BeOne Medicines AG

Good day, everyone. Welcome to B1 Medicine's Q3 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 B1 Medicines. Before we begin, please note that you can find additional materials, including a replay of today's webcast and presentations, 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 investor relations website, along with the 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 third quarter financial results and financial guidance. And Lai Wang, our 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 Chalas, our general manager of North America, and Mark Lanasa, our chief medical officer for Solid Tumors. I'll now pass the call over to John. John?

Thanks, Dan, and thank you everyone for joining us today. The third quarter marked another strong quarter of execution. From a financial perspective, revenue reached 1.4 billion, which represents 41% year-on-year growth. Gap earnings per ADS were $1.09, which represents growth of more than $2 over Q3 of last year. And we generated over 350 million of free cash flow during the quarter. As Erin will touch on, we strengthened our balance sheet and ended the quarter with over 4 billion in cash. Rukinza has continued its momentum with sustained US leadership, and it's now the number one BTK inhibitor globally. Sonro, our next-generation BCL2 inhibitor, recently received FDA breakthrough designation in relapsed refractory mantle cell lymphoma, and we're really excited about the totality of data emerging from that molecule, some of which we're going to highlight today. Rukinza, Sonro, and our BTK CDAC are the core elements of our leadership in B-cell malignancies, and they'll be on display next month at ASHE. where we'll present 47 abstracts from across our heme portfolio. The quarter also yielded multiple developments across our growing solid tumor pipeline, including clinical proof of concept for multiple early stage assets, which Lai is going to discuss in more detail later. So let me start with Brukinza, the backbone of our heme franchise. Brukinza continued to perform exceptionally well in the third quarter, growing 51% and exceeding 1 billion in quarterly global revenue for the first time. As a result, and also for the first time, Brukenza is now the global value share leader amongst the growing BTK market. This, of course, is a major milestone for Brukenza and for our company. As I discussed in detail on our Q2 earnings call, the commercial success of Brukenza is not by chance. It's the direct result of an overwhelming body of evidence that has accumulated over more than a decade. It's evidence that spans preclinical, human pharmacokinetics, head-to-head clinical trials, real-world data sets, and patient-physician preference in the market. The evidence is remarkable for both its strength as well as its consistency, and this evidence continues to build. with each new piece of data both reconfirming and further strengthening our initial therapeutic hypothesis that Brukinza is the best BTK inhibitor. At B1, we're relentlessly focused on our goal of discovering and developing innovative medicines that deliver long-term outcomes for patients. At ASH, we're presenting a 74% landmark at six years for Brukinza in first line CLL. This is from our phase three Sequoia trial. We believe that these data have set the bar for what monotherapy PTK can and should be, what they should achieve in CLL. With all the caveats of cross trial comparisons, this is double digit better than what has been reported. for other single agent BTKIs at 72 months. Interestingly, this level of sustained PFS at six years is in the same ballpark as other recent data from BTK ven fixed duration regimens at only three years. Long-term follow-up from years three through six when patients are not on active therapy will be critically important to inform the future relevance of these relevant regimens within the CLL treatment paradigm. And I think along those lines, what's also relevant about this year's ASH is what you're not seeing. Given what I've just said about the importance of our long-term Brukinza data in CLL, the absence of other long-term follow-up data from many other relevant CLL trials, such as Amplify with the last data cut off April 30th, 2024, captivate, and elevate where data hasn't been reported for a couple years. Long-term data are the gold standard in CLL for a reason, because CLL is an indolent disease, and it takes time to fully and truly understand how these regimens perform. Brukenza delivers the level of progression-free survival that patients and physicians should expect and should demand. We believe in the promise of fixed duration. but we also feel that the current Venn-based options fall far short of that promise. In our view, the current options fail to satisfy the four key criteria that you see on this slide, depth of response, sustained PFS, safety, and convenience. Specifically, we have concerns related to the low MRD negativity rates and sustained PFS for AV combinations. the cardiac safety, uveitis, and general tolerability for IV combinations, the long-term effects on the immune system, and the related additional hospitalizations due to infections of ovenituzumab use, and the overall treatment burden and feasibility of use with all of the Venn-based regimens. Our goal in fixed duration is simple. We aim to develop a more efficacious, time-limited regiment that does not come with caveats or accommodations. And based on the data we've generated to date, we believe that the combination of ZANU and SONRO is well on its way to achieving just that. Our confidence in CS is based on the totality of clinical data to date, but there are a couple of key aspects in the data that we find exceptionally compelling. Here you can see the UMRD rates and the time to blood MRD from our phase one trial. This was presented at our R&D day in June, and we'll provide a further update on these curves at ASH. Of all the data our heme franchise is generating, these might be the most compelling to the KOLs that we meet. So let me explain. First, the combination of ZANU and SONRO can drive very high rates of deep response. Secondly, and perhaps more impressingly, It does so exceptionally quickly with kinetics previously unseen in other trials of drugs targeting similar mechanisms. This slide is so important that we're going to show it to you twice today, once now and once in live section. This is the type of deep response that we're looking for in a fixed duration regimen to give physicians and patients the confidence to stop therapy and to achieve positive long-term outcomes. B1 stands out as the only company with fully owned, potentially best-in-class assets across the three foundational MOAs in CLL, Rukinza, Sonro, and our BTK SEDA. All three are anchored in differentiated design hypotheses and bolstered by an ever-growing body of evidence. All three have the potential for the broadest utility in the class. And all three, whether as monotherapy or in combination, represent significant opportunities for patients, physicians, and for our shareholders. Together, Brickenza-Sonroe and our BTK CDAC are driving the future treatment paradigm in the $12 billion and growing global CLL market. Before I close, I'd like to introduce what we're calling our Development Global Superhighway. For those of you that are newer to our story, B1 was built different. Early on, we recognized the vast majority of the time and cost to develop and deliver a medicine was in clinical trials. We felt that such a critical component of the biopharma supply chain should be a core competency rather than something that is outsourced to a CRO. We saw the synergies that were possible by vertically integrating manufacturing with an industry-leading clinical organization. And we know from experience how hard this can be for a small company. So fast forward 15 years, and we're proud to have built a global organization of nearly 6,000 colleagues across these two areas, clinical development and manufacturing. And in today's hyper-competitive, costly and complicated era of drug development, we really believe that this global superhighway is unique to be one. and it's critical to generating superior returns on R&D investment. To close, we're in the midst of an exciting milestone-rich period for both our heme franchise and our solid tumor pipeline. By the end of 26, we expect the initial global approval and launch of Sonro and potentially pivotal data for our BTK CDAC. Our internal clinical team will be running more than 20 phase three trials We anticipate more than 10 proof of concept data readouts and our research organization will advance around 10 new molecular entities into the clinic, three of which will be in heme and not just in CLL, but broadening our portfolio to help patients in other areas. Now I'll pass it over to Aaron to provide the financial update.