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 speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised, today’s conference is being recorded. [Operator Instructions] Now I’d like to hand the conference over to your first speaker today, Sylke 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 Investors 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 20-F, the ability of BioNTech to supply our COVID-19 vaccine, the planned next steps in BioNTech's pipeline programs, the timing for enrollment initiation, completion and reporting of data from our clinical trials, other risks described in our filings made with the US Securities and Exchange Commission, including our most recent Annual Report on Form 20-F. 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 details 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; Özlem Türeci, our Chief Medical Officer and Co-Founder; Sean Marett, our Chief Business and Commercial Officer; Sierk Poetting, our Chief Financial and Operating Officer; and Ryan Richardson, our Chief Strategy Officer. I’ll 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. The - this early decision and 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 6. 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 sales. This is a major milestone, given the considerable investment in research and development, which we have made over the past 10 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…

Thank you, Ugur. Slide 15 shows flexible manufacturing process about COVID-19 vaccines. We can go from DNA production to sterile filtration and filling in its period nine to 13 days. Although 50,000 steps [ph] are required from manufacturing the mRNA to the bulk drug substance, the overall manufacturing from DNA template to program [ph] finish can be done in less than two weeks. Following production, quality control and release can take another four to five weeks, and then we are ready to deliver the vaccine. One of the advantages of our mRNA technology is that it allows a rapid adoption of the vaccines to variants. Unlike traditional vaccine production, we can adapt our manufacturing to encode a new variant if needed, simply by providing a DNA template which encodes [indiscernible] of the new variant. This can be done within a couple of weeks and without the need for new scale up of the overall process and pending regulatory approval. Another advantage I would like to point out, we can increase or decrease manufacturing quantities with a short lead time. Thus our manufacturing technology provides us with the flexibility to respond to market demand. Moving on to Slide 16, we have firm orders 1.4 billion doses to date. Recently, we announced that the United States have exercised its option for an additional 100 million dosage, bringing the total to 300 million doses. We also announced that the EU will be supplied with an additional 200 million doses with an option for an additional 100 million further doses. This brings the total number of doses to be delivered to the EU member states by the end of 2021 to 500 million, with the potential to increase further up to 600 million doses. Discussions for additional commitments worldwide are ongoing. Beyond [indiscernible] prices…

Thank you, Sean. And hello, everyone. As usual, and in the interest of time, I'm going to provide updates on selected programs. For further details on the status of our other oncology programs, please refer to our annual report which is being filed with the US Securities Exchange Commission today. As to be expected, we have continued to see some ongoing impact from the COVID-19 pandemic on our clinical operation. Specifically, there has been a slowdown in the enrollment in some of our ongoing studies. Despite these constraints, we expect to present several data sets and initiate multiple new trials this year. Slide 18 outlines our immune oncology strategy. Our strategy is based on several first-in-class therapeutic approaches to target cancer to modulate the immune response. The programs address a broad range of cancers in different disease stages. Of our six technology platforms have all reached clinical stage, by now with 13 clinical stage product candidates. We see multiple blockbuster opportunities and the potential for synergistic combination. Our later stage programs are shown on Slide 19. Starting with the BNT111, our FixVac product candidate for the treatment of advanced melanoma, we expect to start a randomized Phase 2 trial in the US and EU in the first half of 2021. The trial will evaluate BNT111 in combination with Regeneron, Libtayo [indiscernible] BNT111 and Libtayo monotherapy in patients with advanced melanoma progressing during or after prior therapy with a PD-1 inhibitor. In February, we received permission from FDA to move forward with the trial. The next FixVac product candidate is BNT113, our mRNA vaccine encoding E6 and E7 proteins of human papillomavirus 16. We expect to start a Phase 2 trial evaluating BNT113in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16…

Thank you, Ozlem. I will summarize our financial results for the fourth quarter and full year 2020 as shown on Slide 27. I will start with the total revenues, which were estimated to be €345.4 million for the fourth quarter of 2020 compared to €28.0 million for the fourth quarter of 2019. For the full year of 2020, total revenues were estimated to be €482.3 million, compared to €108.6 million for the full year of 2019. Total revenues increased due to the recognition of revenues under our new collaboration agreements signed with Pfizer and Fosun Pharma, as part of our vaccine program against COVID-19. Newly generated COVID-19 vaccine commercial revenue significantly drove our total revenues. As a reminder, under the Pfizer collaboration territories have been allocated between the companies based on marketing and distribution rights. A breakdown of our commercial revenues is shown on Slide 28. Our 2020 commercial revenues comprise an estimated amount of €188.5 million share of gross profit from COVID-19 vaccine sales in the Pfizer territory. Please note, this is a next [ph] figure. Additionally, as it will be detailed in our annual report filed with the SEC. This figure is only estimated based on preliminary data shared between Pfizer and us and may be subject to adjustments as they receive final data on input parameters like sales and transfer prices. Changes in our share of the collaboration partners gross profit will be recognized prospectively. Our COVID-19 vaccine commercial revenues also include €61.4 million sales to our collaboration partner or product manufacturer by us and €20.6 million of direct COVID-19 vaccine sales to customers in our territory Germany. Now returning to Slide 27, and moving to cost of sales, which were estimated to be €41.0 million for the fourth quarter of 20202, compared to €4.4 million for…

Thank you, Sierk. Turning to Slide 32 to our 2021 strategic priorities. Our immediate aim is to supply our COVID-19 vaccine to over 1 billion people this year and be in a position to supply it in large quantities in 2022. While we work to broaden access to our vaccine, our goal is to build and maintain a leadership position into 2022 and beyond. With proceeds from the COVID-19 vaccine, we plan to accelerate pipeline development in our core therapeutic areas of immuno-oncology and infectious disease. We currently have nine active preclinical programs in the infectious disease field, and intend to advance additional mRNA vaccines against other infectious diseases. We will provide more details on some of these programs over the course of the year. We remain as committed as ever to our goal of ushering in a new era of immunotherapy for cancer patients. In 2021 and beyond, we intend to accelerate and broaden our immuno-oncology pipeline, where we see a significant opportunity for BioNTech to lead in the emerging fields of individualized cancer medicine, and cell therapy, among others. Finally, we plan to ramp up investments in our platforms and early product development and select emerging therapeutic areas, such as autoimmune disease, inflammatory disease and regenerative medicine. While these areas will not be a major component of our capital allocation near trend [ph] we believe they could become major opportunities for BioNTech in the future. Slide 33 highlight some of the key pipeline milestones we expect in 2021. These include trial updates on at least five ongoing programs, including BNT311 and 312, two bispecific antibodies in Phase 1/2 trials, which we believe have potential as next generation checkpoint immuno-modulators. We also expect to initiate three randomized Phase 2 trials for our FixVac and iNeST programs in 2021. Finally,…

Thank you. [Operator Instructions] Your first question today is from the line of Tazeen Ahmad from Bank of America. Please go ahead.

Hi, good morning. Thanks for taking my questions. As it relates maybe to the COVID vaccine, can you give us a little bit more color, Ugur, about your thoughts about the need for boosters, maybe a couple of parts for that? Do you have any sense of the frequency with which, if needed, people would need boosters? Secondly, you've talked about doing work on the different variants. So on a go-forward basis, with the booster shots, being inclusive of all variants that would be present at the time? And the last part of the question is, do you see value still for switching from the two-dose vaccine to a one-dose in the future? Thank you.

Okay. Thanks for the questions. Actually, this topics are related. So, first of all, what is important is that that the booster dose and the variant interaction are somehow related because some variants, for example, the South African variant come with a reduced neutralization titers. And we, of course, know that antibody titers will drop over time and we see first drop now after six months. So we definitively will need a first booster dose in - yeah, maybe after six months, after nine months. And then the question will be of course after the boosts, how long after the boost the immune response will continue to stay stable that it is six months, nine months or 12 months. So I - we strongly believe that booster doses will be required. And the second reason to ensure that it is - we are now seeing with mRNA vaccines and with the data coming from Israel that the vaccine indeed enables prevention of infection, which is one of the key parameters reducing also the emergence of variants because every infected person is somehow creating the chance for new mutation. And if you want to get a full control of this pandemic, we need to ensure to have high antibody titers to ensure prevention of infection. With regard to the third topic, so, we will see, of course, with the upcoming data that a booster doses are required every 12 months, every 18 months. So this is data coming in. With regard to single versus a double dose vaccine, it’s very clear that also our vaccine is able to provide protection against disease with a single dose, but this is limited, yeah. And we see it - we clearly see that a second dose is required to have a full immunity. We will have the situation end of this year, that in many regions, we will have already a pre-existing immunity in the vast majority of the population. And then we are not any more dealing with the question whether we need two short vaccine or single short vaccine, because everyone who is receiving and vaccine - additional vaccine will be regarded as a booster dose vaccine. And we already know from published data and from our own data, if someone had received prior dose or had COVID disease before, then a single dose is sufficient. So we are now talking about - starting - we need to start to talk in 2020 and beyond about the vaccination. And there is no any more a difference between single dose and two-dose vaccines here.

Thank you. [Operator Instructions] The next question is from the line of Cory Kasimov from JPMorgan. Please go ahead.

Hey, good morning, guys. Thank you for taking my question. Ugur, I wanted to follow-up with you in the comments you just made with around boosters. Are you saying that the participants in your Phase 3 trial who were vaccinated back in late summer, early fall, are now in need of booster shots, that they're no longer adequately protected from COVID? I guess just a follow-up on that. How clear is the regulatory process for boosters and variant vaccines for that matter in terms of the burden of proof on your end to enable authorization or licensure? Thank you.

Yeah. So to the first part of the question, no, I did not say that the participants are not any more protected. And just saying that, we are seeing - we are starting to see a drop off of the antibody response and there are now clear publications showing a correlation between the neutralizing antibody titers and protection over time. So we will see a decline of antibody titers and we have to identify the right timing for a booster dose, yeah. And the right timing of a booster dose comes, of course, with the objectives one would like to accomplish. And if they accomplish, it’s [ph] really to ensure prevention of infections, the boosters dose has to come earlier. And I believe that we need to go for - to accomplish in the population a strategy to avoid infections, not only to avoid diseases, and therefore a booster dose would be needed earlier than later. So that's the first part of the question. Can you repeat the second, your second question, please?

Yeah, just how clear the regulatory process is for boosters and variant vaccines in terms of the burden of proof to enable authorization?

Yeah. So we have already started a clinical trial with boosting participants, who had received two doses of our vaccine. And at the end of the day, it is more or less an automatic approach based on understanding of titers, protection and the level of improvement that can be accomplished by a booster dose.

Okay, great. Thank you very much. Appreciate it.

Yeah.

Thank you. The next question is from the line of Arlinda Lee from Canaccord Genuity. Please go ahead.

Hi, guys. Thank you for taking my questions. I wanted to maybe clarify something, you alluded to single and double doses for the booster studies that are planned and underway. Can you please explain how the study is designed? What you hope to see? And when might we see data from that?

Ozlem, do you like to take the question or should I take the question?

Yes. Can you please repeat, the audio is a bit shaking? It was about boost study, right?

Right. You were talking about the single and double dose - doses for booster studies that would address the variants that are planned and underway. Can you please explain how that study is designed? What you hope to see and when we might see data flow?

So the studies assess a couple of questions. One question is that we assess a search dose, meaning after prime boosts the second booster dose of our vaccine in its current form, and we'll assess how immunogenicity after this dose is boosted and whether it also protects from circulating variants, so, not only tests or neutralization of the vaccine strain, but also for other variants. What these studies will also test is boosting of the BNT162b2 boost participants with use claim of interest of concern. And here we will use the South African strain as a representative of variant of concerns. And additional assessments are in participants who are naive for vaccines, and will need - test it with regards to immunogenicity and protection by stray - by a vaccine which we present a variant strain, meaning in this case with South African strain. These studies have partly already started as amendments of our ongoing for example, Phase 3 trial where those subjects and participants who have been already vaccinated with communality [ph] are now for example getting the first boost with the same vaccine or with the new strain and partly we have submitted them, they have not started yet.

Okay, thank you.

Thank you. The next question is from the line of Daniel Wendorff from Commerzbank. Please go ahead.

Yes, good afternoon. And thanks for taking my questions. I have a question on the - on your development effort of different formulations. And can you maybe elaborate a bit on where we stand there? And is it technically possible also to bring a commonality vaccine to the market which is stable at normal, refrigerator temperatures for longer time. Is it something you work on? So anymore color here would be much appreciated? Thank you.

I can take the question, okay. Yes we are continuously working on - from a new formulation but also on extending the use of our current formulation. So we have recently announced that the existing formulation is - can be stored for a longer time at minus 20 degree. We will update this data also with regard to stability of our formulation at 2 to 8 degrees. So we had announced that that this is an ongoing study with the existing formulation. To relax the conditions for the existing formulation we are developing ready-to-use formulation and lyophilized formulation, which will come into the market in the second half of 2021 and this new formulations will allow much longer stability at such temperature 2 to 8 degree.

Thank you.

Well come.

Thank you. The next question is from a line of Daina Graybosch from SVB Leerink. Please go ahead.

Hi. Thank you for the question. I'm going to ask another one on the boosting variant. Specifically you have suggested that you need to maintain a threshold titer of antibodies. And I wonder what evidence you have that informs what that target threshold is, what's the impact of B-cell affinity maturation on the required threshold? And where did T-cells fit in and could they come save us and not require multiple boosts?

Yeah. So great questions, Daina as always. So what is emerging, so its really a correlation between prevention of disease and prevention of infection by the different types of vaccines and neutralizing antibody titers. So it is - now more and more studies are publishing which provides a clear correlation between vaccine effectiveness, vaccine efficacy and neutralizing antibody titers. And we do not yet have concrete numbers, but this will clearly come in the next 6 to 9 months. And prevention of infection is clearly dependent on neutralizing antibody titers. Severe disease, prevention of severe disease and even maybe also prevention of disease is also driven of course responses, but these are responses coming in only if the virus has reached already the target cells and start replicate – replication. So we are confident that particularly CD8 T-cell responses will provide long-term protection against severe disease, including the variants, but they will not be able to prevent effectively infection in combination with neutralizing antibodies and of course they will be – there will most likely be a situation where lower titers, neutralizing titers can impact compensated by former T-cell responses and vice versa, but this is science [ph] to come or data which will be - which will emerge in the next 6 to 12 months.

Thank you. The next question is from the line of Navin Jacob from UBS. Please go ahead.

Hi. Yes, thanks. I know you said one, but hopefully these two questions are very quick. I just wanted to clarify the lyophilized version of 162 that you're working on, you mentioned that you're starting the study. I just wanted to understand, I'm sorry, I missed it, but what exactly is required to get that approved, is it just immunogenicity data or do you have to run a full outcomes based study or is it just PK data> And then of the 450 million doses contracted in “other regions” how much of that is China? Any color there would be appreciated.

I can take first question maybe and the second question is Ryan or Sean, if that’s okay?

Yeah, I can ask that…

Yeah. So the first question is, so there are different guidelines or guidances at the moment, how to approve - approve a process to ensure that new variants vaccine can be introduced. When they doing that, and this is the way requested by the FDA is to show for a variant strain that a vaccine addressing a variant strain can be manufactured in the same day, released in the same day, then provide safety data for this new variant vaccine and provide immunogenicity data and show comparability of titers accomplished against this variant strain. And then on the data package, on the full data package, and on the comparability data, this could be cite [ph] in a blueprint, a proof blueprint process, so that if a variant vaccine is needed, it could be introduced without the need for an additional clinical trial. So that's the general way to progress. But there are differences suggested by regulators in UK and then by EMA, but at the end of the day, for each of the parties, some sort of study data will be required.

Yeah. Navin on the China question, so the answer is very little, has been included in the 1.4 billion currently signed figure. We've included the doses that have been committed to Hong Kong and Macau, where we have an EU approval, which is just under 10 million doses. We've also committed to Fosun, our partner from Mainland China to supply up to 100 million doses, or at least 100 million doses in 2021, if approval occurs, and we're in the approval process as we speak, but those doses have not been included in the 1.4 billion number.

Thank you. And the last question today is from the line of Akash Tewari from Wolfe Research. Please go ahead.

Thanks so much. So Pfizer has publicly made - I would argue some unusual comments on its desire to go after mRNA themselves. Moving forward, can you comment on your current COVID partnership, how long it lasts, if there are any outs, and when either company be able to develop a vaccine candidate for SARS-CoV-2 at solo at some point? And then maybe on your PD-L1x4-1BB bispecific, Genmab mentioned one of the reasons they selected the 100 million [ph] dose, they wanted to have optimal trimer formation. And that kind of translates to about 60% to 70% occupancy for the PD-L1. How important is that formation of a trimer and why not target a higher PD-L1 occupancy from an efficacy perspective? Thank you.

Okay. Thanks Akash for the question. So the first question. The first question is, first of all, we have an excellent collaboration with Pfizer where the teams are really closely collaborating and we at the management level, for example, with Albert Bourla, we have a daily conversations about the ongoing collaboration, but also about future collaboration opportunities. And with regard to the existing COVID-19 project, it is a partnership. We have a 50-50 partnership and there is no room for any of the partner to do something alone, everything has to be decided in a partnership manner and - but understanding of course, that COVID-19 will stay with us, most likely for at least a decade, this is a long term partnership. With regard to other potential collaborations, Albert Bourla said that they like to work with us, but they don't need to do it. And this is actually a comment I made in the same way. It is an fantastic partnership. And we would like to continue to do additional projects with Pfizer, but we don't have to do it. And I think it's an excellent situation where you just enter into a partnership, if you see the benefits, we see a lot of benefits in doing additional projects together. But we will come up with this update about this in the next weeks.

Yeah, and Ugur, I just like to add to that, of course, you know, I just like to remind everyone that we've been developing I&P [ph] around in our – in a for over a decade. And, of course, that's important for any collaborator when they're thinking about entering into the space themselves. And of course, the other thing we do is, we continue to talk to other pharmaceutical companies to sort of ordinary [ph] course of business matter.

Thanks, Sean for this additional…

The trimer formation?

Yeah, the trimer formation is - indeed the trimer formation is important for the conditional activation of the 4-1BB and with 100 microgram we have the sweet spot of PD-L1 or PD-1 blockade, plus trimer formation in a sufficiently long time. So we exploit here the optimal activation or functions of both arms of the antibody. And this is also in line with objective responses that we have observed with this component which are - which seem to be associated with this dose window.

Thanks so much.

Yeah.

Thank you. I'll now hand back to the speakers.

Yeah. Thank you again for joining the call today. We look forward to speaking to you in the future. Thank you and bye-bye.

Thanks, everyone.

Thank you.

Thank you.

Thank you. That concludes the conference for today. Thank you for participating and you may now disconnect.