Q4 2023 BioNTech SE Earnings Call

March 20, 2024

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Operator: Welcome to BioNTech's Fourth Quarter and Full Year 2023 Earnings Call. I would like to hand the call over to Dr. Victoria Meissner, Vice President of Strategy and Investor Relations. Please go ahead.

Operator: Welcome to BioNTech's Q4 and Full Year 2023 Earnings Call. I would like to hand the call over to Dr. Victoria Meissner, Vice President of Strategy and Investor Relations. Please go ahead.

Victoria Meissner: Welcome to the bio techs fourth quarter and full year 'twenty to 'twenty three earnings call I would like to hand, the call over to Doctor Victoria mice, not vice President of strategy and Investor Relations. Please go ahead.

Victoria Meissner: Thank you. Good morning and good afternoon. Thank you for joining BioNTech's Fourth Quarter and Full year 2023 Earnings Call. As a reminder, the slides we'll be using during this call and the corresponding press release we issued this morning can be found in the Investor Relations section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission.

Victoria Meissner: Thank you. Good morning and good afternoon. Thank you for joining BioNTech's Q4 and full year 2023 earnings call. As a reminder, the slides we'll be using during this call and the corresponding press release we issued this morning can be found in an investor relations section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the US Securities and Exchange Commission. Forward-looking statements in this call are subject to significant risks and uncertainties, speak only as of the date of this conference call, and we undertake no obligation to update or revise any of these statements. On slide three, you can find the agenda for today's call. Today, I'm joined by the following members of BioNTech's management team. Ugur Sahin, our CEO and Co-Founder.

Victoria Meissner: Thank you.

Victoria Meissner: Morning, and good afternoon.

Victoria Meissner: Thank you for joining <unk> fourth quarter and full year 2023 earnings call.

Victoria Meissner: As a reminder, the FIFO would be using during this call and the corresponding press release, we issued this morning can.

Speaker Change: Can be found in the Investor Relations section of our website.

Victoria Meissner: On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this call are subject to significant risks and uncertainties, speak only as of the date of this conference call, and we undertake no obligation to update or revise any of these statements. On slide 3, you can find the agenda for today's call.

Speaker Change: On the next slide you will see our forward looking statements disclaimer additional information about these statements and other risks are described in our filings with the U S Securities and Exchange Commission.

Victoria Meissner: Forward-looking statements in this call are subject to significant risks and uncertainties, speak only as of the date of this conference call, and we undertake no obligation to update or revise any of these statements. On slide three, you can find the agenda for today. Today, I'm joined by the following members of BioNTech's management team. Ugur Sahin, our CEO and co-founder; Ozlem Tureci, Chief Medical Officer and Co-Founder; Jens Holstein, Chief Financial Officer, and Ryan Richardson, Chief Strategy Officer. With this, I would like to hand it over to Ugur.

Forward-looking statements in this call are subject to significant risks and uncertainties, speak only as of the date of this conference call, and we undertake no obligation to update or revise any of these statements. On slide 3, you can find the agenda for today.

Speaker Change: Forward looking statements in this call are subject to significant risks and uncertainties speak only as of the date of this conference call and we undertake no obligation to update or revise any of these statements.

Speaker Change: On slide three you can find the agenda for today's call.

Speaker Change: Today I'm joined by the following members of Biotics management team.

Today, I'm joined by the following members of BioNTech's management team. Ugur Sahin, our CEO and Co-founder; Ozlem Tureci, Chief Medical Officer and Co-Founder; Jens Holstein, Chief Financial Officer, and Ryan Richardson, Chief Strategy Officer. With this, I would like to hand it over to Ugur.

Diane Archie: Diane Archie on cofounder.

Victoria Meissner: Özlem Türeci, Chief Medical Officer and Co-Founder. Jens Holstein, Chief Financial Officer, and Ryan Richardson, Chief Strategy Officer. With this, I would like to hand over to Ugur Sahin.

Diane Archie: Mhm to Ritchie, Chief Medical Officer, and cofounder <unk>.

Diane Archie: Yes, harsh time, Chief Financial Officer, and Ryan Richardson, Chief Strategy Officer.

With this, I would like to hand it over to Ugur.

Uber: With this I would like to hand over to Uber.

Ugur Sahin: Thank you, Victoria. A warm welcome to all those joining us today.

Ugur Sahin: Thank you, Victoria. A warm welcome to all those joining us today. Slide 5. Let me start by reiterating our vision and company goals. BioNTech was founded 15 years ago with the vision to harness the power of the immune system to fight human diseases, particularly cancer. The emergence of the pandemic accelerated our mission, leading to the development of our COVID-19 vaccine. This achievement not only showcased the versatility of our mRNA technology, but also highlighted our unique expertise and ability to execute fast. Our vision was realized and broadened, illuminating the potential of our science across other therapeutic areas. Building on this, our 3 objectives moving forward are to establish a multi-product company powered by our pioneering technologies and science to address medical needs worldwide.

Uber: Thank you Victoria Rhonda come to all those joining us today.

Slide 5. Let me start by reiterating our vision and company goals. BioNTech was founded 15 years ago with the vision to harness the power of the immune system to fight human diseases, particularly cancer. The emergence of the pandemic accelerated our mission, leading to the development of our COVID-19 vaccine. This achievement not only showcases the versatility of our mRNA technology but also highlighted our unique expertise and ability to execute fast.

Uber: But let.

Uber: Let me start by E.

Each elevating our vision of a company called <unk>.

Uber: Atlantic, Wisconsin that 15 years ago with a vision to harnessed the power of the immune system.

Uber: But human diseases, particularly cancer.

Uber: The emergence of the pandemic accelerates our nation, leading to the development of our COVID-19 vaccine.

Uber: This achievement not only showcase the vessel charity.

Uber: On a technical Rushee.

Uber: It also highlighted our unique expertise and.

Uber: Our ability to execute as fast.

Ugur Sahin: Our vision was realized and prudent illuminating the potential of our science across other therapeutic areas. Building on this, our 3 objectives moving forward are to establish a multi-product company powered by our pioneering technologies and science to address medical needs worldwide, to contribute to the development of innovative precision medicines against cancer aiming for multiple product approvals in the coming years, and to expand and strengthen our sustainable respiratory infections disease vaccine business building on the success of our community franchise. Slide six.

Our vision was realized and prudent illuminating the potential of our science across other therapeutic areas. Building on this, our 3 objectives moving forward are to establish a multi-product company powered by our pioneering technologies and science to address medical needs worldwide, to contribute to the development of innovative precision medicines against cancer aiming for multiple product approvals in the coming years, and to expand and strengthen our sustainable respiratory infections disease vaccine business building on the success of our community franchise.

Uber: Our vision was realized and potent eliminating the potential of our science across our dock.

Uber: Our project areas.

Speaker Change: Anything on this.

Speaker Change: Three objectives moving forward.

Speaker Change: It's a multi product company.

Speaker Change: Backed by our pioneering.

Speaker Change: Tayo nearly technology and science to address medical needs right.

Ugur Sahin: To contribute to the development of innovative precision medicines against cancer, aiming for multiple product approvals in the coming years, and to expand and strengthen our sustainable respiratory infectious disease vaccine business, building on the success of our Comirnaty franchise. Slide 6. On the next slide, I want to talk about our clinical achievements in 2023. We successfully advanced our clinical pipeline and enhanced our technology platforms, digital capabilities, and infrastructure by executing across our key strategic initiatives. We continued to develop and empower our innovative oncology and infectious disease pipelines. Today, we have over 20 programs in oncology and 7 programs in infectious disease being evaluated in more than 40 clinical trials, including multiple phase 2 or phase 3 clinical trials. I'm particularly excited about our recent achievements in shaping our oncology pipeline. We started 7 clinical trials in licensed 6 clinical assets throughout the year.

Speaker Change: To contribute to the development of innovative position medicines against cancer aiming for America brick product approvals in the coming years.

Speaker Change: And to expand and strengthen our sustainable respiratory infectious disease vaccine business building on the success of our <unk> franchise slide.

Slide 6. On the next slide, I want to talk about our clinical achievements in 2023. We successfully advanced our clinical pipeline and enhanced our technology platforms, digital capabilities, and infrastructure by executing across our key strategic initiatives. We continue to develop and empower our innovative oncology and infectious disease pipeline.

Ugur Sahin: On the next slide, I want to talk about our clinical achievements in 2025. We successfully advanced our clinical pipeline and enhanced our technology platforms, digital capabilities, and infrastructure by executing across our key strategic initiatives. We continue to develop and empower our innovative oncology and infectious disease practice.

Speaker Change: Slide six on the next slide I want to talk about our clinical achievements incentive fee.

Speaker Change: We successfully advanced our clinical pipeline and enhance our technology platforms digital capabilities and infrastructure by executing across our key strategic initiatives, we continue to develop and empower our.

Speaker Change: Oncology and infectious disease.

Ugur Sahin: Today, we have over 20 programs in oncology and 7 programs in infectious disease being evaluated in more than 40 clinical trials, including multiple Phase II or Phase III clinical trials. I'm particularly excited about our recent achievements in shaping our oncology pipeline. We started seven clinical trials and in-licensed six clinical assets throughout the year. Most importantly, several assets have advanced to mid and late stage development with phase two and phase three clinical trials ongoing. These trials feature antibody drug conjugates, mRNA vaccines, and novel IOtherapies in indications such as non-strong cell lung cancer, breast and endometrial cancer, adjuvant colorectal cancer, and adjuvant pancreatic cancer.

Today, we have over 20 programs in oncology and 7 programs in infectious disease being evaluated in more than 40 clinical trials, including multiple Phase II or Phase III clinical trials.

Speaker Change: To date, we have over 20 programs in oncology and seven core continued infectious disease.

Speaker Change: And more than 40 clinical trials, including multiple phase two a phase III clinical trial.

I'm particularly excited about our recent achievements in shaping our oncology pipeline. We started 7 clinical trials, in-licensed 6 clinical assets throughout the year. Most importantly, several assets have advanced to mid-and late-stage development with Phase II and Phase III clinical trials ongoing. These task feature antibody drug conjugates, mRNA vaccines, and novel IO therapies in indications such as non-small cell lung cancer, breast and endometrial cancer, adjuvant colorectal cancer, and adjuvant pancreatic cancer.

Speaker Change: I'm, particularly excited about our recent achievements and shaping our oncology pipeline.

We started seven clinical class in license six clinical assets throughout the year.

Ugur Sahin: Most importantly, several assets have advanced to mid- and late-stage development with phase 2 and phase 3 clinical trials ongoing. These trials feature antibody-drug conjugates, mRNA vaccines, and novel IO therapies in indications such as non-small cell lung cancer, breast and endometrial cancer, adjuvant colorectal cancer, and adjuvant pancreatic cancer. In infectious disease, we started three first-in-human phase 1 clinical trials leveraging our proprietary mRNA vaccine technology, including candidates being evaluated against shingles, tuberculosis, and mpox. Over the course of 2024, we aim to advance and prioritize additional product candidates to late-stage development. We expect to have 10 or more potential registrational trials running. Slide seven. The field of oncology is currently undergoing a significant shift away from traditional chemotherapy towards combination therapies.

Speaker Change: Most importantly, several assets have advanced to mid and late stage development with phase two and phase three clinical trials.

Speaker Change: Okay.

Speaker Change: This feature.

Speaker Change: Future anti body drug conjugates ammonia vaccines and novel I O therapies in indications such as non small cell lung cancer.

Speaker Change: And endometrial cancer.

In colorectal cancer.

Speaker Change: Excellent contracted culture.

Ugur Sahin: In infectious disease, we started 3 first in human Phase I clinical trials, leveraging our proprietary mRNA vaccine technology, including candidates being evaluated against shingles, tuberculosis, and mpox. Over the course of 2024, we aim to advance and prioritize additional product candidates to late-stage development. We expect to have 10 or more potential regulation test running. Slide seven.

In infectious disease, we started 3 first in human Phase I clinical trials, leveraging our proprietary mRNA vaccine technology, including candidates being evaluated against shingles, tuberculosis, and mpox. Over the course of 2024, we aim to advance and prioritize additional product candidates to late-stage development. We expect to have 10 or more potential regulation trials running.

Speaker Change: In infectious disease, we started three first in human phase one clinical cross leveraging our proprietary mrna vaccine technology, including candidates being evaluated against juniors tuberculosis.

Speaker Change: Okay.

Speaker Change: Over the course of 'twenty, 'twenty, four and be able to advance and prioritize additional product candidates to late stage development.

Speaker Change: Back to have 10 or more potential rigorous pressure test.

Slide 7. The field of oncology is currently undergoing a significant shift away from traditional chemotherapy towards combination therapy. This shift leverages the power of immuno-oncology and antibody drug conjugates to potentially transform also advanced cancers into manageable conditions. As we reflect on the achievements of 2023, we can proudly say that we have accelerated our IO and ADC

Ugur Sahin: The field of oncology is currently undergoing a significant shift away from traditional chemotherapy towards combination therapy. This shift leverages the power of immuno-oncology and antibody drug conjugates to potentially transform even advanced cancers into manageable conditions. As we reflect on the achievements of 2023, we can proudly say that we have accelerated our I.O. and A.D.C.

Seven the fleet of Oncologist currently you end up going to a significant shift away from traditional Shannon therapy towards combination therapies.

Ugur Sahin: This shift leverages the power of immuno-oncology and antibody drug conjugates to potentially transform also advanced cancers into manageable conditions. As we reflect on the achievements of 2023, we can proudly say that we have accelerated our IO and ADC programs by not only starting new trials, but also successfully recruiting over 2,000 patients into our clinical trials across various indications. This is a testament to the hard work and dedication of our team and our collaboration partners, as well as the trust and willingness of patients to participate in our studies. Looking ahead to 2024, we aim to build on this success and recruit patients into our clinical trials across indications such as lung cancer, breast cancer, colorectal cancer, and other indications. Slide eight.

Speaker Change: This shifts literally just the power of immuno oncology and anti body drug conjugates to potentially transform also advance cancers.

As we reflect on the achievements of 2023, we can proudly say that we have accelerated our IO and ADC programs by not only starting new tasks but also successfully recruiting over 2,000 patients into our clinical trials across various indications. This is a testament to the hard work and dedication of our team and our collaboration partners, as well as the trust and willingness of patients to participate in our study. Looking ahead to 2024, we aim to build on this success and recruit patients into our clinical trials across indications such as lung cancer, breast cancer, colorectal cancer, and other indications. Slide 8.

Speaker Change: Manageable condition.

Speaker Change: We reflect on the achievements of 2023.

It can proudly say that we have accelerated our I O and ADC programs are not only starting to attack, but also successfully recruiting over 2000 patients.

Ugur Sahin: programs by not only starting new tasks but also successfully recruiting over 2,000 patients into our clinical trials across various indications. This is a testament to the hard work and dedication of our team and our collaboration partners, as well as the trust and willingness of patients to participate in our studies. Looking ahead to 2024, we aim to build on this success and recruit patients into our clinical trials across indications such as lung cancer, breast cancer, colorectal cancer, and other indications. Slide 8.

Speaker Change: Our clinical progress across various indications.

Speaker Change: This is a testament to the hard work and dedication of our team and our collaboration partners.

Speaker Change: It's the past and willingness of patients to participate in our studies.

Looking ahead to 2024, we aim to build on this success and recruit patients into our clinical trials across indications such as lung cancer, breast cancer, colorectal cancer, and other indications. Slide 8. In 2023, we successfully executed strategic investments, acquisitions, licensing agreements, and public-private partnerships, enabling our continued progress towards building a multi-product, AI-powered, patient-centric company. This is our foundation. We have placed a strong emphasis on computational medicine, data science, artificial intelligence, and machine learning. With the acquisition of InstaDeep, we are integrating capabilities in supercomputing, AI research, and generative AI into various processes, for example, to identify and optimize molecules, to predict biological and clinical outcomes, and to speed up our work. In 2023, we expanded our technology base to include ADCs by initiating new collaborations with reality bio and mediating therapy. We believe ADCs have the potential to supplement or replace highly toxic chemotherapy regimens as a new combination backbone of cancer treatment.

Looking ahead to 2024, we aim to build on this success and recruit patients into our clinical trials across indications such as lung cancer, breast cancer, colorectal cancer, and other indications.

Speaker Change: Looking ahead to 224 the into build on the success and recruit patients into our clinical trials across indications such as lung cancer breast cancer.

Speaker Change: Colorectal cancer and other indications.

Ugur Sahin: In 2023, we successfully executed strategic investments, acquisitions, licensing agreements, and public-private partnerships, enabling our continued progress towards building a multi-product, AI-powered, patient-centric company. This is our foundation. We have placed a strong emphasis on computational medicine, data science, artificial intelligence, and machine learning. With the acquisition of InstaDeep, we are integrating capabilities in supercomputing, AI research, and generative AI into various processes, for example, to identify and optimize molecules, to predict biological and clinical outcomes, and to speed up our work. In 2023, we expanded our technology base to include ADCs by initiating new collaborations with reality bio and mediating therapy. We believe ADCs have the potential to supplement or replace highly toxic chemotherapy regimens as a new combination backbone of cancer treatment.

Ugur Sahin: In 2023, we successfully executed strategic investments, acquisitions, licensing agreements, and public-private partnerships, enabling our continued progress towards building a multi-product, AI-powered, patient-centric company. Since our foundation, we have placed a strong emphasis on computational medicine, data science, artificial intelligence, and machine learning. With the acquisition of InstaDeep, we are integrating capabilities in supercomputing, AI research, and generative AI into various processes. For example, to identify and optimize molecules, to predict biological and clinical outcomes, and to speed up our workflows. In 2023, we expanded our technology base to include ADCs by initiating new collaborations with DualityBio and MediLink Therapeutics. We believe ADCs have the potential to supplement or replace highly toxic chemotherapy regimens as a new combination backbone of cancer treatment.

Slide 8. In 2023, we successfully executed strategic investments, acquisitions, licensing agreements, and public-private partnerships, enabling our continued progress towards building a multi-product, AI-powered patient-centric company. Since our foundation. We have placed a strong emphasis on computational medicine, data science, artificial intelligence, and machine learning. With the acquisition of InstaDeep, we are integrating capabilities in supercomputing, AI research, and generative AI into various processes, for example, to identify and optimize molecules, to predict biological and clinical outcomes, and to speed up our work. In 2023, we expanded our technology base to include ADCs by initiating new collaborations with reality bio and mediating therapy. We believe ADCs have the potential to supplement or replace highly toxic chemotherapy regimens as a new combination backbone of cancer treatment.

Speaker Change: Slide eight in 2023 we successfully executed the scar tissue investments accurate.

Speaker Change: Physician licensing agreements and public private partnerships, enabling our continued progress towards building a multi product AI powered patient centric company.

Since our foundation, we have placed a strong emphasis on computational medicine, data science, artificial intelligence, and machine learning. With the acquisition of InstaDeep, we are integrating capabilities in supercomputing, AI research, and generative AI into various processes, for example, to identify and optimize molecules, to predict biological and clinical outcomes, and to speed up our workflow. In 2023, we expanded our technology base to include ADCs by initiating new collaborations with DualityBio and MediLink Therapeutics. We believe ADCs have the potential to supplement or replace highly toxic chemotherapy regimens as a new combination backbone of cancer treatment.

Speaker Change: With our foundation.

Speaker Change: We placed a strong emphasis.

Speaker Change: Emphasis on computational medicine data science artificial intelligence and machine learning.

Speaker Change: The acquisition of instead.

Speaker Change: Adding capabilities and supercomputing, AI research and generative AI into various processes.

Speaker Change: So identifying optimized molecules to predict biological and clinical outcomes and to speed up our workflows.

Speaker Change: In 2023, we expanded our technology base to include Adcs by initiating new collaboration with quality tile and immediate incorporate the belief adcs has the potential to supplement or replace highly toxic chemotherapy regimen as a new combination backbone of cancer treatment.

Ugur Sahin: Our collaborations with OncoC4 and Biotheus complement our toolkit of technologies with next generation IO antibodies that offer unique mechanisms of action, and have augmented our oncology pipeline with mid to late-stage clinical programs. We have started strongly in 2024 on the collaboration front by announcing a strategic alliance with Autolus, aimed at advancing both companies' autologous CAR T-cell programs towards commercialization. With this collaboration, we will support the development and commercialization of Autolus' lead cell therapy candidate, obe-cel, and retain options to participate in its AUTO1/22 and AUTO6NG programs. Importantly, we have the option to use Autolus commercial and cell therapy manufacturing infrastructure in a cost-efficient manner. This is of relevance for our plans to extend the development of BNT211 to additional claudin-6-positive tumor types and thus realize its full potential. Slide nine. BNT211 is our CAR T-cell therapy targeting claudin-6.

Ugur Sahin: Our collaborations with OncoC4 and Biotheus complement our toolkit of technologies with next-generation IO antibodies that offer unique mechanisms of action and have augmented our oncology pipeline with mid-to-late-stage clinical programs. We started strongly in 2024 on the collaboration front by announcing a strategic alliance with Autolus aimed at advancing both companies' autologous CAR-T cell programs towards commercialization. With this collaboration, we will support the development and commercialization of Autolus lead cell therapy candidate or we sell and retain options to participate in its AUTO1/22 and AUTO6NG programs. Importantly, we have the option to use Autolus commercial and cell therapy manufacturing infrastructure in a cost-efficient manner. This is of relevance for our plans to extend the development of BNT211 to additional closing 6 positive tumor types and thus realize its full potential. Slide nine: BMT211 is our CAR T-cell therapy targeting clotens. To improve CAR-T cell engulfment and persistence, we co-developed a CAR-T cell amplifying RNA vaccine, or CARBAC, for short.

Our collaborations with OncoC4 and Biotheus complement our toolkit of technologies with next-generation IO antibodies that offer unique mechanisms of action and have augmented our oncology pipeline with mid-to-late-stage clinical programs. We started strongly in 2024 on the collaboration front by announcing a strategic alliance with Autolus aimed at advancing both companies' autologous CAR-T cell programs towards commercialization. With this collaboration, we will support the development and commercialization of Autolus lead cell therapy candidate or we sell and retain options to participate in its AUTO1/22 and AUTO6NG programs. Importantly, we have the option to use Autolus commercial and cell therapy manufacturing infrastructure in a cost-efficient manner. This is of relevance for our plans to extend the development of BNT211 to additional closing 6 positive tumor types and thus realize its full potential.

Speaker Change: Our collaborations with <unk> and Biofuels.

Speaker Change: Element of our toolkit of technologies with next generation Io anti bodies that offer unique mechanisms of action and that's complemented our oncology pipeline with mid to late stage clinical programs. We have started slowly in 2024 on the collaboration front by announcing a strategic alliances.

We started strongly in 2024 on the collaboration front by announcing a strategic alliance with Autolus aimed at advancing both companies' autologous CAR-T cell programs towards commercialization. With this collaboration, we will support the development and commercialization of Autolus lead cell therapy candidate or we sell and retain options to participate in its AUTO1/22 and AUTO6NG programs. Importantly, we have the option to use Autolus commercial and cell therapy manufacturing infrastructure in a cost-efficient manner. This is of relevance for our plans to extend the development of BNT211 to additional closing 6 positive tumor types and thus realize its full potential.

Speaker Change: Oculus aimed at advancing both companies' autologous car T cell programs towards commercialization.

Speaker Change: Collaborations and it will support the development and commercialization of autologous cell therapy candidate <unk> and retain options to participate in its auto.

Importantly, we have the option to use Autolus commercial and cell therapy manufacturing infrastructure in a cost-efficient manner. This is of relevance for our plans to extend the development of BNT211 to additional closing 6 positive tumor types and thus realize its full potential.

Speaker Change: 22, and <unk> six Mg programs.

Speaker Change: Importantly, we have the option to use autodesk commercially and cell therapy manufacturing infrastructure in a cost efficient manner.

Speaker Change: This is relevant for our plans to extend the development of BNP to 11, two additional coding six project of tumor types and gas realize its full potential.

Slide 9. BNT211 is our CAR T-cell therapy targeting Claudin-6. To improve CAR-T cell engagement and persistence, we co-developed a CAR-T cell amplifying RNA vaccine, or CARVac, for short. BNT-211 is one example of BioNTech's novel company. The goal is to enhance the persistence and effective function of CAR T-cell by repeated administration of CARVac. Recently, we presented data suggesting a favorable effect of CARVac on CAR-T cell persistence in our clinical trial with Claudin-6 tumor. Based on the promising early clinical results, we believe that BNT211 has the potential to make a significant impact in patients with Claudin-6 positive tumors. Our near-term strategy is to establish Claudin-6 as a proven target in solid tumors and to establish BNT211 as the first CAR-T cell therapy in gene cell tumors. Claudine Six, exposed

Speaker Change: Slide nine BMT to 11, as our car T cell therapy targeting six.

Ugur Sahin: To improve CAR T-cell engraftment and persistence, we co-developed a CAR T-cell amplifying RNA vaccine, or CARVac for short. BNT211 is one example of BioNTech's novel combination. The goal is to enhance persistence and effector function of CAR T-cells by repeated administration of CARVac. Recently, we presented data suggesting a favorable effect of CARVac on CAR T-cell persistence in our clinical trial with claudin-6 tumors. Based on the promising early clinical results, we believe that BNT211 has the potential to make a significant impact in patients with claudin-6-positive tumors. Our nearest term strategy is to establish claudin-6 as a proven target in solid tumors, and to establish BNT211 as the first CAR T-cell therapy in germ cell tumors. Claudin-6 is both expressed in solid cancers including ovarian, lung, gastric, pediatric cancers, and others.

Speaker Change: Six to improve car T cell and guardsman in persistence. The co developed a car T cell amplifying RNA vaccine or <unk> for short.

Ugur Sahin: BNT-211 is one example of BioNTech's novel novel. The goal is to enhance the persistence and effective function of CAR T-cells by repeated administration of CARB-I. Recently, we presented data suggesting a favorable effect of CARBAC on CAR T cell persistence in our clinical trial with Claudine's sixth tumor. Based on promising early clinical results, we believe that BNT211 has the potential to make a significant impact in patients with clotting-6 positive tumors. Our near-term strategy is to establish CHLORIN6 as a proven target in solid tumors and to establish BNT2-11 as the first CAR-T cell therapy in germ cell therapy. Claudine Six, exposed

Speaker Change: We entered 211 is one example of Biotics novel novel combination.

Speaker Change: The goal is to enhance the system.

Speaker Change: And effector function of car T cells by repeated administration of Capex.

Recently, we presented data suggesting a favorable effect of CARVac on CAR-T cell persistence in our clinical trial with Claudin-6 tumor. Based on the promising early clinical results, we believe that BNT211 has the potential to make a significant impact in patients with Claudin-6 positive tumors. Our near-term strategy is to establish Claudin-6 as a proven target in solid tumors and to establish BNT211 as the first CAR-T cell therapy in gene cell tumors.

Speaker Change: Recently, we presented data, suggesting a favorable set of cutback on car T cells.

Speaker Change: Our clinical trial start in six tumor.

Speaker Change: Based on the promising early clinical research, we believe that PMT to 11 has the potential to make a significant impact in patients with starting six positive tumors.

Our near-term strategy is to establish Claudin-6 as a proven target in solid tumors and to establish BNT211 as the first CAR-T cell therapy in gene cell tumors.

Speaker Change: Yes.

Speaker Change: <unk> strategy is to establish <unk> as a prudent target in solid tumor.

Speaker Change: Establish BB&T to 11.

Speaker Change: First car T cell therapy, and John cell tumors.

Claudin-6, is broadly expressed in solid cancers, including ovarian, lung, gastric, pediatric cancers, and others. Upcoming data will inform the development path for other tumor indications. Slide 10. In 2024, we will continue building a portfolio of compound classes that has been adjusted mechanisms of action, including immunomodulators targeted therapies, and mRNA vaccines. We believe that combination of these therapies, if approved, could play an important role in the effort towards potentially curative approaches. With that, I would like to thank you all for your confidence in our success and your continued support. I will now turn the call over to Ozlem, who will speak about our oncology pipeline. Thank you, Ugur. I'm glad to speak with everyone today.

Ugur Sahin: Chlorine 6 is broadly expressed in solid cancers, including ovarian, lung, gastric, pediatric cancers, and others. Coming data will inform the development path for other tumor indexes. Slide 10. In 2024, we will continue building a portfolio of compound classes that test the logistics mechanisms of action, including immunomodulators, targeted therapies, and mRNA vaccines. We believe that the combination of these therapies, if approved, could play an important role in the effort towards potentially curative approaches. With that, I would like to thank you all for your confidence in our success and your continued support. I will now turn the call over to Estan, who will speak about our on-call. Thank you, Ugur. I'm glad to speak with everyone today.

Speaker Change: Six I suppose.

Speaker Change: Clothing, six as both expressed in solid cancers, including ovarian lung gastric cancer and other <unk>.

Ugur Sahin: Upcoming data will inform the development path for other tumor indications. Slide 10. In 2024, we will continue building a portfolio of compound classes that have synergistic mechanisms of action, including immunomodulators, targeted therapies, and mRNA vaccines. We believe that combination of these therapies, if approved, could play an important role in the efforts towards potentially curative approaches. With that, I would like to thank you all for your confidence in our success and your continued support. I will now turn the call over to Özlem, who will speak about our oncology pipeline.

Speaker Change: Coming data would inform the development path for other tumor indications.

Speaker Change: Slide 10 in 2024, we will continue building our portfolio of compounds classes, that's been adjusted mechanisms of action, including immuno modulator targeted therapies in mrna vaccines. We believe the combination of these therapies.

With that, I would like to thank you all for your confidence in our success and your continued support. I will now turn the call over to Ozlem, who will speak about our oncology pipeline.

Speaker Change: <unk> could play an important role in the efforts towards potentially.

Speaker Change: With that I would like to thank you all for your confidence in our success and your continued support.

Speaker Change: Now ill turn the call over to the speaker.

Speaker Change: Speak about on currency pressure.

Özlem Türeci: Thank you, Ugur. Glad to be speaking with everyone today. Starting on slide 12 with an overview of our oncology pipeline. In 2023, we and our partners reported data across our portfolio at multiple medical meetings, including ASCO and ESMO, and we published manuscripts in peer-reviewed journals. More data readouts are expected this year, starting at AACR on BNT122, our individualized neoantigen-based cancer vaccine in ECHOVIN PDAC, and on BNT116, our off-the-shelf cancer vaccine in non-small cell lung cancer. In 2023, we advanced and expanded our pipeline considerably and now have multiple mid- to late-stage trials ongoing. Our aim is to continue to progress our oncology pipeline towards pivotal data readouts and submissions for regulatory approvals in the next 18 months. Slide 13. Here on the left are the ongoing trials in mid- to late-stage development.

Özlem Türeci: Thank you, Ugur. Glad to be speaking with everyone today.

Speaker Change: Thank you God can.

Speaker Change: Speaking with everyone today.

Ozlem Tureci: Starting on slide 12, with an overview of our oncology pipeline. In 2023, we and our partners reported data across our portfolio at multiple medical meetings, including ASCO and ESMO. And we published manuscripts in peer-reviewed journals. More data readouts are expected this year, starting at AACR on BNT122, our individualized neoantigen-based cancer vaccine in adjuvant PDAC, and on BNT116, our off-the-shell cancer vaccine in non-small cell lung cancer. In 2023, we advanced and expanded our pipeline considerably and now have multiple mid-to-late stage trials ongoing. Our aim is to continue to progress our oncology pipeline towards pivotal data readouts and submissions for regulatory approvals in the next 18 months. Slide 13.

Starting on slide 12, with an overview of our oncology pipeline. In 2023, we and our partners reported data across our portfolio at multiple medical meetings, including ASCO and ESMO. And we published manuscripts in peer-reviewed journals. More data readouts are expected this year, starting at AACR on BNT122, our individualized neoantigen-based cancer vaccine in adjuvant PDAC, and on BNT116, our off-the-shell cancer vaccine in non-small cell lung cancer. In 2023, we advanced and expanded our pipeline considerably and now have multiple mid-to-late stage trials ongoing. Our aim is to continue to progress our oncology pipeline towards pivotal data readouts and submissions for regulatory approvals in the next 18 months.

Speaker Change: Starting on slide 12, with an overview of our oncology pipeline in 2023.

Speaker Change: Our partners reported data across our portfolio at multiple medical meetings, including ethical and ethanol and we accomplished novelists correct and Prs mature more data readouts are expected this year starting at ACR on DMD 122, our NDA.

Speaker Change: Thank you life, new enrichment based cancer vaccine in actual than P duck.

Speaker Change: And on PMT 116, our off the shelf cancer vaccine and non small cell lung cancer.

In 2023, we advanced and expanded our pipeline considerably and now have multiple mid-to-late stage trials ongoing. Our aim is to continue to progress our oncology pipeline towards pivotal data readouts and submissions for regulatory approvals in the next 18 months.

Speaker Change: In 2023, we advanced and expanded our pipeline constant directly and now have multiple mentally interest trials ongoing.

Speaker Change: Our aim is to continue to progress our oncology pipeline to what does that sort of data readouts in submission for regulatory approval in the next 18 months.

Slide 13. Here on the left are the ongoing trials in mid-to-late stage development. The 3 on top of the list were initiated in 2023. BNT316, an anti-CTLA-4 antibody in IO experience non-small cell lung cancer, BNT323, an anti-HER2-low ADC in HER2-low breast cancer, and BNT122, our individualized cancer vaccine SCLC pancreatic cancer space. On the right are the product candidates based on ADC, IO, and mRNA cancer vaccine modalities for which we are planning to initiate additional Phase II and Phase III trials. These programs include validated and novel targets, as well as in-house and in-licensed assets with unique modes of action. We believe we have multiple shots on goal.

Ozlem Tureci: Here on the left are the ongoing trials in mid- to late-stage development. The three on top of the list were initiated in 2023. BNT316, an anti-CTLA-4 antibody in I.O.

Speaker Change: Yes.

Speaker Change: Scott for team here on the left are the ongoing trials in mid to late stage development. The three on top of their list were initiated in 2020.

Özlem Türeci: The three on top of the list were initiated in 2023. BNT316, an anti-CTLA-4 in IO-experienced non-small cell lung cancer. BNT323, an anti-HER2 ADC in HER2-low breast cancer, and BNT122, our individualized cancer vaccine in the adjuvant pancreatic cancer space. On the right are the product candidates based on ADC, IO, mRNA cancer vaccine modalities for which we are planning to initiate additional phase 2 and phase 3 trials. These programs include validated and novel targets, as well as in-house and in-licensed assets with unique modes of action. We believe we have multiple shots on goal. Our in-licensed assets are starting to contribute to value creation and towards de-risking our pipeline.

Speaker Change: At 2023 beyond Q3 16.

Speaker Change: TTM for an I O experience non small cell lung.

Ozlem Tureci: experience non-small cell lung cancer, BNT323, an anti-HER2-ABC in HER2-low breast cancer, and BNT122, an individualized cancer vaccine in excellent pancreatic cancer. On the right are the product candidates based on ADC, IOM, and RNA cancer vaccine modalities for which we are planning to initiate additional phase 2 and phase 3 trials. These programs include validated and novel targets, as well as in-house and in-licensed assets with unique modes of execution. We believe we have multiple shots at goal.

Speaker Change: Lung cancer BNP for you 23.

Speaker Change: <unk> heard to ABC in her 200 old breast cancer, and <unk> 1002, our individualized cancer vaccine.

On the right are the product candidates based on ADC, IO, and mRNA cancer vaccine modalities for which we are planning to initiate additional Phase II and Phase III trials. These programs include validated and novel targets, as well as in-house and in-licensed assets with unique modes of action.

Speaker Change: Excellent pancreatic cancer.

Speaker Change: Underwrite other product candidate based on ADC, I O and R&D cancer vaccine modalities for which we are planning to initiate additional phase two and phase III trials.

Speaker Change: These programs include validated and novel targets.

Speaker Change: In power and in license assets with unique mode of action.

We believe we have multiple shots on goal. Our in-licensed assets are starting to contribute to value creation and towards de-risking our pipeline. We plan to explore potential combination product candidates featuring these assets based on the scientific rationale, preclinical, and clinical evidence, and also thinking of future treatment sequencing in different indications to provide options for patients along their disease journey. As shown in slide 14, in 2023, we began building a pipeline of ADC candidates that now include third-generation ADCs directed against 4 distinct targets. These 4 targets collectively cover a wide range of cancer types.

Speaker Change: We believe we have multiple shots on goal in our in license assets.

Ozlem Tureci: Our in-licensed assets are starting to contribute to value creation and towards de-risking our pipeline. We plan to explore potential combination product candidates featuring these assets based on the scientific rationale, preclinical, and clinical evidence, and we are also thinking of future treatment sequencing in different indications to provide options for patients along their disease path. As shown in slide 14, in 2023, we began building a pipeline of ADC candidates that now include third-generation ADCs directed against four distinct targets. These four targets collectively cover a wide range of cancer types.

Speaker Change: Starting to contribute to value creation Antoine Derisking.

Özlem Türeci: We plan to explore potential combination product candidates featuring these assets based on the scientific rationale, preclinical and clinical evidence, and also thinking of future treatment sequencing in different indications to provide options for patients along their disease journey. As shown in slide 14, in 2023, we began building a pipeline of ADC candidates that now includes third generation ADCs directed against four distinct targets. These four targets collectively cover a wide range of cancer types. Our reason for adding this modality to our clinical multi-platform pipeline is that we believe ADCs will transform the oncology space and become broadly used backbones of combination treatment. Our strategy for acquiring these specific assets was based on their potentially differentiated profile, the objective of covering multiple cancer types, and the broad markets they may address. BNT323, a HER2-targeting ADC, is our most advanced ADC.

Speaker Change: We plan to explore potential combination product candidate featuring these assets based on that scientific rationale preclinical and clinical evidence.

Speaker Change: And also thinking of future treatments.

Speaker Change: And different indication to provide options for patients along that to Easter.

As shown in slide 14, in 2023, we began building a pipeline of ADC candidates that now include third-generation ADCs directed against 4 distinct targets. These 4 targets collectively cover a wide range of cancer types. Our reason for adding this modality to our clinical multi-platform pipeline is that we believe ADCs will transform the oncology space and become broadly used backbones of combination treatment. Our strategy for acquiring these specific assets was based on their potentially differentiated profiles, the objective of covering multiple cancer types, and the broad markets they may address. BNT323, a HER2-targeting ABC, is our most advanced and is also one of the frontrunners in our clinical path. Now on slide 15, BNT323 is a third-generation ADC that aims to overcome the drawbacks of first and second generation ADCs to achieve high stability in circulation, low risk of target payload delivery, a high drug-antibody ratio of eight, and an expanded therapeutic window. It is comprised of a humanized anti-HER2 IgG antibody covalently attached to a potent proprietary DNA-propoisomase 1 inhibitor via a stable maliomide tetrapeptide linker selectively cleavable by catapsins that are upregulated in humans. BNT323 binding to HER2 on the surface of tumor cells inhibits HER2 signaling, followed by internalization of the ADC HER2 receptor complex, cleavage of the linker, and release of the membrane's permeable payload.

Speaker Change: As shown on slide 14 in 2020 for you. We began building a pipeline of ADC candidates that now include Frac generation ADC directed against four distinct targets. These four targets collectively cover a wide range of cancer types or read them for ethane.

Ozlem Tureci: Our reason for adding this modality to our clinical multi-platform pipeline is that we believe ADCs will transform the oncology space and become widely used backbones of combination therapy. Our strategy for acquiring these specific assets was based on their potentially differentiated profiles, the objective of covering multiple cancer types, and the broad markets they may address. BNT323, a HER2-targeting ABC, is our most advanced and is also one of the frontrunners in our clinical path. Now on slide 15, BNT323 is a third-generation ADC that aims to overcome the drawbacks of first and second generation ADCs to achieve high stability in circulation, low risk of target payload delivery, a high drug-antibody ratio of eight, and an expanded therapeutic window. It is comprised of a humanized anti-HER2 IgG antibody covalently attached to a potent proprietary DNA-propoisomase 1 inhibitor via a stable maliomide tetrapeptide linker selectively cleavable by catapsins that are upregulated in humans. BNT323 binding to HER2 on the surface of tumor cells inhibits HER2 signaling, followed by internalization of the ADC HER2 receptor complex, cleavage of the linker, and release of the membrane's permeable payload.

Speaker Change: Thats mortality to Akshay nickel market platform pipeline is that we believe adcs will transform the oncology oncology space and become growth use backbone of combination treatment.

Our strategy for acquiring these specific assets was based on their potentially differentiated profiles, the objective of covering multiple cancer types, and the broad markets they may address. BNT323, a HER2-targeting ADC, is our most advanced ADC. It also one of the frontrunners in our clinical pipeline. Now on slide 15, BNT323 is a third-generation ADC that aims to overcome the drawbacks of first-and second-generation ADCs to achieve high stability in such relation, low risk of target halo delivery, a high drug-antibody ratio of 8, and an expanded therapeutic window. It is comprised of a humanized anti-HER2 IgG antibody covalently attached to a potent proprietary DNA-topoisomerase I inhibitor. We via a stable maleimide tetrapeptide linker selectively achievable by cathepsin that are operate regulated in tumor cell. BNT323 binding to HER2 on the surface of tumor cells inhibits HER2 signaling, followed by internalization of the ADC HER2 receptor complex, cleavage of the linker, and release of the membrane's permeable payload.

Speaker Change: Strategy for <unk>.

Speaker Change: <unk> lease specific assets was based on that potentially differentiated profile with the objective of covering multiple cancer subtypes and the growth markets. They may address BMT fleet 23 of her two targeting ADC is our most advanced ADC.

BNT323, a HER2-targeting ABC, is our most advanced and is also one of the frontrunners in our clinical path. Now on slide 15, BNT323 is a third-generation ADC that aims to overcome the drawbacks of first and second generation ADCs to achieve high stability in circulation, low risk of target payload delivery, a high drug-antibody ratio of eight, and an expanded therapeutic window. It is comprised of a humanized anti-HER2 IgG antibody covalently attached to a potent proprietary DNA-propoisomase 1 inhibitor via a stable maliomide tetrapeptide linker selectively cleavable by catapsins that are upregulated in humans. BNT323 binding to HER2 on the surface of tumor cells inhibits HER2 signaling, followed by internalization of the ADC HER2 receptor complex, cleavage of the linker, and release of the membrane's permeable payload.

Özlem Türeci: It also is one of the front runners in our clinical pipeline. Now on slide 15, BNT323 is a third generation ADC that aims to overcome the drawbacks of first and second generation ADCs to achieve high stability in circulation, low risk of target payload delivery, a high drug-antibody ratio of 8, and an expanded therapeutic window. It is comprised of a humanized anti-HER2 IgG antibody covalently attached to a potent proprietary DNA topoisomerase I inhibitor via a stable maleimide tetrapeptide linker, selectively cleavable by cathepsins that are up-regulated in tumor cells. BNT323 binding to HER2 on the surface of tumor cells inhibits HER2 signaling, followed by internalization of the ADC HER2 receptor complex, cleavage of the linker, and release of the membrane-permeable payload.

Speaker Change: <unk> is one of a front runner in our clinical pipeline.

Speaker Change: Now on slide 15, BMT free 23 infrastructure generates generation ADC that aims to overcome the drawbacks of first and second generation Adcs to achieve highest <unk> saturation.

Now on slide 15, BNT323 is a third-generation ADC that aims to overcome the drawbacks of first-and second-generation ADCs to achieve high stability in such relation, low risk of target halo delivery, a high drug-antibody ratio of 8, and an expanded therapeutic window. It is comprised of a humanized anti-HER2 IgG antibody covalently attached to a potent proprietary DNA-topoisomerase I inhibitor. We via a stable maleimide tetrapeptide linker selectively achievable by cathepsin that are operate regulated in tumor cell.

Speaker Change: Of targets payload delivery, a high drug antibody ratio of H and an expanded tier.

Speaker Change: Tariff biotech window. It is comprised of the humanized anti hurt to IGT anti bodies covalently attached to a potent proprietary DNA triple in summary, one inhibitor.

Speaker Change: Our stable <unk> tetra peptide linker selectivity team.

Speaker Change: Capex.

Speaker Change: Regulated into market.

BNT323 binding to HER2 on the surface of tumor cells inhibits HER2 signaling, followed by internalization of a ADC HER2 receptor complex, cleavage of the linker, and release of the membrane permeable payload. The effect is not only killing of these tumor cells but also bystander killing of neighboring tumor cells, regardless of their HER2 expression levels.

Speaker Change: BMT 323.

Speaker Change: Binding to hurt too on the surface of tumor <unk> inhibitor towards secondly, followed by internalization of the ADC. Her two receptor complex cleavage operating income and to release up from membrane permeability payloads. The effect not only kidding of these tumor cells, but also by spend.

Özlem Türeci: The effect is not only killing of these tumor cells, but also bystander killing of neighboring tumor cells, regardless of their HER2 expression levels. In preclinical studies with other third generation ADCs in animal models, BNT323 was observed to have higher stability, lower levels of free payload in circulation, and more efficient payload release within tumor cells, and stronger anti-tumor activity, including in HER2-low models. On slide 16 now, BNT323 is currently being evaluated in a signal-seeking phase 1/2 clinical trial for HER2-expressing advanced solid tumors. The dose expansion part of the phase 1/2 study is enrolling pre-treated patients with advanced or metastatic HER2-expressing solid tumors. As of February of this year, more than 300 patients have received BNT323 in this phase 1/2 trial. The first data from this study were presented at ASCO last year.

Ozlem Tureci: The effect is not only killing of these tumor cells but also bystander killing of neighboring tumor cells, regardless of their HER2 expression level. In preclinical studies with other third-generation ADCs in animal models, BNT323 was observed to have higher stability, lower levels of free payload and circulation, and more efficient payload release within tumor cells, and stronger anti-tumor activity, including in HER2-low model. On slide 16 now, BNT323 is currently being evaluated in a signal-seeking Phase I/II clinical trial for HER2-expressing advanced solid tumor. The dose expansion part of the Phase I/II study is enrolling pre-treated patients with advanced or metastatic HER2-expressing solid tumors. As of February of this year, more than 300 patients have received BNT323 in this Phase I/II trial. The first data from this study were presented at ASCO last year. We reported preliminary anti-tumor activity in heavily pretreated patients with HER2 express in solid tumors. Responses were observed in patients treated with different dose levels and with different HER2 expressions status.

The effect is not only killing of these tumor cells but also bystander killing of neighboring tumor cells, regardless of their HER2 expression level.

Hearing of neighboring bets, regardless of their <unk> two expression in preclinical studies with other first generation Adcs in animal models.

In preclinical studies with other third-generation ADCs in animal models, BNT323 was observed to have higher stability, lower levels of free payload and circulation, and more efficient payload release within tumor cells, and stronger anti-tumor activity, including in HER2-low model. On slide 16 now, BNT323 is currently being evaluated in a signal-seeking Phase I/II clinical trial for HER2-expressing advanced solid tumor. The dose expansion part of the Phase I/II study is enrolling pre-treated patients with advanced or metastatic HER2-expressing solid tumors. As of February of this year, more than 300 patients have received BNT323 in this Phase I/II trial. The first data from this study were presented at ASCO last year. We reported preliminary anti-tumor activity in heavily pretreated patients with HER2 express in solid tumors. Responses were observed in patients treated with different dose levels and with different HER2 expressions status.

Speaker Change: Beyond Q3, 'twenty free was observed to have highest stability lower levels of prepaid audience explanation and more assertion payloads rabies within two months from that anti tumor activity, including indirect hurdle.

On slide 16 now, BNT323 is currently being evaluated in a signal-seeking Phase I/II clinical trial for HER2-expressing advanced solid tumor. The dose expansion part of the Phase I/II study is enrolling pre-treated patients with advanced or metastatic HER2-expressing solid tumors. As of February of this year, more than 300 patients have received BNT323 in this Phase I/II trial. The first data from this study were presented at ASCO last year. We reported preliminary anti-tumor activity in heavily pretreated patients with HER2 express in solid tumors. Responses were observed in patients treated with different dose levels and with different HER2 expressions status.

Speaker Change: On slide 16, now BMT free to free is currently being evaluated in a signal seeking phase one two clinical trial cohort III expressing advanced tonnage.

Speaker Change: The dose expansion part of the <unk> study is enrolling pretreated patients with advanced or metastatic <unk> expressing solid tumor.

As of February of this year, more than 300 patients have received BNT323 in this Phase I/II trial. The first data from this study were presented at ASCO last year. We reported preliminary anti-tumor activity in heavily pretreated patients with HER2 express in solid tumors. Responses were observed in patients treated with different dose levels and with different HER2 expressions status. Based on our findings, in these dark green marked cohorts, on the right, we have initiated potentially registrational trials in patients with endometrial cancer and breast cancer.

Speaker Change: As of February of this year more than 300 patients have received <unk> hundred 23, and then it went to trial. The first data from this study were presented at ESMO last year, we reported preliminary antitumor activity in heavily pre treated.

Özlem Türeci: We reported preliminary anti-tumor activity in heavily pre-treated patients with HER2-expressing solid tumors. Responses were observed in patients treated with different dose levels and with different HER2 expression status. Based on our findings in these dark green marked cohort on the right, we have initiated potentially registrational trials in patients with endometrial cancer and breast cancer. On slide 17, in the breast cancer cohorts of our phase 1/2 trial, the 26 patients with HER2-positive cancer, which means high and intermediate levels of HER2 expression, showed an objective response rate of 50% and a disease control rate of 96.2%. The 13 patients with HER2-low breast cancer that have a particularly high medical need had an objective response rate of 38.5% and a disease control rate of 84.6%. BNT323 was observed to be well-tolerated and all adverse events were manageable.

Speaker Change: Patients with <unk> expressing solid tumor responses were observed in patients treated with different dose levels and with different tweaks question status.

Ozlem Tureci: Based on our findings in these dark green marked cohorts on the right, we have initiated potentially registrational trials in patients with endometrial cancer and breast cancer. On slide 17, in the breast cancer cohorts of our phase 1-2 trial, the 26 patients with HER2 positive cancer, which means high and intermediate levels of HER2 expression, showed an objective response rate of 50% and a disease control rate of 96.2%. The 13 patients referred to low-grade breast cancer that have a particularly high medical need had an objective response rate of 38.5% and a disease control rate of 84.5%. BNT-323 was observed to be well tolerated, and all adverse events were manageable. Interstitial lung disease of grade 1 occurred in 2 out of these 85 patients.

Based on our findings in these dark green marked cohorts on the right, we have initiated potentially registrational trials in patients with endometrial cancer and breast cancer.

Based on our findings in.

Speaker Change: These dot screen cohort on variety, we have initiated potentially registrational trial in patients with endometrial cancer and breast cancer.

On slide 17, in the breast cancer cohorts of our Phase I/II trial, the 26 patients with HER2 positive cancer, which means high and intermediate levels of HER2 expression, showed an objective response rate of 50% and a disease control rate of 96.2%. The 13 patients refer to a low breast cancer that have a particularly high medical need, had an objective response rate of 38.5% and a disease control rate of 84.6%. BNT323 was observed to be well tolerated, and all adverse events were manageable. Interstitial lung disease of Grade 1 occurred in 2 out of these 85 patients.

Speaker Change: On slide 17.

Speaker Change: In the breast cancer cohorts of our phase one two trial, but 26 patients with her two positive.

Speaker Change: Positive cancer, which means high and intermediate levels of Hercules expression showed an objective response rate of 50% and a disease control rate of 96, 2%. The 13 patients were firstly, so breast cancer that have a particular the high medical need.

Speaker Change: At an objective response rate of 38, 5% and the Dd's control a range of 84, 6% Yankee Free 20, <unk> was observed to be well tolerated and adverse events were manageable.

BNT323 was observed to be well tolerated, and all adverse events were manageable. Interstitial lung disease of Grade 1 occurred in 2 out of these 85 patients. Based on these data, we initiated a Phase III study of BNT323 in chemotherapy-naive patients with hormone receptor positive HER2-low breast cancer whose disease has progressed on prior endocrine therapy with or without CDK4/6 inhibition in the metastatic setting versus investigators' charge of chemotherapy. As shown in slide 18, in the U.S., the U.K., and the EU4 and Japan, approximately 700,000 patients per year are diagnosed with breast cancer. The majority of those achieve remission for territory of the initial therapy.

Özlem Türeci: Interstitial lung disease of grade 1 occurred in 2 out of these 85 patients. Based on these data, we initiated a phase 3 study of BNT323 in chemotherapy-naive patients with hormone receptor-positive HER2-low breast cancer, whose disease has progressed on prior endocrine therapy with or without CDK4/6 inhibition in the metastatic setting versus investigator's choice of chemotherapy. As shown in slide 18, in the US, the UK, the EU4, and Japan, approximately 700,000 patients per year are diagnosed with breast cancer. The majority of those achieve remission through surgery or the initial therapy. Those that do not get cured are being treated with hormonal and targeted therapies, and chemotherapy. First-generation HER2-targeting antibodies only benefited those 30% of patients with high or intermediate expression levels of HER2, designated as HER2-positive.

Speaker Change: It has been shown lung disease of great. One occurred in two out of these five patients.

Ozlem Tureci: Based on these data, we initiated a phase 3 study of BNT323 in chemotherapy-nave patients with hormone receptor positive HER2 low breast cancer whose disease has progressed on prior endocrine therapy with or without CDK4-6 inhibition in the metastatic setting versus investigators' choice of chemotherapy. As shown in slide 18, in the U.S., the U.K., and the E.U. In Japan, approximately 700,000 patients per year are diagnosed with breast cancer, and a majority of those achieve remission through surgery or the initial heuristic.

Speaker Change: Based on these data we initiated a phase III study of <unk> hundred 23, and chemotherapy naive patients with hormone receptor positive <unk> breast cancer, whose disease had progressed on prior endocrine therapy with Huawei.

Speaker Change: CDK four six inhibition in the metastatic setting, whereas this investigator's choice of chemotherapy.

As shown in slide 18, in the U.S., the U.K., and the EU4 and Japan, approximately 700,000 patients per year are diagnosed with breast cancer. The majority of those achieve remission for territory of the initial therapy. Those that do not get cured are being treated with hormonal and targeted therapies and chemotherapy.

Speaker Change: As shown on slide 18 in the U S. The UK and the EU for in Japan.

Speaker Change: <unk> 700000 patients per year are diagnosed with breast cancer majority also achieved remission for current street other initiatives here at.

Ozlem Tureci: Those that do not get cured are being treated with hormonal and targeted therapies and chemotherapy. First generations of HER2-targeting antibodies only benefited those 30% of patients with high or intermediate expression levels of HER2, designated as HER2-positive. More recently, patients with HER2 low expression that comprise two-thirds of the remaining 70 percent of breast cancer patients have been shown to benefit substantially from new generation HER2-targeted ADC therapy.

Those that do not get cured are being treated with hormonal and targeted therapies and chemotherapy.

Speaker Change: Those that do not get shoes are being treated with pulmonary and targeted therapies.

Speaker Change: Europes first generations of her two targeting antibody only benefited the strategy for percent of patients with high intermediate expression levels of her two designated experts with positive.

First generations of HER2-targeting antibodies only benefited those 30% of patients with high or intermediate expression levels of HER2, designated as HER2-positive. More recently, patients with HER2-low expression that comprise 2/3 of the remaining 70% percent of breast cancer patients have been shown to benefit substantially from new generation HER2-targeted ADC therapy.

Özlem Türeci: More recently, patients with HER2-low expression that comprise two-thirds of the remaining 70% breast cancer patients have been shown to benefit substantially from new-generation HER2-targeted ADC therapy. HER2-directed ADCs are currently only approved for chemotherapy-experienced patients, meaning from first-line onwards. In our ongoing phase 3 study, we are targeting chemo-naive patients from second-line onwards, as marked here in dark green. Slide 19. Coming back to our phase 1/2 trial and the findings in endometrial cancer patients with advanced recurrent or metastatic HER2-positive and HER2-low tumors. For endometrial cancer, we received Fast Track Designation and Breakthrough Designation from the FDA in 2023. In September 2023, clinical data from 17 patients with endometrial cancer were presented at the ASCO annual meeting. All patients had received one or more treatment lines, including immunotherapy, anti-HER2 antibody, or endocrine therapy.

Speaker Change: More recently patients with virtually no expression that comprise two thirds of.

Speaker Change: The remaining 17% breast cancer patients have been shown to benefit substantially from new generation virtual targeted.

Ozlem Tureci: Two directed ADCs are currently only approved for chemotherapy experienced patients, meaning from first line onward. In our ongoing phase 3 study, we are targeting chemo-naive patients from second line onwards, as marked here in dark. Slide 19.

HER2 directed ADCs are currently only approved for chemotherapy experienced patients, meaning from first-line onwards. In our ongoing Phase III study, we are targeting chemo-naive patients from second-line onwards, as marked here in dark green.

Speaker Change: <unk>.

Speaker Change: Towards directed Adcs are currently only approved drug chemotherapy.

Furious patients, meaning from <unk> nine onward.

Speaker Change: In our ongoing phase III study, we are targeting chemo naive patients from second line on what's esmark tier in dark green.

Slide 19. Coming back to our Phase I/II trial and the findings in endometrial cancer patients with advanced recurrent or metastatic HER2-positive or HER2-low, For endometrial cancer, we received fast-track designation and breakthrough designation from the FDA in 2023. In September 2023, clinical data from 17 patients with endometrial cancer were presented at the ASCO Annual Meeting. All patients had received 1 or more treatment lines, including immunotherapy, anti-HER2 antibody therapy, or endocrine therapy. BNT323 shows promising anti-tumor activity across different HER2 expression levels, including IHC1 plus expression, which is a low expression, with an objective response rate of 58.8%, of which 35.5% are pending confirmation. The disease control rate was 94.1%.

Ozlem Tureci: Coming back to our Phase 1-2 trial and the findings in endometrial cancer patients with advanced recurrent or metastatic HER2-positive or HER2-low, For endometrial cancer, we received fast-track designation and breakthrough designation from the FDA in 2023. In September 2023, clinical data from 17 patients with endometrial cancer were presented at the ESCO annual meeting. All patients received one or more treatment lines, including immunotherapy, anti-HER2 antibody therapy, or endocrine therapy. BNT323 shows promising anti-tumor activity across different HER2 expression levels, including IHC1 plus expression, which is a low expression, with an objective response rate of 58.8%, of which 35.5% pending consummation. The disease control rate was 94.1%.

Slide 19 coming back to our phase one trial at the timings in endometrial cancer patients with advanced recurrent or metastatic correctly positive and hard to note for.

Speaker Change: For endometrial cancer, we received fast track designation breakthrough designation from the FDA in 2023.

Speaker Change: In September 2023 clinical data from 17 patients with endometrial cancer were presented at the ESMO annual meeting odd patients have received one or more treatment times, including immunotherapy anti <unk>, two antibody or endocrine therapy beyond Q3 'twenty three.

Özlem Türeci: BNT323 shows promising antitumor activity across different HER2 expression levels, including IHC 1+ expression, which is low expression, with an objective response rate of 58.8%, of which 35.5% are pending confirmation. The disease control rate was 94.1%. While the sample size is still small and data cut-off is too early to draw conclusions on less frequent treatment-emergent adverse events and TEAEs with protracted manifestation, the safety profile was manageable and no new safety signals were observed. Slide 20. Patients with advanced, unresectable, or recurrent endometrial cancer receive treatment based on their molecular profile. The latest clinical data support adding immunotherapy to chemotherapy as a frontline treatment for patients with stage four endometrial cancer and dMMR status. Patients who overexpress HER2 can be treated with HER2-targeting therapies such as trastuzumab in combination with chemotherapy as a frontline treatment.

Speaker Change: <unk> showed promising anti tumor activity across different her two expression level, including IHT, one class expression, which is low expression with an objective response rate of 58, 8% of which purchased five 5% are pending.

BNT323 shows promising anti-tumor activity across different HER2 expression levels, including IHC1 plus expression, which is a low expression, with an objective response rate of 58.8%, of which 35.5% are pending confirmation. The disease control rate was 94.1%.

Speaker Change: Contamination.

Speaker Change: The disease control rate was 94, 1%.

Ozlem Tureci: While the sample size is still small and data cutoff is too early to draw conclusions on less frequent treatment emergent adverse events and TEAEs with protracted manifestations, the safety profile was manageable, and no new safety signals were observed. On Slide 20, patients with advanced, unrespectable, or recurrent endometrial cancer receive treatment based on their molecular profile. The latest clinical data support adding immunotherapy to chemotherapy as a front-line treatment for patients with stage 4 endometrial cancer and DMMR stage.

While the sample size is still small and data cutoff is too early to draw conclusions on less frequent treatment emergent adverse events and TEAEs with protracted manifestation, the safety profile was manageable, and no new safety signals were observed.

Speaker Change: I have a separate sciences smart and data cutoff, it's too early to draw conclusions on less frequent treatment emergent adverse events and <unk> east with protracted manifestation. The safety profile was manageable and no new safety signals were observed.

Speaker Change: So that's slide 20 patients with advanced Unresectable or recurrent endometrial cancer and treatment based on their molecular profile, but it Ain't just clinical data support adding immunotherapy to chemotherapy.

On Slide 20, patients with advanced, unresectable, or recurrent endometrial cancer receive treatment based on their molecular profile. The latest clinical data support adding immunotherapy to chemotherapy as a front-line treatment. Despite the recent advancements in first-line treatment, most patients relapse. At present, there is no targeted therapy approved for patients who progressed on first-line treatment and post-tumor expressed HER2. This is the patient population we are currently focusing on with the BNT323. Slide 21. I would like to reemphasize that our aim for 2024 is to further expand our key programs for into late-stage development with the aim of contributing to the next generation of oncology medicines that could include candidates featured on this slide. W patients with Stage 4 endometrial cancer and dMMR Stage. Patients who overexpress HER2 can be treated with HER2-targeting therapies, such as trastuzumab in combination with chemotherapy, as a frontline treatment. However, despite the recent advancements in frontline treatment, most patients relapse. At present, there is no targeted therapy approved for patients who progress on first-line treatment and who do not express their truth.

On Slide 20, patients with advanced, unresectable, or recurrent endometrial cancer receive treatment based on their molecular profile. The latest clinical data support adding immunotherapy to chemotherapy as a front-line treatment. Despite the recent advancements in first-line treatment, most patients relapse. At present, there is no targeted therapy approved for patients who progressed on first-line treatment and post-tumor expressed HER2. This is the patient population we are currently focusing on with the BNT323. Slide 21. I would like to reemphasize that our aim for 2024 is to further expand our key programs for into late-stage development with the aim of contributing to the next generation of oncology medicines that could include candidates featured on this slide. We believe our investments and efforts will pave the way for an initial wave of oncology product launches from 2026 onwards.

Speaker Change: As a frontline treatment for patients with stage four endometrial cancer and.

Slide 21. I would like to reemphasize that our aim for 2024 is to further expand our key programs for into late-stage development with the aim of contributing to the next generation of oncology medicines that could include candidates featured on this slide. We believe our investments and efforts will pave the way for an initial wave of oncology product launches from 2026 onwards.

Ozlem Tureci: Patients who overexpress HER2 can be treated with HER2-targeting therapies, such as trastuzumab in combination with chemotherapy, as a frontline treatment. However, despite the recent advancements in frontline treatment, most patients relapse. At present, there is no targeted therapy approved for patients who progress on first-line treatment and who do not express their truth.

Speaker Change: And our status patients to over expressed her tool can be treated with <unk> targeting therapies, such as trastuzumab in combination with chemotherapy as a frontline treatment.

patients with Stage 4 endometrial cancer and dMMR Stage. Patients who overexpress HER2 can be treated with HER2-targeting therapies, such as trastuzumab in combination with chemotherapy, as a frontline treatment. However, despite the recent advancements in frontline treatment, most patients relapse. At present, there is no targeted therapy approved for patients who progress on first-line treatment and who do not express their truth. This is the patient population we are currently focusing on with BNT323. Slide 21. I would like to reemphasize that our aim for 2024 is to further advance our key programs into late-stage development with the aim of contributing to the next generation of oncology medicines, which could include candidates featured on this slide. We believe our investments and efforts will pave the way for an initial wave of oncology product launches in 2026.

Özlem Türeci: Despite the recent advancements in frontline treatment, most patients relapse. At present, there is no targeted therapy approved for patients who progress on first-line treatment and whose tumors express HER2. This is the patient population we are currently focusing on with BNT323. Slide 21. I would like to re-emphasize that our aim for 2024 is to further advance our key programs into late-stage development with the aim of contributing to the next generation of oncology medicines that could include candidates featured on this slide. We believe our investments and efforts will pave the way for an initial wave of oncology product launches from 2026 onwards. I now pass the presentation to our CFO, Jens Holstein.

Tied to the recent advancements in frontline treatment most patients reading out.

Speaker Change: At present, there is no targeted therapy approved for patients who progressed on first line treatment.

Speaker Change: Whose tumors expressed expressed hurt this is a patient population. We are currently focusing on what's beyond Q.

Ozlem Tureci: This is the patient population we are currently focusing on with BNT323. Slide 21. I would like to reemphasize that our aim for 2024 is to further advance our key programs into late-stage development with the aim of contributing to the next generation of oncology medicines, which could include candidates featured on this slide. We believe our investments and efforts will pave the way for an initial wave of oncology product launches in 2026. I will now pass the presentation to our CFO, Jens Holstein. Thank you, Ozlem, and a warm welcome to everyone who has dialed in for today's call.

This is the patient population we are currently focusing on with BNT323. Slide 21. I would like to reemphasize that our aim for 2024 is to further advance our key programs into late-stage development with the aim of contributing to the next generation of oncology medicines, which could include candidates featured on this slide. We believe our investments and efforts will pave the way for an initial wave of oncology product launches in 2026.

Speaker Change: Two fleet.

Speaker Change: Slide 21, I would like to reemphasize that our aim for 2024 is to further advance our key programs into late stage development with the aim of contributing to the next generation of oncology medicine that could include candidates featured on this slide.

Speaker Change: We believe our investments and efforts with paper away for an initial wave of oncology product launches from 2026.

I will now pass the presentation to our CFO, Jens Holstein. Thank you, Ozlem, and a warm welcome to everyone who has dialed in for today's call.

I will now pass the presentation to our CFO, Jens Holstein.

Thank you, Ozlem, and a warm welcome to everyone who has dialed in today's call. 2023 was another successful year for BioNTech on its journey to develop novel therapies for cancer in its. Let me highlight three main points that kept our global COVID-19 vaccine market leadership. We grew and advanced our late-stage pipeline, and we again delivered a strong financial performance, highlighted by 3.8 billion euros of total recognized revenue and 1.2 billion euros of profit before tax, resulting in earnings per share on a fully diluted basis of 3.83 euros. With this, we ended the 2023 financial year with approximately €17.7 billion of cash, cash equivalents, and security investment. Turning to the next.

Jens Holstein: Thank you, Ozlem, and a warm welcome to everyone who has dialed in today's call.

Speaker Change: I'll now pass the presentation to our CFO.

Jens Holstein: Thank you, Özlem, and a warm welcome to everyone who has dialed in today's call. 2023 was another successful year for BioNTech on its journey to develop novel therapies for cancer and infectious diseases. Let me highlight three main points here. We kept our global COVID-19 vaccine market leadership. We grew and advanced our late-stage pipeline, and we again delivered a strong financial performance, highlighted by EUR 3.8 billion of total recognized revenues, EUR 1.2 billion of profit before tax, resulting in earnings per share on a fully diluted basis of EUR 3.83. With this, we ended the 2023 financial year with approximately EUR 17.7 billion of cash equivalents, and securities investments. Turning to the next slide.

Sure.

CFO: Thank you Liz Lange and a warm welcome to everyone who has dialed in todays call.

2023 was another successful year for BioNTech on its journey to develop novel therapies for cancer and infectious diseases. Let me highlight 3 main points here. We kept our global COVID-19 vaccine market leadership. We grew and advanced our late-stage pipeline. And we again, delivered a strong financial performance, highlighted by EUR 3.8 billion of total recognized revenue and EUR 1.2 billion of profit before tax, resulting in earnings per share on a fully diluted basis of EUR 3.83. With this, we ended the 2023 financial year with approximately EUR 17.7 billion of cash, cash equivalents, and security investment. Turning to the next.

Jens H. Holstein: 2023 was another successful year for BioNTech on its journey to develop novel therapies for cancer in its. Let me highlight three main points that kept our global COVID-19 vaccine market leadership. We grew and advanced our late-stage pipeline, and we again delivered a strong financial performance, highlighted by 3.8 billion euros of total recognized revenue and 1.2 billion euros of profit before tax, resulting in earnings per share on a fully diluted basis of 3.83 euros. With this, we ended the 2023 financial year with approximately €17.7 billion of cash, cash equivalents, and security investment. Turning to the next.

CFO: 2023 was another successful year for biotech on its journey to develop novel therapies for cancer and infectious diseases.

CFO: Let me highlight three main points here.

CFO: We kept our global COVID-19 vaccine market leadership.

CFO: Through an advanced our late stage pipeline and we again delivered a strong financial performance highlighted by $3 8 billion of total recognized revenues.

CFO: One 2 billion euros of profit before tax resulting in earnings per share on a fully diluted basis of three euro <unk> 83 years.

CFO: With this we ended the 2023 financial year was approximately $17 7 billion of cash cash equivalents and security investments.

Turning to the next slide. While our financial performance in 2023 was strong, and we were able to maintain profitability, there were also some financial challenges that we had to navigate through. In our third-quarter earnings call last year, we updated our full-year 2023 COVID-19 vaccine revenue guidance to around EUR 4 billion, reflecting write-downs in the amount of approximately EUR 600 million by our collaboration partner Pfizer. In Q4, Pfizer recognized additional write-downs of approximately 300 million euros that negatively impacted our top line figure compared to our initial expectations. The negative impact on our revenue for 2023 accumulated to a total of approximately 900 million euros. Write-downs related to EG inventory would typically have a negative impact on the gross profit in the P&L.

Turning to the next slide.

Jens H. Holstein: While our financial performance in 2023 was strong, and we were able to maintain profitability, there were also some financial challenges that we had to live with. In our third-quarter earnings call last year, we updated our full-year 2023 COVID-19 vaccine revenue guidance to around €4 billion, reflecting write-downs in the amount of approximately €600 million by our collaboration partner Pfizer. In Q4, Pfizer recognized additional write-downs of approximately 300 million euros that negatively impacted our top line figure compared to our initial expectations. The negative impact on our revenue for 2023 accumulated to a total of approximately 900 million euros. Write-downs related to EG inventory would typically have a negative impact on the gross profit in the P&L.

Jens Holstein: While our financial performance in 2023 was strong and we were able to maintain profitability, there were also some financial challenges that we had to navigate through. In our Q3 earnings call last year, we updated our full-year 2023 COVID-19 vaccine revenue guidance to around EUR 4 billion, reflecting write-downs in the amount of approximately EUR 600 million by our collaboration partner, Pfizer. In Q4, Pfizer recognized additional write-downs of approximately EUR 300 million that negatively impacted our top line figure compared to our initial expectations for Q4. The negative impact on our revenue for 2023 accumulated to a total of approximately -EUR 900 million. Write-downs related to aged inventory would typically have a negative impact on the gross profit in a P&L.

CFO: While our financial performance in 2023 was strong and we were able to maintain profitability. There are also some financial challenges that we had to navigate.

CFO: In our third quarter earnings call last year, we updated our full year 2023, COVID-19 vaccine revenue guidance to around $4 billion, reflecting write downs in the amount of approximately 600 million euros by our collaboration partner <unk>.

In Q4, Pfizer recognized additional write-downs of approximately EUR 300 million that negatively impacted our top-line figure compared to our initial expectations. The negative impact on our revenue for 2023 accumulated to a total of approximately EUR 900 million. Write-downs related to EG inventory would typically have a negative impact on the gross profit in the P&L.

CFO: In Q4, Pfizer recognized additional write downs of approximately 300 million.

CFO: That negatively impacted our top line figure compared to our initial expectations for Q4.

CFO: The negative impact on our revenue for 2023 accumulated to a total of approximately 900 million euros.

CFO: Write downs related to EG inventory, which typically have a negative impact on the gross profit in our P&L.

Jens Holstein: Following our gross profit share agreement for Pfizer, write-downs by our partner have a negative effect on BioNTech's revenue figure that made our revenue guidance for 2023 challenging. Having said that, the agreement has an important advantage. BioNTech only requires very little commercial infrastructure in the COVID-19 vaccine franchise, and with this has low expenses related to sales and marketing in comparison to other players in the field. This is, we believe, favorable as Comirnaty is a leading brand in the global COVID-19 vaccine market. Despite the decrease in our revenues in 2023 and despite the negative impact of these write-downs, we were able to both remain profitable in 2023 and grew our year-end financial position in respect of cash equivalents, and security investments to EUR 17.7 billion compared to EUR 13.9 billion at the end of 2022.

Jens H. Holstein: Following our gross profit share agreement for Pfizer, write-downs by our partner have a negative effect on BioNTech's revenue figure. That made our revenue guidance for 2023 challenging. Having said that, the agreement has an important advantage. BioNTech only requires very little commercial infrastructure in the COVID-19 vaccine franchise, and with this, it has low expenses related to sales and marketing in comparison to other players in this field. This is, we believe, favorable as COMIRNATY is the leading brand in the global COVID-19 vaccine market. Despite the decrease in our revenues in 2023 and despite the negative impact of these write-downs, we were able to both remain profitable in 2023 and grow our year-end financial position in respect of cash, cash equivalents, and security investments to EUR 17.7 billion compared to EUR 13.9 billion at the end of 2020. Please note that the contractual settlement of the gross profit share has a temporal offset of more than one calendar quarter. In addition, Pfizer's financial quarter for the subsidiaries outside the United States differs from ours.

Following our gross profit share agreement for Pfizer, write-downs by our partner have a negative effect on BioNTech's revenue figure. That made our revenue guidance for 2023 challenging. Having said that, the agreement has an important advantage. BioNTech only requires very little commercial infrastructure in the COVID-19 vaccine franchise, and with this, it has low expenses related to sales and marketing in comparison to other players in this field. This is, we believe, favorable as COMIRNATY is the leading brand in the global COVID-19 vaccine market.

CFO: Following our gross profit check waiting for further write downs by our partner have a negative effect on <unk> revenues you got it.

That made our revenue guidance for 2023 challenging.

CFO: Having said that the agreement has an important advantage.

CFO: <unk> only requires very little commercial infrastructure, and our COVID-19 vaccine franchise and with this has low expenses relates to sales and marketing in comparison to other players in the field. This is we believe favorable as <unk> is a leading brand in the global COVID-19 vaccine market.

Despite the decrease in our revenues in 2023 and despite the negative impact of these write-downs, we were able to both remain profitable in 2023 and grow our year-end financial position in respect of cash, cash equivalents, and security investments to EUR 17.7 billion compared to EUR 13.9 billion at the end of 2020. Please note that the contractual settlement of the gross profit share has a temporal offset of more than one calendar quarter. In addition, Pfizer's financial quarter for the subsidiaries outside the United States differs from ours.

CFO: Despite the decrease in our revenues in 2023 and despite the negative impact of these write downs, we were able to both remained profitable in 2023 and through our year end financial position in respect of cash cash equivalents and security investments to $17 7 billion euros compared to $13 9 billion euros.

At the end of 2022.

Jens Holstein: Please note that the contractual settlement of the gross profit share has a temporal offset of more than one calendar quarter. In addition, Pfizer's financial quarter for the subsidiaries outside the United States differs from ours. I'll be moving now to the summary of our financial results for Q4 2023 and full year 2023, as shown on the next slide. For the three months ended 31 December 2023, we recognized EUR 1.5 billion in COVID-19 vaccine revenues, compared to EUR 4.3 billion for the comparative period in 2022. For the financial year 2023, our total reported revenues reached EUR 3.8 billion compared to EUR 17.3 billion in 2022.

Please note that the contractual settlement of the gross profit share has a temporal offset of more than one calendar quarter. In addition, Pfizer's financial quarter for the subsidiaries outside the United States differs from ours.

CFO: Please note that the contractual settlement of our gross profit share has temporarily offset of more than one calendar quarter.

CFO: In addition, Pfizer financial quarter for the subsidiaries outside the United States differs from malls.

Jens H. Holstein: I'll be moving now to the summary of our financial results for the fourth quarter of 2023 and full year of 2023, as shown on the next slide. For the 3 months ended December 31st, 2023, we recognized EUR 1.5 billion in COVID-19 vaccine revenues compared to EUR 4.3 billion for the comparative period in 2020. For the financial year 2023, our total reported revenues reached EUR 3.8 billion compared to EUR 17.3 billion in 2022. This was primarily driven by lower COVID-19 vaccine market demand and as stated before, write-downs reported by our collaboration partner, Pfizer, which negatively influenced our revenues. Moving to cost of sales. Cost of sales amounted to EUR 179 million in the fourth quarter of 2023, in line with the EUR 183.5 million for the comparative prior year period.

I'll be moving now to the summary of our financial results for the fourth quarter of 2023 and full year of 2023, as shown on the next slide. For the 3 months ended December 31st, 2023, we recognized EUR 1.5 billion in COVID-19 vaccine revenues compared to EUR 4.3 billion for the comparative period in 2020.

Speaker Change: I'll be moving now to the summary of our financial results for the fourth quarter of 2023 and full year of 2023 as shown on the next slide.

Speaker Change: For the three months ended December 31, 2020 free we recognized $1 5 billion euros, and COVID-19 vaccine revenues compared to $4 3 billion for the comparative period in 2022.

For the financial year 2023, our total reported revenues reached EUR 3.8 billion compared to EUR 17.3 billion in 2022. This was primarily driven by lower COVID-19 vaccine market demand and as stated before, write-downs reported by our collaboration partner, Pfizer, which negatively influenced our revenues. Moving to cost of sales. Cost of sales amounted to EUR 179 million in the fourth quarter of 2023, in line with the EUR 183.5 million for the comparative prior year period.

Speaker Change: Yeah.

Speaker Change: For the financial year 2023, our total reported revenues reached $3 8 billion euros compared to $17 3 billion euros. In 2022. This was primarily driven by lower COVID-19 vaccine market demand and as stated before write downs reported by our collaboration partner Pfizer, which neck.

Jens Holstein: This was primarily driven by lower COVID-19 vaccine market demand and, as stated before, write-downs reported by our collaboration partner, Pfizer, which negatively influenced our revenues. Moving to cost of sales. Cost of sales amounted to EUR 179 million in Q4 2023, in line with the EUR 183.5 million for the comparative prior year period. For the 2023 financial year, the cost of sales amounted to close to EUR 600 million, compared to approximately EUR 3 billion in 2022. The drop was mainly caused by the decrease in COVID-19 vaccine sales. Research and development expenses reached EUR 578 million for Q4 2023, compared to EUR 510 million for the comparative period in 2022.

Moving to cost of sales. Cost of sales amounted to EUR 179 million in the fourth quarter of 2023, in line with the EUR 183.5 million for the comparative prior year period. For the 2023 financial year, the cost of sales amounted to close to EUR 600 million, compared to approximately EUR 3 billion in 2022. The drop was mainly caused by a decrease in COVID-19 vaccine sales.

Speaker Change: <unk> influenced our revenues.

Speaker Change: Moving to cost of sales.

Speaker Change: Cost of sales amounted to $179 million in the fourth quarter of 2023 in line with the $183 5 million for the comparative prior year period.

Jens H. Holstein: For the 2023 financial year, the cost of sales amounted to close to EUR 600 million, compared to approximately EUR 3 billion in 2022. The drop was mainly caused by a decrease in COVID-19 vaccine sales. Research and development expenses reached EUR 578 million for the fourth quarter of 2023, compared to EUR 510 million for the comparative period in 2022. For the 2023 financial year, research and development expenses amounted to approximately EUR 1.8 billion compared to EUR 1.5 billion in 2022. The increase was mainly influenced by progressing clinical studies for pipeline candidates, as well as by our newly acquired product candidates and the development of variant-adapted COVID-19 vaccines. In line with a higher headcount compared to the previous year to--for example, support our existing clinical trials and future growth initiatives, we also saw respective higher costs in wages, benefits, and social security expenses in the financial year 2023.

For the 2023 financial year, the cost of sales amounted to close to EUR 600 million, compared to approximately EUR 3 billion in 2022. The drop was mainly caused by a decrease in COVID-19 vaccine sales. Research and development expenses reached EUR 578 million for the fourth quarter of 2023, compared to EUR 510 million for the comparative period in 2022. For the 2023 financial year, research and development expenses amounted to approximately EUR 1.8 billion compared to EUR 1.5 billion in 2022. The increase was mainly influenced by progressing clinical studies for pipeline candidates, as well as by our newly acquired product candidates and the development of variant-adapted COVID-19 vaccines.

Speaker Change: For the 2023 financial year, the cost of sales amounted to close to 600 million euros compared to approximately 3 billion euros in 2022.

Speaker Change: The drop was mainly caused by the decrease in COVID-19 vaccine sales.

Speaker Change: Research and development expenses reached 578 million for the fourth quarter of 2023 compared to 510 million euros for the comparative period in 2022.

Research and development expenses reached EUR 578 million for the fourth quarter of 2023, compared to EUR 510 million for the comparative period in 2022. For the 2023 financial year, research and development expenses amounted to approximately EUR 1.8 billion compared to EUR 1.5 billion in 2022. The increase was mainly influenced by progressing clinical studies for pipeline candidates, as well as by our newly acquired product candidates and the development of variant-adapted COVID-19 vaccines.

Jens Holstein: For the 2023 financial year, research and development expenses amounted to approximately EUR 1.8 billion, compared to EUR 1.5 billion in 2022. The increase was mainly influenced by progressing clinical studies for pipeline candidates, as well as by our newly acquired product candidates and the development of variant-adapted COVID-19 vaccines. In line with a higher headcount compared to the previous year to, for example, support our existing clinical trials and future growth initiatives, we also saw respective higher costs in wages, benefits, and social security expenses in the financial year 2023. General and administrative expenses amounted to approximately EUR 0.1 billion for both the Q4 2023 as well as for the comparative period in 2022.

Speaker Change: For the 2023 financial year research and development expenses amounted to approximately $1 8 billion euros compared to $1 5 billion euros in 2022.

For the 2023 financial year, research and development expenses amounted to approximately EUR 1.8 billion compared to EUR 1.5 billion in 2022. The increase was mainly influenced by progressing clinical studies for pipeline candidates, as well as by our newly acquired product candidates and the development of variant-adapted COVID-19 vaccines.

Speaker Change: The increase was mainly influenced by progressing clinical studies for pipeline candidates as well as by our newly acquired product candidates and the development of variant adaptive COVID-19 vaccines.

Speaker Change: In line with the higher head count compared to the previous year to for example to support our existing clinical trials and future growth initiatives. We also saw respective higher costs in wages benefits and social security expenses in the financial year 2023.

Speaker Change: General and administrative expenses amounted to approximately $1 1 billion for both the fourth quarter of 2023 as well as for the comparative period in 2022.

In line with a higher headcount compared to the previous year to--for example, support our existing clinical trials and future growth initiatives, we also saw respective higher costs in wages, benefits, and social security expenses in the financial year 2023.

Jens Holstein: For the 2023 financial year, general and administrative expenses remained at EUR 0.5 billion, around the same level as in the previous year. The slight increase in G&A was mainly influenced by increased expenses for IT services as well as by wages, benefits, and social security expenses resulting from an increase in headcount. Income taxes were accrued with an amount of EUR 205.3 million for Q4 2023, compared to EUR 893.9 million for the comparative period in 2022. For the 2023 financial year, income taxes were accrued with an amount of EUR 255.8 million compared to EUR 3.5 billion in 2022.

Speaker Change: For the 2023 financial year General and administrative expenses remained at <unk> 5 billion euros around the same level as in the previous year, a slight increase in G&A was mainly influenced by increased expenses for it services as well as by wages benefits and social security expenses, resulting from an increase.

Jens H. Holstein: General and administrative expenses amounted to approximately EUR 0.1 million for both the fourth quarter of 2023 as well as for the competitive period in 2022. For the 2023 financial year, general and administrative expenses remained at around EUR 0.5 billion, around the same level as in the previous year. The slight increase in G&A was mainly influenced by increased expenses for IT services, as well as by wages, benefits, and social security expenses, resulting from an increase in income. Income taxes were accrued at an amount of EUR 205.3 million for the fourth quarter of 2023 compared to EUR 893.9 million for the comparative period in 2022. For the 2023 financial year, income taxes were accrued with an amount of EUR 255.8 million compared to EUR 3.5 billion in 2022.

General and administrative expenses amounted to approximately EUR 0.1 million for both the fourth quarter of 2023 as well as for the competitive period in 2022. For the 2023 financial year, general and administrative expenses remained at around EUR 0.5 billion, around the same level as in the previous year. The slight increase in G&A was mainly influenced by increased expenses for IT services, as well as by wages, benefits, and social security expenses, resulting from an increase in income.

Speaker Change: And head count.

Speaker Change: Income taxes accrued with an amount of $205 3 million for the fourth quarter of 2023 compared to $893 9 million for the comparative period in 2022.

Speaker Change: For the 2023 financial year income taxes were approved with an amount of $255 8 million compared to $3 5 billion in 2022.

Jens Holstein: The derived effective income tax rate for the 2023 financial year was 21.6%, roughly in line with our expectations of around 21%, improved versus last year's tax rate of 27%. For Q4 2023, net profit reached EUR 457.9 million compared to EUR 2.3 billion in the comparative period in 2022. For the year ended 31 December 2023, net profit reached EUR 0.9 billion compared to EUR 9.4 billion in 2022. Our diluted earnings per share for Q4 2023 amounted to EUR 1.90, compared to EUR 9.26 for the comparative period in 2022.

Speaker Change: The derived effective income tax rate for the 2023 financial year was 21, 6% roughly in line with our expectations of around 21% improved versus last year's tax rate of 27%.

Speaker Change: For the fourth quarter of 2023, net profit reached $457 9 million compared to $2 3 billion in the comparative period in 2022.

Income taxes were accrued at an amount of EUR 205.3 million for the fourth quarter of 2023 compared to EUR 893.9 million for the comparative period in 2022. For the 2023 financial year, income taxes were accrued with an amount of EUR 255.8 million compared to EUR 3.5 billion in 2022. The derived effective income tax rate for the 2023 financial year was 21.6%, roughly in line with our expectations of around 21%, improved versus last year's tax rate of 27%.

Speaker Change: For the year ended December 31, 2023, net profit reached <unk> 9 billion compared to $9 4 billion to 2022.

Speaker Change: Our diluted earnings per share for the fourth quarter of 2023 amounted to one year or 90 euro cents compared to nine years of 26 zero cents for the comparative period in 2022.

Jens Holstein: For the 2023 financial year, our diluted earnings per share amounted to EUR 3.83 compared to EUR 37.77 in 2022. Let's continue with the next slide. This shows the 2023 financial guidance provided to you during our Q3 earnings call in November 2023, in comparison with the actuals for the 2023 financial year. Starting from the top, we recognized EUR 3.8 billion of COVID-19 vaccine revenues compared to our guidance of around EUR 4 billion. Approximately EUR 300 million additional write-downs by our collaboration partner had to be unexpectedly recognized in Q4. Moving to R&D expenses. During the 2023 financial year, our R&D expenses were nearly EUR 1.8 billion, slightly below our amended guidance from November 2023 of EUR 1.82 billion.

Speaker Change: For the 2023 financial year.

Jens H. Holstein: The derived effective income tax rate for the 2023 financial year was 21.6%, roughly in line with our expectations of around 21%, although improved versus last year's tax rate of $27. For the fourth quarter of 2023, net profit reached 457.9 million euros, compared to 2.3 billion euros in the comparative period of 2020. For the year ended December 31st, 2023, net profit reached 0.9 billion euros, compared to 9.4 billion euros in 2020. Our diluted earnings per share for the fourth quarter of 2023 amounted to €1.90, compared to €9.26 for the competitive period in 2022. For the 2023 financial year,

The derived effective income tax rate for the 2023 financial year was 21.6%, roughly in line with our expectations of around 21%, although improved versus last year's tax rate of $27.

Speaker Change: Diluted earnings per share amounted to three euros, an 83 year of cents compared to <unk> 37 year olds and 77 years in 2022.

Speaker Change: Let's continue with the next slide.

Speaker Change: It shows that 2023 financial guidance provided during our Q3 earnings call in November 2023 in comparison with the actuals for the 2023 financially.

For the fourth quarter of 2023, net profit reached EUR 457.9 million, compared to EUR 2.3 billion in the comparative period of 2022. For the year ended December 31st, 2023, net profit reached EUR 0.9 billion, compared to EUR 9.4 billion in 2022. Our diluted earnings per share for the fourth quarter of 2023 amounted to EUR 1.90, compared to EUR 9.26 for the competitive period in 2022. For the 2023 financial year,

Speaker Change: Starting from the top.

Speaker Change: We recognized $3 8 billion euros of COVID-19 vaccine revenues compared to our guidance of around 4 billion euros.

Speaker Change: Approximately 300 million euros additional write downs by our collaboration partner had to be unexpectedly recognized in Q4.

Speaker Change: Moving to R&D expenses during the 2023 financial year R&D expenses were nearly $1 8 billion slightly below our amended guidance from November of 2023, a 182 billion euros.

Jens Holstein: Lower spending in, for example, all our collaborations have been a main contributor as well as strong cost control measures. Our core R&D activities in 2023 focused on broadening and accelerating our existing pipeline of product candidates in oncology and infectious diseases in line with our expectations. Moving to SG&A expenses. During the 2023 financial year, we recognized EUR 558 million in SG&A expenses, slightly below the lower end of our amended guidance of EUR 600 to 650 million. Again, we were closely monitoring our spending to reflect the uncertainty on the revenues without jeopardizing the future needs in this area. Moving to CapEx. Our 2023 financial year capital expenditures for operating activities amounted to EUR 276 million, whereof the majority was related to investment in building our laboratory and office facilities in Mainz, Germany.

Speaker Change: No our spending in for example, other collaborations have been the main contributor as well as strong cost control measures.

Speaker Change: Our core R&D activities in 2023 focused on broadening and accelerating our existing pipeline of product candidates in oncology and infectious diseases in line with our expectations.

For the 2023 financial year, our diluted earnings per share amounted to EUR 3.83 compared to EUR 37.77 in 2022. Let's continue with the next slide. This shows the 2023 financial guidance provided to you during our Q3 earnings call in November 2023 in comparison with the actuals for the 2023 financial year. Starting from the top. We recognized 3.8 billion euros of COVID-19 vaccine revenues compared to our guidance of around 4 billion euros. Additionally, approximately 300 million euros additional write-downs by our collaboration partner had to be unexpectedly recognized. Moving to R&D. During the 2023 financial year, our R&D expenses were nearly 1.8 billion euros, slightly below our amended guidance from November of 2023 of 1.8 to the linear. NOAA spending on, for example, oil collaborations has been a main contributor, as well as strong cost control measures.

For the 2023 financial year, our diluted earnings per share amounted to EUR 3.83 compared to EUR 37.77 in 2022.

Jens H. Holstein: Our diluted earnings per share amounted to €3.83 compared to €37.77 in 2022. Now, let's continue with the next slide. This shows the 2023 financial guidance provided to you during our Q3 earnings call in November 2023 in comparison with the actuals for the 2023 financial year, starting from the top. We recognized 3.8 billion euros of COVID-19 vaccine revenues compared to our guidance of around 4 billion euros. Additionally, approximately 300 million euros additional write-downs by our collaboration partner had to be unexpectedly recognized. Moving to R&D. During the 2023 financial year, our R&D expenses were nearly 1.8 billion euros, slightly below our amended guidance from November of 2023 of 1.8 to the linear. NOAA spending on, for example, oil collaborations has been a main contributor, as well as strong cost control measures.

Speaker Change: Moving to SG&A expenses.

Let's continue with the next slide. This shows the 2023 financial guidance provided to you during our Q3 earnings call in November 2023 in comparison with the actuals for the 2023 financial year.

Speaker Change: During the 2023 financial year, we recognized 558 million and SG&A expenses slightly below the lower end of our amended guidance of $600 million to $650 million.

Speaker Change: Again, we were closely monitoring monitoring our spending to reflect the uncertainty on the revenues without jeopardizing the future needs in this area.

Starting from the top. We recognized EUR 3.8 billion of COVID-19 vaccine revenues compared to our guidance of around EUR 4 billion. Approximately EUR 300 million additional write-downs by our collaboration partner had to be unexpectedly recognized in Q4. Moving to R&D expenses. During the 2023 financial year, our R&D expenses were nearly EUR 1.8 billion, slightly below our amended guidance from November of 2023 of EUR 1.82 billion. Lower spending in, for example, our collaborations has been a main contributor, as well as strong cost control measures.

Speaker Change: Moving to Capex, our 2023 financial year capital expenditures for operating activities amounted to 276 million years. We're off the majority was related to investments in building, our laboratory and office facilities in Mainz, Germany.

Jens Holstein: The spending is in line with our expectations, ranging from EUR 200 to 300 million. Lastly, tax. As already mentioned, during the 2023 financial year, we reached an annual effective income tax rate of 21.6%, which is roughly in line with our amended guidance of around 21%. Turning to the next slide, showing the 2024 financial year guidance. Let me highlight now some key aspects of the company's outlook for the 2024 financial year. Starting with total revenues for the BioNTech group. We expect total revenues in the range of EUR 2.5 to 3.1 billion for 2024. In providing a range estimate today, we take to some extent potential up and down cuts into account. For example, we assume largely the same vaccination rate for the US market, but have seen some price pressure in the US in Q4.

Moving to R&D expenses. During the 2023 financial year, our R&D expenses were nearly EUR 1.8 billion, slightly below our amended guidance from November of 2023 of EUR 1.82 billion. Lower spending in, for example, our collaborations has been a main contributor, as well as strong cost control measures. Our co-R&D activities in 2023 focused on broadening and accelerating our existing pipeline of product candidates in oncology and infectious diseases in line with our expectations.

The spending is in line with our expectations ranging from 200 to 300 million euros.

Speaker Change: ASCII text.

Speaker Change: As already mentioned during the 2023 financial year, we reached an annual effective income tax rate of 21, 6%, which is roughly in line with our amended guidance of around 21%.

Speaker Change: Turning to the next slide showing the 'twenty to 'twenty four financial year guidance.

Speaker Change: Let me highlight now some key aspects of the company's outlook for the 2024 financial year.

Jens H. Holstein: Our co-R&D activities in 2023 focused on broadening and accelerating our existing pipeline of product candidates in oncology and infectious diseases in line with our expectations. Moving to SG&A expenses. During the 2023 financial year, we recognized EUR 558 million in SG&A expenses, slightly below the lower end of our amended guidance of EUR 600 million to EUR 650 million. Again, we were closely monitoring our spending to reflect the uncertainty on the revenues without jeopardizing the future needs in this area. Moving to cap. Our 2023 financial year capital expenditures for operating activities amounted to 276 million euros, the majority of which was related to investments in building our laboratory and office facilities in Mainz, Germany. The spending is in line with our expectations, ranging from 200 to 300 million euros.

Our co-R&D activities in 2023 focused on broadening and accelerating our existing pipeline of product candidates in oncology and infectious diseases in line with our expectations. Moving to SG&A expenses. During the 2023 financial year, we recognized EUR 558 million in SG&A expenses, slightly below the lower end of our amended guidance of EUR 600 million to EUR 650 million. Again, we were closely monitoring our spending to reflect the uncertainty on the revenues without jeopardizing the future needs in this area.

Our co-R&D activities in 2023 focused on broadening and accelerating our existing pipeline of product candidates in oncology and infectious diseases in line with our expectations.

Speaker Change: Starting with total revenues for the biotech group.

Speaker Change: We expect total revenues in the range of two five to $3 1 billion euros for 2024.

Moving to SG&A expenses. During the 2023 financial year, we recognized EUR 558 million in SG&A expenses, slightly below the lower end of our amended guidance of EUR 600 million to EUR 650 million. Again, we were closely monitoring our spending to reflect the uncertainty on the revenues without jeopardizing the future needs in this area.

Speaker Change: In providing a range estimate today, we take some extent potential up and down such into account. For example, we assume largely the same vaccination rate for the U S market.

Speaker Change: But have seen some price pressure in the U S. In Q4, some smaller inventory write down with our collaboration partner Pfizer as we have faced again additional write downs above the previous ones that hit our revenue in Q4 2023.

Jens Holstein: Some smaller inventory write-down risk by our collaboration partner, Pfizer, as we have faced, again, additional write-downs above the previously announced ones that hit our revenue figure in Q4 2023. We also assume that we generate revenues from a German Pandemic Preparedness contract with the German government in 2024. For the 2024 financial guidance, we expect our R&D expenses to be in the range of EUR 2.4 to 2.6 billion, while our SG&A expenses are expected to be in the range of EUR 700 to 800 million. Please note that anticipated expenses related to the external legal advice in connection with legal litigations is not reflected in SG&A, but in other operating expenses.

Moving to CAPEX. Our 2023 financial year capital expenditures for operating activities amounted to EUR 276 million, whereof the majority was related to investments in building our laboratory and office facilities in Mainz, Germany. The spending is in line with our expectations, ranging from EUR 200 million to EUR 300 million.

Speaker Change: We also assumed that we generate revenues from a pandemic purpose contract with the German government in 2024.

Speaker Change: For the 2024 financial guidance, we expect R&D expenses to be in the range of $2 40 to $2 6 billion euros, while our SG&A expenses are expected to be in the range of 700 to 800 million euros.

Please note that anticipated expenses related to the external legal advice in connection with legal litigation is not reflected in SG&A, but in other operating expenses.

Jens H. Holstein: Lastly, tax. As already mentioned, during the 2023 financial year, we reached an annual effective income tax rate of 21.6%, which is roughly in line with our amended guidance of around 21%. Turning to the next slide, showing the 2024 financial year guidance. Let me highlight now some key aspects of the company's outlook for the 2024 financial year. Starting with total revenues for BioNTech Group. We expect total revenues in the range of EUR 2.5 billion to EUR 3.1 billion for 2024. In providing a range estimate today, we take, to some extent potential up and downsides into account. For example, we assume largely the same vaccination rate for the U.S. market. But have seen some price pressure in the U.S. in Q4, some smaller inventory write-down risk by our collaboration partner Pfizer, as we have faced, again, additional write-downs about the previous announced ones that hit our revenue figure in Q4 2023.

Lastly, tax. As already mentioned, during the 2023 financial year, we reached an annual effective income tax rate of 21.6%, which is roughly in line with our amended guidance of around 21%. Turning to the next slide, showing the 2024 financial year guidance. Let me highlight now some key aspects of the company's outlook for the 2024 financial year. Starting with total revenues for BioNTech Group.

Jens Holstein: Additionally, the guidance does not include, but may be impacted by potential payments resulting from any collaboration agreements or in-licensing deals, M&A transactions, or outcomes of ongoing or future legal disputes or related activities such as judgments or settlements. Lastly, capital expenditures for the 2024 financial year are expected to be in the range of EUR 400 to 500 million. In 2024, we will be increasing our operating expenses in R&D and SG&A to accelerate BioNTech's transition into a multi-product oncology and infectious disease company with a commercial footprint. For that, we want to increase our investments to lift the potential value that we see in our portfolio of product candidates. In 2023, we in-licensed multiple assets to bolster our late-stage pipeline. This year, we will invest in progressing our candidates into later-stage trials to fuel BioNTech's next stage of growth.

Speaker Change: Additionally, the guidance does not include that maybe impacted by potential payments, resulting from any collaboration agreements or in licensing deals M&A transactions or outcomes of ongoing or future legal disputes related activities, such as judgments or settlements.

Speaker Change: Lastly capital expenditures for the 2024 financial year I expect it to be in the range of 400 to 500 million euros.

Speaker Change: In 2024, we will be increasing our operating expenses in R&D and SG&A to accelerate <unk> transition into a multi product oncology and infectious disease company with a commercial footprint for that we want to increase our investments to lift the potential value that we see in our portfolio of product candidates.

We expect total revenues in the range of EUR 2.5 billion to EUR 3.1 billion for 2024. In providing a range estimate today, we take, to some extent potential up and downsides into account. For example, we assume largely the same vaccination rate for the U.S. market. But have seen some price pressure in the U.S. in Q4, some smaller inventory write-down risk by our collaboration partner Pfizer, as we have faced, again, additional write-downs about the previous announced ones that hit our revenue figure in Q4 2023.

Speaker Change: In 2023, we in licensed multiple assets to bolster our late stage pipeline. This year, we will invest in progressing our candidates into later stage trials to fueled by <unk> next stage of growth.

Jens Holstein: As previously mentioned, we aim to have 10 or more potentially registrational clinical trials ongoing by the end of 2024. With this, we pave the way for multiple potential product approvals, estimated to begin with first launch in 2026. As previously indicated, 2024 will be a transition year for our company, during which we will continue to invest in our long-term growth strategy while maintaining strict cost discipline. Overall, during this transition year, our revenues will be driven largely by the uptake of our COVID-19 vaccines in H2 2024. As a consequence of the expected revenue range and taking into account cost of sales, R&D and all other expenses, we do not expect to be profitable in 2024. Turning to the next slide. Today, BioNTech has a leading and profitable COVID-19 vaccine business.

Speaker Change: F.

Speaker Change: As previously mentioned, we aim to have 10 or more potentially registrational clinical trials ongoing by the end of 2024.

Speaker Change: With this we paved the way for multiple potential product approvals estimated to begin with first launch in 2026.

Jens H. Holstein: We also assume that we generate revenues from a pandemic preparedness contract with the German government in 2024. For the 2024 financial guidance, we expect our R&D expenses to be in the range of EUR 2.4 billion to EUR 2.6 billion, while our SG&A expenses are expected to be in the range of EUR 700 million to EUR 800 million. Please note that anticipated expenses related to the external legal advice in connection with legal litigation is not reflected in SG&A but in other operating expenses.

We also assume that we generate revenues from a pandemic preparedness contract with the German government in 2024. For the 2024 financial guidance, we expect our R&D expenses to be in the range of EUR 2.4 billion to EUR 2.6 billion, while our SG&A expenses are expected to be in the range of EUR 700 million to EUR 800 million.

Speaker Change: As previously indicated 2024 will be a transition year for our company during which we will continue to invest in our long term growth strategy, while maintaining strict cost discipline.

Speaker Change: Overall during this transition year.

Speaker Change: Revenues will be just will be driven largely by the uptake of our COVID-19 vaccines in the second half of 2024.

Speaker Change: As a consequence of the expected revenue range and taking into account cost of sales R&D and all other expenses, we do not expect to be profitable in 2024.

Please note that anticipated expenses related to the external legal advice in connection with legal litigation is not reflected in SG&A but in other operating expenses.

Speaker Change: Turning to the next slide.

Speaker Change: Today biotech has a leading and profitable COVID-19 vaccine business as you can see on the slide our COVID-19 vaccine business benefited from its lean fixed cost structure in 2023 and generates very attractive positive results.

Jens Holstein: As you can see on the slide, our COVID-19 vaccine business benefited from its lean, fixed cost structure in 2023 and generates very attractive positive results. In the coming years, we aim to invest alongside our partner in bringing variant-adapted and potentially combination vaccines to market with a goal to further contributing to our future value generation. In addition to our value-contributing COVID-19 vaccine franchise, we are investing into long-term value creation with our multiple product oncology pipeline. Let me highlight three value drivers. We plan to have 10 or more potentially registrational trials ongoing by the end of 2024. We aim to have a first potential oncology launch in 2026, adding to our top line. Thirdly, we believe to have a diversified clinical pipeline that offers multiple product growth opportunities for the years to come.

Jens H. Holstein: Additionally, the guidance does not include, but may be impacted by potential payments resulting from any collaboration agreements or in-licensing deals. M&A transactions, or outcomes of ongoing or future legal disputes or related activities such as judgments for settlement. Lastly, capital expenditures for the 2024 financial year are expected to be in the range of EUR 400 million to EUR 500 million. In 2024, we will be increasing our operating expenses in R&D and SG&A to accelerate BioNTech's transition into a multi-product oncology and infectious disease company with a commercial footprint. For that, we want to increase our investments to lift the potential value that we see in our portfolio of products candidates. In 2023, we will in-licensed multiple assets to bolster our late-stage pipeline. This year, we will invest in progressing our candidates into later-stage trials to fuel BioNTech's next stage of growth.

Additionally, the guidance does not include, but may be impacted by potential payments resulting from any collaboration agreements or in-licensing deals. M&A transactions, or outcomes of ongoing or future legal disputes or related activities such as judgments for settlement. Lastly, capital expenditures for the 2024 financial year are expected to be in the range of EUR 400 million to EUR 500 million. In 2024, we will be increasing our operating expenses in R&D and SG&A to accelerate BioNTech's transition into a multi-product oncology and infectious disease company with a commercial footprint. For that, we want to increase our investments to lift the potential value that we see in our portfolio of products candidates.

Speaker Change: In the coming years, we aim to invest alongside our partner in bringing variant adapted and potentially combination vaccines to market.

Speaker Change: With a goal to further contributing to our future value generation.

Lastly, capital expenditures for the 2024 financial year are expected to be in the range of EUR 400 million to EUR 500 million. In 2024, we will be increasing our operating expenses in R&D and SG&A to accelerate BioNTech's transition into a multi-product oncology and infectious disease company with a commercial footprint. For that, we want to increase our investments to lift the potential value that we see in our portfolio of products candidates.

Speaker Change: In addition to our value contributing COVID-19 vaccine franchise.

We are investing into long term value creation with our multiple product oncology pipeline.

Speaker Change: Let me highlight three value drivers.

Speaker Change: We plan to have 10 or more potentially registrational trials ongoing by the end of 2024.

We aim to have a first potential oncology launch in 2026, adding to our topline.

Speaker Change: And thirdly, we believe to have a diversified clinical pipeline that offers multiple product growth opportunities for the years to come.

Jens Holstein: Summarizing, we believe that our COVID-19 vaccine franchise and our innovative pipeline of product candidates will drive long-term value creation for the company. Our Chief Strategy Officer, Ryan Richardson, will now talk you through some of the strategic drivers for this transformation. Thank you.

In 2023, we will in-licensed multiple assets to bolster our late-stage pipeline. This year, we will invest in progressing our candidates into later-stage trials to fuel BioNTech's next stage of growth. As previously mentioned, we aim to have 10 or more potentially registrational clinical trials ongoing by the end of 2024. With this, we pave the way for multiple potential product approvals estimated to begin with first launch in 2026.

Speaker Change: Summarizing we believe that our COVID-19 vaccine franchise and our innovative pipeline of product candidates will drive long term value creation for the company.

Speaker Change: Our Chief Strategy Officer, Ryan Richardson will now talk you through some of the strategic drivers for this transformation. Thank you.

Jens H. Holstein: As previously mentioned, we aim to have 10 or more potentially registrational clinical trials ongoing by the end of 2025. With this, we pave the way for multiple potential product approvals estimated to begin with the first launch in 2023. As previously indicated, 2024 will be a transition year for our company during which we will continue to invest in our long-term growth strategy while maintaining strict cost decisions. Overall, during this transition year, our revenues will be driven largely by the uptake of our COVID-19 vaccines in the second half of 2020. As a consequence of the expected revenue range and taking into account the cost of sales, R&D, and all other expenses, we do not expect to be profitable in 2020. Turning to the next slide.

As previously mentioned, we aim to have 10 or more potentially registrational clinical trials ongoing by the end of 2025.

Ryan Richardson: Thank you, Jens Holstein. To wrap up our prepared remarks, I'll provide a high-level overview of our 2030 strategy and the path to value creation from our mid and late-stage oncology pipeline programs before concluding with a few important dates to mark on your calendars. On the next slide, we highlight the broad value creation opportunities underpinning our 2030 strategy. Our balance sheet has been further strengthened in 2023 and will continue to serve as a strategic asset to fuel long-term growth. We will continue to invest behind our market-leading COVID-19 vaccine franchise, leveraging our partnership with Pfizer across R&D, manufacturing, and commercial functions. On a product contribution basis, we expect this franchise to continue to be highly cash generative. We are working with Pfizer to develop a COVID-19 and influenza combination vaccine, which, if successful in late-stage trials, could reach the market as early as fall 2025.

Ryan Richardson: Thank you Tara.

Ryan Richardson: <unk> prepared remarks, I'll provide a high level overview of our 2030 strategy and the path to value creation from our mid and late stage oncology pipeline programs before concluding with a few important dates to mark on your calendars.

With this, we pave the way for multiple potential product approvals estimated to begin with the first launch in 2023. As previously indicated, 2024 will be a transition year for our company during which we will continue to invest in our long-term growth strategy while maintaining strict cost decisions. Overall, during this transition year, our revenues will be driven largely by the uptake of our COVID-19 vaccines in the second half of 2020. As a consequence of the expected revenue range and taking into account the cost of sales, R&D, and all other expenses, we do not expect to be profitable in 2020. Turning to the next slide.

With this, we pave the way for multiple potential product approvals estimated to begin with the first launch in 2023.

Ryan Richardson: On the next slide we highlight the broad value creation opportunities underpinning our 2030 strategy.

As previously indicated, 2024 will be a transition year for our company during which we will continue to invest in our long-term growth strategy while maintaining strict cost decisions. Overall, during this transition year, our revenues will be driven largely by the uptake of our COVID-19 vaccines in the second half of 2024. As a consequence of the expected revenue range and taking into account the cost of sales, R&D, and all other expenses, we do not expect to be profitable in 2024. Turning to the next slide.

Ryan Richardson: Our balance sheet has been further strengthened in 2023 and will continue to serve as a strategic asset to fuel long term growth.

Ryan Richardson: We will continue to invest behind our market, leading COVID-19 vaccine franchise, leveraging our partnership with Pfizer across R&D manufacturing and commercial functions.

Ryan Richardson: On a product contribution basis, we expect this franchise to continue to be highly cash generative.

Ryan Richardson: We are working with Pfizer to develop a COVID-19, and influenza combination vaccine, which is successful in late stage trials could reach the market as early as fall 2025.

Ryan Richardson: We are ramping up our investments into our expanding and diverse late-stage oncology pipeline. Our goal is to have at least 10 trials initiated with registrational potential by the end of this year. We believe this broad pipeline can deliver multiple new commercial product launches in the years ahead. Finally, we will continue to invest to industrialize our mRNA vaccine platform to address infectious diseases with high unmet global need. Today, we have 5 infectious disease vaccines beyond COVID-19 in phase 1 clinical trials. By 2030, we aim to bring our first vaccines from this pipeline to market, complemented by an expanding late-stage infectious disease vaccine pipeline. Our 2030 strategy aims to transform BioNTech into a diversified cash flow-generating multi-product company that can deliver sustained long-term growth.

Ryan Richardson: We are ramping up our investments into our expanding and diverse late stage oncology pipeline.

Ryan Richardson: Our goal is to have at least 10 trials initiated with registrational potential by the end of this year.

Turning to the next slide. Today, BioNTech has a leading and profitable COVID-19 vaccine business. As you can see on the slide, our COVID-19 vaccine business benefited from its lean fixed cost structure in 2023 and generates very attractive positive results. In the coming years, we aim to invest alongside our partner in bringing variant-adapted and potentially combination vaccines to market with a goal to further contribute to our future value generation. In addition to our value-contributing COVID-19 vaccine franchise, we are investing into long-term value creation with our multiple product oncology pipeline. Let me highlight three value drives.

Ryan Richardson: We believe this broad pipeline can deliver multiple new commercial product launches in the years ahead.

Jens H. Holstein: Today, BioNTech has a leading and profitable COVID-19 vaccine business. As you can see on the slide, our COVID-19 vaccine business benefited from its lean fixed cost structure in 2023 and generated very attractive positive results. In the coming years, we aim to invest alongside our partner in bringing variant-adapted and potentially combination vaccines to market with a goal to further contribute to our future value chain, in addition to our value-contributing COVID-19 vaccine franchise. We are investing in long-term value creation with our multiple product oncology. Let me highlight three value drives.

Ryan Richardson: Finally, we will continue to invest to industrialize, our mrna vaccine platform to address infectious diseases with high unmet global need.

Ryan Richardson: Today, we have five infectious disease vaccines beyond COVID-19, and phase one clinical trials by 2030, we aimed to bring our first vaccines from this pipeline to market complemented by an expanding late stage infectious disease vaccine pipeline.

Ryan Richardson: Okay.

Ryan Richardson: Our 2030 strategy aims to transform <unk> into a diversified cash flow generating multi product company that can deliver sustained long term growth.

Ryan Richardson: Turning to the next slide, I would like to spend a little more time today on the growth potential of our expanding late-stage pipeline. This pipeline includes 7 mid and late-stage programs that are currently in phase 2 and 3 trials. We have mentioned our goal to have 10+ trials with registrational potential initiated by the end of 2024. Also expect a busy calendar of program updates this year. These include updates on several cancer vaccine programs at AACR, which were announced last week, and further anticipated updates for specific IO and ADC programs at other major medical conferences throughout the year. 2024 will therefore be an important year of execution as we transition toward our goal of commercializing our oncology portfolio. We are looking forward to sharing further details on these programs throughout the course of the year.

Ryan Richardson: Turning to the next slide I would like to spend a little more time today on the growth potential of our expanding late stage pipeline.

Ryan Richardson: This pipeline includes seven mid and late stage programs that are currently in phase II and III trials.

Ryan Richardson: We have mentioned our goal to have 10, plus trials with Registrational potential initiated by the end of 2024.

Let me highlight 3 value drives. We plan to have 10 or more potentially registrational trials ongoing by the end of 2024. We aim to have our first potential oncology launch in 2026, heading to our top-line. And thirdly, we believe to have a diversified clinical pipeline that offers multiple product growth opportunities for the years. Summarizing, we believe that our COVID-19 vaccine franchise and our innovative pipeline of product candidates will drive long-term value creation for the company. Our Chief Strategy Officer, Ryan Richardson, will now talk you through some of the strategic drivers for this transformation. Thank you. Thank you, Jens.

Ryan Richardson: We also expect a busy calendar of program updates this year.

Jens H. Holstein: We plan to have 10 or more potentially registrational trials ongoing by the end of 2024. We aim to have our first potential oncology launch in 2026, heading to our top line. And thirdly, we believe to have a diversified clinical pipeline that offers multiple product growth opportunities over the years. In summary, we believe that our COVID-19 vaccine franchise and our innovative pipeline of product candidates will drive long-term value creation for us. Our Chief Strategy Officer, Ryan Richardson, will now talk you through some of the strategic drivers for this transformation. Thank you. Thank you, Jens.

Ryan Richardson: These include updates on several cancer vaccine programs at ACR, which were announced last week and further anticipated updates for specific Io and ADC programs at other major medical conferences throughout the year.

2024 will therefore be an important year of execution as we transition toward our goal of commercializing our oncology portfolio.

Ryan Richardson: We are looking forward to sharing further details on these programs throughout the course of the year.

Ryan Richardson: Ultimately, we believe our oncology pipeline can deliver one or more indication launches per year from 2026 onwards. We see significant potential for our mid- and late-stage programs to address unmet medical need across a broad range of cancer types and across the cancer treatment continuum. We are truly excited by the potential our oncology pipeline holds to expand and improve on cancer treatment options for people around the world. In closing, I would like to highlight, on the next slide, a few important investor events we will be holding this year. Our annual general meeting will take place on 17 May, and the next innovation series event on 14 November. This year, we will also introduce a new and exciting event focused on our expanding work in the field of artificial intelligence and machine learning, which will take place on 1 October.

Our Chief Strategy Officer, Ryan Richardson, will now talk you through some of the strategic drivers for this transformation. Thank you.

Ryan Richardson: Ultimately, we believe our oncology pipeline can deliver one or more indication launches per year from 2026 onwards.

Thank you, Jens. To wrap up our prepared remarks, I'll provide a high-level overview of our 2030 strategy and the path to value creation from our mid- and late-stage oncology pipeline programs before concluding with a few important dates to mark on your calendars. On the next slide, we highlight the broad value creation opportunities underpinning our 2030 strategy. Our balance sheet has been further strengthened in 2023 and will continue to serve as a strategic asset to fuel long-term growth. We will continue to invest behind our market-leading COVID-19 vaccine franchise, leveraging our partnership with Pfizer across R&D, manufacturing, and commercial functions. On a product contribution basis, we expect this franchise to continue to be highly cash-generous. We are working with Pfizer to develop a COVID-19 and influenza combination vaccine, which is successful in late-stage trials, and could reach the market as early as fall 2020.

Ryan Richardson: Thank you, Jens. To wrap up our prepared remarks, I'll provide a high-level overview of our 2030 strategy and the path to value creation from our mid- and late-stage oncology pipeline programs before concluding with a few important dates to mark on your calendars.

We see significant potential for our mid and late stage programs to address unmet medical need across a broad range of cancer types and across the cancer treatment continuum. We are truly excited by the potential our oncology pipeline holds to expand and improve on cancer treatment options for people around the world.

Ryan Richardson: To wrap up our prepared remarks, I'll provide a high-level overview of our 2030 strategy and the path to value creation from our mid- and late-stage oncology pipeline programs before concluding with a few important dates to mark on your calendar. On the next slide, we highlight the broad value creation opportunities underpinning our 2030 strategy. Our balance sheet has been further strengthened in 2023 and will continue to serve as a strategic asset to fuel long-term growth. We will continue to invest behind our market-leading COVID-19 vaccine franchise, leveraging our partnership with Pfizer across R&D, manufacturing, and commercial functions. On a product contribution basis, we expect this franchise to continue to be highly cash-generous. We are working with Pfizer to develop a COVID-19 and influenza combination vaccine, which is successful in late-stage trials, and could reach the market as early as fall 2020.

Ryan Richardson: Closing I would like to highlight on the next slide a few important investor events, we will be holding this year.

On the next slide, we highlight the broad value creation opportunities underpinning our 2030 strategy. Our balance sheet has been further strengthened in 2023, and will continue to serve as a strategic asset to fuel long-term growth. We will continue to invest behind our market-leading COVID-19 vaccine franchise, leveraging our partnership with Pfizer across R&D, manufacturing, and commercial functions. On a product contribution basis, we expect this franchise to continue to be highly cash-generative. We are working with Pfizer to develop a COVID-19 and influenza combination vaccine, which is successful in late-stage trials, could reach the market as early as fall 2025.

Ryan Richardson: Our annual General meeting will take place on May 17th and the next innovation series event on November 14th.

Ryan Richardson: This year, we will also introduce a new and exciting event focused on our expanding work in the field of artificial intelligence and machine learning, which will take place on October one.

Ryan Richardson: We look forward to sharing further details on both of them in the near future.

We will continue to invest behind our market-leading COVID-19 vaccine franchise, leveraging our partnership with Pfizer across R&D, manufacturing, and commercial functions. On a product contribution basis, we expect this franchise to continue to be highly cash-generative.

Ryan Richardson: That I would like to thank our shareholders for their continued support and open the floor for questions.

Operator: Thank you. To ask a question, you will need to press star one zero one on your telephone and wait for your name to be announced. To withdraw your question, please press star one zero one again. We will now go to your first question. One moment, please. Your first question comes from the line of Daina Graybosch from Leerink Partners. Please go ahead.

Speaker Change: Thank you.

Speaker Change: To ask a question you will need to press star one on your telephone and wait for your name to be announced to restore your question. Please press star one on one again.

Speaker Change: We will now go to your first question.

We are working with Pfizer to develop a COVID-19 and influenza combination vaccine, which is successful in late-stage trials, could reach the market as early as fall 2025. We are ramping up our investments into our expanding and diverse late-stage oncology pipeline. Our goal is to have at least 10 trials initiated with registrational potential by the end of this year. We believe this broad pipeline can deliver multiple new commercial product launches in the years ahead. Finally, we will continue to invest to industrialize our mRNA vaccine platform to address infectious diseases with high unmet global need. Today, we have 5 infectious disease vaccines beyond COVID-19 in Phase I clinical trials.

Speaker Change: One moment please.

Speaker Change: And your first question comes from the line of Dan gave us from Leerink partners. Please go ahead.

Daina Graybosch: Yeah. Thank you, guys. Thanks for the update and the question. As you look forward to these 10 potential registrational trials, I wonder if you can talk about maybe even a range of revenue expectations that you could be looking at by 2030 from the oncology portfolio, and then I have a follow-up.

Dan: Yeah. Thank you guys. Thanks for the update and the question.

Ryan Richardson: We are ramping up our investments in our expanding and diverse late-stage oncology pipeline. Our goal is to have at least 10 trials initiated with registrational potential by the end of this year. We believe this broad pipeline can deliver multiple new commercial product launches in the years ahead. Finally, we will continue to invest in industrializing our mRNA vaccine platform to address infectious diseases with high unmet global need. Today, we have five infectious disease vaccines beyond COVID-19 in phase one clinical trials.

Our goal is to have at least 10 trials initiated with registrational potential by the end of this year. We believe this broad pipeline can deliver multiple new commercial product launches in the years ahead. Finally, we will continue to invest to industrialize our mRNA vaccine platform to address infectious diseases with high unmet global need. Today, we have 5 infectious disease vaccines beyond COVID-19 in Phase I clinical trials.

Dan: As you look forward to these 10 potential registrational trials I Wonder if you can talk about maybe even a range of revenue expectations.

That you could be looking at by 2030 from the oncology portfolio and then I have a follow up.

Finally, we will continue to invest to industrialize our mRNA vaccine platform to address infectious diseases with high unmet global need. Today, we have 5 infectious disease vaccines beyond COVID-19 in Phase I clinical trials. By 2030, we aim to bring our first vaccines from this pipeline to market, complemented by an expanding late-stage infectious disease vaccine pipeline. Our 2030 strategy aims to transform BioNTech into a diversified, cash flow-generating, multi-product company that can deliver sustained long-term growth.

Ryan Richardson: Yes. Thanks, Daina. You know, I think the pipeline's quite broad, and one of the criteria that is common among most of those assets in that list is actually that they can target multiple solid tumors. That means that actually the peak sales estimate for that collection of assets is actually well over EUR 10 billion in our range long term, in our estimates long term. I think we're focused now on executing in those first launches. I think we're not prepared yet to give you a 2030 number. We do think that we're talking here about, you know, double-digit indications that we can address across the solid tumor landscape.

Dan: Okay.

Speaker Change: Yes, thanks, and thanks, Dana I think the pipeline is quite broad and one of the criteria that is common among most of those assets in that list is actually that they can target multiple solid tumors.

Speaker Change: And so that means that.

Ryan Richardson: By 2030, we aim to bring our first vaccines from this pipeline to market, complemented by an expanding late stage infectious disease pipeline. Our 2030 strategy aims to transform BioNTech into a diversified, cashflow-generating, multi-product company that can deliver sustained long-term growth. Turning to the next slide, I would like to spend a little more time today on the growth potential of our expanding labor force.

By 2030, we aim to bring our first vaccines from this pipeline to market, complemented by an expanding late stage infectious disease pipeline.

But actually the peak sales estimate for those for that collection of assets is actually well over $10 billion in our range long term our estimates long term.

Speaker Change: And but I think we're focused now on executing in those first launches. So I think we're not prepared yet to give you a 2030 number but we do think that the.

Our 2030 strategy aims to transform BioNTech into a diversified, cash flow-generating, multi-product company that can deliver sustained long-term growth. Turning to the next slide, I would like to spend a little more time today on the growth potential of our expanding labor force.

Our 2030 strategy aims to transform BioNTech into a diversified, cash flow-generating, multi-product company that can deliver sustained long-term growth.

Turning to the next slide, I would like to spend a little more time today on the growth potential of our expanding late-stage pipeline. This pipeline includes 7 mid-and late-stage programs that are currently in Phase II and III trials. We have mentioned our goal to have 10-plus trials with registrational potential initiated by the end of 2024. Also, expect a busy calendar of program updates this year. These include updates on several cancer vaccine programs at AACR, which were announced last week, and further anticipated updates for specific IO and ADC

Speaker Change: We're talking here about.

Speaker Change: Double digit indications that we can address across the solid tumor landscape.

Daina Graybosch: Great. Thank you. My follow-up is more specific on the Autolus collaboration. I wonder if you could talk about potential scenarios for how you see your CAR T business with Autolus maturing and advancing in the next five years.

Speaker Change: Great. Thank you and then my follow up is that more specific on the auto let's collaboration I Wonder if you could talk about potential scenarios for how you see your car T business with Ottawa.

Ryan Richardson: This pipeline includes seven mid and late stage programs that are currently in phase two and three trials. We have mentioned our goal to have 10 plus trials with registrational potential initiated by the end of 2024. Also, expect a busy calendar of program updates. These include updates on several cancer vaccine programs at AACR, which were announced last week, and further anticipated updates for specific I.O. and A.D.C.

We have mentioned our goal to have 10-plus trials with registrational potential initiated by the end of 2024. Also, expect a busy calendar of program updates this year. These include updates on several cancer vaccine programs at AACR, which were announced last week, and further anticipated updates for specific IO and ADC programs at other major medical conferences throughout the year.

Speaker Change: Maturing or a bad thing in the next five years.

Ryan Richardson: Sure. So I'll start with that too. So the primary rationale for Autolus was that as we ended 2023, we actually had higher conviction on moving forward more aggressively with BNT211, which is our lead cell therapy CAR-T program, as you know, targeting CLDN6, with an mRNA vaccine amplifier. We've talked about testicular cancer being a potential lead indication, and a potential fast to market path given the high unmet need in the refractory setting. We're also seeing strong and encouraging data in other indications such as refractory ovarian cancer and even seeing responses in lung cancer and other CLDN6 positive tumors.

Speaker Change: Sure So I'll start with that too so.

Speaker Change: The primary rationale for auto it was that as we enter 2023, we actually had higher conviction on moving forward more aggressively with the NT <unk> hundred one which is our lead cell therapy car T program as you know targeting calling six.

Speaker Change: It's an mrna vaccine amplifier and so we've talked about testicular cancer being a potential lead indication.

Ryan Richardson: programs at other major medical conferences throughout the year. 2024 will therefore be an important year of execution as we transition toward our goal of commercializing our oncology portfolio. We are looking forward to sharing further details on these programs throughout the course of the evening. Ultimately, we believe our oncology pipeline can deliver one or more indication launches per year from 2026 onwards. We see significant potential for our mid and late stage programs to address unmet medical need across a broad range of cancer types and across the cancer treatment continuum. We are truly excited by the potential our oncology pipeline holds to expand and improve cancer treatment options for people around the world. In closing, I would like to highlight on the next slide a few important investor events we will be holding this year. Our annual general meeting will take place on May 17th and the next Innovation Series event on November 4th. This year, we will also introduce a new and exciting event focused on our expanding work in the field of artificial intelligence and machine learning, which will take place in October.

programs at other major medical conferences throughout the year.

Speaker Change: And SaaS to a potential fast to market path given the high unmet need in the refractory setting, but we're also seeing strong and encouraging data in other indications such as refractory ovarian cancer and even the same responses in lung cancer and other clients <unk> positive tumors and so the <unk> collaboration gives us a sort of one way to.

2024 will therefore be an important year of execution, as we transition toward our goal of commercializing our oncology portfolio. We are looking forward to sharing further details on these programs throughout the course of the year. Ultimately, we believe our oncology pipeline can deliver one or more indication launches per year from 2026 onwards. We see significant potential for our mid-and late-stage programs to address unmet medical need across a broad range of cancer types and across the cancer treatment continuum. We are truly excited by the potential our oncology pipeline holds to expand and improve on cancer treatment options for people around the world. In closing, I would like to highlight on the next slide a few important investor events we will be holding this year. Our Annual General Meeting will take place on May 17th, and the next Innovation Series event on November 4th. This year, we will also introduce a new and exciting event focused on our expanding work in the field of artificial intelligence and machine learning, which will take place in October.

Ryan Richardson: The Autolus collaboration gives us a sort of runway to more aggressively explore multiple pivotal trials in parallel, leveraging the manufacturing infrastructure that we have in the United States through the Kite acquisition of assets that we had two and a half years ago, but also combined with the Autolus state-of-the-art manufacturing infrastructure in the United Kingdom. That's the first rationale. In addition to that, the deal incorporates some options where we could come in at the pivotal trial stage into a couple of Autolus' programs. We find their phase I data for their CD19/22 very encouraging. It's early, but it's encouraging. And also the GD2 CAR, we think is an interesting approach that could be complementary.

Ultimately, we believe our oncology pipeline can deliver one or more indication launches per year from 2026 onwards. We see significant potential for our mid-and late-stage programs to address unmet medical need across a broad range of cancer types and across the cancer treatment continuum. We are truly excited by the potential our oncology pipeline holds to expand and improve on cancer treatment options for people around the world. In closing, I would like to highlight on the next slide a few important investor events we will be holding this year. Our Annual General Meeting will take place on May 17th, and the next Innovation Series event on November 4th.

Speaker Change: More aggressively explore multiple pivotal trials in parallel leveraging the manufacturing infrastructure that we have in the United States through the kite acquisition.

Speaker Change: The assets that we had two and a half years ago, but also combined with the <unk> state of the art manufacturing infrastructure in the United Kingdom.

Speaker Change: So that's the first rationale and then in addition to that the deal incorporates some options where we could come in at the pivotal trial stage into a couple of auto assist programs.

In closing, I would like to highlight on the next slide a few important investor events we will be holding this year. Our Annual General Meeting will take place on May 17th, and the next Innovation Series event on November 14th.

Speaker Change: We find their phase one data for our C 1922, very encouraging its early but it is encouraging and also the Gd Truecar. We think is an interesting approach that could be complementary.

Ryan Richardson: The collaboration construct gives us the optionality to actually scale into a multi-product franchise in cell therapy while keeping our fixed costs lean and allowing us to accelerate BNT211 forward.

Speaker Change: The collaboration contract gives us the optionality to actually scale into a multi product franchise in cell therapy, while keeping our fixed cost lean and allowing us to accelerate into Q2 on one forward.

This year, we will also introduce a new and exciting event focused on our expanding work in the field of Artificial Intelligence and Machine Learning, which will take place on October 1st. We look forward to sharing further details on both events in the near future. With that, I would like to thank our shareholders for their continued support and open the floor for questions.

Speaker Change: Yeah.

Daina Graybosch: Great.

Speaker Change: Great.

Ryan Richardson: We look forward to sharing further details on both events in the near future. With that, I would like to thank our shareholders for their continued support and open the floor for questions. Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced.

We look forward to sharing further details on both events in the near future. With that, I would like to thank our shareholders for their continued support and open the floor for questions.

Operator: Thank you. We will now go to the next question. Your next question comes from the line of Chris Shibutani from Goldman Sachs. Please go ahead.

Speaker Change: Thank you.

Speaker Change: We will now go to the next question.

With that, I would like to thank our shareholders for their continued support and open the floor for questions.

Speaker Change: And your next question comes from the line of Chris She was telling me from Goldman Sachs. Please go ahead.

Operator: [Operator Instructions] And your first question comes from Daina Graybosch from Leerink Partners. Please go ahead.

[Analyst] (Goldman Sachs): Hey, this is Stephen on for Chris. Thank you for taking our questions. I had one on the financial side. Can you just give a little bit of color about what's driving the increase in SG&A guidance? I think at the midpoint it's about over a 30% increase from the prior year. So just wondering if that's related to COVID or if that's more related to building out the oncology franchise. And then specifically on your HER2 ADC, can you just talk about what type of clinical profile would be attractive in that HER2-low breast cancer indication? Thank you.

Speaker Change: Hey, this is Steven on for Chris. Thank you for taking our questions I had one on the financial side.

Steven: You just gave a little bit of color about what's driving the increase in SG&A guidance I think at the midpoint, it's about over a 30% increase from the prior year. So just wondering if that's related to COVID-19 or if that's more related to building out the oncology franchise.

Unknown Executive: To withdraw your question, please press star 1 and 1 again. We will now go to your first question. One moment, please.

Unknown Executive: And your first question comes from Daina Graybosch from Leering Partners. Please go ahead. Yeah, thank you guys. Thanks for the update and the question. As you look forward to these 10 potential registrational trials, I wonder if you could talk about maybe even a range of revenue expectations that you could be looking at by 2030 from the oncology portfolio, and then I have a follow-up. Yeah, thanks. Thanks, Daina.

And your first question comes from Daina Graybosch from Leering Partners. Please go ahead.

Steven: And then specifically on your her to ADP.

Steven: About what type of clinical profile would be attractive enough or too low breast cancer indication. Thank you.

Yes. Thank you, guys. Thanks for the update and the question. As you look forward to these 10 potential registrational trials, I wonder if you can talk about maybe even a range of revenue expectations that you could be looking at by 2030 from the oncology portfolio? And then I have a follow-up. Yeah, thanks. Thanks, Daina.

Daina Graybosch: Yes. Thank you, guys. Thanks for the update and the question. As you look forward to these 10 potential registrational trials, I wonder if you can talk about maybe even a range of revenue expectations that you could be looking at by 2030 from the oncology portfolio? And then I have a follow-up.

Jens Holstein: Yeah, thanks for the question. I'll take the first one on the SG&A expense increase that we anticipate for 2024. You have heard from us that, you know, we're planning to launch potentially our first product in 2026. Of course, we've got to build up the infrastructure to be able to commercialize those compounds that are coming then in 2026 and onwards. Therefore, you know, we intend to invest in infrastructure, specifically also in commercial setup in the US going forward.

Speaker Change: Yes. Thanks for the question I'll take the first one on the SG&A expense increase that we anticipate for 2024.

Speaker Change: You have heard some from us.

Speaker Change: <unk> planned to launch potentially our first product in 2026 of course, we've got a built up the infrastructure to be able to.

Speaker Change: To commercialize those compounds.

Speaker Change: That are coming down in 'twenty six onwards, and therefore, we intend to invest in infrastructure specifically also in the commercial setup in the U S going forward.

Yes. Thanks, Daina. I think that the pipeline is quite broad. And one of the criteria that is common among most of those assets in that list is actually that they can target multiple solid tumors. And so that means that actually the peak sales estimate for that collection of assets is actually well over 10 billion in our range long-term, in our estimates long-term. But I think we're focused now on executing those first launches. So I think we're not prepared yet to give you a 2030 number. But we do think that we're talking here about double-digit indications that we can address across the solid tumor landscape. Great, thank you. And then my follow-up is more specific on the Autolus collaboration. I wonder if you could talk about potential scenarios for how you see your CAR-T business with Autolus maturing and advancing in the next five years. Sure. So I'll start with that too.

Ryan Richardson: Yes. Thanks, Daina. I think that the pipeline is quite broad. And one of the criteria that is common among most of those assets in that list is actually that they can target multiple solid tumors. And so that means that actually the peak sales estimate for that collection of assets is actually well over 10 billion in our range long-term, in our estimates long-term. But I think we're focused now on executing those first launches. So I think we're not prepared yet to give you a 2030 number. But we do think that we're talking here about double-digit indications that we can address across the solid tumor landscape.

Ryan Richardson: You know, I think that the pipeline is quite broad, and one of the criteria that is common among most of those assets in that list is that they can target multiple solid tumors. And so that means that the peak sales estimate for that collection of assets is actually well over $10 billion in our range long term, in our estimates long term.

Speaker Change: Yeah.

Özlem Türeci: The second question was what makes for our HER2 ADC the indication of hormone receptor positive HER2-low breast cancer interesting. Did I get that right?

Speaker Change: With.

Speaker Change: The second question was what makes for a little hard to see the indication of.

Speaker Change: Hormone receptor positive Uh huh.

Speaker Change: No breast cancer interesting did I get that right.

[Analyst] (Goldman Sachs): More kind of expectations for what type of clinical profile would be attractive in that space.

Speaker Change: A more kind of expectations for what type of clinical profile would be attractive in that space.

Ryan Richardson: But I think we're focused now on executing those first launches. So I think we're not prepared yet to give you a 2030 number. But we do think that we're talking here about double-digit indications that we can address across the solid tumor landscape.

Jens Holstein: The TPP. Our HER2 ADC, we think, has a differentiable safety efficacy profile, and this is what we want to see in our phase 3 trial, which is ongoing.

Speaker Change: Okay.

Jens Holstein: The TPP. Our HER2 ADC, we think, has a differentiable safety efficacy profile, and this is what we want to see in our phase 3 trial, which is ongoing.

Speaker Change: Oh, okay.

Ryan Richardson: But I think we're focused now on executing on those first launches, so I think we're not prepared yet to give you a 2030 number. But we do think that we're talking here about, you know, double-digit indications that we can address across the solar tumor. Great, thank you. And then my follow-up is more specific on the Autolus collaboration. I wonder if you could talk about potential scenarios for how you see your CAR-T business with Autolus maturing and advancing in the next five years. Sure. So I'll start with that too.

So so.

Speaker Change: Oh Oh.

Speaker Change: Her two ADC Oh, we think has a differential.

Speaker Change: Hum safety efficacy profile and this is what we want to see.

Great. Thank you. And then my follow-up is more specific on the Autolus collaboration. I wonder if you could talk about potential scenarios for how you see your CAR-T business with Autolus maturing and advancing in the next 5 years? Sure. So I'll start with that too.

Daina Graybosch: Great. Thank you. And then my follow-up is more specific on the Autolus collaboration. I wonder if you could talk about potential scenarios for how you see your CAR-T business with Autolus maturing and advancing in the next 5 years?

Speaker Change: In our phase III trial, which is ongoing.

Ryan Richardson: Yeah. Just to add on that, what Özlem Türeci shared is we have a profile allowing us to dose to provide higher doses. We believe that this is particularly important in the HER2 1+ population, which is around half of the HER2-low population. Particularly, this is interesting in breast cancer as well in endometrial cancer and other HER2-positive tumors. We believe that we can position here the product with higher objective response rates plus higher durability of response.

Speaker Change: Yeah, and just to add on that as well.

Speaker Change: Sure.

Speaker Change: Yes.

Speaker Change: We have a profile, allowing us to dose.

Speaker Change: Cobalt at higher doses.

And we believe that this is particularly important.

Sure. So I'll start with that too. So the primary rationale for Autolus was that, as we ended 2023, we actually had higher conviction on moving forward more aggressively with BNT211, which is our lead cell therapy CAR-T program, as you know, targeting Claudin-6 with an mRNA vaccine amplifier. And so we've talked about testicular cancer being a potential lead indication and a potential fast-to-market path given the high unmet need in the refractory setting. But we're also seeing strong and encouraging data and other indications, such as refractory ovarian cancer and even seeing responses in lung cancer and other Claudin-6 positive tumors. And so the Autolus collaboration gives us a sort of runway to more aggressively explore multiple pivotal trials in parallel, leveraging the manufacturing infrastructure that we have in the United States through the Kite acquisition of assets that we had 2.5 years ago, but also combine with the Autolus state-of-the-art manufacturing infrastructure in the United Kingdom. So that's the first rationale.

Ryan Richardson: Sure. So I'll start with that too. So the primary rationale for Autolus was that, as we ended 2023, we actually had higher conviction on moving forward more aggressively with BNT211, which is our lead cell therapy CAR-T program, as you know, targeting Claudin-6 with an mRNA vaccine amplifier.

Speaker Change: Art Van plus.

Speaker Change: <unk> population.

Ryan Richardson: So the primary rationale for Autolis was that as we ended 2023, we actually had higher conviction on moving forward more aggressively with BNT211, which is our lead cell therapy CAR-T program, as you know, targeting COLT-M6 with an mRNA vaccine amplifier. And so we've talked about testicular cancer being a potential lead indication and a potential fast-to-market path given the high unmet need in the re But we're also seeing strong and encouraging data and other indications, such as refractory ovarian cancer and even seeing responses in lung cancer and other COLT-M6 positive tumors. And so the Autolis collaboration gives us a sort of runway to more aggressively explore multiple pivotal trials in parallel, leveraging the manufacturing infrastructure that we have in the United States through the kite acquisition of assets that we had two and a half years ago but also So that's the first rationale.

Speaker Change: Rich.

Speaker Change: Yes.

Speaker Change: Excellent.

Speaker Change: Uh huh.

Speaker Change: Uh-huh low population.

Speaker Change: Particularly this is interesting interesting.

Speaker Change: <unk> and <unk>.

Speaker Change: In breast cancer as well.

Speaker Change: <unk> and other her two positive tumors and we believe that we can position here.

Speaker Change: The product was higher.

Speaker Change: Hi.

Speaker Change: Uptake of football space, plus higher durability of response.

And so we've talked about testicular cancer being a potential lead indication and a potential fast-to-market path given the high unmet need in the refractory setting. But we're also seeing strong and encouraging data and other indications, such as refractory ovarian cancer and even seeing responses in lung cancer and other Claudin-6 positive tumors. And so the Autolus collaboration gives us a sort of runway to more aggressively explore multiple pivotal trials in parallel, leveraging the manufacturing infrastructure that we have in the United States through the Kite acquisition of assets that we had 2.5 years ago, but also combine with the Autolus state-of-the-art manufacturing infrastructure in the United Kingdom. So that's the first rationale.

[Analyst] (Goldman Sachs): Okay. Thank you very much, team.

Speaker Change: Okay. Thank you very much Tim.

Operator: Thank you. Your next question comes from the line of Bill Maughan from Canaccord. Please go ahead.

Speaker Change: Yes.

Speaker Change: Thank you.

Speaker Change: Your next question comes from the line of Phil Mcgough from Canaccord. Please go ahead.

Bill Maughan [Director and Senior Analyst: Good morning, thanks. I have kind of a two-part question about your ability to maintain market share on the COVID vaccine going forward. Just wondering how you're thinking about your ability to, I guess, defend and/or grow that, just given, for example, I know Arcturus is in Japan with a self-amplifying RNA for COVID, and Moderna has previously made a lot of noise about their pre-filled syringe. I know that Pfizer's rolling out a pre-filled syringe, but I guess I'm just wondering how widespread that is and if you've seen any competitive advantage where that has become available. Thank you.

Bill Maughan: Good morning, thanks. I have kind of a two-part question about your ability to maintain market share on the COVID vaccine going forward. Just wondering how you're thinking about your ability to, I guess, defend and/or grow that, just given, for example, I know Arcturus is in Japan with a self-amplifying RNA for COVID, and Moderna has previously made a lot of noise about their pre-filled syringe. I know that Pfizer's rolling out a pre-filled syringe, but I guess I'm just wondering how widespread that is and if you've seen any competitive advantage where that has become available. Thank you.

Good morning, and thanks, So I have.

Phil Mcgough: Kind of a two part question about your ability to maintain.

Phil Mcgough: <unk> maintained market share on the Covid vaccine going forward, just wondering how youre thinking about your ability to defend and grow that.

And so the Autolus collaboration gives us a sort of runway to more aggressively explore multiple pivotal trials in parallel, leveraging the manufacturing infrastructure that we have in the United States through the Kite acquisition of assets that we had 2.5 years ago, but also combine with the Autolus state-of-the-art manufacturing infrastructure in the United Kingdom. So that's the first rationale.

Phil Mcgough: Just given for example, and or tourists was in Japan with a self amplifying RNA for Covid and Mcdermott has previously made a lot of noise about their pre filled syringe I know that there is just rolling out a pre filled syringe, but I guess I'm just wondering how widespread that is.

Phil Mcgough: Seen any competitive advantage where that has become available. Thank you.

Ryan Richardson: Yeah. Thank you for the question. We believe that we still performed very strong in 2023 in having globally above a 50% market share for the COVID franchise. We did see some market share pressure in a couple of markets like the United States, as you point out. We've also had market share gains in a number of other geographies. We maintained a very high market share above 85% in Europe.

Speaker Change: Yes. Thank you for the question.

Speaker Change: So we believe that we still performed very strong in 2023.

Speaker Change: And having globally above a 50% market share for the Covid franchise, we did see some market share.

Ryan Richardson: And then, in addition to that, the deal incorporates some options where we could come in at the pivotal trial stage and do a couple of Atolus' programs. We find their Phase I data for their CD19/22 very encouraging. It's early, but it's encouraging. And also, the GD2 CAR, we think, is an interesting approach that could be complementary. So the collaboration contract gives us the optionality to actually scale into a multiproduct franchise in cell therapy while keeping our fixed costs lean and allowing us to accelerate BNT211 forward.

And then, in addition to that, the deal incorporates some options where we could come in at the pivotal trial stage and do a couple of Atolus' programs. We find their Phase I data for their CD19/22 very encouraging. It's early, but it's encouraging. And also, the GD2 CAR, we think, is an interesting approach that could be complementary.

And a couple of markets like the United States as you point out. We've also had market share gains in a number of other geographies. We maintained a very high market share above 85% in Europe and also grew.

Ryan Richardson: grew our market share in countries like Japan, which have actually been pretty sizable from a volume perspective over the last 12 months. Going into 2024, we do feel confident that we can continue to maintain a leadership position above the 50% mark globally. To your question on competition, yes, we do expect there to be some new entrants, mostly niche players in some of the peripheral markets. I think that you pointed out also the role of pre-filled syringes, which is an important point. I think last year it is fair to say that part of the reduction in market share in the United States that we experienced was due to a sort of lack or limited supply of pre-filled syringes.

<unk> our market share in countries like Japan, which has actually been pretty sizable from a volume perspective over the last over the last 12 months.

Speaker Change: Going into 2024, we do feel confident that we can continue to maintain a leadership position.

So the collaboration contract gives us the optionality to actually scale into a multiproduct franchise in cell therapy while keeping our fixed costs lean and allowing us to accelerate BNT211 forward.

Speaker Change: Above the 50% Mark globally.

Speaker Change: To your question on competition, Yes, we do expect there to be some new entrants, mostly niche players and some of the peripheral markets.

Chris Shibutani: Thank you. We will now go to the next question. And your next question comes from the line of Chris Shibutani from Goldman Sachs. Please go ahead. Hey, this is Steven. I'm on behalf of Chris.

Operator: Thank you. We will now go to the next question. And your next question comes from the line of Chris Shibutani from Goldman Sachs. Please go ahead.

Speaker Change: I think that you pointed out.

Speaker Change: Also the role of Prefilled syringes, which is an important point I think last year. It is fair to say that part of the reduction in market share in United States that we experienced was was due to.

Please go ahead. Hey, this is Steven. I'm on behalf of Chris.

Please go ahead.

Hey, this is Steven. I'm on behalf of Chris. Thank you for taking our question. I had one on the financial side. Can you just give a little bit of color about what's driving the increase in SG&A guidance? I think at the midpoint, it's about over a 30% increase from the prior year. So just wondering if that's related to COVID or if that's more related to building out the oncology franchise? And then specifically, on your HER2-ADC, can you just talk about what type of clinical profile would be attractive in that HER2-low breast cancer indication? Thank you. Yeah, thanks for the question.

Unknown Analyst: Hey, this is Steven on for Chris. Thank you for taking our question. I had one on the financial side. Can you just give a little bit of color about what's driving the increase in SG&A guidance? I think at the midpoint, it's about over a 30% increase from the prior year. So just wondering if that's related to COVID or if that's more related to building out the oncology franchise?

Speaker Change: Lack or limited supply of pre filled syringes last year, we did have some supply in the United States, but we also had <unk>.

Unknown Executive: Thank you for taking our question. I had one on the financial side. Can you just give a little bit of color about what's driving the increase in SG&A guidance? I think at the midpoint, it's about over a 30% increase from the prior year. So just wondering if that's related to COVID or if that's more related to building out the oncology franchise. And then specifically, on your HER2-ADC, can you just talk about what type of clinical profile would be attractive in that HER2-low breast cancer indication? Thank you. Yeah, thanks for the question.

Ryan Richardson: Last year we did have some supply in the United States, but we also had single dose vials as well, and clearly the market preference was for pre-filled syringes. As we go into 2024, we have taken steps with Pfizer to dramatically increase our supply of pre-filled syringes in the United States but also elsewhere.

Speaker Change: Those files as well and clearly the market preference was for pre filled syringes as we go into 2024, we have taken steps with Pfizer to dramatically increase our supply of Prefilled syringes.

Speaker Change: In the United States, but also elsewhere.

Speaker 17: Thank you.

Bill Maughan: Thank you.

Speaker Change: Thank you.

Operator: Thank you. Your next question comes from the line of Akash Tewari from Jefferies. Please go ahead.

Speaker Change: Thank you.

And then specifically, on your HER2 ADC, can you just talk about what type of clinical profile would be attractive in that HER2-low breast cancer indication? Thank you.

Speaker Change: Your next question.

Speaker Change: Comes from the line of <unk> from Jefferies. Please go ahead.

Speaker 18: Good morning, this is Ivy on for Akash. Thanks for taking our questions. We have two. The first one is on COVID. For COVID vaccines gross margin, given that Pfizer reported $5.4 billion for revenue versus your EUR 1.5 billion, and that you are splitting gross profit 50/50 with Pfizer, it seems to imply a gross margin of 60%, which is lower than previous levels of around 80%. Is this just because of the additional write-off Pfizer had in Q4? Additionally, I think what's your view on gross margin in 2024 and beyond for your COVID business, especially when competitors seem to talk about a higher GTN discount? My second question is quickly for pipeline. I guess, how encouraged are you with the early signals of BNT122 in other tumors outside of pancreatic?

[Analyst] (Jefferies): Good morning, this is Ivy on for Akash. Thanks for taking our questions. We have two. The first one is on COVID. For COVID vaccines gross margin, given that Pfizer reported $5.4 billion for revenue versus your EUR 1.5 billion, and that you are splitting gross profit 50/50 with Pfizer, it seems to imply a gross margin of 60%, which is lower than previous levels of around 80%. Is this just because of the additional write-off Pfizer had in Q4? Additionally, I think what's your view on gross margin in 2024 and beyond for your COVID business, especially when competitors seem to talk about a higher GTN discount? My second question is quickly for pipeline. I guess, how encouraged are you with the early signals of BNT122 in other tumors outside of pancreatic?

Speaker Change: Good morning. This is Ivy on Fred Hutch, Thanks for taking all my questions. We have two the first one is on Covid. So far cooler vaccines gross margin given that Pfizer reported $5 4 billion for revenue versus your $1 5 billion and that U S bleeding gross perfect fit perfectly with Pfizer It seems.

Yes. Thanks for the question. I'll take the first one on the SG&A expense increase that we anticipate for 2024. You have heard from us that we're planning to launch potentially our first product in 2026. Of course, we've got to build up the infrastructure to be able to commercialize those compounds that are coming then in '26 and onwards. And therefore, we intend to invest in infrastructure, specifically also in commercial setups in the U.S. going forward. The second question was what makes our HER2 ADC, the indication of hormone receptor positive HER2 low breast cancer interesting. Did I get that right?

Jens Holstein: Yes. Thanks for the question. I'll take the first one on the SG&A expense increase that we anticipate for 2024. You have heard from us that we're planning to launch potentially our first product in 2026. Of course, we've got to build up the infrastructure to be able to commercialize those compounds that are coming then in '26 and onwards. And therefore, we intend to invest in infrastructure, specifically also in commercial setups in the U.S. going forward.

Unknown Executive: I'll take the first one on the STNA expense increase that we anticipate for 2024. You have heard from us that, you know, we're planning to launch our first product in 2026. Of course, we've got to build up the infrastructure to be able to commercialize those compounds that are coming then in 26 and onwards. And therefore, we intend to invest in infrastructure, specifically in commercial setups in the US going forward. The second question was what makes our HER2 ADC, the indication of hormone receptor positive HER2 low breast cancer interesting. Did I get that right?

Speaker Change: Still enquire gross margin of 60%, which is lower than previous levels of around 80%. So that's just because of the addition of everybody else why they're higher in Q4. Additionally, I think what's your view on gross margin in 'twenty four and beyond.

Özlem Türeci: The second question was, what makes for HER2 ADC, the indication of hormone receptor positive HER2-low breast cancer interesting. Did I get that right?

Speaker Change: Kobe business, especially when the competitor seems to talk about a higher TTM discount and my second question is quickly for a pipeline I guess how in car ratio are you with the earliest take note of BB&T once you too.

Unknown Executive: More kind of expectations for what type of clinical profile would be attractive in that space. So, so our, our, her 280C, we think has a differentiable safety and efficacy profile. And this is what we want to see in our phase three trial, which is ongoing. Yeah, and just to add to that, what Aslam shared is that we have a profile allowing us to dose higher doses. And we believe that this is particularly important in the HER2 1 plus population, which is around half of the HER2 low population. So this is particularly interesting in breast cancer as well, in endometrial cancer, and other HER2 positive tumors.

Unknown Analyst: More kind of expectations for what type of clinical profile would be attractive in that space.

So COVID as a TPP. So our HER2 ADC, we think has a differentiable safety efficacy profile. And this is what we want to see in our Phase III trial, which is ongoing. Yeah, and just to add to that, what Aslam shared is that we have a profile allowing us to dose higher doses. And we believe that this is particularly important in the HER2 1 plus population, which is around half of the HER2 low population. So this is particularly interesting in breast cancer as well, in endometrial cancer, and other HER2 positive tumors.

Özlem Türeci: So COVID as a TPP. So our HER2 ADC, we think has a differentiable safety efficacy profile. And this is what we want to see in our Phase III trial, which is ongoing.

Speaker Change: Other tumors outside of pancreatic and is there any read across from the pancreas pancreatic data that will be presented at ACR soon thanks.

Speaker 18: Is there any read across from the pancreatic data that will be presented at AACR soon? Thanks.

[Analyst] (Jefferies): Is there any read across from the pancreatic data that will be presented at AACR soon? Thanks.

Ugur Sahin: Yes. And just to add on that, what Ozlem shared is that we have a profile allowing us to dose--to provide higher doses. And we believe that this is particularly important in the HER2 1-plus population, which is around half of the HER2 low population. So particularly, this is interesting in breast cancer as well, in endometrial cancer, and other HER2 positive tumors. And we believe that we can position here the product with higher objective response rates plus higher durability of response.

Jens Holstein: Yeah. Let me take the first question, thanks for the question. To just clarify, you know, Pfizer is, as you know, responsible for the commercialization of Comirnaty in most markets, with the exception of Germany and Turkey, and we have a gross profit share. That methodology works in a way that of course, you know, whatever Pfizer is writing off on in the write off on inventories or something like this, will go in the gross profit share and will reduce our revenue figure. That is, you know, what we are trying to highlight for the last quarters because we have been hit by around EUR 900 million due to that procedure.

Speaker Change: Yeah, Let me take the first question and thanks for the question to just clarify.

Speaker Change: Neither is as you know responsible for the commercialization of commonality in most markets with the exception of Germany, and Turkey, and we have a gross profit share.

Unknown Executive: And we believe that we can position this product with higher objective response rates plus higher durability of response. Okay, thank you very much, team. Thank you. Your next question comes from the line of Bill McGann from Canaccord. Please go ahead. Good morning, and thanks. So I have kind of a two-part question about your ability to maintain market share on the COVID vaccine going forward. Just wondering how you're thinking about your ability to, I guess, defend and or grow that. Just given, for example, I know Arcturus is in Japan with a self-amplifying RNA for COVID.

And we believe that we can position this product with higher objective response rates plus higher durability of response.

Okay, thank you very much, team. Thank you. Your next question comes from the line of Bill McGann from Canaccord. Please go ahead. Good morning, and thanks. So I have kind of a two-part question about your ability to maintain market share on the COVID vaccine going forward. Just wondering how you're thinking about your ability to, I guess, defend and or grow that. Just given, for example, I know Arcturus is in Japan with a self-amplifying RNA for COVID.

Okay, thank you very much, team. Thank you. Your next question comes from the line of Bill McGann from Canaccord. Please go ahead.

Unknown Analyst: Okay. Thank you very much, team.

Operator: Thank you. Your next question comes from the line of Bill Maughan from Canaccord. Please go ahead.

Speaker Change: And that methodology works in a way that of course, you know whatever and plaza is riding off.

Speaker Change: In the.

Good morning, and thanks. So I have kind of a two-part question about your ability to maintain market share on the COVID vaccine going forward. Just wondering how you're thinking about your ability to, I guess, defend and or grow that. Just given, for example, I know Arcturus is in Japan with a self-amplifying RNA for COVID.

Speaker Change: Write offs on inventories so something that we're going to cross profit share and will reduce our revenue figure that is what we are trying to highlight.

Speaker Change: For the for the last quarters, because we have been hit by round about $900 million due to that procedure.

Jens Holstein: This means for us this is basically 100% profit for us before COGS that come across due to the manufacturing activities that we are responsible for, and they are limited. If you compare the margin development that we'll have in 2023 versus 2022, you know, you will see that, you know, we are above 480% margin. You can't really read through from what Pfizer's reporting really to our numbers that we report.

Speaker Change: This means for US this is basically 100% profit for us before Cogs that come across due to the manufacturing activities that we are responsible for and there are limited and if you compare the margin development that will have.

Unknown Executive: [[[And Moderna has previously made a lot of noise about their pre-filled syringe. I know that Pfizer's rolling out a pre-filled syringe, but I guess I'm just wondering how widespread that is and if you've seen any competitive advantage where that has. Yeah, thank you for the question. We believe that we will still perform very strongly in 2023 and have globally above a 50% market share for the COVID franchise. We did see some market share pressure in a couple of markets like the United States, but as you point out, we've also had market share gains in a number of other geographies. We maintained a very high market share, above 85% in Europe, and also grew our market share in countries like Japan, which have actually been pretty sizable from a volume perspective over the last 12 months.

Speaker Change: 23 versus <unk> 22.

Speaker Change: You will see that we are we are above 80% margin. So you can't really read through from what Pfizer is reporting.

Speaker Change: Really to our numbers that we report.

Özlem Türeci: With regard to your question to our BNT122 and its performance in PDAC, we are very encouraged. Not surprised, but really encouraged. This is also the reason why following the data disclosure of our phase 1 PDAC trial, we have initiated phase 2 PDAC trial in the adjuvant setting with BNT122, which is enrolling patients. The results we saw in this cancer type, which is considered as immunosuppressive, cold, and low in tumor mutational load, is encouraging us also to go into other cancer indications with this type of immunological profile.

Speaker Change: With regard to your question a two hour BMT 122, and its performance in P duck.

We are very encouraged not surprised but really encourage them. This is also the reason why following the data and disclosure of our phase one P. Dr. Trier, we have initiated.

Speaker Change: Phase two trial in the adjuvant setting with the empty 122, which is.

Unknown Executive: Going into 2024, we do feel confident that we can continue to maintain a leadership position above the 50% mark globally. To your question on competition, yes, we do expect there to be some new entrants, mostly niche players, in some of the peripheral markets. I think that you also pointed out the role of pre-filled syringes, which is an important point. I think last year it was fair to say that part of the reduction in market share in the United States that we experienced was due to a lack or limited supply of pre-filled syringes. Last year, we did have some supply in the United States, but we also had single-dose vials as well. And clearly, the market preference was for pre-filled syringes.

Speaker Change: Enrolling of patients.

Speaker Change: Uh huh.

Speaker Change: As we saw in this.

Speaker Change: Cancer types, which is considered as immune suppressive in cohort and a.

Speaker Change: Oh and tumor mutational load is encouraging US also to go to go into other cancer indications.

Speaker Change: With this type of of.

Özlem Türeci: In fact, in our phase I trials in other such indications, we have collected data which supports the PDAC findings and which we currently are compiling to be published as manuscripts.

Speaker Change: Immunological profile and in fact in.

Speaker Change: Okay, just wanted to try it and other such indications.

Speaker Change: We have collected data, which supports a repeat of findings and which we currently are compiling too weak to be published at ESMO scripts.

Unknown Executive: As we go into 2024, we have taken steps with Pfizer to dramatically increase our supply of pre-filled syringes in the United States but also elsewhere. Thank you. Your next question comes from the line of Akash Tewari from Jeffreys. Please go ahead. Good morning, this is Ileana for Akash. Thanks for taking our questions. We have two.

Speaker 18: Thanks.

[Analyst] (Jefferies): Thanks.

Speaker Change: Thanks.

Operator: Thank you. Your next question comes from the line of Yaron Werber from TD Cowen. Please go ahead.

Speaker Change: Thank you.

Speaker Change: Your next question.

TD column: Comes from the line of gallon five up from TD column. Please go ahead.

Ryan Richardson: Right. Good morning and, thanks for taking that. I have a couple of questions as well. Maybe the first one is on BNT323, the ongoing Phase 3 study, the DYNASTY-Breast02. Can you talk a little bit about the powering on the PFS? It sounds like if I remember correctly, chemo, the ORR that historically is 11% to 36%, PFS is about 3 to 8. You showed a 39% ORR. Sort of, it depends how the chemo is gonna do, which is kinda will determine kind of how the study works.

Yaron Werber: Right. Good morning and, thanks for taking that. I have a couple of questions as well. Maybe the first one is on BNT323, the ongoing Phase 3 study, the DYNASTY-Breast02. Can you talk a little bit about the powering on the PFS? It sounds like if I remember correctly, chemo, the ORR that historically is 11% to 36%, PFS is about 3 to 8. You showed a 39% ORR. Sort of, it depends how the chemo is gonna do, which is kinda will determine kind of how the study works.

Gallon: Alright, good morning, and thanks for taking that over a couple of questions as well. So maybe the first one is on 323, the ongoing phase III study.

Unknown Executive: The first one is on COVID. So for COVID's gross margin, given that Pfizer reported $5.4 billion in revenue versus your $1.5 billion and that you are splitting gross profits 50-50 with Pfizer, it seems to imply a gross margin of 60%, which is lower than previous levels of around 80%. So is this just because of the additional write-offs Pfizer had in Q4? Additionally, what's your view on gross margin in 24 and beyond for your COVID business, especially when the competitor seems to talk about a higher GTN discount? And my second question is quickly for Pipeline.

Speaker Change: The dynasty breast <unk> can you talk a little bit about the powering.

Speaker Change: PFS.

Speaker Change: And it sounds like if I remember correctly.

The Dr are that historically is 11% to 36% PFS is about three to eight you showed a 39% or ars disorder.

It depends on the chemo is going to do which is kind of will determine kind of how the study works. So maybe if you could talk about the powering of the study and maybe a little bit if you can share any phase one two data on PFS. So we can colleges.

Ryan Richardson: Maybe if you can talk about the powering of the study and maybe a little bit if you can share any phase 1, 2 data on PFS so we can kinda just get a sense of what you're expecting. Secondly, just curious, you have such a huge pipeline already and you've executed and you're obviously continuing to execute and you need to grow the company a lot to continue to execute.

Yaron Werber: Maybe if you can talk about the powering of the study and maybe a little bit if you can share any phase 1, 2 data on PFS so we can kinda just get a sense of what you're expecting. Secondly, just curious, you have such a huge pipeline already and you've executed and you're obviously continuing to execute and you need to grow the company a lot to continue to execute.

Unknown Executive: I guess, how encouraged are you with the early signals of BNT122 in other tumors outside of pancreatic? And is there any read across from the pancreatic data that will be presented at AACR soon? Thanks. Yeah, let me take the first question.

Speaker Change: So to what you're expecting and then secondly, just curious you have such a huge pipeline already.

Speaker Change: You've executed and you're obviously continuing to execute and you need to grow the company allowed to continue to execute whats the purpose to do potentially more BD given that you have so much alright. Thank you.

Speaker 19: What's the purpose to doing potentially more BD, given that you have so much already? Thank you.

Yaron Werber: What's the purpose to doing potentially more BD, given that you have so much already? Thank you.

Unknown Executive: Thanks for the question. To just clarify, you know, Pfizer is, as you know, responsible for the commercialization of Comirnaty in most markets, with the exception of Germany and Turkey. And we have a gross profit share. And that methodology works in a way that, of course, you know, whatever Pfizer is writing off in write-offs on inventories or something like this will go into the gross profit share and will reduce our revenue

Ryan Richardson: Thanks, Yaron. I'll start with the second question, and then we'll come to the first. I think, you know, we were obviously very active last year on the BD front, bringing in-house six clinical stage or near clinical stage assets. We are gonna continue to be active, but Yaron, I think we would agree that, you know, we feel that we already have actually now a very broad toolkit that allows us to do a lot. We are focused increasingly on execution. I do think that, you know, we're gonna continue to be active in BD, but probably not as active in terms of the number of clinical stage assets that we're looking to bring on board.

Speaker Change: Thanks, <unk>, so I'll start with the second question.

Speaker Change: Coming to the first so I think.

Speaker Change: We're obviously very active last year on the BD front, bringing house six clinical stage or near clinical stage assets.

Speaker Change: We are going to continue to be active but youre right. I think we would agree that we feel that we already have actually now a very broad toolkit that allows us to do a lot.

Speaker Change: And so we're focused increasingly on execution, so I do think that.

Ozlem Tureci: That is, you know, what we are trying to highlight for the last quarters because we have been hit by around $900 million due to that procedure. This means for us, this is basically 100% profit for us before COGS that come across due to the manufacturing activities that we are responsible for, and they are limited. And if you compare the margin development that we'll have in 23 versus 22, you will see that, you know, we are, we are above 80% margin. So you can't really read through from what Pfizer is reporting to our numbers that we, With regard to your question about our BNT122 and its performance in PDAC, we are very encouraged, not surprised, but really encouraged.

Speaker Change: We're going to continue to be active in BD, but probably not as active in terms of the number of clinical stage assets that we're looking to bring on board where the focus this year is going to be more on executing and getting pivotal trials initiated.

Ryan Richardson: The focus this year is gonna be more on executing and getting pivotal trials initiated and enrolled.

And enrollment.

Speaker 20: Yeah. To your second question, I think the second question can be better answered with the powered for a hazard ratio, which we usually do around 0.7, 0.65. With that we have a power of 90%. This gives rise to a study of around 450 patients that we will enroll.

Ryan Richardson: Yeah. To your second question, I think the second question can be better answered with the powered for a hazard ratio, which we usually do around 0.7, 0.65. With that we have a power of 90%. This gives rise to a study of around 450 patients that we will enroll.

Speaker Change: Okay.

Speaker Change: So you are to your second question.

Speaker Change: I think the second question can be it can be better onset wisdom.

Speaker Change: Power for a hazard ratio.

Speaker Change: We usually do it harmed opened seven opens kick start.

Speaker Change: And with that we have a pull off 90% okay.

Speaker Change: Sure.

Speaker Change: And this is this gives us two of study.

Speaker Change: 530 patients that we will onboard.

Operator: Thank you. I will now go to the next question. Your next question comes from the line of Etzer Darout from BMO Capital. Please go ahead.

Speaker Change: Thanks Keith.

Keith: I will now go to the next question.

Ozlem Tureci: And this is also the reason why, following the data disclosure of our phase one PDAC trial, we have initiated a phase two PDAC trial in the adjuvant setting with BNT122, which is enrolling a patient. The results we saw in this cancer type, which is considered immune suppressive and cold and low in tumor mutational load, are encouraging us also to go into other cancer indications with this type of immunological profile.

Speaker Change: I am doing next question comes from the line of <unk> from BMO capital. Please go ahead.

Speaker 21: Great. Thanks for taking the question. Just one question from me. On BNT327, your VEGF PD-L1, you highlighted the program sort of prominently a couple of slides and looking at sort of phase 3 2024 and beyond. Just wondering if you would be providing any clinical updates for this program in 2024 and what we could expect to see there. Any more specifics as well on sort of the potential path to phase 3 and what programs or what indications specifically you may be able to sort of pursue with this molecule. Thank you.

Etzer Darout: Great. Thanks for taking the question. Just one question from me. On BNT327, your VEGF PD-L1, you highlighted the program sort of prominently a couple of slides and looking at sort of phase 3 2024 and beyond. Just wondering if you would be providing any clinical updates for this program in 2024 and what we could expect to see there. Any more specifics as well on sort of the potential path to phase 3 and what programs or what indications specifically you may be able to sort of pursue with this molecule. Thank you.

Unknown Executive: Great. Thanks for taking my question just one question for me on <unk> hundred 27, Djerba Gotcha PDL. One you highlighted the program sort of permanently a couple of slides and looking at sort of phase III in 2021 beyond just wondered if you would be providing any clinical updates.

Ozlem Tureci: And in fact, in our phase one trials, in other such indications, we have collected data which supports the PDAC findings and which we are currently compiling to be published as, Thank you. Your next question comes from the line of Yaron Werber from TD Cowan. Please go ahead. Right, good morning, and thanks for taking that. I have a couple of questions as well. Perhaps the first one is on 323, the ongoing phase 3 study, Dynasty Breast 02. Can you talk a little bit about the powering on the PFS?

Unknown Executive: This program in 2020 for what we could expect to see there and any more specifics as well and sort of the potential path to phase III and what programs or what indications specifically you've made.

Unknown Executive: Are you able to sort of pursue with this molecule. Thank you.

Speaker 20: Yeah, thank you for the question. Indeed, we will see a number of clinical trial updates on this molecule, multiple indications. Just to remind everyone, this is a bispecific molecule which has PD-L1 for PD-1 blocking and anti-VEGF arm. Yeah. What we have seen so far consistently in a number of cohorts is the objective response rates which are very encouraging in various indications. What we have also reported already are first two combination trials in small cell lung cancer and in triple negative breast cancer patients.

Ryan Richardson: Yeah, thank you for the question. Indeed, we will see a number of clinical trial updates on this molecule, multiple indications. Just to remind everyone, this is a bispecific molecule which has PD-L1 for PD-1 blocking and anti-VEGF arm. Yeah. What we have seen so far consistently in a number of cohorts is the objective response rates which are very encouraging in various indications. What we have also reported already are first two combination trials in small cell lung cancer and in triple negative breast cancer patients.

Speaker Change: Yes. Thank you for the question Indeed, we will see a number of.

Speaker Change: The clinical trial.

Speaker Change: Its own on this molecule in multiple indications just to remind everyone. This is the best specific molecule.

Speaker Change: As a.

Speaker Change: Could you PD one.

Speaker Change: PD one blocking antibody.

Unknown Executive: And it sounds like, if I remember correctly, chemo, the ORR that historically is 11 to 36 percent, and PFS is about 3 to 8. You showed a 39 percent ORR, so sort of, it depends on what chemo is going to do, which is kind of, will determine kind of how the study works. So maybe if you could talk about the powering of the study and maybe a little bit if you could share any phase 1, 2 data on PFS, so we can kind of just get a sense of what you're expecting. And then, secondly, just curious. You have such a huge pipeline already, and you've executed, and you obviously continue to execute, and you need to grow the company a lot to continue to execute. What's the purpose of doing potentially more BD, given that you have so much already?

Speaker Change: <unk> what we're.

Speaker Change: Since of consistently and in a number of cohorts.

Speaker Change: The uptick the postponed escapes which are very encouraging in various indications and what they have.

Speaker Change: <unk> also reported over the first two first combi.

Speaker Change: Combination paths in small cell lung cancer, and triple negative breast cancer cancer patients and what is really exciting in these indications.

Speaker 20: What is really exciting in these indications is not only the high response rates in the range of 60% to 75% in triple negative breast cancer patients, but also the response rate in the patient population who are negative for immune infiltrates, which is unusual for checkpoint blockade. We believe that we can replicate this molecule not only in these two indications, small cell lung cancer and triple negative breast cancer, but also in a wider range of indications with free sites, allowing us to position the molecule as a combination partner for classical chemotherapy and, even more importantly, for our ADC portfolio.

Ryan Richardson: What is really exciting in these indications is not only the high response rates in the range of 60% to 75% in triple negative breast cancer patients, but also the response rate in the patient population who are negative for immune infiltrates, which is unusual for checkpoint blockade. We believe that we can replicate this molecule not only in these two indications, small cell lung cancer and triple negative breast cancer, but also in a wider range of indications with free sites, allowing us to position the molecule as a combination partner for classical chemotherapy and, even more importantly, for our ADC portfolio.

Speaker Change: Not only the high response rates.

Speaker Change: In the range of 60% to 75% in triple negative breast cancer patients, but also the response in the patient population.

Speaker Change: Who are negative for ammonium sulfate, which is unusual.

For checkpoint blockade. So we believe that this model could equip.

Unknown Executive: Thank you. Thanks, Yaron. So I'll start with the second question. And then we'll come to the first.

Speaker Change: We conducted kit business molecule not only in those two indications.

Our lung cancer and triple negative breast cancer, but also in Nevada that range of indications this results, allowing us to.

Ryan Richardson: So I think, you know, we were obviously very active last year on the BD front, six clinical stage or near clinical stage assets. We are gonna continue to be active, but Yaron, I think we would agree that we already have a very broad toolkit that allows us to do a lot. And so we are increasingly focused on execution.

Speaker Change: Positioning the molecule.

Speaker Change: Combination partner for classical chemotherapy, and even more importantly for our ADC portfolio.

Speaker 21: Thank you.

Etzer Darout: Thank you.

Speaker Change: Thank you.

Operator: Thank you. Your next question comes from the line of Tazeen Ahmad from JP Morgan. Please go ahead.

Speaker Change: Thank you.

Speaker Change: Your next question.

Speaker Change: It comes from the line of Jessica Fye from Jpmorgan. Please go ahead.

Speaker 19: Hey, guys. Good morning. Thanks for taking my questions. First on the top line guidance. I think you previously talked about roughly EUR 3 billion top line just a couple months ago, and appreciate you highlighting the variables that factor into the guidance, but can you just expand on which of those assumptions drove the change? Then second on the pipeline, related to the HER2 space, what are you guys gonna be watching for in the DESTINY-Breast06 readout as it relates to your HER2 ADC? Thank you.

Yaron Werber: Hey, guys. Good morning. Thanks for taking my questions. First on the top line guidance. I think you previously talked about roughly EUR 3 billion top line just a couple months ago, and appreciate you highlighting the variables that factor into the guidance, but can you just expand on which of those assumptions drove the change? Then second on the pipeline, related to the HER2 space, what are you guys gonna be watching for in the DESTINY-Breast06 readout as it relates to your HER2 ADC? Thank you.

Hey, guys. Good morning, Thanks for taking my questions first on the topline guidance I think you previously talked about roughly a 3 billion Euro top line just a couple of months ago and I. Appreciate you highlighting the variables that factor into the guidance, but can you just expand on which of those assumptions drove that change and then second on the pipeline.

Jens H. Holstein: So I do think that we're gonna continue to be active in VD, but probably not as active in terms of the number of clinical stage assets that we're looking to bring on board. The focus this year is gonna be more on execution and getting pivotal trials initiated and enrolled. Yeah, to your second question. I think the second question can be better answered with the powering for hazard ratio, which we usually do around 0.7, 0.65.

Speaker Change: And related to the her two space what are you guys going to be watching for.

Speaker Change: The Destiny breath show six readout as it relates to Europe.

Speaker Change: ADC. Thank you.

Speaker 20: Let me take the first question. We broadened the range. You know, we felt that the top line guidance should reflect the assumptions that we've made with respect to the vaccination rates and the price levels that we currently have seen. You know, Comirnaty of course is significantly relevant. We also have made assumptions related to the inventory write-offs that hit us back in 2023. You know, there will be some write-offs that we gotta anticipate going forward. We've included some assumptions here. Of course, there are also some additional anticipated revenues related to our service business and the German Pandemic Preparedness contract that we have in hand or we are finalizing currently with the government.

Speaker Change: Okay.

Unknown Executive: And with that, we have a power of 90%, and this gives rise to a study of around 530 patients that we will enroll. Thank you. I will now go to the next question. And your next question comes from the line of Etta Daru from BMO Capital. Please go ahead. Great. Thanks for taking the question. Just one question for me.

Ryan Richardson: Let me take the first question. We broadened the range. You know, we felt that the top line guidance should reflect the assumptions that we've made with respect to the vaccination rates and the price levels that we currently have seen. You know, Comirnaty of course is significantly relevant. We also have made assumptions related to the inventory write-offs that hit us back in 2023. You know, there will be some write-offs that we gotta anticipate going forward. We've included some assumptions here. Of course, there are also some additional anticipated revenues related to our service business and the German Pandemic Preparedness contract that we have in hand or we are finalizing currently with the government.

Speaker Change: So yes, let me take the first question.

Speaker Change: So we broadened the range without that the topline guidance should reflect the assumptions that we've made with respect to the vaccination rates and the price levels that we currently have seen.

Speaker Change: They're significant.

Speaker Change: Commonality of course significantly.

Relevant we also have made assumptions related to the inventory write offs that hit us back in 'twenty three.

Speaker Change: There will be some write offs that we got to anticipate going forward. So we've done. Some some included are some assumptions and.

Speaker Change: Of course, there are also some additional anticipated revenues related to our service business and the German collateral capacity contract.

Unknown Executive: On BNT-327, your GFPD-01, you highlighted the program sort of prominently on a couple of slides and looked at sort of Phase 3, 2024, and beyond. Just wondered if you would be providing any clinical updates for this program in 2024 and what we could expect to see there, and any more specifics as well on sort of the potential path to Phase 3 and what programs or what indications specifically you may be able to sort of pursue with this molecule. Thank you. Yeah, thank you for the question. Indeed, we will see a number of clinical trial updates on this molecule for multiple indications. Just to remind everyone, this is a biospecific molecule that has a PD-L1 for PD-1 blocking and an anti-VGF arm.

Speaker Change: We have in hand, or we are finalizing currently with the government. So therefore, we feel we have.

Speaker 20: You know, we feel we have that was driving basically the broadening of that range.

Ryan Richardson: You know, we feel we have that was driving basically the broadening of that range.

Speaker Change: That was driving basically.

Speaker Change: The broadening of that range.

Speaker 19: Each of those really factored into the broadening?

Tazeen Ahmad: Each of those really factored into the broadening?

Speaker Change: So each of those really factored into the broadening.

Speaker 20: This, you know, there are some upsides, there are some downsides that I mentioned and, you know, we'll try to work it in with, of course current assumptions, you know, that could vary over time, but that's what we've done, yes.

Ryan Richardson: This, you know, there are some upsides, there are some downsides that I mentioned and, you know, we'll try to work it in with, of course current assumptions, you know, that could vary over time, but that's what we've done, yes.

Speaker Change: This is this there are some upsides there are some downside that I mentioned.

Speaker Change: We'll try to work it in with of course current assumptions.

Speaker Change: That could vary over time, but that's what we've done yet.

Jens Holstein: Got it.

Tazeen Ahmad: Got it.

Speaker 20: Yes. With regard to our HER2 ADC, the concept of HER2 ADCs and the molecules which are around, that's a great concept. That's very obvious, and we are very excited about our HER2 ADC, the molecule, the BNT323 which we have partnered with DualityBio. As Ugur pointed out earlier, in HER2-low breast cancer we are looking for making a difference in this high medical need population. You also have heard about our target of the hazard ratio which we are targeting.

Ryan Richardson: Yes. With regard to our HER2 ADC, the concept of HER2 ADCs and the molecules which are around, that's a great concept. That's very obvious, and we are very excited about our HER2 ADC, the molecule, the BNT323 which we have partnered with DualityBio. As Ugur pointed out earlier, in HER2-low breast cancer we are looking for making a difference in this high medical need population. You also have heard about our target of the hazard ratio which we are targeting.

Speaker Change: Got it yeah, so with regard to I heard two ADC the concept of her two Adcs center molecules, which are around.

Speaker Change: That's a great concept, that's that's very obvious and we are very excited about oh or two ADC molecule will be empty.

Speaker Change: 323, which we have partnered with reality and as will pointed out earlier are in.

Ozlem Tureci: What we have seen so far consistently in a number of cohorts is objective response rates, which are very encouraging in various indications. And what we have also reported already are first combination trials in small cell lung cancer and in triple negative breast cancer patients. And what is really exciting about these indications is not only the high response rates in the range of 60 to 75 percent in triple negative breast cancer patients but also the response rate in the patient population who are negative for immune infiltrate, which is unusual for checkpoint blockage.

Speaker Change: Hum.

Speaker Change: No breast cancer are looking for making a difference in this high medical need population I also have heard about a lot of target the hazard ratio of which we are targeting.

Jens Holstein: Yeah. We can't, of course, comment on the clinical trials of third parties.

Speaker Change: And we cannot of course comment on the clinical class.

Speaker Change: Pocket.

Speaker 20: Thank you.

Ryan Richardson: Thank you.

Speaker Change: Thank you.

Operator: Thank you. Your next question comes from the line of Simon Baker from Redburn. Please go ahead.

Speaker Change: Thank you.

Speaker Change: Your next question.

Speaker Change: Comes from the line of.

Speaker Change: Simon Baker from Redburn. Please go ahead.

Speaker 22: Thank you for taking my question. Two quick ones if I may. The 2024 R&D guidance of EUR 2.4 to 2.6 billion is a step up on 2023 and against the plethora of studies you're running, that makes perfect sense. I was wondering, is this the new normal? And was wondering what you could say about the anticipated levels of R&D expense beyond 2024. And finally, there's been an awful lot of deal activity in the radiopharmaceutical space of late. Be interested to get your thoughts on the attractiveness of that modality. Thanks so much.

Simon Baker: Thank you for taking my question. Two quick ones if I may. The 2024 R&D guidance of EUR 2.4 to 2.6 billion is a step up on 2023 and against the plethora of studies you're running, that makes perfect sense. I was wondering, is this the new normal? And was wondering what you could say about the anticipated levels of R&D expense beyond 2024. And finally, there's been an awful lot of deal activity in the radiopharmaceutical space of late. Be interested to get your thoughts on the attractiveness of that modality. Thanks so much.

Simon P. Baker: Thank you for taking my question two quick ones if I may.

Ozlem Tureci: So we believe that this molecule could, that we can replicate this molecule not only in the two indications, small cell lung cancer and triple negative breast cancer, but also in a wider range of indications, this results in allowing us to position the molecule as a combination partner for classical chemotherapy and, even more importantly, for our ADC population. Thank you. Your next question comes from the line of Jessica Fye from J.P. Morgan. Please go ahead. Hey guys. Good morning.

Simon P. Baker: For R&D guidance.

2.42.

Simon P. Baker: $2 6 billion as of September 20, <unk> and against the.

Pressure studies, you're running now that makes perfect sense, but I wish I was wondering is this the new normal.

Simon P. Baker: Just wondering what you could say about the anticipated levels of R&D expense beyond 2024.

Simon P. Baker: And finally the.

Simon P. Baker: There's been an awful lot of deal activity in the radiopharmaceutical space of late.

Jessica Macomber Fye: Thanks for taking my questions. First, on the top-line guidance, I think you previously talked about roughly a 3 billion-euro top line just a couple months ago, and I appreciate you highlighting the variables that factor into the guidance, but can you just expand on which of those assumptions drove the change?

Simon P. Baker: Be interested to get your thoughts on the attractiveness.

Speaker Change: Thanks very much.

Jens Holstein: Yeah, happy to take the first question. As you pointed out correctly, of course, you know, we have broadened our portfolio. We have more and more late-stage clinical trials running, and those drive the costs up to a great extent yet. Going forward, as you know, we haven't given any guidance here yet for 2025 and the following years. You know, you gotta bear with us a little bit, but of course, you know, late-stage clinical trials will cost some money. We will carefully look, you know, where we invest our money.

Speaker Change: Yeah happy to take the first question so.

Speaker Change: As you pointed out correctly of course, we are broadening we have broadened our portfolio, we have more and more of a late stage clinical trials running in those drive costs up to a great extent yet.

Jens H. Holstein: And then second, on the pipeline related to the HER2 space, what are you guys going to be watching for in the Destiny Breast 06 readout as it relates to your HER2? So, yeah. Let me take the first question. So we broadened the range, you know; we felt that the top line guidance should reflect the assumptions that we've made with respect to the vaccination rates and the price levels that we currently have seen. You know, we're a significant player where Cominati, of course, is significantly relevant. We also have made assumptions related to the inventory write-offs that hit us back in 23.

Speaker Change: And going forward as well.

Speaker Change: No we haven't given any guidance yet for 2005 the following years.

Speaker Change: So.

Speaker Change: You've got to bear with us a little bit but of course in our late stage clinical trials will cost some money, we will carefully look where we invest our money.

Jens Holstein: You know, we have shown that in 2023 already, where we had the same sort of range at the beginning, and then we reduced costs, also reflecting, you know, the pressure that we have faced on the top line, regarding the COVID revenue figures that we had to adjust during 2023. There is some level of insecurity. I think it's part of our job to manage our costs here, and of course, we will do that in 2024 and in the ongoing years. We will invest in the areas where we feel we create value for the company and value for the shareholders. That remains, you know, on top of our list going forward.

Speaker Change: Have shown that in 'twenty, three already where we had the same sort of range at the beginning and then we'll reduce costs also reflecting the pressure that we have faced on the top line regarding the COVID-19 revenue figures that we that we had to adjust during 2023. So there is some level of in security I think it's part of our job to manage our costs.

Speaker Change: And of course, we will do that.

Ozlem Tureci: And, you know, there will be some write-offs that we've got to anticipate going forward. So we've included some assumptions here. And, of course, there are also some additional anticipated revenues related to our service business and the German pandemic preparedness contract that we have in hand or that we are finalizing currently with the government. So, therefore, you know, we feel we have that was driving, basically, the broadening of that. So each of those really factored into the broadening. This is this, you know, there are some upsides, there are some downsides that I mentioned, and, you know, we'll try to work it in with, of course, current assumptions that could vary over time. But that's what we've done. Yes, with regard to our HER2-ADC, the concept of HER2-ADCs and the molecules which are around, that's a great idea. That's very obvious.

Speaker Change: 24, and the ongoing yet, but we will invest in the areas, where we feel we create value for the company and value for the shareholders that remains on top of our list going forward.

Speaker 20: Yeah, the second part of your question about attractiveness of radioligands, I would like to say, and I am repeating myself, is that oncology is being in a transformation, and we will see this transformation ongoing in the next 10 to 15 years. The transformation happens because there are new concepts, and one of the new concept is targeting tumor cells but having bystander effect. This is what we are seeing in radioligands. We have this targeting of tumor cells plus the additional bystander effect, and this is even more pronounced in the ADC field. Yeah. We will see really tremendous transformation in the oncology, providing us the opportunity to open up indications where we believed in the past that we can't offer patients anything.

Ryan Richardson: Yeah, the second part of your question about attractiveness of radioligands, I would like to say, and I am repeating myself, is that oncology is being in a transformation, and we will see this transformation ongoing in the next 10 to 15 years. The transformation happens because there are new concepts, and one of the new concept is targeting tumor cells but having bystander effect. This is what we are seeing in radioligands. We have this targeting of tumor cells plus the additional bystander effect, and this is even more pronounced in the ADC field. Yeah. We will see really tremendous transformation in the oncology, providing us the opportunity to open up indications where we believed in the past that we can't offer patients anything.

Speaker Change: And the second part of your question about attractiveness of gradual vacant.

Speaker Change: I would like to say.

Yeah.

Speaker Change: We're taking myself is that oncology is being in a transformation and we will see this transformation ongoing in the next 10 to 15 years.

Speaker Change: The transformation happens because they are new concepts in one of the new concept is targeting tumor cells about having by bystander effect and this is what you guys see it.

Speaker Change: <unk> ligands.

Speaker Change: We have this targeting of tumor SaaS plus the addition of a bystander effect and this is even more pronounced in the ADC field.

Speaker Change: So we will see a tremendous.

This transformation in the oncology, providing us the opportunity to open up indications, where we believe in the past patients.

Speaker 20: This is offering now the opportunity to treat patients with advanced diseases and not only with the disease, but bring in combinations and thereby ensure that even in patients with advanced disease, we really get a considerable clinical benefit.

Ozlem Tureci: And we are very excited about our HER2-ADC, the molecule BNT323, which we have partnered with Duality. And as Ugur pointed out earlier, in HER2, low breast cancer is looking for making a difference in this high-medical need population. You also have heard about our target, the hazard ratio, which we are targeting. Yeah, and we can't, of course, comment on the clinical trials of third parties.

Speaker Change: <unk> offer patients anything and this is also now the opportunity to treat patients with advanced diseases.

Ryan Richardson: This is offering now the opportunity to treat patients with advanced diseases and not only with the disease, but bring in combinations and thereby ensure that even in patients with advanced disease, we really get a considerable clinical benefit.

Speaker Change: And not only with adcs attain combinations and thereby thereby ensure that even in patients with advanced disease, They really get a considerable clinical benefit.

Speaker 22: Great. Thanks so much.

Simon Baker: Great. Thanks so much.

Speaker Change: Great. Thanks, so much.

Operator: Thank you. Your next question comes from the line of Ellie Merle from UBS. Please go ahead.

Speaker Change: Thank you.

Speaker Change: Your next question.

Speaker Change: It comes from the line of Ali Mello from UBS. Please go ahead.

Speaker 23: Hi, this is Sarah on for Ellie. Thanks so much for taking our question. Could you remind us the latest thinking about when we could see data from iNeST phase 2 randomized trial and what you're hoping to see there that would continue to give you guys confidence in the program and moving forward?

[Analyst] (UBS): Hi, this is Sarah on for Ellie. Thanks so much for taking our question. Could you remind us the latest thinking about when we could see data from iNeST phase 2 randomized trial and what you're hoping to see there that would continue to give you guys confidence in the program and moving forward?

Speaker Change: Hi, This is Sarah on for Elliot. Thanks, So much for taking our question.

Ozlem Tureci: Thank you. Your next question comes from the line of... Simon Baker from Redburn. Please go ahead. Thank you for taking my question; two quick ones if I may, the 2024 R&D guidance of 2.4 to 2.6 billion is a step up from 23 and against the plethora of studies you're running, that makes perfect sense, but I was wondering if this is the new normal and was wondering what you could say about the anticipated levels of R&D expense beyond 2024? And finally, there's been an awful lot of deal activity in Thanks very much. Yeah, happy to take the first question. So, as you pointed out correctly, of course, we are broadening, we have broadened our portfolio, we have more and more late stage clinical trials running, and those drive the costs up to a great extent yet. And going forward, you know, we haven't given any guidance here yet for the next 25 years. So, you know, we have got to bear with each other a little bit.

Sarah: Could you remind us the latest thinking.

Sarah: When we could see data from.

Sarah: <unk> phase two randomized trial, and what you're hoping to see there that would continue to give you guys confidence in the program and moving forward.

Speaker 20: To shortly, we will report iNeST data on our melanoma trial this year, latest in the H2 of this year, and we expect the next update for our colorectal cancer study end of 2025.

Ryan Richardson: To shortly, we will report iNeST data on our melanoma trial this year, latest in the H2 of this year, and we expect the next update for our colorectal cancer study end of 2025.

Sarah: Okay.

Speaker Change: Yeah. So.

Speaker Change: Shortly we believe part.

Data on our melanoma tie this year.

Speaker Change: The latest in the second half of this year.

Speaker Change: We expect the next update for our colorectal cancer study and end of 2025.

Speaker 23: Great. Thanks.

[Analyst] (UBS): Great. Thanks.

Speaker Change: Great. Thanks.

Operator: Thank you. We will now go to our final question for today. Your final question comes from the line of Manos Mastorakis from Deutsche Bank. Please go ahead.

Speaker Change: Thank you.

Speaker Change: We will now go to our final question for today.

Speaker Change: Until final question.

Comes from the line of.

Speaker Change: Manav most of our kids from Deutsche Bank. Please go ahead.

Speaker 24: Hello. Thank you. Quick question from us, Manos Mastorakis, Deutsche Bank. Just wanted to know what are the first Phase 3 readouts we will see for the rest of the portfolio in 2025 or beyond. I'm assuming nothing major in 2024. Please correct me if I'm wrong. Thank you.

Manos Mastorakis: Hello. Thank you. Quick question from us, Manos Mastorakis, Deutsche Bank. Just wanted to know what are the first Phase 3 readouts we will see for the rest of the portfolio in 2025 or beyond. I'm assuming nothing major in 2024. Please correct me if I'm wrong. Thank you.

Speaker Change: Okay.

Manav: Hello. Thank you so a quick question from us.

Manav: Manav I'm sorry, Deutsche Bank. So just wanted to know what are the first.

Jens H. Holstein: But of course, you know, late-stage clinical trials will cost some money; we will carefully look, you know, where we invest our money. You know, we have shown that in 23 already, where we had the same sort of range at the beginning, and then we reduced costs, also reflecting, you know, the pressure that we have faced on the top line regarding the COVID revenue figures that we had to adjust during 2023. So there is some level of insecurity; I think it's part of our job to manage our costs here.

Manav: Phase III Readouts, we will see for the rest of the portfolio.

Manav: 25, or beyond and I'm, assuming none.

Manav: Major in 2024.

Manav: Please correct me if I'm wrong.

Jens Holstein: Yeah. Thank you, Manos. We talked about a couple of different trials that we think could produce data.

Manav: Yes, Thank you Monica.

Speaker Change: So we talked about a couple of different trials that we think could produce data in.

Ryan Richardson: In 2025 ahead of product approvals if successful, and that includes the ongoing phase 2 randomized trial for iNeST and CRC that Uwe just mentioned. I mean, there's the potential for an interim update in H2 2025 or early 2026. We've also talked about the BNT323 program in refractory and second- and third-line endometrial cancer. Those initial readouts are likely to be phase 2, but we think they could have registrational potential if the data is strong. I think obviously the goal by the end of this year is to start many phase 3s. Some of those have already started, so we could have further data updates as well from the pipeline. Those are the two that I would point you to.

In 2025 ahead of product approvals and successful and that includes.

Monica: The phase II randomized trial for IMS and CRC.

Ozlem Tureci: And of course, we will do that in 24 and the ongoing years, but we will invest in the areas where we feel we create value for the company and value for the shareholders. That remains, you know, on top of our list going forward. Yeah, and the second part of your question about the attractiveness of radial vacancy.

Monica: We were just Uber just mentioned I mean, there is the potential for an interim update in the second half of 2025 or early 2026.

Monica: And we've also talked about.

Monica: The <unk> three program in refractory second third line endometrial cancer.

Ozlem Tureci: I would like to say, and I am repeating myself, oncology is in a transformation, and we will see this transformation ongoing in the next 10 to 15 years. And the transformation happens because there are new concepts, and one of the new concepts is targeting tumor cells but having a bystander effect. And this is what we are seeing in radioligins. So we have this targeting of tumor cells plus additional bystander effects, and this is even more pronounced in the ADC field.

Monica: Those initial readouts are likely to be phase III, but we think they could have registrational potential with the data is strong.

Monica: I think obviously the goal by the end of this year is to start many phase III. Some of those have already started so we could have further.

<unk> updates as well from the pipeline, but those are the two that I would that I would point you to.

Speaker 25: Thank you.

Manos Mastorakis: Thank you.

Monica: Okay.

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

Speaker Change: Thank you.

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

Speaker Change: Okay.

Speaker Change: [music].

Ozlem Tureci: So we will see really tremendous transformation in oncology, providing us the opportunity to open up indications where we believed in past patients that we couldn't offer patients anything, and this is offering now the opportunity to treat patients with advanced diseases, and not only with their disease, but combinations and thereby ensure that even in patients with advanced disease, they really get a contributory clinical benefit. Thanks so much. Thank you. Your next question comes from the line of Ellie Merle from UBS. Please go ahead. Hi, this is Sarah on behalf of LA.

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Unknown Executive: Thanks so much for taking our question. Could you remind us of the latest thinking about when we could see data from the INAST phase two randomized trial and what you're hoping to see there that would continue to give you guys confidence in the program and moving forward? Okay. Yeah, so shortly we will report INS data on our melanoma trial this year, latest in the second half of this year, and we expect the next update for our colorectal cancer study at the end of 2021. Great things are ahead.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Tim.

Speaker Change: [music].

Unknown Executive: Thank you. We will now go to our final question for today. And your final question comes from the line of... Manos Masarakis from Deutsche Bank, please go ahead. Hello, thank you. So, a quick question from us.

Unknown Executive: So, just wanted to know what are the first phase three readouts we will see for the rest of the portfolio in 2025 or beyond? And I'm assuming nothing major in 2024. Please correct me if I'm wrong.

Speaker Change: Okay.

[music].

Okay.

Speaker Change: [music].

Unknown Executive: Thank you. Yeah, thank you, Maz. So we've talked about a couple of different trials that we think could produce data in 2025, ahead of product approvals, and that includes the phase two randomized trial for INEST and CRC, that Ugur just mentioned. There's the potential for an interim update in the second half of 2025 or early 2026. And we've also talked about the BNT 323 program in refractory and second, third-line endometrial cancer. So those initial readouts are likely to be phase two, but we think they could have registrational potential based on the data. I think, obviously, the goal by the end of this year is to start many phase three projects. Some of those have already started. So we could have further data updates as well from the pipeline, but those are the two that I would point out.

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Unknown Executive: Thank you, thank you. Thank you. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Tazeen Ahmad, Terence Flynn, Yaron Werber, William Maughan, Eliana Merle, Michael Wenger, Daina Graybosch, Ugur Sahin, Ryan Richardson, Zhiqiang Shu, Akash Tewari, Victoria Meissner, Karim Beguir, Ilhan Celik, Michael Wenger, BioNTech, Thank you for watching! Tazeen Ahmad, Terence Flynn, Yaron Werber, William Maughan, Eliana Merle, Michael Wenger, Daina Graybosch, Ugur Sahin, Ryan Richardson, Zhiqiang Shu, Akash Tewari, Victoria Meissner, Karim Beguir, Ilhan Celik, Michael Wenger, BioNTech

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Sure.

Q4 2023 BioNTech SE Earnings Call

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