Q2 2026 BeOne Medicines AG Earnings Call

August 5, 2026

Operator: Prevent any background noise. After the speakers remark, there will be a question-and-answer session. At this time, I would like to turn the call over to the company.

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 turn 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.

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

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.

Dan Maller: Reconciliations between GAAP and non-GAAP financial measures discussed on this call are provided in the appendix to our presentation, which is posted to our investor relations website, along with our earnings release. All information in this presentation is as of the date of this presentation, and we undertake no duty to update such information unless required by law. Now turning to today's call as outlined on slide three. John Oyler, our Co-founder, Chairman, and CEO, will provide a business update. Aaron Rosenberg, our CFO, will provide an update on our second quarter financial results and 2026 financial guidance. Lai Wang, President and Global Head of R&D, will discuss our R&D and pipeline progress. We will open the call to questions.

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 #1: Good day, everyone. Welcome to B1 Medicine's Q2 2026 earnings call webcast. All lines have been placed on mute to prevent any background noise. After the speaker's remark, there will be a question-and-answer session.

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.

Dan Maller: Joining the team for the Q&A portion of the call will be Dr. Wu, President and Chief Operating Officer, Matt Shaulis, General Manager of North America, Mark Lanasa, Chief Medical Officer for Solid Tumors, and Amit Agarwal, Chief Medical Officer for Hematology. I'll now pass the call over to John. John?

Speaker #1: to turn the call over to the company.

Speaker #2: Matt Schallis, 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: 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, irr.b1medicines.com.

Speaker #2: Good day. I'm Dan Maller, Head of Investor Relations at BeOne Medicines. Before we begin, please note that you can find additional materials—including a replay of today's webcast and presentation—on the Investor Relations section of our website, irr.b1medicines.com. Hello and welcome.

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 ADF.

John Oyler: Thank you, Dan, and welcome everyone. Q2 was a very strong quarter across every dimension of our business. From a financial perspective, we achieved $1.7 billion in total revenues and $2.05 in GAAP earnings per ADS. This represents growth of 30% and 144% compared to the prior year, respectively. BRUKINSA, our foundational BTK inhibitor, continues to exceed our high expectations in the marketplace. More than six and a half years after its initial launch, BRUKINSA is seeing its highest level of sustained new patient starts, showing favorable early trends in duration of therapy, and it is showing strong growth across all 5 approved indications. 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. Aaron will detail this later.

Speaker #2: I would like to remain remind all participants that during this call, you may make forward-looking statements regarding, among other things, the company's future prospects and business strategy.

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

Speaker #2: Please also carefully review the forward-looking statements disclaimer and the slide deck that accompanies this. 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 #3: More than 6.5 years after its initial launch, Brook Hinza 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 #2: All information in this presentation is as of the date of this presentation, and we undertake no duty to update such information unless required by law.

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 #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 #2: And Lai Wang, president and global head of R&D, presentation. will discuss our R&D and pipeline progress. We will then open the call to questions.

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.

Speaker #2: Joining the team for the Q&A portion of the call will be Dr. Reconciliations between GAAP and Wu, president and chief operating officer. Matt Shalis, general manager of North America.

John Oyler: As impressive as our financial performance was in the quarter, our pipeline progress was equally significant. This is highlighted by the FDA approval of Beqalzi as the first and only BCL-2 inhibitor in mantle cell lymphoma, 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 2 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 #2: Mark Lanassa, Chief Medical Officer for Solid Tumors, and Amit, Hematology. I'll now pass the call over to John. John?

Speaker #3: And the success of the phase 3 mangrove study of Brook Hinza, which is so exciting that it warrants the entire next slide. We also announced a $300 million expansion of our flagship U.S.

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

Speaker #3: $1.7 billion in total revenue, Agarwal, chief medical officer for revenues, and $2.05 in GAAP earnings per ADS. This represents growth of 30% and 144% compared to the prior year, respectively.

Speaker #3: manufacturing site, in Hopewell, New Jersey. Mangrove is yet another example of the growing body of evidence supporting Brook Hinza 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: For Kenza, our foundational BTK inhibitor continues to exceed our high expectations in the marketplace. More than 6.5 years after its initial launch, Brook Kenza 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: And secondly, because when you see the data, we believe the efficacy will speak for itself. We're confident that this Brook Hinza-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 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, and we're looking forward to sharing the full data at an upcoming medical meeting. Let's now turn to BRUKINSA's commercial performance. In Q2, BRUKINSA's global revenues reached over $1.2 billion, representing growth of 31% year over year. BRUKINSA is the number one BTK inhibitor both in the 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, and with good reason. It is important to remember that BRUKINSA is a very important option for patients with other B-cell malignancies, including MCL, Waldenstrom's, marginal zone, and follicular lymphoma.

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: 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 Hinza's commercial performance.

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

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 Hinza in the context of CLL, and with good reason.

Speaker #3: And the success of the Phase 3 mangrove study of Brook Kenza, which is so exciting that it warrants the entire next slide. We also announced a $300 million expansion of our flagship U.S.

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

Speaker #3: manufacturing site in Hopewell, New Jersey. Mangrove is yet another example of the growing body of evidence supporting Brook Kenza as the foundational BTK inhibitor.

Speaker #3: Brook Hinza 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.

John Oyler: BRUKINSA has now treated more than 300,000 patients across 80-plus markets. Market share alone doesn't tell the whole story. The reason we're winning is scientific, and that story has 3 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. 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.

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

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

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

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

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

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 Kenza in the context of CLL and with good reason.

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

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

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

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

Speaker #3: Brook Kenza 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 #3: From day 1, Brook Hinza 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 #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 #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. Let me remind you now that Brook Hinza is the only BTK inhibitor that has demonstrated PFS superiority versus ibrutinib in a head-to-head randomized trial.

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

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

Speaker #3: In alpine, Brook Hinza 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.

John Oyler: 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. 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's important to understand the protocol differences that may affect patient selection and event reporting.

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

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 two arms, with 48 PFS events reported for PERTO versus 50 for ibrutinib.

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

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

Speaker #3: From day one, Brook Kenza 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 #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. Let me remind you now that Brook Kenza 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 #3: As you can see on the left, both Brook Hinza 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.

John Oyler: 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. 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. So factoring for this level of age difference in studies really matters.

Speaker #3: 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, acalabrutinib showed early separation from ibrutinib, but that separation was not sustained.

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 #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 #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.

John Oyler: Despite the differences in inclusion criteria, which may have led to roughly half the percentage of patients above the age of 75 in BRUIN CLL-313 and BRUIN CLL-314 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. 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.

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 Hinza arm.

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.

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.

John Oyler: Although some have suggested that pirtobrutinib may be well-suited for use in older patients due to lower AFib risk and improved tolerability, it is the least studied BTK inhibitor in that population. It lacks relevant long-term data with only 28 months of follow-up, and the narrative about being more tolerable and having less AFib are not supported by the data. The totality of evidence continues to support BRUKINSA's best-in-class profile. One of the key lessons we've recently learned in CLL trials is that long-term follow-up matters. Many regimens can appear highly effective in the first 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 III trials for the frontline treatment regimens. Recognizing the limitations of cross-trial comparisons, a few items jump out.

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

John Oyler: One, the landmark PFS rates for BRUKINSA are higher and continue to diverge over time compared to the other two continuous BTKIs. In fact, in year 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 BRUKINSA's landmark PFS and that of VO. 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. 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.

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 Hinza's landmark PFS and that of VO.

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 #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 Hinza in unmutated IgHV patients.

Speaker #3: Those with the highest unmet medical need. Brook Hinza 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.

John Oyler: BRUKINSA 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, a 40-point collapse. 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. 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 option for higher risk patients, where foundational BRUKINSA has generated the best-in-class data. 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, especially in high-risk patients.

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 #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 Hinza has generated the best-in-class data.

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 #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.

John Oyler: 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. 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 that 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. Patient outcomes are at stake. The durability advantage that we're seeing in the clinical data for foundational BRUKINSA is increasingly being reinforced in the real world, and it's both consistent and it's compelling. At ASCO 2026, we publish an analysis of over 10,500 Medicare free service patients with previously untreated CLL. This is the largest real-world data set ever assembled in this setting.

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

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

John Oyler: In this patient population, BRUKINSA reported statistically significant 24% and 36% reduction in the risk of death compared to those treated with acalabrutinib 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's since been published in a peer-reviewed journal. 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 acalabrutinib. Stepping back, BeOne is the only company in the world with foundational medicines across the three mechanisms of action for B-cell malignancies.

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 Hinza.

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 Hinza versus a CALA.

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 Hinza are foundational BTK inhibitor, but Calzi are recently approved next-generation potentially best-in-class BCL2 inhibitor, and Takabrutadeg are potentially first and best-in-class BTK degrader.

John Oyler: BRUKINSA, our foundational BTK inhibitor, Beqalzi, our recently approved next-generation, potentially best-in-class BCL-2 inhibitor, and tacabrutideg, our potentially first and best-in-class BTK degrader. Only BeOne is equipped to provide the best-in-class therapies as monotherapy or in combination for every CLL patient and other lymphomas, regardless of their stage of disease, risk status or treatment preference. I've spoken about how 2026 is an inflection year for our solid tumor pipeline, and we presented data this quarter that supports our confidence in moving our CDK4 inhibitor, our B7-H4 ADC, and our GPC3/4-1BB 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 #3: 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: ...Aution and the risk of death, compared to those treated with a CALA and a Brutinib, respectively: 24% and 36%. As you can imagine, this dataset generated significant interest from physicians at ASCO, given both its size and the importance of these findings to the real-world U.S.

Speaker #1: Your money rates than VO. They put in a FINETTE-CLL clocks regimen, which demonstrated comparable PFS outcomes as VO. As a result, if a BTK inhibitor plus BCL-2 in a hep 2 combination achieves similar UMRD rates as VO, it should translate into better PFS than VO.

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.

Speaker #1: Given the high UMRD rates and the exceptional durability observed with the Zanio Solon regimen in Study 101, we remain highly confident in achieving the PFS endpoint.

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: Medicare population. The study has since been published in a peer-reviewed journal. Importantly, this is now one of several large real-world analyses showing a consistent advantage for Brukenza.

Speaker #1: Next, our BTK degrader, Takabuti-Deck, continues to advance through potentially registrational phase 2 studies, while our phase 3 CADENCE-304 study against the protocol remains on track.

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: Including a recent study of claims data from 17,000 frontline CLL patients, which also reported improved survival and treatment durability for Brukenza versus acalabrutinib.

Speaker #1: 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 FD acceptance and the quality review of our HER2 positive GA application.

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.

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 #1: Starting with our commercial performance, we delivered another strong quarter across the portfolio with continued broad-based growth. Total revenue for the representing 30% growth compared to the prior year.

Speaker #1: We also made regulatory progress in China, with the CDE accepting submissions for both Devembera and Zahera. Beyond Devembera, we'll continue to advance a diversified and increasingly innovative pipeline.

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

B1 is the only company in the world with foundational. Medicines across the 3 mechanisms of action for Dell malignancies group Kenza our foundational BTK inhibitor but Cally. Our recently approved Next Generation potentially best-in-class bcl2, inhibitor and Taca. Bruited egg are potentially first and best-in-class. BTK the greater

Speaker #1: 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 #1: 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, is on track to progress from first in-human studies to pivotal stage in approximately 2.5 years.

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

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

Speaker #1: And while duration of therapy remains immature for Brook Hinza, 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 Hinza in time to discontinuation relative to both a Calabrutinib 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 maintained its market leadership in China in the face of steep competition.

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 b7h, 48C and our GPC 341 VB by specific antibody into registrational trials. Looking forward, asmo will be sharing, similar proof of concept. Data sets for 2, more potentially best-in-class medicines our prmt5 inhibitor and our CA ADC

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: 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 #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 Hinza.

Thanks, John, our second quarter, Financial results, reflects 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.

Speaker #1: Beyond Brook Hinza, to Vimbera generated $229 million in global sales, reporting 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.

Total revenue for the quarter was $1.7 billion, representing 30% growth compared to the prior year.

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

Operator: Good day, everyone. Welcome to BeOne Medicines' Q2 2026 Earnings Call Webcast. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. At this time, I would like to turn the call over to the company.

Aaron Rosenberg: Our global launches are also gaining traction. This is ahead of the potential catalyst associated with the approval of TEVIMBRA in combination with ramucirumab 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. 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 #1: Our Amgen in-license portfolio also delivered 157 million in revenue, growing 25% year over year.

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

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.

Us preka sales totaled. 893 million representing growth of 31%. We succeeded expectations due to several underlying factors. Despite the competitive environment in Q2, we saw the highest level of sustained, new patient starts since Britain's launch prescribers, increasingly selected rekindler 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 pretends a label and the diversification of the franchise.

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 Hinza.

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.

And while duration of therapy remains immature, for rekindle 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 reinforced statistically significant advantages for Britain. And the time to discontinuation relative to both the caliber nib and iterative.

Dan Maller: Reconciliations between GAAP and non-GAAP financial measures discussed on this call are provided in the appendix to our presentation, which is posted to our investor relations website, along with our earnings release. All information in this presentation is as of the date of this presentation, and we undertake no duty to update such information unless required by law. Now turning to today's call as outlined on slide three. John Oyler, our Co-founder, Chairman, and CEO, will provide a business update. Aaron Rosenberg, our CFO, will provide an update on our Q2 financial results and 2026 financial guidance. Lai Wang, President and Global Head of R&D, will discuss our R&D and pipeline progress. We will open the call to questions.

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.

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.

And finally, patient endurance 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 bikinis.

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 Brook Hinza and to Vimbera.

Dan Maller: Lai Wang, President and Global Head of R&D, will discuss our R&D and pipeline progress. We will open the call to questions. Joining the team for the Q&A portion of the call will be Dr. Wu, President and Chief Operating Officer, Matt Shaulis, General Manager of North America, Mark Lanasa, Chief Medical Officer for Solid Tumors, and Amit Agarwal, Chief Medical Officer for Hematology. I'll now pass the call over to John. John?

Speaker #1: 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.

Beyond Baeza, Tove generated $229 million in global sales, representing 18% growth versus the prior period. Tove is maintaining its market leadership in China in the face of deep competition. Our global launches are also gaining traction, and this is ahead of the potential catalyst associated with the approval of Tove in combination with Zahra and chemotherapy for patients with first-line HER2-positive GA.

Growing 25% year-over-year.

Speaker #1: And finally, net income totaled $237 million, this includes the previously disclosed tax audit settlement, which had an approximate $60 million impact.

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

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

Speaker #2: Gap diluted earnings per ADS were $2.05, compared with $84 in the prior period.

Growth across geographies. The US remained our largest market, contributing approximately $899 million in revenue during the quarter and growing 31% year over year.

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.

Aaron Rosenberg: 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 generation 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.

In revenue and grew 17% year-over-year, demonstrated across our commercial portfolio. While maintaining Market leadership for both Tober and Brew Kenza note that foreign exchange contributed 7% of reported growth given year-over-year rent in be strengthening

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.

Europe continues to be an important growth driver for the company, generating approximately $208 million in revenue and growing 37% year-over-year.

We also continue to see strong momentum across our rest of World Markets, where Revenue more than doubled to approximately 73 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 Hinza's performance in the U.S., ongoing global expansion, and continued contributions from the broader commercial portfolio.

Key markets such as Japan and Brazil are making contributions that are increasingly meaningful at the Enterprise level.

Turning to the Gap p&l.

Gross profit was $1.5 billion, with a gross margin of just under 90%, benefiting from mix as well as productivity improvements for both Brooken and Tober.

John V. Oyler: As impressive as our financial performance was in the quarter, our pipeline progress was equally significant. This is highlighted by the FDA approval of BEQALZI as the first and only BCL-2 inhibitor in mantle cell lymphoma, 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 are excited about MANGROVE for two key reasons. The first is because it represents the first chemo-free treatment option for patients with frontline mantle cell. Secondly, because when you see the data, we believe the efficacy will speak for itself.

John Oyler: As impressive as our financial performance was in the quarter, our pipeline progress was equally significant. This is highlighted by the FDA approval of BEQALZI as the first and only BCL-2 inhibitor in mantle cell lymphoma, 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 are excited about MANGR 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 #2: 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 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. 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. This updated outlook reflects the strong performance we have delivered year to date, and our confidence in continued execution for the remainder of the year.

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 #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.

And finally, net income total of 237 million. This includes the previously disclosed tax audit settlement, which had an approximate 60 million impact,

Gap. Diluted earnings per ads where $2.05, compared with 84 cents in the prior period?

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 #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.

Aaron Rosenberg: As we have now rounded the H1 of the year, and while staying away from providing detailed guidance, I'd like to provide some perspectives as you update your models and begin thinking beyond this year. Our 2026 outlook provides confidence in the durability of our commercial business, including the prospects for continued BRUKINSA growth despite the competitive environment. As you see in our 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.

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 adds increased to 3.84 cents compared with $2.25 a year ago.

John V. Oyler: We are confident that this Brukinsa-based chemo-free regimen has the potential to become the future standard of care for the roughly 21,000 new patients diagnosed with MCL each year in the major markets. Global submissions are planned for H2 2026. We are looking forward to sharing the full data at an upcoming medical meeting. Let us now turn to Brukinsa's commercial performance. In Q2, Brukinsa's global revenues reached over $1.2 billion, representing growth of 31% year over year. Brukinsa is the number one BTK inhibitor both in the US and globally. It has the broadest label of any BTKI, with approvals in five B-cell malignancies. We often talk about Brukinsa in the context of CLL, with good reason. It is important to remember that Brukinsa is a very important option for patients with other B-cell malignancies, including MCL, Waldenström's, marginal zone, and follicular lymphoma.

John Oyler: We are confident that this Brukinsa-based chemo-free regimen has the potential to become the future standard of care for the roughly 21,000 new patients diagnosed with MCL each year in the major markets. Global submissions are planned for H2 2026. We are looking forward to sharing the full data at an upcoming medical meeting. Let us now turn to Brukinsa's commercial performance. In Q2, Brukinsa's global revenues reached over $1.2 billion, representing growth of 31% year over year. Brukinsa is the number one BTK inhibitor both in the US and globally. It has the broadest label of any BTKI, with approvals in five B-cell malignancies. We often talk about Brukinsa in the context of CLL, with good reason. It is important to remember that Brukinsa is a very important option for patients with other B-cell malignancies, including MCL, Waldenström's, marginal zone, and follicular lymphoma.

Speaker #2: Our 2026 outlook provides confidence in the durability of our commercial business, including the prospects for continued Brook Hinza 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.

Cast 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.

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.

This increase reflects the continued strength we are seeing across the portfolio, led by Brutus in the US, ongoing global expansion, and continued contributions from the broader commercial portfolio.

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 Lun.

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.

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 #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.

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.

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

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

Including those investments, the strength of the business translates to the bottom line, with guidance raised 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.

Speaker #2: unchanged. Overall, this updated outlook reflects the strong performance we've delivered year to date.

Other underlying assumptions. Remain unchanged.

Speaker #3: Brook Hinza 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, Sonal regimen did not reach statistical superiority in the UMRD analysis versus the VO regimen, the IDMC recommended the study continue toward its primary regulatory endpoint of progression-free survival.

Speaker #3: While the UMRD comparison was an interesting scientific question, UMRD superiority represented a very high bar given the historical high UMRD rates associated with VO regimen.

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

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 phenetoclax regimen demonstrated comparable PFS outcomes as VO.

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

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

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: Given the high UMRD rates and exceptional durability observed with the Zanu, Sonal regimen in study 101, we remain highly confident in achieving the PFS endpoint.

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 PERDO remains on track.

Speaker #3: Together, this program supports 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.

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 Beqalzi. Beyond TEVIMBRA, we'll continue to advance a diversified and increasingly innovative pipeline. Our CDK4 inhibitor has begun phase III development in breast cancer. Our GPC3/4-1BB bispecific recently completed enrollment in a potentially China registration-enabling HCC cohort. We also remain on track to initiate a phase III study in second-line HCC before year-end. In addition, our PRMT5 inhibitor received FDA orphan drug designation for pancreatic cancer, and we initiated clinical development of our PD-1/VEGF/CTLA-4 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.

John V. Oyler: In ALPINE, BRUKINSA delivered a hazard ratio of 0.69. That separation has been sustained to a median follow-up of 42.5 months. In ELEVATE-RR, acalabrutinib showed early separation from ibrutinib; that separation was not sustained. The curves crossed, and the final hazard—

John Oyler: In ALPINE, BRUKINSA delivered a hazard ratio of 0.69, that separation has been sustained to a median follow-up of 42.5 months. In ELEVATE-RR, acalabrutinib showed early separation from ibrutinib, that separation was not sustained. The curves crossed, the final hazard.

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

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

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 initiate clinical development of our PD1, VGF, CTA4 trispecific.

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.

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: 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: 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: 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.

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 GPC3/4-1BB, we're completing enrollment of the China registration intended expansion cohort with approximately 100 patients in just two and a half months. You heard it right. It's only two and a half months, underscoring our ability to execute at an exceptional speed.

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.

The Milestones from the last quarter are a reflection of more than strong execution, they demonstrate that the power of focused on these strategy.

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.

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 to kids.

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 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.

From the greatest 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 writer therapeutic approach.

The result is a pipeline design not just to be brought but to be sustainable.

Speaker #3: 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.

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 a 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.

As our innovation engine matures, we're creating depth within each disease area, with multiple assets and mechanisms working together.

Speaker #3: In parallel, our CADC and the PMT5 inhibitor have achieved a 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.

That deps opens the door to properly combinations from within our own portfolio, driving differentiation and maximizing, the value of our Innovation Investments.

As we discussed on the previous slide.

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 ASCO.

Our Innovation engine is generating a growing number of high-quality opportunity across the portfolio historically. Our solitary human pipeline was heavily weighted toward the immune, oncology the cdk for in have to mark the beginning of a new chapter 1 defined by more Diversified mechanisms broader modalities and a sharper focus on specific tumor types.

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.

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: 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 atirmociclib 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, BCL-2 inhibitor, and a CDK6 inhibitor. Turning to our GPC3/4-1BB program, BGB-B2033 continues to demonstrate what could be a breakthrough profile in HCC, combining strong monotherapy activity with a highly favorable safety profile.

Speaker #1: Our CDK4 inhibitor is already enrolled in phase 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 2.5 months.

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 #1: You heard it right. It's only 2.5 months. Underscoring our ability to execute at an exceptional speed. Based on this momentum, we're also expect to initiate a phase 3 study in second-line HCC by year-end.

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

Speaker #1: 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: They also create opportunities for novel combinations across our portfolio, including with our CDK2 degrader, B-cell2 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 #1: 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: At ASCO, we reported objective response rate of over 30% in second line plus HCC. Comparable to current first line combination regimens and well above what was reported with available TKIs in the post-IO setting.

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

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

Speaker #1: At the phase 3 dose, BGB43395 achieved an objective response rate of around 70% in combination with letrozole in first-line HR positive HER2 negative metastatic breast cancer.

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 accelerate approval pathways in second line plus HCC based on the compelling efficacy and the safety profile observed to date.

Speaker #1: 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 #1: 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 3 program, which is enrolling rapidly.

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 #1: They also create opportunities for novel combinations across our portfolio, including with our CDK2 degrader, B cell 2 inhibitor, and a Cas6 inhibitor. Turning to our GPC3 form BB program.

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 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. This profile is particularly attractive in the maintenance setting, where long-term tolerability is critical. We're also reporting encouraging efficacy, including activity that appears independent of B7-H4 expression, supporting our 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 expand that opportunity to endometrial cancer and TNBC. Taken together, BG-C9074 combines competitive efficacy with potentially best-in-class tolerability, positioning it as the leading B7-H4 ADC. We're excited for ESMO, where we have 12 abstracts accepted, including one rapid oral presentation and nine posters.

Speaker #1: BGBB2033 continues to demonstrate what could be a breakthrough profile in HCC, combining strong monotherapy activity with a highly favorable safety profile. At the article, we reported objective response rate of over 30% in second-line plus HCC.

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 #1: Comparable to current first-line combination regimens and well above what was reported with available TKIs in the post-IO setting. Safety remains a key differentiator. Enabled by our unique form BB approach.

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. We're continuing to expand the opportunity to endometrial cancer and TMBC.

Speaker #1: This profile supports development in earlier lines. We're approximately 70 patients have already been enrolled in combination, with November and BevaSuzumab. Development momentum also remains strong.

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 abstract accepted including one rapid oral presentation and night posters.

Speaker #1: 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 accelerate approval pathways in second-line plus HCC based on the compelling efficacy and the safety profile observed to date.

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 GPC3/4-1BB bispecific phase I dose optimization data, the first disclosure of phase I proof-of-concept data for our PRMT5 inhibitor, with a focus on non-small cell lung cancer and the initial evidence of 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, this presentation highlights 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 tacabrutideg 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 tacabrutideg/sonrotoclax fixed-duration combination phase III development in relapsed/refractory CLL in 2027.

Speaker #1: Turning to our B74 ADC. BGC9074. At the article, we presented data that supports its potential to become a leading program in ovarian cancer. The key differentiator is safety.

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 #1: 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: 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 refractive CL by the end of this year.

Speaker #1: 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: Further expanding our CL franchise in B-cell malignancies. In addition, we plan to start TECA soon on fixed duration combination phase three developments in relaxed refractive CL in 2027.

Speaker #1: 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: 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 PRMT5 inhibitor and the CEA ADC are positioned to enter phase III development in 2027. I will now turn it back to John.

Speaker #1: 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 abstract accepted, including one rapid oral presentation and 9 posters.

Speaker #3: Looking further ahead, both our PMT5 inhibitor and the CADC are positioned to enter phase three 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.

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 #1: 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 #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 #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 #1: 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 #1: 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 CO by the end of this year.

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

Speaker #1: Further expanding our CO franchise in B cell malignancies. In addition, we plan to start TECA soon on fixed duration combination phase 3 developments in relaxed refrigerated CO in 2027.

Speaker #1: 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.

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: 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 #4: And also very quickly, 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 #2: 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 #4: Thank you.

Speaker #1: 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 ACALA plus then.

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 Rosenberg and he can answer your general BRUKINSA question, and we can come to CELESTIAL with Amit Agarwal. Let me just start. I think right now we are not seeing much impact from the acalabrutinib/venetoclax AMPLIFY in the US. It is early, it is hard to say how it will evolve, and if Amit Agarwal has extra detail on that, he can add it when he jumps to CELESTIAL. With that, Aaron Rosenberg, do you want to talk more broadly about where growth is coming from?

Speaker #2: Operator, please go ahead.

Speaker #3: 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: 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 Yananzu with Wells Fargo.

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 #3: Please unmute your audio and ask your question.

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 #5: 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.

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 Q, we talked about the strength that we saw coming out of April and May, and obviously that has 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 are really pleased to see the uptake in the marketplace. This is driven by strength in CLL as well as our non-CLL indications. We really do see that durable growth across all indications. You talked a bit about context.

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

Speaker #4: And also very quickly, Celestrio 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 #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 #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 #4: Thank you.

Aaron Rosenberg: If you look at just prevalence across the five approved indications, there is about a third of the total prevalence in those non-CLL indications, and we are punching a little bit above our weight in those areas because we actually have really strong share in those indications. The other piece that we had talked about was duration of therapy, and that continues to be highly constructive, yet immature. This is reinforced by real-world data. We talked about the study in 10,000 Medicare patients that were recently published. This was really noteworthy with BRUKINSA showing meaningful long-term benefits on discontinuation of therapy versus acalabrutinib and ibrutinib. In fact, BRUKINSA did not meet the median time to discontinuation in this data cut. What we are 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: 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 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: 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.

Maybe I will start and give a quick answer, you know, related to your question on, um, aala plus then, um, then we can jump to Aaron and he can answer your general brooken question and we can come to Celestial with Amit. So, you know, let let me just start, you know, I think right now we're not seeing much impact, um, from The Av amplify.

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.

In the US, you know, it's early. It's hard to say how it'll evolve and if a MIT 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 gross coming from?

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, and overall, the business is just performing exceptionally well. Amit Agarwal, will you take the next question?

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

Speaker #3: Yeah. 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.

Lai Wang: Yeah. Thank you, Aaron. I think the question was about AMPLIFY. I think John mentioned this in his remarks, 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.

Amit Agarwal: As we've seen, there is a huge difference between what happens with patients between years three and six. For AV, we only have the 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 will happen with this data set in 6 years, we do have other data sets 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: 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 when-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 #3: Including when O and when I. And when we look at these data, they're really highlight some of the challenges that are seen with the current when-based fixed duration regimens.

Thank you. So we really saw Brooke Kenza growth and really for the rest of our portfolio, uh, driven by strong growth in demand across all of our regions. Uh, we spent some time talking about our us business. And, you know, at the last quarter, we talked about the strengths that we saw coming out of April and May and obviously that's continued uh, into our second quarter performance. You know, I highlighted in my prepared, Mark III Corps areas, uh the first we are achieving our highest level of new patient starts since launch. So we're really pleased to see the uptake in the marketplace. Um, this is driven by strength in CLL as well as our non coal indication. So uh, we really do see that, um, durable growth across all indications. You talked a bit about sort of context. I mean, if you look at just prevalence across the 5 approximately, a third of the total prevalence in those non-call indications, and we're punching a little bit above our weight, in those areas, because we actually have really strong share in those indications, um, the other piece that we had talked

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 Breconza and other when-based combinations.

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 doing so well with ven-based regimens. The fact that BRUKINSA is the treatment of choice makes a lot of sense.

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

Talked about the duration of therapy and that continues to be highly constructive yet immature. Um, this is reinforced by real world data. We, we talked about, uh, the study in 10,000, Medicare patients that were recently published and this was really noteworthy with Bruins is showing meaningful long-term, uh, benefits on discontinuation of therapy versus, uh, a caliber of and ibrutinib. In fact, bruten did not meet the median time to discontinuation in this data cut. Uh, 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 #3: This really matters. Now, when we couple this with the fact that there are safety issues and some of the when-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 when-based regimens.

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

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, 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.

And overall, the business is just performing exceptionally well. So on it, will you take the next question? Yeah. So thank you, Aaron. I think the question was about amplify and I think um, John mentioned this in his remarks, but long-term outcomes are very important in CLM as we've seen, there is a huge difference between what happens with patients between years 3 and 6. And for AP, we only have the 3 year data. We don't have a long-term data. And what we've seen from that data is the lowest rate of mrd as well as Landmark PFS, even among the, when based regimens.

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 in the for the primary regulatory endpoint, which is PFS.

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, uh, Ave at the three-year mark with the longer follow-up.

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

Including, uh, when all—and when I and when we—look at these data, they really highlight some of the challenges that are seen with the current, uh, fixed-duration regimens.

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

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

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

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

Now, in particular, when we look at that unmutated IGHV patient population, which represents a majority of the frontline CLL patients, there's a clear distinction between the results from rucentrin and other BTK inhibitor–based combinations.

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

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?

for example, at 6 years Brooklyn, just shows up 70% PFS whereas the fixed duration when based regimens show PFS in the low 40s,

We're talking about a 30% difference in the PFS.

This really matters.

Speaker #6: Which has already been approved. Thanks.

Now, when we couple this with the fact that there are safety issues and some of the, when-based regimens have serious infection rates of 20% to 30%, including fatal infections,

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 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.

and the fact that almost half of the progression of events are debts, not even allowing patients an opportunity for retreatment

Speaker #3: 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.

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

It is clear that these patients are really not being served well with, when based regimens. And the fact that Brookins has the treatment of choice? Makes a lot of sense.

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, and that frontline MCL setting.

Speaker #3: 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.

Now, maybe I'll quickly address this Celestial question around the hazard ratio. So, uh, as lime mentioned, in his prepared remarks, this was, uh, an idmc event where the idmc reviewed the data for, uh, the, um, Rd and, uh, B1 remains on blinded to the data. So we do not have the details of the hazard ratio, but having said that again, we remain very confident in the PFS end point. And uh, our ability to show superiority for uh, Zs overview. And the for for the primary regulatory end point, which is BFS

With that, I'll turn it back to John.

Yeah. Thank, thank you so much. Um, I'm it and can we have another question, please operator?

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 to be superior to BR with a hazard ratio of 0.57 in favor of the ZR arm.

Amit Agarwal: MANGROVE, for the first time, showed that a chemo-free regimen of ZR was superior to BR with a hazard ratio of 0.57 in favor of the ZR arm. These results themselves are really unprecedented in terms of thinking about that chemo-free regimen. We've talked about the OS data being immature, I think when you see that data, it will really sort of tell an important story there. When we share 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.

Your next question comes from the line of Renni Benjamin with Citizens. 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 #3: 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, actually there is a high level of interest in understanding what this rituximab maintenance-free regimen will also look like.

Hey, good morning guys. Thanks for taking the questions and congratulations on an outstanding quarter. That's 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 on the study not including a Ritu maintenance arm and, and kind of how they're they're viewing the data and and how do these Physicians, kind of interpret this relative to the echo regimen which is already been approved. Thanks,

Sure. Thank, thank you so much for the question. Um, you know, again, we haven't disclosed that much data on this yet, but I think I'm it, uh, this is back in your, uh, wheelhouse.

Speaker #3: And so 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 #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 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?

Yeah. Thank you John, and thank you for the question, Randy. So uh, really I think you know we're all very excited about the mangrove results and and really what Mangrove has let us do is it's another great example of how Brookins has differentiated profiles leads to really meaningful Advantage for patients. So from a design perspective, you know, 1 of the important differences for Mangrove compared to some of the other studies is that mangroo was designed to test the chemo. Free regimen in that Frontline MCL setting.

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 relative factory CLL.

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

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 Norex Roche program?

And show for the first time that it actually is better than the standard of care chemo, free. Uh, chemotherapy regimens the other, uh, BTK Inhibitors as you mentioned Echo. Being 1 example, have really added the BTK inhibitor to that uh, chemotherapy regimen 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 to Superior to BR with a hazard ratio of 0.57, uh, in favor of the zrm. And these results themselves are really unprecedented in terms of, you know, thinking about that chemotherapy regimen.

Speaker #5: 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?

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

Amit Agarwal: Yes. Thank you, John. As Lai mentioned in his remarks, if we remain on track and if the data supports this, we're looking forward to that AA submission in Q4 of this year. Now, I'll remind folks that the FDA has previously granted Fast Track designation for tacabrutideg for adult patients with relapsed/refractory CLL who'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, and when we think about previous accelerated approvals, we think that the profile really supports accelerated approval in that context.

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

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. Uh, avoid the redo map infusion actually. There is a, a high level of interest in understanding, you know what, this redo map maintenance, uh, free. Uh, regimen would also look like. And so overall, we've received very positive feedback from uh, from the MC community so far.

Yeah, thanks, man. I just want to reiterate that, you know, the response I've had is—um—is wonderful. So, thank you so much. Operator, could we have the next question, please?

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.

Your next question comes from the line of Michael Schmidt with googleheim. And please let me your audio and ask your question.

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 tachybrotodeg versus vertebrotinib, the non-covalent BTK inhibitor.

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

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 tachybrotodeg plus synrodoclax relapse refractory study that we also plan to initiate early next year.

Hey, good morning, thanks for taking my questions. Um, I had 1 on the BTK, the greater programs just sticking with hematology, um, maybe comment a bit about how you're tracking towards completing the first registration study in rule of the factory. CLL, um, what is the efficacy bar in this setting, uh, especially in the context of a single study um, and longer term? How do you see uh, the degree of program position relative to other uh, programs specifically the norx roach program. Thanks so much.

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 tachybrotodeg to become a foundational asset in CLL along with the rest of our portfolio.

Uh, thanks Michael. Nice to hear your voice. Uh,

I think that Aid is very popular this morning. So please uh, can you jump into

Speaker #1: Thanks, Amit. And 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.

Etzer Darout: Thanks for taking the question and congrats on the update today. Maybe another one on MANGROVE, if you can maybe talk about when we could see an additional data cut here and any sort of potential presentations we may see around that. Secondly, maybe one for Lai around the pipeline, just curious around the CDK6 design elements, and the potential to combine maybe with the CDK4 selective program or other programs in the pipeline, just given sort of some of the other efficacies we've seen with that and the intriguing profile that that could have. Again, the safety being limited, just curious around sort of your design elements there to maybe overcome some of those limitations would be great. Thank you.

Speaker #6: 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 #6: 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 and the intriguing profile that could have.

Speaker #6: 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.

That yeah, yes. Uh, thank you John. Uh, so as I mentioned in his, uh, remarks, you know, if we remain on track and if the data supports this, we're looking forward to that, uh, uh, a submission, uh, in Q4 of this year. Now, I'll remind folks that the FDA has previously, granted, Fast Track, designation for tax for adult patients, with relapse refractory CLL who received at least 2 prior lines of therapy including a BTK and bcl2 inhibitor. Uh and and in the context of what we've seen so far from our Phase 1 data, you know, across different patient populations. We've seen very encouraging uh both response rates as well as the durability of those responses. And we think that this is a profile, which is compelling. And when we think about previous accelerated approvals, we think that the the profile really, you know, uh, supports accelerated approval in that context. Now, in addition to this, we also have important phase 3 studies, which are uh executing

Speaker #6: Thank you.

Speaker #1: 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: 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.

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

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

Speaker #1: Yeah. In terms of the CAT6, this module was designed to be more selective for CAT6 trying to spare in the CAT7. This is a main differentiation versus Pfizer's CAT6 program.

Lai Wang: Yeah, in term for the CDK6, this molecule was designed to be more selective for CDK6, trying to spare the CDK7. This is the main differentiation versus Pfizer's CDK6 program. We believe this can potentially leading to less hematological toxicities. So far, we certainly, starting from last year, we had this program entering connect to, initiated first-in-human study in breast cancer. While the design there used to be combined with our CDK4 inhibitor, certainly in our pipeline, there are many other potential molecules which we can combine with CDK6 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 CDK6 molecule in AML.

Very well. Uh particularly I would call out a head-to-head comparison of uh tackle rooted egg versus perto route. Net, the non-covalent BTK inhibitor, the study is enrolling very well and we're very excited to share those results when they're available. And in addition to this uh live mentioned the stack of rooted eggplants and Roto flax relapse refractory study that we also plan to initiate early next year. So, overall, I think, you know, this will need reflects our growing confidence in the program and our ability to execute on a on a sort of profile, which is going to allow table, rooted egg to become a foundational asset in along with the rest of our portfolio.

Speaker #1: 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.

Thanks for that, and operator, we're ready for another question.

Your next question comes from the line of eater doubt with barklay. Please unmute your audio and ask for question.

Speaker #1: 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 #1: 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 #1: We have seen quite a bit interesting preclinical translational data about CAT6 in AML and we're certainly looking forward to seeing this molecule how it does in the AML.

Lai Wang: We have seen quite a bit interesting preclinical translational data about CDK6 in AML. We're certainly looking forward to seeing this molecule, how it does in AML.

Great. Thanks for taking the question and grass on the update. So today, but maybe another 1 on Mangrove. If you can maybe talk about when we could see an additional um, data cut here and in any sort of potential presentations, we may see around that and then secondly and maybe 1 for like around the pipeline, just curious around the cat 6 Design Elements, um, and and the potential to put, you know, combined, maybe with the cdk4 selective program or other, um, programs in the pipeline, just give in sort of some of the, um, other efficacy. We've seen with that in the

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

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

Speaker #4: Your next question comes from the line of Yaron Werber with TD Cohen. 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.

Intriguing profile that that could have. But again this the safety being limited just just curious around sort of your Your Design Elements there to to maybe overcome some of those limitations would be great. Thank you.

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, and you are the lead essentially with the brain-penetrant molecule. It sounds like you are going to have data in lung cancer at ESMO. Can you give us a sense what we might be able to see, because you are 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.

Thanks so much for the question. Let's start with a minute and jump to lie.

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?

Yeah, I think the question about Mangrove was really just when we presenting the data. And I think, you know, as, as you mentioned John we are uh, very excited to present this at an upcoming Congress. So we'll hopefully share the details very soon. Uh, like

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 #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?

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

Speaker #3: 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.

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 2025, so this is our initial disclosure and therefore will include the monotherapy phase I-A dose escalation data. We'll also include a significant number of patients who have been enrolled in expansion phases. Because our molecule is designed to be CNS penetrant, we have had an emphasis on enrolling patients with non-small cell lung cancer. As you heard from Lai, we'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.

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

Um, so far, we certainly starting from last year, we had this program entering connect to initiate the first inhuman study in breast cancer. While the design, there used to be combined with our cdk4 inhibitor, but certainly in our pipeline, there are many other potential molecules, which we can combine with cast 6 in the breast cancer. But in addition to that, um,

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.

Speaker #3: 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.

I think was just last month. We also initiate our second uh Phase 1 study. This 1 is to explore in this cast, 6 molecule in ml AML we have seen quite a bit interesting uh, pre clinical translational data, about casting AML, and we're certainly uh, looking forward to seeing this molecule. How it does in the AML

Thanks so much. Uh, gentlemen. And uh, back to the operator for another question.

Speaker #3: Again, while we have an emphasis on lung cancer, we intend to have a broad development plan for this molecule.

Mark Lanasa: Again, while we have an emphasis on lung cancer, we intend to have a broad development plan for this molecule.

Your next question comes from the line of your in wber. With TD Cohen, you may unmute your mic and ask for a question.

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

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

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

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

Speaker #5: 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?

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

Great. Uh, congrats on on a really nice quarter. Um, question theorem D5 is a really important Target in your uh, the the lead essentially with the brain penetrant molecule. So it sounds like you're going to have data in in lung cancer at esmo. Can you give us a sense? What what, we might be able to see because you're moving that into phase 3 next year. And I think also, uh, pancreatic cancer achieve POC, um, is there any chance? We might see some of that data as more, is that going to be in the next meeting and is that

Moving to phase 3 next year as well. Thank you.

Speaker #5: 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?

Uh, hi, you're on. Thanks for the great question. And, uh, Mark, why don't you, uh, speak to that, since you're closest to the detail?

Speaker #5: Thank you.

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

Mark Lanasa: Thanks, Jessica. Please, Aaron and Mark.

Speaker #2: 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, and thanks for the question, Jess. I covered, I think, many of the factors that were driving performance for the quarter. The ones I highlighted are all areas of strength for BRUKINSA, whether it be the level of new patient starts we're seeing, the strength across all indications, and certainly improvements in our understanding of duration of therapy and how that's manifest in demand. All these are areas of strength for the business and candidly ahead of our expectations at the beginning of the year. We're really pleased to see this. Ultimately, this means impact for patients, and we look forward to continuing to growing the franchise as we move forward.

Speaker #2: 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 #2: 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 #2: So ultimately this means impact for patients. And we look forward to continuing to growing the franchise as we move forward.

Speaker #3: 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.

Mark Lanasa: Thanks, Jess. Regarding the CEA-ADC, as I mentioned for PRMT5, again, we're very excited to make our initial data disclosure at the upcoming ESMO. Because this is the first disclosure, this will include the phase I dose escalation data as well as the expansion data. We do have a first-in-class proof of concept in non-small cell lung cancer, and we think that these data compare favorably to other investigational ADCs in the non-small cell lung cancer space. Based on these data, we want to leverage our lead mover advantage, 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. Thanks so much. Another question, please.

Thank you, your own. We're very excited about our PRT 5 program and look forward to the initial disclosure that's upcoming at esmo, our molecule entered the clinic in the first quarter of 25. 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 because our molecule is designed to be CNS penetrant. Uh, we have had an emphasis on enrolling patients with non small cell lung cancer. As you heard from live, we'll share some data showing that we have early evidence of clinically meaningful CNS coverage. Uh, but we will share data across tumor types. Inclusive of non small cell, lung cancer, pancreatic cancer and other tumor types. Uh, again while we have an emphasis on lung cancer, we intend to have a broad development plan for this molecule.

Thanks so much. Uh, Mark, and back for another question, please.

Speaker #3: 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.

Your next question comes from the line of Jessica fee with JP Morgan. Please unmute your audio and ask a question.

Speaker #3: 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 so the initial registration opportunities will be at a later line setting.

Hey guys, good morning. Uh thanks for taking my question. Um maybe 1 for uh Aaron and 1 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: But we're actively working to generate evidence in an earlier line setting given the strength of data that's emerging.

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

And then for Mark on the cea, ADC for lung cancer. Can you talk in Broad Strokes? About the phase 3, you envision running for that product next year. Thank you.

Speaker #4: Your next question comes from the line of Faisal Khurshid with Jeffries. 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.

Thanks Jessica. Um, please Aaron and Mark.

Speaker #6: Hello, this is Anand Shawn for Faisal. Just give a little more detail on your PRMT5 and RAST strategy. Would the phase three for the PRMT5 lung cancer study be a combo or mono?

Anant Shan: Hello, this is Anant Shan for Faisal. Can 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 #6: 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.

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

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.

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.

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

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 #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 #3: 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 #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.

Mark Lanasa: Going back to RAS, we have additional RAS-targeting molecules that we're advancing, including a KRAS-targeting degrader, as well as a RAS-ON ADC, where our RAS-ON inhibitor will be the payload for the molecule.

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 1 dose escalation data as well as the expansion data. Uh, we do have a first and last proof of concept in non small cell, lung cancer. And we think that these data compared favorably to other investigational, adcs in the non small cell, lung, cancer space, uh, based on these data, we want to leverage our lead, mover Advantage. So the initial registration opportunities will be in a later line setting. Uh but we're actively working to generate evidence in an earlier line setting given the strength of data that's emerging.

Speaker #3: As well as a RAS on ADC where a RAS on inhibitor will be the payload for the molecule.

Thanks so much. Uh, another question, please.

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

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

Your next question comes from the line of fesal Creuset with Jeff. Please unmute your audio and ask your question.

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

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

Speaker #7: 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.

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

Hello, this is Anon Sean for feasel. Just give a little more detail on your prmt5 and Ras strategy would the phase 3 for the prmt5, lung cancer study, be a combo or mono and could you provide any further details on your razon inhibitor? Thank you.

So Mark, I think that's back to you.

Speaker #7: 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 #7: 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 #7: Thanks so much.

Speaker #1: Thanks for the you wrap up Q&A? We'll close.

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

Speaker #3: 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.

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

Speaker #3: So this is a franchise with great assets. We're on the verge of launching our opportunity with MDELTRA in the marketplace. I did touch on the last quarter.

Speaker #3: 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.

Thank you very much for the question. Uh, rash 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 wrasse on inhibitor that will enter the clinic prior to the end of this year, uh, similar to our PRT 5 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. Uh, we are uh, certainly aware and excited of the day, excited about the data. Uh, when a wrasse 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. Uh, and then going back to Ras, we have additional Ras.

Targeting molecules that were advancing. Including a kras targeting degrader uh, as well as a Ras on ADC, whereas on inhibitor, will be the payload for the molecule

Speaker #3: And we'll share more details of that as our understanding of the situation comes to light. Thank you.

Thanks so much, and back to the operator for one more question.

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.

John Oyler: 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 pipeline's at an inflection point. The global organization is executing at a very high level.

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

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.

John Oyler: That said, there's a lot of cancer out there, and it's tough, and there's still a lot of work ahead. 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, the physicians, our partners, and our more than 12,000 colleagues and their families who focus with urgency every day to make this progress possible. Thank you all for joining us and being part of things. Have a wonderful rest of the day. Thank you.

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.

Great. Uh thank you and good morning John and team congrats on the quarter and thanks for taking my question. John maybe 1 1 for Aaron and just as we we look across the portfolio when it comes to the mg portfolio, Aaron mentioned the growth of 25% or so just curious how we should be thinking about its contribution it continuously outperforms. Um expectations, certainly, some some nice growth there. But where do you see the portfolio going? And how should we be framing the the contributor to the Top Line? Thanks so much.

Uh, thanks for the question. Aaron, uh, why don't you wrap up Q&A? We'll close.

Sure. Uh, thanks for the question. We're obviously very pleased with the performance of our mg portfolio. Uh, this year and really since the Inception of of this important collaboration. Um, so this is this is a a franchise with great assets. We're on the verge of launching our, um, our opportunity with them Delta in the marketplace, uh, I

Did touch on the last quarter, um, by a similar competition, that's coming for XGA, uh, we'll share more on that Evolution as uh, as our understanding of the situation evolves. Uh, that's not a near-term impact. But it's certainly something that could, uh, influence performance as we move Beyond this year and we'll share more details of that. As that as our understanding of the situation comes to light. Thank you.

Uh, thanks so much Aaron.

In closing, I just want to share that. Uh, you know, we believe the company is never been better positioned. The commercial engine is really delivering the pipelines at an inflection point. The global organization is executing at a very high level.

That said there's a lot of cancer out there and it's tough and there's still a lot of work ahead 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 and their families that were serving the Physicians our partners, and our more than 12,000 colleagues in 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. Um, have a wonderful rest of the day. Thank you.

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Q2 2026 BeOne Medicines AG Earnings Call

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