BioNTech SE

Good morning and good afternoon. Thank you for joining us today to review BioNTech's third quarter 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 BioNTech's efforts to combat COVID-19, the potential safety and efficacy of BNT162, the timing for submission of data for or received of or potential approval or emergency use authorization with respect to our BNT162 program, the ability of BioNTech to supply BNT162 to plan next steps in BioNTech's pipeline programs, the timing for enrollment, initiation, completion, and reporting of data from our clinical trials, and BioNTech's anticipated cash usage for fiscal year 2020 and beyond. Actual results could differ from those we currently anticipate. Use therefore caution not to place undue reliance on any forward-looking statements which speak only as of the date of this conference call and webcast. On the call with biotech management today will be Ugur Sahin, our chief executive officer and co-founder, Ozlem Tureci, our chief medical officer and co-founder, Sean Merritt, our chief business and commercial officer, Sierk Pötting, our chief financial and operating officer, and Ryan Richardson, our chief strategy officer. The agenda for today's call is shown on slide three. Ugur will start with Q3 highlights and an update on our COVID-19 program before handing over to Sean to provide an update on our commercial distribution plan for BNT162. Ozlem will then update on our oncology timeline. She will walk through some of the data we are highlighting this week at SITC for BNT311, our PBL141EP checkpoint immunomodulator. Sierk will then provide a recap of our financial results for the first quarter and our financial outlook for the rest of 2020 before handing back to Ugur for concluding remarks. We will then open the call for Q&A. I now hand the call over to Ugur Sahin, Biontech's CEO.

Thank you, Sierk. Good morning and thank you to everyone joining the call today. Let's start the slide for... I'm incredibly happy about the accomplishments we can report to you today. We announced yesterday that our COVID-19 vaccine program demonstrated evidence of efficacy against COVID-19 based on the first interim analysis. Just to remind you, so far we have continued to see evidence from mild to moderate tolerability profile in our phase 3 trial. It is consistent with what we have observed in the earlier studies. We believe the news from yesterday represents a watershed milestone for our company and one that we believe will constitute an important step for the world after more than eight months into the worst pandemic in more than a century. When we made this decision to initiate a COVID-19 vaccine program in January, we did that against a backdrop of considerable uncertainty. For example, it was not known at that time point if a vaccine would work at all. But when that decision was made, we went all in. We devoted considerable resources, both in terms of time and attention, human resources, and also capital towards addressing this challenge. We did so without knowing How the pandemic would play out. We did so because we felt a duty to try and to do something. Because we believe our technology has the potential to make a difference. And with the news this week, I believe now more than ever that we are in the position to make that difference. And we will still have a lot of work to do and we'll continue to focus on the goal every single day. We, along with our collaboration partner Pfizer, have already initiated the regulatory submission process to the EMA, to the MHIR in the UK, and to Health Canada. We believe we are on track to submit an emergency use authorization to the FDA as early as the third week of November. Whether we have initiated clinical trials in Japan, in China as part of what we expect will be a recreational pathway in each country. Finally, we recently acquired a GMP manufacturing facility in Marburg, Germany, intended to increase our capacity to produce COVID-19 vaccines in 2021. And we continue to plan for what would be our first commercial launch with our partners Pfizer and Pfosten Pharma if they are granted an approval. We had some slowdowns in our oncology trials, but despite that, the new trials start to... But anyway, we are pleased to present early phase 1 data for our next generation checkpoint immune modulator, BNT311, at the CITSE meeting this week. This molecule is jointly owned by BioNTech and GENREP in a 50-50 cost and profit split collaboration. BNT311 has demonstrated promising data across multiple tumors, and Ozlem will cover in some detail the findings from the ongoing Phase I-II study. In addition, in the third quarter, we provided multiple Phase I data updates for several other programs, including BNT131 and our intratumor messenger RNA partnered with Sanofi at SITSE and one arm from our expiratory phase 1 trial BNT1-1-4 at ESMO. Finally, in the third quarter, we received IMD approvals for our randomized phase 2 trial of INS BNT1-2-2 in adjuvant colorectal cancer and recorded the first patient dose in our phase 1-2 trial of BNT4-1-1 Our small molecule TLR7 agonist in multiple solid tumors including small cell lung cancer. And finally, we strengthen our financial position in the third quarter to a mix of equity, debt financing, grant commitments of approximately 1.2 million cumulative cost proceeds. Hence, we are in a strong position to capitalize on our opportunity that lies ahead of us. Slide 6. Slide 6 highlights the development timeline since initiating of our BNT162 program in January after the SARS-CoV-2 sequence was first published. The accelerated development path depicted here reflects the intense focus that we and our partners have brought into this program from day one, all without cutting corners. We started the first of multiple phase 1 trials in late April, which means that our update yesterday demonstrated 90% of efficacy as of our interim efficacy analysis and a pivotal phase 3 trial comes approximately 6.5 months after initiating the phase 1 trial. Again, this accomplishment speaks to the incredible dedication and hard work of our team and of our collaborator Pfizer. We and Pfizer published our protocol so all the endpoints are clear for the world to see. We defined our primary efficacy endpoint in this trial as the efficacy of our BNT162b2 vaccine against confirmed COVID-19 participants without evidence of infection before vaccination. have sufficient safety data to support our emergency use authorization submission to the FDA as early as the third week of November. This safety data set is needed to be in position to request emergency use authorization in the US. We kept the stage of testing that we have gone through with our BNT162b2 vaccine. which have so far resulted in three peer-reviewed publications in journals at the New England Journal of Medicine and Nature. The important point here is that we have done extensive testing over the past nine months in many different contexts and overall I would say we have seen a consistent picture of the vaccine's pharmacodynamic effects. We conducted preclinical testing starting with more than 20 vaccine candidates. This preclinical testing was conducted in multiple animal models and included a full GLP toxicology testing. Preclinical testing were observed as dose-dependent immune response against virus and pseudovirus including antibody types as well as strong CD4 and CD8 responses. In a non-human primal study, Our vaccine prevented lung infection in 100% of SARS-CoV-2-challenged rhesus macaques. Further, no viral RNA was detected in the nose three days post-challenge. Following successful preclinical studies, we conducted multiple distinct phase 1 trials and we observed for the first time that our vaccine candidate resulted in mild to moderate side effects with no serious adverse events. Moreover, in phase 1 trials, we observed strong neutralizing antibody titers at or above the level of convalescence era from patients who have recovered from SARS-CoV-2. We also have observed high magnitude CD4 as well as CD8 T cells in vaccinated subjects. So on slide number seven, The key question what we had to address in the phase 3 trial is whether the vaccine can prevent COVID-19 in humans while having a good safety profile. Based on our announcements yesterday, we now have early evidence that it can prevent COVID-19 infection with high efficacy. The vaccine candidate was found to be more than 90% are effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. So the first analysis evaluated 94 confirmed cases of COVID-19 in the trial participants. The case split between the vaccinated individuals and those who received the placebo indicates the vaccine efficacy rate above 90%. have measured seven days after the second dose. This means that protection was achieved 28 days after the initiation of vaccination, which consists of a two-dose schedule. As of yesterday, the study enrolled more than 43,000 participants, with 42% having diverse backgrounds. It is important to mention that no serious safety concerns have been observed to date. We plan to collect further data on the other endpoints in the trial and will continue to collect longer term safety data. We would like to remind you that the clinical trial is continuing to the final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate performance against other study endpoints. On slide eight, slide eight illustrates the current status of the BNT162 program globally. There are ongoing clinical trials in the countries shown in green. This includes the phase three trial in the US and Germany as well ongoing trials in Brazil, Argentina, Turkey, South Africa, China, and Japan. The phase one, two trial in Japan initiated in October will evaluate safety, tolerability, and immunogenicity of two doses of BNT162B2, again separated by 21 days, and a single dose of BNT162B2 in healthy adults to 20 to 85 years of age. The Phase 1 study in China remains ongoing. With our partner Fosun, we expect to initiate the Phase 2 clinical trial with our BNT162B2 and 62B2 candidates by the end of 2020. Once getting regulatory IMD approval from the Chinese regulatory authority and the NMPHPA, we will start the clinical trial. There are ongoing rolling regulatory submissions in the countries in blue, including EMA, the UK and Health Canada. We plan to work with EMAC Committee for Medicinal Products for Human Use to complete the rolling review process to facilitate the final marketing authorization application. The rolling submission in Canada was accepted under the Minister of Health's interim order allowing companies to submit safety and efficacy data and information as it becomes available. We expect to be in the position to request an emergency use authorization potentially as early as the end of November. I'm now going to ask Sean to provide a brief update on our commercial supply and distribution model. Sean?

Yeah, thanks, Igor. So, just turning to slide 9, here we're providing a snapshot of Thank you very much. diligently with Pfizer to complete additional commercial supply agreements and are in negotiation with a number of governments around the world and other bodies like COVAX. All agreements, of course, are subject to clinical success and regulatory approval of the vaccines. Just moving on to slide 10, here we're highlighting the distribution model that we expect for the vaccine in the pandemic phase. We have a co-commercialization arrangement in place with Pfizer, as many of you know, and are really working very, very closely with them and with the government for global distribution. Pfizer has developed a thermal shipper unit which has GPS tracking specifically for this vaccine, which is designed to keep the product at low temperatures for up to 10 days. It's stored at 15 to 25 degrees Celsius without opening the shipper. And if we do over there, then Upon re-icing, several times we can extend to 15 days on reopening. Further, we have the ability for five days of storage in a refrigerator at 2 to 8 degrees centigrade. So that gives us really some flexibility with respect to storage and distribution. The distribution model will, of course, depend on the region. But in general, we're engaging specialized supply chain providers, which we've indicated in the picture here. for air and ground shipping to and from our manufacturing sites in Europe and the United States to distribution hubs all around the world. And from those distribution hubs we expect to distribute the vaccine to specialized points of care. In some markets we expect there to be a focus on a more centralized network of points of care with high revenue distribution, whereas in other regions there will be a higher number of these points of care. In most regions of the world, we will leverage Pfizer's distribution capabilities through, though in some markets, for example, here in Germany, BioNTech plans to distribute. However, it's important to note that our agreement with Pfizer is 50-50 profit sharing worldwide, excluding China. So the economics to BioNTech are the same. regardless of who distributes the vaccine. Okay, so going further, it is important to note that at the point of care, we will have multiple short-term storage options available as we mentioned earlier. In addition to the thermal shipper which I described earlier, Sharks, of course, can use ultra-low temperature freezers. These freezers are commercially available and provide the ability to store the product as a frozen liquid at minus 70 degrees for long-term storage. For shorter periods, the product can be stored up to five days, two to eight, as I said earlier. It's important to note that if there is a freezer available, ultra low temperature freezer available, the vaccine can be still for up to six months in these freezers. I'll now turn over to Ozlem to provide an update on the oncology pipeline.