BioNTech SE

Good day and thank you for standing by. Welcome to BioNTech's corporate update and financial results fourth quarter and full year 2020 conference call. At this time all participants are in a listen-only mode. After the speaker's presentation there'll be a question and answer session. To ask a question during the session you'll need to press star 1 on your telephone. Please be advised today's conference is being recorded. If you require any further assistance, please press star zero. Now I'd like to hand the conference over to your first speaker today, Silke Maas, Vice President, Investor Relations and Strategy. Please go ahead.

Thank you. Good morning and good afternoon. Thank you for joining us today to review BioNTech's fourth quarter and full year 2020 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 press release issued this morning, both of which are accessible on our website in the investor section. As shown on slide 2, during today's presentation, we will be making several forward-looking statements. These forward-looking statements include, but are not limited to, our current estimate COVID vaccine revenues, based on current contracted supply orders, expenses, expenditures, and tax rate for 2021. Our target vaccine production capacity for 2021, our COVID-19 vaccine revenues, which are subject to numerous estimates as more fully described in our annual report in Form 20F, the ability of BioNTech to supply our COVID-19 vaccine, the plant's next steps in BioNTech's pipeline program, The timing for enrollment, initiation, completion, and reporting of data from our clinical trials. Other risks described in our findings made with the U.S. Securities and Exchange Commission, including our most recent annual report on Form 20-S. Actual results could differ from those we currently anticipate. We are therefore cautious not to place undue reliance on any forward-looking statements which speak only as of today. share 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. On the call from BioNTech management today will be Ugur Sahin, our chief executive officer and co-founder, Ozlem Tureci, our chief medical officer and co-founder, Jean Merritt, our chief business and commercial officer, Sierk Pötting, our Chief Financial and Operating Officer and Ryan Richardson, our Chief Strategy Officer. I now hand the call over to Ugur Sahin, BioNTech's CEO.

Good morning and good afternoon and thank you to everyone joining the call today. I'm delighted to be here to discuss the progress that we made in 2020 and I would like to introduce the important milestones we have planned in 2021 and beyond. Slide 5. One year ago, the whole world was witnessing the rapid spread of the SARS-CoV-2 virus. At BioNTech, we made an early decision in January last year to tackle the virus head-on. We utilized a powerful mRNA vaccine platform and our deep immunoengineering competencies we have been developing for over a decade. This early decision and the enormous amount of work and energy that followed it resulted in a highly effective vaccine in less than a year. Now, one year later, we are already seeing the first signs of positive impact that vaccines are having in reducing infections, hospitalizations, and mortality. Our work against COVID-19 is not finished. In today's presentation, I will summarize what we are currently doing and what will come next. Turning to slide six. 2020 has literally transformed BioNTech. Our COVID-19 vaccine has now been authorized for use in more than 65 countries, with more than 200 million doses having been supplied as of March 23rd. During the fourth quarter of 2020, we recognized our first commercial product safe. This is a major milestone given the considerable investment in research and development which we have made over the past 13 years. We are now a fully integrated biopharmaceutical company. We have built a sales force in Germany and we have built global commercial scale manufacturing capacity. We expect to be able to produce up to 1 billion doses of our vaccine in 2021 in BioNTech's own manufacturing network. Our Marburg facility has made remarkable progress since we acquired it and will be ramping up production in the second quarter. Despite COVID-19 being the spotlight last year, we made progress in advancing our oncology pipeline. We now have 13 oncology product candidates and 14 ongoing trials across four different drug classes. Many of these products demonstrate promising activity in phase one clinical trials and we plan to initiate multiple phase two trials this year. We recently started first in human trials for our Carvac product BNT211 and for our ribocytokines product BNT151. Further, we are advancing our first wave of product opportunities towards the market. We expect up to three product candidates including our mRNA cancer vaccines and our lead by specific antibody will be entering into randomized phase 2 trials by the end of this year. Ultimately, the core of our success is our employees. We have built a global footprint with establishment of our U.S. research and development hub, and we have increased our workforce to over 1,900 employees worldwide. I want to again thank our employees for their tremendous efforts during a challenging and exciting year. Moving to slide 7. I want to highlight some key takeaways for us as we reflect on 2020. First, it became clear that our mRNA pharmaceuticals have a great potential to address major health challenges. While the first generation of our mRNA vaccine technology has already proven to be powerful, we are working on rapid iterations to further improve this new class of products. Our mRNA approach is not based on a simple technology. Our way of developing novel technologies is not based on the idea of a single trick pony. Rather, our goal from the very beginning was to build a novel industrial approach for precision pharmaceuticals that can address medical needs in multiple disease areas. We did more than a decade-long research to develop a broad toolbox of mRNA technology platforms. Each of these technology platforms tailored and optimized for potency and immunological precision to enable the development of best-in-class product candidates for various disease areas. Second, we believe that mRNA will revolutionize the field of immunology, and BioNTech is well-placed to continue to lead the revolution, given our broad technology base, vast IP portfolio, and the deep know-how in the field. We intend to increase further our investment in the space given the tremendous opportunity we see. In addition, we learned from our COVID-19 experience that product development can be faster. We intend to apply the capabilities and learnings we developed during the project Lightspeed to rapidly advance our pipeline products toward the market. And finally, we learned that our collaboration model works. Our focus on innovation and our strategic partnership with powerful collaborators like Pfizer has helped us not only develop a product in record time, but establish an early market leading position. We intend to continue to leverage our strategic partnerships by building our own capabilities in long term. As depicted on slide eight, we see a great opportunity ahead. We will accelerate the development of our innovative pipeline and expand the number of product candidates and indications we pursue. Our goal is to launch several additional products in oncology and infectious disease fields over the next five years. Our long-term goal remains to build a 21st century global immunotherapy powerhouse, developing products from multiple disease areas. Later in our prepared remarks, and Ryan will provide some more detail into the steps we are taking to realize this vision. Moving to slide nine. mRNA vaccines are now established as a powerful new drug class. On the back of this validation, we intend to rapidly industrialize our mRNA technology. We believe mRNA vaccines are poised in the near term to displace or complement traditional modalities in a range of infectious diseases and in the field of immuno-oncology. The proceeds from our COVID-19 vaccines will allow us to accelerate our pipeline development in this core area. Longer term, we see applications for the technology in the field of autoimmune diseases, allergy, inflammatory diseases and even regenerative medicine. We have established early research program at BioNTech in this research area and we plan to significantly wrap up This is the effort in the coming years. Finally, it is important to point out that our ability to industrialize a minor technology is linked to the deep expertise and know-how we have built over the course of more than a decade. It is also underpinned by a broad IP portfolio covering our platforms, product candidates, and often the targets and formulations we use. Now, moving to slide 11. The strong clinical results observed for our vaccine in our global phase 3 trial were a clear highlight in the fourth quarter. The study results demonstrated that our vaccine can prevent symptomatic COVID-19 with a well-tolerated safety profile. BNT162b2 demonstrated 95% efficacy in that trial with approximately 44,000 participants, including 94% efficacy in participants older than 65 years. The safety profile was favorable with a low frequency of stage 3 adverse events and mostly typical vaccine-related side effects. Key characteristics of our vaccines are both immunogenicity profile that is poly-epitopic and multi-effector. The vaccine induces high status of neutralizing antibodies. TH1 type CD4 T cell responses and robust CD8 T cell responses. We believe all of these factors contribute to the protection conferred by our vaccine. Turning to slide 12. We recently announced first real-world evidence data supporting the clinical profile of our vaccine. This exciting news comes from an observation analysis conducted by the Israeli Ministry of Health. between January 17 and March 6, 2021. During this time, our COVID-19 vaccine was the only vaccine available in the country. Specifically, the data from Israel shows that two weeks after the second dose, vaccine effectiveness was at least 97% in preventing symptomatic disease, severe and critical disease, hospitalization, and death. The analysis also showed a vaccine effectiveness Thank you very much. We have published data in the New England Journal from in vitro studies of our vaccine neutralization activity against three different variants. In these studies, they have neutralized all the viruses tested and showed no significant reduction in activity against B.1.1.7 and P.1. spike viruses. The neutralization of the South African variant B.1.351 spike virus was lower, but it was still robust. In addition to this in vitro testing, we are continuing to monitor real-world efficacy against several emerging variants. As outlined on slide 13, we anticipate that COVID-19 may become an endemic disease over the next few years. We already see evidence that immune responses in vaccinated individuals wanes over time. This is not surprising, indicating that reboosting may be required. In addition, there is a growing body of evidence showing that new variants with antibody escape mutations are driving new infections in many regions. As a result, we believe that there is likely a future need for additional vaccine boosters and potentially also variant-specific vaccines. Due to their ability to be rapidly designed, customized, and rapidly produced at scale, we believe that mRNA vaccines are very suited to play an important role in addressing the next stage of the disease. Expanding broad access to BNT1 and B2 remains a key focus for us, as shown on slide 14. We highlight here six key levels to expand BNT1 and B2 reach. The first is supply. We have increased our supply target for 2021 to 2.5 billion doses. This will require further process improvements and further expansion of our supplier and CCMO network, but we believe we are on track to achieve this. Continuing to broaden our vaccines label is also a key priority. We have extended our clinical program to additional vulnerable populations such as pregnant women, In February, first participants were those in Global Phase II trials in healthy pregnant women. The study will recruit 4,000 healthy pregnant women 18 years of age or older during the 24th and 34th weeks of gestation. Another important pillar is our pediatric trials. We plan to submit the safety and efficacy data in 2000 children 12 to 15 years of age from the phase 3 trial to the regulatory authorities in the second quarter. Another study in healthy children 6 months to 11 years of age has started. We are also planning further studies in individuals with compromised immune systems. Another key level is Geographic expansion. Our vaccine has now been approved for emergency or temporary use or granted conditional marketing authorization in more than 65 countries and they are moving in additional regions. In Japan, a phase one clinical trial started in October to evaluate our vaccine's activity in adults of 20 to 85 years of age. In February, Japan Health Minister approved BNT162b2 under the Exceptional Approval Scheme. Last November, a Phase 2 clinical trial of our vaccine started in China to evaluate BNT162b2 in healthy individuals of up to 85 years of age. We now have initiated the regulatory submission process in mainland China and hope to be able to provide an update soon. We are working to broaden, access, and enable more decentralized approach to vaccine provision. While BNT1 and B2 is available in the U.S. under emergency use authorization, we are preparing BLA filing the second quarter for full regulatory approval. Further regulatory submissions in other regions are also expected. Stability and formulation testing and optimization work remains another key focus. Over the past few weeks, the U.S. FDA and EMA approved the update that undiluted frozen vials of our vaccine may be transported and stored at minus 25 degrees Celsius to minus 15 degrees Celsius for a period up to two weeks. They expect additional stability profile updates over the next few months. We are also developing ready-to-use and lyophilized formulation with improved thermal stability profiles. We are fast-tracking development of the ready-to-use formulation and do not currently expect additional clinical studies to be required for this formulation. For the live-life formulation, we announced today that we will start a trial to evaluate the safety, tolerability, and immunogenicity of this formulation. We expect data from this trial in Q3 or Q4 2021. Antibody responses drain over time. To address the waning of immune responses, we are evaluating the safety and immunogenicity of a third dose of our vaccine. The aim of this trial is to understand the effect of a booster to prolong immunity against COVID-19 caused by the circulating and potentially newly emerging SARS-CoV-2 variants. As mentioned to date, there is no evidence that an adaptation of our current vaccine against key identified emerging variants is necessary. Despite this, we have developed a comprehensive strategy to address these variants should the need arise in the future. In March 2021, the FDA approved an additional amendment to the study protocol of the Global Phase 1-2 free trial to include for a third dose of BNT1 and C2B2 or a third dose with its modified version of the vaccine carrying the spike protein sequence, the so-called South African variant, in order to further describe duration of protection and protection against potential immersion variants of concern. An additional group of BNT1 and C2B2 naive participants will be enrolled and receive two doses of the South African variant vaccine version to discuss protection against the emerging variants of concern against this reference trait. The part of this trial with the variant is expected to start by end of March. I will now turn the call over to Sean to provide an update on our COVID-19 manufacturing and commercial supply status.