BeOne Medicines AG

Good day everyone. Welcome to B1 Q2 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 Mallor 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 .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 business strategy. Actual results may differ materially from those indicated and the forward statements has resulted 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. Reconciliation between gap and non-gap financial measures discussed on this call provided in the appendix to our presentation which is posted to our investor relations website along with our instruments. 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. 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 second 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 I'll now pass the call over to John.

John. Thank you Dan and welcome everyone to our Q2 earnings call. We had a spectacular second quarter. Our revenue reached 1.3 billion which represents 42 percent -on-year growth. Gap earnings per ADS grew two dollars from Q2 of last year and we generated 220 million of free cash flow in Q2. This is an absolute increase of over 400 million versus last year. From a commercial perspective, Brukinsa has cemented itself as the number one BTK inhibitor in the U.S. market. This quarter we also hosted an R&D day where we shared three takeaways with you. First, why we believe our internal capabilities and our sense of urgency will drive superior returns on R&D. Second, how our hematology franchise is poised for sustained leadership into the next decade. And three, why you should pay close attention to our prolific and differentiated solid tumor pipeline. I want to come back now to Brukinsa, the cornerstone of our CLL franchise. Brukinsa's best in class profile has resulted in rapid adoption by patients and physicians across the U.S. despite launching in CLL nine years after Brutonib. Here we see the U.S. revenue performance of the three approved covalent BTK inhibitors since Brukinsa's CLL approval. The chart speaks for itself. The gap between us and the competition continues to widen. Brukinsa is both the market share leader and it's the fastest growing brand and it's the only BTK to be approved in five indications. Now the success of Brukinsa is not an accident. It's the direct result of an overwhelming body of evidence accumulated over more than a decade. This evidence is remarkable both for its strength as well as its consistency. When we designed Brukinsa, our preclinical hypothesis was that sustained inhibition of BTK in the disease compartment and improved selectivity for BTK over off-target kinases would translate to a differentiated medicine for patients. Since then, Brukinsa has treated thousands of patients in clinical trials and over 200,000 patients commercially. Brukinsa has differentiated itself each and every step of the way from human PK to clinical response to PFS and now in the market where it continues to generate compelling real-world data. As you know, the goal in oncology drug development is to hit the target hard and never let up, never give the cancer an opportunity to grow. As you can see on this slide, the prior generation BTK inhibitors only hit the target for a fraction of the day. But Brukinsa is different. It was designed to inhibit BTK 24 hours a day, seven days a week. We hypothesized that Brukinsa's superior target coverage would translate to superior clinical benefits for patients. As you can see on this slide, in the Alpine trial, Brukinsa drove higher responses compared to the previous trial. This result was clear at the earliest data cut and more importantly, it was maintained with longer follow-up. Next, we followed the data to see whether the collective and consistent results across preclinical human PK and tumor shrinkage would be associated with improved and sustained PFS. Clearly, it was. Brukinsa is the only BTK to demonstrate superior PFS and favorable safety in a -to-head trial against Ibrutinib. In the Alpine trial, Brukinsa exhibited a 34% reduced risk of progression or death and lower cardiac toxicity versus Ibrutinib. There were zero cardiac deaths in the Brukinsa arm versus six on the Ibrutinib arm. In the deletion 17P and TP53 subpopulations, which are the toughest patients to treat, Brukinsa's treatment effect was even more pronounced. Brukinsa showed a remarkable 52% reduced risk of progression or death versus Ibrutinib. The Alpine data showed that Brukinsa is the -in-class option for all types of patients, regardless of mutation or risk status. So fast forward to today. Patient and physician adoption has driven Brukinsa to be the top BTK inhibitor in the U.S. This slide shows two examples of recent presentations and publications supporting Brukinsa's differentiation versus both a Calibrutinib and Ibrutinib. On the left is a real-world study that demonstrated that patients treated with Brukinsa had longer time to discontinuation, lower discontinuation rates, and less health care resource utilization than those treated with a Calibrutinib and Ibrutinib across all patients. And this was even more pronounced in the population of older patients over 65, as shown here. On the right is just one example of another recent publication by a leading CLL KOL that recognizes Brukinsa's differentiated data and how Brukinsa can provide the best outcome for their patients. Looking beyond Brukinsa, B1 stands out as the only company with fully owned, differentiated, and potentially -in-class assets across all three foundational MOAs in CLL. We're already combining these assets in multiple Phase III trials with the goal of improving outcomes for patients even further. We believe our relentless focus on serial innovation in CLL positions us as the only company that can address the full scope of unmet patient need across all lines of therapy and subpopulations. With that said, we're far more than a CLL company. We're a global oncology company, and we have a wealth of upcoming milestones on the horizon. By the end of 2026, we expect the initial global approval of SONRO and potentially pivotal data for our BTK CDAC. Our internal clinical team will be running more than 20 Phase III trials, and we anticipate more than 10 -of-concept data readouts, and our research organization will again advance more than 10 NMEs into the clinic. And with that, I'll pass it over to Aaron to provide the financial update.