, Brook Kinza 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.

Speaker #1: Here you can see Bruchenza 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 Bruchenza has the most reported and ongoing Phase III data of any BTKI agent.

Speaker #3: And over a decade of clinical and real-world evidence has really borne that out. And that's what the next few slides show. Levery reminds you now that Brook Kinza is the only BTK inhibitor that has demonstrated PFS superiority versus ibrutinib in a head-to-head randomized trial.

John V. Oyler: 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. 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 3 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.

John Oyler: 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. 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 3 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.

Speaker #1: This slide demonstrates the scale of Bruchenza's development plan compared to the more curated efforts of our peers. In addition to mangrove, Bruchenza has 4 more potentially market-expanding Phase III readouts, in the next 3 years.

Speaker #3: In alpine, Brook Kinza delivered a hazard ratio of 0.69. And that separation has been sustained to a median follow-up of 42.5 months. In elevator RR, Acala showed early separation from ibrutinib, but that separation was not sustained.

Speaker #1: A major wave of data is coming, that will extend Bruchenza's evidence base and its label well into the future. One quick reminder of why Bruchenza performs the way it does.

Speaker #3: The curves crossed. And the final hazard ratio was 1. And in Bruin 314, PERTO reported a hazard ratio of 0.845. Put simply, there was very little differentiation between the 2 arms, with 48 PFS events reported for PERTO versus 50 for ibrutinib.

Speaker #1: From day 1, Bruchenza 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.

John V. Oyler: Continuous BTK coverage would translate into a superior therapeutic profile. Over a decade of clinical and real-world evidence has really borne that out, and that is what the next few slides show. 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, and that separation has been sustained to a median follow-up of 42.5 months. In ELEVATE-RR, acala showed early separation from ibrutinib, but that separation was not sustained. The curves crossed, and the final hazard ratio was one. In BRUIN CLL-314, perto reported a hazard ratio of 0.845. Put simply, there was very little differentiation between the two arms, with 48 PFS events reported for perto versus 50 for ibrutinib.

John Oyler: Continuous BTK coverage would translate into a superior therapeutic profile. Over a decade of clinical and real-world evidence has really borne that out, and that is what the next few slides show. 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, and that separation has been sustained to a median follow-up of 42.5 months. In ELEVATE-RR, acala showed early separation from ibrutinib, but that separation was not sustained. The curves crossed, and the final hazard ratio was one. In BRUIN CLL-314, perto reported a hazard ratio of 0.845. Put simply, there was very little differentiation between the two arms, with 48 PFS events reported for perto versus 50 for ibrutinib.

Speaker #3: And with respect to tolerability, PERTO showed numerically more discontinuations due to AEs than ibrutinib. Whereas both Brook Kinza and Acala each showed markedly fewer discontinuations than ibrutinib in their respective head-to-head trials.

Speaker #1: At over a decade of clinical and real-world evidence has really borne that out. And that's what the next few slides show. Levery reminds you now that Bruchenza is the only BTK inhibitor that has demonstrated PFS superiority versus ibrutinib in a head-to-head randomized trial.

Speaker #3: 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.

Speaker #1: In alpine, Bruchenza delivered a hazard ratio of 0.69. And that separation has been sustained to a median follow-up of 42.5 Acala showed early separation from ibrutinib, but that separation was not sustained.

Speaker #3: As you can see on the left, both Brook Kinza and Acala studies in frontline CLL used highly similar eligibility criteria and afib reporting. In contrast, the PERTO studies utilized more restrictive eligibility criteria that may have resolved it in a fitter study population and they also incorporated sponsor adjudication of afib events.

Speaker #1: The curves crossed, and the final hazard ratio was 1. In BRUIN 314, PERTO reported a hazard ratio of 0.845. Put simply, there was very little differentiation between the two arms, with 48 PFS events reported for PERTO versus 50 for ibrutinib.

Speaker #3: 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.

Speaker #1: And with respect to tolerability, PERTO showed numerically more discontinuations due to AEs than ibrutinib, whereas both Bruchenza and Acala each showed markedly fewer discontinuations than ibrutinib in their respective head-to-head trials.

John V. Oyler: With respect to tolerability, perto 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. When comparing AFib rates of next-generation BTK inhibitors across studies, it is 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 perto studies utilized more restrictive eligibility criteria that may have resulted in a fitter study population, and they also incorporated sponsor adjudication of AFib events. As a reminder, AFib events and rates are known to rise substantially with age.

John Oyler: With respect to tolerability, perto 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. When comparing AFib rates of next-generation BTK inhibitors across studies, it is 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 perto studies utilized more restrictive eligibility criteria that may have resulted in a fitter study population, and they also incorporated sponsor adjudication of AFib events. As a reminder, AFib events and rates are known to rise substantially with age.

Speaker #3: primary care clinics, the absolute prevalence of afib was nearly 4% higher among those aged 70 to 74 as compared to 65 to 69. So factoring for this level of age difference in studies, really matters.

Speaker #1: 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.

Speaker #3: Despite the differences in inclusion criteria, which may have led to roughly half the percentage of patients above the age of 75 in Bruin 313, and a 4-year lower median age in the PERTO studies, and despite the differences in afib reporting methods, afib rates were generally similar in the active treatment arms across studies.

Speaker #1: As you can see on the left, both the Bruchenza and Acala studies in frontline CLL used highly similar eligibility criteria and AFib reporting. In contrast, the PERTO studies utilized more restrictive eligibility criteria that may have resulted in a fitter study population, and they also incorporated sponsor adjudication of AFib events.

Speaker #3: Interestingly, if we applied the more restrictive Bruin 313 and 314 eligibility criteria to the Sequoia population, 15 of the highest-risk patients would have been excluded from the Brook Kinza arm.

Speaker #1: 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.

Speaker #3: And 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.

John V. Oyler: In a large study of more than 17,000 adults in US primary care clinics, the absolute prevalence of AFib was nearly 4% higher among those aged 70 to 74 as compared to 65 to 69. Factoring for this level of age difference in studies really matters. Despite the differences in inclusion criteria, which may have led to roughly half the percentage of patients above the age of 75 in BRUIN CLL-313 and a four-year lower median age in the perto studies, and despite the differences in AFib reporting methods, AFib rates were generally similar in the active treatment arms across studies. Interestingly, if we applied the more restrictive BRUIN CLL-313 and BRUIN CLL-314 eligibility criteria to the SEQUOIA population, 15 of the highest-risk patients would have been excluded from the BRUKINSA arm.

John Oyler: In a large study of more than 17,000 adults in US primary care clinics, the absolute prevalence of AFib was nearly 4% higher among those aged 70 to 74 as compared to 65 to 69. Factoring for this level of age difference in studies really matters. Despite the differences in inclusion criteria, which may have led to roughly half the percentage of patients above the age of 75 in BRUIN CLL-313 and a four-year lower median age in the perto studies, and despite the differences in AFib reporting methods, AFib rates were generally similar in the active treatment arms across studies. Interestingly, if we applied the more restrictive BRUIN CLL-313 and BRUIN CLL-314 eligibility criteria to the SEQUOIA population, 15 of the highest-risk patients would have been excluded from the BRUKINSA arm.

Speaker #1: In primary care clinics, the absolute prevalence of AFib was nearly 4% higher among those aged 70 to 74 as compared to those aged 65 to 69. So factoring for this level of age difference in studies really matters.

Speaker #3: This analysis underscores the extent to which differences in protocol inclusion criteria may play a key role in the clinical narrative. Although some have suggested that PERTO 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.

Speaker #1: Despite the differences in inclusion criteria—which may have led to roughly half the percentage of patients above the age of 75 in Bruen 313, and a 4-year lower median age in the PERTO studies—and despite the differences in AFib reporting methods, AFib rates were generally similar in the active treatment arms across studies.

Speaker #3: 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.

Speaker #3: The totality of evidence continues to support Brook Kinza's best-in-class profile. One of the key lessons we've recently learned in CLL trials is that long-term follow-up matters.

Speaker #1: Interestingly, if we applied the more restrictive Bruen 313 and 314 eligibility criteria to the Sequoia population, 15 of the highest-risk patients would have been excluded from the Bruchenza arm.

Speaker #3: Many regimens can appear highly effective in the first 3 years. But that's not enough time to understand their true durability. This slide shows the reported landmark PFS at years 3 through 6 across the respective frontline CLL phase 3 trials, for the frontline treatment regimens.

Speaker #1: And 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.

John V. Oyler: 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. Although some have suggested that perto may be well-suited for use in older patients due to lower AFib risks 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 have recently learned in CLL trials is that long-term follow-up matters.

John Oyler: 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. Although some have suggested that perto may be well-suited for use in older patients due to lower AFib risks 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 have recently learned in CLL trials is that long-term follow-up matters.

Speaker #1: This analysis underscores that the protocol inclusion criteria may play a key role in the clinical narrative. Although some have suggested that PERTO 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.

Speaker #3: Recognizing the limitations of cross-trial comparisons, a few items jump out. One, the landmark PFS rates for Brook Kinza are higher and continue to diverge over time compared to the other 2 continuous BTKIs.

Speaker #3: In fact, in year 6, the delta between the landmark PFS rates reaches 12%, which is equivalent of 1 in 8 patients not progressing. Two, there's an even more pronounced delta between Brook Kinza's landmark PFS and that of VO.

Speaker #1: It lacks relevant long-term data, with only 28 months of follow-up, and the narrative about being more tolerable and having less Afib is not supported by the data.

Speaker #1: The totality of evidence continues to support Brukenza’s best-in-class profile. One of the key lessons we’ve recently learned in CLL trials is that long-term follow-up matters.

Speaker #3: In year 6, there's a delta of 21%, or roughly 1 in 5 patients. While the all-comer story is compelling, the high-risk story is even more striking.

Speaker #1: Many regimens can appear highly effective in the first 3 years. But that's not enough time to understand their true durability. This slide shows the reported landmark PFS at years 3 through 6 across the respective frontline CLL phase 3 trials, for the frontline treatment regimens.

John V. Oyler: 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. Recognizing the limitations of cross-trial comparisons, a few items jump out. 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. There's an even more pronounced delta between BRUKINSA's landmark PFS and that of VO. 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.

John Oyler: 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. Recognizing the limitations of cross-trial comparisons, a few items jump out. 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. There's an even more pronounced delta between BRUKINSA's landmark PFS and that of VO. 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.

Speaker #3: 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.

Speaker #3: This is not a small patient subgroup. This slide shows how the current fixed-duration treatments perform relative to the foundational Brook Kinza in unmutated IgHV patients.

Speaker #1: Recognizing the limitations of cross-trial comparisons, a few items jump out. One, the landmark PFS rates for Bruchenza are higher and continue to diverge over time compared to the other two continuous BTKIs.

Speaker #3: Those with the highest unmet medical need. Brook Kinza remains durable, 84% landmark PFS at year 3 and 70% at year 6. In contrast, VO drops from 82% at year 3 to just 42% at year 6.

Speaker #1: In fact, in year 6, the delta between the landmark PFS rates reaches 12%, which is equivalent to 1 in 8 patients not progressing. Second, there's an even more pronounced delta between Bruchenza's landmark PFS and that of VO.

Speaker #3: A 40-point collapse. And AV amplify based on the limited data disclosed to date shows just 69% at year 3. Which is, of course, lower than VO at a similar time point.

Speaker #1: In year 6, there's a delta of 21%, or roughly 1 in 5 patients. While the all-comer story is compelling, the high-risk story is even more striking.

Speaker #3: There's a few important takeaways from this slide. First, while we're big believers in the promise of fixed duration, the existing ven-based treatments are not compelling options for higher-risk patients where foundational Brook Kinza has generated the best-in-class data.

Speaker #1: 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 V. Oyler: 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. 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, VO drops from 82% at year three to just 42% at year six, a 40-point collapse. AV amplified, based on the limited data disclosed to date, shows just 69% at year three, which is, of course, lower than VO at a similar time point. There's a few important takeaways from this slide.

John Oyler: 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. 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, VO drops from 82% at year three to just 42% at year six, a 40-point collapse. AV amplified, based on the limited data disclosed to date, shows just 69% at year three, which is, of course, lower than VO at a similar time point. There's a few important takeaways from this slide.

Speaker #1: 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.

Speaker #3: Second, long-term follow-up is critical in CLL. As you can see on this slide, many regimens look promising at 3 years, but by 6 years the outcomes can diverge meaningfully.

Speaker #1: Those with the highest unmet medical need. Bruchenza remains durable, 84% landmark PFS at year 3 and 70% at year 6. In contrast, VO drops from 82% at year 3 to just 42% at year 6.

Speaker #3: Especially in high-risk patients. And that's why we've consistently prioritized long-term follow-up in our studies. And why we believe 6-year data provide a more complete picture of treatment durability.

Speaker #3: It's also why we're concerned when conclusions reached on regimens based on only 3 years of data or less are made. We've been very surprised at some studies have not continued to report longer-term follow-up data, because years 3 to 6 are critical to evaluate the true long-term benefit of any CLL therapy.

Speaker #1: A 40-point collapse. And AV amplified based on the limited data disclosed to date shows just 69% at year 3. Which is, of course, lower than VO at a similar time point.

Speaker #1: There's a few important takeaways from this slide. First, while we're big believers in the promise of fixed-duration, the existing ven-based treatments are not compelling options for higher-risk patients where foundational Bruchenza has generated the best-in-class data.

Speaker #3: Patient outcomes are at stake. The durability advantage that we're seeing in the clinical data for foundational Brook Kinza is increasingly being reinforced in the real world.

John V. Oyler: While we're big believers in the promise of fixed duration, the existing venetoclax-based treatments are not compelling option for higher risk patients where foundational BRUKINSA has generated the best-in-class data. Long-term follow-up is critical in CLL. As you can see on this slide, many regimens look promising at three years. 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 why we believe six-year data provide a more complete picture of treatment variability. 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: While we're big believers in the promise of fixed duration, the existing venetoclax-based treatments are not compelling option for higher risk patients where foundational BRUKINSA has generated the best-in-class data. Long-term follow-up is critical in CLL. As you can see on this slide, many regimens look promising at three years. 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 why we believe six-year data provide a more complete picture of treatment variability. 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.

Speaker #3: And it's both consistent and it's compelling. At ASCO 2026, we published an analysis of over 10,000 500 Medicare Free Service patients with previously untreated CLL.

Speaker #1: 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.

Speaker #3: This is the largest real-world dataset ever assembled in this setting. In this patient population, Brook Kinza reported statistically significant 24% and 36% reduction in the risk of death compared to those treated with Acala and Ibrutinib, respectively.

Speaker #1: Especially in high-risk patients. And that's why we've consistently prioritized long-term follow-up in our studies, and why we believe 6-year data provide a more complete picture of treatment durability.

Speaker #1: It's also why we're concerned when conclusions reached on regimens based on only 3 years of data or less are made. We've been very surprised at some studies have not continued to report longer-term follow-up data because years 3 to 6 are critical to evaluate the true long-term benefit of any CLL therapy.

Speaker #3: 24% and 36%. As you can imagine, this dataset generated significant interest from physicians at ASCO, given its both its size and the importance of these findings to the real-world U.S.

Speaker #3: Medicare population. The study has since been published in a peer-reviewed journal. And importantly, this is now one of several large real-world analyses showing a consistent advantage for Brook Kinza.

Speaker #1: Patient outcomes are at stake. The durability advantage that we're seeing in the clinical data for foundational Bruchenza is increasingly being reinforced in the real world.

John V. 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 fee-for-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 US Medicare population. The study has since been published in a peer-reviewed journal.

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 fee-for-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 US Medicare population. The study has since been published in a peer-reviewed journal.

Speaker #3: Including a recent study of claims data from 17,000 frontline CLL patients which also reported improved survival and treatment durability for Brook Kinza versus Acala.

Speaker #1: And it's both consistent and it's compelling. At ASCO 2026, we published an analysis of over 10,000 500 Medicare Free Service patients with previously untreated CLL.

Speaker #3: Stepping back, B1 is the only company in the world with foundational medicines across the 3 mechanisms of action for B-cell malignancies. Brook Kinza are foundational BTK inhibitor, but CALZI are recently approved next-generation potentially best-in-class BCL2 inhibitor.

Speaker #1: This is the largest real-world dataset ever assembled in this setting. In this patient population, Bruchenza reported a statistically significant 24% and 36% reduction in the risk of death compared to those treated with Acala and Ibrutinib, respectively.

Speaker #3: And Takabrutinib are potentially first and best-in-class BTK degrader. Only B1 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.

Speaker #1: 24% and 36%. As you can imagine, this dataset generated significant interest from physicians at ASCO, given its both its size and the importance of these findings to the real-world U.S.

Speaker #1: Medicare population. The study's since been published in a peer-reviewed journal. And, importantly, this is now one of several large real-world analyses showing a consistent advantage for Bruchenza, including a recent study of claims data from 17,000 frontline CLL patients, which also reported improved survival and treatment durability for Bruchenza versus Acala.

Speaker #3: 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 B7H4ADC, and our GPC341BB bispecific antibody into registrational trials.

John V. 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 tacobrutinib, our potentially first and best-in-class BTK degrader. 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.

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 tacobrutinib, our potentially first and best-in-class BTK degrader. 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.

Speaker #3: Looking forward to ASMO, we'll be sharing similar proof of concept datasets for 2 more potentially best-in-class medicines. Our PRMT5 inhibitor and our CEA ADC.

Speaker #1: Stepping back, B1 is the only company in the world with foundational medicines across the free mechanisms of action for B-cell malignancies. Bruchenza are foundational BTK inhibitor, because our recently approved next-generation potentially best-in-class BCL2 inhibitor and Takabrutadeg are potentially first and best-in-class BTK degrader.

Speaker #3: It's an incredibly exciting time for our company, for our portfolio, and for our pipeline. And with that, I'll hand it over to Aaron for the financial results.

Speaker #1: 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.

Speaker #1: Only B1 is equipped to provide best-in-class therapies as monotherapy or in combination for every CLL patient and other lymphomas, regardless of their disease stage, risk status, or treatment preference.

Speaker #1: Starting with our 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.

Speaker #1: 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 B7H4ADC, and our GPC341BB bispecific antibody into registrational trials.

John V. Oyler: 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 B7H4 ADC, and our GPC3 4-1BB bispecific antibody into registrational trials. Looking forward to ESMO, we'll 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.

John Oyler: 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 B7H4 ADC, and our GPC3 4-1BB bispecific antibody into registrational trials. Looking forward to ESMO, we'll 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.

Speaker #1: U.S. Brook Kinza 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 Brook Kinza's launch.

Speaker #1: Looking forward to ASMO, we'll be sharing similar proof-of-concept datasets for two more potentially best-in-class medicines: our PRMT5 inhibitor and our CEA ADC.

Speaker #1: Prescribers increasingly selected Brook Kinza for their patients given the totality of evidence for efficacy and durability, supported by the clinical data and their real-world experience.

Speaker #1: 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.

Speaker #1: We also continue to see meaningful growth from indications beyond CLL, which speaks to the breadth of the Brook Kinza label and the diversification of the franchise.

Speaker #1: And while duration of therapy remains immature for Brook Kinza, 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 Brook Kinza in time to discontinuation relative to both Acala/Ibrutinib and Ibrutinib.

Speaker #2: Thanks, John. Our second quarter financial results reflect strong execution and a durable, healthy underlying business as we invest with discipline to support growth over the long term.

Aaron Rosenberg: Thanks, John. Our Q2 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. US 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. 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.

Speaker #2: 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.

Speaker #1: And 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.

Speaker #2: U.S. Bruchenza 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 Bruchenza's launch.

Speaker #1: 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 Brook Kinza.

Speaker #2: Prescribers increasingly selected Bruchenza for their patients given the totality of evidence for efficacy and durability supported by the clinical data and their real-world experience.

Speaker #1: Beyond Brook Kinza, to Vimbera generated $229 million in global sales, representing 18% growth versus the prior period. To Vimbera maintained its market leadership in China in the face of steep competition, our global launches are also gaining traction, and this is ahead of the potential catalysts associated with the approval of To Vimbera in combination with Zyhera and chemotherapy for patients with first-line HER2 positive GEA.

Speaker #2: 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.

Speaker #2: And while duration of therapy remains immature for Bruchenza, 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 Bruchenza in time to discontinuation relative to both Acala/Brutinib and Ibrutinib.

Aaron Rosenberg: 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. High adherence rates are important for patient outcomes, and we are pleased to see this progress. These factors are not unique to the US, 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 maintains its market leadership in China in the face of steep competition.

Speaker #1: Our Amgen in-licensed portfolio also delivered 157 million in revenue, growing 25% year over year.

Speaker #2: Next, 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.

Speaker #2: And finally, patient adherence has also improved, potentially linked to the launch this year, which reduced both pill size and burden. High adherence rates are important for patient outcomes, and we are pleased to see this progress.

Speaker #2: China contributed approximately $500 million in revenue and grew 17% year over year, demonstrating continued strength across our commercial portfolio while maintaining market leadership for both To Vimbera and Brook Kinza.

Speaker #2: These factors are not unique to the U.S., and we expect they will support durable, long-term global demand growth for Bruchenza. Beyond Bruchenza, to Vimbera generated $229 million in global sales, representing 18% growth versus the prior period.

Speaker #2: 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 $208 million in revenue and growing 37% year over year.

Speaker #2: Tovimbera maintained its market leadership in China in the face of steep competition. Our global launches are also gaining traction, and this is ahead of the potential catalysts associated with the approval of Tovimbera in combination with Zyhera and chemotherapy for patients with first-line HER2-positive GEA.

Aaron Rosenberg: This is ahead of the potential catalysts associated with the approval of TEVIMBRA in combination with Ziihera and chemotherapy for patients with first-line HER2 positive GEA. Our Amgen in-license portfolio also delivered $157 million in revenue, growing 25% year-over-year. Next, I'd like to highlight the broad-based nature of growth across geographies. The US remained our largest market, contributing approximately $899 million in revenue during the quarter and growing 31% year-over-year. China contributed approximately $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 an important growth driver for the company, generating approximately $208 million in revenue and growing 37% year-over-year.

Speaker #2: We also continue to see strong momentum across our rest of world markets, where revenue more than doubled to approximately $73 million. Key markets, such as Japan and Brazil, are making contributions that are increasingly meaningful at the enterprise level.

Speaker #2: Our Amgen in-license portfolio also delivered $157 million in revenue, growing 25% year over year.

Speaker #2: Turning to the gap P&L, gross profit was $1.5 billion with gross margin of just under 90%, benefiting from mix as well as productivity improvements for both Brook Kinza and To Vimbera.

Speaker #1: Next, 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.

Speaker #2: Operating expenses totaled $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 $325 million.

Speaker #1: China contributed approximately $500 million in revenue and grew 17% year over year, demonstrating continued strength across our commercial portfolio while maintaining market leadership for both to Vimbera and Bruchenza.

Speaker #2: And finally, net income totaled $237 million. This includes the previously disclosed tax audit settlement, which had an approximate $60 million impact.

Speaker #1: 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 $208 million in revenue and growing 37% year over year.

Speaker #1: Gap diluted earnings per ADS were $2.05, compared with $84 in the prior period.

Speaker #1: We also continue to see strong momentum across our Rest of World markets, where revenue more than doubled to approximately $73 million. Key markets such as Japan and Brazil are making contributions that are increasingly meaningful at the enterprise level.

Aaron Rosenberg: We also continue to see strong momentum across our rest of world markets, where revenue more than doubled to approximately $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 $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 $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 $325 million. Finally, net income totaled $237 million. This includes the previously disclosed tax audit settlement, which had an approximate $60 million impact. GAAP diluted earnings per ADS were $2.05, compared with $0.84 in the prior period.

Speaker #2: Now turning to our adjusted results, with a full reconciliation provided in the appendix of our results presentation. Adjusted income from operations increased to $503 million, representing growth of more than 80% year over year.

Speaker #1: Turning to the gap P&L, gross profit was $1.5 billion with gross margin of just under 90%, benefiting from mix as well as productivity improvements for both Bruchenza and to Vimbera.

Speaker #2: Adjusted net income increased to $444 million, while adjusted diluted earnings per ADS increased to $3.84, compared with $2.25 a year ago. Cash generations continues to build momentum, with free cash flow doubling from the prior year period to $435 million.

Speaker #1: Operating expenses totaled $1.2 billion, representing 13% growth. This reflects the advancement of key clinical programs and continued investment to support commercial growth. We continue to demonstrate the scalability of our model this quarter, with income from operations growing to $325 million.

Speaker #2: Turning to our updated full year outlook, which reflects the strong first half performance and confidence in the trajectory of our business. We are raising our revenue outlook by $300 million to a range of $6.6 to $6.8 billion, this increase reflects the continued strength we are seeing across the portfolio led by Brook Kinza's performance in the U.S., ongoing global expansion, and continued contributions from the broader commercial portfolio.

Speaker #1: And finally, net income totaled $237 million. This includes the previously disclosed tax audit settlement, which had an approximate $60 million impact. Gap diluted earnings for ADS were $2.05, compared with $84 in the prior period.

Speaker #1: Now, turning to our adjusted results, with a full reconciliation provided in the appendix of our results presentation. Adjusted income from operations increased to $503 million, representing growth of more than 80% year over year.

Speaker #2: We continue to expect gross margin to remain in the high 80% range, where investing in both commercial execution and pipeline advancement with a modest increase in operating expenses to an updated range of $4.8 to $5 billion.

Aaron Rosenberg: Now turning to our adjusted results with a full reconciliation provided in the appendix of our results presentation. Adjusted income from operations increased to $503 million, representing growth of more than 80% year-over-year. Adjusted net income increased to $444 million, while adjusted diluted earnings per ADS increased to $3.84, compared with $2.25 a year ago. Cash generations continues to build momentum, with free cash flow doubling from the prior year period to $435 million. Turning to our updated full-year outlook, which reflects the strong first half performance and confidence in the trajectory of our business. We are raising our revenue outlook by $300 million to a range of $6.6 to 6.8 billion. This increase reflects the continued strength we are seeing across the portfolio, led by BRUKINSA's performance in the US, ongoing global expansion, and continued contributions from the broader commercial portfolio.

Aaron Rosenberg: Now turning to our adjusted results with a full reconciliation provided in the appendix of our results presentation. Adjusted income from operations increased to $503 million, representing growth of more than 80% year-over-year. Adjusted net income increased to $444 million, while adjusted diluted earnings per ADS increased to $3.84, compared with $2.25 a year ago. Cash generations continues to build momentum, with free cash flow doubling from the prior year period to $435 million. Turning to our updated full-year outlook, which reflects the strong H1 performance and confidence in the trajectory of our business. We are raising our revenue outlook by $300 million to a range of $6.6 to 6.8 billion. This increase reflects the continued strength we are seeing across the portfolio, led by BRUKINSA's performance in the US, ongoing global expansion, and continued contributions from the broader commercial portfolio.

Speaker #1: Adjusted net income increased to $444 million, while adjusted diluted earnings per ADS increased to $3.84, compared with $2.25 a year ago. Cash generations continues to build momentum, with free cash flow doubling from the prior year period to $435 million.

Speaker #2: Including those investments, the strength of the business translates to the bottom line, with a guidance phrase in 2026 operating income by $250 million across the range.

Speaker #2: We now expect gap operating income of $1 billion to $1.1 billion, and non-gap operating income of $1.7 to $1.8 building. Other underlying assumptions remain unchanged.

Speaker #1: Turning to our updated full-year outlook, which reflects the strong first half performance and confidence in the trajectory of our business, we are raising our revenue outlook by $300 million to a range of $6.6 to $6.8 billion, this increase reflects the continued strength we are seeing across the portfolio led by Bruchenza's performance in the U.S., ongoing global expansion, and continued contributions from the broader commercial portfolio.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Our 2026 outlook provides confidence in the durability of our commercial business, including the prospects for continued Brook Kinza growth despite the competitive environment. And as you see in our implied operating expense guidance for the second half of the year, we are investing to realize the full potential of our pipeline that we believe will drive sustainable, long-term value for shareholders and the potential to address multiple unmet need for patients.

Speaker #1: We continue to expect gross margin to remain in the high 80% range, we are investing in both commercial execution and pipeline advancement with a modest increase in operating expenses to an updated range of $4.8 to $5 billion.

Aaron Rosenberg: 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 $4.8 to 5 billion. Including those investments, the strength of the business translates to the bottom line, with a guidance raise in 2026 operating income by $250 million across the range. We now expect GAAP operating income of $1 billion to 1.1 billion and non-GAAP operating income of $1.7 to 1.8 billion. 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.

Speaker #1: Including those investments, the strength of the business translates to the bottom line, with a guidance raise in 2026 operating income by $250 million across the range.

Speaker #2: 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.

Speaker #1: We now expect GAAP operating income of $1.0 billion to $1.1 billion and non-GAAP operating income of $1.7 billion to $1.8 billion. Other underlying assumptions remain unchanged.

Speaker #1: 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.

Speaker #1: We look forward to providing our next financial update in November with Q3 results. And with that, I'll now pass the presentation over to Lai.

Speaker #1: 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.

Aaron Rosenberg: As we have now rounded the H1 of the year, 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 implied operating expense guidance for the H2 of the year, we are investing to realize the full potential of our pipeline that we believe will drive sustainable long-term value for shareholders and the potential to address multiple unmet need for patients. We remain committed to our dual objectives of growth with measured margin expansion in the near term.

Speaker #3: 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 readouts from the Mangrove study in treatment naive mental cell lymphoma.

Speaker #1: Our 2026 outlook provides confidence in the durability of our commercial business, including the prospects for continued Bruchenza growth despite the competitive environment. And as you see in our implied operating expense guidance for the second half of the year, we are investing to realize the full potential of our pipeline that we believe will drive sustainable, long-term value for shareholders and the potential to address multiple unmet needs for patients.

Speaker #3: Brook Kinza plus Rituximab has the potential to redefine frontline treatment and become the first chemo-free regimen for this patients. For Becozi, we achieved our first FDA approval in the last refactoring mental cell lymphoma.

Speaker #3: Moving on to the Celestial 301 study update, the Zanu, Sonro regimen did not reach statistical superiority in the UMRD analysis versus the VO regimen.

Speaker #1: 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.

Aaron Rosenberg: 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.

Speaker #3: The IDMC recommended 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.

Speaker #2: We look forward to providing our next financial update in November with Q3 results. And with that, I'll now pass the presentation over to Lai Wang.

Speaker #3: Thank you, Aaron. Hello everyone, and thank you for joining us today. Across our portfolio, we'll continue to deliver meaningful progress. Starting with hematology, John already highlighted the positive readouts from the MANGROVE study in treatment-naive mantle cell lymphoma.

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 readouts 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 CELESTIAL-301 study update. The zanubrutinib-sonrotoclax 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.

Speaker #3: Importantly, UMRD rates do not consistently predict PFS outcomes when comparing different MOAs. Such as BTK inhibitor versus anti-CD20 antibody. For example, in 017, despite 26% lower UMRD rates than VO, the ibutimab-fenetoclax regimen demonstrated comparable PFS outcomes as VO.

Speaker #3: Bruchenza plus Rituximab has the potential to redefine frontline treatment and become the first chemo-free regimen for this patients. Public housing, we achieved our first FDA approval in the last refractory mental cell lymphoma.

Speaker #3: As a result, if a BTK inhibitor plus BCR2 inhibitor combination achieves similar UMRD rates as VO, it should translate into better PFS than VO.

Speaker #3: Moving on to the Celestial 301 study update, the Zanu, Sonro regimen did not reach statistical superiority in the UMRD analysis versus the VO regimen.

Speaker #3: 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.

Speaker #3: The IDMC recommended 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.

Speaker #3: Next, our BTK degrader Tecabutidac. Continues to advance through potentially restrictional phase 2 studies, while our phase 3 Cadence 304 study against the PERDL remains on track.

Speaker #3: Together, this program support our ambition to lead the next generation of therapy in B-cell malignancies. In solid tumors, Devember reached another important milestone with FDA acceptance and the quality review of our HER2 positive GA application, we also made regulatory progress in China with the Ziyi accepting submissions for both Devember and the Sahara.

Speaker #3: Importantly, UMRD rates do not consistently predict PFS outcomes when comparing different MOAs. Such as BTK inhibitor versus anti-CD20 antibody. For example, in 017, despite 26% lower UMRD rates than VO, the ibutinib-fenetoclax regimen demonstrated comparable PFS outcomes as VO.

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 zanubrutinib-sonrotoclax regimen in Study 101, we remain highly confident in achieving the PFS endpoint. Next, our BTK degrader, BGB-16673, continues to advance through potentially registrational phase II studies, while our phase III CaDAnCe-304 study against ibrutinib remains on track. Together, this program support our ambition to lead the next generation of therapy in B-cell malignancies.

Speaker #3: Beyond Devember, we'll continue to advance a diversified and increasingly innovative pipeline. Our CDK4 inhibitor has begun phase 3 development in breast cancer, our GPC3 form BB bispecific recently completed enrollment in a potentially China restriction enabling HCC cohort.

Speaker #3: As a result, if a BTK inhibitor plus BCL2 inhibitor combination achieves similar UMRD rates as VO, it should translate into better PFS than VO.

Speaker #3: Given the high UMRD rates and the exceptional durability observed with the Zanu/Sonro regimen in Study 101, we remain highly confident in achieving the PFS endpoint.

Speaker #3: We also remain on track to initiate a phase 3 study in second line HCC before year end. In addition, our PMT5 inhibitor received FDA orphan drug designation for pancreatic cancer, and we initiated clinical development of our PD1, VGF, CTA4 trispecific.

Speaker #3: Next, our BTK degrader takobutidec. Continues to advance through potentially restrictional phase two studies. While our phase three cadence 304 study against the PROTO remains on track.

Speaker #3: The milestones from the last quarter are a reflection of more than strong execution. They demonstrate the power of focused on these strategies. We concentrate our investments in disease areas where we can establish leadership, building disease franchises, rather than standalone products.

Speaker #3: Together, this program support our ambition to lead the next generation of therapy in B-cell malignancies. In solid tumors, November reached another important milestone with FDA acceptance and the quality review of our HER2 positive GA application.

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 bi-specific 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 tri-specific. The milestones from the last quarter are a reflection of more than strong execution. They demonstrate the power of focused R&D strategy.

Speaker #3: We also made regulatory progress in China with the CD accepting submissions for both November and the Sahara. Beyond November, we'll continue to advance a diversified and increasingly innovative pipeline.

Speaker #3: Supporting that strategy is a growing technology toolkit from degraders, and the novel payload ADCs, to cell therapies and the T-cell engagers. Because we're not tied to any single modality, we can pair the right biology with the right therapeutic approach.

Speaker #3: Our CDK4 inhibitor has become phase three developments in breast cancer. Our GPC3 form BB bispecific recently completed enrollment in a potentially China restriction enabling HCC cohort.

Speaker #3: The result is a pipeline designed not just to be broad, but to be sustainable. As our innovation engine matures, we're creating depth within quality disease area.

Speaker #3: We also remain on track to initiate a phase three study in second line HCC before year end. In addition, our PMT5 inhibitor received FDA orphan drug designation for pancreatic cancer, and we initiated clinical development of our PD1, VGF, CTA4 trispecific.

Speaker #3: 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.

Speaker #3: 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 the immuno-oncology.

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 the novel payload ADCs to cell therapies and the 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.

Speaker #3: 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.

Speaker #3: Supporting that strategy is a growing technology toolkit, from degraders and the 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.

Speaker #3: Today, that evolution is clearly visible. We now have five solid tumor programs that have achieved clinical proof concept and are advancing toward a pivotal development.

Speaker #3: The result is a pipeline designed not just to be broad, but to be sustainable. As our innovation engine matures, we're creating depth within quality disease area, with multiple assets and mechanisms working together.

Speaker #3: 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 enrolled in phase 3.

Speaker #3: The B74 ADC is expected to enter a pivotal study in ovarian cancer by year end. For GPC3 form BB, we're complete enrollment of the China restriction 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.

Speaker #3: 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 opportunities across the portfolio.

Speaker #3: Underscoring our ability to execute at an exceptional speed. Based on this momentum, we also expect to initiate a phase 3 study in second line HCC by year end.

Speaker #3: Historically, our solid tumor pipeline was heavily weighted toward the immuno-oncology. 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.

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 phase III. The B7-H4 ADC is expected to enter a pivotal study in ovarian cancer by year-end. For GPC3/4 bi-specific, we completed enrollments 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.

Speaker #3: In parallel, our CADC and the PMT5 inhibitor have achieved the proof concept and are advancing toward restriction enabling development. Taken together, these programs demonstrate a repeatable model built on differentiated science, disciplined portfolio strategy, and a strong clinical execution.

Speaker #3: 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.

Speaker #3: 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 enrolled in phase three.

Speaker #3: As multiple internal discovered assets advance into late stage development, we're creating a growing number of value inflection points. Now let's take a closer look at some of the assets we highlighted at the article.

Speaker #3: The B74 ADC is expected to enter a pivotal study in ovarian cancer by year end. For GPC3 form BB, we complete enrollment of the China restriction expansion cohort with approximately 100 patients in just two and a half months.

Speaker #3: Starting with our CDK4 inhibitor, the data continue to be highly encouraging and are consistent with our scientific hypothesis. At article, we report a potentially best-in-class profile combining promising efficacy with differentiated hematological safety.

Speaker #3: You heard it right. It's only two and a half months. Underscoring our ability to execute at an exceptional speed. Based on this momentum, we also expect to initiate a phase three study in second line HCC by year end.

Speaker #3: At the phase 3 BGB43395 achieved an objective response rate of around 70% in combination with letrozole in first line HR positive HER2 negative metastatic breast cancer.

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 the 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 a 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.

Speaker #3: In parallel, our CADC and the PMT5 inhibitor have achieved the proof concept and are advancing toward restriction enabling development. Taken together, this program demonstrated a repeatable model built on differentiated science, disciplined portfolio strategy, and a strong clinical execution.

Speaker #3: Safety remains a key point of differentiation. At a 400 milligram, the overall neutropenia rate was just 21%, with no grade 3 or higher events.

Speaker #3: This compels favorably with both a thermocyclic and approved CDK46 inhibitors. We're severe neutropenia remains a meaningful clinical challenge. Together, this findings provides strong support for our ongoing phase 3 program, which is enrolling rapidly.

Speaker #3: They also create opportunities for novel combinations across our portfolio, including with our CDK2 degrader, B-cell 2 inhibitor, and the Cas6 inhibitor. Turning to our GPC3 form BB program, BGBB2033 continues to demonstrate what could be a breakthrough profile in HCC, combining strong monotherapy activity with a highly favorable safety profile.

Speaker #3: 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.

Speaker #3: At the phase three dose, BGB43395 achieved an objective response rate of around 70% in combination with letrozole in first line HR positive HER2 negative metastatic breast cancer.

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 atomozavid and approved CDK4/6 inhibitors, where severe neutropenia remains a meaningful clinical challenge. Together, these findings provide 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, BCL2 inhibitor, and a Caspase-6 inhibitor. Turning to our GPC3 x 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.

Speaker #3: At article, we reported objective response rate of over 30% in second line plus HCC. Comparable to current first line combination regimens and we're above what was reported with available TKIs in the post-IO setting.

Speaker #3: Safety remains a key point of differentiation. At a 400 milligram, the overall neutropenia rate was just 21%, with no grade three or higher events.

Speaker #3: Safety remains a key differentiator, enabled by our unique form BB approach. This profile supports developments in earlier lines. We're approximately 70 patients have already been enrolled in combination, with November and BevaSuzumab.

Speaker #3: This compels favorably with both a thermocyclic and approved CDK46 inhibitors. Where severe neutropenia remains a meaningful clinical challenge. Together, these findings provide strong support for our ongoing phase three program, which is enrolling rapidly.

Speaker #3: Development momentum also remains strong. We completed enrollments in a potentially China registration enabling expansion cohort in post-IO post-TKI HCC. In parallel, we're engaging with global regulatory authorities to explore accelerate approval pathways in second line plus HCC based on the compelling efficacy and the safety profile observed to date.

Speaker #3: They also create opportunities for novel combinations across our portfolio, including with our CDK2 degrader, BCL2 inhibitor, and the CAS6 inhibitor. Turning to our GPC3 F2B program, BG-BB2033 continues to demonstrate what could be a breakthrough profile in HCC, combining strong monotherapy activity with a highly favorable safety profile.

Speaker #3: Turning to our B74 ADC, BGC9074. At article, we presented data that supports its potential to become a leading program in ovarian cancer. The key differentiator is safety.

Speaker #3: At ASCO, we reported an 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.

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 were 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 earlier 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 potential China registration enabling expansion cohort in post-IO, post-TKI HCC. In parallel, we are 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, BG-C9074. At ASCO, we presented data that supports its potential to become a leading program in ovarian cancer. The key differentiator is safety.

Speaker #3: At a 6 mic per kilo, 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.

Speaker #3: Safety remains a key differentiator. Enabled by our unique form BB approach, this profile supports development in earlier lines. We're approximately 70 patients have already been enrolled in combination, with 12 and about Suzumab.

Speaker #3: 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 B74 expression, supporting an all-common development strategy.

Speaker #3: Development momentum also remains strong. We completed enrollment in a potentially China registration-enabling expansion cohort in post-IO, post-TKI HCC. 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 safety profile observed to date.

Speaker #3: Based on this data, we plan to initiate a phase 3 study in first line maintenance ovarian cancer before the end of 2026. While continuing to expand the opportunity to endometrial cancer and TMBC.

Speaker #3: Taken together, C9074 combines competitive efficacy with potentially best-in-class tolerability positioning it as a leading B74 ADC. We're excited for ASMO, where we have 12 extra accepted including one rapid oral presentation and night posters.

Speaker #3: Turning to our B74 ADC, BGC9074. At ASCO, we presented data that supports its potential to become a leading program in ovarian cancer. The key differentiator is safety.

Speaker #3: At a six mic per kilo, treatment-related grade three 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.

Lai Wang: 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. 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 extend the 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 are excited for ESMO, where we have 12 abstracts accepted, including one rapid oral presentation and nine posters.

Speaker #3: Highlights include our GPC3 form BB bispecific phase 1 dose optimization data, the first disclosure of phase 1 proof concept data for our PMT5 inhibitor with a focus on non-small cell lung cancer and the initial evidence of clinical meaningful brain activity.

Speaker #3: And the initial proof concept data for CADC that underscore its compelling first-in-class potential in non-small cell lung cancer. Together, this presentation highlights the strengths and the breadth of our innovation engine.

Speaker #3: Based on this data, we plan to initiate a phase three study in first line maintenance ovarian cancer before the end of 2026. While continuing to extend the opportunity to endometrial cancer and TMBC.

Speaker #3: We have covered most of the milestones already. I will just quote a few items on this slide. We remain on track for potential accelerate approval submission of TECA in relaxed refrigerated cell by the end of this year.

Speaker #3: Taken together, C9074 combines competitive efficacy with potentially best-in-class tolerability positioning it as a leading B74 ADC. We're excited for ASMO. Where we have 12 abstracts accepted, including one rapid oral presentation and night posters.

Speaker #3: Further malignancies. In addition, we plan to start TECA sorrel fixed duration combination phase 3 developments in relaxed refrigerated cell in 2027. In solid tumors, we expect to initiate a pivotal studies for both our GPC3 form BB bispecific in second line plus HCC and our B7H4 ADC in first line maintenance ovarian cancer before year end.

Speaker #3: Highlights include our GPC3 form BB bispecific phase one dose optimization data, the first disclosure of phase one proof concept data for our PMT5 inhibitor with a focus on non-small cell lung cancer and the initial evidence of clinical meaningful brain activity.

Lai Wang: Highlights include our GPC3 x 4-1BB bispecific phase I dose optimization data, the first disclosure of phase I proof of concept data for our PMGF inhibitor, with a focus on non-small cell lung cancer and the initial evidence of clinically meaningful brain activity, and the initial proof of concept data for CDAC that underscore its compelling first-in-class potential in non-small cell lung cancer. Together, these presentations highlight the strength 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 TECA 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 TECA strong fixed-duration combination phase III development in relapsed/refractory CLL in 2027.

Speaker #3: Looking further ahead, both our PMT5 inhibitor and the CADC are positioned to enter phase 3 developments in 2027. I will now turn it back to John.

Speaker #1: Thanks so much, Lai. And 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.

Speaker #1: Operator, please go ahead.

Speaker #2: 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.

Speaker #3: We have covered most of the milestones already. I will just quote a few items on this slide. We remain on track for a potential accelerated approval submission of TECA in relapsed/refractory CO by the end of this year.

Speaker #2: 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.

Speaker #3: Further expanding our CO franchise in B-cell malignancies. In addition, we plan to start TECA soon on fixed duration combination phase three developments in relaxed refrigerated CO in 2027.

Speaker #3: In solid tumors, we expect to initiate pivotal studies for both our GPC3 form BB bispecific in second line plus HCC and our B7H4 ADC in first line maintenance ovarian cancer before year end.

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 PMGF inhibitor and the CDAC are positioned to enter phase III development in 2027. I will now turn it back to John.

Speaker #2: Please unmute your audio and ask your question.

Speaker #4: Great. Thanks for taking our questions and congrats on a beat and raised quarter. So could you provide more color on the growth of Breconza sales and specifically was wondering if you can quantify how much of the growth is coming from indications outside CLL versus CLL itself.

Speaker #3: Looking further ahead, both our PMT5 inhibitor and the CADC are positioned to enter Phase 3 development in 2027. I will now turn it back to John.

Speaker #1: Thanks so much, Lai. And 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.

John V. 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.

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.

Speaker #4: And within CLL, do you see any impact from the Acala then launch and how do you think the dynamics could evolve in the next couple of quarters from that perspective?

Speaker #1: Operator, please go ahead.

Speaker #2: 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.

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.

Speaker #4: And also very quickly, on Celestial 301, any color on the HR of the two arms? Sounds like it could be similar. As a stage, but any color would be helpful.

Speaker #4: Thank you.

Speaker #1: Thanks. So I think we kind of got three sub-questions in there. Maybe I will start and give a quick answer related to your question on Acala plus then.

Speaker #2: Please unmute your audio and ask your question.

Speaker #4: Great. Thanks for taking our questions and congrats on a beat-and-raise quarter. So could you provide more color on the growth of BRCA cells and specifically was wondering if you can quantify how much of the growth is coming from indications outside CLL versus CLL itself.

Yanan Zhu: Great. Thanks for taking our questions and 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 acalabrutinib ven launch? How do you think the dynamics could evolve in the next couple of quarters from that perspective? Also, very quickly, on CELESTIAL-TNCLL, 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.

Speaker #1: Then we can jump to Aaron and he can answer your general Breconza question. And we can come to Celestial with Amit. So let me just start.

Speaker #1: I think right now we're not seeing much impact. From the AV amplify in the US, it's early. It's hard to say how it'll evolve.

Speaker #4: And within CLL, do you see any impact from the ACALA then launch? And how do you think the dynamics could evolve in the next couple of quarters from that perspective?

Speaker #1: And if Amit has extra detail on that, he can add it when he jumps to Celestial. So with that, Aaron, do you want to talk more broadly about where growth's coming from?

Speaker #3: Thank you. So we really saw Breconza growth and really for the rest of our portfolio driven by strong growth and demand across all of our regions.

Speaker #4: And also, very quickly, on Celestial 301, any color on the HR of the two arms? Sounds like it could be similar. As a stage, but any color would be helpful.

Speaker #3: We spent some time talking about our US business and at the last quarter we talked about the strength that we saw coming out of April and May.

Speaker #4: Thank

Speaker #3: And obviously that's continued into our second quarter performance. I highlighted in my preparer remark three core areas. The first, we are achieving our highest level of new patient starts since launch.

Speaker #1: Thanks. So I think we kind of got three sub-questions in there. Maybe I will start and give a quick answer related to your question on ACALA plus then.

John V. Oyler: Thanks. I think we kind of got three sub-questions in there. Maybe I will start and give a quick answer related to your question on acalabrutinib plus venetoclax. We can jump to Aaron, and he can answer your general BRUKINSA question, and we can come to CELESTIAL with Amit. Let me just start. I think right now we're not seeing much impact from the AMPLIFY in the US. It's early, it's hard to say how it'll evolve, and if Amit has extra detail on that, he can add it when he jumps to CELESTIAL. With that, Aaron, do you want to talk more broadly about where growth's coming from?

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

Speaker #3: So we're really pleased to see 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.

Speaker #1: Then we can jump to Aaron and he can answer your general BRCA question. And we can come to Celestial with Amit. So let me just start.

Speaker #3: You talked a bit about sort of context. I mean, if you look at just prevalence across the five approved indications, there's about a third of the total prevalence in those non-CLL indications.

Speaker #1: I think right now we're not seeing much impact. From the AV amplify in the US, it's early. It's hard to say how it'll evolve.

Speaker #3: 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.

Speaker #1: And if Amit has extra detail on that, he can add it when he jumps to Celestial. So, with that, Aaron, do you want to talk more broadly about where growth's coming from?

Speaker #3: 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.

Speaker #5: Thank you. So we really saw BRCA growth and really for the rest of our portfolio driven by strong growth and demand across all of our regions.

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 US business, and at the last Q4, we talked about the strength that we saw coming out of April and May, and obviously that's continued into our Q2 performance. I highlighted in my prepared remarks three core areas. The first, we are achieving our highest level of new patient starts since launch. 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 sort of context.

Speaker #3: And this was really noteworthy with Breconza showing meaningful long-term benefits on discontinuation of therapy versus Acalabrutinib and ibrutinib. In fact, Breconza did not meet the median time to discontinuation in this data cut.

Speaker #5: We spent some time talking about our US business, and in the last quarter we talked about the strength that we saw coming out of April and May.

Speaker #5: And obviously that's continued into our second quarter performance. I highlight in my preparer mark three core areas. The first, we are achieving our highest level of new patient starts since launch.

Speaker #3: And 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.

Speaker #5: 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.

Speaker #3: 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.

Speaker #3: So Amit, will you take the next question?

Speaker #5: You talked a bit about sort of context. I mean, if you look at just prevalence across the five approved indications, there's about a third of the total prevalence in those non-CLL indications.

Speaker #1: Yeah. Thank you, Aaron. I think

Speaker #5: the question was about amplify. And I think John mentioned this in his remarks. But 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.

Aaron Rosenberg: If you look at just prevalence across the five approved indications, there's about a third of the total prevalence in those non-CLL indications. 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, ibrutinib. 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. This is what you see in our overall demand growth.

Speaker #5: 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.

Speaker #5: And for AV, we only have the three-year data. We don't have long-term data. And what we've seen from that data is the lowest rate of UMRD as well as landmark PFS, even among the WEN-based regimens.

Speaker #5: 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.

Speaker #5: So 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.

Speaker #5: And this was really noteworthy with BRCA showing meaningful long-term benefits on discontinuation of therapy versus ACALA brutative and ibrutinib. In fact, BRCA did not meet the median time to discontinuation in this data cut.

Speaker #5: Including WEN-O and WEN-I. And when we look at these data, they're really highlight some of the challenges that are seen with the current WEN-based fixed duration regimens.

Speaker #5: And 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.

Speaker #5: Now, in particular, when we look at that unmutated IgHB patient population, which represents a majority of the frontline CLL patients, there's a clear distinction between the results from Breconza and other WEN-based combinations.

Speaker #5: 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.

Aaron Rosenberg: As a result of data such as this, we have updated our internal planning assumptions to reflect longer duration of therapy. Overall, the business is just performing exceptionally well. Amit, will you take the next question?

Speaker #5: So Amit, will you take the next question?

Speaker #1: Yeah. Thank you,

[Company Representative] (BeOne): Thank you, Aaron. I think the question was about AMPLIFY, and I think John mentioned this in his remarks, but long-term outcomes are very important in CLL. As we've seen, there is a huge difference between what happens with patients between years 3 and 6. For AV, we only have the 3-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 would happen with this dataset in 6 years, we do have other datasets that look better than AV at the 3-year mark with the longer follow-up, including ven O and ven I. When we look at these data, they really highlight some of the challenges that are seen with the current ven-based fixed duration regimens.

Speaker #5: For example, at six years, Breconza shows a 70% PFS, whereas the fixed duration WEN-based regimens show PFS in the low 40s. We're talking about a 30% difference in the PFS.

Amit Agarwal: Thank you, Aaron. I think the question was about AMPLIFY, and I think John mentioned this in his remarks, but long-term outcomes are very important in CLL. As we've seen, there is a huge difference between what happens with patients between years 3 and 6. For AV, we only have the 3-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 would happen with this dataset in 6 years, we do have other datasets that look better than AV at the 3-year mark with the longer follow-up, including ven O and ven I. When we look at these data, they really highlight some of the challenges that are seen with the current ven-based fixed duration regimens.

Speaker #3: Aaron. I think the question was about amplify. And I think John mentioned this in his remarks. But long-term outcomes are very important in CLL.

Speaker #3: As we've seen, there is a huge difference between what happens with patients between years three and six. And for AV, we only have the three-year data.

Speaker #5: This really matters. Now, when we couple this with the fact that there are safety issues and some of the WEN-based regimens have serious infection rates of 20% to 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 WEN-based regimens.

Speaker #3: We don't have long-term data. And what we've seen from that data is the lowest rate of UMRD as well as landmark PFS, even among the WEN-based regimens.

Speaker #3: So 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.

Speaker #5: And the fact that Breconza is the treatment of choice makes a lot of sense. Now, maybe I'll quickly address the Celestial question around the hazard ratio.

Speaker #3: Including WEN-O and WEN-I. And when we look at these data, they're really highlight some of the challenges that are seen with the current WEN-based fixed duration regimens.

Speaker #5: So 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.

Speaker #3: Now, in particular, when we look at that unmutated IgHB patient population, which represents a majority of the frontline CLL patients, there's a clear distinction between the results from BRCA and other WEN-based combinations.

[Company Representative] (BeOne): 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 6 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% to 30%, including fatal infections, 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. The fact that BRUKINSA is the treatment of choice makes a lot of sense.

Amit Agarwal: 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 6 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% to 30%, including fatal infections, 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. The fact that BRUKINSA is the treatment of choice makes a lot of sense.

Speaker #5: So we do not have the details of the hazard ratio. But 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.

Speaker #3: For example, at six years, BRCA shows a 70% PFS, whereas the fixed-duration WEN-based regimens show PFS in the low 40s. We're talking about a 30% difference in the PFS.

Speaker #5: With that, I'll turn it back to John.

Speaker #1: Yeah. Thank you so much. Amit, and can we have another question, please, operator?

Speaker #3: This really matters. Now, when we couple this with the fact that there are safety issues, and some of the WEN-based regimens have serious infection rates of 20% to 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 WEN-based regimens.

Speaker #4: Your next question comes from the line of Reni Benjamin with Citizens. Please unmute your audio and ask your question.

Speaker #2: 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.

Speaker #2: 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?

Speaker #3: And the fact that BRCA is the treatment of choice makes a lot of sense. Now, maybe I'll quickly address the Celestial question around the hazard ratio.

[Company Representative] (BeOne): Maybe I'll quickly address the CELESTIAL 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. BeOne remains unblinded to the data, so 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 BO and for the primary regulatory endpoint, which is PFS. With that, I'll turn it back to John.

Amit Agarwal: Maybe I'll quickly address the CELESTIAL 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. BeOne remains unblinded to the data, so 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 BO and for the primary regulatory endpoint, which is PFS. With that, I'll turn it back to John.

Speaker #3: So 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.

Speaker #2: Which is already been approved. Thanks.

Speaker #1: 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.

Speaker #3: So, we do not have the details of the hazard ratio. But having said that, again, we remain very confident in the PFS endpoint and our ability to show superiority for ZS over VO for the primary regulatory endpoint, which is PFS.

Speaker #5: Yeah. Thank you, John. And thank you for the question, Reni. So really, I think we're all very excited about the mangrove results. And really, what mangrove has let us do is it's another great example of how Breconza has differentiated profile leads to really meaningful advantage for patients.

Speaker #3: With that, I'll turn it back to John.

Speaker #1: Yeah. Thank you so much. Amit, and can we have another question, please, operator?

John V. Oyler: Thank you so much, Amit. Can we have another question, please, operator?

John Oyler: Thank you so much, Amit. Can we have another question, please, operator?

Speaker #5: So 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.

Speaker #4: Next question comes from the line of Rennie Benjamin with Citizens. Please unmute your audio and ask your question.

Operator: Next question comes from the line of Renny Benjamin with Citizens. Please unmute your audio and ask your question.

Speaker #6: 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.

Reni Benjamin: Hey, good morning, guys. Thanks for taking the questions, 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 how they're viewing the data, and how do the physicians interpret this relative to the ECHO regimen, which has already been approved? Thanks.

Speaker #5: And that frontline MCL setting. And show for the first time that it actually is better than the standard of care chemo-therapy regimens. The other BTK inhibitors, as you mentioned, ECHO being one example, have really added the BTK inhibitor to that chemotherapy regimen.

Speaker #6: 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?

Speaker #5: And so they're more add-on rather than replacement designs. And 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.

Speaker #6: Thanks.

Speaker #1: 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.

John V. 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.

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.

Speaker #5: And these results themselves are really unprecedented in terms of thinking about that chemo-free regimen. We've talked about the OS data being immature, but I think when you see that data, it will really sort of tell an important story there.

Speaker #3: Yeah. Thank you, John. And thank you for the question, Rennie. So really, I think we're all very excited about the mangrove results. And really, what mangrove has let us do is it's another great example of how BRCA is differentiated profile leads to really meaningful advantage for patients.

[Company Representative] (BeOne): Yeah. Thank you, John, and thank you for the question, Randy. 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 front-line 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. They're more add-on rather than replacement designs.

Amit Agarwal: Yeah. Thank you, John, and thank you for the question, Randy. 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 front-line 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. They're more add-on rather than replacement designs.

Speaker #5: And when we shared these results with physicians, carers, experts who treat MCL, they're really excited about this data. 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.

Speaker #3: So 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.

Speaker #3: And that frontline MCL setting. And so for the first time, that it actually is better than the standard of care chemo-free chemotherapy regimens. The other BTK inhibitors, as you mentioned, ECHO being one example, have really added the BTK inhibitor to that chemotherapy regimen.

Speaker #5: Actually, there is a high level of interest in understanding what this rituximab maintenance-free regimen would also look like. And so overall, we've received very positive feedback from the MCL community so far.

Speaker #3: And so they're more add-on rather than replacement designs. And 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.

Speaker #1: Yeah. Thanks, Amit. I just want to reiterate that the response I've had is wonderful. So thank you so much, operator. Could we have the next question, please?

[Company Representative] (BeOne): 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 tell an important story there. When we shared these results with physicians, KOLs, experts who treat MCL, they're really excited about this data. 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.

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 tell an important story there. When we shared these results with physicians, KOLs, experts who treat MCL, they're really excited about this data. 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.

Speaker #4: Your next question comes from the line of Michael Schmidt with Guggenheim. And please unmute your audio and ask your question.

Speaker #3: And these results themselves are really unprecedented in terms of thinking about that chemo-free regimen. We've talked about the OS data being immature, but I think when you see that data, it will really sort of tell an important story there.

Speaker #6: 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 relative factory CLL.

Speaker #3: And when we shared these results with physicians, carers, and experts who treat MCL, they're really excited about this data. I think they really understand the impact that this can have—the fact that the chemo-free regimen is really going to allow patients to avoid some of the toxicities that are seen with chemotherapy.

Speaker #6: What is the efficacy bar in this setting? Especially in the context of a single-arm study, and longer term, how do you see the degrader program position relative to other programs specifically the Nurix Roche program?

Speaker #3: Avoid the rituximab infusion. Actually, there is a high level of interest in understanding what this rituximab maintenance-free regimen will also look like. And so overall, we've received very positive feedback from the MCL community so far.

Speaker #6: Thanks so much.

Speaker #1: Thanks, Michael. Nice to hear your voice. I think that Amit is very popular this morning. So please can you jump into that?

[Company Representative] (BeOne): Overall, we've received very positive feedback from the MCL community so far.

Amit Agarwal: Overall, we've received very positive feedback from the MCL community so far.

Speaker #5: Yeah. Yes. Thank you, John. So as Lai mentioned in his remarks, if we remain on track and if the data supports this, we're looking forward to that e-submission in Q4 of this year.

Speaker #1: Yeah. Thanks, Amit. I just want to reiterate that the response I've had is wonderful. So thank you so much, operator. Could we have the next question, please?

John V. Oyler: Yeah. 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?

John Oyler: Yeah. 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?

Speaker #5: Now, I'll remind folks that the FDA has previously granted fast-track designation for tacobrutadine for adult patients with relapse refractory CLL who've received at least two prior lines of therapy, including a BTK and BCL2 inhibitor.

Speaker #4: Your next question comes from the line of Michael Schmidt with Guggenheim. And please unmute your audio and ask your question.

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

Speaker #5: 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.

Michael Schmidt: 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 program? Thanks so much.

Speaker #5: And in the context of what we've seen so far from a phase one data, across different patient populations, we've seen very encouraging both response rates as well as the durability of those responses.

Speaker #5: What is the efficacy bar in this setting? Especially in the context of a single-arm study, and longer term, how do you see the degrader program position relative to other programs specifically the Nurix Roche program?

Speaker #5: And 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.

Speaker #5: Thanks so much.

Speaker #5: Now, in addition to this, we also have important phase three studies which are executing very well. Particularly, I would call out our head-to-head comparison of tacobrutadine versus pertibrutinib, the non-covalent BTK well and we're very excited to share those results when they're available.

Speaker #1: Thanks, Michael. Nice to hear your voice. I think that Amit is very popular this morning. So please can you jump into that?

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

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

Speaker #3: Yeah. Yes. Thank you, John. So, as Lai mentioned in his remarks, we remain on track. And if the data supports this, we're looking forward to that AA submission in Q4 of this year.

[Company Representative] (BeOne): Yes. Thank you, John. As Lai mentioned in his remarks, we remain on track, and if the data supports us, 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 tacobrutinib for adult patients with relapsed/refractory CLL who've 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. When we think about previous accelerated approvals, we think that the profile really supports accelerated approval in that context.

Amit Agarwal: Yes. Thank you, John. As Lai mentioned in his remarks, we remain on track, and if the data supports us, 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 tacobrutinib for adult patients with relapsed/refractory CLL who've 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. When we think about previous accelerated approvals, we think that the profile really supports accelerated approval in that context.

Speaker #5: And in addition to this, Lai mentioned the tacobrutadine plus synrodoclax relapse refractory study that we also plan to initiate early next year. So 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 tacobrutadine to become a foundational asset in CLL along with the rest of our portfolio.

Speaker #3: Now, I'll remind folks that the FDA has previously granted fast-track designation for tacobrutadine for adult patients with relapsed/refractory CLL who've received at least two prior lines of therapy, including a BTK and a BCL2 inhibitor.

Speaker #3: And in the context of what we've seen so far from a phase one data, across different patient populations, we've seen very encouraging both response rates as well as the durability of those responses.

Speaker #1: Thanks, Amit. And operator, we're ready for another question.

Speaker #4: Your next question comes from the line of Etzer Darout with Barclays. Please unmute your audio and ask your question.

Speaker #3: And 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.

Speaker #7: Great. Thanks for taking the question and glass 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.

Speaker #3: Now, in addition to this, we also have important phase three studies which are executing very well. Particularly, I would call out our head-to-head comparison of tacobrutadine versus pertibrutinib, the non-covalent BTK inhibitor.

[Company Representative] (BeOne): Now, in addition to this, we also have important phase III studies which are executing very well. Particularly, I would call out a head-to-head comparison of tacobrutinib versus pirtobrutinib, the non-covalent BTK inhibitor. The study is enrolling very well, and we're very excited to share those results when they're available. In addition to this, Lai mentioned the tacobrutinib plus lenalidomide 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 tacobrutinib to become a foundational asset in CLL, along with the rest of our portfolio.

Amit Agarwal: Now, in addition to this, we also have important phase III studies which are executing very well. Particularly, I would call out a head-to-head comparison of tacobrutinib versus pirtobrutinib, the non-covalent BTK inhibitor. The study is enrolling very well, and we're very excited to share those results when they're available. In addition to this, Lai mentioned the tacobrutinib plus lenalidomide 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 tacobrutinib to become a foundational asset in CLL, along with the rest of our portfolio.

Speaker #7: And then secondly, maybe one for Lai around the pipeline. Just curious around the CAT6 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 in the intriguing profile that could have.

Speaker #3: This study is enrolling very well and we're very excited to share those results when they're available. And in addition to this, Lai mentioned the tacobrutadine plus synrodoclax relapse refractory study that we also plan to initiate early next year.

Speaker #3: So 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 tacobrutadine to become a foundational asset in CLL along with the rest of our portfolio.

Speaker #7: But again, the safety being limited, just curious around sort of your design elements there to maybe overcome some of those limitations would be great.

Speaker #7: Thank

Speaker #1: Thanks so much for the Lai.

Speaker #5: 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.

Speaker #1: Thanks, Amit. And operator, we're ready for another question.

John V. Oyler: Thanks, Amit. Operator, we're ready for another question.

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

Speaker #4: Your next question comes from the line of Etzer Darut with Barclays. Please unmute your audio and ask your question.

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

Speaker #5: So we'll hopefully share the details very soon. Lai?

Speaker #3: Great, thanks for taking the question and the color on the update. Maybe another one on Mangrove. If you could maybe talk about when we could see an additional data cut here, and any sort of potential presentations we may see around that.

Etzer Darout: Great. Thanks for taking the question and grasp on the updates 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. Then secondly, and maybe one for Lai around the pipeline, just curious around the Caspase-6 design elements, and the potential to combine maybe with the CDK4 selective program or other programs in the pipeline, just given 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.

Speaker #3: Yeah. In terms for the CAT6, this module was designed to be more selective for CAT6 trying to spare in the CAT7. This is the main differentiation versus Pfizer's CAT6 program.

Speaker #3: We believe this can potentially lead to less hematological toxicities. So far, we certainly starting from last year, we had this program enter and connect to initiated first in human study in breast cancer.

Speaker #3: And then secondly, maybe one for Lai around the pipeline. Just curious about the CAT6 design elements, and the potential to combine it with the CDK4 selective program or other programs in the pipeline.

Speaker #3: While the design there is to be combined with our CDK4 inhibitor, but certainly in our pipeline, there are many other potential molecules which we can combine with CAT6 in the breast cancer.

Speaker #3: Just given sort of some of the other efficacies we've seen with that in the intriguing profile that could have. But again, the safety being limited, just curious around sort of your design elements there to maybe overcome some of those limitations would be great.

Speaker #3: But in addition to that, I think it was just last month, we also initiated our second phase one study. This one is to exploring this CAT6 molecule in MLAML.

Speaker #3: Thank you.

Speaker #1: Thanks so much for the question. Let's start with Amit and jump to Lai.

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

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

Speaker #3: We have seen quite a bit of interesting preclinical translational data about CAT6 in AML. And we're certainly looking forward to seeing this molecule, how it does in the AML.

Speaker #3: 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.

[Company Representative] (BeOne): Yeah, I think the question about MANGROVE was really just when are we presenting the data, 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?

Amit Agarwal: Yeah, I think the question about MANGROVE was really just when are we presenting the data, 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?

Speaker #1: Thanks so much. Gentlemen and back to the operator for another question.

Speaker #3: So we'll hopefully share the details very soon. Lai?

Speaker #5: Yeah. In terms of the CAT6, this module was designed to be more selective for CAT6. Trying to spare in the CAT7. This is the main differentiation versus Pfizer's CAT6 program.

Lai Wang: Yeah. In terms for the Caspase-6, this molecule was designed to be more selective for Caspase-6, trying to spare in the Caspase-7. This is the main differentiation versus Pfizer's Caspase-6 program. We believe this can potentially leading to less hematological toxicities. Far, we certainly, starting from last year, we had this program initiated first in human study in breast cancer. While the design there used to be combined with our CDK4 inhibitor, certainly in our pipeline, there are many other potential molecules which we can combine with Caspase-6 in the breast cancer. 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 Caspase-6 molecule in AML.

Speaker #4: Your next question comes from the line of Yaron Werber with TD Cohen. You may unmute your mic and ask your question.

Speaker #1: Great. Congrats on a really nice quarter. Question, PRMT5, is that really important target in your the lead essentially with the brain penetrant molecule. So it sounds like you're going to have data in lung cancer and asthma.

Speaker #5: We believe this can potentially lead to less hematological toxicities. So far, we certainly starting from last year, we had this program enter and connect to initiate the first in-human study in breast cancer.

Speaker #1: Can you give us a sense what we might be able to see? Because you're moving that into phase three next year. And I think also pancreatic cancer achieved POC.

Speaker #5: One of the design there is to be combined with our CDK4 inhibitor. But certainly in our pipeline, there are many other potential molecules which we can combine with CAT6 in the breast cancer.

Speaker #1: Is there any chance we might see some of that data at asthma? Or is that going to be in the next meeting? And is that moving to phase three next year as well?

Speaker #5: But in addition to that, I think it was just last month, we also initiated our second Phase 1 study. This one is to explore this CAT6 molecule in ML.

Speaker #1: Thank you. Hi, Yaron. Thanks for the great question. And Mark, why don't you speak to that since you're closest to the detail?

Speaker #5: We have seen quite a bit interesting preclinical translational data about CAT6 in ML. And we're certainly looking forward to seeing this molecule, how it does in the ML.

Lai Wang: We have seen quite a bit interesting preclinical translational data about Caspase-6 in AML, we're certainly looking forward to seeing this molecule, how it does in AML.

Speaker #5: Thank you, Yaron. We're very excited about our PRMT5 program and look forward to the initial disclosure that's upcoming at asthma. Our molecule entered the clinic in the first quarter of '25.

Speaker #1: Thanks so much. Gentlemen and back to the operator for another question.

John V. Oyler: Thanks so much, gentlemen, back to the operator for another question.

John Oyler: Thanks so much, gentlemen, back to the operator for another question.

Speaker #5: So this is our initial disclosure and therefore will include the monotherapy phase 1A dose escalation data. But we'll also include a significant number of patients who have been enrolled in expansion phases.

Speaker #4: Your next question comes from the line of Aaron Werber with TD Cowen. You may unmute your mic and ask your question.

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

Speaker #1: Great. Congrats on a really nice quarter. Question. PRMT5, is that really important target in your the lead essentially with the brain penetrant molecule? So it sounds like you're going to have data in lung cancer and asthma?

Yaron Werber: Great. Congrats on a really nice quarter. Question, PRMT5 is a really important target in your, 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? 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.

Speaker #5: 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'll share some data showing that we have early evidence of clinically meaningful CNS coverage.

Speaker #1: Can you give us a sense what we might be able to see? Because you're moving that into phase three next year. And I think also pancreatic cancer achieve POC?

Speaker #5: 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 the molecule.

Speaker #1: Is there any chance we might see some of that data in asthma? Or is that going to be in the next meeting? And is that moving to phase three next year as well?

Speaker #1: Thank you. Hi, Aaron. Thanks for the great question. And Mark, why don't you speak to that, since you're closest to the detail?

Speaker #1: Thanks so much. Mark and back for another question, please.

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

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

Speaker #4: Your next question comes from the line of Jessica Fye with JP Morgan. Please unmute your audio and ask your question.

Speaker #3: Thank you, Aaron. We're very excited about our PRMT5 program and look forward to the initial disclosure that's upcoming at asthma. Our molecule entered the clinic in the first quarter of '25.

[Company Representative] (BeOne): Thank you, Yaron. We're very excited about our PRMT5 program and look forward to the initial disclosure that's upcoming at ESMO. Our molecule entered the clinic in Q1 of 2025. This is our initial disclosure and therefore will include the monotherapy phase I-A dose escalation data. Will also include a significant number of patients who have been enrolled in expansion phases. 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'll 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.

Mark Lanasa: Thank you, Yaron. We're very excited about our PRMT5 program and look forward to the initial disclosure that's upcoming at ESMO. Our molecule entered the clinic in Q1 of 2025. This is our initial disclosure and therefore will include the monotherapy phase I-A dose escalation data. Will also include a significant number of patients who have been enrolled in expansion phases. 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'll 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.

Speaker #6: 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?

Speaker #3: So, this is our initial disclosure and therefore will include the monotherapy Phase 1a dose escalation data. But we'll also include a significant number of patients who have been enrolled in expansion phases.

Speaker #6: And then for Mark, on the CEA ADC for lung cancer, can you talk in broad strokes about the phase three you envision running for that product next year?

Speaker #3: 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'll share some data showing that we have early evidence of clinically meaningful CNS coverage.

Speaker #6: Thank you.

Speaker #1: Thanks, Jessica. Please, Aaron and Mark.

Speaker #5: Sure. And I'll be fairly brief and thanks for the question, Jess. I covered, I think, many of the factors that were driving performance for the quarter.

Speaker #3: 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 the molecule.

Speaker #5: The ones I highlighted are all areas of strength for Brokinza, 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.

Speaker #1: Thanks so much. Mark and back for another question, please.

John V. Oyler: Thanks so much, Mark. Back for another question, please.

John Oyler: Thanks so much, Mark. Back for another question, please.

Speaker #4: Your next question comes from the line of Jessica Fai with JP Morgan. Please unmute your audio and ask your question.

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

Speaker #5: All these are areas of strength for the business and candidly ahead of our expectations at the beginning of the year. We're really pleased to see this.

Speaker #5: Ultimately, this means impact for patients. And we look forward to continuing to growing the franchise as we move forward. 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 asthma.

Speaker #6: 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?

Jessica Fye [Managing Director, Equity Research Analyst: 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? Then 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.

Jessica Fye: 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? Then 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.

Speaker #6: And then for Mark, on the CEA ADC for lung cancer, can you talk in broad strokes about the phase three you envision running for that product next year?

Speaker #5: Because this is the first disclosure, this will include the phase one 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.

Speaker #6: Thank you.

Speaker #1: Thanks, Jessica. Please, Aaron and Mark.

John V. Oyler: Thanks, Jessica. Please, Aaron and Mark.

John Oyler: Thanks, Jessica. Please, Aaron and Mark.

Speaker #5: 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.

Speaker #3: Sure. And I'll be fairly brief and thanks for the question, Jess. I covered, I think, many of the factors that were driving performance for the quarter.

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, certainly improvements in our understanding of duration of therapy and how that's manifest in demand. All these are areas of strength of 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.

Speaker #5: So the initial registration opportunities will be at a later line setting. But we're actively working to generate evidence in an earlier line setting given the strength of data that's emerging.

Speaker #3: The ones I highlighted are all areas of strength for Brokinza, 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 manifesting in demand.

Speaker #1: Thanks so much. Another question, please.

Speaker #4: Your next question comes from the line of Faisal Khurshid with Jefferies. Please unmute your audio and ask your question.

Speaker #3: All of these are areas of strength for the business, and, candidly, are ahead of our expectations at the beginning of the year. We're really pleased to see this.

Speaker #7: Hello. This is Anand Shah for Faisal. Just give a little more detail on your PRMT5 and RAS strategy. Would the phase three for the PRMT5 lung cancer study be a combo or mono?

Speaker #3: So ultimately, this means impact for patients, and we look forward to continuing to grow the franchise as we move forward.

Speaker #1: 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 asthma.

[Company Representative] (BeOne): 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, 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, so 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.

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, 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, so 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.

Speaker #7: And could you provide any further details on your RAS on inhibitor? Thank you.

Speaker #1: So Mark, I think that's back to you.

Speaker #1: Because this is the first disclosure, this will include the phase one 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.

Speaker #5: 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.

Speaker #1: 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.

Speaker #5: 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.

Speaker #1: So the initial registration opportunities will be at a later line setting. But we're actively working to generate evidence in an earlier line setting given the strength of data that's emerging.

Speaker #5: 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.

Speaker #1: Thank you so much. Another question, please.

John V. Oyler: Thanks so much. Another question, please.

John Oyler: Thanks so much. Another question, please.

Speaker #5: We are certainly aware and excited of the data excited about the data when a RAS on inhibitor is combined with a PRMT5 inhibitor in MTAP deleted pancreatic cancer.

Speaker #4: Your next question comes from the line of Faisal Khurshid with Jefferies. Please unmute your audio and ask your question.

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

Speaker #7: Hello. This is Anand Shan for Faisal. Just give a little more detail on your PRMT5 and RAS strategy. Would the phase three for the PRMT5 lung cancer study be a combo or mono?

Anupam Shah: Hello, this is Anupam 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.

Speaker #5: We will be looking to generate evidence in that regard as swiftly as possible. And then going back to RAS, we have additional RAS targeting molecules that we're advancing, including a KRAS targeting degrader.

Speaker #7: And could you provide any further details on your RAS on inhibitor? Thank you.

Speaker #5: As well as a RAS on ADC, where our RAS on inhibitor will be the payload for the molecule.

Speaker #1: So Mark, I think that's back to you.

John V. Oyler: Mark, I think that's back to you.

John Oyler: Mark, I think that's back to you.

Speaker #1: Thanks so much. And back to the operator for one more question.

Speaker #3: 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.

[Company Representative] (BeOne): 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. Therefore, we're particularly excited about the opportunities for that molecule in non-small cell lung cancer. 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.

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. Therefore, we're particularly excited about the opportunities for that molecule in non-small cell lung cancer. 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.

Speaker #4: Your last question comes from the line of Gregory Renza. With truth securities, please unmute your audio and ask your question.

Speaker #3: 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.

Speaker #2: Great. Thank you. And good morning, John and team. Congrats on the quarter. And thanks for taking my question. John, maybe one for Aaron and just as we look across the portfolio.

Speaker #3: 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.

Speaker #2: When it comes to the MGEN portfolio, Aaron mentioned the growth of 25% or so. Just curious how we should be thinking about its contribution.

Speaker #3: We are certainly aware and excited of the data when a RAS on inhibitor is combined with a PRMT5 inhibitor in MTAP deleted pancreatic cancer.

Speaker #2: It continuously outperforms expectations certainly some nice growth there. But where do you see the portfolio going and how should we be framing the contributor to the top line?

Speaker #3: We will be looking to generate evidence in that regard as swiftly as possible. And then going back to RAS, we have additional RAS targeting molecules that we're advancing, including a KRAS targeting degrader.

Speaker #2: Thanks so much.

Speaker #1: Thanks for the question, Aaron. Why don't you wrap up Q&A? We'll close.

[Company Representative] (BeOne): Going back to RAS, we have additional RAS-targeting molecules that we're advancing, including a KRAS targeting degrader.

Mark Lanasa: Going back to RAS, we have additional RAS-targeting molecules that we're advancing, including a KRAS targeting degrader.

Speaker #5: Sure. Thanks for the question. We're obviously very pleased with the performance of our MGEN portfolio. This year and really since the inception of this important collaboration.

Speaker #5: So this is a franchise with great assets. We're on the verge of launching our opportunity within DELTRA in the marketplace. I did touch on the last quarter.

Speaker #5: 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, but it's certainly something that could influence performance as we move beyond this year.

Speaker #5: And we'll share more details of that as our understanding of the situation comes to light. Thank you.

Speaker #1: Thanks so much, Aaron. In closing, I just want to share that we believe the company has never been better positioned the commercial engine is really delivering the pipelines at an inflection point.

Speaker #1: The global organization is executing at a very high level. That said, there's a lot of cancer out there, and it's tough. And there's still a lot of work ahead.

Speaker #1: But we're really excited about the opportunity in front of us. And we do want to just take a moment to thank the patients, their families, that we're serving.

Speaker #1: 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. So thank you all for joining us and being part of things.

Q2 2026 BeOne Medicines AG Earnings Call

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