Q2 2022 BioNTech SE Earnings Call
Yes.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Operator: The conference will begin shortly.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
Operator: To raise your hand during Q&A, you can dial star 1 1.
[music].
Okay.
Operator: Welcome to the BioNTech second quarter 2022 update call.
Operator: Have a nice day.
Welcome to the bio Tech second quarter 'twenty to 'twenty, two update call I would like to hand, the call over to the Vice President of Investor Relations and strategy. Please go ahead Sir.
Operator: I would like to hand the call over to the, Vice President of Investor Relations and Strategy, Silke Maas.
Operator: Please go ahead, Silke.
Good morning, and good afternoon. Thank you for joining us today to review Biotechs second quarter 'twenty, two clinical in preparation of brokerage and financial results. If you housekeeping items before we start I invite you to if you were to fly.
Silke Maas: Good morning and good afternoon.
That accompany the webcast in the second quarter 2022 press release, both of which were issued this morning and can be found in the investor section.
Right.
As outlined on slide two during today's presentation, we will be making several forward looking statements. These forward looking statements.
We're not limited to our current COVID-19 vaccine revenue. These include figures that are derived from preliminary estimates provided by our partners or estimated financial thoughts about 'twenty 'twenty. Two the continued global demand for our COVID-19 vaccine or Taco truck seat protection capacity for 2022 and beyond our ability to supply of a cold.
19 vaccine the planned next steps in our pipeline program the timing for enrollment initiation completion and reporting data from all the.
The timing of our ability to obtain and maintain regulatory approvals for our product candidates and other risks described in our filings.
Made with the U S Securities Exchange Commission, including our most recent quarterly report filed today.
Actual results could differ from those we currently anticipate you are therefore cautioned not to place undue reliance on any forward looking statements, which speak only as of today shut today during this conference call and webcast.
Also please note that slides sweet 0.5, like you talked an important safety information regarding COVID-19 vaccine.
Silke Maas: Thank you for joining us today to review BioNTech's second, quarter 22 clinical and operational progress and financial results.
Finally, you can find the agenda for todays call on slide six.
It's my pleasure to welcome the members of my management team participating in today's call.
I'm trying to date.
Oh and co founder will shine.
And until that Qi, our chief Medical Officer, and co founder and toy Stein, Our Chief Financial Officer, and Brian Richardson, Our Chief strategy Officer.
Silke Maas: A few housekeeping items before we start.
I would like to turn the call over to will shine.
Silke Maas: I invite you to view the slides that accompany the webcast of the second quarter 2022 press release, both of which were issued this morning and can be found in the investor, section of our website.
Thank you Sarah good morning, and good afternoon, and hearty welcome to all call participants.
Silke Maas: As outlined on slide two during today's presentation, we will be making several forward-looking statements.
We appreciate your continued support.
Today, it's my pleasure to provide an overview of the key highlights from the second quarter.
Silke Maas: These forward-looking statements include but are not limited to our current COVID-19 vaccine revenues as these include figures that are derived from preliminary estimates provided by our partners, our estimated financial results 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 next steps in our pipeline programs, the timing for enrollment, initiation, completion, reporting of data from our clinical trials, the timing of our ability to obtain and maintain regulatory approval for our product candidates, and other risks described in our filing made with the U.S.
Our objectives for the remainder of the year.
Silke Maas: Securities and Exchange Commission, including our most recent quarterly report filed today. Actual results could differ from those we currently anticipate.
Our team will provide further details before we open the call for questions.
We have made significant progress in the second quarter as we continue to advance toward our vision of building our global immunotherapy powerhouse.
Our deep expertise in immuno Archie and fully integrated spectrum of translational research development manufacturing.
Salivation competence.
All doubt positioned for success.
We're watching our multi platform strategy built on our innovation engine.
Price of various cutting edge technologies.
This approach enables us to advance our differentiated pipeline of novel Immunotherapies for mouse were based on innovation.
We have earned a position of market leadership with our COVID-19 vaccine.
Our goal is to continue to deepen that leadership, we believe that desktop to be with us for the foreseeable future.
Therefore necessary to evolve our products.
The ever changing challenges caused by the virus.
In oncology the F 18 programs in 'twenty three ongoing clinical trials.
Including type randomized phase II trials.
We intend to advance several of these programs into pivotal studies in the coming years and infectious diseases.
Ongoing phase one program and more than 10 preclinical programs addressing diseases, which could present significant challenges globally.
We expect to bring four of these programs into the clinic this or beginning of next year.
Our aim is to bring multiple new products in oncology and infectious disease to market over the next three to five years.
We believe that our technology innovation engine has the potential to address a broad set of diseases beyond cancer and infectious disease.
The ambition application of <unk> technology in the treatment of inflammatory cardiovascular Newark is genetic diseases and in regenerative medicine.
There are several active exploratory programs in these areas.
In the product candidate selection stage.
<unk> continues to impact the health of people about the vac and thereby create long term value for our shareholders.
Silke Maas: You are therefore cautioned, not to rely on any forward-looking statements which speak only as of today, shared today during this conference call and webcast.
Silke Maas: Also, please note that slides three, four, and five provide detailed and important safety information regarding our COVID-19 vaccine.
I will now provide an overview of our accomplishments for the second quarter, starting with the cockpit and pipeline updates.
Silke Maas: Finally, you can find the agenda for today's call on slide six.
Silke Maas: It's my pleasure to welcome the, members of MindTax's management team participating in today's call.
Slide eight.
Silke Maas: I'm joined today by our CEO and co-founder Uwe Sahin, Özlem Türeci, our chief medical officer and co-founder, Jens Holstein, our chief financial officer, and Ryan Richardson, our chief strategy officer.
Following a better than anticipated first quarter.
Quarter of 2022 was in line with our financial expectations.
Silke Maas: I would like to turn the call over to Uwe Sahin.
Ugur Sahin: Thank you, Silke.
We reported total revenues of <unk>.
One 2 billion yours contributing to total revenues of $9 6 billion.
Ugur Sahin: Good morning and good afternoon and hearty welcome to all call participants.
The first half of the year.
Ugur Sahin: We appreciate your continued support.
In June .
Well count and began construction of our first by our China manufacturing facility on the ethylene continent in Q1.
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Potentially includes our COVID-19 vaccine.
As well as investigational malaria tuberculosis vaccine candidates that we expect to advance into the clinic in the coming months.
We have signed a new equal share cost and <unk>.
Profit collaboration agreement with <unk> for the joint development of anti body targeting CD 27.
This expands our existing strategic collaboration for developing next generation immune checkpoint modulators.
Several positive developments in our oncology pipeline.
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Two of our <unk> product candidate partnered with Genentech.
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Finally, BMT 211, our next generation car T cell therapy, with <unk>, and EMA priority medicines or prime designation for third or later line of testicular cancer.
As a result, <unk> 11 benefit from earlier and more frequent interactions with the EMA for the next development phase.
Prime designation came on the heels of exciting preliminary clinical data for 14 Evaluable patients presented at the ACR meeting.
Details of the data.
Earnings call last quarter.
Ugur Sahin: Today, it's my pleasure to provide an overview of the, key highlights from the second quarter and our objectives for the remainder of the year.
On slide nine we highlight several significant achievements in our COVID-19 vaccine program that further strengthen our market leadership position.
We continue to expand our label in test with multiple regulatory progress.
Our COVID-19 vaccine in the second quarter.
We have received emergency use authorization for vaccination of children six months for four years of age. The label now includes a three dose series in this age group.
Also received emergency use authorization process Kosta and children age five to 11 years old.
Recently, our COVID-19 vaccine with the full approval.
States for adolescence, SaaS year, an order and they have submitted for full approval in the co.
In several geographies.
With this regulatory approvals our COVID-19 vaccine has achieved one of the bolder flavors among available vaccines.
Ugur Sahin: Our team will provide further details before we open the call for questions.
On the distribution front as the beginning of July we have delivered more than six.
Ugur Sahin: We have made significant progress in the second quarter as we continue to advance, toward our vision of building our global immunotherapy powerhouse.
Ugur Sahin: With our deep expertise in immunology and fully integrated spectrum of translational, research, development, manufacturing and commercialization competences, we are all well positioned for success.
Ugur Sahin: We are leveraging a multi-platform strategy built on our innovation engine comprised of, various cutting-edge technologies.
Ugur Sahin: This approach enables us to advance our differentiated pipeline of novel immunotherapies for multiple, waves of innovation.
Billion doses to 180 countries and regions since launch in December 2020.
Ugur Sahin: We have earned a position of market leadership with our COVID-19 vaccine.
Ugur Sahin: Our goal is to continue to deepen that leadership.
Strong global distribution makes us the market leading provider of COVID-19 vaccines.
Ugur Sahin: We believe that SARS-CoV-2 will be with us for the foreseeable future.
We recently signed a new agreement with the U S government to supply an additional 100 plus million court.
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Option for the U S to purchase up to an additional 195 million doses.
Our 2022 order book now includes approximately $2 5 billion doses.
Global has equity is a priority for us.
We are pursuing with a multi pronged strategy.
This includes our pledge to provide 2 billion doses for low and middle income countries by the end of 2022, we are on track to achieve this goal.
Ugur Sahin: It is therefore necessary to evolve our products to address the ever-changing challenges posed, by the virus.
As part of our long term COVID-19 strategy begin to develop vaccines that generate and now August bold and long lasting immune response, and an EBIT task response to the dynamics of emerging new variants.
Ugur Sahin: In oncology, we have 18 programs in 23 ongoing clinical trials, including five randomized, phase II trials.
In our clinical programs, our army can be a one adapt monovalent and bivalent vaccine candidates demonstrated high immune responses and tried out the safety profile.
Ugur Sahin: We intend to advance several of these programs into pre-workload studies in the coming years.
Ugur Sahin: In infectious diseases, we have one ongoing phase I program and more than 10 preclinical, programs addressing diseases which represent significant health challenges globally. We expect to bring four of these programs into the clinic this or beginning of next, year.
As part of our relentless development book.
Ugur Sahin: Our aim is to bring multiple new products in oncology and infectious disease to market, over the next three to five years.
Ugur Sahin: We believe that our technology innovation engine has the potential to address a broad, set of diseases beyond cancer and infectious disease. We envision application of our mRNA technology in the treatment of inflammatory, cardiovascular, and neurodegenerative diseases and in regenerative medicine. We have several active exploratory programs in these areas that are in the product candidate, selection stage.
Ugur Sahin: We aim to continuously impact the health of people around the world and thereby create, long-term value for all shareholders.
As the COVID-19 variance, we now have regulatory submission for omicron, B, one and B for fast adapted bivalent vaccine.
Ugur Sahin: I will now provide an overview of our accomplishments from the second quarter, starting with the, corporate and pipeline updates on slide eight.
Ugur Sahin: Following a better than anticipated first quarter, the second quarter of 2022 was in, line with our financial expectations. We reported total revenues of 3.2 billion euros, contributing to total revenues of 9.6, billion euros in the first half of the year.
Ugur Sahin: In June, we broke ground and began construction of our first biontainer mRNA manufacturing, facility on the African continent in Kigali, Rwanda. The site will manufacture a range of mRNA-based vaccines to address the needs of the African, Union member states. This potentially includes our COVID-19 vaccine, as well as investigational malaria and tuberculosis, vaccine candidates that we expect to advance into the clinic the coming months.
Ugur Sahin: We have signed a new equal share cost and profit collaboration agreement with GenLab, for the joint development of an antibody targeting CD27. This expands our existing strategic collaboration for developing next generation immune checkpoint, modulators.
Ugur Sahin: There are several positive developments in our oncology pipeline. Based data from an investigator-initiated phase one study of BNT122, our INS product, candidate partnered with Genentech, were reported at the 2022 ASCO meeting with encouraging signs of immunogenicity and disease control in patients with reflected pancreatic cancer.
Ugur Sahin: We recently initiated two more clinical trials. This includes a phase one trial of BNT142, our second product built on the Ribomab platform.
Ugur Sahin: We also dosed the first patient in the first human phase one trial of our fixed product, candidate BNT116 in patients with advanced non-small cell lung cancer.
Ugur Sahin: Finally, BNT211, our next generation CAR T-cell therapy, received an EMA priority medicine, or prime designation for third or later line treatment of testicular cancer. As a result, BNT211 will benefit from early and more frequent interactions with the EMA, for the next development phase. The prime designation came on the heels of exciting preliminary clinical data from 14, available patients presented at the ACR meeting.
Ugur Sahin: We reported details of the data in our earnings call last quarter.
Boeing website.
Our strategy includes multiple next generation, a COVID-19 vaccine approaches.
Ugur Sahin: On slide nine, we highlight several significant achievements in our COVID-19 vaccine program, that further strengthen our market leadership position.
Effort is progressing with the initiation of a phase II trial of BMT 62. Besides the first of several vaccine candidates designed to optimize and prolong the immune response.
PMT bandwidth 60 to be fast is the bivalent vaccine candidate based on enhanced versions of SaaS.
And cash flow stream and Amit Columbia, two variant snipe, 14th engine yet for broader immunity.
10, underscores the critical need to reduce vaccine adaptation cabinets to match the speed at which the virus Mutates yes.
Ugur Sahin: We continue to expand our label and have received multiple regulatory approvals for our COVID-19, vaccine in the second quarter.
We have all experienced the rise and fall of multiple COVID-19 billion over the last two and half years.
Ugur Sahin: We received emergency use authorization for vaccination of children six months to four, years of age. The label now includes a three-dose series in this age group.
Ugur Sahin: We also received emergency use authorization for our third booster in children age five, to 11 years old.
Since the emergence of the omicron lean edge every.
Two to three months, we've seen a new sapling image.
Ugur Sahin: Recently, our COVID-19 vaccine received full approval in the United States for adolescents, 12 years and older, and they have submitted for full approval in this age group in several other geographies. With these regulatory approvals, our COVID-19 vaccine has achieved one of the broadest labels, among available vaccines.
Cause us to rapidly changing it is imperative to establish vaccine development project cost and regulatory pathways that keep up with the pace of New Orleans.
Ugur Sahin: On the distribution front, at the beginning of July, we have delivered more than 3.6 billion, doses to 180 countries and regions since launch in December 2020. The strong global distribution makes us the market-leading provider of COVID-19 vaccines. We recently signed a new agreement with the U.S. government to supply an additional 105, million COVID vaccine doses as an option for the U.S. to purchase up to an additional 195 million doses. Our 2022 order book now includes approximately 2.5 billion doses.
Ugur Sahin: Global health equity is a priority for us, which we are pursuing with a multi-pronged, strategy. This includes our pledge to provide 2 billion doses for low- and middle-income countries, by the end of 2022. We are on the track to achieve this goal. As part of our long-term COVID-19 strategy, we aim to develop vaccines that generate a, more robust, broad, and long-lasting immune response and enable fast response to the dynamics of emerging new variants.
With the current development path. It is January has taken us eight months to develop a new variant adaptive X gene and progressive for clinical trials.
Discussions with regulators are ongoing to define the most appropriate cost base to leverage current experience and ensure that very adept at vaccines can be made available in the future.
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We believe that based on the Plato half generated data has a potential to reduce the existing vaccine or depression.
As little as three months flat 11 regulatory bodies around the globe agree that current vaccines require adaptation to the new omni constrained subsidy images.
Ugur Sahin: In our clinical programs, our Omicron BA1-adapted monovalent and bivalent vaccine candidates, demonstrated high immune responses and tolerable safety profiles.
On the scientific evidence, including our B, one adaptive vaccine clinical data MBA for fast preclinical data presented at the FDA Advisory Committee meeting in June .
Ugur Sahin: As part of our relentless development work aimed at addressing COVID-19 variants, we, now have regulatory submission for Omicron BA1 and BA4-5-adapted bivalent vaccines ongoing worldwide.
Ugur Sahin: Our strategy includes multiple next-generation COVID-19 vaccine approaches. This effort is progressing with the initiation of a Phase 2 trial of BNT162B5, the first, of several vaccine candidates designed to optimize and prolong the immune response. BNT162B5 is a bivalent vaccine candidate based on enhanced versions of SARS-CoV-2 and Kestrel, strain and Omicron BA2 variant swipe proteins engineered for broader immunity.
FDA published guidance by commending the introduction of violent booster vaccines in collaborating despite 14 from the amico MBA for five star.
Ugur Sahin: Slide 10 underscores the critical need to reduce vaccine adaptation timelines to match, the speed at which the virus mutates.
Other explanation components this fall.
Ugur Sahin: We have all experienced the rise and fall of multiple COVID-19 variants over the last, two and a half years. Since the emergence of the Omicron lineage, every two to three months, we have seen a, new sub-lineage. Because SARS-CoV-2 is rapidly changing, it is imperative to establish vaccine development, protocols and regulatory pathways that keep up with the pace of virus mutants. With the current development path, it generally has taken us eight months to develop a new, variant-adapted vaccine and progress it for clinical trials.
In Europe , we have finalized the adaptive bivalent vaccine sufficient to EMA, including a comprehensive clinical data package.
Ugur Sahin: Discussions with regulators are ongoing to define the most appropriate pathways to leverage, current experience and ensure that variant-adapted vaccines can be made available in the future to address newly emerging variants or sub-lineages in a timely manner.
In addition, we are preparing a rolling submission of preclinical and CMC data for an Ami can be adapted bivalent vaccine to EMA, which we expect to begin.
Ugur Sahin: We believe that based on the plethora of generated data, there's a potential to reduce the existing, vaccine adaptation timelines to as little as three months.
Meeting this month.
Ugur Sahin: Slide 11.
In parallel as submission of our omicron adaptor pilot in vaccine data packages.
Advancing with regulators about flat.
We are preparing for a clinical trial on the Columbia forecast adaptor pilot in vaccine, which is expected to commence in August .
Ugur Sahin: Regulatory bodies around the globe agree that current vaccines require adaptation to the, new Omicron strain sub-lineages. Based on the scientific evidence, including our BA1-adapted vaccine clinical data and, BA4-5 preclinical data presented at the FDA Advisory Committee meeting in June, the FDA published guidance recommending the introduction of bivalent booster vaccines incorporating the spike protein from the Omicron BA4-5 sub-lineage for the vaccination campaign this fall.
In anticipation of our launch of the Omicron adapted bivalent vaccines.
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Started to manufacture both.
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This proactive approach enables us for multiple loss scenarios based on the different regulatory recommendations you plan to scribe both vaccines for the booster.
Campaign this fall.
And part of our team and the cooperation of our partner and grateful for the hard work that has been continuously deliver to provide next year too.
People around the globe to address this evolving COVID-19 threat.
With that I will turn the call over to Ursula.
Thank you.
I'm delighted to provide our pipeline updates to date.
Ugur Sahin: In Europe, we have finalized BA1-adapted bivalent vaccine submission to EMA, including a comprehensive, clinical data package.
<unk> protein as Gordon mentioned, we shared our most recent data from the clinical trial evaluating safety and Immunogenicity of Omicron VA, one adapted <unk> candidates with the regulators, including the SBA vaccine Advisory Committee this slot.
Ugur Sahin: In addition, we are preparing a rolling submission of preclinical and CMC data for an Omicron, BA45-adapted bivalent vaccine to EMA, which we expect to begin submitting this month.
Ugur Sahin: In parallel, submission of our Omicron-adapted bivalent vaccine data packages is advancing, with regulators worldwide.
Ugur Sahin: We are preparing for a clinical trial of our Omicron BA45-adapted bivalent vaccine, which, is expected to commence in August. In anticipation of a launch of the Omicron-adapted bivalent vaccines as early as October 2022, we have started to manufacture both BA1 and BA45-adapted vaccines. This proactive approach enables us for multiple launch scenarios based on the different regulatory, recommendations.
Ugur Sahin: We plan to supply both vaccines for the booster campaign this fall.
Ugur Sahin: I am proud of our team and the cooperation of our partners.
Ugur Sahin: I am grateful for the hard work that has been continuously delivered to provide vaccines, to people around the globe to address this evolving COVID-19 threat.
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Ugur Sahin: With that, I will turn the call over to Ursula.
Ursula: Thank you, Ugo.
Vaccinated individuals one months after administration.
Ursula: I'm delighted to provide our pipeline update to date.
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Ursula: First slide, 13.
Ursula: As Ugo mentioned, we shared our most recent data from the clinical trial evaluating safety, and immunogenicity of Omicron BA1-adapted vaccine candidates with the regulators, including the FDA Vaccine Advisory Committee. This slide shows one of our representative datasets, testing of adapted vaccine candidates, as a booster dose in vaccinated individuals. One month after administration, a fourth dose of a monovalent Omicron BA1-adapted candidate, in triple vaccinated individuals increased neutralizing geometric mean titers against, Omicron BA1 13.5 and 19.6-fold above pre-booster dose levels.
Ursula: Booster vaccination with Omicron BA1-adapted bivalent vaccine candidates at the 30 and, 60 microgram doses resulted in a 9.1 and 10.9-fold increase in neutralizing geometric mean titers against Omicron BA1.
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Pinpoint ninefold increase in neutralizing geometric mean titers against Amit from D. A.
Ursula: This means both monovalent and bivalent Omicron BA1-adapted vaccine candidates met superiority, for the ratio of geometric mean titers and non-inferiority for zero responses compared to the current vaccine.
This means both monovalent and bivalent Ami Crumby, a one adapter tech zing candidates met superiority.
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Ursula: The monovalent Omicron adapted vaccine candidate showed superiority for the ratio of geometric, mean titers. The safety and reactogenicity profile of the Omicron BA1-adapted vaccine candidates were, overall similar to BNT162b2, with similar local reactions and systemic events.
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Ursula: Overall, these data provide the proof of concept for Omicron-adapted vaccine candidates achieving, immunogenicity and safety goals and meeting the regulatory requirements for successful trials. We also tested neutralization activity of the sera generated in this trial against the Omicron BA4-5 sublinage.
Overall these data provide a proof of concept for omicron adapt with vaccine candidates, achieving immunogenicity and safety goals and meeting the regulatory requirements.
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We also tested neutralization activity also Sara generated in this trial against the Omicron B a floor type subsidy image. These were all lower compared to a neutralization activity against Army Krump, Juan Pablo Monovalent and Bivalent D. A.
Ursula: These were lower compared to the neutralization activity against Omicron BA1 for both monovalent, and bivalent BA1-adapted vaccine candidates.
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Ursula: This is not surprising, given the mutational differences between the spike proteins of these two sublinages.
Ursula: On slide 14, the sequences show how Omicron BA4-5 is distinct from the BA2 and BA1 strains.
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Ursula: BA4-5 sublinage is carrying its own unique mutations, including changes in the receptor binding domain, the RBD, and the N-terminal domain, the NTD.
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Ursula: The new mutations in the RBD may change its ability to latch onto host cells and evade immunity, resulting from exposure to earlier strains.
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Ursula: Of note, BA4-5s are distinct from BA1 in their N-terminal domain and, in fact, are more closely related to the wild-type ancestral strain in that regard.
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Ursula: Our clinical development program has extended to include BA4-5-adapted vaccine candidates in addition to BA1 now. As previously mentioned, for the BA4-5 candidates, we expect a clinical trial will be initiated in August this year.
Our clinical development program.
Has extended to include a four five adapted vaccine candidates.
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As previously mentioned for the full five candidates, we expect a clinical trial will be initiated in August . This year. We however already have cross neutralization data in mouse models.
Ursula: We, however, already have cross-neutralization data in mouse models. As shown on slide 15, Omicron BA4-5-adapted monovalent and bivalent boosters in mice substantially increased, neutralization responses for all Omicron subvariants as well as the wild-type strain compared to Omicron BA1-adapted boosters. Both the monovalent Omicron BA4-5-adapted vaccine as well as the bivalent Omicron BA4-5-adapted vaccine, show strong neutralization of the Omicron sublinages, including the most distinct sublinage, BA1.
As shown on slide 15, omicron be a four five adapted monovalent and bivalent boost us in mice.
The increased neutralization responses.
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Putting the most distinct <unk> based on our previous experience, we consider cross neutralization data from such mouse models to be predictive of what will be observed in humans.
Ursula: Based on our previous experience, we consider the cross-neutralization data from such mouse models, to be predictive for what will be observed in humans.
Ursula: Our extensive clinical experience with variant-adapted vaccines and the broad database may enable preclinical immunogenicity data, and CMC package to be sufficient for future emergency use, approvals, and authorizations subject to regulatory approval. This may enable a fast regulatory pathway for timely response to emerging cases.
Extensive clinical experience with varying depths with vaccines and the broad database may enable preclinical immunogenicity data and CMC package to be sufficient for future emergency use approval authorization subject to regulatory approval.
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S regulatory pathway for timely response to emerging variants.
Ursula: Now to slide 16, our long-term scientific strategy includes exploring multiple next-generation, COVID-19 vaccine approaches to achieve a broad and longer-lasting immune response and high levels of protection against SARS-CoV-2 as it evolves. We are designing and testing several different constructs that engage multiple effector arms, of the immune system, including antibodies and T-cells.
Now I'll just add 16 hour long term scientific strategy includes exploring multiple next generation COVID-19 vaccine approaches to achieve our growth and long lasting immune response and high level of protection against Sars Cov, two as it evolves, we are designing and testing several different.
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Ursula: In July, we and our partner, Pfizer, dosed the first patient in the Phase II study evaluating, the safety, tolerability, and immunogenicity of BNT162B5, our first next-generation vaccine candidate to enter the clinic. BNT162B5 is a bivalent vaccine candidate, which includes enhanced SARS-CoV-2 spike antigens, of the ancestral strain and the Omicron BA2 sublinage engineered for increased immunogenicity.
In July we and our partner Pfizer dosed the first patient in the phase II study evaluating the safety Tolerability and Immunogenicity of <unk> hundred 60, <unk> five our first next generation vaccine candidates to enter or exit.
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Ursula: BNT162B5 is modified to elicit antibodies that we believe will offer superior protection, against infection, regardless of the circulating variant. This is accomplished through the introduction of modifications designed to expose more neutralization-sensitive, epitopes to the immune system.
Anti bodies that we believe will offer superior protection against infection, regardless of the circulating variant. This is accomplished proven introduction of modifications designed to expose more neutralization sensitive epitopes.
Ursula: We have also initiated preclinical work on other next-generation vaccine modalities, including multi-antigen T-cell-enhancing vaccines and potential pan-SARS-CoV-2 vaccines.
Immune system, we have also initiated preclinical work on others.
Next generation vaccine modalities, including marquee antigen, Keith said, enhancing vaccines and potential pans out cost to vaccines, we believe that T cell immunity to COVID-19 is important when striving for module rubber and broad protection and protection against.
Ursula: We believe that T-cell immunity to COVID-19 is important when striving for more durable, and broad protection and protection against severe disease cause.
Severe disease cause.
Ursula: We anticipate advancing candidates for both T-cell-enhancing and pan-SARS-CoV-2 approaches, into the clinic in the second half of 2022. We believe that taking this multipronged approach will enable us to achieve our ultimate, goal of delivering a pan-SARS-CoV-2 vaccine with higher and more durable protection and superior breadth, helping us to better manage future variants of concern.
Anticipate advancing candidates for both Keith said enhancing and pans out cost two approaches into the clinic in the second half of 2022.
We believe that taking this multi pronged approach.
Enabled us to achieve our ultimate goal of delivering a pan Sars Cov, two vaccine was high and Mod Europe their protection and superior rats, helping us to better manage future variants of concern.
Ursula: Slide 17 highlights our expansive oncology pipeline that is grounded in our multi-modality, toolbox and our focused execution over the last years.
Slide 17.
Highlights Alex concepts oncology pipeline that is grounded in our multi modality toolbox and focused execution.
Over the last year.
Ursula: We have reviewed our oncology pipeline intensively at our Innovation Day in June. However, we had developments since then. We now have a total of 18 clinical product candidates leveraging immune-therapeutic modalities, that are either targeting tumor cells directly or that are modulating the immune response against the tumor.
We have refuge our oncology pipeline 10 safely at our innovation day in June . However, we have developments. Since then we now have a tortured off 18 clinical product candidates leveraging immune for your project modalities that are either targeting tumors, that's directly or that modulate.
The immune response against the tumor.
Ursula: Our programs have combination potential both within our pipeline and with other approved, therapies.
Our programs have combination potential both within our pipeline and with other approved therapies or product candidates are currently being evaluated in 'twenty three.
Ursula: Our product candidates are currently being evaluated in 23 ongoing clinical trials, five, of which are randomized phase 2 trials.
<unk> clinical trials, some of which are randomized phase two trial, we initiated phase one trial for <unk> 16, the new program of AGA, Essex platform and <unk> 42, a second program from our rival net platform. We also have a new preclinical program.
Ursula: We initiated phase 1 trials for BNT1-16, a new program of our FIXAC platform, and for, Platform.
Ursula: We also have a new preclinical program through our collaboration with our partner GenMED, the NT3-13, a CD27 antibody for solid tumors.
Through our collaboration with our partner Genmab. The antifreeze her team the CD 27 anti body for solid tumors.
Ursula: Moving to slide 18, FIXVAC leverages our proprietary uridine mRNA backbone for full actualization of the intrinsic adjuvanticity of RNA.
Moving to slide 18, six swap leverage our proprietary <unk>, Oregon mrna backbone for food extra live nation of intrinsic adjuvant into city of R&D. It in quotes Kansas specific shared antigens for intravenous administration using the <unk>.
Ursula: It encodes cancer-specific shared antigens for intravenous administration using the proprietary, RNA LPX formulation. It's optimized for induction of strong antigen-specific immune responses.
Briatore RNA LPX formulation, just optimized for induction of strong antigen specific immune responses.
Ursula: Our FIXVAC product candidate, BNT116, contains six of such tumor-associated antigens, covering, up to 100 of patients in all major histological subtypes of non-small cell lung cancer. In July 2020, the first participant was dosed in a first in-human clinical trial, evaluating the, safety, tolerability, and preliminary efficacy of BNT116 alone and in combination in patients with advanced or metastasized non-small cell lung cancer. The trial will comprise several cohorts to establish a safe dose for BNT116 monotherapy, as well as for BNT116 in combination with a semiprimab, which is Regeneron's Liptayo, in patients who have progressed on prior PD-1 inhibitor treatment and are not eligible for chemotherapy. And in combination with, docetaxel in patients who have received prior platinum-based chemotherapy.
Our <unk> product candidate <unk> hundred 16 contains six of such tumor associated antigen covering up to 100 of patients in all major histologic subtype types of non small cell lung cancer.
In July 2020, the first participant was dosed in the first in human clinical trial.
<unk> the safety Tolerability and preliminary efficacy of <unk> thousand 16 alone and in combination in patients with advanced on the test is that non small cell lung cancer. The trial will comprise several cohorts to establish a safe dose will be empty 116 monotherapy.
That's why that's for the <unk> 16 in combination with our semi came up which is the regeneron.
<unk> in patients who have progressed on prior PD, one inhibitor treatment and not at all.
Not eligible for chemotherapy and in combination with Docetaxel in patients who have received prior platinum based chemotherapy.
Ursula: On slide 19 now, another first in-human trial started recently for our second ribomab product, candidate, BNT142. Our ribomab product candidates encode cancer cell-targeting antibodies and are based on nucleoside-optimized RNA designed to minimize immunogenicity and to maximize protein expression. Product candidates are formulated using liver-targeting LNPs for intravenous delivery and aim to address the limitations of recombinant antibodies, including complex manufacturing processes. The ribomab product candidate, BNT142, is a nucleoside-modified RNA that encodes a bispecific T-cell-engaging antibody. This antibody targets CD3, a T-cell receptor component, and Claudin 6, an oncofetal cell surface antigen found in solid tumors such as testicular and ovarian cancers.
On slide 19, now another first in human trials topic recently.
Our second <unk> product candidate <unk> 142.
All right well my product candidates and cold cancer targeting anti bodies and based on new clothes that optimize R&D designed to minimize immunogenicity until next so much protein expression product candidates are formulated using liver targeting lnp's, but intra.
Intravenous delivery and aim to address the limitations of recombinant anti bodies, including complex manufacturing processes.
The rebound my product candidate <unk> 142 is a nucleoside modified RNA that encodes the bispecific T cell engaging antibody.
Anti body targets CD free the T cell receptor component and Claude and six and encore feature set surface antigen.
Ursula: The phase 1-2 dose escalation trial evaluates the safety and pharmacokinetics of BNT142 in patients with Claudin 6-positive advanced solid tumors.
In solid tumors, such as testicular and ovarian cancer.
First one to a dose escalation trial.
The safety and pharmacokinetics of <unk> 42 in patients with <unk> positive advanced solid tumors.
Ursula: On slide 20, at the ESCO meeting in June, positive data from an investigator sponsored phase 1 study of autogen-cervulneurone, individualized cancer vaccine, was released, team, partnered with Genentech, was reported. This study was conducted by our colleagues at Memorial Sloan Kettering Cancer Center in adjuvant treatment of patients with localized pancreatic, adenocarcinoma.
On slide 20.
<unk> meeting in June positive data from an investigator sponsored phase one study of origin, So Hunan individualized cancer vaccine partnered with Genentech.
As reported this study was conducted by our colleagues at Memorial Sloan Kettering Cancer Center in adjuvant treatment of patients with localized pancreatic adenocarcinoma.
Ursula: After standard of care surgery and resection of the tumor, our zero, our one resected patients were treated with one dose of atezolizumab.
After standard of care surgery resection of the tumor.
<unk> zero or one receptor patients were treated with one dose of it is already so much patience then received eight doses of our individualized vaccine.
Ursula: Patients then received eight doses of our individualized vaccine, followed by standard of care adjuvant chemotherapy with modified full furinox. After 12 weeks of chemotherapy, patients received one additional booster vaccination with our individualized vaccine.
By standard of care adjuvant chemotherapy with modified Fars your remarks.
After 12 weeks of chemotherapy patients received one additional booster vaccination with our individual individualized vaccine the five year survival rates after a reduction alone as low as 10% in pancreatic cancer.
Ursula: The five-year survival rates after resection alone are as low as 10% in pancreatic cancer, so that the need for further improving adjuvant treatment of early-stage pancreatic cancer is urgent.
That's a need to talk to them about improving adjuvant treatment of already stage pancreatic cancer is urgent we believe our new antigen vaccines are well suited for the treatment of this low mutation burden tumor, especially in the adjuvant setting the main findings in the value of their patients that's worth.
Ursula: We believe our neoantigen vaccines are well-suited for the treatment of this low-mutation burden tumor, especially in the adjuvant setting.
Ursula: The main findings in the valuable patients that were, firstly, half of the patients developed high-magnitude immune responses against at least one of the targets in their individualized set of neoantigen candidates they were vaccinated with. As in this study, an assay with a high threshold was used to interrogate the immune response of all patients on an individual target basis. Lower-magnitude vaccine-induced immune responses against further neoantigen targets cannot be excluded.
Firstly half of the patients develop timing magnitude immune responses against at least one of the targets in that individualized set of new antigen candidates.
They were vaccinated with <unk> in this study and estimate with a high threshold was used to enter or Interrogates. The immune response of all patients on an individual target basis.
<unk> vaccine induced immune responses against revenue antigen targets cannot be excluded.
Even though pancreatic cancer is considered a low mutation to more tied with an unfavorable coach tumor microenvironment engineering of an individualized vaccine was shown to be feasible that was capable of mobilizing an adaptive T cell response.
Ursula: So even though pancreatic cancer is considered a low-mutation tumor type with an unfavorable cold tumor microenvironment, engineering of an individualized vaccine was shown to be feasible. That was capable of mobilizing an adaptive T-cell response.
Ursula: Second, patients with high-magnitude vaccine-induced neoantigen-specific immune responses, in this study, shown by two immune response assays, had a higher median recurrence, free survival, compared to non-immune responders, suggesting that the vaccine is conferring clinical benefit.
Second patients with high magnitude vaccine induced neo antigen specific immune responses in this study.
Shown by tool immune response essays had a higher median recurrence free survival compared to non immune respond us suggesting that the vaccine is contrary clinical benefit.
Ursula: While early, this data is encouraging and has motivated us to plan for a randomized phase two trial.
While early these data is encouraging and has motivated us to plan for a randomized phase two trial.
Turning to slide 21, I'll provide an overview of our strategic collaboration with our esteemed partners.
Ursula: Turning to slide 21, I provide an overview of our strategic collaboration with our esteemed partners from GenNet, in which we are developing multiple next-generation immune checkpoint immune modulators designed to prime and activate anti-tumor T-cell and natural killer cell function.
From Genmab, and which we are developing market sort of next generation immune checkpoint immune modulators designed to private and to activate anti tumor T cell and natural killer cells.
Ursula: The NT311 is our bispecific antibody, which conditionally co-stimulates 4-1BB while blocking the PD-1, PD-L1 axis. This candidate is being evaluated in two ongoing trials, including a phase two trial in refractory or recurrent non-small cell lung cancer and a phase one, two trial in advanced solid Tumors.
Thank you for your 11 this hour by specific by specific anti body, which conditionally co stimulator for one D. B Y blocking the PD one PDL one axis. This candidate is being evaluated in two ongoing trials, including our phase II trial in refractory or recurrent non small cell lung cancer and a phase one two.
<unk> trial in advanced solid tumors P&G free trials of our second bi specific anti body being evaluated in advanced solid tumors stimulates the immune system for a combination of pure conditional activation of C. D 40, unprofessional antigen presenting cells.
Ursula: BNT312, our second bispecific antibody, being evaluated in advanced solid tumors, stimulates, the immune system through a combination of dual conditional activation of CD40 on professional antigen-presenting cells and 41BB on antigen-specific T-cells.
For one be beyond antigen specific T cells.
We have expanded our collaboration with Genmab for a new agreement in which we will develop <unk> mono specific kicks up what are you targeting CD 27 on the east and activated T cells. We are planning to initiate a phase one two clinical trial in solid tumors the first patient.
Ursula: We have expanded our collaboration with GenMap through a new agreement in which we will develop BNT313, a monospecific hexabody targeting CD27 on naive and activated T-cells. We are planning to initiate a phase I-II clinical trial in solid tumors. The first patient is expected to be dosed in the second half of this year.
Is expected to be dosed in the second half of this year.
Ursula: With that, I conclude the pipeline update and will now turn over the call to Jens Holzstein, our CFO, who will provide the financial update.
With that I conclude for a pipeline update and we'll now turn over the call to Dan touched on our CFO , who will provide the financial update.
Jens Holstein: Thank you, Ozlem, and a warm, welcome to those of you on the phone.
Thank you Ed.
Jens Holstein: I'll start my section by presenting the key highlights for the second quarter of 2022, which you can find on slide 23. Our total revenues reported for the second quarter of 2022 reached 3.2 billion euros.
Welcome to those of you on the phone.
I'll start my section by presenting the key highlights for the second quarter of 2022, which you can find on slide 23.
Our total revenues reported for the second quarter of 2022 reached $3 2 billion euros.
Together with a strong first quarter, we outperformed our prior year development.
Jens Holstein: Together with a strong first quarter, we outperformed our prior year development, as I will show you when taking a look at the year-to-date figures. As a consequence to this top-line number, we ended the second quarter with an operating result of 2.2 billion euros and generated earnings per share on the fully diluted basis of 6.45 euros.
It will show you wouldn't take a look at the year to date figures.
As a consequence to the topline number we ended the second quarter with an operating result of $2 2 billion euros, we generated earnings per share on a fully diluted basis of six euros 45 uhm.
With respect to the company's financial position. We ended the second quarter of 2022 with $9 3 billion euros of cash and cash equivalents as well as trade receivables of around $10 4 billion years.
Jens Holstein: With respect to the company's financial position, we ended the second quarter of 2022 with 9.3 billion euros of cash and cash equivalents, as well as trade receivables of around 10.4 billion euros. 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. From our outstanding trade receivables as of June 30th, we had already collected 5.6 billion euros in cash as of July 15th, improving our cash, and in turn reducing our trade receivable position subsequent to the end of Q2. By end of July 15th, 2022, our cash and cash equivalents were 14.9 billion euros.
The trade receivables are mainly derived from our collaboration with Pfizer and mainly remained outstanding due to the contractual settlement of the gross profits you under the collaboration.
From our outstanding trade receivables as of June <unk>, we.
We had already collected $5 6 billion euros in cash as of July 15.
Improving our cash and in turn reducing our trade receivable position subsequent to the end of Q2.
By the end of July 15th 2022, our cash and cash equivalents of $14 9 billion euros.
Jens Holstein: Continuing with slide 24, we recognized approximately 3.2 billion euros of COVID-19, vaccine revenues during the second quarter and 9.5 billion euros during the first six months of 2022. The half-year numbers are fully in line with our expectations and are based on invoice doses, in the amount of approximately 1.2 billion.
Continuing with slide 24.
We recognized approximately $3 2 billion euros of COVID-19 vaccine revenues during the second quarter and $9 5 billion euros. During the first six months of 2022.
The half year numbers.
Fully in line with our expectations and are based on the invoice doses in the amount of approximately $1 2 billion.
We believe the development of the pandemic has been and remains dynamic caused the re phasing of orders.
It's leading to fluctuations in quarterly revenues.
Jens Holstein: We believe the development of the pandemic has been and remains dynamic, causing a refacing of orders and with this leading to fluctuations in quarterly revenues. Let me give you some more details on our revenue streams. As a reminder, on our COVID-19 vaccine collaborations, territories have been allocated between us, Pfizer and Fosun Pharma, based on marketing and distribution. Our COVID-19 vaccine revenues included 2 billion euros for the second quarter and 6.6 billion, euros for the first six months of 2022 that are related to our share of gross profit from, COVID-19 vaccine sales in the collaboration partners' territories.
Let me give you some more details on our revenue streams.
As a reminder, our COVID-19 vaccine collaborations territories have been allocated between us Pfizer and Fosun pharma based on marketing and distribution rights.
Our COVID-19 vaccine revenues included 2 billion euros for the second quarter and $6 6 billion euros for the first six months of 2022 that are related to our share of gross profit from COVID-19 vaccine sales in the collaboration partner territories.
Jens Holstein: These revenues represent a net figure, meaning that we generate 100% gross profit on those, revenues. As we have mentioned in the past and explained in more detail in our financial statements, and filings with the ACC, our profit share is to some extent estimated based on preliminary data shared between our collaboration partner Pfizer and us. Our COVID-19 vaccine revenues from direct COVID-19 vaccine sales to customers in our, territory were 0.6 billion euros for the second quarter and 1.7 billion euros for the first six months of 2022. Those revenues were significantly driven by the orders that were placed in late 2021 following, the emerging Omicron variant.
These revenues represented less vigor, meaning that we generate 100% gross profit on those revenues.
As we have mentioned in the past is explained in more detail in our financial statements and filings with the SEC.
Sure.
Some extent estimated based on preliminary data shared between our collaboration partner Pfizer and us.
Our COVID-19 vaccine revenues from direct COVID-19 vaccine sales to customers in our territory were <unk> 6 billion euros for the second quarter and $1 7 billion for the first six months of 2022.
Those revenues were significantly driven by the orders that we will.
Placed in late 2021 fully emergent omicron variant.
Jens Holstein: Also included in our COVID-19 vaccine revenues were 0.6 billion euros for the second quarter, and 1.2 billion euros for the first six months of 2022 of revenues from sales to our collaboration partners.
Also included in our COVID-19 vaccine revenues were opened 6 billion euros for the second quarter and $1 2 billion euros for the first six months of 2022 of revenues from sales to our collaboration partners.
Jens Holstein: I'll be moving to our financial results for the first quarter of 2022 as shown on slide, 25.
I'll be moving to offer an interim results for the first quarter of 2022.
On slide 25.
Jens Holstein: Having explained our revenues on the previous slide, let me move to cost of sales that reached, approximately 0.8 billion euros in the second quarter of 2022 compared to 0.9 billion euros for the comparative prior year period. For the first six months of 2022, the cost of sales reached approximately 2.1 billion, euros compared to 1.1 billion euros for the comparative prior year period. The change in cost of sales resulted mainly from the recognition of costs related to our, COVID-19 vaccine revenues in our own territories. This includes the share of gross profit that we owe to our collaboration partner Pfizer.
Having explained our revenues on the previous slide let me move to cost of sales reached approximately $1 8 billion euros in the second quarter of 2022 compared to $1 9 billion euros for the comparative.
Period.
For the first six months of 2022, the cost of sales reached approximately $2 1 billion euros compared to $1 1 billion euros for the comparative prior year period.
The change in cost of sales resulted mainly from the recognition of costs related to our COVID-19 vaccine revenues in our own territories.
This includes the share of gross profit.
That we owe to our collaboration partner Pfizer.
Jens Holstein: In addition, cost of sales were impacted by expenses arising from inventory write-offs, and expenses for production capacities derived from contracts with contract manufacturing organizations.
In addition cost of sales were impacted by expenses arising from inventory write offs and expenses full production capacity is derived from contracts with contract manufacturing organizations.
Jens Holstein: Research and development expenses reached 399.6 million euros for the second quarter, of 2022 compared to 201.1 million euros for the comparative period in 2021. For the first six months of 2022, research and development expenses amounted to 685.4, million euros compared to 417.3 million euros for the comparative prior year period. The increase was mainly due to the recognizing costs related to the manufacturing of prelaunched, Omicron vaccine candidates as research and development expenses in the period incurred as well as an increase in headcount.
Research and development expenses reached $399 6 million euros for the second quarter of 2022 compared to $201 1 million euros for the comparative period in 2021.
For the first six months of 2020 to research and development expenses amounted to 600.
$85 4 million euros compared to $417 3 million euros for the comparative prior year period.
The increase was mainly due to the recognizing costs related to the manufacturing of prelaunch omicron vaccine candidates.
Research and development expenses in the period incurred as well as an increase in head count.
Jens Holstein: General and administrative expenses reached 130 million euros for the second quarter of, 2022 compared to 47.8 million euros for the comparative period in 2021.
General and administrative expenses reached 130 million euros for the second quarter of 2022 compared to $47 8 million for the comparative period in 2021.
For the first six months of 2022 general and administrative expenses reached 228 million euros.
Jens Holstein: For the first six months of 2022, general and administrative expenses reached 220.8, million euros compared to 86.7 million euros for the comparative prior year period. The increase in GNA was mainly driven by the planned increase in headcount and increased, expenses for purchased external services.
<unk> to $86 7 million euros for the comparative prior year period.
The increase in G&A was mainly driven by the planned increase in head count and increased expenses for purchase.
Total services.
Jens Holstein: Income taxes were accrued with an amount of 0.6 billion euros for the second quarter, of 2022, compared to 1.2 billion euros for the comparative period in 2021.
Income taxes were accrued with an amount of <unk> 6 billion euros for the second quarter of 2022 compared to $1 2 billion euros for the comparative period in 2021.
Jens Holstein: For the first six months of 2022, income taxes were accrued with an amount of 2 billion euros, compared to 1.7 billion euros for the comparative prior year period. The derived effective income tax rate for the first six months of 2022 was 26.8 percent, and is expected to be around 28 percent for the full year.
For the first six months of 2022 income taxes were accrued within about a 2 billion.
Compared to $1 7 billion for the comparative prior year period.
The derived effective income tax rate for the first six months of 2022 with 26, 8% and is expected to be around 28% for the full year.
Jens Holstein: For the second quarter of 2022, net profit reached 1.7 billion euros compared to 2.8, billion euros for the comparative period in 2021.
For the second quarter of 2022 net profit reached $1 7 billion euros compared to $2 8 billion euros for the comparative period in 2021.
Jens Holstein: For the first six months of 2022, net profit reached 5.4 billion euros compared to 3.9, billion euros for the comparative prior year period.
For the first six months of 2022 net profit reached $5 4 billion euros compared to $3 9 billion euros for the comparative prior year period.
Jens Holstein: Our diluted earnings per share for the second quarter of 2022 amounted to 6.45 euros compared, to 10.77 euros for the comparative period in 2021.
Our diluted earnings per share for the second quarter of 2022 amounted to six euros and 45000 compared to 10 year olds and 77 euros since for the comparative period in 2021.
Jens Holstein: For the first six months of 2022, our diluted earnings per share was 20.69 euros compared, to 15.14 euros in 2021.
For the first six months of 2022, our diluted earnings per share was 20 euros 69, <unk> compared to 50 euros and 14 euro cents in 2021.
Jens Holstein: Before turning to the financial guidance, I would like to take a moment to speak about, the natural gas supply situation in Europe, as we feel it is a topic to be addressed.
Before turning to the financial guidance I would like to take a moment to speak about the natural gas supply situation in Europe , as we see that as the topics to be addressed.
Jens Holstein: We carefully monitor the impact of the natural gas supply situation on our business continuity.
We carefully monitor the impact of the natural gas supply situation on our business continuity.
Jens Holstein: According to our most recent information and analysis, commercial mRNA manufacturing, in our facility is not expected to be impacted.
According to our most recent information and analysis.
Mrna manufacturing in our facility is not expected to be impacted.
Jens Holstein: We are currently evaluating the impact originating from our partners, suppliers, and service, providers.
We are currently evaluating the impact of originating from our partners suppliers and service providers.
Jens Holstein: At this time, it is too early to conclude which impact, if any, may be driven by our, partners, suppliers, and service providers.
At this time it is too early to conclude which impact if any may be driven by our partners suppliers and service providers.
Jens Holstein: In addition, we are closely monitoring potential implications for all of our business.
In addition, we are closely monitoring potential applications for all of our business.
Jens Holstein: Our R&D and clinical development activities are currently dependent on gas, and we are, putting measures in place to mitigate related risks.
Our R&D and clinical development activities are currently dependent on gas.
Putting measures in place to mitigate related risks.
Jens Holstein: We are proactively engaging with collaboration partners and governmental authorities to mitigate, adverse developments from any potential energy shortage in the future.
We are proactively engaging with collaboration partners and governmental authorities to mitigate adverse development from any potential LNG shortage in the future.
Jens Holstein: Now let's move to slide 26.
Now, let's move to slide 26, we reiterate our outlook for the 2022 financial year.
Jens Holstein: We reiterate our outlook for the 2022 financial year, our very strong start into the 2022, financial year, and the results achieved during Q2 confirm that we are on track to achieve our previous financial guidance for the 2022 financial year.
Our very strong start into 2020 to fund the GDS and the results achieved during Q to confirm that we are on track to achieve our previous financial guidance for the 2022 financial year.
Jens Holstein: As mentioned, we experience the refacing of orders and therefore expect an uptake in demand, in our key markets in the fourth quarter of 2022 related to the Omicron-adapted bivalent vaccine, subject to regulatory approval.
As mentioned, we experienced the re phasing of orders and therefore expect an uptick in demand in our key markets in the fourth quarter of 2022 related to the omicron adapted by valent vaccine subject to regulatory approval.
Jens Holstein: Overall, we are confirming our estimated COVID-19 vaccine revenue of approximately 13 to 17, billion euros for the full 2022 financial year, and also reiterate our planned expenses and capex, as well as the estimated annual effective income tax rate, which we have summarized for you on the slide.
Overall, we are confirming our estimated COVID-19 vaccine revenue.
Approximately 13% to 17 billion euros for the full 2022 financial year and also reiterate our planned expenses and Capex as well as the estimated annual effective income tax rate, which we have summarized for you on the slide.
Ryan Richardson: And with that, I turn the call over to our Chief Strategy Officer, Ryan Richardson, for, an update on our outlook for 2022, in concluding remarks.
And with that I turn the call over to our Chief strategy Officer, Ryan Richardson for an update on our outlook for 2022 and concluding remarks. Thank you.
Ryan Richardson: Thank you.
Ryan Richardson: Thank you, Jens.
Ryan Richardson: Turning to slide 28, our COVID-19 vaccine continues to play a major role in addressing, the pandemic, and the outlook remains strong. As highlighted earlier, we and our partner, Pfizer, have shipped more than 3.6 billion, doses of BNT162b2 to more than 180 countries and territories worldwide.
Thank you yes.
Turning to slide 28.
Our COVID-19 vaccine continues to play a major role in addressing the pandemic and the outlook remains strong.
As highlighted earlier, we and our partner Pfizer have shipped more than $3 6 billion doses of <unk> 160, <unk> to more than 180 countries and territories worldwide.
Ryan Richardson: In the first half of the year, we and our partner, Pfizer, believe that we have increased, market share in select geographies where we operate and where market share data is reported. In these markets, we estimate that the cumulative share of doses administered increased from, approximately 52% in January 2022 to approximately 63% in July.
In the first half of the year, we and our partner Pfizer believes that we have increased market share in select geographies, where we operate and more market share data is reported.
In these markets, we estimate that the cumulative share of doses administered increased from approximately 52% in January 2022.
Approximately 63% in July .
Ryan Richardson: In developed markets over the same time period, we estimate that our share increased from, approximately 59% to 68%. Our 2022 signed order book stands at approximately 2.5 billion doses. In the second quarter, the United States government agreed to purchase an additional 105 million, doses with an option for up to another 195 million doses, bringing the potential total to 300 million doses. Upon delivery of the initial 105 million doses, we and Pfizer will receive 3.2 billion U.S, dollars.
In developed markets over the same time period, we estimate that our share increased from approximately 59%.
It's a 68%.
Our 2022 signed order book stands at approximately $2 5 billion doses.
In the second quarter, the United States government agreed to purchase an additional 105 million doses with an option for up to another 195 million doses.
Bringing the potential total to 300 million doses.
Upon delivery of the initial 105 million doses, we and Pfizer will receive $3 2 billion in U S dollars.
Ryan Richardson: We also have an order for more than 650 million doses to be delivered to EC member states, this year. We amended the contract to rephase deliveries toward the fourth quarter. This rephasing will not change the total doses expected to be delivered in 2022. With the expected launch of our Omicron variant-adapted vaccines, we anticipate that shipment volumes, will increase in the late fall should we receive regulatory authorization.
We also have an order for more than 650 million doses to be delivered to EC member States. This year.
We amended the contract to re phase deliveries towards the fourth quarter.
This re phasing will not change the total doses expected to be delivered in 2022.
With the expected launch of our Omicron Varian adopted vaccines, we anticipate that shipment volumes will increase in the late fall.
Should we received regulatory authorization.
Ryan Richardson: We also continue to prioritize equitable access to our medicines.
We also continue to prioritize equitable access to our medicines.
Ryan Richardson: As shown on slide 29, we are making substantial progress towards our commitment to provide, 2 billion doses of our COVID-19 vaccine to low- and middle-income countries, having shipped over 1.5 billion doses as of July 17, 2022.
Shown on slide 29, we are making substantial progress towards our commitment to provide 2 billion doses of our COVID-19 vaccine to low and middle income countries, having shipped over $1 5 billion doses as of July 17 2022.
Ryan Richardson: At the end of June, we also broke ground and started construction of our first BioNTainer, site in Kigali, Rwanda. This is the first node in a decentralized manufacturing network of at least three sites, on the African continent. Additional sites are planned for Senegal and South Africa. Once fully operational, each BioNTainer unit will have the capacity to manufacture up to, 50 million doses per year.
At the end of June we also broke ground and started construction of our first <unk> painter site in Kigali Rwanda.
This is the first node in a decentralized manufacturing network or.
Or at least three sites on the African continent.
Additional sites are planned for cynical in South Africa.
Once fully operational each Fontana unit will have the capacity to manufacture up to 50 million doses per year.
Ryan Richardson: On slide 30, we highlight select pipeline milestones for the year.
On slide 30, we highlight select pipeline milestones for the year.
Ryan Richardson: We plan to begin testing the immunogenicity and safety of an Omicron BA45-adapted bivalent, vaccine in August.
We plan to begin testing, the immunogenicity and safety of and Omicron four five adapted bivalent vaccine in August .
Ryan Richardson: We anticipate advancing additional next-generation vaccines into the clinic during the second, half of the year, and plan to provide further data updates on our expanding COVID-19 vaccine portfolio in the second half.
We anticipate advancing additional next generation vaccines into the clinic during the second half of the year.
We plan to provide further data updates on our expanding COVID-19 vaccine portfolio in the second half.
Ryan Richardson: Also in the second half of the year, we intend to begin dosing patients with our Shingles, vaccine, partnered with Pfizer.
Also on the second half of the year, we intend to begin dosing patients with our shingles vaccine partnered with Pfizer.
Ryan Richardson: We also anticipate initiating clinical trials for our herpes simplex 2 virus vaccine BNT162, in the second half as well as for our tuberculosis and malaria vaccines BNT164 and BNT165 respectively also in the second half of the year or early 2023.
We also anticipate initiating clinical trials for our herpes simplex two virus vaccine.
162.
In the second half as well as for our tuberculosis and malaria vaccines P&C 164, and 165, respectively also in the second half of the year or early 2023.
Ryan Richardson: Based on encouraging results demonstrated by BNT161, our Pfizer partnered modified, mRNA seasonal influenza vaccine, Pfizer plans to initiate a phase 3 clinical trial in the second half of the year.
Based on encouraging results demonstrated by <unk> 106, one our Pfizer partnered modified mrna seasonal influenza vaccine.
Pfizer plans to initiate a phase III clinical trial in the second half the year.
Ryan Richardson: In oncology and together with our collaboration partner GenMed, we plan to start a first in human phase 1-2 clinical trial in the second half for our CD27 targeted antibody BNT313.
In oncology.
And together with our collaboration partner Genmab, we plan to start our first in human Phase one two clinical trial in the second half for our CD 27 targeted antibody <unk> 313.
Ryan Richardson: We also expect to provide data updates later this year for our Claudin 6 positive CAR T cell, candidate BNT211 which is in trials multiple solid tumors.
We also expect to provide data updates later this year for our cloud and six positive car T cell candidate <unk>, which is in trials multiple solid tumors.
We anticipate disclosing data from our ongoing phase II trial evaluating our <unk> candidates <unk> <unk> and.
Ryan Richardson: We anticipate disclosing data from our ongoing phase 2 trial evaluating our INES candidate BNT122 in first line melanoma in combination with pembrolizumab in the first half of 2023.
In first line melanoma in combination with <unk> in the first half of 2023.
Ryan Richardson: Concluding on slide 31, we remain focused on executing against our strategic objectives for the remainder of the year.
Concluding on slide 31.
We remain focused on executing against our strategic objectives for the remainder of the year.
Ryan Richardson: We are in a strong position to continue our COVID-19 leadership with the potential launch of our first variant adapted vaccines later this fall alongside the continued development of multiple next generation product candidates.
We are in a strong position to continue our COVID-19 leadership with the potential launch of our first variant adopted vaccines. Later this fall alongside the continued development of multiple next generation product candidates.
Ryan Richardson: We will also continue to broaden and accelerate our oncology pipeline development with the planned initiation of multiple registrational and first in human trials.
We will also continue to broaden and accelerate our oncology pipeline development with the planned initiation of multiple registrational and first in human trials.
Ryan Richardson: An infectious disease beyond COVID-19, we plan to initiate multiple first in human vaccine trials by year end.
In infectious disease beyond COVID-19, we plan to initiate multiple first in human vaccine trials by year end and.
Ryan Richardson: And we also continue to progress more than 10 preclinical stage MRNA vaccine and precision antibacterial programs.
And we also continue to progress more than 10, preclinical stage mrna vaccine and precision anti bacterial programs.
Ryan Richardson: We expect continued corporate development activity in the second half as well.
We expect continued corporate development activity in the second half as well.
We are currently evaluating a wide range of opportunities, which could complement and expand both our pipeline and technology toolkit.
Ryan Richardson: We are currently evaluating a wide range of opportunities which could complement and expand both our pipeline and technology toolkit.
Ryan Richardson: And we continue to add capability and scale to our organization as we expand our footprint, in Europe, United States, Asia, and Africa.
And we continue to add capability and scale to our organization as we expand our footprint in Europe , United States Asia and Africa.
We are investing in human capital, bringing on the people and expertise needed to further transform our global research and development and commercial organization to support our growing pipeline and long term vision.
Ryan Richardson: We are investing in human capital, bringing on the people and expertise needed to further transform our global research and development and commercial organization to support our growing pipeline and long-term vision.
Ryan Richardson: We remain as focused as ever on creating true long-term value for patients, shareholders, and society.
We remain as focused as ever on creating true long term value for patients shareholders and society.
Ryan Richardson: With that, I would like to thank our shareholders for their continued support and would now open the floor for questions.
With that I would like to thank our shareholders for their continued support and we'll now open the floor for questions.
Operator: Thank you.
Thank you Dear participants we will now begin the question and answer session. As a reminder to ask a question you will need to press star one bond on the telephone might find them to be announced.
To ensure everyone has the opportunity to ask a question today. Please limit yourself to one question. Thank you very much for your understanding.
Operator: Dear participants, we will now begin the question and answer session.
Now we're going to take our first question.
Operator: As a reminder to, ask a question, you will need to press star 11 on your telephone and wait for your name to be announced.
Yeah.
Thank you and bye.
Operator: To ensure everyone has the opportunity to ask a question today, please limit yourself just to one question.
And the first question comes from the line of Mitchell Harrison from Morgan Stanley . Your line is open. Please ask your question.
Operator: Thank you very much for your understanding.
Operator: Now we're going to take our first question.
Great. Good morning, Thanks for taking the question.
Brian I guess I just wanted to follow up on one of the comments you made towards the end about.
The size and scope of the opportunities that you're evaluating how you think about broadly uses of cash here and should investors be expecting.
That you would consider deals that are that are quite sizable or should we be thinking much more about us.
Smaller bolt on technology deals thanks very much.
Operator: Please stand by.
Yes, thanks for the question Matt.
Matthew Harrison: And the first question comes to the line of Matthew Harrison from Morgan Stanley.
So we are looking at a wide range of opportunities, but for the most part Matt we're looking really at bolt on.
Acquisitions and or strategic partnerships.
Our focus is going to continue to be on organic R&D and scaling that up over the coming years and as we get into more registrational trials with our own pipeline. We think we'll have.
Better ability say over the next 24 months or so to be able to deploy capital into those pivotal trials that could deliver products for launches over the next three to five years as we've laid out so so really it's about complementing that organic strategy.
And that includes expanding our pipeline either early or mid stage pipeline and complementary ways. We're really looking for programs and technologies that synergize with what were already doing and that may include extending our RNA platforms into new verticals or new white space or bolstering our cell therapy pipeline.
Lynn.
Okay.
Does that answer your question.
It does thank you Brian .
Thank you.
Now we're going to take our next question.
Okay.
Please standby.
And the next question comes from the line of <unk> <unk> from Bank of America. Your line is open piece ask your question.
Operator: Your line is open.
Matthew Harrison: Please ask your question.
Matthew Harrison: Great.
Matthew Harrison: Good morning.
Matthew Harrison: Thanks for taking the question.
Okay. Thank you thanks for taking my question.
Matthew Harrison: Ryan, I guess I just wanted to follow up on one of the comments you made towards the end, about size and scope of the opportunities that you're evaluating, how you think about, you know, broadly uses of cash here, and, you know, should investors be expecting that you would consider deals that are quite sizable, or should we be thinking much more about smaller bolt-on technology deals?
Brian maybe I also wanted to ask you about some of the comments that you made about.
Matthew Harrison: Thanks very much.
Deliveries for the rest of the year. So for this quarter. When you mentioned that some deliveries have been pushed out are you just referring to the portion of delivery of that biotech is responsible for what it also apply to some of what Pfizer was delivering in the U S and then.
Same topic, how should we think about your capacity.
City to deliver doses for the rest of the year once you get to full scale production.
So for the new variant basically do you have a sense of how many doses you would have capacity to deliver between now and year end. Thanks.
Ryan Richardson: Yeah, thanks for the question, Matt. So we are looking at a wide range of opportunities, but for the most part, Matt, we're looking, really at bolt-on acquisitions and or strategic partnerships.
Ryan Richardson: Our focus is going to continue to be on organic R&D and scaling that up over the coming years.
Ryan Richardson: Does that answer your question?
Ryan Richardson: And as we get into more registrational trials with our own pipeline, we think we'll have, a better ability, say, over the next 24 months or so to be able to deploy capital into those pivotal trials that could deliver products for launches over the next three to five years as Uber laid out.
Thank you to Zane I'll start with that and then and then also ask Yens Holstein to weigh in as well on your first question with regard to the shift in doses towards the end of the year.
Ryan Richardson: So really it's about complementing that organic strategy, and that includes expanding our, pipeline in either early or mid-stage pipeline in complementary ways.
Ryan Richardson: We're really looking for programs and technologies that synergize with what we're already doing, and that may include extending our RNA platforms into new verticals or new white space, or bolstering our cell therapy pipeline.
Matthew Harrison: It does.
That is a that does reflect both both ours and pfizer's scheduled deliveries I think namely it includes the orders.
For delivery to the European Union, we had announced during the quarter that some of those deliveries would be shifted into the back end of the year and Thats a pretty sizable number of orders, it's actually our largest order for this year.
And extends into next year so.
That's a big component of the shift to the to Q4, but we also see that in other markets as well.
It's less about shifting.
Because of the orders the original contract orders went through April .
And then as we mentioned on the call today, we had an additional order.
We expect will be delivered over the second half of the year.
Likely heavily weighted in Q4.
Maybe before we go to the capacity point, yes, do you want to add to that.
Matthew Harrison: Thank you, Ryan.
Thank you Brian .
Matthew Harrison: Thank you.
You basically gave the answer already.
Operator: Now we're going to take our next question.
Maybe a bit to add here I mean, we have we have of course in other countries also some some delays specifically if we look at euro.
Luckily we have some shift from Q2.
Q4, and Ryan was alluding to this in his speech that we have 650 million doses.
We expect to be delivered.
In the course of this year.
I mean all of this of course is is heavily influence that we've seen that throughout the year. So far by the dynamic of the pandemic of course specifically.
How the timing will be for approval from the FDA and from EMA and that will that will influence. The total amount that we are able to deliver to our customers at the end of the day. So there is that.
That's the main reason.
While we have been cautious in terms of looking at our guidance of 14 to 17 I think overall if you look at the nine 6 billion that we have reported for the first six months, we feel very very good about it.
Maybe allude also to what we said in the Q1 call and on the basis of $2 4 billion doses. We said, we will end up somewhere in the middle of that range.
So.
Of course, there are some fluctuations that we have seen already last year.
While our delivery move from one months for the next months that can happen over the end of the quarter over the end of the year as well as of course, so and all of this.
This keeps us.
The guidance that we have given to you on 13 to 17.
But we are overall very optimistic.
That we will see it.
Year 2022.
Yes, and on your capacity question.
Just say that of course, we our objective is to deliver the full order book the full $2 5 billion doses.
That are scheduled for delivery this year.
This year I think one factor that will that could impact that would be the timing of the various authorizations that we do expect in the fall for the Omicron variant vaccine I think we do have to manage inventory.
We've alluded to here on the call we have produced.
The different vaccines at risk in order to be able to supply readily we do feel confident that we'll be able to supply.
To meet demand, but of course as mentioned as these things are dynamic the demand is dynamic and we will be following regulatory authorizations.
Should they occur so.
We feel good about the position, but theres always a chance of course, but planned deliveries will shift as we move throughout the year and we just have to and we've been operating under those assumptions for a year and a half now.
And have to continue to do so.
Okay. That's a lot of color. Thank you.
Thank you.
Yeah.
Now we're going to take our next question.
Operator: Please stand by.
Please standby.
Tazin Ahmad: And the next question comes to the line of Tazin Ahmad from Bank of America.
And the next question comes from the line of Dan <unk> from Seb Securities. Your line is open. Please ask your question.
Operator: Your line is open.
Tazin Ahmad: Please ask your question.
Tazin Ahmad: Okay.
Thank you all for the question I have one sort of a three parter under fall booster that we've talked about the EMEA and you ask them, whether they want to be a one versus da four five can you give us a breakdown of the rest of the world and your expectations for which of these versions.
Well guide to our one.
And the second part is do you think will be unlocked use of both versions for us to understand the relative vaccine effectiveness compare across countries is going to be a.
John .
So it could be a four five and finally as Europeans 45 does it have spikes from both the $8 five or have you selected one thank you.
Tazin Ahmad: Thank you.
Okay.
Hi, Dana.
Thanks for the question.
And so this we got to be so.
The U S.
The FDA expects NBA for five <unk>.
Tazin Ahmad: Thanks for taking my question.
<unk> appears to be open to both be one.
<unk> SBS four five.
Tazin Ahmad: Ryan, maybe I also want to ask you about some of the comments that you made about deliveries, for the rest of the year.
Tazin Ahmad: So for this quarter, when you mentioned that some deliveries have been pushed out, are, you just referring to the portion of deliveries that BioNTech is responsible for, or would it also have applied to some of what Pfizer was delivering in the U.S.?
Based on that.
Preparing our SaaS to manufacture and supply both vaccine and vaccine compositions both.
Tazin Ahmad: And then same topic, how should we think about, you know, your capacity to deliver doses for, the rest of the year once you get to full-scale production, you know, for the new variant?
Bivalent vaccine with regard to the rest of the world They have to see how the setup pandemic pandemic is there continue can be it appears to be that the dominating sapling.
Based on the two NBA for $5 subsidy and adjust and if this continues to be.
We anticipate that <unk> be fought prospects scene, which has our highest similarity to the tool and edge.
The produce.
Our strong on neutralizing antibody response against both tier four five is that SBA. Two there is some evidence from preclinical data that we have generated an impact presented oil.
Already and there is also evidence from ongoing ongoing studies.
In.
Humans.
Full infection, indicating indicating.
And that too.
B, a four five vaccine could teva bought on utilization.
Okay.
And as we got to be a four five spike youll know that <unk> four five.
And the origin of sequencing shared the same spike sequence.
And therefore, the or this is to be a fore sight.
Great. Thank you.
Thank you.
Now we're going to take our next question.
Please standby.
Tazin Ahmad: Basically, do you have a sense of how many doses you'd have capacity to deliver between, now and year-end?
And the next question comes from the line of Chris <unk> from Goldman Sachs. Your line is open. Please ask your question.
Tazin Ahmad: Thanks.
Ryan Richardson: Yeah, thank you, Tazin.
Hi, Good morning. This is Steven on for Chris. Thank you for taking my question I had one on cost of sales.
Ryan Richardson: I'll start with that and then also ask Jens Holstein to weigh in as well.
Ryan Richardson: On your first question with regard to the shift in doses towards the end of the year, that is a – that does reflect both our and Pfizer's scheduled deliveries. I think namely it includes the orders for delivery to the European Union.
Ryan Richardson: We had announced during the quarter that some of those deliveries would be shifted into, the back end of the year, and that's a pretty sizable number of orders. It's actually our largest order for this year and extends into next year.
As noted that this was affected by inventory write offs. We were just wondering if you could provide some context around these write offs, maybe quantify the impact and then on a related note how we should be thinking about margins on a forward basis. Thank you.
Ryan Richardson: So that's a big component of the shift to Q4, but we also see that in other markets, as well.
Ryan Richardson: The U.S. is less about shifting because the orders – the original contract orders went, through April, and then as we mentioned on the call today, we've had an additional order which we expect will be delivered over the second half of the year, likely heavily weighted in Q4.
Yes, Steven Thanks for the question.
So indeed, we have some write offs in Q2.
You'll see that in the filing Dr. Lindsey talk about round about $400 million.
Impacted negatively our cocks figure if you look if you take that out the gross margin in the in the range of what we have seen in.
Previous quarters.
Despite the fact that the the increase.
In terms of volume that went into low income countries and middle income countries actually slightly increased in Q2.
No.
That is something that we had to swallow in Q2, depending on hold that forward they'll take off or something that as well.
We remain a topic that we have to keep in Q1 and the quarters, depending on all the time.
Ryan Richardson: Maybe before we go to the capacity point, Jens, do you want to add to that?
Endemic evolves.
Got it okay. Thank you very much youre welcome.
Thank you.
Now we're going to take one last question.
Jens Holstein: Thank you, Ryan.
Please standby.
And the last question comes from the line of onshore from them that because your line is open. Please ask your question.
Jens Holstein: But you two basically gave the answer already.
Hi, Thanks for taking my questions.
Like to ask about the next generation vaccine approaches.
In particular with regard to the T cell and in vaccines and before we go can you talk about the advantage of this vaccine.
And regarding the Pan Sars Cov two vaccine.
I was wondering if you can talk about the visibility here, whether you could just.
Vaccine will include multiple strains or or end.
Including some of the.
Appreciation stability.
Approaches you've taken there and a quick follow up on be in tier one to two maybe for Oslo in terms. So the first one in melanoma I noticed the data is released it shifted to first half of 'twenty three and can you talk about some of the considerations there.
Jens Holstein: Maybe a bit to add here, I mean, we have, we have, of course, in other countries, also, some some delays, specifically if we look at Euro, or not delays, we have some shifts from Q2 and Q4.
Jens Holstein: And Ryan was alluding to this in his speech, that we have 650 million doses that we expect, to be delivered in the course of this year.
Jens Holstein: I mean, all of this, of course, is, is heavily influenced, and we've seen that throughout, the year so far by the dynamic of the pandemic, and of course, specifically, how the timing will be for approval from the FDA and from EMA, and that will, that will influence the total amount that we are able to deliver to our customers at the end of the day.
Okay.
Jens Holstein: So there is, that's, that's the main reason, you know, when we, why we have been cautious, in terms of looking at our guidance in 13 to 17.
Jens Holstein: I think overall, if you look at the 9.6 billion that we have reported for the first six months, I mean, we feel very, very good about it.
I'm happy to take both questions.
Jens Holstein: And just to maybe allude also to what we said in the Q1 call, and on the basis of 2.4 billion, doses, we said we will end up somewhere in the middle of that range.
Jens Holstein: So, of course, there are some fluctuations that we have seen already last year, you know, when, when that delivery moved from one month into the next month, that can happen over the end of the quarter, over the end of the year as well, of course.
Jens Holstein: So and all this, you know, just keeps us with the guidance that we have given to you on, 13 to 17.
First off first of all obviously got to our our strategy for next generation vaccines.
Jens Holstein: But we are overall very optimistic, you know, that we, that we will see a good year 2022.
Jens Holstein: Yeah, and Tazine, on your capacity question, you know, I would just say that, of course, we, our objective is to deliver the full order book, the full 2.5 billion doses that are scheduled for delivery this year, this year.
Ryan Richardson: I think one factor that will, that could impact that would be the timing of the various authorizations, that we do expect in the fall for the Omicron variant vaccine.
Ryan Richardson: I think we do have to manage inventory, as we've alluded to here, here on the call.
Ryan Richardson: We have produced different vaccines at risk in order to be able to supply readily.
Ryan Richardson: We do feel confident that we'll be able to supply to meet demand, but of course, as mentioned, these things are dynamic, the demand is dynamic, and will be following regulatory authorizations should they occur.
Tazin Ahmad: So, you know, we feel good about the position, but there's always a chance, of course, that, the planned deliveries will shift as we move throughout the year, and we just have to, we've been operating under those assumptions for a year and a half now, and have to continue to do so.
A number of ongoing preclinical programs and decided to bring two clinical programs into two preclinical programs into clinical testing one is.
Tazin Ahmad: Okay, that's a lot of color.
It is related to.
Two two.
Tazin Ahmad: Thank you.
Next generation vaccines aiming to increase the neutralizing antibody titers.
And potent neutralizing antibody titers.
Operator: Now, we're going to take our next question.
Operator: Please stand by.
Hi.
By Marty Marty five modestly a modification of the of the spike protein and.
And the second approach. So this is this is about about strengthening the b cell response, and and second approach aims for the further development of broadly active T cell T cell.
Diana Gray-Bosch: And the next question comes to line of Diana Gray-Bosch from SVB Securities.
Vaccine.
No.
<unk>.
The target off of.
Tom evolution.
Hi mutation rate and the concept of T cell vaccine is to strengthen the cellular immunity against COVID-19. It is now established that the cellular immunity is a paramount effect on preventing severe disease.
And we see here the opportunity.
Two identify identify epitopes that.
That's a concern among all.
Our SaaS SaaS.
Two variants and and this is this is an approach where we will share more information in the coming weeks, how how this development.
Ah relate to the already existing existing vaccine approaches.
With regard to BMT event too.
And so the shifted.
Art.
For the phase two next year in the background is here and that debt.
Recruitment of patients into the study was delayed also related to the pandemic and post pandemic effects and therefore, the readout is shifted to 2023.
Great. Thank you very much.
Okay.
Thank you.
There are no further questions over to you.
Operator: Your line is open.
Thank you. Thank you all for joining us today, and we look forward to speaking flu here in Q2, Thank you and stay safe.
Diana Gray-Bosch: Please ask your question.
Diana Gray-Bosch: Hi, thank you all for the question.
Silke Maas: Thank you all for joining us today, and we look forward to speaking with you in future.
Diana Gray-Bosch: I have one, sort of a three-parter on the fall boosters.
Operator: Thank you, and stay safe.
Diana Gray-Bosch: So we've talked about the EMA and U.S. and whether they want VA-1 versus VA-4-5.
Diana Gray-Bosch: Can you give us a breakdown of the rest of the world and your expectations for which of these, versions they'll guide to or want?
Diana Gray-Bosch: And the second part is, do you think there'll be enough use of both versions for us to understand the relative vaccine effectiveness if we compare across countries using VA-1 versus the VA-4-5?
Diana Gray-Bosch: And finally, is your VA-4-5, does it have spikes from both VA-4-5 or have you selected one?
Diana Gray-Bosch: Thank you.
Ugur Sahin: Hi, Dana.
Operator: That does conclude our conference for today.
Ugur Sahin: Yes, Ugo.
Operator: Thank you for participating.
That does conclude our conference for today. Thank you for participating you may all disconnect have a nice day.
Ugur Sahin: Thanks for the question.
Ugur Sahin: So with regard to VA, so you are aware that the FDA, expects a VA-4-5 vaccine, whereas the EMA appears to be open to both VA-1 as well as VA-4-5.
Ugur Sahin: And based on that, we are preparing ourselves to manufacture and supply, both vaccine compositions, both as a bivalent vaccine.
Operator: You may all, disconnect.
Ugur Sahin: With regard to the rest of the world, we have to see how the further pandemic will continue.
Ugur Sahin: Currently, it appears to be that the dominating sub-lineages are based on VA-2 and VA-4-5 sub-lineages.
Ugur Sahin: And if this continues, we anticipate that the VA-4-5 vaccine, which has a higher similarity to the VA-2 lineage, will produce a stronger neutralizing antibody response against both VA-4-5 as well as VA-2. There is some evidence from preclinical data that we have generated and in part presented, already, and there is also evidence from ongoing studies in humans with flu infection indicating that VA-2 or VA-4-5 vaccine could have a border neutralization.
Ugur Sahin: And with regard to VA-4-5 spike, you know that VA-4-5 and the original sequence, share the same spike sequence, and therefore, we always refer to VA-4-5.
Ugur Sahin: Great.
Diana Gray-Bosch: Thank you.
Diana Gray-Bosch: Thank you.
Operator: Now, we're going to take our next question.
Yeah.
Operator: Please stand by.
Chris Shibutani: And the next question comes to the line of Chris Shibutani from Goldman Sachs.
Operator: Your line is open.
Chris Shibutani: Please ask your question.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
Chris Shibutani: Hi.
Chris Shibutani: Good morning.
Chris Shibutani: This is Stephen on for Chris.
Chris Shibutani: Thank you for taking our question.
Chris Shibutani: I had one on cost of sales. It was noted that this was affected by inventory write-offs.
Chris Shibutani: We're just wondering if you could provide some context around these write-offs, maybe quantify the impact, and then on a related note, how we should be thinking about margins on a core basis.
Chris Shibutani: Thank you.
[music].
Jens Holstein: Stephen, thanks for the question.
Jens Holstein: So, indeed, we have some riders in Q2.
Jens Holstein: You will see that, in the filing document, we talk about roundabout 400 million that have impacted negatively our COX figure.
Jens Holstein: If you look, if you take that out, you know, the cross margin in the range of what we have seen in previous quarters, despite the fact that the increase in terms of volume that went into low-income countries and middle-income countries actually slightly increased in Q2.
Jens Holstein: So, that is something that we had to swallow in Q2, depending on, you know, how much more risk we'll take.
Jens Holstein: Of course, something that this will remain a topic that we have to keep a view on in the quarters, depending on, you know, how the pandemic evolves.
Chris Shibutani: Got it.
Chris Shibutani: Okay.
Chris Shibutani: Thank you very much.
Chris Shibutani: You're welcome.
Chris Shibutani: Thank you.
Operator: Now, we're going to take, our last question.
Operator: Please stand by.
Zhiguang Xu: And the last question comes from Zhiguang Xu from, Barenbeck.
Operator: The line is open.
Zhiguang Xu: Please ask your question.
Zhiguang Xu: Hi.
Zhiguang Xu: Thanks for taking my question.
Zhiguang Xu: I'd like to ask about the next-generation vaccine approaches.
Zhiguang Xu: In particular, with regard, to the T cell enhancing vaccines, can you talk about the advantage of this vaccine?
Zhiguang Xu: And regarding the pan-SARS-CoV-2 vaccine, I was wondering if you can talk about the, feasibility here, whether you could – this vaccine will include multiple strains or – and including some of the upper effusion stability approaches you've taken there.
Zhiguang Xu: And a quick follow-up on BNT1 to 2, maybe for Oslim, in terms of the first-line melanoma.
Zhiguang Xu: I noticed the data release shifted to first-line 23.
Zhiguang Xu: Can you talk about some of the considerations there?
Zhiguang Xu: Okay.
Ursula: So, I'm happy to take both questions.
Ursula: So, first of all, with regard to our strategy for, next-generation vaccines, we have a number of ongoing preclinical programs and decided to bring two preclinical programs into clinical testing. One is related to next-generation vaccines, aiming to increase the neutralizing antibody titers and broaden the neutralizing antibody titers by modification of the spike protein.
Ursula: And the second approach – so, this is about strengthening the B cell response – and the second approach aims for the development of broadly active T cell vaccine.
Ursula: As you know, the spike protein is the target of strong evolution and has a high mutation rate.
Ursula: And the concept of a T cell vaccine is to strengthen the cellular immunity against COVID-19. It is now established that cellular immunity has a paramount effect on preventing severe disease.
Ursula: And we see here the opportunity to identify epitopes that are conserved among all SARS-CoV-2 variants.
Ursula: And this is an approach where we will share more information in the coming weeks, how this development would relate to the already existing vaccine approach.
Ursula: With regard to BNT.1.2.2, we shifted the readout for the Phase 2 to next year, and the background, is here, and that the recruitment of patients into the study was delayed, also related to the pandemic and post-pandemic effects, and therefore the readout is shifted to 2023.
Zhiguang Xu: Great.
Zhiguang Xu: Thank you very much.
Zhiguang Xu: Thank you.
Operator: Thank you.
Operator: There are no further questions.
Silke Maas: Silke, over to you.
Silke Maas: Thank you.