BeOne Medicines AG

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. At this time, I would like to turn the call over to the company.

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. I would like to 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. 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. 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. 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, 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?

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 gap earnings per ADS. This represents growth of 30% and 144% compared to the prior year, respectively. Brukinza, our foundational BTK inhibitor, continues to exceed our high expectations in the marketplace. More than six and a half years after its initial launch, Brukinza 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 five approved indications. On the back of these strong results, we're raising our 2026 guidance ranges for revenue and gap operating income by $300 million and $250 million, respectively. And Aaron will detail this later. As impressive as our financial performance was in the quarter, our pipeline progress was equally significant. Thank you for joining us. Mangrove is yet another example of the growing body of evidence supporting Brukinza as the foundational BTK inhibitor. We're excited about Mangrove for two key reasons. The first is because it represents the first chemo-free treatment option for patients with frontline mantle cell. And secondly, because when you see the data, we believe the efficacy will speak for itself. We're confident that this Brukinza-based chemo-free regimen has the potential to become the future standard of care for the roughly 21,000 new patients diagnosed with MCL each year in the major markets. Global submissions are planned for the second half of 2026, and we're looking forward to sharing the full data at an upcoming medical meeting. Let's now turn to Brukinza's commercial performance. In Q2, Brookins' global revenues reached over $1.2 billion, representing growth of 31% year-over-year. Brookins is the number one BTK inhibitor both in the U.S. and globally, and it has the broadest label of any BTKI, with approvals in five B-cell malignancies. We often talk about Brukinza in the context of CLL and with good reason. 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. Brukinza 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. And that story has three 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. On the left side of this slide, you can see the highlights of the breadth of Phase III data generated for Brukinza as a single agent. Here you can see Brickenza 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 Brickenza has the most reported and ongoing Phase III data of any BTKI agent. This slide demonstrates the scale of Brukinza's development plan compared to the more curated efforts of our peers. In addition to Mangrove, Brukinza has four more potentially market-expanding Phase 3 readouts in the next three years. A major wave of data is coming that will extend Brukinza's evidence base and its label well into the future. One quick reminder of why Brukinza performs the way it does. From day one, Brukinza was designed to deliver complete and sustained PTK inhibition through its potency and its PK profile. Our hypothesis was simple. Continuous PTK coverage would translate into a superior therapeutic profile. and over a decade of clinical and real world evidence has really borne that out. And that's what the next few slides show. Let me remind you now that Brukinza is the only BTK inhibitor that has demonstrated PFS superiority versus Ibrutinib in a head-to-head randomized trial. In Alpine, Brukinza 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 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. And with respect to tolerability, PERTO showed numerically more discontinuations due to AEs than ibrutinib, whereas both Brukinza 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. As you can see on the left, both Brukinza and Akala 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 U.S. 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. 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 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 313 and 314 eligibility criteria to the Sequoia population, 15 of the highest risk patients would have been excluded from the Brukinza arm. 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. 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. 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 Brickenza's best-in-class profile. One of the key lessons we've recently learned in CLL trials is that long-term follow-up matters. Many regimens can appear highly effective in the first three years, but that's not enough time to understand their true durability. This slide shows the reported landmark PFS at years three through six across the respective frontline CLL phase three trials for the frontline treatment regimens. Recognizing the limitations of cross-trial comparisons, a few items jump out. One, the landmark PFS rates for Brukinza are higher and continue to diverge over time compared to the other two continuous BTKIs. In fact, in year six, the delta between the landmark PFS rates reaches 12%, which is equivalent of one in eight patients not progressing. 2. There's an even more pronounced delta between Brukinza'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 in unmutated IGHV patients, those with the highest unmet medical need. Brookinsa 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. and AV Amplify, based on the limited data disclosed to date, shows just 69% at year three, which is of course lower than VO at a similar time point. There's a few important takeaways from this slide. First, While we're big believers in the promise of fixed duration, the existing Venn-based treatments are not a compelling option for higher-risk patients where foundational Brukinza 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 three years, but by six years the outcomes can diverge meaningfully, especially in high-risk patients. And that's why we've consistently prioritized long-term follow-up in our studies and why we believe six-year data provide a more complete picture of treatment durability. It's also why we're concerned when conclusions reached on regimens based on only three years of data or less are made. We've been very surprised that some studies have not continued to report longer-term follow-up data because years three to six are critical to evaluate the true long-term benefit of any CLL therapy. Patient outcomes are at stake. The durability advantage that we're seeing in the clinical data for foundational Brukinza is increasingly being reinforced Thank you for joining us. In this patient population, Brickenza reported statistically significant 24% and 36% reduction in the risk of death compared to those treated with Acala and Ibrutinib, respectively. 24% and 36%. As you can imagine, this dataset generated significant interest from physicians at ASCO, given both its size and the importance of these findings to the real-world US Medicare population. The study has since been published in a peer-reviewed journal. And importantly, this is now one of several large real-world analyses showing a consistent advantage for Brukinza, including a recent study of claims data from 17,000 frontline CLL patients, which also reported improved survival and treatment durability for Brukinza versus Acala. Stepping back. B1 is the only company in the world with foundational medicines across the three mechanisms of action for B-cell malignancies. Brukinza, our foundational BTK inhibitor, Bacalzi, our recently approved next generation, potentially best-in-class BCL2 inhibitor, and Tachybrutideg, our potentially first and best-in-class BTK degrader. Only B1 is equipped to provide the best-in-class therapies as monotherapy or in combination for every CLL patient and other lymphomas regardless of their stage of disease, risk status, or treatment preference. I've spoken about how 2026 is an inflection year for our solid tumor pipeline, and we presented data this quarter that supports our confidence in moving our CDK4 inhibitor, our B7H4 ADC, and our GPC341BB bispecific antibody into registrational trials. Looking forward to ASMO, 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. And with that, I'll hand it over to Aaron for the financial results.