Q3 2021 BioNTech SE Earnings Call

[music].

Thank you for standing by and welcome to buy into a third quarter 2021 update call. At this time all participants are in listen only mode. There'll be presentation, followed by a question and answer session at which time, if you'd like to ask a question. Please press star one on your telephone.

Operator: Standing by, and welcome to BioNTech's third quarter 2021 update. At this time, all participants are in listen only mode.

Operator: There will be a presentation, followed by a question and answer session, at which time, if you would like to ask a question, please press star 1 on your telephone. However, we would like to ask you to please limit yourself to one question. I must advise you, this call is being recorded today, Tuesday, the 9th of November 2021, and I would now like to hand the meeting over to the Vice President, Investor Relations and Strategy, Silke Maas. Please go ahead.

We would like to ask to please limit yourself to one question per person.

I must advise you. This call is being recorded today Tuesday, the 19th of November 2021, and I would now like to hand anything over to the Vice President Investor Relations and strategy. So Ken Moss. Please go ahead.

Silke Maas: Good morning and good afternoon. Thank you for joining us today to review BioNTech's third quarter 2021 operational program. Before we start, we encourage you to view the slides for this webcast, as well as the operational and financial..................................................................................................................... Both of which are accessible on our website in our As shown on slide two, during today's presentation, we will be making several forward-looking statements, including but are not limited to our current estimated COVID-19 vaccine revenue, based on current contracted supply orders.

Good morning, and good afternoon. Thank you for joining us today to review biotech third quarter 2021 operation of brokers and financial results before we start with what you to view the slides for this webcast as well as the operational and financial results press release issued this morning, both of which accessibility.

On the whole website.

Sure.

Okay.

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 estimated COVID-19 vaccine revenues.

Based on current contracted supply orders, particularly for those figures that are derived from preliminary estimates provided by our partners.

Silke Maas: Our estimated financial results for 2021, and our continued global demand for our COVID-19 vaccine, Target Vaccine Products, beyond our ability to supply. The planned next steps in our pipeline program, the timing for enrollment, initiation, and other risks described in our findings made with the U.S. Securities and Exchange Commission, including our most recent annual, The doctoral results could differ from those currently available. You are therefore cautioned not to place undue reliance on any forward-looking statement, speak only as of today, or chat today. Also, please know... for Provide Details and Imports.

Oh estimated financial results for 2021.

Oh, a continued global demand for COVID-19 vaccine.

We're talking vaccine production capacity for 'twenty, 'twenty, one and beyond our ability to supply 19 vaccine.

The plants like steps and our pipeline programs the timing for involvement initiation completion and reporting data from Hartford life and other risks described in our filings made with the U S Securities and Exchange Commission, including our most recent report on form 20-F.

Actual results could differ from those currently anticipate you are therefore cautioned not to place undue reliance on any forward looking statements, which speak only as of today. She had to day during this conference call and webcast.

Also please note that slides three and four provide you taken important safety information regarding our COVID-19 vaccine.

Silke Maas: Slide five is our agenda for our call. I'm joined today by our CEO and co-founder, Ugur Sahin; Medical Officer and Co-Founder, John Merritt; and our Chief Business and Commercial Officer, Jens Holstein. I now turn the call over to Ugur.

Slide five with all the agenda for our call today.

I'm joined today by our CEO and cofounder.

Open until catchy or chief Medical Officer, and Kupono, Bill Merritt, Chief business, and commercial officer, and potent Stein, our Chief Financial Officer.

Ugur Sahin: Thank you, Zeke. Good morning and good afternoon, and thank you to everyone joining the call today. Today I will walk you through the key highlights of last quarter's performance before inviting my team to go into further detail. Our strong performance continued in the third quarter in terms of commercial execution and clinical pipeline advances. With our partner Pfizer, we have shipped more than 2 billion doses of our COVID-19 vaccine to more than 152 countries or regions worldwide.

Ryan Richardson Chief strategy Officer.

Our chief operating officer.

I now turn the call over to Wolfgang.

Uh huh.

Thank you Victor good morning, and good afternoon, and thank you to everyone joining the call today.

Today I will walk you through the key hires that are blocked Crawford performance before inviting my team to go into further detail.

Our strong performance continued in the third quarter in terms of commercial execution and pipeline advancement.

With all the partners that we have shipped more than 2 billion doses of COVID-19 vaccine to more than 152 countries.

That's right.

Ugur Sahin: We continue to be humbled by the impact our vaccine and our company is having on addressing the global pandemic. We still have further to go to reach many parts of the world. We are prioritizing equitable vaccine access to low- and middle-income countries.

We continue to be Hamburg, but it picked up or vaccine.

Company is having in addressing the global pandemic.

We still have further to go to reach many parts of good yeah.

We are prioritizing equitable vaccine access to low and middle income countries.

Ugur Sahin: In the first three quarters of 2021, we expanded our oncology pipeline faster than during any other period in our company's history. We initiated three randomized phase II trials and multiple trials in human studies. We will present data for six of our programs at the upcoming CITSI conference, clearly demonstrating the progress in our cancer pipeline. zlem will provide detail and some of this update in her prepared remarks. Moving to set seven.

The first quarter 2021.

We expanded our oncology pipeline has that been doing any other periods in our company's history.

We initiated pre randomized phase two tests in alcohol SaaS in human studies.

There are present data for six of our programs.

60.

50 comfort around Covid.

Here again, we're creating the pockets in our cancer pipeline.

Adam will provide detail on some of the upticks.

Pet remarks.

Moving to slide seven.

Ugur Sahin: Our strategy remains focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to patients worldwide to address cancer and a growing list of infectious diseases. The transformation of BioNTech into a global, fully integrated immunotherapy powerhouse is continuing at a rapid pace, and we are adding talent to our team.

Our strategy remains focused on bringing our pipeline of next generation Immunotherapies and vaccines to patients, but not tried to breast cancer and a growing list of infectious diseases.

The transformation of <unk> into a global fully integrated immunotherapy powerhouse is continuing at a rapid pace.

We are adding talent to our team.

Ugur Sahin: We are expanding our capabilities and geographic presence. We are increasing our investment in automation, digitalization, and AI technology. Our vision is to build the highest technology company of the coming years. We are developing and exploiting innovations at the intersection of immunology and synthetic biology. We believe our innovations can make a profound difference for people around the world, and we remain committed to investing in the company to deliver on this vision in the years to come. Slide eight.

We are expanding our capabilities and geographic presence.

We're increasing our investment in automation digitalization and AI technology.

Our vision is to build the highest technologic companies coming age.

We are developing an exciting innovations at the intersection of immunology and synthetic biology.

We believe our innovation can make a profound difference for people onto that.

And we remain committed to investing in the company to deliver on this vision in the years to come.

Ugur Sahin: We are driving innovations across multiple therapeutic platforms to harness the power of the immune system and to transform treatment paradigms in infectious disease and sordid tumors. The last 18 months have demonstrated the power, flexibility, and speed of our mRNA vaccine technology. We have established a proven path to regulatory approval for our first mRNA vaccine and have created one of the largest safety databases for pharmaceutical products. This is supported by a global manufacturing and distribution network that has the capacity to provide billions of doses of vaccine supply for the world.

Slide eight.

We are driving innovation across multiple platforms.

How often your system and the <unk> treatment paradigm.

And in Texas disease, and so it is two months.

The last 18 months have demonstrated the power flexibility and the speed of our.

<unk> technology.

We have to establish a prudent path to regulatory approval for our first analytics team and have created one of the largest safety database as well.

So it's a good product.

This is supported by our global manufacturing and distribution network that test capacity to provide billions up towards a vaccine supply part of it.

Ugur Sahin: Behind COVID-19, we are advancing a pipeline of 10 novel vaccines and immunotherapies for diseases that pose major global health challenges, including influenza, HIV, tuberculosis, and malaria. We plan to accelerate our efforts here and aim to initiate multiple clinical trials in the next 18 months. In oncology, we are building a toolbox of technologies across a range of drug classes. We now have 15 oncology product candidates in 19 ongoing clinical trials, including four active Phase II trials.

Beyond COVID-19.

Lansing pipeline 10, our vaccines in Immunotherapies for the thesis, which pose major global health challenges, including influenza HIV tuberculosis and malaria.

We plan to accelerate our efforts here and aim to initiate multiple clinical trials in the next 18 months.

In oncology, we are building a toolbox of technologies across a range of broad classes.

15 of course your product candidates in 19 ongoing clinical trials.

Including four active phase two a cut.

Ugur Sahin: We are addressing a wide range of therapeutic targets with diverse and complementary modes of action. We believe that this multimodal approach opens up new and powerful combination therapy opportunities across a broad range of solid tumors where current standards of care remain insufficient. Finally, we believe that the broad spectrum of our technologies will enable us to bring forward new treatment approaches that have the potential to broaden the disease horizon beyond oncology and infectious diseases, like autoimmune and inflammatory diseases, and even regenerative medicine. Slide nine summarizes the key highlights for the third quarter.

Yeah, attracting a wide range of therapeutic targets this diverse and complementary.

Action.

We believe that this move to modal approach opens up new and powerful combination therapy opportunities across a broad range of solid tumors that can stand that appear not.

Not to be sufficient.

Finally, we believe that the broad spectrum of our technologies.

That could bring forward new treatment approaches.

To test the potential to broaden the horizon beyond of course, you're an infectious disease.

Like autoimmune and inflammatory diseases, and even regenerative medicine.

Slide nine summarizes the key highlights for the third quarter.

Our financial performance continues to be strong we recorded in Q3 revenues of approximately 6 billion driven.

Ugur Sahin: Our financial performance continues to be strong. We recorded revenues of approximately 6 billion euros in Q3, driven by the continued ramp-up of COVID-19 vaccine production and delivery worldwide. Today we are announcing a new expansion of our Infectious Disease Toolkit, a new class of precision antibacterials, through the acquisition of Phagomate, an Austrian biotechnology company. The transaction complements our infectious disease pipeline of mRNA vaccines and mRNA-encoded antibodies with a new precision antibacterial technology that we believe could be useful against the global challenge of antimicrobial resistance.

It wasn't by the continued ramp up COVID-19 vaccine production and delivery is that right.

Today, we announced a new expansion of our infectious disease toolkit.

The new cap position antibacterial through the acquisition of cargo Mint and Austrian Biotechnology company.

<unk> complements our infectious disease pipeline.

<unk> and mrna encoded antibody with a new precision and put back their technology that we believe could be useful against the global challenge of.

Antimicrobial resistance.

Ugur Sahin: In the third quarter, we initiated dosing in our randomized phase 2 trial of autogene sevumaran, or BNT122, our INS candidate for the adjuvant treatment of high-risk colorectal cancer patients who are positive for circulating tumor DNA. In addition, our six-pack product candidate, BNT111, was recently granted orphaned designation by the U.S. FDA for the treatment of advanced checkpoint inhibitory refractory or resistant melanoma.

In the third quarter, we initiated dosing in our randomized phase two a time of autos deal stable Nirvana.

1002, or I Miss candidates for the adjuvant treatment of high risk colorectal cancer patient.

Positive for circulating tumor DNA.

In addition, our <unk> product candidate PMT 111, most recently granted orphan designation by the U S. FDA for the treatment of advanced checkpoint inhibitory attractively or resistant melanoma.

[noise] infectious diseases Incept, Denver private initiated obsessed human study of BMT 161, and influenza vaccine based on our technology.

Moving to the highlights of our COVID-19 vaccine we have now distributed.

More than 2 billion vaccine doses globally.

Ugur Sahin: In Infectious Diseases, in September, Pfizer initiated the first human study of BNT161, an influenza vaccine based on our mRNA technology. Moving the highlights of our COVID-19 vaccine, we have now distributed a total of more than two billion vaccine doses globally. We expect to produce up to 3 billion doses for 2021 and expect to deliver up to 2.5 billion COVID-19 doses by the end of this year. In 2022, we expect a manufacturing capacity of up to 4 billion doses.

We expect to produce up to 3 billion doses for 2021 and expect to deliver up to two points.

COVID-19 doses by the end of this year.

2022 we expect our manufacturing capacity of up to 4 billion doses.

Our COVID-19 vaccine has now received via.

<unk> approval in the United States for the use in individuals aged 60 and older.

FDA has also authorized a boosting with a set dose of the vaccine for some high risk population in the EU a booster dose has been approved for septic atheists in order.

To support the extension of the vaccine label to include children each half two.

First our clinical data package has been submitted to regulators around the globe.

The FDA has recently granted emergency use authorization BMT 162, B two insureds.

Ugur Sahin: Our COVID-19 vaccine has now received full VLA-FDA approval in the United States for the use in individuals age 16 and older. The U.S. FDA has also authorized a booster dose with a third dose of the vaccine for some high-risk populations. In the EU, a booster dose has been approved for subjects 18 years and older, to support the extension of the vaccine label to include children age 5 to. And at 12, a clinical data package has been submitted to regulators around the globe.

Hi.

And the U S government put purchased an additional 50 million pediatric doses.

I feel that Honda about our team's continued exceptional backend lag to close my remarks by emphasizing that even if <unk> is transforming we will continue to stay true to our vision and remain focused on our goal to bring next generation immunotherapies to patients around COVID-19.

I will now turn the call over to Sean will provide update on our COVID-19 program.

Thanks Hugo.

It's a pleasure to be speaking with everyone today.

Turning now to slide 11.

Ugur Sahin: The FDA recently granted emergency use authorization of BNT162b2 in children aged 5 to under 12, and the U.S. government purchased an additional 50 million pediatric doses. I feel humbled about our team's continued exceptional work and would like to close my remarks by emphasizing that even if BioNTech is transforming, we will continue to stay true to our vision and remain focused on our goal to bring next-generation immunotherapies to patients around the world. I will now turn the call over to Sean, who will provide updates on our COVID-19 program. Thanks, Ugur.

Together with our collaborators at Pfizer and Fosun pharma, we enter Stablish to global development program, a distribution network for our COVID-19 vaccine.

Our order book for 2021 continues to be strong with the addition of several new orders from the U S, Japan and other regions last quarter.

Discussions with regard to additional contracts for 2022 and beyond remain ongoing.

We anticipate that the additional 50 million pediatric doses ordered by the U S government.

Should be delivered by April 32.

2022.

Sean: It's a pleasure to be speaking with everyone today. Turning now to slide 11.

With this or to the U S government has exercised its final purchase auction under its existing supply agreement.

Sean: Together with our collaborators Pfizer and Fosun Pharma, we have established a global development program and distribution network for our COVID-19 vaccine. Our order book for 2021 continues to be strong, with the addition of several new orders from the US, Japan, and other regions last quarter. Discussions with regard to additional contracts for 2022 and beyond remain ongoing.

Bringing the total number of B and T. One six to two doses cleared under this agreement.

At the start of the pandemic.

Two $600 million.

We continued to lead in insuring.

We took bold vaccine access to low and middle income countries.

Biotech is pledged 2 billion doses by the end of 2022.

And a significant amount of our remaining 2021 manufacturing will be allocated to equitable vaccine access.

Sean: We anticipate that the additional 50 million pediatric doses ordered by the U.S. government should be delivered by April 30th, 2022. With this order, the U.S. government has exercised its final purchase option under its existing supply agreement, bringing the total number of BNT162B2 doses secured under this agreement since the start of the pandemic to 600 million. We continue to lead in ensuring equitable vaccine access to low and middle-income countries. BioNTech has pledged 2 billion doses by the end of 2022, and a significant amount of our remaining 2021 manufacturing will be allocated to equitable vaccine acquisition.

Importantly, we have expanded our agreement with the U S government from 500 million to 1 billion doses at a not for profit price for 2021.

And 2022.

These doses are intended for donation to low lower middle income countries and organizations that support.

Our hope is that by increasing vaccine access in these regions.

She is an infection will be brought under control in many parts of the world.

We and our partner <unk> also expanding our global manufacturing capabilities with regional solutions in Africa, and Latin America.

This includes the letter of intent.

Signed with Eurex on the laboratory in Brazil to.

To manufacture our COVID-19 vaccine.

Per the agreement Euro Exxonmobil obtained from product from facilities in the United States.

Sean: Importantly, we have expanded our agreement with the US government from 500 million to 1 billion doses at a not-for-profit price for 2021 and 2022. These doses are intended for donation to low- and lower-middle-income countries and organizations that support them.

And manufacturing our finished doses are expected to commence in 2022.

Full operational capacity annual production is expected to exceed 100 million finished doses annually.

Additionally, we recently signed a memorandum of understanding with the random government Institute past.

That car.

And announced plans to start the construction in mid 2022.

Sean: Our hope is that by increasing vaccine access in these regions, surges in infection will be brought under control in many parts of the world. We and our partner Pfizer are also expanding our global manufacturing capabilities with regional solutions in Africa and Latin America. This includes the letter of intent we signed with Europharma Laboratories in Brazil to manufacture our COVID-19. Per the agreement, Europharma will obtain raw product from facilities in the United States, and manufacturing of finished doses is expected to commence in 2022. At full operational capacity, the annual production is expected to exceed 100 million finished doses annually.

The first stage of the manufacturing side for mrna based vaccines and the African youth.

We believe this facility can become a node in a decentralized a robust African end to end manufacturing network to provide sustainable.

Vaccine supply on the African continent.

The establishment of this regional network is expected to enable annual manufacturing capacity of several hundreds.

<unk>.

Of mrna vaccine doses.

Moving to slide 12.

We'll provide an update on our strategic key leavers to expand the global reach of our vaccine.

Sean: We recently signed a memorandum of understanding with the Rwandan government and the Institut Pasteur de Dakar and announced plans to start the construction in mid-2022 of the first state-of-the-art manufacturing site for mRNA-based vaccines in the African Union. We believe this facility can become a node in a decentralized and robust African end-to-end manufacturing network to provide sustainable vaccine supply on the African continent. Establishment of this regional network is expected to enable annual manufacturing capacity of several hundreds of millions of mRNA vaccine doses. Moving to slide 12, I will provide an update on our strategic key levers to explain the global reach of our partners. Thank you.

This slide provides an overview of progress across all areas, but I will only be highlighting those details which haven't already been touched on by Google.

Starting with our manufacturing capacity.

We have.

Worked continuously with our partner <unk> to increase the capacity of the global supply chain and manufacturing network, which now includes more than 20 facilities across four continents.

To expand our vaccine is able to generate useful data and additional populations.

We have multiple ongoing clinical trials, which we have detailed previously including trials in younger children and pregnant women.

Currently expect data for children two to five years of age in children six months two years of age in late Q4 2021.

Sean: The slide provides an overview of progress across all areas, but I will only be highlighting those details which haven't already been touched on by Ugur. Starting with our manufacturing capacity, we have worked continually with our partner Pfizer to increase the capacity of the global supply chain and manufacturing network, which now includes more than 20 facilities across four continents. To expand our vaccine label and generate useful data in additional populations, we have multiple ongoing clinical trials, which we have detailed previously, including trials in younger children and pregnant women.

Early Q1 to SaaS and in 'twenty two.

Ooh Ooh go already highlighted a significant price system, the regulatory front and no data in children five to 11 years of age which has Lynn will cover in detail.

We have further optimized our vaccine formulations to simplify access globally and we recently received authorization from both U S. D. A M.

<unk>.

To store a vaccine for up to nine months and minus 90 to minus 60 degrees Celsius.

Additionally, following a positive opinion from E C H M P.

D C approved a useful origination of BB&T when <unk> further simplifies vaccine handling.

Sean: We currently expect data for children 2 to 5 years of age and children 6 months to 2 years of age in late Q4 2021 or early Q1 2022. Ugur has already highlighted our significant process on the regulatory front and our data for children of 5 to 11 years of age, which Ozlem will cover in detail.

And with optimized storage conditions.

The volumes can be stored up to 10 weeks at standard refrigeration temperatures.

Two eight degrees Celsius.

Our understanding of the human immune response to COVID-19, as well as emerging variance continues to involve and our team is continuously evaluating are linked to some interesting data as well as data from our own clinical studies to rapidly respond to the changing.

Sean: We have further optimized our vaccine formulations to simplify access globally, and we recently received authorization from both the FDA and the EMA to store our vaccine for up to nine months at minus 90 to minus 60 degrees Celsius. Additionally, following a positive opinion from Hema CHMP, the EC approved a new formulation of BNT 162b2 that further simplifies vaccine handling and optimizes storage conditions. The vials can be stored up to 10 weeks at standard refrigeration temperatures of 2 to 8 degrees Celsius.

Dynamics of the pandemic.

<unk> trials are ongoing to address the needs of a booster dose of BMT, one six to be too.

We are currently studying very.

Specific vaccine versions, while we don't plan to commercialize and there is a specific version of the vaccine at this time.

<unk> ready to adapt <unk> technology manufacturing and regulatory process to ensure our vaccine provides robust protection against COVID-19.

We are very pleased with the latest clinical and regulatory developments from a vaccine, which demonstrate our strong execution in response to the COVID-19 pandemic.

Sean: Our understanding of the human immune response to COVID-19, as well as emerging variants, continues to evolve, and our team is continuously evaluating the latest scientific data, as well as data from our own clinical studies to rapidly respond to the changing dynamics of the pandemic. Multiple trials are ongoing to address the need for a boosted dose of BNT162b2. We are currently studying various... [inaudible] While we don't plan to commercialize a variant-specific version of the vaccine at this time, we remain ready to adapt our technology, manufacturing, and regulatory process to ensure our vaccine provides robust protection against COVID-19.

I'll now turn the call over to Ed.

As Lynn who will provide details of our recent vaccine study results as well as provide an overview of our oncology programs, including positive data to be presented at the upcoming <unk>.

Come from.

Thank you Sean.

I'm going to share with you today, new data for <unk> hundred 60, <unk> and our future vaccine strategy to combat the COVID-19 pandemic.

Summarized on slide 13, the empty 162, B two has demonstrated high efficacy in our phase III pivotal trial with approximately 44000 subjects, 95% efficacy after the second dose in subjects with and without evidence of insects.

<unk>.

For six months following the two primary areas.

Sean: We are very pleased with the latest clinical and regulatory developments from our vaccine, which demonstrate a strong execution in response to the COVID-19 pandemic. I'll now turn the call over to Ozlem, who will provide details of our recent vaccine study results, as well as provide an overview of our oncology program, including positive data to be presented at the upcoming SITC.

Are there lessons.

Eight of 16, and <unk>, 91% efficacy against symptomatic.

And 95% efficacy against.

Please well that's demonstrated.

The net of all that.

It has now been administered to over a $1 billion does.

Since closing.

That's the way you recognize that the prevention of disease in children, its reaching herd immunity and equally important we have expanded our clinical trials in children in 12 to 15 year olds or vaccine administered according to the same regimen as far it does demonstrate.

Ozlem Tureci: I'm going to share with you today new data for BNT162b2 and our future vaccine strategy to combat the COVID-19 pandemic. As summarized on slide 13, BNT162b2 has demonstrated high efficacy in our Phase III pivotal trial with approximately 44,000 subjects, 95% efficacy after the second dose in subjects with and without evidence of infection.

Protection, 100% vaccine efficacy against Covid, 19 infection, and those with and without evidence of prior infection and 100% efficacy against certain entities.

The immune response was non inferior compared to that is it.

And 16% to 25, and <unk> 62 to demonstrate that they're well tolerated safety profile similar to the safety profile.

Hi.

Ozlem Tureci: Through six months following the two-dose primary series in adults and adolescents aged 16 and over, 91% efficacy against symptomatic disease and 95% efficacy against severe disease were demonstrated. We estimate that our vaccine has now been administered to over 1 billion adults and adolescents globally. As we recognize that the prevention of disease in children and reaching herd immunity are equally important, we have expanded our clinical trials in children. In 12- to 15-year-olds, our vaccine, administered according to the same regimen as for adults, demonstrated strong protection with 100% vaccine efficacy against COVID-19 infection in those with and without evidence of prior infection and 100% efficacy against severe disease.

In the.

Your children, a two dose regimen of <unk> 10, micrograms administered 21 days apart curfews robust neutralizing antibody titers similar to that observed in adults, aged 16 to 20 sites and work the way it's harder right at <unk>.

Efficacy against symptomatic COVID-19 infection was nine key 7% up two one months totaling the second door and no cases of severe COVID-19 was seen in Q1 62.

Clinical trials in children six months to get it.

Two years of age and 225 years of age are underway.

And Alex Andre.

200, <unk> hundred 62, B tool accessible for all ages.

We expect data to be available from those age cohorts in the fourth quarter of 2021 or early first quarter 2022.

On slide 14, our clinical strategy addressing the need for a third dose blister to restoring neutralizing antibody titers in vaccine efficacy given waning <unk> dolomite interval.

Ozlem Tureci: The immune response was non-inferior compared to that elicited in 16- to 25-year-olds, and BNT162b2 demonstrated a well-tolerated safety profile, similar to the safety profile seen in adults. In 5 to 11-year-old children, a two-dose regimen of 10 micrograms administered 21 days apart produced robust neutralizing antibody titers similar to that observed in adults aged 16 to Vaccine efficacy against symptomatic COVID-19 infection was 90.7 percent up to one month following the second dose, and no cases of severe COVID-19 were seen in BNT162b2.

Filing a second dose it's Sean.

Clinical data to support a third dose blister to augment X gene protection over that time.

Does over 16 years of age, including high risk populations and immuno compromised individuals.

Evaluating the impact of that first dose booster on neutralizing antibody titers in T cell responses.

Approximately 300 subjects in our phase one and pace to try it.

Additionally, we have undertaken a phase III trial in up to 10000 subject to measure relative to <unk> efficacy in those vaccinated was such a booster dose of 160 <unk>, whereas it with.

Who did not receive a booster dose.

Following the primary two dose serious.

Ozlem Tureci: Clinical trials in children six months to two years of age and two to five years of age are underway, building on our expanding labels to make BNT162b2 accessible for all ages. We expect data from those age cohorts to be available in the fourth quarter of 2021 or early the first quarter of 2022.

We are constantly monitoring new emerging variance and assessing the ability of <unk> hundred 60, it will be too to a.

Neutralized these areas of concern the empty 162, B two has demonstrated high efficacy against variants of concern in both its ability to inhibit anti bodies that neutralize varian and from the vaccine effectiveness perspective in that regard.

As part of our prototype approach to predict the actual margin variance of concern that's made kipp immunity.

Ozlem Tureci: On slide 14, our clinical strategy addressing the need for a third dose booster to restore neutralizing antibody titers and vaccine efficacy given waning vaccine immunity at longer intervals following a second dose is shown. However, clinical data support a first-dose booster to augment vaccine protection over time in adults over 16 years of age, including high-risk populations and immunocompromised individuals. We are evaluating the impact of a third-dose booster on neutralizing antibody titers and T-cell responses in approximately 300 subjects in our Phase I and Phase II-III trials.

So to say Oh that's.

That's true vaccine version, we are testing, both varian and coding monovalent 90 basis.

Clinical trials underway.

One of the valent, that's how varian vaccine was administered to a 300 vaccinated individuals.

A phase III trial is the first dose and to 360 net net mix individually.

Additionally, we have undertaken trial to evaluate a multivalent data I saw variant according vaccine and one of valent vaccine zinc coating either at Santa Barbara and her variant.

That is the side doors are in naive subjects.

I could try it.

Data is expected in the first quarter of 2022.

Data from these trials could support a flexible platform approach for product adoption should it be needed.

Ozlem Tureci: Additionally, we have undertaken a phase three trial in up to 10,000 subjects to measure relative vaccine efficacy in those vaccinated with such a booster dose of BNT162b2 versus those who did not receive a booster dose following the primary two-dose trial. We are constantly monitoring new emerging variants and assessing the ability of BNT162b2 to neutralize these variants of concern. BNT162b2 has demonstrated high efficacy against variants of concern in both its ability to elicit antibodies that neutralize variants and from a vaccine effectiveness perspective in the real world. As part of a prototype approach to prepare for emerging variants of concern that may escape immunity elicited by our ancestral vaccine version, we are testing both variant-encoding monovalent and multivalent vaccines.

Now to slide 15.

The graph on the left shows set in elderly adults neutralization has are more fraud and the level of detection by this essay after seven to nine months boosting with upside stores between seven and.

Nine months after adult tool.

This is a robust neutralization response.

Beyond what was originally upturn after those too.

Sarah Tan from participants one month after adults who need this.

Hi, neutralization titers against the original ancestor, it's train that's ovarian and so the desktop variant.

Utilization high test against the desktop version of upsides for overdose observed after dose tool and the aged 18 to 55 years and even over 11 for it in the older age group 65 to 85.

The difference in neutralizing titers against the <unk> virus, that's a variant narrow which after the third dose compared to after the second door, implying that addition to prolonging threat protection effect of boost that may increase the breadth of neutral.

And I think response against Sars Cov two area.

Data in support of a booster dose a trove of strengthened with evidence of a phase III vaccine efficacy booths that tri Ed in 9000 subjects. The <unk> hundred 60, <unk> demonstrated 95 plus than rather just vaccine efficacy, which reflects the reduction in <unk>.

This occurrence in the most difficult for us its been nonexistent.

Those with and without evidence of prior years as cost to infection. After a median of 11 months following the second dose rather than a vaccine efficacy with consistent irrespective of age sex weight ethnicity comorbid conditions.

Ozlem Tureci: Clinical trials are underway where our monovalent beta variant vaccine was administered to 300 vaccinated individuals in our phase 3 trial as a third dose and to 300 vaccine-naive individuals. Additionally, we have undertaken trials to evaluate a multivalent delta-alpha variant encoding vaccine and monovalent vaccines encoding either the delta or the alpha variant administered as a third dose or to naive subjects in clinical trials. Data is expected in the first quarter of 2022. Data from these trials could support a flexible platform approach for product adaptation should it be needed. Now to slide 15.

<unk> hundred 62, B, two was well tolerated and adverse events were similar to those observed previous heat index, indicating a troublesome.

Moving to slide 16.

The global distribution of <unk> 60 to be towards that's generated a vast area of weird word vaccine effectiveness data dive.

Diverse population it is reassuring to.

It took the highlight of vaccine effectiveness.

The primary to deliver millions of high efficacy demonstrated against symptomatic infections asymptomatic infections severe severe infection hospitalization and deaths and read the words vaccine effectiveness China.

Ozlem Tureci: The graph on the left shows that in elderly adults, neutralization has almost fallen to the level of detection by this assay after seven to nine months. Boosting with a first dose between seven and nine months after the second dose induces a robust neutralization rate beyond what was originally observed after those. Sarah obtained from participants one month after those three high-neutralization titers against the original ancestors, the beta variant, and also the delta variant.

We have less data confirms that vaccine effectiveness decreases over time as the.

And how about after the second dose increases.

Vaccine effectiveness against hospitalization.

Hi.

It was evidence shows also that highest vaccine effectiveness its way towards with the first dose and stuff both against severe disease.

Confirmed infections as seen in Israel, and those 816 and all of that.

<unk> 12 days after first dose booster there wasn't 10 fourth reduction in risk of confirmed infection across all age groups.

Ozlem Tureci: Neutralization titers against the Delta variant are over 5-fold over those observed after dose 2 in the age group 18 to 55 years and even over 11-fold in the older age group 65 to 85 years old. The difference in neutralizing titers against the ancestral virus and the beta variant narrowed after the third dose compared to after the second dose, implying that in addition to prolonging protection, a third-dose booster may increase the breadth of the neutralizing response against SARS-CoV-2 variants.

Yes.

Cohorts that received the initial two dose ceiling is.

And 18 for at risk reduction in severe disease was observed in the 60 and older age group and 22 folks like reduction in those aged 46% to 60 with regard to COVID-19 associated that's.

Watching for at risk reduction was observed for those aged 60 and older.

Can you to monitoring offering of our data and Immunogenicity data, it's more oriented to understand the effect of booster doses on VAT.

Seen effectiveness against COVID-19 caused by SaaS.

King.

Ozlem Tureci: Data in support of a booster dose are further strengthened with evidence from a phase three vaccine efficacy booster trial in 9,000 subjects. The NT162b2 demonstrated 95% relative vaccine efficacy, which reflects the reduction in disease occurrence in the boosted group versus the non-boosted group in those without evidence of prior SARS-CoV-2 infection at a median of 11 months following the trial. Relative vaccine efficacy was consistent irrespective of age, sex, race, ethnicity, or comorbid conditions.

Now starting with slide 18 that update on our immuno oncology pipeline with multiple assets across different therapeutic modalities with potential to ticket two months using complementary strategies either by targeting two months has direct.

Oh, sorry in modulating the immune response against the tumor.

Many of our product candidates have the potential to be combined with other pipeline assets.

Slide 19 highlights our strong clinical execution in 'twenty to 'twenty. One we are presenting several of these state updates and seven presentation. It says, let's see but is that just six annual meeting.

Ozlem Tureci: BNT162b2 was well-tolerated, and adverse events were similar to those observed previously in clinical development. Moving to slide 16, the global distribution of BNT162b2 has generated a vast array of real-world vaccine effectiveness data in diverse populations. It is reassuring to see high rates of vaccine effectiveness after the primary two doses, mirroring the high efficacy demonstrated against symptomatic infections, asymptomatic infections, severe infections, hospitalizations, and deaths in real-world vaccine effectiveness trials. However, real-world data confirms that vaccine effectiveness decreases over time as the interval after the second dose increases.

Torture, we now have four ongoing randomized phase two clinical trials three of which started in 2021 and additional randomized phase II trials for the next generation immuno modulator <unk> 11 that we are developing with I'll ask Jim Quinn from churn that is expected.

To start in the fourth quarter of 2021.

We have also started I first in human clinical trials and our diverse tier acuity coke.

Yeah.

Moving to slide 20, and O I missed.

That candidate audience of women of USD 122. This program is partnered with Genentech Roche beyond Q1, 'twenty. Two is designed to target patient specific and different and there's a 40 individualized cancer vaccines with two ongoing trials in metastatic Kansas.

Of which one is a randomized phase two.

First on melanoma.

The nation West Palm temporarily.

We are now moving into the adjuvant treatment space with a randomized phase two trial in colorectal cancer patients for which we announced first patient dose in October 2021.

Ozlem Tureci: Vaccine effectiveness against hospitalization is still high. Real-world evidence also shows that high vaccine effectiveness is restored with a third dose booster both against severe disease as well as confirmed infections, as seen in Israel in those aged 16 and older. Starting 12 days after a first-dose booster, there was a 10-fold reduction in risk of confirmed infection across all age groups compared to the cohort that received the initial two-dose seal.

The second deadliest cancer, where outside the medical need for novel therapies to treat colorectal cancer remains high the current standard of care plus stage to Ohio as they treat patients with localized cancer. This is the removal of the primary tumor and adjuvant chemotherapy.

Followed by a walk watchful waiting to see if too much weaker.

Ozlem Tureci: An 18-fold risk reduction in severe disease was observed in the 60 and over age group and a 22-fold risk reduction in those aged 46 to 65. Furthermore, with regard to COVID-19-related deaths, a 14-fold risk reduction was observed for those aged 60 and over. Continued monitoring of real-world data and immunogenicity data is warranted to understand the effect of booster doses on vaccine effectiveness against COVID-19 caused by SARS-CoV-2 and emerging variants.

Sure proportion of these patients.

That's a trend a recurrence of the tumor within two to three years after that surgery harvest triad patients at high risk for recurrence will be identified with a highly sensitive test detecting circulating tumor DNA and the way we see our vaccine following three to six months.

After their adjuvant chemotherapy and circulating tumor DNA positive colorectal cancer patients after adjuvant chemotherapy and disease free survival.

Six months is estimated the primary endpoint of our phase two trial is contained suites adviser Trevor objectives include overall survival and safety. The trial also has a biomarker cohort includes patients with <unk>.

Ozlem Tureci: Starting with slide 18, an update on our immuno-oncology pipeline. We have multiple assets across different therapeutic modalities with the potential to tackle tumors using complementary strategies, either by targeting tumor cells directly or by modulating the immune response against the tumor. Many of our product candidates have the potential to be combined with other pipelines.

I'll stop here.

<unk> too much in these stages.

Slide 21 highlights our presence at the <unk>.

Since the annual meeting on November 10th to 14th we will present data across six programs in fourth year of periodic debt funds and two hour presentation entitled forced us over on the data that we are presenting some favorable safety profile and promising signs of clinical activity for <unk>.

Ozlem Tureci: Slide 19 highlights our strong clinical execution in 2021. We are presenting several of these data updates and seven presentations at the ZIP-C 36th annual meeting. In total, we now have four ongoing randomized phase II clinical trials, three of which started in 2021. An additional randomized phase II trial for the next generation immunomodulator, BNT311, that we are developing with our esteemed colleagues from GenMED is expected to start in the fourth quarter of 2021. We have also started five first-in-human clinical trials in our diverse therapeutic program. Moving to slide 20 and our INS product candidate, Autogen Sevumarin or BNT122. This program is partnered with Genentech.

Our six clinical programs and the trials we are reporting at 50, we observed preliminary biologic or a clinical activity in the monotherapy arm and.

And then very difficult to treat the patient population more due to the next slide.

On slide 22 preliminary data now does this sounds a phase one trial of our candidate <unk> 11 from our wholly owned six platform BMT 111, its auspicious RNA vaccine that encodes a fixed set of flagship antigen cover covering.

Up to 95% of Q.

Cutaneous melanoma patients melanoma remains an area of unmet need, particularly for patients who have progressed upon checkpoint inhibitor treatment more than half of those patients who do not respond to checkpoint inhibitor in patients with stage four disease space as well.

Thus we believe.

The next wave of development is combining checkpoint inhibitors with other agents in 2020, we published promising data on BNP 111 in checkpoint inhibitor experienced patients with detectable disease and metastatic melanoma.

Ozlem Tureci: The NT122 is designed to target patient-specific neoantigens and is a fully individualized cancer vaccine with two ongoing trials in metastatic, of which one is a randomized phase 2 trial in first-line melanoma in combination with Pembrolin. We are now moving into the adjuvant treatment space with a randomized phase 2 trial in colorectal cancer patients, for which we announced the first patient dose in October 20 As the second deadliest cancer worldwide, the medical need for novel therapies to treat colorectal cancer remains high.

Sure.

With that showed that PMT, one indefinitely, one of Europe and in combination with checkpoint inhibition was weighted toward oriented and can do it do you have the object objective responses in this disease setting and trigger the initiation of our phase two trials in checkpoint refractory all.

Resistant melanoma testing beyond Q1, 11 in combination with the anti PD, one <unk> and our partnership with Regeneron.

You know, there's just which we are presenting at 50 includes a cohort of pre treated patients with stage three and four cutaneous melanoma with no evidence of disease. That's received BNP 111, one over here.

Overall, the empty 111 had a favorable safety profile with similar safety in patients with evidence of disease and without evidence of disease. Most treatment related adverse events were mild to moderate flu like symptoms overall the rate of serious adverse events.

Ozlem Tureci: The current standard of care for stage 2 high-risk and stage 3 patients with localized cancer is removal of the primary tumor and adjuvant chemotherapy followed by a watchful waiting to see if tumors recur. A substantial proportion of these patients are expected to have a recurrence of their tumor within 2 to 3 years after their surgery. For this trial, patients at high risk for recurrence will be identified with a highly sensitive blood test detecting circulating tumor DNA and will receive our vaccine following 3 to 6 months after their adjuvant chemotherapy. In circulating tumor DNA-positive colorectal cancer patients after adjuvant chemotherapy, a disease-free survival of only six months is estimated.

In line with our previous data on patients with evidence of disease beyond Q1, 11 induced CD four and CDA T cell responses that ex vivo assay results showed that similar proportions of patients in both pools with funded to at least one tumor associated antigen also.

Thanks.

A substantial proportion of patients presented to Novo T cell responses only detectable.

The vaccination.

Medium duty free survival of patients with no evidence of disease was $34 eight months highlighting that PNG. One would have been one of Europe's shows promising thickness of prolonged disease control in patients with no evidence of disease the ability to induce she said.

Ozlem Tureci: The primary endpoint of our Phase II trial is disease-free survival. Further objectives include overall survival in, The trial also has a biomarker cohort that includes patients irrespective of circulating tumor DNA. Slide 21 highlights our presence at the ZIPSI annual meeting on November 10th to 14th.

It was picked up off the presence of a clinically already geologically detectable tumor is it potential sign of two months of millions maybe eight five <unk>. We believe that these findings have the potential to translate into significant clinical benefits and encourage further.

Ozlem Tureci: We will present data across six programs and four therapeutic platforms, two oral presentations, and five posters. Overall, the data that we are presenting show favorable safety profiles and promising signs of clinical activity for all six clinical programs. In the trials we are reporting at CITSI, we observed preliminary biological or clinical activity in the monoferative arms, and in a very difficult-to-treat patient population. More details will follow on the next slide.

Development.

The <unk> 11 in early of melanoma setting.

We are also presenting data from our expect PMT, one twist phase one to try as shown on slide 23 at 15, <unk> encodes a fixed set of five prostate associated antigens. The first in human phase one two trial assessing the safety and.

Jeanette City of PNG 112, one of Europe's ERP or in combination with some we put them up in patients with metastatic castration resistant resistant prostate cancer and with newly diagnosed high risk localized prostate cancer.

Ozlem Tureci: On slide 22, preliminary data from a sub-analysis from the phase one trial of our candidate BNT111, an off-the-shelf RNA vaccine that encodes a fixed set of four shared antigens covering up to 95% of cutaneous melanoma patients, from our wholly owned FIGFAC test. Melanoma remains an area of unmet need, particularly for patients who have progressed on checkpoint inhibitor treatment. However, more than half of those patients who do not respond to checkpoint inhibitors and patients with stage 4 disease still face poor odds. Thus, we believe the next wave of development is combining checkpoint inhibitors with other agents.

This cancer is a major health issue with one 3 million new cases worldwide each year localized prostate cancer frequently becomes metastatic which are in various needs pay to prognosis remains important and novel therapeutic approaches are required part one.

If the trial, which is a.

BMT one class dose titration is complete and thoroughly comment the recommended dose range for part two has been determined perhaps to the dose expansion with TNT 112, as a monotherapy and in combination with <unk> to meet them up is currently recruiting.

Preliminary preliminary results from the trial as of June 2021 are as follows nine patients have been treated with the anti <unk> with more of European part one always heavily pre treated.

It's.

Ozlem Tureci: In 2020, we published promising data on BNT111 and checkpoint inhibitor experience patients with detectable disease and metastatic melanoma in nature. Those results showed that BNT111 monotherapy and in combination with checkpoint inhibition were well-tolerated and induced durable objective responses in this disease setting, and triggered the initiation of our phase 2 trials in checkpoint refractory or resistant melanoma testing BNT111 in combination with the anti A new analysis which we are presenting at SIPCI includes a cohort of pre-treated patients with stage 3 and 4 cutaneous melanoma with no evidence of disease who received BMP111 monohumans. Overall, BNT111 had a favorable safety profile with similar safety in patients with evidence of disease and without evidence. Most treatment-related work events were mild to moderate, and true-life.

Stage cancer types patients were treated in part to overall most adverse events that occurred in part one were mild or moderate there were two instances of quite free hypertension, leading to dose reductions both patients recovered within 24 hours and these events did not meet.

The criteria of dose limiting toxicity.

Our reported serious adverse events in pad one work ones. So that's unrelated to BMT.

<unk> no safety sickness, our concerns were identified and talk to and which patients received BMT 112, only or in combination with <unk>.

Second patients who were in the yoga exhibited detect the immune responses. We also confirmed that all sides tumor associated antigens, where immunogenic and identify T cell responses to each antigen in at least two patients to patients with late stage cancer treated with <unk>.

We have monotherapy have decreases in prostate specific antigen.

The well known prostate cancer biomarker.

In summary, these data suggests that <unk> has a ton of other safety profile and enrollment to part two is ongoing in monotherapy.

In combination with <unk>.

With good signal of activity in patients with advanced prostate cancer.

Slide 24, and moving to BMT to 11 that comprises two drug products brought in six car T cell and car T cell emphasize R&D vaccine in short topic.

Ozlem Tureci: Overall, the rate of serious adverse events was low. In line with our previous data on patients with evidence of disease, BNT111 induced CD4 and CD8 T cell responses. The ex vivo ELISPOT assay results showed that similar proportions of patients in both groups responded to at least one tumor-associated antigen of the vaccine. Additionally, a substantial proportion of patients presented de novo T cell responses only detectable after vaccination.

Six car T cells are equipped with with a second generation chimeric antigen receptor of high sensitivity and specificity for the tumor specific antigen called <unk> six.

<unk> six is absent in healthy adult tissues get frequently express and high medical need cancer, making this tumor antigen and Ikea target for car T cell therapy preclinical studies demonstrate that that's kind of off track in vivo expansion of construct copy said increasing that persistence.

Ozlem Tureci: The median disease-free survival of patients with no evidence of disease was 34.8 months, highlighting that BNT111 monotherapy shows promising signals of prolonged disease control in patients with no evidence of disease. The ability to induce T cell immunity irrespective of the presence of a clinically or radiologically detectable tumor is a potential sign of tumor surveillance mediated by BNT111. We believe that these findings have the potential to translate into significant clinical benefits and encourage further development of BNT111 in earlier melanoma disease.

It took us BMT to 11 is expected to overcome car T cell therapy limitation in patients with solid tumors. The first in human phase one dose escalation trial evaluates the safety and efficacy.

Clothing, six car T cell immunotherapy and in combination with <unk> in patients with Covid positive relapsed or refractory advanced solid tumors had one comprises six car T mono therapy dose escalation cohorts and part two is a dose escalation of car T combined.

Ozlem Tureci: We are also presenting data from our FIXVAC BNT112 Phase 1-2 trial, which encodes a fixed set of five prostate-associated antigens, on slide 23 at SITC. The first in human Phase 1-2 trial assesses the safety and immunogenicity of BNT112 monotherapy or in combination with semiplimib in patients with metastatic castration-resistant prostate cancer and with newly diagnosed high-risk localized prostate cancer. Prostate cancer is a major health issue, with 1.3 million new cases worldwide each year. Localized prostate cancer frequently becomes metastatic, which is invariably fatal.

With a fixed dose of topic.

There are three dose level cohorts for each part.

He couldn't dose expansion with focus on ovarian particular in endometrial cancer.

Other coding six positive Kansas as of July 23rd dose level two of part one and those are the one or two uncles on slide 25, we show preliminary results from the phase one two BMT tool could try that will be presented at the.

The eight patients included in the analysis were all heavily pre treated with testicular ovarian and endometrial cancer and sarcoma.

Steve to car T cells, one of European Free Kaki said, that's topic vaccine combination here.

Clothing six car. She said that's one of your peers, all combined with cockpit topic, where a well tolerated at the dose levels evaluated and no dose limiting toxicities were observed some cases of cytokine release syndrome occurred were manageable with no signs of neurotoxicity increases oftentimes.

Ozlem Tureci: Prognosis remains poor, and novel therapeutic approaches are required. Part one of the trial, which is a BNT-112 dose titration, is complete, and the recommended dose range for part two has been determined. Part 2, the Dose Expansion, with BNT112 as monotherapy and in combination with Simiprimab, is currently recruiting. Preliminary results from the trial as of June 2021 are as follows. Nine patients have been treated with BNT112 monotherapy in part one, all with heavily pretreated late stage disease.

Kim six N C reactive protein were transient and northridge patients receiving the combination therapy had trends in food <unk> symptoms that result within 24 hours.

And then just of Patchy said frequency in the peripheral blood of patients. We did robust car T cell and grassman up to date 17 post infusion sort of expansion was noted into patients with liver metastasis accompanied by elevations to bad debt were also encouraging.

Signs of clinical activity in patients for which a six week Tomorrow assessment was available free patients showed initial tumor shrinkage with tumor reduction between 18 and 27%. According to resist signs of initial tumor.

Ozlem Tureci: Stage cancer, five patients were treated in part two. Overall, most adverse events that occurred in part one were mild or moderate. There were two instances of grade three hypertension, leading to dose reductions. Both patients recovered within 24 hours, and these events did not meet the criteria of dose-limiting toxicity. All reported serious adverse events in Part 1 were considered unrelated to BNT112.

Shrink Quechua identified even at the lowest dose tested data on one additional patient evaluated between the abstract submission and the conference will be shared during the presentation.

The data from the trial are very encouraging and we look forward to presenting updated data from the open cohorts and especially for the combination part with Kovack.

Coming Congresses.

When we move to a data update on the ongoing phase one towards fire on a lot.

Ozlem Tureci: No safety signals or concerns were identified in Part 2, in which patients received BNT112 only or in combination with Simipri. Additionally, all seven patients who were A-spot-valuable exhibited detectable immune responses. We also confirmed that all five tumor-associated antigens were immunogenic and identified T-cell responses to each antigen in at least two patients. Additionally, two patients with late-stage cancer treated with BNT112 monotherapy had decreases in prostate-specific antigen, a well-known prostate cancer biomarker. In summary, these data suggest that BNT112 has a tolerable safety profile, and enrollment to part two is ongoing as monotherapy, as well as in combination with semiprimab, with a risk signal of activity in patients with advanced prostate cancer.

By specific anti body be antifreeze, 11, which we are developing in collaboration with Genmab.

26 shows the mechanism of action of PMT for Ya evidence of phase one to try to decide.

The antifreeze 11 is the first in class I specific anti body.

<unk> to elicit an anti tumor immune response, but some of your 10 years and complementary brocade of PDL, one on too much sets and conditioners for one BP stimulation on T cells and natural killer cells.

Previous analyses presented at 52020 showed encouraging signs of clinical activity and manageable safety profile in patients with advanced solid tumors.

During the dose escalation phase of the ongoing phase one two trial. These data along with semi mechanistic pharmacokinetic Pharmacodynamic predictive models and translational work established 100 milligram of <unk> every three weeks after the dose flexpath.

Cohorts four tickets on this module will be presented at <unk>.

Ozlem Tureci: Slide 24, and moving to BNT2-11 that comprises two drug products, cloridine-6-carotene cells and a carotene cell-amplifying RNA vaccine in short carbon. Cloridin-6 CAR-T cells are equipped with a second-generation chimeric antigen receptor of high sensitivity and specificity for the tumor-specific antigen Cloridin-6. Cloridin 6 is absent in healthy adult tissues yet frequently expressed in high-medical-need cancers, making this tumor antigen an ideal target for CAR T-cell therapy. Preclinical studies demonstrated that CARVAC drives in vivo expansion of transferred CAR T-cells, increasing their persistence and efficacy.

Since since the dose escalation, we have proceeded to the dose expansion cohorts of heavily pretreated patients with relapsed or refractory advanced or metastatic solid tumors with preliminary data shown on slide 27. The safety data are in line with our previous disclosure.

And most treatment related adverse events were mild to moderate.

No we don't see no tightening of peripheral blood measurements of soluble immune nikitas from Syria, that's centered and immunohistochemistry analysis of tumor biopsies showed that the antifreeze 11 elicited pharmacodynamic effects consistent with its proposed mechanism of action.

Identified PURPA and tumor immune activity in patients, including the modulation of immune cytokine the expansion of CD eight effect on memory T cells and.

Natural.

Activation type patients had partial responses and show the trend toward greater conduction of cytokines and immune endpoints compared to none on that.

We also identified associations between disease control and potential lost anti PD one therapy prior to the study treatment and PDL one expression on tumor.

Ozlem Tureci: BNT2.11 is expected to overcome cortisone therapy limitations in patients with 32-year-olds. The first in human phase 1-2 dose escalation trial evaluates the safety and efficacy of Cloridine-6 CAR T-cell monotherapy and in combination with CARVEC in patients with Cloridine-6 positive relapsed or refractory advanced solitarily. Part 1 comprises Claudian 6-CAR-T monotherapy dose escalation cohorts, and Part 2 is a dose escalation of CAR-T combined with a fixed dose of CAR-T. There are three dose-level cohorts for each part.

The disease control rates were higher among patients who had progressed with prior anti PD one therapy within eight months prior to the first dose of TNT.

11 tumor reduction of any degree occurred mainly in patients with PDL one positive tumor these timing support that patient selection and <unk> anti PD. One combination therapy may lead to further improved clinical efficacy, we expect to start a phase two trial of PMT free it doesn't.

As monotherapy and in combination with pinpoint somewhat in refractory or relapsed metastatic non small cell lung cancer within the next weeks on.

On slide 28, or a second first in class by specific anti body BMT fleet trends, which we are also developing in collaboration with Genmab.

Ozlem Tureci: The subsequent dose expansion will focus on ovarian, testicular, and endometrial cancers, as well as other protein-6 positive tumors. As of July 23rd, dose level 2 of part 1 and dose level 1 of part 2 are ongoing. On slide 25, we show preliminary results from the phase 1 to BNT2-11 clinical trial that will be presented at CITSI. The eight patients included in the analysis were all heavily pretreated with testicular, ovarian, and endometrial cancers and sarcoma.

It combines targeting and conditional activation of <unk> 14 for <unk> on immune cells, resulting in enhanced training and activation of tumor specific community there.

The ongoing first in human trial evaluates the safety and anti tumor activity of P&G free to it.

As shown on slide 29 as of July 1st 2021, 50 patients have received PNT free to ask one of Europe in the dose escalation part the most common types of cancer include colorectal cancer melanoma, and non small cell lung cancer in patients who have undergone.

The median of 2.5 treatments that goes to.

Ozlem Tureci: Five received CAR-T cells, one of European free CAR-T cells, plus CAR-VEC vaccine combination. Protein 6-carb T-cells as monofural P or combined with Carvex were well-tolerated at the dose levels evaluated, and no dose-limiting toxicities were observed. Some cases of cytokine release syndrome occurred but were manageable with no signs of neurotoxicity. Increases of interleukin 6 and C-reactive protein were transient and moderate.

To date, the maximum tolerated dose had not been reached and be antifreeze 12 has demonstrated a favorable safety profile with treatment related adverse events being mostly mild to moderate one dose limiting toxicity of paas and the needs innovation occurs at the 200 milligram dose and with that.

Asked upon corticosteroid administration.

We have observed increases in person one aside entrant dendritic cells cytokine and also increased levels of CD eight and effect on memory T. Cells. This suggests biological activity that is consistent with the proposed mechanism of action for the antifreeze with now over about half.

Ozlem Tureci: Patients receiving the combination therapy had transient flu-like symptoms that resolved within 24 hours. The analysis of CAR-T cell frequency in the peripheral blood of a patient revealed robust CAR-T cell engraftment up to day 17 post-infusion. Further expansion was noted in two patients with liver metastasis accompanied by elevated liver enzymes.

These patients who had exhausted and that figure please.

Disease control it to patients with melanoma and newer newer endocrine lung cancer, who had confirmed partial responses.

We have identified 100 milligrams every three weeks for dose expansion also for the store button. The study was recently updated to include multiple expansion cohorts, including as a frontline treatment in head and neck squamous cell carcinoma, melanoma and pancreatic ductal adapt to it I don't know.

Ozlem Tureci: There were also encouraging signs of clinical activity in patients for which a six-week tumor assessment was available. Three patients showed initial tumor shrinkage with tumor reductions between 18% and 27%, according to research. Signs of initial tumor shrinkage were identified even at the lowest dose test.

No I'm not.

Additional expansion cohorts will include combination with <unk> in first line non small cell lung cancer in combination with henkel and chemotherapy in first line head and neck squamous cell carcinoma.

As shown on slide 36.

We will also present data from the phase one two trial in patients with solid tumors of our toll like receptor seven product candidates BMT four P.

Ozlem Tureci: Data on one additional patient evaluated between the abstract submission and the conference will be shared during the ZIPC presentation. The data from the trial are very encouraging, and we look forward to presenting updated data from the open cohorts, and especially for the combination part with CARVAC, at upcoming conferences. Now we move to a data update on an ongoing Phase I-II trial on our bi-specific antibody, BNT311, which we are developing in collaboration with GenLabs.

And before he definitely the small molecule designed to activate both the adaptive and innate immune system for her child up receptors seven pathway to stimulate antigen specific CDA T said, he says and innate immune cells.

During the dose escalation part of patients with metastatic or I'm going back to the solid tumors that have exhausted available treatments, where receipts BNP for 11, one off ERP, it's up to eight different dose levels and a second dose escalation arm patients with chemotherapy naive extensive stage small cell.

Cancer, but where we keep Yankee for 11 in combination with Paclitaxel therapies, and Chuck a checkpoint inhibitor.

Ozlem Tureci: Slide 26 shows the mechanism of action of BNT311 and the Phase I-II trials. BNT311 is a first-in-class, bi-specific antibody designed to elicit an anti-tumor immune response by simultaneous and complementary blockade of PD-L1 on tumor cells and conditional 4-1BB stimulation of T-cells and natural killers.

The dose escalation part will be followed by <unk>.

Dose expansion cohorts, that's as of July 1st 2021, it doesn't have any pre treated patients have received PMT for 11, one of Europe's.

That's a type of eight dose levels had been Piet for evaluation.

To date PMT for 11 had the tolerable safety profile with no dose limiting toxicity, the only drug related adverse events reported were a non serious pyrexia and smartphone market with India. The biological activity of P&G for nothing was consistent with its mechanism of action as.

Ozlem Tureci: Previous analyses presented at CITSI 2020 showed encouraging signs of clinical activity and a manageable safety profile in patients with advanced solid tumors during the dose escalation phase of this ongoing phase one treatment. These data, along with a semi-mechanistic pharmacokinetic pharmacodynamic predictive model and translational work, established 100 milligrams of BNT311 every three weeks as the dose for expansion cohorts. Full details on this model will be presented

Weighted by the induction of plasma cytokines and increased levels of interferon gamma induced protein.

Based on preliminary unclean data the best response seen for PMT for 11, one of European and these few patients was five months of stable disease in a patient with anti PD, one pre treated squamous cell carcinomas. These data support that spun off the trial until that dose.

Our nation pop in which patients receive BNP for 11th in combination with cytotoxic therapies and checkpoint inhibitors and recruitment into the theory therapy started in June.

Ozlem Tureci: Since the dose escalation, we have proceeded to the dose expansion course of heavily pre-treated patients with relapsed or refractory, advanced, and or metastatic solid tumors, with preliminary data shown on slide 27. The safety data are in line with our previous disclosures, and most treatment-related adverse events were mild to moderate. Immunophenotyping of peripheral blood, measurements of soluble immune mediators from serial blood samples, and immunohistochemistry analysis of tumor biopsies showed that BNT311 elicited pharmacodynamic effects consistent with its proposed mechanism of action. We identified peripheral and tumoral immune activity in patients, including the modulation of immune cytokines, the expansion of CD8, effector memory T-cells, and natural killer cell activation.

Recruitment for the expansion cohort is expected to begin next year.

Encouraging data from our oncology programs, which we will present at the <unk> 2021.

Indicative of significant progress in the oncology portfolio.

They represent critical steps for us towards bringing cancer immunotherapy until the next generation.

I'll now turn over to our Chief Financial Officer, Jim <unk>, who will discuss our financial results.

Thank you Linda.

Welcome to those of you on the phone.

I'll stop my section by moving to our financial results for the third quarter of 2021 as shown on slide 32.

Total revenues were estimated to be approximately 6.1 billion for the third quarter of 2021 compared to $67 5 million euros for the comparative period in 2020.

For the period of nine months ended September 32021, we've reported estimated total revenues of around $13 4 million euros compared to $136 9 million euros for the comparative prior year period.

Ozlem Tureci: Five patients had partial responses and showed a trend toward greater induction of cytokines and immune endpoints compared to non-responses. We also identified associations between disease control and the time from the last anti-PD-1 therapy prior to the study treatment and PD-L1 expression on tumors. The disease control rates were higher among patients who had progressed with prior anti-PD-1 therapy within eight months prior to the first dose of BNT311. Tumor reduction of any degree occurred mainly in patients with PD-L1 positive tumors.

Total revenues increased due to the rapid increase in supply and sales of our COVID-19 vaccine worldwide.

As a reminder, on our COVID-19 vaccine collaborations territories have been allocated between Pfizer and Fosun pharma based on marketing and distribution.

A breakdown of our commercial revenues as shown on slide 33.

Our third quarter 2021 commercial revenues include approximately $4 4 billion euros, and prospectively $10 2 billion euros for the first three quarters of 2021.

Our gross profit generated by our collaboration partners and their respective territories.

As well as sales milestone.

Sales milestones included in the figure I, just mentioned amounted to 17 million euros for the third quarter and $432 8 million euros for the period of nine months ended September 32021.

Similar to previous quarters.

Good for profit you are estimated based on preliminary data shared between us.

Ozlem Tureci: These findings support that patient selection and or anti-PD-1 combination therapy may lead to further improved clinical efficacy. We expect to start a Phase II trial of BNT311 as monotherapy and in combination with Pembrolizumab in refractory or relapsed metastatic non-small cell lung cancer within the next week. On slide 28, our second first-in-class bi-specific antibody, BNT3-12, which we are also developing in collaboration with General. It combines targeting and conditional activation of CD40 and 4-1BB on immune cells, resulting in enhanced priming and activation of tumor-specific immunity.

And may be subject to adjustment pending final data on input Panorama tests like south volume. They used it's one of those types of approaches.

Any changes in our share of collaboration partners gross profit will be recognized prospectively.

Our COVID-19 vaccine commercial revenues in the third quarter also include $312 3 million euros in sales to our collaboration partner of <unk>.

<unk> manufactured by Us.

And 1.4 billion euros of direct COVID-19 vaccine sales to customers in all that territory, which includes Germany and Turkey.

For the period of nine months ended September 32021, we had sales to our collaboration partners a five on it and 14 3 million euros and approximately $2 6 billion euros direct COVID-19 vaccine sales in Germany and Turkey.

Now returning back to slide 32, and moving to cost of sales, which was estimated to be $1 2 billion for third quarter of 2021 compared to $6 8 million euros for the comparative period in 2020 for the nine months ended September 32021.

Total cost of sales were estimated to be around $2 3 billion euros compared to $18 3 million yours for the comparative prior year period.

Ozlem Tureci: The ongoing first in human trial evaluates the safety and anti-tumor activity of BNT-3G. As shown on slide 29, as of July 1st, 2021, 50 patients have received BNT312 monotherapy in the dose escalation part. The most common types of cancer include colorectal cancer, melanoma, and non-small cell lung cancer, and patients have undergone a median of 2.5 treatments. To date, the maximum tolerated dose has not been reached, and BNT-312 has demonstrated a favorable safety profile with treatment-related adverse events being mostly mild to moderate. One dose-limiting toxicity of transaminase elevation occurred at the 200th milligram dose and resulted from corticosteroid administration.

Increase was driven by Costco, so recognized with respect to our COVID-19 vaccine sales.

And included the shelf gross profit that we owe our collaboration partner Pfizer on wholesale.

Research and development expenses were $260 4 million euros for the third quarter of 2021 compared to $227 7 million euros for the comparative period in 2020.

For the nine months ended September 32021 research and development expenses reached $677 7 million euros compared to 388 million euros for the comparable prior year period.

The increase was mainly due to an increase in research and development expenses from the BMT 162 program.

As a reminder, development costs are shared equally between five land off.

The increase was further driven by an increase in wages benefits and social security expenses. Following an increase in head count the reputation of eventual compensation expenses as well as expenses incurred on the share based payment arrangements from the company.

General and administrative expenses were $68 2 million euros for the same quarter of 2021 compared to $23 5 million euros for the comparable prior year period.

Period.

For the nine months ended September <unk>.

2021 general and administrative expenses reached $54 9 million compared to $58 1 million for the comparable prior year period.

Ozlem Tureci: We have observed increases in peripheral monocyte and dendritic cell cytokines and also increased levels of CD8 and effector memory T cells. This suggests biological activity that is consistent with the proposed mechanism of action for BNT312. Moreover, about half of these patients who had exhausted standard therapies achieved disease control, and we have identified 100 mg every three weeks for dose expansion, also for the stool body.

Similar to R&D the increase in G&A was driven by an increase in head count and expenses incurred under the company share based payment arrangements.

<unk> expenses for purchased management consulting and legal services.

Well as higher insurance premiums caused by the increased business volume.

Interim income taxes with food in an amount of approximately $1 5 billion euros for the third quarter of 2021.

And around $3 2 billion euros for the nine months ended September 32021.

With nice using the estimated annual effective income tax rate of approximately 31%.

For the third quarter of 2021 net profit reached approximately $3 2 billion euros compared to a net loss of 410 million euros compared.

Compared to prior year period.

For the nine months ended September 32021, total net profit reached approximately $7 1 billion euros.

Compared to a total net loss of $351 7 million euros for the comparative peer.

Period.

As of September 30th 2021, cash and cash equivalents totaled $2 4 billion euros Pease note that the contractual settlement of the gross profit share under our COVID-19 collaborations with Pfizer.

Ozlem Tureci: The study was recently updated to include multiple expansion cohorts, including as a front-line treatment for head and neck squamous cell carcinoma, melanoma, and pancreatic ductal adenocarcinoma. Additional expansion cohorts will include combination with pembrolizumab in first-line non-small cell lung cancer and combination with pembrolizumab and chemotherapy in first-line head and neck squam As shown on slide 30, we will also present data from a phase 1, 2 trial in patients with solid tumors of our Toll-like Receptor 7 agonist product candidate, BNT411. BNT411 is a small molecule designed to activate both the adaptive and innate immune system through the Toll-like Receptor 7 pathway and to stimulate antigen-specific CD8 T-cells, B-cells, and innate immune.

That's helpful.

Set of more than one claim in the quarter.

As far as the fiscal quarter for subsidiaries outside the United States.

All of this creates an additional time lag between the recognition of revenues of the patent.

I see.

Consequently, trade receivables, which were outstanding as of September 30th 2021.

We received payments only in October 2021, improving our cash position relative to the amount at September <unk> 2021.

Moving to slide 34.

Our outlook for the 'twenty to 'twenty, one financial year has been updated.

Based on planned deliveries of up to $2 5 billion doses into calendar year 2021.

Providing estimated COVID-19 vaccine revenues of approximately 16 to 17 billion euros for the full 2021 financial year.

This estimate reflect expected revenues from direct COVID-19 vaccine sales to customers in all the territory.

Expected revenues from sales to our collaboration partners.

Expected sales milestone payments from our collaboration partners and expected revenues related to our shelf Rustbucket from COVID-19 vaccine sales in the collaboration part of the territory.

Please note that this figure has been estimated at constant foreign exchange rates.

Please keep in mind that we will deliver significant number of doses to middle low income countries, where prices are in line with income levels or at non-profit spaces to serve the purpose.

We maintain our previous cost guidance for the fiscal year 2021 and expect to incur R&D expenses in a range of 950 million euros to $1 1 billion.

Ozlem Tureci: During the dose escalation phase, patients with metastatic or unrejectable solid tumors that have exhausted available treatments will receive BNT4-11 monotherapy at up to eight different dose levels. In a second dose escalation arm, patients with chemotherapy-nave extensive stage small cell lung cancer will receive BNT4-11 in combination with cytotoxic therapies and chocolate checkpoint inhibitors. The dose escalation part will be followed by the dose expansion cohort. As of July 1st, 2021, 11 heavily pre-treated patients have received BNT411 Monoferib. Thus far, five of eight dose levels have been cleared for evaluation. To date, BNT411 has had a tolerable safety profile with no dose-limiting toxicity. The only drug-related adverse events reported were non-serious pyrexia and micromoderate anemia.

Taking a further ramp up of R&D investments in the fourth quarter of 2021.

Given our plans to expand and accelerate our pipeline development.

SG&A expenses are estimated to be in a range of 250 million to 300 million here Kevin.

Capital expenditures for the year 2021, I expect it to be in a range of 175 million to 225 million years.

These figures have again been estimated constant foreign exchange rates and reflect our current base case protection.

Finally, please note that we still expect an estimated annual effective income tax rate of approximately 31% for the biotech group.

And with that I'll turn the call to our Chief strategy Officer, Ryan Richardson for an update on our corporate development activities and cooks and do remark. Thank you.

Thanks Vince.

Now to slide 36.

In the third quarter, we acquired <unk>, a biotechnology company based in Vienna, Austria.

The acquisition expands our infectious disease toolkit into synthetic license, a new class of precision anti bacterial which we believe have potential to address a wide range of pathogens and also the growing global challenge of anti microbial resistance.

In addition to its highly trained team the acquisition brings us <unk> licensed builder technology, a proprietary and silicone therapeutics platform designed to enable the rapid production of a competent natural license, which are optimized for potency and stability in manufacturing yields.

Ozlem Tureci: The biological activity of BNT411 was consistent with its mechanism of action as indicated by the induction of plasma cytokines and increased levels of interferon gamma-induced protein. Based on preliminary unclean data, the best response seen for BNT411 monotherapy in these few patients was five months of stable disease in a patient with anti-PD-1 pretreated squamous cell carcinoma of the lung. These data support the advancement of the trial into the dose escalation phase in which patients received BNT411 in combination with cytotoxic therapy and checkpoint inhibitors, and recruitment into the treatment arm started in June.

The transaction, which closed in the third quarter included an upfront cash payment of approximately $50 million Euro. In addition to potential future performance based development milestones of up to 100 million Euro.

<unk> now operates as biotech R&D, Austria and will serve as biotechs R&D hub for precision anti bacterial <unk>.

We are pleased to add this new class of precision therapies to our infectious disease portfolio of mrna vaccines in mrna encoded antibodies.

As you can see on slide 37, we continue to expand our infectious disease capabilities and pipeline to address global health challenges.

In addition to our COVID-19 of influenza vaccine programs, which are partnered with Pfizer. We now have active research and preclinical development programs against more than 10 distinct infectious diseases spanning both vaccine and therapeutic approaches.

Ozlem Tureci: Recruitment for the expansion cohort is expected to begin next year. These encouraging data from our oncology programs, which we will present at CIPSE 2021, are indicative of significant progress in our oncology portfolio, and they represent critical steps for us towards bringing cancer immunotherapy into the next generation. I now turn over to our Chief Financial Officer, Jens Holstein, who will discuss our financial results. Thank you, Ozlem, and a warm welcome to all of you.

Several of these programs could represent accelerated development opportunities.

For example, we plan to initiate first in human trials for our malaria and tuberculosis mrna vaccine candidates in 2022 and look forward to providing further program updates in the coming months.

Slide 38 depicts our clinical stage oncology pipeline, comprising 15 programs in 19 ongoing clinical trials across four drug classes.

With the new trial initiation. So far this year, we now have four ongoing randomized phase II trials in oncology.

We expect our pipeline to continue to broaden.

As we head into 2022.

I would like to point out that even though we have strong partners for certain programs, including Roche Genmab and Sanofi. The majority of our programs are fully owned.

Jens Holstein: I'll start my section by moving to our financial results for the third quarter of 2021, as shown on slide 32. Total revenues are estimated to be approximately €6.1 billion for the third quarter of 2021, compared to €67.5 million for the comparative period. For the period of nine months ended September 30th, 2021, we reported estimated total revenues of around 13.4 billion euros compared to 136.9 million euros for the corresponding prior year. Total revenues increased due to this rapid increase in supply and sales of our COVID-19 vaccine worldwide. As a reminder, in our COVID-19 vaccine calibrations, territories have been allocated between us, Pfizer, and Pfizer Pharma, based on marketing and distribution.

And even where we have partnered we have retained the right to co commercialize our products to major markets alongside our partners.

To close on slide 39.

We are poised to further accelerate the company's transformation as we head into the final stage of the year.

Our COVID-19 vaccine continues to be in strong demand globally, and our production network continues to deliver at scale.

Our oncology pipeline.

Is advancing on multiple fronts and we are similarly, broadening our infectious disease pipeline of novel vaccines and therapeutics behind COVID-19.

Hiring top talent continues to be a strategic priority.

And we have now expanded our team to more than 2800 employees globally.

We will continue to make investments in digital automation and manufacturing with.

With further mrna production centers planned in Singapore in Africa.

Finally, we continue to expand our global footprint across geographies, including in Europe. The U S.

Africa, and Asia, as we look to build long term value for patients our shareholders and society.

And with that we can now open up.

Thank you well now begin the question and answer session. Please press star and one I'd like to ask a question. Please limit yourself to one question per person.

Jens Holstein: A breakdown of our commercial revenues is shown on slide 13. Our third quarter 2021 commercial revenues include approximately 4.4 billion euros and, respectively, 10.2 billion euros for the first three quarters of 2021. It comprises our cross-profit share generated by our collaboration partners in their respective territories as well as sales markets.

And your first your question is from the line of Cory cause they've moved from Jpmorgan. Please go ahead.

Hey, good morning, guys. Thank you for taking my question I think I'm, starting to pretty obvious place, but on a broad level can you talk about the type of impact you see the oral anti virals Harbin on the demand for COVID-19, vaccines and boosters over both the short and long term. Thank you.

Okay.

Jens Holstein: Sales milestones included in the figure just mentioned amounted to €17 million for the third quarter and €432.8 million for the period of nine months ended September 30, 2021, similar to previous quarters. The figures for our profit share are estimated based on preliminary data shared between Pfizer and AstraZeneca and may be subject to adjustment pending final data on input parameters like shelf volume and values, as well as transparency. Any changes in our share of the collaboration partners' gross profit will be recognized for. Our COVID-19 vaccine commercial revenues in the third quarter also include 312.3 million euros in sales to our collaboration partners of products manufactured by us, and 1.4 billion euros of direct COVID-19 vaccine sales to customers in our territory, which includes Germany and Turkey. For the period of nine months ended September 30, 2021, we had sales to our collaboration partners.

I can take this question I.

I hope that you can hear me I'm Linda.

A part and that might be because the life.

So hey.

The over oral inhibitor of course provides the opportunity for treatment. If the disease is a step in the key question is indeed that.

This.

Just a couple of yourself with a reduced vaccination weight in the overall population, which we cant estimate at the moment.

We have two two to understand understand first of all that.

Hum.

How how much this or is it because they will be available in 2022.

But your percentage and they have of course to understand that that are the highest efficacy was supposed to be part it. They lost over a long time. They know what they're thinking is seamless treatments this inhibitor and <unk> CFO.

Yes.

You brought up in.

Development of assistance.

Assistance.

It's just consistent we have.

Wait and see how this this type of additional pizza, but yes. It is.

Jens Holstein: 514.3 million euros and approximately 2.6 billion euros in direct COVID-19 vaccine sales in Germany and Turkey. Now returning to slide 32 and moving to customer sales, which were estimated to be 1.2 billion euros for the third quarter of 2021 compared to 6.8 million euros for the comparative period in 2020 for the nine months ended September 30th, 2021. Total cost of sales was estimated to be around 2.3 billion euros, compared to 18.3 million euros for the comparable by AP.

It is fantastic to have now in the market.

The complement or even even.

Computers vaccines I personally don't believe that.

It's a huge impact on the on the.

Vaccination explanation of it and in future, but we have to to Monty Cook monitor the.

He is an upcoming future.

Yeah.

Okay. Thank you. Thank you. Your next question is from the line of Chris Cheap Otani of Goldman Sachs. Please go ahead.

Great. Thank you for the question regarding the outlook for the booster market. There are two important opportunities that impact the intermediate and the longer term outlook for your vaccine revenues one being booths.

Boosters for the broader adult population not just the high risk elderly and the second being what would be the potential frequency going forward longer term of subsequent boosters for instance would be annual if you look back at how this played out for the original boosters evidenced came a few months before regulators and advisory groups.

Jens Holstein: The increase was driven by cost of sales recognized with respect to our COVID-19 vaccine sales and included the share of gross profit that we owe our collaboration partner Pfizer on our Research and development expenses were €260.4 million for the third quarter of 2021, compared to €227.7 million for the comparative period in 2020. For the nine months ended September 30th, 2021, research and development expenses reached 677.7 million euros compared to 388 million euros for the corresponding prior year period.

Addressed the issue and got onboard what's your expectation for the kind of evidence and the debate and how this will play out for these two issues one the broader population for booster recommendation and two the frequency of subsequent boosters longer term. Thank you.

Yes, yes, the the value boost us boost the boost of explanations not only for the elderly but for the overall population is.

Becoming more and more evident so we have some real data.

Particularly from <unk> showing that booster vaccination.

Jens Holstein: The increase was mainly due to an increase in research and development expenses from the BNT162 program. As a reminder, development costs are shared equally between Pfizer and. The increase was further driven by an increase in wages, benefits, and social security expenses following an increase in headcount. The recognition of inventory compensation expenses as well as expenses incurred under share-based payment arrangements from the company.

The overall population can reduce dramatically the debate of infections as compared to two two.

The.

Population, who did not receive the booster vaccination in the range of 15 to 20 volt.

And we have no evidence from our CFO.

Ah kidney cotai there'll be compare the efficacy.

Scott and Scott.

Joseph a booster dose.

Jens Holstein: General and administrative expenses were 68.2 million euros for the third quarter of 2021 compared to 23.5 million euros for the comparative prior year period. For the nine months ended September 30th, 2021, general and administrative expenses reached €164.9 million, compared to €58.1 million for the comparative prior year period. Similar to R&D, the increase in GNA was driven by an increase in headcount and expenses incurred under the company's share-based payment, increased expenses for purchase, management, consulting and legal services, as well as higher insurance premiums caused by the increased, Interim income taxes were accrued in an amount of approximately 1.5 billion euros for the third quarter of 2021, and around 3.2 billion euros for the nine months ended September 30th, 2021 and were recognized using the estimated annual effective income tax rate of approximately 31%.

Uh huh.

My profession and obsessed than debt an additional boost our income.

Increases happen.

If you could see a more than 95%.

Which is in line with Ah.

And type of deal with sponsors.

Obsessed in this population and this supports the overall population, but you didn't see any differences in the elderly.

And in the younger population, indicating that boosted boost of explanation for maybe dramatically as it used to the infection rate we believe that.

Boost us ever hesitate value in an AR.

Controlling the pandemic, particularly particularly this winter.

<unk>, where we.

It has to be on the one side with the challenge that the overall population is not not.

The vaccination late it's still not sufficient.

To control the desktop Abient and fifth the increasing raining.

<unk> seen the sponsor diversity within the vaccinated population and increase increase of infection. So we clearly see that there is a scientific rationale for boosting the overall population.

Jens Holstein: For the third quarter of 2021, net profit reached approximately 3.2 billion euros compared to a net loss of 210 million euros for the comparative prior year. For the nine months ended September 30th, 2021, total net profit reached approximately 7.1 billion euros, compared to a total net loss of €351.7 million for the comparative pie period. As of September 30, 2021, cash-in-cash equivalents totaled 2.4 billion euros. Please note that the contractual settlement of the gross profit share under our COVID-19 collaboration with Pfizer has a temporal offset of more than one calendar quarter.

How this will continue next year, we don't know we have to just collect the data the of course note that despite of US is that it.

Early in the evolution.

We do we will definitely CFO.

The patients of the infection that we would see at a pace.

Patients adaptations of anti body escape variance coming in which will cause by.

Public do you require adaptation of the vaccine, but we cant say at the moment. Then this is going to happen, but boost us upcoming is it 12 months or 18 months or 24 months.

Jens Holstein: As far as the fiscal quota for subsidiaries outside the United States differs from ours, it creates an additional time lag between the recognition of revenues and the payment. Consequently, trade receivables, which were outstanding as of September 30th, 2021, were received as payments only in October 2021, improving our cash position relative to the amount at September 30th, 2021. Moving to slide 35.

Thank you.

Sure. Thank you.

Thank you. Our next question is from the line of caffeine smartphone.

Alright.

Yes.

Hey, guys good morning.

And good afternoon, just a couple of points of clarification for me.

With regards to this presentation. The first one for one of the 11 should we expect to see an upbeat on safety or will there be an update on advocacy specifically I think back in March you had provided an update on disease free survival numbers should we expect to see that updated at all.

Jens Holstein: Our outlook for the 2021 financial year has been up, based on planned deliveries of up to 2.5 billion doses in the calendar year 2021. We're providing estimated COVID-19 vaccine revenues of approximately 16 to 17 billion euros for the full 2021 financial year. This estimate reflects expected revenues from direct COVID-19 vaccine sales to customers in our territory, expected revenues from sales to our 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 partners' territory.

And then secondly for 312, I think youre going to be doing in many world for that as well. Similar question is the focus of that is going to be primarily on safety, although we get a little bit more granularity on the doses that you're using in the dose escalation portion and what kind of efficacy, but there. Thank you.

Yeah. So for 11, we have now started the phase two clinical testing.

This despite the generated data.

The earliest in 'twenty 'twenty.

Free.

From this phase two clinical trial for <unk>.

Pre one <unk> levered.

We will update on Sip see about about the clinical clinical findings of course, including the dose levels.

Jens Holstein: Please note that this figure has been estimated at constant 4. Please keep in mind that we will deliver a significant number of doses to middle and low-income countries where prices are in line with income levels or on a non-for-profit basis. We maintain our previous cost guidance for the fiscal year 2021 and expect to incur R&D expenses in a range of €950 million to €1.1 billion, reflecting a further ramp-up of R&D investments in the fourth quarter of 2021. Given our plans to expand and accelerate our pipeline development, estimated expenses are estimated to be in a range of $250 million to $300 million.

And we will certainly provide updates doing high school, a score and ethanol.

Next year.

Yeah.

Okay. Thank you.

Yeah.

Thank you. Your next question is from the line of Dana.

Weibo's of SVP Leerink. Please go ahead.

Well I think it kind of question I Wonder if you could give us an update of where you are with your partner schools in China.

On a regulatory approval and potential distribution.

Yeah.

Yeah sure I can take that one Dana.

So we have we were granted emergency use authorization in Q1 in Hong Kong, Macau, which is a first in territory and we have been distributing vaccine to that region over the course of the year. We've also signed a 15 million dose deal with Taiwan, which is also posted on commercialization territory and have commenced shipment of vaccine.

Jens Holstein: Capital expenditures for the year 2021 are expected to be in the range of $175 million to $225 million. These figures have again been estimated at constant foreign exchange rates and reflect our current base case projections. Finally, please note that we still expect an estimated annual effective income tax rate of approximately 31% for BioNTech.

And to the Taiwan territory in mainland China, we have submitted data for effectively a BLA approval and we are still waiting.

For.

Core response from from the regulator and still engage with the regulator to open up the approval pathway in mainland China.

Thank you.

Your next question is from the line of our cash to worry from Jefferies. Please go ahead.

Ryan Richardson: And with that, I turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our corporate development activities and closing remarks. Thank you. Thanks, Jens. Moving now to slide 36.

Hey, Thanks, so much just a few.

To follow up on a prior question what specifically in your feedback with the agency would you have to show to support boosters for all do you feel like the agency is focused on a drop in protection for severe Ah.

Ryan Richardson: In the third quarter, we acquired Phagomed, a biotechnology company based in Vienna, Austria. The acquisition expands our Infectious Disease Toolkit into Synthetic License, a new class of precision antibacterials, which we believe have potential to address a wide range of pathogens and also the growing global challenge of antimicrobial resistance.

Severe disease for the general population and if so what is the kind of threshold of protection that you think would support.

Support bleachers for all versus not supporting boosters for all.

And then I I consensus estimates for your Covid vaccine next year around 16 billion. So in the ballpark of what you're tracking for 2021 can you talk about how many boost your specific contract doses, you've already locked up and if replicating. The sales you had this year is a reasonable base case.

Ryan Richardson: In addition to its highly trained team, the acquisition brings us SpackleMed's licensed builder technology, a proprietary and silico therapeutics platform.

Hi.

I could take the first part of the question.

Ryan Richardson: The transaction, which closed in the third quarter, included an upfront cash payment of approximately €50 million in addition to potential future performance-based development milestones.

So.

So it's just a.

Okay Cool data convinced this is of course, the overall data package at the time point.

Ryan Richardson: of up to $100 million.

And then the when they requested access to it.

Ryan Richardson: Fagoment now operates as BioNTech R&D Austria and will serve as BioNTech's

Also this nation of the booster doses.

We had a we had data from some from anti body responses increases neutralizing antibody titers and they had we had data data coming in from some from real world data from what you're saying.

Ryan Richardson: R&D Hub for Precision Antibacterial We are pleased to add this new class of precision therapies to our

Ryan Richardson: to our infectious disease portfolio of mRNA vaccines and mRNA-encoded antibodies.

Ryan Richardson: As you can see on slide 37, we continue to expand our infectious disease capabilities and pipeline to address global health challenges. In addition to our COVID-19 and influenza vaccine programs, which are partnered with Pfizer, we now have active research and preclinical development programs against more than 10 distinct infectious diseases.

There's now an additional data package from the randomized part of it.

We are going to submit.

To further support.

Booster doses in the overall population showing a 95% more than 95% efficacy efficacy.

In in subjects, who received.

But there was a belief that the increasing level of evidence and.

Ryan Richardson: Spanning both vaccine and therapeutic approaches, several of these programs could represent accelerated development opportunities. For example, we plan to initiate first-in-human trials for our malaria and tuberculosis mRNA vaccine candidates in 2022 and look forward to

Four four.

Protection.

From deceased bye bye bye booster doses.

<unk> is an increasingly good argument.

<unk> enables the authorization of our vaccines.

The overall population.

My estimate is.

Ryan Richardson: and look forward to providing further program updates in the coming months. Slide 38 depicts our clinical stage oncology pipeline, comprising 15 programs and 19 ongoing clinical trials across four drug classes. With the new trial initiation so far this year, we now have four ongoing randomized phase two trials in oncology. We expect our pipeline to continue to broaden as we head into 2020.

Even though we see a good.

Good.

Protection against severe disease.

Even after eight nine and 10 months, we will see also for protection from severe disease and further decline, maybe an extra month, 8% and if you'll if you calculate calculate that.

Ryan Richardson: I would like to point out that even though we have strong partners for certain programs, including Roche, GenMab, and Sanofi, the majority of our programs are fully owned, and even where we have partnered, we have retained the right to co-commercialize our products in major markets alongside our partners.

Mr dose.

It could increase the overall protection against the Bdcs from 80% to 97%, 98% is a good reason to provide booster doses for the overall population. So so so we expect that the evidence that increase over the next few weeks and months.

Ryan Richardson: We close on slide 39. We are poised to further accelerate the company's transformation as we head into the final stage of the year. Our COVID-19 vaccine continues to be in...

This quick.

Lead to overall authorization of booster doses.

The broader population.

Okay.

And thank you well maybe for the second question now Kash This is <unk>.

Ryan Richardson: continues to be in strong demand globally, and our production network continues to deliver at scale.

You know that we announced that we intend to build out the capacity of production that we are able together with Pfizer.

Ryan Richardson: Our oncology pipeline is advancing on multiple fronts.

Ryan Richardson: And we are similarly broadening our infectious disease pipeline of novel vaccines and therapeutics behind COVID-19. Hiring top talent continues to be a strategic priority, and we have now expanded our team to more than 2,800 employees globally. We will continue to make investments in digital automation and manufacturing with further mRNA production centers planned in Singapore and Africa. Finally, we continue to expand our global footprint across geography.

For delivery next year to 4 billion overall in terms of guiding of what the final number for revenues will be independent of the split between booster and stand up sort of vaccination.

Bear with us until sometime early next year. Please.

Generally.

You can envisage that at this point in time, we are unable to give any split in terms of how much is booster and what what will be actually the contribution of basic vaccination. We all know that big parts of this world are still not vaccinated at all percentages are very low specifically in low and middle income countries still and therefore.

Ryan Richardson: [inaudible] Africa and Asia, as we look to build.

We have to look how things are evolving over time, and then we will add.

Ryan Richardson: as we look to build long-term value for patients, our shareholders, and society.

Sometime next year to give you an update on where we stand.

Thank you.

Your next question is from the line of Daniela Bendorf off although it would be Hey, Josh. Please go ahead.

Ryan Richardson: And with that, we can now open up.

Operator: Thank you. We'll now begin the question and answer session. Please press star and one.

Yeah. Thanks for taking my question and good afternoon.

Morning to everyone.

Operator: If you'd like to ask a question, please limit yourself to one question per person. And your first request is from the line of Corey Kazimov from J.P. Morgan. Please go ahead. Hey, good morning, guys. Thank you for taking my question. I think I'm starting in a pretty obvious place.

My question would be in general related to.

Two vaccines eventually eligible oh, so far being booster shots again some U.

Coronavirus is that something.

Very likely only limited to the mrna vaccines are do you see any.

For the.

Vaccine class potentially could.

Electrical proposed thresholds potentially also just looking beyond the third dose if that's.

It necessary at one point in time to potentially.

Private label stuff thoughts thank you.

Unknown Executive: On a broad level, can you talk about the type of impact you see oral antivirals having on the demand for COVID-19 vaccines and boosters over both the short and long term? Thank you.

I didn't get the question could you could you specify your question the countries themselves. Yes. So in simple terms, whether it be just mrna vaccines being electrical for being booster shot.

Unknown Executive: I can take this question. I hope you can hear me. I'm at the airport, and there might be background noise.

Are there any new developments.

Ah patients talk to other vaccines, which would also make them.

Likely that.

But you picked up a booster shot.

Unknown Executive: So oral inhibitors, of course, provide the opportunity for treatment if the disease is established. The key question is indeed whether this will come with a reduced vaccination rate in the overall population, which we can't estimate at the moment. We have to understand, first of all, how much oral inhibitors will be available in 2022, at which percentage rate. And we have, of course, to understand whether the high efficacy which was reported will last for a longer time.

Yeah, we can't comment on other vaccines, but I don't see see any any fundamental reason why it should not be eligible for Paul booster booster.

Don't see it as a base.

Based of course on that.

The ability of data and evidence that they provide a good risk benefit profile.

Okay. Thank you.

Yeah.

Thank you. Your next question is from the line of.

Arlinda Lee from Canaccord. Please go ahead.

Unknown Executive: We know that single treatments with inhibitors in viral disease often result in the development of resistance. And we have to wait and see how this type of additional treatment, which is fantastic to have now on the market, will complement or even compete with vaccines. I personally don't believe that this will have a huge impact on the vaccination rate in the future. But we have to monitor the field in the near future.

Hi, guys. Thanks for taking my question.

Yes.

What's your commitment to equitable access in certain price points during the pandemic, how do you think about pricing and access them.

In terms of boosters.

<unk>.

Pricing for the <unk>.

Children's doses that maybe 110th and one third of.

The original adult dose.

And then potentially argue.

Out of the pandemic. Thanks al Thank you.

Okay.

I'll take that one.

I think that they are with the middle income 11 come constraints as we made some of the pandemic.

You still have to consider.

One of those countries.

Operator: Okay.

Operator: Thank you. Your next question is from the line of Chris Shibutani of Goldman Sachs. Please go ahead. Great; thank you for the question. Regarding the outlook for the booster market, there are two important opportunities that impact the intermediate and the longer-term outlook for your vaccine revenues, one being boosters for the broader adult population, not just the high-risk or elderly, and the second being what would be the potential frequency going forward for subsequent boosters, for instance, what would be annual. If we look back at how this played out for the original boosters, the evidence came a few months before regulators and the advisory groups.

And that will be.

Our consideration in how we calculate.

Our future.

And then the price with the pediatric.

Again, I think you'll have to look good.

Have to look at it from a value perspective.

And are not a straight reduction in underground so what programs.

Kick.

In terms of in terms of some.

Yeah.

The price that we.

We would consider.

But again I would say that that will.

Certainly.

And then price and of course, where we're currently working on that we're still pretty much in the pandemic.

Yeah.

Okay.

Thank you and our last question today is from the line of Ivy Marathon from UBS. Please go ahead.

Unknown Executive: What's your expectation for the kind of evidence and the debate and how this will play out for these two issues, one for the broader population?

Hey, guys. Thanks, so much for taking my question I just have your business development strategy going forward I guess it after the fact in that.

Unknown Executive: for Booster Recommendations, and two, the frequency of subsequent boosters over the longer term.

Acquisition should we expect to see.

More deals of that sort and I guess going forward are there particular therapeutic areas or modalities that you are looking at most closely are that you think kind of center guys best with your platform and pipeline currently thanks.

Unknown Executive: and Bruce's longer term goals. Thank you.

Unknown Executive: Yes, the value of booster vaccinations, not only for the elderly but for the overall population, is becoming more and more evident. So we have real-world data, particularly from Israel, showing that booster vaccinations in the overall population can reduce dramatically the rate of infections as compared to the population who did not receive the booster vaccination by a range of 15 to 20-fold. And we now have evidence from our phase 3 clinical trial where we compared the efficacy of a third dose, of a booster dose, in a randomized fashion and observed that an additional booster dose had a relative efficacy of more than 95 percent, which is in line with the strong antibody responses that we observed in this population.

Yeah I can take that question. Thank you.

So yeah, I think you've seen us do two acquisitions. This year the first the acquisition of.

The solid tumor assets from kite.

TCR assets and cell therapy manufacturing facility in the nine states and then.

Now you've seen the cycle about acquisition and I do think you can expect to see more of these types of deals.

And our our key criteria will be to broaden our technology base.

The saga med into to new classes of medicines that are complementary to our pipeline.

But also potentially clinical stage programs.

Unknown Executive: And this was the overall population; we didn't see any differences in the elderly and in the younger population, indicating that booster vaccinations really dramatically reduced the infection rate. We believe that boosters have great value in controlling the pandemic, particularly this winter, where we have to deal, on the one side, with the challenge that the overall population is not, and the vaccination rate is still not sufficient to control the Delta variant. And with the increasing waning of vaccine responses, we will also see an increase in infections in the vaccinated population.

In our core therapeutic areas and by that I would include oncology and infectious disease is two key areas of focus.

Okay.

Thank you.

There are no further questions. Please continue.

Thank you.

With that we would like to close the call today. Thank you for joining today's call and we're looking forward to talking to you in future. Thank you.

That concludes the presentation today. Thank you for participating you may disconnect.

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Unknown Executive: So we clearly see that there is a scientific rationale for boosting the overall population. But how this will continue next year, we don't know. We have just collected data. We, of course, know that this virus is relatively early in the evolution, and we will definitely see further adaptations of the infection rate; we will see adaptations of antibody escape variants coming in, which will require, which will probably require, adaptation of the vaccine. But we can't say at the moment when this is going to happen, whether boosters are coming every 12 months or every 18 months or 24 months. Thank you. [inaudible]

Okay.

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Operator: Okay, guys, good morning and good afternoon. I just have a couple of points of clarification for you.

Yes.

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Operator: with regard to the sixty presentations. The first one for

Operator: 111. Should we expect to see an update on safety, or will there be an update on efficacy soon?

Operator: Specifically, I think back in March you provided an update on the disease pre-survival numbers. Should we expect to see that update?

Operator: [inaudible]

Operator: Escalation Portion, and what kind of advocacy you can expect there. Thank you.

Operator: Thank you.

Unknown Executive: Yes, so for 1.11, we have now started the Phase II clinical testing, and this trial will generate data earliest in 2023 from the Phase II clinical trial. For 3.12, we will update on CITSI about the clinical findings, of course, including the dose levels, and we will certainly provide updates during ASCO and ESMO next year.

Operator: Okay, thank you. Thank you. Your next question is from the line of Daina Graybosch of SVB Alluring. Please go ahead. Hi, thank you for the question. I wonder if you could give us an update of where you are with your partner, Fosun, in China on a regular basis.

Operator: on Regulatory Approval and Potential Distribution.

Unknown Executive: Yeah, sure, I can take that one, Daina. So we were granted emergency use authorization in Q1 in Hong Kong and Macau, which is a Fosun territory, and we've been distributing the vaccine to that region over the course of the year. We've also signed a 15 million dose deal with Taiwan, which is also a Fosun commercialization territory, and have commenced shipment of the vaccine to Taiwan. In mainland China, we have submitted data for effectively a BLA approval, and we are still waiting for a response from the regulator and are still engaging with the regulator to open up the approval pathway in mainland China. Thank you. Your next question is from the line of Akash Tewari from Jefferies. Please go ahead. Hey, thanks so much.

Operator: Hey, thanks so much. Just a few. To follow up on a prior question, what specifically in your feedback with the agency would you have to show to support Boosters for All? Do you feel like the agency is focused on a drop in protection for severe diseases for the general population? And if so, what kind of threshold of protection do you think would support Boosters for All versus not supporting Boosters for All?

Yes.

Okay.

Operator: And then consensus estimates for your COVID vaccine next year are around $16 billion. So in the ballpark of what you're tracking for 2021, can you talk about how many Boosters specific contract doses you've already locked up? And if replicating the sales you had this year is a reasonable base case? Thanks.

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Thanks.

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Unknown Executive: I could take the first part of the question. So what regulators convince us is, of course, the overall data package. At the time point when we requested authorization of the booster doses, we had data from antibody responses, increased neutralizing antibody status, and data coming in from real world data from Israel. We now have an additional data package from the randomized trials, which we are going to submit to further support booster doses in the overall population, showing a 95 percent, more than 95 percent, efficacy, relative efficacy, in subjects who received a third dose.

Okay.

Yes.

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Okay.

Unknown Executive: We believe that the increasing level of evidence for protection from disease by booster doses is an increasingly good argument to enable authorization of our vaccines in the overall population. My estimate is that even though we see good protection against severe disease, even after 8, 9, and 10 months, we will see a further decline, maybe in the direction of 80 percent. And if you calculate that a booster dose could increase overall protection against severe disease from 80 percent to 97 or 98 percent, it's a good reason to provide booster doses for the overall population.

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Unknown Executive: So we expect that the evidence will increase over the next few weeks and months and that this could lead to overall authorization of booster doses for the broader population. And thank you, Ugur, perhaps for the second question. Akash, this is Jens.

Yes.

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Okay.

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Jens Holstein: You know that we announced that we intend to build up the capacity of production that we are able, together with Pfizer, to deliver next year to $4 billion. Overall, in terms of guidance of what the final number for revenues will be, independent now of the split between booster and standard sorts of vaccination, you have got to bear with us until sometime early next year, please. Generally, you can imagine that at this point in time, we're unable to give any split in terms of how much is a booster and what will actually be the contribution of basic vaccination. We all know that large parts of this world are still not vaccinated at all. Percentages are very low, specifically in low and middle income countries.

Okay.

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Operator: And therefore, you know, we have to look how things are evolving over time, and then we will sometime next year give you an update on where we stand. Your next question is from the line of Daniel Wendorf of Odo BHS. Please go ahead. Thanks for taking the time...

Okay.

Okay.

Yes.

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Hey.

Operator: Thanks for taking my question and good afternoon or good morning to everyone. My question would be, in general, related to vaccines eventually eligible for being booster shots against the new coronavirus. Is that something very likely only limited to the MRA vaccines, or do you see any kind of other vaccine class potentially being eligible for booster shots, potentially also looking beyond the third dose if it is necessary at one point in time to potentially have regular booster shots?

Okay.

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Operator: I didn't understand the question; could you please specify your question again, please? I'm sorry.

Operator: Yes, so in simple terms, will it be just the mRNA vaccine? illegible for Are there any new developments, other patients to other vaccines, which would also make them likely? Yeah, we can't comment on other vaccines, but I don't see any formal reason why other vaccines should not be eligible for booster doses. It will be based, of course, on the availability of data and evidence that they provide a good risk-benefit profile. Thank you. Your next question is from the line of... Arlinda Lee from CannaCode. Please go ahead.

Okay.

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Operator: Hi guys, thanks for taking my questions.

Operator: With your commitment to equitable access and certain price points during the pandemic, how do you think about pricing and access in terms of boosters? Pricing for children's doses that may be one-tenth and one-third of the original adult dose, and then potentially emerging out of the pandemic control. Thank you.

Okay.

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Unknown Executive: I'll take that one. I think with the middle income and low income countries, as we live out of the pandemic, you still have to consider what those countries can pay. And that will be a consideration in how we calculate a future X pandemic price. With the pediatric vaccine, again, I think you have to look at it from a value perspective and not a straight reduction in milligrams or micrograms per kick in terms of the price that we would consider. Again, I would say that there will certainly be an ex-pandemic price, and of course, we're currently working on that. We're still very much in the pandemic.

Okay.

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Yes.

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Operator: Thank you. And our last question today is from the line of Elie Merle from UBS. Please go ahead.

Operator: Hey guys, thanks so much for taking the question. Just about the business development strategy going forward, I guess, just after the Fagomed acquisition, should we expect to see more deals of that sort? And I guess going forward, are there particular therapeutic areas or modalities that you're looking at most closely or that you think kind of synergize best with your platform and pipeline currently? Thanks. Yeah, I can take that question. Thank you.

Okay.

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Ryan Richardson: So yeah, I think you've seen us do two acquisitions this year. The first was the acquisition of the solid tumor assets from KITE, the TCR assets, and cell therapy manufacturing facility in the United States. And now you've seen the Phagomet acquisition, and I do think you can expect to see more of these types of deals. And our key criteria will be to broaden our technology base, as with Phagomet, into new classes of medicines that I think are complementary to our pipeline but also potentially clinical stage programs in our core therapeutic areas. And by that, I would include oncology and infectious disease as two key areas of focus.

Sure.

Okay.

Yeah.

Yes.

Okay.

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Operator: infectious disease as two key areas of focus.

Operator: There are no further questions; please continue. Thank you. So with that, we would like to close the call today. Thank you for joining today's call, and we are looking forward to talking to you in the future. Thank you. That concludes my presentation today. Thank you for participating. You may disconnect. Thanks for watching!

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