BioNTech SE

Welcome to the BioNTech's fourth quarter and full year 2023 earnings call. I would like to hand the call over to Dr. Victoria Meissner, Vice President of Strategy and Investor Relations. Please go ahead.

Thank you. Good morning and good afternoon. Thank you for joining BioNTech's fourth quarter and full year 2023 earnings call. As a reminder, the slides we'll be using during this call and the corresponding press release we issued this morning can be found in an investor relations 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 in this call are subject to significant risks and uncertainties, speak only as of the date of this conference call, and we undertake no obligation to update or revise any of these statements. On slide three, you can find the agenda for today's call. Today, I'm joined by the following members of BioNTech's management team. Ugr Sahin, our CEO and co-founder, Erlim Tureci, chief medical officer and co-founder, Jens Holstein, chief financial officer, and Ryan Richardson, chief strategy officer. With this, I would like to hand over to Ugr.

Thank you, Victoria. A warm welcome to all those joining us today. Slide five. Let me start by reiterating our vision and company goals. BioNTech was founded 15 years ago with the vision to harness the power of the immune system to fight human diseases, particularly cancer. The emergence of the pandemic accelerated our mission leading to the development of our COVID-19 vaccine. This achievement not only showcased the versatility of our mRNA technology, but also highlighted our unique expertise and ability to execute fast. Our vision was realized and broadened, illuminating the potential of our science across other therapeutic areas. Building on this, our three objectives moving forward are to establish a multi-product company powered by our pioneering technologies and science to address medical needs worldwide. to contribute to the development of innovative precision medicines against cancer, aiming for multiple product approvals in the coming years, and to expand and strengthen our sustainable respiratory infectious disease vaccine business, building on the success of our Cominati franchise. Slide six. On the next slide, I want to talk about our clinical achievements in 2023. We successfully advanced our clinical pipeline and enhance our technology platforms, digital capabilities, and infrastructure by executing across our key strategic initiatives. We continue to develop and empower our innovative oncology and infectious disease pipelines. Today, we have over 20 programs in oncology and seven programs in infectious disease being evaluated in more than 40 clinical trials, including multiple phase two or phase three clinical trials. I'm particularly excited about our recent achievements in shaping our oncology pipeline. We started seven clinical trials in license six clinical assets throughout the year. Most importantly, several assets have advanced to mid and late stage development with phase two and phase three clinical trials ongoing. These trials feature antibody drug conjugates, mRNA vaccines, and novel IO therapies in indications such as lung cancer, breast and endometrial cancer, adjuvant colorectal cancer, and adjuvant pancreatic cancer. In infectious disease, we started three first in human phase one clinical trials, leveraging our proprietary mRNA vaccine technology, including candidates being evaluated against shingles, tuberculosis, and mpox. Over the course of 2024, we aim to advance and prioritize additional product candidates to late-stage development. We expect to have 10 or more potential regular situational tests running. Slide 7. The field of oncology is currently undergoing a significant shift away from traditional chemotherapy towards combination therapies. This shift leverages the power of immuno-oncology and antibody drug conjugates to potentially transform also advanced cancers into manageable conditions. As we reflect on the achievements of 2023, we can proudly say that we have accelerated our IO and ADC programs by not only starting new trials, but also successfully recruiting over 2,000 patients into our clinical trials across various indications. This is a testament to the hard work and dedication of our team and our collaboration partners, as well as the trust and willingness of patients to participate in our studies. Looking ahead to 2024, we aim to build on the success and recruit patients into our clinical trials across indications such as lung cancer, breast cancer, colorectal cancer, and other indications. Slide eight, in 2023, We successfully executed strategic investments, acquisitions, licensing agreements, and public-private partnerships, enabling our continued progress towards building a multi-product, AI-powered, patient-centric company. Since our foundation, we have placed a strong emphasis on computational medicine, data science, artificial intelligence, and machine learning. With the acquisition of InstaDeep, we are integrating capabilities in supercomputing, AI research, and generative AI into various processes. For example, to identify and optimize molecules, to predict biological and clinical outcomes, and to speed up our workflow. In 2023, we expanded our technology base to include ADCs by initiating new collaborations with Duality Bio and MediLink Therapeutics. We believe ADCs have the potential to supplement or replace highly toxic chemotherapy regimens as a new combination backbone of cancer treatment. Our collaborations with OncoC4 and BioFeos complement our toolkit of technologies with next-generation IO antibodies that offer unique mechanisms of action and have augmented our oncology pipeline with mid- to late-stage clinical programs. We have started strongly in 2024 on the collaboration front by announcing a strategic alliance with Autolus aimed at advancing both companies' autologous CAR-T cell programs towards commercialization. With this collaboration, we will support the development and commercialization of Autolus' lead cell therapy candidate, OviCell, and retain options to participate in its Auto-122 and Auto-6NG programs. Importantly, we have the option to use auto-loss commercial and cell therapy manufacturing infrastructure in a cost-efficient manner. This is of relevance for our plans to extend the development of BNT211 to additional Clotin-6 positive tumor types and thus realize its full potential. Slide 9. BNT211 is our CAR T-cell therapy targeting Clotin-6. To improve CAR-T cell engulfment and persistence, we co-developed a CAR-T cell amplifying RNA vaccine, or CARVAC for short. BNT211 is one example of BioNTech's novel-novel combination. The goal is to enhance persistence and effector function of CAR-T cells by repeated administration of CARVAC. Recently, we presented data suggesting a favorable effect of CARVAC on CAR-T cell persistence in our clinical trial with Claudine 6 tumor. Based on the promising early clinical results, we believe that BNT211 has the potential to make a significant impact in patients with Clotin-6 positive tumors. Our near-term strategy is to establish Clotin-6 as a proven target in solid tumors and to establish BNT211 as the first CAR T cell therapy in germ cell tumors. Clotin-6 is both Clotin-6 is broadly expressed in solid cancers, including ovarian, lung, gastric, pediatric cancers, and others. Upcoming data will inform the development path for other tumor indications. Slide 10. In 2024, we will continue building a portfolio of compound classes that have been adjusted mechanisms of action, including immunomodulators, targeted therapies, and mRNA vaccines. We believe that combination of these therapies, if approved, could play an important role in the efforts towards potentially curative approaches. With that, I would like to thank you all for your confidence in our success and your continued support. I will now turn the call over to Özlem, who will speak about our oncology practice.