BioNTech SE

Thank you all for joining us today as we review our third quarter operational highlights and provide you with a financial update. BioNTech is an exciting phase of its corporate development and we are delighted to share our brokerage with you. A few housekeeping items before we start. I invite you to view the slides that accompany the webcast and the third quarter 2022 press release, both of which were issued this morning and can be found in the investor section of our website. Taking a first look at slide two, I would like to remind you that during today's presentation, we will make several forward-looking statements. These forward-looking statements include but are not limited to our COVID-19 vaccine revenues, as these include figures that are derived from preliminary estimates provided by our partners, our estimated financial results for 2022, the continued global demand for COVID-19 vaccine, expected COVID-19 vaccine production, supply and delivery for 2022 and beyond, the planned next steps in our pipeline programs, the timing for enrollment, initiation, completion, reporting of data from our clinical trials, the timing of and our ability to obtain and maintain regulatory approval for our product candidates, and other risks described in our findings made with the U.S. Securities and Exchange Commission, including our most recent quarterly report today. Actual results could differ from those we currently anticipate. You are therefore cautioned not to place undue reliance on any forward-looking statements which speak only as of today, shared today during the conference call and webcast. Also, please note that slides three and four provide detailed and important safety information regarding our COVID-19 vaccine. Finally, today's agenda can be found on slide five. It is my pleasure to welcome the BioNTech management team, who will guide you through our third quarter update. I'm joined by Uwe Schahin, CEO and co-founder of BioNTech, Erzlem Tureci, our chief medical officer and co-founder, Jens Holstein, our chief financial officer, and Brian Richardson, our chief strategy officer. With that, I would like to turn the call over to Uwe.

Thank you, Silke. A warm welcome to all participants of today's conference call. I am pleased to update you on BioNTech's operational progress during the third quarter of 2022. Before I start, let me tell you the fundamentals of our success. With our deep expertise in immuno-oncology, our scientific rigor, our fully integrated spectrum of translation research and manufacturing competencies, we succeeded together with our partner Pfizer in developing and supplying variant-adapted vaccines globally. We did so at an unprecedented speed. Since BioNTech inception, we have pursued our vision to establish a fully integrated global immunotherapy powerhouse aspiring to translate science into survival. We follow a technology-agnostic, solution-focused, multi-platform strategy. Our innovation engine leverages various emerging technologies and therapeutic approaches. Our aim is to address high unmet medical needs in oncology, infectious diseases, and beyond. We are advancing a diversified product pipeline of immunotherapies and are saving an unprecedented opportunity to accelerate our progress towards our long-term vision to bring the next generation of immunotherapies to patients. Moving to our third quarter highlights, we reported total revenues of 3.5 billion euros, contributing to total revenues of 13 billion euros for the first nine months of the year. The strong performance can be attributed to the continued successful execution in our COVID-19 vaccine franchise and reflects shipments of the Omicron adapted vaccine booster, which started early in September. We are updating our 2022 financial guidance by raising our vaccine revenues estimated to 16 to 17 billion euros. We have expanded our team to more than 4,000 employees around the world. We are expanding our global mRNA manufacturing network to ensure access to our innovative medicines worldwide. We recently signed a letter of intent with Australia's State of Victoria for strategic partnerships to establish an mRNA research and innovation center and help to translate encouraging academic research into the clinic. We will establish one of our modular BioNTena manufacturing facilities in Melbourne to enable end-to-end clinical scale manufacturing of mRNA product candidates. In oncology, we are executing across our broad pipeline. We have advanced a total of 19 candidates in 24 ongoing clinical trials, including five Phase II trials. In the third quarter, three new programs entered Phase I. At this year ESMO conference in September, we presented another positive clinical update for BNT211 for the treatment of solid tumors. Ersan will share more detail on the data update momentarily. Slide seven highlights our quarter three progress with our COVID-19 franchise. This quarter, we and our partner Pfizer continue to build on our global COVID-19 vaccine leadership with first-to-market Omicron BA.4, BA.5-adapted vaccine launches across multiple countries and regions worldwide. As of mid-October 2022, we have invoiced approximately 300 million doses of our BA.1 or BA.4.5-adapted bivalent vaccines. We had multiple regulatory developments around our original Cominati vaccine. The vaccine is undergoing conversion to full market approval in several regions around the globe. It has received full marketing authorization in the EU for all existing and upcoming indications and formulation. Additionally, we received EC approval for free dose primary series in children aged six months to five years in the EU and for a third booster dose for children aged 5 to 11 years. A fourth booster dose was recently approved by the EC for individuals aged 12 and older. With these regulatory approvals, our COVID-19 vaccine has one of the broadest labels among available vaccines. Our Omicron BA.4.5 bivalent vaccine boosters now have approvals for use in more than 45 countries and regions worldwide. We recently reported initial positive data at the 30-day post-boost time point in the phase 2 free clinical trial of our Omicron BA.4.5 adapted bivalent vaccine in individuals 12 years and older. Additionally, we initiated a phase 1.2 free trial of the Omicron BA.4.5 adapted bivalent vaccine in children aged 6 months to 11 years. At the end of October, as part of our ongoing collaboration, we and our partner Pfizer initiated a phase one clinical trial evaluating our Omicron BA.4.5 adapted bivalent vaccine in combination with an mRNA influenza vaccine. The mRNA influenza vaccine candidate is also partnered with Pfizer and has now advanced to phase three clinical testing after positive data from the phase two trial were reported in second quarter of this year. Slide 8 highlights our COVID-19 vaccine execution on a global scale. Our mRNA platform and established processes allow for development, testing, and manufacturing of variant-adapted vaccines at unprecedented speed, supporting a rapid regulatory path. With the occurrence of Omicron end of 2021, we and Pfizer started evaluating monovalent and bivalent vaccines directed against Omicron sub-lineages and other strains of SARS-CoV-2. Data from this study were presented to regulatory agencies in June and July 2022, which supported regulators' definition of the most appropriate regulatory pathway. It took us approximately two months to go from the first regulatory recommendation for B.4.5 adapted vaccine to our first shipment of the respective vaccine. The ability to execute with such a speed was enabled by three factors. Our continued surveillance and analysis of variants of concern, our extensive and proactive COVID-19 clinical program, and the rapid manufacturing adaptation. We are well positioned to supply countries and regions around the globe. I thank our team and collaborators for their tireless efforts to make this accomplishment possible again. in such a short period of time. Slide nine. The need for an Omicron BA.4.5 adapted booster supported by current research, including our own data, as shown on slide nine. In the northern hemisphere, we tend to see case numbers steadily rising. Epidemiologically speaking, BA.4.5 and their related sub-images continue to be the dominant strains. Omicron BA.4.5 adapted bivalent vaccines may also confer robust protection against potential future emerging omicron sublineages or new variants of concern that are closer to the wild-type strain. The enhanced neutralization breath may be driven by expansion of memory B-cells against epitope-shared pro-EMM variants, as well as, in part, induction of de novo immune responses against new epitopes. Moreover, expansion and preservation of T cell responses may protect against severe disease. Slide 10, looking at the evolution of COVID-19 pandemic and current real world evidence, we anticipate a long-term need for annual or seasonal variant adapted boosters. If the virus is in a state of continuous evolution, the possibility of a new wave of infections driven by novel immune evasive strains remains. We are vigilantly monitoring the landscape and are prepared to adapt our vaccines as needed. The risk of severe COVID-19 disease remains high in the vulnerable population. The full extent of the prevalence of COVID-19 patients who go on to experience longer-term health consequences is also not yet fully understood. Clinical data have demonstrated that boosters extend the protection offered by COVID-19 vaccines, which research has shown natural immunity acquired by SARS-CoV-2 infection is valuable across individuals and the protection it offers reigns over time. A booster restores and enhances infection-acquired immune protection and further reduces the risk of the infection. Slide 11 shows our framework to support a sustainable vaccine business in future. First, we have demonstrated the safety, tolerability, and efficacy of our mRNA COVID-19 vaccines. Second, we have shown our ability to rapidly adapt our product and processes to address emerging variants of concern. Third, our expertise at navigating the evolving regulatory landscape on a global scale has positioned us as a first mover and enabled us to receive one of the boldest labels among currently available COVID-19 vaccines. This applies to both the original Cominati vaccine and our Omicron BA.4.5 adapted vaccine. Fourth, with continued innovation, we are improving the already strong product profile of our COVID-19 vaccine. targeting continued protection from current and future viral threats. These four pillars are built on our validated mRNA platform of proven science, discovery, development, manufacturing, and commercialization, and position us for success as we continue to expand and advance our pipeline and build our 21st century immunotherapy powerhouse. With that, I would like to thank you all for your confidence in our success and your continued support and turn the call over to Erslan.

Thank you, Uwe.