BioNTech SE

Welcome to BioNTech's fourth quarter and full year 2025 earnings call. I will now hand the call over to Doug Maffei, Vice President, Strategy, Investor Relations. Please go ahead.

Thank you, Operator. Welcome to BioNTech's fourth quarter and full year 2025 earnings call. As a reminder, the slides we will be using during this call and the corresponding press release can be found in the investor section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements on this call are subject to significant risks and uncertainties and speak only as of the date of this conference call. We undertake no obligation to update or revise any of these statements. On slide three, you will see the agenda for today's call. I'm joined today by the following members of BioNTech's management team. Ugo Shaheen, Chief Executive Officer and Co-Founder, Oslem Tureci, Chief Medical Officer and Co-Founder, and Ramon Zapata, Chief Financial Officer. With this, I'll hand the call over to Ugar.

Thank you, Doug, and a warm welcome to everyone as you join us today. As BioNTech has grown, our vision has remained constant, namely translating science into survival. Our focus is on oncologies. Cancer remains a complex systems problem, varying between patients and further with an individual tumor. We believe that the future lies in rationally designed therapeutic combinations that pair potent precise mechanisms of action to achieve biological synergies. To this end, we have purpose-built a diversified clinical pipeline, spending next generation immunomodulators antibody drug conjugates, and mRNA immunotherapies that enable effective personalized precision medicine and novel-novel combinations across soda tumors. In 2025 and early 2026, we have made strong progress towards realizing our ambitions. The year was marked by important achievements in four key areas. We have maintained our leadership in the COVID vaccine market and launched our variant adapted vaccine in partnership with Pfizer. Our vaccine is now distributed in over 180 countries with more than 50% market share in major markets. Second, we have advanced our oncology programs with a registrational nucleus advancing in lung and breast. supported by a bold clinical evidence base with more than 4,000 patients enrolled across Phase II and Phase III studies. As I've said, we anticipate multiple late-stage event-driven readouts in 2026. In parallel, we now have more than 10 novel-novel combination trials with Prometamic in progress. We executed key strategic deals most importantly with BMS, to strengthen the execution of and help de-risk our Prometamic programs. We acquired Bioceus, thus gaining full rights to our cornerstone acid Prometamic, and completed the acquisition of CureVac, strengthening our position in the mRNA field. And last but not least, we exceeded our already increased 2025 revenue guidance and ended the year in a strong financial position with more than 17 billion euros in cash, cash equivalents and securities. We maintained disciplined resource allocation with active portfolio management, focusing on late-stage programs that provide a clear potential to drive value appreciation. For 2026, we are focused on three key priorities. The first is to accelerate the late-stage development of our first wave of oncology assets, and we anticipate key late-stage data readouts this year. Second is building momentum in our combination-based approach. Multiple data readouts from our novel novel thrombotomic combination trials are expected this year and will inform our first thrombotomic plus ADC pivotal trials. Third is to continue our evolution from our platform-centric approach to a tumor-centric clinical development program centered around high-incidence cancers, including lung cancer, breast cancer, and other tumors. The foundation of this matrix approach is leveraging our diverse clinical assets for combination strategies, which will allow us to address several lines of treatment with different combinations. Our current late-stage pipeline illustrates the broad and robust approach we are taking to advance our ambition to become a multi-product company. Today, we have a growing set of late-stage and pivotal programs across high-incidence tumors with a clear registrational path and stage expansion options where we believe we can make meaningful difference for patients. We expect a sustained cadence of event-driven late-stage readouts across different tumor types from 2026 to 2030. Our clinical program provides multiple approval opportunities, and we are building launch readiness now, deepening indication-specific expertise, and advancing commercial and market access capabilities in the tumor types where we anticipate first launches. Earlier today, we announced plans to pursue next-generation mRNA innovations in a new independent company as BioNTech advances towards becoming a multi-product company by 2030. The new company will be founded and led by Aslam and me, and we are both excited at the prospect of this new chapter on our personal journey towards our vision to translate our science into meaningful advances for patients. In order to do this, our new company will be built with distinct resources, operations, and funding options. BioNTech plans to contribute related rights and mRNA technologies to the new company. In exchange, BioNTech will hold a minority stake in the company. This will enable and support prioritized development of these innovative technologies. A binding agreement is expected to be signed by the end of the first half of this year. Özlem and I will transition to lead our new company by the end of 2026, when our current BioNTech service agreements end. As BioNTech founders and significant shareholders, we will remain close to the company. BioNTech will continue to sharpen its strategic focus on the development and commercialization of its growing late-stage pipeline spanning innovative immunomodulators, ADCs, and mRNA candidates. Combination approaches are a core part of BioNTech's strategy to maximize the value of our next-generation immune oncology backbone candidate, Pumetamic. BioNTech's potential stake in the new company will provide both organizations with opportunities to collaborate on combination approaches involving their candidates with the potential to create new complementary or synergistic treatment strategies. BioNTech and our new company will each have unique capabilities, world leading expertise and the focus on their respective strategic priorities to maximize value for patients and shareholders. Over the past 18 years, we have built BioNTech from a startup into a global biopharmaceutical company with a strong and diversified pipeline. During the COVID-19 pandemic, we expanded beyond oncology to develop the first approved mRNA vaccine helping to protect people worldwide. None of this would have been possible without the extraordinary dedication of our teams, the trust of our shareholders and supervisory board, and the commitment of the partners who have supported us along the way. Today, BioNTech is well positioned to advance its mission and become a commercial multi-product company. I look forward to updating you on our progress throughout this year. Thank you all. With this, I will hand over to Esten for an update on our oncology execution.