Q1 2021 BioNTech SE Earnings Call

[music].

Thank you for standing by and welcome to the buy in Texas quota of 2021 update call at.

Operator: Standing by, and welcome to the BioNTech First Quarter 2021 update call. At this time, all participants are in a listen-only mode.

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

Operator: There will be a presentation followed by a question and answer session. To ask a question during the session, you will need to press star and one on your telephone. If you require any further assistance, please press star and zero.

That would be of presentation, followed by a question answer session.

To ask a question during the session you will need the press star and one on your telephone.

Quite any further assistance please press star zero.

Operator: I must advise you this call is being recorded today, Monday the 10th of May 2021. And I would now like to hand the call over to the Vice President, Investor Relations and Strategy, Silke Maats. Please go ahead.

I must advise you the coldest being the quota today Monday, the 10th of May of 2021.

And I would now like to hand, the call over to the Vice President Investor Relations and strategy. So we'll come on please go ahead.

Good morning, and good afternoon. Thank you for joining us today to review buying trucks for the 2021 operation with brokers and financial the thoughts before we start we encourage you to few of the slides for this webcast is one of the separation of financial results Press release issued this morning, both of which are accessible on.

Silke Maats: Good morning and good afternoon. Thank you for joining us today to review BioNTech's first quarter 2021 operational progress and financial results. Before we start, we encourage you to view the slides for this webcast, as well as the operational and financial results of the press release issued this morning, both of which are accessible on our website in the Investing section. As shown on slide two, during today's presentation, we will be making several forward-looking statements.

Our web site in the investors section.

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 biotech supports to combat COVID-19 the cause.

Deliberation between biotech and part of the regarding our COVID-19 vaccine our expectations regarding the potential characteristics of if he wants it to be to our ongoing trials and arent in commercial use based on data observations to date, including real world data of Cabot.

Silke Maats: These forward-looking statements include but are not limited to BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer regarding a COVID-19 vaccine; and our expectations regarding the potential characteristics of BNT162b2 in our ongoing trials and or in commercial use based on data observations to date, including real world data gathered.

The ability of B a T. He wants it to be too to prevent COVID-19 caused by emerging virus variants.

Pick the time point for additional read all of it on.

On drive data of BNP once it gets to be too in on where we can drive the timing for submission of data for or received any marketing approval of merchants, who use authorization of.

Contemplated the shipping and storage plant, including the SD.

The entire Nemo, how does get paid for what we began to find out that the ability of biotech to supply of the quantities of being 162 to support clinical development and if approved market demand.

Our production estimates some targets for 2021 and 'twenty 'twenty two.

The planned next steps in our pipeline programs, and specifically, including but not limited to statements regarding plans to initiate clinical trials.

A lot of product candidates all of expansion in South East Asia.

Expectations for data announcements with respect for our clinical trials of current estimated COVID-19 vaccine revenue based on current contract for supply.

Silke Maats: The ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants, the expected time point for additional readout, trial data of BNT162b2 in ongoing trials, and timing for submission of data for or receipt of any marketing approval or emergency use authorization. Our Contemplated Shipping and Storage Plan, including our Estimates and Targets for 2021 and 2022 and the ability of BioNTech to supply the quantities of BNT-162 to support clinical development and, if approved, market demand, including our Production Estimates and Targets for 2021 and 2022.

Like order of projected expenses capital expenditures and tax rate for 2021 of.

We're talking to vaccine production capacity for 2021 of 22, Oh quoted vaccine revenue, which are subject to numerous estimates as more fully described in our report.

On form 20-F, and quarterly report for the free months ended March.

So I think the <unk> 2021 and all of which is described in our filings made with the U S Securities and Exchange Commission, including our most recent and we'll report on form 20-F.

Actual results could differ from those we currently anticipate.

Therefore cautioned not to place undue reliance on any forward looking statements, which speak only as of today shut you on today.

She had to day during this conference call and webcast.

Okay.

Also please note that's like three provides detailed in the important safety information regarding our recently launched the COVID-19 vaccine.

Like for.

On the clock from Biotechs management today, we'd be Zhang our Chief Executive Officer, and co founder of <unk>.

And then to get you all of our Chief Medical Officer, and cofounder draw on merit or chief business and commercial off the table.

Putting a lot of cheap financing and operating off of something.

And Brian Richardson for what.

Chief strategy Officer.

I now hand, the call over to resign biotechs C E O.

Good morning, and good afternoon, and thank you for everybody on joining the call today.

I'm delighted to discuss of our continued progress in the first quarter.

Leaving us well positioned to achieve the my store.

The plan for this year and beyond.

Slide five.

During our last quarterly update only six weeks ago, the details by on picks confirmation.

The fully integrated biopharmaceutical company because.

It's been a remarkable timeframe.

That's the most of the challenge of a global pandemic.

Yes, they talk to our vision of upon I think the full potential of the immune system.

The overcomes the teleport the Kevin just off the day bye.

Combining excellent in the on auto sheet.

You know what type of technology.

For our core competence.

And what sorts of effects.

Over the last decade the.

Got it take up all of the second person you got up in the past of course I'm on it.

The COVID-19.

The success of its become the foundation of our exciting and ambitious Johnny to church of treatment paradigm.

Silke Maats: The planned next steps in our pipeline programs, specifically including but not limited to statements regarding plans to initiate clinical trials for our product candidates or expansion in Southeast Asia; expectations for data announcements with respect to our clinical trials; and our current estimated COVID-19 vaccine revenues based on current contracts. Supply orders, our projected expenses, capital expenditures, and tax rate for 2021, or target vaccine production capacity for 2021 and 2022. Our quoted vaccine revenues, which are subject to numerous estimates, as more fully described in our annual report on Form 20-F and quarterly report for the three months ended March 31st, 2021, and our risk, as described in our findings made with the U.S. Securities and Exchange Commission, including our most recent annual report on Form The actual results could differ from those we currently anticipate.

That range area.

From a hopeless popped on with more than plenty of product can be debt.

The oncology.

Purchase the thesis.

Beyond the flex the ambition.

We are in the.

And that's quite unique position to strategically invest cash flow from all of COVID-19 vaccine into the debt maturing the company the Debra multiple products on ship over the next price here.

The slide six.

Our global goal is to build the 21st century immunotherapy powerhouse.

Trust me, we continue to increase our global footprint.

The office the Bill.

On our subsidiary in the United States.

It includes our commercial substance of it in Germany, and Turkey on.

For your generous headquarter in Singapore.

He will discuss later on the car.

Second we are expanding our integrated infrastructure for cross that your investments in scientific and technological innovation.

This is in the heart of thing we do.

It is investment spending clinical commercial manufacturing extra income.

Moving digital capabilities.

The support future for that long.

Our success is driven by people.

For a cracking on retaining top talent remains a crucial imperative for us.

Lastly, we see a tremendous opportunity as the advance our robust pipeline and infectious diseases and oncology and expand to new tower for the area.

Extra nugget, the thought of X gene revenue.

Oh of pipeline currently consists of 14 products.

The ongoing clinical costs.

Building on compelling data.

The price to initiate multiple potentially registrational studies in first in human costs in 2021.

Oh of dynamic in which in turn are on D.

Yeah.

Where do you complement that with the protected in licensing.

Slide seven.

Slide seven highlights key achievements since our last update on March.

Yes.

With respect to all of our oncology pipeline.

Closet pre first in human oncology costs and some of the incentive one.

These include two sets of a piece of namely BMT 211, our Capex program from BNP to plenty of run on most of them, yeah antigen targeting T cell therapy.

The fact is that what's the card will start to kind of program featuring an optimized in total in two of value.

That's been the detail of getting programs and have your marks.

With respect to our COVID-19 vaccine I remain the lives by the exception the excellence of our team along with our partner Pfizer of exhibited.

Silke Maats: You are therefore cautioned not to place undue reliance on any forward-looking statements which speak only as of today, shared during today's meeting, and shared to date during this conference call and webinar. Also, please note that slide three provides detailed and important safety information regarding our recently launched COVID-19 vaccine. Flight 4.

The day, we did.

But more than 450 million doses of our of COVID-19 vaccine.

91 countries until it's always bad right.

What's on the 'twenty one the number of contact the doses has increased to about one 8 billion.

The contracts in place for 'twenty, 'twenty, two and beyond.

The last week, we announced together with the Pfizer the signing of a memorandum of understanding with the international Olympic committed for donate doses of our COVID-19 vaccine prep vaccinate upbeat on the.

Their dedication.

Silke Maats: On the call from BioNTech's management today will be Ugur Sahin, our Chief Executive Officer and Co-Founder, Ozlem Tureci, our Chief Medical Officer and Co-Founder, John Merritt, our Chief Business and Commercial Officer, and our Chief Financial Officer for Rating, and Ryan Richardson. I now hand the call over to Ugur Sahin, BioNTech's CEO. Good morning and good afternoon, and thank you to everyone joining the call

It's the picking in the Olympic and Paralympic Olympic Games, which are scheduled to take place in Tokyo in July of 2021.

The strong execution across our entire organization, along with all of partner Pfizer debt to the right.

Mission of 2 billion and COVID-19 vaccine revenues in our so that's part of of course.

19 commercialization.

Our COVID-19 vaccine continues to demonstrate what was the kidney code of besides.

Since our last call with the close whereas the significant positive clinical updates, including top line of sight from our credit card the confirm type of efficacy that no serious safety concerns with the up to six months following the second dose.

And this and that is the 920.

Seven consumption at the cases of COVID-19.

The empty around on the 50 to be to the most crazy 90 of 1.3.

3% vaccine efficacy.

The vaccine was 100% effective in preventing the vlccs.

Ugur Sahin: I'm delighted to discuss our continued progress in the third quarter, leaving us well positioned to achieve the milestones we have planned for this year and beyond. I'm glad to be part of it. During our last quarterly update, only six weeks ago, we detailed BioNTech's transformation into a fully integrated biopharmaceutical company within a remarkable timeframe as it rose to the challenge of a global pandemic. We have stayed true to our vision of harnessing the full potential of the immune system to overcome the therapeutic challenges of today by combining excellence in immunology and innovative technology.

But the U S C D E and 95, 3% effective in preventing the W. E T.

As defined by the FDA.

The data also showed the vaccine was highly effective at preventing COVID-19 cases in South Africa. The B run free of five one minute is prevalent.

We anticipate publication in peer reviewed journals and plan to submit the <unk>.

That's the regulator in the.

The upcoming weeks.

We also announced positive top line data of our U S people for the study of <unk> 2260 Aguilar expense.

That's true yes.

And yes of age.

We're creating 100% efficacy in participants this all of this out.

The cost of two infections.

The antibodies in the system to be to cause that celebrated the.

Quickly on Immunogenicity of the stuff.

Two of neutralizing antibody type of one month after the second dose.

We remain focused on six key lever to expand our COVID-19 vaccine each.

You see the order number.

The other main focus on six key let us take a part of our COVID-19 vaccine of age globally.

Cost of funds Democrat demographics as shown on slide eight.

Ugur Sahin: Our core competences and resources acquired over the last decade were validated by our success in developing the first approved mRNA vaccine against COVID-19. This success has become the foundation of our exciting and ambitious journey to change treatment paradigms in a range of disease areas.

We are now targeting the manufacturing capacity to reach up to a free billion doses by the end of 2021 and more than 6 billion goes and kind of different it too.

The first shipments from a module facility, but the day that mitigates the if the.

The market the accomplishment for biotech manufacturing scale up.

In Singapore, we plan to accept the agent or the headquarter that will also include the highly automated end to end on the manufacturing facility.

Ugur Sahin: Our robust pipeline with more than 20 product candidates addressing oncology and infectious diseases and beyond reflects this ambition. We are in, in a quite unique position to strategically invest cash flow from our COVID-19 vaccine into further maturing the company to deliver multiple product launches over the next five years. Our global goal is to build a 21st century immunotherapy powerhouse. First, we continue to increase our global footprint with new offices beyond our subsidiary in the United States.

We continue to broaden our vaccine labor, we expect to hear back from the FDA on our application for expanded emergency use authorization follow of COVID-19 vaccine to include individuals theft of the 15 years of age.

Do you also expect feedback from EMA on our stock.

At the David expansion for this the same age of Coke is going on.

Last week of Canada has all the talk ask the youth BMT the.

It would help the antibody to be taught in that age group for already.

Ongoing targets include the Globus two of free and has the.

As the price of women.

The study in children six to.

Six months to 11 years of age we expect to announce safety data from those studies in the third and fourth quarter.

Plenty of them.

We are determined to contribute to the vaccine excess globally and the of X gene has been approved for emergency our tempo of yours or kind of conditional market, the marketing authorization and more than 70 countries and regions, including emergency use lifting from the W. H R.

Ugur Sahin: This includes our commercial subsidiary in Germany, in Turkey, and plant regional headquarters in Singapore, which we will discuss later in the call. Second, we are expanding our integrated infrastructure for strategic investment in scientific and technological innovation. This is at the heart of everything we do.

And generally.

In addition, I want to highlight that the regulatory submission for mainland China is now underway in collaboration with our partner fossil.

The board and decentralized vaccine except the.

Initiated the or all of the biologic license application in the United States for the antibody the Mississippi to be to you.

For the approval of all of the extent and countries. The regulatory submissions have been made an emergency use authorization or equivalent are currently in place.

Ugur Sahin: These investments, spanning clinical, commercial, manufacturing, excellence, including digital capabilities, will support future product launches. Our success is driven by people. Therefore, attracting and retaining top talent remains a crucial imperative for us. Lastly, we see a tremendous opportunity as we advance our robust pipeline in infectious diseases and oncology and expand to new therapeutic areas. Accelerator Power Vaccine Revenue Our pipeline currently consists of 14 products and 15 ongoing clinical trials. Building on compelling data, we are poised to initiate multiple potentially registrational studies and test in human trials in 2021. Our dynamic and rich internal R&D efforts will be complemented by strategic in-licensing. Slide seven.

Both the SBA and have updated our labor the two big storage and transport at minus five to minus 50.

The decrease.

Recently, we have net.

The stability data for the FTE to broaden our labor to standard that's of Great Joe right. It sounds like that means to the pace of south of the well up to four weeks. We are also developing ready to use and biosimilar formulation the impulse channel stability profile.

Dependency on coach at the Cross section.

We have initiated a types of evaluate IOP lives and ready to use formulations with data expect expect it in the.

The quarter.

A lot understanding of the cost to is evolving of new data generation and the understand that immunity may wane over time and debt new variance of much but I do believe the boost the rarity of high value to it.

For the music we.

We do not know yet then how frequently.

Will it be needed.

Also the current you know evidenced it's an adaptation of our current vaccine against any of the circulate in the guidance necessary and the continued to monitor of weird the efficacy against the emerging variant.

However, you want to learn and pre Emptively prepare today for a response path the case growth.

Both of the grain of deprecation there'll be the.

Quiet in future.

Black Knight.

So this and we have to develop a comprehensive credit that she that use of the stuff.

African barrier is the prototype for potentially emerging tour of Cape.

Ugur Sahin: That's seven key achievements since our last update on March 3rd. With respect to our oncology pipeline, we have started pre-stress in human oncology trials in 2021. These include two cell therapies, namely BNT211, our CARB-X program, and BNT221, our neostim neoantigen targeting T-cell therapy. The third is our third tribocytokine program featuring an optimized interleukin-2 variant. These are some of the details and programs in her reminder.

In subjects, who have been vaccinated with two doses of the antibody to be to be of value.

Dose of either the antibodies to be two of the BMT.

The two south African.

The price, but also in all of group of PMT from 60 to be to not each participant.

The six two doses of the antibody to be too tough ethic of variance for us.

The data will inform us about safety. In addition, the boost the post the ability of the immune response and effect of the additional boost us on immunity against the circulating live with potential new emerging desktop to value.

The data expected from the second quarter of incentive on.

This effort will also provide the blueprint for how this time regulatory path day in pet.

Pet from correct of the manufacturing process for each future of Valeant.

I will now turn over to Sean to provide an update on our COVID-19, the order book and manufacturing based on Sean.

Ugur Sahin: With respect to our COVID-19 vaccine, I remain delighted by the exceptional excellence of our team, along with our partner Pfizer, has exhibited. To date, we've delivered more than 450 million doses of our COVID vaccine to 91 countries and territories worldwide. For 2021, the number of contracted doses has increased to about 1.8 million. The third contract is in place for 2022 and beyond.

Thank you Hugo.

Great to be with everyone today.

Moving to slide 10 for an update on the distribution progressive of vaccine.

We now have contracted orders for approximately $1 8 billion doses from 2021.

Which includes increased orders from the EU and U K and the number of developing countries.

Multi year contracts with two 'twenty 'twenty, two and beyond the being negotiated with the number of countries around the world.

Demonstrating that there will be Kim on for a vaccine in the post pandemic market.

We have reached an agreement with these routes of supply millions of doses from 'twenty to 'twenty two.

Ugur Sahin: Last week, we announced, together with Pfizer, the signing of a memorandum of understanding with the International Olympic Committee to donate doses of our COVID-19 vaccine to vaccinate athletes and their delegations participating in the Olympic and Paralympic Games, which are scheduled to take place in Tokyo in July 2021. The strong execution across our entire organization, along with our partner Pfizer, led to the recognition of $2 billion in COVID-19 vaccine revenues in our first quarter of commercialization.

With the candidate the supply up to 125 million doses in 2022, and 2023 for the options to supply up to 60 million of additional doses in 2024.

We look forward to the expanding supply to additional geographies beyond those shown here.

Turning our attention to slide the lesson.

We are aiming to increase our supply capacity to up to 3 billion doses in 2021.

And we expect to be able to manufacture more than 3 billion doses in 2022.

This increase was driven by the critical need the remains of many parts of the growth requiring access to vaccine supply as well as vaccinations.

Looking at beyond Texas manufacturing networks, I would like to point out of the beyond Texas manufactured Bolton 50%.

Ugur Sahin: Our COVID-19 vaccine continues to demonstrate robust clinical results. In our last call, we disclosed two additional significant positive clinical updates, including top-line results from our phase 3 trial that confirmed high efficacy with no serious safety concerns up to six months following the second dose. In this analysis, 910.. seven confirmed symptomatic cases of COVID-19.

Of the drug substance rolled out to date.

Wide.

Marburg facility has made significant progress.

Many of the established M O and any manufacturing at the Mt. The shot in less than six months.

<unk> image of the approval of the manufacturing of our COVID-19 vaccine product at the facility.

In late March.

As Hugo noted the first batches of vaccines on the Opex side with delivered the mid April.

Which is truly a remarkable achievement.

With the mob bedside fully operational the Olympics of annual vaccine manufacturing capacity will be approximately 1 billion doses on an annual run rate right.

Ugur Sahin: BNT162b2 demonstrated 91.3% vaccine efficacy. The vaccine was 100% effective in preventing severe disease as defined by the U.S. CDC and 95.3% effective in preventing severe disease as defined by the FDA. The data also showed the vaccine was highly effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalent. We anticipate publication in peer-reviewed journals and plan to submit this data to regulators in the coming weeks. We also announced positive topline data from our U.S. pivotal study of 2,260 adolescents 12 to 15 years of age, demonstrating 100% efficacy in participants with or without triaxial COS2 impact. The anti-162B2 was well-tolerated, demonstrated strong immunogenicity, and thus cost two neutralizing antibody titers one month after the second dose.

Beyond the COVID-19, this launch in house manufacturing capability position us for future success with additional pipeline products the VA.

Anticipate launching in the coming years.

I'll now turn the call over to us of them to provide an update on our oncology.

The line.

Thank you Sean.

Let me pull that and provide updates on selected immuno oncology programs, which have recently advanced in clinical stage, all for which we expect the reached significant milestones. This year just shy of a D cats on the other programs. Please refer to our annual report, which was filed with the.

U S Securities Exchange Commission on March 5th Keith and all of our quarterly update which where the fires with the FCC today.

But on the Niobrara impact of COVID-19 pandemic on our clinical operations, we expect to present, several datasets and initiate marketing you try it sites.

Slide 14 provides a snapshot of a lot of immuno oncology platforms.

The distinct drug classes of our pipeline covers a broad range of immune therapy approaches that leverage power for the mechanisms of action and the diverse arie of novel targets to address the unique molecular signature of each patients tumor.

We believe that tie on this thing complementary modes of action increases the likelihood of therapeutic success and on Lux of larger potential market.

Combination trp's of trucks that work Synergistically on X.

Hector to be particularly useful for fear of P of resistant tumor types for which the Cmos of.

The chemotherapy and targeted approaches has shaped.

All of our platforms are being developed to address these limitations and provide the pipeline of potentially combine of the product, which complimentary and the with complementary and synergistic immune modular Terry modes of action kind of.

For Kovack is one of our opportunities already in clinical testing. It combines all of six sick immune of Europe with our another car T therapies.

From a pipeline highlights several of our product candidates with the port.

Ugur Sahin: We remain focused on six key levels to expand our COVID-19 vaccine reach globally and across different demographics, as shown on slide 8. We are now targeting a manufacturing capacity of up to 3 billion doses by the end of 2021 and more than 3 billion doses in 2022. The first shipments from our Marburg facility were delivered in April, a remarkable accomplishment for BioNTech manufacturing to scale up. In Singapore, we plan to establish a regional headquarters that will also include highly automated end-to-end mRNA manufacturing facilities.

Ken Funston of just the combinations that are currently in clinical trials.

Oh on most advanced oncology programs, including upcoming near term milestones as shown on slide 14.

For all of <unk> product candidates TMT 111 in PMT one for Jean.

We expect to start phase two trials chewing BMT 111 for the treatment of advanced melanoma and details for of our mentality.

Yeah on tier one for a team a lot of mrna vaccine encoding <unk> seven proteins of human Papilloma virus 16, where the evaluated in combination with Penn broadly from the floors as temporary relief from not alone as the first line treatment in patients with Unresectable recurrent.

On metastatic HPV 16 positive head and neck squamous cell carcinoma, expressing PD out of one.

For the BMT 122 of our odds of genes of whom Iran for individuals individualized neo antigen specific immunotherapy partner with Roche Genentech.

Phase two trial in first line treatment of metastatic melanoma and for phase one basket trial in solid tumors remain ongoing based on promising data I've seen for I missed we decided to move into the adjuvant treatment settings, starting with colorectal cancer.

The slow enrollment caused by the ongoing pandemic, we are updating our guidance and expect to dose. The first patient in the second half of this year and the randomized phase two trial evaluating the on Q1, 'twenty, two and fluctuating tumor DNA positive subject to the of research.

Ugur Sahin: We continue to broaden our vaccine labor. We expect to hear back shortly from the FDA on our application for expanded emergency use authorization for our COVID-19 vaccine to include individuals 12 to 15 years of age. We also expect feedback from EMA on our submitted label expansion for the same age group. As announced last week, Canada has already authorized the USBNT, the use of BNT1 and CC2B2 in that age group already.

Debt stage, two high risk of stage III colorectal cancer patients together with Genentech, we are evaluating other options for treating early stage cancer patients with P&G won 22 of.

Tenders of on next generation checkpoint immune modulator program, which is part of that question that week.

To provide the data update in the second half of 2021 for the ongoing phase one two of Trier of PMT free 11, which targets PDL, one and for one BP. We remain very encouraged by very tight seem to date and believes the product has significant for.

Ugur Sahin: Ongoing trials include a global phase 2 trial in healthy pregnant women and a study in children six to, six months to 11 years of age. We expect to announce safety data from those studies in the third and fourth quarters of 2021. We are determined to contribute to vaccine access globally, and our vaccine has been approved for emergency or temporary use or granted conditional marketing authorizations in more than 70 countries and regions, including emergency use, lifting from the WHO in January. In addition, I would highlight that the regulatory submission from Mainland China is now underway in collaboration with our partners.

10 show the cross Mike you pay the oncology indications given the unmet need for improved checkpoint Immunotherapies. We also plan to present data on the second half of 2021 from the ongoing phase one two trial of P&G free trials, which is of which conditionality.

Target CD 40 and for one BP.

Slide 15 provides an overview of our next wave oncology assets, including six programs across four different technology platforms that have the potential to advance innovation beyond current boundaries.

Of these six highly innovative programs.

In preclinical stage.

Luxurious kovack product candidate has entered clinical testing and we will be presenting first 30 day trial for BNP to 11.

The ongoing Kim 2021, he came on.

Also of the first product from our Nielsen Tcs ERP program the empty to 'twenty. One has entered clinical testing. The first patient was dosed in the phase one trial in April.

Ugur Sahin: For broad and decentralized vaccine access, we initiated the rolling biologic license application in the United States for BNT1 and S62B2. We will seek full approval of our vaccine in countries where regulatory submissions have been made and emergency use authorization or equivalents are currently in place. Both the FDA and EMA have updated our label with two-week storage and transport at minus 25 to minus 50 Celsius degrees. Recently, we have submitted new stability data to the FDA to broaden our label to standard refrigerator temperature, that means 2 to 8 degrees of Celsius for up to 4 weeks.

I discussed both have the CRP programs in greater detail shortly on.

Last quarter of course, we also noticed that for PMT 151 of our first rivals cytokine programs and coding of modified.

I have two the first patient was dosed in the phase one trial in solid tumors in February the phase one trial of the N. T 152 P. M. T 150 free of lot of IL two IL seven the rival type of kind of combination in multiple solid tumors is expected to us.

The starts this year.

It's all phase one trials in multiple solid tumor for.

PMT 141 M. P M to 142 of our first drive them up from.

Moving to slide 16.

Got it.

Second product candidate BMT 111 were soon be advancing into a randomized phase two trial of this intravenous next scene in coats of six sets of for cancer specific antigen.

Expressed in the O I M on apex backbone optimized for Immunogenicity and then there's the instead of live up to an hour hour and a life of Opex formulation before.

The floor injections and coated and be on tier 111 of common to about 95 per cent of all of melanoma patients patient.

As previously published in nature, the empty 111, and one of your repeat and even more so in combination with anti PD. One has shown promising data in C. P. I experienced patients with advanced melanoma and all of his one try and hold on.

Ugur Sahin: We are also developing ready-to-use and biofuelized formulations with improved thermo-stability profiles to reduce dependency on cold-changing processes. We have initiated a trial to evaluate a lyophilized and ready-to-use formulation, with data expected in the third quarter. Our understanding of SARS-CoV-2 is evolving as new data is generated, and we understand that immunity may wane over time and that new variants emerge. But I do believe a booster will be of high value to establish polymerity.

The safety gear of the objective responses and in a checkpoint inhibitor of experience experienced patients with the value of the disease at baseline and high magnitude and persistent PD for N. CDA T cell responses have been observed we believe that these.

The strong positive data for.

Right compelling support for advancement of the N T 111 in combination with anti PD one into a phase two of study and the high medical need set the namely patients with anti PD, one refractory or relapsed unresectable stage, three or four of melanoma.

Just blow the study is the collaboration with Regeneron and as outlined on slide 1700, 20 patients where the randomized two to one to one into free treatment arms evaluating the N Q1, 11, plus Regeneron for me came up and each drug test on one of Europe's the primary end.

Ugur Sahin: We do not know yet how frequently this will be needed. Also, there is currently no evidence that an adaptation of our current vaccine against any of the circulating variants is necessary, and we continue to monitor real-world efficacy against emerging variants. However, we want to learn and preemptively prepare today to respond fast in case a third dose of strain adaptation will be required in the future. Like, Comment, Share, and Subscribe.

Point is overall response rate and the BMT 111, plus the new pick them up on now.

Now moving to slide eight.

PMT to 11 aspire on tech first to make of stage chimeric antigen receptor of product candidate.

<unk> 211 targets that you must specific antigen Claude and six and was developed in combination with the car T cell amplifying RNA vaccine shot kovack in preclinical studies.

In those studies, we demonstrated that kovack treatment the heaps.

For NV for expansion of Adaptively transferred Kaki said recycling and increased persistence and the theory of functionality.

The ante to 11 is expected to overcome car T cell therapy of limitations that kantar.

Efficacy in patients with solid tumors and fast limit widespread use of car T cell therapies.

<unk> six is the target antigen for BB&T to 11, and an ideal candidate for the car T therapy due to its absence and has the adult of tissues and the frequent expression and high medical need cancer the <unk>.

Ugur Sahin: To this end, we have developed a comprehensive strategy that uses the South African variant as a prototype for potentially emerging tool escape. In subjects who have been vaccinated with two doses of BNT162b2, we evaluated a third dose of either BNT162b2 or the BNT162b2 South African variant. The trial will also enroll a group of BNT162b2 naive participants who will receive two doses of the BNT162b2 South African variant vaccine. The data will inform us about safety and additional boosters, boostability of the immune response, and the effect of these additional boosters on immunity against the circulating virus and potential new emerging SARS-CoV-2 variants. First data is expected in the second quarter of 2021.

Boeing phase one two trials its current D of recruiting patients with COVID-19 and sixth positive relapsed or refractory advanced solid tumors, such as the Varian testicular lung gastric and endometrial cancer slide.

Slide 19 shows for the trial design of the first in human Phase one two trial of BMT 211, evaluating the safety and efficacy of increasing dose levels of Claudius six car T. It says first with all of it and then with coffee.

We have completed the dose a dose level one of them one of Europe's he with free patients and the <unk>.

Next dose level is open for clearance why the initial phase one data from this trial is expected in the second half of this year. We are presenting some very early data from the trial, that's the ongoing Kim 2021 and your conference.

Slide 20 shows the preliminary Mary data from the first dose cohort with free patients that were treated with the starting dose of Claude in fixed Kaki said in one of Europes the underlying diseases of the ovarian carcinoma sarcoma and testicular carcinoma all heavily pre.

Reach it to date, we have not of so observed any ex huge toxicities or dose limiting toxicities in these patients all observed tourists events for a transient and mild to moderate we are very excited to report for them and that is the self taught in six car T cell magnitude in peripheral.

The large reserve detectable car T cells with car T and graft meant and all patients had he says it.

Shunt one declined after two weeks for patient free of 90 fold expansion of what's seen car T sets of patients to expand it further reaching of 700 for expansion and just stay there plateau from day 24 on awards from our shrink rate shrinkage was of search.

Ugur Sahin: This effort will also provide a blueprint for a trial design, regulatory pathway, and platform, and Tess Tomkarek of the manufacturing process for each future variant. I will now turn over to Sean to provide an update on our COVID-19 order book and manufacturing status.

For the patient with 11% to 38% reductions into our free target lesions the sick.

Six weeks after him off the car T cell transfer.

So while early the initial data from the trial are very encouraging and we look forward to presenting additional data in the second half of free yes.

Sean: Thank you, Ugur. It's great to be with everyone today. Moving to slide 10, for an update on the distribution progress of our vaccine, we now have contracted orders for approximately 1.8 billion doses in 2021, which includes increased orders from the EU and UK and a number of developing countries. Multi-year contracts for 2022 and beyond are being negotiated with a number of countries around the world, demonstrating that there will be demand for our vaccine in the post-pandemic market.

Moving to slide 21.

I'm excited to discuss our night on your skin.

Q2, 'twenty one program <unk> to 'twenty, one is a fully personalized neo antigen targeted adoptive T cell therapy can be candidate consisting of T cells targeting the most pure of pure takes the irrelevant new antigens from each patient's tumor we believe PMT to 'twenty one.

The first several significant advantages as compared to the kids Europe's but he says all derived from the patients on peripheral blood, which is advantageous with respect to accessibility since tumor acquisition may be limited cash European approach is typically rely on the existing T cell repertoire.

The repertoire in the tumor center, we use for a wreck on bio informatics platform to select for the most therapeutically relevant neo antigen specific to each patient. We then custom menu of picture on new antigen peptides for each patient, which are used to activate and expand from there.

Sean: We have reached an agreement with Israel to supply millions of doses in 2022 and with Canada to supply up to 125 million doses in 2022 and 2023, with options to supply up to 60 million additional doses in 2024. We look forward to expanding supply to additional geographies beyond those shown here. Now, turning our attention to slide 11.

The antigen specific T cells, recognizing patient specific new antigens ex vivo.

He said responses from both the net if repertoire in the memory compartment or expanded this for us and C D for and CDA T cells against multiple tumor specific targets, reducing the risk of antigen escape and off target toxicity, the ante to 'twenty, one induced the T cell culture day.

Cause of nice autologous patient tumor material, providing strong support for all our approach.

And the adoptive T cell therapy approaches are supported by high dose and you can too to facilitate the grafman BMT two of 21 does not require Iowa true, providing an important advantage in terms of product safety and tolerability.

Sean: We are aiming to increase our supply capacity to up to 3 billion doses in 2021, and we expect to be able to manufacture more than 3 billion doses in 2022. This increase was driven by the critical need that remains in many parts of the world, requiring access to vaccine supply as well as vaccination. Looking at BioNTech's manufacturing network, I would like to point out that BioNTech has manufactured more than 50% of the drug substance rolled out to date worldwide. Our Marburg facility has made significant progress.

We believe this approach has potential to drive a robust and persistent anti tumor response with improved safety and reduced the antigen escape.

On Oh for other therapies in April of 2021 the first patient was dosed in the first in human phase one dose escalation trial in metastatic melanoma refractory are unresponsive to checkpoint inhibitors.

With this I will now hand, the call over to debt to provide an update on our financials.

Thank you for asking them.

I will summarize our financial results for the first quarter of 2021 as shown on slide 23.

I will start with the total revenues, which were estimated to be $2 $48 4 million euros for the first quarter of 2021 compared to $27 7 billion euros for the first quarter of 2020.

Sean: We have established MRNA manufacturing at the Marlberg site in less than six months.

Sean: less than six months, including EMA's approval of the manufacturing of our COVID-19 vaccine product at the facility. Enlightenment. As Ugur noted, the first batches of vaccine from the Marburg site were delivered in mid-April, which is truly a remarkable achievement. With the Marburg site fully operational, BioNTech's annual vaccine manufacturing capacity will be approximately 1 billion doses at an annual runway rate. Beyond COVID-19, this large in-house manufacturing capability positions us for future success with additional pipeline products that we anticipate launching in the coming year. I now turn the call over to Ozlem to provide an update on our oncology pipeline. Thank you, Sean.

Total revenues increased due to rapidly increasing the supply of our COVID-19 vaccine worldwide.

As a reminder.

COVID-19 collaborations territories being allocated between the us Pfizer and Fosun pharma based on marketing and distribution rights.

A breakdown of our commercial revenues as shown on slide 24 of them.

First quarter 2021, commercial revenues, including the amount of 1700 51.9 billion euros, comprising our share of gross profit from COVID-19 vaccine sales in the collaboration partners territory, which represents a net figure.

Well as to the milestones.

This figure is estimated based on preliminary data showed between the Pfizer in the us and may be subject to adjustments as we receive final data on input parameters like sales of transfer prices.

Changes in our share of the collaboration partners gross profit would be recognized prospectively.

Our COVID-19 vaccine commercial revenues also include $63 9 billion euros in sales through our collaboration partners of products manufactured by Us and $199 8 billion of direct COVID-19 sales.

Two customers in our territory.

Now returning back to slide 23 of moving to cost of sales, which were estimated to be 233 point of 1 billion euros for the first quarter of 2021 compared to $5 9 billion for the first quarter of 2020. The increase was driven by the estimate of $223 2 million euros.

Ozlem Tureci: I will provide updates on selected immune oncology programs which have recently advanced to the clinical stage or for which we expect to reach significant milestones this year. For further details on other programs, please refer to our annual report which was filed with the U.S. Securities and Exchange Commission on March 13th and our quarterly update, which will be filed with the SEC today. Despite the undeniable impact of the COVID-19 pandemic on our clinical operations, we expect to present several data sets and initiate multiple new trials.

Cost of sales, which were recognized with respect to our COVID-19 vaccine sales and include Pfizer's share of gross profit for us.

R&D expenses were 216 for 2 million euros for the first quarter of 2021 compared to $65 1 million euros for the comparable period in 2020 of.

The increase was primarily due to an increase of the R&D expenses related to our BNP. Once the two program recorded as purchased services versus with respect to the expenses, which were initially incurred by Pfizer and sex of the country charged to us on the older collaboration agreement.

As a reminder.

Ozlem Tureci: Slide 13 provides a snapshot of our immune oncology platforms across distinct drug classes. Our pipeline covers a broad range of immune therapy approaches that leverage powerful mechanisms of action and a diverse array of novel targets to address the unique molecular signature of each patient's tumor. We believe that harnessing complementary modes of action increases the likelihood of therapeutic success and unlocks a larger potential market; combination therapies of drugs that work synergistically are expected to be particularly useful for therapy-resistant tumor types for which chemotherapy and targeted approaches have failed. Our platforms are being developed to address these limitations and provide a pipeline of potentially combinable products with complementary and synergistic immune modulatory modes of action. Carvec is one of our opportunities already in clinical testing.

Of course of shared equally between the two companies.

The increase was further driven by an increase in wages benefits of social security expenses from increasing head count and the recognition of expenses incurred on the new share based payment arrangements.

G&A expenses were $38 9 million euros for the first quarter of 2021 compared to 15.8 million euros for the comparable periods in 2020.

The increase was mainly due to the higher expenses for professional services and increase in wages benefits and social security expenses from increased headcounts.

The recognition of expenses incurred under the new share based payment arrangements as well as higher towards the premiums.

Interim income taxes were 514 for 2 million euros for the first quarter of 2021 airport recognized using the estimated annual effective income tax rate off of <unk>.

Proximately 31 per cent.

Okay.

For the first quarter of 2021 net profit was 1001 of the $28 1 million euros compared to of 53 4 million euros. The net loss for the first quarter of 2020.

As of March 31, 2021, cash and cash equivalents totaled $891 5 billion euros.

Moving to slide 25.

We remain on track to achieve our 2021 financial outlook.

Based on the current contracted supply orders of approximately $1 8 billion doses. We are providing estimated COVID-19 vaccine revenues to buy on pick of approximately $12 4 billion euros.

This estimate reflects the expected revenues from direct COVID-19 vaccine sales to customers in all the territories expected revenues from sales of our collaboration partners expected milestone payments from our collaboration partners and expected revenues relates to all of our sales gross profit from the COVID-19 vaccine sales in the collaboration partners carry.

Ozlem Tureci: It combines our FIXVAC immunotherapy with our novel CAR-TP. Our pipeline highlights several other product candidates with the potential for synergistic combinations that are currently in clinical trials. Our most advanced oncology programs, including upcoming near-term milestones, are shown on slide 14. For our FIXAC product candidates, BNT111 and BNT113, we expect to start phase two trials soon. BNT111 is for the treatment of advanced melanoma, and I will detail it further momentarily. BNT113, our mRNA vaccine encoding the E6 and E7 proteins of human papillomavirus-16, will be evaluated in combination with pembrolizumab versus pembrolizumab alone as a first-line treatment in patients with unreflectable recurrent or metastatic HPV-16 positive head and neck squamous cell carcinoma expressed in PD-L1.

Of course.

We expect additional revenues related to serve the supply contracts for deliveries in 'twenty two the one with first contract in place for 2022 and beyond.

In terms of guidance for the full year 2021, we expect R&D expenses to recur in the range of 750 million euros eight.

850 million euros for the full year, 'twenty, 'twenty, one, reflecting the or explorations to broaden and accelerate our pipeline development, which we plan to ramp up, especially the second half of 2021.

SG&A expenses are estimated to increase to up to 200 million euros.

Capital expenditures for the year 'twenty to 'twenty, one of our expected to be in the range of 175 million to 225 million euros.

And I would like to emphasize that all of these figures reflect our current base case projections.

Finally, please note that in terms of full year 2021 tax impact we still expect the German tax group corporate tax of approximately 31%.

And with that I turn the call to Ryan for an update on the corporate development activities and concluding remarks.

Share turning to slide 27, we continue to expand our geographic footprint on the first quarter. In addition to establishing the subsidiary in Turkey to commercialize our COVID-19 vaccine. We are pleased to announce today plans to expand our footprint to Asia with the establishment of our regional headquarters for Southeast Asia and Singapore.

The plan to establish a fully integrated mrna manufacturing facility in Singapore It will be.

Be equipped to produce a range of novel mrna vaccines and therapeutics for regional and even global supply and add resiliency to our global supply network.

Ozlem Tureci: For BNT122, our autogenes, the Wumeran for individualized neoantigen-specific immunotherapy partnered with Roche Genentech. The phase two trial in first-line treatment of metastatic melanoma and the phase one basket trial in solid tumors remain ongoing. Based on promising data seen for INEST, we decided to move into adjuvant treatment settings starting with colorectal.

Based on our current plans in partnership with the government of Singapore facility will also form part of the rapid response capability for southeast Asia to address future potential pandemic threats.

Pending the necessary regulatory approvals, we plan to initiate construction of the manufacturing facility in 2021 and expect the site could be operations as early as 2023.

So with this planned expansion, we expect to have boots on the ground in Asia Pacific by the end of this year building on our existing footprint in Europe, the United States on Turkey.

Slide 20 highlights our expected pipeline milestones for the remainder of 2021.

Ozlem Tureci: Due to slow enrollment caused by the ongoing pandemic, we are updating our guidance and expect to dose the first patient in the second half of this year in a randomized phase two trial, evaluating BNT1-22 and circulating tumor DNA positive, surgically resected stage two high-risk or stage three colorectal cancer patients. Together with Genentech, we are evaluating other options for treating early stage cancer patients with BNT1-22. Then there is our Next Generation Checkpoint Immune Modulator program, which is partnered with GenMaps.

The start of the year, we have initiated three first in human clinical trials on oncology and we expect to initiate three more before the end of the year.

We remain on track to start three potentially registrational phase II trials with our wholly owned fixed back and IMS programs. This year.

And infectious diseases the into 161 of our seasonal flu vaccine program partnered with Pfizer is expected to enter a phase one clinical trial on third quarter of 2021.

Moving multiple other programs towards the clinic and plan to provide further updates on our infectious disease pipeline throughout the year.

Finally, we expect data updates on up to five different programs in 2021, including our next generation checkpoint modulators, BNP 311, and <unk> 312 in the second half of the year.

Ozlem Tureci: We expect to provide a data update in the second half of 2021 for the ongoing Phase I-II trial of BNT pre-11, which targets PD-L1 and 4-1BB. We remain very encouraged by the results seen to date and believe this product has significant potential across multiple oncology indications, given the unmet need for improved checkpoint immunotherapy. We also plan to present data in the second half of 2021 from the ongoing Phase I-II trial of BNT312, which conditionally targets CD40 and 4-1B.

Turning to a few closing remarks on the next slide we remain focused on ramping up supply of our COVID-19 vaccine with the goal of Vaccinating more than 1 billion people this year and potentially even more in 2022.

We believe we have a responsibility to support large quantities of on vaccine throughout the world, including to the developing world and are working hard to make that happen.

In parallel for executing against COVID-19.

We will accelerate our pipeline development in our core therapeutic areas of immuno oncology and infectious diseases, we intend to advance.

Advanced mrna vaccines against the range of pathogens building on our non active preclinical programs.

We will provide more details on some of these exciting programs over the course of this year.

Finally, we intend to ramp up of investment in our clinical commercial and manufacturing infrastructure and teams as we transform by on tagging on to a global biopharmaceutical company and prepare to bring next generation of immunotherapy the people around the world.

And with that I'll conclude our presentation and hope the open up the call for questions.

Thank you as a reminder to ask the question you will need to press star one on your telephone and wait for the name to be announced please try to keep to one question per person to its truly a question Keith pressed the pounds of Husky. Once again that is star one if you wish to ask the question.

Ozlem Tureci: Slide 15 provides an overview of our Next Wave Oncology Assets, including six programs across four different technology platforms that have the potential to advance innovation beyond current boundaries. Three of these six highly innovative programs are in the preclinical stage.

And your first question comes from the line of Cory <unk> from J P. Morgan. Please go ahead. Your line is open.

Ozlem Tureci: Our first CARB-ACT product candidate has entered clinical testing, and we will be presenting first early data for BNT2-11 at the ongoing KIMT 2021 meet. Also, the first product from our Neostim T-Cell therapy program, DNT221, has entered clinical testing, and the first patient was dosed in a phase one trial in April. I will discuss both health therapy programs in greater detail shortly.

Hey, good morning, guys. Thank you for taking my question I will stick to one I'm curious like what you. Your views are on all of the controversy last week on the patent waiver frightened and kind of what do you see as the potential impact here for beyond Tech and kind of next steps you're waiting to hear on on on this topic. Thank you.

Yeah, Yeah, I can take the question.

Hi, Colby. Thanks, Thanks for the test and so on so first of all of course, we understand the importance of global distribution of all of XC.

And let me just shortly summarize the status quo, which we have at the moment, we have delivered our vaccine two of them more than 90 countries.

Ozlem Tureci: On last quarter's call, we also noted that for BNT151, our first ribocytokine program, encoding a modified IL-2, the first patient was dosed in a phase one trial in solid tumors in February. A phase one trial of BNT152, and BNT153, our IL-2, IL-7 ribocytokine combination in multiple solid tumors is expected to also start this year. SR phase 1 trials in multiple solid tumors for BNT-141 and BNT-142, our first riboMAP probe. Moving to slide six.

And so.

So far and the continued to support.

The global supply.

Including the lower and middle income countries. So our capacity of our initial capacity for 2021.

Loss in the range of 1.3 billion doses the.

Now skewed.

The minus section of capacity up to.

3 billion doses in 'twenty, 'twenty, one and more than 40% of the stores. The is expected to go to mid and low income countries.

The only near term solution and that we see is there is really to ensure.

Debt the debt the produce from the existing net sucks increase our existing manufacturing network and ensure that the vaccines they could produce and the euro.

The states and in Europe, and it can be continuously get the but let's go to the low income countries and waiving of.

Ozlem Tureci: Our lead FIXVAC product candidate BNT111 will soon be advancing into a randomized phase 2 trial. This intravenous vaccine encodes a fixed set of four cancer-specific antigens expressed in our mRNA backbone, optimized for immunogenicity, and delivered in our RNA-LipoPack formula. The four antigens encoded in BNT1-11 are common to about 95% of all melanoma patients. As previously published in Nature, BNT1-11 monotherapy and, even more so, in combination with N-Type PD-1 has shown promising data in CPI-experienced patients with advanced melanoma in our Phase I patients.

At the IP.

What's not increased chart on medium term supply of the vaccine.

So of the hedging of the manufacturing process is complex.

It will take at least one year and not even more.

The two set up a new manufacturing in the doughnut see any of value in invade the persons.

We are at the discussed this morning.

Already expanding our manufacturing networks from Europe also to Asia.

We are setting up manufacturing in Singapore, and then also the income implement manufacturing in our JV.

In China, and we believe together with the with the other.

The other vaccines vaccines effort of us.

And in the next nine to 12 months, there will be more than enough vaccine put to use and there's absolutely no need for safe and patents.

Okay. Thank you very much bigger of a lot more questions for you, but I'll stick to the one and hop back in queue. Thank you.

Thank you. Your next question comes from <unk> Ahmad from Bank of America. Please go ahead. Your line is open.

Hi, there good morning, Thanks for taking my question.

For me I wanted to just ask a little bit more about the booster and Uber or are you thinking that the the booster for the a bunch of a formulation that you had been factored for the Wuhan variant would be sufficient.

Ozlem Tureci: Tolerable Safety, Durable Objective Responses in Checkpoint Inhibitor Experienced Patients with Evaluable Disease at Baseline, and High-Magnitude and Persistent CD4 and CD8 T-cell Responses have been observed. We believe that these strong positive data provide compelling support for advancement of BNT1-11 in combination with N-Type PD-1 into a phase two study in a high medical need setting, namely patients with N- This global study is a collaboration with Regeneron and is outlined on slide 7.

For future protection or do you think that the rate of.

Change of each of the variance with necessitate any kind of change to the for the actual vaccine itself and if it's the if it's the latter of if you do have the modify the vaccine.

All of us in any way does that change your rate of production plans for for the need of boosters you know starting let's say next year on beyond thank you.

Yeah.

Yeah excellent cash and so at the moment of vitamin C and the need for changing our vaccine.

As you as you know the has done in the in the last six months of value.

Is it more than more than 30 different.

Savi in for.

And evaluated in.

In the English points of anti body of the points Intuit's device type of vaccines for the new authorization in B C and D C for the most navient.

Almost almost equal the tonnage.

Station that's in the meantime, also the yoga data for the activity of our vaccine for example against the U K variant that's all of them.

Ozlem Tureci: 120 patients will be randomized 2-to-1-to-1 into three treatment arms evaluating BNT1-11 plus Regeneron, Samiclimab, and each drug as a monoferop. The primary endpoint is overall response rate in the BNT111 plus semiplumab arm. Now moving to slide eight.

More than 90% and are in the East Bay area of the data.

Almost 19, 90% from gear of the data from Qatar and the have also seen the us last Friday of the public.

Patients in a show me the data from Qatar.

Showing that our vaccine and vaccine is able also to prevent infection PCR consent infection instead of.

With the 75 per cent of effectiveness they have all of them all.

The scene in our level of until the next time and debt increasing the north organization of the anti bodies tied the Toyota and I am the size also an increase of neutralizing antibody titer and almost no on the no authorization of the anti body type of test.

And against like something South of ethics and Valeant.

At the moment, we don't see any of the eastern.

The adapt our vaccine, but we have working on on establishing establishing of process and and debate on the SME framed up by executing a blueprint tie to ensure debt and the potential change to our debt to a new variant.

Ozlem Tureci: BNT211 is BioNTech's first clinical stage chimeric antigen receptor product candidate. NT2-11 targets the tumor-specific antigen Claudine 6 and was developed in combination with a CAR T-cell amplifying RNA vaccine, short CARVEC, in preclinical studies. In those studies, we demonstrated that CARVAC treatment leads to in vivo expansion of adoptively transferred CAR-T cells, resulting in increased persistence and superior functionality. BNT211 is expected to overcome CAR T-Cell therapy limitations that hamper efficacy in patients with solid tumors and thus limit the widespread use of CAR T-Cell therapy. Claudine 6 is the target antigen for BNT2-11 and an ideal candidate for Kikati cell therapy due to its absence in healthy adult tissues and its frequent expression in high-medical-need patients.

On the impact M S.

Aside from you can see at the moment.

Just the DNA template without changing any of the at a pull system an infection point that appears to be absolutely of all.

Sure.

For all kinds of Fabienne.

It means that means from the habit decision the patient for a new new Valeant you can just change the change the DNA template and without losing any production capacity come up with the supply of the.

The more value and vaccine.

Okay. Thank you.

Thank you and your next question comes from Dana Great Bush from SVP Leerink. Please go ahead. Your line is open.

Hi, Thanks for the question, it's a follow up on right on the conversation you just had I've given this a really impressive real world effectiveness against the 1351 I think you mentioned in Qatar was 75%.

Wondering how you plan to select between the for different booster strategies that you currently have in the clinic.

Do you think that you can't get of differentiate and predictive signal on Immunogenicity data or is that decision kind of require a larger outcomes trial.

Hi, Dana.

So it's the the the clinical tie that debt to the debt. We have to farming is really evaluating evaluating different questions. On one question is unquestioned.

Ozlem Tureci: The ongoing Phase 1-2 trial is currently recruiting patients with Claudine 6 positive, relapsed, or refractory advanced solid tumors, such as ovarian, testicular, lung, gastric, and endometrial. Slide 19 shows the trial design of the first in-human Phase I-II trial of BNT211, evaluating the safety and efficacy of increasing dose levels of Claudine-6 CAR-T cells, first We have completed dose level one of a monotherapy arm with three patients, and the next dose level is open for clearance.

Of what are what is the immune response that debt, we get if the use of my.

The local supposed to and this will be of course analyzed against the virus types of cranes, but also against our near term debt debt debt, Chris That's the answer the question that I've seen the booster.

Improving also the other sponsor against the Valeant and then we have success and debt that a.

Boost of vaccine with the variant is EBIT to produce.

The valley and specific immune responses and the and we will analyze and allies debt again, evaluating biotech and Fabienne Cyrus.

The virus neutralization of the SaaS and then the the last question. The last question is the debt.

The debt of Valeant.

The explanation that the valeant in the east subjects.

Deal with this and deal with this.

Values specific immune responses and the free.

One day as we have seen with the vaccination of the right type of naive subjects.

The different types of craft since some of success since our scientific and address the also also future future adaptation protects the strategies some on more pragmatic.

<unk> just a change of all of the of all the next scene vaccine and providing the regulatory framework.

Sorry, just a quick follow up on that so when you have all of this immunogenicity data against the wild type of invariant, what's the regulatory path just the one that has the best neutralization of the profile you go forward.

Ozlem Tureci: While the initial phase one data from this trial is expected in the second half of this year, we are presenting some very early data from the trial at the ongoing KIMT 2021 annual conference. Slide 20 shows preliminary data from the first dose cohort with three patients that were treated with the starting dose of Claudine 6-Cartefelmonoferib. The underlying diseases were ovarian carcinoma, sarcoma, and testicular carcinoma, all heavily pretreated. To date, we have not observed any acute toxicities or dose-limiting toxicities in these patients. All observed adverse events were transient and mild to moderate.

No it's Jeff.

On the regulatory path and see the enabling and anything of flexible response.

So yeah. So the price is not not in the sense of decision making the.

If the.

It has two objectives on objective is really providing the regulatory path.

To enable an EBIT of based on a on a non in south of you always hear on that as this debt our debt a very and vaccine can be can be can be established.

I need it and that's the one and the second is the set of scientific question that I, just add up the way it.

Very helpful. Thanks.

Okay.

Thank you. Your next question comes from Daniel Wendorff from Commerzbank. Please go ahead. Your line is open.

Yes, hi, good afternoon on.

Good morning, everyone and thanks for taking my question.

I would have lots of follow up question on the potential of the regularity of course the shots.

Ozlem Tureci: We are very excited to report that an analysis of Claudine-6 CAR T-cell magnitude in peripheral blood revealed detectable CAR T-cells with CAR T engraftment in all patients, although CAR T-cells in patient one declined after two weeks. For patient three, a 90-fold expansion was seen. However, the CAR T-cells of patient two expanded further, reaching a 700-fold expansion and a stable plateau from day 24 onwards. Tumor shrinkage was observed in this patient, with 11 to 38% reductions in two or three target lesions.

To be given looking into 2022 2023, and you mentioned already if you contract with customers, having just been fine for you.

Can you kind of at all.

How do you think the boost.

Explanation of campaign would look like would it be thought.

She is the lead people then I'm receiving the booster shots again would it be more younger people.

In order to establish a certain level of people wanted to the amongst the younger generation tool.

And he idea of views you have currently on this topic would be much appreciated. Thank you.

Sure sure I can take this question on the these questions about about prioritization and concrete roll out of the potential boost the campaign the.

The success of genes are we as a vaccine developer and manufacturer cannot decide piece of policy question center have to be decided by the respective regulatory authorities all of them.

Ozlem Tureci: Six weeks after the CAR T-cell transplant. So, while early, the initial data from the trial are very encouraging, and we look forward to presenting additional data in the second half of the year. Moving to slide 21.

With regard tools, a necessity of foodstuffs shirts, we believe and why do we believe that booths the shots worthy of high volume to re establish for immunity and it looks like the also expanded against of emerging very.

Yes, we do not know yet when and how frequently we do just on Egypt on the upcoming data from follow up of immune responses and also the real world data are regarding protection.

Ozlem Tureci: I'm excited to discuss our NeoSTEM BNT221 program. BNT221 is a fully personalized neoantigen-targeted adoptive T-cell therapy candidate consisting of T-cells targeting the most therapeutically relevant neoantigens from each patient's tumor. We believe BNT221 offers several significant advantages as compared to TELL therapy.

And from a us about this.

Okay. Thank you.

Thank you. Your next question comes from cash to Ari from Wolfe Research. Please go ahead. Your line is open.

Hi, This is the name of for our cash we have one.

The question regarding about the governance.

Of note Tls bought the laser so kind of that low T O kind of compare of bio tax outbound kind of two casino tech transfer of information such as I don't disclose the inflammation of trade secrets outside of the published patent. Thank you.

Ozlem Tureci: The T-cells are derived from the patient's own peripheral blood, which is advantageous with respect to accessibility since tumor acquisition may be limited. Whereas European approaches typically rely on existing T-cell repertoires in the tumor, we use the RACN bioinformatics platform to select the most therapeutically relevant neoantigens specific to each patient. We then custom manufacture neoantigen peptides for each patient, which are used to activate and expand neoantigen-specific T-cells recognizing patient-specific neoantigens ex vivo.

Ryan can you take this question.

Sure.

As I understood. It the question was.

Can the WTO compelled manufacturers to release information.

Beyond the patent is that the question.

Yes.

Yeah, Yeah, I think it's too.

I think it's a little bit premature to two of them to try to pinpoint precisely what the.

A hypothetical resolution may or may not include.

And thank all of our position on on the on the resolution was mentioned earlier by Uber and on that as the IP.

IP is the is an important part of of boats.

Dietary asset for buying check it's something that we've spent over a decade of investment has gone into our IP portfolio.

Ozlem Tureci: T-cell responses from both the nave repertoire and the memory compartment are expanded, resulting in CD4 and CD8 T-cells against multiple tumor-specific targets, reducing the risk of antigen escape and off-target toxicity. BNT221-induced T-cell cultures directly recognize autologous patient tumor material, providing strong support for our approach. Many adoptive T-cell therapy approaches are supported by high-dose interleukin-2 to facilitate engraftment. BNT221 does not require IL-2, providing an important advantage in terms of product safety and tolerability.

But we don't believe that it's the bottleneck to them too.

Two accelerating production or supply of our vaccine to the world and actually.

When you look at our global supply network that we already have assembled at <unk>.

<unk> actually 15 different production nodes.

In that network. So we've already taken great steps to cut to try to.

Expand our supply footprint on both sides of the Atlantic and now with the next steps announced today into Asia. So.

That would be my response.

For the question, but I think it's a little bit of a little bit early to tell how this will help us for quite low.

Thank you.

Yeah.

Thank you. Your next question comes from Arlinda Lee from Canaccord. Please go ahead. Your line is open.

Hi, guys. Thanks for taking my question.

I was wondering on the.

On your comments on becoming a fully integrated global net immunotherapy company.

Areas of emerging therapeutics like you'd be interested in you had to pay for recently on auto immune disease.

Disease can you maybe talk about that a little bit. Thank you.

Okay.

So yeah I.

Hi.

This is a more general question because of the direction, which we which we are addressing this.

Ozlem Tureci: We believe this approach has the potential to drive a robust and persistent anti-tumor response with improved safety and reduced antigen escape over other therapies. In April 2021, the first patient was dosed in a first in human phase one dose escalation trial in metastatic melanoma, refractory or unresponsive to checkpoint. With this, I will now hand the call over to Zirk to provide an update on our finances. Thank you

I'm on a development so in the last two years, we have shown debt and debt.

Or am I on a vaccine.

Technology platforms allow us to develop.

Classic of that cancer vaccines personalized cancer vaccine.

We have now a pull from that review.

M on the vaccine to stimulate costs he says the debt.

That's the first step from the cancer vaccine for the two of the code the T cell space.

It definitely has shown that the M. On the vaccines can be used or stored in preclinical setting tool and the Elliot autoimmune disease. The emphasis this is for sure.

The the address in the next year.

It translates for support.

All of the out using <unk> to deliver kind of a party proteins.

A state that we have knowledge of the test.

Zirk: I will summarize our financial results for the first quarter of 2021, as shown on slide 23. I will start with total revenues, which were estimated to be €2048.4 million for the first quarter of 2021, compared to €27.7 million for the first quarter of 2020. Total revenues increased due to rapidly increasing the supply of our COVID-19 vaccine worldwide, as a reminder, under our COVID-19 collaboration.

M on it and call that cytokine molecule in clinical testing.

More cuts, okay and on the type of kind of in our pipeline.

The half a M on it and core debt anti bodies, which of it to include the anti bodies et cetera by specific antibody with that means our clinical Scott already per day cover a number of of our of Oh from a theoretical molecule.

The molecules to be delivered by the army and we've assessed the expanded debt and we're certainly also for store.

Correct.

The accelerate the clinical development of some of the smaller growth towards the market.

Thank you.

Thank you. Your next question comes from Sheetrock shoe from Bad debt. Please go ahead. Your line is open.

Hi.

Thank you for taking my questions I'd like to ask about the flu vaccine youre going to move forward in the clinical trial with Pfizer I was wondering what kind of does the.

Zirk: [inaudible]

Zirk: and us, Pfizer and Fosun Pharma, based on marketing and distribution rights. A breakdown of our commercial revenues is shown on slide 24. Our first quarter 2021 commercial revenues include an amount of €1,751.9 million, comprising our share of gross profit from COVID-19 vaccine sales in the collaboration partners.

Mrna construct on is that.

I recall in 2017 published the South Kent for refining.

Hi.

That's the amplifying mrna version in the preclinical study.

And related to that Oh, do you plan to share results getting yourselves amplifying our Colgate vaccine and then but it is also test the increase the one trial thanks very much.

Much.

Yes. Thank you. Thank you for the question, we have not yet the closed which a specific vaccine platform and from that mrna for them that weighted the news.

And on the of cooperative development also of flu vaccine together with a size that with regards to all of the how about platforms. We are working on for example for the self amplifying our vaccine platform.

Zirk: Collaboration Partners Collaboratory, which represents a net figure as well as sales milestones. This figure is estimated based on preliminary data shared between Pfizer and us and may be subject to adjustments as we receive final data on input parameters like sales and transfer prices. Changes in our share of the Collaboration Partners Gross Profit would be recognized prospectively.

That was the data sometime next year, which we will disclose from our ongoing assessment of its also clinical assessments.

Thank you.

Thank you we will now take on last question and this comes from the line of Simon Baker from Redburn. Please go ahead. Your line is open.

Thank you for taking my question on the P&L on if I may please.

Two part of I am, especially for the gross margin were there any distorting factors.

In the gross margin this quarter relates to previously expense for inventory always thought of good run rate for the rest of the year.

Zirk: Our COVID-19 vaccine commercial revenues also include €63.9 million in sales to our collaboration partners of products manufactured by us and €199.8 million in direct COVID-19 sales.

And also on Capex.

It doesn't look like you've you slice of any.

Tax carryforward losses in the quarter given the rate was close to the German corporate rates do you intend to use those.

Later on in the year of what was 31% of recent indication for the for the.

Zirk: COVID-19 sales to customers in our territory.

Active tax rate for 2020 of them. Thanks, so much.

Yeah, Hi, this is specific I'll, let the equity cushion.

If you take the question.

Zirk: Now, returning to slide 23 and moving to cost of sales, which were estimated to be €233.1 million for the first quarter of 2021, compared to €5.9 million for the first quarter of 2020. The increase was driven by an estimated €223.1 million.

There are.

Some of them. Some case milestone is actually in the in the numbers. So this is a little bit of the sort.

But keep in mind that the.

So if we are showing.

For predominantly part like price.

The gross <unk>.

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50, 50 split already so what Pfizer and we share of profit.

The RPT is it for you.

So thats why there is.

There is some let's call it the fortunate but you can.

Pro rata I'd go with like.

The.

The volume that the that we sell into the market. So this is one of the effect, but yes. In this number of it. There's also a safe smartphones included and especially of the gross margin from Pfizer. So this has come in one of them.

Zirk: Thank you very much.

The comment too.

Yes, we're going to lose.

Zirk: R&D expenses were €216.2 million for the first quarter of 2021 compared to €65.1 million for the comparable period in 2020. The increase was primarily due to an increase in R&D expenses related to our BNT-162 program recorded as purchase services with

Our tax loss carryforward, the partially included already in this tax calculation.

This is the.

The text that we calculate them.

Is.

We have the fact when you for per cent of the Tech class cleared for what is already in this quarter.

We are actually.

Uptake because of the calculation with the deferred tax asset that we have from last year.

So the types of carry forward.

We will see of net rate of 31% roundabout, Indiana.

Alright, thanks, so much.

Zirk: with respect to those expenses, which were initially incurred by Pfizer and subsequently charged to us under...

Sure.

Thank you we have no set of questions. At this time I would now on that can you back to silicon on for closing remarks.

Zirk: Thank you very much.

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

Zirk: All of these revenue costs are shared equally between the two companies.

This concludes today's conference call. Thank you for participating you may now disconnect.

Zirk: The increase was further driven by an increase in wages, benefits, and social security expenses due to increased headcount.

Please standby.

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Okay.

Zirk: The recognition of expenses incurred under the new

Yeah.

Yeah.

Uh huh.

Zirk: Shared Based Payment Arrangement. G&A expenses were €38.9 million for the first quarter of 2021 compared to €15.8 million for the comparable period in 2020. The increase was mainly due to higher expenses for professional services, an increase in wages, benefits, and social security expenses from increasing headcounts, and the recognition of expenses incurred

[music].

Zirk: and Jens are incurred under the new share-based payment arrangements, as well as higher insurance costs.

Okay.

[music].

Yes.

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Yes.

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Right.

Yes.

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Zirk: Interim income taxes were 514.2 million euros for the first quarter of 2021 and were recognized using an estimated annual effective income tax rate of approximately 31 percent.

Yeah.

Zirk: For the first quarter of 2021, net profit was €1,128.1 million, compared to a €53.4 million net loss for the first quarter of 2020. As of March 31, 2021, cash and cash equivalents totaled €891.5 million.

Yeah.

Uh huh.

Okay.

[music].

Zirk: Moving to slide 25. We remain on track to achieve our 2021 financial outcome. Based on the current contracted supply orders of approximately 1.8 billion doses, we are providing estimated COVID-19 vaccine revenues of approximately 12.4 billion euros to BioNTech. This estimate reflects expected revenues from direct COVID-19 vaccine sales to customers in our territory.

Yeah.

Yeah.

Zirk: expected revenues from sales to our collaboration partners, and expected sales milestone payments from our collaboration partners.

[music].

Zirk: And expected revenues related to our share of gross profit from COVID-19 vaccine sales in the collaboration partners' territories.

Zirk: We expect additional revenues related to further supply contracts for deliveries in 2021, with the first contract in place for 2022 and

Zirk: In terms of guidance for the full year 2021, we expect our expenses to occur in the range of 750 million euros to 850 million euros for the full year 2021, reflecting our aspirations to broaden and accelerate our pipeline development, which we plan to ramp up especially in the second half of 2021. SG&A expenses are estimated to increase to up to 200 million euros. Capital expenditures for the year 2021 are expected to

Zirk: be in the range of 175 million to 225 million euros. And I would like to emphasize that all of these figures reflect our current base case.

Okay.

Okay.

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Okay.

[music].

Yes.

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Zirk: Finally, please note that in terms of full year 2021 tax impact, we still expect German tax group corporate tax of approximately 31%. And with that, I turn the call over to Ryan for an update on our corporate tax.

Ryan: Corporate Development Activities and concluding remarks.

Ryan: Thank you, Sir. Turning to slide 27, we continue to expand our geographic footprint in the first quarter. In addition to establishing a subsidiary in Turkey to commercialize our COVID-19 vaccine, we are pleased to announce today plans to expand our footprint to Asia with the establishment of a regional headquarters for Southeast Asia in Singapore. We plan to establish a fully integrated mRNA manufacturing facility in Singapore. It will be equipped to produce a range of novel mRNA vaccines and therapeutics for regional and even global supply and add resilience to our global supply network.

Ryan: Based on our current plans, in partnership with the government of Singapore, the facility will also form part of a rapid response capability for Southeast Asia to address future potential pandemic threats. Pending the necessary regulatory approvals, we plan to initiate construction of the manufacturing facility in 2021 and expect the site to be operational as early as 2023. So with this planned expansion, we expect to have boots on the ground in Asia-Pacific by the end of this year, building on our existing footprint in Europe, the United States, and Turkey.

Yeah.

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Ryan: Slide 28 highlights our expected pipeline milestones for the remainder of 2021. Since the start of the year, we have initiated three first-in-human clinical trials in oncology, and we expect to initiate three more before the end of the year. We remain on track to start three potentially registrational phase two trials with our wholly owned FIXVAC and INS programs this year, and Infectious Diseases BNT161, our seasonal flu vaccine program partnered with Pfizer, is expected to enter a phase one clinical trial in the third quarter of 2021.

Okay.

Okay.

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Ryan: We are moving multiple other programs toward the clinic and plan to provide further updates on our infectious disease pipeline throughout the year. Finally, we expect data updates on up to five different programs in 2021, including our Next Generation Checkpoint Immunomodulators, BNT311 and BNT312, in the second half of the year. Turning to a few closing remarks on the next slide.

Okay.

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Yes.

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Ryan: We remain focused on ramping up supply of our COVID-19 vaccine with the goal of vaccinating more than one billion people this year and potentially even more in 2020. We believe we have a responsibility to supply large quantities of our vaccine throughout the world, including to the developing world, and are working hard to make that happen, in parallel to executing against COVID-19. We will accelerate pipeline development in our core therapeutic areas of immuno-oncology and infectious disease.

Ryan: We intend to advance mRNA vaccines against a range of pathogens, building on our nine active preclinical programs. We will provide more details on some of these exciting programs over the course of this year. Finally, we intend to ramp up investment in our clinical, commercial, and manufacturing infrastructure and teams as we transform BioNTech into a global biopharmaceutical company and prepare to bring next-generation immunotherapy to people around the world.

Ryan: And with that, I'll conclude our presentation and open up the floor for questions. Thank you. As a reminder, to ask a question, you will need to press the star and one on your telephone and wait for your name to be announced. Please try to keep to one question per person. To withdraw your question, please press the pound or hash key. Once again, that is a star and one if you wish to ask a question.

Yeah.

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Ryan: And your first question comes from the line of Corey Kazimoff from J.P. Morgan. Please go ahead, your line is open. Hey, good morning, guys. Thank you for taking my question. I will stick to one. I'm curious what your views are on.

Corey Kazimoff: What your views are on all the controversy last week on the patent waiver front and kind of what you see as the potential impact here for BioNTech and what kind of next steps you're waiting to hear on this topic.

Ugur Sahin: Yeah, I can take the question. Hi Corey, thanks for the question. First of all, of course, we understand the importance of global distribution of our vaccine. And let me just briefly summarize the status quo, which we have at the moment.

Okay.

Okay.

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Ugur Sahin: We have delivered our vaccine to more than 90 countries so far, and we continue to support the global supply, including lower and middle income countries. So our capacity, our initial capacity for 2021 was in the range of 1.3 billion doses. We have now scaled the manufacturing capacity up to 3 billion doses in 2021, and more than 40% of these doses is expected to go to middle and low income countries.

Okay.

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Ugur Sahin: The only near-term solution that we see is really to ensure that we produce from the existing network; we have increased our existing manufacturing network and ensure that the vaccines which are produced in the United States and in Europe can be continuously delivered also to low-income countries. And waiving IP would not increase the short or medium-term supply of the vaccine. So the setting up of the manufacturing process is complex.

Yeah.

Ugur Sahin: It will take at least one year, not even more, to set up a new manufacturing facility, and we do not see any value in waiving patents. We are, as we discussed this morning, already expanding our manufacturing networks from Europe to Asia. We are setting up manufacturing in Singapore, and we'll also implement manufacturing in our JV in China. And we believe, together with the other vaccine developers, in the next nine to 12 months, there will be more than enough vaccines produced, and there is absolutely no need for waiving patents. Okay.

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Okay.

Okay.

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Okay.

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Corey Kazimoff: Okay, thank you very much, Ugur. I have a lot more questions for you, but I'll stick to this one and hop back in queue. Thank you.

Operator: Thank you. Your next question comes from Tazeen Ahmad from Bank of America. Please go ahead, your line is open. Hi there.

Tazeen Ahmad: Good morning. Thanks for taking my question. For me, I wanted to just ask a little bit more about the booster. And Ugur, are you thinking that the booster for the original formulation that you had manufactured for the Wuhan variant would be sufficient for future protection, or do you think that the rate of change of each of the variants would necessitate any kind of change to the actual vaccine itself? And if it's the latter, if you do have to modify the vaccine, how, if in any way, does that change your rate of production plans for the need for boosters, you know, starting, let's say, next year and beyond? Thank you. Yeah, yeah, an excellent question.

Yeah.

Ugur Sahin: So at the moment, we don't see a need for changing our vaccine. As you know, we have done in the last six months, we have evaluated more than 30 different variants for an evaluated immune response with antibody responses induced with the wild type vaccine for neutralization, and we see we see for the most variants almost almost equal neutralization. We have in the meantime also real world data for the activity of our vaccines, for example, against the UK variants with more than 90 percent in Israel, real world data, and almost 90 percent from real world data from Qatar.

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Ugur Sahin: And we have also seen last Friday a publication showing real world data from Qatar showing that our vaccine is able also to prevent infection, PCR-concerned infection, with a 75 percent effectiveness. We have also seen in our laboratory experiments that increasing the neutralization antibody titer titer resides also an increase of neutralizing antibody titer and almost normal neutralization antibody titers in against, for example, the South African variant. So at the moment, we don't see any reason to adapt our vaccine, but we are working on establishing a process and the regulatory framework by executing a blueprint to ensure that, as far as we can see at the moment, just the DNA template would only impact, as far as we can see at the moment, just the DNA template without changing any other other process. The manufacturing process appears to be absolutely robust for all kinds of variants.

Okay.

Okay.

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Okay.

[music].

Tazeen Ahmad: So that means that means once we have a decision decision for a new new variant, we can just change the DNA template and, without losing any production capacity, come up with a supply of the new variant. Okay, thank you. Thank you. And your next question comes from Daina Graybosch from SVB Lyrinc. Please go ahead, your line is open.

Daina Graybosch: Hi, thanks for the question. And it's a follow-up right on the conversation you just had. Given this really impressive real-world effectiveness against B.1.3.5.1, I think you mentioned in Qatar was 75%.

Daina Graybosch: I'm wondering how you plan to select between the four different booster strategies that you currently have in the clinic. Do you think that you can get a differentiating predictive signal from immunogenicity data, or is that decision going to require a larger outcomes trial? Hi, Daina.

Ugur Sahin: So the clinical trial that we are performing is really evaluating different questions. One question is, what is the immune response that we get if we use a homologous booster? And this will be, of course, analyzed against the wild-type strains, but also against mutants. So that will answer the question whether a single booster is improving the response against the variants as well. And then we have the question whether a booster vaccine with a variant is able to produce variant-specific immune responses, and we will analyze that again, evaluating wild type and variant virus, and virus neutralization assays.

Yeah.

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Ugur Sahin: And then the last question, the last question is whether the variant, vaccination with a variant in naive subjects induces variant-specific immune responses in the same way as we have seen with the vaccination of the wild type in naive subjects. So these are different types of questions. Some of the questions are scientific and address also future adaptation strategies. Some are more pragmatic, aiding just a change in our vaccine and providing the regulatory framework.

Ugur Sahin: Sorry, just a quick follow-up on that. So when you have all this immunogenicity data against the wild-type invariant, what's the regulatory path? Just the one that has the best neutralization profile, you'll go forward? No, it's just the regulatory path is really enabling a flexible response, yeah? So the trial is not in the sense of decision-making. The trial has two objectives. One objective is really providing the regulatory path to enable, based on a non-inferiority analysis, that a variant vaccine can be established whenever needed.

Okay.

Okay.

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Daina Graybosch: Yeah, that's the one. And the second is the set of scientific questions that I just elaborated on. Very helpful, thank you. Thank you. Your next question comes from Daniel Wendel from Commerzbank. Please go ahead, your line is open.

Okay.

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Daniel Wendel: Yes, good afternoon and good morning everyone, and thanks for taking my question. I would also have a follow-up question on the potential regularity of booster shots to be given looking into 2022-2023. And you mentioned already that a few contracts with customers have already been signed here, e.g.

Daniel Wendel: Canada. How do you think the booster vaccination campaign would look like? Would it be largely elderly people then receiving the booster shots again? Or would it be more younger people in order to establish a certain level of immunity amongst the younger generation? So any ideas or views you have currently on this topic would be much appreciated. Thank you. Sure, sure. I can take this question.

Ugur Sahin: Sure, sure. I can take this question.

Ugur Sahin: These questions about prioritization and the concrete rollout of a potential booster campaign are questions we as vaccine developers and manufacturers cannot decide. These are policy questions and have to be decided by the respective regulatory authorities or governments. With regard to the necessity of booster shots, we believe that booster shots will be of high value to reestablish full immunity and, most likely, also expand it against emerging variants. We do not know yet when and how frequently these are needed.

Yeah.

Uh huh.

Uh huh.

Ugur Sahin: The upcoming data from follow-up of immune responses and also the real-world data regarding protection will inform us about that. Okay, thank you. Thank you. Your next question comes from Akash Tewari from Wolf Research. Please go ahead, your line is open. Hi, this is Aliyah O'Farrill.

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Akash Tewari: Hi, this is Leo from Akash. We have one question regarding WTO's YP waiver. So can WTO compare BioNTech or cashier tech to transfer information such as undisclosed information or trade secrets outside the published patent? Thank you.

Yeah.

Yeah.

Ryan: Ryan, can you take this question? Sure. So, as I understood it, the question was, can the WTO compel manufacturers to release information beyond the patent? Is that the question? Yes. Yeah, I think it's a little bit premature to try to pinpoint precisely what a hypothetical resolution may or may not include. I think our position on the resolution was mentioned earlier by Ugur, and that is that IP is an important part of a proprietary asset for BioNTech. It's something that we've spent over a decade of investment going into our IP portfolio. However, we don't believe that it's the bottleneck to accelerating production or supply of our vaccine to the world.

True.

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Ryan: And actually, when you look at our global supply network that we already have assembled, it includes 15 different production nodes. Thank you. Thank you. Your next question comes from Arlinda Lee from Canaccord. Please go ahead. Your line is open. Hi guys, thanks for taking my questions. I was wondering about the... on your comment on becoming a fully integrated global...

Okay.

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Arlinda Lee: What areas of emerging therapeutics might you...

Arlinda Lee: be interested in. You had a paper recently on...

Okay.

Arlinda Lee: on autoimmune disease. Can we maybe talk about it?

Okay.

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Yes.

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Arlinda Lee: Disease. Can we maybe talk about that a little bit?

Ugur Sahin: Thank you. So, I believe this is a more general question, which is the direction we are addressing with our mRNA development. So, in the last years, we have shown that our mRNA vaccine and technology platforms allow us to develop classical cancer vaccines, personalized cancer vaccines. We have now a program where we use mRNA to stimulate CAR T-cells. So, that means that this is the first step from the cancer vaccine to the T-cell space.

Ugur Sahin: Then we have shown that mRNA vaccines can also be used in preclinical settings to ameliorate autoimmune disease. And this is for sure a direction which we will address in the next years and can translate to support.

Yeah.

Yeah.

Uh huh.

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Ugur Sahin: Moreover, we are using mRNA to deliver therapeutic proteins. As I stated, we have now the first mRNA-encoded cytokine molecule in clinical testing. There are more mRNA-encoded cytokines in our pipeline. We have mRNA-encoded antibodies, which include IgG antibodies as well as bispecific antibodies.

Thanks for that.

[music].

[music].

Okay.

Okay.

Yes.

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Ugur Sahin: So, that means our clinical pipeline already today covers a number of pharmaceutical molecules to be delivered by mRNA, and we will certainly expand that, and we will certainly also accelerate the clinical development of some of these molecules towards the market. Thank you. Your next question comes from Zhiqiang Shu from Bernberg. Please go ahead. Your line is open.

Zhiqiang Shu: Thank you for taking my question. I'd like to ask about the flu vaccine you're going to move forward with in the clinical trial with Pfizer. I was wondering what kind of MRA construct that is.

Zhiqiang Shu: I recall in 2017, you published a self-implifying public... implifying mRNA aversion in a preclinical study. And related to that, do you plan to share results for your self-amplifying COVID vaccine? Remember, it is also testing in Phase 1 trials. Thanks very much.

Ugur Sahin: Yes, thank you. Thank you for the question. We have not yet disclosed which specific vaccine platform and format, mRNA format, will be used in the cooperative development of the flu vaccine together with Pfizer.

Yeah.

Uh huh.

Uh huh.

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Ugur Sahin: With regard to the other platforms we are working on, for example, the self-amplifying vaccine platform, there will be data sometime next year which we will disclose from our ongoing assessments, also clinical assessments. Thank you. Thank you. We will now take our last question. And this comes from the line of Simon Baker from Redburn. Please go ahead. Your line is open.

Simon P. Baker: Thank you for taking my question. On the P&L, if I may, please. A two-parter.

Thanks for that.

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Simon P. Baker: Firstly, for the gross margin, were there any distorting factors in the gross margin this quarter related to previously expensed inventory, or is that a good run rate for the rest of the year? And also on tax, it doesn't look like you've utilised any tax carry forward losses in the quarter, given the rate was close to the German corporate rate. Do you intend to use those later in the year, or is 31% a reasonable indication for the effective tax rate for 2021? Yeah, hi, this is Sierke.

Okay.

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Yes.

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Sierke: Let me quickly take the question. There are some phase milestones actually in the numbers. So this is a little bit of a distortion. But keep in mind that the states that we're showing are predominantly part of it. It's like Pfizer's gross contribution after a 50-50 split already. So what Pfizer and we share as profit comes into our P&L as a sales item. So that's why there's some, not call it distortion, but you can pro rata go with like the volume that we sell into the market.

Sierke: Yeah, so this is one effect. But yes, in this number, there are also sales milestones included, and especially the gross margin from Pfizer. So this is comment number one.

Sierke: And comment two, yes, we're going to use our tax loss carry forward. They're partially included already in this tax calculation. This is the tax that we are calculating.

Sierke: is we have like 24% of the tax loss clear forward is already in this quarter. We are actually [inaudible]

Sierke: Thank you. We have no further questions at this time. I would now like to turn you back to Silke Maas for closing remarks. Thank you again for joining the call today. We look forward to speaking to you in the future. Thank you and bye-bye. This concludes today's conference call. Thank you for participating. You may now disconnect. Readers, please stand by.

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