Q4 2021 BioNTech SE Earnings Call
Unknown Executive: Welcome to the BioNTech fourth quarter and year end update call. I would like to hand the call over to the Vice President of Investor Relations and Strategy, Zirka Mas, please come ahead Zirka. Good morning and good afternoon and thank you for joining us today to review BioNTech's fourth quarter and fiscal year 2021 operational progress and financial results. A few housekeeping items before we start.
Welcome to the biotech fourth quarter and year end update call I would like to hand, the call over to the Vice President of Investor Relations and strategy. So you come off. Please go ahead Jessica.
Good morning, and good afternoon, and thank you for joining us today to review <unk> fourth quarter fiscal year, 2021 operation brokers and financial results.
A few housekeeping items before we start.
Unknown Executive: I invite you to view the slides that accompany the webcast and the fourth quarter and full year 2021 press release, both of which were issued this morning and can be found in the investor section of our website. As outlined on slide two during today's presentation, we will be making several forward-looking statements. These forward-looking statements include, but are not limited to, our current COVID-19 vaccine revenues, as these figure include figures that are derived from preliminary estimates provided by our partners, our estimated financial response for 2022, the continued global demand for our COVID-19 vaccine, our target vaccine production capacity for 2022 and beyond, our ability to supply our COVID-19 vaccine, the planned success in our pipeline programs, the timing for enrollment, initiation, completion and reporting of data from our clinical trials, the timing of our ability to obtain and maintain regular regulatory approval for our product candidates, and other risks described in our findings made with the U.S. Security and Exchange Commission, including our most recent annual report on Form 20-F. Actual results could differ from those we currently anticipate.
I invite you to review the slides accompany the webcast.
The fourth quarter and full year 2021 press release.
Which were issued this morning and can be found in the investor section of our website.
As outlined on slide two today's presentation would be making several forward looking statements. These.
These forward looking statements include but are not limited to our current COVID-19 X gene revenue at least they got into it because at least preliminary estimates provided by our partners.
Our estimated financially responsible 2022 the continued global demand for our COVID-19 vaccine.
Our target mix.
The production capacity for 2022 and beyond.
Our ability to supply our COVID-19 vaccine the plastics, that's an old pipeline broken tiny important relevant initiation completion and reporting of data from our clinical trials.
<unk> of our ability to obtain and maintain readiness.
Improved as well, although that any day.
Despite.
<unk> made with the U S Securities Exchange Commission, including our most recent report on form 20-F.
Actual results could differ from those currently anticipated you are therefore cautioned not to place undue reliance on any forward looking statements, which speak only as of today chat today during this conference call and webcast.
Unknown Executive: We are therefore cautioned not to place undue reliance on any forward-looking statements which speak only as of today, shared today during this conference call and webcast, also known that slide three and four provide detailed and important safety information regarding our COVID-19 vaccine. Finally, you can find our agenda for today's call on slide five.
Also note.
Slides three and four provide important safety information regarding our COVID-19 vaccine.
You can find all agenda for todays call on slide five.
Zirka Mas: It's my pleasure to introduce the members of BioNTech's management team participating in today's call. I'm joined today by our CEO and Co-Founders, Ugur Sahin, Ozlem Tureci, our Chief Medical Officer and Co-Founder, Jens Holstein, our Chief Financial Officer, and Ryan Richardson, our Chief Strategy Officer. I would like to turn the call over to Ugur Sahin.
It's my pleasure to introduce the member of plastics management team participating on today's call I'm.
I'm joined today by CEO and co founder who design.
Essentially our chief Medical Officer, and co founder and our Chief Financial Officer, and Brian Richardson, Our Chief strategy Officer.
I would like to turn the call over to Wassa.
Ugur Sahin: Thank you, Jekyll. Good morning and good afternoon, and a warm welcome to all the call participants. We appreciate your continued support. Today, I'm delighted to point out a few key fourth quarter and full year 2021 highlights and priorities before I pass the call over to my team to go through some further details. We will then open the call for questions.
Thank you Jake good morning, and good afternoon, and a warm welcome to all the call participants.
We appreciate your continued support.
I'm delighted to point out a few key talk fourth and full year 2021 highlight and priorities before I pass the call over to my team to go through some further details.
We're down to open the call for questions.
Ugur Sahin: Francis Six, Since our company was founded in 2008, we have followed our vision to harness the immune system to fight human disease. The COVID-19 pandemic has provided us with a unique opportunity, not only to help protect well over 1 billion people with our first product, but also accelerate our long-term vision to bring the next generation of immunotherapy to patients. BioNTech integrates the full spectrum of competences for biopharmaceutical drug development, covering discovery, translational research, development, GMP manufacturing, and commercial capability. We are pursuing a multi-platform strategy powered by a technology agnostic innovation engine coupled with strong leadership and competencies in powerful emerging technology.
Slide six.
Ugur Sahin: And we are rapidly expanding and advancing a diversified product pipeline of immunotherapies that address multiple high medical need oncology and infectious disease indicators. We are building a 21st century immunotherapy powerhouse with a mission anchored by a strong sense of our global social responsibility. We seek to make a positive impact on global health and democratize access to cutting-edge medicine. Moving to slide seven.
Since our company was founded in 2008, you have followed our vision is to harness the immune system to fight human diseases.
Ugur Sahin: 2021 was a year of historic impact that BioNTech has made on human health and the economy around the globe. We ended the year with a strong first quarter, demonstrating our commercial execution and clinical pipeline advances. Together with our partner Pfizer, we have delivered approximately 2.6 billion doses of our COVID-19 vaccines to more than 166 countries over the end of last year. The global deployment of our vaccine has likely saved millions of lives and is helping people all over the world find their way back to a more normal way of living.
The COVID-19 pandemic has provided us with a unique opportunity not only to help protect that.
Ugur Sahin: By the end of 2021, as part of our commitment to equitable access to COVID-19, vaccines globally. We provided more than 1 billion doses, or approximately 40% of our COVID-19 vaccine supply globally to low- and middle-income countries. We are committed to provide more than 2 billion doses to lower and middle income countries by the end of 2022. It has also been an active year for our oncology path. During 2021 and 2022 and to date, we expanded and advanced our clinical pipeline extensively with multiple novel oncology platforms entering the clinic. We have five ongoing randomized phase 2 trials across a range of solid tumor indicators. This includes our fixed-fact, I-ness by specific antibody focus.
1 billion people plus product, but also excellent at our long term vision to bring the next generation of immunotherapy to patients.
Don't take integrate the full spectrum of comprehensive for biopharmaceutical talk development covering discovery translational research development, GMP manufacturing and commercial capabilities.
We are pursuing a multi platform strategy powered by a technology agnostic innovation engine, coupled with strong leadership and competencies in power for emerging technologies.
And we are rapidly expanding and advancing our diversified product pipeline of immunotherapies that address multiple high medical need oncology and infectious disease indications.
We are building a 21st century immunotherapy powerhouse with a mission and cut fast posture of our global social responsibility.
To make a positive impact on global Hawk, and democratize access to cutting edge medicines.
Moving to slide seven.
2021 was a year of your stomach impact that <unk> has made on the human health.
The economy around the globe.
We ended the year with a strong fourth quarter, demonstrating our commercial execution and clinical pipeline advancement.
Together with our partner <unk>, we have delivered approximately two 6 billion doses of our COVID-19 vaccine for more than 100 countries.
Over at the end of last year.
The global deployment of our vaccine is likely save millions of lives and it's having people all over the board.
Frank debate back to a more normal way of living.
At the end of 2021.
Part of our commitment to equitable access to COVID-19.
X gene's globally, you've provided more than 1 billion doses.
Approximately 40% of our COVID-19 vaccine supply globally to low and middle income countries.
We are committed to provide more than 2 billion doses, so low and middle income countries by the end of 2022.
It has also been an efficacy for our oncology pipeline.
During 2021 and 2022 and to date, we expand and advance our clinical pipeline extensively with multiple nowhere oncology platforms entering the clinic.
Yes.
<unk> ongoing randomized phase two types across a range of solid tumor indications.
This includes our picks back I left by specific anti body program.
Ugur Sahin: We advanced four new platforms into first in human studies comprising of our mRNA-encoded ribocytokines and ribomaps, our next-generation CAR T-cell therapy, and our Neostim ex vivo T-cell therapy, report in multiple assets, and FORGE collaborations to complement our existing technologies and capabilities. This includes the cell therapy facility we acquired from Kite, as well as the MediGene Asset Acquisition and Discovery Collaboration that further expanded our TCR pipeline. Given the scope of transformation efforts, we have grown our global organization to more than 3,000 employees and expanded our footprint to include new offices in the U.S., Europe, and Asia.
We advanced our new platform into first in human studies, comprising of our and coated Ivo cytokines and <unk>. Our next generation car T cell therapy, and our Neostem ex vivo T cell count.
We bought in multiple exits and parched collaborations to complement our existing technologies and capabilities.
This includes the Cherokee facility, we acquired from <unk> as well as the.
Messaging asset acquisition and discovery collaboration that further expanded our TCR pipeline.
Given the scope of transformation effort, there Cohen, our global organization to more than 8000 employees and expanded our footprint to include new offices in the U S Europe and Asia.
Ugur Sahin: Taken together, our advancement and expansion has built the foundation for our 21st century immunotherapy powerhouse. We are well-capitalized to continue rapid pipeline advancement and global expansion in pursuit of our mission. The COVID-19 vaccine supplies in 2021 both reported full-year revenues of approximately 19 billion euro and a diluted earnings per share of 39.63 euro. It is a historically unique moment to advance the next frontier of immunology to transform medicine. And we are well-positioned to face this once-in-a-generation opportunity. Slide eight.
Taken together our advancement in expansion has built the foundation for a 21st century immunotherapy powerhouse.
That capitalized to continue rapid pipeline advancement and global expansion in pursuit of our mission.
The COVID-19 vaccine supply in 2021 both reported full year revenues of approximately 19 billion Euro and a diluted earnings per share of 39.6 CEO .
It is historically unique moment.
And the next tranche of immuno Archie to transform medicine, and we are better positioned to face. This once in a generation opportunity.
Ugur Sahin: Slide 8 illustrates the building blocks of our technology and innovation strategy. Our strategy aims to drive terapeutic innovation by developing and linking a toolkit of versatile modular technology platforms for precision medicine. Our first-in-class therapeutic technology platform includes mRNA vaccines, gene and personalized T-cell therapies, targeted antibody therapeutics, and next-generation immunomodulators. We have strengthened our capabilities through synergistic acquisitions and collaborations, and we will continue to do so. The Medellin collaboration provides us the opportunity to expand the spectrum of personalized T-cell therapies against various targets.
Slide eight.
Slide eight illustrates the building blocks of our technology and innovation strategy.
Our strategy aims to drive cannot put innovation by developing and linking a toolkit of versatile modular technology platforms for precision medicine.
Our first in class therapeutic technology platform include mrna vaccines gene and personalized T cell therapies targeting anti body tab politics, and next generation immuno modulator.
They have strengthened our capabilities towards the logistic acquisition and collaboration and we will continue to do so.
The messaging collaboration provides us the opportunity to expand the spectrum of personalized T cell therapy against various targets by.
Ugur Sahin: One example is Supreme TCR, which we believe has the potential to be best in class for a range of solid tumors. Similarly, with the acquisition of Fagomate, we have entered the field of lysine-based precision antibacterials, a powerful new drug class that could overcome the challenges posed by multidrug-resistant bacteria.
One example is <unk>, which we believe has the potential to be best in class for a range of solid tumors.
Similarly, with the acquisition of pack Amit we have entered the field of lighting based precision until the FDA is a powerful and you will crack.
That could overcome the challenges posed by multi drug resistant bacteria.
Ugur Sahin: And with Crescendo Biologics, we gain access to technology and know-how that strengthens our capabilities in the field of engineered cell therapies and multi-targeted environments. This modular and multi-platform approach has enabled us to generate a robust pipeline of clinical stage candidates. Currently we have more than 16 clinical stage product candidates spanning 10 different modalities in 20 clinical trials. Moving to slide nine.
And this crescendo biologics they gain access to technology and Knowhow that frankness, our capabilities in the field of engineered cell therapies, and multi targeted and tablets.
This module, yeah, and multi platform approach has enabled us to generate an August pipeline of clinical stage candidates.
Ive asked modest 16 clinical stage product candidates spanning 10 different modalities in <unk>.
Clinical costs.
Moving to slide nine.
Ugur Sahin: Our strategic priorities for 2022 can be summarized in four areas. First, we will continue to address the evolving challenge of COVID-19 around the world. We are developing next generation COVID-19 vaccines and further continuing to focus on label and geographic expansion. In parallel, we have several innovation initiatives underway for pandemic preparedness. Second, in the oncology space in 2022, we will continue to accelerate our programs towards seeking marketing approval. We have started preparation for registrational studies for our mid-stage programs.
Our strategic priorities for 2022 can be summarized in four areas.
Sure.
We'll continue.
Bogging challenge of COVID-19.
We are developing next generation COVID-19, vaccines and third continuing to focus on label and geographic expansion.
In parallel we have several innovation initiatives underway for pandemic book yet.
Ugur Sahin: 2022 is expected to bring our first lead out from a randomized phase two trial in oncology. In addition, we plan to provide proof-of-concept data for our CAR-T cell therapy in solid tumors. Third, we believe that infectious diseases are a long-term growth pillar for BioNTech. Our objective is to develop mRNA vaccines against infectious diseases that have a major impact on global population health. We plan to initiate clinical trials for four infectious disease programs in 2022. Herpes Zympex virus 2, Mycobacterium tuberculosis, malaria, which are all fully owned by BioNTech, and shingles, which is partnered with Pfizer.
Second in the oncology space in 2022 we will continue to accelerate our programs towards seeking marketing approval. We have started preparation for patients.
Creation of studies for our mid stage program 72 is expected to bring our first weeks out from our randomized phase two trial in oncology.
In addition, we plan to provide proof of concept data for our car T cell therapy in solid tumors.
Ugur Sahin: In addition, our preclinical infectious disease portfolio includes more than 10 other mRNA vaccine programs and precision antibacterial. Fourth, we are expanding the reach of our platforms into new therapeutic areas such as autoimmune disease, regenerative medicine, and cardiovascular disease. We continue to drive our future growth and transformation by reinvesting in the foundation of our company. We are further strengthening our digital and AI capabilities and technologies, as well as expanding our development team, manufacturing infrastructure, and our global footprint. We believe delivering on our 2022 strategic priorities will position the company for long-term success. Slide 10.
But the belief that infectious diseases, our long term growth pillar for biotech.
Our objective is to develop mrna vaccines against infectious diseases that have a major impact on global population, we plan to initiate clinical costs for infectious disease program in 2022.
It expires two mycobacterium tuberculosis, malaria, which are all fully owned by by Ontic and shingles, which is partner with Pat.
In addition, our preclinical infectious disease portfolio includes more than 10 other I'm on it it's important and precision antibacterial.
Paul.
Expanding the reach of our platform into new tap party areas, such as auto immune disease, regenerative medicine and cardiovascular disease.
We continue to drive our future growth and transformation.
Investing in the foundation of our company the arthritis hunting, a lot digital and AI capabilities and technologies as well as expanding our development team manufacturing infrastructure and our global footprint, we believe delivering on our 2022 strategic buyer.
<unk> will position the company for long term success.
Ugur Sahin: Global social responsibility is at the core of who we are as a company. It is best demonstrated through our commitment to democratizing access to innovative products. As part of our 2021 pledge, we and our partner Pfizer plan to supply more than 2 billion doses of COVID-19 vaccine to low- and middle-income countries by the end of 2022. We are increasing the reach of our innovations worldwide, taking geographical needs and sustainability into account. One example of this is the way we are handling infectious diseases with high medical needs on the African continent.
Slide 10, Nova those scope responsibility is at the core of who we are as a company.
It is best demonstrated to our commitment to democratizing access to innovative products.
Part of our 2021 pledge.
Our partner has a plan to supply more than 2 billion doses of COVID-19 vaccine to low and middle income countries by the end of 2022.
We are increasing the reach of our innovations Bert, but taking geographical needs and sustainability into account.
An example of this is the baby.
Infectious diseases. This time medical needs on the African continent, we have launched on a vaccine discovery programs for prevention and treatment of HIV malaria and turbo clauses.
Ugur Sahin: We have launched mRNA vaccine discovery programs for prevention and treatment of HIV, malaria, and tuberculosis, the latter two of which will enter the clinics this year. Recently, we announced the launch of our BioNTenus initiative to provide modular mRNA manufacturing facilities. Our bioantennas are designed to enable local production of mRNA vaccines on a flexible scale according to the needs of each partner company. We believe that local production of vaccines that meet international standards is the most sustainable way to achieve vaccine access.
The latter two of which will enter the clinic this year.
Recently, we announced the launch of our buy on Peanuts initiative to provide modular manufacturing.
Manufacturing facilities.
Our bi antennas are designed to enable local production.
Any vaccines on a flexible scripts care. According to the needs of each patent country. We believe that local production of X gene that meet internationally and that is the most sustainable way to achieve <unk> equity.
Ugur Sahin: Another example of new avenues for access to our vaccines is that we are introducing drone vaccine delivery programs in Ghana. We are also committed to a responsible governance, environmental and climate protection, as well as respecting human rights.
And as a campus on new avenues for access to our vaccines is that we are introducing drawn vaccine delivery program.
Anna.
We are also committed to a responsible governance environmental and climate protection as well as respecting human rights.
Ugur Sahin: We set climate protection targets fulfilling the requirements of the Science-Based Targets Initiative. We target an absolute reduction of 42% in our scope 1 and 2 greenhouse gas emissions by 2030 against base year of 2021. We strive to adhere to ethical business practices, including good corporate governance, social and societal responsibility, and sustainability, is signed the United Nations Global Compact.
We set climate protection package fulfilling the requirement of the science based targets initiatives.
We target an absolute reduction of 42% in our scope, one and two greenhouse gas emissions by 2030 against base year of 2021. These ties to adhere to ethical business practices, including good corporate governance, social and Soc type of responsibility and fast.
Inability is fine the United.
Nations Global compact.
Ozlem Tureci: We are committed to continuously strengthening our employee recruiting and development. Our team is well diversified with employees from more than 60 countries. With that, I conclude my remarks and hand over to Ozlem Tureci, our Chief Medical Officer, who will give you the latest updates on COVID-19 vaccines and our oncology. Thank you, Ugur.
Committed to continuously tightening our employee recruiting and development.
Our team is good diversified as employees from more than 60 countries.
Is that right.
Conclude my remarks, and turn it over to SMB maturity, our Chief Medical Officer, who will give you the latest update on COVID-19 vaccine and our oncology programs.
Ozlem Tureci: I'm delighted to speak with everyone today. Our achievements to date have positioned BioNTech well for continued success in 2022. This is also supported by a solid financial foundation, backed by a strong order book for 2022, which already includes 2.4 billion science dollars. We continue to broaden the label of our COVID-19 vaccine, gaining approval in the U.S. and E.U. for a two-dose primary regimen for children aged 5 to under 12 years.
Thank you God I'm delighted to speak with everyone. Today, our achievements to date have positioned <unk> well for continued success into a new 22. This is also supported by a solid financial Foundation.
By a strong order book for 2022, which already includes 2.4 billion times.
We continue to broaden the label for Covid.
COVID-19 vaccine gaming Tuesday in the U S and EU for a two dose primary regimen for children age five to under twist here.
Ozlem Tureci: As for adults with the emergence of the Omicron variant, a third vaccine dose may also be needed in the pediatric age group to prolong protection. And we are evaluating a booster dose in the 5 to 12-year-olds as well. In children six months to under five years of age, we are evaluating a primary regimen of, Data on the first dose are expected in April 2022.
That's what it does with the emergence of the Army Crum variant.
<unk> may also be needed in the pet D. N Trig age group two program put protection and we are evaluating a booster dose in the times to 12, Oh It's S.
As to win.
In children six months to under five years of age we are evaluating the primary regimen of <unk>.
Data on the dose.
In April 2020 tool in this age group and we have begun enrolling a emergency use.
Ozlem Tureci: In this age group, and we have begun a rolling emergency use application submission with the FDA and with other regulators. The EU product information has been updated to include use of the vaccine during pregnancy and breastfeeding based on the large body of data showing no increase in pregnancy complications or risk to breastfed infants. Regarding booster vaccines, we have received approval in the U.S. and EU for a third dose in individuals 12 years of age and older.
Vacation submission with the FDA and other regulators.
The EU product information has been updated to include use of the vaccine during pregnancy and breast feeding based on the large body of data showing no increase in pregnancy complications.
Two breath.
Regarding booster vaccines, we have received approval in the U S and EU for a first dose individuals 12 years of age and older.
Ozlem Tureci: This week we have received the approval from the FDA for the expansion of the emergency use authorization to include a second booster dose of our COVID-19 vaccine to individuals aged 50 years and older who have previously received a booster of any authorized COVID-19. At the same time, the FDA also authorized the second booster dose to individuals aged 12 years and older with certain kinds of immunocompromised who have received the first booster of any authorized COVID-19 vaccine. Our global manufacturing network continues to grow. We are building state-of-the-art manufacturing facilities in Africa and Asia to ensure sustainable local supply.
This week, we have received the approval from the SBA for the X.
After an emergency use authorization to include that could push the dose of our COVID-19 vaccine to individuals aged 50 and older who have previously received a boost of any authorized COVID-19 vaccine.
At the same time the FDA also authorized the second was the dose to individuals aged 12 and older with certain kinds of immuno compromised who have received the first booster.
Any authorized Covid Covid 1916, our global manufacturing network continues to grow we are building state of the Ottoman you're factoring facilities.
Africa, and Asia to ensure sustainable low cost supply as Luca mentioned, the bio <unk> initiative is designed to rapidly build modular mrna vaccine production.
Ozlem Tureci: As Ugur mentioned, the BioNTainer initiative is designed to rapidly build modular mRNA vaccine production nodes. We continue to closely monitor the impact of the Omicron variant and other new variants of concern. The development of an Omicron-adapted vaccine is part of our comprehensive development program for variant-adapted vaccines. We are well on track with the development of an Omicron-adapted vaccine, which we started in early December 2021. We have designed the Omicron-adapted vaccine, scaled up production, and started manufacturing.
We continue to closely monitor the <unk>.
Also on the Crown variant and other new areas of concern, but development Joseph Omicron adapted vaccine as part of our comprehensive development program from Varian detected vaccines, we are well on track with the development of not only from the depth of 16, which restarted in early December .
'twenty one we have designed the omicron adapted vaccine scared a protection and started manufacturing we are conducting clinical trials with this vaccine in support of a potential regulatory submission and expect to have this rich data from the Australia.
Ozlem Tureci: We are conducting clinical trials with this vaccine in support of a potential regulatory submission and expect to have the first data from these trials in April 2022. Our vaccine development strategy continues to be based on scientific data. It is based on our extensive research in the development of SARS-CoV-2 directed immunity and how it is further shaped by vaccination, booster vaccination, and natural infection. As part of our preventive approach, we are collaborating with InstaDeep on further development of an early warning system for new variants of concern.
2022.
Our vaccine development strategy continues to be based on scientific data it just there.
Based on our extensive research and the development of staff costs directed immunity and how it's progressed shaped by a explanation of explanation in that trend.
This is part of our preventive approach we are collaborating with deep on further development of an early warning system for new variance of concern. The approach is based on the new computational message that and then I'm just gonna open your beta the sequencing data and predict.
Ozlem Tureci: The approach is based on a new computational method that analyzes globally available sequencing data and predicts high-risk variants of SARS-CoV-2. The early warning system is capable of evaluating new variants in just minutes and performing near real-time risk assessment of variant lineages. It is also fully scalable as new variant data becomes available.
Higher risk variant of that cost.
The early warning system. This capability evaluating new variants in just minutes and performing near real time risk assessment of the IMT niches. It didn't answer 40 scale up at its new variant data becomes available.
Ozlem Tureci: The Nietzsche, For a pandemic vaccine continues, as you can see on set 13, large portions of the world's population are still not fully vaccinated or not vaccinated at all. At the same time, COVID-19 continues to spread worldwide, and infection rates are increasing with the emergence of highly transmissible areas. The COVID-19 continues to spread worldwide, and COVID-19 continues to spread worldwide. The Omicron variant, which emerged late last November, is the most evolutionarily distant reported COVID variant and one that partially escapes the immune system.
The needs.
The pandemic vaccine continues as you can see on slide 13 that portions of the words population are still not fully vaccinated are not vaccinated etch or at the same time, COVID-19 continues to spread worldwide and infection rates increasing with the emerge.
<unk> a highly transmissible areas.
The omicron variant, which emerged late last November is our most evolutionary leap distance reported COVID-19 variant and one that partially escapes the immune system.
Ozlem Tureci: Omicron is highly transmissible and has outcompeted the Delta variant. Countries at higher risk of COVID-19 spread are those with low vaccination rates with inadequate population protection, often accompanied with high natural immunity rates, which wane faster than vaccine-induced immunity over time.
From this highly transmissible and has competed for that type of area countries at higher risk of COVID-19.
Our spreads are those with pseudo vaccination rates with inadequate population protection, often accompanied with time natural immunity right, which win yep.
Ozlem Tureci: Reinfections with emerging sublinages of Omicron and newer variants of concern are possible even in persons with prior infections. As evidenced by the current Omicron... On site 14, while the primary two-dose regimen of BNT162b2 alone provides insufficient protection against symptomatic Omicron-caused infections, it continues to protect against severe disease and hospitalization. There is a plethora of global real-world data supporting the importance of a booster dose in improving protection against Omicron. A third dose provides higher vaccine effectiveness against Omicron, 70-80% against overall infections, 50-85% against symptomatic infections, and 75-90% against hospitalization.
<unk> seen induce immunity overtime, we infections with emerging happening it yourself Army Cronin newmont variant of concern a cut of it even in person switched.
Action is evident.
By the current earnings run ways.
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On Slide 14 was primarily two dose regimen of P&G won 62, B two alone provide sufficient protection against symptomatic.
Infection. It continues to protect against severe disease and hospitalization, there's a plethora of Kroger weird, where data supporting the importance of a booster dose and improving protection against Omnicom, a third dose provide tire the casino chips.
Tiffany against Omicron, seven two T to 80% against broad infection, 50% to 85% against symptomatic infections, and 75% to 90% against customer temporary isolation.
Ozlem Tureci: For certain populations, a fourth dose of BNT162b2 may be beneficial as long as an Omicron-adapted vaccine is not available. We have submitted an application to the U.S. FDA for emergency use authorization of a fourth dose of BNT162b2 for adults aged 65 and older who have received any prior authorized or approved COVID-19 vaccine. We observed that at 12 days post-force dose, rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received a force dose of BNP162B2 4 months or more after the third dose compared to individuals who received a third dose on...
Certain populations across dose of <unk> hundred 62, B two may be beneficial as long as the omicron adapted vaccine is not.
We have submitted an application to the U S FDA for emergency use authorized nation.
For those of P&G won 60, it will be true for.
H 965, and older who have received any prior.
Authorized or approved COVID-19 vaccine we observed that.
Today's post fourth dose rates of confirmed infections were two times to the long end rates.
Yeah in this were four times.
Among individuals who received a first dose of <unk> hundred 60, <unk> will be two four months or more.
After the third dose compared to individually individuals who received a first dose or me.
Ozlem Tureci: However vaccine effectiveness of the NT-162, the two boosters against Omicron, start waning after the first few months. We believe that Omicron-debted vaccines are required to prolong duration of protection, reduce transmission of disease, improve breath, of response, and protection against emerging variants of countries. We believe that Omicron-debted vaccines are required to prolong duration of protection. We believe that Omicron-debted vaccines are required to prolong duration of protection. As you can see on slide 15, Omicron comprises almost 100% of sequence genomes in most parts of the world.
That vaccine effectiveness of BMT 162, b to boost us against Omicron start waning. After the first few months, we believe that on the crop Dusters X genes are required to prolong duration of protection reduce transmission of Td's improved breadth of response and.
Protection against emerging areas of concern.
As you can see on slide 16, Amit from comprises almost 100% of sequence genomes in most parts of the word new variants can arise from any niche they are more likely to have a rights from the variant with heightened section right.
Ozlem Tureci: While new variants can arise from any lineage, they are more likely to arise from a variant with high infection rate, especially if such a variant is the main reservoir for ongoing replication. We see evidence of this with further sublinages of Omicron that evolved in recent months, such as BA1, BA2, and BA3.
Actually as Petra variant is the main reservoir for ongoing rent vacation, we see evidence of this with service happening as just omicron. That's been launched in recent months, such SBA 128, Weird, where data has confirmed that vaccine induced immunity provides a higher degree of.
Ozlem Tureci: Real-world data has confirmed that vaccine-induced immunity provides a higher degree of protection than natural immunity, and that as natural immunity wanes, vaccination can extend the level of protection against re-infection. Vaccination remains an important critical strategy to protect against current and new emerging variants of constipation. We anticipate that as SARS-CoV-2 further evolves, either seasonal or annual variant-adapted boosters will be required to sustain protection against COVID-19. On slide 16, already last year, we preemptively launched a program to test and develop variant-adapted vaccines as part of our Comprehensive Pandemic Preparedness Strategy.
Protection that natural immunity and that naturally immunity right.
The explanation.
<unk> been in every of protection against three infection vaccination remains an important critical strategy to protect against.
Current and new emerging variants of concern.
Anticipate that SaaS cross tools, whether it was either not at all and you are very under that.
Would it be required to sustain protection against COVID-19.
On slide 16 already last year, we pre intend to preemptively announced a program to test and develop variant that detects in it's part of our comprehensive pandemic preparedness strategy with the emergence of Amit from this program has been expanded to include the development of Amit.
Ozlem Tureci: With the emergence of Omicron, this program has been expanded to include the development of Omicron-adapted vaccines. We are investigating the safety and immunogenicity of different treatment regimens of a monovagrant Omicron booster in vaccine-experienced individuals aged 18 to 55. Treatment regimens include a third dose after the primary two doses of a BNT162b2 vaccine series, or a fourth dose after three doses of BNT162b2, or a third plus a fourth dose of an Omicron-based vaccine after the primary series with BNT162b2. In vaccine-naive individuals aged 18 to 55 years, the Omicron-matched monovalent vaccine will be administered as a primary vaccine and booster. Data from these studies will be available in April.
<unk>, we are investigating the safety and immunogenicity of different treatment regimens for lunar Vaden Omicron index.
<unk> experienced individuals aged 18 to 55 years.
Treatment regimens include a third dose after the primary two doses.
For P N T 162, B two vaccine serious.
Fourth dose after three doses of <unk> it will be too.
First just a foster often omicron based vaccine after the primary series with PNG 162.
And vaccine that is individuals aged 18 to 55 years, the omicron niche monovalent vaccine will be administered as a primary <unk>.
And Scott.
Data from these studies will be available in April and we are also studying omicron based five valent and combined vaccines at the standard dose of 30 microgram and at a higher dose in order to move up.
Ozlem Tureci: We are also studying omicron-based bivalent and combined vaccines at the standard dose of 30 microgram and at a higher dose in older people over 55 years of age. Our goal is to understand the protection these vaccines provide against Omicron, as well as the cross-protection they provide against previous variants of concern. Currently, there is no regulatory consensus on the need for Omicron-based vaccines.
55 years of age.
Our goal is to understand the protection. These vaccines provide against omicron estimate as a cross protection they provide against previous variance of concern. Currently there is no regulatory consensus on the need for Omnicom based vaccine. However, we anticipate.
Ozlem Tureci: However, we anticipate regulatory developments as clinically meaningful data become available. We remain prepared to adapt our technology, manufacturing and regulatory processes to ensure that our vaccine provides robust protection against current and emerging variants of concern. Slide 18 highlights our strong clinical execution in 2021 and 2022 for our oncology pipeline and the key milestones achieved. In 2021, we presented multiple clinical data updates from our oncology programs at MedicalCon. I would like to highlight our data updates from the ongoing Phase 1-2 trial of our first CAR-T product, candidate BNT211. I will discuss this data in more detail in a few minutes.
To date regulatory developments as clinically meaningful data have become as well.
We remain prepared to adapt our technology manufacturing and regulatory processes to ensure that our vaccine provides robust protection against current and emerging variants of concept.
Slide 18 highlights our strong clinical execution in 2021, and 2022 for our oncology pipeline and the key milestones achieved in 2021, we presented multiple clinical data update from our oncology programs at medical conferences I would like to have.
Highlight our data updates from the ongoing phase one two trial of our first car T product candidates.
I'm going to discuss these data in more detail in a few minutes.
Ozlem Tureci: We also made significant progress in advancing and expanding our clinical programs with four randomized phase II trials starts and five phase I trials. In the fourth quarter, we dosed the first patient in a randomized phase 2 clinical trial of our bi-specific antibody BNT311 in PD-L1 positive refractory relapsed non-small cell lung cancer patients, a patient population with significant need for new treatment. Additionally, the first product candidate of our RepoHub platform, BNT141, entered clinical testing with the first patient dosed in January of this year. Our RepoMod product candidates encode antibodies directed against cancer cell surface markers and have the potential to address limitations of recombinant antibodies.
We also made significant progress in advancing and expanding our clinical programs with four randomized phase II trial starts and five states one train of thought.
It was a tough quarter, we dosed the first patient in the randomized phase two clinical trial.
Our bi specific antibody the anti free 11 in PD lone positive refractory relapsed non small cell lung cancer patients the patient population with significant need for new treatment options. Additionally, the first product candidate from our repo.
Beyond Q1 for one entered clinical testing with the first patient dosed in January of this year.
Or we bring our product candidates include antibodies directed against cancer cell surface markers and has the potential to address limitations of recombinant anti bodies.
Ozlem Tureci: Complimented by the progress we made earlier in 2021, including our phase two trial starts for FIXVAC in melanoma and HPV16-positive head and neck cancer and INUS and adjuvant colorectal cancer and first in human trials for our self-healing platforms, our ribocytokine and riboma platforms, we believe we are entering an important new era of growth for our oncology pipeline Moving to our bi-specific antibody, BNP311, on slide 19. Through blockade of PD-L1 on tumor cells and antigen-presenting cells and conditional 4-1BB stimulation on T-cells and natural killer cells, BNP311 primes and activates anti-tumor immune effectors.
Complemented by the progress we made earlier in 2021, including a phase two trial starts for <unk>.
It's expected in melanoma, and HPV 16 positive head neck cancer.
<unk> and adjuvant colorectal cancer and first in human trials for since you're just got forms or rigor cytokine and sleep warm ups Epsilon. We believe we are entering an important new era of growth for our oncology pipeline, which is poised to continue to advance and expand in 2022.
Moving to our bi specific antibody the antifreeze 11 on slide nine.
Locate of PDL, one on tumor sets, an antigen presenting cells and conditioner for one of these simulation he sets and network edge BMT Sweet 11, Prime sent activates anti tumor immune effector function.
Ozlem Tureci: BNT311 is partnered with our colleagues from GenMed. At CITSI 2021, we presented data from the ongoing Phase 1-2 trial. These data, along with a semi-mechanistic kinetic pharmacodynamic predictive model and translational work, established 100 mg of BNT311 every three weeks as the dose for expansion. We observed encouraging signs of clinical activity and a manageable safety profile in patients with advanced solid tumors during the dose escalation and dose expansion phase of this trial. The NT311 elicited pharmacodynamic effects consistent with its proposed mechanism of action.
<unk> 311, it's partnered with our colleagues from Genmab.
At 60, <unk> 2021 we presented data from the ongoing phase one two trial. These data along with the semi mechanistic pharmacokinetic Cognetics Pharmacodynamic predictive margin translational work.
Established hundred grams of P&G fleet, you'd even every three weeks as the dose for expansion cohorts.
Yes.
We observed encouraging signs of clinical activity and a manageable safety profile in patients with advanced solid tumors during the dose escalation and dose expansion phase.
Just trying to get it.
<unk> never seen incentives pharmacodynamic effects.
Proposal <unk>.
Ozlem Tureci: Patients with tumor reduction have mainly PD-L1-positive tumors. The tumor reduction was observed in 7 of 11 patients with PD-L1-positive tumors, including patients with checkpoint inhibitor-experienced non-small cell lung cancer. These findings support that patient selection and or anti-PD-1 combination therapy may lead to further improved clinical efficacy. The randomized trial that is shown on slide 20 was started in December 2021. It will enroll 130 patients with PD-L1 positive refractory relapsed non-small cell lung cancer that have failed checkpoint inhibitor treatment.
Patients with <unk>.
In one month.
The tumor reduction was observed in seven of 11 patients with PDL, one positive tumors, including patients with checkpoint inhibitor experienced non small cell lung cancer.
These findings support that patient selection and <unk> anti PD, one combination therapy may lead to further improved clinical efficacy.
The randomized trial.
On slide 21.
Started in December 2021.
It will enroll 130 patients with PDL, one positive refractory relapsed non small cell lung cancer that has seen a checkpoint inhibitor treatment. After an initial safety run in for the combination with Tam Leesville not the trial has three treatment arms, one evaluating <unk>.
Ozlem Tureci: After an initial safety run-in for the combination with pembrolizumab, the trial has three treatment arms, one evaluating BNT3-11 as immunotherapy and two arms with different treatment schedules evaluating BNT3-11 in combination with pembrolizumab. The primary endpoint of the trials is overall response rate, while the secondary endpoints include progression-free survival and duration of respiration. The steady outcome will be compared, again, to send out off-care chemotherapy treatment with dosa- We believe BNT311 has the potential to provide a new treatment option for a high medical need patient population.
As Bruno for European two arms, where it's different treatment schedule is evaluating <unk> in combination with what is the.
The primary end point of the Tri Ed.
Overall response rate, while the secondary endpoints include progression free survival duration of response.
Study outcome will be compared against standard of care chemotherapy treatment with dose that Texan. We bring you. The antifreeze 11 has the potential to provide a new treatment option for a high medical need patient population, whereas required about one 8 million people die.
Ozlem Tureci: Worldwide, about 1.8 million people die of lung cancer every year, with non-small cell lung cancer being the most common type, accounting for 85% of lung cancers. While with existing approved therapies, the five-year survival rate is only 4% in advanced disease. Despite the success of checkpoint inhibitors in the treatment of non-small cell lung cancer, the majority of patients eventually fail to respond to checkpoint inhibitor therapy due to evolution of therapy resistance.
Lung cancer every year with non small cell lung cancer being the most common type accounting for 85% of that we have.
With existing approved therapies with five year survival rate is only 12% in advanced disease.
Despite the success of checkpoint inhibitors in the treatment of non small cell lung cancer. The majority of patients eventually appeared to respond to checkpoint inhibitor therapy due to evolution of PRP resistance.
Ozlem Tureci: Non-small cell lung cancer patients that have progressed after treatment with the checkpoint inhibitor have a particularly poor prognosis with a progression-free survival of about six months and overall survival of less than a year. Clearly, there is a gap for new treatment strategies to overcome resistance and improve efficacy. On slide 21 now, we are continuing to evaluate BND311 in 10-dose expansion cohorts in our ongoing Phase 1-2 trial, each enrolling up to 40 subjects. Those cohorts include non-small cell lung cancer, orophelial cancer, endometrial cancer, triple negative breast cancer, head and neck squamous cell carcinoma, and cervical.
Small cell lung cancer patients that have progressed after treatment with a checkpoint inhibitor has a particularly poor prognosis versus a progression free survival.
About six months and overall survival of less than a year. He any there is a gap for new treatment strategies to overcome resistance and improved efficacy.
On slide 21, now we are continuing to evaluate the <unk> 11.
10 dose expansion cohorts in our ongoing phase one two trial each enrolling up to 40 subjects.
This cohort includes non small cell lung cancer with few yet cancer endometrial cancer triple negative breast cancer head and neck squamous cell carcinoma cervical cancer.
Ozlem Tureci: The NT312, the second antibody we are developing together with our colleagues from GenMap, is a bi-specific antibody targeting CD40 and 4.1BB. The phase 1-2 trial of this antibody includes a monotherapy expansion cohort in melanoma, post-checkpoint inhibitor treatment, and combination therapy expansion cohorts in melanoma, non-small cell lung cancer, head, neck, cranial cell carcinoma, and pancreatic adenoma. The combination of European expansion cohorts are currently recruited. We expect expansion cohort data from both Phase I-II trials for BNT3-11 and BNT3-12 in early 2023.
Yeah in Q3 trends the second anti body, we are developing together with our colleagues from Genentech.
Is a bi specific antibody targeting CD 40, and 41 BB BBB.
<unk> <unk> two trial of this anti body includes our monotherapy expansion cohort in melanoma, plus checkpoint inhibitor treatment and combination therapy expansion cohorts in melanoma, and non small cell lung cancer head and neck squamous cell carcinoma and pancreatic adenocarcinoma.
Combination therapy expansion cohorts.
Currently you're recruiting.
We expect expansion cohort data from both phase one two trials.
<unk> 11 and <unk>.
PMT free trials in early 2023. These data will inform the clinical development path forward for these programs, including potentially the latest stage try it if approved we foresee potential combination therapy with the existing standard of care and with oil.
Ozlem Tureci: These data will inform the clinical development path forward for these programs, including potential later stage trials. If approved, we foresee potential combination therapy with the existing standard of care and with all FIXSEC and INIS products in development. Moving to BNT2-11 on slide 22, which combines two of our platforms with complementary modes of action. Claudine-6 CAR-T cells and a CAR-T cell amplifying RNA-Lipopex vaccine in short CAR-V. Claudine-6 CAR T-cells are equipped with a second-generation chimeric antigen receptor of high sensitivity and specificity for the carcinoembryonic tumor-specific antigen Claudine-6. Claudine-6 is absent in healthy adult tissue, yet frequently expressed in high-medical-need cancers, making this tumor antigen an ideal candidate for CAR T-cell theory.
Six sick and I in this product in development.
Moving to BNP to 11 on slide 22, which combines two of our platforms with complementary modes of action quoted six car T cell and car T cell and defying all in <unk> 16 in short comic Jordan six cut she says.
Equipped with a second generation chimeric antigen receptor of high sensitivity and specificity for the casino embryonic tumor specific antigen protein.
Got it excellent and healthy tissue, yet frequently expressed in high medical need 10 sets, making this tumor antigen and ideas candidate for car T therapy in preclinical studies, we demonstrated with Kovack drive indeed likes option of transfer.
Ozlem Tureci: In preclinical studies, we demonstrated that CARBAP drives in vivo expansion of transferred CAR T-cells, increasing their persistence and efficacy. BioNTech 2.11 is expected to overcome CAR T-Cythera predimentation in patients with solid tumors. The first in-human phase 1-2 trial evaluates the safety and efficacy of cloridine-6 CAR-T cells as monotherapy and in combination with CAR-VEC in patients with cloridine-6 positive relapsed or refractory advanced solitude.
<unk> car T cells, increasing that persistence and BMT.
PMT to 11 is expected to overcome car T cell therapy gene mutation in patients were started two months. The first in human phase one two trial evaluates the safety and efficacy of <unk> car T cells as monotherapy and in combination with Kovack in patients with <unk>.
The chip relapsed or refractory advanced solid tumors.
Ozlem Tureci: We are testing three dose levels of protein-6 CAR-T as monotherapy dose escalation as well as combined with the sixth dose of the RNA-VAX. The subsequent dose expansion cohorts represent ovarian, testicular, and endometrial cancers, as well as other rare Claudian-6 positive cancer types, such as sarcoma. We had several data presentations from the trial, which started only about a year. The most recent data presentation shown on slide 23 from our BNT211 trial was at the ESMO-IO conference in December last year, reporting data from 15 patients.
We anticipate pre dose levels of trading six car keys as monotherapy dose escalation as well as combined with a fixed dose of the efficacy.
<unk> six <unk> dose expansion cohorts represent ovarian to secure and endometrial cancers as well.
About <unk> six positive cancer types, such as second line, we had several data presentations from the trial, which started only about a year ago.
The most recent data presentation shown on slide 23 from our BN key to that and try it once at the ESMO Conference in December last year reporting data from 15 patients.
Ozlem Tureci: 146 CAR-T cells as monotherapy and combined with CAR-VEC were well tolerated at the dose levels evaluated, with only one case of dose-limiting toxicity. Cases of cytokine-release syndrome were grade 1 or 2 and were manageable. Neurotoxicity was not observed.
14, six car T cells, one of European combined with Kovack, we're winning ton oriented at the dose levels evaluated with only one case of dose limiting toxicity observed cases of cytokine release syndrome were grade one or two and manage open neurotoxicity was not all served but.
Ozlem Tureci: The analysis of CAR T-cell frequency in the peripheral blood of a patient revealed robust CAR T-cell engraftment in 9 of 10 evaluable patients. We have observed initial disease, and four of these nine patients experienced partial responses. Three patients with partial response were testicular cancer patients who were pre-treated with recent relapse and progressive disease after high-dose chemotherapy and autologous stem cell transplantation.
And then just a soft patch. He says makes them seem the peripheral blood of patients we've hit robust car T cell and grassman in nine of 10.
The patients we have observed initiating these swaps.
Swap fees nine patients experience partial responses treat patients with partial response were to stick your neck cancer patients.
Who were pre treated with recently that said progressive disease after high dose chemotherapy and autologous stem cell transplantation. We are very excited that we will be sharing more data, including safety and efficacy data from the last follow up period.
Ozlem Tureci: We are very excited that we will be sharing more data, including safety and efficacy data from a longer follow-up period, an updated cortisol engraftment analysis, and selected clinical case reports at the upcoming AACR conference on April 20th. I'd now like to turn the call over to Jens Holstein, who will cover our financial results, 2022 guidance, and our capital allocation. Thank you, Ozlem, and a warm welcome to those who come.
Aged car T cell and Grassman analysis and selected clinical case reports.
Humming ACR conference on April 10th.
I'd now like to turn over the call. It two yen tons with cover all financial results 2022 guidance and our capital allocation framework.
Thank you everyone and a warm welcome to those of you on the phone.
Jens Holstein: I'll start my section by presenting the key highlights for the 2021 financial year, which you can find on slide 25. The 2021 financial year has been an extraordinary year, which also becomes visible by looking at our key financial highlights. Our total revenues reported for the 2021 financial year reached 19 billion euros and included 18.8 billion euros COVID vaccine revenues exceeding our guidance of 16 to 17. We ended our 2021 financial year with an operating result of 15.3 billion euros, and generated earnings per share on a diluted basis of 39 euros and 63 euros.
I'll start my section by presenting the key highlights for the 2021 financial year, which you can find on slide 25.
The 2021 financial year has been an extraordinary one which also becomes visible by looking at our key financial highlights.
Our total revenues reported for the 'twenty to 'twenty, one financial year reached 19 billion euros and included $18 8 billion euros Covid vaccine revenues exceeding our guidance of 16 to 17 bps.
We ended our 'twenty to 'twenty, one financial year with an operating result of $15 3 billion euros.
And generated earnings per share on a diluted basis or 39 euros 63 euro cents.
Jens Holstein: We ended the 2021 financial year with 2.1 billion euros of cash and cash deposits, as well as trade receivables of around 12.4 billion. These trade receivables are mainly derived from our collaboration with Pfizer and mainly remained outstanding due to the contractual settlement of the gross profit share under the collaboration.
We ended the 2021 financial year with $2 1 billion euros of cash and cash deposits as well as trade receivables of around $12 4 billion.
The trade receivables are mainly derived from our collaboration with Pfizer and mainly remained outstanding due to the contractual settlement of the gross profit share under the collaboration.
I would explain the timing effects in more depth in a minute.
Jens Holstein: In summary, we believe that those figures just mentioned reflect a clearly remarkable year for Biotech. Let's take a deeper look into our COVID-19 vaccine commercial revenues and touch on the related gross margin on slide 26. During the year ended December 31st, 2021.
In summary, we believe that those figures just mentioned reflected clearly remarkable year for biotech.
Let's take a deeper look into our COVID-19 vaccine commercial revenues and touch on the related gross margin on slide 26.
During the year ended December 31 2021.
Jens Holstein: We recognized 18.8 billion euros of COVID-19 vaccine commercial revenue. As a reminder, under our COVID-19 vaccine collaborations, territories have been allocated between us, Pfizer, and Fosum Pharma based on marketing and distribution. Our COVID-19 vaccine revenues included 14.8 billion euros, revenues related to our share of gross profit from COVID-19 vaccine sales in the collaboration partners territories, together with a number of sales models. These revenues represent already a net figure which means that we generate 100% gross margin on those revenues.
We recognized $18 8 billion euros of COVID-19 vaccine commercial revenues.
Jens Holstein: We would like to point out again that our profit share is estimated on preliminary data shared between all our collaboration partner Pfizer and us, especially with respect to the month of December for Pfizer's business outside the U.S., by which hour in Pfizer's reporting cycles. The profit share may thus be subject to adjustments pending final data on input parameters like sales volume and values, as well as transfer price.
As a reminder, under our COVID-19 vaccine collaborations territories have been allocated between us and Pfizer and Fosun pharma based on marketing and distribution rights.
Our COVID-19 vaccine revenues included $14 8 billion euros revenues related to our share of gross profit from COVID-19 vaccine sales in the collaboration partner territories together with a number of sales milestones.
These revenues represent already in that figure, which means that we generate 100% gross margins on those revenues.
We would like to point out again that our.
Profit share is estimated.
Women every data shared between all of our collaboration partner Pfizer and us.
Especially with respect to the month of December well Pfizer's business outside the U S by which our incise us reporting cycles differ.
The profit share may thus be subject to adjustments pending final data on input parameters like sales volume and values as well as transfer prices.
Any changes in our share of the collaboration partners gross profit will be recognized prospectively.
Jens Holstein: Any changes in our share of the collaboration partners' gross profit will be recognized prospectively. Our COVID-19 vaccine revenues during the year ended December 31st, 2021 comprised 3 billion euros revenues from direct COVID-19 vaccine sales to customers in our territory, as well as 1 billion euros revenues from sales to our collaboration partners. Together with our collaboration partners, we have delivered approximately 2.6 billion doses COVID-19 vaccine during the year ended December 31, 2020. We and Pfizer have previously disclosed the objective to deliver about 40% of our vaccines to low and middle income, while fulfilling the early orders of high... This objective has been achieved.
Our COVID-19 vaccine revenues during the year ended December 31st 2021 comprised 3 billion euros revenues from direct COVID-19 vaccine sales to customers in our territory.
As well as 1 billion euros revenues from sales to our collaboration partners.
Together with our collaboration partners, we have delivered approximately $2 6 billion doses COVID-19 vaccine during the year ended December 31st 2021.
We and Pfizer have previously disclosed the objective to deliver about 40% of our vaccines to low and middle income countries, while fulfilling the early orders of high income countries.
This objective has been achieved.
Jens Holstein: The volume of COVID-19 vaccines delivered worldwide, as well as the allocation of approximately 60% of deliveries to high income countries, included additional deliveries in December 2021 due to the then emerging Omicron variant, and led to COVID-19 vaccine revenues that clearly exceeded our expectations for the 2021 financial, Our 2021 COVID-19 vaccine revenues were significantly influenced by the extraordinary circumstances of the ongoing pandemic. For the 2022 financial year, we expect to further increase the share of delivered vaccine doses to low and middle income, where prices are in line with income levels or at non-for-profit basis.
The volume of COVID-19, vaccines delivered worldwide as well as the allocation of approximately 60% of deliveries to high income countries included additional deliveries in December 2021, due to the then emerging omicron variant.
And let the COVID-19 vaccine revenues that clearly exceeded our expectations for the 2021 financial year.
Our 2021, COVID-19 vaccine revenues were significantly influenced by the extraordinary circumstances of the ongoing pandemic.
For the 2022 financial year, we expect to further increase the share of delivered vaccine doses to low and middle income countries.
Prices are in line with income levels or not.
For profit basis.
Jens Holstein: This shift will impact our estimated COVID-19 vaccine revenues for the 2022 financial year. I will give you some more color what this means when we come to our 2022 financial guide. Overall, we have clearly overachieved our revenue margin.
This shift will impact our estimated COVID-19 vaccine revenues for the 2022 financial year.
I will give you some more color on what this means when we come to our 2022 financial guidance.
Overall, we have clearly over achieved our revenue and margin expectations for 'twenty.
Jens Holstein: To remind everyone, the gross margin of our COVID-19 vaccine business during the financial year 2021 is influenced by all three revenue streams listed on this slide. As mentioned before, the revenues related to our share of gross profit from COVID-19 vaccine sales and the collaboration partners' territories and our sales milestones have 100% gross margin and have been in 2021 the dominant factor for our gross margin figure. The other two effects on the overall gross margin of the company are the revenues generated in our own territory and the revenues for product sales to our collaboration. Those two revenue streams have of course a lower gross margin. The mix has, in consequence, a significant influence on the overall. The overall mix causes the fluctuations that become visible when looking at quarterly gross margins.
To remind everyone. The gross margin of our COVID-19 vaccine business during the financial year 'twenty 'twenty. One is influenced by all three revenue streams listed on this slide.
As mentioned before the revenues related to our share of gross profit from COVID-19 vaccine sales in the collaboration partners territories and our sales milestones.
100% gross margin and have been in 2021, the dominant factor for our cross Marshall figure.
The other two effects on the overall gross margin of the company are the revenues generated in our own territory and the revenues for product sales to our collaboration partners.
Those two revenue streams have of course, a lower gross margin and the mix Hasnt consequence, if I can.
If we can influence on the overall gross margin.
The overall mix causes the fluctuations that becomes visible when looking at quarterly gross margin figures.
Jens Holstein: As shown on slide 27, we ended our 2021 financial year with 1.7 billion euros cash and cash equivalents, as well as cash deposits in the amount of $0.4 billion. The letter will return to Cash and Cash Equivalents in January and February. When Analyzing Our Liquidity, We anticipate certain significant balance sheet items that are expected to improve our cash and cash equivalence balance subsequent to the end of the reporting. Acknowledging that this is only a selection and cash outlays need to be considered as offsetting factors.
As shown on slide 27, we ended our 2021 financial year with $1 7 billion euros cash and cash equivalents.
As well as cash deposits in the amount of $4 4 billion euros.
The letter were returned to cash and cash equivalents in January and February 2022.
When analyzing our liquidity.
We anticipate certain significant balance sheet items.
Specced, it to improve our cash and cash equivalents balance subsequent to the end of the reporting period.
Acknowledging that this is only a selection and cash outlays needs to be considered is offsetting factors, our cash and cash equivalent balance subsequent to the end of the reporting period is expected to be significantly improved our trade receivables.
Jens Holstein: Our cash and cash equivalent balance subsequent to the end of the reporting period is expected to be significantly improved by our trade receivables. We expect these funds to be used to finance our growth, which we will outline further in our capital allocation framework. As already mentioned, mainly due to the contractual settlement of a gross profit share under our COVID-19 collaboration with Pfizer, trade receivables remained outstanding as of December 31st, 2021. Trade receivables include, for example, the gross profit share for the third quarter of 2021, for which the settlement payment was received subsequent to the end of the reporting period in January.
We expect these funds to be used to finance our growth, which we will outline further in our capital allocation framework.
As already mentioned, mainly due to the contractual settlement of the gross profit share under or COVID-19 collaborations with Pfizer.
Trade receivables remained outstanding as of December 31, 2021.
Trade receivables include for example, the cross profit share for the third quarter of 2021 for which the settlement payment was received subsequent to the end of the reporting period in January 2022.
Jens Holstein: The settlement payment from Pfizer for the fourth quarter... 2021 is expected to be received in April 2022 and is also included in our trade receivables as of December 31st. In addition, please keep in mind that the settlement for the profit share of December 2021 for the territory outside, States will only be paid in July. Of course, there are always certain collection risks with trade receivables.
The settlement payment from Pfizer for the fourth quarter of 2021 is expected to be received in April 2022, and is also included in our trade receivables as of December 31st 2021.
Yeah.
In addition, please keep in mind that the settlement for the profit shelf December 2021 for the territory outside the U S. It states will only be paid in July of 2022.
Of course, there are always certain collection risk with trade receivables.
Jens Holstein: The settlement timing explains why the cash position is relatively low by year-end 2021 versus a relatively high amount of trade. As of December 31, 2021, our trade receivables amounted to approximately 12.4 billion euros, of which the biggest amount is driven by the just-mentioned outstanding Pfizer, From those outstanding trade receivables, we had already collected €4.7 billion in cash by mid-generation. I now switch to the comparison between our actuals of the 2021 financial year to the guidance announced in our last earnings call on slide 28.
The settlement timing explains why the cash position is relatively low by year end 2021 or is this a relatively high amount of trade receivables.
As of December 31st 2021, our trade receivables amounted to approximately $12 4 billion euros of which the biggest amount is driven by the just mentioned outstanding funds up payments.
From those outstanding trade receivables.
We had already collected $4 7 billion euros in cash by mid January 2022.
And now switch to the comparison between our actuals of the 2021 financial year, two the guidance announced in our last earnings call on Slide 28.
Jens Holstein: During the year ended December 31st, 2021, we recognized 18.8 billion euros COVID-19 vaccine revenue. As just explained, those included revenues related to our share of gross profit from COVID-19 vaccine sales in the Collaboration Partners Territories and sales models. Revenues from direct COVID-19 vaccines sells to customers in our territory, as well as revenues from sales to all collaboration partners. We exceeded our guidance by about 2 billion euros, caused by mainly two factors.
During the year ended December 31st 2021, we recognized $18 8 billion euros, COVID-19 vaccine revenues.
Just explained those included revenues related to our share of gross profit from COVID-19 vaccine sales in the collaboration partners territories and sales milestones.
Revenues from direct COVID-19 vaccine sales to customers in our territory as.
As well as revenues from sales to our collaboration partners.
We exceeded our guidance by about 2 billion euros caused by mainly two factors.
Jens Holstein: Firstly, we were able to increase the volume of COVID-19 vaccine doses delivered to 2.6 billion doses, exceeding our expectation of up to 2.5 billion doses included in our guidance. Secondly, again exceeding our expectation at this time in terms of price, the proportion of doses sold to high-income countries was also higher than anticipated. Both factors were mainly related for the high demand for booster vaccinations, mainly in Europe and the United States, in response to the Omicron variant emerging in late, During the year ended 31st, 2021, our R&D expenses reached €950 million, meeting our guidance.
Firstly, we were able to increase the volume of COVID-19 vaccine doses delivered to two 6 billion doses exceeding our expectation of up to $2 5 billion doses included in our guidance.
Secondly, again exceeding all expansion at this time in terms of price the proportion of doses sold two two in high income countries was also higher than anticipated.
Yeah.
Both factors were mainly related for the high demand for boost of vaccinations, mainly in Europe , and the United States in response to the AMA conversion emerging in late 2021.
Jens Holstein: These expenditures included approximately 40% of R&D expenses related to COVID-19 vaccine clinical trials. Moving to the SG&A expenses, during the year ended December 31st, 2021, we recognized 340 million euros SG&A expenses compared to originally anticipated 300 million. The expenditures were mainly driven by supporting our rapid and sustainable growth, including accelerating our internal operating activity, as well as investing in inorganic opportunities, adding to the total SG&A spend. Our capital expenditures during the year ended December 31st 2021 amounted to 180 million euros meeting our guidance.
During the year ended 31st 2021, our R&D expenses reached 950 million meeting our guidance.
These expenditures included approximately 40% of R&D expenses related to COVID-19 vaccine clinical trials.
Moving to the SG&A expenses during the year ended December 31st 2021, we recognized 340 million euros SG&A expenses compared to originally anticipated 300 million.
The expenditures were mainly driven by supporting a rapid and sustainable growth, including accelerating our internal operating activities as well as investing in inorganic opportunities, adding to the total SG&A spending.
Our capital expenditures during the year ended December 31st 2021 amounted to 180 million euros, beating our guidance.
Jens Holstein: These expenditures included inorganic growth investments, investment in infrastructure, and investments in our COVID-19 vaccine production capacities, ensuring our projected production capacity. I'll be moving to our financial results for the fourth quarter of 2021 as shown on slide 20. For the fourth quarter of 2021, we report total revenues of 5.5 billion euros compared to 0.3 billion euros for the comparative period in 2021. Total revenues increased due to the high demand of our COVID-19 vaccine. Now moving to cost of sales. Our cost of sales reached €583.2 million for the fourth quarter of 2021 compared to €41 million for the comparative period.
These expenditures included inorganic growth investments investment in infrastructure and investments in our COVID-19 vaccine production capacities.
Ensuring a protected production capacities.
Jens Holstein: The increase was again driven by cost of sales recognized with respect to our COVID-19 vaccine sales, and included the share of gross profit that we owe our collaboration partner Pfizer on our own sales in Germany in terms of, Research and development expenses were €271.5 million for the fourth quarter of 2020, compared to 257 million euros for the comparative period. The increase was mainly due to an increase in research and development expenses from the BNT162 clinical trials.
I'll be moving to our financial results for the fourth quarter of 2021 as shown on slide 29.
Jens Holstein: The increase was further driven by an increase in wages, benefits, and social security expenses resulting from additional headcounts, as well as expenses occurred under our share-based payment arrangements. In the fourth quarter of 2020, inventories had been expensed prior to the launch of our COVID-19 vaccine. Those did not reoccur in the fourth quarter.
For the fourth quarter of 2021, we've reported total revenues of $5 5 billion euros.
Jens Holstein: General and administrative expenses reached €130.9 million for the fourth quarter of 2021, compared to €35.9 million for the comparative period. Similar to R&D, the increase in G&A was mainly due to an increase in wages, benefits, and social security expenses resulting from an increase in headcount and expenses incurred under the share-based payment arrangements, increased expenses for purchase management consulting and legal services, as well as higher insurance premiums caused by the increased There have been expenses incurred caused by new collaborations and acquisitions that have driven costs up.
Jens Holstein: For the fourth quarter of 2021, net profit reached €3.2 billion, compared to €0.5 billion for the comparative period in, Our diluted earnings per share for the fourth quarter of 2021 amounted to €12.18 compared to €1.43 for the comparative period in 2020. Moving to slide 30, I would like to share with you the company's outlook for the 2022 financial year. As of mid-March, we and Pfizer have signed orders of approximately 2.4 billion doses for deliveries during the 2022 financial year.
<unk> two opened 3 billion euros for the comparative period in 2020.
Total revenues increased due to the high demand of our COVID-19 vaccine.
Now moving to cost of sales.
Our cost of sales reached $583 2 million euros for the fourth quarter of 2021 compared to 41 million euros for the comparative period in 2020.
The increase was again driven by cost of sales recognized with respect to our COVID-19 vaccine cells.
And included the shelf gross profit that we owe our collaboration partner Pfizer on our own sales in Germany and Turkey.
Research and development expenses were 271 5 million euros for the fourth quarter of 2021 compared to 257 million euros for the comparative period in 2020.
The increase was mainly due to an increase in research and development expenses from the Pn T 162 clinical trials.
The increase was further driven by an increase in wages benefits and social security expenses, resulting from additional head count as well as expenses occurred under our share based payment arrangements in the fourth quarter of 2020 inventories had been expensed prior to the launch of our COVID-19.
Exceed those did not reoccur in the fourth quarter of 2021.
General and administrative expenses reached 139 million euros for the fourth quarter of 2021 compared to $35 9 million euros for the comparative period in 2020.
Similar to R&D the increase in G&A was mainly due to an increase in wages benefits and social security expenses, resulting from an increase in head count and expenses incurred under the share based payment arrangements increased expenses for purchased management consulting and legal services as well as our insurers and.
<unk> premiums caused by the increased business volume.
There have been expenses incurred costs by new collaborations and acquisitions that drove costs up to.
Income taxes were accrued in the amount of $1 5 billion euros tax expenses for the fourth quarter of 2021 compared to <unk> 2 billion euros tax income for the comparative period in 2020.
For the fourth quarter of 2021 net profit reached $3 2 billion euros compared to <unk> 5 billion euros for the comparative period in 2020.
Our diluted earnings per share for the fourth quarter of 2021 amounted to 12 year is an 18 year of cents compared to <unk> 43 year or a sense for the comparative periods in 2020.
Moving to slide 30, I would like to share with you the company's outlook for the 2022 financial year.
As of mid March we and Pfizer have signed orders of approximately $2 4 billion doses for deliveries during the 2022 financial year.
Jens Holstein: We reiterate our guidance from January 2022 presented at the JPMorgan Healthcare Conference, and are providing estimated COVID-19 vaccine revenues of approximately 13 to 17 billion euros for the full year of 2022. This range considers the uncertainty derived from the evolution of the virus.
We reiterate our guidance from January 2022 presented at the JP Morgan Health Care Conference.
Providing estimated COVID-19 vaccine revenues of approximately 13% to 17 billion euros for the full year of 2022.
This range considers the uncertainty derived from the evolution of the virus, we see three key variables driving the revenues outcome for the 2022 financial year.
Jens Holstein: We see three key variables driving the revenues outcome for the 2022 financial year. These are firstly the number of delivered doses. Secondly, the regional mix in terms of high, middle, and low-income countries.
These are firstly the number of delivered doses.
Secondly, the regional mix in terms of high middle and low income countries.
Jens Holstein: And thirdly, the effects depending on whether revenues are generated by one of our partners or ourselves, or if we sell products to our partners. We expect to further increase the share of deliveries of COVID-19 vaccine doses to low and middle-income countries based on the signed order. Due to this anticipated shift, we're assuming a lower average price per dollars versus 2021, as prices in low- and middle-income countries are in line with income levels or at a non-for-profit basis.
Thirdly, the effects, depending on whether revenues are generated by one of our partners well self Oh, if we sell products to our partners.
We expect to further increase the shelf deliveries.
COVID-19 vaccine doses to low and middle income countries based on the signed order book.
Due to this anticipated shift we're assuming a lower average price per dose versus 2021 as prices in low and middle income countries are in line with the income level or at the non for profit basis.
Jens Holstein: The financial success of 2021 allows us to redeploy in the years to come meaningful investments into our R&D. Product Pipeline and Business, preparing us for anticipated strong growth ahead. For the 2022 financial year, we plan to spend €1.4 billion to €1.5 billion, which represents an increase of about 50% compared to 2021, and we intend to accelerate those investments in the years to come. Our clinical trial programs in Oncology and Infectious Disease, which comprise five ongoing randomized phase two clinical trials in oncology, will be accelerated further while ensuring that we build up our organizational and personal capabilities for continued and sustainable growth.
The financial success of 2021 allows us to redeploy in the years to come meaningful investments into our R&D engine.
Product pipeline and business operations preparing us for anticipated strong growth ahead.
For the 2022 financial year, we plan to spend $1 4 billion to $1 5 billion euros.
Which represents an increase of about 50% compared to 2021.
And we intend to accelerate those investments in the years to come.
Oh, our clinical trial programs in oncology and infectious diseases, which comprised five ongoing randomized phase two clinical trials in oncology.
It would be accelerated further while ensuring that we build up our organizational and personal capabilities for continued and sustainable growth S.
Jens Holstein: SG&A expenses are estimated to be in the range of 450 to 550 million euros, as we plan to continue to invest in our enabling functions to support our operational growth. Capital expenditures for the 2022 financial year are expected to be in the range of $450 million to $550 million.
SG&A expenses are estimated to be in the range of 150 to 550 million euros.
As we plan to continue to invest in our enabling functions to support our operational growth.
Capital expenditures for the 2022 financial year I expect it to be in the range of one and $50 million to 550 million euros.
Jens Holstein: We are, for example, planning to extend our R&D and production facilities and to enhance and continue to invest into our digitalization industry. Please note, all ranges reflect current base case projections, excluding potential M&A activities and color. Finally, please note that in terms of the 2022 full-year tax impact, our tax burden is expected to improve significantly as we expected the estimated annual effective tax rate for the BioNTech Group to decrease from 31.6% to around 28%. On slide 31, I would like to take the opportunity to highlight our capital allocation, and there will be some more details presented by my colleague. Four key areas are at the center of our activity.
We are for example, planning to extend our R&D and production facilities and to enhance and continue to invest into our digitalization initiatives.
Please note all ranges reflect current base case projections, excluding potential M&A activities and collaborations.
Finally, please note that in terms of the 'twenty to 'twenty, two full year tax impact our textbook.
It's expected to improve significantly as we expect that the estimated annual effective tax rate for the biotech group to decrease from 31, 6% to around 28%.
On slide 31, I would like to take the opportunity to highlight our capital allocation framework and there would be some more details presented by my colleague Ryan.
Four key areas are at the center of our activities first and foremost R&D.
Jens Holstein: First and foremost, R&D. We have proven to the world that our science is game-changing. On top, we believe that our technologies and science can have an even broader impact on, Therefore, we intend to further accelerate our initiatives to create additional long-term value for our shareholders. Secondly, M&A in business development.
We have proven to the world that our science is game changing on top we believe that our technologies and science can have an even broader impact on People's health.
We intend to further accelerate our initiatives to create additional long term value for our shareholders.
Secondly, M&A and business development.
Jens Holstein: To supplement our technologies and digital capabilities, we strive to extend and augment our expertise with synergistic acquisitions. Thirdly, we develop our global footprint in Europe, the U.S., Asia, and Africa and plan to invest in our manufacturing capabilities for key technologies. Finally, after such an extraordinary year, we would like our shareholders to participate in our success. Consequently, we expect to authorize a share repurchase program of ADSes, pursuant to which we may repurchase ADSes in the amount of up to 1.5 billion US dollars over the next two years.
To supplement our technologies and digital capabilities, we strive to extend and augment our expertise with synergistic acquisitions and collaborations.
Thirdly, we develop our global footprint in Europe , The U S Asia, and Africa and plan to invest in our manufacturing capabilities for key technologies.
Finally, after such an extraordinary year, we would like all shareholders to participate in our success.
Consequently, we expect to authorize a share repurchase program of 80 S. S pursuant to which we may repurchase 80 S is in the amount of up to 1.5 billion U S dollars over the next two years.
Jens Holstein: We expect to use all or a portion of the ADSs we repurchase and hold in treasury to satisfy upcoming settlement obligations under our share-based payment. In addition, we, the Management Board, and the Supervisory Board, will propose a special cash dividend of 2 euros per ordinary share, including those held in the form of ADS.
We expect to use all or a portion of the Ats, we repurchase and hold in treasury to satisfy upcoming settlement obligations under our share based payment arrangements.
In addition, we the management board and the Supervisory Board will propose a special cash dividend of two euros per ordinary share.
Including those held in form of Ats.
Jens Holstein: This corresponds to an aggregate of approximately 486 million euros based on the shares outstanding as of March 30, 2021. The Special Cash Dividend is subject to approval of our upcoming Annual General Meeting. In this respect, I'm pleased to inform you that our 2022 AGM is scheduled to take place on June the, And with that, I turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our corporate development activities and concluding. Thank you, Jens.
This corresponds to an aggregate of approximately 486 million euros based on the shares outstanding as of March 30, <unk> 2022.
The special cash dividend is subject to approval of our upcoming annual general meeting in this respect I am pleased to inform you that our 2022 AGM is scheduled to take place on June the first.
And with that I turn the call over to our Chief strategy Officer, Ryan Richardson.
Update on our corporate development activities and concluding remarks. Thank you.
Thank you guys.
Ryan Richardson: Turning to slide 33, I'd like to highlight five key areas of strategic focus in 2022. We will continue to invest significantly in our COVID-19 vaccine program. We expect multiple data updates throughout the rest of the year, including data from our Omicron-based vaccine, for which we are on track to finalize the data package for potential submission to regulators. This year, we plan to continue our rapid pipeline expansion with data updates expected for up to three additional oncology and infectious disease programs. We are currently investing to build out our global development organization to support continued pipeline expansion that will include the preparation of potential registration. We also expect to further strengthen and extend our international presence.
Turning to slide 33, I would like to highlight five key areas of strategic focus in 2022.
We will continue to invest significantly in our COVID-19 vaccine program.
We expect multiple data updates throughout the rest of the year, including data from our omicron based vaccine for which we are on track to finalize the data package for potential submission to regulators.
This year, we plan to continue our rapid pipeline expansion with data updates expected for up to three additional oncology and infectious disease programs were.
We are currently investing to build out our global development organizations to support continued pipeline expansion.
We'll include the preparation of potential registration trials.
We also expect to further strengthen and extend our international presence.
Ryan Richardson: This will include expansion of our teams and capabilities in the United States, Europe, Africa, and Asia. In addition to further automating our existing production facilities in Germany, we are investing into new manufacturing nodes in the US and Asia to support our future mRNA and cell therapy products. Finally, we expect to remain active on the corporate development front. Already this year, we have announced a diverse set of new collaborations with Pfizer, Regeneron, Medellin, and Crescendo.
This will include expansion of our teams and capabilities in the United States, Europe Africa and Asia.
In addition to further automating our existing production facilities in Germany, we are investing into new manufacturing nodes in the U S and Asia to support our future mrna in cell therapy product portfolio.
Finally, we expect to remain active on the corporate development front.
Already this year, we have announced the diverse set of new collaborations with Pfizer Regeneron <unk> crescendo.
Ryan Richardson: We will continue to expand our access to complementary technologies in the field of synthetic biology, and we will continue to invest in our manufacturing infrastructure and digital capabilities. This could include new partnerships, M&A, and in-licensing deals, in addition to organic investment.
We will continue to expand our access to complementary technologies in the field of synthetic biology.
And we will continue to invest in our manufacturing infrastructure and digital capabilities.
This could include new partnerships M&A and in licensing deals in addition to organic investments.
Ryan Richardson: Slide 34 details some selected pipeline milestones expected in the remainder of 2022, which includes eight potential data updates. We expect multiple trial updates for Comirnaty, including data expected for a fourth dose in adults ages 16 to 65 plus. A third dose in children ages 5 to 12 years, and data for a three-dose regimen in children ages six months to five years, which is expected in April.
Slide 34 details some selected pipeline milestones expected in the remainder of 2022, which includes <unk> peak potential data updates.
We expect multiple trial updates for <unk>, including data expected for a fourth dose.
Age of 60% to 65 plus.
The third dose in children ages, five to 12 years.
And data for three dose regimen in children ages six months to five years, which is expected in April .
Ryan Richardson: In addition, we expect preliminary safety and immunogenicity data for our Omicron variant vaccine in April, which includes the Omicron vaccine both as a third dose and a third and fourth dose after primary vaccination with coronavirus. If the data is positive, we intend to submit it to regulatory authorities, and subject to a decision from the regulators to support an authorization of our Omicron vaccine award. In addition, we have multiple next-generation COVID-19 vaccines in development, including variant combinations, multivalent vaccines. We expect to provide further updates on these programs in the second half of the year. We also expect to provide data updates for several other pipeline programs this year.
In addition, we expect preliminary safety and Immunogenicity data for Lumichrome variant vaccine in April .
Which includes the omicron vaccine both of the third dose and a third and fourth dose after primary vaccination with commodity.
If the data is positive we intend to submitted to regulatory authorities.
And subject to a decision from the regulators to support an authorization of our vaccine worldwide.
In addition, we have multiple next generation COVID-19 vaccines in development, including various combinations multivalent vaccines, we expect to provide further updates on these programs in the second half of the year.
We also expect to provide data updates for several other pipeline programs this year.
Ryan Richardson: This includes phase 1 data from our mRNA influenza vaccine program, which is licensed to Pfizer in the first half of the year. We also expect our first randomized phase 2 data update for INEST and first-line melanoma in combination with Pimbralizumab versus Pimbralolone in the second half of 2020. And we expect further updates from our Phase 1-2A trial of BNT211, our Claudin-6 CAR T-cell program, against multiple-celled tumors. As in 2021, we expect this year will also be a year of further pipeline expansion.
This includes phase one data from our mrna influenza vaccine program, which is licensed to Pfizer in the first half of the year.
We also expect our first randomized phase two data update for <unk> in first line melanoma in combination with embolism.
Versus timber alone in the second half of 2022.
And we expect further updates from our phase <unk> trial of beauty to one one our current six car T cell program against multiple solid tumors.
As in 2021, we expect this year will also be your further pipeline extension.
Ryan Richardson: On slide 35, we highlight up to seven first-in-human trials, which we aim to initiate in 2022. This includes four additional mRNA vaccines for infectious diseases, including shingles. Tuberculosis, HSV-2, and Malaria.
On slide 35, we highlight up to seven planned first in human trials, which we aim to initiate in 2022.
This includes four additional mrna vaccines for infectious diseases, including shingles tuberculosis, HSV, two and malaria.
Ryan Richardson: In oncology, we expect three additional trial initiations this year. This includes trial starts for two ribonmab programs targeting solid tumors, BNT141 and BNT142, and the start of a Phase I-II trial of our thick-vac NSCLC immunotherapy, which we will administer with Liptio in the first-line setting in advanced NSCLC. All these programs have first-in-class potential.
In oncology, we expect three additional trial initiations this year.
This includes trial starts for two writing programs targeting solid tumors <unk> one for one in 142.
And the start of a phase one two trial of our fixed stock in SCLC immunotherapy, which we will administer wood look tile in the first line setting in advanced and our CLC.
All of these programs are first in class potential.
Ryan Richardson: Before concluding, I would like to highlight on slide 36 that we will have our Annual General Meeting on June 1st and our Virtual Capital Markets Day on Wednesday, June 29th. We will provide further details in the coming weeks on both of them. I would like to thank our shareholders for their continued support.
Before concluding I would like to highlight on slide 36 that we will have our annual general meeting on June one.
Virtual capital markets day on Wednesday June 29.
We will provide further details in the coming weeks on both events.
I would like to thank our shareholders for their continued support.
Operator: And with this, I'd like to conclude our prepared remarks and open the floor. I will now turn the call over to the operator for Q&A. Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone, please limit yourselves to one question only.
With this I'd like to conclude our prepared remarks and open the floor for questions.
I will now turn the call over to the operator for Q&A.
Thank you as a reminder to ask a question you will need to press star one on your telephone please.
Please limit yourself to one question only once again, if you'd like to ask a question. Please press star one on your telephone keypad. Please limit yourselves to one question only.
Operator: Once again, if you'd like to ask a question, please press star and one on your telephone keypad, and please limit yourselves to one question only. Your first question today comes from the line of Cory Kasimov from J.P. Morgan. Please go ahead; your line is open. Hi guys.
Your first question today comes from the line of call. It caused them off from J P. Morgan. Please go ahead. Your line is open.
Cory Kasimov: Thank you for taking my question. The question for you on the COVID vaccine front is, at what point are you expecting the US market to transition into a private pay environment versus the current government contracts? And what kind of impact do you expect this could have on overall market dynamics?
Hi, guys. Thank you for taking my question a question for you on the Covid vaccine front at what point are you expecting the U S market to transition into a private pay environment versus the current government contracts and what kind of impact do you expect this could have on overall market dynamics. Thank you.
Sean: Thank you. Yes, Sean, you want to take that question? Yeah, hi, Cory.
Yes, Sean you want to take that question.
Sean: Yeah, I think it's, it's difficult to say because the market is so dynamic with some variant development, and of course Omicron being specific to that. There's lots of things that could happen. The U.S. government may order more or we may go to a different private market dynamic. I think it's simply too early to say.
Yeah, Hi, Corey.
I think it's it's difficult to say because.
The market is so dynamic with.
Varian to buy them.
And of course on the Colombian specific to that.
There's lots of things that could happen.
U S government may order more Oh, we might go to.
Project market dynamic I think it's simply too early to say.
Okay. Thank you.
Yeah.
Operator: Okay, thank you. Thank you. Your next question comes from the line of. Tazeen Ahmad from Bank of America.
Thank you.
Our next question comes from the line of.
<unk> Ahmad from Bank of America. Please go ahead your line is open.
Tazeen Ahmad: Please go ahead, your line is open. Great, good morning guys. Thanks for taking my question. As it relates to frequency of the need for booster dosing, can you give us some clarity on how you're thinking about it? Over here in the US, it does seem like they are recommending a second booster for certain age groups, of the original vaccine.
Great. Good morning, guys. Thanks for taking my question as it relates to frequency of the need for booster dosing.
Ozlem Tureci: But how much protection do you think that getting a booster for from the original is going to confer for Omicron and B2 versus a more specific booster that you're working on right now? Thank you. Thank you very much for this question.
Can you give us some clarity on how you're thinking about it over here in the U S. It does seem like they are recommending a second booster for certain age groups.
Of the original vaccine, but how much protection do you think that getting a booster for from the original is gonna confer for AMR chronic b two versus a more specific let's say that you're working on right now. Thank you.
Ozlem Tureci: The recommendation of additional boosters is actually based on the current data, which is being produced by us, other groups, and also the real-world data, which shows that with Omicron emerging, the immune response needs an additional booster. It's very difficult to predict how frequent such boosters would be needed, because that really depends also on newly upcoming variants, their potential to evade or partially evade immunity, and needs to be simply monitored as long as we are in this still very dynamic situation. Okay, thanks. Thank you. Your next question comes from the line of Matthew Harrison from Morgan Stanley. Please go ahead, your line is open. Great. Good morning.
Justin Thank you very much for this question the recommendation of additional does is a it is actually based on the current data, which is being produced by US other groups and also the real world data, which shows that.
With Army Corps.
Magic, the immune response and needs and additionally, stuff, it's very difficult to predict how freaks and such foodstuffs would be needed because.
Because that really depends also on newly upcoming variants that potential too.
They are partially abate our immunity and.
Needs to be a simply money towards as long as we are and this is still a very dynamic situation.
Okay. Thanks.
Yeah.
Thank you.
Next question comes from the line of Matthew Harrison from Morgan Stanley . Please go ahead. Your line is open.
Great. Good morning, Thanks for taking the question I was wondering if you could just comment on how you think about <unk>.
Matthew Harrison: Thanks for taking the question. I was wondering if you could just comment on how you think about durability of boosters with Omicron and sub-variants. Obviously, Moderna has talked about multivalent, Boosters is potentially having better durability. I wonder if you see the same thing with your booster and just how you think about monovalent versus multivalent boosters, in terms of durability. Thanks. Yeah, so it is still...
The ability of boosters.
With Micron and club variant obviously.
Madonna has talked about multi valent.
Boosters as potentially having better durability I wonder if you see the same thing.
With your booster and just how you think about monovalent Bush's multi balanced boosters.
In terms of durability. Thanks.
Yep.
Sure.
Ozlem Tureci: It is at the moment still early to come to a conclusion. However, we believe that this Omicron being now almost 99.5% of all variants worldwide. There is currently no clear need for a combined vaccine. It is important to evaluate also the exposure of the experienced immune system to Omicron spike protein. There are now published data indicating that exposure to Omicron spike in pre-vaccinated individuals produces extremely broad antibody responses, neutralizing all different variants. And we believe that it could be even disadvantageous to come up with a vaccine which has different variants because we would dilute the effect of a purely Omicron-based vaccine. Does that answer your question, Matthew?
At the moment.
And I'll leave that to them.
Will it come to a conclusion. However, we believe that this all may call them being no almost 99, 5% of.
All of that.
Yeah.
It's kind of ignored.
For combined.
Find a vaccine.
It is important to us.
It's also the exposure.
The experience immune system.
Let me close by.
I'll publish data, indicating that the exposure.
Spike.
Please vaccinated individuals put you extremely bolt.
Anti body other sponsor.
And even for deicing or different failure.
We believe that it could be even even at a disadvantage.
To come up with a vaccine the chess different.
Because we will dilute the effect of a purely omnicom basis.
Does that answer your question Matthew.
Yes, yes. It does thank you.
Thank you.
Matthew Harrison: Yes, yes, it does. Thank you. Thank you. Your next question comes from the line of Chris Shibutani from Goldman Sachs. Please go ahead, your line is open.
Your next question comes from the line of Chris Shiver Tani from Goldman Sachs. Please go ahead. Your line is open.
Chris Shibutani: Thank you. It seems we'll have data coming up for a bunch of different variation options, including the Omicron-specific in the next couple of months. Can you clarify what you believe to be the regulatory requirements for the Omicron-specific variant? And what do you think will be the goalposts for determining which of the different regimens you're comparing will be the one that you think will be recommended? And in particular, are we thinking about preventing infection? Are we talking about severe disease? Where are the goalposts?
Thank you. It seems we have data coming up for a bunch of different variation options, including the omicron specific in the next couple of months.
Can you clarify what you believe to be the regulatory requirements for the omicron specific variant and what do you think will be the goalposts for determining which of the different regimens, you're comparing will be the one that you think will be recommended and in particular are we thinking about preventing infection.
Are we talking about severe disease, where the goalposts and how should we contextualize the different combination sets and data that are coming up over the next month or so.
Ozlem Tureci: And how should we contextualize the different combination sets and data that are coming up over the next.., month or so, and how the regulators may view that. Thank you for this question. So the regulatory pathway, which is expected from regulators, is simple superiority of neutralization.
And how the regulators may be with us.
Thank you for that that's one of his questions. So.
Other regulatory pathway.
Which is expected from regulators.
Chip Perry R. A T a neutral lot of neutralize Asian, and what do we do it two quarters here against the Micron Army Cross adept touch vaccine against the current the authorized a wild type of vaccine.
Ozlem Tureci: And what we do is to compare against the Omicron adapted vaccine against the current deauthorized wild type vaccine. And its potential to neutralize Omicron and other variants of concern. We like to talk about or to name our vaccine Omicron adapted rather than Omicron specific, because Omicron specific somehow creates the impression that we only neutralize against Omicron. But in immunological terms, because an Omicron spike carries also conserved epitopes, you can imagine that the neutralization is much, maybe much broader.
It's potentially neutralize.
Amit Crown and other.
Uh huh.
In itself of course, Sir.
We like to talk about until it to a name or a vaccine omicron adapt to drop out then I'll make from specific because I'm a crown specific somehow creates ah that Andreas.
Christian that we own neutralized against all make Robin, but immunologic response, because omicron bike carriers also conserved epitope you can imagine that the neutralization as much might may be much broader and in fact, what.
Ozlem Tureci: And in fact, what we see, it is also much broader, including also other variants. Your second question was about the endpoint. So the objective is to prevent symptomatic disease. And this is also why we compare against wild type variant and its neutralizing capability, because we know that at the neutralization time, as we see there, there is symptomatic, Production.
We see it it's also much boarder, including also above area.
Second question was about the end point.
So the objective is to.
Revenge send it to a metric.
Sometimes that takes D. C. And this is also why are we call them tier against Wild type, Barry and and it's neutralizing capability, because we know that the best utilization titles. So see there are there is.
Symptomatic disease.
Yes.
Thank you.
Ozlem Tureci: Thank you. We will take our next question from the line of Akash Tewari from Jeffreys. Please go ahead, your line is open. Hi, this is Leo for Akash.
We'll take our next question from the line of our cash to Huawei from Jefferies. Please go ahead. Your line is open.
Hi, This is the name for a cash thank you for taking our question. So.
Akash Tewari: Thank you for taking our question. So previously, last December, you had to show some alpha-specific boosted data that had higher neutralizing titer against Omicron than the original wild-type vaccine. Do you think the coming Omicron Adaptive Booster may outperform the Alpha Booster?
Obviously last December you had a shelf opex specific with the data that had higher neutralizing titer of games almond crop that original lifetime vaccine do you think that coming.
And crown adapted it booster may outperformed booster.
Ozlem Tureci: And maybe I can squeeze another question about the flu vaccine into this. So how should we think about the AE profile of an mRNA flu vaccine? Currently, we have a vaccine on the market that shows a pretty good safety profile. How should we think about the therapeutic window of an mRNA vaccine? Is this something related to the size of the encoded protein, or is it something else?
And maybe if I can squeeze in maybe another question about flu vaccine. So how shall we think about where the AE profile often on a 90 day flu vaccine currently we have a already have them.
I can't I'm, not cash flow pretty good safety profile, how should we think about the therapeutic window.
And I'll relate that to see if there's something related to the size I think I've got a protein or something else. Thank you very much.
Akash Tewari: Thank you very much. Thank you, Akash. So, first of all, the indication is that an Omicron-adapted vaccine should be able to induce higher neutralizing antibody responses as compared to the wild type. We are not comparing and benchmarking against alpha.
Oh gosh.
So first of all.
And I'll make one adaptive vaccine.
That should be able to induce high Uh huh.
Utilizing anti body responses as compared to the Viper, yeah, not compelling and benchmarking against against ISR.
Ozlem Tureci: Omicron has some lineage similarities with alpha, but the benchmarking partner here is for sure the wild type. With regard to a potential combination with an influenza vaccine, we cannot make any statements at the moment since we don't have data. Thank you. Thank you. Your next question comes from the line of Daina Graybosch from SVB Lear Inc. Please go ahead, your line is open.
The court has some damage.
Image similarities with Ita.
The benchmarking benchmarking partner here is.
For sure a device type.
As we got to.
Sure.
Cancer combination with that.
So that it can we cannot make any statements at the moment since we don't have the data.
Thank you.
Thank you.
Next question comes from the line of Dana Bosch from SVP Leerink. Please go ahead. Your line is open.
Daina Graybosch: Hi, thank you for the question. I want to ask one about next-generation vaccines, Omicron and beyond. And that is, I wonder if you could talk about your hypotheses over whether with an Omicron-adapted, we'll need two boosts of an Omicron-adapted to boost that new Omicron spike versus one. And then I also wonder if you're working on any next-generation vaccines beyond variants, so ones that would have an increased breadth and epitope, or may work to stimulate mucosal immunity, for example. Hi, Daina.
Hi, Thank you for the question I wanted to ask one about next generation vaccines on the con and beyond and that is I Wonder if you could talk about your hypotheses over whether Watson omicron adapted will need to boost up the omicron adapted.
To boost that new omicron spike versus one.
And then I also wonder if youre working on any next generation vaccines beyond variance. So ones that would have an increased threats and epitope or may all work to stimulate mucosal immunity for example.
Ozlem Tureci: Thank you for the question. So let's start with the second part of the question, next generation vaccines. Yes, we are evaluating in a preclinical setting a number of next generation concepts, including vaccines with improved neutralizing antibody responses, with broader neutralizing antibody responses or strengthened T cell responses. So these are still in preclinical stage, and we will report on this work definitely within the next three to six months. So the first question was about... One.
Hi, Dana Thank you for the question so.
So.
So let's start with the <unk>.
Second part of the question. The next generation vaccine yesterday, a variation in the preclinical setting a number of next generation concept.
<unk> vaccines in Torbay impulse, neutralizing antibody responses bode well for us.
Our strength in our T cell responses. So it is a is that still in preclinical stage and give us a little bit.
Paul.
Stuck definitely catch me in this in the next two to three to six months.
As of the first question was about.
One.
Ozlem Tureci: Yeah, so the first question is also very interesting. Your question refers most likely to the fact that one injection could boost memory responses, whereas two injections may be also able to prime and boost against new epitopes.
Yeah.
The first question.
So very interesting question.
Yes.
Are most likely to the stack and that one.
One.
Injection could boost my mother of a sponsor.
F C.
Two injections.
You're also able to prime and boost.
New epitopes and this is exactly what we are evaluating clinical part and we will be happy to answer that in about six weeks from now.
Ozlem Tureci: And this is exactly what we are evaluating in our clinical trial, and we will be happy to answer that in about six weeks from now. Great, thank you. Thank you. We will now take our last two questions of the day and the first one of the two comes from the line of Arlinda Lee from Canna Cord. Please go ahead, your line is open.
Great. Thank you.
Thank you we will now take our last two questions of the day and the first one of the two comes from the line of Arlinda Lee from cannot cord. Please go ahead. Your line is open.
Arlinda Lee: Hey guys, thanks for taking my, I actually have questions about your oncology pipeline. Let's talk a little bit about what data we're expecting, at AACR, and then maybe just your broader strategy as you think about potential collaboration. So with regard to AACR, we believe the most important update will be the update about the ongoing BMP211 study. So the study now has recruited more patients. To remind you, we had seen four objective responses in the December presentation, and there's now longer data, availability data available, plus additional patients who have been treated. So this is an exciting data set.
Hey, guys. Thanks for taking my questions actually I have questions about your oncology pipeline can you.
Talk a little bit about what data, we're expecting and at ACR and then maybe just your broader strategy as you think about potential collaborations and.
Acquisitions as well thank you.
Hum once we got to a CR.
For at least the most important therapy.
The update.
About two weeks.
Your bedroom study so the study is now now.
Has recruited more patients.
Nice to.
C. Four objective responses in the <unk>.
Scott.
I'll take the first point is that.
December December presentation, and asking how long our data durability data.
Ozlem Tureci: With regard to our further development and collaboration strategy, as Ryan Richardson mentioned, our key goals is, on the one side, accelerating of our pipeline with the Phase II clinical trials. To remind you, we will have a readout from our first randomized Phase II trial in this year from our INES platform for comparing the effects of INES plus anti-PD-1 versus PD-1 in patients with first-line melanoma. This trial is important because it could undate other first-line indications.
Plus our additional patients.
Who has been treated.
So this is an exciting dataset with regard to our so what are some of the development and collaborations.
As Richard.
Richard mentioned it's.
Our T goes it's that one the one side et cetera.
Oh typed on this.
To.
To remind you of either Heather it out for us.
Yes.
I have just.
And then I think you put in this year, Oh, I guess that's fun.
For comparing the effects of Ah I in this class.
Plus anti PD, one PD one in patients with first line melanoma.
Trial is important because it puts them good either first line.
Indications.
We expect our into some of the data.
The ongoing ongoing studies phase <unk> studies, which could guys just additional phase two studies this year.
Ozlem Tureci: We expect interim data from multiple ongoing studies, Phase I studies, which could guide us to additional Phase II studies this year. And the third aspect, of course, is we will continue to complement our technology portfolio and pipeline by complementing synergistic technologies, and we'll update on new partnerships in the near future. Thank you. We will now take our last question and the question comes from the line of TK Yang Xu from Berenberg.
The first aspect of course, we will continue to complement our technology portfolio and pipeline.
Complementary and synergistic technologies, and we'll update on your partnerships.
In the future.
Thank you.
Yeah.
Thank you.
We will now take our last question and the question comes from the line of <unk>.
TK Yang Xu: Please go ahead, your line is open. Great, thanks very much for squeezing me in. I have a question also on the oncology pipeline by May. Specifically on BNT2-11, the CAR-T program targeting Claudins-6. I wonder. I wonder if the data so far has supported Clotin-6 as a safe target for a solid tumor as a CAR-T approach. And then also secondly...
He can shoe from Diamondback. Please go ahead your line is open.
Great. Thanks, very much for squeezing me do I have a question also on the oncology pipeline. If I may specifically be N T. Two to 11, the car T program targeting a cot and fix them I wonder.
I wonder if the data so far has supported caught in six as a safe target for for solid tumor as a car T approach and then also secondly.
Ozlem Tureci: Does this data so far support your hypothesis on the, on the Six Lacks of... I think that mRNA vaccine can increase the persistence of your CAR T therapy. And then finally, I wonder if the data so far supports further development of other targets in other tumor types. Thank you very much. Thank you for your questions.
Does the data so far support the.
Your hypothesis.
On the.
On the yard stick vacs.
Fix our mrna vaccine Ken can increase the persistence of your car T therapy.
And then finally I want I wonder if the data so far support fertility blunden either other targets other tumor types. Thank you very much.
Yeah.
Ozlem Tureci: So the first question was, with respect to the adverse event profile, whether it supports further pursuing this strategy? And here I can wholeheartedly respond that yes, the adverse event profile, which we see is a manageable one, as expected for our CAR T-cells. We see CRSs, but mild ones, grade one and grade two, which are fully manageable.
Thank you for your for your question.
So the first question was with respect to the tourist eventful fire whereby supports father pursuing that strategy and here I can.
Ozlem Tureci: We do not see neurotoxicity, so that we will continue to explore our CARB-EQ approach with this highly tumor-selective target. As you know, Claudine 6 is a carcinoembryonic antigen and selective target. With regard to your second question, whether we see an effect of the vaccine on further boosting the adductively transferred and circulating CAR T-cells? We will report on this in our upcoming AACR presentation, and I don't want to preemptively disclose data. But what I can already say is that we will show case reports and cases of patients who have been boosted several times with the vaccine.
Absolutely.
Ill respond to that yes, the adverse event profile, which we see is a manageable one.
As expected for a car T cells, we see a C. R s's, but miles was grade one and great Ah tool, which are manageable and we do not see neurotoxicity. So that we will continue to explore a long topic.
Roche with fifth Heidi to more selective targets.
Got it and fix it the casino embryonic antigen and a selective target.
With regard to your second question, whether we.
We see an effect of the vaccine on top of that thing.
The adopt to see trends that are circulating a car T cells.
We will report on this in our upcoming AAC.
A S. The opera Dentation and I don't want to preempt carefully at the close data, but what I can already say is that we will show a case reports in cases of or patients who have been boosted.
Several times with.
The vaccine and she will see data would show us how under vaccination adopt 50 transfer out T cells continue to.
Ozlem Tureci: And you will see data which shows how, under vaccination, the adductively transferred T-cells continue to circulate. The third question was, is the approach as such of interest for other targets which are expressed in other tumors? Also, here the answer is yes, and we are actively exploring additional targets and preparing respective CAR T-cells. These are currently in preclinical stage, but will be evaluated for entering clinical stage as well.
Two a tool to start Q&A.
The third question was is the approach as such.
Of interest for other targets, which.
Expressed and how about your Maus are also here.
The answer is yes, and we are actively exploring additional targets and preparing a respect of our car T cells. Besides currency in preclinical stage, but with Ah I evaluate it for entering clinical stages.
Sure.
Operator: Great, thank you very much. Thank you. I will now hand the call back for closing remarks. Thank you for joining today's call. We look forward to speaking with you in the future. Thank you and bye-bye. Thank you, that does conclude today's conference call. Thank you for participating, you may now disconnect. [music]
Great. Thank you very much.
Right.
Thank you I will now hand, the call back for closing remarks.
Thank you for joining today's call. We look forward to speaking with you in future. Thank you bye bye.
Okay.
Thank you that does conclude today's conference call. Thank you for participating you may now disconnect.
Okay.
[music].