BioNTech SE

Good morning and good afternoon. Thank you for joining us today to review Bintoc's first 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 financial results press release issued this morning, both of which are accessible on our website in the 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 BioNTech's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer regarding a COVID-19 vaccine, our expectations regarding the potential characteristics of BNT162b2 in our ongoing trials and or in commercial use based on data observations to date, including real-world data gathered. stability of BNT162b2 to prevent COVID-19 caused by emerging virus variants, the expected time point for additional readouts on trial data of BNT162b2 in ongoing trials, the timing for submission of data for or receipt of any marketing approval or emergency use authorization, our contemplated shipping and storage plan, including our estimated product shelf, life at various temperatures, and the ability of BioNTech to supply the quantities of BMT162 to support clinical development and, if approved, market demand, including our production estimates and targets for 2021 and 2022. The planned next steps in our pipeline programs, and specifically including but not limited to statements regarding plans to initiate clinical trials, of our product candidates or expansion in Southeast Asia. Expectations for data announcements with respect to our clinical trials, our current estimated COVID-19 vaccine revenues based on current contract supply orders, our projected expenses, capital expenditures, and tax rate for 2021. Our target vaccine production capacity for 2021 and 22, our quoted vaccine revenues, which are subject to numerous estimates as more fully described in our annual report on Form 20F and quarterly report for the three months ended March 31st, 2021, and our risk 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, You 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 provides detailed and important safety information regarding our recently launched COVID-19 vaccine. Slide four. On the call from BioNTech's management today, will be Uwe Sahin, our Chief Executive Officer and Co-Founder, Aslam Toureji, our Chief Medical Officer and Co-Founder, John Merritt, our Chief Business and Commercial Officer, Sid Putting, our Chief Financial and Operating Officer, and Ryan Richardson, our Chief Strategy Officer. I now hand the call over to Uwe Sahin, BioNTech's CEO.

Good morning. and good afternoon and thank you to everyone joining the call today. I'm delighted to discuss our continued progress in the first quarter, leaving us well positioned to achieve the milestones we have planned for this year and beyond. Slide five. During our last quarterly update, only six weeks ago, we detailed BioNTech's transformation into a fully integrated biopharmaceutical company within a remarkable timeframe as we rose to the challenge of a global pandemic. We have stayed true to our vision of harnessing the full potential of the immune system to overcome the therapeutic challenges of today by combining excellence in immunology and innovative technology. Our core competencies and resources established over the last decade were validated by our success in developing the first approved mRNA vaccine against COVID-19. The success has become the foundation of our exciting and ambitious journey to change treatment paradigms in a range of disease areas. Our robust pipeline with more than 20 product candidates addressing oncology and infectious diseases and beyond reflects this ambition. We are in a quite unique position to strategically invest cash flow from our COVID-19 vaccine into further maturing the company to deliver multiple product launches over the next five years. So slide six. Our global goal is to build a 21st century immunotherapy powerhouse. Firstly, we continue to increase our global footprint with new offices beyond our subsidiary in the United States. This includes our commercial subsidiary in Germany, in Turkey, and plant regional headquarters in Singapore that we will discuss later in the call. Second, we are expanding our integrated infrastructure for strategic investment in scientific and technological innovations. This is in the heart of everything we do. These investments, spanning clinical, commercial, manufacturing excellence, including digital capabilities, will support future product launches. Our success is driven by people. Therefore, attracting and retaining top talent remains a crucial imperative for us. Lastly, we see a tremendous opportunity as we advance our robust pipeline in infectious diseases and oncology and expand to new therapeutic areas. Accelerated our vaccine revenues. Our pipeline currently consists of 14 products and 15 ongoing clinical trials. Building on compelling data, we are poised to initiate multiple potentially registrational studies and First in Human Trust in 2021. Our dynamic and rich internal R&D efforts will be complemented with strategic in-licensing. Slide seven. Slide seven highlights key achievements since our last update on March 30th. With respect to our oncology pipeline, we have started pre-First in Human Oncology Trust in 2021. These include two cell therapies, namely BNT211, our CARVAC program, and BNT221, our Neosim neoantigen-targeting T-cell therapy. The third is our first ribocytocam program featuring an optimized interleukin-2 variant. Ersan will detail this program in her remarks. With respect to our COVID-19 vaccine, I remain delighted by the exceptional excellence of our team, along with our partner Pfizer, has exhibited. To date, we delivered more than 416 million doses of our COVID vaccine to 91 countries and territories worldwide. For 2021, the number of contracted doses has increased to about 1.8 billion. with first contracts in place for 2022 and beyond. Last week, we announced together with Pfizer the signing of a memorandum of understanding with the International Olympic Committee to donate doses of our COVID-19 vaccine to vaccinated athletes and their delegations participating in Olympic and Paralympic Games, which are scheduled to take place in Tokyo in July 2021. The strong execution across our entire organization, along with our partner Pfizer, led to the recognition of $2 billion in COVID-19 vaccine revenues in our first quarter of COVID-19 commercialization. Our COVID-19 vaccine continues to demonstrate robust clinical results. Since our last call, we disclosed two additional significant positive clinical updates. including top line results from our phase three trial that confirmed high efficacy with no serious safety concerns up to six months following the second dose. In this analysis, 927 confirmed symptomatic cases of COVID-19. BNT162b2 demonstrated 91.3% vaccine efficacy. The vaccine was 100% effective in preventing severe disease as defined by the US CDC and 95.3% effective in preventing severe disease as defined by the FDA. The data also showed the vaccine was highly effective in preventing COVID-19 cases in South Africa where B.1.351 lineage is prevalent. We anticipate publication in peer-reviewed journals and plan to submit this data to regulators in the upcoming weeks. We also announced positive top-line data of our US pivotal study of 2,260 adolescents 12 to 15 years of age, demonstrating 100% efficacy in participants with or without prior SARS-CoV-2 infection. The NT162b2 was well-tolerated, demonstrated strong immunogenicity, with just two neutralizing antibody titers one month after the second dose. We remain focused on six key levels to expand our COVID-19 vaccine reach globally and across different demographics as shown on slide eight. We are now targeting a manufacturing capacity to reach up to 3 billion doses by the end of 2021 and more than 3 billion doses in 2022. The first shipments from our Marburg facility were delivered mid-April, a remarkable accomplishment for BioNTech manufacturing scale-up. In Singapore, we plan to establish a regional headquarter that will also include highly automated end-to-end mRNA manufacturing facility. We continue to broaden our vaccine label. We expect to hear back shortly from the FDA on our application for expanded emergency use authorization for our COVID-19 vaccine to include individuals 12 to 15 years of age. We also expect feedback from AMA on our submitted label expansion for the same age group. As announced last week, Canada has authorized the use the use of BNT1 and 62B2 in that age group already. Ongoing trials include a global phase 2 free in healthy pregnant women and a study in children six months to 11 years of age. We expect to announce safety data from those studies in the third and fourth quarter of 2021. We are determined to contribute to vaccine access globally, and our vaccine has been approved for emergency or temporary use or granted conditional marketing authorizations in more than 70 countries and regions, including emergency use listing from the WHO in January. In addition, I would highlight that the regulatory submission from mainland China is now underway in collaboration with our partner, Fosun. For broad and decentralized vaccine access, we initiated the rolling biologic license application in the United States for BNT1-62B2. We will seek full approval of our vaccine in countries where regulatory submissions have been made and emergency use authorization or equivalents are currently in place. Both the FDA and EMA have updated our label with two-week storage and transport at minus 25 to minus 50 Celsius degree. Recently, we have submitted new stability data to the FDA to broaden our label to standard refrigerator temperature, that means two to eight degrees of Celsius for up to four weeks. We are also developing ready-to-use and lyophilized formulations with improved thermal stability profile to reduce dependency on cold chain infrastructure. We have initiated a trial to evaluate a lyophilized and ready-to-use formulation with data expected in the third quarter. Our understanding of SARS-CoV-2 is evolving as new data is generated, and we understand that immunity may wane over time and that new variants emerge. While I do believe a booster will be of high value to its receptive immunity, we do not know yet when and how frequently this will be needed. Also, there is currently no evidence that an adaptation of our current vaccine against any of the circulating variants is necessary, and we continue to monitor real-world efficacy against emerging variants. However, we want to learn and preemptively prepare today to respond fast in case a third dose of strain adaptation will be required in future. Slide 9. To this aim, we have developed a comprehensive strategy that uses the South African variant as a prototype for potentially emerging true escape strains. In subjects who have been vaccinated with two doses of BNT162b2, we evaluate a third dose of either BNT162b2 or of the BNT162b2 South African variant version. The trial will also enroll a group of BNT162b2 naive participants who will receive two doses of the BNT162b2 South African variant version. The data will inform us about safety and additional boosters, boostability of the immune response, and effects of these additional boosters on immunity against circulating virus and potential new emerging SARS-CoV-2 variants. First data expected in the second quarter of 2021. This effort will also provide a blueprint for trial design, regulatory pathway, and platform character of the manufacturing process for each future variant. I will now turn over to Sean to provide an update on our COVID-19 order book and manufacturing status. Sean?

Thank you, Hugo. Great to be with everyone today. Moving to slide 10 for an update on the distribution progress of our vaccine. We now have contracted orders for approximately 1.8 billion doses in 2021. which includes increased orders from the EU and UK and a number of developing countries. Multi-year contracts for 2022 and beyond are being negotiated with a number of countries around the world, demonstrating that there will be demand for our vaccine in the post-pandemic market. We have reached an agreement with Israel to supply millions of doses in 2022, and with Canada to supply up to 125 million doses in 2022 and 2023, with options to supply up to 60 million additional doses in 2024. We look forward to expanding supply to additional geographies beyond those shown here. Turning our attention to slide 11. We are aiming to increase our supply capacity to up to 3 billion doses in 2021. And we expect to be able to manufacture more than 3 billion doses in 2022. This increase was driven by the critical need that remains in many parts of the world requiring access to vaccine supply as well as vaccinations. Looking at BioNTech's manufacturing network, I would like to point out that BioNTech has manufactured more than 50% of the drug substance rolled out to date worldwide. Our Marburg facility has made significant progress. We have established mRNA manufacturing at the Marburg site in less than six months, including EMA's approval of the manufacturing of our COVID-19 vaccine product at the facility. in late March. As Ugur noted, the first batches of vaccine from the Marburg site were delivered in mid-April, which is truly a remarkable achievement. With the Marburg site fully operational, BioNTech's annual vaccine manufacturing capacity will be approximately one billion doses on an annual runway rate. Beyond COVID-19, this large in-house manufacturing capability position us for future success with additional pipeline products that we anticipate launching in the coming years. I now turn the call over to Özlem to provide an update on our oncology pipeline.