BioNTech SE

Thank you for standing by and welcome to the Buy and Tech second quarter 2020 operational progress and financial results call. At this time all participants are in a listen only mode. There will be a presentation followed by a question and answer session. I must advise you this call is being recorded today, Tuesday the 11th of August 2020. and I would now like to hand the call over to the Vice President, Investor Relations and Business Strategy, Silke Mars. Please go ahead.

Thank you for joining us today for BioNTech's second quarter 2020 update call. Before we start, we encourage you to view the slides for the webcast as well as operational and financial results press release issues 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, the timing of enrollment, initiation, completion and reporting of data from our clinical trials, the potential registrational nature of certain clinical trials, the impact of the COVID pandemic on our business and financial outlook, The timing for any potential emergency use authorizations or approvals for BNT162, the potential safety and efficacy of BNT162, and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. Actual results could differ from those we currently anticipate. You are therefore cautioned not to place a new reliance on any forward-looking statements which speak only as of the date of this conference call and webcast. Speaking and available for questions today will be Ugur Sahin, Chief Executive Officer, Ozlem Tureci, Chief Medical Officer, Jean Merritt, Chief Business and Commercial Officer, Sierk Pötting, Chief Financial and Operating Officer, and Ryan Richardson, Chief Strategy Officer. I now hand the call over to Ugur Sahin, BioNTech's CEO.

Thank you, Silke. It's a pleasure to welcome you to our second quarter 2020 conference call. The last few months have been again changing time for BioNTech. The groundbreaking potential of our technologies as well as our ability to quickly respond to new challenges and execute path has been on full display. One key highlight is the initiation of the pivotal phase 2b free trial of our lead BNT162 COVID-19 vaccine candidate within six months of starting the lifespan vaccine discovery preclinical and clinical research program. In parallel to the COVID-19 program, we have continued to advance our oncology pipeline and broadened our base of strategic collaboration. I'm happy about the accomplishments we have made in the second quarter and would like to thank our entire team and also our partners for their tireless efforts and outstanding commitment. Slide 5 summarizes some of our key highlights since our last quarterly update. We reached a number of important milestones over the past few months. We continue to advance our clinical stage pipeline. We now have 12 immunotherapies in clinical testing across three classes that include eight messenger anaerobic programs, three antibody programs, and one small molecule immune modulatory program. In July, we and Pfizer selected BNT162b2 as our lead COVID-19 vaccine candidate and initiated a pre-votor stage 2b free trial. We have made progress in ramping up our manufacturing capacities to support global supply. We have signed commercial supply agreements with multiple countries around the world for more than 250 million doses in 2020 and 2021. This also includes an option to purchase up to 500 million additional doses. All this is subject to regulatory approval. In parallel to our effort to bring COVID-19 vaccine to the market as quickly as possible, we also continued to advance our oncology pipeline. Ozlem will provide the key updates later in the call, including for our INS program, BNT-122, or our BNT-111 six-act melanoma program. Here we announce a new collaboration with Regeneron to combine BNT-111 with Viptario and N-type PD-1 in a randomized Phase II trial, which we believe could have a registrational potential. Moreover, we significantly strengthened our balance sheet, bringing in commitments of approximately 1.1 billion in gross proceeds from non-dilutive upfront cash payments and equity and debt financing commitments. These accomplishments have strengthened our ability to advance our pipeline on multiple fronts and deliver on our longer-term vision to bring novel immunotherapies to patients across a range of diseases. Moving to slide 6, I would like to touch on the importance of our strategic collaboration. This is important because these collaborations continue to play a crucial role in how we are building our business. Our partnerships extend our execution capabilities and global reach, and in some cases provide us the The first half of 2020, we expanded our existing partnership with Pfizer to jointly develop our COVID-19 vaccine program. In addition, we have established a new collaboration with Regeneron in the oncology field. The important aspect here is that we have retained significant economics on our programs through these collaborations. Sean will provide some further details on the Pfizer collaboration later in our prepared remarks. In the case of our general deal, it is important to note that each party keeps 100% of the rights to its own product. That means that BioNTech has kept full product commercialization rights for BNP111 and Melanoma Six-Rack. On slide seven, you see an updated version of our multi-platform immuno-oncology strategy. The cornerstone of this strategy is to leverage our immunotherapy expertise with new therapeutic approaches to target cancer and modulate immune responses simultaneously. We believe the approach can produce multiple Blockbuster Product Opportunities, but also will enable the development of powerful combination treatment approaches, which combine complementary mechanisms of actions. Despite the challenges associated with the COVID-19 pandemic, we have continued to execute our immune oncology strategy on multiple fronts. We are on track to initiate multiple late-stage trials for six weeks and INS product candidates. We are anticipating the first data update for our next generation checkpoint immunomodulator BNT311, a bispecific antibody targeting anti-PDL1 and 4.1VB later this year. Furthermore, since our last earnings call, we have initiated a phase 1-2 trial for our TLR7 agonist small and for BNT221, our neoantigen T-cell therapy. As we have done in the past, we will continue to be data-driven in how we assess each product opportunity we take into clinical testing. I will now turn it over to Özlem to provide an update on our programs.