Q3 2020 BioNTech SE Earnings Call

[music].

And well.

Operator: and welcome to the BioNTech third quarter 2020 update call. At this time, all participants are in a listen-only mode.

<unk>.

Okay Trenched uptake cool.

Time, all participants are in listen only mode.

Operator: There will be a presentation followed by a question and answer session at which time, if you wish to ask a question, you will need to press the star and one on your telephone keypad. I must advise you this call is being recorded today, Tuesday, the 10th of November 2020, and I would now like to hand the call over to Vice President Investor Relations, Silke Maas. Please go ahead.

Our country <unk>, followed by question and answer session at which time, if you wish to ask a question.

The star and one on your telephone keypad.

This call is being recorded today Tuesday.

<unk>, because you're trying to trend change.

I'd like to turn the corner <unk>.

<unk> Vice President Investor Relations.

So come out. Please go ahead.

Good morning. Good afternoon. Thank you for joining us today to review Biotechs, Slickwater Twentytwenty operational Brooklyn financial research.

Silke Maas: Good morning and good afternoon. Thank you for joining us today to review BioNTech's third quarter 2020 operational progress and financial results. Before we start, we encourage you to view the slides for this webcast, as well as the operational and financial results press release issued this morning, both of which are accessible on our website in the investor section. As shown on slide 2, during today's presentation, we will be making several forward-looking statements. These forward-looking statements include but are not limited to BioNTech's efforts to combat COVID-19, the potential safety and efficacy of BNT162, the timing for submission of data for or receipt of or potential approval or emergency use authorization with respect to our BNT162 program, the ability of BioNTech to supply BNT162 to plan next steps in its pipeline programs, the timing for enrollment, initiation, completion, and reporting of data from our However, actual results could differ from those we currently anticipate.

Before we start to be quick to few of the slides for this webcast as well as the operational and financial results Press release issued this morning, both of which are accessible on our website in the Investor section.

As shown on slide two during today's presentation, we'll be making several forward looking statements. These.

These forward looking statements include but are not limited to bounce exports to combat COVID-19 the.

The potential safety efficacy. If you went to the timing for submission of data for ARX <unk> call or potential approval or not you see use hookers station with respect to our she wants to program the ability.

Biotic to supply because he wants to diplomatic steps and biotechs pipeline programs the timing for enrollment in the Asian Competion reporting of data from our clinical trials and Fioptics anticipated cash usage corpus could get 2020 and beyond.

Actual results could differ from those we currently anticipate therefore cautioned not to place undue reliance on any forward looking statements, which speak only English off the date of this conference call at what cost.

Silke Maas: You are therefore cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this conference call and webcast. On the call with BioNTech Management today will be Ugur Sahin, our Chief Executive Officer and Co-Founder. Ozlem Tureci, our Chief Medical Officer and Co-Founder, Jean Marit, our Chief Business and Commercial Officer, Zirk Pötting, our Chief Financial and Operating Officer, and Ryan Richardson, our Chief Strategy Officer.

On the call with biotech management today would be without he's our chief Executive Officer co founder.

That's it into Lichy poet, Chief Medical Officer, and Cofounder show Maverick, Oh Gee business in commercial officer sits putting our chief financial and operating officer, and Ryan Richardson Chief strategy Officer.

The agenda for today's call is shown on slide three.

Ugur Sahin: The agenda for today's call is shown on slide three. Ugur will start with Q3 highlights and an update on our COVID-19 program before handing over to Sean to provide an update on our commercial distribution plan for BNT162. Ozlem will then update on our oncology timeline, and she will walk through some of the data we are highlighting this week at SITC for BNP311, our PD-L141BP checkpoint immunomodulator. Silke will then provide a recap of our financial results for the first quarter and our financial outlook for the rest of 2020 before handing back to Ugur for closing remarks. We will then open the call to questions and answers. I now hand the call over to Ugur Sahin, BioNTech's CEO. Thank you, Vika. Good morning, and thank you to everyone joining the call today. Let's start with slide four.

Go with Dod.

For Q3 highlights and an update on our COVID-19 program before handing over to Sean to provide an update on coal combustion distribution plan for BT Onesix too.

Awesome with an update on a low quality pilot.

But she.

She will walk through some of the data we're highlighting this week at 64 B piece, we won one I'll walk you got one for one checkpoint modulator.

Sick will then provide to be kept oh fun exercise for the fourth quarter financial outlook for the west of 2020 before handing back to will for concluding remarks.

We will then open the call. Unfortunately.

I now hand, the call over to resign phone text field.

Thank you as they occur.

Good morning, and thank you to everyone joining the call today [noise].

Let's start to slide four.

I'm incredibly happy about that completion methods, we can report to you today.

Ugur Sahin: I'm incredibly happy about the accomplishments we can report to you today. Yesterday, we announced that our COVID-19 vaccine program demonstrated evidence of efficacy against COVID-19 based on the first interim analysis. Just to remind you, so far, we have continued to see evidence of a mild to moderate tolerability profile in our phase 3 trial, which is consistent with what we have observed in the earlier studies. We believe the news from yesterday represents a watershed milestone for our company and one that we believe will constitute an important step for the world after more than eight months of the worst pandemic in more than a century. When we made this decision to initiate a COVID-19 vaccine program in January, we did that against a backdrop of considerably uncertainty. For example, it was not known at that time point if a vaccine would work at all when that decision was made. We went all in.

You know its yesterday that I'll call. It 19 vaccine program demonstrated I become sophisticated see against <unk> 19 based.

Based on the first interim analysis.

Just on my job. So far we have continued to see evidence from mild to moderate tolerability poor fighting illustrates the type which.

Which is consistent with.

Well, what we have so that there will be a studies.

I believe the news from yesterday.

Good thing.

At both have shut milestone for our company.

That's the belief that constitute an important steps have divorced after more than eight months into that.

That's right.

More than that.

Okay.

When we made this decision to initiate it of course, Nancy 19 axiom Qualcomm in January.

It did that against the backdrop of considerable uncertainty.

Touched on but it was not known at the time point, it's a vaccine whatsoever or.

But then that decision was made.

Event all in.

We devoted considerable resources, both in terms of time and attention.

Ugur Sahin: We have devoted considerable resources, both in terms of time and attention, human resources, and also capital, towards addressing this challenge. We did so without knowing how the pandemic would play out. We did so because we felt a duty to CHI and to do something, because we believe our technology has the potential to make a difference. And with the news this week,

Human resources.

And also kept good to watch addressing this challenge.

But it still gets out knowing how dependent it would play out.

Yeah.

They did so because we felt that you would be to try and to do something.

Of course, we believe our technology has the potential to make a difference.

And that's been used to speak.

I believe.

Ugur Sahin: I believe now more than ever that we are in the position to make that difference, and we will still have a lot of work to do, and we'll continue to focus on the goal every single day. We, along with our collaboration partner Pfizer, have already initiated the regulatory submission process to the EMA, to the MHIR in the UK, and to Health Canada. We believe we are on track to submit an emergency use authorization to the FDA as early as the third week of November. In addition, we have initiated clinical trials in Japan and China as part of what we expect will be a restoration pathway in each country. Finally, we recently acquired a GMP manufacturing facility in Marburg, Germany, intended to increase our capacity to produce COVID-19 vaccines in 2021.

Now more than ever that beyond the position to make that decision.

Let me go still have a lot of work to do and the continued to focus on the go.

Okay.

We along with our critical of I should emphasize that have already initiated the regulatory submission of course is to the EMA today.

In the UK and perhaps Canada.

I believe yeah correct.

To submit an emergency use authorization to the ft.

At the outset biegelsen with them.

Set up you have to initiate the clinical trial in Japan in China, It's part of what we expect will be out of.

The installation the top three in each country.

I never really recently acquired at U.P. money Petchem facility in my book, Germany intended to increase our capacity to put your 19 vaccines in centric. Thank you bye.

And they continue to plan for Lucky what.

Ugur Sahin: And we continue to plan for what would be our first commercial launch with our partners Pfizer and Fost & Farmer if we are granted approval. We had some slowdowns in our oncology trials, but despite that, the new trials have started to... But anyway, we are pleased to present early phase 1 data for our next generation checkpoint immune modulator, BNT311, at the CITSE meeting this week. This molecule is jointly owned by BioNTech and GenMap in a 50-50 cost and profit split collaboration.

Oh sure <unk> commercial launch with Philip <unk> size and Paulson, Tom If you can put in a pullback.

We had some so Philadelphia.

Color she does.

Despite that's the new type stuff.

But.

But anyway, we are.

At least two to push them early phase one data for next generation checkpoint in the immune modulator BNP Paribas.

At the.

C C meeting this week.

This molecule, it's John you own thought violent.

I'm not sure about 50, 50 cost and profit because of the basin.

Ugur Sahin: BNT 311 has demonstrated promising data across multiple tumors, and Ozlem will cover in some detail the findings from the ongoing PHAS-1-2 study. In addition, in the third quarter, we provided multiple Phase I data updates for several other programs, including BNT131 for inter-tumor messenger RNA partnered with Sanofi at CITSI and one arm from our expiratory Phase I trial, BNT114 at ASIMO. Finally, in the third quarter, we received IMD approval for our randomized phase two trial of INS BNT 1.2.2 in accurate colorectal cancer and recorded the first patient dose in our phase one, two trial of BNT 4.1.1, a small molecule TLR7 agonist in multiple solid tumors, including small cell lung cancer. And finally, we strengthened our financial position in the third quarter to a mix of equity, debt financing, and grant commitments Hence, we are in a strong position to capitalize on the opportunity that lies ahead of us. Slide 6.

On T. Birnbaum has demonstrated.

Promising data across multiple tumor.

Some of the cutback in some detail they take the findings from the ongoing phase two study.

In addition, the so far have you pulled that multiple states bomb data updates for several other programs, including BMT once they've been caught in Potomac messenger on <unk> not the Sanofi It fits you and been from both ways case, Vonpar BNP 114.

A small.

Finally in the second quarter would be the C and D of Cooper for our randomized phase two trial I know you had to been to to actually going colorectal cancer and they called it. The first patient dose you know Oscar spoke to price or BMT fall, one bomb, although small molecule TLR seven agonist and multiples.

Solid tumors, including small cell lung cancer.

And finally, we strengthened our financial position in the first quarter to a mix of equity financing commitments of approximately 1.2 million cumulative cost puts seats.

Since we are in a strong position to capitalize on opportunities that lie ahead of us.

Slide six.

Slide six highlights the development timeline.

Ugur Sahin: So that's six highlights of the development timeline. Timeline since initiating our BNT162 program in January after the SARS-CoV-2 sequence was first published. The accelerated development path depicted here reflects the intense focus that we and our partners have brought into this program from day one, all without cutting corners. We started the first of multiple Phase I trials in late April, which means that our update yesterday demonstrated 90% of efficacy as of our interim efficacy analysis in a pivotal Phase III trial comes approximately six and a half months after initiating the Phase I trial. Again, this accomplishment speaks to the incredible dedication and hard work of our team and of our collaborators.

[laughter] <unk> since initiating awful lot B and C 162 program in January after.

After the soft cost to fix some sports Fest published.

The accelerated development path. It picked up here reflects the intense focus that we and our partners have bought into this program from day, one or two without cutting corners.

We stopped at the CES multiple states on price in the late April which means that <unk> up that yes. They demonstrate 90 per cent. If he can see that's of our interim efficacy analysis in up keep people towards tastykake comps, approximately six and six and half months out.

<unk> initiating a phase one trial.

Again this is complishments speaks to the incredible dedication and talked about couple of about two cents of I'll call. It three to five so.

Ugur Sahin: We and Pfizer published our protocol, so all the endpoints are clear for the world to see. We defined our primary efficacy endpoint in this trial as the efficacy of our BNT1 and BNT2 vaccine against confirmed COVID-19 participants without evidence of infection before vaccination. We expect to have sufficient safety data to support our emergency use authorization submission to the FDA as early as the third week of November. This safety data set is needed to be in position to request emergency use authorization in the U.S. We recapped the stage of testing that we have gone through with our BNT162B2 vaccine, which has so far resulted in three peer-reviewed publications in journals, such as the New England Journal of Medicine and Nature. The important point here is that we have done extensive testing over the past nine months in many different contexts.

We and tries to publish our portal called so all the endpoints are clear for the drugs to be defined our primary efficacy endpoint. In this part is the efficacy of our PNC one of the 60 to be two vaccine against COVID-19 seconds without evidence of infection before.

Vaccination.

We expect test sufficiency sufficient safety data to support our emergency use authorization submission to the ft.

The second week of November.

This safety data set is needed to be in position total access emergency use authorization or.

Indeed in the U.S.

Yeah, we kept the stage of testing that you ask one tool. This I'll be in people and that seems to be two vaccine, which has so far that started in sleep you ever have your publication in John that's at the mutant Jonathan Medicine nature.

Impulse Paunchy, that's yes done extensive testing over the past nine months in many different contexts, and overall I would say we have seen a consistent picture of the vaccine pharmacodynamic effects.

Ugur Sahin: And overall, I would say we have seen a consistent picture of the vaccine's pharmacodynamic effects. We conducted preclinical testing, starting with more than 20 vaccine candidates. The preclinical testing was conducted in multiple animal models and included a full GIP toxicology test, and dose-dependent immune responses were observed against virus and pseudovirus, including antibody titers, as well as strong CD4 and CD8 responses. In a non-human primate study, our vaccine prevented lung infection in 100% of SARS-CoV-2-challenged rhesus macaques. In addition, no viral RNA was detected in the nose three days post-challenge.

We conducted clinical testing starting with Morgan tons. He thinks he can do this.

Its preclinical testing was conducted multiple and my mother.

Included hold your people across your core.

Clinical coffee obsessed a dose dependent no response.

Again against five us and sort of I guess.

Including anti body, Tata, that's balanced on Cdfour and Cdeight T cell responses.

Well, none of them upon Bobby Oh vaccine put them took lung infection and humbled to stop selling coal cost to challenge raises macaques shada novagold on it whats the talk that in the nose fleet days plus chat.

[noise] <unk> successful clinical studies, we conducted multiple distinct tastes on price and Europe soft for the first time that our vaccine candidate society in my some alternate side effects with no serious well see that.

Ugur Sahin: Following successful preclinical studies, we conducted multiple distinct phase 1 trials, and we observed for the first time that our vaccine candidate resulted in mild to moderate side effects with no serious adverse events. Moreover, in Phase I trials, we observed strong neutralizing antibody levels at or above the level of convalescence zero in patients who had recovered from SARS-CoV-2. We also have observed high-magnitude CD4 as well as CD8 T-cells in vaccinated subjects. So, on slide number seven.

No open pits on cost the obsessed on your pricing model or anti body taught us at.

Or above the level of consistency about some patients will have to be cut from past costs too.

Also Oh, sorry, Hi, Mexico City for SLS to do eight T cells indexing it subjects.

So on slide number seven.

The key question, what we had to address let's say private.

Hi, it's that other fixed income could then coat 19 women, but having a good safety profile.

Ugur Sahin: The key question we had to address in the phase 3 trial is whether the vaccine can prevent COVID-19 in humans while having a good safety profile. Based on our announcement yesterday, we now have early evidence that it can prevent COVID-19 infection with high efficacy. The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. Therefore, the first analysis evaluated 94 confirmed cases of COVID-19 among the trial participants. The case split between the vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate of above 90 percent, as measured seven days after the second dose. This means that protection was achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule. As of yesterday, the study enrolled more than 43,000 participants, with 42% having diverse backgrounds. It is important to mention that no serious safety concerns have been observed to date.

Based on our announcement in Austin yesterday.

I'll have to fund everything it can.

Let them <unk> 19 infection this heightened circus.

The vaccine candidate, let's call it could be more than 90% exit in preventing <unk> 19, petrophysical without evidence prior to infection and the.

Huh income 60 analysis.

So the <unk> analysis evaluated 94 kids so called its 19 in the <unk>.

Uh huh.

The case, but it seemed to vaccinate, the indigo and those who received the Pepsi putting the kids.

16, as it could be a bit above 90%.

That's nice <unk> seven days after the second dose.

That's me.

I actually want to quantify it day after the initiation of vaccination, which consists of a two dose schedule.

As of yesterday, the study enrolled more than 14040 feet collision parts is good but.

Lucky to put some cutting guides us that college is.

It is important to mention that north sea of its based upon so have a good day.

We plan to collect data on the other end pause in the tide and they continue to collect long term safety data.

If you look back took when might you that the clinical parties continue to define it and how does it at 164 come some cases in order to collect data and characterize the vaccine can be they perform against Ida study endpoints.

On slide eight.

Slide it quicker count they just have to be at 262 pool come globally.

Got ongoing clinical trials and the tough comps as shown in green.

It includes the pit because in the U.S. and Germany is that ongoing pod in Brazil, Argentina, Turkey, South Africa, China and Japan.

Ugur Sahin: We plan to collect further data on the other endpoints in the file and will continue to collect longer-term safety data. We would like to remind you that the clinical trial is continuing to the final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate performance against other study endpoints, and Slide 8. Slide 8 illustrates the current status of the BNT 162 program globally. There are ongoing clinical trials in the countries shown in green. This includes the phase three trial in the U.S. and Germany, as well as ongoing trials in Brazil, Argentina, Turkey, South Africa, China, and Japan. The Phase 1-2 trial in Japan, initiated in October, will evaluate safety, tolerability, and immunogenicity of two doses of BNT162B2, again separated by 21 days, and a single dose of BNT162B2 in healthy adults aged between 20 to 85 years of age. The phase one study in China remains ongoing.

The phase two trial in Japan initiated in October.

At that mid safety Tolerability and when it comes to give two doses of the antibody that 60 to be to begin the public sector.

Thank you I'm Dave.

He has built on them that 60 to be two in healthy adults.

Up to 70 to 85 to yourself H.

The phase one study in China remains ongoing.

With our partner fulsome expects to initiate a phase two clinical car without doing something to 60 to be two candidates by the end of 2017.

I'm.

Once gain regulatory idea pool was from the Chinese regulatory volatility.

And.

P. H P. Eight we vote people got the clinic or Todd.

They are ongoing quoting regulatory submissions in the comp base in blue.

Jordan EMA.

The UK and test, Canada and plan to talk with you My call me take on that is seeing a quota for human use to complete the voting by fuel costs to be.

Let me take the final marketing authorization application.

The only thing that's kinda adult accepted under the Minister has incredible order, allowing companies.

Yeah, that's it could be good and information as it becomes.

The company is able to.

In the U.S., we expect to be in a position to accept an American emergency use authorization potentially that's already.

November.

I'm now going to ask Sean to provide a brief update on our commercial supply and distribution model Sean.

Yeah, Thanks, a girl.

So just turning to slide nine here with regard to the stuff. So that's where we are on the commercial side.

Demand is strong around the world.

How come there ive entered into commitments with purchases to support.

570 million doses by the end of 2021.

Ugur Sahin: With our partner FOSUM, we expect to initiate the Phase II clinical trial with our BNP162b2 candidates by the end of 2020. Once regulatory IMD approval comes from the Chinese Regulatory Authority and the NMPHPA, we will start the clinical trial. There are ongoing rolling regulatory submissions in the countries in blue, including EMA, the UK, and half of Canada.

With options in the United States and Europe for an additional 600 million doses.

We continue to work diligently with five cents a complete additional commercial supply agreements.

So we are in negotiation with a number of governments around the world.

And other bodies SAR contracts.

All agreements of course is subject to kind of make a success and Ricky retreat.

Thanks.

Just moving on to slide Chen, Cambridge, highlighting distribution more to do we expect for the vaccine in the pandemic phase.

We'd have a co commercialization arrangement in place as far as many of you know.

Sean: We plan to work with EMA's Committee for Medicinal Products for Human Use to complete the rolling review process to facilitate the final marketing authorization application. The rolling submission in Canada was accepted under the Minister of Health's interim order, allowing companies to submit safety and efficacy data and information as it becomes available. In the U.S., we expect to be in the position to request an emergency use authorization potentially as early as next year, at the end of November. Now, I'm going to ask Sean to provide a brief update on our commercial supply and distribution model. Sean?

Oh really working very very closely with them or.

And with the a couple of months.

Global distribution.

Pfizer's developed some ship though.

Unit, which has GPS tracking.

Specifically for this vaccine, which is designed to keep the product at low temperatures for up to 10 days you Stuart.

50 to 25 degrees Celsius without counting.

Sean: Yeah, thanks, Igor. So just turning to slide nine, here we're providing a snapshot of where we are on the commercial side. Demand is strong around the world, and we have currently entered into commitments with purchases to supply 570 million doses by the end of 2021, with options in the United States and Europe for an additional 600 million dollars. We continue to work diligently with Pfizer to complete additional commercial supply agreements and are in negotiations with a number of governments around the world and other bodies like COVAX. All agreements, of course, are subject to clinical success and regulatory approval by the bank.

The shipper.

And if we do it for their then upon rehashing. It several times, we can extend to 15 days.

Ah reopening.

So that we have the ability or.

Four five times a storage in the refrigerator keytrade degrees centigrade.

So that gives us really some flexibility with <unk> with respect to storage and distribution.

The distribution multiple of course, depending on the region.

In general way reinvention specialized supply chain providers, which are as indicated in the picture here.

Sean: Moving on to slide 10, here we're highlighting the distribution model that we expect for the vaccine in the pandemic phase. We have a co-commercialization arrangement in place with Pfizer, as many of you know, and are really working very, very closely with them and with the government for global distribution. Pfizer has developed a thermal shipper unit which has GPS tracking specifically for this vaccine, which is designed to keep the product at low temperatures for up to 10 days. It's stored at 15 to 25 degrees Celsius without opening the ship.

[music].

For air and ground shipping to inform our manufacturing sites in Europe, and the United States distribution helped all around the world.

I'm from those distribution hubs, we expect to distribute vaccine to step specialized points of care.

In some markets, we expect that to be a focus on a more centralized network appointments care with high book do distribution Mers and other regions that there will be a higher than the Hokies corns care.

In most regions of the world.

We will leverage crisis distribution capabilities through though in some markets for example, here in Germany, the own type plans to distribute.

Sean: And if we do open it there, then upon re-icing several times, we can extend it to 15 days on re-opening. Further, we have the ability to store it for five days in a refrigerator at 2 to 8 degrees. So that gives us really some flexibility with respect to Storage and Distribution. The distribution model will, of course, depend on the region. But in general, we're engaging specialized supply chain providers, which we've indicated in the picture here, for Air and Ground Shipping to and from our manufacturing sites in Europe and the United States. The distribution hubs are all around the world, and from those distribution hubs, we expect to distribute the vaccine to specialized points of care. In some markets, we expect there to be a focus on a more centralized network of points of care with high value distribution, whereas in other regions, there will be a higher number of these points of care.

However, it's important to note that our agreement with Pfizer. It is a 50 50.

Profit sharing worldwide excluding China.

So the economics to be on took hold the same.

Doubtless.

Who distributes the vaccine.

Okay. So.

Having said that it is important to note that the.

The points of Cat.

We will have multiple show.

Storage options available as we mentioned earlier.

In addition to that Sendmail shipper, which I described earlier.

Of course can use ultra low temperature leases.

These increases are commercially available and provide the ability to that sold the product as a freshly liquid.

Minus 70 degrees for long term storage.

The shorter.

Sean: In most regions of the world, we will leverage Pfizer's distribution capabilities, though in some markets, for example, here in Germany, BioNTech plans to distribute. However, it's important to note that our agreement with Pfizer is a 50-50 profit sharing worldwide, excluding China. So the economics of BioNTech are the same regardless of who distributes the vaccines. Okay, so going further, it is important to note that at the points of care, we will have multiple short-term storage options available, as we mentioned earlier. In addition to the thermal shipper which I described earlier, sites can use ultra-low temperature freezers. These freezers are commercially available and provide the ability to store the product as a frozen liquid at minus 70 degrees for long-term storage, for short term. The product can be stored for up to five days, two to eight, as I said earlier.

Peter it's the product can be a start up to five days at two two and as I said, it's important to note that if there is a caesar available ultra low temperature freezers available the vaccine can be still for up to six months in these patients.

I'll now turn over to Islam, supervising uptake called the cheap.

Yes, I'm sure, Sean we have change and yet no.

On slide 12.

Yes, Alex and nickel oncology pipeline in the interest of time I'm going to provide update on select set of problems Onep and Twop Yankees, we loved one detail.

They probably yesterday at the confluence plus provide details on the purpose of other problems.

<unk> for for a fortune update which with which we released this morning.

I wanted to know if that's clear.

Some continued impact from the ongoing COVID-19 pandemic on Helocs and cooperation.

Mississippi, There has been a slowdown in that role in light of some of our ongoing studies and.

Hi, myself clinical site initiation of a lot of sense.

Ozlem Tureci: It's important to note that if there is a freezer available, an ultra-low temperature freezer available, the vaccine can be stored for up to six months in these freezers. I'll now turn over to Ozlem to provide an update on the oncology part. Yes, thank you, Sean. We are changing gears now, and on slide 12, you can see our clinical oncology pipeline. In the interest of time, I'm going to provide updates on selected programs only and, for BNT 3.11, detail the data released yesterday at the CICI conference. For further details on the status of other programs, please refer to our full quarterly update, which we released this morning. I want to note that we have seen some continued impact from the ongoing COVID-19 pandemic on our clinical operations. Specifically, there has been a slowdown in the enrollment of some of our ongoing studies and impairments in clinical site initiation of our plan.

This is causing us to delay time I caught some of.

Okay.

Now starting with.

11, along the line almost successful wrong on that.

Our <unk>, which is composed of four non you'll keep it in that I don't mind switching.

Well, we publish the next dollar probably based on that business and we'll show from our ongoing phase one client.

Publication highlights the favorable safety profile, again, 111, and Sage and paid for melanoma patients who were treated with several lines of here.

PD one inhibitor.

Oh, a publication also note said, yes.

111 ability to live.

The objective with wonderful both as it sounds.

And also in combination with a cool anti PD one antibody.

Up and how important somewhat.

During the current quarter that we entered into a tragic calibration took you a development program with a let's call it somewhere general.

We plan to investigate the combination of PNG, one doesn't encourage analog because the ones okay.

<unk> also known as some that came up.

Patients with on that sets the stage three or four melanoma.

That's cool Greg.

Well I'll start.

With PD ones Okay.

<unk> one.

Two randomized open label trials.

That's the quote unquote, Hundredtwenty participants where we.

Yes, well you never know you may not be in combination or I've often oncology alone.

Primary outcome measure of the trials.

Ozlem Tureci: This is causing us to delay the timeline for some of our, Now starting with BNT111, our melanoma fix-back program on an RNA vaccine which is composed of four non-mutated melanomas. Recently, we published an exploratory data analysis in nature from our ongoing phase one study. The publication highlighted the favorable safety profile of CNT1-11 in stage 3bc and stage 4 melanoma patients who were pre-treated with Our publication also noted NT1-11's ability to mediate durable objective responses, both as a single agent and also in combination with approved anti-PD-1 antibodies, nivolumab and pembrolizumab. During the third quarter, we entered into a strategic collaboration to pursue a development program with our colleagues from Regeneron. We plan to investigate the combination of BNT-111 and Regeneron's PD-1 blocker, Liptayo, also known as Nipimab, in patients with unreflectable stage 3 or 4 melanoma who have progressed under or after treatment with PD-1 blockers. The Phase II randomized and open-label trial is expected to include 120 participants who will receive either BNT-111 and Simicrima The primary outcome measure for the trials is the objective response rate for the combination. Moving to BNT113, our RNA vaccine encoding the E6 and E7 proteins of human papillomavirus 16.

The objective response rate public condemnation.

Moving to be and we won 13, our our name vaccines encoding exactly seven cocaine all human papilloma virus.

Oh, I randomized open label trial.

That's that's what Anabelle was 185 patients in the first line setting with respect separately Collins on that topic. When I was hopping on also happens next set up positive for HPV <unk>. The trial will include.

Thank you on income from safety and Tolerability in combination with Pembrolizumab.

Upon completion also take you on in the trial is designed to evaluate yes. She wants that in combination with and will work with Carnival alone.

Oh, yes, no one even Evan one person on Colonsay under review by the Oh, we are targeting commencement often its toll phase <unk> trial in the first half off sometimes one subject to allowance of <unk> five yes, yes.

No.

Individual life Neo antigen specific enjoying therapy <unk>.

That's a problem, which is which is partnered up with Roche Genentech.

Yes, one thing too and first line melanoma, but.

Right Yeah.

No other than originally expected due to the impact of a cold night endemic along with our partner Genentech. We are currently evaluating the timing <unk> conducting an interim analysis for this quiet and we'll provide an update once finalized.

<unk> trials I managed to investigate yes, 21 22 in the EPS are then sets in the first extra one trial would include patients with already an excellent stage non small cell lung cancer. The second is on patients with quote on cancer.

Just really sets the stage to high risk with circulating tumor is CVN 80, and page sweep for the patients are they treat patients for.

Yes, dozing is expected in the first half of Twentytwenty, one the U.S.I. EMC application called the supply of wasn't approved in July.

Ethanol in September we presented data from the ongoing.

Marriage trial in patients with triple negative breast cancer, who had undergone a children's apparel that pace.

Patients in one I'm also quite yet well vaccinated with all while keeping alive and switching off here, but.

The data presented at ESMO provided the preliminary analysis of inertia T cell responses.

Watching Austin Houston.

But now does this demonstrates that the neoantigen vaccine, it's highly efficient in English thing wrong any of the topics T cell responses in the post.

Ozlem Tureci: Our randomized, open-label trial is expected to enroll 285 patients in the first line setting with unrespectable recurrent or metastatic brain cell carcinoma of the head and neck that are positive for HPV 16. The trial will include a safety run-in to confirm safety and tolerability in combination with Pembrolizumab. Upon completion of the safety run-in, the trial is designed to evaluate BNT 113 in combination with Pembrolizumab versus Pembrbrololone. Both BNT111 and BNT113 are currently under review by the FDA. We are targeting commencement of these two Phase II trials in the first half of 2021, subject to allowance of the IMD by the FDA. Now moving to our individualized neoantigen-specific immune therapy platform, which is partnered with Roche Genex.

EPS of and actual that setting and can be seen in all 14 patients.

End of <unk>.

He said it was once again up to 10 neo antigens for detected with the majority of which were a de novo, indicating that this tumor type maybe a candidate gone you I am picking specific in your therapy as well.

Interim results from ongoing first in human Phase one trial, yet 131 patients with advanced solid.

<unk> <unk>.

I have seen we used.

The conference and.

When you presented there.

On T., one cookie, one popping up with Sanofi as their nuclear all sides modified R&D that encodes sigal kinds, namely Io 12, I have 15, G.M.C.S. EPS and interferon Alpha <unk> interruption.

Ration. This study is a dose escalation and expansion trial evaluating safety PK and PD aside as untouched antitumor activity.

Ozlem Tureci: For BNT122 in first-line melanoma, the enrollment rate has been slower than originally expected due to the impact of the COVID-19 pandemic. Along with our partner, Genentech, we are currently evaluating the timing for conducting an interim analysis for this trial, and we will provide an update once finalized. Two trials are planned to investigate ENT 1.22 in EPSHA-1. The first adjuvant trial will include patients with early and advanced non-small cell lung cancer.

As of July 17 patients had received PNG 131 will interfere or P and six patients received <unk> beyond Q1 for Q1 in combination with Regenerons PD, one girl cuts to meet him up.

Thank you I'm, sorry, Q1 was generally well tolerated no patient experience a dose limiting toxicity and no great free all grades have treatment related adverse events.

Our reported to date.

Downstream insecticide to kind of nuts and keep the interest in situation in the longest healy therapy on subsets annual model Natale.

Ozlem Tureci: The second trial is in patients with colon cancer, surgically resected stage 2 high-risk with circulating tumor cDNA and stage 3 patients. First dosing is expected in the first half of 2021. The US IMD application for this trial was approved in July.

Correct.

We are pleased with any preliminary thoughts on go pull but to continue development of this program with our partner Sanofi <unk>.

Our preclinical pipeline on slide 13, I would just like to point out that while we had claims trends.

Ozlem Tureci: At ESMO in September, we presented data from the ongoing TMDC merit trial in patients with triple negative breast cancer who had undergone neoadjuvant therapy. Patients in one arm of this trial were vaccinated with our individualized neoantigen immunotherapy. The data presented at ESMORE provided a preliminary analysis of initial T cell responses in 14 of these patients. The analysis demonstrated that the neoantigen vaccine is highly efficient in inducing strong polyepitopic T cell responses in the post-neoadjuvant setting in TNVC. In all 14 patients, vaccine-induced T cell responses against up to 10 neoantigens were detected, the majority of which were de novo, indicating that this tumor type may be a candidate for neoantigen-specific immunotherapy as well.

Also COVID-19 pandemic to overcome a week next the first half of tend to trend. He wanted to be very active in terms of all on what damage is entering the clinic, we have Sean type ones here that we expect to start phase one fights for including Oh, I said there were two programs PNG too.

11, which is our call back approach and Yankee toward 21, the personalized adoptive transfer our approach of automobiles. He said by all U.S.

We also expect to initiate first in human trials for our we will mop and drive the cytokine kind of excellence.

Now moving to slide 14, and Yankee Free 11 also Hearts Gen 10 46.

Uh huh.

The first of two next generation by specific antibody programs.

We have partnered with a lot of steam coal from Gen. Two.

To date to date headsets, featuring Bianchi for 11, where were you at the Citi Conference.

Which include a on the one hand preclinical mode of action data and is a dose escalation and preliminary expansion data from our first in human phase one two trials, we are delighted with the clinical data presentation. What's the next advice it seemed to be feature but what are some examples why not.

Ozlem Tureci: Interim results from our ongoing first in human phase one trial of BNT131 in patients with advanced polytumor have been released for the CICI conference and will be presented there. BNT131, partnered with Sanofi, is a nucleoside-modified RNA that encodes side-waves, namely IL-12, IL-15, GM-CSF, and interferon alpha for intratumoral administration. The study is a dose escalation and expansion trial evaluating safety, PK, and PD, as well as anti-tumor activity. As of July, 17 patients had received BNT131 monotherapy, and 6 patients received BNT131 in combination with Regeneron's PD-1 glucosamine. The NT131 was generally well-tolerated.

Our investigators at the press briefing.

Also conference yesterday.

Yes. She had free 11 is a first in class next generation checkpoint immune therapy being investigated for the treatment of advanced solid tumors.

Despite specific anti body skin your attainments can block the PD, one axis and activate T cells for conditional.

All one VB quotes and co stimulation conditional activation of small one B.B. is crucial as clinical development of four one DB agonist has been hampered by severe liver toxicity. The preclinical studies presented at 50 demonstrate that this dual targeting <unk>.

Ozlem Tureci: No patient experienced a dose-limiting toxicity, and no grade-three or greater treatment-related adverse events have been reported to date. Downstream refactor cytokine signals and T-cell infiltration in the monotherapy arm suggest an immune modulatory effect. We are pleased with these preliminary results and look forward to continued development of this program with our partners. For our preclinical pipeline on slide 13, I would just like to point out that while we had constraints of the COVID-19 pandemic to overcome, we expect the first half of 2021 to be very active in terms of our new modalities entering the clinic. We have shown five programs here that we expect to start phase one trials for, including our cell therapy programs, BNT211, which is our CARBAC approach, and BNT221, the personalized adoptive transfer approach of autologous T cells by our U.S. We also expect to initiate first-in-human trials for our ribomab and ribocytokine platform. Now moving to slide 14 and BNT-311, also called Gen 10

Additional mechanism affection induces a strong and improved immune response in my eyes compared to PDL. One it was owned in both the too much a draining lymph nodes and tumor like what is the environment of semis and increased CD eight two key Rick racial was observed which led to a potent anti tumor.

<unk> activity in the annex.

Slide 15, I'll show us the phase one dose escalation part of this open label single arm trials are expected to enroll up 292 patients on the left side patients enrolled in the trial.

That's what's in the test Patrick Unreal sex to that so that you must one not candidates for us and that's where it peaked.

In the dose escalation part 61 patients received let doses of PNG for 11 at dose level ranging from 25 to 1200 milligrams every three weeks on to disease progression or unacceptable toxicity to determine the requirement.

It has to do with.

The expansion part of the study will include cohorts cohorts of patients with non small cell lung cancer youre easier cancer endometrial triple negative breast cancer squamous cell carcinoma office, the head and neck and cervical cancer as shown on slide 16, most tweaks and.

Occasions treated in the dose escalation part where of course director ovarian and pancreatic and lung cancer patients enrolled were heavily pretreated and nearly 40% hedged with youth prior PD, one PDL one treatment.

Ozlem Tureci: The first of two next-generation bi-specific antibody programs we have partnered with our esteemed colleagues from GEM. Two datasets featuring BNT311 were released at the CITSI conference, which include, on the one hand, preclinical mode-of-action data and dose escalation and preliminary expansion data from our first in-human Phase I-II trials. We are delighted that the clinical data presentation was selected by CICI to be featured by Professor Melero, one of our investigators, at the press briefing of the conference yesterday. BNTF311 is a first-in-class, next-generation checkpoint immune therapy being investigated for the treatment of advanced solid tumors. This bi-specific antibody simultaneously blocks the PD-L1 axis and activates T-cells through conditional 4-1BB co-stimulation. Conditional activation of 4-1BB is crucial as clinical development of 4-1BB agonists has been hampered by severe liver... The preclinical studies presented at CICI demonstrate that this dual-targeting conditional mechanism of action induces a stronger and improved immune response in mice compared to PD-L1 alone in both the tumor-draining lymph nodes and tumor microenvironment of the mice. An increased CDA to TREC ratio was observed, which led to potent anti-tumor activity in the animal.

It's off a data cut off date treatment is ongoing and 10 patients and the maximally tolerated dose has not really changed.

On Slide 17, we show initial safety observations from the phase one dose escalation part of the trial overall.

Overall, the answer for you Evan was generally well tolerated the most common treatment related adverse events were trends in the nice elevation type of heart Tyler Dizon said keep treatment related trends I mean, these elevations occurred in about 26% of patients a 9.8 plus.

Send off patients had great suite trends in the nation, and the elevations, which improved with Cartus cluster, we're tweaking and there were no patients with great for trends in these innovations are treatment related but it will be an increase it.

Dose limiting toxicity toxicities occurred in six patients and we thought without secretly.

On slide 18, you can see pharmacodynamic activity, which we observed over a broad range with Nexsan. The induction April 15th 15 base. Following treatment. These included interferon gamma and I'd be 10 increase increase frequencies of proliferate into the Eightys.

Beds and sort of shrinking CD eight effect on the memory T cells or together, providing evidence of biological activity.

On Slide 19, now we show antitumor activity observed with BNP fleet 11 during the dose escalation phase why this is early data only three months median follow up clinical benefit was observed across different dose levels. We were quite pleased to see disease control in it.

Ozlem Tureci: Slide 15 now shows the phase 1 dose escalation part of this open-label, single-arm trial expected to enroll up to 192 patients on the left. Patients enrolled in the trial are adults with metastatic or unresectable solid tumors who are not candidates for standard therapy. In the dose escalation part, 61 patients received flat doses of BNT311 at dose levels ranging from 25 to 1,200 milligrams every three weeks until disease progression or unacceptable toxicity to determine the recommended phase two dose. The expansion part of the study will include cohorts of patients with non-small cell lung cancer, urofilial cancer, endometrial, triple negative breast cancer, squamous cell carcinoma of the head and neck, and cervix.

6.6% off the 61 patients, including four partial responses one in a triple negative breast cancer patient one in ovarian cancer patient and to an immune checkpoint inhibitor pretreated non small cell lung cancer patients.

Finally on slide 20, we see trends non small cell lung cancer patients from the dose expansion cohort who could be objectives. We assessed these patients had progressed on Oscar immune checkpoint blockade. So I got to be antifreeze, Evan treatment, we observe.

Served two confirmed partial responses, one unconfirmed partial responses and four patients with stable disease.

Our agenda colleagues and we are considering these with I think.

Howard thing, we are actively enrolling additional patients in the dose expansion cohorts I previously mentioned, we'll look forward to presenting additional data for this potentially powerful new checkpoint.

Ozlem Tureci: As shown on slide 16, the most frequent indications treated in the dose escalation part were colorectal, ovarian, pancreatic, and lung cancer. Patients enrolled were heavily pretreated, and nearly 40% had received prior PD-1, and PD-L1. As of the data cutoff date, treatment is ongoing in 10 patients, and the maximal tolerated dose has not been released. On slide 17, we show initial safety observations from the phase one dose escalation part of the trial. Overall, BNT311 was generally well tolerated. The most common treatment-related at-risk events were transaminase elevations, hypothyroidism, and fatigue. Treatment-related transaminase elevations occurred in about 26% of patients. 9.8% of patients had grade three transaminase elevations, which improved with costeroid treatment. However, there were no patients with grade four transaminase elevations or treatment-related bilirubin increases.

More data in the future.

I will now Hansa core over to Deb.

Provides an update on our financials.

Thank you good luck.

I would like to summarize our financial results for the quarter that are shown on slide 22.

Our total revenue, which primarily consists of revenue from both collaboration agreements was 67.5 million euros for the third quarter 2020, compared to 28.7 billion euros for the third quarter 2013.

So for the period of nine months ended September 32020, or total revenue was 136.9 billion euros compared to 80.6 million euros for the comparative prior year period.

The revenue from collaboration agreements overall increased due to the recognition of revenue Nucor, New collaboration agreement with Pfizer and wholesome horrible as part of the company's BNP Onesix Tulips. He program becomes clear with my team.

Lease revenues from upfront payments are recognized based on the underlying cost incurred an increase with increasing cost.

Revenues from other states are the actions increased due to increased orders and they could save that caustic product peptides retroviral reflectors, okay. Good supply development manufacturing services sold to third party customers.

Ozlem Tureci: Those emitted toxicities occurred in six patients and resolved without sequelae. On slide 18, you can see pharmacodynamic activity, which we observed over a broad range with maximal induction 8 to 15 days following treatment. These included interferon gamma and IP10, increased frequencies of proliferating CD8 T-cells, and proliferating CD8 effector memory, all together providing evidence of biological activity. Now, on slide 19, we show anti-tumor activity observed with BNT311 during the dose escalation phase.

Research and development expenses were $227.7 million for the third quarter 2020, compared to $60.4 million for the third quarter 2014.

The nine months ended September 32020, total research and development expenses were 388 million euros compared to 161.

Renewals for the comparative prior year period.

Period end.

Increase was mainly due to the increase in the development expenses come or you had people in six two program.

In addition from the date of acquisition to our new U.S. based subsidiary by on Thank you.

Speak contributed to our research and development expenses.

Ozlem Tureci: While this is early data, only three months of medium follow-up, clinical benefit was observed across different dose levels. We were quite pleased to see disease control in 66% of the 61 patients, including four partial responses, one in a triple negative breast cancer patient, one in an ovarian cancer patient, and two in immune checkpoint inhibitor pre-treated non-small cell lung cancer. Finally, on slide 20, we see 12 non-small cell lung cancer patients from the dose expansion cohort who could be objectively assessed. These patients had progressed on or after immune checkpoint blockade prior to BNT311.

General and administrative expenses were $23.3 million for the third quarter, when compared to $10.6 million for the third quarter 20, but.

For the nine months ended September Thirtyth 20 potent general.

Administrative expenses were 68 billion euros compared to 34.5 million euros quarterly comparative part of your peers.

This increase was being eaten crudes by expenses corporate just minutes for consulting services as well as an increase in headcount leading to high wages benefits and social security expenses.

And in addition from the date of acquisition the all New York based subsidiary bound to USA Inc. contributing to our general and administrative expenses is what.

The net loss was $210 million for the third quarter Twentytwenty compared to 30.1 to use for the third quarter 21 team and for the nine months ended September 32020, total net loss was 351.7 billion euros compared to $120.9 million for the comparative prior.

Ozlem Tureci: We observed two confirmed partial responses, one unconfirmed partial response, and four patients with stable disease. Our GenMap colleagues and we are considering these results as encouraging. We are actively enrolling additional patients in the dose expansion cohorts I previously mentioned, and we look forward to presenting additional data for this potentially powerful new checkpoint immune modulator in the future. With that, I will now hand the call over to Zirk to provide an update on our finances. Thank you, everyone.

Yeah.

So now turning to slide 23.

Just turning to the balance sheet.

Biotic ended the third quarter 2020, with cash and cash equivalents of 990.5 for the year olds or what.

1000.

$159.7 million, so that is 1.2.

<unk> dollars, which excludes 658.9 million euros or $776.7 million in gross proceeds from the old pull on underwritten offering of common equity placement I think.

Unknown Executive: I would like to summarize our financial results for the quarter, which are shown on slide 22. Our total revenue, which primarily consists of revenue from our collaboration agreements, was €67.5 million for the third quarter of 2020 compared to €28.7 million for the third quarter of 2019. So for the period of nine months ended September 30, 2020, our total revenue was €136.9 million compared to €80.6 million for the corresponding prior year period. The revenue from collaboration agreements overall, Thank you very much. These revenues from upfront payments are recognized based on the underlying costs incurred and increased with increasing costs.

In investment in the four year mandatory convertible notes completed in the quarter.

Mainly influenced by the spending related to our BNP Onesix two program, we still expect net cash used in operating activities and of course, that's the property plant and equipment to be between 450 million euros and $600 million for the full year 2020 likely to the upper end of the range due to our acquisition of the.

Manufacturing facilities bumper.

And with that I will return the call to work for concluding remarks.

Okay.

And kids Rick.

So Connie Cook <unk> 24.

As we entered the foreigner veeco could trend to be our focus on executing our ongoing phase credit card.

COVID-19 vaccine and kind of mission along with our partners.

We are preparing for commercial launch.

With our partner skies, Unfortunately, and continue to scale up our money's picturing a foot cool and sure its support for global <unk>.

They are getting very promising data for BMT is between 11 and a continuing to advance the rest of our oncology pipeline to whats multiple day stage caused intend to 21.

Unknown Executive: The revenues from other sales transactions increased due to increased orders and include sales of diagnostic products, peptides, retroviral vectors for critical supply and development, and manufacturing services sold to third parties. Research and development expenses were €227.7 million for the third quarter 2020 compared to €50.4 million for the third quarter 2019. For the nine-month-ended September 30, 2020, total research and development expenses were €388 million, compared to €161 million for the comparative prior year period. This increase was mainly due to an increase in development expenses from our BNT162 program. In addition, from the date of acquisition, our new U.S.-based subsidiary, BioNTech U.S. Inc., contributed to our research and development expenses. General and administrative expenses were 23.3 million euros for the third quarter 2020 compared to 10.6 million euros for the third quarter 2019. And for the nine months ended September 30, 2020, total general and administrative expenses were 58 million euros compared to 34.5 million euros for the comparable prior year period. This increase was mainly influenced by high expenses for purchased management consulting and legal services, as well as an increase in headcount leading to higher wages, benefits, and social security expenses.

And we expect to initiate that was in human Todd Pope to cell therapy.

This includes BMP two on that 11 hour kabak poke on targeting coding six.

<unk> coating six specific car T cell therapy, the profit Toby advanced cancers.

And BNP to 11, our personalized neoantigen targeted pizza therapy patients, who have effectively or that's been said two checkpoint inhibitor profit.

We are also that kept the callout to deliver on our commercial operation and pipe and milestones.

Our vision has always been to bring other therapies to patients most in need the development of a vaccine to prevent call. It 90.

But be a remarkable accomplishment of our vision.

Because we believe that if we have excess floor.

It has an echo all the nabil.

280, not only to inspect the some dynamic on a build to suit here, but have also the opportunity to accelerate our long term ambition to go to the next generation immuno therapy somewhat similar to the company.

We think our shareholder components for the Crescent Park.

And we'll now open up the profit.

Yeah.

I'll cover it.

Thank you as a reminder, ladies and gentlemen, if you wish to ask a question. Please press the star and one on your telephone keypad and wait for your name.

And to be in line.

Your first question comes from the line of Tazeen Ahmad from Bank of America.

Hi, good morning, and good afternoon. Thanks, so much for taking my questions as it relates to a couple of feet of follow up for coal did I wanted to get a little bit more color. So for pediatric patients I know that you had opened up your study to younger.

Patients I think that occurred maybe in October I'm, just wondering if any pediatric patients have been enrolled and are being studied a with the vaccine at the moment and what would be the longer term needs in order to get a label that would be inclusive of pediatric patients.

Unknown Executive: And in addition, from the date of acquisition, our new U.S.-based subsidiary, BioNTech U.S. Inc., contributed to our general and administrative expenses as well. The net loss was €210 million for the third quarter of 2020 compared to €30.1 million for the third quarter of 2019. And for the nine months ended September 30, 2020, the total net loss was 351.7 million euros compared to 120.9 million euros for the comparative prior year period.

And then my second question is as it relates to the durability of response based on what you know now about the profile of the vaccine do you think booster shots will be needed I think for modeling purposes. Most of us are assuming that after the two dose regimen folks won't happen.

The re vaccinated, but we'd like to know if you know that isn't a proper assumption to be making or is it too early to know thanks.

Unknown Executive: For now, turn to slide 23. We're just turning to the balance sheet. BioNTech entered the third quarter of 2020 with cash and cash equivalents of €990.5 million or $159.7 million, so that is $1.2 billion. This includes 658.9 million euros or $776.7 million in gross proceeds from our follow-on underwritten offering, a private equity placement, and an investment in a four-year mandatory convertible note completed in the quarter. Although mainly influenced by the spending related to our BNT 162 program, we still expect net cash used in operating activities and for investments in property planning equipment to be between 450 million euros and 600 million euros for the full year 2020, likely to hit the upper end of the range due to our acquisition of the manufacturing facility in Marlboro. And with that, I will return the call to Ugur for his concluding remarks. Thank you. So, turning to slide 24.

Yes. Thank you for the question. So the class a first question was about picky I treat patients in the global.

The ongoing global study we have included a smaller cohorts off had yet to break patients a cohort of 16 to 17 year old as are lessons and go smaller cohort of 12 to 15 year old Oh, Oh or top checks.

And.

So the thought as I said, a small dog cohorts. We are currently discussing with regulators with FDA and EMA, a lot pedal theatrical plan, including which types of studies in which in in which.

He couldn't it's in a witch H <unk> offered <unk> pad to pad yet treat populations Ah we quite yet.

This client we can oh, not make any comments about oh, we wouldn't be able to do so soon once these agreements have been accomplished.

The second question was cure visit Gee, what do you want to funnel.

Yes, I can't say I can pick up here so.

Ugur Sahin: As we enter the final weeks of 2020, we are focused on executing our ongoing phase three trial of the COVID-19 vaccine and planning the submissions along with our partners. We are preparing for commercial launch, and with our partners Pfizer and Moderna, we continue to scale up our manufacturing effort to ensure support for global supply. We have generated promising data for BNT311 and are continuing to advance the rest of our oncology pipeline towards multiple late-stage trials in 2021. And we expect to initiate our search in human trials for true cell therapy. This includes BMT-211, our CARVAC program targeting Clodian-6 with a Clodian-6 specific CAR T-cell therapy in refractory advanced solid cancers, and BNT211, our personalized neoantigen-targeted T-cell therapy in patients who are refractory or unresponsive to checkpoint inhibitor treatment.

So we are we do not yet.

<unk> data for predicting the dual ability off or in your own good sponsors.

Based on our observations that we have a up to now for up to three months.

Oh second there was a the belief that the dealer body appeals, nor could I wasn't antibody responses.

Both would creek, but be from here.

Or or the or that you know from prior year study on that the messenger on his experience us to tupper for prime boost boost a poacher. So so that means a believer generate data in the upcoming six to nine months to or.

LDH about it but it's such a course of course.

Identify identify appropriate scheduler are for optimal boost Porto close.

Okay, and if I could just ask one last question how important do you think it is to be able to come up with the formulation, where it's just one shot for patients as opposed to the current two because there are patients that are not it might be a small number but there are patients that are not coming back for the for the second.

Though.

And do you think that that could be something and that in a commercial setting to be somewhat rate limiting thank you.

Ugur Sahin: We are also well-capitalized to deliver on our commercial, operational, and pipeline miles. Our vision has always been to bring novel therapies to patients most in need. The development of a vaccine to prevent COVID-19 would be a remarkable accomplishment of our vision. We truly believe that if we are successful, we will have an extraordinary opportunity not only to impact this pandemic on a global scale but also to accelerate our long-term vision to build a next-generation immunotherapy pharmaceutical company. We thank our shareholders and partners for their trust and support and will now open up the floor for questions. Operator.

Yeah, I thought a bundle with exceeding its it's a quick bias to two P. P formations or we do not have at the moment and the biomark appropriately for protection human.

It does it just there it's definitely good hi, neutralizing anti body taught us.

A big fight yard for preventing preventing infection.

And two sets of a quiet for preventing disease.

'cause also now established that given the highest suneet deal gives us cost.

Cost to Spike Coty, and two to put the human receptor.

That's a very high in pedagogy concentrations of like fighter to translate this into into strong neutralizing antibody titer.

Operator: As a reminder, ladies and gentlemen, if you wish to ask a question, please press the star and 1 on your telephone keypad and wait for your name to be announced. The first question comes from the line of Tazeen Ahmad. Hi, good morning and good afternoon.

So at the moment, but you have to do on that tool to injection to those so fixed fee and I need to perhaps an effective effective prevention from infection.

Tazeen Ahmad: Thanks so much for taking my questions. As it relates to a couple of data follow-ups for COVID, I wanted to get a little bit more color. So, for pediatric patients, I know that you opened up your study to younger patients. I think that occurred maybe in October.

You put on in the next six to 12 months, but let's go to work towards a neutralizing antibody titer might be might be sufficient to come up or to continue with that though with a because it's kept you want a bitch have just a single injection.

Ozlem Tureci: I'm just wondering if any pediatric patients have been enrolled and are being studied with the vaccine at the moment. And what would be the longer-term needs in order to get a label that would be inclusive of pediatric patients? And then my second question is, as it relates to durability of response. Based on what you know now about the profile of the vaccine, do you think booster shots will be needed? I think for modeling purposes, most of us are assuming that after the two-dose regimen, folks won't have to be revaccinated, but we'd like to know if that is a proper assumption to be making, or is it too early to know? So, the first question was about pediatric patients. In the ongoing global study, we have included smaller cohorts of pediatric patients, a cohort of 16 to 17-year-old adolescents, and a smaller cohort of 12 to 15-year-old subjects. And so, these are, as I said, smaller cohorts.

Okay. Thank you.

Your next question comes from the line of Cory Kasimov JP.

Okay.

Hi, Good morning, everyone I'm first off a big congrats and thank you for that matter for all the intense efforts and the great results with your targeted vaccine.

So my first question is on manufacturing and <unk> and how we should think about the scale up process of going from roughly producing 50 million doses by the end of this year to about 1.3 billion by the end of next year is it best to assume something of a linear trajectory here or is it a process that's likely to be.

Be a little bit more backend loaded and then I have a follow up.

Jack would you like to take the question.

Latin America could take it yes, [noise]. Thank you Corey.

I think this is more like a step wise approach actually so you have like Pfizer regularly updating that work and we are ramping up our networks or the European Biotic network and I think it will it come come in transit so bigger deal with of course coming up the facility a pfizer in Belgium, but for the submission drug product than anything.

If it's we view it would be rather like a step changes. So I don't think that that you would expect.

Ozlem Tureci: We are currently discussing with regulators, with the FDA and EMA, our pediatric plan, including which types of studies in which sequence, in which age strata of the pediatric populations are required. At this point, we cannot make any comments, but we will be able to do so soon once these agreements have been accomplished. The second question was durability. Ugur, do you want this one? Yes, I can take it.

Lower volumes that go.

Go higher.

I think you would have like bigger chunks in Q1 coming up and then another chunk could do to kind of go up actually so then.

Jeff I mean, the bottling mix, we'd be moving all the time. So maybe can you have like a drug substance, which would come up that you were booking pickup truck product and then you up like they reach the finish.

Ugur Sahin: Yes, so we do not yet have robust data for predicting the durability of immune responses based on our observations that we have so far for up to three months of the second dose. However, we believe that the durability of neutralizing antibody responses would reach at least one year, and we already know from prior studies that messenger RNA vaccines are suitable for prime boost approaches. So that means we will generate data in the upcoming six to nine months to also evaluate such protocols and identify an appropriate schedule for optimal boost protocols. And if I could just ask one last question.

Capacities and I think eventually Barbra comes really up and running and stable.

Then she no.

Obstacle acquity duration.

So, but not step wise.

The biggest step ups that come away from the 50 would probably be one.

Okay, perfect and then on the logistics front do you expect that Didnt time, it'll be possible to improve upon the current cold chain storage that's required for BMT Onesix too could you just talk about the work that's going on there.

Sean would you like to take the question.

Right, Yes sure.

Cory yet.

Yeah of course.

We're not stopping they did better than them closely Frank seeking them, we're looking out for.

Formulations or should I.

Oh more lets say ordinary course of business huge we have programs.

Ugur Sahin: How important do you think it is to be able to come up with a formulation where it's just one shot for patients as opposed to the current two? Because there are patients that are not, it might be a small number, but there are patients that are not coming back for the second dose. And do you think that that could be something that, in a commercial setting, could be somewhat rate-limiting?

Running to do that.

And.

We're successful in generating the data.

In those programs.

We will of course be launching.

And extensions that.

More.

The more let's say over the course of this lesson.

Ugur Sahin: Thank you. Yeah, so the one-dose vaccine requires two key ingredients. First of all, we do not at the moment have a biomarker correlate for protection in humans. However, it is well established that high neutralizing antibody titers are required for preventing infection, and T-cells are required for preventing disease. And it is also now established that given the high affinity of the SARS-CoV-2 spike protein to the human receptor, very high antibody concentrations are required to translate this into strong neutralizing antibody titers.

Pardon me cancellations can stick them in the for tool.

A longer period of time.

Okay very helpful. Thank you guys very much.

Your next question comes from the line of Dana Grey Fox XP.

Thank you for the question and thank you for all the work that you're doing and congratulations on can't say that enough.

I have many many questions, but I'll I'll focus perhaps on to a the first is do you believe the efficacy you've seen a greater than 90% prevention of BNP when six to suggest that all vaccines against the spike protein will be effective or do you believe there are some unique element to your.

Ugur Sahin: And so at the moment, we have to assume that two injections, two doses of vaccine are needed to have effective prevention of infection. But we will learn in the next six to 12 months that also lower titers, neutralizing antibody titers, might be sufficient to come up with or to continue with a schedule which has just a single injection. Okay, thank you. Good morning, everyone.

Platform that potentially could be differentiating short term and long term.

And then second question is when do you think we'll learn about the potential protection against infection and transmission have you seen in the protocol that you're looking at exploratory through allergy at one in six months.

Will we be able to see anything at one month.

Already at the Eway filing or do you think we'll need to wait for six months to understand that and then I guess finally on that do you believe that this vaccine will protect against infection. So.

Ugur Sahin: First off, a big congratulations and, for that matter, a thank you for all the intense efforts and the great results with your COVID vaccines. So my first question is about manufacturing and how we should think about the scale-up process of going from roughly producing 50 million doses by the end of this year to about 1.3 billion by the end of next year. Is it best to assume something of a linear trajectory here, or is it a process that's likely to be a little bit more back-end loaded?

[laughter]. Thank you think your Dana so I will start with the easier question, but [laughter] that's right yeah.

[noise] [laughter]. So so it so first of all I think the good message for for for for Mankind is is that we now understand that infection COVID-19 infection can be indeed.

Unknown Executive: And then I have a follow-up question. Sir, would you like to take the question? I'm happy to take it. Yes. Thank you, Corey.

Prevented biotech seed, yes and of course of course, they believe that that our vaccine, they're not be the only vaccine, which a country that there are a number of vaccine caused the profit.

Unknown Executive: I think this is more like a stepwise approach, actually. So you have companies like Pfizer ramping up their network, and we are ramping up our network, the European BioNTech network. And I think it will come in tranches. So basically, with the course coming up, the facility of Pfizer in Belgium, with Philips Finish and the drug product, and then adding our facility, it would be rather like step changes. So I don't think that you would expect lower volumes that go higher evenly.

Hey screen vaccine caused ongoing.

With regard to the could could or if he could see we have the tools to understand and this will come in the next six to 12 months out what cost.

The prevention prevention, but if that doesn't neutralizing antibody target is it the T cell response is that the combination of both so we expect that other vaccines would also be be affected but the of course don't know how effective that the 16 cost it would be and maybe depending on the efficacy of the different vaccines.

Unknown Executive: I think you would have bigger chunks in Q1 coming up, and then another chunk in Q2 coming up, actually. So then you have, I mean, the bottlenecks will be moving all the time. So basically, you have like a drug substance which will come up, and then you will bottleneck on the drug product, and then you have like various Philips Finish capacities. And I think eventually, if Marburg is really up and running and stable, potentially, yeah, upside color collaboration in the end.

Cost because they're on more about the mode of action.

Pension quoted 90 can be a number of different publications and that the neutralizing antibody titer, a required course or to prevent NPL device into south but did this or so that definitely and that are that are on that.

Okay with pre existing T cell responses.

I have that much pickup poconos. This clinical <unk> knows that you picked up this quarter at 19. So it so we have to see and ER and how how did the immune response was co relate Cody This prevention.

Unknown Executive: So, stepwise, the biggest step ups that come away from the 50 will probably be in Q1. Okay, perfect. And then on the logistics front, do you expect that, in time, it'll be possible to improve upon the current cold chain storage that's required for BNT 162? Could you just talk about the work that's going on there? Sean, would you like to take the question?

If we got to or are you maybe snuff infections. This is difficult to assess that this. This this this this would vote Creek fire a completely different approach far far.

For clinic or testing, meaning that we would also need to test subjects without having any Andy Andy any symptoms. A this is kind of being not not to go based on the complexity of such costs, but to be we might get get you know.

Sean: Yeah, sure. Corey, of course, we're not stopping the development of the vaccine. And we're looking at formulations that are more, let's say, ordinary courses of business use. We have programs running to do that.

Amazing the night in direct fashion.

Oh from come out from come from.

Sean: And if we're successful in generating data in those programs, we will, of course, be launching line extensions that are more, that are more, as I say, more than the cost of business, so primary care physicians can stick them in the fridge for a longer period of time. Okay, very helpful. Thank you guys very much. And thank you for the question and thank you for all the work that you're doing. I can't say that enough.

Our from our ongoing Cod I expect that type of information should not be so it started before the time time timeframe or six to tough month.

Very very helpful. Thank you again.

For America.

Thank you.

Next question comes from the line.

Okay.

[music].

Hello. Thank you so much for taking my question and congrats to the old bound tech team for.

Very hard work and a amazing results up to two if I may on onesix to be too or the covert program and two if I may on Gen 10, 46 on the Cobi program.

Daina Graybosch: I have many, many questions, but I'll focus perhaps on two. The first is, do you believe the efficacy you've seen, greater than 90% prevention of BNT162, suggests that all vaccines against the spike protein will be effective, or do you believe there are some unique elements to your platform that potentially could be differentiating short-term and long-term? And then the second question is, when do you think we'll learn about the potential protection against infection and transmission? We've seen in the protocol that you're looking at exploratory serology at one in six months. Will we be able to see anything at one month already from the EUA filing, or do you think we'll need to wait six months to understand that?

Wondering if if you could share with us.

Amit cases severe cases of COVID-19 were seen in the placebo arm I'm presuming at least five that was or I believe the requirement per the guidelines.

And then secondly, I'm wondering if you could provide an update on your son self amplifying program and how that technology contrasts with the Arcturus self amplifying a vaccine. Thank you. So much and then if I can follow up on July 10 46 after.

Yeah. The first part of the question that we got this we got cool to that specific information. So we can provide at the moment on this type of information because the.

Ugur Sahin: And then, I guess, on that, do you believe that this vaccine will protect against infection? Thank you. Thank you, Daina.

And the extent of information that we got from that they come on at Cowen Committee is extremely limited.

Ugur Sahin: So I will start with the easier question, which is the first one. So, first of all, I think the good message for mankind is that we now understand that COVID-19 infection can indeed be prevented by a vaccine. And of course, we believe that our vaccine will not be the only vaccine which accomplishes that. There are a number of vaccine trials, phase 3 vaccine trials ongoing. With regard to efficacy, we have to understand, and this will come in the next six to 12 months, what drives the prevention rate. Is it the neutralizing antibody data? Is it the T cell response? Or is it a combination of both?

To ensure the integrity of the of the pro.

Family and point, which is expected in about about two to three weeks from now.

Sophie we expect that in prediabetes, <unk> pretty big people will be able to answer this question and many other questions quick stop but also what's the question how is the protection great in the elderly as compare.

To the to the younger population.

With regard to the to the tallest Seth and good times vaccine approach be deep core prioritized.

Fixing cars or the the Oh assess amplifying messenger Ami pie that is still in the dose escalation.

At least a dose of pre Michael come at the moment and so that outside the dose escalation is ongoing we have.

Ugur Sahin: So we expect that other vaccines will also be effective, but we, of course, don't know how effective these vaccine trials will be, and maybe, depending on the efficacy of these different vaccine trials, we can learn more about the mode of action of prevention of COVID-19. Currently, a number of different publications hint that neutralizing antibody titers are required, of course, to prevent entry of the virus into cells, but it is also well established that people with pre-existing T cell responses have a much better prognosis than those infected with COVID-19. So we have to see how these immune responses correlate with prevention. With regard to the addition of injections, this is difficult to assess. This would require a completely different approach to clinical testing, meaning that we would also need to test subjects without having any symptoms.

We'll be able to either a totally park immunogenicity data initially we expect that to report and you should immunogenicity data end of October this the become now more picking me beginning next year.

Thank you and then on Gen 10, 46 is on my end. Thank you for taking the questions, but wondering if and I know you touched upon this slightly but the mechanistic rationale for.

Seeing lower lower lumber talks with 10 46 versus perhaps other oh on Bebe molecules and then also I'm sorry, if I missed this but what dose was selected for for dose expansion for us.

10, 46 or 311 in non small so please.

So the first question.

Please for.

Q was a liver toxicity as the conditional binding mechanism to fall, one beep beep, which means that oh, the anti body has to be born to PDL to PDL one in order to be able to go onto two gone too far one BP.

Ugur Sahin: This is currently not doable based on the complexity of such trials, but we might get information in an indirect fashion from our ongoing trials. I expect this type of information will not be solid before the timeframe of six to 12 months. Very, very helpful. Thank you again.

Bye bye and confirmation of a change as the second question was what along a recommended phase two dose. If this would be 100, maybe caught many crops.

Operator: You're welcome. Thank you. Your next question comes from the line... Hello.

Operator: Thank you so much for taking the question. And congratulations to the whole BioNTech team for the very hard work and amazing results. Two, if I may, on 162B2, or the COVID program, and two, if I may, on Gen 1046.

Thank you very much.

Your next question comes from the line of.

Uh huh.

Perfect.

Hey, Thanks, so much for taking my question and thanks again for all of your hard work on the vaccine Brian.

A few if I may I just wanted to confirm I think on the call you mentioned that tighter levels were similar to natural infection was that similar or were they a multiple fold higher like you've seen in your previous data and did you see any level of tighter corresponding to advocacy based on the <unk>. The 94 patients you've looked at so far.

Operator: On the COVID program, I'm wondering if you could share with us how many cases, severe cases of COVID-19, were seen in the placebo arm. I'm presuming at least five. That was, I believe, the requirement per the guidelines. And secondly, I'm wondering if you could provide an update on your self-amplifying program and how that technology contrasts with the Arcturus self-amplifying vaccine. Thank you so much.

And I guess I'll ask this a little bluntly, what's the split of U S and X U.S. dose allocation and if someone were to say Pfizer biotic could sell the remaining 700 billion dose allocation 20, you know $20 a dose that that could be a reasonable uh huh.

Ugur Sahin: And then if I can follow up on Gen 1046 after that. Yeah, the first part of the question with regard to further specific information, so we can't provide at the moment this type of information because the extent of the information that we got from the data monitoring committee is extremely limited to ensure the integrity of the primary endpoint, which is expected in about two to three weeks from now. And so we expect that in three weeks we will be able to answer this question and many other questions, for example, also the question, how is the protection rate in the elderly as compared to the younger population? With regard to our self-amplifying vaccine approach, we did prioritize this vaccine trial. Our self-amplifying messenger RNA trial is still in dose escalation.

Good for 2021, how would you respond to that.

That assertion and then lastly in your updated protocol for the code vaccine. We saw that you introduce a new manufacturing process in order to scale up what are the differences between your old manufacturing process and the new one and what are the kind of be at D.A. and European Rick.

Firemen in terms of demonstrating equivalent using those two manufacturing processes. Thank you.

Oh Sandro discussed it's a multiple access let's let me try to to to address a dress or most all of them except for the but but crumb rush of aspect, maybe I can start with the question relates to the.

Ugur Sahin: We reached a dose of three micrograms at the moment, and further dose escalation is ongoing. We will be able to report immunogenicity data. Initially, we expected to report immunogenicity data at the end of October. This will become more important beginning next year.

The with a supply of fixing Scott.

Yes, sure. So Oh gosh, you EPS, yeah, U.S. versus X.U.S. and so the U.S.

It's 100 million order with an option for an additional 500 million.

Ugur Sahin: And then on Gen 1046, if I may, and thank you for taking the questions, but wondering if, and I know you touched upon this slightly, the mechanistic rationale for seeing lower liver toxin with 1046 versus perhaps other 411BB molecules. And then also, I'm sorry if I missed this, but what dose was selected for dose expansion for 1046 or 311 in non-small cell, please? So the first question is the reason for reduced liver toxicity is the conditional binding mechanism of 241BB, which means that the antibody has to be bound to PDL-1 in order to be able to bind to 241BB by a conformational change.

And so it's about a fifth of or a six actually of the of the over 570 million dose commitment that we mentioned of course, the option would take it much higher but not too too to as much as high as 600 million doses. So you can see the bookings there once.

Six to about half.

In terms of your your average price question.

At this point, we can't provide an average price what we can say is that we've indicated that the price for the U.S. for the first 200 million doses was 1950 per dose.

For the first 100 million doses and that you can think about that as a benchmark for how we would price the vaccine for the developed world for similar volumes.

Ozlem Tureci: The second question was what our recommended phase 2 dose is; this will be 100 milligrams. Thank you very much. Your next question comes from the line of Akash Tewari. Hey, thanks so much for taking my questions. And thanks again for all of your hard work on the vaccine front. A few questions, if I may, I just wanted to confirm that, I think, on the call, you mentioned that titer levels were similar to natural infection. Was that similar?

So we do expect prices to differ by country by region, but.

But for the developed World I think thats, the key benchmark and you can see from the dose and that dose numbers that we've indicated here in the presentation today most of those levees committed orders art or in the developed world, but we are as mentioned also looking to to supply the developing world. So it's going to be a an average across those.

So [noise] so I can continue with the with the question relates to the to the vaccine as.

Akash Tewari: Or were they multiple folds higher, like you've seen in your previous data? And did you see any level of titer corresponding to efficacy based on the 94 patients you've looked at so far? I guess I'll ask this a little bluntly.

So like a neutralizing antibody titer has indeed at least two to Threex fourx higher.

Then the tightest that youre upsetting that they can but then Uh huh.

I think that the note that that that a leveling off of of protest.

Ugur Sahin: What's the split of US and ex-US dose allocation? And if someone were to say Pfizer BioNTech could sell the remaining $700 million dose allocation at $20 a dose, that that could be a reasonable target for 2021? How would you respond to that assertion?

In the same level is only 2444 sub proportion proportion of <unk> from from hospitalized patients.

And then the second question related to the to the manufacturing process and so the money sectional post SSP kicked up and doing during the development, including including changes changes in that vein, how the messenger on a pure always try to ensure.

Ugur Sahin: And then lastly, in your updated protocol for the COVID vaccine, we saw that you introduced a new manufacturing process in order to scale it up. What are the differences between your old manufacturing process and the new one? And what are the FDA and European requirements in terms of demonstrating equivalence using those two manufacturing processes? Thank you. Thank you. This is for multiple questions. Let me try to address most of them, except for the commercial aspect.

Let's see here, maybe Ken can increase under the bed side.

As if men detection changes did not.

Besides in any any change or any change or the police could tell ya.

So to put that remain in the in the <unk> and and into specific patient health coach in the product.

And so far the comparability data that detect be generated show on.

Ugur Sahin: Maybe Ryan can start with the question related to the supply of vaccines. Yeah, sure. So, Akash, the U.S. guest, U.S. versus ex-U.S. And so the U.S. is a $100 million order with an option for an additional $500 million. And so it's about a fifth of, or a sixth, actually, of the over $570 million dose commitment that we mentioned. Of course, the option would take it much higher, to as much as, as high as 600 million doses. So you can see the bookends there, one-sixth to about a half. In terms of your average price question, at this point, we can't provide an average price.

That that both processes are comparable to the EPS mid to the states have to ask it to EMA and I can be in discussion bespoke auto at Ti <unk> to.

To ensure that this infection chain. It's a change is accepted and then discuss potential additional studies to be to be perform.

Yes, we got to get them to them to the to the spirit Oh, we can't provide any information.

Because the information that the.

We obtained from the data monitoring committee is extremely limited and essentially.

ER each piece of information is already quoted in the press could be so additional information to come up with a because the finding of eat out in about three weeks.

Ryan Richardson: What we can say is that we've indicated that the price for the U.S. for the first 100 million doses was $19.50 per dose for the first 100 million doses, and that you can think about that as a benchmark for how we would price the vaccine for the developed world for similar volumes. So we do expect prices to differ by country and by region. But for the developed world, I think that's the key benchmark.

Thanks, so much.

Thank you. Your next question comes from the line of Arlinda Lee kind of code.

Hi, guys I'm congratulations on the impressive efficacy and thank you for the tremendous effort to get here. So quickly and I had a few questions about one to two and then also 311 I guess I'm curious on the dose guide.

And the 1.3 billion doses from for next year does that guidance doesn't seem to have changed so I'm wondering if the marburg.

What is included in that and then on on the logistics of delivery and there's some debate in the U.S. about allocations and I'm curious when you deliver the hundred million to the U.S. are you delivering to that site her.

Ugur Sahin: And you can see from the dose numbers that we've indicated here in the presentation today that most of those committed orders are in the developed world. But we are, as mentioned, also looking to supply the developing world. So it's going to be an average across those.

Based on where they tell you to go or how does that work.

And then on four ones either.

The conditional activity to be about I'm wondering.

Glenn how did you decide on the expansion cohorts and if that's correct conditional activity or something that you're planning to work into some of your other basketball. Thank you.

Ugur Sahin: So I can continue with the questions related to the vaccine. So the neutralizing antibody titers are indeed at least two to three-fold higher than the titers that we observed in the reconvalescence era. I think that the note that the level of titers at the same level is only true for a sub-proportion of sera from hospitalized patients. The second question related to the manufacturing process. So the manufacturing process has been scaled up during development, including changes in the way the messenger RNA is purified to ensure that we can increase the batch size. However, the manufacturing changes did not result in any change of the release criteria.

[noise], where do you want to take the four won't be part and then ill.

Uh huh.

Guidance.

Okay.

[laughter] Micron combined.

[noise] [noise], Okay I was.

[laughter].

[laughter]. It takes some time that the that the that can be executed.

Executing at different patient population.

And with different indication.

Based on that observation that you made in the <unk> in this patient patient population and then based on the most actionable.

The component we decide that besides that tour tour to select select indication second line indication that's me.

Ugur Sahin: So, the product remains in the specification of the original product, and so far, the comparability data that has been generated show that both processes are comparable. We have submitted this data to FDA and to EMA, and are currently in discussions with both authorities to ensure that this manufacturing change is accepted and to discuss potential additional studies to be performed. With regard to the split, we can't provide any information because the information that we obtained from the Data Monitoring Committee is extremely limited, and essentially each piece of information is already in the press release, so additional information will come out with the final readout in about three weeks. Hi guys, congratulations on the impressive efficacy, and thank you for the tremendous effort to get here so quickly.

Checkpoint forms of indications with patients that whole space craft checkpoint blockade that was fun question not because our expectation is that.

That's the dual body that has my test significant activity, even in patients, who who did not respond or failed checkpoint brocade treatment or pulled pressed upon upon successful checkpoint cook it creates the.

The second second Gokul patients patient cool clinical indications outside line lung patients, yeah, particularly kotick there'll be a clinical indications and bridge checkpoint blockade is already approved but the effect size is still limited.

That non small cell lung to cook a negative breast cancer.

Can you discuss the expansion cohort.

Ugur Sahin: I had a few questions about 162 and then also 311. I guess I'm curious about the dose guidance, the 1.3 billion doses for next year. That guidance doesn't seem to have changed, so I'm wondering if the Marburg facility is included in that. And then on the logistics of delivery, there's some debate in the U.S. about allocations, and I'm curious, when you deliver the $100 million just to the U.S., are you delivering based on where they tell you to go or how does that work?

And this expansion cohort and that's to guide Us house in a process.

That's cool.

Toward randomized phase two expansion.

[laughter].

Yeah on the first part of your question to 1.3 billion I think it's important to remember that that's a supply capacity number for <unk>.

Cumulative supply by the end of folks 2021, and you're correct that we haven't updated the guidance since the acquisition of Marburg.

Site at certain mentioned, the Marburg side will really accelerate our production ramp up over the course of 2021, starting in the <unk> in the first half of the year.

Ryan Richardson: And then on 4.1BB, what's the conditional activity of that? I'm wondering... One, how did you decide on the expansion cohorts and if that conditional activity is something that you're planning to work into some of your other programs as well? Thank you. If you want to take the 4-1BB part, and then I'll... take the guidance. Okay. Background noise.

And the the extra volumes will support both the Pfizer Alliance and also the personal lines and its important remember there are two that the 1.3 billion guidance number for supply was a pfizer bounce that number and we have not yet guided.

Specifically to two the two China market opportunity so.

Ozlem Tureci: Okay, I will... So the phase one trial that we are currently executing had different patient populations and different indications. And based on the observations that we made in the patient populations and based on the mode of action of the compound, we decided to select indications, second-line indications, that means checkpoint responsive indications with patients who failed prior checkpoints. That is one rationale because our expectation is that the dual body will have, might have significant activity even in patients who did not respond to or failed checkpoint blockade treatment or progressed upon successful checkpoint blocka The second group of patients, patient groups, or clinical indications are first-line patients, and particularly clinical indications in which checkpoint blockade is already approved but the effect size is still limited, like non-small cell lung cancer and triple negative breast cancer. These are currently discussed as expansion costs.

Yeah that would be on top of the 1.3 billion.

[noise], Okay. Thank you and then on the logistics of delivery with it I'm just curious about how how you're going to deliver it to the U.S. and whether you're going to give it to the sites in particular as it gets direct or how does.

Got it.

Yeah. So the logistics plan for the U.S. just to it so we're going to have a number of centralized depots.

Followed by the <unk> and the more diffuse distribution points that the that we alluded to in the presentation. So centralized depots and then spread out throughout the country distribution sites, including high volume.

And also lower volume sides, which Ah and there will be distribution, United States will be executed by Pfizer.

Q.

Thank you.

Next question comes from good night.

I'm back.

Hi, good morning, Thanks for taking my questions and I want to add my congrats as well to the team it's definitely a critical moment for him or her and her by on target.

A few questions on upcoming 19 vaccine.

So the first one is I like to know what was the initial rationale for the protocol change from 32 cases to 62 cases for for the first the first interim analysis and then secondly, I assumed that once you reach the final efficacy analysis, you would unblind the trial.

Ozlem Tureci: And these expansion cohorts are intended to guide us in a fast session to control randomized phase II, and phase III trials. Yeah, and on the first part of your question, the $1.3 billion, I think it's important to remember that that's a supply capacity number for cumulative supply by the end of 2021. And you're correct that we haven't updated the guidance since the acquisition of Marburg, the Marburg site. As Cirque mentioned, the Marburg site will really accelerate our production ramp-up over the course of 2021, starting in the first half of the year.

I Wonder how would you be short a fair assessment of long term protection safety once you I'm going to trial.

And then and then also I like to understand the.

Uh huh.

Sure.

Looking to sale as I mentioned, I remember I recall there.

There are a few countries that you would pick pick the.

At the South book to sales.

Ryan Richardson: And the extra volumes will support both the Pfizer alliance and also the Fosun alliance. And it's important to remember there too that the $1.3 billion guidance number for supply was a Pfizer BioNTech number, and we have not yet guided specifically to Chinese market opportunities. So that would be on top of the $1.3 billion number.

Okay Fair enough a few European countries would you would you disclose those countries at this time.

And then finally for the oncology I have a quick question IP into why 11.

Plus PD one study that.

You mentioned in your press release that you you would conduct additional trials for registration can provide more color on that why do you think that will be the case and therefore.

Sean: And then on the logistics of delivery, I'm just curious about how you're going to deliver it to the U.S. and whether you're going to give it to the space in particular as the U.S. directs, or how does that work? Yeah, so the logistics plan for the US is to have a number of centralized depots, followed by the more diffuse distribution points that we alluded to in the presentation. So, centralized depots and then spread out throughout the country, distribution sites including high volume and also lower volume sites.

Can you remind us the randomized arms for for the Phase I trial, BNP wireless and plus PD one.

Thanks very much.

Yeah.

Oh, okay. Okay. So so that's.

Let's start with the successor access into their pricing for the protocol change as old and then then the Scott.

Besides support her car construct this sometime sometime in in July it was not clear how that pandemic situation. There continue to evolve and been run Denali awards that are on that the number number of touches the section grades.

A quick twop.

Providing providing a at the security to collect that's just some cases and tend to extend it.

Sean: So, it's, and it will be, distribution in the United States will be executed by Pfizer. Thank you. This question comes from the line of Zhiqiang Shu.

Therefore, we have it could be that included an early interim analysis, but Turkey two cases.

Zhiqiang Shu: Hi, good morning. Thanks for getting to my questions. And I want to add my congratulations as well to the team. It's definitely a critical moment for mRNA and for BioNTech. A few questions on the COVID-19 vaccine.

But what happens is the quantitatively that.

Oh popping off the.

Of the infection, great. They affect some great great rent up as you have seen in the last week dramatically and basketball via realized on that but [laughter] pawn being 32 kids and 62 cases.

Ugur Sahin: So the first one is, I'd like to know what the initial rationale was for the protocol change from 32 cases to 62 cases for the first interim analysis. And then secondly, I assume that once you reach the final efficacy analysis, you would unblind the trial. I wonder how you would ensure a fair assessment of long-term protection and safety once you unblind the trial? And then also, I'd like to understand how you book the sales. I recall there are a few countries that you would take for booking the sales. For a few European countries, would you disclose those countries at this time?

So close to each other.

But ah that it doesn't make sense to do that we thought to Turkey. Two cases, we went back to two the ft and great crested if he can pull up the 32 cases.

He asked the evaluating evaluating the Porto cause change except that.

The whole process took took about been beak, and then B b starts that we've got the evaluation of the number of cases. The V has cost US 62 cases and came up with 94 cases, so that's the background for the.

Ugur Sahin: And then finally, for oncology, I have a quick question on the BNT Y11 plus PD-1 study that you mentioned in your press release that you would conduct additional trials for registration. Can you provide more color on that? Why do you think that would be the case?

For the portal coaching.

[noise].

Second question.

Is that related to be in the 111, yes, there will be a hobby we plan the plan to tool Oh Mick Hello.

Then my it's safe to say to quote unquote, it's leased up or I must say to a protocol for PMT about 11 or with with.

Ryan Richardson: And then, can you remind us to randomize the arms for that trial, BMP111 plus PD-1? Thanks very much. Okay, okay.

Well I'm I'm, combining anti PD, one, but BMT running 11 run or anti PD, one alone and an idea carded play to 'em vaccine alone.

Ugur Sahin: So, let's start with the first question about the rationale for the protocol change. So, when we designed the protocol, this was sometime in July, it was not clear how the pandemic situation would continue to evolve, and one scenario was that the number of infections, the infection rates, could drop, making it difficult to collect sufficient cases in 2020. Therefore, we have included an early interim analysis arm with 32 cases. But what happened is, on the contrary, instead of dropping the infection rate, the infection rate went up, as we have seen in the last week, dramatically.

And ER and.

And with the Port <unk>, the the feedback from the XT eight or was that.

That's on the EPS. The it was its kind of excess earned that that.

Couldn't occur Chi Chi's quarter card poker cortical over the Christmas cards would require the potency assays.

HM.

Additional crestor queued up the questions I addressed be supplemented now at a modest profit protocols, including the inflammation click a clutter potency essay and expect to see that from the data in the coming quarter to.

Ugur Sahin: And therefore, we realized that the time points between 32 cases and 62 cases were so close to each other that it did not make sense to reach out to 32 cases. We went back to the FDA and requested permission to drop the 32 cases; the FDA, after evaluating the protocols changed, accepted that. The whole process took about one week, and when we restarted the evaluation of the number of cases, we passed the 62 cases and came up with 94 cases. So that's the background for the protocol change.

Yeah and on the bookings sales question.

We intend to book sales in Germany were still assessing the overall accounting treatment, but you can assume Germany, where we're we're going to commercialize.

And also will expect our profit share from our partners Pfizer and sodas and.

Also to flow through the piano of course, and remember that's a gross a gross profit share I don't know circuit. If you want to you want to add to that.

Yeah. That's correct I think we would we are evaluating right now is because we have to like the accounting, but suffice it because they have the U.S. GAAP and we are.

Ugur Sahin: The second question is related to BNP-111, so we plan to submit our randomized phase 2 protocol for BNP-111 with three arms, with one arm combining anti-PD-1 with BNP-111, one arm anti-PD-1 alone, and another calibrator arm vaccine alone. [inaudible] The feedback from the FDA was an additional request that the clinical trial protocol for a registrational trial would require a potency assay, and we got The questions are addressed, and we have now submitted the modified protocol, including the information for the potency assay, and expect feedback from the FDA in the coming 30 days. Yeah, and on the booking sales question. We intend to book sales in Germany.

Yes.

Although similar especially of this revenue recognition there are a couple of a subtle differences between what you're working on right now and once we know what piece it flows through which line item actually on the P. and I think we'd give you guidance actually that you could actually.

Modeled this out a little bit more more softly.

Great and then.

Can I ask about the.

Assessment of long term protection, if the tras on blinded to your comment on that as well. Thank you.

Yeah, I'm sorry, so the key reason for potential I'm glad you know of course is that that's the stuff that secrecy of course at the same time point, we have to offer offer or so for the pet people Kuka vaccine.

And we will continue with tool more neutral Monty talked about the the new infection in.

In the vaccine.

And this is my gift cards in direct evidence based or so or so by comparison compared with most epidemiologic data, how just don't come quick action, but but but evolve and so we are confident that.

Ryan Richardson: We're still assessing the overall accounting treatment, but you can assume Germany where we're going to commercialize it. And also, we'll expect our profit share from our partners, Pfizer and Fossen, also to flow through the P&L, of course. And remember, that's a gross profit share.

The two year follow up including a follow up Oh, neutralizing antibody titer in there and a sub group Oh subjects would allow us.

Unknown Executive: I don't know, Cirque, if you want to add to that. Yeah, that's correct. I think what we are evaluating right now is because we have to align on the accounting with Pfizer because they're under US GAAP, and we are under IFRS. Although similar, especially on revenue recognition, there are a couple of subtle differences which we are working out right now.

To give an estimate <unk> long term protection.

That's very helpful. Thank you.

No there.

Thank you we have two more questions on your next question comes from the line of Daniel.

Thanks.

Yes, good afternoon, and thanks for taking my questions.

So congratulations from my side on this achievement.

And two questions on Q1, six two if I may.

The first one on on the interim analysis.

Ugur Sahin: And once we know what piece flows through which line item on the P&L, it will give you guidance so that you can actually model this out a little bit more subtly. Great. And then, um, some questions I asked about the, uh, Assessment of long-term protection if the child is unblinded. Can you comment on that as well? Thank you. Yeah, so the key reason for potential unblinding, of course, is that with this efficacy, of course, at a certain time point, we have to offer the vaccine to the placebo group as well. And we will continue to monitor the new infections in the vaccine arm, and this might give us indirect evidence, based also on comparison of epidemiological data, of how this long-term protection would evolve.

Can you talk about the phasing coffee.

So COVID-19 cases in the vaccine did.

Colorado at the beginning of the final more towards the end if you have to say that on already.

And my second question would be on and on the gross profit per.

Dose basically two assuming whats your sense on on potential pricing assumptions for modeling purposes.

How should we think about the gross profit.

But was there any kind of guidance you can you can give us.

Thing aside how your book you'd actually than the gross profit a problem from Pfizer potentially thank you.

Yes. Thank you for the question I can create T onset of first one as well has pointed out the interim analysis.

Was the Verizon deal in one it was really about assessing the primary end point and Ah in particular, we asked the blinded ones have not any further information or we have to wait a couple of weeks so that the final analysis and all that.

Ugur Sahin: And so we are confident that this two-year follow-up, including a follow-up of neutralizing antibody titers in a subgroup of subjects, would allow us to give an estimate of long-term protection. This is very helpful. Thank you. You're welcome. Two more questions and you're next, on the line for Daniel Wendel. Good afternoon, and thanks for taking my questions. Also, a big congratulations from my side on this achievement. Two questions on BMT162, if I may. The first one on the interim analysis, can you talk about the phasing? [inaudible] Do you have the state at all already? And my second question would be on the gross profit per dose, basically, you assuming what you said about potential pricing assumptions for modeling. How should we think about the gross profit? Is there any kind of guidance you can give us in general putting aside how you book eventually?

The specified assessments, including also that her understanding off the kinetics of Oh, when cases evolved a it's a it's available for us.

Well the second I guess I have to do that to to to Ryan onset.

Yeah sure I can I can take it up Unfortunately, Daniel we can't provide.

An updated gross margin guidance at this point, it's going to depend on of course mix ultimately and sales, but we will plan to provide a further update as we get closer to commercialization.

Okay fair enough. Thank you.

Thank you and your final question today comes from the line of Oh, Yes.

Brian Goldner.

<unk>.

Good afternoon, and congratulations and many many things on all the hard work I have two questions one on closed.

Operator: then the gross profit share from Pfizer. Yes, thank you for the questions. I can quickly answer the first one. As Ugur has pointed out, the interim analysis was a very lean one.

Well the vaccine.

Thinking about a potential upcoming EEI submission well you can see due to fly all our rights have to sufficient safety data.

Ozlem Tureci: It was really about assessing the primary endpoint. And in particular, we as the blinded ones have not got any further information. We have to wait a couple of weeks so that the final analysis and all the pre-specified assessments, including a better understanding of the kinetics of when cases evolved, are available for us. For a second, I guess I have to defer to Ryan or Ozlem.

I was if he can see which basically it takes you a data available at that point or would you wait for the food out a was a 164 events.

I think your public restaurant. So so this is really very agencies specific and we have been and close the entire action with all the agencies, including F.D.A. and and he might and M.H.R.A. and and others from the very beginning and.

Ryan Richardson: Yeah, sure, I can, I can take it. Unfortunately, Daniel, we can't provide an updated gross margin guidance at this point. It's going to depend, of course, on mixed, ultimately and sales, but we will plan to provide a further update as we get closer to commercialization. Fair enough, thank you. And your final question today comes from the line of Olga Slemenca, Brian. Good afternoon, and many congratulations and many, many thanks for all the hard work. I have a few questions, one on.

Has their respective specifications, which type of data.

They want to see a with regard to EMA for Exxon to you May know that we are we have we have started actually a rolling submission.

At some time ago, and Oh, complementing batch and subsequent rose for <unk> S. T. A oh for you a approve of that so for example, the key safety end points of the F.D.A. wants to see and we are hearing.

Ugur Sahin: COVID-19 vaccine. Thinking about potential upcoming EUA submissions, would you consider filing right after sufficient safety data with efficacy data available at that point, or would you wait for the full readout with 164 events? Thank you for the question. So this is really very agency specific, and we have been in close interaction with all agencies, including FDA and EMA and MHRA and others, from the very beginning and have the respective specifications for the type of data they want to see. With regard to EMA, for example, you may know that we started a rolling submission some time ago and are complementing that in subsequent roles for the FDA for EUA approval. There are, for example, key safety endpoints the FDA wants to see, and we are adhering to those requests of the respective agencies with regard to when and what exactly to file. Okay, thank you. And maybe...

Two of those three weeks that offer.

ER respective agencies with regard to when and what exactly to find.

Okay. Thank you and maybe Oh.

Oh, I when I might expect additional stability data and maybe could you I stick Leach what do you expect to see a like potential stability at minus two in your longer stabilities situated temperatures in nature.

Yeah. So a number of stability studies are ongoing we have stability studies, including minus 10 to minus 40 degree that's better stability studies to support to extend that extend that extend that storage at two to eight degrees. So it.

The everywhere has continuous updates on the stability stability studies expecting expecting the next update sometime in mid December.

Ugur Sahin: When might we expect additional stability data, and maybe could you speculate what they expect to see, like potential stability at minus three, no longer stability at refrigerated temperatures, etc. Yeah, so a number of stability studies are ongoing. We have stability studies including minus 20, minus 40 degrees, as well as stability studies to support extended storage at 2 to 8 degrees.

Okay. Thank you and just a quick one on odd being keys to me when one deal on an awful lot of divestiture for the responded to patients or do you have any visibility on the PDL one status.

And for those that we see EPS, Brian a checkpoint inhibitors, even more considered sort of non responders or our other developed a quieter resistance.

[noise] Sylvie we had several cases.

Ugur Sahin: So we will have continuous updates on the stability studies, expecting the next update sometime in mid-December. Great, thank you. And just a quick one on BNT311, PD-L1-400B-Y specific. For the responded patients, do you have any visibility on the PD-L1 status? And for those that received prior checkpoint inhibitors, if they were considered sort of non-responders or rather acquired resistance, so we had several cases where patients did not respond at all to initial checkpoint blockade treatment and progressed under treatment. We do not so far have a correlation between the objective responses that we have observed and the PD-L1 status of the original tumor.

The patients patients did not respond at all to initially not checkpoint blockade treatments and and progress on the under treatment.

So far do not have a call date, a correlation between the objective responses that you have ups and to P.D. as I'm state because of the ore to know tumor.

That's clear thank you.

<unk>.

Thank you that was your final question.

Thank you for joining the call today.

We look forward to speaking to you in Q2 can you and have a nice day bye bye.

Thank you. Thank you [laughter] and that does conclude your call.

Thank you.

Okay and you may now disconnect.

Ozlem Tureci: That's clear, thank you. Thank you for joining the call today. We look forward to speaking to you in the future. Thank you and have a nice day. Bye-bye.

[music].

Thank you. Thank you. Thank you. Thank you all for participating and you may now. ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??