Q2 2021 BioNTech SE Earnings Call
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Thank you for standard by them welcomes the buy on Tech second quarter 2021 update call at this time all participants are in a listen only mode.
Operator: by and welcome to the BioNTech second quarter 2021 update call. At this time, all participants are in a listen-only mode. There will be a presentation, followed by a question and answer session. To ask a question during the session, you will need to press star one on your telephone.
There will be a presentation followed by a question and answer session to ask a question. During the session you will need to press star 1 on your telephone I must advise you. The call is being recorded today on Monday, the 19th of August 2021 I would now like to hand, the call over to your Vice President of Investor Relations and strategy still come on please go.
Operator: I must advise you the call is being recorded today on Monday, the 9th of August, 2020. I would now like to hand the call over to your Vice President of Investor Relations and Strategy, Silke Maas. Please go ahead.
Ahead.
Good morning, and good afternoon. Thank you for joining us today to review biotech second quarter 2021 operations broke with financial results.
Silke Maas: Good morning and good afternoon. Thank you for joining us today to review BioNTech's second quarter. One, Operations Brokers and Financiers. Before we start, we encourage you to view the slides for this webcast, as well as the operational and financial morning, both of which are accessible on our website, on slide two during today's presentation. We will be making several forward-looking statements, including but not limited to our current estimated COVID-19 vaccine revenues based on current supply orders and our estimated continued global demand for our COVID-19 vaccines, our target vaccine production capacity for 2021, and our ability to supply our COVID-19 vaccines.
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 web.
But in the investors section.
As shown on slide 2 during today's presentation.
We'd be making several forward looking statements.
These forward looking statements include but are not limited to our current estimated COVID-19 vaccine revenues based on current contracted supply order.
Estimated financial results for 2021.
Continued global demand for our COVID-19 vaccine or target vaccine production capacity for 2021 and B zone.
Our ability supply of a COVID-19 vaccine for planting next step in our pipeline broke on the timing for enrollment in the stage of completion and reporting of data from Pelican cooked right on the other risks described in our filings made with the U S Securities and Exchange Commission, including our most recent annual report on form 20-F.
Silke Maas: The planned next steps in our pipeline program, the timing for enrollment, and data from our clinical trials. Other words describing our findings, including our most recent annual report. The actual results could differ from those we currently have. You are therefore cautioned not to blaze under reliance on any forward-looking statements, And only as of today, share today. Also, please note..., three and four provide.
Actual results could differ from those we currently anticipate.
Therefore cautioned not to place undue reliance on any forward looking statements, which speak only as of today share today. During this conference call on webcast.
Also please note that's not 3 and for provide you tell an important safety information regarding our COVID-19 vaccine.
I'm joined today by our CEO and cofounder was on E.
Silke Maas: I'm joined today by our CEO and co-founder, Ugur Sahin; Ozlem Tureci; co-founder, Jean Marit; our Chief Business and Commercial Officer, Jens Holstein; Financial Officer, Ryan Richardson; our Chief Strategy Officer, and Luke Petting, our Chief Operator. I now turn the call over to Ugur. Thank you, Silke.
For us now to Ritchie, our Chief Medical Officer, and cofounder Maverick, our Chief commercial officer cancellation on our Chief Financial Officer, Ryan Richardson, Chief strategy Officer for putting our Chief operating officer.
I'll now turn the call over to Wes I E.
Thank you.
Ugur Sahin: Good morning and good afternoon, and thank you to everyone joining the call today. On slide six, I will provide an update on the last quarter's performance before inviting my team to go into further detail. Our performance in the second quarter continues to be strong as we transform BioNTech and accelerate our pipeline of novel immunotherapies. I'm happy to report that we and our partner have crossed the one billion mark for COVID-19 vaccine doses shipped worldwide. We still have further to go to reach our ambitious targets for the full year, but we are on track with where we wanted to be at this time.
Good morning, and good afternoon, and thank you for everyone joining the call today.
Slide 6 I will provide an update on the last quarter's performance before embarking on my team to go into further detail.
Our performance in the second quarter continued to be strong has been confirmed by on the tech.
And accelerate our pipeline of novel Immunotherapies.
I'm happy for a big part debt D and our partner have crossed the 1 billion Mark for COVID-19 vaccine doses shipped back but.
It's gonna have to further to go to reach our ambitious targets for the full year.
But we are on track with where we wanted to be at this time.
Ugur Sahin: We are truly humbled by the impact our vaccine and our company is having in addressing the global pandemic. We have also had a strong first half year in terms of the number of new trial starts in oncology as we accelerate the development of our bold pipeline. But then we'll go into further detail and some of this new task in a prepared remark. Moving to slide seven.
They are truly humbled by the impact our vaccine and our company is having in addressing the global pandemic.
We have also had a strong.
Yeah.
In terms of the number from you with price stance in oncology as the accelerated development of our both pipeline.
Assembly going further on new paid on some of this new accounts in our Pud.
Cash remarks.
Moving to slide 7.
Ugur Sahin: Our strategy remains focused on developing a broad pipeline of next-generation immunotherapies and vaccines and bringing them to people worldwide to address unmet medical needs in cancer, infectious disease, as well as a growing list of other diseases. To accomplish this, we are building a fully integrated global immunotherapy company, anchored around deep expertise in immunology and complemented by an expanding set of capabilities. To be more concrete, here is what this means.
Our strategy remains focused on developing a broad pipeline of next generation Immunotherapies and vaccines.
And bring them to pizza, but to address unmet medical need in cancer infectious disease.
They're in a growing this.
Other diseases.
To accomplish this we are building a fully integrated global immunotherapy company.
And kind of on deep expertise in immunology and complemented by an expanded an expanding set of capabilities.
To be more concrete Russ what this means.
Ugur Sahin: In addition to shipping more than 1 billion doses of our first authorized product in the second quarter, we expanded our oncology pipeline to a total of 15 clinical-stage programs and 18 ongoing trials. I expect our partners to continue to expand as we broaden our research and development and initiate additional clinical trials over the next 12 to 24 months. We are also increasing investment to strengthen our cost capabilities, including our digital technology spectrum.
In addition to shipping more than 1 billion doses of our first authorized products in the second quarter, we expanded our oncology pipeline to torture.
Deep clinical stage programs and 18 ongoing costs.
I expect our pattern to continue to Borden is the bolt on our research and development and initiate additional clinical costs over the mix, but to 24 months.
We are also increasing investment to strengthen our capabilities, including our digital technology standpoint.
Ugur Sahin: In the first half of the year, we have initiated a number of new research and development projects which aim to exploit the power of artificial intelligence and machine learning technologies across our research and development organizations to discover and optimize new immunotherapies. BioNTech will become a technology company of the coming age, exploring and exploiting innovations at the border of various emerging technologies. We believe in a future where our innovations can make a difference for many people around the world with diseases that cannot be effectively treated today.
In the first half of the year.
<unk> initiated a number of new research and development projects, which aim to exploit the power of artificial intelligence and machine learning technologies across our research and development organization to discover.
To optimize new Immunotherapies.
<unk> will become a technology company of the coming age.
Blogging and exploring innovations at the border of very describes in Russia for Ya.
We believe in our future that our innovation can make a difference for many people that answer but there's this thesis that cannot be effectively treated today.
Finally to accelerate the accomplishment of this objective we have continued to hire exceptional people around COVID-19 going.
Ugur Sahin: Finally, to accelerate the accomplishment of these objectives, we have continued to hire exceptional people around the world, growing our firm to more than 2,500 team members in Europe, North America, and now Asia. We remain focused on innovating and accelerating our pipeline with the aim of launching multiple products in the next five years. Slide 8 shows the key highlights for the second quarter.
To more than 2 towers with price on the team members in Europe, North America, and now Asia.
We remain focused on innovating on accelerating our pipeline.
The aim launching multiple products in the mixed price yes.
Slide 8 shows shows the key highlights for the second quarter.
Starting this COVID-19, we have now distributed vaccine doses to northern run on the countries and regions globally.
Ugur Sahin: Starting with COVID-19, we have now distributed vaccine doses to more than 100 countries and regions globally, as of July 21st. We and our partners have signed supply contracts for delivery of approximately 2.2 billion doses in 2021. In addition, we have committed to supply more than 2 billion doses of our vaccine to low and middle-income countries between this year and the next. This is a considerable commitment that is only possible due to the investment we have made with our partners over the past 12 months to continuously increase our joint manufacturing capacity, now well over 3 billion doses per year. In oncology, we have initiated six trials in the first half of 2021. This includes randomized phase 2 trials for our BNT111 six-vac in checkpoint-inhibitory refractory melanoma and for BNT113 six-vac in HPV-positive head and neck cancer.
As of July 31st, we and our partners signed supply contracts for delivery of approximately $2.2 billion in 2021.
So we are committed to supply more than 2 billion doses of a vaccine for low and middle income countries between this year and the mix.
This is a considerable commitment that is only possible due to the investment we have made with our partners over the.
Past customers to continuously increase our John on infection capacity now being.
That's over 1 billion doses per year.
In oncology, we have initiated 6 price in the first half of 'twenty 'twenty 1.
This include randomized phase II price for.
Our BNP run 11, 6 spec in checkpoint inhibitor refractory melanoma and for BNP 113, 6 back in HPV positive head and neck cancer.
Ugur Sahin: For our INS program, BNT-122, we began screening patients in our phase two trial for adjuvant colorectal cancer. In addition to these later-stage trials, we initiated first-in-human trials for the first program on three novel platforms in the first half of the year. This includes our third CARBAC-CaTESER program, our NeoSTEM ex vivo T-Cell program, and the first program from our ribocytokin platform where we target cytokines in vivo using messenger RNAs. All of these programs are targeting solid tumors and are wholly owned by BioNTech. We welcome Jens Holstein as our new CFO. He joined our executive management team on July 3rd. Jens is an accomplished executive who brings deep experience as a financial steward and operator.
For IMF program BNP, 1 tended to be begun screening patients in our phase II trial for.
For <unk> in colorectal cancer.
In addition to this latest cash card the initiated first in humans cut for the first program from <unk> and other platforms in the first half of the year.
This includes our first <unk> car T cell program.
EMEA Neostem ex vivo T cell program and the first program.
From our hydro cytokine platform.
For the encode cytokines in vivo using message on me.
All of these programs are targeting solid tumors.
Wholly owned by <unk>.
Yes, hearthstone as our new CFO with giant our executive management team on July <unk>.
Yes is an accomplished executive who brings deep experience financial steward and operator.
Ugur Sahin: His appointment will enable Zerk to fully focus on his role as COO going forward. We recorded Q2 revenues of approximately €5.3 billion, driven by the ramp-up of COVID-19 vaccine production and delivery worldwide. Finally, we recently announced the acquisition of CUT's personalized TCR research and development platform and the clinical stage cell therapy manufacturing facility in Gettysburg, Maryland, in the United States. This transaction strengthens our position in cell therapy by giving us a turnkey clinical stage cell therapy manufacturing site on both sides of the Atlantic.
As a punishment enables them to fully focus on this for as COO going forward.
We recorded Q2 revenues of approximately 5.3 billion euros.
<unk> by the ramp up of the COVID-19 vaccine production and deliberately Bert but.
Finally, the recently announced acquisition of cuts personalized TCR research and development platform and the clinical stage cell therapy manufacturing facility and get this book.
Netherlands in the United States.
This price actions strengthened our position in cell therapy by giving US a turn key clinical stage cell therapy manufacturing side on both sides of Atlantic.
The size of the support our volume clinical stage cell therapy pipeline.
Ugur Sahin: The site will support our clinical stage therapy pipeline. The acquisition will also provide us with a team of more than 50 highly specialized cell therapy experts and a personalized TCR platform, which complements our pipeline of individualized cancer therapies on which we aim to build a long-term leadership position.
The acquisition will also provide us with a team of more than 50 highly specialized setup expert and personalized TCR platform, which complements our pipeline of individualized cancer therapies.
We aim to build long.
Our long term leadership position.
Turning to slide 9.
We see infectious disease at the long term growth pillar for by Olympic.
We believe the technology behind COVID-19 vaccine has the potential against a range of other infectious diseases.
Ugur Sahin: We see infectious disease as a long-term growth pillar for BioNTech. We believe the technology behind the COVID-19 vaccine has the potential to be used against a range of other infectious diseases, as well as the potential to play an important role in future pandemic preparedness talks. They are investing in mRNA vaccine programs to address diseases with a massive health burden, in particular in lower income countries, such as malaria, tuberculosis, and HIV. As part of this, we recently announced our plan to develop sustainable solutions to address infectious diseases on the African continent.
Debt at <unk>.
Potential to play an important role in future pandemic preparedness talk on.
They are investing on a vaccine programs to address the thesis is the message.
Net.
In particular in lower income countries, such as malaria tuberculosis and HIV.
As part of this we recently announced our plan to develop sustainable solutions to address infectious disease on debt.
Africa continent.
We aim to develop the first on on it exceeds the durable protective immunity for prevention of malaria.
Initiation of a clinical path by the end of 'twenty 'twenty 2.
Malawi, the deceased debt FX more than 200 million people growth side every year diverse affected being young children will have no immunity against this pathogen.
Ugur Sahin: We aim to develop the first mRNA vaccines with durable, protected immunity for the prevention of malaria with the initiation of a clinical trial by the end of 2022. Malaria is a disease that affects more than 200 million people worldwide every year, the worst affected being young children who have no immunity against this pathogen.
Our malaria project is part of the epic eradicate malaria initiative by the <unk> Foundation.
The second layer of our malaria project is dedicated to the development of sustainable vaccine production and end to end supply solutions on the African continent.
We are exploring possibilities for establishing state of the art.
Manufacturing facilities in Africa.
Our partners or on our own.
Our ethics price.
But by the John Convening power of the W. H O and the Africa centre for disease control and prevention.
Ugur Sahin: Our Malaria Project is part of the Eradicate Malaria Initiative by the CanUp Foundation. The second layer of our Malaria Project is dedicated to the development of sustainable vaccine production and end-to-end supply solutions on the African continent. We are exploring possibilities for establishing state-of-the-art M&A manufacturing facilities in Africa, either with our partners or on our own.
Besides the W H or the European Commission and other organizations have been involved in the early planning phase on malaria project and offered their support to identify it and set up needed infrastructure.
As a reminder, we have multiple product candidates in preclinical development for tuberculosis and HIV in collaboration with the Bill and Melinda Gates Foundation.
We plan to start the clinical follow up for book, an order for vaccine candidate in 2022, only about 2.5 years.
Ugur Sahin: Our efforts are supported by the joint convening powers of the WHO and the Africa Centre for Disease Control and Prevention. Besides the WHO, the European Commission, and other organizations have been involved in the early planning phase of our malaria project and offered their support to identify and set up needed infrastructures. As a reminder, we have multiple product candidates in preclinical development for tuberculosis and HIV in collaboration with the Bill & Melinda Gates Foundation.
The initiation of the research program.
As part of our collaboration with the University of Pennsylvania, We are developing after tenant messenger RNA vaccine candidates for various infectious diseases.
On unmet medical need with multiple programs in preclinical development, we expect for bringing the first product candidate in the clinic by the next year.
Finally, BMT 161 day influenza vaccine program from our partner.
<unk> expects to initiate the first in human trial.
Third quarter of 2021.
They are eligible to receive milestone payments and up to double digit for biopsies for this program for our licensing agreement this time zone.
On slide 10, we show a depiction of the toolkit, we are building across our technological platform, which includes a diverse range of potentially first in class third party.
Ugur Sahin: We plan to start the clinical trial for our tuberculosis vaccine candidate in 2022, only about 2.5 years after initiation of the research. As part of our collaboration with the University of Pennsylvania, we are developing up to 10 messenger vaccine candidates for various infectious diseases assigned an unmet medical need, with multiple programs and preclinical developments.
Approaches.
But our focus historically has been on immuno oncology, we are investing to expand the application spectrum technology toolkit to address an even broader range of immunological targets and mechanisms of action.
This means building out our platforms and EBIT developing new complementary reported with Thomas the power of the immune system.
Ugur Sahin: We expect to bring the first product candidate to the clinic by the next year. Finally, BNT161, the influenza vaccine program. Our partner, Pfizer, expects to initiate the first in-human trial in the third quarter of 2021. We are eligible to receive milestone payments and up to double-digit royalties for this program through our licensing agreement with Pfizer.
To conclude on slide 11.
We believe that the broad spectrum of our technology.
Enable us to bring forward new product paradigm that has the potential for bolt on the disease.
Awesome.
Beyond oncology and infectious disease for allergy autoimmune disease and inflammatory diseases and.
And even without generative medicine.
We believe that the new product paradigms that <unk> has the potential to expand on traditional top quality supported.
Ugur Sahin: On slide 10, we show a depiction of the broad toolkit we are building across our technology platform, which includes a diverse range of potentially first-in-class therapeutic approaches. While our focus historically has been on immuno-oncology, we are investing to expand the application spectrum of our technology toolkit to address an even broader range of immunological targets and mechanisms of action. This means building out our platforms and even developing new complementary approaches that harness the power of the immune system. To conclude, slide 11.
This includes mrna vaccines for other infectious diseases, where we believe our technology has the potential to improve efficacy.
For disability beyond what has been a cheaper bovis other modalities.
You also see the opportunity for new modalities, such on <unk> cancer vaccine or immunotherapy based on mrna encoded protein such as our IPO net and hypothetical platforms.
And finally, we believe our toolkit quickly.
Quickly to new disruptive modalities at the intersection of <unk> therapy, such as our Kovack approach that we use M&A to address T cell persistence in vivo.
Ugur Sahin: We believe that the broad spectrum of our technologies will enable us to bring forward new product paradigms that have the potential to broaden the disease horizon beyond oncology and infectious disease to allergy, autoimmune disease, and inflammatory diseases, and even regenerative medicine. We believe that the new product paradigms that we are creating have the potential to expand traditional therapeutic approaches.
We will continue to combine our immuno oncology expertise in power for seat of technology to unlock this new tower partake universe of opportunities.
I will now turn the call over to Sean who was that.
Provide updates on our COVID-19 program.
Thanks Nicole.
Pleasure to be speaking with everyone today.
Our partnerships with Pfizer and Fosun pharma have enabled us to establish a global development program on distribution network.
It remains our goal to deliver as many doses of our COVID-19 vaccine as possible to people around the world to help in this pandemic and facilitate the return to a normal life.
Ugur Sahin: This includes mRNA vaccines for other infectious diseases, where we believe our technology has the potential to improve efficacy or producibility beyond what has been achievable with other vaccine modalities. We also see the opportunity for new modalities such as mRNA-therapeutic cancer vaccines or immunotherapies based on mRNA-encoded proteins, such as our Ribonep and Ribocetakine platelets. And finally, we believe our toolkit could lead to new disruptive modalities at the intersection of mRNA and cell therapy, such as our CARB-1 approach, where we use mRNA to address T-cell persistence in vivo.
As the leading provider of COVID-19 vaccines globally, the demand for our vaccine remains high.
We have a strong order book in place for 2021 on several contracts already signed for 2022 and beyond.
Shown on slide 13.
Discussions for additional contracts remains ongoing.
As of the 21 July.
Along with Pfizer secured orders for approximately $2.2 billion doses of the vaccine to be delivered in 2021.
We expect the number of doses to continue to grow through additional orders.
For example, we recently announced that the U S government purchased an additional 200 million doses, bringing the total number of doses under the existing supply agreement to $500 million.
Ugur Sahin: We will continue to combine our immuno-oncology expertise and a powerful suite of technologies to unlock this new therapeutic universe of opportunity. I will now turn the call over to Sean, who will provide updates on our COVID-19 program. Thanks, Ugur.
We expect to deliver $110 million of the additional doses.
By December 31.2021.
And the remaining 90 million doses no later than April 20th 2022.
Sean: It's a pleasure to be speaking with everyone today. Our partnerships with Pfizer and Fosun Pharma have enabled us to establish a global development program and distribution network. It remains our goal to deliver as many doses of our COVID-19 vaccine as possible to people around the world to help end this pandemic and facilitate the return to normal life. As a leading provider of COVID-19 vaccines globally, the demand for our vaccine remains high. We have a strong order book in place for 2021 and several contracts already signed for 2022 and beyond, shown on slide 13. Discussion for additional contracts remains ongoing.
We also have a contract to supply 900 million doses to the European Union for the years 2022 to 2023 inclusive.
With an option for an additional 900 million doses.
This is a historic development as it is the largest supply contract in the history of the pharmaceutical industry.
We have also contracted for more than 1 billion doses of our COVID-19 vaccine to date for 2022.
Beyond.
Both the United States government on the European Commission also have the option to and acquire to acquire an updated version of the vaccine.
Address potential variance and also unique formulations.
Saleable and authorized.
We are serious about our responsibility to help combat COVID-19 globally and are committed to ensuring that low and middle income countries. Many of which are experiencing serious outbreak receive our vaccine.
We anticipate that a significant amount of the remaining 2021 vaccine manufacturing capacity will be delivered to middle and low income countries, where we price.
Sean: As of the 21st of July, we, along with Pfizer, have secured orders for approximately 2.2 billion doses of the vaccine to be delivered in 2021. We expect the number of doses to continue to grow through additional orders. For example, we recently announced that the U.S. government purchased an additional 200 million doses, bringing the total number of doses under the existing supply agreement to 500 million. We expect to deliver 110 million of the additional doses by December 31st, 2021, and the remaining 90 million doses no later than April 20th, 2022.
In line with income levels.
For other not for profit price.
To this end as <unk> mentioned, we have pledged 2 billion doses over the next 18 months to ensure global acoustical vaccine access.
This includes our plans to provide the U S government 500 million doses of our COVID-19 vaccine.
No.
Not for profit price.
Of which 200 million doses are in 2021.
On 300 million doses.
First half from 2022.
The U S government will intern donate the price would be on tech vaccine doses to lower and middle income countries on organizations that support.
This will further support our multilateral efforts to address the surge of infections in many parts of the world.
Recently, we along with our partner <unk> announced that we had signed a letter of intent to.
Sean: We also have a contract to supply 900 million doses to the European Union for the years 2022 to 2023, inclusive, with an option for an additional 900 million doses. This is a historic development, as it is the largest supply contract in the history of the pharmaceutical industry.
To collaborate with.
<unk> for the manufacture and distribution of our COVID-19 vaccine in Africa.
On vaccine doses manufactured at this new CMO site will exclusively be distributed within the 55 member States to makeup the African Union.
Moving now to slide 40 as well.
Sean: We have also contracted for more than 1 billion doses of our COVID-19 vaccine to date for 2022. Both the United States government and the European Commission also have the option to acquire an updated version of the vaccine to address potential variants and also new formulations, which is available and author. We are serious about our responsibility to help combat COVID-19 globally and are committed to ensuring that low and middle income countries, many of which are experiencing serious, receive all of that.
We have done on previous calls I will provide an update of our key leaders to expand the global reach about vaccine.
Starting with manufacturing.
We have been continuously increasing our capacity on the <unk>.
On Tech and Pfizer global supply chain and manufacturing network now spans 3 continents on increased more than 20 facilities.
At this time, we expect to have up to 3 billion doses manufacturing capacity in place by the end of this year and up to 4 billion doses capacity in 2022.
We will continue to expand our multi continent manufacturing capabilities in the future by establishing new facilities in additional geographies.
I just mentioned on new collaboration with biotech, which is located in Cape Town South Africa.
Sean: We anticipate that a significant amount of the remaining 2021 vaccine manufacturing capacity will be delivered to middle and low-income countries where we price it in line with income levels or at a not-for-profit price. To this end, as Ugur mentioned, we have pledged 2 billion doses over the next 18 months to ensure global equitable vaccine access. This includes our plan to provide the U.S. government 500 million doses of our COVID-19 vaccine at a not-for-profit price, of which 200 million doses are in 2021 and 300 million doses are in the first half of 2022.
On which will perform manufacturing and distribution activities in the region.
We and our partner Pfizer for immediately begun technology transfer onsite development on <unk>.
Quick installation.
At the new site.
As for.
Operational capacity buybacks annual fill and finish capacity will exceed 100 million doses.
Allowing for more rapid distribution across the African continent.
We expect to begin delivery of vaccine doses from this site by 2022.
In our efforts to expand our vaccine label to more population. We are pleased that we have received expanded authorizations for adolescents 12 years of age and older.
In the United States, the European Union and many other countries.
As we have discussed in detail previously we have multiple ongoing clinical trials to support further expansions.
Including in pregnant women and children age 6 months to 11 years.
Sean: The U.S. government will, in turn, donate the Pfizer-BioNTech vaccine doses to lower and middle-income countries and organizations that support them. This will further support multilateral efforts to address the surge of infection in many parts of the world. Recently, we, along with our partner Pfizer, announced that we had signed a letter of intent to collaborate with BioVac for the manufacture and distribution of our COVID-19 vaccine in Africa. All vaccine doses manufactured at this new CMO site will exclusively be distributed within the 55 member states that make up the African Union. Moving now to slide 14.
We expect data from the study in children 2 to 11 years in the third quarter of this year.
And data from children 6 months 2 years in the fourth quarter true this year.
If the results from the study are positive we expect to submit the data to regulators, including the FDA and EMA MAA for.
Potential label expansion for children 5 to 11 years old in the September to October 2021 timeframe from <unk>.
Soon after for children 6 months to 5 years.
On the regulatory front, our U S. BLA submission for a COVID-19 vaccine was recently accepted by the FDA and granted priority review designation.
The prescription drug user fee act or <unk> date.
For a decision by the FDA is in January 2022.
Sean: As we've done on previous calls, I will provide an update on our key levers to expand the global reach of our vaccine. Starting with manufacturing, we have been continuously increasing our capacity, and the BioNTech and Pfizer Global Supply Chain and Manufacturing Network now spans three continents and includes more than 20 facilities. At this time, we expect to have up to three billion doses of manufacturing capacity in place by the end of this year and up to four billion doses of manufacturing capacity in 2022. We will continue to expand our multi-continent manufacturing capabilities in the future by establishing new facilities in additional geographies.
The BLA includes clinical data from the pivotal phase III trial on of the vaccine.
Where the vaccine's efficacy and favorable side effect profile works amped up to 6 months after the second.
And we're also pursuing submissions for standard approval in additional countries for matching C. Authorizations are currently in place.
And China BLA submission is underway too.
In terms of optimizing vaccine formulations to simple slide global access.
We have received regulatory approval from both the EMA and FDA for storage at 2 to 8 degrees Celsius for up to 31 days on.
An ongoing phase III trial is evaluating ready to use and I authorized for organizations with data expected in the third quarter of 2021.
As we continue to learn about emerging periods.
<unk> for rapidly responding to the dynamics of the pandemic by adapting technology manufacturing and regulatory processes to ensure we continue to have a robust vaccine that protects you on humanity from COVID-19.
Sean: I just mentioned our new collaboration with BioVac, which is located in Cape Town, South Africa, and which will perform manufacturing and distribution activities in the region. We and our partner Pfizer have immediately begun technology transfer, on-site development, and equipment installation at the new site. At full operational capacity, BioVAX's annual fill and finish capacity will exceed 100 million doses, allowing for more rapid distribution across the African continent. We expect to begin delivery of vaccine doses from this site by 2022.
To address potential waning immunity and emerging viral verizon's, we have expanded trials to expand both payment on specific versions of BMT, 1 <unk> as well as the third dose of <unk> 106 to be too given 6 to 12 months after the.
Second dies.
Initial data from the <unk> boost to trial.
I've been recently disclosed on Earth and will now provide you further details on our but boosting and varian strategy.
I'll now turn the call over to outlook.
Thank you Sean to pick up flash on top we believe circulation of vaccine induced protection and cross protection against variance.
On interdependent outcomes.
Net 15 shows follow up data from Harlan not Tri Ed that enrolling more than 46000 participants at more than 150 sites around the hotel EBITDA.
<unk> efficacy to remain high at 91, 2% for up to 6 months following the dose 2 of our vaccine. After a 971 confront symptomatic cases of COVID-19, and the Tri Ed 889 cases, we're on.
Sean: In our efforts to expand our vaccine label to more population, we are pleased that we have received expanded authorizations for adolescents 12 years of age and older in the United States, the European Union, and many other countries. As we have discussed in detail previously, we have multiple ongoing clinical trials to support further labor expansion, including in pregnant women and in children aged 6 months to 11 years. We expect data from the study in children 2 to 11 years old in the third quarter of this year, and data from children six months to two years old in the fourth quarter.
In the placebo group and 82 cases, where <unk> hundred 60, <unk> group in the trial vaccine efficacy against so net net is that 6 months after the second thoughts at 95, 7%.
800 participants in South Africa, where the debt.
How variant was prevalent at that time 9 cases of COVID-19, with APE aimed at that time variant were observed in the placebo group demonstrating clinical protection again, that's true.
What about the debt half Ariane twitches plenty of major concern.
Net App server data sources to look into shown on slide 6.1 of neutralizing anti bodies, we constantly assess sara from vaccine with English Atkins and the Tri Ed.
Sean: If the results from the study are positive, we expect to submit the data to regulators, including the FDA and EMA, for potential label expansion for children 5 to 11 years old in the September to October 2021 time frame, and soon after for children 6 months to 5 years. On the regulatory front, our U.S. BLA submission for our COVID-19 vaccine was recently accepted by the FDA and granted priority review designation. The Prescription Drug User Fee Act, or PDUFA, dates for a decision by the FDA are in January 2022.
Ability to neutralize emerging varian.
Sarah from participants.
2 doses of <unk> hundred $62, 2 demonstrated conserved in vitro neutralizing activity against several variants of concern, including data and data related ones.
As shown in the last 10 years, while the neutralization titers against debt. Noah then against the origin of Strange Awac's 2000, Twenty's neutralization is still robust T cell responses.
Day of defense.
<unk> hundred 60, <unk> 2 targets multiple epitopes with index type protein sequences of the epitopes recognized by these key effects on us.
So on and aligned for 5 task of tool Neenah chips in Mexico on the top right showing that these ethical highly conserved across.
Iot of different variants, including the debt.
Sean: The BLA includes clinical data from the pivotal phase three trial of the vaccine, where the vaccine's efficacy and favorable side effect profile were observed up to six months after. They are also pursuing submissions for standard approval in additional countries where emergency authorizations are currently in place. In China, our BLA submission is underway too, in terms of optimizing vaccine formulations to simplify global access. We have received regulatory approval from both the EMA and FDA for storage at 2 to 8 degrees Celsius for up to 31 days.
Additionally, there is true.
Data from vaccine effectiveness that heads to assess protection against emerging variants.
For instance, starting by public cat and non England towards debt.
Vaccination with <unk> hundred 62002 was 88% effective against symptomatic disease from.
The debt half area and provided 96% vaccine effectiveness again hospitalization costs by the debt ovarian study from Canada from that for vaccination with <unk> hundred 62, B 2 resulted in the vaccine effectiveness against symptomatic infection from Delta.
On 87% and hungry for protection against hospitalization and.
Sean: An ongoing Phase III trial is evaluating ready-to-use and lyophilized formulations, with data expected in the third quarter of 2020. As we continue to learn about emerging theories... Our teams are rapidly responding to the dynamics of the pandemic by adapting technology, manufacturing, and regulatory processes to ensure we continue to have a robust vaccine that protects humanity from COVID-19 to address potential waning immunity and emerging viral variants. We have expanded trials to expand both variant-specific versions of BNT162b2, as well as a third dose of BNT162b2, given 6 to 12 months after the second. Initial data from the BNT162b2 booster trial have recently been disclosed. And Ozlem will now provide you with further details on our boosting and variance strategy. I'll now turn the call over to Ozlem. Thank you, Sean.
A nationwide survey in study <unk>.
Rising swap line for.
$5.4 million people from Scotland.
Tomato to net <unk> 62, B, 2 was 17, 9% effective against debt.
In July.
It has been extremely reported at <unk> $162, 2 mitigated effectiveness in presenting both infection and symptomatic disease had fallen to 39% from 60 for a 4% a year in July.
Effectiveness against severe COVID-19 disease, including prevention of hospitalization continue to be as high as 91, 4%.
Blaming vaccine effectiveness of theft in Israel, it coincides with the spread of data and the end of social distancing and restrictions and elsewhere.
<unk> set another important factor is that.
Already thought date of issuance vaccination program relative to the rest of the world and net many high risk populations had received a second dose more than 6 months prior to July.
<unk>, which increases the risk of infection in these individually.
Ozlem Tureci: To pick up where Sean left off, we believe that duration of vaccine-induced protection and cross-protection against variants are interdependent outcomes. Slide 15 shows follow-up data from our landmark trial that enrolled more than 46,000 participants at more than 150 sites around the globe. These data show vaccine efficacy to remain high, 91.2%, for up to six months following dose two of our vaccine. Of the 971 confirmed symptomatic cases of COVID-19 in the trial, 889 cases were in the placebo group, and 82 cases were in the BNT162b2 group.
The point I want to make is broadly speaking as of now evidence points to a robust vaccine effectiveness effectiveness against circulating variance.
Setting, including a high vaccine effectiveness against severe disease.
This across different geographies, such as top of cash measures and restrictions that are in place. We also have an impact on how this plays out in the REO or et cetera.
Continue to monitoring offering advanced data and Immunogenicity data, it's warranted to on that.
1 a boost or a variant adaptive X gene will be required which of course is at the discretion of growth. They have authority to be prepared for the scenario. That's a response to a variant of concern may become unnecessary zone, we are establishing free and carefully and development and <unk>.
On the Atari pathway for <unk>.
Marion specific prototype approach as shown on slide 17.
Ozlem Tureci: In the trial, vaccine efficacy against severe disease at six months after the second dose was 95.7%. In 800 participants in South Africa, where the beta variant was prevalent at that time, nine cases of COVID-19, with eight being the beta variant, were observed, all in the placebo group, demonstrating clinical protection against the beta. What about the Delta variant, which is currently a major concern? There are several data sources to look into, shown on the slide.
This approach also aims to address a question why not boosting with the SaaS type Yankee 162, B tool on.
He made.
<unk> are very ended that patients may be required.
On a prototype approach includes Walworth trains.
For us to evaluate a church stones of PNG 162, 2 and fully be on Q1.62 between vaccinated participant.
300 participants were assessed for safety and Immunogenicity and I'm going to show data on the next slide another 10000 participants will be assessed for efficacy of the first dose of <unk> 160, it will be 2 with data expected in Q4 this year.
Third ongoing try to evaluate safety and Immunogenicity of <unk> hundred 62, B tool or a better varian specific vaccine version of it and 340 <unk> hundred 60, <unk> will be to vaccinated participants. That's why that $2 is often debt has specific version and 300.
Ozlem Tureci: One is neutralizing antibodies. We constantly assess. There are from vaccine recipients in the trials for ability to neutralize emerging variants. Some participants who received two doses of BNT162b2 demonstrated preserved in vitro neutralizing activity against several variants of concern, including delta and delta-related ones, as shown in the left panel. While the neutralization titers against Delta are lower than against the original strain, USAWA 2020, the neutralization is still robust. T-cell responses are a second layout. Those elicited by BNT162b2 target multiple epitopes within this spike protein.
<unk> net income participants data from this trial is expected in Q3.2021 on.
Also we are planning to start to try on that wed evaluate debt have variance specific version.
I have very specific version and also 97 vaccine, including both versions of <unk> 160 <unk>. This trial will include about 600 estimated participants and 300 net net participants data from the Tri Ed as expected.
In Q4.
We expect the data from these trials for significantly enlarge our knowledge about vaccine protection and variance of concern and also help to inform the optimal path going forward pieces of data from our comprehensive and Davao impact already available at least.
Ozlem Tureci: The sequences of the epitopes recognized by these T-cells are shown and aligned for five SARS-CoV-2 lineages in the figure on the right, showing that these epitopes are highly conserved across a variety of different variants, including the Delta. Additionally, there is real-world data for vaccine effectiveness that helps to assess protection against emerging variants. A recent study by Public Health England found that full vaccination with BNT162b2 was 88% effective against symptomatic disease from the Delta variant and provided 96% vaccine effectiveness against hospitalization caused by the Delta variant.
From key published data from this first work stream is shown on slide 18, evaluating that administration offer for <unk> hundred 60, <unk> 2 dose 7 to 9 months after dose to the growth.
Ralph on the tough price. So it's not an elderly adults neutralization has almost for them to the level of detection by this essay after 7 to 9 months boosting with the share between 789 months after those tool induces robust neutral.
Neutralization with pumps.
1 what was originated after observed after accounts to sell.
Sarah obtained from participants 1 months asked on this dose range and it sets a high neutralization titers against the origin of this.
Ozlem Tureci: A study from Canada found that full vaccination with BNT162b2 resulted in a vaccine effectiveness against symptomatic infection from Delta of 87% and 100% protection against hospitalization. However, a nationwide surveillance study involving 5.4 million people from Scotland estimated that BNT162b2 was 79% effective against Delta. In July, the Israel Health Ministry reported that BNT162b2-mediated effectiveness in preventing both infection and symptomatic disease had fallen to 39% from 64% earlier in July, while effectiveness against severe COVID-19 disease, including prevention of hospitalization, continued to be as high as 91.4%. Waning vaccine effectiveness observed in Israel coincides with the spread of Delta and the end of social distancing restrictions in Israel.
Strength training.
And also against that that's how variant and for desktop and <unk>.
Neutralization titers against the debt of Orient, our OLED <unk> for those that those observed after the dose after those 2 and the age group 18 to 55 years and even over in asking for it in the order. It Scoop 65 to 85 year old as shown on the graph on the bottom line.
Furthermore, the difference and neutralizing titers against the interest rate environments and so that's how variant.
<unk> after subset dose compared to after the second dose implying that in addition to prolonged prolonging protection a booster dose may increase the breadth of neutralizing often neutralizing response against Sars Cov 2 variants.
And the third dose is safe and tolerant according to all day.
Each day.
Being price had for submission for a regulatory authority globally to support the potential introduction of a booster dose our first 1 in the product and foundation. We continue to believe it is likely that the correct dose with that may be needed within a 6 to 12 months.
After force explanation to maintain the highest level of protection. Therefore, we are in ongoing discussions with regulatory agencies regarding a potential faculty and staff of our current debt.
Ozlem Tureci: We believe that another important factor is the early start date of Israel's vaccination program relative to the rest of the world and that many high-risk populations had received their second dose more than six months prior to July, which increases the risk of infection in these individuals. So the point I want to make is, broadly speaking, as of now, evidence points to robust vaccine effectiveness against circulating variants in the real world setting, including high vaccine effectiveness against severe disease. Variables across different geographies, such as public health measures and restrictions that are in place, will also have an impact on how this plays out in the real world.
Transitioning to our oncology pipeline on slide 20.
We'll go ahead for <unk> already outlined our immuno oncology strategy.
Which is based on server for us in class immunotherapy approaches to modulate the immune response against cancer each of our last year of Puget platform has at least 1 product candidates in the clinic and several of our product candidates have a potential can be combined synergistic.
Other pipeline for growth.
Slide 21 provides updates on.
On select oncology programs, we now have 16 product candidates in clinical trials, including free sales to trends no I would expect that for them. We have started to phase 2 clients in the last 2 months.
We're discussing those programs and widen 10 in a few moments.
Ozlem Tureci: Continued monitoring of real-world data and immunogenicity data is warranted to understand when a booster or a variant-adapted vaccine will be required, which, of course, is at the discretion of global health authorities. To be prepared for the scenario that a response to a variant of concern may become necessary soon, we are establishing a preemptively a development and regulatory pathway for a variant-specific prototype approach, as shown on slide 17. This approach also aims to address the question whether boosting with the ancestral BNT162b2 only may suffice, or variant adaptations may be required.
Also anticipate dosing the first patient in.
I missed sales to try it in the adjuvant colorectal cancer setting in the second half of 2021, we expect data read outs across both of our next generation immune modulator.
<unk> <unk> hundred 12.
That we developed with our colleagues from Genentech.
That would be a data update for clotting 6 car T therapy.
211 in the second half off for a year.
Enrollment into a higher dose level.
It's ongoing and Thats why it and we have also treated for transportation with <unk> car T. He says in which the car X gene to selectively stimulate adopter flip transferred engineered engineered tests has been conducted.
PMT to 'twenty, 1 it's a second half CRP programs in solid tumors, which started first in human clinical testing for <unk>.
Moving now to slide 22, I will discuss our wholly owned <unk> platform, which has 5 product candidates for multiple indications in clinical trials.
Ozlem Tureci: Our prototype approach includes four works, and prefers to evaluate a third dose of BNT162b2 in fully vaccinated participants. 300 participants were assessed for safety and immunogenicity, and I'm going to show data on the next. Another 10,000 participants will be assessed for efficacy of a third dose of BNT162B2, with data expected in Q4 this year. The third ongoing trial evaluates safety and immunogenicity of BNT162b2 or a beta variant-specific vaccine version of it in 300 fully BNT162b2 vaccinated participants as well as two doses of the beta-specific version in 300 vaccine-naive participants.
Each 6 product candidate targets, a set of <unk> tumor associated antigens, which are commonly expressed that by a significant portion of patients in a given cancer type.
Now on a technology design elements newest force expect intuit on a backbone optimized for high protein yet augmentation of induction of innate immune responses RPX formulation for systemic absolute price.
Our RNA lipo plexus approach has been optimized for body wide delivery of tumor antigen.
Electricity.
<unk> compartment resident dendritic cells to induce strong T cell responses as shown on the bottom of this slide we have observed strong vaccine induced CDA T cell responses.
Ozlem Tureci: Data from this trial is expected in Q3 2021. Also, we are planning to start a trial that will evaluate a delta variant-specific version, an alpha variant-specific version, and also a multivalent vaccine, including both versions of BNT162b2. This trial will include about 600 vaccinated participants and 300 naive participants. Data from the trial is expected in Q4. We expect the data from these trials to significantly enlarge our knowledge about vaccine protection and variants of concern and also help to inform the optimal path going forward. Pieces of data from our comprehensive endeavor are, in fact, already available.
Trusts different cancer types against non mutated chats tumor associated antigens for melanoma and that <unk> been faithful on Tri Ed and for HPV 16 positive head neck cancer and will be on Q1 tracking based on trade it.
Our clinical trials and preclinical studies have demonstrated that <unk> stock price activates and expands our complementary reported on CD for MTBE <unk> said and also that these newly generated Keith said benefit from PD 1 blockade.
That's next themes based on non mutant tumor associated antigens may be of particular clinical utility in combination with anti PD 1 for tumor control in patients with no on rotational burdens, including those who have already.
<unk> checkpoint inhibitor therapy.
2.6 SEC programs, just moved in phase II trials, BMT 111 in checkpoint inhibitor refractory or resistant melanoma and beyond Q1, 13, and HPV 16 positive net net.
Ozlem Tureci: Recently published data from this first work stream is shown on slide 18, evaluating the administration of a third BNT162B2 dose seven to nine months after dose two. The graph on the top right shows that in elderly adults, neutralization has almost fallen to the level of detection by this assay after seven to nine months. Boosting with a third dose between 7 and 9 months after dose 2 induces a robust neutralization response beyond what was originally observed after dose 2. STERA obtained from participants one month after this dose read elicits high neutralization titers against the original ancestral strain and also against the beta variant and the delta variant.
Neck cancer. In addition, we have an ongoing phase 1 trial for our view on Q1.12 program in metastatic castrate resistant prostate cancer on.
Set out on slide 23.
Nearly 50% increase of melanoma globally over the last decade, and it is predicted that by 2025 for number off net and on my desk when it increased by a for about 20%.
But they can't see our cubic advancement, we've seen in the standard of care immune checkpoint inhibitor in particular for PD 1 blockade.
Why checkpoint.
And yet the testing needs to deliver.
It's upon us in a small fraction of patients and the majority of patients duration of response is short and more than half of the patients are refractory to all in all we lapse on immune checkpoint inhibitors, those who are refractory to <unk>.
Ozlem Tureci: Neutralization titers against the Delta variant are over 5-fold over those observed after dose 2 in the age group 18 to 55 years, and even over 11-fold in the older age group 65 to 85 years old, as shown in the graph on the bottom right. Furthermore, the difference in neutralizing TITUS against the ancestral virus and the beta variant narrowed after the third dose compared to after the second dose, implying that in addition to prolonging protection, a booster dose may increase the breadth of a neutralizing response against SARS-CoV-2 variants, and the third dose is safe and tolerant, according to our data.
These compounds on labs, havent, especially poor prognosis with survival as short as 6 months, depending on the risk hectares.
Oh I think for candidate PMT 111 on slide 24, and codes a fixed set of for shaft antigen covering more than 90% of cutaneous melanoma patients in 2020, we published promising preliminary data from our phase 1 to try it in nature.
<unk> as a monotherapy and in combination with anti PD, 1 showed a tolerable safety profile and durable objective responses and checkpoint inhibitor experienced melanoma patients with <unk>. We believe that these positive data provide compelling <unk>.
Ozlem Tureci: These data are being prepared for submission to regulatory authorities globally to support the potential introduction of a third dose, a third one, in the product information. We continue to believe it is likely that a third dose may be needed within six to 12 months after full vaccination to maintain the highest level of protection.
Part for PNG 111 in combination with anti PD 1.
In June 2021, and that was the <unk> program moved into a phase 2 trial in patients with anti PD, 1 refractory or relapsed unresectable stage for you all saw net adenoma.
This sales I try here, which we are conducting in collaboration with Regeneron as outlined on slide 2500, 20 patients will be randomized 2 to 1 to 1 in the from treatment.
Ozlem Tureci: Therefore, we are in ongoing discussions with regulatory agencies regarding the potential third dose booster of our current vaccine. Transitioning to our Oncology Pipeline on slide 20. Ugur has already outlined our immune oncology strategy, which is based on several first-in-class immune therapy approaches to modulate the immune response against cancer. Each of our therapeutic platforms has at least one product candidate in the clinic, and several of our product candidates have the potential to be combined synergistically with other pipeline molecules.
Evaluating the MQ111 in combination with Regeneron for Midland.
And each truck as a mono therapy. The primary endpoint is overall response rate in the beyond Q1, 11, plus sneaking up on them with a constant I was studying a success of state has shown an overall response rate of 30% and the duration of response of more than 15.
On slide 26, we have our 6 net product candidate <unk> for the treatment of HPV 16 positive head and neck cancer, Although for India, Ken says for the most common head and neck cancer type accounting for 70% of head and neck cancer and up to up to 90% of sales.
<unk> H.
Ozlem Tureci: Slide 21 provides updates on select oncology programs. We now have 15 product candidates and 18 clinical trials, including three phase 2 trials. On our six-factor platform, we have started two phase 2 trials in the last two months. I will discuss those programs in more detail in a few moments.
HPV 16 positive.
In contrast to other types of head neck cancer, HPV 16 positive Ken typically occur in young our pizza and it's not.
Our net associated with typical risk factors such as for backhaul at on the majority of patients are diagnosed at more advanced clinical stages and are usually treated with chemotherapy surgery and radiation.
Ozlem Tureci: We also anticipate dosing the first patient in our INIS Phase II trial in the adjuvant colorectal cancer setting in the second half of 2021. We expect data readouts across both of the next generation immune modulators, BNT311 and BNT312, that we developed with our colleagues from GEM, and there will be a data update for our Claudium VI CAR TCEF ULP BNT211 in the second half of the
From checkpoint inhibitors temporarily from up in Bordeaux map out for approved for treatment of recurrent or metastatic head and neck cancer and will need to have this approved as first line therapy in patients who present with unresectable or metastatic disease.
The historical overall response rates for importing some of our new volume up in a recurrent metastatic head and neck cancer are in the range of 13 planned for you to 17% for those patients who failed or progressed on checkpoint inhibitors. There are only limited treatment option.
We see a significant opportunity to improve for treatment landscape with PMT, 1 tracking that has the potential to augment clinical responses in patients being treated with checkpoint broadcasts.
Ozlem Tureci: Enrollment into higher dose levels is ongoing in that trial, and we have also treated the first patient with Claudine CAR-T cells in which the CARVAC vaccine to selectively stimulate this adoptively transferred engineered cells has been conducted. BNT-221 is our second cell therapy program in solid tumors, which started first in human clinical testing this year as well. Moving now to slide 22, I will discuss our wholly owned FIXRAC platform, which has five product candidates for multiple indications in clinical trials.
Moving to slide 27 on the empty 113 is designed to targets on web characterized HPV 16 <unk> oncoprotein.
<unk> thousand 7 these proteins are strongly into an authentic firing neo antigens that are found in HPV 16 positive started 2 months.
Our exclusively expressed in medicine says viola Oncogen oncogene, a commonly acknowledged it saved on promising targets for immunotherapy and half full and have proven to be highly immunogenic and are not subject to immune escape.
Ozlem Tureci: Each FIXRAC product candidate targets a set of shared tumor-associated antigens, which are commonly expressed by a significant portion of patients in a given cancer type. RNA technology design elements used for FIXVAC include an RNA backbone optimized for high protein yield, augmentation of the induction of innate and immune responses, and LPX formulation for systemic administration. Our RNA-lipoplex approach has been optimized for body-wide delivery of tumor antigens selectively to lymphatic compartment resident dendritic cells to induce strong T-cell recognition.
Moving behind number of patients with HPV 16 positive had a net cancer. While also PDL 1 positive. We believe that there is potential for synergistic anti tumor effect when <unk> is combined with checkpoint blockade.
Slide 28 shows early clinical data in HPV 16 positive head and neck cancer from our ongoing phase 1 to try it with strong vaccine antigen specific CD 8 and ask you for T cell responses and the majority of patients.
Shown in preclinical experiments.
Newly price Keith says benefit from immune checkpoint blockade. We have started <unk> phase 2 clinical trial shown on slide 29, and recently dosed. The first patients in the safety run in part and the subsequent trend on my part patients with Unresectable or recur.
Ozlem Tureci: As shown on the bottom of this slide, we have observed strong vaccine-induced CD8 T cell responses across different cancer types against non-mutated shared tumor-associated antigens for melanoma in the BNT1-11 phase 1 trial and for HPV16-positive head-neck cancer in the BNT1-13 phase 1 trial. Our clinical trials and preclinical studies have demonstrated that FIXVAC Primes activates and expands a complementary pool of CD4 and CD8 T-cells, and also that these newly generated T-cells benefit from PD-1 blockades. Thus, vaccines based on non-mutant tumor-associated antigens may be of particular clinical utility in combination with anti-PD-1 for tumor control in patients with a lower mutational burden, including those who have already experienced checkpoint inhibitor fears.
Current on net aesthetic and then Nick.
On top of cancer positive for HPV, 16, and expressing PD L..1 will be treated with <unk> on <unk> in combination with a checkpoint inhibitor for needs somewhat whereas this temporarily from up monotherapy as first line treatments overall survival and objective for us.
On slide a key endpoints of Australia with targeted median overall survival for 18 months and an overall response rate of 40% and the combination treatment.
We are quoting that helping a PCR based companion diagnostic to select patients for treatment with <unk>, which would be clinically validated as part of this trial.
Moving to slide 17, now I would like to provide a short update on our <unk> program BMD, 1 turnkey tool, which is partnered with Genentech growth beyond Q1, 2012 designed to target patient specific neo antigen centers or for the Internet.
Individualized cancer vaccine with 2 ongoing trials in metastatic cancer, we are now moving into the adjuvant treatment space.
Ozlem Tureci: Two FIXAC programs have just moved into Phase 2 trials, BNT1-11 in checkpoint inhibitor refractory or resistant melanoma, and BNT1-13 in HPV-16 positive head-neck cancer. In addition, we have an ongoing Phase 1 trial for our BNT1-12 program in metastatic, castrate-resistant prostates. On slide 23, there has been a nearly 50% increase in melanoma globally over the last decade, and it is predicted that by 2025, the number of melanoma deaths will increase by a further 20%.
Faced with triad.
In colorectal cancer being the first such indication.
The study will compare the efficacy of BNP you on 'twenty, 2 whereas it's watchful waiting in resected stage too high risk and stage III colorectal cancer patients for IFC TBN a positive following 3 to 6 months of adjuvant chemotherapy as standard of care for it.
As cleaning round, the circulating tumor DNA Archie TPN a state status of the patients will be determined for is its ability, which is the main risk sector for disease recurrence.
In a second screening of interest rotations Neo antigen selection based on the patient's individual tumor will be performed and P&G won 22 manufacturing will be initiated.
Ozlem Tureci: The latest therapeutic advancement we've seen in the standard of care are immune checkpoint inhibitors, in particular the PD-1 group. While checkpoint inhibitors lead to durable responses in a small fraction of patients, in the majority of patients, the duration of responses is short, and more than half of the patients are refractory to or relapse on immune checkpoint inhibitors. Those who are refractory to these compounds or have relapsed have an especially poor prognosis with survival as short as six months, depending on the risk factors.
But that's how it takes about 3 to 6 weeks why patients undergoing.
Mood with trades from 6 months of excellent standard of cats here.
China energy ability for the study will be assessed in there for <unk>.
Electrical patients will then be randomized 1 to 1 into the main treatment arms to compare the efficacy of the on Q1 'twenty 2 whereas this watchful waiting for patients and the experimenting on where we see 6 we see explanations for note by to be the weekly vaccination that on.
After a explanation will be given at least 6 weeks for up to 12 months.
Try it also has a biomarker cohort that includes patients irrespective of CTG and its status.
Second exploratory cohort will include patients who had for recurrent disease at best price screening patients in both of these cohorts will be dosed with the <unk> 22.
Ozlem Tureci: Our fixed-set candidate, BNT111, on slide 24 encodes a fixed set of four shared antigens covering more than 90% of cutaneous melanoma patients. In 2020, we published promising preliminary data from our Phase I-II trials in Nature. BNT111 as immunotherapy and in combination with NTLPD-1 showed a tolerable safety profile and endurable objective responses in checkpoint inhibitor-experienced melanoma patients with valuable disease. We believe that these positive data provide compelling support for BNT111 in combination with NTLPD-1.
Recruitment has started for the study and we anticipate dosing the first patients later this year.
Coming up next on slide 31, and <unk> cytokine kind platform, which is 1 of example of a high diversification of our RNA technology, which depending on the design elements, we choose from our toolbox to use it can be used for various purposes.
In this case, we use our new technology and coach Keith said on new aesthetic cytokine, which otherwise would be at munis that S recombinant proteins.
<unk> encoded by mrna and produced in the patient has the potential for improved safety and therapeutic efficacy and net more favorable cost of goods.
Mary Combatant 14 day counterparts.
We continent protein based Iot for example has been shown to India, Europe, and responsive income tumor types, but has significant drawbacks.
Ozlem Tureci: In June 2021, our BNT111 program moved into a Phase II trial in patients with N-type PD-1 refractory or relapsed unreflectable stage 3 or 4 melanin. This global trial, which we are conducting in collaboration with Regeneron, is outlined on slide 25. 120 patients will be randomized 2 to 1 to 1 in the free treatment arms, evaluating BNT111 in combination with Regeneron semiplimap and each drug as a monotherapy. The primary endpoint is overall response rate to BNT111 plus semiplimap.
Short half live try on frequent anti dosing associated with toxicities, such as infusion reactions and deliver on.
Our ride the cycle times are designed for improved Tom a quick genetic properties with us for a long see around half lives and tied by a Vegas index.
This allows for a lot less frequent dosing, which may result in better tone on us.
Alright arrival cytokines and corpus cytokine fused to human albumin the debt.
Our in APAC bone is optimized for high protein production and it is nucleoside modified and thus non Ian Hudson. The RNA is encapsulated in liver targeting and then piece that allows for intravenous systemic delivery shown on slide 32.
Half 2.
<unk> arrival cytokine product candidates.
In our clinical trials that feature on it too.
A key cytokine and key sales in unity supporting differentiation proliferation survival and effector functions of Keith said.
Ozlem Tureci: We will consider the study a success if data shows an overall response rate of 30% and a duration of response of more than 50%. On slide 26, we have our fixed product candidate BNT113 for the treatment of HPV-16 positive head and neck cancer. Pharyngeal cancer is the most common type of head and neck cancer type, accounting for 70% of head and neck cancers, and up to 90% of those cancers are HPV-16 positive. In contrast to other types of head and neck cancer, HPV-16 positive cancers typically occur in younger people and are not associated with typical risk factors such as tobacco or alcohol.
In addition for activating effector T cells.
I guess I had 2 as a physiological content on regulatory mechanism.
Activates suppressive, Frank if I can.
Terry T sets by a 1 of its fleet tagging on a receptor, namely the IL 2 receptor alpha swaps on it also referred to SGD 25 BMT.
<unk> 51, as a sequence modified IL 2 engineered to reduce binding to this unit was maintained binding to the other IL 2 receptor that's without extensively triggering immunosuppressive regulatory T cells, it's extra debt is sector and type.
Mark you said with a preference for those factors that have low to no expression of CD 25, as such we anticipate at <unk> 51 was an optimal combination partner for anti PD, 1 non anti PDL, 1 Cherokee with PMT $1.50.
Ozlem Tureci: The majority of patients are diagnosed at more advanced clinical stages and are usually treated with chemotherapy, surgery, and radiation. The immune checkpoint inhibitors Pembrolizumab and Ivolumab are approved for treatment of recurrent or metastatic head and neck cancer, and Pembrolizumab is approved as first-line therapy in patients who present with unresectable or metastatic disease. The historical overall response rates for pembrolizumab and nivolumab in recurrent metastatic head and neck cancer are in the range of 13.3 to 17 percent.
1 a phase 1 trial is ongoing.
Our PMT 150 to 153 product candidate has 2 components BMT won 50 free and quotes for net for I O tool, which maintained high affinity binding to a CD 25 positive he said.
Accordingly.
<unk> Suisse from X to date, it anti tumor T cells and regulatory T cells B on key 162, the second component of this product can be day in court I have 7 which tends at times as Keith said to either true wireless controls for a fraction of immune suppressive.
Regulatory T cells.
We believe the on Q1.52, plus 153 could be a potent combination for.
Our partner for cancer vaccines and vaccine induced T SEC.
High levels of CD 25.
Ozlem Tureci: For those patients who fail or progress on checkpoint inhibitors, there are only limited treatment options. We see a significant opportunity to improve the treatment landscape with BNT113 that has the potential to augment clinical responses in patients being treated with checkpoint blockers. Moving to slide 27.
We dosed the first patient in June 2021, and our first human phase 1 trial in patients with solid tumors. We plan to combine this combination of key said homeostatic cytokine with other products of our pipeline for example, with elastic search platform.
Now to wrap up my part for today, So excited for you, which highlights a number of key milestones.
So far this year, it's not as significant milestones we expect in the back half of 2021. In addition to our Microstat clinical updates from our COVID-19 vaccine program, we expect for more data updates for oncology programs. We have started 2 randomized phase 2 clinical trial.
Ozlem Tureci: The BNT1 protein is designed to target the well-characterized HPV16-derived oncoproteins E6 and E7. These proteins are strongly immunogenic viral neoantigens that are found in HPV16-positive solids. They are exclusively expressed in malignancy. Viral oncogenes are commonly acknowledged as safe and promising targets for immunotherapy, have proven to be highly immunogenic, and are not subject to immunization. Given the high number of patients with HPV-16-positive head and neck cancer who are also PD-L1-positive, we believe that there is potential for a synergistic anti-tumor effect when BNT1-13 is combined with a checkpoint blockade.
With 1 more expected to start in the second half of 2021, we have started to fall for us in human clinical trials of our diverse therapeutic programs and expect framework for this year. We have made significant progress with regard to accelerating our pipeline in the first half.
Yeah, and I look forward to updating you on upcoming milestones in the near future.
So I'll now turn over to our Chief financial Officer, and touch and Hartstein, who will discuss our financial results.
Thank you for them and a warm welcome to those of you on the phone.
I've been in my role a few weeks now and I'm delighted to have joined <unk> at this exciting time in the company's growth trajectory.
Ozlem Tureci: Slide 28 shows early clinical data in HPV-16-positive head and neck cancer from our ongoing Phase 1-2 trial with strong vaccine-antigen-specific CD8 and or CD4 T cell responses in the majority of patients. As shown in preclinical experiments, these newly primed T cells benefit from immune checkpoint blockade.
With great pleasure I look forward to supporting my colleagues you know on mission to make a significant impact on human health.
Let me now start my section by moving to our financial results for the second quarter of 2021 as shown on slide 35.
I'll start with total revenues estimated to be approximately 5.3 billion euros for the second quarter of 2021.
Ozlem Tureci: We have started our BNT113 Phase II clinical trial, shown on slide 29, and recently dosed the first patients in the safety run-in. In the subsequent randomized part, patients with unresectable recurrent or metastatic head and neck cancer positive for HPV16 and expressing PD-L1 will be treated with BNT113 in combination with the checkpoint inhibitor pembrolizumab versus pembrolizumab monotherapy as first-line Overall survival and objective response rate are key endpoints of this trial, with a targeted median overall survival of 18 months and an overall response rate of 40% in the combination treatment arm.
Path to $41.7 million euros for the comparative period in 2000.
For the period of 6 months ended June 32021, we report an estimate a total revenue of around 7.4 billion euros compared to $69.4 million euros for the comparative period prior year period.
Total revenues increased due to the rapid increase in supply and sales of our COVID-19 vaccine worldwide.
As a reminder, on our COVID-19 collaborations territories have been allocated between us.
Is that in for some pharma.
Based on marketing and distribution rights.
A breakdown of our commercial revenue as shown on slide 36.
Our second quarter 2021 commercial revenues include approximately $4.1 billion euros and $5.8 billion for the first 2 quarters of 2021 that comprise our gross profit share generated by all our collaborations for us in their respective territories as well as sales milestones.
Ozlem Tureci: We are co-developing a PCR-based companion diagnosis to select patients for treatment with BNT113, which will be clinically validated as part of his trial. Moving to slide 30, now, I would like to provide a short update on our INES program, BNT122, which is partnered with Genentech Roche. BNT122 is designed to target patient-specific neoantigens and is a fully individualized cancer vaccine with two ongoing trials in metastatic cancers. We are now moving into the adjuvant treatment space, with a phase 2 trial in colorectal cancer being the first such indication.
The sales milestones included in the figures just mentioned amounted to $168.6 million euros for the second quarter and $415.8 million euros for the period of 6 months ended June 32021.
Similar to previous quarters, the figure for our profit share estimated based on preliminary data share between fives on us it may be subject to adjustments pending final data input parameters like sales volume and values as well as transfer prices and.
The changes for dollar share of the collaboration partners gross profit will be recognized prospectively.
Our COVID-19 vaccine commercial revenues in the second quarter also included $148.1 billion euros in sales to our collaboration partners products manufactured for us and.
Ozlem Tureci: The study will compare the efficacy of BNT122 versus watchful waiting in resected stage 2 high-risk and stage 3 colorectal cancer patients who are ctDNA positive following 3 to 6 months of adjuvant chemotherapy as standard of care. In the first screening round, the circulating tumor DNA or ctDNA status of the patient will be determined for eligibility, which is the main risk factor for disease recurrence. In a second screening of eligible patients, neoantigen selection based on the patient's individual tumor will be performed, and BNT122 manufacturing will be initiated. The letter takes about 3-6 weeks, while patients undergo the usual 3-6 months of adjuvant standard of care therapy.
In round 1 billion euros of direct COVID-19 vaccine sales for customers in our territory, Germany and Turkey.
For the period of 6 months ended June 30th 2021 itself to all of our collaboration partners of 202 million.
Approximately $1.2 billion euros direct COVID-19 sales in Germany and Turkey.
Now turning back to slide 35, and moving to cost of sales, which were estimated to be 893.8 million for the second quarter of 2021 compared to $5.6 million was for the comparative period in 2020.
For the 6 months ended June 32021, total cost of sales were estimated to be around $1.1 billion euros compared to $11.5 million euros for the comparative prior year.
For a period.
The increase was driven by an estimated amount of $872.1 million for the second quarter of 2021.
Around $1.1 billion euros for the period of 6 months ended June <unk> 2021, respectively that was recognized as cost of sales with respect to our COVID-19 vaccine sales and included the shelf gross profit that we owe to our collaboration partner Pfizer on all sales.
Research and development expenses were $201.1 million euros for the second quarter of 2021 compared to $95.2 million euros for the comparative period in 2020.
Ozlem Tureci: Final eligibility for the study will be assessed in a firm. Eligible patients will then be randomized one-to-one into the main treatment arms to compare the efficacy of BNT122 versus watchful weighting. The patients in the experimental arm will receive six weekly vaccinations, followed by two weekly vaccinations. The subsequent vaccinations will be given every six weeks for up to 12 weeks.
For the 6 months ended June 32021 research and development expenses reached $417.3 million euros compared to 163 million euros for the comparative prior year period.
The increase was mainly due to an increase in research and development expenses related to our <unk> 2 program.
Ozlem Tureci: The trial also has a biomarker cohort that includes patients irrespective of ctDNA status. A second exploratory cohort will include patients who had recurrent disease at the first screening. Patients in both of these cohorts will be dosed with NT122. Recruitment has started for this study, and we anticipate dosing the first patient later this year. Coming up next on slide 31 is the ReboCytoKind platform, which is one of the examples of the high diversification of our RNA technology, which, depending on the design elements we choose from our toolbox, can be used for varying purposes.
Quoted as purchased services with respect to those expenses, which were initially trip of Pfizer and subsequently charged to us on the off Carnival.
As a reminder, development costs are shared equally between the 2 companies.
Kris was further driven by an increase in wages benefits and social security expenses due to increases in head count recognizing inventive compensation expense as well as expenses incurred under the new share based payment arrangements.
General and administrative expenses were $47.8 million euros for the second quarter of 2021 compared to $18.8 million euros for the comparative period in 2020.
For the 6 months ended June 32021, general and administrative expenses were $86.7 million euros compared to $34.6 million loss for the comparative prior year period.
Ozlem Tureci: In this case, we use our RNA technology to encode T-cell homo-neostatic cytokines, which otherwise would be administered as recombinant proteins. Cytokines encoded by mRNA and produced in the patient have a potential for improved safety and therapeutic efficacy and a more favorable cost of goods over their recombinant protein-based counterparts. Recombinant protein-based IL-2, for example, has been shown to induce durable responses in some tumor types but has significant drawbacks, such as a short half-life requiring frequent and high doses associated with toxicities such as infusion reactions and liver disease. Our ribocytokines are designed for improved pharmacokinetic properties with a prolonged serum half-life and high bioavailability. This allows for lower and less frequent dosing, which may result in better tolerability.
The increase was mainly due to an increase in wages benefits on social security and expenses for it.
Freezing head counts and recognized expenses incurred under the new share based payment arrangements high expenses for purchased management consulting and legal fees as well as the higher insurance premiums.
Interim income taxes were approximately $1.2 billion for the second quarter of 2021 and around $1.7 billion for the 6 months ended June <unk> 2021, and well recognized using the estimated annual effective income tax rate of approximately 31%.
For the second quarter of 2021 net profit reached approximately 2.8 day any rose compared to a net loss of $88.3 million euros for the comparative period in 2020.
For the 6 months ended June 32021, total net profit was approximately $3.9 billion euros compared to a total net loss of $141.7 million euros for the comparative prior year period.
Ozlem Tureci: Our ribocytokines encode the cytokine fused to human albumin. The RNA backbone is optimized for high-protein production, and it is nucleoside modified and thus non-immunogenic. The RNA is encapsulated in liver-targeting LNPs that allow for intravenous systemic delivery. We have two rival cytokine product candidates in clinical trials that feature IL-2, a T-cytokine in T-cell immunity supporting differentiation, proliferation, survival, and effector functions of T-cells. In addition to activating effector TZ, IL-2, as a physiological counter-regulatory mechanism, also activates suppressive regulatory T-cells via one of its three cellular receptors, namely the IL-2 receptor alpha subunit, also referred to as CD25.
Net of tool series 2021 cash on cash equivalents totaled $914.1 million euros.
Please note that the contractual settlement of our gross profit share on the on COVID-19 collaborations with Pfizer.
Temporarily offset of more than 1 calendar quarter.
As far as the fiscal quarter for subsidiaries outside the United States differs from ours create.
Creates an additional time lag between the recognition of revenues and the payment receipt.
Consequently, trade receivables, which were outstanding as of June 32021 were received as payments only July 2021, moving our cash position relative to the amount of June 32021.
Moving to slide 37.
Our 2021 financial outlook has been updated as we expand and accelerate the development of our broad pipeline.
Ozlem Tureci: BNT-151 is a sequence-modified IL-2 engineered to reduce binding to this subunit, with maintained binding to the other IL-2 regions. Thus, without extensively triggering immune suppressor regulatory T-cells, it activates effector anti-tumor T-cells with a preference for those effectors that have low to no expression of CD25.
Based on the current construction supply orders of approximately $2.2 billion doses with providing estimated COVID-19 vaccine revenues to be on track in 2021 of approximately $15.9 billion euros.
This estimate reflects expected revenues from direct COVID-19 vaccine sales for customers in all the territory expected revenues from sales to our collaboration partners.
Ozlem Tureci: As such, we anticipate that BND1 51 is an optimal combination partner for anti-PD-1 or anti-PD-L1 therapy. With BND1 51, a phase one trial is ongoing. Our BNT 152-153 product candidate has two components. BNT 153 encodes the natural IL-2 with maintained high affinity binding to CD25 positive T-cells. Accordingly, it simulates recently activated. Anti-Tumor Tests and Regulatory
Expected sales milestone payments from our collaboration partners and expected revenues related to our shelf gross profit from COVID-19 vaccine sales in the cooperation partner for territories.
Please note that this figure has been estimated constant foreign exchange rates.
We expect additional revenues related to further supply contracts for deliveries in 2021 with contracts in place for 2022 would be on.
Please keep in mind that we will deliver a significant amount of doses to Midland low income countries. What prices are in line with income levels or at non for profit basis to serve the poorest.
In terms of guidance for the full year 2021, we expect to incur R&D expenses in the range of 950 million euros 1.15 billion euros, reflecting a ramp up especially in the second half of 'twenty, 1 given our plans to expand and accelerate our pipeline development.
Ozlem Tureci: BNT-152, the second component of this product candidate, encodes IL-7, which sensitizes T-cells to IL-2 while it controls the fraction of immunosuppressive regulatory T cells. We believe BNT152 plus BNT153 could be a potent combination for a partner for cancer vaccines, as vaccine-induced T-cells express high levels of CD25. We dosed the first patient in June 2021 in a first human phase 1 trial in patients with solid tumors. We plan to combine this combination of T-cell homeostatic cytokines with other products of our pipeline, for example, with our fixex.
SG&A expenses are estimated to be in a range of 250 million to 300 million.
Capital expenditures for the year 2021, I expect it to be in the range of $175 million for 225 million.
These figures have again been estimated at constant foreign exchange rates.
Reflect our current base case projections.
Finally, please note that in terms of our full year 2021 tax impact we still expect a biotech group estimated annual effective income tax approximately 31%.
And with that I turn the call to our Chief strategy Officer, Ryan Richardson for an update on our corporate development activities and concluding remarks.
Thank you, yes, moving on slide 39, I'd like to briefly discuss our recently announced acquisition of Kite pharma is personalized TCR platform and manufacturing facility in Gaithersburg, Maryland.
Ozlem Tureci: Now to wrap up my part for today, slide 33, which highlights a number of key milestones achieved so far this year, as well as significant milestones we expect in the back half of 2021. In addition to our multiple clinical updates from our COVID-19 vaccine program, we expect four more data updates for our oncology. We have started two randomized phase 2 clinical trials, with one more expected to start in the second half of 2021. We have started four first-in-human clinical trials of our diverse therapeutic programs and expect three more this year.
Cell therapy forms an important component of our immuno oncology toolkit alongside our mrna cancer vaccines antibodies small molecule modulators engineered biologicals and next generation immuno modulators.
The acquisition adds to our cell therapy capabilities and specialized infrastructure to support our on cell therapy pipeline.
<unk> car T cell therapy.
And ex vivo T cell therapy, and personalized TCR T.
Turning to slide 40.
Interest broke facility, we've acquired will provide a turnkey production side to support clinical trial in the United States complementing our existing cell therapy manufacturing facility in <unk>.
Ozlem Tureci: We have made significant progress with regard to accelerating our pipeline in the first half of this year, and I look forward to updating you on upcoming milestones in the near future. So I now turn over to our Chief Financial Officer, Jens Holstein, who will discuss our financial results. Thank you, Ozlem, and a warm welcome to those of you on the phone.
On Germany.
On New U S site will support the development of our expanding pipeline of novel cell therapies, including cancer product candidates based on a carve out programs and Nielsen platforms as well as <unk>.
Newly acquired individualized Neo energy tissue.
Hi.
Further on behalf of the acquisition bond taxable gain a team of more than 50 professionals with deep expertise in cell and gene therapy, including a cell therapy production team on personal lines, new antigen TCR research team.
This acquisition on the supports our leadership position in individualized cancer therapy.
Slide 41 highlights 3 individualized treatment platforms developing in house for biotech to address solid tumors.
Jens Holstein: I've been in my role for a few weeks now, and I'm delighted to have joined BioNTech at this exciting time in the company's growth. With great pleasure, I look forward to supporting my colleagues in our mission to make a significant difference. Let me now start my session by moving to our financial results for the second quarter of 2021, as shown on slide 35. I'll start with total revenues estimated to be approximately 5.3 billion euros for the second quarter of 2020, compared to 41.7 million euros for the comparative period for the period of six months ended June 30th.
Including <unk>, 1% or 2 on us.
And <unk> 2 to 1 you know soon.
And our personalized TCR T program.
Each of these modalities exploits a distinct mechanism of action and is uniquely suited to specific tumor types broadening the types of solid tumors, we can target.
Individualized them on a cancer vaccine used for patients on cancer mutations to generate yield management specific CD 4 T cell responses from BMO.
We believe this modality is well suited to earn an adjuvant stage cancers.
<unk> and our individualized <unk> T cell therapy, which uses <unk> to induce an expand multiple CD for in Cte Atlanta true T cell populations ex vivo.
Jens Holstein: We report an estimated total revenue of around €7.4 billion, compared to €69.4 million for the comparative period the previous year. Total revenues increased due to the rapid increase in supply and sales of our COVID-19 vaccine worldwide. As a reminder, under our COVID-19 collaboration, territories have been allocated between us, Pfizer, and Fosun Pharma.
This modality is expected to enter the clinic in 2021 targeting checkpoint.
Non responsive tumors.
Finally, the TCR platform acquisition strengthens our own in house personalized TCR T cell therapy program.
As ex vivo engineered neo antigen specific TCR T cells to address advanced tumors.
We believe the breadth of these therapeutic modalities position us well to usher in a new era of individualized cancer therapy.
To conclude on slide 42, we have strong momentum in our business as we move into the second half of the year on.
Our COVID-19 vaccine is continuing to have a major impact on addressing the global pandemic and there was early data supporting the potential benefits of an additional booster dose.
Moreover, our oncology pipeline continues to expand for sweep programs now advancing into later stage trials.
Jens Holstein: A breakdown of our commercial revenues is shown on slide. Our second quarter 2021 commercial revenues include approximately €4.1 billion and €5.8 billion for the first two quarters. (Inaudible) The sales milestones included in the figure just mentioned amounted to €168.6 million for the second quarter and 415.8 million for the period of six months, June 30.
We expect a number of significant clinical trial updates in the second half of 2021.
These include for data Readouts on oncology programs and the start of our fourth randomized phase 2 trial.
Additionally, we're on track to start 2 more first in human trials this year.
We are transforming our business through additional investments into our technology platforms building out our global team and expanding on list of collaborators.
We believe that we are well positioned for success as we execute on our strategy to achieve our mission of harnessing the immune systems for potential to fight human disease.
Our strong financial position enables us to invest more than ever.
From an innovation engine with the aim to build a true long term value for patients shareholders and society.
Jens Holstein: Similar to previous quarters, the figure for our profit share is estimated based on preliminary data shared between Pfizer and us. It may be subject to adjustments pending final data input parameters like sales volume in values as well as. Any changes in our share of the collaboration partners' gross profit will be recognized prospectively. Our COVID-19 vaccine commercial revenues in the second quarter also include €138.1 million in sales to our collaboration partners of products manufactured by us, and around 1 billion euros of direct COVID-19 vaccine sales to customers in our territory, Germany.
We thank our shareholders and partners for their ongoing collaboration on support and with that we'll conclude our presentation and open up for questions.
As a reminder to ask a question you will need to press star 1 on your telephone.
Your question. Please press the pound or the hash key only 1 question will be taken per person. Please stand by while we compile the Q&A roster.
Your first question comes from the line of core cash them off of J P. Morgan. Please ask your question.
Great. Good morning, and good afternoon, everyone. Thanks for taking my question I wanted to ask you about your booster strategy with the new Delta trial on the ongoing testing for joining for the beta specific vaccine on.
No I was not surprised when we talk about the emergence of additional variance is it your expectation that the original vaccine will ultimately be best to use for boosting, especially given the emerging data that you have there or do you think this is going to trend towards some type of multifamily product in the future just kind of related to that would be interested in your thoughts around some of the.
Jens Holstein: For the period of six months and June 30th, 2021, we had sales to our collaboration partners of 202 million euros, approximately 1.2 billion euros of direct COVID-19 sales in Germany. Now, returning back to slide 35 and moving to the cost of sales, which were estimated to be $800,000. 21 compared to 5.6 million euros for the comparative period.
The commentary out of organizations like the CDC around boosters and why do you think it's going to take a surge in breakthrough infections to really mobilize the idea of boosters on a broader basis. Thank you.
I can take this question I call me.
At the moment are allowing our bodies a victory.
<unk> performed well.
Experiments.
Clearly showed that are subject to a worthless.
Jens Holstein: For the six months ended June 30, 2021, total cost of sales was estimated to be around $1.1 billion, compared to 11.5 million euros for the comparative prior year period. The increase was driven by an estimated amount of 872.1 million euros for the second quarter of 2021, and around 1.1 billion euros for the period of six months and June 30, 2021, respectively. That was recognized as cost of sales with respect to our COVID-19 vaccine sales and included the share of gross profit that we owe to our collaboration partner, Pfizer.
But those are those.
Hat.
Show increased.
Neutralization anti body type of not only against the origin of about volume, but almost.
It's the same level.
So I guess the desktop Elliot.
We believe that the best approach at the moment to deal with with this the situation is to continue with a with a booster dose.
Existing bypass credit, which creates anti body for sponsors which are about half for its higher.
The anti body.
Tied to us localizing antibody titers.
After the second shot it is quite possible debt in the.
Next 6 to 12 months.
So that volume.
Much debt, what's the buy up.
Station of the of the of the vaccine, but it is at the moment not yet the case.
Yeah.
Thank you.
Your next question comes from the line of Tuffy Hamad.
Jens Holstein: Research and development expenses were €201.1 million for the second quarter of 2021, compared to €95.2 million for the comparative period in 2020. For the six months ended June 30th, 2021, research and development expenses reached 417.3 million euros, compared to 160.3 million euros for the comparative prior year. The increase was mainly due to an increase in research and development expenses related to our BNT-162 program, recorded as purchased services with respect to those expenses, which were initially incurred by Pfizer and subsequently charged to us under our As a reminder, development costs are shared equally between. It was further driven by an increase in wages, benefits, and social security expenses due to increases in headcount, recognizing inventor compensation expenses as well as expenses incurred under the new share
Bank of America. Please ask your question.
Hi, good morning, Thanks for the very thorough update on my 1 question is.
In relation to the to the strategy around booster.
How much of the view that a third.
Of the original vaccine is sufficient in the current environment is based on.
Potentially not enough with the population.
Being vaccinated, that's allowing the.
Virus to continue to spread and so with that the pace of vaccination does increase.
In the future would you continue to believe that the booster of the original shot would be sufficient or do you think that we would move to a more.
<unk> plan of boosting shocked when you have different variants in Marseille.
I can't I can take this 1 as well go ahead pointed out for calling strategy, which is based on the currently available data.
To continue with our ancestors train so with the current very young age or what's the original vaccine.
And rather than debt King just to boost our with that train and a large part of this data after supporting data comes from for example, neutralizing anti body.
Testimony Oh I have presented 1 piece of data, but there's also other data from other groups are I would say I would show us that.
Jens Holstein: General and administrative expenses were €47.8 million for the second quarter of 2021 compared to €18.8 million for the comparative period in 2020. For the six months ended June 30, 2021, general and administrative expenses were $86.7 million, compared to $34.6 million for the comparative prior year period. The increase was mainly due to an increase in wages, benefits, and Social Security due to increased headcounts and recognized expenses incurred under the new share-based payment arrangement, higher expenses for purchase management, consulting, and legal fees, as well as a higher insurance premium.
Uh huh.
The vaccine that in fact for a vaccine generates anti body titles and neutralizing antibodies, which are cross reactive even dose after the second dose and Clos neutralizing to watch other strains, including the day to have variant.
Specifically, our third dose based on we have also shown on this after the second dose or start dose data shows that the highly boosted anti body neutralizing anti bodies in a day.
<unk> seen they are above the once we generate with the second dose are also cross neutralizing against standard how about also getting better. So it is a robust strategy to continue with force thing with the interest incest drivetrain I have also.
Jens Holstein: Interim income taxes were approximately 1.2 billion euros for the second quarter of 2021 and around 1.7 billion for the six months ended June 30, 2021 and were recognized using an estimated annual effective income tax rate of approximately 31%. For the second quarter of 2021, net profit reached approximately $2.8 billion, compared to a net loss of 88.3 million euros for the comparative period. For the six months ended June 30th, 2021, total net profit was approximately 3.9 billion euros compared to a total net loss of 141.7 million euros for the comparative prior year. Net-of-tune failures 2021.
Shown Allah plans going for that in terms of producing additional data and a better understanding what a debt king this train.
Caught a bring in terms of added they you and are there.
Safety margin.
It's the data from our planned and ongoing clinical trials, where we were vaccine need.
Net E.
Subject, but also subjects, who have received the first 2 dose serious with them cash dredged range. This would be vaccinated with a south African varian, but also with the deadlines I felt very young.
Jens Holstein: Cash and cash equivalents totaled 914.1 million euros. Please note that the contractual settlement of a gross profit share under our COVID-19 collaboration with Pfizer has a temporal offset of more than one calendar quarter. The Pfizer system quota for subsidiaries outside the United States differs from ours, creating an additional time lag between the recognition of revenues and the payment. Consequently, trade receivables, which were outstanding as of June 30, 2021, were received as payments only in July, proving our cash position relative to the amount of June 30th. Moving to slide 37.
The video on vaccines, but also as a mighty Varian vaccines and these studies with tell US once we are able to investigate and net the immune responses and understand also that if he could see whether it is.
Quiet and watch in terms of additional benefits it would bring to adapt for vaccines. So this is definitely something which will be investigated it might be then the strategy for the future.
Yes.
Thank you.
The next question comes from the line of Chris Sheppard Tani, If Goldman Sachs. Please ask your question.
Thank you very much I did want to ask some practical question about the booster. It seems as if we will get the phase III readout in the fourth quarter would you anticipate that that is a data requirement for an emergency use authorization for the booster and in that scenario that we get a full approval of the <unk>.
Jens Holstein: Our 2021 financial outlook has been updated as we expand and accelerate the development of our broad, Based on the current contractual supply orders of approximately 2.2 billion doses, we're providing estimated COVID-19 vaccine revenues to BioNTech in 2021, approximately $15.9 billion. This estimate reflects expected revenues from direct COVID-19 vaccine sales to customers in our territory, and expected revenues from sales to our collaboration partners. Estimated sales milestone payments from our collaboration partners and expected revenues related to our share of gross profits from COVID-19 vaccine sales in our collaboration partners' territories.
Initial doses.
How would it work practically speaking in the commercial realm, where you may have the initial doses fully approved and a booster on an EUA.
Yeah.
So I can take the question.
No.
What we expect.
Debt and.
But based on the date for Paypal.
I don't have any debt.
Including the phase II data.
Our recommendation for.
Use of boost that though with us both logo with what's come in in different from each other.
Good day.
They are already say commendations for exactly.
In 2 huge booster doses also.
Let me come.
Jens Holstein: Please note that this figure has been estimated constant for an exchange. We expect additional revenues related to further supply contracts for deliveries in 2021 with contracts in place for 2022 and beyond. Please keep in mind that we will deliver a significant amount of doses to middle and low-income countries where prices are in line with income levels or on a non-for-profit basis to serve.
Commended the use of course, the Dorothy elderly.
And this will happen on this happens on debt.
Emergency use.
But what needs to be or what is going on.
Going on it's on the 1 side in part of this is difficult for cross something that we can directly influence it.
Primarily the explanation of those who had not received for vaccine.
To either reduce the infection.
And on the other thought a tool to be commended.
To enable booster explanation for growth.
Jens Holstein: In terms of guidance for the full year 2021, we expect to incur R&D expenses in the range of €950 million to €1.05 billion, reflecting a ramp-up, especially in the second half, and given our plans to expand and accelerate our program. SG&A expenses are estimated to be in the range of $250 million to $300 million. Capital expenditures for the year 2021 are expected to be in the range of $175 million to $295 million.
And a prime boost explanation.
For 6 months ago to ensure increase increased interest of anti bodies.
So let me think.
Things were.
Happened in Canada.
Uh huh.
Uh huh country by for each of them, but they commendation may support from policy.
Yeah.
So are you implying that you are.
<unk> has the potential to be a designated bot risk populations for the booster, particularly with the U S. FDA.
Yes. It is it is it is it is.
You would need to reach them by a recent bout with point of purchase for.
Jens Holstein: These figures have again been estimated at constant foreign exchange rates and reflect our current base case. Finally, please note that in terms of a full year 2021 tax impact, we still expect a BioNTech group estimated annual effective income of approximately $31. With that, I turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our corporate development activities and conclusions.
Thanks, Paul for your.
First of all debt.
Cool.
And then.
In different countries and they are they are eager eager recommendations bye bye.
By the vaccine Committee.
Our policy speech on it.
From government.
Government weighted.
So it just made a different TV net adds in the region will come up with the solution will be a mix so the ocean and mixed policies.
And then if I may may adhere debt. This is that because this is a pandemic situation. It's also and unused way situation in terms of regulatory pathway. So we are working with the health authority and how.
Secondly, the implementation all for go with us.
Ryan Richardson: Jens. Moving now to slide 39. I'd like to briefly discuss our recently announced acquisition of Kite Pharma's personalized TCR platform and manufacturing facility in Gaithersburg, Maryland. Cell therapy forms an important component of our immuno-oncology toolkit, alongside our mRNA cancer vaccines, antibodies, small-molecule immunomodulators, engineered biologicals, and next-generation immunomodulators. This acquisition adds to our cell therapy capability and specialized infrastructure to support our growing cell therapy pipeline, including Advanced CAR T-Cell Therapy, Neoantigen Ex-Vivo T-Cell Therapy, and Personalized TCRT. Turning to slide 40.
Within U S or for submissions at some point.
It should be implemented in order to ensure that this all sourced for overall has from a strategy all for respective region or country. This is something which we need to be worked out together with the heck of our interest.
Which will guide us so I would not want to speculate what exactly is later in the neighborhood also for approval or in the UAE business really work in progress.
In our in the interaction with the respective regulatory authority in the U S with the F D. A.
Ryan Richardson: The Gaithersburg facility we've acquired will provide a turnkey production site to support clinical trials in the United States, complementing our existing cell therapy manufacturing facility in Edar-Oberstein, Germany. The new U.S. site will support the development of our expanding pipeline of novel cell therapies, including cancer product candidates based on our CARVAC program and Neostim platforms, as well as the newly acquired individualized neoantigen. Furthermore, as a result of the acquisition, BioNTech will gain a team of more than 50 professionals with deep expertise in cell and gene therapy, including a cell therapy production team and a personalized neoantigen TCR.
Okay. Thank you sound quite dynamic will keep cuts I appreciate it.
Thank you. Thank you. The next question comes from the line of day and a great Bush from SBB Leerink. Please ask your question.
Hi, Good afternoon. Good morning. Thanks for the question I Wonder if you could talk a bit more about your business development approach and what you are looking to.
To deal with it may be near term on long term.
In terms of capabilities capacity targets on modalities and also with that do you believe that you need on your own PD 1 to support.
For a rich portfolio of I O program.
Hi day, not a what's the.
What's the question about the business.
That's actually all about that.
Good day.
Developments for quite tissue.
Our business development for licensing and acquisition strategy.
I see I see so although dana via on AR at the moment nobody on site accelerating and broadening our internal pipeline.
Ryan Richardson: This acquisition further supports our leadership position in individualized cancer. Slide 41 highlights the three individualized treatment platforms we are developing in-house at BioNTech to address solid tumors. These include BNT 1-2-2, INES, and BNT221 Neos, and our personalized GCRP program. Each of these modalities exploits a distinct mechanism of action and is uniquely suited to specific tumor types, broadening the types of solid tumors we can see. Individualized mRNA cancer vaccines use the patient's own cancer mutations
And of course, we are interest the interest is also complementing our pipeline with additional I O molecules. So.
1 molecule could be could be an option.
If it goes that could pay off debt peak seeking.
At the moment.
On Io molecules also for the PD PD, 1 blockade function in development if you net.
You know and.
And cockpit.
1 plus.
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For <unk> bi specific.
On the Q1 cash.
In Canada in Toronto.
Internet KOL gun.
Also also are progressing at this Oh Aye Aye.
Okay, Great and then the next Nik craft or 18 months. It was certainly suddenly come up with this this uh huh.
Ryan Richardson: We believe this modality is well-suited to early enactment. Neostim is our individualized neoantigen T-cell therapy that uses PBMCs to induce and expand multiple CD4 and CD8 neoantigen T-cell populations. This modality is expected to enter the clinic in 2021 targeting checkpoint, non-responsive tumors. Finally, the CHI-TCR platform acquisition strengthens our own in-house personalized TCRT cell therapy program, which leverages ex vivo engineered neo-antigen specific TCRT cells to address We believe the breadth of these therapeutic modalities positions us well to usher in a new era of individualized care. To conclude on slide 42, we have strong momentum in our business as we move into the second half.
Allowing us to increase our pipeline a 2 third.
A good combination partner for.
For the vaccine.
And immune motivates us if you have already in place.
Very helpful. Thank you.
Thank you for next question comes from the line of Sequin Chu of Bank debt. Please ask your question.
Hi.
Good afternoon. Thanks for taking my question I'd like to also ask the other booster opportunity here.
The the waning protection.
On the of the vaccine.
A critical question is about the T cell response.
Can't talk about.
Based on our current understanding what what is the role of T cell response, particularly on memory T cells and T cells here.
In terms of configuring the protection.
Also I want to ask about the on.
Coffee pot pipeline regarding.
Back.
How should we think about the the local cros.
Read across from.
Across different.
Cancer types with liver related allergy of the tumor types or relate.
Election day.
You know Ashton thanks very much.
Ryan Richardson: Our COVID-19 vaccine is continuing to have a major impact in addressing the global pandemic, and there is early data supporting the potential benefits of an additional boost. Moreover, our oncology pipeline continues to expand, with the first wave of programs now advancing into later stage trials. We expect a number of significant clinical trial updates in the second half of 2021, including four data readouts in our oncology programs and the start of our fourth randomized phase two trial. Additionally, we're on track to start two more first-in-human trials. We are transforming our business through additional investments in our technology platforms, building out our global team, and expanding our list of collaborators.
Yeah.
Yeah, let.
We start with the first question for all of our T cell for we have 2 layers of immunity against the against this virus, but certainly if the neutralizing antibody response on the firstly its good points that the sponsor both for inhibiting the uptake of the virus is it.
Inhibitor for infection in the second layer is once the virus has managed to enter themselves and then the T cells are the second lay out a day subsidy, a pizza, which are able to pick up nice impact itself.
Did I not.
And the debt as well as.
Maybe for Keith.
Richard.
For the accelerated anti body and T cell responses to restore the anti body of what's going on and we no debt and debt are in animal experiments is known for zoster.
For more than 30 year debt T cells.
Protecting against severe disease and they are non bulk publications are now.
Ryan Richardson: We believe that we are well-positioned for success as we execute on our strategy to achieve our vision of harnessing the immune system's full potential to fight human disease, and our strong financial position enables us to invest more than ever in our firm and our innovation engine with the aim of building true long-term value for patients, shareholders, and society. We thank our shareholders and partners for their ongoing collaboration and support, and with that, we'll conclude our presentation and open it up to questions.
Indicating that this is the case also for Sars cov, 2 and the.
So that means the price of the share presence of pizza.
Yeah.
It's inhibiting it becomes the development of severe disease and this is in line with what the Oh sucking it from here.
Studies are so even though the decreasing anti body types out there on mall break for infection.
Most of the infections are Mike, yeah, and severe disease.
If they're protected are there the reason for debt is that the T cell response is lasting longer.
A T cell responses can last up to a convenient yet.
And therefore, therefore the situation is that we will get straight for infections, but most of.
Ryan Richardson: Thank you. As a reminder, to ask a question, you will need to press Star 1 on your telephone. To withdraw your question, please press the pound or the hash key. Only one question will be taken per person.
The cough the subjects.
It would be of the pizza they'd be protected against the Vlccs.
So just for your first question can you repeat your second question, sorry, I forgot it.
Yes, yes, I. The same question I am I like to ask about the the kind of the real cross a different.
Operator: Please stand by while we compile the Q&A roster. Your first question comes from the line of Corey Kathamoff of J.P. Morgan. Please ask your question. Great. Good morning. Good afternoon, everyone.
Different tumor types regarding your fixed back obviously a positive.
Credit card data in melanoma, and how should we think about added for Titan.
Yeah.
Yes.
2 approaches for for inducing Ah.
In using antigen specific immune responses from cancer patients. It's the picks back to fix back is it a combination of antigens, which are which are which are specifically tailored for certain cancer right.
Corey Kathamoff: Thanks for taking the question. I wanted to ask you about your booster strategy with the new Delta trial and the ongoing testing you're doing for the beta-specific vaccine. Now, there's not surprisingly talk about the emergence of additional variants. Is it your expectation that the original vaccine will ultimately be best to use for boosting, especially given the emerging data that you have there? Or do you think this is going to trend towards some type of multivalent product in the future?
Fix back, but I know, we are developing a 6 black lung cancer via that picks back non small cell.
For it picks back ovarian cancer head and neck cancer.
So these are collections collections of antigens for specific cancer type.
And the complementary approach is then is the I missed the porch.
Targeting cancer with our in our indenture that assertion there.
Using universal approach for that this approach could be universally applicable to all kinds of cancer and it is based on the concept that we identify personal neo antigens and tailor an individually vaccine and the support if universal in nature.
Unknown Executive: And just kind of related to that, I'd be interested in your thoughts around some of the commentary out of organizations like the CDC around boosters and whether you think it's going to take a surge and breakthrough infections to really mobilize the idea of boosters on a broader basis. Thank you. I can take this question, right, Kobi?
It could be applied for many many different cancer types for veeva.
Yeah.
Can cause tied up on them.
And normally we have a basket trial in multiple indications I think its still a phase 1 study and they have just recently started I missed tie using essentially the same approach for colorectal cancer.
Great. Thanks, very much congrats on the progress.
Unknown Executive: So, at the moment, our studies, which we have performed with lab experiments, clearly show that subjects who had received a third dose showed increased neutralization antibody responses, not only against the original variant but almost at the same level also against the delta variant. So, we believe that the best approach at the moment to deal with the situation is to continue with a booster dose of the existing Y-type strain, which creates antibody responses that are about five-fold higher than the antibody titers, neutralizing antibody titers after the second shot.
Yep.
Thank you. Your next question comes from the line of Arlinda Lee of Canaccord. Please ask your question.
Hi, guys. Thanks for taking my question.
I was also curious about the boost your and maybe your broader strategy on the Covid.
The COVID-19 situation I know it.
Fluid, but on the multi balance.
Could that include other Sars COVID-19.2 proteins and I saw that you guys were looking at adding for additional variance and then I guess, maybe as a follow up to that on how easily can your manufacturing them.
That change too.
To manufacture some of these variants. Thank you.
Unknown Executive: It is quite possible that in the next six to 12 months, further variants emerge, and that would require adaptation of the vaccine, but that is not yet the case. Thank you. Your next question comes from the line of Tazeen Ahmad of Bank of America. Please ask your question. Hi, good morning.
Okay. Thank you.
So it's talking with the last question, we have the ability to rapidly change Ah Ah Ah Ah the plane for from manufacturing to the only step that we need to do is.
To us and now that the eighth template for new volume and then we can keep them on.
Tazeen Ahmad: Thanks for the very thorough update. My one question is in relation to the strategy around booster shots. How much of the view that a third dose of the original vaccine is sufficient in the current environment is based on potentially not enough of the population being vaccinated, thus allowing the, (inaudible] specified plan of boosting just when you have different variants emerging? I can take this one, Tazeen.
The complete manufacturing process without any changes and John that day.
The chip adapted for the value that this is technically possible and and we are we are you already doing debt right.
Cream of clinical trials, and so on and Cai.
For the better better for everyone.
Unknown Executive: As Ugur has pointed out, the current strategy, which is based on the currently available data, is to continue with the ancestral strain, so with the current variant or with the original vaccine, and rather than adapting, just to boost with that strain. And a large part of this data, of the supporting data, comes from, for example, neutralizing antibody assessments. I have presented one piece of data, but there is also other data from other groups out there that shows that the vaccine, the ancestral vaccine, generates antibody titers, neutralizing antibodies which are cross-reactive, even those after the second dose, and cross-neutralizing towards other strains, including the delta variant and specifically our third-dose data.
And we're going to start.
In this month.
Kyle again against a debate causality.
And it was at.
The key question is is and this is not the only exception.
For buy on tech, but it just it is more a general question.
Yeah.
For for the half also V teeth and for the public debt.
He is the best time to change your plane.
If you have a situation a fixed time for in for equally inside the cranes are defined every year by the W. H O and on.
Manufacturer, that's just produce the vaccines for RSV for the product I live in credit.
We do not yet.
Such a situation for both.
For the for Nevada.
Uh huh.
On the cabinets at the moment the global challenge is good for a different variants on different continents, even though the debt cause valeant is dominating most region yeah other regions like South Africa, but I thought about it.
Unknown Executive: We have also shown this after the second dose. Our third-dose data shows that the highly-boosted antibody, neutralizing antibodies, and as you have seen, they are above the ones we generate with the second dose, are also cross-neutralizing against delta, but also against beta. So it is a robust strategy to continue with boosting with the ancestral strain. I have also shown our plans going forward in terms of producing additional data and a better understanding of what adapting the strain could bring in terms of added value and added safety margin.
More prevalent and therefore, therefore, we would really need to to get the perfect timing to make a decision.
For a new Ravi in for vaccine and the deflation.
It should be based on.
On on stuff.
Standard you get the existing vaccines, a boost of his existing legacy will not suck or is sub optimal.
Unknown Executive: This data is from our plans and ongoing clinical trials where we will vaccinate naive subjects but also subjects who have received the first two-dose series with the ancestral strain. These will be vaccinated with the South African variant, but also with the delta and alpha variants as individual vaccines, but also as multivariant vaccines.
And the second our second understanding is debt via EDI like volume and that this is a figure that for Ya.
And we had such a case for example, with the list I've thought about it yet the.
There wasn't didn't hear Bobby and pitches from ADP.
Dominance on but that's a diaper volume beyond now at the moment seeing the guys have value and desktop class Fabienne on cars.
Not yet clear which of the past guidance might have much yeah. So it it are making a decision at the moment.
Unknown Executive: And these studies will tell us once we are able to investigate and map the immune responses and understand also the efficacy, whether it is required, and what in terms of additional benefit it would bring to adapt the vaccine. So this is definitely something which will be investigated and might be the strategy for the future. Thank you. The next question comes from the line of Chris Shibutani of Goldman Sachs. Please ask your question. Thank you very much.
My son, a ton out could be for them in.
For you or 6 months and that that value is dominating therefore, the timing of the decision must be appropriate.
And the growth.
Vinyl operations, but it does not make sense to change to change to a drug library on the vaccine now at the moment, we have a good understanding that the booster vaccine.
Chris Shibutani: I did want to ask some practical questions about the booster. It seems as if we'll get the phase three readout in the fourth quarter. Would you anticipate that that is a data requirement for an emergency use authorization for the booster?
That's the that's the pattern for Spain is complete these.
Fishing, yeah, there is no need to change the variant.
And we don't know what it is.
It's going to happen in the next few months, but if it turns out that cause comp in 6 or 9 months, new values are much which require a booster.
Unknown Executive: And in that scenario where we get a full approval of the initial doses, how would it work, practically speaking, in the commercial realm where you may have the initial doses fully approved and a booster on an EUA? Thank you.
Levered.
We need to understand if the COVID-19 with the monovalent vaccine. That's just this new value or if there are multiple valeant, it's equal with a with a with a those other theme which has separate Italians.
Unknown Executive: So, what we expect is that based on the data that's generated, including the safety data, recommendations for the use of booster doses will come from different regions. So, there are already recommendations, for example, in Israel, to use booster doses. Also, Germany recommends the use of booster doses in the elderly, and this will happen, and this happens under emergency use.
All of this option it technically executable.
On EBIT.
And the payout was tough.
To ensure we got this what kind of solutions if needed debt you can execute debt.
Thank you.
Thank you and our final question comes from the line of Simon Baker from Redburn. Please ask your question.
Thank you very much for taking my question on just continuing on the.
Unknown Executive: And what needs to be, or what is going on is, on the one side, in parallel, this is, of course, something that we can't directly influence, is the primary vaccination of those who have not received the vaccine to really reduce the infection, and on the other side, to, if this is recommended, to enable booster vaccination for those who had received a prime boost vaccination five or six months ago to ensure an increase in antibody status. So, this means these things will happen in parallel, and country-wide or region-wide recommendations may support different policies.
Boost is in relation to the last question could you give us an idea of the lead time from identification of.
The desirable fabien for new vaccines to how quickly you could.
Get it into.
Manufacturing on.
If I may just a very quick P&L question could you give us an idea of how representative this quarter's gross margin is for the rest of the thanks so much.
So we had communicated that we can do it change in debt 100 days.
On the technical pork, that's the standard space.
Come become shorter with time, because they are improving of our methods.
And making.
Making it more efficient that's the first part of that.
On Saturday.
Maybe Brian.
Hum can.
Unknown Executive: So are you implying that an EUA has the potential to be designated by risk populations for the booster, particularly with the U.S. FDA? Yes, you would need really different approaches across regions. For example, for Europe, there is first of all approval, which is the first step.
Oh sure quick answer the next question.
Yeah happy to take that question and so on.
Hum.
Yes.
Of course, you know the the revenue development as well as across margin development depends highly on the mixture.
So if the revenues are coming from our collaborations with Pfizer on for milestones or from from delivering products to our collaboration partners.
Unknown Executive: And then in different countries, there are either recommendations by the vaccine committee or policies which are coming from governments. So it is really different per region, and every region will come up with a solution. It will be a mixed solution and mixed policy. If I may add here, because this is a pandemic situation, it's also an unusual situation in terms of regulatory pathway. So, we are working with the health authorities and on how exactly the implementation of third doses within EUA's full submissions should be implemented at some point in order to ensure that this all serves the overall health strategy of the respective region or country.
And that obviously influences the gross margins to a great extent. In addition, please keep in mind.
Going forward there will be also quite a number of deliveries of products from ourselves.
But mainly from all parts of course.
Where we deliver to middle and low income countries for which we have lower prices of course or non non for profit price. So.
So that influences the gross margin going forward to some extent so towards the year end I would expect that maybe in Q3 or Q4, you will see a slight decrease of the margin that you have seen in Q2.
Unknown Executive: This is something which really needs to be worked out together with the health authorities, who will guide us. So, I would not want to speculate what exactly is later in the label of the full approval or in the EUA.
Perfect. Thanks, so much.
Thank you.
I will now hand, the call back to still come up to close.
Thank you again for joining the call today, we look forward to speaking with you in future. Thank you bye bye.
Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
Unknown Executive: This is really work in progress in the interaction with the respective regulatory authorities and, in the U.S., with the FDA. Okay, thank you. Sounds quite dynamic. We'll keep the caps.
Yeah.
Okay.
[music].
Unknown Executive: Appreciate it. Yeah, thank you. Thank you. The next question comes from the line of Daina Graybosch of SVB Lear Inc. Please ask your question. Hi, good afternoon. Good morning.
Daina Graybosch: Thanks for the question. I wonder if you could talk a bit more about your business development approach? And what you're looking to do is, maybe near term and long term, in terms of capabilities, capacity, targets, or modalities. And also, with that, do you believe that you need your own PD1 to support your rich portfolio of IOPs? Hi Daina. What's your question about the business strategy or about the development strategy? Business Development for Licensing and Acquisition Strategies
Unknown Executive: I see, I see. So, Daina, we are, at the moment, accelerating and broadening our internal pipeline, and, of course, we are also interested in complementing our pipeline with additional IO molecules. So, a PV1 molecule could be an option, yeah, if it fulfills the criteria that we are seeking.
Unknown Executive: We have, at the moment, our own IO molecules, also with that PV1 blockade function in development, as you know. And the entire PDL1 plus 4, 1 dB by specific is one of the molecules. And we have internal programs also addressing additional IO pathways. And in the next 12 to 18 months, we will certainly come up with this deal, allowing us to increase our pipeline to further gain combination partners for the vaccines and immune modulators that we have already in place. Thank you. Thank you. The next question comes from the line of Zhiqiang Shu of Berenberg.
[music].
Zhiqiang Shu: Please ask your question. Hi. Good morning. Good afternoon.
Unknown Executive: Thanks for taking my questions. I'd also like to ask you a booster opportunity here. Given the waning protection of the vaccine, I think a critical question is about the T cell response. Ugur, can you talk about what the role of the T-cell response, particularly mammary T-cells and B-cells here, in terms of conferring protection? Also, I want to ask about the oncology pipeline regarding six VACs. How should we think about the look across, read across, across different, Thanks very much.
Unknown Executive: Let me start with the first question, the role of T-cells. So we have two layers of protection against this virus. The first layer is the neutralizing antibody response, and the first layer is responsible for inhibiting the uptake of the virus, thus inhibiting the infection. And the second layer is once the virus has managed to enter the cells, then the T-cells are the second layer; these are CD8 T-cells, which are able to recognize infected cells and kill the recognized, as well as CD4 T-cells, which help to further accelerate antibody and T-cell responses to restore the antibody response.
Unknown Executive: And we know that in animal experiments, it has been known for more than 20 years that T cells protect against severe disease. And there are a number of publications now indicating that this is the case also for SARS-CoV-2. So that means the presence, the sheer presence of T cells is inhibiting the development of severe disease. And this is in line with what we are observing in real-world studies.
Unknown Executive: So even though decreasing antibody titers means there are more breakthrough infections, most of the infections are mild, and severe disease is still protected. The reason for that is that the T cell response is lasting longer. T cell responses can last up to many years. Therefore, the situation is that we will get breakthrough infections, but most of the subjects of the people will be protected against severe disease. So this was your first question, and can you repeat your second question, please? I forgot it.
Unknown Executive: Yes, yes. The same question I like to ask about the kind of the real across different tumor types regarding your feedback, obviously, positive, quite important data in melanoma, and how should we think about how to, Yes, we have two approaches for inducing antigen-specific immune responses in cancer patients. It's called FIXAC.
Unknown Executive: The FIXAC is a combination of antigens which are specifically tailored for certain cancer types. We have a six-pack melanoma, we are developing a six-pack lung cancer, we have a six-pack non-small cell, a six-pack ovarian cancer, and a six-pack head and neck cancer. So these are collections of antigens for specific cancer types. And the complementary approach is the INS approach, which targets cancer in an individualized fashion where we use a universal approach, so that means this approach could be universally applicable to all kinds of cancers.
Unknown Executive: It is based on the concept that we identify personal neo-antigens and tailor an individual vaccine. And since this approach is universal in its nature, it could be applied to many, many different cancer types. So we have an INS clinical trial running in melanoma, we have a basket trial in multiple indications running, it's still a phase one study, and we have just recently started an INS trial using essentially the same approach for colorectal cancer.
Unknown Executive: Great, thanks very much, congratulations on the profits. Thank you. Thank you. Your next question comes from the line of Arlinda Lee of Canaccord.
Arlinda Lee: Please ask your question, guys. Thanks for taking my question. I was also curious about the booster and maybe your broader strategy on COVID. The COVID situation, I know it's fluid, but on the multivalent, could that include other SARS-CoV-2 proteins? And I saw that you guys were looking at adding additional variants. And then, I guess, maybe as a follow-up to that, how easily could your manufacturing set up?
Unknown Executive: to manufacture some of these variants. Okay, thank you. So, starting with the last question, we have the ability to rapidly change the strain for manufacturing. The only step that we need to do is to use another DNA template for a new variant, and then we can keep the complete manufacturing process without any changes and generate a vaccine that is adapted to the variant. So, this is technically possible, and we are already doing that in the framework of clinical trials.
[music].
Unknown Executive: So, we have a running trial for the beta variant, and we are going to start this month also a trial against the delta variant. So, the key question is, and this is not only a question for BioNTech, but it is more a general question for the health authorities and for the public, when is the best time to change a strain? So, we have a situation, for example, with influenza, where the strains are defined every year by the WHO, and manufacturers just produce the vaccines for the relevant strains.
Unknown Executive: We do not yet have such a situation for the coronavirus, and the challenge at the moment, the global challenge, is that there are different variants on different continents, even though the Delta variant is dominating most regions, there are other regions, for example, in South Africa, where other variants are more prevalent, and therefore, we would really need to get the perfect timing to make a decision for a new variant vaccine, and the decision should be based on, first, the understanding that the existing vaccine, a booster of the existing vaccine will not work, or is suboptimal, and the second understanding is that we really need to get the right variant, and whether this is a single variant, and we had such a case, for example, with the Alpha variant, where there was a single variant, which is really a dominant one, but with the Delta variant, we are now, at the moment, seeing the Delta variant and Delta plus variant, and it is not yet clear which of the plus variants might emerge, so making a decision at the moment might turn out to be wrong in three or six months if another variant is dominating.
Unknown Executive: Therefore, the timing of the decision must be appropriate, and this is also one of the reasons why it does not make sense to change to a Delta variant vaccine now. At the moment, we have a good understanding that the booster vaccine with the parental strain is completely sufficient. There is no need to change the variant, and we don't know what is going to happen in the next few months, but if it turns out that, for example, in six or nine months, new variants emerge which require a booster, we need then to understand if we go with the monovalent vaccine, just with this new variant, or if there are multiple variants, if we go with a vaccine that has several variants. All of these options are technically executable with mRNA vaccines, and we are preparing ourselves to ensure, regardless of what kind of solution is needed, that we can deliver that.
Unknown Executive: Thank you, and our final question comes from the line of Simon Baker of Redburn. Please ask your question. Thank you very much for taking my question, about Boost, in relation to the last question.
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Simon P. Baker: Give us an idea of the lead time from Identification of... Volume Manufacturing. And, if I may, just a very quick P&L question. Could you give us an idea of how representative this quarter's gross margin is? So we communicated that we could do a change in less than 100 days, and this technical progress, this 100 days, will become shorter with time because we are improving our methods and making them more efficient. That's the first part of the answer, and maybe Ryan or Zurg or Sean could answer the next question. Yeah, happy to take that question, Simon. This is Jens.
Unknown Executive: Of course, you know, the revenue development as well as the cross-margin development depends highly on the mixture. So if the revenues are coming from our collaboration with Pfizer or from milestones or from delivering products to our collaboration partners, that obviously influences the cross-margin to a great extent. In addition, please keep in mind, you know, that going forward, there will also be quite a number of deliveries of products from ourselves, but mainly from our partners, of course, where we deliver to middle and low-income countries for which we have lower prices, of course, or non-for-profit prices. So that influences the cross-margin going forward to some extent.
Unknown Executive: So towards the year-end, I would expect that maybe in Q3 or Q4, you will see a slight decrease in the margin that you have seen in Q2. Perfect, thanks so much. Thank you. I will now hand the call back to Silke Maas to close. Thank you again for joining the call today. We look forward to speaking with you in the future. Thank you, bye-bye. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Thanks for watching!
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