BeOne Medicines AG

Good day, everyone. Welcome to B1 Medicine's Q1 2026 earnings call webcast. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, 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. Thanks 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, 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. 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 IR 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 Euler, our co-founder, chairman, and CEO, will provide a business update. Aaron Rosenberg, our CFO, will provide an update on our first quarter financial results and 2026 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. And joining the team for the Q&A portion of the call will be Xiaobin Wu, President and Chief Operating Officer, Matt Shaulis, General Manager of North America, Mark Lanassa, 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, and thank you for your time today. We entered 2026 with tremendous momentum. and our Q1 performance reflects strong execution across the business and a very solid start to the year. From a financial perspective, we achieved significant product revenue growth and gap earnings per ADS. These results underpin our confidence to raise our 2026 revenue guidance range by 100 million, as Aaron will discuss later. Our foundational hematology franchise consisting of Brukinza, Sonro, and our BTK CDAC is rapidly progressing, with approvals, launches, and key pivotal trial milestones expected in the near term. Both our heme franchise and our solid tumor pipeline will be on display at ASCO and EHA, where we have over 60 acceptances. At ASCO, we will present proof-of-concept data from three exciting solid tumor programs moving into late stage clinical trials, which Lai will tell you more about shortly. I'll begin today by highlighting the exceptional commercial and clinical progress of Brukinza, which has firmly established itself as the foundational BTK inhibitor. Brukinza continued its global leadership in the growing BTK market with first quarter sales of 1.1 billion, representing growth of 38%. We are seeing strong performance in all markets and all indications. Brukinza's large, consistent, and expanding body of clinical and real-world evidence has elevated the benchmark for what is possible in CLL. We believe that the data shows that only Brukinza provides the long-term outcomes that patients and physicians should expect and should demand. From its inception, Brukinza was designed to provide the best-in-class 24-7 BTK inhibition. Our hypothesis was that achieving complete and sustained BTK inhibition would result in a superior therapeutic profile, and that has been borne out in the almost seven years since, which I'll cover in the next few slides. At ASH 2025, Rukinza set a new standard in frontline CLL, with six-year progression-free survival reported at 74% and overall survival of 84%. Adjusting for COVID, those are 77% for PFS and 87% for OS at six years. CLL is an indolent disease, and admittedly, much of the data across the various medicines for the first three years looks similar, but outcomes beyond this are what truly matter to patients. So this slide builds on the scatter plot, but focuses on the landmark reported PFS at years three through six across phase three trials in frontline CLL. On the left, we see the data for Brukinza and the two continuous PTK inhibitors. Recognizing the limitations of cross-trial comparisons, the early landmark PFS rates for Brukinza are higher and continue to diverge over time. In year six, that reaches a delta of 12%, the equivalent of one in eight patients not progressing. On the right, we see an even more pronounced delta between Brukinza's landmark PFS and that of fixed duration regimens, such as VO. In year six, that's a delta of 21%, or roughly one in five patients. In the unmutated population, which is the majority of CLL patients, the difference between continuous Brukinza and VO is 27%, which is more than one in four patients who started the study. Now, AV has not reported the long-term landmark PFS data to be fully represented on this chart, but I will note that despite Amplify being studied in a young, fit population, which has a median age of 61 versus Sequoia's median age of 70, It has the lowest PFS of any regimen at three years. The last amplified data cut was April 30th, 2024, over two years ago. An additional follow-up data has not been provided, though. Of course, it exists. Brukinza is the only BTK inhibitor that has demonstrated superiority on efficacy versus ibrutinib in a head-to-head trial. Here, we can see the Kaplan-Meier curves from Brukinza and the other BTK inhibitors in their respective head-to-head trials versus ibrutinib in relapsed refractory BTK-naive CLL patients. Brukinza demonstrated superiority with a hazard ratio of 0.69 and a p-value of 0.001. When we presented the initial early cut of these data to the CLL community, the universal feedback was, this is great, but in an indolent disease, we need to see longer follow-up. And there was an important scientific reason for that. Ibrutinib has a known tolerability issues that could potentially influence a patient's ability to stay on the therapy during early treatment. In the ElevateRR study at Calibrutinib, had previously showed early PFS separation from ibrutinib, but that early separation was not sustained. As you can see in the middle panel, acalabrutinib actually crossed over and became numerically worse than ibrutinib at roughly 33 months and reported a hazard ratio of one. And again, while early separation was an encouraging signal, CLL prescribers wanted to see, with Brukinza, sustained separation with longer follow-up to be convinced. You can see that in Alpine, Brukinza showed exactly that. After these data were presented, the adoption of Brukinza began in earnest. Perto, with a very short follow-up period of only 18 months, shows the weakest early separation versus Ibrutinib. with a hazard ratio of 0.845 and a p-value of 0.4102. The CLL community needs to see much longer follow-up data from PERTO, but given this curve, PERTO may face challenges demonstrating statistical superiority on PFS. So what about tolerability? PERTO is self-described as a third-generation BTK inhibitor. with the hope that it would be more tolerable than the second generation covalent BTK inhibitors. In reality, the Bruin 314 study, HERTO demonstrated numerically more adverse events leading to discontinuation than ibrutinib. This is important because it has potential ramifications for use in specific subgroups, such as older patients. Notably, in the BRUIN 313 trial in first-line CLL, the average age of patients randomized to PERTO was 65 years old, roughly five years younger than the respective first-line trials for both of the second-generation covalent BTKIs. But taken together, PERTO's limited follow-up, lack of differentiation on efficacy and tolerability over abrutinib, and its mechanistic rationale designed for covalent BTKI resistance do not support moving it from the relapse setting where it currently plays a much needed role. Brukinza's comprehensive body of evidence continues to expand. It consistently is supporting it as the foundational best-in-class BTK inhibitor. Last quarter, we highlighted three published studies that illustrate Brukinza's efficacy and safety benefits over the existing fixed duration regimens, VO, IV, and AV. And at ASCO, we'll present new evidence from over 58,000 real-world patient data sets, each of which demonstrate the significant real-world benefits of Brukinza. While Brukinza's momentum as the foundational BTK continues, we're aggressively moving to redefine the fixed duration treatment landscape with our next-generation foundational BCL2 inhibitor, Sonro. We intentionally designed Sonro to be 14 times more potent and 6 times more selective than Venetoclax, and with a much shorter half-life to minimize drug accumulation. This differentiated profile may enable a simpler ramp-up compared to the burdensome monitoring that is required by the first-generation agent. The trial studying this optimized ramp-up schedule is progressing well. Sonro's first approvals are as monotherapy, but its true transformative potential lies in combination with Brukinza. The clinical data that we're generating with the combination of Brukinza and Sonro is truly exciting. In the 101 trial shown here, ZS demonstrated a UMRD rate of above 90%. a remarkably flat PFS curve, and a favorable safety profile. This compares very favorably with AV on the right, where in a much healthier, younger population, they saw a UMRD of only 34%. We look forward to sharing updated data from this trial at ASCO. With three phase studies underway, The ZS combination has the potential to change the first-line CLL treatment paradigm and enable B1 to participate in half of the market where today we have no presence. Finally, I want to highlight the progress of our BTK-CDAC, a novel potential therapy for patients who have progressed on other treatments. Our BTK-CDAC is first in class. It shows complete BTK degradation, and it holds a clear mechanistic advantage in terms of BTK mutation coverage. Data presented at ASH 2025 showcased its profound efficacy in heavily pretreated patients, including those with mutations conferring resistance to both covalent and non-covalent BTK inhibitors. In our Phase I-II study, the patients receiving the recommended 200 mg dose achieved an outstanding 94.4% overall response rate, with responses deepening consistently over time. Based on the strong efficacy and favorable safety profile of the molecule, we're advancing highly ambitious clinical development plan, including several phase three trials that are well underway. We've guided to a potential accelerated approval submission in the U.S., relapsed refractory CLL in the second half of this year. In summary, our foundational hematology franchise has never been stronger. Brukinza's driving continued global revenue growth, Sonro is poised to disrupt the fixed duration market, and our BTK-CDAC is leading the next wave of innovation in CLL. Only B1 is uniquely equipped to provide the best-in-class therapies every CLL patient, regardless of their stage of disease. We're looking forward to ASCO and EHA this year, where we will have a large leadership presence, highlighting our foundational medicines and our three rising stars from the solid tumor portfolio, which Lai will tell us more about shortly. With that, I'll pass it over to Erin to provide our financial update.