BioNTech SE

Good morning and good afternoon. Thank you for joining us today to review BioNTech's third quarter 2021 operational progress and financial results. Before we start, we encourage you to view the slides for this webcast, as well as the operational and financial results pressed for these issues this morning, both of which are accessible on our website in our investor section. As shown on slide two, during today's presentation, we will be making several forward-looking statements. These forward-looking statements include, but are not limited to, our current estimated COVID-19 vaccine revenues based on current contracted supply orders, particularly for those figures that are derived from preliminary estimates provided by our partners, our estimated financial results for 2021, our continued global demand for our COVID-19 vaccine, our target vaccine production capacity for 2021, and beyond our ability to supply our COVID-19 vaccines. The planned next steps in our pipeline program, the time for enrollment, initiation, completion, and reporting of data from our clinical trials, and other risks described in our findings made with the U.S. Securities and Exchange Commission, including our most recent annual report on Form 20F. Actual results could differ from those we currently anticipate. We are therefore cautioned not to place undue reliance on any forward-looking statements which speak only as of today, shared today during this conference call and webcast. Also, please note that slide three and four provide detailed and important safety information regarding our COVID-19 vaccine. Slide five is our agenda for our call today. I'm joined today by our CEO and co-founder, Ugo Zahin, Eslento Reggie, our Chief Medical Officer and Co-Founder, John Merritt, our Chief Business and Commercial Officer, Jens Holstein, our Chief Financial Officer, Ryan Richardson, our Chief Strategy Officer, and Sid Cutting, our Chief Operating Officer. I now turn the call over to Uwe Sahin. Uwe?

Thank you, Silke. Good morning and good afternoon, and thank you to everyone joining the call today. Today, I will walk you through the key highlights of last quarter's performance before inviting my team to go into further detail. Our strong performance continued in the third quarter in terms of commercial execution and clinical pipeline advancement. With our partner Pfizer, we have shipped more than 2 billion doses of our COVID-19 vaccine to more than 152 countries or regions worldwide. We continue to be humbled by the impact of our vaccine and of our company is having in addressing the global pandemic. We still have further to go to reach many parts of the world. We are prioritizing equitable vaccine access to low- and middle-income countries. In the first three quarters of 2021, we expanded our oncology pipeline faster than during any other period in our company's history. We initiated three randomized phase two trials and multiple first in human studies. We will present data for six of our programs at the upcoming CITSE conference, clearly demonstrating the progress in our cancer pipeline. Ersan will provide details on some of these updates in her prepared remarks. Moving to slide seven. Our strategy remains focused on bringing our board pipeline of next generation immunotherapies and vaccines to patients worldwide to address cancer and a growing list of infectious diseases. The transformation of BioNTech into a global, fully integrated immunotherapy powerhouse is continuing at a rapid pace. We are adding talent to our team. We are expanding our capabilities and geographic presence we are increasing our investment in automation, digitalization, and AI technologies. Our vision is to build a high-technology company of the coming age. We are developing and extracting innovations at the intersection of immunology and synthetic biology. We believe our innovations can make a profound difference for people around the world, and we remain committed to investing in the company to deliver on this vision in the years to come. Slide eight. We are driving innovations across multiple therapeutic platforms to harness the power of the immune system and to transform treatment paradise in infectious disease and solid tumors. The last 18 months have demonstrated the power, flexibility, and the speed of our mRNA vaccine technology. We have established a proven path to regulatory approval for our first mRNA vaccine and have created one of the largest safety databases for a pharmaceutical product. This is supported by a global manufacturing and distribution network that has capacity to provide billions of doses of vaccine supply for the world. Behind COVID-19, we are advancing a pipeline of 10 novel vaccines and immunotherapies for diseases which pose major global health challenges, including influenza, HIV, tuberculosis, and malaria. We plan to accelerate our efforts here and aim to initiate multiple clinical trials in the next 18 months. In oncology, we are building a toolbox of technologies across a range of drug classes, We now have 15 oncology product candidates in 19 ongoing clinical trials, including four active phase two trials. We are addressing a wide range of therapeutic targets with diverse and complementary modes of action. We believe that this multi-modal approach opens up new and powerful combination therapy opportunities across a broad range of solid tumors where current standards of care remain not to be sufficient. Finally, we believe that the broad spectrum of our technologies will enable us to bring forward new treatment approaches that have the potential to broaden the disease horizon beyond oncology and infectious disease, like autoimmune and inflammatory diseases, and even regenerative medicine. Slide nine summarizes the key highlights for the third quarter. Our financial performance continues to be strong. We recorded in Q3 revenues of approximately 6 billion euros driven by the continued ramp up of COVID-19 vaccine production and delivery worldwide. Today we are announcing a new expansion of our infectious disease toolkit. a new class of precision antibacterials through the acquisition of Phagomate, an Austrian biotechnology company. The transaction complements our infectious disease pipeline of mRNA vaccines and mRNA-encoded antibodies with a new precision antibacterial technology that we believe could be useful against the global challenge of antimicrobial resistance. In the third quarter, we initiated dosing in our randomized phase 2 trial of autogene sevomeran, or BNT122, our INS candidates for the adjuvant treatment of high-risk colorectal cancer patients who are positive for circulating tumor DNA. In addition, our fixed product candidate, BNT111, was recently granted orphan designation by the US FDA for the treatment of advanced checkpoint inhibitory refractory or resistant melanoma. In infectious diseases, in September, Pfizer initiated a first human study of BNT161, an influenza vaccine based on our mRNA technology. Moving the highlights of our COVID-19 vaccine, we have now distributed a total of more than 2 billion vaccine doses globally. We expect to produce up to 3 billion doses for 2021 and expect to deliver up to 2.5 billion COVID-19 doses by the end of this year. In 2022, we expect a manufacturing capacity of up to 4 billion doses. Our COVID-19 vaccine has now received full VLA FDA approval in the United States for the use in individuals age 16 and older. The U.S. FDA has also authorized a boosting with a third dose of the vaccine for some high-risk population. In the EU, a booster dose has been approved for subjects 18 years and older. To support the extension of the vaccine label to include children age 5 to under 12, a clinical data package has been submitted to regulators around the globe. The FDA has recently granted emergency use authorization of BNT162B2 in children age 5 to under 12, and the U.S. government purchased an additional 50 million pediatric doses. I feel humbled about our team's continued exceptional work and would like to close my remarks by emphasizing that even if BioNTech is transforming, we will continue to stay true to our vision and remain focused on our goal to bring next-generation immunotherapies to patients around the world. I will now turn the call over to Sean, who will provide updates on our COVID-19 program.

Thanks, Ugo. It's a pleasure to be speaking with everyone today. Turning now to slide 11, together with our collaborators Pfizer and Fosun Pharma, we have established a global development program and distribution network for our COVID-19 vaccine. Our order book for 2021 continues to be strong with the addition of several new orders from the US, Japan, and other regions last quarter. Discussions with regard to additional contracts for 2022 and beyond remain ongoing. We anticipate that the additional 50 million pediatric doses ordered by the US government should be delivered by April 30th, 2022. With this order, the U.S. government has exercised its final purchase option under its existing supply agreement, bringing the total number of BNT162b2 doses secured under this agreement since the start of the pandemic to 600 million. We continue to lead in ensuring equitable vaccine access to low and middle income countries BioNTech has pledged 2 billion doses by the end of 2022, and a significant amount of our remaining 2021 manufacturing will be allocated to equitable vaccine access. Importantly, we have expanded our agreement with the US government from 500 million to 1 billion doses at a not-for-profit price for 2021 and 2022. These doses are intended for donation to low and lower middle-income countries and organizations that support them. Our hope is that by increasing vaccine access in these regions, surges in infection will be brought under control in many parts of the world. We and our partner Pfizer are also expanding our global manufacturing capabilities with regional solutions in Africa and Latin America. This includes the letter of intent we signed with Europharma Laboratories in Brazil to manufacture our COVID-19 vaccine. Per the agreement, Europharma will obtain drug product from facilities in the United States and manufacturing of finished doses are expected to commence in 2022. At full operational capacity, the annual production is expected to exceed 100 million finished doses annually. Additionally, we recently signed a memorandum of understanding with the Rwandan government and the Institut Pasteur de Dakar and announced plans to start the construction in mid-2022 of the first state-of-the-art manufacturing site for mRNA-based vaccines in the African Union. We believe this facility can become a node in a decentralized and robust African end-to-end manufacturing network to provide sustainable vaccine supply on the African continent. Establishment of this regional network is expected to enable annual manufacturing capacity of several hundreds of millions of mRNA vaccine doses. Moving to slide 12, I will provide an update on our strategic key levers to expand the global reach of our vaccines. The slide provides an overview of progress across all areas, but I will only be highlighting those details which haven't already been touched on by Ugo. Starting with our manufacturing capacity, we have worked continually with our partner Pfizer to increase the capacity of the global supply chain and manufacturing network To expand our vaccine label and generate useful data in additional populations, we have multiple ongoing clinical trials which we have detailed previously, including trials in younger children and pregnant women. We currently expect data for children two to five years of age and children six months to two years of age in late Q4 2021 or early Q1 2022. Ugor already highlighted our significant process on the regulatory front, and our data in children of 5 to 11 years of age, which Özlem will cover in detail. We have further optimized our vaccine formulations to simplify access globally, and we recently received authorization from both the FDA and EMA to store our vaccine for up to nine months at minus 90 to minus 60 degrees Celsius. Additionally, following a positive opinion from EMA's CHMP, the EC approved a new formulation of BNT162B2 that further simplifies vaccine handling and with optimized storage conditions. The vials can be stored up to 10 weeks at standard refrigeration temperatures of 2 to 8 degrees Celsius. Our understanding of the human immune response to COVID-19, as well as emerging variants, continues to evolve, and our team is continuously evaluating the scientific data. dynamics of the pandemic. Multiple trials are ongoing to address need for boosted dose of BNT162B2. We are currently studying variant specific vaccine versions. While we don't plan to commercialize a variant specific version of the vaccine at this time, we remain ready to adapt our technology and manufacturing and regulatory process to ensure our vaccine provides robust protection against COVID-19. We are very pleased with the latest clinical and regulatory developments from our vaccine, which demonstrate a strong execution in response to the COVID-19 pandemic. I'll now turn the call over to Ursuline. who will provide details of our recent vaccine study results, as well as provide an overview of our oncology programs, including positive data to be presented at the upcoming CITSE conference.