BeOne Medicines AG

Good day, everyone. Welcome to Beijing's Q1 2025 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 Beijing. Before we begin, please note that you can find additional materials including a replay of today's webcast and presentation 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 displayed on 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 to the date of the 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. Xiaobin Wu, our president and chief operating officer, will provide an update on our global commercial progress. Matt Shaulis, our general manager of North America, will provide an update on the U.S. commercial performance of Burkinza. Lai Wong, our global head of R&D, will discuss our R&D and pipeline progress. And Aaron Rosenberg, our CFO, will review the first quarter financial results and financial guidance. We will then open the call to your questions. I'll pass the call over to John. John?

Thank you, Dan, and welcome everyone to our Q1 earnings call. Last quarter's call, I spoke about three priorities for 2025. The first was solidifying and deepening our hematology franchise leadership. The second was advancing our prolific pipeline of internally developed assets. And the third was driving superior financial performance. I'm excited to share with you how we delivered on these priorities through the first quarter. Beijing is the only company with an internally discovered and wholly owned portfolio of potentially best-in-class molecules across all three foundational mechanisms in CLL. We believe our relentless focus on serial innovation in CLL uniquely positions us to address the full scope of unmet patient need across all lines of therapy in subpopulations. Brukinza is the best-in-class BTK inhibitor that serves as the backbone of our franchise. In the U.S., Brukinza is the leader in new patient starts for both frontline and relapsed refractory CLL and across all of its approved indications. Brukinza possesses the broadest label of any BTKI. And for the first time, Brukinza has surpassed both ibrutinib and acalabrutinib in overall U.S. quarterly revenue and continues to outpace its BTKI competitors in year-over-year growth. This leadership follows the science and the data and reflects Brukinza's clear clinical differentiation. Brukinza is the only BTKI to exhibit complete and sustained inhibition. And it's the only BTKI to demonstrate superior efficacy and safety in a head-to-head trial against ibrutinib. And anchored by its best-in-class clinical data, Brukinza has now treated over 200,000 patients globally. Sonro, our potentially best-in-class BCL2 inhibitor, continues to advance rapidly through late-stage clinical development. We've completed enrollment in our Phase 3 celestial trial of Sonro plus Xanu in treatment-naive CLL, and we've progressed two additional Phase 3 trials, as Lai will review. Importantly, we've reached our first registrational milestone for Sonro with a regulatory filing submitted in China, and we plan to submit our first global filing in the second half of this year. These filings mark the beginning of Sonro's evolution in a potential game-changing therapy across multiple B-cell malignancies. We're the leading next generation of innovation in CLL with our first-in-class BTK-CDAC program, which has now dosed over 600 patients and continues to progress rapidly. We've reached an agreement with the FDA on a Phase III dose, and we've already initiated our first Phase III trial, with plans to initiate another Phase III trial against pertubrutinib in the second half of the year. We continue to expect data from our potentially pivotal phase two trial next year, and pending positive results intend to complete global regulatory submissions. Outside of heme, we continue to advance one of the broadest solid tumor pipelines in the industry. Our CDK4 inhibitor continues to advance rapidly, with over 300 patients enrolled, including over 100 in just the past two months. Our B7H4 program, a key area of enthusiasm, has completed seven monotherapy cohorts with promising signs of clinical activity. We enrolled the first patients in both of our Claudine 6 CD3 bispecific program for gynecological and other solid tumors and our second generation BCL2 for metastatic breast cancer. And our PRMT5 inhibitor also entered the clinic in early Q1, marking another milestone in our targeted lung cancer therapy portfolio. This year, we anticipate more than 10 proof-of-concept readouts across our solid tumor pipeline, each representing a potential near-term value inflection point. These assets feature differentiated potentially first and or best in class profiles and have the potential to deliver transformational impact for both patients and shareholders. Our internal clinical development team of 3,700 plus continues to demonstrate time, cost, and quality advantages that are driving higher ROI for each R&D dollar spent. And we're routinely seeing proof of these advantages and programs in competitive settings like our BTK-CDAC, our BCL-2, and our CDK-4 inhibitor, just to name a few. Moving to financial performance, we achieved a major milestone in Q1. Gap profitability for the first time. Aaron will provide more detail later in the call, but these strong quarterly results pace us on solid footing to deliver on our full year of financial guidance. I'd like to close by sharing a few reflections on the external landscape as our industry continues to navigate in an increasingly challenging and complex global environment. I believe our unique model positions us exceptionally well to succeed in spite of today's challenges. Over the past 15 years, we've built an organization from scratch that is technology enabled, time and cost advantaged, and now vertically integrated. It was built not only to survive, but to thrive in a world with pricing pressure. In today's macro environment, a global manufacturing footprint and regional resilient supply chain are essential to ensuring product availability and operational continuity. This has been a foundational principle of our operations across the U.S., Europe, China, and other key markets. We've realized this vision with action, including most recently an $800 million investment in our Hopewell, New Jersey manufacturing facility, which opened in 2024. With the landscape around trade policies and tariffs will continue to evolve, our commitment to regional manufacturing helps us mitigate potential risks and maintain reliable supply. Finally, I'm pleased to announce that the shareholders have approved our re-domiciling to Switzerland from the Cayman Islands, as well as our name change to B1 Medicines, reflecting our continued evolution into a globally diversified oncology leader and our deepening ties to the world-class Swiss biotech ecosystem. And with that, I'll pass it over to Xiaobing to provide a global commercial update.