Q1 2024 BioNTech SE Earnings Call

May 6, 2024

Operator: Welcome to BioNTech First Quarter 2024 Earnings Call. I would like to hand, the call over to Dr. Victoria Meissner; Vice President of Strategy and Investor Relations. Please go ahead.

Welcome to buoy on tax first quarter 'twenty 'twenty four earnings call I would like to hand, the call over to Dr. Victoria Myself, Vice President of strategy and Investor Relations. Please go ahead.

Thank you good morning, and good afternoon. Thank you for joining BioNTech First Quarter 2024 Earnings Call. A reminder, the slides we will be using on the call and the corresponding press release, published this morning can be found at Investor Relations section of our website. On the next slide you'll 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 First Quarter 2024 Earnings Call. A reminder, the slides we will be using on the call and the corresponding press release, published this morning can be found at Investor Relations section of our website.

Thank you for joining <unk> first quarter 'twenty 'twenty four earnings call.

A reminder, the slides we will be using the oldest called <unk>.

Speaker Change: And the corresponding press release, we issued this morning can be found at Investor Relations section of our website.

On the next slide, you'll 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 and speak only as the date of this conference call. We undertake no obligation to update or revise any of these statements.

On the next slide you'll 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 and speak only as of the date of this conference call. We undertake no obligation to update or revise any of these statements.

We undertake no obligation to update or revise any of these statements.

On slide 3, you can find the agenda for today's call. Today I'm joined by the following members of beyond exploration team. Ugur Sahin, Chief Executive Officer and Co-Founder; 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.

On slide 3, you can find the agenda for today's call. Today I'm joined by the following members of BioNTech's management team. Ugur Sahin, Chief Executive Officer and Co-Founder; Özlem Türeci, Chief Medical Officer and Co-Founder; Jens Holstein, Chief Financial Officer, and Ryan Richardson, Chief Strategy Officer.

Speaker Change: Today I'm joined by the following members of beyond exploration team.

Ooh Stein, Chief Executive Officer, and co founder.

Atlanta, Ritchie, Chief Medical Officer, and co founder.

Yeah, So our Stein Chief Financial Officer, and Ryan Richardson, Chief Strategy Officer.

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

I would like to hand over to her.

Ugur Sahin: Thank you, Victoria. A warm welcome to all those joining us today. We believe that we are entering a transformational period for BioNTech. We have founded BioNTech with the vision to discover and develop scientific growth to harness the immune system to fight diseases and bring new medicines to patients. In the years following our establishment, we developed various tire platform, demonstrate the safety and clinical effectiveness of drug candidates in early clinical trials. The period from now to 2030 is about progressing this candidate into late-stage development and registrational hires to become a market product company was the first product to be delivered by our late-stage oncology pipeline.

We believe that we are entering a transformational period for <unk>. We have found it undertake with submission to discover and develop scientific great booth to tarnish the immune system to fight diseases and bring new medicines to patients in. In the years following our establishment. Various third party platform demonstrate the safety and clinical effectiveness of dairy. Candidates in early clinical cuts to periods from now to 2030 is about progressing this candidate into late stage development and registration paths to become a market product company was the first product to be delivered by our late stage oncology pipeline.

We have found it undertake with submission to discover and develop scientific great booth to tarnish the immune system to fight diseases and bring new medicines to patients in.

In the years following our establishment.

Speaker Change: Various third party platform demonstrate the safety and clinical effectiveness of dairy.

Candidates in early clinical cuts to periods from now to 2030 is about progressing this candidate into late stage development and registration paths to become a market product company was the first product to be delivered by our late stage oncology pipeline.

Speaker Change: We are continuing to execute especially in our strategic priorities with its intense focus. In the first quarter, we progressed, our late-stage oncology pipeline on multiple fronts. We dosed the first patient in the pivotal Phase III clinical trial evaluating our HER2 ADC BNT323 in HR-positive HER2 low metastatic breast cancer. At the AACR Annual Meeting we presented 3 year follow-up data from our clinical trials evaluating our individualized cancer vaccine AUTOGENE CEVUMERAN vaccine in pancreatic cancer. .

In the first quarter, we progressed, our late stage oncology pipeline on multiple fronts.

The first patient in the pivotal phase III clinical tie everything over her two ADC BNP to sweep in HR positive to load metastatic breast cancer.

ACR annual meeting.

Presented two year follow up data from our clinical trials.

Or into that monarch is a vaccine or <unk>.

One in Connecticut.

This data showed encouraging relapse free survival in certain patients with immunogenic response to the vaccine, demonstrating the promise of our vaccine platform to induce consistent de novo neoantigen-specific T cell responses that correlate with improvements in survival. We have also taken significant.

We have also taken significant steps for our first launches in oncology. Annemarie Hanekamp an accomplished leader with a remarkable track record is joining our team in July to drive and execute our global commercialization strategy. We appointed a general manager in the U.S. who has commenced building out our commercial operations in the U.S. We appointed further expertise in our global commercial team for our COVID-19 vaccine franchise initiated preparations to unpack to introduce a new variant adaptive COVID-19 vaccine for the upcoming season, we have received preliminary strain selection recommendations from the task. Organization and the European Medicine.

We have also taken significant.

Our first tranche is in oncology. Annemarie hanukkah and our country's EWC a remarkable track record is joining our team in July to drive and execute our global commercialization strategy.

Annemarie hanukkah and our country's EWC a remarkable track record is joining our team in July to drive and execute our global commercialization strategy.

We appointed a general manager in the U S who has commenced building out our commercial operations in the U S. We appointed Feta expertise and our global commercial team for our COVID-19 vaccine franchise initiated preparations to unpack to introduce a new variant adaptive COVID-19 vaccine for the upcoming season, we have received preliminary strain selection recommendations from the task. Organization and the European Medicine.

We appointed Feta expertise and our global commercial team for our COVID-19 vaccine franchise initiated preparations to unpack to introduce a new variant adaptive COVID-19 vaccine for the upcoming season, we have received preliminary strain selection recommendations from the task.

For our COVID-19 vaccine franchise initiated preparations to be on track to introduce a new variant adaptive COVID-19 vaccine for the upcoming season. We have received preliminary strain selection recommendations from the World Health organization and the European Medicine Agency and plan to submit for regulatory approval later this month. Today, Özlem and I are focus on our oncology strategy, while Jens and Ryan will provide updates on our financial and corporate progress.

Organization and the European Medicine.

Agency and plan to submit for regulatory approval later this month.

And is the focus on our oncology strategy by yes, and Brian will provide updates on our financial and corporate progress.

Slide 6. Our oncology portfolio strategy is driven by understanding the key challenges in cancer. Cancer is genetically diverse and heterogeneous disease driven by the substantial acquisition of mutations. One consequence of this is that many treatments have an initial effect, but are not associated with long term remission or cure.

Our oncology portfolio strategy is driven by understanding the key challenges in cancer cancer is genetically diverse and heterogeneous disease driven by the substantial acquisition of mutations and consequence of this is that many initial.

Initial effect, but are not associated with long term remission or cure.

Brian: Our aim is to provide solutions across the continuum of cancer disease and establish a new treatment paradigm. We believe our cancer vaccine candidates are particularly suited for early intervention, while thoughtfully designed combination treatments are intended for our clients and high volume tumors. We want to bring our therapies to as many patients as possible and we want to use the potential power of our platform alone and in combination.

We believe our cancer vaccine candidates are particularly suited for early intervention.

Not fully defined combination treatments are intended for our clients and high volume tumors, we want to bring our therapies to as many patients as possible and we want to use the potential power of our platform alone and in combination.

Slide 8, our center project strategy brings together synergistic mechanisms of action across key categories. The first our novel immune modulators or IO, which are designed to engage the immune system overcome cancer mediated immune suppression and amplify immune responses. Second, targeted therapies, which include CAR-T cell therapies, and antibody drug conjugates that can dramatically reduce the tumor gap. The third category are mRNA vaccines, which are the centerpiece of our oncology strategy. Our mRNA cancer vaccines are designed to target multiple cancer antigens in parallel and can be individualized for each patient. BioNTech was built from the very beginning as a technology agnostic company. We do not limit ourselves to any one technology. We are interested in addressing unmet medical need with the best possible solutions. Having a diversity of assets in our pipeline, we are positioned to pursue combination approaches that are proprietary and unique.

Brian: First our novel immune modulators or <unk>, which are designed to engage the immune system overcome cancer mediated immune suppression and amplify immune responses.

Second targeted therapies, which include car T cell therapies, and anti body drug conjugates that can dramatically reduce the tumor but the.

The third category and <unk>, which are the centerpiece of our oncology strategy.

The amount of cancer vaccines are designed to target multiple cancer antigens in parallel and can be individualized for each patient.

<unk> was built from the very beginning as a technology agnostic company, we do not limit our SaaS to any one technology. We are interested in addressing unmet medical need with the best possible solutions. Diversity of assets in our pipeline, we are positioned to pursue combination approaches that are popular Italy and unique.

Diversity of assets in our pipeline, we are positioned to pursue combination approaches that are popular Italy and unique.

This strategic advantage allow us to evaluate the activity of each individual compound and enables us to determine dose patient population for which monotherapy or the logistic combinations are best suited. The potential for synergy in this combination is significant, enabling us to define treatment regimen that could lead to improved patient outcomes and broaden the scope of therapeutic options. We believe that our strategy has the potential to address fundamental challenges of cancer and to drive meaningful improvements in the long-term survival rates for patients.

The potential for synergy in this combination is significant enabling us to define treatment regimen that could lead to improved patient outcomes and broaden the scope of therapeutic options. We believe that our strategy has the potential to address fundamental challenges of cancer and to drive meaningful improvements in the lung.

Term survival rates for patients.

Slide 9. To iterate, we are entering a transformative period for BioNTech specifically in the development of our oncology pipeline and the formation of our oncology business, which will continue to evolve over the next few years. In 2024, we are aiming to increase the number of potential pivotal trials across our lead programs to 10 or more by year-end. These trial will focus on areas of unmet medical need clinical indications in which we may achieve an expedited path to market and that after the first approval in the initial indication is a high potential for expanding the market opportunity to additional indications. Starting in 2025, and continuing into the following years, we expect to enter a period, which was pivotal data that if positive could support regulatory submissions for marketing authorization across our pipeline.

We iterate, we are entering a transformative period for biotech specific in the development of our oncology pipeline and the formation of our oncology business, which will continue to evolve over the next few years in 2024, we are aiming to increase the number of potential pivotal trials across our lead programs to turn on.

By year end.

These tie with focus on areas of unmet medical need clinical indications in which we may achieve an expedited path to market and that after the first approval in the initial indication is a high potential for expanding the market opportunity to additional indications starting in 'twenty.

25, and continuing into the following years, we expect to enter a period, which was pivotal data that if positive could support regulatory submissions for marketing authorization across our pipeline.

Starting in 2025, and continuing into the following years, we expect to enter a period, which was pivotal data that if positive could support regulatory submissions for marketing authorization across our pipeline. We have begun building a fully integrated oncology organization to support our transition into a global multi product company. This process will be accelerated this year, as we bring our new Chief Commercial Officer onboard. Ultimately, we are building our organization to support multiple oncology launches beginning in 2026.

We have begun building a fully integrated oncology organization to support our transition into a global multi product company. This process will be accelerated this year, as we bring our new Chief Commercial Officer onboard. Ultimately, we are building our organization to support multiple oncology launches beginning in 2026. With that, I would like to thank you all for your ongoing support, I will now turn the call over to Özlem. Thank you.

This process will be accelerated this year as we bring our new chief commercial officer onboard.

Ultimately we are building our organization to support multiple oncology launches beginning in 2026 with that I would like to thank you all for your ongoing support I will now turn the call over to <unk>.

With that, I would like to thank you all for your ongoing support, I will now turn the call over to Özlem.

Thank you.

Özlem Türeci: Thank you, Ugur. Glad to be speaking with everyone today. As Ugur highlighted, we are very focused in the next few years on increasing the number of potentially pivotal clinical trials to fuel our transition to what's becoming a multiproduct company by 2030.

Glad to be speaking with everyone today.

As was highlighted we are very focused in the next few years on increasing the number of potentially pivotal clinical trials to fuel our transition to what's becoming a multi product company by 2020.

In oncology, we have already started to execute against this goal. This is why you can see that for the next stage part of our pipeline on this slide, is enriched and populated with multiple trials that feature our priority assets such as our mRNA vaccines and also our most advanced ADCs and IOs, including those which we consider as attractive exports of unique combination treatments. To highlight recent additions to our pipeline. One is the Phase III trial in collaboration with DualityBio evaluating the BNT323 in patients with hormone receptor positive and HER2-low metastatic breast cancer that has progressed on hormone therapy, and/or cyclin-dependent kinase for $6. With BNT323, we are also planning to start a confirmatory Phase III trial.

Advanced ADC anti. Including those which we consider as attractive exports of unique combination treatments. To highlight recent additions to our pipeline one of the phase III trial in collaboration with <unk>. <unk> <unk> hundred two three in patients with hormone receptor positive and her two low metastatic breast cancer that has progressed on hormone therapy. Our cyclin dependent kinase plus fixed price. With the anti <unk> three and we are also planning to start a confirmatory phase III trial.

Including those which we consider as attractive exports of unique combination treatments.

To highlight recent additions to our pipeline one of the phase III trial in collaboration with <unk>.

<unk> <unk> hundred two three in patients with hormone receptor positive and her two low metastatic breast cancer that has progressed on hormone therapy.

Our cyclin dependent kinase plus fixed price.

With BNT323, we are also planning to start a confirmatory Phase III trial this year in patients with metastatic endometrial cancer that will complement our ongoing single arm trial in this indication. In our early-stage pipeline, we have started the Phase I/II trial in collaboration with Genmab evaluating BNT314 a bispecific antibody product candidate with dependent--EpCAM dependent 4-1BB agonistic activity in multiple solid tumors. Our aim is to continue to progress our oncology pipeline towards pivotal data readouts and submissions for regulatory approval in the next 18 months. Before highlighting some of the programs and platforms that we consider our priority assets to contribute clinical progress, let me say a couple of words to execution.

With the anti <unk> three and we are also planning to start a confirmatory phase III trial.

Yes in patients with metastatic endometrial cancer that will complement our ongoing single arm trial. Indication. No what early stage pipeline, we have started the phase one two trial in collaboration with Genmab evaluating BMT three one for a bispecific antibody product candidate was. Pendants, one BP agonistic activity in multiple solid tumors. Our aim is to continue to progress our oncology pipeline towards pivotal data readouts and submissions for regulatory approval in the next 18 months before highlighting some of the programs.

Indication.

No what early stage pipeline, we have started the phase one two trial in collaboration with Genmab evaluating BMT three one for a bispecific antibody product candidate was.

Pendants, one BP agonistic activity in multiple solid tumors.

Our aim is to continue to progress our oncology pipeline towards pivotal data readouts and submissions for regulatory approval in the next 18 months before highlighting some of the programs.

Before highlighting some of the programs and platforms that we consider our priority assets to contribute clinical progress, let me say a couple of words to execution. The coming years will be about late-stage clinical trial execution, enrolling the patients to participate in clinical trials require coordination across multiple functions within our company and with our partners and collaborators who are integral part of our global trial execution approach. As we and our partners have increased the number of ongoing late-stage trials. We have also drastically increased the number of patients that participate in trial generating data for our fully owned and partner product candidates.

Once that we consider our priority assets to contribute clinical progress, let me say a couple of words to execution. The coming years with me about late stage clinical trial execution and eroding the patients to participate in clinical trials require coordination across multiple functions within our company and with our partners and collaborators who are integral part of our global Tri Ed. Execution approach as we and our partners have increased the number of ongoing late stage trials. We have also drastically increased the number of patients that participate in triad generating data for our fully owned <unk>. <unk> product candidates.

Once that we consider our priority assets to contribute clinical progress, let me say a couple of words to execution.

The coming years with me about late stage clinical trial execution and eroding the patients to participate in clinical trials require coordination across multiple functions within our company and with our partners and collaborators who are integral part of our global Tri Ed.

The coming years will be about late-stage clinical trial execution, enrolling the patients to participate in clinical trials require coordination across multiple functions within our company and with our partners and collaborators who are integral part of our global trial execution approach. As we and our partners have increased the number of ongoing late-stage trials. We have also drastically increased the number of patients that participate in trial generating data for our fully owned and partner product candidates.

As we and our partners have increased the number of ongoing late-stage trials. We have also drastically increased the number of patients that participate in trial generating data for our fully owned and partner product candidates.

Brian: Execution approach as we and our partners have increased the number of ongoing late stage trials. We have also drastically increased the number of patients that participate in triad generating data for our fully owned <unk>.

<unk> product candidates.

Compering the average quarterly number of patients enrolled across the last few years, here on this slide, our quarterly average in 2022 through the first quarter of 2024, we have increased the number of patients enrolled by over 40%. On the back of the significant increase in enrollment and task progress and clinical trial execution. We expect our clinical development pipeline to generate a corresponding increase in the number of data sets in the coming year or I can let's call. It bion tickets to bring our data scientific breakthroughs to patients in need.

And Thats progress and clinical trial execution, we expect syndicate development pipeline to generate a corresponding increase in the number of data sets in the coming year or I can let's call. It bion tickets to bring our data scientific breakthroughs to patients in need.

Our ultimate goal at BioNTech is to bring our data scientific breakthroughs to patients in need. Moving to our priority assets, let me start with BNT327 or PM8002 a bispecific antibody, consisting of an anti-VEGF-AFC silence IgG fused humanized anti-PD-L1 VHH binder being developed in collaboration with our partner Biopsies, BNMT327 combined 2 validated mechanisms of action. VEGF-A binding inhibitor VEGF-A, VEGF-R axis blocks tumor angiogenesis, which leads to reduced tumor cell proliferation and survival. VEGF-A inhibition also contact formation of the immune-suppressive tumor microenvironment as does the PD-L1 arm of this bispecific antibody by reverting PD-L1, PD-L1 axis mediated T-cell exhaustion.

Moving to our priority assets, let me start with BMT free to seven RPM H or tool. Specific anti body, consisting of an anti VEGF AFC silence ITG fused humanized anti PDL, one PHH finder being developed in collaboration with our partner biopsies Yankee three to seven combined two.

Specific anti body, consisting of an anti VEGF AFC silence ITG fused humanized anti PDL, one PHH finder being developed in collaboration with our partner biopsies Yankee three to seven combined two.

Hey, David mechanisms of action. V-chip eight binding inhibitor of VEGF eight VEGF R. X's last tumor angiogenesis, which leads to reduced two months had proliferation and surfactant.

V-chip eight binding inhibitor of VEGF eight VEGF R. X's last tumor angiogenesis, which leads to reduced two months had proliferation and surfactant.

<unk> inhibition also contact formation of the immune suppressive tumor microenvironment and stuff the PDL, one offset by specific anti body by reworking PD, one PD, one excess mitigated T cell exhaustion.

Brian: The PD-L1 arm also anchors this antibody to the tumor [Inaudible] for efficient and localized scavenging of VEGF-A, which may contribute to mitigate off-tumor on target side effects. Data from our ongoing Phase I/II clinical trials across several indications in over 600 patients executed by our partner Biotheus have shown a favorable safety profile. Our partner Biotheus presented selected examples of this compound performance in 2023, showing strong single compound activity and high response rates in combination with chemotherapy in triple negative breast cancer, and small cell lung cancer. In first-line TNBC in combination with PACLITAXEL, almost 80% objective response rate as shown on this slide.

The PD-L1 arm also anchors this antibody to the tumor [Inaudible] for efficient and localized scavenging of VEGF-A, which may contribute to mitigate off-tumor on target side effects. Data from our ongoing Phase I/II clinical trials across several indications in over 600 patients executed by our partner Biotheus have shown a favorable safety profile. Our partner Biotheus presented selected examples of this compound performance in 2023, showing strong single compound activity and high response rates in combination with chemotherapy in triple negative breast cancer, and small cell lung cancer.

Odds to anchor this anti body to the tune opex for efficient and localized scavenging off the TSA, which may contribute to mitigate. Timna on target side effects. Data from our ongoing phase one two clinical trials. Across several indications in over 600 patients executed by our partner <unk> have shown a favorable safety profile.

Timna on target side effects. Data from our ongoing phase one two clinical trials. Across several indications in over 600 patients executed by our partner <unk> have shown a favorable safety profile.

Data from our ongoing phase one two clinical trials.

Across several indications in over 600 patients executed by our partner <unk> have shown a favorable safety profile.

<unk> presented selected examples of.

This compound performance in 2023, showing strong signals from connectivity and high response rates in combination with chemotherapy in triple negative breast cancer, and small cell lung cancer and.

<unk> in combination with Nab Paclitaxel, almost 80% objective response rate as shown on this slide.

In first-line TNBC in combination with PACLITAXEL, almost 80% objective response rate as shown on this slide. At ASCO now, there will be more data disclosure in cervical, in ovarian cancer, and non-small cell lung cancer. An investigational new drug application has been accepted by the FDA for further studies in the United States and we plan to start global trials in several indications this year. One area that we're seeing increased development activity in the coming years will be our mRNA cancer vaccine candidates. mRNA cancer vaccines are centerpiece of our pipeline and are pivotal to our goal of developing breakthrough for cancer patients. The aim is to develop this technology as monotherapy in combination with standard of care and in combination with candidates from our proprietary pipeline.

Our school now that will be more data this quarter and sorry, if I could. Ovarian cancer, and non small cell lung cancer and investigational new drug application has been accepted by the FDA for further studies in the United States and we plan to stop global trials in several indications this year. One area that we're seeing increased development activity in the coming years will be our mrna cancer vaccine candidates and all. Rene cancer vaccines. Centerpiece of our pipeline and our board of developing breakthrough for cancer patients.

Ovarian cancer, and non small cell lung cancer and investigational new drug application has been accepted by the FDA for further studies in the United States and we plan to stop global trials in several indications this year.

One area that we're seeing increased development activity in the coming years will be our mrna cancer vaccine candidates and all.

Rene cancer vaccines.

Centerpiece of our pipeline and our board of developing breakthrough for cancer patients.

The aim is to develop this technology has been one of Europe's in combination with standard of care and in combination with candidates from our proprietary pipeline. <unk> youth sets of multiple antigens chef by patients across one tumor type. Our individualized vaccine program partnered with Genentech identifies neo antigens derived from cancer mutations that are unique to an individual consumer while the IMAX and <unk> target different types of cancer antigens. They are based on that same mrna.

The aim is to develop this technology has been one of Europe's in combination with standard of care and in combination with candidates from our proprietary pipeline.

<unk> youth sets of multiple antigens chef by patients across one tumor type.

Our FIXVAC vaccine use sets of multiple antigens shared by patients across one tumor type. iNeST our individualized vaccine program partnered with Genentech identifies neoantigens derived from cancer mutations that are unique to an individual consumer. While iNeST and FIXVAC target different types of cancer cell antigens, they are based on that same mRNA and delivery technology, namely, our uridine mRNA-lipoplex platform. Distinct mechanism of action is that the delivered antigen that's presented by professional antigen presenting cells lymphoid compartment body in white in close proximity to T cells to be induced and. That it comes with intrinsic adjuvant <unk>. These features by design promote induction of kind of magnitude T cell immune responses that we have been detecting and all of our clinical trials across tumor types and for various types of targeted cancer antigens as shown on the right hand side of this slide.

Our individualized vaccine program partnered with Genentech identifies neo antigens derived from cancer mutations that are unique to an individual consumer while the IMAX and <unk> target different types of cancer antigens. They are based on that same mrna.

Delivery technology, namely, our Oregon mrna like Opex platform. Distinct mechanism of action is that the delivered antigen that's presented by professional antigen presenting cells lymphoid compartment body in white in close proximity to T cells to be induced and. That it comes with intrinsic adjuvant <unk>. These features by design promote induction of kind of magnitude T cell immune responses that we have been detecting and all of our clinical trials across tumor types and for various types of targeted cancer antigens as shown on the right hand side of this slide.

Its distinct mechanism of action is that the delivered antigen that's presented by professional antigen-preventing cells lymphoid compartment body-wide in close proximity to T-cells to be induced and that it comes with intrinsic adjuvanticity. These features by design promote induction of kind of magnitude T-cell immune responses that we have been detecting in all of our clinical trials across tumor types and for various types of targeted cancer antigens as shown on the right hand side of this slide.

Distinct mechanism of action is that the delivered antigen that's presented by professional antigen presenting cells lymphoid compartment body in white in close proximity to T cells to be induced and.

That it comes with intrinsic adjuvant <unk>.

These features by design promote induction of kind of magnitude T cell immune responses that we have been detecting and all of our clinical trials across tumor types and for various types of targeted cancer antigens as shown on the right hand side of this slide.

On the next slide, you can see exemplary data from different trials and different treatment settings, and tumor types in which we are evaluating our neoantigen based individualized cancer vaccines, including several years of follow-up. Our mRNA based neoantigen vaccine has demonstrated the ability to induce the novo neoantigen-specific functional polyspecific and consistent T-cell responses at substantial magnitude and high proportions of treated patients. Frequently, against tumor antigens that are overlooked by the patient's immune system, so called the novo immune responses.

Our mrna based neo antigen vaccine has demonstrated the ability to induce the novel antigen specific 40, functionally 40 specific and consistent set of responses at substantial magnitude and high proportions of treated patients.

Brian: Frequently against tumor antigens that are overlooked by the patients immune system. So card scheme novel immune responses.

We have shown that our vaccine induced T-cell persist over years and build immunological memory. In the 2 papers quoted on this slide we have shown that vaccination with neoantigens and encoding mRNA is associated with reduction of recurrence in patients. The favorite setting for developing our individualized vaccines are patients who have minimal residual disease or require adjuvant treatment to reduce the probability of recurrence.

Thank you for joining us vaccines are patients who have minimal residual disease.

Our adjuvant treatment to reduce the probability of recurrence.

Today, we have iNeST and FIXVAC trials in multiple disease settings, and indications and data releases from several of the trials shown on this slide are planned. In our FIXVAC program, we are evaluating 4 vaccine candidates, which each target tumor associated antigens specific to melanoma, HPV 16 positive head and neck cancer, prostate cancer and non-small lung cancer as monotherapy and in several combinations.

We expect program, we are evaluating four vaccine candidates, which each target tumor associated antigens specific to melanoma, HPV 16 positive head and neck cancer prostate cancer and non small lung cancer is one of Europe's and integral combination.

We shared early data for all FIXVAC candidates in the past years and plan to present additional data this and next year. Further we plan to start an additional trial with iNeST in the adjuvant setting with our collaborator Genentech. I would like to highlight 3 of these programs that are on our priority list. Two programs using our individualized cancer vaccine in cancer types that have a low tumor mutational burden and are resistant to immunotherapy, namely colorectal cancer and PDAC and our NSCLC FIXVAC program. Starting with CRC, with colorectal cancer, the majority of patients with early-stage localized and receptor CRC undergo surgery, followed by adjuvant chemotherapy, standard of care in stage 2 high risk and stage 3 disease after adjuvant treatment is watchful waiting 20% to 35% of patients experience recurrence of their disease. <unk> is a marker for minimal residual disease and identify patients with. With higher risk of perhaps recurrence.

We shared early data for all FIXVAC candidates in the past years and plan to present additional data this and next year. Further we plan to start an additional trial with iNeST in the adjuvant setting with our collaborator Genentech. I would like to highlight 3 of these programs that are on our priority list. Two programs using our individualized cancer vaccine in cancer types that have a low tumor mutational burden and are resistant to immunotherapy, namely colorectal cancer and PDAC and our NSCLC FIXVAC program. Starting with CRC, with colorectal cancer, the majority of patients with early-stage localized and receptor CRC undergo surgery, followed by adjuvant chemotherapy, standard of care in Stage 2 high risk and Stage 3 disease after adjuvant treatment is watchful waiting 20% to 35% of patients experience recurrence of their disease.

We plan to start an additional trial with <unk> in the adjuvant setting with our collaborator Genentech. Would like to highlight three of these programs that are on our priority list two programs using our individualized cancer vaccine in cancer types that Kevin no tumor mutational burden and are resistant to immunotherapy, namely colorectal cancer and <unk> and NFC.

Would like to highlight three of these programs that are on our priority list two programs using our individualized cancer vaccine in cancer types that Kevin no tumor mutational burden and are resistant to immunotherapy, namely colorectal cancer and <unk> and NFC.

<unk> SEC program.

Starting with Trc with colorectal cancer, the majority of patients with early stage localized and respect to the CRC and Diebold surgery, followed by adjuvant chemotherapy standard of care in stage, two high risk and stay treating fees after adjuvant treatment.

Watchful waiting 20% to 35% of patients experienced recurrence of their disease. <unk> is a marker for minimal residual disease and identify patients with. With higher risk of perhaps recurrence.

ctDNA is a marker for minimal residual disease and identify patients with higher risk of such recurrence. We are running a Phase II trial with our individualized vaccine in Stage 2 high-risk and Stage III resected CRC patients that are ctDNA positive post surgery. After adjuvant chemotherapy patients are randomized to either receive AUTOGEN CEVUMERAN or individualized vaccine observation. We expect the first readout of this trial in the second half of 2025. Secondly, our randomized Phase II clinical trial evaluating our individualized vaccine in combination with the anti-PD-L1 agent ATEZOLIZUMAB followed by standard of care chemotherapy in patients with resected pancreatic cancer or PDAC compared to chemotherapy alone was started in collaboration with Genentech in 2023 and is recruiting patients.

<unk> is a marker for minimal residual disease and identify patients with.

With higher risk of perhaps recurrence.

We are running a phase II trial. With our individualized vaccine in stage, two hiring and stage III redacted CRC patients that are <unk> eight positive post surgery. After adjuvant chemotherapy patients are randomized to either receive arterton several neuron or individualized vaccine observation. We expect the first readout of this trial and the second half of 2025. Secondly, our randomized phase two clinical trial evaluating our individualized vaccine in combination with the anti PD one agent at this police them up followed by standard of care chemotherapy in patients with resected pancreatic cancer PDOC compared to Q. After adjuvant chemotherapy patients are randomized to either receive arterton several neuron or individualized vaccine observation. We expect the first readout of this trial and the second half of 2025. Secondly, our randomized phase two clinical trial evaluating our individualized vaccine in combination with the anti PD one agent at this police them up followed by standard of care chemotherapy in patients with resected pancreatic cancer PDOC compared to Q.

With our individualized vaccine in stage, two hiring and stage III redacted CRC patients that are <unk> eight positive post surgery. After adjuvant chemotherapy patients are randomized to either receive arterton several neuron or individualized vaccine observation. We expect the first readout of this trial and the second half of 2025. Secondly, our randomized phase two clinical trial evaluating our individualized vaccine in combination with the anti PD one agent at this police them up followed by standard of care chemotherapy in patients with resected pancreatic cancer PDOC compared to Q. After adjuvant chemotherapy patients are randomized to either receive arterton several neuron or individualized vaccine observation. We expect the first readout of this trial and the second half of 2025. Secondly, our randomized phase two clinical trial evaluating our individualized vaccine in combination with the anti PD one agent at this police them up followed by standard of care chemotherapy in patients with resected pancreatic cancer PDOC compared to Q.

After adjuvant chemotherapy patients are randomized to either receive arterton several neuron or individualized vaccine observation. We expect the first readout of this trial and the second half of 2025. Secondly, our randomized phase two clinical trial evaluating our individualized vaccine in combination with the anti PD one agent at this police them up followed by standard of care chemotherapy in patients with resected pancreatic cancer PDOC compared to Q.

Secondly, our randomized phase two clinical trial evaluating our individualized vaccine in combination with the anti PD one agent at this police them up followed by standard of care chemotherapy in patients with resected pancreatic cancer PDOC compared to Q.

Brian: If European loan what started in collaboration with Genentech in 2023 and is recruiting patients. It's a high medical need to not expect it to become the second leading cause in cancer related deaths up to 85% of patients with localized pancreatic cancer, that's under Goldstein co infection and adjuvant chemotherapy. Theory recurrence of disease. This trial was initiated based on data from an investigator initiated trial that were published last year. And updated at ACR, a few weeks ago that phase one trial showed that with our individualized vaccine combined with potentially some up and standard of care adjuvant chemotherapy half off of 16 treated patients develop high magnitude vaccine induced immune responses and that these patients have a much lower.

If European loan what started in collaboration with Genentech in 2023 and is recruiting patients.

PDAC is a high medical need tumor expect it to become the second leading cause in cancer related death. Up to 85% of patients with localized pancreatic cancer, that undergo surgical resection and adjuvant chemotherapy do experience recurrence of disease. This trial was initiated based on data from an investigator initiated trial that were published last year and updated at ACR, a few weeks ago. That Phase I trial showed that with our individualized vaccine combined with ATEZOLIZUMAB and standard of care adjuvant chemotherapy half of the 16 treated patients develop high magnitude vaccine-induced immune responses and that these patients have a much lower risk of tumor recurrence at 1.5 years of median follow up and continue to do so after a 3-year follow up period.

It's a high medical need to not expect it to become the second leading cause in cancer related deaths up to 85% of patients with localized pancreatic cancer, that's under Goldstein co infection and adjuvant chemotherapy. Theory recurrence of disease. This trial was initiated based on data from an investigator initiated trial that were published last year. And updated at ACR, a few weeks ago that phase one trial showed that with our individualized vaccine combined with potentially some up and standard of care adjuvant chemotherapy half off of 16 treated patients develop high magnitude vaccine induced immune responses and that these patients have a much lower.

Theory recurrence of disease. This trial was initiated based on data from an investigator initiated trial that were published last year. And updated at ACR, a few weeks ago that phase one trial showed that with our individualized vaccine combined with potentially some up and standard of care adjuvant chemotherapy half off of 16 treated patients develop high magnitude vaccine induced immune responses and that these patients have a much lower.

This trial was initiated based on data from an investigator initiated trial that were published last year. And updated at ACR, a few weeks ago that phase one trial showed that with our individualized vaccine combined with potentially some up and standard of care adjuvant chemotherapy half off of 16 treated patients develop high magnitude vaccine induced immune responses and that these patients have a much lower.

And updated at ACR, a few weeks ago that phase one trial showed that with our individualized vaccine combined with potentially some up and standard of care adjuvant chemotherapy half off of 16 treated patients develop high magnitude vaccine induced immune responses and that these patients have a much lower.

Robert of tumor recurrence at one five years of median follow up and continue to do so after a three year follow up period. Moving to allow for shaft tumor associated antigen based mrna cancer vaccine candidate <unk> 16, <unk> 16 is in the R&D line. <unk> cancer vaccine candidate comprising six M. Rnas each encoding a tumor associated antigen MAGE a free card in six <unk>, one frame Mitch a form HC one. We have selected these tumor associated antigens by and cynical approach developed projects are not expect X gene for different tumor types and based on low or lack of expression and toxicity you write up in all kinds of expression and a suspension of fraction of that with two months of various histology immunogenicity. Two more biological enroll about 85% of FCS specimens express at least one of the six selected tumor associated antigens and more than 60% expressed at least two of them.

Robert of tumor recurrence at one five years of median follow up and continue to do so after a three year follow up period.

Moving to our off-the-shelf tumor associated antigen based mRNA cancer vaccine candidate BNT116. BNT116 is an RNA lipoplex cancer vaccine candidate comprising 6 mRNAs each encoding a tumor associated antigen MAGE-A3, CLDN6, KK-LC-1, PRAME, MAGE-C1. We have selected these tumor associated antigens by and cynical approach developed for design of FIXVAC vaccine for different tumor types and based on low or lack of expression in toxicity-relevant organs expression and a suspension of fraction of lung tumors of various histologies immunogenicity and tumor biological role. About 85% of NSCLC specimens express at least one of the six selected tumor associated antigens and more than 60% expressed at least 2 of them.

Moving to allow for shaft tumor associated antigen based mrna cancer vaccine candidate <unk> 16, <unk> 16 is in the R&D line. <unk> cancer vaccine candidate comprising six M. Rnas each encoding a tumor associated antigen MAGE a free card in six <unk>, one frame Mitch a form HC one.

<unk> cancer vaccine candidate comprising six M. Rnas each encoding a tumor associated antigen MAGE a free card in six <unk>, one frame Mitch a form HC one.

We have selected these tumor associated antigens by and cynical approach developed projects are not expect X gene for different tumor types and based on low or lack of expression and toxicity you write up in all kinds of expression and a suspension of fraction of that with two months of various histology immunogenicity.

Two more biological enroll about 85% of FCS specimens express at least one of the six selected tumor associated antigens and more than 60% expressed at least two of them.

BNT116 is currently being evaluated with our partner Regeneron in two clinical trials that cover various non-small cell lung cancer patient population. One of the Phase I trial investigating BNT116 in adjuvant first-line and second-line setting and various treatment regimens as listed on the left side of this slide. We plan to introduce novel unique combination cohorts into the multi cohort phase one trial. The second trial is a randomized phase two evaluating <unk> in combination with to meet him up and first time treatment of patients with PDL, one high expressing non small cell lung cancer shown on the.

And various treatment regimens assisted hunger that side of the slide.

We plan to introduce novel unique combination cohorts into the multi cohort Phase I trial. The second trial is a randomized Phase II evaluating the BNT116 in combination with CEMIPLIMAB in first-line treatment of patients with PDL-L1 high expressing non-small cell lung cancer shown on the right side of the slide. At AACR, we presented preliminary results from Cohort 3 of LuCa-MERIT -1 Phase I trial evaluating BNT116 in combination with DOCETAXEL in patients with advanced unresectable or metastatic non-small cell lung cancer that progressed on PD-1/ PD-L1 inhibitor platinum-based chemotherapy. Combination treatment with BNT116 and DOCETAXEL was active with an overall response rate of 30%, a disease control rate of 85% medium progression free survival of 4.4 months. Comparable to other things that can be dates PMT 116 presents a manageable safety profile alone and in combination. We expect further data from this cohort in the next 12 months and that would inform further development of P and Q1 16 and markets.

We plan to introduce novel unique combination cohorts into the multi cohort phase one trial. The second trial is a randomized phase two evaluating <unk> in combination with to meet him up and first time treatment of patients with PDL, one high expressing non small cell lung cancer shown on the.

All right side of the slide. At ACR, we presented preliminary results from cohort three of them who've come Merit, a one phase one trial evaluating <unk> in combination with Docetaxel in patients with advanced <unk>. I know injectable or metastatic non small cell lung cancer that has progressed on PD, one PDL one inhibitor in professional based chemotherapy. Combination treatment with PMT 116, and puts it up say to what extent. As an overall response rate of 30%. Disease control rate of 85% median progression free survival of $12 four months. Comparable to other things that can be dates PMT 116 presents a manageable safety profile alone and in combination. We expect further data from this cohort in the next 12 months and that would inform further development of P and Q1 16 and markets.

At ACR, we presented preliminary results from cohort three of them who've come Merit, a one phase one trial evaluating <unk> in combination with Docetaxel in patients with advanced <unk>.

I know injectable or metastatic non small cell lung cancer that has progressed on PD, one PDL one inhibitor in professional based chemotherapy.

Combination treatment with PMT 116, and puts it up say to what extent.

As an overall response rate of 30%. Disease control rate of 85% median progression free survival of $12 four months. Comparable to other things that can be dates PMT 116 presents a manageable safety profile alone and in combination. We expect further data from this cohort in the next 12 months and that would inform further development of P and Q1 16 and markets.

Disease control rate of 85% median progression free survival of $12 four months.

Comparable to other FIXVAC candidates BNT116 presents a manageable safety profile alone and in combination. We expect further data from this cohort in the next 12 months and that would inform further development of BNT116 in lung cancer.

Comparable to other things that can be dates PMT 116 presents a manageable safety profile alone and in combination.

We expect further data from this cohort in the next 12 months and that would inform further development of P and Q1 16 and markets.

The ASCO annual meeting is right around the corner. At ASCO we and our partners will present new clinical data for several of our programs, data that is of relevance for making and informed decisions about the direction of those projects development. first. Firstly, we Amgen my plan to present data for PMT for 11 from losses tool and post <unk> non small cell lung cancer patients be antifreeze and evidenced by specific antibody candidate combining PD, one checkpoint inhibition with 41 BB co stimulatory activation.

Firstly, we Amgen my plan to present data for PMT for 11 from losses tool and post <unk> non small cell lung cancer patients be antifreeze and evidenced by specific antibody candidate combining PD, one checkpoint inhibition with 41 BB co stimulatory activation.

Firstly, we and Genmab plan to present data for BNT311 from our Phase II in post-IO non-small cell lung cancer patients. BNT311 is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with 4-1BB costimulatory activation.

Second, as already mentioned monotherapy data from Phase II trials are planned to be presented for BNT327, the bispecific anti VEGF anti-PD-L1 antibody we are developing in collaboration with Biotheus. We and our partner <unk> plan to present first in human data for all of our free targeting ADC. Then we will also present evidently corelogic data, including post operative Cte DNA prevalence and prognostic value from a non interventional observational study in patients with resected high risk stage, two stage III colorectal cancer.

Third, we and our partner MediLink plan to present first in human data for our free targeting ADC. Then we will also present epidemiologic data, including post operative ctDNA prevalence and prognostic value from a non-interventional observational study in patients with resected high risk Stage 2, Stage 3 colorectal cancer that supports and inform the development of our individualized vaccine in this patient population. and lastly for PMT to 11 or car T cell product candidate, we plan to initiate a potentially registrational trial in patients with jumped at it at school will be very present, we awards evidenced of AUM. There are survivors and treatment of this patient population in the U S that will inform the trial design for our phase two trial. With that I would not possible presentation to our CFO Jim touched on.

We and our partner <unk> plan to present first in human data for all of our free targeting ADC.

Then we will also present evidently corelogic data, including post operative Cte DNA prevalence and prognostic value from a non interventional observational study in patients with resected high risk stage, two stage III colorectal cancer.

That supports and inform the development of our individualized vaccine in this patient population and lastly for PMT to 11 or car T cell product candidate, we plan to initiate a potentially registrational trial in patients with jumped at it at school will be very present, we awards evidenced of AUM. There are survivors and treatment of this patient population in the U S that will inform the trial design for our phase two trial. With that I would not possible presentation to our CFO Jim touched on.

And lastly for BNT211 our CAR-T cell product candidate, we plan to initiate a potentially registrational trial in patients with germ cell tumors. At ASCO, we will be very present real-world evidence of overall survival and treatment patterns of this patient population in the U.S. that will inform the trial design for our Phase II trial. With that, I will now pass the presentation to our CFO, Jens Holstein.

There are survivors and treatment of this patient population in the U S that will inform the trial design for our phase two trial.

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

With that I would not possible presentation to our CFO Jim touched on.

Thank you, Özlem, and a warm welcome to everyone who has dialed in today's call. Let me begin my section with some key financial figures for Q1 2024. In the first quarter of 2024, we reported total revenues of approximately EUR 188 million, driven mostly by commercial revenues from the sales of our COVID-19 vaccine. This revenue figure is consistent with our internal expectations for the period and reflects the seasonality that we expect in endemic environment for our COVID-19 vaccine. Our group revenues will continue to be driven largely by the uptake of our COVID-19 vaccines until oncology revenues would be recognized.

Jens Holstein: Thank you, Özlem, and a warm welcome to everyone who has dialed in today's call. Let me begin my section with some key financial figures for Q1 2024. In the first quarter of 2024, we reported total revenues of approximately EUR 188 million, driven mostly by commercial revenues from the sales of our COVID-19 vaccine. This revenue figure is consistent with our internal expectations for the period and reflects the seasonality that we expect in endemic environment for our COVID-19 vaccine.

Let me begin my section with some key financial figures for Q1 2024.

In the first quarter of 2024, we reported total revenues of approximately 188 million euros, driven mostly by commercial revenues from the sales of our COVID-19 vaccine.

This revenue figure is consistent with our internal expectations for the period and reflects the seasonality that we expect.

<unk> environment for our COVID-19 vaccine.

Our group revenues will continue to be driven largely by the uptake of our COVID-19 vaccines until oncology revenues would be recognized. We expect to recognize approximately 90% of our full year revenues in the last months of 2024, mostly in Q4. In terms of our operational spending, we are also in line with our internal plans and ended the first quarter with the loss before tax of 332 million euros. We maintained our strong financial position was $16 9 billion and total cash plus security investments at the end of the quarter. As mentioned by my colleague before we started the year, making real progress across our oncology pipeline, we dose the first patient in our second pivotal phase III trial and are on track to start multiple additional potentially registrational trials this year.

Our group revenues will continue to be driven largely by the uptake of our COVID-19 vaccines until oncology revenues would be recognized.

We expect to recognize approximately 90% of our full year revenues in the last months of 2024, mostly in Q4. In terms of our operational spending we are also in line with our internal plans and ended the first quarter with the loss before tax of 332 million euros. We maintained our strong financial position was $16 9 billion and total cash plus security investments at the end of the quarter. As mentioned by my colleague before we started the year, making real progress across our oncology pipeline, we dose the first patient in our second pivotal phase III trial and are on track to start multiple additional potentially registrational trials this year.

In terms of our operational spending, we are also in line with our internal plans and ended the first quarter with the loss before tax of EUR 332 million. We maintained our strong financial position with EUR 16.9 billion in total cash plus security investments at the end of the quarter. As mentioned by my colleague before, we started the year, making real progress across our oncology pipeline. We dosed the first patient in our second pivotal Phase III trial and are on track to start multiple additional potentially registrational trials this year.

In terms of our operational spending we are also in line with our internal plans and ended the first quarter with the loss before tax of 332 million euros. We maintained our strong financial position was $16 9 billion and total cash plus security investments at the end of the quarter. As mentioned by my colleague before we started the year, making real progress across our oncology pipeline, we dose the first patient in our second pivotal phase III trial and are on track to start multiple additional potentially registrational trials this year.

We maintained our strong financial position was $16 9 billion and total cash plus security investments at the end of the quarter. As mentioned by my colleague before we started the year, making real progress across our oncology pipeline, we dose the first patient in our second pivotal phase III trial and are on track to start multiple additional potentially registrational trials this year.

As mentioned by my colleague before we started the year, making real progress across our oncology pipeline, we dose the first patient in our second pivotal phase III trial and are on track to start multiple additional potentially registrational trials this year.

Our focus remains on our late-stage clinical trials and to invest in our mRNA platform approaches that represent the core capability of BioNTech and differentiates us from others in the industry. We also continue to invest in our leading and profitable COVID-19 vaccine business. Alongside our partner Pfizer, we are working on very undetected COVID-19 vaccines for the upcoming vaccination season. We also continue to invest in our leading and profit of our COVID-19 vaccine business. Alongside our partner Pfizer, we are working on variance detected COVID-19 vaccines for the upcoming vaccination season. We are also investing in a COVID-19 flu combination vaccine candidate, which we expect to potentially drive additional demand if approved. Bolstered by our strong cash position and stringent cost discipline, we will continue to invest in our pipeline and are well positioned to achieve future sustainable growth.

We also continue to invest in our leading and profitable COVID-19 vaccine business. Im sorry, our partner Pfizer, we are working on very undetected COVID-19 vaccines for the upcoming vaccination season. We also continue to invest in our leading and profit of our COVID-19 vaccine business alongside. Alongside our partner Pfizer, we are working on variance detected COVID-19 vaccines for the upcoming vaccination season. We are also investing in a COVID-19 flu combination vaccine candidate, which we expect to potentially drive additional demand if approved. Bolstered by our strong cash position and stringent cost discipline, we will continue to invest in our pipeline and are well positioned to achieve future sustainable growth.

Im sorry, our partner Pfizer, we are working on very undetected COVID-19 vaccines for the upcoming vaccination season. We also continue to invest in our leading and profit of our COVID-19 vaccine business alongside. Alongside our partner Pfizer, we are working on variance detected COVID-19 vaccines for the upcoming vaccination season. We are also investing in a COVID-19 flu combination vaccine candidate, which we expect to potentially drive additional demand if approved. Bolstered by our strong cash position and stringent cost discipline, we will continue to invest in our pipeline and are well positioned to achieve future sustainable growth.

We also continue to invest in our leading and profit of our COVID-19 vaccine business alongside. Alongside our partner Pfizer, we are working on variance detected COVID-19 vaccines for the upcoming vaccination season. We are also investing in a COVID-19 flu combination vaccine candidate, which we expect to potentially drive additional demand if approved. Bolstered by our strong cash position and stringent cost discipline, we will continue to invest in our pipeline and are well positioned to achieve future sustainable growth.

Alongside our partner Pfizer, we are working on variance detected COVID-19 vaccines for the upcoming vaccination season. We are also investing in a COVID-19 flu combination vaccine candidate, which we expect to potentially drive additional demand if approved. Bolstered by our strong cash position and stringent cost discipline, we will continue to invest in our pipeline and are well positioned to achieve future sustainable growth.

We are also investing in a COVID-19 flu combination vaccine candidate, which we expect to potentially drive additional demand if approved. Bolstered by our strong cash position and stringent cost discipline, we will continue to invest in our pipeline and are well positioned to achieve future sustainable growth.

Bolstered by our strong cash position and stringent cost discipline, we will continue to invest in our pipeline and are well positioned to achieve future sustainable growth.

I'll now be going into a little more detail on our financial results for the first quarter of 2024. As noted earlier, our total revenues reported for the first quarter of 2024 reached EUR 188 million compared with approximately EUR 1.3 billion for the first quarter of 2023. Moving to cost of sales these amounted to EUR 59.1 million for the first quarter of 2024 compared to EUR 96 million for the comparative prior year period. Research and development expenses reached EUR 508 million for the first quarter of 2024 compared to EUR 334 million for the comparative prior year period. The increase was mainly due to progressing clinical studies for oncology pipeline and related personnel expenses to manage those. Sales and marketing expenses of EUR 60 million compared to the first quarter of 2024 compared to EUR 12 million in the comparative prior-year period.

As noted earlier, our total revenues reported for the first quarter of 2024 reached 188 million euros compared with approximately $1 3 billion for the first quarter of 2023. Moving to cost of sales these amounted to 59.1 million euros for the first quarter of 2024 compared to 96 million euros for the comparative prior year period. Research and development expenses reached 508 million euros for the first quarter of 2024 compared to 334 million euros for the comparative prior year period. The increase was mainly due to progressing clinical studies for oncology pipeline and related personnel expenses to manage those. Sales and marketing expenses of 60 million euros compared to the first quarter of 2024 compared to 12 million euros in the comparative prior year period. Sales and marketing expenses of 60 million euros compared to the first quarter of 2024 compared to 12 million euros in the comparative prior year period.

Moving to cost of sales these amounted to 59.1 million euros for the first quarter of 2024 compared to 96 million euros for the comparative prior year period. Research and development expenses reached 508 million euros for the first quarter of 2024 compared to 334 million euros for the comparative prior year period. The increase was mainly due to progressing clinical studies for oncology pipeline and related personnel expenses to manage those. Sales and marketing expenses of 60 million euros compared to the first quarter of 2024 compared to 12 million euros in the comparative prior year period. Sales and marketing expenses of 60 million euros compared to the first quarter of 2024 compared to 12 million euros in the comparative prior year period.

Research and development expenses reached 508 million euros for the first quarter of 2024 compared to 334 million euros for the comparative prior year period. The increase was mainly due to progressing clinical studies for oncology pipeline and related personnel expenses to manage those. Sales and marketing expenses of 60 million euros compared to the first quarter of 2024 compared to 12 million euros in the comparative prior year period. Sales and marketing expenses of 60 million euros compared to the first quarter of 2024 compared to 12 million euros in the comparative prior year period.

The increase was mainly due to progressing clinical studies for oncology pipeline and related personnel expenses to manage those. Sales and marketing expenses of 60 million euros compared to the first quarter of 2024 compared to 12 million euros in the comparative prior year period. Sales and marketing expenses of 60 million euros compared to the first quarter of 2024 compared to 12 million euros in the comparative prior year period.

Brian: Sales and marketing expenses of 60 million euros compared to the first quarter of 2024 compared to 12 million euros in the comparative prior year period.

General and administrative expenses amounted to EUR 117 million for the first quarter of 2024 compared to EUR 112 million for the comparative prior-year period. The increase in SG&A was mainly due to increased expenses for IT services as well as an increase in headcount to support the scaling of our business. Income taxes were realized with an amount of EUR 16.7 million for the first quarter of 2024 compared to EUR 205.5 million of tax expenses for the comparative prior-year period. The derived effective income tax rate for the first quarter of 2024 was approximately 5% applicable on the negative income. For the first quarter of 2024, we reported a net loss of EUR 315 million compared to a net profit of approximately EUR 502 million for the comparative prior year period. Our loss per share for the first quarter of 2024 amounted to EUR 1.31 compared to a diluted profit per share of EUR 2.05 for the comparative prior-year period.

The increase in SG&A was mainly due to increased expenses for it services as well as an increase in head count to support the scaling of our business. Income taxes were realized with an amount of $16 7 million for the first quarter of 2024 compared to $205 5 million of tax expenses for the comparative prior year period. The derived effective income tax rate for the first quarter of 2024 was approximately 5%. Applicable on the negative income. For the first quarter of 2024, we reported a net loss of 315 million euros compared to a net profit of approximately 502 million euros for the comparative prior year period.

Income taxes were realized with an amount of $16 7 million for the first quarter of 2024 compared to $205 5 million of tax expenses for the comparative prior year period. The derived effective income tax rate for the first quarter of 2024 was approximately 5%. Applicable on the negative income. For the first quarter of 2024, we reported a net loss of 315 million euros compared to a net profit of approximately 502 million euros for the comparative prior year period.

The derived effective income tax rate for the first quarter of 2024 was approximately 5%. Applicable on the negative income. For the first quarter of 2024, we reported a net loss of 315 million euros compared to a net profit of approximately 502 million euros for the comparative prior year period.

Applicable on the negative income. For the first quarter of 2024, we reported a net loss of 315 million euros compared to a net profit of approximately 502 million euros for the comparative prior year period.

For the first quarter of 2024, we reported a net loss of 315 million euros compared to a net profit of approximately 502 million euros for the comparative prior year period.

For the first quarter of 2024, we reported a net loss of EUR 315 million compared to a net profit of approximately EUR 502 million for the comparative prior year period. Our loss per share for the first quarter of 2024 amounted to EUR 1.31 compared to a diluted profit per share of EUR 2.05 for the comparative prior-year period.

Our loss per share for the first quarter of 2024 amounted to one euro uncertainty one euro cents compared to a diluted profit per share of two euros and five year a sense for the comparative prior year period.

As indicated earlier this year, 2024 is a year for our company during which we will continue to invest in our long-term growth strategy. We aim to have potentially 10-plus pivotal trials running by year end 2024, which we believe will change the picture of the company going forward. Besides having a strong franchise infectious diseases, we aim to have multiple oncology products, reaching the market by 2026 onwards. Yeah. Turning to the next slide I would like to emphasize that we are reiterating the companys financial guidance for the 2024 financial year as mentioned previously we expect to recognize approximately 90% of our full year revenues in the last months of 2020 for mostly in Q4. Additionally, we also reiterate our R&D and SG&A guidance from our year end call with two four to $2 6 billion euros for R&D and 700 to 800 million euros for SG&A expenses. <unk> expenses are expected to gradually increase quarter by quarter until the year end.

Besides having a strong franchise infectious diseases, we aim to have multiple oncology products, reaching the market by 2026 onwards.

Turning to the next slide, I would like to emphasize that we are reiterating the company's financial guidance for the 2024 financial year. As mentioned previously, we expect to recognize approximately 90% of our full year revenues in the last months of 2024, mostly in Q4. Additionally, we also reiterate our R&D and SG&A guidance from our year end call with EUR 2.4 to EUR 2.6 billion for R&D and EUR 700 to EUR 800 million for SG&A expenses. <unk> expenses are expected to gradually increase quarter by quarter until the year end.

Turning to the next slide, I would like to emphasize that we are reiterating the company's financial guidance for the 2024 financial year. As mentioned previously, we expect to recognize approximately 90% of our full year revenues in the last months of 2024, mostly in Q4. Additionally, we also reiterate our R&D and SG&A guidance from our year end call with EUR 2.4 billion to EUR 2.6 billion for R&D and EUR 700 million to EUR 800 million for SG&A expenses. Those expenses are expected to gradually increase quarter by quarter until the year end.

Yeah. Turning to the next slide I would like to emphasize that we are reiterating the companys financial guidance for the 2024 financial year as mentioned previously we expect to recognize approximately 90% of our full year revenues in the last months of 2020 for mostly in Q4.

Turning to the next slide I would like to emphasize that we are reiterating the companys financial guidance for the 2024 financial year as mentioned previously we expect to recognize approximately 90% of our full year revenues in the last months of 2020 for mostly in Q4.

Additionally, we also reiterate our R&D and SG&A guidance from our year end call with two four to $2 6 billion euros for R&D and 700 to 800 million euros for SG&A expenses. <unk> expenses are expected to gradually increase quarter by quarter until the year end.

<unk> expenses are expected to gradually increase quarter by quarter until the year end.

With that I would like to turn the call over to our Chief strategy Officer, Ryan Richardson for an update on our strategy outlook and concluding remarks. Thank you, yes, we are working with Pfizer to be ready to launch our variant adaptive COVID-19 vaccine in the second half of the year upon regulatory approval. <unk> system with the <unk> recommendation, we expect that the updated vaccine will include the Jan one Barrett and will be modeled valent.

With that, I would like to turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our strategy outlook and concluding remarks.

Thank you, yes, we are working with Pfizer to be ready to launch our variant adaptive COVID-19 vaccine in the second half of the year upon regulatory approval. <unk> system with the <unk> recommendation, we expect that the updated vaccine will include the Jan one Barrett and will be modeled valent.

Ryan Richardson: Thank you, Jens. We are working with Pfizer to be ready to launch our variant adaptive COVID-19 vaccine in the second half of the year upon regulatory approval. Consistent with the WHO's recommendation, we expect that the updated vaccine will include the JN.1 variant and will be monovalent. As of April 2024, over 90% of SARS-CoV-2, genetic sequences and publicly available databases were derived from the JN.1 variant.

<unk> system with the <unk> recommendation, we expect that the updated vaccine will include the Jan one Barrett and will be modeled valent.

As of April 2024, over 90% of SARS-CoV-2, genetic sequences and publicly available databases were derived from the JN.1 variant In 2023, we received strain inclusion recommendations from the W. H O and other advisory committees in May and June and were granted approval in late August and September. This year the timelines for strange selection and those anticipated for approval are expected to come earlier. The W. H O and he might have already received strong recommendations and expect additional regulatory updates in mid may. We expect approval in the EU and FDA could come in late July and August respectively. This occurs it could enable an earlier launch of vaccines relative to last year to support fall vaccination campaigns. We are preparing to launch the Varian adopted COVID-19 vaccine in over 80 geographies worldwide. While most regions outside the U S will continue to be served by government contracts. We do expect some new private markets in regions like the U K to open in 2024.

As of April 2024, over 90% of SARS-CoV-2, genetic sequences and publicly available databases were derived from the JN.1 variant.

In 2023, we received strain inclusion recommendations from the WHO and other advisory committees in May and June and were granted approval in late August and September. This year the timelines for strange selection and those anticipated for approval are expected to come earlier. The WHO and EMA have already received strain recommendations and expect additional regulatory updates in mid may. We expect approval in the EU and FDA could come in late July and August respectively. If this occurs it could enable an earlier launch of vaccines relative to last year to support full vaccination campaigns. We are preparing to launch the Varian adopted COVID-19 vaccine in over 80 geographies worldwide. While most regions outside the U S will continue to be served by government contracts. We do expect some new private markets in regions like the U K to open in 2024.

In 2023, we received strain inclusion recommendations from the W. H O and other advisory committees in May and June and were granted approval in late August and September.

This year the timelines for strange selection and those anticipated for approval are expected to come earlier. The W. H O and he might have already received strong recommendations and expect additional regulatory updates in mid may. We expect approval in the EU and FDA could come in late July and August respectively. This occurs it could enable an earlier launch of vaccines relative to last year to support fall vaccination campaigns. We are preparing to launch the Varian adopted COVID-19 vaccine in over 80 geographies worldwide. While most regions outside the U S will continue to be served by government contracts. We do expect some new private markets in regions like the U K to open in 2024.

The W. H O and he might have already received strong recommendations and expect additional regulatory updates in mid may. We expect approval in the EU and FDA could come in late July and August respectively. This occurs it could enable an earlier launch of vaccines relative to last year to support fall vaccination campaigns. We are preparing to launch the Varian adopted COVID-19 vaccine in over 80 geographies worldwide. While most regions outside the U S will continue to be served by government contracts. We do expect some new private markets in regions like the U K to open in 2024.

We expect approval in the EU and FDA could come in late July and August respectively. This occurs it could enable an earlier launch of vaccines relative to last year to support fall vaccination campaigns. We are preparing to launch the Varian adopted COVID-19 vaccine in over 80 geographies worldwide. While most regions outside the U S will continue to be served by government contracts. We do expect some new private markets in regions like the U K to open in 2024.

This occurs it could enable an earlier launch of vaccines relative to last year to support fall vaccination campaigns. We are preparing to launch the Varian adopted COVID-19 vaccine in over 80 geographies worldwide. While most regions outside the U S will continue to be served by government contracts. We do expect some new private markets in regions like the U K to open in 2024.

We are preparing to launch the varian-adapted COVID-19 vaccine in over 80 geographies worldwide. While most regions outside the U.S. will continue to be served by government contracts. We do expect some new private markets in regions like the U.K. to open in 2024. This could enable individuals who may not qualify under existing immunization recommendations to access updated COVID-19 vaccine should they choose to do so.

We are preparing to launch the Varian adopted COVID-19 vaccine in over 80 geographies worldwide. While most regions outside the U S will continue to be served by government contracts. We do expect some new private markets in regions like the U K to open in 2024.

While most regions outside the U S will continue to be served by government contracts. We do expect some new private markets in regions like the U K to open in 2024.

This could enable individuals who may not qualify under existing immunization recommendations. To access updated COVID-19 vaccine should they choose to do so. Turning to the next slide our aim is to create value for patients and shareholders by delivering sustained long term growth and our strategy is to continue to invest in our technology platforms and diverse pipeline. We believe each of the drug classes, we are investing in containing product candidates that aimed to address major unmet needs and could unlock significant commercial potential. We are entering a catalyst rich period over the next 12 months to 24 months with data updates expected for more and more product candidates across each of these classes.

This could enable individuals who may not qualify under existing immunization recommendations. To access updated COVID-19 vaccine should they choose to do so.

To access updated COVID-19 vaccine should they choose to do so. Turning to the next slide our aim is to create value for patients and shareholders by delivering sustained long term growth and our strategy is to continue to invest in our technology platforms and diverse pipeline.

Turning to the next slide our aim is to create value for patients and shareholders by delivering sustained long-term growth and our strategy is to continue to invest in our technology platforms and diverse pipeline. We believe each of the drug classes, we are investing in, contain product candidates that aimed to address major unmet needs and could unlock significant commercial potential. We are entering a catalyst rich period over the next 12 months to 24 months with data updates expected for more and more product candidates across each of these classes.

Turning to the next slide our aim is to create value for patients and shareholders by delivering sustained long term growth and our strategy is to continue to invest in our technology platforms and diverse pipeline.

We believe each of the drug classes, we are investing in containing product candidates that aimed to address major unmet needs and could unlock significant commercial potential.

We are entering a catalyst rich period over the next 12 months to 24 months with data updates expected for more and more product candidates across each of these classes.

We look forward to disclosing additional pivotal trials more details on our go-to-market strategy for selected programs in the months ahead. To conclude on the next slide our aim is to transform medicine through successive waves of innovation. We remained focus on our near-term goal to have 10-plus potentially registrational trials initiated by year end 2024. And to continue to ramp up our commercial readiness activities. Over the midterm, we aim to enter the commercial stage oncology by 2026 with our first product candidates, while advancing our pipeline of late stage of novel combination therapies.

To conclude on the next slide our aim is to transform medicine through successive waves of innovation.

We remained focus on our near term goal to have 10, plus potentially registrational trials initiated by year end 2024.

And to continue to ramp up our commercial readiness activities.

Over the midterm, we aim to enter the commercial stage oncology by 2026 with our first product candidates, while advancing our pipeline of late stage of novel combination therapies.

Longer term, we aim to broaden our portfolio of approved products and transform BioNTech into a diversified multi product immunotherapy company, that is in a position to redefine medicine, we are truly excited by the potential of our technologies in pipeline holes to make a difference for patients around the world. Before opening the floor for questions I would like to highlight on the next slide important investor events, we will be holding this year.

That is in a position to redefine medicine, we are truly excited by the potential of our technologies in pipeline holes to make a difference for patients around the world.

Before opening the floor for questions, I would like to highlight on the next slide important investor events, we will be holding this year. Our Annual General Meeting will take place on May 17th at our inaugural artificial intelligence and machine learning event will take place on October 1st. Our main 2024 innovation series events planned for November 14th. We will share further details on these events in due course. With that, I would like to open the call for questions. Thank you. So I'll ask a question you will need to press star one on your telephone and wait for your name to be announced please limit yourself to one question only. To withdraw your question. Please press star one on one again.

Before opening the floor for questions I would like to highlight on the next slide important investor events, we will be holding this year.

Brian: Our annual General meeting will take place on May 17th at our inaugural artificial intelligence and machine learning event will take place on October one. Our main 2024 innovation series events planned for November 14, we will share further details on these events in due course with that I would like to open the call up for questions. Thank you. So I'll ask a question you will need to press star one on your telephone and wait for your name to be announced please limit yourself to one question only. To withdraw your question. Please press star one on one again.

Our main 2024 innovation series events planned for November 14, we will share further details on these events in due course with that I would like to open the call up for questions. Thank you. So I'll ask a question you will need to press star one on your telephone and wait for your name to be announced please limit yourself to one question only.

With that, I would like to open the call for questions. Thank you. So I'll ask a question you will need to press star one on your telephone and wait for your name to be announced please limit yourself to one question only. To withdraw your question. Please press star one on one again.

With that, I would like to open the call for questions.

Thank you. So I'll ask a question you will need to press star one on your telephone and wait for your name to be announced please limit yourself to one question only.

Operator: [Operator Instructions] And your first question comes from the line of Tazeen Ahmad from Bank of America. Please go ahead.

To withdraw your question. Please press star one on one again.

We will now go to our first question. One moment please. On your first question comes from the line of <unk> Ahmed from Bank of America. Please go ahead.

One moment please. On your first question comes from the line of <unk> Ahmed from Bank of America. Please go ahead.

On your first question comes from the line of <unk> Ahmed from Bank of America. Please go ahead.

Tazeen Ahmad: Hi, Good morning. Thanks for taking my question. For the data that you're going to be presenting at the upcoming ASCO conference as it relates to the Genmab compound, can you just remind us how many patients worth of data to expect and once that data is presented can you talk to us about the next steps in the development plan for that program? Thanks.

Thanks, Tazeen. The first question was about the number of patients, which we will present for the second-line non-small cell lung cancer trial with BNT311. Did I get that right? yes, that's right. Thanks. That will be. I cannot. You have a specific number from the top of my head, but it goes with me around Tonbridge patients. So a substantial number of patients.

Özlem Türeci: Thanks, Tazeen. The first question was about the number of patients, which we will present for the second-line non-small cell lung cancer trial with BNT311. Did I get that right?

It has been the first question was about the number of patients, which we were present Havas second line non small cell lung cancer trial.

The Engie fleet is often did I get that right, yes, that's right. Thanks.

yes, that's right. Thanks. That will be. I cannot. You have a specific number from the top of my head, but it goes with me around Tonbridge patients. So a substantial number of patients.

Tazeen Ahmad: Yes, that's right.

Özlem Türeci: So that will be-- I cannot tell you the specific numbers from the top of my head, but this will be around 100 patients, so a substantial number of patients.

That will be.

I cannot.

You have a specific number from the top of my head, but it goes with me around Tonbridge patients. So a substantial number of patients.

And also what level of detail should we expect to see? So you will see safety data of activity data, which which we have until. And Oh. Or are all data. Okay, and what is the plan moving forward with this program. We are in the planning phase with our partner Genmab, So that we cannot. Disclose any specifics at this time, but you will hear more about this program sometime later this year.

Tazeen Ahmad: And also what level of detail should we expect to see?

So you will see safety data of activity data, which which we have until.

So you will see safety data, the activity data, which we have until then and ORR data. Okay, and what is the plan moving forward with this program. We are in the planning phase with our partner Genmab, So that we cannot. Disclose any specifics at this time, but you will hear more about this program sometime later this year.

Özlem Türeci: So you will see safety data, the activity data, which we have until then and ORR data.

And Oh.

Or are all data.

Okay. And what is the plan moving forward with this program? We are in the planning phase with our partner Genmab, So that we cannot disclose any specifics at this time, but you will hear more about this program sometime later this year.

Tazeen Ahmad: Okay. And what is the plan moving forward with this program?

Okay, and what is the plan moving forward with this program.

Özlem Türeci: We are in the planning phase with our partner Genmab, So that we cannot disclose any specifics at this time, but you will hear more about this program sometime later this year.

We are in the planning phase with our partner Genmab, So that we cannot.

Disclose any specifics at this time, but you will hear more about this program sometime later this year.

Operator: [Operator Instructions] And your next question comes from the line of Daina Graybosch from Leerink Partners. Please go ahead.

Thank you. Once again as a reminder, please limit yourself to one question only.

Once again as a reminder, please limit yourself to one question only.

We will now go to the next question. And your next question comes from the line of Dana Gray Bar from Leerink Partners. Please go ahead.

And your next question comes from the line of Dana Gray Bar from Leerink Partners. Please go ahead.

Daina Graybosch: Hi. Thank you for the question. I have another one on ASCO. So I wonder if you could talk more about the data we should expect from PM8002 at ASCO. And also if you could talk about how this molecule compared to the competitor from a Akeso Summit, which also is a bispecific of VEGF but targeting PD-1 rather than your PD-L1. How much read through positively can we take from the Akeso data to yours and from your to the Akeso data for the overall approach? Thank you.

Data, we should expect from P. M. A L O two at ESCO and also if you could talk about.

How this molecule compared to the competitor from a Keystone summit, which also is a bi specific of that Jeff, but targeting PD, one rather than your PD L. One how much read through.

Brian: Positively can we take from the Keystone got into yours and from year to the acute so data for the overall approach. Thank you.

Ugur Sahin: Hi, Daina. So we have, at the moment, the clinical trial running in multiple indications, including also indications with single arm and in combination. What you are going to update is on ASCO is on the cervical cancer, and platinum resistant ovarian cancer, and non-small cell lung cancer. And you will see response data and safety data in this cohort. Just to remind you, we have presented already our response data on the combination in triple negative breast cancer, and small cell lung cancer, which are very encouraging, showing also our responses in the PD-L1, or cold tumors, PD-L1 negative or cold tumors.

So it so we have at the moment. The clinical trial running in multiple indications.

The clinical trial running in multiple indications.

Including also indications we're seeing it in combination and what you are going to update.

<unk> is an ESCO is on the cervical cancer.

Brian: And platinum resistant ovarian cancer, and non small cell lung cancer.

Brian: Tires. And you will see response data.

And you will see response data.

And safety data in this cohort.

Just to remind you. We have a we have. Presented already. Our response data on the combination in triple negative breast cancer, and small cell lung cancer I was just which are that they incur. Salvaging shows and also our responses. And PD Airvana, a cold tumors. A cold tumors.

We have a we have.

Presented already.

Our response data on the combination in triple negative breast cancer, and small cell lung cancer I was just which are that they incur.

Salvaging shows and also our responses.

And PD Airvana, a cold tumors.

A cold tumors.

And we expect to present some of that data now for non-small cell lung cancer. Of course, we do not have that comparison comparative data with Akeso, but I think the data that we're seeing goes in the same direction and this bispecific and that means direct targeting of the PD-L1 access is--appears to be associated with a better response rate as well as a better safety profile as compared to anti-VEGF treatment. So we are. Very excited about about using these compounds. Combination combination a combination approach.

And we expect to present some of that data now for non-small cell lung cancer. Of course, we do not have that comparison comparative data with Akeso, but I think the data that we're seeing goes in the same direction and this bispecific and that means direct targeting of the PD-L1 access is--appears to be associated with a better response rate as well as a better safety profile as compared to anti-VEGF treatment. So we are very excited about about using these compounds a combination approach for chemotherapies and in the upcoming future for ADCS.

We expect to present some of that data now for non small cell lung cancer of course, we do not have that comparison comparative data data with Accusal eh.

But.

But I think I think the data that you're seeing gold goes into the same direction and that I'm dead, Despite specific and that means bank targeting.

And targeting of the PDL, one excess capacity J F excess. Appears to be associated with a better response rate yet. As well as a better safety profile as compared to anti VEGF treatment. So we are. Very excited about about using these compounds. Combination combination a combination approach.

Appears to be associated with a better response rate yet.

As well as a better safety profile as compared to anti VEGF treatment. So we are.

So we are very excited about about using these compounds a combination approach for chemotherapies and in the upcoming future for ADCS.

Very excited about about using these compounds.

Combination combination a combination approach.

Shimmer therapies and in the upcoming future for ADC.

Operator: And your next question comes from the line of Akash Tewari from Jefferies. Please go ahead.

Thank you. We will now go to the next question. I am doing next question comes from the line of our cash to RV from Jefferies. Please go ahead.

We will now go to the next question. I am doing next question comes from the line of our cash to RV from Jefferies. Please go ahead.

I am doing next question comes from the line of our cash to RV from Jefferies. Please go ahead.

Akash Tewari: Hey. This is more high level. But in the past, I know the team has tried to position BioNTech as an earnings growth story. With that in mind, what is the best estimate for BioNTech returning to consistent profitability is this something that should occur once COVID flu enters the market? Or is it more tied to your oncology pipeline? And then separately, would you look to work with large cap partner to launch your ADCs and broader oncology pipeline? Or would you look to build that commercial sales force internally?

Large cap partner to launch your ADC and broader oncology pipeline or would you look to build that commercial sales force internally. Thanks, so much. Yes. Thanks for the question I'll start with maybe the second part of it I think. Strategic partnerships have been one of the hallmark. Approach in oncology early on and also with COVID-19, and I think. We will continue to evaluate partnerships asset by asset to see if that could help us to accelerate certain assets broaden their reach geographically or even help us reach. Reach profitability sooner. Specific assets, where there might be a partner that brings.

Large cap partner to launch your ADC and broader oncology pipeline or would you look to build that commercial sales force internally.

Ryan Richardson: Thanks, Akash. Thanks for the question. I'll start with maybe the second part of it. I think strategic partnerships have been one of the hallmarks approach in oncology early on and also with COVID-19. And I think we will continue to evaluate partnerships asset by asset to see if that could help us to accelerate certain assets broaden their reach geographically or even help us reach profitability sooner for specific assets, where there might be a partner that brings Infrastructure that's relevant. Generally speaking though, we do now have a strong balance sheet, we do want to retain more of the economics as a general matter strategy.

Yes. Thanks for the question I'll start with maybe the second part of it I think. Strategic partnerships have been one of the hallmark. Approach in oncology early on and also with COVID-19, and I think. We will continue to evaluate partnerships asset by asset to see if that could help us to accelerate certain assets broaden their reach geographically or even help us reach. Reach profitability sooner. Specific assets, where there might be a partner that brings.

Strategic partnerships have been one of the hallmark. Approach in oncology early on and also with COVID-19, and I think. We will continue to evaluate partnerships asset by asset to see if that could help us to accelerate certain assets broaden their reach geographically or even help us reach. Reach profitability sooner. Specific assets, where there might be a partner that brings.

Approach in oncology early on and also with COVID-19, and I think. We will continue to evaluate partnerships asset by asset to see if that could help us to accelerate certain assets broaden their reach geographically or even help us reach. Reach profitability sooner. Specific assets, where there might be a partner that brings.

We will continue to evaluate partnerships asset by asset to see if that could help us to accelerate certain assets broaden their reach geographically or even help us reach.

Reach profitability sooner. Specific assets, where there might be a partner that brings.

Brian: Specific assets, where there might be a partner that brings.

Infrastructure, that's relevant generally speaking, though we do now have a strong balance sheet, we do want to retain more of the economics as a general matter strategy. So I think that the those partnering decisions are going to really be made on an asset by asset basis. While at the same time, we do commit to actually build a commercial presence in oncology in the major markets and so that is. Going to be a priority over the next couple of years. Yes speak a little bit to the profitability point, but I'll, just say high level at the outset that. We do see as you've alluded that there is opportunity here with the pipeline that we're building and advancing now into late stage studies. To deliver long term sustained growth driven by successful product launches. Indicated 2026. Significant time point in those plans, but really of the plants go beyond that. That's why we put out the target of having 10 approvals in oncology by 2030, highlighting that we do think that that revenue growth can come from multiple indication approvals in multiple products and so that our priority is to get on that long term growth trajectory.

Infrastructure, that's relevant generally speaking, though we do now have a strong balance sheet, we do want to retain more of the economics as a general matter strategy.

So I think that the those partnering decisions are going to really be made on an asset by asset basis. While at the same time, we do commit to actually build a commercial presence in oncology in the major markets. And so that is going to be a priority over the next couple of years. I'll let Jens speak a little bit to the profitability point, but I'll just say high level at the outset that we do see as you've alluded that there is opportunity here with the pipeline that we're building and advancing now into late-stage studies to deliver long-term sustained growth driven by successful product launches. We've indicated 2026 as a significant time point in those plans, but really, the plans go beyond that, and that's why we put out the target of having 10 approvals in oncology by 2030, highlighting that we do think that that revenue growth can come from multiple indication approvals and multiple products. and so that our priority is to get on that long term growth trajectory.

Going to be a priority over the next couple of years. Yes speak a little bit to the profitability point, but I'll, just say high level at the outset that. We do see as you've alluded that there is opportunity here with the pipeline that we're building and advancing now into late stage studies. To deliver long term sustained growth driven by successful product launches. Indicated 2026. Significant time point in those plans, but really of the plants go beyond that. That's why we put out the target of having 10 approvals in oncology by 2030, highlighting that we do think that that revenue growth can come from multiple indication approvals in multiple products and so that our priority is to get on that long term growth trajectory.

Speaker Change: Yes speak a little bit to the profitability point, but I'll, just say high level at the outset that. We do see as you've alluded that there is opportunity here with the pipeline that we're building and advancing now into late stage studies. To deliver long term sustained growth driven by successful product launches. Indicated 2026. Significant time point in those plans, but really of the plants go beyond that. That's why we put out the target of having 10 approvals in oncology by 2030, highlighting that we do think that that revenue growth can come from multiple indication approvals in multiple products and so that our priority is to get on that long term growth trajectory.

We do see as you've alluded that there is opportunity here with the pipeline that we're building and advancing now into late stage studies. To deliver long term sustained growth driven by successful product launches. Indicated 2026. Significant time point in those plans, but really of the plants go beyond that. That's why we put out the target of having 10 approvals in oncology by 2030, highlighting that we do think that that revenue growth can come from multiple indication approvals in multiple products and so that our priority is to get on that long term growth trajectory.

To deliver long term sustained growth driven by successful product launches. Indicated 2026. Significant time point in those plans, but really of the plants go beyond that. That's why we put out the target of having 10 approvals in oncology by 2030, highlighting that we do think that that revenue growth can come from multiple indication approvals in multiple products and so that our priority is to get on that long term growth trajectory.

Indicated 2026. Significant time point in those plans, but really of the plants go beyond that. That's why we put out the target of having 10 approvals in oncology by 2030, highlighting that we do think that that revenue growth can come from multiple indication approvals in multiple products and so that our priority is to get on that long term growth trajectory.

We've indicated 2026 as a significant time point in those plans, but really, the plans go beyond that, and that's why we put out the target of having 10 approvals in oncology by 2030, highlighting that we do think that that revenue growth can come from multiple indication approvals and multiple products. And so that-- our priority is to get on that long-term growth trajectory. And of course being profitable is important, but the focus right now is really getting on that growth trajectory.

Significant time point in those plans, but really of the plants go beyond that. That's why we put out the target of having 10 approvals in oncology by 2030, highlighting that we do think that that revenue growth can come from multiple indication approvals in multiple products and so that our priority is to get on that long term growth trajectory.

That's why we put out the target of having 10 approvals in oncology by 2030, highlighting that we do think that that revenue growth can come from multiple indication approvals in multiple products and so that our priority is to get on that long term growth trajectory.

And so that-- our priority is to get on that long-term growth trajectory. And of course being profitable is important, but the focus right now is really getting on that growth trajectory.

And of course being profitable is important. But the focus right now is really getting on that growth trajectory. Yeah. Thanks, Ron I think you made the most important statements already so. I mean, if you look into the revenue development going forward of course, we see some potential upside when we have. Through a combination between the market and how big that upside could be. Not 100% clear yet we haven't given any guidance for 25 and the ongoing years. For that combination, we got to see how it evolves. In terms of our spend I think we have shown that we control the costs as good as we can as sensible as it is we want to create value investing in our oncology portfolio.

And of course being profitable is important. But the focus right now is really getting on that growth trajectory.

But the focus right now is really getting on that growth trajectory. Yeah. Thanks, Ron I think you made the most important statements already so. I mean, if you look into the revenue development going forward of course, we see some potential upside when we have. Through a combination between the market and how big that upside could be. Not 100% clear yet we haven't given any guidance for 25 and the ongoing years. For that combination, we got to see how it evolves. In terms of our spend I think we have shown that we control the costs as good as we can as sensible as it is we want to create value investing in our oncology portfolio.

Yes. Thanks, Ryan. I think you made the most important statements already. So, I mean, if you look into the revenue development going forward of course, we see some potential upside when we have a COVID flu combination between the market. And how big that upside could be, we are not 100% clear yet. We haven't given any guidance for '25 in the ongoing years for that combination. We got to see how it evolves. In terms of our spend I think we have shown that we control the costs as good as we can, as sensible as it is. We want to create value investing in our oncology portfolio. And to lift it, I think Ryan made the statement already. We are looking of course to have some partners here and they're regionally to lift the value going forward. But we are very optimistic in terms of the growth that we have in front of us as a company. Yes, and I think so what youre hearing from us of the cautious in the very short term, we do think that the COVID-19 combination vaccine with flu if successful. The profitability is going to be dependent in part on Covid vaccination rates and that's one of the near term drivers that has the potential to bring those rates up. Thank you.

Jens Holstein: Yes. Thanks, Ryan. I think you made the most important statements already. So, I mean, if you look into the revenue development going forward of course, we see some potential upside when we have a COVID flu combination between the market. And how big that upside could be, we are not 100% clear yet. We haven't given any guidance for '25 in the ongoing years for that combination. We got to see how it evolves. In terms of our spend I think we have shown that we control the costs as good as we can, as sensible as it is. We want to create value investing in our oncology portfolio. And to lift it, I think Ryan made the statement already. We are looking of course to have some partners here and they're regionally to lift the value going forward. But we are very optimistic in terms of the growth that we have in front of us as a company.

Yeah. Thanks, Ron I think you made the most important statements already so. I mean, if you look into the revenue development going forward of course, we see some potential upside when we have. Through a combination between the market and how big that upside could be. Not 100% clear yet we haven't given any guidance for 25 and the ongoing years. For that combination, we got to see how it evolves. In terms of our spend I think we have shown that we control the costs as good as we can as sensible as it is we want to create value investing in our oncology portfolio.

I mean, if you look into the revenue development going forward of course, we see some potential upside when we have. Through a combination between the market and how big that upside could be. Not 100% clear yet we haven't given any guidance for 25 and the ongoing years. For that combination, we got to see how it evolves. In terms of our spend I think we have shown that we control the costs as good as we can as sensible as it is we want to create value investing in our oncology portfolio.

Through a combination between the market and how big that upside could be. Not 100% clear yet we haven't given any guidance for 25 and the ongoing years. For that combination, we got to see how it evolves. In terms of our spend I think we have shown that we control the costs as good as we can as sensible as it is we want to create value investing in our oncology portfolio.

Not 100% clear yet we haven't given any guidance for 25 and the ongoing years. For that combination, we got to see how it evolves. In terms of our spend I think we have shown that we control the costs as good as we can as sensible as it is we want to create value investing in our oncology portfolio.

For that combination, we got to see how it evolves. In terms of our spend I think we have shown that we control the costs as good as we can as sensible as it is we want to create value investing in our oncology portfolio.

In terms of our spend I think we have shown that we control the costs as good as we can as sensible as it is we want to create value investing in our oncology portfolio.

And lifted I think Brian made the statement already. We are looking of course to have some some partners here and they're regionally. To lift the value going forward. We are very optimistic in terms of the growth that we have in front of us as a company. Yes, and I think so what youre hearing from us of the cautious in the very short term, we do think that the COVID-19 combination vaccine with flu if successful. The profitability is going to be dependent in part on Covid vaccination rates and that's one of the near term drivers that has the potential to bring those rates up. Thank you.

We are looking of course to have some some partners here and they're regionally. To lift the value going forward. We are very optimistic in terms of the growth that we have in front of us as a company. Yes, and I think so what youre hearing from us of the cautious in the very short term, we do think that the COVID-19 combination vaccine with flu if successful.

To lift the value going forward. We are very optimistic in terms of the growth that we have in front of us as a company. Yes, and I think so what youre hearing from us of the cautious in the very short term, we do think that the COVID-19 combination vaccine with flu if successful.

We are very optimistic in terms of the growth that we have in front of us as a company. Yes, and I think so what youre hearing from us of the cautious in the very short term, we do think that the COVID-19 combination vaccine with flu if successful.

Ryan Richardson: Yes. And I think---so what you're hearing from us Akash, is in the very short term, we do think that the COVID combination vaccine with flu, if successful, the profitability is going to be dependent in part on COVID vaccination rates and that's one of the near-term drivers that has the potential to bring those rates up.

Yes, and I think so what youre hearing from us of the cautious in the very short term, we do think that the COVID-19 combination vaccine with flu if successful.

The profitability is going to be dependent in part on Covid vaccination rates and that's one of the near term drivers that has the potential to bring those rates up.

Thank you.

Okay.

Operator: And your next question comes from the line of Jessica Fye from JP Morgan. Please go ahead.

And your next question comes from the line of Jessica Fye from Jpmorgan. Please go ahead.

Jessica Fye: Hey, there. Thanks for taking my question. Coming back to BNT311, and the ASCO update, which regimen would you focus us on? And what element of the profile do you expect to best showcase the product's efficacy. And related to that what's the right benchmark to compare that efficacy metric to? Thank you.

And related to that what's the right benchmark to compare that efficacy metric metric too. Thank you.

So the regimen we will be presenting will be a combination of BNT311 with PEMBROLIZUMAB in second line non-small cell lung cancer and the post CPI population to which you would then need to compare this regimen. Okay, maybe I'll just throw in one more can you recap a hypothetical list of what. The 10, potentially registrational trials running by year end might be right. Imagine you've contemplated a few scenarios here, but maybe you could throw out an example or two. Hoboken trying to we are we are trying.

Özlem Türeci: So the regimen we will be presenting will be a combination of BNT311 with PEMBROLIZUMAB in second line non-small cell lung cancer and the post CPI population to which you would then need to compare this regimen.

In second line non small cell lung cancer Center, a post C. P. I am a popular destination.

Maybe I'll just throw in one more. Can you recap a hypothetical list of what the 10, potentially registrational trials running by year end might be? I imagine you've contemplated a few scenarios here, but maybe you could throw out an example or two? Hoboken trying to we are we are trying.

Jessica Fye: Maybe I'll just throw in one more. Can you recap a hypothetical list of what the 10, potentially registrational trials running by year end might be? I imagine you've contemplated a few scenarios here, but maybe you could throw out an example or two?

To which you would then need to compete.

This regimen.

Okay, maybe I'll just throw in one more can you recap a hypothetical list of what.

Speaker Change: The 10, potentially registrational trials running by year end might be right.

Speaker Change: Imagine you've contemplated a few scenarios here, but maybe you could throw out an example or two.

[Inaudible] trials we are trying to activate or do you want examples. Is this the question? So we have several of them activated. One example is the BNT316 trial, our cooperation with OncoC4 an entire CTLA-4 which is in non-small cell lung cancer in PD-1, PD-L1 experience in Phase III. Another trial, which is potentially registrational is our breast cancer trial in HER2-low breast cancer, with BNT323 also Phase III, which has started earlier this year. Then in this priority asset list, we have trials with AUTOGENE CEVUMERAN, the individualized vaccine, we are codeveloping with Genentech-Roche. One example is a colorectal cancer trial. Which will reach out.

Özlem Türeci: [Inaudible] trials we are trying to activate or do you want examples. Is this the question? So we have several of them activated. One example is the BNT316 trial, our cooperation with OncoC4 an entire CTLA-4 which is in non-small cell lung cancer in PD-1, PD-L1 experience in Phase III. Another trial, which is potentially registrational is our breast cancer trial in HER2-low breast cancer, with BNT323 also Phase III, which has started earlier this year. Then in this priority asset list, we have trials with AUTOGENE CEVUMERAN, the individualized vaccine, we are codeveloping with Genentech-Roche.

Hoboken trying to we are we are trying.

Trying to activate or you wanted to do you want to Exxon pitch is this the question. So we have. Chevron often activated one example is gonna be antifreeze 16, Triage, Oh Corporation with a C floor and anti <unk>, four which is in non small cell lung cancer in PD, one PDL one experienced in faith suite a novel trial. Which is potentially registrational.

So we have. Chevron often activated one example is gonna be antifreeze 16, Triage, Oh Corporation with a C floor and anti <unk>, four which is in non small cell lung cancer in PD, one PDL one experienced in faith suite a novel trial.

Chevron often activated one example is gonna be antifreeze 16, Triage, Oh Corporation with a C floor and anti <unk>, four which is in non small cell lung cancer in PD, one PDL one experienced in faith suite a novel trial.

Which is potentially registrational.

It is a lot of breast cancer trial in her two low breast cancer, which BMT free two feet. Also a phase III, which has started already this year then are in this fight. Alrighty asset list, we have trials with origin, so civil neuron the individualized vaccine we are co developing with. Genentech Rush. One example is a colorectal cancer trial. Which will reach out.

Also a phase III, which has started already this year then are in this fight.

Alrighty asset list, we have trials with origin, so civil neuron the individualized vaccine we are co developing with.

Genentech Rush. One example is a colorectal cancer trial.

One example is our colorectal cancer trial, which will read out in around 2026. Another example is our adjuvant pancreatic cancer trial. Additionally, we will activate trials with BNT327, so the PD-L1, VEGF compound we have talked about earlier. So these are several of the examples of potentially registrational trials, we would like to activate by end of this year. One very exciting one, I should also list here, which is our trial with CAR-T cell, CLDN6 CART-cell in testicular cancer.

Which will reach out.

In. Around 2026. Another example is a adjuvant. Pancreatic cancer trial. Additionally, we will activate trials with them <unk> hundred 27. So the P. P M on the G. S compound we have talked about earlier. So you saw a several I'll say example of potentially Registrational trials, we would like to activate by end of this year. One one very exciting one I should also this tier which is. Ah trial with a car T cell clothing, six car T cell in testicular cancer.

Around 2026. Another example is a adjuvant.

Pancreatic cancer trial.

Additionally, we will activate trials with them <unk> hundred 27.

So the P. P M on the G. S compound we have talked about earlier. So you saw a several I'll say example of potentially Registrational trials, we would like to activate by end of this year. One one very exciting one I should also this tier which is.

Ah trial with a car T cell clothing, six car T cell in testicular cancer.

Operator: And your next question comes from the line of Yaron Werber from TD Cowen. Please go ahead.

We will now go to the next question. And your next question comes from the line of yarn Fab from TD Colin. Please go ahead.

And your next question comes from the line of yarn Fab from TD Colin. Please go ahead.

Unknown Analyst: All right, great. This is [Brendan] on for Yaron. Thanks for taking the question. Just a quick one from us actually on the infectious disease pipeline. It looks like we're going to have a Phase I update from the shingles vaccine sometime this year. But I wanted to also see where you're at with the enrollment and potential timing to data for maybe malaria, HSV and TB programs It just be in television programs any kind of, if there's any notable updates on how you're prioritizing this as part of the pipeline? Thanks very much.

It looks like you know, we're gonna have a phase one update from the shingles vaccine sometime this year about wanted to also see where you're at with the enrollment and potential timing to data for babies malaria. It just be in television programs.

Kind of if there's any notable updates and how youre prioritizing as part of the pipeline. Thanks very much.

Ugur Sahin: Yes, we will provide data updates actually on the HSV-2 trial on the TB trial on the malaria time, which are created safety and immunogenicity data in a Phase I and are proceeding now until Phase II setting, and the data will come until end of this year.

Provide data updates. Actually on the HSV two trial. <unk> tied on the malaria tie. Which are created safety and Immunogenicity data data in our phase one and are proceeding now until phase two setting.

Actually on the HSV two trial. <unk> tied on the malaria tie. Which are created safety and Immunogenicity data data in our phase one and are proceeding now until phase two setting.

<unk> tied on the malaria tie. Which are created safety and Immunogenicity data data in our phase one and are proceeding now until phase two setting.

Which are created safety and Immunogenicity data data in our phase one and are proceeding now until phase two setting.

And the data.

Yeah. This event until the end of this year. Okay. Yeah. Thank you. We will now go to the next question. I'm Joe next question. Comes from the line of at such a route from BMO capital markets. Please go ahead. Great. Thanks for taking the question just another bigger picture strategy question around oncology to slightly early combination approaches rely on external molecules, but just curious about the strategy for moving combinations of internal assets, particularly. Combination of immunotherapy and targeted therapy assets moving those into proof of concept studies and when we could start maybe seeing some of those sort of emerge. Thank you.

Yeah. This event until the end of this year.

This event until the end of this year.

And your next question comes from the line of Etzer Darout from BMO Capital Markets. Please go ahead. Great. Thanks for taking the question just another bigger picture strategy question around oncology to slightly early combination approaches rely on external molecules, but just curious about the strategy for moving combinations of internal assets, particularly. Combination of immunotherapy and targeted therapy assets moving those into proof of concept studies and when we could start maybe seeing some of those sort of emerge. Thank you.

Operator: And your next question comes from the line of Etzer Darout from BMO Capital Markets. Please go ahead.

Okay. Yeah. Thank you. We will now go to the next question. I'm Joe next question. Comes from the line of at such a route from BMO capital markets. Please go ahead. Great. Thanks for taking the question just another bigger picture strategy question around oncology to slightly early combination approaches rely on external molecules, but just curious about the strategy for moving combinations of internal assets, particularly.

Yeah. Thank you. We will now go to the next question. I'm Joe next question.

Thank you. We will now go to the next question.

We will now go to the next question.

Etzer Darout: Great. Thanks for taking the question. Just another bigger picture strategy question around oncology. The fact the early combination approaches rely on external molecules, but just curious about the strategy for moving combinations of internal assets, particularly combination of immunotherapy and targeted therapy assets moving those into proof-of-concept studies and when we could start maybe seeing some of those sort of emerge. Thank you.

I'm Joe next question.

Comes from the line of at such a route from BMO capital markets. Please go ahead.

Great. Thanks for taking the question just another bigger picture strategy question around oncology to slightly early combination approaches rely on external molecules, but just curious about the strategy for moving combinations of internal assets, particularly.

Combination of immunotherapy and targeted therapy assets moving those into proof of concept studies and when we could start maybe seeing some of those sort of emerge. Thank you.

Ugur Sahin: Yes. Excellent question. This is actually actually one of the strengths that we would like now to activate. The first type of combination trial with internal assets is CLDN6 CAR-T cell therapy, if it's on a vaccine that recently reported data shown indeed synergy between the 2 of the combination increasing he persistence of T-cell b. We will see a start end of this year the first combination price of our ADC compounds with our IO portfolio. And actually, 2025 will be an intense year where we will do multiple combination price dedicated to a contribution of component price and safety assessment to bring us into the position to go into the first registrational price in our convert in the second half of 2025.

Speaker Change: Thanks. We would like now to activate. The first type of combination ties with Internet assets. Clothing, six car T cell therapy, if it's on a vaccine that recently reported data shortly indeed, a synergy between the two of them. The nation increasing. Increasing the persistence of T cell b. Do you ever see a start end of this year the first combination products. ADC compounds. Our I O portfolio. Hum. And actually <unk> five will be an intense yet have that lever to multiple combination plus a dedicated to a contribution of component parts. And safety assessment. So bring us into the position to go into the first week is placed on pause in our combos in the second half of 'twenty to 'twenty five. Thank you.

We would like now to activate. The first type of combination ties with Internet assets. Clothing, six car T cell therapy, if it's on a vaccine that recently reported data shortly indeed, a synergy between the two of them.

The first type of combination ties with Internet assets. Clothing, six car T cell therapy, if it's on a vaccine that recently reported data shortly indeed, a synergy between the two of them.

Clothing, six car T cell therapy, if it's on a vaccine that recently reported data shortly indeed, a synergy between the two of them.

The nation increasing.

Increasing the persistence of T cell b. Do you ever see a start end of this year the first combination products. ADC compounds. Our I O portfolio. Hum. And actually <unk> five will be an intense yet have that lever to multiple combination plus a dedicated to a contribution of component parts. And safety assessment. So bring us into the position to go into the first week is placed on pause in our combos in the second half of 'twenty to 'twenty five. Thank you.

Do you ever see a start end of this year the first combination products. ADC compounds. Our I O portfolio. Hum.

ADC compounds. Our I O portfolio. Hum.

Our I O portfolio. Hum.

Hum.

And actually <unk> five will be an intense yet have that lever to multiple combination plus a dedicated to a contribution of component parts. And safety assessment. So bring us into the position to go into the first week is placed on pause in our combos in the second half of 'twenty to 'twenty five. Thank you.

And safety assessment. So bring us into the position to go into the first week is placed on pause in our combos in the second half of 'twenty to 'twenty five. Thank you.

So bring us into the position to go into the first week is placed on pause in our combos in the second half of 'twenty to 'twenty five. Thank you.

Thank you.

Operator: And your next question comes from the line of Terence Flynn from Morgan Stanley. Please go ahead.

No no good for the next question. And your next question comes from the line of Terence Flynn from Morgan Stanley. Please go ahead. Great. Thanks for taking the question for PMT $1 22, it sounds like it was on your list of a Registrational trial. So just wondering for the data next year from that phase II CRC trial, what you'd need to show on an efficacy basis to consider filing for an accelerated approval. Then again I noticed you had in <unk> presentation on some epidemiology of logic data here.

No no good for the next question. And your next question comes from the line of Terence Flynn from Morgan Stanley. Please go ahead.

And your next question comes from the line of Terence Flynn from Morgan Stanley. Please go ahead. Great. Thanks for taking the question for PMT $1 22, it sounds like it was on your list of a Registrational trial. So just wondering for the data next year from that phase II CRC trial, what you'd need to show on an efficacy basis to consider filing for an accelerated approval. Then again I noticed you had in <unk> presentation on some epidemiology of logic data here.

Please go ahead. Great. Thanks for taking the question for PMT $1 22, it sounds like it was on your list of a Registrational trial. So just wondering for the data next year from that phase II CRC trial, what you'd need to show on an efficacy basis to consider filing for an accelerated approval. Then again I noticed you had in <unk> presentation on some epidemiology of logic data here.

Please go ahead.

Great. Thanks for taking the question. for BNT122, it sounds like it was on your list of a registrational trial. So just wondering for the data next year from that Phase II CRC trial, what you'd need to show on an efficacy basis to consider filing for an accelerated approval. And then again, I noticed you had an ASCO presentation on some epidemiologic data here. Again, just what are you expecting to show their at ASCO? Or what would be the key learnings? Thank you. Yeah. So this is this is this study is sufficiently powered phase two study. As he said a patient population of colorectal cancer patients who are seated DNA positive.

Terence C. Flynn: Great. Thanks for taking the question. for BNT122, it sounds like it was on your list of a registrational trial. So just wondering for the data next year from that Phase II CRC trial, what you'd need to show on an efficacy basis to consider filing for an accelerated approval. And then again, I noticed you had an ASCO presentation on some epidemiologic data here. Again, just what are you expecting to show their at ASCO? Or what would be the key learnings? Thank you.

Great. Thanks for taking the question for PMT $1 22, it sounds like it was on your list of a Registrational trial. So just wondering for the data next year from that phase II CRC trial, what you'd need to show on an efficacy basis to consider filing for an accelerated approval. Then again I noticed you had in <unk> presentation on some epidemiology of logic data here.

Then again I noticed you had in <unk> presentation on some epidemiology of logic data here.

Again, just what what are you expecting to show their it IOSCO or what would be the key learnings. Thank you. Yeah. So this is this is this study is sufficiently powered phase two study. As he said a patient population of colorectal cancer patients who are seated DNA positive.

Yeah. So this is this is this study is sufficiently powered phase two study. As he said a patient population of colorectal cancer patients who are seated DNA positive.

Ugur Sahin: Yes. So this is study is sufficiently powered Phase II study. It is in a patient population of colorectal cancer patients who are ctDNA positive. Multiple epidemiological studies have shown that this patient population have a very poor prognosis actually--and PFS in this patient population after surgery is around 12 months, after chemotherapy is about 7 months. This is actually an early metastatic patient population and the clinical trial compares compares standard of care which adjuvant chemotherapy in this patient population versus standard of care followed by the personal [Inaudible].

As he said a patient population of colorectal cancer patients who are seated DNA positive.

Multiple multiple epidemiological studies have shown that this patient population. Hum. Barry. Poor prognosis actually Oh and. PFS in this patient population after surgery is account. Months after after Shimmer therapy is about seven months. This is actually a metastatic early metastatic patient population and the clinical trial compares compares. And out of care. <unk>, which is which. Adjuvant chemotherapy in this patient population.

Hum.

Barry. Poor prognosis actually Oh and. PFS in this patient population after surgery is account. Months after after Shimmer therapy is about seven months. This is actually a metastatic early metastatic patient population and the clinical trial compares compares. And out of care. <unk>, which is which. Adjuvant chemotherapy in this patient population.

Poor prognosis actually Oh and. PFS in this patient population after surgery is account. Months after after Shimmer therapy is about seven months. This is actually a metastatic early metastatic patient population and the clinical trial compares compares. And out of care. <unk>, which is which. Adjuvant chemotherapy in this patient population.

PFS in this patient population after surgery is account. Months after after Shimmer therapy is about seven months. This is actually a metastatic early metastatic patient population and the clinical trial compares compares.

Months after after Shimmer therapy is about seven months. This is actually a metastatic early metastatic patient population and the clinical trial compares compares.

Speaker Change: This is actually a metastatic early metastatic patient population and the clinical trial compares compares.

Speaker Change: And out of care.

<unk>, which is which.

Adjuvant chemotherapy in this patient population.

The clinical endpoint is disease free survival. And we expect and the endpoint analysis for this prior, in the second half of 2025. The trial is enrolling as expected at the moment. And of course, this is all what we can say is looking as it will depend on the totality of the data. So a few words about the epidemiological study Alaska. Yes, I can I can do it and so what we will present at ash coal isn't it epidemiological studies. So it's it's not. A treatment study and we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in all of our ongoing clinical trials with P&G won 20 tool in particular also a subpopulation switch off <unk>. D N a positive because that for that informs our ongoing clinical trial. In addition to this epidemiological try it is a prescreening. We are screening trial to identify patients to recruit into all our investigation is try. It. So you will get in particular epidemiological data of <unk> positivity rates are in high risk. Populations in colorectal cancer and. Disease free survival. Which I've seen in this population.

And. We expect and. The endpoint analysis for this pie in the second half of 2025. Hi, this is <unk>. <unk> is expected at the moment and of course. This is all what we can say is looking as it will depend on the on the totality of the data. So a few words about the epidemiological study Alaska. Yes, I can I can do it and so what we will present at ash coal isn't it epidemiological studies. So it's it's not. A treatment study and we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in all of our ongoing clinical trials with P&G won 20 tool in particular also a subpopulation switch off <unk>. D N a positive because that for that informs our ongoing clinical trial. In addition to this epidemiological try it is a prescreening. We are screening trial to identify patients to recruit into all our investigation is try. It. So you will get in particular epidemiological data of <unk> positivity rates are in high risk.

We expect and. The endpoint analysis for this pie in the second half of 2025. Hi, this is <unk>. <unk> is expected at the moment and of course. This is all what we can say is looking as it will depend on the on the totality of the data. So a few words about the epidemiological study Alaska. Yes, I can I can do it and so what we will present at ash coal isn't it epidemiological studies. So it's it's not. A treatment study and we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in all of our ongoing clinical trials with P&G won 20 tool in particular also a subpopulation switch off <unk>. D N a positive because that for that informs our ongoing clinical trial. In addition to this epidemiological try it is a prescreening. We are screening trial to identify patients to recruit into all our investigation is try. It. So you will get in particular epidemiological data of <unk> positivity rates are in high risk.

The endpoint analysis for this pie in the second half of 2025. Hi, this is <unk>. <unk> is expected at the moment and of course. This is all what we can say is looking as it will depend on the on the totality of the data. So a few words about the epidemiological study Alaska. Yes, I can I can do it and so what we will present at ash coal isn't it epidemiological studies. So it's it's not. A treatment study and we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in all of our ongoing clinical trials with P&G won 20 tool in particular also a subpopulation switch off <unk>. D N a positive because that for that informs our ongoing clinical trial. In addition to this epidemiological try it is a prescreening. We are screening trial to identify patients to recruit into all our investigation is try. It. So you will get in particular epidemiological data of <unk> positivity rates are in high risk.

Hi, this is <unk>. <unk> is expected at the moment and of course. This is all what we can say is looking as it will depend on the on the totality of the data. So a few words about the epidemiological study Alaska. Yes, I can I can do it and so what we will present at ash coal isn't it epidemiological studies. So it's it's not. A treatment study and we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in all of our ongoing clinical trials with P&G won 20 tool in particular also a subpopulation switch off <unk>. D N a positive because that for that informs our ongoing clinical trial. In addition to this epidemiological try it is a prescreening. We are screening trial to identify patients to recruit into all our investigation is try. It. So you will get in particular epidemiological data of <unk> positivity rates are in high risk.

<unk> is expected at the moment and of course. This is all what we can say is looking as it will depend on the on the totality of the data. So a few words about the epidemiological study Alaska. Yes, I can I can do it and so what we will present at ash coal isn't it epidemiological studies. So it's it's not. A treatment study and we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in all of our ongoing clinical trials with P&G won 20 tool in particular also a subpopulation switch off <unk>. D N a positive because that for that informs our ongoing clinical trial. In addition to this epidemiological try it is a prescreening. We are screening trial to identify patients to recruit into all our investigation is try. It. So you will get in particular epidemiological data of <unk> positivity rates are in high risk.

So a few words about the epidemiological study Alaska. Yes, I can I can do it and so what we will present at ash coal isn't it epidemiological studies. So it's it's not. A treatment study and we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in all of our ongoing clinical trials with P&G won 20 tool in particular also a subpopulation switch off <unk>. D N a positive because that for that informs our ongoing clinical trial. In addition to this epidemiological try it is a prescreening. We are screening trial to identify patients to recruit into all our investigation is try. It. So you will get in particular epidemiological data of <unk> positivity rates are in high risk. Populations in colorectal cancer and. Disease free survival. Which I've seen in this population.

Ryan Richardson: Do you want to say a few words about the epidemiological study at Asco.

Özlem Türeci: Yes, I can do it. So what we will present at ASCO is an epidemiological studies. So it's not a treatment study. And we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in our ongoing clinical trials with BNT122 in particular also a subpopulation which are ctDNA positive because that further informs our ongoing clinical trial. In addition, this epidemiological trial it is a pre screening we are screening trial to identify patients to recruit into our investigation trials. So you will get in particular epidemiological data of ctDNA positivity rates in high risk populations in colorectal cancer and disease-free survival, which I've seen in this subpopulation.

Yes, I can I can do it and so what we will present at ash coal isn't it epidemiological studies. So it's it's not. A treatment study and we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in all of our ongoing clinical trials with P&G won 20 tool in particular also a subpopulation switch off <unk>. D N a positive because that for that informs our ongoing clinical trial. In addition to this epidemiological try it is a prescreening. We are screening trial to identify patients to recruit into all our investigation is try. It. So you will get in particular epidemiological data of <unk> positivity rates are in high risk.

A treatment study and we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in all of our ongoing clinical trials with P&G won 20 tool in particular also a subpopulation switch off <unk>. D N a positive because that for that informs our ongoing clinical trial. In addition to this epidemiological try it is a prescreening. We are screening trial to identify patients to recruit into all our investigation is try. It. So you will get in particular epidemiological data of <unk> positivity rates are in high risk.

D N a positive because that for that informs our ongoing clinical trial. In addition to this epidemiological try it is a prescreening.

We are screening trial to identify patients to recruit into all our investigation is try. It. So you will get in particular epidemiological data of <unk> positivity rates are in high risk.

Populations in colorectal cancer and. Disease free survival. Which I've seen in this population.

Disease free survival. Which I've seen in this population.

Which I've seen in this population.

Your next question comes from the line of Ellie Merle from UBS. Please go ahead. Hello Ali is your phone on mute. And he is you'll see it on mute. Okay due to no response I will go to the next question. One moment please.

Operator: Your next question comes from the line of Ellie Merle from UBS. Please go ahead. Hello Ali is your phone on mute. And he is you'll see it on mute. Okay due to no response I will go to the next question. One moment please. And your next question comes from the line of Bill My God from Canaccord. Please go ahead.

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

Thank you. Your next question. It comes from the line of Elie Matta from UBS. Please go ahead. Hello Ali is your phone on mute. And he is you'll see it on mute. Okay due to no response I will go to the next question. One moment please.

Your next question. It comes from the line of Elie Matta from UBS. Please go ahead. Hello Ali is your phone on mute. And he is you'll see it on mute. Okay due to no response I will go to the next question. One moment please.

It comes from the line of Elie Matta from UBS. Please go ahead. Hello Ali is your phone on mute. And he is you'll see it on mute. Okay due to no response I will go to the next question. One moment please.

Operator: Hello Ellie is your phone on mute? Okay due to no response I will go to the next question. One moment please. And your next question comes from the line of Bill Maughan from Canaccord. Please go ahead.

Hello Ali is your phone on mute. And he is you'll see it on mute. Okay due to no response I will go to the next question. One moment please. And your next question comes from the line of Bill My God from Canaccord. Please go ahead. Hi, and thank you. So as it is a technology agnostic oncology company, who has not yet gotten into radiotherapy do you see the excitement recently in that field as warranted and if so could we expect beyond take to potentially. Get some stake in radiotherapy combination or technology. By partnership or just bringing it internally it seems like a lot of the deal sizes recently could be in the range that beyond tech could look at thank you. Yeah, so indeed indeed. About your immunotherapy. It is is reaching between our maturity. And this is this is one of the aspects that you are following. We are currently not looking for opportunities for in licensing, but some of the research that you're doing internally could go into that direction. We could talk about this end of this year than the first validation data.

Hello Ali is your phone on mute. And he is you'll see it on mute. Okay due to no response I will go to the next question. One moment please.

And he is you'll see it on mute. Okay due to no response I will go to the next question. One moment please.

Speaker Change: Okay due to no response I will go to the next question. One moment please.

One moment please.

Hi, and thank you. So as a technology agnostic oncology company, who has not yet gotten into radiotherapy, do you see the excitement recently in that field as warranted? And if so could we expect BioNTech to potentially get some stake in radiotherapy combination or technology by partnership or just bringing it internally? It seems like a lot of the deal sizes recently could be in the range that BioNTech could look at? Thank you. Yeah, so indeed indeed. About your immunotherapy. It is is reaching between our maturity. And this is this is one of the aspects that you are following. We are currently not looking for opportunities for in licensing, but some of the research that you're doing internally could go into that direction. We could talk about this end of this year than the first validation data.

William Maughan: Hi, and thank you. So as a technology agnostic oncology company, who has not yet gotten into radiotherapy, do you see the excitement recently in that field as warranted? And if so could we expect BioNTech to potentially get some stake in radiotherapy combination or technology by partnership or just bringing it internally? It seems like a lot of the deal sizes recently could be in the range that BioNTech could look at? Thank you.

And your next question comes from the line of Bill My God from Canaccord. Please go ahead. Hi, and thank you. So as it is a technology agnostic oncology company, who has not yet gotten into radiotherapy do you see the excitement recently in that field as warranted and if so could we expect beyond take to potentially. Get some stake in radiotherapy combination or technology. By partnership or just bringing it internally it seems like a lot of the deal sizes recently could be in the range that beyond tech could look at thank you. Yeah, so indeed indeed. About your immunotherapy. It is is reaching between our maturity. And this is this is one of the aspects that you are following. We are currently not looking for opportunities for in licensing, but some of the research that you're doing internally could go into that direction. We could talk about this end of this year than the first validation data.

Hi, and thank you. So as it is a technology agnostic oncology company, who has not yet gotten into radiotherapy do you see the excitement recently in that field as warranted and if so could we expect beyond take to potentially.

So as it is a technology agnostic oncology company, who has not yet gotten into radiotherapy do you see the excitement recently in that field as warranted and if so could we expect beyond take to potentially.

Get some stake in radiotherapy combination or technology. By partnership or just bringing it internally it seems like a lot of the deal sizes recently could be in the range that beyond tech could look at thank you. Yeah, so indeed indeed. About your immunotherapy. It is is reaching between our maturity. And this is this is one of the aspects that you are following. We are currently not looking for opportunities for in licensing, but some of the research that you're doing internally could go into that direction.

By partnership or just bringing it internally it seems like a lot of the deal sizes recently could be in the range that beyond tech could look at thank you. Yeah, so indeed indeed. About your immunotherapy. It is is reaching between our maturity. And this is this is one of the aspects that you are following. We are currently not looking for opportunities for in licensing, but some of the research that you're doing internally could go into that direction.

Ugur Sahin: Yes. So indeed, value immunotherapy is reaching between our maturity. And this is one of the aspects that we are following. We are currently not looking for opportunities for in licensing, but some of the research that we're doing internally could go into that direction. We could talk about this end of this year when we have validation data.

Yeah, so indeed indeed. About your immunotherapy. It is is reaching between our maturity. And this is this is one of the aspects that you are following. We are currently not looking for opportunities for in licensing, but some of the research that you're doing internally could go into that direction.

About your immunotherapy. It is is reaching between our maturity. And this is this is one of the aspects that you are following. We are currently not looking for opportunities for in licensing, but some of the research that you're doing internally could go into that direction.

It is is reaching between our maturity. And this is this is one of the aspects that you are following. We are currently not looking for opportunities for in licensing, but some of the research that you're doing internally could go into that direction.

And this is this is one of the aspects that you are following. We are currently not looking for opportunities for in licensing, but some of the research that you're doing internally could go into that direction.

We are currently not looking for opportunities for in licensing, but some of the research that you're doing internally could go into that direction.

We could talk about this end of this year than the first validation data.

Operator: And your next question comes from the line of Hartaj Singh from Oppenheimer. Please go ahead.

Thank you. We will now go to the next question. I am doing next question comes from the line of Hothouse thing from Oppenheimer. Please go ahead.

We will now go to the next question. I am doing next question comes from the line of Hothouse thing from Oppenheimer. Please go ahead.

I am doing next question comes from the line of Hothouse thing from Oppenheimer. Please go ahead.

Hartaj Singh: Great. Thank you. Thank you for the question. I just wanted to ask a question on the slide where you listed the average quarterly patient enrollment. Over the last couple of years, we've seen actually real difficulty with companies in oncology, just because of the vast number of trials going on in oncology and IO recruiting patients. And you've seen a really nice acceleration in 2022 to '23 in the first quarter of '24. So can you just put some color behind that are meat on the bone of what exactly are you doing? Is it just the ability to-- the calls getting RV approval more trials actually moving ahead to late-stage, maybe spending more patients on recruiting trials at site. I'd love to hear that. And then how does this change your thinking on potential readouts? I mean, it's nice to see the improvement enrollment but how does that translate to when readouts could actually happen? Thank you.

I just wanted to ask a question on slide where you've got lifted the average quarterly patient enrollments. Over the last couple of years, we've seen actually. Real difficulty all with companies in oncology, just because of the vast number of trials going on in oncology and I O recruiting patients and you've seen a really nice acceleration in 2022 to 'twenty three.

Over the last couple of years, we've seen actually. Real difficulty all with companies in oncology, just because of the vast number of trials going on in oncology and I O recruiting patients and you've seen a really nice acceleration in 2022 to 'twenty three.

Real difficulty all with companies in oncology, just because of the vast number of trials going on in oncology and I O recruiting patients and you've seen a really nice acceleration in 2022 to 'twenty three.

In the first quarter 'twenty four so can you just put some color behind that are meat on the bone of what exactly are you doing is it just the ability to the calls getting IRB approved more trial once you're moving ahead to late stage, maybe spending more patients on recruiting troll that site all love to hear that and then how does this change.

Range Youre thinking on potential Readouts I mean. It's nice to see the improvement enrollment but. How does that translate to when readouts could actually happen. Thank you. Yes. Yes. Let me take the first part of the question. So in. In the timeline of 'twenty to 'twenty to 'twenty, two 'twenty to 'twenty 2020 free of cost me doubtless early clinical costs, which which are typically reporting. Although a number of patients are defining AR based on dose escalation. Oh cohort safety assessments biomarker assessment and so on and we are now reaching a face that'd be asked multiple times in phase II. And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

Range Youre thinking on potential Readouts I mean. It's nice to see the improvement enrollment but. How does that translate to when readouts could actually happen. Thank you.

Hartaj Singh: And then how does this change your thinking on potential readouts? I mean, it's nice to see the improvement enrollment but how does that translate to when readouts could actually happen? Thank you.

It's nice to see the improvement enrollment but. How does that translate to when readouts could actually happen. Thank you. Yes. Yes. Let me take the first part of the question. So in. In the timeline of 'twenty to 'twenty to 'twenty, two 'twenty to 'twenty 2020 free of cost me doubtless early clinical costs, which which are typically reporting. Although a number of patients are defining AR based on dose escalation. Oh cohort safety assessments biomarker assessment and so on and we are now reaching a face that'd be asked multiple times in phase II. And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

Speaker Change: How does that translate to when readouts could actually happen. Thank you. Yes. Yes. Let me take the first part of the question. So in. In the timeline of 'twenty to 'twenty to 'twenty, two 'twenty to 'twenty 2020 free of cost me doubtless early clinical costs, which which are typically reporting. Although a number of patients are defining AR based on dose escalation. Oh cohort safety assessments biomarker assessment and so on and we are now reaching a face that'd be asked multiple times in phase II. And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

Yes. Yes. Let me take the first part of the question. So in. In the timeline of 'twenty to 'twenty to 'twenty, two 'twenty to 'twenty 2020 free of cost me doubtless early clinical costs, which which are typically reporting. Although a number of patients are defining AR based on dose escalation. Oh cohort safety assessments biomarker assessment and so on and we are now reaching a face that'd be asked multiple times in phase II. And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

Thank you. Yes. Yes. Let me take the first part of the question. So in. In the timeline of 'twenty to 'twenty to 'twenty, two 'twenty to 'twenty 2020 free of cost me doubtless early clinical costs, which which are typically reporting. Although a number of patients are defining AR based on dose escalation. Oh cohort safety assessments biomarker assessment and so on and we are now reaching a face that'd be asked multiple times in phase II. And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

Thank you.

Yes. Let me take the first part of the question. So in the timeline of 2020, to 2022, 2023 of course, we dealt with early clinical trials, which are typically recruiting a lower number of patients and defining based on dose escalations of cohort safety assessments biomarker assessment and so on. And we are now reaching a phase where we are multiple times in Phase II. And tests clinical trials in Phase III which naturally allow us to enroll faster and ensure that we get the statistics. And this is also the reason why we are now are able to move multiple clinical trials into registration trials, we will provide the timeline then we expect to read out. is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

Ugur Sahin: Yes. Let me take the first part of the question. So in the timeline of 2020, to 2022, 2023 of course, we dealt with early clinical trials, which are typically recruiting a lower number of patients and defining based on dose escalations of cohort safety assessments biomarker assessment and so on. And we are now reaching a phase where we are multiple times in Phase II. And tests clinical trials in Phase III which naturally allow us to enroll faster and ensure that we get the statistics. And this is also the reason why we are now are able to move multiple clinical trials into registration trials, end of this year. And for all of the registrational trials we will provide the timeline then we expect to read out.

Yes. Let me take the first part of the question. So in. In the timeline of 'twenty to 'twenty to 'twenty, two 'twenty to 'twenty 2020 free of cost me doubtless early clinical costs, which which are typically reporting. Although a number of patients are defining AR based on dose escalation. Oh cohort safety assessments biomarker assessment and so on and we are now reaching a face that'd be asked multiple times in phase II. And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

Let me take the first part of the question. So in. In the timeline of 'twenty to 'twenty to 'twenty, two 'twenty to 'twenty 2020 free of cost me doubtless early clinical costs, which which are typically reporting. Although a number of patients are defining AR based on dose escalation. Oh cohort safety assessments biomarker assessment and so on and we are now reaching a face that'd be asked multiple times in phase II. And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

So in. In the timeline of 'twenty to 'twenty to 'twenty, two 'twenty to 'twenty 2020 free of cost me doubtless early clinical costs, which which are typically reporting. Although a number of patients are defining AR based on dose escalation. Oh cohort safety assessments biomarker assessment and so on and we are now reaching a face that'd be asked multiple times in phase II. And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

In the timeline of 'twenty to 'twenty to 'twenty, two 'twenty to 'twenty 2020 free of cost me doubtless early clinical costs, which which are typically reporting. Although a number of patients are defining AR based on dose escalation. Oh cohort safety assessments biomarker assessment and so on and we are now reaching a face that'd be asked multiple times in phase II. And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

Although a number of patients are defining AR based on dose escalation. Oh cohort safety assessments biomarker assessment and so on and we are now reaching a face that'd be asked multiple times in phase II. And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

Oh cohort safety assessments biomarker assessment and so on and we are now reaching a face that'd be asked multiple times in phase II. And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

And tests clinical trials in phase, three which which naturally allow us to invoice. Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

Faster. And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

And sure and sure that we've. Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

Get the statistics and this is also the reason why we are now that are able to move multiple clinical sites until legislation is passed and of the end of this year and for all of the Vegas placements policy will provide the timeline than we expected without S. M. S M.

As Ryan alluded the first read out for our first potential registration trial is in endometrial cancer, will be next year, second half--or mid next year with the opportunity to get most authorizations end of next year. And we will have some multiple internal read read outs for-- to be presented at ASCO and ESMO and City this year on the current cohorts. If I understand it's a tool that you have to have a. Pointed out quite correctly that a patient recruitment and it comes from the line more difficult. We are in. And the fortunate situation that we have a richness of different. Such and thereby a design space to chose those assets and a combination trial, which can give us several hits on our target to become a multi product oncology company continue by 'twenty tricky, but it was very clear to us from the very beginning that this also.

Bryan alluded the first assessed Ah read outs, Carla so potentially I guess placement type. Endometrial cancer. It will be next year. Todd. Mid next year with the opportunity to get most organizations end up next year, and we will have some out to the entire beat outs for <unk>. To be presented at ESMO and ethanol as 60 this yet. On the on the copy of adding cohorts. If I understand it's a tool that you have to have a. Pointed out quite correctly that a patient recruitment and it comes from the line more difficult. We are in. And the fortunate situation that we have a richness of different. Such and thereby a design space to chose those assets and a combination trial, which can give us several hits on our target to become a multi product oncology company continue by 'twenty tricky, but it was very clear to us from the very beginning that this also.

Endometrial cancer. It will be next year. Todd. Mid next year with the opportunity to get most organizations end up next year, and we will have some out to the entire beat outs for <unk>. To be presented at ESMO and ethanol as 60 this yet.

It will be next year. Todd. Mid next year with the opportunity to get most organizations end up next year, and we will have some out to the entire beat outs for <unk>. To be presented at ESMO and ethanol as 60 this yet.

Todd. Mid next year with the opportunity to get most organizations end up next year, and we will have some out to the entire beat outs for <unk>. To be presented at ESMO and ethanol as 60 this yet.

Mid next year with the opportunity to get most organizations end up next year, and we will have some out to the entire beat outs for <unk>. To be presented at ESMO and ethanol as 60 this yet.

If I may add to that, you have pointed out quite correctly that a patient recruitment becomes more and more difficult. We are in the fortunate situation that we have a richness of different assets and thereby a design space to chose those assets and a combination trials, which can give us several hits on our target to become a multi product oncology company continue by 2030. But it was very clear to us from the very beginning that we have to improve our capability to execute these clinical trials. So we have invested and this is what this bar chart shows, we have invested major efforts to mature our clinical development operations, organization and also to grow it. And we also have invested into models such as working with our partners. Partners with our partner companies. Enrollment into our joint trials and a public private partnership for example, like the partnership we have with U K in which we are bidding a cancer vaccine launch and thereby mobilizing on a national leverage a large numbers of all of our clinical sites and <unk>. Basically what this numbers reflect.

Özlem Türeci: If I may add to that, you have pointed out quite correctly that a patient recruitment becomes more and more difficult. We are in the fortunate situation that we have a richness of different assets and thereby a design space to chose those assets and a combination trials, which can give us several hits on our target to become a multi product oncology company continue by 2030. But it was very clear to us from the very beginning that we have to improve our capability to execute these clinical trials. So we have invested and this is what this bar chart shows, we have invested major efforts to mature our clinical development operations, organization and also to grow it.

To be presented at ESMO and ethanol as 60 this yet.

On the on the copy of adding cohorts. If I understand it's a tool that you have to have a. Pointed out quite correctly that a patient recruitment and it comes from the line more difficult. We are in. And the fortunate situation that we have a richness of different. Such and thereby a design space to chose those assets and a combination trial, which can give us several hits on our target to become a multi product oncology company continue by 'twenty tricky, but it was very clear to us from the very beginning that this also.

If I understand it's a tool that you have to have a. Pointed out quite correctly that a patient recruitment and it comes from the line more difficult. We are in. And the fortunate situation that we have a richness of different. Such and thereby a design space to chose those assets and a combination trial, which can give us several hits on our target to become a multi product oncology company continue by 'twenty tricky, but it was very clear to us from the very beginning that this also.

Pointed out quite correctly that a patient recruitment and it comes from the line more difficult. We are in. And the fortunate situation that we have a richness of different. Such and thereby a design space to chose those assets and a combination trial, which can give us several hits on our target to become a multi product oncology company continue by 'twenty tricky, but it was very clear to us from the very beginning that this also.

Speaker Change: We are in. And the fortunate situation that we have a richness of different. Such and thereby a design space to chose those assets and a combination trial, which can give us several hits on our target to become a multi product oncology company continue by 'twenty tricky, but it was very clear to us from the very beginning that this also.

And the fortunate situation that we have a richness of different. Such and thereby a design space to chose those assets and a combination trial, which can give us several hits on our target to become a multi product oncology company continue by 'twenty tricky, but it was very clear to us from the very beginning that this also.

Speaker Change: Such and thereby a design space to chose those assets and a combination trial, which can give us several hits on our target to become a multi product oncology company continue by 'twenty tricky, but it was very clear to us from the very beginning that this also.

But we have to. <unk> are a lot of capability to execute these clinical trials. So we have invested and this is what this bar chart shows we have invested major efforts to mature all of our clinical development operations organization and also to grow. And we also have invested into models such as working with our partners. Partners with our partner companies. Enrollment into our joint trials and a public private partnership for example, like the partnership we have with U K in which we are bidding a cancer vaccine launch and thereby mobilizing on a national leverage a large numbers of all of our clinical sites and <unk>. Basically what this numbers reflect.

<unk> are a lot of capability to execute these clinical trials. So we have invested and this is what this bar chart shows we have invested major efforts to mature all of our clinical development operations organization and also to grow. And we also have invested into models such as working with our partners. Partners with our partner companies. Enrollment into our joint trials and a public private partnership for example, like the partnership we have with U K in which we are bidding a cancer vaccine launch and thereby mobilizing on a national leverage a large numbers of all of our clinical sites and <unk>.

And we also have invested into models such as working with our partners, with our partner companies to enroll into our joint trials and a public private partnership for example, like the partnership we have with U.K. in which we are bidding a cancer vaccine launch and thereby mobilizing on a national leverage a large numbers of our clinical sites. And this is basically what this numbers reflect.

And we also have invested into models such as working with our partners. Partners with our partner companies. Enrollment into our joint trials and a public private partnership for example, like the partnership we have with U K in which we are bidding a cancer vaccine launch and thereby mobilizing on a national leverage a large numbers of all of our clinical sites and <unk>.

Partners with our partner companies. Enrollment into our joint trials and a public private partnership for example, like the partnership we have with U K in which we are bidding a cancer vaccine launch and thereby mobilizing on a national leverage a large numbers of all of our clinical sites and <unk>.

Speaker Change: Enrollment into our joint trials and a public private partnership for example, like the partnership we have with U K in which we are bidding a cancer vaccine launch and thereby mobilizing on a national leverage a large numbers of all of our clinical sites and <unk>.

Basically what this numbers reflect.

Thank you. Well now take the next question I'm doing next question comes from the line of Ellie Merle O U B S. Hey, guys can you hear me now. We can hear you. Okay perfect. Thank you just a fear of her two ADC. Well you got breakthrough. Endometrial cancer at late last year, and I think you just mentioned do you expect to have the pivotal data out in the second half of next year, if I heard that correctly. Can you tell us a little bit more on the design of the pivotal study and also how you're thinking about the opportunity for this asset and endometrial and where it would fit in the broader landscape.

Operator: And your next question comes from the line of Ellie Merle, UBS.

Well now take the next question I'm doing next question comes from the line of Ellie Merle O U B S.

Eliana Merle: Hey, guys can you hear me now. Okay perfect. Thank you. Just for your HER2 ADC, where you got breakthrough endometrial cancer at late last year, and I think you just mentioned do you expect to have the pivotal data out in the second half of next year, if I heard that correctly. Can you tell us a little bit more on the design of the pivotal study and also how you're thinking about the opportunity for this asset and endometrial and where it would fit in the broader landscape there?

Hey, guys can you hear me now. We can hear you. Okay perfect. Thank you just a fear of her two ADC. Well you got breakthrough. Endometrial cancer at late last year, and I think you just mentioned do you expect to have the pivotal data out in the second half of next year, if I heard that correctly. Can you tell us a little bit more on the design of the pivotal study and also how you're thinking about the opportunity for this asset and endometrial and where it would fit in the broader landscape.

We can hear you. Okay perfect. Thank you just a fear of her two ADC. Well you got breakthrough. Endometrial cancer at late last year, and I think you just mentioned do you expect to have the pivotal data out in the second half of next year, if I heard that correctly. Can you tell us a little bit more on the design of the pivotal study and also how you're thinking about the opportunity for this asset and endometrial and where it would fit in the broader landscape.

Eliana Rachel Merle: Okay perfect. Thank you just a fear of her two ADC. Well you got breakthrough. Endometrial cancer at late last year, and I think you just mentioned do you expect to have the pivotal data out in the second half of next year, if I heard that correctly. Can you tell us a little bit more on the design of the pivotal study and also how you're thinking about the opportunity for this asset and endometrial and where it would fit in the broader landscape.

Eliana Rachel Merle: Well you got breakthrough. Endometrial cancer at late last year, and I think you just mentioned do you expect to have the pivotal data out in the second half of next year, if I heard that correctly. Can you tell us a little bit more on the design of the pivotal study and also how you're thinking about the opportunity for this asset and endometrial and where it would fit in the broader landscape.

Endometrial cancer at late last year, and I think you just mentioned do you expect to have the pivotal data out in the second half of next year, if I heard that correctly. Can you tell us a little bit more on the design of the pivotal study and also how you're thinking about the opportunity for this asset and endometrial and where it would fit in the broader landscape.

Can you tell us a little bit more on the design of the pivotal study and also how you're thinking about the opportunity for this asset and endometrial and where it would fit in the broader landscape.

Ugur Sahin: Yes. [Inaudible] as a single arm trial in this population. And it is the registration will be based on safety data and the response data and durability of response data. This will be combined with confirmatory trial for which we still are in the planning phase, and we will inform, yes, in the around 3 to 4 months about the design of the complementary trial.

Okay. You're running pride as a single arm trial. Our interest in this population. It is the legislation will be based on safety data and the response data and durability of response data. This will be combined with the <unk>.

You're running pride as a single arm trial. Our interest in this population. It is the legislation will be based on safety data and the response data and durability of response data. This will be combined with the <unk>.

Our interest in this population. It is the legislation will be based on safety data and the response data and durability of response data. This will be combined with the <unk>.

It is the legislation will be based on safety data and the response data and durability of response data.

This will be combined with the <unk>.

The confirmatory trial. Falls, which we still are independent space, but in farm.

Falls, which we still are independent space, but in farm.

Yes. And around three to four months about the design of the Continental Vita.

And around three to four months about the design of the Continental Vita.

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

Your next question. Comes from the line of Simon Baker from Redburn Atlantic. Please go ahead.

Comes from the line of Simon Baker from Redburn Atlantic. Please go ahead.

Simon Baker: Thank you for taking my question. It's on SG&A. Your guidance implies an increase of between EUR 160 million to EUR 260 million this year. I would assume a large part of that is the global. commercial footprint build out. I just wondering if you could give us an idea of how that phases over this year and also '24 versus '25? Is most of the spend this year or is it most of it in 2025? Some idea of the cadence of that bild out would be great. Thanks so much.

It's on SG&A your guidance implies an increase of between $160 million to $260 million realized this year. I would assume a large part of that is the global. Commercial footprint build out. Wondering if you could give us an idea of how that phases over this year and also 24 versus 25 most of the spend this year or was most of it in 2025 similar idea of the cadence of that bill that would be great. Thanks, so much.

I would assume a large part of that is the global. Commercial footprint build out. Wondering if you could give us an idea of how that phases over this year and also 24 versus 25 most of the spend this year or was most of it in 2025 similar idea of the cadence of that bill that would be great. Thanks, so much.

Commercial footprint build out. Wondering if you could give us an idea of how that phases over this year and also 24 versus 25 most of the spend this year or was most of it in 2025 similar idea of the cadence of that bill that would be great. Thanks, so much.

Wondering if you could give us an idea of how that phases over this year and also 24 versus 25 most of the spend this year or was most of it in 2025 similar idea of the cadence of that bill that would be great. Thanks, so much.

Yes, thanks for the question. You should expect with '24 that we have slight increase quarter-by-quarter in terms of S&M costs and the G&A cost there in '24. And then for '25, likely to have a further increase in the setup. Of course, you start to hire personnel for the commercialization you'll see force to only shortly before you launch, and that will-- the timing of that will drive the spend in '25. Okay. Thanks, so much. Thank you. Your next question. It comes from the line of from HSBC. Please go ahead.

Jens Holstein: Yes, thanks for the question. You should expect with '24 that we have slight increase quarter-by-quarter in terms of S&M costs and the G&A cost there in '24. And then for '25, likely to have a further increase in the setup. Of course, you start to hire personnel for the commercialization you'll see force to only shortly before you launch, and that will-- the timing of that will drive the spend in '25.

You should expect with 24 that we have slight increases quarter by quarter in terms of. S N M costs and the G&A cost. In 'twenty four and then for 'twenty five. Likely to have a further increase in the in the. The setup. Of course, Youll start of higher personnel for the commercialization you'll see force. Only shortly before you launch and that will the timing of that will drive spend in 'twenty five. Okay. Thanks, so much. Thank you. Your next question. It comes from the line of from HSBC. Please go ahead.

S N M costs and the G&A cost. In 'twenty four and then for 'twenty five. Likely to have a further increase in the in the. The setup. Of course, Youll start of higher personnel for the commercialization you'll see force. Only shortly before you launch and that will the timing of that will drive spend in 'twenty five. Okay. Thanks, so much. Thank you. Your next question. It comes from the line of from HSBC. Please go ahead.

In 'twenty four and then for 'twenty five. Likely to have a further increase in the in the. The setup. Of course, Youll start of higher personnel for the commercialization you'll see force. Only shortly before you launch and that will the timing of that will drive spend in 'twenty five. Okay. Thanks, so much. Thank you. Your next question. It comes from the line of from HSBC. Please go ahead.

Likely to have a further increase in the in the. The setup. Of course, Youll start of higher personnel for the commercialization you'll see force. Only shortly before you launch and that will the timing of that will drive spend in 'twenty five. Okay. Thanks, so much.

The setup. Of course, Youll start of higher personnel for the commercialization you'll see force. Only shortly before you launch and that will the timing of that will drive spend in 'twenty five. Okay. Thanks, so much.

Of course, Youll start of higher personnel for the commercialization you'll see force. Only shortly before you launch and that will the timing of that will drive spend in 'twenty five. Okay. Thanks, so much.

Only shortly before you launch and that will the timing of that will drive spend in 'twenty five. Okay. Thanks, so much.

Okay. Thanks, so much.

Thank you. Your next question. It comes from the line of from HSBC. Please go ahead.

Operator: Thank you. Your next question comes from the line of Yifeng Liu from HSBC. Please go ahead.

Your next question. It comes from the line of from HSBC. Please go ahead.

It comes from the line of from HSBC. Please go ahead.

Hello, Thanks for taking my question. One question on your HER2 ADC in breast cancer. How do you think about the biomarker expectation there when you have HER2-low andHER perhaps and whether you think about HER2 ultra low as well in the design of your pivotal study? Thanks. Yeah. This is Jim. This is a good question indeed indeed. Uh huh. Yeah Yeah. The question is is it's about 212, no one plus two plus. Or even oil probably low or even negative. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on. And the for the upcoming price. And will most likely. We've talked about the clinical trial sites and of this year.

Yifeng Liu: Hello, Thanks for taking my question. One question on your HER2 ADC in breast cancer. How do you think about the biomarker expectation there when you have HER2-low andHER perhaps and whether you think about HER2 ultra low as well in the design of your pivotal study? Thanks.

One question on your Uh Huh, where do you see. In breast cancer. Do you think about the the bomb. Biomarker expression there when you have like.

In breast cancer. Do you think about the the bomb. Biomarker expression there when you have like.

Do you think about the the bomb. Biomarker expression there when you have like.

Biomarker expression there when you have like.

Oh to learn. And whether you think about her two ultra low is probably in the design of your pivotal study. Thanks. Yeah. This is Jim. This is a good question indeed indeed. Uh huh. Yeah Yeah. The question is is it's about 212, no one plus two plus. Or even oil probably low or even negative. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on.

And whether you think about her two ultra low is probably in the design of your pivotal study. Thanks. Yeah. This is Jim. This is a good question indeed indeed. Uh huh. Yeah Yeah. The question is is it's about 212, no one plus two plus. Or even oil probably low or even negative. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on.

Ugur Sahin: Yes. This is a good question indeed. Indeed the question is about HER2-low 1 plus 2 plus or even ultra low, or even negative. So we are considering all patient cohorts in our prior design and will make it that would make a decision on the patient population to be enrolled and the patient population to be analyzed later on. And the for the upcoming price and will most likely report about the clinical trial signed end of this year.

Yeah. This is Jim. This is a good question indeed indeed. Uh huh. Yeah Yeah. The question is is it's about 212, no one plus two plus. Or even oil probably low or even negative. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on.

This is a good question indeed indeed. Uh huh. Yeah Yeah. The question is is it's about 212, no one plus two plus. Or even oil probably low or even negative. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on.

Uh huh. Yeah Yeah. The question is is it's about 212, no one plus two plus. Or even oil probably low or even negative. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on.

Yeah Yeah. The question is is it's about 212, no one plus two plus. Or even oil probably low or even negative. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on.

Eliana Rachel Merle: The question is is it's about 212, no one plus two plus. Or even oil probably low or even negative. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on.

Or even oil probably low or even negative. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on. So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on.

So if you are considering or or patient cohorts in our Thai tire design and will make it that would make a decision on the on the patient population to be enrolled in the patient population to be energized later on.

And the for the upcoming price. And will most likely. We've talked about the clinical trial sites and of this year.

Eliana Rachel Merle: And will most likely. We've talked about the clinical trial sites and of this year.

Eliana Rachel Merle: We've talked about the clinical trial sites and of this year.

Operator: We will now take our final question for today. And your final question comes from the line of Suzanne van Voorthuizen from [VOK]. Please go ahead.

Thank you. We will now take our final question for today. Until final question comes from the line of Zondervan faults Houston from CLK. Please go ahead.

We will now take our final question for today. Until final question comes from the line of Zondervan faults Houston from CLK. Please go ahead.

Until final question comes from the line of Zondervan faults Houston from CLK. Please go ahead. Hi, there this is suzanne from P. Okay. Thanks for taking my question, which relate to our business development and M&A. Last year, you were fairly active on dealmaking fronts. So okay. Going forward for this and next year. You have a lot of cash on hand, but also those projects run and many moving parts on the profitability side. So I was wondering if you are continuing. Continuing to pursue similar deals in essence. Previously or does your appetite change.

Until final question comes from the line of Zondervan faults Houston from CLK. Please go ahead.

Suzanne van Voorthuizen: Hi, there. This is Suzanne from VOK. Thanks for taking my question, which relate to our business development and M&A. Last year, you were fairly active on deal-making fronts. So, can you give [Inaudible] going forward for this and next year. You have a lot of cash on hand, but also a lot of projects run and many moving parts on the profitability side. So I was wondering if you are continuing to pursue similar deals and assets as previously? Or does your appetite change? Thank you.

Hi, there this is suzanne from P. Okay. Thanks for taking my question, which relate to our business development and M&A. Last year, you were fairly active on dealmaking fronts. So okay. Going forward for this and next year. You have a lot of cash on hand, but also those projects run and many moving parts on the profitability side. So I was wondering if you are continuing. Continuing to pursue similar deals in essence. Previously or does your appetite change.

Last year, you were fairly active on dealmaking fronts. So okay. Going forward for this and next year. You have a lot of cash on hand, but also those projects run and many moving parts on the profitability side. So I was wondering if you are continuing. Continuing to pursue similar deals in essence. Previously or does your appetite change.

Going forward for this and next year. You have a lot of cash on hand, but also those projects run and many moving parts on the profitability side. So I was wondering if you are continuing. Continuing to pursue similar deals in essence. Previously or does your appetite change.

You have a lot of cash on hand, but also those projects run and many moving parts on the profitability side. So I was wondering if you are continuing. Continuing to pursue similar deals in essence. Previously or does your appetite change.

Continuing to pursue similar deals in essence.

Previously or does your appetite change.

Thank you. Yes, Thanks Suzanne. Carl. Our focus this year was more on clinical execution that said. Our focus this year was more on clinical execution that said. We will be opportunistic. But we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decrease this year. We will be opportunistic. But we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decrease this year.

Thank you.

Yes, Thanks Suzanne. I think our focus this year is more on clinical execution. That said, we will be opportunistic. But we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decreased this year. We will be opportunistic. But we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decrease this year.

Ryan Richardson: Yes, Thanks Suzanne. I think our focus this year is more on clinical execution. That said, we will be opportunistic. And if we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decreased this year.

Yes, Thanks Suzanne. Carl. Our focus this year was more on clinical execution that said. Our focus this year was more on clinical execution that said. We will be opportunistic. But we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decrease this year. We will be opportunistic. But we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decrease this year.

Carl. Our focus this year was more on clinical execution that said. Our focus this year was more on clinical execution that said. We will be opportunistic. But we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decrease this year. We will be opportunistic. But we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decrease this year.

Our focus this year was more on clinical execution that said.

We will be opportunistic. But we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decrease this year.

But we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decrease this year.

We will be opportunistic. But we're open to synergistic assets, but I think you can expect a general level of activity in terms of number of deals to be decrease this year.

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

Yeah. Yeah. Thank you. This concludes today's conference call. Thank you for participating you may now disconnect. Okay. [music]. Okay. [music]. Okay. [music]. [music]. Okay. Hum. Hum. [music]. Okay. [music]. Yes. [music]. Okay. [music]. Hum. [music].

Yeah.

Thank you.

Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect. Okay. [music]. Okay. [music]. Okay. [music]. [music]. Okay. Hum. Hum. [music]. Okay. [music]. Yes. [music]. Okay. [music]. Hum. [music].

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