Q4 2020 BioNTech SE Earnings Call

[music].

Good day, and thank you for standing by and welcome.

Operator: 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 will be a question and answer session. To ask a question during the session, you'll need to press star 1 on your telephone.

And spy on text corporate update and financial results fourth quarter, and full year, 2020 conference call.

At this time, all participants are on a listen only mode.

After the Speakers' presentation, there'll be a question and answer session.

And I'll ask the question during the session you will need to press the star one on your telephone.

Operator: 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.

Please be advised today's conference is being the quote at Shire.

If you require any further assistance please press star zero right now.

And I'd like to hand, the conference over to your first speaker today, So <unk> Vice President Investor Relations and strategy. Please go ahead.

Thank you.

Morning, and good afternoon.

Silke Maas: Thank you for joining us today to review BioNTech's fourth quarter and four-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, which is accessible on our Embassy website. 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, our current estimate of COVID vaccine revenues based on current contracted supply orders. Expenses, expenditures, and tax rate for 2021

Thank you for joining us today to review by on textbook quarter, and full year 2020 operation of broker and financial results.

Before we start of the courts, you to view of the slide for the webcast as well as the operational and financial results Press release issued this morning, both of which accessible on our website at the investors section.

As shown on slide two during today's presentation, we will be making separate and forward looking statements.

These forward looking statements include but are not limited to our current estimate COVID-19 vaccine.

The news based on current contracted supply orders.

Tens of expenditures and tax rate for 2021.

Oh of cockpit vaccine production capacity for 2021 hour of COVID-19 vaccine revenues, which are subject to numerous estimates.

Silke Maas: 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 28, the ability of BioNTech to supply our COVID-19 vaccine, and the 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 are consistent with the U.S. Securities and Exchange Commission, including our most recent annual report on Form 20S. Actual results could differ from those we currently anticipate. You are therefore cautioned not to place any reliance on any forward-looking statements which speak only as of today.

More fully described in our annual report on form 20-F the.

The ability of biotech to supply all of COVID-19 vaccine. The plan next steps and biotech pipeline program.

The timing for it and relevant initiation and completion and reporting data from our clinical trials.

And other risks described in our filings made with the U S Securities and Exchange Commission, including almost recent and we report on form 20-F.

Actual results could differ from those because the anticipated.

And therefore cautioned not to place and you rely on any forward looking statements, which speak only as of today check the day during this conference call and webcast.

Silke Maas: Share today during this conference call and webinar. Also, please note that slide three provides 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, Silke Pötting, 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.

Also please note that slide three provides.

And the detailed at the.

Of course and safety information regarding our recently launched the COVID-19 vaccine.

On the call from biotech management today would be work on our chief ex that you took office on co founder of <unk>, Our Chief Medical Officer, and cofounder and Sean Marett Chief.

Heath business and commercial Apis the.

Putting all of the Chief financial and operating Officer, and Brian Richardson, Our Chief strategy Officer.

I'll now hand, the call over to resign biotechs C of O.

Good morning, and good afternoon, and thank you to airports on.

Silke Maas: 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. Slash pie.

Joining the call today.

And I'm delighted to be here to discuss the progress that you've made in terms of turnkey and I would like to introduce the important milestones to be of plant.

The intent to 'twenty, one and beyond.

Flat price.

Ugur Sahin: 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 utilize the powerful mRNA vaccine platform and our deep immunoengineering competences 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.

On a year ago, the whole blood flow spit, something though that part of the last couple of violence and buy.

And I'll take the made an early decision in January of last year to tackle the virus head on.

And utilize the Paul put them on the vaccine platform and our deep in Euro and Canadian competence with the has been developing for all of that okay.

The this other decisions and the enormous amount of Bakken and edgy that followed the stocks and the highly effective vaccine and less than a year.

Now on the data you're already seeing the first signs of positive impact the vaccines are having and reducing infections hospitalizations and mortality.

Ugur Sahin: Now, one year later, we are already seeing the first signs of the positive impact that vaccines are having in reducing infections, hospitalizations, and mortality. But 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.

Oh book against COVID-19 is not finished.

And today's presentation of the some of ours, plus the economy doing and what the come next.

Turning to slide six.

Ugur Sahin: 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 will recognize our first commercial product sales.

2020 has literally transformed by on Pik.

Our COVID-19 vaccine has now been the hotel has put us in more than 60 countries with more than 20 million doses, having been supply of.

March 20 foot.

During the fourth quarter of 2020, but right at the corner.

Cash the products it isn't.

Ugur Sahin: 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.

This is a major milestone and given the concerns that the investment and the touch on development.

We have made over the past tech and yes.

And now a fully integrated biopharmaceutical company.

Build the SaaS, plus and Germany and.

We have the global commercial scale manufacturing capacity there.

We expect to be able to produce up to 1 billion doses of all of vaccine and intend to 'twenty, one and by on pickup on manufacturing like book all of them.

Ugur Sahin: They expect to be able to produce up to 1 billion doses of our vaccine in 2021 in BioNTech's own manufacturing network. Our Marvel 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 demonstrated promising activity in Phase I clinical trials, and we plan to initiate multiple Phase II trials this year.

<unk> made remarkable progress since we acquired it and we'll be ramping up production and the second quarter.

Despite the COVID-19, and being the spotlight last year.

Made progress in advancing of our oncology pipeline.

And now Pat touching on quality of product candidates and parking.

The ongoing type of cost part of different classes.

Many of the has put us the amongst the demonstrates the promising activity and placed on critical Cai.

And we plan to initiate multiple phase two of this.

Yeah.

Ugur Sahin: We recently started the first human trials for our CARBAC product, BNT211, and for our ribocytokine product, BNT151. Further, we are advancing our first wave of product opportunities toward the market. We expect up to three product candidates, including our mRNA cancer vaccines and our lead bispecific antibody, will be entering into randomized phase two trials by the end of this year. Ultimately, the core of our success is our employees.

And the recently started the testing human price per hour Kovack product BNP to 11 and for our type of kind of product BNP 151.

Further we are advancing all of the base of.

The product opportunities to book the market.

We expect that the free product candidates, including all of them and monarch cancer vaccines and our lead by specific anti body will be entering into a randomized phase two trial by the end of this year.

Ultimately the cough our success is our employees.

Ugur Sahin: We have built a global footprint with the 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 seven.

The global footprint of this establishment of our U S. The second develop and tap.

And the other piece of all of the path to over 19 of hundreds of employees.

I once again, thank our employees for their tremendous efforts going on.

A challenging and exciting year.

Moving to slide seven.

And I went to a highlight some key takeaways for us that'd be the.

Ugur Sahin: I want to highlight some key takeaways for us as we reflect on 2020. It became clear that our mRNA pharmaceuticals have great potential to address major health challenges. Well, the first generation of our mRNA vaccine technology has already proven to be powerful, and we are working on rapid iterations to further improve this new class of product. 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-prick pony.

And on 2020.

It became clear that Oh I'm on it from the sort of take a set of great potential to address the major health challenges or the.

The first generation of I'm on a vaccine and she has.

Already proven to be powerful.

Backing on rapid innovations to further improve this new class of products.

And on the airport is not based on the simple technical issue.

The way of developing novel technologies is not based on the idea of of seamless click pony.

Ugur Sahin: 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 of research to develop a broad toolbox of mRNA technology platforms. Each of these technology platforms is 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 deep know-how in the field.

Our goal from the very beginning was to build and novel the industrial approach for proficient and type of thought I think of that kind of addressed and that they couldn't need and market, but do you see cepheid.

More than a decade long research the devote a boat toolbox of M on it and technology platform.

Each of this technology platform tailored and optimized for potency on the immunological proficient to enable the development of best in class product candidate from Valeant and D. C staff, yes.

Second we believe the on either of the evolution of the field of immuno all of them and.

I don't think it's that pace the continued to lead the evolution given our broad technology base.

The IP portfolio and the deep know how in the field.

The intent to increase so that way of investment in the space given the tremendous opportunity we see.

Ugur Sahin: 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.

And Additionally, we learnt from our COVID-19 expense that product and can be faster.

We intend to apply the capabilities and the earnings to develop during the project that speed to rapidly advance our pipeline and put up to what the market.

And finally cash.

And we learned that our collaboration model of about our focus on innovation and all of our strategic partnership with powerful caught up on that because that type of has.

Ugur Sahin: 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 leadership position. We intend to continue to leverage our strategic partnerships by building our own capabilities in the long term. As depicted on slide 8, we see a great opportunity ahead. It will accelerate the development of our innovative pipeline and expand the number of product candidates and indications we pursue.

Is that that's not the point of developed product back at the time, but the therapy and the early market leading position and.

And we intend to continue to lever that was part of your partnerships by building our own capabilities and long term.

As depicted on slide eight we see a great opportunity ahead of you going to accelerate.

The development of our you know about the pipeline and expand the number of product candidate the rock and indications we pursue.

Our goal is to launch several of the addition put up and oncology and infectious disease.

Ugur Sahin: Our goal is to launch several additional products in the 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 for multiple disease areas. Later in our prepared remarks, Ryan will provide some more detail on the steps we are taking to realize this vision.

Over the next tax year and.

And long term.

The long term goal remains to build the 25 tenths of the global immunotherapy power the.

And product from multiple of D C. Sylvia.

Later in our prepared remarks.

And we'll provide some more detail and to the steps we have taken told me the that this day.

Moving to slide nine and.

Ugur Sahin: 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.

And on the vaccines and now establishes a powerful new truck on the back of the validation and we intend to separately and that's the good Oh I'm on the technology.

We believe mrna vaccines are part and the near term to displays of complement modalities and a range of infectious diseases and and the field of immuno oncology the <unk>.

Ugur Sahin: The proceeds from our COVID-19 vaccines will allow us to accelerate our pipeline development in this core area. In the 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 programs at BioNTech in this research area, and we plan to significantly ramp up the effort in the coming years. Finally, it is important to point out that our ability to industrialize mRNA 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.

<unk> from our COVID-19 vaccines that allow us to ex perfect. Our pipeline development in this call out of a yes or.

The on what Tom with the applications for the technology and the field of auto immune diseases allergy and somewhat of ATC.

And even if ive done out of medicine.

Separately the other research program that violence, taking the lead.

Just out of it and we plan to see efficacy.

The.

The effort and the coming yes.

Finally, it is important to point out that our ability to industrialize and monetary policy is linked to the deep expertise and Knowhow. We have built over the course of more than a decade.

This is the also underpinned by our broad IP portfolio of covering our pet from product candidate and often the targets and formulations of fields.

Now moving to slide 11, and the strong clinical of SaaS of SAP.

Ugur Sahin: The strong clinical results observed for our vaccine in our global phase 3 trials 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. BioNTech 162b2 demonstrated 95% efficacy in a 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.

Oh, the vaccine and our global Phase III trial.

The a highlight in the fourth quarter the <unk>.

Study of US has demonstrated that the all vaccine can prevent symptomatic of COVID-19 is the best part of it the safety profile.

BMT one of them to be true demand created 95% the efficacy and that price is approximately 44000 participants, including 94 per cent of secrecy and participants ordered 60 per year.

The safety profile of a favorable because of lower frequency of goods, especially the.

And the mostly typical vaccine related side effects.

Key characteristics of our rack vaccines.

Ugur Sahin: Key characteristics of our vaccines are a broad immunogenicity profile, that is polyepitopic and multi-effector. The vaccine induces a high level 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 vaccines.

Both immunogenicity profile, that's probably at the Capex and multi effects on.

The vaccine and uses high titers of neutralizing anti bodies.

Fund type of CD, four T cell responses and see.

CD eight T cell responses.

We believe all of this factors contribute to the protection from threats by all of X gene.

Ugur Sahin: [inaudible] We recently announced first real-world evidence data supporting the clinical profile of our vaccine. This exciting news comes from an observational analysis conducted by the Israel 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.

Turning to slide.

The recently announced firstly of the evidence data supporting the clinical profile of all of Etsy.

This exciting news comes from and the observation and that is conducted by the ministry of between.

Between January 17 as of March six 2021 day.

And this time, our COVID-19 vaccine, but the only vaccine available in the country.

Ugur Sahin: 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 of 94% against asymptomatic SARS-CoV-2 infection. At the time of the Israel study, the UK variant, B.1.1.7, was the dominant strain in the country, indicating the likely effectiveness of our vaccines against COVID-19 caused by this variant. In this context, it is important to point out that in vitro data also support our COVID-19 vaccine's efficacy against several variants.

Specifically the data from <unk> shows that two weeks after the second dose vaccine effectiveness was at least 97% and preventing symptomatic disease severe and critical disease hospitalization and death.

And then there's always short of vaccine effectiveness.

And 94% against asymptomatic task of two infections.

At this time of the <unk> study, the UK, Valeant and Viva and seven what's the dominant brand in the country, indicating the likely effectiveness of.

And our vaccines against COVID-19 caused by the Valeant.

In this context it is important to point out that in vitro data also supports our COVID-19 vaccine efficacy against several of the balance.

Ugur Sahin: 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, Serum neutralized all the viruses tested and showed no significant reduction in activity against B.1.1.7 and P.1.0 spike viruses. The neutralization of the South African variant B.1.351 spike virus was lower, but it was still robust.

Has published data and then you're in the genre from in vitro studies of our vaccine neutralization and activity against the different Valeant and these studies. They are on neutral as all of the virus is tested and shorten the.

Deduction and activity against the $1 seven and pier one spike viruses they're.

And they're not realization of the South African volume be run between 51 Spike virus was lower but it was robust and.

Ugur Sahin: 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 wane over time. This is not surprising, indicating that reboosting may be required.

In addition to the in vitro testing, we are continuing to monitor the efficacy against several emerging value.

As outlined on slide 30, and the anticipated COVID-19 may become an endemic the seasonal but the next few years.

The already see evidence that the immune responses index the native in the real space of attack. This.

This is not surprising indicating that we of boosting may be required.

In addition day is a growing body of evidence showing that youll variances the anti body of escape of mutations and driving new infections in many regions.

Ugur Sahin: 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 well suited to play an important role in addressing the next stage of the disease. Expanding broad access to BNT1 and 2B2 remains a key focus for us, as shown on slide 14. We highlight here six key levels to expand BNT1 and BNT2 each. The first is supply.

And the size, we believe the day.

Likely of future needs for additional vaccine booster and potentially what's the value of specific vaccines.

Due to the ability to get to be rapidly. This time customized and produce at scale the belief that amount of ex since the vast <unk> to play an important role in addressing the next stage of the disease.

Expanding both excess to BNP volume to be two of remains a key focus for us as shown on slide 14.

The highlight of six key levers to expand the antibody and seek.

To be two each.

The first the supply increase our supply of target for 2021 to two 5 billion doses.

Ugur Sahin: They 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 vaccine label is also a key priority. We have extended our clinical program to additional vulnerable populations, such as pregnant women. In February, the first participants were those in the Global Phase II trial 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.

This will require further process improvements and further expansion of our supplier in CCM on net.

Book, but we believe we are on track to achieve this.

Continuing to both of our vaccines day, but it's also a key part of it.

We have extended our clinical program to additional of vulnerable populations such as pregnant women.

And people are we first participants of the dose in the global Phase III price and has the pregnant women and the study will record first half of the patents and.

18 years of age or all the during the 20th fought and took Q4 weeks of gestation.

And other important pillar of our pediatric test the plan to submit the safety and efficacy data in 2000 and children 12 to 15 years of age from the phase III price to the regulatory authorities and the second quarter and neither study in healthy children six months to 11 years of age.

Ugur Sahin: Another important pillar is our pediatric trials. We plan to submit the safety and efficacy data from 2,000 children, 12 to 15 years of age, from the phase three trial to the regulatory authorities in the second quarter. Another study in healthy children, six months to 11 years of age, has started. We are also planning further studies in individuals with compromised immune systems.

I started the alts.

And so planning further studies in the individuals with compromised immune system.

And other key lever is geographic expansion. Our vaccine has now been approved for emergency of temporary use of granted conditional marketing authorization and more than 65 countries and they are moving and additional regions and Japan. The phase one clinical price starting in October two.

Ugur Sahin: Our vaccine has now been approved for emergency or temporary use or granted conditional marketing authorization in more than 65 countries, and it is moving into 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's health minister approved BNT-162B2 under the exceptional approval scheme. Last November, a Phase 2 clinical trial of our vaccine started in China to evaluate BNT1, BNT2, and BNT2 in healthy individuals of up to 85 years of age. We have now initiated the regulatory submission process in mainland China and hope to be able to provide an update soon.

Our vaccines activity.

And the address of 20 to 85 years of age and February Japan half minutes, the approved <unk> antibody and the city to be too under the exceptional approvals.

Last November our phase two clinical trial of our vaccine started in China to evaluate the antibodies to be too and the house the individuals of.

Up to 85 years of age we now have initiated the regulatory submission process in mainland China, and I hope to be able to provide an update soon.

We are working to broaden access and even more dense of central as opposed to the vaccine provision.

But the empty balance to be too is available and the U S. Under emergency use authorization, we are preparing BLA filing in the second quarter for full regulatory approval further regulatory submissions and other reasons are also expected.

Ugur Sahin: We are working to broaden access and enable a more decentralized approach to vaccine provision. While BNT1 and BNT2 are available in the U.S. under emergency use authorization, we are preparing BLA filings in the second quarter for full regulatory approval. Further regulatory submissions in other regions are also expected. Stability and formulation testing and optimization work remain 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 of up to two weeks.

Stability and formulation testing and optimization book remains another key focus over the past few weeks the U S FDA and EMA approved the update.

And diluted for the advice of our vaccine may be transported and stored at minus 25 degrees Celsius to minus 50 degrees Celsius for a period of two weeks, we expect additional stability profile of updates over the next few months.

We are also developing ready to use and <unk> formulation of this improved time of stability profile of <unk>, yes.

The development of the ready to use formulation and do not currently expect additional clinical studies to be required for this formulation for the life of that formulation and we announced the data we will start at price to evaluate the safety Tolerability and immunogenicity of the formulation and we expect data.

Ugur Sahin: They expect additional stability profile updates over the next few months. We are also developing ready-to-use and life-of-the-life formulations with improved thermostability 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 life-of-the-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 decline over time.

And from this trial in Q3 or for 2021.

Antibody responses and then over time.

The rest of the value of immune responses and the safety and Immunogenicity of the first dose of our of exiting the aim of this trial is to understand the effect for booster to prolong immunity against COVID-19 caused by the circulating and potentially the newly emerging SaaS cost to values.

As mentioned two day Theres no evidence that and adaptation of our current vaccine against key identified and the arching variance if necessary.

Ugur Sahin: 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 dose to prolong immunity against COVID-19 caused by the circulating and potentially newly emerged SARS-CoV-2 variant. As mentioned, to date, there is no evidence that an adaptation of our current vaccine against key identified emerging variants is necessary. Nevertheless, despite this, we have developed a comprehensive strategy to address these variants should the need arise in the future.

Despite this we have developed a comprehensive strategy to address these variance should the need arise and the future and.

On March 2021 of the FDA approved and in addition, the amendment to the study protocol of the global Phase two.

And to feed tie to income include four of factors of PMT balance seemed to be too of first off. This is modified version of the vaccine carrying the spike protein sequence the thought.

Caught south asset value in.

In order to further describe duration of protection and protection against potential and the ocean variance of concerns.

And additional group of BMT balance to be too naive participants the there'll be on hold and received two doses of the South African variant ex inversion to this cut protection against the emerge and balance of concern against the scaffold and spread the part of the price.

Ugur Sahin: In March 2021, the FDA approved an additional amendment to the study protocol of the global phase 1, 2, 3 trial to include a third dose of BNT1 and C2V2 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 BNT2 naive participants will be enrolled and receive two doses of the South African variant vaccine version to exclude protection against emerging variants of concern against this reference trait.

It's the variant is expected to start by the end of March.

I will now turn the call over to Sean to provide and update on our COVID-19 manufacturing and commercial supply per stages.

Thank you Hugo.

Slide 15 shows the flexible manufacturing process about COVID-19 vaccine.

We can go from DNA.

The production to sterile filtration and spending and that's.

He was nine to the team.

Well, the 50000 and stacks are required for manufacturing the ammo and the nature of the bulk drug substance.

The overall manufacturing from game.

On a template to cool and finish can be done and less than two weeks.

Following production quality control of the movies.

Ugur Sahin: The part of this trial with the variant is expected to start by the 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. Thank you, Ugur.

Another four to five weeks and then we are ready to deliver the vaccine.

One of the advantages of both of them are taken.

Technology is that it allows for rapid adoption of the vaccine to variance.

Unlike traditional banks and production, we can adapt our manufacturing to encode and youth area and took the needed.

Sean: Slide 15 shows the flexible manufacturing process of our COVID-19 vaccine. We can go from DNA template production to sterile filtration and filling in as few as 9 to 13 days. Although 50,000 steps are required from manufacturing the mRNA to the bold drug supply, the overall manufacturing from the DMA template to fill and finish can be done in less than two weeks. Following production, quality control, and release can take another four to five years, and then we are ready to deliver the vaccine.

Simply put providing of DNA template and foods or the suite.

All of the news area.

This can be done within a couple of weeks and without the need and scale up of yogurt prices and.

Pending regulatory approval.

Another advantage of I would like to point out.

We can increase or decrease manufacturing quantities with the short lead time.

That's on manufacturing technology provides us with the flexibility to respond to market the law.

Moving on to slide 16, we.

We have firm or just 1.4 billion doses per day.

Recently, we announced but of the United States of the exercise we focus on current and additional 100 million doses.

Sean: One of the advantages of our mRNA technology is that it allows for rapid adaption of the vaccines to variants. Unlike traditional vaccine production, we can adapt our manufacturing process to encode a new variant if needed, simply by providing a DNA template that includes all the sequences of the new variants. This can be done within a couple of weeks and without the need for new scale-up of the overall process or pending regulatory approval. Another advantage I would like to point out.

Bringing the total to 300 million doses.

We also announced the.

You will be supplied with the additional coupon Goodman.

With an option for an additional one of them good movies and for.

Good day.

This brings the total number of doses.

Delivered to the United States by the end of 2021.

500 million.

With the potential to increase per live up to six of them.

Yes.

Discussions for additional commitments worldwide Oh go range.

The I'll take on prices and initial go was the none of those types of up to $1 3 billion doses and to.

Sean: We can increase or decrease manufacturing quantities with a short leap. Thus, our manufacturing technology provides us with the flexibility to respond to market demand. Moving on to slide 16, we have firm orders for 1.4 billion doses today. Recently, we announced that the United States has exercised its option for an additional 100 million doses, bringing the total to 300 million doses. We also announce that the EU will be supplied with an additional $200 million, with an option for an additional 100 million further doses.

And then in 'twenty one.

We've been able to increase our toward the capacity to up to two four and five.

And does the.

Yeah.

The increase was driven by a number of factors, including the increase from five to six doses per vial.

Additional supplies and see them much.

The continued success and process optimization and the initiation of production at all.

So let's see.

On March 26, we announced the the Mer proof of the manufacturing of the COVID-19 and Scott.

At the facility and Mt.

The approvals might be on Petsmarts of the manufacturing side, one of the largest mrna vaccine manufacturing sites worldwide.

Sean: This brings the total number of doses to be delivered to the EU member states by the end of 2020 to 500 million, with the potential to increase further up to 600. Discussions for additional commitments worldwide are ongoing.

With an annual production capacity of up to one big won't go a whole lot of COVID-19 effects and one.

For the operation.

Due to optimize operational efficiencies, which were initiated last year.

We were able to increase the expected annual manufacturing capacity by 215.

Sean: BioNTech and Pfizer's initial goal was to manufacture up to 1.3 billion doses in 2021, but we've been able to increase our target capacity to up to 2.5. Brilliant. This is called The Year. The increase was driven by a number of factors, including an increase from five to six doses per vial. Additionally, additional suppliers and CMOs continued success in process optimization and initiation of production at our Marburg facility. On March 26th, we announced that the EMA approved the manufacturing of the COVID-19 vaccine drug product at the facility.

The FERC batches of that and then eventually it.

Does the law books are expected to be delivered and the second half of the bank.

We plan to produce up to 250 million doses of <unk>, one six to beat to the number.

First of all go to 2021.

Lastly, we have taken all the debt and the strategic cholesterol stretch to for COVID-19 vaccine and Jim.

What Pfizer is responsible for the rest of the book outside of China.

This is the first on the biotech is commercialized the product from us.

Lots of luck.

On that turn the call over to <unk>.

But on the update on the quota.

Thank you Shaun and Hello, everyone.

Sean: The approval was made by BioNTech's Marlborough manufacturing site, one of the largest mRNA vaccine manufacturing sites worldwide, with an annual production capacity of up to 1 billion doses of our COVID-19 vaccine once fully operational. Due to optimized operational efficiencies which were initiated last year, we were able to increase the expected annual manufacturing capacity by 250.

And in the inter.

Rest of time I'm going to provide updates on sort of exited programs for further details on the status of our other oncology programs. Please refer to our annual report, which has been filed with the U S Securities Exchange Commission to date.

The expected we have continued to see some ongoing impact from the COVID-19 pandemic on the luxury of nickel operations.

Typically there has been a slowdown and the enrollment and some of our ongoing studies. Despite these constraints, we expect to present several of data sets and initiate Mike and you try it this year.

Sean: The first batches of vaccine manufactured at the Marlborough site are expected to be delivered in the second half of April. We plan to produce up to 250 million doses of BNT-160B2 in the first half of 2021. Lastly, we have taken our first step in executing our commercial strategy for our COVID-19 vaccine in Germany. What Pfizer? is responsible for the rest of the world outside of China.

Slide 18 outlines our immuno oncology strategy. Our strategy is based on several first in class therapeutic approaches so targets, Ken and to modulate the immune response the probe.

Address a broad range of cancers and different disease states.

Sean: This is the first time that BioNTech has commercialized a product from its pipeline. I'll now turn the call over to Ozlem to provide an update on our colleagues. Thank you, Sean, and hello everyone.

Six technology platforms have all reached clinical stage right now with Qiagen clinical stage product candidates and we see most of the drop softball cuts your energy center potentially question net just the combination of.

Ozlem Tureci: As usual, and in the interest of time, I'm going to provide updates on selected programs. For further details on the stages of our other... Programs, please refer to our annual report which is being filed with the U.S. Securities and Exchange Commission today. As expected, we have continued to see some ongoing impact from the COVID-19 pandemic on our clinical operations. For example, there has been a slowdown in enrollment in some of our ongoing studies.

And our later stage programs are shown on slide 19.

Starting with BMG 111, and our <unk> product candidates of the treatment of advanced melanoma, we expect to start the randomized phase two trial and the U S and EU and the first half of 2021.

Trial, which evaluated <unk> in combination with regeneron flip tayo, whereas the cell.

Ozlem Tureci: Despite these constraints, we expect to present several data sets and initiate multiple new trials this year. Slide 18 outlines our immuno-oncology strategy. Our strategy is based on several first-in-class therapeutic approaches to target cancer and to modulate the immune system. The programs address a broad range of cancers and different diseases.

P&G won 11 on tier one of European and patients with advanced melanoma progressing during after prior therapy with the PD one inhibitor.

In February we received permission from FDA to move forward with the trial the <unk>.

Ozlem Tureci: Our six technology platforms have all reached the clinical stage. By now, we're 13 clinical stage products. We see multiple blockbuster opportunities and the potential for synergistic combination. All later stage programs are shown on screen.

Six of that product candidate has the and do you want to achieve our mrna vaccine and coding the 6007 protein.

And papilloma virus 16, we expect the start of phase two trial evaluating <unk> in combination with Penguin from upwards of the sample of the sum up one on CRP as the first line treatment in patients with Unresectable recurrence on that.

Ozlem Tureci: Starting with VNT111, our six-pack product candidate for the treatment of advanced melanoma, we expect to start randomized phase two trials in the U.S. and EU in the first half of 2021. The trial will evaluate BNT111 in combination with Regeneron's Leptio versus both BNT111 and Leptio monotherapy in patients with advanced melanoma progressing during or after prior therapy with a PD-1 inhibitor.

The static HPV 16 positive head and neck squamous cell carcinoma.

Question, PDL, one and the first half of 2021.

U S and EU the.

<unk> has not been combined with anti PD, one before end of phase two trial with start with the run in the portion.

<unk> to demonstrate the safety of the combination of <unk> and <unk>.

Each day to all required to address the partial clinical hold on just the current randomized part of the face to try and.

Ozlem Tureci: And in February, we received permission from FDA to move forward with the trial. The next six-pack product candidate is BNT1-13, our mRNA vaccine encoding E6 and E7 proteins of human papillomavirus. We expect to start a phase two trial evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment for patients with unrespectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma expressing PD-L1 in the first half of 2021 in the US and EU.

Moving to our individualized antigen specific immunotherapy.

The platform, which is partnered with Roche Genentech.

And I know product can be day 122 has been given the international non proprietary name Arthur gene several of them.

On the phase two trial and first line melanoma and the phase one basket trial in solid tumor.

And ongoing data updates on <unk>.

Texted for these trials.

Yes.

We along with Genentech has made the strategic decision to discontinue the previously planned phase two trial in patients with high risk we checked the early stage non small cell lung cancer.

Ozlem Tureci: BNT1-13 has not been combined with NTi-PD-1 before, and the Phase II trial will start with a run-in portion designed to demonstrate the safety of the combination of BNT1-13 and Pembrolin. These data are required to address the partial clinical hold on the subsequent randomized part of the case. Moving to our individualized neoantigen-specific immune therapy platform, or INS platform, which is partnered with Rush Genetics. Our INES product candidate, BND1-22, has been given the international non-proprietary name, Autogyro. The Phase II trial in first-line melanoma and the Phase I BASC trial in solid tumors remain ongoing, but data updates are not expected for these trials.

And then challenging of cooler timelines and the context of SaaS to pandemic and so.

Evolving landscape of treatment options, we and our partner Genentech.

Other options for treating early disease cancer patients with on this.

One of the.

Development option and the adjuvant setting is colorectal cancer.

The next to dose the first patient and the first half of the year in the randomized phase two trial evaluates and beyond Q1, 'twenty, two and circulating tumor DNA positive.

Surgically resected stage too high risk of stage free colorectal cancer, we strongly believe that could be best positioned and the earliest stage adjuvant setting and minimal residual disease detection moves.

Ozlem Tureci: We, along with Genentech, have made the strategic decision to discontinue the previously planned phase two trial in patients with high-risk, restricted, early-stage, non-small-cell lung cancer, given challenging accrual timelines in the context of the SARS-CoV-2 pandemic and the evolving landscape of treatment. We and our partner German Tech are evaluating other options for treating early-stage cancer patients with IMD. One of these early disease development options in the adjuvant setting is colorectal cancer.

Moving to our next generation checkpoint immuno modulator program, which is partnered with Genmab.

We expect to present, the data update and the second half of 2021 for the first in human phase one to try and ask the anti free.

And also cause Gen 10, 46 P M.

Free 11 condition of the targets PDL, one and four one BB and has the potential to be first in class.

Given the unmet need for improved checkpoint Immunotherapies, we remain very encouraged by the results presented at the.

Ozlem Tureci: We plan to dose the first patient in the first half of the year in a randomized phase two trial evaluating BNT126, in circulating two more DNA-positive surgeons that Stage 2 high-risk or Stage 3 colorectal. We strongly believe that INES could be best positioned in the earlier stage or adjuvant setting with minimal residual disease. Moving to our Next Generation Checkpoint Immunomodulators program, which is partnered with GEMMA, we expect to present data in the second half of 2021 for the first in-human phase 1-2 trial of BNT311, also called Gen1046. BNP311 conditionally targeted at TDL 1 and 4.1BB and has the potential to be first in class.

Last year, the conference and seem to date and believe the product has significant potential across much of clue oncology indication.

12 of which to moving the program.

The twist.

So of BMT free.

Of which condition of the targets CD 40, and 41 BB, we plan to present data from the ongoing phase one two trial and the SEC.

On top of 2021.

And in addition, and abstract highlighting preclinical data from P&G of Retreads and has been accepted for presentation.

At the upcoming ASC on the team.

Chuck described some of the mechanism of action of <unk>.

Additionally, the four and four <unk> activity to induce dendritic cell maturation and the enhancement of T cell activation and effector function.

Ozlem Tureci: Given the unmatched need for improved checkpoint immunotherapies, we remain very encouraged by the results presented at last year's TIPC conference and seen to date and believe the product has significant potential across multiple oncologies. We look forward to moving this program forward with BNK48. 2012, which conditionally targets CD40 and CD41BB; we plan to present data from the ongoing Phase I-II trial in the second half of 2021. In addition, an abstract highlighting preclinical data for BNT-free trials has been accepted for presentation at the upcoming AHC Aum. The abstract describes the mechanism of exoskeletons.

Slide 20 provides an overview of programs of across four different technologies that have the potential to advance innovation beyond current voluntary.

We are pleased to announce that from our current key technology on welfare.

How about product candidate has and touch clinical testing, we dosed the first patient in the first in human trial in February from BNP to 11, I will discuss with growth from and detailed schottky.

And the first half of 2021, we also expect to dose the walk participation with BMG.

One of the first product from a lot of Neostem T cell therapy programs, which feature the adoptive transfer of individualized Neo antigen specific autologous T cells.

This phase one dose escalation part to try and evaluate the safety and Immunogenicity and efficacy of P&G to 'twenty, one and patients with checkpoint inhibitor refractory ore on the with concepts and the best Patrick.

Ozlem Tureci: Conditional CD4 and 4-1BB Activity to Induce Dendritic Cell Maturation and Enhancement of T-Cell Activation and Effectiveness. Slide 20 provides an overview of programs across four different technologies that have the potential to advance innovation beyond current boundaries. We are pleased to announce that from our CAR-T technology, our first CARVAC product candidate has entered clinical trials. We dosed the first patient in a first in-human trial in February for BNT2-11. I'll discuss this program in detail.

Patrick melanoma.

Awesome.

The reported that the first patient was dosed in the phase one trial and solid tumors and February four.

PMT 151 hour drive of cytokine and taxi and the code testing and also discuss this program and greater detail Schottky.

For the <unk> 152, and CMT 150 free and combination.

Second drive of cytokine program.

It's the one trial in multiple solid tumors.

Ozlem Tureci: In the first half of 2021, we also plan to dose our first patient with BNT. 21, the first product from our Neostem T-Cell Therapy program, which features adoptive transfer of individualized neoantigen-specific autologous cells. This phase one dose escalation trial will evaluate the safety, immunogenicity, and efficacy of BMT221 in patients with Checkpoint Inhibitor Refractory or Unreturned, and Oz to report that the first patient was dosed in a phase one trial in solid I'll also discuss this program in greater detail.

The expected.

And the first half of 2021 the BN.

PMT 152, plus P and Q1 dollars 50 free IMD for the phase one trial and the U S. Once approved by the FDA and of course.

All of them.

As the law lives of cytokine.

So all of our rival net.

141, and <unk>, one swatch of tool and <unk>.

And you must be it from the net DUC immune therapies with all and <unk> and coded proteins expressed in the liver and deployed into the vascular compartment to reach your pubic the extra Sal and concentration phase one price will fall off and.

The solid tumors I expect it to start and the second half of 2021. The FDA recently allowed a lot of the Engie 141 I M D.

Starting with slide 21, Rodriquez, two BMT to 11, the first clinical stage product candidates.

Ozlem Tureci: For BNT-152 and BNT-153 in combination, our second rival cytokine program, a phase one trial in multiple solid tumors is expected to start in the first half of 2020. The BNT-152 plus BNT-153 IMD for the Phase I trial in the U.S. was approved by the FDA end of Feb. Also, our rival 141 and BNT 142 are intravenously administered immune therapies with RNA-encoded proteins expressed in the liver and deployed into the vascular compartment to reach therapeutically active cells.

From our engineered T cell program, which is expected to overcome car T cell therapy. So yes that was strictly because of the end of widespread use of car T cell therapies, particularly the in patients with solid tumors.

PMT to 11 consists of two components.

One is another chimeric antigen receptor function and the last was in the anti blood derived coty and <unk>.

Finding domain with exclusive specificity anti sense of the sensitivity hook load and fixed.

So I didnt fixes and ideas.

Candidate for car T cell therapy, due to its absence and healthy.

Tissue, while the high medical need cancer frequently sort of ex question of this to my attention.

Ozlem Tureci: Phase 1 trials with our first ribomaps in multiple solid tumors are expected to start in the second half of 2021. The FDA recently approved our BNT141 IgA. Starting with slide 21, more details on BNT2-11, the first clinical stage product candidate from our engineered T-cell program, which is expected to overcome CAR T-cell therapy barriers that restrict the efficacy and the widespread use of CAR T-cell therapy, particularly in patients with solid tumors. The NT2-11 consists of two components.

The second generation cost carefully on things.

Of course stimulatory domain for one day, which we believe maybe eight co lungs survival and the repurchase of killing ability of engineered consciousness and.

And preclinical studies PMT to 11 demonstrated strong recognition and advisers of Clos.

The sixth positive targets.

As shown on slide 22 of the second component of the Ante to 11 is the key.

So and the flying hours.

The next the named coffee.

From a proprietary RNA lipo plexus technology non from six studies to encode full length, Claude and six.

Ozlem Tureci: One is another chimeric antigen receptor, functionalized with an antibody-derived co-ordinator, binding domain with exclusive specificity and high sensitivity for clotting. Claudine Six is an ideal candidate for CAR T-Cell therapy due to its absence in healthy adults, while high medical need cancers frequently show expression of this tumor. The second generation cost scaffold also includes a co-stimulatory domain for 1B, which we believe mediates prolonged survival and the Repetitive Killing Ability of Engineered Cartoon. In preclinical studies, BMT2.11 demonstrated strong recognition and lysis of Claudine 6 positive targets.

Mainly the car T targets.

Following intravenous administration of RNA Lipo plexus, and the R&D is specifically.

Deliver the antigen presenting cells residing and secondary lymphoid organ.

This isn't the expression of Coty and six on the surface of the specialized says that's flawed and fixes the recognized by a doctor free transferred car T cells in the lymphoid compartment that provide some idea of context plus strong stimulation of the.

And Jim yet.

Ted.

The repurchase of administration of Kovack allows for control and the voice prompts you to keep the frequency of car T cells on therapeutic level. That's expansion and also result in increased.

Ozlem Tureci: As shown in slide 22, the second component of BNT211 is a called T-cell amplifier. RNA vaccine named CARVAC. We use our proprietary RNA lipoplex technology, known from six vaccines, to encode full-length claudia. Following intravenous administration of RNA lipoplexes, the mRNA is specific. Delivered to Antigen-Presenting Cells Residing in Secondary Lymphoid Organs, This mediates expression of Claudian 6 on the surface of those special...

Austin and.

And superior functionality of car T cells, which require the memory phenotype and preclinical and markets.

We are optimistic that our kovack approach allow us to overcome challenges related to car T cell therapy, which includes severe toxicities restrict the trafficking and activation within two months, it's about half of optimized that.

Ozlem Tureci: Thus Claudine-6 is recognized by adoptively transferred CAR-T cells in the lymphoid compartment, which provides an ideal environment for strong stimulation. Office Engineered, The competitive administration of CARBAC allows for controlled in vivo expansion to keep the frequency of CAR T-cells at therapeutic levels. The expansion also results in increased Systems, and Superior Functionality of Cartel, which acquires the memory penotype in BricsCAD. We'll be out that our Carvec approach allows to overcome key challenges related to quality self-therapy, which include severe toxicities, restricted trafficking to and activation within tumors, as well as suboptimal persistence in wheat.

Assistance and the Whipple.

This is an excellent example of the potential of all of your Pudic modality Watson and that just sticks combinations.

Slide 20 free shows of the trial design for PMT to 11, and the phase one trial will recruit patients with Covid positive relapsed or refractory advanced solid tumor had one of the trial the dose escalation of clothing and six car T cell is one of Europe's largest part two of the prior to this place the combination of closings.

The car T cells with Claude and sixth topic once the maximum tolerated dose of all recommended phase II dose is determined there was the expansion cohorts with shallow and ovarian to stick your line dmitry on non small cell lung and gastric cancer.

Initial phase one data from the trial is expected and the second half of this year the clinical material for the tireless menu of pet shop at our GMP certified.

Ozlem Tureci: This is an excellent example of the potential of our therapeutic modality for Synergistic Combination. Slide 23 shows the trial design for BNT2-11. The phase one trial will..., with Claudine C positive, relapsed or refractory advanced fold. Part 1 of the trial is the dose escalation of Cloridium 6-CART, he says, as monocular. While Part 2 of the trial displays the combination of Cloridine-6 CAR-T cells with Cloridine-6 CARB-X. Once the maximum tolerated dose or recommended phase 2 dose is determined, dose expansion cohorts will follow in ovarian, testicular, endometrial, non-small cell lung, and gastric.

With some of the Chi and eat out, Russia, and Germany, which has extensive cell and gene therapy manufacturing capabilities.

Oh on rival cycle times on Slide 24 on another example for another class of RNA based therapeutics from our immuno oncology pipeline designed to address the limitations of current therapeutic approaches.

And I'm just associated with some of your beauty of Qs of cytokines relate to the short half life and flow bioassay availability the CMP.

Pete therapeutic efficacy and necessitate high and frequent dosing, which often results in dose limiting toxicities.

And coding hydrocarbon by MRI and producing them in the patient address the speed shortcomings. The right side of the slide describes our first of all of the cytokine candidate <unk> 51, which has entered clinical testing.

Ozlem Tureci: Initial Phase I data from this trial is expected in the second half of. The clinical material for this trial is manufactured at our GMP-certified INSS facility in Ida-Oberstein, Germany, which has extensive cell and gene therapy manufacturing capabilities. [inaudible] on slide 24 is another example of a novel class of RNA-based fear from our Immune Oncology Pipeline, designed to address the limitations of current therapeutic approaches. Major challenges associated with the therapeutic use of cytokines relate to their short serum half-life and low bioavailability.

The empty 151 of the nucleoside modified mrna that encodes and optimized interleukin two fusion protein.

As the key cytokine and she said and unity and reporting differentiation proliferation survival and the effects of functions the drafting sign of uptick.

Optimized to improve pharmacokinetic properties with an increased turn of our ability and activity of IL two and.

Porton P&G won 51 has been designed to stimulate the impact you much he says without triggering helix and <unk>.

As shown on slide 25, the ongoing phase one trial in solid tumors with no made of the standup CRP of features one of European combination therapy dose escalation.

Ozlem Tureci: This impedes therapeutic efficacy and necessitates high-end frequent dosing, which often results in dose-limiting treatments encoding cytokines by mRNA and producing them at the patient address. The right side of the slide describes our first rising star. BNT 151, which has entered clinical trials. DNT151 is a nucleoside-modified mRNA that encodes an optimized interleukin-2 fusion. I2 is a T-cytokine and T-cell immunity supporting differentiation, proliferation, and survival. The draft design is optimal to improve pharmacokinetic properties with increased tolerability and activity of IL-2.

151, where the combined with anti PD, one of their standard of care and Ken subtype of such as the risk.

Squamous cell carcinoma, and so had the neck hip auto carcinomas renal cancer, CNBC and non small cell lung cancer.

Why is the product.

The chart Kovack rival cytokines of driver and Laura.

On a based approaches they quite obviously default of one from another and from the version of our mrna technology used for creating the first COVID-19 vaccine the.

Again, demonstrating the high diversification of our mrna platform.

And the many years of know how would you that ultimate that went into it.

I will now and.

The call over to Doug, who will provide an update on all of <unk>.

Thank you you asked the <unk>.

Ozlem Tureci: [inaudible] BNT-151 has been designed to stimulate anti-tumor T-cells without triggering the As shown in slide 25, the ongoing phase 1 trial in solid tumors with no available standard therapy features monotherapy and combination therapy dose escalation. BNP151 will be combined with NTiPB1 or another agent in cancer types such as squamous cell carcinoma of the head and neck, hepatochorostenom Havik, RivalCytoKinds and RivalMaps, M.R.N.

To summarize our financial results for the fourth quarter and the full year 2020 as shown on slide 27.

I'll start with the total revenues, which were estimated to be $345 4 million euros for the fourth quarter of 2020 compared to 28.0 million euros for the fourth quarter of 2019.

For the full year of 2020 total revenues.

To be $482 3 million euros compared to $108 6 million euros for the full year of 2019.

Total revenues increased due to the recognition of revenues under a new collaboration agreement signed with Pfizer and Fosun pharma as part of our vaccine program against COVID-19.

Ozlem Tureci: They quite obviously differ one from another and from the version of our mRNA technology used for creating the first COVID-19 vaccine. Again, demonstrating the high diversification of our mRNA platform, the many years of know-how that went into... I will now... make a call over to ZURC to provide an update on our finances. Thank you, Ozlem.

Newly generated COVID-19 vaccine commercial revenue significantly drove our total revenues.

As a reminder.

On the the Pfizer collaboration territories have been allocated between the companies based on marketing and distribution rights.

ZURC: I will summarize our financial results for the fourth quarter and the full year of 2020, as shown on slide 27. I'll start with 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.

A breakdown of our commercial revenues the shown on slide 28.

Our 2020 commercial revenues comprised of an estimated amount of 188 5 billion euros share of gross profit from COVID-19 vaccine and the size of the territory.

Please note this is a net figure.

Additionally, as it was the DPP as our annual report filed with the SEC and this figure is on the estimated based on preliminary data shared between Pfizer and us and may be subject to adjustments. If we receive final data input parameters like sales and transfer prices.

ZURC: Total revenues increased due to the recognition of revenues under our new collaboration agreement signed with Pfizer and Pfazer Pharma as part of our vaccine program against COVID-19. Newly generated COVID-19 vaccine commercial revenues 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 the next figure.

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 seats, all collaboration partner of <unk>.

The manufactured by Us.

And 26 million euros of direct COVID-19 vaccine sales to customers of our territory Germany.

Okay.

No.

Returning to slide 27, and moving to cost of sales, which were estimated to be 41.0 million euros for the fourth quarter of 2020.

ZURC: Additionally, as 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 we receive final data on input parameters like sales and transfer prices. Additionally, changes in our share of the collaboration partners' gross profit will be recognized. Our COVID-19 vaccine commercial revenues also include 61.4 million sales to our collaboration partner of products manufactured by us and €20.6 million of direct COVID-19 vaccine sales to customers in our territory, Germany.

Compared to $4 4 million euros for the fourth quarter of 2019.

For the full year of 2020 cost of sales were estimated to be at $59 3 million euros.

<unk> to $17 4 million for the prior year.

The increase was driven by estimated $35 6 billion gross cost of sales, which were recognized for the first time with respect to our COVID-19 vaccine sales.

And includes Pfizer's share of gross profit earned by us.

Note that.

The cost of sales do not include costs related to the production of prelaunch products and those were expense is R&D expenses and the periods and Kurt.

ZURC: Now, returning to slide 27 and moving to cost of sales, which were estimated to be €41.0 million for the fourth quarter of 2020, compared to €4.4 million for the fourth quarter of 2019. For the full year of 2020, cost of sales is estimated to be 59.3 million euros, compared to 17.4 million euros for the prior year.

R&D expenses were 257 zero million euros for the fourth quarter of 2020 compared to $65 4 million euros for the comparable period in 2019.

For the full year of 2020, R&D expenses were 645.0 million euros compared to $226 5 million for the full year 2019.

The increase was primarily due to an increase in R&D expenses related to our B and T 162 program.

R&D expenses include our share of expenses under the terms of the size of collaboration agreement.

ZURC: The increase was driven by an estimated €35.6 billion cost of sales, which were recognized for the first time with respect to our COVID-19 vaccine sales and include Pfizer's share of gross profit earned by us. However, costs related to the production of pre-launch products since those were expensed as R&D expenses in the period incurred. R&D expenses were 257.0 million euros for the fourth quarter of 2020 compared to 65.4 million euros for the comparable period in 2019.

A binder development costs equally shared between the two companies.

Higher expenses for purchased laboratory supplies as well as the increase in head count grew due to higher wages benefits and social security expenses contributed to the increase.

And in addition from the date of acquisition are U S based subsidiary <unk>, Inc.

And so contributed to our R&D expenses.

G&A expenses were $36 1 billion euros for the fourth quarter of Covid in 'twenty compared to $11 1 billion euros for the comparable periods from 2019.

For the full year of 2020, G&A expenses were 94 zero million euros compared to $45 5 million for the prior year period the.

ZURC: For the full year of 2020, R&D expenses were €645.0 million compared to €226.5 million for the full year of 2019. The increase was primarily due to an increase in R&D expenses related to our BNT162 program. R&D expenses include our share of expenses under the terms of the Pfizer collaboration. As a reminder, development costs are equally shared between the two companies. Higher expenses for purchased laboratory supplies, as well as an increase in headcount leading to higher wages, benefits, and social security expenses contributed to the increase.

The increase was mainly due to higher expenses for professional services and increasing the head count the entire wages benefits and social security and expenses and higher insurance premiums.

In addition from the date of acquisition the or U S. Based subsidiary Jan. Thank you ex Inc. Also contributed to our G&A expenses.

Following of the authorization of approval of our COVID-19 vaccine for emergency or temporary use or having been granted conditional marketing authorization the recognition of deferred tax assets whats the reevaluated and.

As of December 31, and 2020 net deferred tax assets with respect to the accumulated tax losses and the temporary differences of the German tax group were recognized with 161.0 million euros and income tax effect.

ZURC: And in addition, from the date of acquisition, our U.S.-based subsidiary BioNTech U.S. Inc. also contributed to our R&D expenses. G&A expenses were 36.1 million euros for the fourth quarter of 2020 compared to 11.1 million euros for the comparable period in 2019. For the full year of 2020, G&A expenses were 94.0 million euros compared to 45.5 million for the prior year. The increase was mainly due to higher expenses for professional services, an increase in headcount, higher wages, benefits, and social security expenses, and higher insurance premiums.

For the fourth quarter of 2020, we show the net profit of $366 9 million euros.

And this compared to $58 2 million net loss for the fourth quarter of 2019.

For the full year of 2020, we were also profitable showing the net profit of $15 2 million euros compared to $179 2 million and Europe net loss and the prior year period.

We ended 2020 with cash and cash equivalents of $1 2 billion euros as the result of successful financing transactions and 2020, which strengthened our position for the execution of our strategy, which would be accelerated by 2021 growth.

ZURC: In addition, from the date of acquisition, our U.S.-based subsidiary, BioNTech U.S. Inc., also contributed to our G&A expenses. Furthermore, following the authorization of approval of our COVID-19 vaccine for emergency or temporary use, or having been granted conditional marketing authorization, the recognition of deferred tax assets was re-evaluated. As of December 31, 2020, net deferred tax assets with respect to the accumulated tax losses and temporary differences of the German tax group were recognized with an income tax effect of €161.0 million. For the fourth quarter of 2020, we showed a net profit of €366.9 million. This compares to a 58.2 million euro net loss for the fourth quarter of 2019.

Now moving to slide 29 that outlines our 2021 financial outlook.

Based on the current contracted supply orders of approximately $1 4 billion doses. We are providing estimated COVID-19 vaccine revenues to buy on tech.

And approximately nine 8 billion euros.

This estimate reflects expected revenues from direct COVID-19 vaccines today, the two customers and our territories.

The expected revenues from sales of our collaboration partner <unk>.

We expect the sales milestone payments from the old collaboration partners and expect the revenues related to our share of gross profit from COVID-19 vaccine sales in the collaboration part of the territories.

We expect additional revenues related to further supply contracts for deliveries in 2021.

I would like to point out again, the we have raised all the manufacturing capacity target from 2.0 to $2 5 billion doses for the full year 2020 to be able to address increased demand.

ZURC: For the full year of 2020, we were also profitable, showing a net profit of €15.2 million, compared to a net loss of €179.2 million in the prior year period. We ended 2020 with cash and cash equivalents of 1.2 billion euros as a result of successful financing transactions in 2020, which strengthened our position for the execution of our strategy, which will be accelerated by 2021 growth. Now moving to slide 29, which outlines our 2021 financial outlook.

In terms of guidance for the full year 2021, we expect R&D expenses to incur and the range of 760 million euros to 850 million euros for the full year 2021, reflecting our aspirations to broaden and accelerate our pipeline development, which we plan to ramp up especially in the sector.

And half of 2021.

SG&A expenses estimated to rise up to 200 million euros.

Capital expenditures for the year 2020, one are expected to be and the range of 175 million to 225 million euros.

ZURC: Based on the current contracted supply orders of approximately 1.4 billion doses, we are providing estimated COVID-19 vaccine revenues of approximately 9.8 billion euros to BioNTech. This estimate reflects expected revenues from direct COVID-19 vaccine sales to customers in our territory, expected revenues from states or collaboration partners, expected sales milestone payments from our collaboration partners, and expected revenues related to our share of gross profit from COVID-19 vaccine sales in the collaboration partner's territory.

And we'd like to emphasize that all of these figures reflect a current base case projections.

And finally.

Please note that in terms of full year 2021 tax impact we expect the German tax group corporate tax rate of approximately 31%.

We have approximately 450 million accumulated tax loss carryforwards with respect to the German tax group as of December 31, 2020.

And was that.

I turn the call to Ryan for concluding remarks.

Thank you Sir.

Turning to slide 32, our 2021 strategic priorities.

Our immediate aim is to supply our COVID-19 vaccine to over 1 billion people this year and be and are positioned to supply it and large quantities in 2022.

ZURC: We expect additional revenues related to further supply contracts for deliveries in 2021. I would like to point out again that we have raised our manufacturing capacity target from 2.0 to 2.5 billion doses for the full year 2020 to be able to address increased demand. In terms of guidance for the full year 2021, we expect R&D expenses to incur in a range of 750 million euros to 850 million euros for the full year 2021, reflecting our aspirations to broaden and accelerate our pipeline development, which we plan to ramp up, especially in the second half of 2021. SG&A expenses are estimated to rise up to 200 million euros.

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 and our core therapeutic areas of immuno oncology and infectious disease.

We currently have nine active preclinical programs and 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.

And 2021 and beyond we intend to accelerate and broaden our immuno oncology pipeline, where we see a significant opportunity for <unk> to lead and the emerging fields of individualized cancer medicine and cell therapy among others.

ZURC: Capital expenditures for the year 2021 are expected to be in the range of €175 million to €225 million. I would like to emphasize that all these figures reflect our current case projection. (Inaudible) Please note that, in terms of full-year 2021 tax impact, we expect a German tax group corporate tax rate of approximately 31%.

Finally, we plan to ramp up investments and 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 and near term, we believe they could become major opportunities for bonds and the future.

Slide 33 highlights some of the key pipeline milestones, we expect in 2021.

These income trial updates on at least five ongoing programs, including BMT, 311% and three one to two by specific antibodies and phase one two trials, which we believe have potential as the next generation and checkpoint of immuno modulators.

ZURC: We have approximately €450 million in accumulated tax loss carry forwards with respect to the German tax group as of December 31st, 2020. And with that... I turn the call over to Ryan for concluding remarks. Turning to slide 32, our 2021 strategy, 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 2020. While we work to broaden access to our vaccine, our goal is to build and maintain a leadership position by 2022.

We also expect to initiate three randomized phase II trials for our fixed back and IMS programs and 2021.

Finally, we're on track to initiate and up to six first in human phase one trials across a range of novel Io platforms with the start of phase one trials for <unk> and 151 of the first quarter two of the six milestones listed here have already been reached.

Importantly, all of the product candidates entering the clinic and 2021 of our wholly owned by <unk>.

We were also pleased to announce our first capital markets day, which will be held and the second half of the year.

We will confirm the date and the coming weeks.

Turning to slide 35, we believe we are better positioned and effort to bring innovative immuno therapy the patients by.

ZURC: 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 clinical programs in the infectious disease area and intend to advance additional mRNA vaccines against other infections. We will provide more details on some of these programs over the course of the year.

And by reinvesting the proceeds from our COVID-19 vaccine and plan to accelerate our vision to build the 20 <unk> century immunotherapy powerhouse and we see a tremendous opportunity to build long term value for patients our shareholders and society.

To broaden our global reach we will continue to expand and key strategic locations and the U S and Europe and have near term plans to establish a presence in Asia.

Ryan: We remain as committed as ever to our goal of ushering in a new era of immunotherapy for cancer. 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 personalized cancer medicine and cell therapy, among others. Finally, we plan to ramp up investments in our platforms and early product development and select emerging areas, such as autoimmune disease, inflammatory disease, and regenerative medicine. While these areas will not be a major component of our capital allocation in the near term, we believe they could become major opportunities for BIONTech.

To support our expanding pipeline, we intend to further invest in our clinical commercial and manufacturing and infrastructure and will also make further investments to build out our digital infrastructure and capabilities.

Finally, we will double down on what got us here true innovation.

Long-sighted planned increases and internal R&D investment, we will continue to actively source complementary external innovation that fits with our long term strategy to harness the full power of the immune system to address serious disease.

And with that I will conclude our presentation and thank our shareholders and partners for their ongoing collaboration and support and we'll now open up the floor for questions.

Thank you as a reminder, if you would like to ask a question. Please press star and one on your telephone keypad and.

Ryan: Slide 33 highlights some of the key pipeline milestones we expect in 2020. These include trial updates on at least five ongoing programs, including BNT 311 and 312, two bispecific antibodies in phase one, two trials which we believe have potential as next-generation checkpoint immunomodulins. We also expect to initiate three randomized phase two trials for our FIXVAC and IMS programs in 2021. Finally, we're on track to initiate up to six first-in-human Phase I trials across a range of novel IOPs.

And to withdraw your question you compress the cash.

Okay.

And one to ask the question.

Your first question today is from the line of <unk> Ahmad from Bank of America. Please go ahead.

Hi, good morning, Thanks for taking my questions.

And it relates maybe to the Covid vaccine can you give us a little bit more color will go on.

About your thoughts about the need for the boosters.

And maybe a couple of parts of that do you have any sense of the frequency with which you know if needed.

Or would meet boosters.

And secondly, you've talked about doing work on the different variants. So on a go forward basis with the booster shot on the inclusive of all of them variance that would be pressed.

Ryan: With the start of Phase 1 trials for BMT211 and 151 in the first quarter, two of the six milestones listed here have already been met. Importantly, all of the product candidates entering the clinic in 2021 are wholly owned.

Presents at the time and the last part of the question is.

Do you see value still for switching from the two dose.

And the vaccine to a one dose and the future. Thank you.

Okay. Thanks for the questions actually actually the topics related to the first of our first of all of them.

Ryan: We are also pleased to announce our first capital market, which will be held in the second half. We will confirm the date in the coming Turn to slide 35. We believe we are better positioned than ever to bring innovative and unifair.

What is important is that that the booster dose and the and the volume question.

Somehow related because because of some variance and fix the topic just south of earthquake medallion the.

Ryan: By reinvesting the proceeds from our COVID-19 vaccine, we plan to accelerate our vision to build a 21st century immunotherapy power. We see a tremendous opportunity ahead to build long-term value for patients, our shareholders, and society. To broaden our global reach, we will continue to expand in key strategic locations in the U.S. and around the world, and have near-term plans to establish a presence in Asia.

Okay.

<unk>, which is the reduced new accreditation Titus and and the of course know the anti body type that's moved up over time and the NBC. The CFS drop now after after after the <unk>.

Six six months and.

So the definitely typically per meter.

First the.

The.

First boost the booster dose and yeah, maybe after six months after nine months and then the question will be of course after after the boost how long how long after the boost the.

Ryan: We intend to further invest in our clinical, commercial, and manufacturing infrastructure, and we'll also make further investments to build out our digital infrastructure. Finally, we will double down on what got us here, true innovation, alongside planned increases in internal R&D. We will continue to actively source complementary external innovation that fits with our long-term strategy and harness the full power of the immune system to address it. And with that, I will conclude our presentation. We thank our shareholders and partners for their ongoing collaboration and support, and we'll now open up the floor to questions.

Immune response.

The continue to to stay stable.

Six months nine months on assessments. So we strongly believe the booster doses there'll be relatively quiet.

And the second piece and the two a tool to ensure that it is we are now seeing.

The the mrna vaccines and <unk>.

But as the data coming from East got here and that the vaccine and indeed indeed.

And apus and prevention of infection and.

Operator: Thank you. As a reminder, if you would like to ask a question, please press star and one on your telephone keypad. And to withdraw your question, you can press the hash key.

Average.

Which is one of the key key a pair of on many tests, reducing also the and.

The hedges of variance because every infected person is somehow somehow creating a page and the chance of a new mutation and if we were.

Operator: Your first question today is from the line of Tazeen Ahmad from Bank of America. Please go ahead. Hi, good morning.

And to get the full control of the pandemic, we need to ensure.

Hi, anti bodies, Titus and to ensure and prevention of infection.

Tazeen Ahmad: 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 to that.

With regard to the fact the third.

So we will see of course, because the upcoming data at the booster doses are quite yet and we fast months every 18 months. So this piece of this is state that kind of coming in and.

Ugur Sahin: Do you have any sense of the frequency with which, you know, if needed, people would need boosters? Secondly, you've talked about doing work on the different variants. So, on a go-forward basis, would the booster shots be inclusive of all variants that would be present at the time? And the last part of the question is, do you still see value in switching from the two-dose vaccine to a one-dose vaccine in the future? Thank you. Okay, thanks for the questions. Actually, the topics are related.

And if we got to scenario does us.

But the.

The us that's a double dose vaccine and.

It's very clear that yeah, what's the order of vaccine is able to provide protection and.

Again against the D C.

The single dose, but this is limited.

And the NBC and clearly see that a second dose it's great to have the full immunity and even though the situation and of the end of this year and that and that.

Ugur Sahin: So first of all, what is important is that the booster dose and the variant question are somehow related because some variants, for example, the South African variant, come with a reduced neutralization antibody titus. And we, of course, know that antibody titus will drop over time. And we see a first drop now after six months.

And that in.

Many of the regions, we will have already already of pre existing immunity and the.

And majority of the population and Denver and the more of dealing with the question that of it need.

Two shot vaccine or things of that short vaccine because everyone who is receiving.

Ugur Sahin: So we definitely will need a first booster dose, maybe after six months, after nine months. And then the question will be, of course, after the boost, how long after the boost the immune response will continue to stay stable, whether it is six months, nine months, or 12 months. So 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 mutations.

Moving and vaccine additional of X gene.

Got it that's the booster booster dose vaccine and the already know from published data and from our own data. If someone had had received a prior probably idose or had.

The COVID-19.

And just before the nice thing of the dose of sufficient. So we are now talking about stocking we need to start to talk in 2020 and beyond about about the B vaccination and there is no any more of a difference between being between single dose and the end.

And the two dose vaccine CEA.

Yeah.

Yeah.

Thank you as a reminder, if you would like to ask a question on staff and one on your key paradigm. We do ask for one question per caller. The next question is from the line of cool recast them off from Jpmorgan. Please go ahead.

Ugur Sahin: And if we want to get full control of this pandemic, we need to ensure that we have high antibody levels to ensure prevention of infection. With regard to the third topic, we will see, of course, with the upcoming data that booster doses are required every 12 months, every 18 months. So this is the data coming in.

Hey, good morning, guys. Thank you for taking my question I wanted to follow up with you and the comments you just made with <unk>.

And boosters are you, saying that the the participants and your phase III trial, who were vaccinated back in late summer early fall are now and need of booster shots that there are no longer adequately protected from Covid and I guess, just a follow up on that.

Ugur Sahin: With regard to single versus double dose vaccines, it is very clear that our vaccine is also able to provide protection against disease with a single dose, but this is limited, and we clearly see that a second dose is required to have full immunity. By the end of this year, we will have a situation in many regions where we already have pre-existing immunity in the vast majority of the population.

How clear is the regulatory process for boosters and variant vaccines for that matter in terms of the burden of proof on your and to enable authorization or licensure and thank you.

So the the first part of the of the question no I I I did not say that the participants are not any more protected and.

Ugur Sahin: And then we are no longer dealing with the question of whether we need a two-shot vaccine or a single-shot vaccine, because everyone who is receiving an additional vaccine will be regarded as a booster dose. And we already know from published data and from our own data that if someone has received a 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 v-vaccinations.

And just saying that we are seeing the ex talking to to see a drop off of.

And the N type of audio response, and and down now because the applications showing a correlation between the neutralizing antibody titers and protection of overtime. So we will see a decline of the of our offer of the antibody titers and we have to identify the right timing from booster.

Booster dose yeah.

And the timing of a booster dose the booster dose.

And of course with the with the.

The objective one would like to accomplish and and if the accomplish is really to ensure the prevention of infection and the booster dose has to come earlier and I believe that the need to go for it and.

Ugur Sahin: And there is no more difference between single dose and two-dose vaccines here. Thank you. As a reminder, if you would like to ask a question, that's a star and one on your keypad, and we do ask for one question per caller. The next question is from the line of Corey Kazimoff from J.P. Morgan. Please go ahead. Hey, good morning, guys.

And two to accomplish and in the and the population.

Our strategy to avoid the infection and not only to avoid the csis and therefore, a booster dose would be needed earlier, and then 10 days and so that's the first part of the crested the can you repeat the second.

Corey Kazimoff: Thank you for taking my question. Ugur, I wanted to follow up with you on the comments you just made about boosters. Are you saying that the participants in your phase three trial who were vaccinated back in late summer, early fall are now in need of booster shots because they're no longer adequately protected from COVID? I guess just to 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.

Second question. Please yes, just how clear the regulatory process is for boosters and variant and vaccines in terms of the burden of proof to enable authorization yes.

And yes, we have already started started a clinical trial, but that is the was the this boosting boosting Uh huh.

The participants who who had received two doses of our vaccine.

And and just the <unk>.

And of the day. It is it just more or less and that was dramatic automatic approach based on on understanding of the tightest protection and the level of of improvement and that can be accomplished by a booster dose.

Ugur Sahin: So, to the first part of the question, no, I did not say that the participants are no longer protected. I'm just saying that we are starting to see a drop in the antibody response, and there are now clear publications showing a correlation between the neutralizing antibody status and protection over time. So, we will see a decline in antibody status, and we have to identify the right timing for a booster dose.

Okay, great. Thank you very much I appreciate it.

Okay.

Thank you. The next question is from the line of Arlinda Lee from Canaccord.

Please go ahead.

Hi, guys. Thank you for taking my questions.

And I wanted to maybe clarify something you alluded to the 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 flow from that.

Ugur Sahin: And the right timing of a booster dose comes, of course, with the objectives one would like to accomplish. And if the goal is really to ensure the prevention of infections, the booster dose has to come earlier. And I believe that we need to go for, to accomplish in the population 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.

Yeah.

And then would you like to take the question or should I take the question.

And yes can you please repeat the arduous the shaking it was about <unk>.

Right you were talking about the single and double dose or doses of the booster studies that would address the variance on.

And that are planned and underway can you. Please explain how that study is designed what you hope to see on when we might see data flow.

So that's the.

Ladies and.

Ugur Sahin: 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, Yeah, so we have already started a clinical trial with boosting participants who have received two doses of our vaccine. And at the end of the day, it is more or less an automatic approach based on understanding titer protection and the level of improvement that can be accomplished by a boosted dose. Okay, great. Thank you very much. I appreciate it. Thank you. The next question is from the line of Arlinda Lee from Canaccord Unity.

Couple of questions. One question is and that we assess the third dose and meaning.

Meaning of the prime boost of the second step dose of.

Oh of vaccine and the tower and farm and word of says how and.

And Mr. Chi asked of Us those Oh boy.

And whether it's also protects from circulating varian, so not the only test on.

Neutral ization of of the the vaccine strain, but also so all of that variance what and these studies will also test.

Is boosting of.

And you on 62, B, two more steps and participants with a crane.

Arlinda Lee: Please go ahead. Hi guys, thank you for taking the time to answer 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 we might see data flow from that? Ozlem, would you like to take the question, or should I take the question? Yes, can you please repeat that? The audio is a bit shaky.

Duane of interests of all of concern and.

And here, we use the south African strain and.

As of as a.

A representative of a variant of concern and our addition of a.

Assessments, and participants, who and who are naive flow vaccine and Whitney of tests that are with regards to our immunogenicity and protection by a stray everybody of vaccine, which we present, a very and strain.

Ozlem Tureci: Was it about booster doses? Right, you were talking about single and double doses for the 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 for that? So, the studies assess a couple of questions. One question is whether we assess a third dose, meaning after the prime booster, the second booster dose of our vaccine in its current form, and will assess how immunogenicity is boosted after this dose is boosted, and whether it also protects from circulating variants.

Meaning in this case the self FY constrained.

These studies have parking and you're already <unk> already started and amendments of all of our ongoing for example, the phase III trial way out of those subjects and participants.

We have seen already vaccinated with Columbia, Nokia now Fox on for getting the first forced with the same vaccine or with the Eh and <unk>.

On the strain and partly we on them we have submitted some day, if not the charge of kits.

Okay. Thank you.

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

Ozlem Tureci: So, not only will neutralization of the vaccine strain be tested, but also further variants. What these studies will also test is boosting of BNT162B2-boosted participants with a new strain of interest or of concern. And here, we will use the South African strain as a representative of a variant of concern. Additional assessments will be done in participants who are naive to vaccines and will be tested with regard to immunogenicity and protection by

Yes, good afternoon, and thanks for taking my questions and I have a question of on the on the development efforts of different formulations.

And can you maybe elaborate a bit on where we stand there and is it technically possible and also to bring the commonality of vaccine.

And to the market, which is stable at normal refrigerator temperatures prolong. The time. This is something we work on and so any more color here would be much appreciated. Thank you.

Hi, Ken and pick the question is okay.

Yes, the are continuously working on on.

From a new formulation, but also on on.

Ozlem Tureci: Transcripts provided by Transcription Outsourcing, LLC. These studies have partly already started as amendments to our ongoing, for example, phase three trial, where those subjects and participants who have already been vaccinated with Comirnaty are now, for example, getting the third boost with the same vaccine or with the new strain. And partly we have submitted them; they have not started yet.

Extending extending the use of our current formulation. So we have recently announced that the.

And that are the existing formulation is can be stopped for a long of time at minus 20 degree that'd be the.

The update this data.

All of this we've got two of stability of our formulation at two to eight degrees there'll be announced that the ongoing ongoing are ongoing.

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

Daniel Wendorf: Yes, good afternoon, and thanks for taking my question. I have a question about your development efforts for different formulations. Can you maybe elaborate a bit on where we stand there? And is it technically possible also to bring a Comirnaty vaccine to the market, which is stable at normal refrigerator temperatures for a longer time? Is it something you work on?

The study with the existing formulation to relax the conditions, but for the existing formulation of <unk> developed and ready to use formulation and lyophilize formulation.

And really come into the market and the second task authentic plenty of run and this new formulations. The allow allow much long stability at a quicker and put you at two two of ethically.

Ugur Sahin: So any more color here would be much appreciated. Thank you. I can take the question, if that's okay with you.

Okay.

Thank you.

Right.

Thank you. The next question is from the line of Dana carries book from SVP Leerink. Please go ahead.

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

Hi, Thank you for the question I'm going to ask another one on the boost and variant.

Specifically you have suggested that you need to maintain a threshold titer of antibody and I wonder what evidence you have that informs what that target threshold and.

What's the impact of B cell affinity maturation on the required threshold and where does T cells, the N and could they come save us and not require multiple days.

Yeah, So great question.

Dana.

Okay.

So and.

What is what is the matching.

And it is really the correlation between the prevention of disease and prevention of infection by the different type of effect of <unk> and and neutralizing antibody titers.

Daina Graybosch: Yes. Thank you. Thank you. The next question is from a line Daina Graybosch from SCB Lear Inc. Please go ahead.

So it just it just now of more and more studies of publishing which provides a clear correlation between vaccine effectiveness vaccine efficacy and.

Ugur Sahin: Hi, thank you for the question. I'm going to ask another one on boost and variance. 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 do T-cells fit in, and could they come save us and not require multiple B-cells? Yeah, so great questions, Daina, as always.

And what kind of an anti body types of us and and that we do not yet tapped.

The concrete numbers, but the clearly come in the next six to nine months and and prevention of infection and if it's really dependent on the north of the anti bodies tied the severe disease prevention of the Vlccs and <unk>.

And even maybe also the prevention of disease and.

Ugur Sahin: So what is emerging is really a correlation between prevention of disease and prevention of infection by this different type of vaccine and neutralizing antibody titers. So now more and more studies are published which provide a clear correlation between vaccine effectiveness, vaccine efficacy, and neutralizing antibody titers. And we do not yet have concrete numbers, but this will clearly emerge in the next six to nine months.

It's also driven of course by the sponsors.

But these type of sponsors are coming in.

And only if the if the virus has reached all the idea that the targets SaaS and Paas.

Replicate that vacation and.

And so and so we are confident that particularly through the T cell responses that would provide long term.

Protection against the the adcs, including the body and yeah.

Ugur Sahin: And prevention of infection is clearly dependent on neutralizing antibody titers. Severe disease, prevention of severe disease, and even maybe also prevention of disease are also driven, of course, by T cell responses. But T cell responses come in only if the virus has already reached the target cells and starts 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 effectively prevent infection. In combination with neutralizing antibodies, and, of course, there will most likely be a situation where lower titers, neutralizing titers, can be compensated for by stronger T cell responses and vice versa.

And but the but they will not be able to prevent prevent the effectively infection and combination with neutralizing anti bodies and.

Of course, the there'll be there'll be a day at the.

The most likely be a situation, where the what tied to what the rising tide of Kent in part compensated by storm that you start with the sponsor and.

And and vice versa.

But the signs in times to come or data.

There'll be a.

And match and the next to ask us the.

The <unk> class.

And then.

Yeah.

Thank you. The next question is from the line up the Vin Jacob from UBS. Please go ahead.

Hi, yes. Thanks.

And I know you said the one but hopefully these two questions of very quick and I just wanted to clarify the loss of lives.

Ugur Sahin: But these are signs to come or data which will emerge in the next six to 12 months. Thank you. The next question is from a line by Vin Jacob from UBS. Please go ahead. Hi, yes, thanks. I know you said one, but hopefully these two questions will be very quick. I just wanted to clarify the lyophilized version of 162 that you're working on. You mentioned that you were 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 quote-unquote other regions,

Version.

Of 162 that Youre working on what you mentioned that Youre, starting the study I just wanted to understand I'm, sorry, I missed it but what exactly is required to get that approved or is it just you.

Immunogenicity data or do you have to run a full outcomes based study or is it just the PK data and then of the 450 million doses contracted and quick what other regions.

How much of that is China.

Any color there would be appreciated.

Hi, and takes the best question, maybe and the second question is Ryan of Sean is that okay.

Yes, I can answer that.

Yeah, Yeah, yeah, so and so the FES pet so.

First question is and so and they.

Vin Jacob: and other regions. How much of that is China? Any color there would be appreciated.

And they are they are different and different guidelines or guidance is at the moment, how tour to approve a proof of process and.

Ryan: I can take the first question, maybe, and the second question is Ryan or Sean. Is that okay? Yeah, I can fix that. So the first question is, so there are different guidelines or guidelines at the moment, how to approve a process to ensure that a new variant vaccine can be introduced. One way of 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 way, released in the same way, then provide safety data for this new variant vaccine, provide immunogenicity data, and show comparability of TITUS accomplished against this variant strain.

To ensure and sure that a new variant XD and can be into juice run the day, one day of doing that the emphasis. This this this is the way.

Great crested the requested by the FDA, it's add too.

The two shell for value and Spain and.

That the vaccine and the passing of Valeant spray and can be it can be managed to catch up and the and the same day of the at least on the same day.

And then provide safety data for this new new variant and vaccine and provide immunogenicity data and show show comparability of podcasts are tied to us and <unk>.

Placed against the value variance play and and then on.

Ryan: And on the data package, on the full data package, and on the comparability data, this could reside in a blueprint, an approved 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 address that. There are differences suggested by regulators in the UK and by EMA, but at the end of the day, for each of the parties, some sort of study and data will be required.

On the data package on the full data package and on the comparability data this could recite in AR.

The blueprint.

The proof blueprint and post it so that that yeah. If the valiant vaccine is needed and it could be introduced and without without the need to F. On additional critical tie. It. So that's that's the that's the general day to try the best that they are different.

And that's suggested by the regulators in UK and and by EMA and.

But at the end of the day.

For each of the parties some sort of study study.

The study data as the study and data there's the other.

Ugur Sahin: Yeah, Naveen on the China question. So the answer is very little has been included in the 1.4 billion. We've included the doses that have been committed to Hong Kong and Macau, where we have an EUA approval, which is just under 10 million doses. We've also committed to Fosun, our partner in 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. Thank you. And the last question today is from the line of Akash Tewari from Wolf Research. Please go ahead.

Yeah.

Yeah, and they've been on.

On the China question. So the answer is very little has been included and the one 4 billion.

Currently signed figure.

We've included the the doses that have been committed to Hong Kong, Macau, where we have an EUA approval, which is just under 10 million doses.

We're also committed to function our partner from mainland China.

To supply of up to 100 million doses or at least 100 million doses in 2021, if approval of <unk>.

And we're and the approval process as we speak but those those doses have not been included and the $1 4 billion number.

Yeah.

Thank you and stuff.

The last question today is from the line of our cash to worry from Wolfe Research. Please go ahead.

Akash Tewari: Thanks so much. 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 will last, if there are any outs, and would either company be able to develop a vaccine candidate for SARS-CoV-2 at solo at some point? And then maybe on your PL1 or 1BB specifically, GenMed mentioned one of the reasons they selected the 100 big dose is that they want to have optimal trimer formation, and that kind of translates to about 60 to 70% occupancy for the PD-L1 receptor. How important is the formation of a trimer?

Thanks, So much. So Pfizer has publicly made I would argue from unusual comments on its desire to go after mrna themselves moving forward can you comment on your current and Cobra Covid partnership how long it last and if there are any outs and with either company and be able to develop a vaccine candidate for Sars COVID-19 two it so low.

And at some point and.

And then maybe on your <unk> and DVD Bispecific Genmab mentioned, one of the reasons. They selected the 100 gig dose.

And they wanted to have the optimal time of formation and that kind of translates to about 60% to 70% occupancy for the PD Lone receptor. How important is the formation of the climber and why not target a higher PD L. One occupancy from an efficacy perspective. Thank you.

Ugur Sahin: And why not target higher PD-L1 occupancy from an efficacy perspective? Thank you. Okay, thanks, Akash, for the question. So 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 Buller, have 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 partners to do something alone. Everything has to be decided in a partnership manner and with an understanding, of course, that COVID-19 will stay with us for at least ten years.

You know of cases things of that cash for the for the question. So the the stress test question. The first question. It's first of all.

We have and excellent put obligation vis vis vis the.

Tied the bad the teams are really closely collaborating and and we at the management level like Santa Paula We have daily day daily conversations about the ongoing collaboration but also about future caught up on Asian opportunities and if we got to the existing COVID-19.

19 project. It is it is a partnership the at the 50 50 partnership and and.

And there is no room for any of the partner and.

Who do could do something something.

Hello, and everything has to be decided decided and that partnership manner and but.

Understanding of course that COVID-19 book stayed with US most likely for at least the decade.

Ugur Sahin: This is a long-term partnership. With regard to other potential collaborations, Albert Buller said that they would 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's a long term partnership with regard to two two and the potential code of obligations are the products that they they like to breakfast, but they they don't need to do it and does this actually of comment I.

Making the same day and it just it doesn't fantastic partnership and we would like to continue to do two additional projects with the site.

Ugur Sahin: It is a fantastic partnership, and we would like to continue to do additional projects with Pfizer, but we don't have to do them. And I think it's an excellent situation where you just enter into a partnership if you see the benefits.

But the we.

We don't have to do it and and I think it's a it's an excellent situation value.

Just the enter into a partnership if you will see the benefits, we see a lot of benefits and.

Sean: We see a lot of benefits in doing additional projects together, but we will come up with updates about this in the next week. Yeah, and Ugur, I'd just like to add to that, of course, you know, I'd just like to remind everyone that we've been developing IP around MRNA for over a decade. And of course, that's important for any collaborator when they're thinking about entering the space themselves. And, of course, the other thing we do is we continue to talk to other pharmaceutical companies, too, as an ordinary course of business.

And and doing additional projects together, but the tivo and come up with the updates about this and the next weeks.

Yeah, and the who go I'd just like to add to that of course.

The slides from the Jetblue on that.

We've been developing IP around day and night over a decade and and of course, that's important for full and collaborate.

The net thinking about.

And entering into entering into the space.

Themselves and.

Of course, yeah.

The thing we do too.

As we continue to true throughout the pharmaceutical companies too.

Both of the close of business matter.

Ugur Sahin: Yeah, thanks, Sean, for this edition. Please, the timer formation. Yeah, the trimer formation is indeed important for the conditional activation of the 4-1 VBR, and with 100 microgram, we have the sweet spot of PD-L1 or PD-1 blockade plus trimer formation for 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 the objective responses that we have observed with this compound, which seem to be associated with this dose window.

Yes.

Yeah. Thanks, Sean.

Additionally, please.

The time of formation.

Yeah at the time of formation.

Indeed, the kind of formation is important for the condition of the activation of the Oh yeah.

Four of them to be on.

And and vis vis the 100 micro come and we have speaks the sweet spot of a of a P D of everyone or PD one blockade.

Plus prime of formation.

Yeah and are sufficient in the long time, so it's sort of the exploit exploit he had the optimal chopped and the.

Ex.

The Asian.

A funky.

Functions of both arms of the update of the anti body and and this is also in line with the with the objective responses. That's the act obsessed and.

Ugur Sahin: Thanks so much, and I'll 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. Bye bye. Thank you, everyone. Thank you. Thank you. That concludes the conference for today. Thank you for participating, and you may now disconnect.

With this with the components, HR, which seem to b to b to B and.

Associated with the dose window.

Thanks, so much.

Yeah.

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

Yeah. Thank you again for joining the call today, we look forward to speaking to you and the future. Thank you bye bye.

Thanks, Evan Thank you. Thank you.

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

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