Q4 2024 BioNTech SE Earnings Call
Unknown Executive: Welcome to BioNTech's fourth quarter and full year 2024 earnings call.
Welcome to biotech fourth quarter and full year 'twenty 'twenty four earnings call I would like to hand, the call over to Michael Horowitz Director of Investor Relations. Please go ahead.
Michael Horowitz: I would like to hand the call over to Michael Horowitz, Director Investor Relations. Please go ahead. Thank you. Good morning and good afternoon. Thank you for joining BioNTech's fourth quarter and full year 2024 earnings call. As a reminder, the slides we will be using during this call and the corresponding press release we issued this morning can be found in the investor relations section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission.
Please go ahead.
Speaker Change: Thank you. Good morning and good afternoon. Thank you for joining BioNTech's fourth quarter and full year 2024 earnings call. As a reminder, the slides that we will be using during this call and the corresponding press release we issued this morning can be found in the investor relations section of our website.
Michael Horowitz: Forward-looking statements on 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.
Unknown Executive: On slide three, you can find the agenda for today's call.
Unknown Executive: Today, I'm joined by the following members of BioNTech's management team.
Unknown Executive: Uzair Zaheem, Chief Executive Officer and Co-Founder, Ozlem Tureci, Chief Medical Officer and Co-Founder, Jens Holstein, Chief Financial Officer, and Ryan Richardson, Chief Strategy Officer.
Ugur Sahin: With this, I would like to hand over to Ugur.
Ugur Sahin: Thank you, Michael.
Ugur Sahin: A warm welcome to all those joining us today. We will spend today's call on our key areas of focus for this year. Before we do so, I want to speak briefly about our original vision and the strategy to become an immunotherapy powerhouse and a fully integrated biopharmaceutical company with multiple approved products. While BioNTech has evolved significantly since its founding in 2008, our vision has remained steadfast. to translate science into survival for patients by fully harnessing the power of the immune system to fight human diseases, particularly cancer. In 2024, we made significant progress on this vision.
Speaker Change: This multiple approved products.
Speaker Change: Bye Bye ontic has evolved significantly since its founding in 2008, our vision has remained steadfast.
Speaker Change: Translate into survival for patients.
Speaker Change: Fully harnessing the power of the immune system to fight human disease.
Speaker Change: Clearly cancer.
Speaker Change: In 2025, we made significant progress on this vision.
Ugur Sahin: Thanks to the excellent work and dedication of our BioNTech team, our collaboration partners, and the trust of patients who participated in our clinical trials. We have a clear focus. We will continue to invest in our technologies and drug candidates that have the potential to improve outcomes for patients across a wide range of tumor types. In oncology, we have identified two key pan-tumor programs. of mRNA cancer immunotherapy SIGCHI and INUS. and our bi-specific anti-PDR1, anti-VQF antibody, we interviewed to seven. We believe that these programs have disruptive potential and align with our vision. Successfully developed and approved, these programs could establish a new standard of care and enhance patient outcomes in multiple cancer indications groups.
Speaker Change: As to the excellent work and dedication of our biotech team.
Speaker Change: Our collaboration partner.
Speaker Change: And the cost of patients who participated in our clinical costs.
Speaker Change: We have a clear focus.
Speaker Change: We will continue to invest in our technologies and product candidates.
Speaker Change: The potential to improve outcomes for patients across a wide range of tumor types in oncology, we have identified two key pan tumor programs.
Speaker Change: And on a cancer immunotherapy six back in August.
Speaker Change: And our bi specific anti PD airvana anti VEGF anti body, we introduce the seven we believe that these programs have disruptive potential.
Speaker Change: And that's our ambition.
Speaker Change: First fully developed and approved.
Speaker Change: Programs establish a new standard of care and.
Speaker Change: Patient outcomes in multiple cancer indications globally.
Ugur Sahin: We are significantly investing in the clinical development of this program across various cancer... building up commercial functions for their future commercialization in key markets and enhancing manufacturing capabilities to support both clinical type and commercial. In the infectious disease sector, we are advancing the development of our next generation COVID-19 and combination vaccines. Our Infectious Disease Product Strategy. focuses on sustainable value creation with active pipeline prioritization and rigorous opportunity assessment based on strategic fit and operational efficiency. Consequently, as outlined in our 20th signing today, we are prioritizing areas with disruptive potential for value generation. Moreover, we are planning to adjust our resources in manufacturing, administrative functions, and pre-clinical research over the next three years to further solidify efficient equipment.
Speaker Change: We are significantly investing in the clinical development programs across various cancer types building up commercial functions for their future commercialization in key market.
Speaker Change: Hansen manufacturing capabilities to support both clinical and.
Speaker Change: Commercial supply in the infectious disease sector, we are advancing the development of our next generation COVID-19 and combination vaccine.
Speaker Change: Our infectious disease Kodak.
Speaker Change: Focus is on sustainable value creation with active pipeline prioritization because opportunity assessment based on strategic fit.
Speaker Change: So the efficiency.
Speaker Change: Consequently, as outlined in our 20-F filing today.
Speaker Change: We are prioritizing areas with disruptive potential.
Speaker Change: Our new generation.
Speaker Change: Moreover, we are planning to adjust our resources manufacturing administrative functions and create clinical research over the next few years to further solidify efficient execution.
Ugur Sahin: Let me continue with a look back at what we have achieved in 2024. For our mRNA cancer immunotherapies, we initiated a third-phase two-tribe evaluating autogen serum miran in an adjuvant setting, namely in bladder cancer. In early 2025, we will also publish two manuscripts describing our insights from two Phase I trials for autogenes in human organs. For three of the shared FIXAC programs, we reported data including the announcement that FIXAC candidate BNT111 met the primary endpoint in a randomized phase 2 trial in patients with anti-PD-1 relapse of refractory melanoma. We presented multiple data sets for our next generation IO BNT327 at PD-L1 VGS by specific antibody and initiated phase 3 and phase 2 free trials in small cell lung cancer and non-small cell lung cancer.
Speaker Change: Let me continue with a look back at what we have achieved in 2024.
Speaker Change: I'm on a cancer immunotherapy initiated the phase two trial.
Speaker Change: Evaluating or T cell <unk> in adjuvant setting.
Speaker Change: Namely in bladder cancer.
Speaker Change: In early 2025, Youre also published to Manav Gupta with.
Speaker Change: Describing our insights from two first one for.
Speaker Change: Or could you in Salem, Oregon.
Speaker Change: For a free of the shafts exact programs we've reported.
Speaker Change: After including the announcement that.
Speaker Change: Sixth candidate BMT.
Speaker Change: 11 met the primary endpoint in a randomized phase two trial in patients with anti PD one with that.
Speaker Change: Factory melanoma.
Speaker Change: Presented multiple data sets for our next generation <unk> 23 to seven pediatric Brian VEGF by specific anti body and initiated phase three and phase two.
Speaker Change: Cost in small cell lung cancer, and non small cell lung cancer.
Ugur Sahin: We plan to initiate a phase 3 trial in triple negative breast cancer. We announce our intention to acquire BioTheos to secure global control over BNT327 and expand our immunotherapy capability. This transaction closed earlier this year and we are thrilled to welcome BioFuse as a new arm of our operations in China. With regard to our COVID-19 vaccine, we and Pfizer maintain our leading market share globally. We also continued to podcast several other programs in our early stage infectious disease package. Lastly, we were able to achieve all this by maintaining our strong financial position. We believe these achievements positions us well for further progress in 2025.
Speaker Change: We plan to initiate a phase III in triple negative breast cancer this year.
Speaker Change: We announced our intention to acquire <unk>.
Speaker Change: To secure global control over $83, seven and expand our immunotherapy capabilities.
Speaker Change: This transaction closed earlier this year and be a threat to the field.
Speaker Change: <unk>.
Speaker Change: Our operations in China.
Speaker Change: With regard to our COVID-19 vaccine.
Speaker Change: <unk> maintained our leading market share globally.
Speaker Change: You also continued to progress several other programs in our early stage infectious disease programs.
Speaker Change: Lastly, we were able to achieve all of this while maintaining our strong financial position.
Speaker Change: We believe these achievements position us for further progress in 2025.
Ugur Sahin: As already pointed out, in oncology, we are focused on the development of candidates addressing the full spectrum of solid tumors with a focus on two pan-tumor folks. First, our personalized mRNA cancer immunotherapies, including mutant neoantigens for application, primarily for the early stage, including adjuvant setting. And our FIXVAC immunotherapies targeting tumor-associated antigens in combination with checkpoint immunotherapy, respectively. Second, our PDR1-BGF biospecific antibody BNT-307, which we believe has the potential to become a next-generation I.O. backbone for the treatment of advanced cancer. We believe that both programs have pan-tumor potential and could be combined with different modalities to address large patient populations with high unmet medical needs.
Speaker Change: As already pointed out in oncology the our focus on the development of candidates addressing the full spectrum of solid tumors.
Speaker Change: With a focus on tube pan tumor programs.
Speaker Change: First our personalized.
Speaker Change: Cancer immuno therapies and <unk>.
Speaker Change: Coding Newton, new academic application, primarily for the early stage, including adjuvant setting.
Speaker Change: Our <unk> immunotherapies targeting tumor associated antigens in combination with checkpoint immunotherapy, respectively.
Speaker Change: Second our PDL one ETF.
Kevin: Specific anti body BMT for you Kevin.
Kevin: Which we believe has the potential to become a next generation Io backbone for the treatment of advanced cancer.
Kevin: We believe that both programs have pan tumor potential and could be combined with different modalities to address large patient population.
Kevin: High unmet medical need.
Ugur Sahin: 2025 will be an important year for these priority programs. We expect to generate and share new clinical data that will help inform our development.
Kevin: 2025, there will be an important year for DS priority programs, we expect to generate and Shannon you clinical data that we'll have in front of our development strategy.
Ugur Sahin: I want to take a moment to highlight our recently completed acquisition of Biosphere.
Kevin: I want to take a moment to highlight our recently completed acquisition of past years.
Ugur Sahin: We are excited to now formally welcome BioCEOS team to BioNTech. Having worked for a year with the highly skilled and dedicated team at BioCEOS, we have decided to plan for an acquisition of the company. Now as one company, we have the capabilities to accelerate and expand the global development of BNT327.
Kevin: We are excited to now formally Viacom biopsy team to biotech having drug for a year is the highest and.
Kevin: The team at <unk>.
Kevin: We have decided to plan for an acquisition of the company.
Kevin: Now as one company, we have the capability to accelerate and expand the global development of BNP three to seven.
Ugur Sahin: However, there are other factors of this acquisition, which are also strategically important for us. We are going to build a strong and experienced clinical development organization in China that can help us to further accelerate the development across programs and tumor types. We believe this will facilitate more streamlined clinical development and decision-making, allowing us to bring other programs into late-stage and global development.
Kevin: Or are there other factors of this acquisition, which are also strategically important to us.
Kevin: We are going to build a strong and experienced clinical development organization in China that can help us to product development across all camps and tumor types.
Kevin: Belief this will facilitate more streamlined clinical development and decision making.
Kevin: As to bring other programs into late stage and global developed.
Ugur Sahin: With the acquisition of BioFuse, we have now a fully integrated antibody manufacturing network in China. The site supplies antibodies for clinical trials and could potentially support initial commercial supply for market. Lastly, BioFuse comes with leading antibody engineering technology and expertise. With their capability, they have very quickly built a diverse pipeline of programs that we are evaluating and which we believe could offer additional value in the coming years.
Kevin: This acquisition of <unk>.
Kevin: Now a fully integrated anti body manufacturing network in China.
Kevin: The sites surpass anti bodies for clinical costs and could potentially support initial commercial supply for market launch.
Kevin: Lastly, biofuels comfort of meeting antibody engineering technology and expertise.
Kevin: With their capability they have very quickly build a diverse pipeline of programs that we are evaluating and which we believe could offer additional value in the coming year.
Esther: With that, I will turn the call over to Esther. Thank you, Ugur. Glad to be speaking with everyone today.
Kevin: With that I will.
Kevin: I'll turn the call over to Esther thank.
Esther: Thank you glad to be speaking with everyone today before talking about our focus programs introduced by <unk> I wanted to take a minute to show our pipeline progress in 2024.
Esther: Before talking about our focus programs introduced by Ugur, I wanted to take a minute to show our pipeline progress. If you compare our oncology pipeline today to previous years, you can see that we have significantly increased the number of face-to-hand free trials that are ongoing, both as a total number and as a percentage of the total trials we are running. When choosing which programs to move forward into late-stage trials, we maintain a high bar for prioritization, which is guided by clinical data, unmet medical need, and commercial potential. As Ugur pointed out, our mRNA immunotherapies and our BNT327-centered clinical development program are dominantly represented in our pipeline, and particularly so in the advanced clinical stages, with BNT327 becoming our platform for unique combinations with several of our other assets, in particular our As Ugur mentioned, 2025 will be an important year for both of our priorities.
Esther: If you compare our oncology pipeline today to previous year, you can see that we have significantly increased the number of phase III trials.
Esther: Our ongoing both as a total number and does the percentage of total trades we are running.
Esther: When choosing which programs to move forward into late stage trials, we maintain a high buffer prioritization, which is guided by clinical data unmet medical need and commercial potential as it will go up.
Esther: Pointed out.
Esther: R&D Immunotherapies and RPM Chief reached 2007, <unk> clinical development program a dominant <unk>.
Esther: Centers in our pipeline and particularly so in the advanced clinical stages.
Esther: BMT for years 2007, becoming our platform for unique combinations with several of our other assets in particular or ADC.
Esther: As mentioned 2025 would be an important year for both of our priority programs.
Esther: BNT327, by co-localizing the blockade of PD-L1 and VEGF-A signaling to the tumor, is designed to deliver superior anti-tumor, immune modulatory, and anti-angiogenic effects compared to the individual targeting of PD-L1 and VEGF-A, with the potential to minimize adverse events associated with systemic anti-VEGF-A therapy. With the anti-PD-L1 and anti-VEGF-A mechanisms being validated across numerous tumor types, and in some cases in combination, we have a roadmap for development. We have made strong progress over the past few months across all three waves of our BNT327 clinical development program. The first wave is focused on lung cancer and TNBC as key indications to establish BNT327 combined with standard-of-care chemotherapy with first approvals and first-line settings of these indications.
Esther: Q3, 2007 by cooler localizing that blockade of PD, one and VEGF a signaling to the tumor is designed to deliver superior anti tumor immune module rytary and anti angiogenic effects compared to the individual targeting of PDL, one and VEGF a.
Esther: With the potential to minimize adverse events associated with systemic anti VEGF AC RFP with the anti PD, one anti VEGF a mechanism being validated across numerous tumor types and in some cases in combination we have a roadmap roadmap for diesel.
Esther: We have made strong progress over the past few months across all three waves of our <unk> hundred 27 clinical development program. The first wave is focused on lung cancer and CNBC S. Key indications to establish <unk> hundred 27, combined with standard of care.
Esther: ERP with first approval in first line settings of these indications.
Esther: We have completed enrollment in our global phase two dose optimization studies in small cell lung cancer and TNDC. In small cell lung cancer, we have begun enrolling patients in the global randomized phase three trial. In TMBC, we will start a global registrational study later. In non-small cell lung cancer, we have begun enrolling patients in our global phase two free registrational clinics. Our second wave of development with BNT327 reflects that IO plus ADC combos are an emerging treatment paradigm in oncology. We have started exploring combinations of BNT327 with four ADCs directed against drop two, HER2, HER3, B7H3, from our partnerships with Duality and MediLink and informed by a robust database of single agent data for these ADCs.
Esther: We have completed enrollment in our global phase two dose optimization studies in small cell lung cancer and <unk> in small cell lung cancer, we have begun enrolling patients in the global randomized phase III trial.
Esther: In <unk>, we will start a global Registrational study later this year.
Esther: In non small cell lung cancer, we have begun enrolling patients in our global phase three registration clinical trials.
Esther: Our second wave of development with the anti <unk> hundred 27 reflects that I O plus ADC combos are an emerging treatment paradigm in oncology. We have started exploring combinations of <unk> hundred 2007, with adcs directed against Trop two.
Esther: To her freebie 70, <unk> from our partnerships with <unk> meeting and informed by a robust database of single agent data for these adcs.
Esther: A BNT327 ADC combination study with our drop two ADC, BNT325, is already enrolling patients. In the coming months, we expect to dose the first patients combining BNT327 with our HER2 ADC, 323, and our B7H3. Throughout this year, we will evaluate the data from these initial combination trials and will start additional novel combinations across two more types to broaden our global clinical development program with BNT-free trials. With this focused clinical development program, we aim to leverage BNT327's full potential. As previously mentioned, we expect 2025 to be a data-rich year across our whole pipeline, and especially for BNT pre-27.
Esther: <unk> pre 2700, ADC combination study with our trop two ADC <unk> hundred 25 is already enrolling patients in the <unk>.
Esther: <unk> months, we expect to dose the first patients combining <unk> hundred 2007 with all of her two ADC <unk> hundred 23, and <unk> 780, <unk> hundred 80 <unk>.
Esther: Throughout this year was evaluate the data from these initial combination trials and will start additional novel combinations across tumor types to broaden our global clinical development program with <unk> hundred 2007.
Esther: With this focus clinical development program, we aim to leverage <unk> 27 for potentially.
Esther: As previously mentioned, we expect 2025 to be a data rich year across our long haul pipeline and especially for PMT pre 2007. The first of these data sets will come later this month at the European lung cancer Congress and feature our trials in small cell lung cancer.
Esther: The first of these data sets will come later this month at the European Lung Cancer Congress and feature our trials in small cell lungs. Small cell lung cancer is a tumor type with notable incidence worldwide and an immunologically cold tumor for which high unmet need remains. With current standard of care treatment, the durability of responses is quite short and five-year survival rate for extended stage small cell lung cancer is only 3%. Based on our emerging data, we believe that BNT-327 has the potential to improve clinical outcomes for patients with small cell lung. At ESMO 2023, data were presented which show encouraging activity of BNT327 in combination with standard-of-care chemotherapy in second-line small cell lung cancer that has motivated us to pursue small cell lung cancer as one of our priority indications for BNT327.
Esther: So lung cancer is a tumor type.
Esther: With notable incidents worldwide and an immunologically cold tumors for which high unmet need remains with current standard of care treatment with your ability of responses is quite short and five year survival rate for extended stage small cell lung cancer is only 3%.
Esther: Based on our emerging data, we believe that PMT free 27 has the potential to improve clinical outcomes for patients with small cell lung cancer.
Esther: At ESMO 2020 free data were presented.
Esther: Which showed encouraging activity of the anti <unk> hundred 27 in combination with standard of care chemotherapy in second line small cell lung cancer that has motivated us to pursue small cell lung cancer is one of our priority indications for <unk> hundred 2007, we plan to present.
Esther: We plan to present three data sets from trials in small cell lung cancer this year, including data from two separate single arm phase two trials, evaluating BNT327 plus chemotherapy as a first or second line treatment for extensive stage small cell lung. These data sets continue to support our enthusiasm for evaluating BNT-327 for the potential treatment of first-line mortal lung cancer in our ongoing global phase. As Ryan will cover later, we expect to share additional important clinical data updates throughout the year.
Esther: Free data sets from trials in small cell lung cancer this year, including data from two separate single arm phase II trials.
Esther: Uhm BMT free 27, plus chemotherapy therapy as the first or second line treatment for extensive stage small cell lung cancer. These data sets continue to support our enthusiasm for evaluating the antifreeze 27 for the potential treatment of <unk>.
Esther: Most of lung cancer.
Esther: Ongoing global Phase III trial.
Esther: Ryan will cover later, we expect to share additional important clinical data updates throughout the year.
Esther: Our mRNA cancer immune therapy platforms, INES and CICFAC, are the other cornerstone of our oncology portfolio. Autogen Sivumaran, aka BNT-122, developed in partnership with Genentech, is based on the INAS targets neoantigens, unique tumor-specific mutations, and is manufactured on demand for each individual patient. FixVac, in contrast, targets shared non-mutated tumor antigens and is an off-the-shelf approach. Both platforms utilize our proprietary uridine mRNA LPX delivery. The discovery of these two different types of target antigens is one of our core competencies. Over the past several years, we've accumulated substantial data from INUS and FIXVAC trials across various tumor types.
Esther: Our mrna cancer immune therapy platforms, <unk> and <unk>.
Esther: Cornerstone of our oncology portfolio.
Esther: <unk> neuron AK BMT, one 'twenty tool developed in partnership with Genentech is based on the IMS platform.
Esther: Targets Neo antigens.
Esther: <unk> tumor specific mutations and is manufactured on demand for each individual patient.
Esther: <unk> second contrast target chap non mutated tumor antigen and there is an off the shelf approach both platform utilizes our proprietary uridine mrna IPX delivery technology. The discovery of these two different types of targets antigens.
Esther: As one of our core competencies.
Esther: Over the past several years, we've accumulated substantial data from <unk> and <unk> trials across various tumor types. These data consistently demonstrate that uridine mrna RPX based immunotherapies have manageable safety profile whereby used as single agents.
Esther: These data consistently demonstrate that uridine mRNA LPX-based immunotherapies have manageable safety profile, whereby used as single agents in combination with anti-PD-1, PD-L1 inhibitors or with chemotherapies. Crucially, our data also indicate that these immunotherapies are highly effective at inducing and expanding high-magnitude, functional, and long-lived T cell responses in a significant proportion of patients. This robust immune response is a prerequisite for clinical action. We have multiple trials. with both FIXVAC and I-NEST ongoing and have had multiple data reports in the past years and in particular in 2024.
Esther: In combination with anti PD, one PDL one inhibitors.
Esther: With chemotherapy crucially our data also indicate that these immune of Europeans are highly effective at inducing and expanding high magnitude functional in Columbus T cell responses in a significant proportion of patients.
Esther: This robust immune response is a prerequisite for clinical activity.
Esther: We have multiple trials.
Esther: With go fix like an.
Esther: Ongoing and have had much better data reports in the past years and in particular in 2020 for today I would like to focus on <unk> and recent data we have obtained in the Tri Ed highlighted here from which we recently published data in nature Medicine.
Esther: Today, I would like to focus on I-NEST and recent data we have obtained in the trial highlighted here from which we recently published data in NatureMed. This is our first phase one clinical trial of autogenesivumaran published in Nature Medicine, which included over 200 patients with resistant refractory advanced and metastatic solid This trial evaluated autogenesivumaran both with and without the checkpoint inhibitor atezolizumab. It is known that only a small fraction, 1% to 2% of cancer mutations, spontaneously elicit an anti-tumor immune response. Our mRNA cancer immune therapy approach aims to significantly increase these antitumor immune In this phase one trial, autogens of Omran successfully induced T cell responses across multiple cancer types, converting a high portion of patients into immune responders.
Esther: This is our first phase one clinical trial of <unk>.
Esther: Published in nature Medicine, which included over 200 patients with resistant refractory advanced and metastatic solid tumors.
Esther: This trial evaluated at origin to Wuhan.
Esther: Absent without with checkpoint inhibitor occasionally some of it.
Esther: It is known that only a small fraction, 1% to 2% of cancer mutations spontaneously listed anti tumor immune response.
Esther: Our mrna cancer immunotherapy approach aims to significantly increase this anti tumor immune responses.
Esther: In this phase one trial oxygen to Wuhan successfully induced T cell responses across multiple cancer types converting a high portion of patients into immune responders.
Esther: The majority of these responses were polyepitopic, directed against multiple mRNA-encoded neoantigens. And these responses were de novo, meaning they were newly generated against the encoded neoantigens and did not exist prior to treatment. In some patients, we observed up to a two order of magnitude amplification. of existing neo-antigens. Furthermore, in several patients, we detected newly-induced anti-tumor T-cells infiltrating the tumor of treatment. These findings demonstrate the potent immunogenicity of autogenesivumaran even in patients with advanced, rapidly-progressing cancers, which is a prerequisite for clinical action. In our ongoing phase two clinical trials, we aim to confirm these data and evaluate in which treatment setting and indications for immune responses translate best into clinical activity.
Esther: Clarity of these responses were fully epic topic directed against multiple mrna encoded antigens and these responses were a de novo, meaning they were newly generated against the uncoated Neo antigens and did not exist prior to treatment.
Esther: In some patients we observed up to two order of magnitude amplification of existing antigen specific T cells.
Esther: Furthermore, and several patients we detected newly induced anti tumor T cells infiltrating the tumor of treated patients.
Esther: These findings demonstrate potent immunogenicity.
Esther: <unk> will run even in patients with advanced rapidly progressing, Kansas, which is a pre requisite for clinical activity.
Ongoing phase two clinical trials, we aim to confirm these data and evaluate in which treatment setting and indication for immune responses translate best into clinical activity.
Esther: While we saw strong immune responses in this phase one trial, we observed modest signals of clinical activity. which was expected given that this phase one trial was conducted in heavily pretreated, resistant refractory, fast-growing advance.
Esther: We saw strong immune responses in this phase one trial.
They're modest signals of clinical activity, which was expected given that this phase one trial was conducted in heavily pretreated resistant refractory cost growing advanced cancer.
Esther: We recently also received top-line data from the IMCODE-001 Phase II trial marked here on this slide. This was the first randomized proof-of-concept phase 2 trial of an INES candidate, evaluating autogen savumaran in combination with pembrolizumab versus pembrolizumab alone, a first-line treatment for patients with metastatic or advanced melanoma. This trial is part of a broader mCODE study program initiated in 2017 by our partner Genentech and us, designed to identify optimal treatment settings and patient populations for individualized mRNA cancer immunosuppressants. including early and late stages. Bible-initialed data confirm our observations that autogen sarumaran induces high-magnitude immune responses against encoded neoantigens in this advanced treatment setting.
Esther: We recently also received top line data from the in code or one phase II trial marked here on this slide.
Esther: This was the first randomized proof of concept phase two trial of an IMS candidate evaluating <unk> in combination with <unk> will be somewhat lower.
Esther: On the first line treatment for patients with metastatic advanced.
Esther: Advanced melanoma.
Esther: This trial is part of a broader study program initiated in 2017 by our partner Genentech and design.
Esther: Designed to identify optimal treatment settings, and patient population for individualized mrna cancer immunotherapies, including early and late stage cancers by the initial data confirmed observations that occupancy will neuron induces high magnitude immune responses against encoded.
Esther: New antigens in this advanced treatment setting.
Esther: Here in patients with advanced and metastatic melanoma, the trial did not meet its primary endpoint of a statistically significant improvement in progression-free survival. However, we did observe a numerical trend favoring the combination arm in overall survival. The combination of autogen sarumaran with PD-1 blockade was well tolerated with adverse events consistent with the known safety profiles of the individual. We are continuing to analyze the results, including exploratory endpoints and biomarker correlations. We and our partner, Genentech, will share this data with the scientific community at an upcoming medical conference. The outcome confirms what we have observed in our phase one trial in patients with heavily pre-treated resistant refractory fast-growing advanced cancers and provides valuable information.
Esther: Here in patients with advanced and metastatic melanoma. The trial did not meet its primary endpoint of a statistically significant improvement in progression free survival.
Esther: However, we did observe a numerical trend favoring the combination and overall survival at the <unk>.
Esther: Combination.
Esther: Auto <unk> with PD, one blockade was well tolerated with adverse events consistent with the known safety profile of the individual treatments.
Esther: We are continuing to analyze our results, including exploratory endpoints and biomarker correlations.
Esther: We and our partner Genentech with shared these data with the scientific community at an upcoming medical conference.
Esther: Outcome confirms what we have observed in our phase one trial in patients with heavily pretreated resistant refractory costs growing advanced cancer and provides valuable insight page.
Esther: Patients in the first-line metastatic melanoma setting have a substantial tumor burden and rapid disease progression. An effective immune response, even a potent one, requires time to develop, typically six to eight weeks, based on our data. This timeframe may be insufficient to control rapidly growing advanced disease and may require treatment combinations with other modalities.
Esther: Patients in the first line metastatic melanoma setting has a substantial tumor garden and rapid disease progression.
Esther: Effective immune response, even a potent one requires time to develop typically.
Esther: Six to eight weeks based on our data this timeframe may be insufficient to control the rapidly growing advanced disease and may require treatment combinations with other modalities.
Esther: This experience combined with our extensive translational data, reconfirm our strategic focus on using INIS in the adjuvant setting, where patients have rejectable cancers and minimal residual disease. We believe this setting offers a strong biological rationale for success due to several reasons. Adjuvant therapy targets a much smaller number of residual tumor cells after surgery. The slower disease progression in the adjuvant setting allows sufficient time for the vaccine-induced immune response to develop and mature. Also in earlier disease stages, mechanisms of resistance, clonal heterogeneity, and an immune-suppressive tumor microenvironment are typically less effective. Patients in the adjuvant setting often have heavier immune systems and less compromised T cell function, increasing the likelihood of a clinically meaningful recovery.
Esther: <unk> combined with our extensive translational data reconfirms, our strategic focus on using <unk> in the adjuvant setting where patients have resectable cancer and minimal residual disease. We believe the setting of a strong biological rationale for success due to <unk>.
Esther: Several reasons.
Esther: It's driven therapy targets, a much smaller number of residual tumor cells. After surgery, the slower disease progression in the adjuvant setting allow sufficient time for the vaccine induced immune response team to develop and mature also in earlier disease stages mechanisms of resistance.
Esther: Net heterogeneity and an immune suppressive tumor microenvironment up typically nexus tablet.
Esther: Patients in the adjuvant setting often have have yet immune systems and less compromised T cell function, increasing the likelihood of a clinically meaningful response. This rationale is the reason why we strategically focused our advanced <unk> program on the adjuvant setting we currently have free.
Esther: This rationale is the reason why we strategically focused our advanced INES program on the education of young people. We currently have three ongoing randomized phase two trials of autogen sarumaran, one in colorectal cancer that is enrolling stage two high-risk and stage three CRC patients who are ctDNA positive after surgical resection and standard of care chemotherapy. These patients are at high risk of recurrence, often within a year. We continue to anticipate initial data from the study either late this year or in early 2020. These data will be critical for informing the next stages of development and regulatory discussion.
Esther: Boeing randomized phase III trials of origins of whom around one in colorectal cancer that is enrolling stage too high risk and stay treat CRC patients.
Esther: Our CP DNA positive after a surgical resection and standard of care chemotherapy. These patients are at high risk of recurrence often within the year. We continue to anticipate initial data from this study either late this year or in early 2026.
Esther: These data will be critical for informing the next stages of development and regulatory discussions.
Esther: We are also evaluating autogen sarumaran as an adjuvant treatment for pancreas. This phase two is informed by a small phase one trial in which we showed strong immune responses induced by autogenes sevumaran and their correlation with significant improvement of recurrence-free survival. A randomized control phase 2 trial in bladder cancer was initiated in the fourth quarter of last year. We believe individualized cancer immunotherapies have a potential to change the current standard of care and improve overall survival by delaying or preventing recurrence of cancer metastases.
Esther: We are also evaluating <unk> as an adjuvant treatment for pancreatic cancer. This phase two is informed by a small phase one trial in which we showed strong immune responses induced by origin Cimarron and their correlation with significant improvement of <unk>.
Esther: Current suite survival.
Esther: Randomized controlled phase two trial in bladder cancer was initiated in the fourth quarter of last year, we believe individualized cancer immune of European <unk> has the potential to change the current standard of care and improve overall survival.
Esther: They are preventing recurrence of cancer metastasis 2025 will be an important year for biotech we are intensely focused on the execution of our late stage trials, particularly in the adjuvant setting where we believe our individualized mrna immunotherapy approach is the greatest.
Esther: 2025 will be an important year for BioNTech. We are intensely focused on the execution of our late-stage trials, particularly in the adjuvant setting, where we believe our individualized mRNA immunotherapy approach has the greatest potential for clinical impact, while we are evaluating novel I-O combinations for the treatment of advanced, rapidly-progressing, high-volume tumors. We look forward to providing updates on our approach.
Esther: <unk> for clinical impact, while we are evaluating novel I O combinations for the treatment of.
Esther: Advanced rapidly progressing high volume two months, we look forward to providing updates on our progress.
Jens Holstein: With that, I will now pass the presentation to our CFO, Jens. Thank you, Ozlem, and a warm welcome to everyone who has dialed in today. I'll start with our fourth quarter and full year results 2025. Then I'll share our 2025 financial guide. In terms of our financial results, we executed the year according to our plan. We recognized around 2.8 billion euros in revenues, meeting the approximate midpoint of our full year 2024 revenue. And were they slightly better than our previously announced... Driven by effective cost management, we limited our full year 2024 losses before taxes to approximately €678 million in a diluted loss per share of €2.77.
Esther: With that I will now possible presentation for our CF OEM touched on.
Esther: Thank you Allison and a warm welcome to everyone who has dialed in todays call.
Esther: I'll start with our fourth quarter and full year results 2024.
Esther: Sure or 2025 financial guidance.
Esther: In terms of our financial results, we executed the year according to our plan.
Esther: We recognized around $2 8 billion in revenues meeting the approximate midpoint of our full year 2020 for revenue guidance and with a slightly better than our previously announced expectations.
Esther: Driven by effective cost management, we limited our full year 2024 losses before taxes to approximately 678 million euros and a diluted loss per share of two euros and 77.
Jens Holstein: Our cash position, including cash equivalents and investments in securities, amounted to 17.4 billion euros at the end of 2020. This leaves us financially well-positioned to continue with the execution of our strategy in 2020. Please note that this year-end cash position has not yet reflected the closed acquisition of biofuels to the amount of approximately 800 million U.S. dollars and payments derived from the settlement of the contractual disputes with NIH and the University of Pennsylvania to the amount of 792 million and 467 million U.S. dollars respectively. We expect that the Biotheus acquisition payment and the NIH payment, totaling approximately 1.6 billion US dollars, will be reflected in our first quarter 2025 financial position.
Esther: Our cash position, including cash equivalents in investments in securities amounted to $17 4 billion at the end of 2024.
Esther: This leaves us financially well positioned to continue with the execution of our strategy in 2025.
Esther: Please note that this year end cash position has not yet reflected the closed acquisition of policies to the amount of approximately $800 million and payments derived from the settlement of a contractual disputes with NIH at the University of Pennsylvania to the amount of $792 million and $467 million.
Esther: Respectively.
Esther: We expect that the <unk> acquisition payment and the NIH payments totaling approximately $1 6 billion in U S dollars will be reflected in our first quarter 2025 financial position.
Jens Holstein: We expect that the University of Pennsylvania settlement payment will be reflected in our second quarter 2025. With respect to the settlements, we also expect a reimbursement of approximately 535 million U.S. dollars from our partner Pfizer during 2025 and 2026.
Esther: We expect that the University of Pennsylvania settlement payment will be reflected in our second quarter 2025 positions.
Esther: With respect to the settlements. We also expect the reimbursement of approximately $535 million from our partner Pfizer during 2025 and 2026.
Jens Holstein: I'll be moving now to the summary of our financial results for the fourth quarter and the full year of 2024 as shown on the next slide. For the three months ended December 31st, 2024, we recognized total revenues of approximately 1.2 billion euros compared to approximately 1.5 billion euros in the prior year period. For the full year, we recognized around 2.8 billion euros compared to around 3.8 billion euros in 2026. The reduction was primarily driven by a lower COVID-19 vaccine market. In addition, write-downs by our collaboration partner Pfizer reduced our gross profit share and hence negatively influenced our revenues for 2020.
Esther: I'll be moving now to the summary of our financial results for the fourth quarter and the full year of 2024 as shown on the next slide.
Esther: For the three months ended December 31, 2024, we recognized total revenues of approximately $1 2 billion compared to approximately one 5 billion euros in the prior year period for the full year, we recognized around the $2 8 billion euros compared to around $3 8 billion euros in 2023.
Esther: The reduction was primarily driven by a lower COVID-19 vaccine market demand. In addition, write downs by our collaboration partner Pfizer reduced our gross profit and hence negatively influenced our revenues for 2020.
Jens Holstein: Research and development expenses reached 612 million euros for the fourth quarter of 2024 compared to 578 million euros for the comparative period in 2025. For 2024, R&D expenses amounted to approximately 2.3 billion euros compared to roughly 1.8 billion euros in 2020. The increase was mainly influenced by the planned advancing of our priority programs, including BNT327 towards late-stage development. SG&A expenses amounted to approximately 132 million euros for the fourth quarter of 2024 compared to 142 million euros in the same period of the previous year. For the 2024 financial year, SG&A expenses amounted to approximately €599 million, compared to €558 million in 2020.
Esther: Research and development expenses reached 612 million for the fourth quarter of 2024 compared to 578 million euros for the comparative period in 2023.
Esther: For 2020 for R&D expenses amounted to approximately $2 3 billion euros compared to roughly $1 8 billion euros in 2023.
Esther: The increase was mainly influenced by the planned advancing of our priority programs, including <unk>, 3% to 7% towards late stage development.
Esther: SG&A expenses amounted to approximately 132 million for the fourth quarter of 2024 compared to 142 million euros in the same period of the previous year.
Esther: For the 2024 financial year, SG&A expenses amounted to approximately 599 million euros compared to 558 million euros in 2023.
Jens Holstein: The increase in SG&E expenses is primarily attributable to the build-out of our commercial organization. With respect to the company's other operating results, we reported negative 671 million euros for the 2024 financial year, as compared to negative 188 million euros in 2020. This was mainly due to payments and expenses related to the above-mentioned contractual disputes with NIH and UPA. Net of aforementioned related reimbursement by our collaboration partner Pfizer. For the fourth quarter of 2024, we reported a net profit of approximately €260 million, compared to around €458 million for the comparative period in 2023. For the full year 2024, we reported a net loss of €665 million, compared to a net profit of €930 million in the prior year.
The increase in SG&A expenses is primarily attributable to the build out of our commercial organization with respect to the company's operating results. We reported negative 671 million euros for the 2024 financial year as compared to negative 188 million euros in 2023.
Esther: This was mainly due to payments and expenses related to the above mentioned contractual disputes with NIH and <unk>.
Esther: Net of the aforementioned related reimbursement for our collaboration partner Pfizer.
Esther: For the fourth quarter of 2024, we reported a net profit of approximately 260 million euros compared to around 458 million euros for the comparative period in 2023 for the full year 2024, we reported a net loss of 665 million euros compared to a net profit of $930 million.
Jens Holstein: Our diluted earnings per share for the fourth quarter of 2024 amounted to €1.08 compared to €1.88 in the comparative period in 2020. For the 2024 financial year, our diluted loss per share amounted to €2.77 compared to €3.83 for the prior year.
Esther: In the prior year.
Esther: Our diluted earnings per share for the fourth quarter of 2024 amounted to $1 <unk> compared to one year owned 88.
Esther: In the comparative period in 2023.
Esther: For the 2024 financial year, our diluted loss per share amounted to two euros of <unk> 77, compared to three euros 83 for the prior year.
Jens Holstein: Let's now continue with the next slide. As depicted on the slide, we executed well against our 2024 financial guidance update that was provided in our third quarter earnings call in November. Starting from the top, we achieved roughly the midpoint of our full year 2024 revenue guidance of 2.5 billion to 3.1 billion euros. During our third quarter 2024 earnings call, we stated that we expected full year 2024 revenues to be at the low end of the guidance. In the final month of the year, we experienced stronger-than-expected sales outside the DOA. On R&D, we report roughly 2.3 billion euros in expenses for 2024, slightly below the low end of our full year 2024 financial guidance range of 2.4 to 2.6 billion euros.
Esther: Let's now continue with the next slide as depicted on the slide we executed well against our 2024 financial guidance update that was provided in our third quarter earnings call in November.
Esther: Starting from the top we achieved roughly the midpoint of our full year 2020 for revenue guidance of $2 5 billion to $3 1 billion euros.
Esther: During our third quarter 2024 earnings call. We stated that we expected full year 2020 for revenues to be at the low end of the guidance range in the final month of the year, we experienced stronger than expected sales outside the U S.
Esther: On R&D, we report roughly from $2 3 billion euros and expenses for 2024 slightly below the low end of our full year 2024 financial guidance range of four to 6 million euros.
Jens Holstein: This was, in part, driven by our active portfolio management and the shifting of some registrational study costs from 2024 into 2020. On SG&A and capital expenditures for operating activities, we ended at the lower end of our 2024 expectations from our last earnings.
Esther: This was in part driven by our active portfolio management and the shifting of some Registrational study costs from 2024 and through 2020.
Esther: On SG&A and capital expenditures for operating activities. We ended at the lower end of our 2024 expectations from our last earnings call.
Jens Holstein: Meeting these lower guidance ranges is the result of our continued cost monetary and financial Turning to the next slide, let me highlight now some key aspects for the company's outlook for the 2025 financial year. We expect total revenues in the range of 1.7 billion to 2.2 billion euros for 2025. Our revenue guidance assumes relatively stable vaccination rates, pricing, and market share as compared to 2024. We also anticipate a revenue phasing similar to last year, with the last three to four months driving the full year revenue. In addition, we estimate some inventory write-downs and other charges in the range of roughly 15% of BioNTech's share of gross profit from COVID-19 vaccine sales in Pfizer's charity.
Esther: Tvs lower guidance ranges as a result of our continued cost monetary and financial discipline.
Esther: Turning to the next slide let me highlight now some key aspects for the Companys outlook for the 2025 financial year.
Esther: We expect total revenues in the range of $1 7 billion to $2 2 billion for 2025.
Esther: Our revenue guidance assumes relatively stable vaccination rates.
<unk> in market share as compared to 2024.
Esther: We also anticipate our revenue phasing similar to last year with the last three to four months driving the full year revenue figure.
Esther: In addition, we estimate some inventory write downs and other charges in the range of roughly 15% of biotechs share of gross profit from COVID-19 vaccine sales in spite of territory.
Jens Holstein: We also expect revenues related to our service businesses, as well as revenues from the German Pandemic Preparedness Agreement to contribute to our overall group revenue. Please note that potential changes in law or government policy at the state or national level and evolving public sentiment around vaccines and mRNA technology in the United States and or elsewhere could also negatively influence BioNTech's COVID-19 vaccine revenues and financial results. Turning to operating expenses, in 2025 we expect R&D expenses to be in the range of 2.6 to 2.8 billion Euro. As compared to 2024, we expect to see an increase in investment into our priority late-stage programs in 2025, namely BNT-327, our mRNA cancer immunotherapies, and our AEC pilot.
Esther: We also expect revenues related to our service business.
Esther: As well as revenues from the gym Olympic pattern. This agreement to contribute to our overall revenues.
Esther: Please note that potential changes in law or government policy at the state or national level.
Esther: And evolving public sentiment around vaccines and mrna technology in the United States and elsewhere could also negatively influenced by <unk> COVID-19 vaccine revenues and financial results.
Esther: Turning to operating expenses in 2025, we expect R&D expenses to be in the range of two six to $2 8 billion euros as.
Esther: As compared to 2024, we expect to see an increase in investment into our priority late stage programs in 2025, <unk> hundred two seven or mrna cancer immunotherapy and our ADC pipeline.
Jens Holstein: Consistent with our portfolio prioritization strategy, we also expect to decrease our R&D spend outside of our priority areas. We will continue to follow the data generated by our pipeline to ensure we are investing appropriately to drive innovation and create value. Next, SG&A. We expect SG&A expenses to be in the range of 650 to 750 million euros. We're anticipating an increase compared to 2024 as we continue our commercial build out for oncology and prepare for our first oncology launch. Lastly, capital expenditures for the 2025 financial year are expected to be in the range of 250 to 350 million euros.
Esther: Consistent with our portfolio prioritization strategy will also expect to decrease our R&D spend outside of our priority areas. We will continue to follow the data generated by our pipeline to ensure we are investing appropriately to drive innovation and create value.
Esther: Next SG&A.
Esther: We expect SG&A expenses to be in the range of $650 to 750 million euros we.
Esther: Supporting an increase compared to 2024 as we continue our commercial build out for oncology and prepare for our first oncology launch.
Esther: Lastly capital expenditures for the 2025 financial year I expect it to be in the range of 250 to 350 million euros.
Jens Holstein: With these investments, we're paving the way for multiple potential product launches. Investments include manufacturing expansion projects and investment in commercial IT systems to support portfolio growth and build capacity for the development and commercialization of our potentially disruptive pan-tumor technology.
Esther: With these investments we're paving the way for multiple potential product launches.
Esther: Investments include manufacturing expansion project and investment in commercial it systems to support portfolio growth and build capacity for the development and commercialization of a potentially disruptive <unk> technologies.
Jens Holstein: In summary, 2025 will be another year of continued transition for BioNTech with the aim to become a multi-product commercial oncologist. We will continue to diligently invest in our long-term growth strategy while maintaining strict financial distance. With that, we remain focused on achieving long term sustainable growth and generating value for patients and shelves.
Esther: In summary, 2025 will be another year of continued transition for biotech with the aim to become a multi product commercial oncology company.
Esther: We will continue to diligently invest in our long term growth strategy.
Esther: Maintaining strict financial discipline.
Esther: We remain focused on achieving long term sustainable growth and generating value for patients and shareholders.
Ryan Richardson: Now I would like to turn the call over to our Chief Strategy Officer, Ryan Richardson, for our strategic outlook and concluding remarks. Thank you. Thank you, Jens.
Speaker Change: I would like to turn the call over to our Chief strategy Officer, Ryan Richardson for our strategic outlook and concluding remarks. Thank you.
Ryan Richardson: I would like to end our prepared remarks with a summary of our priorities for 2025 and our key anticipated upcoming clinical and regulatory milestones for our oncology pipeline. This year, our focus will remain on executing on two pan-tumor product opportunities, BNT327 and our mRNA cancer immunotherapy. Each of these programs are in Phase 2 or Phase 3 trials and will generate data updates over the course of the year. We will continue to build out our commercial capabilities and oncology to support our goal of becoming a fully integrated biopharmaceutical. In infectious disease, we will continue to invest to maintain our and Pfizer's global leadership position in the COVID-19 vaccine market while continuing to advance next generation and combination vaccines in the clinic.
Ryan Richardson: Thank you James I would like to end our prepared remarks with a summary of our priorities for 2025, and our key anticipated upcoming clinical and regulatory milestones for our oncology pipeline.
Ryan Richardson: This year, our focus will remain on executing on two pan tumor product opportunities.
Ryan Richardson: 327% and.
Ryan Richardson: And our mrna cancer Immunotherapies.
Ryan Richardson: Each of these programs are in phase II phase III trials and will generate data updates over the course of the year.
Ryan Richardson: We will continue to build out our commercial capabilities in oncology to support our goal of becoming a fully integrated biopharmaceutical company.
Ryan Richardson: In infectious disease, we will continue to invest to maintain our and Pfizer's global leadership position in the COVID-19 vaccine market, while continuing to advance next generation and combination vaccines in the clinic.
Ryan Richardson: We expect to provide multiple updates from our early stage infectious disease pipeline over the course of the year. We are in a catalyst-rich period for BioNTech. We plan to share multiple clinical updates across our focus programs throughout 2025, including at upcoming oncology conferences in March and April. In addition to the data for BNT-327, we plan to share data updates for our mRNA cancer immunotherapies, INEST, and fixed. And with regards to our first potential oncology product and HER2-ADC-BNT323, we plan to share phase two data from a single arm registrational trial in HER2-expressing endometrial cancer. as we prepare for a potential BLA submission later this year.
Ryan Richardson: We expect to provide multiple updates from our early stage infectious disease pipeline over the course of the year.
Ryan Richardson: We are in a catalyst rich period for biotech.
Ryan Richardson: Plan to share multiple clinical updates across our focused programs throughout 2025, including at upcoming oncology conferences in March and April.
Ryan Richardson: In addition to the data for <unk> hundred seven we plan to share data updates for our mrna cancer Immunotherapies and fixed pack.
Ryan Richardson: And with regards to our first potential oncology products in her two ADC <unk> hundred <unk> three we plan to share phase II data from a single arm Registrational trial in her two expressing endometrial cancer as.
Ryan Richardson: As we prepare for a potential BLA submission later this year.
Ryan Richardson: In closing, I would like to highlight on the next slide important investor events we will be holding throughout the year. Our annual general meeting will take place on May 16th. We are excited to once again host two innovation series events this year. The first will be another AI event on October 1st. The second will be our R&D day on November 8th. We will share further details on both events later in the year.
Ryan Richardson: In closing I would like to highlight on the next slide important industrial events, we will be holding throughout the year or.
Ryan Richardson: Our annual General meeting will take place on May 16th.
Ryan Richardson: We are excited to once again host to innovation series events. This year. The first will be another AI event on October one.
Ryan Richardson: Second will be our R&D day on November 18th.
Ryan Richardson: We'll share further details on both events later in the year.
Unknown Executive: With that, we would like to open the floor for questions. Thank you. To ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. We kindly ask participants to ask only one question per person.
Ryan Richardson: With that we'd like to open the floor for questions.
Ryan Richardson: Okay.
Ryan Richardson: Thank you.
Speaker Change: I'll ask a question. Please press star one one on your telephone and wait for your name to be announced.
Speaker Change: To withdraw your question. Please press star one on one again with currently I ask participants to ask only one question per person.
Daina Graybosch: We will now take the first question. From the line of Daina Graybosch from Learink Partners, please go ahead. Hi, thank you for that question. You had a few charges related to legal events that you talked about, Jens. There's a lot more IP cases going on, and they seem to be accelerating and coming to some conclusions. And I wonder if you could just help give us an overview or roadmap of any particular ones that we should pay attention to that you think could have outcomes decided in the next quarter than this year. Thank you.
Speaker Change: We will now take the first question.
Diana: From the line of Diana <unk> from Leerink partners. Please go ahead.
Speaker Change: Hi, Thank you for that question.
Diana: You have a few charges related to legal events.
Speaker Change: You talked about <unk>.
Speaker Change: A lot more IP.
Speaker Change:
Speaker Change: Cases going on and they seem to be accelerating and coming to some conclusions and I Wonder if you could just help give us an overview of our roadmap of any particular ones that we should pay attention to.
Speaker Change: That you think could have.
Speaker Change: <unk> decided in the next quarter than this year. Thank you.
Jens Holstein: Thanks, Daina, for the question. I mean, it's very difficult to predict the timing of certain events in such legal disputes. I would like to refer to the 20th where we have explained the circumstances in detail. And I can't comment more than what we have published in the 20th. Yeah, the data just to add to that, you know, I think as we've said in the 20th as well, that, you know, we're confident in the strength of our IP estate. And some of these sometimes these processes can can go through multiple appeals processes, but we think we're in a good position and are going to continue.
Speaker Change: Okay. Thanks, Dana for the question.
Speaker Change: I mean, it's very difficult to predict the timing of certain events and such legal disputes.
Speaker Change: I would like to refer to the 20-F, we have explained the circumstances in detail and I can't comment more than what we have published.
Speaker Change: Yes.
Speaker Change: Yes, I think David just to add to that I think as we've said in the 20-F as well.
Speaker Change: We're confident in the strength of our IPO statements and some of them. Sometimes these processes can go through multiple appeals processes, but we think we're in a good position and we're going to continue to.
Jens Holstein: to defend our IP estate along with our partners.
Speaker Change: To defend our IP estate, along with our partner Pfizer.
Unknown Executive: Great. And maybe one more, because that was quick.
Speaker Change: Great and maybe one more because that would be quick on the fixed.
Ozlem Tureci: On the fix-back data that you're going to share this year of semlipomab, can you just remind us of the context going into that, or recall that that was a top-line success, and sort of how we should be thinking about a vaccine in relapsed refractory melanoma in context of, Ozlem, you sharing that the personalized vaccine didn't work in a metastatic melanoma setting. Thank you. Hi, thank you for the question. I'm not sure whether I got it correctly. So, the question was with regard to our melanoma fixate, DNT111, right, where we have reported top-line results that we have, that it was a successful trial and that we have achieved the endpoint.
Speaker Change: Data that youre going to share this year of similar to map can you just remind us of the context going into that recall that that was the top line success and sort of how we should be thinking about a vaccine and relapsed refractory melanoma.
Speaker Change: Context of Assam, you're sharing that.
Speaker Change: The personalized vaccines in network and a metastatic melanoma study. Thank you.
Speaker Change: Hi, Thank you for the question I'm not sure whether I got it correctly. So the question was.
Speaker Change: With regard to our melanoma <unk> 11, right, where we have reported top.
Speaker Change: Topline results that we have.
Speaker Change: Uh Huh, that's it was a successful trial and that we have achieved that endpoint.
Ozlem Tureci: We will, we will have data presentations on this later this year on one of the conferences and are also preparing a manuscript, so there will be more information about that. As you pointed out, yes, we observed that for our INEST, the first-line setting is not the right one, so metastatic setting with advanced cancers and tumor, higher tumor burden, is not optimal and, which actually is not surprising. I have described the reasons for this, which can explain in my, in my talk today. That's also why we are focusing our INEST approach, our individualized cancer approach, on the atrovan setting and have initiated three trials in this setting.
Speaker Change:
Speaker Change: Hmm data presentations on this later this year on one of our conferences and also preparing a manuscript so there will be more information about that.
Speaker Change: You pointed out yes, we observed for a while I missed.
Speaker Change: The first line setting.
Speaker Change: It is not right for metastatic setting.
Speaker Change: With advanced Ken.
Speaker Change: Ken says and to more of a higher tumor burden.
Speaker Change: It's not optimal and.
Speaker Change: Which actually is not surprising I have described the reasons for this which can explain.
Speaker Change: In my in my talk.
Speaker Change: Today, and that's also why we are focusing our IMS approach our individualized cancer approach on the adjuvant setting and have initiated a free trials in this setting we believe that.
Ozlem Tureci: We believe that here the probability of getting robust clinical benefit is much higher due to, simply, the biology of atrovan. Daina, one of the key differences between the INS approach and the FIXVAC approach is that FIXVAC can be applied immediately, without any delay, and for the IVAC approach, at the time point of the clinical trial, we had turnaround times in the range of 6 to 8 weeks, which is, in a metastatic setting, really difficult, because the tumors tend to progress particularly while vaccination is ongoing and immune responses are built. So, based on that, we, early on, adapted our strategy and went into the adjuvant stage, where patients, patients, before they progress, have 3, 6, 9, 12 months before, before PFS events occur.
Speaker Change: Yeah Uh huh.
Speaker Change: Uh huh.
Speaker Change: Probability of getting robust clinical benefit is much higher due to simply the biology of extra than cancer.
Speaker Change: The key key differences between that and Thats. The approach and expect support is let's expect can be applied immediately.
Speaker Change: Any delay.
But <unk> approach.
Speaker Change: <unk> point about the clinical trial.
Speaker Change: A turnaround times in the range of six to eight weeks.
Speaker Change: Which is in the metastatic setting.
Speaker Change: Difficult because the tumor tend to forecast, particularly.
Speaker Change: Uh huh.
Speaker Change: By explanations ongoing immune responses.
Speaker Change: And so based on that.
Speaker Change: Early on adapted our strategy into the adjuvant stage.
Speaker Change: The Ah patients patients before they pull back half peak six 912 months.
Speaker Change: Before before.
Speaker Change: Okay.
Unknown Executive: Great, thank you. Thank you.
Speaker Change: Great. Thank you.
Akash Tewari: We will now take the next question. From the line of Akash Tewari from Jefferies, please go ahead. Hey, thanks so much. Just on 327, I know in the past, your teams alluded to kind of the costs associated with developing an agent like this, across different tumor types, and certainly Merck's talking about running a lot of different phase three trials over time. And you guys have hinted at a potential 50-50 partnership.
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: From the line of <unk> from Jefferies. Please go ahead.
Speaker Change: Hey, Thanks, so much just on <unk> I know in the past your team's alluded to kind of the cost associated with developing an agent like this across different tumor types and certainly merck's talking about running a lot of different phase III trials over time and you guys have hinted at a potential 50 50 partnership.
Ryan Richardson: Where does BioNTech currently stand on the partnership question on 327? And what clinical or commercial capabilities would you be looking at for an external partner? Thank Yeah, thanks, Akash. I'll start with that. So, we're proceeding right now on our own. And actually, we think we have the capabilities to execute against 327 in these initial trials that we've started. And that's really the focal point this year. So, non-small cell lung cancer, small cell lung cancer, and triple negative breast cancer being the first indications. But we are looking at a much broader set of additional indications, including the ADC combinations, as we've alluded to in our prepared remarks.
Speaker Change: Where does plant that currently stand on the partnership question on <unk>, seven and what clinical or commercial capabilities would you be looking at for an external partner. Thank you.
Speaker Change: Yeah, Thanks, Kash I'll start with that.
Speaker Change: So we are proceeding right now.
Speaker Change: On our own and actually we think we have the capabilities to execute against $32 seven and these initial trials that we've started and thats really the focal point. This year, so non small cell lung cancer small cell lung cancer and triple negative breast cancer being the first indications, but but we are looking at a much broader set of additional indications, including ADC combinations as we've alluded to.
Ryan Richardson: So, that's really the focus for 2025. What we have said, though, is that we recognize that with such a broad potential IO backbone therapy, the combinations with other companies' agents could prove useful down the road. And indeed, we have been approached by different companies who are interested in potentially combining with BNT 327. And so, we are evaluating those potential collaborations. And nothing to announce at this point, but I think given the broad applicability, it is plausible and actually probably likely that we'll enter into some combination of partnerships over the next 12 to 18 months. I won't comment beyond that at this point.
Speaker Change: In our prepared remarks, and so that's really the focus for 2025.
Speaker Change: What we have said, though is that we recognize that with such a such a broad potential iron backbone therapy. The combinations with other companies agents could could prove useful down the road and indeed, we have been approached by different companies, who are interested in potentially combining with <unk> hundred $2 seven and so we are evaluating those.
Speaker Change: Potential collaborations and nothing to announce at this point.
Speaker Change: But I think given the broad applicability it is.
Speaker Change: Plausible and actually probably likely that we will enter into some combination partner.
Speaker Change: Partnerships over the next 12 to 18 months.
Speaker Change: We won't comment beyond that at this point.
Ryan Richardson: But we do think that it's worth, given the breadth of the program potential, that it makes sense for us to evaluate all opportunities. and to potentially speed up and expand. Thank you.
Speaker Change: But we do think that it's worth given the breadth of the program potential.
Speaker Change: Thats it.
Speaker Change: It makes sense for us to evaluate all opportunities.
Speaker Change: To potentially speed up and expand the program.
Speaker Change: Yes.
Chris Shibutani: We will now take the next question. From the line of Chris Shibutani from Goldman Sachs, please go ahead. Good morning, thank you so much. With your plan for 327, obviously, the scope of opportunity is considerable. And as we think about the other leading player developing Summit Akizo, they're mapping out a pretty broad plan. Can you clarify how you see what you think will be differentiating in your approach?
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: From the line of Chris <unk> from Goldman Sachs. Please go ahead.
Speaker Change: Good morning. Thank you so much with your plan for <unk> seven obviously, the scope of opportunity is considerable and as we think about the other leading player developing some of the keys, though they are mapping out a pretty broad plan can you clarify how you see what you think will be differentiating in your approach.
Ryan Richardson: I think preliminarily, we noticed that you have maybe further along with TNBC, but is there some sort of strategic overlay, whether it's thinking about PD-L1 agnosticism, geographies, something that helps discern how your approach may be differentiated to ultimately also demonstrate differentiated clinical data? Thank you.
Speaker Change: I think preliminarily, we noticed that you have maybe further along with CNBC, but is there some sort of strategic overlay, whether it's thinking about PD lone agnosticism.
Speaker Change: Geographies something that helps discern how your approach may be differentiated to ultimately also demonstrate differentiated clinical data. Thank you.
Ryan Richardson: So I can start and Ugur and Ozlem can add. So I think the first point to mention, Chris, is that because we see such a broad potential therapeutic opportunity here for this product in terms of many different tumor indications, also different patient segments within tumor indications, both where PD-1, PD-L1 therapies have been successful, but also potentially in patient segments where PD-1, PD-L1 historically has not been successful. Given that potential breadth, we think that the most important element of strategy is actually going to be clinical development strategy and targeting the right patient groups and executing against those initial set of trials.
Speaker Change: Like you started.
Speaker Change: Everyone knows in connect so I think the first part.
Chris: First point to mention Chris is that.
Speaker Change: We see such a broad potential therapeutic.
Speaker Change: The opportunity here for this product in terms of many different tumor indications also different patient segments within tumor indications, both where PD one PDL one therapies had been successful, but also potentially in <unk>.
Speaker Change: And patient segments, where PD one PDL, one historically has not been successful given the potential breadth.
Speaker Change: I think that the most important element of strategy is actually going to be clinical development strategy in targeting the right patient groups and in executing against those initials setup.
Ryan Richardson: The initial batch of trials are likely to involve chemotherapy combinations, and you see that with the three indications that we've disclosed so far. But down the road, as we've also mentioned, we think a further angle of differentiation is going to be other combinations, including with ADCs, and I think there BioNTech is uniquely situated given the broad portfolio of both ADCs and also cancer vaccines that we have that could enable such novel combinations. I don't know, Ugur, do you want to add? No. No, I'm just, it's really about the execution of the trials. If you really consider the full spectrum, it will take many years in multiple indications.
Speaker Change: Set of trials.
Speaker Change: The initial batch of trials are likely to involve chemotherapy combinations and you see that with the three indications.
Speaker Change: We've disclosed so far.
Speaker Change: But down the road as we've also mentioned we think a further angle of differentiation is going to be.
Speaker Change: Other combinations, including thing with Adcs and I think their biotech is uniquely situated given.
Speaker Change: <unk> portfolio of both Adcs and also also cancer vaccines that we have.
Speaker Change: Good enabled such novel combinations.
No no I'm just just just it's really about.
Speaker Change: The execution of this trial.
Speaker Change: It will.
Speaker Change: Have you considered the full spectrum.
Speaker Change: The take many years.
Ugur Sahin: So when you revisit what has happened in the IO field for anti-PD-1 treatments, this is also a process which went and is still ongoing the last 10 years. And this is something which we expect also for the next generation of an anti-PD-1 locate with the bi-specific antibody. So this is something where we see in the next year the need to start multiple clinical trials in multiple indications, but not only do the trials in combination with standard of care, but also consider combinations with novel compounds that can help to differentiate the efficacy seen by BNT-327 alone.
Speaker Change: In multiple indications.
Speaker Change: So then you'll revisit.
Speaker Change: What has happened in the <unk> anti PD one treatment. This is a post test, which rent and it's still ongoing in the last 10 years.
Speaker Change: And this is something something that we expect also for the next generation of an anti PD one blockade.
Specific anti body, but this is something that we see in the next year the need to to start multiple clinical trials in multiple indications, but not only to the time and this in combination with standard of care, but also consider.
Speaker Change: Consider combinations with our components that can help.
Speaker Change: Help to differentiate our.
Speaker Change: The efficacy seen by basically two seven of them.
Unknown Executive: Can I follow up with a quick related question? Are you seeing any issues with enrollment of trials or competing for sites for enrollment of patients? Thank you. We don't see anything specific. I mean, you know that clinical trial enrollment in particular in those high medical need indications like non-small cell lung cancer and breast cancer and so on is generally speaking very competitive because there is a lot going on, but we don't see any effects on our trials and have actually very good enrollment in particular into the 327 trials, which seems to be a compound where investigators are very enthusiastic.
Speaker Change: Can I follow up with a quick related question are you seeing any issues with enrollment of trials are competing for our sites for enrollment of patients. Thank you.
Speaker Change: We don't see any anything specific I mean, you know that our clinical trial enrollment in particular.
Speaker Change: Those high medical need indications like non small cell lung cancer and in breast cancer and so on is generally speaking very competitive because there is a lot going on but we don't see any specific effects on our trials and.
Speaker Change: We have actually.
Speaker Change: Very good enrollment in particular in two of the 327 trials, which seems to be in.
Speaker Change: <unk> investigators are very enthusiastic about.
Unknown Executive: Thank you.
Unknown Executive: I appreciate the follow-up. Thank you.
Speaker Change: Thank you I appreciate the follow up.
Tazeen Ahmad: We will now take the next question.
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Tazeen Ahmad: From the line of Tazeen Ahmad from Bank of America Securities, please go ahead. Hi, good morning. Thanks for taking my question. Can I just ask you what you're expecting the bar for efficacy to need to be for 3.2.3 for the endometrial data that you're expecting this year that would be able to support a filing this year?
Speaker Change: From the line of <unk> of March from Bank of America Securities. Please go ahead.
Speaker Change: Hi, good morning, Thanks for taking my question.
Can I just ask you what youre expecting the bar for efficacy needs to be for 323 for the endometrial data that youre expecting this year that would be able to support a filing this year and then related to that maybe the second part of the question for Ryan how.
Ryan Richardson: And then related to that, maybe the second part of the question is for Ryan. How are you preparing for the launch of 3.2.3 if, in fact, you're able to do so in 2026?
Speaker Change: How are you preparing for the launch of three to three if in fact, you're able to do so in 2026, and maybe I wanted to follow up on that previous question. A few minutes ago about partnership how are you thinking about building out commercial organization versus waiting for the partner.
Ryan Richardson: And maybe I wanted to follow up on that previous question a few minutes ago about partnership. How are you thinking about building out commercial organization versus waiting to partner? Thanks. Yeah, thanks, Tazeen. So on the first question, just to clarify, I think you're asking the efficacy bar for BNT323 in endometrial cancer, correct? Yeah. Yeah, so as you know, endometrial cancer is an indication where patients can be categorized into HER2 plus and HER2 low tumors. And based on that, we expect efficiencies in the range of ADCs that have been evaluated in this indication. It's a single arm study.
Speaker Change: Yes.
Speaker Change: Yeah. Thanks, <unk>. So on the first question I, just just to clarify I think youre asking the efficacy bar for <unk> three in endometrial cancer correct yeah.
Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: As you know endometrial cancer is an indication.
Speaker Change: Ah patients.
Speaker Change: Patients can be categorized into telco, plus and how to low tumor center.
Speaker Change: And based on that.
Speaker Change: The expect expect.
Speaker Change: Efficiency efficient.
Speaker Change: Proceeds in the range of Adcs that has been evaluated in this indication indications. It's a single arm study at the standard of care Shimmer therapy that.
Ryan Richardson: The standard of care is chemotherapy with a very short PFS and OS. As you know, the compound basically receives breakthrough designation in this indication. So we are confident that the results will fulfill the requirements for potential registration. Yeah, and to Ugur's point, I mean, we've seen within HER2 response rates around 50%. But increasingly, we're expecting in HER2 to move into the first line. And if we look at the other second line therapies that are available, including methicizumab plus chemo, you know, we're seeing response rates far lower than that in terms of standard of care. So in the sort of 20% range.
Speaker Change: A sharp PFS and OS.
Speaker Change: As we all know the.
Speaker Change: Compound basically.
Speaker Change: Ah I received breakthrough designation in this indication so we are confident.
Speaker Change: Debt.
Speaker Change: That's fair.
Speaker Change: Fulfill their requirements potential potential.
Speaker Change: Yes.
Speaker Change: To <unk> point I mean.
Speaker Change: We've seen within her to response rates are around 50%, but increasingly we're expecting in her two to move into the first line and if we look at the other second line therapies that are available, including Bevacizumab plus chemo.
Speaker Change: We're seeing response rates far lower than that in terms of standard of care. So in the sort of.
Speaker Change: 20% range.
Unknown Executive: Thank you.
Unknown Executive: Could you just repeat the second question, please? Oh my god, I mean this is crazy.
Speaker Change: Thank you could you just repeat the question please.
Speaker Change: Oh My God.
Terence Flynn: Sorry, we will now take the next question from the line of Terence Flynn from Morgan Stanley, please go ahead. Hi, thanks for taking the question. I know you mentioned you're going to have some 327 phase 2 data for small cell lung cancer here over the next month or so. I was just wondering if you can help frame expectations there in terms of what you're hoping to see and actually how much data we'll get. Will we get anything with respect to PFS, etc. Thank you.
Speaker Change: This is crazy.
Speaker Change: Alright, we will now take the next question from the line of Terence Flynn.
Speaker Change: Morgan Stanley. Please go ahead.
Speaker Change: Hi, Thanks for taking the question I know you mentioned youre going to have some $302 seven phase III data for small cell lung cancer here over the next month or so I was just wondering if you could help frame expectations. There in terms of what you're hoping to see and actually how much data will get when we get anything with respect to PFS et cetera.
Speaker Change: Thank you.
Ryan Richardson: So I think in the first instance, I'll start and then Ugur can join. So we've already published some data in small cell lung cancer where we showed response rates in the 70% range with a combination with chemotherapy. We're expecting that these data sets that are coming are to an extent going to further validate and expand on that and further justify our decision to move aggressively into pivotal trials in small cell. I think one of the unique things here is that we are going to be coming out with both data in first line and also additional data in second line.
Speaker Change: So I think in the first instance, and I'll start.
Speaker Change: Zubair can join so we've already published some data in small cell lung cancer, where we showed.
Speaker Change: Response rates in the 70% range for the combination with chemotherapy and we're expecting that these datasets that are coming or to an extent go into to further validate and expand on that and further justifies our decision to move aggressively into pivotal trials in small cell I think one of the unique things here is that we are going to be coming out with both data in first line.
Speaker Change: And also additional data in second line so thats its.
Ugur Sahin: And so that's going to build on the previous data sets that we put out there. Yes, and there will be a data report this year, which will on the one hand be a follow up and update on an ongoing clinical trial, which has been presented last year. So you will get follow up data, but also new data from our dose justification clinical trials, which we have. Thank you.
Speaker Change: And build on the previous datasets that we've put out there.
That that wouldn't be a data report this.
Speaker Change: This year.
Speaker Change: Which oh well on the one hand.
Speaker Change: A follow up and update on.
An ongoing clinical trial, which has been presented last year.
Speaker Change: We'll get a point of update how about also new data from our Oh, a dose justification clinical trials, which we have initiated.
Harry Gillis: We will now take the next question. From the line of Harry Gillis from Berenberg, please go ahead. Thank you for taking the question. Just on the 2025 revenue guidance, you talk about relative stability and vaccination rates, pricing and market share.
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: From the line of Harry <unk> from Darrin third. Please go ahead.
Speaker Change: Thank you for taking the question just on the 2025 revenue guidance mutual quite relative stability and vaccination rates pricing and market share I was just wondering if you could provide maybe some quantification or detail.
Jens Holstein: I was wondering if you could provide maybe some quantification or details on what those metrics look like at the low and high end of your guidance, and perhaps specifically what you're factoring into your forecast for US vaccination rates and any impacts from Sanofi's commercialization of the Novavax vaccine. Thank you. Yeah, thanks very much. Happy to take the question. So, you know, of course, as you pointed out, you know, we, our revenue guidance assumes relatively stable vaccination with the market share as we've seen it for 2024. We have, though, to include as a company, if you if you think about Pfizer's guidance, that we have some write-offs to reflect, you know, part returns, or write-offs that consist out of write-offs on material, like we've seen in 24.
Speaker Change: Okay.
Speaker Change: Those metrics look like at the low and high end of guidance.
Speaker Change: And perhaps specifically what you're what you're factoring into your cost per use vaccination rates.
Speaker Change: And any impact from China cease commercialization of the stock.
Speaker Change: Thank you.
Speaker Change: Yes, thanks, very much happy to take the question.
Speaker Change: So.
As you pointed out we have our revenue guidance assumes relatively stable of explanation with some market share as we've seen it for 2024, we have though to include as a company. If you think about pfizer's guidance that we have some write offs to reflect.
Returns.
Speaker Change: All right I'll stick consists out of write offs on material like we've seen in 'twenty four we had to change one way or <unk>.
Jens Holstein: We had J1, we had KP2 variants, and we had to face some write-offs here, because Pfizer was producing it. And we, of course, have to take half of it. So, it goes in our gross profit share. That's part number one. The second is that we also took into account some minor price and volume effect in the US in 2025, reflecting, you know, a bit potential competitive pressure here.
Speaker Change: Variants.
Speaker Change: And produce and we had to face some write offs here because pfizer was producing it and we of course have to take half of it. So it goes in hog cost profit share.
Speaker Change: That's part number one the second is that we also took in telecom and some minor price and volume effect in the U S. In 2025, reflecting a little bit potential competitive pressure here.
Jens Holstein: So, to your point on Sanofi. And thirdly, you know, there is potentially also some risk that the EU is moving a little bit of a volume towards from 2025 contractually towards 2026, they're contractually having the opportunity to do so. And to some extent, we also have reflected that. And that explains, you know, why we are at the midpoint at this Thank you.
Your appointment Sanofi and thirdly.
Speaker Change: There is potentially also some risk that the EU is moving a little bit of volume towards 2025 contractually towards 2026, they're contractually having the opportunity to do so and to some extent. We also have reflected that and that explains.
Speaker Change: While we are at the midpoint at this at this range.
Speaker Change: Yes.
Speaker Change: Thank you.
Corrie Kasimov: We will now take the next question from the line of Corrie Kasimov from Evercore. Please go ahead. Hey guys, thanks for taking the question. I wanted to follow up on Terence's question regarding setting the stage for the update later this month at ELCC. Are you able to comment on how much follow up you will have at the meeting? And what do you see as the appropriate comp at this stage? Thank you. We will have PFS data. I cannot say from the top of my head what the follow-up time within the study is, but we will have PFS data on our small cell lungs.
Speaker Change: We will now take the next question from the line of Cory <unk> from Evercore. Please go ahead.
Speaker Change: Hey, guys. Thanks for taking the question I wanted to follow up on <unk> question regarding setting the stage for the update later this month at LCC are you able to comment on how much follow up you will have at the meeting and what do you see as the appropriate comp at this stage. Thank you.
Speaker Change: So.
Speaker Change: We wouldn't have PFS data I cannot say it from the top of my my head Oh, what's the follow up time with them to study, but we have to we will have PFS data on that.
Speaker Change: Small cell lung cancer subtype.
Speaker Change: Okay.
Ugur Sahin: and Emerging OS Data. No Median OS, but Emerging OS Data. Yeah, and in terms of the standard of care, it continues to be in the first line setting. It continues to be tit-centric plus chemotherapy. Great, thank you. Thank you.
Speaker Change: Got you.
Speaker Change: And emerging western Norwegian the last batch of emerging OSA.
Speaker Change: Yes, yes, yes.
Speaker Change: And then in terms of the standard of care eye continues to be in the first line setting and continue the concentric plus chemotherapy with.
Speaker Change: As the benchmark.
Speaker Change: Great. Thank you.
Speaker Change: Thank you.
Speaker Change: Second pillar, one Turkey chili trial as a benchmark what's that Ted.
Speaker Change: Yeah.
Unknown Executive: We will now take the next question.
Speaker Change: Thank you.
Speaker Change: We'll now take the next question.
Mohit Bansal: From the line of Mohit Bansal from Wells Fargo, please go ahead. Hi, this is Sadia Rahman on for MOHIT. Thanks for taking our questions. So another question on 327, with a competitor expected to read out their OS data on lung cancer later this year, how would you view read-through from those results to 327 in lung cancer? And can you discuss any differences in how you're approaching development, specifically in non-small cell lung cancer from the competitor, just any differences or similarities that you would highlight? Thank you.
Speaker Change: From the line of Mohit Bansal from Wells Fargo. Please go ahead.
Speaker Change: Hi, This is Saudi online on for Mohit, Thanks for taking our questions.
Speaker Change: Another question on three to start then with it with a competitor expected to read out there.
Speaker Change: Eight in lung cancer later this year, how would you view read through from those results to 32 seven.
Speaker Change: And in lung cancer and can you discuss any differences in how you're approaching development.
Speaker Change: Specifically in non small cell lung cancer from the <unk>.
Speaker Change: And just any differences or similarities that you would highlight thank you.
Ugur Sahin: Our non-stroke lung cancer study is actually two studies in one study, addressing the complete population of agar-negative lung cancer patients. That means the PD-L1 high, PD-L1 low, and agar-negative population. In squamous and non-squamous patients, our comparator is pembrolizumab plus shigma therapy. and the treatment group will receive BNC-327 plus chemotherapy and endpoints are as usual PFS and OS. Thank you.
Speaker Change: Okay.
Speaker Change: Our non small lung cancer study is actually ex these two studies in one study.
Speaker Change: Addressing the complete population of.
Speaker Change: Ah got negative first line lung cancer patients.
Speaker Change: The PD Aragon, hi, together lower in PD lone negative population in squamous and non squamous.
Speaker Change: Ah patients our competitor.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Pembina has come up but shipments have a peak okay.
Speaker Change: The treatment group received BMT 57, plus <unk> and <unk>.
Speaker Change: And.
Speaker Change: Endpoints.
Speaker Change: It's usually a PFS and OS.
Speaker Change: Okay.
Ugur Sahin: We will now take the next question from the line of Archdeacon Gunuwardena from Two Securities. Please go ahead. Hi guys, thanks for taking my question. Ozlem, you mentioned that you started recruiting patients through the Phase 2, 3 trial in non-sponsored lung cancer. Could you give a little bit more color on the size of that Phase 2 cohort and if you plan on reporting that data and maybe a little bit of guidelines on expectations that are enrolling that Phase 2 portion? And then sort of related to this, guys, could you maybe comment on the statistical analysis of this study?
Speaker Change: Thank you.
Speaker Change: We'll now take the next question.
Speaker Change: From the line of our CCAR CUNA Award Dennis from <unk> Securities. Please go ahead.
Speaker Change: Hi, guys. Thanks for taking my question.
Speaker Change: I don't know if you mentioned that you started recruiting patients to the phase III.
Speaker Change: Trial in non small cell lung cancer.
Speaker Change: You give a little bit more color on the size of that phase II cohort.
Speaker Change: And if you plan on reporting that data and.
Speaker Change: And maybe a little bit of guidelines on expectations for enrolling the phase two portion and then sort of related to this guidance.
Speaker Change: Could you maybe comment on the statistical analysis of this study.
Ugur Sahin: And I believe you're considering the non-squamous and squamous populations separately, which is different from how your competitor summit is doing their analysis of Harmony 3. So, why do you prefer your method?
Speaker Change: And I believe youre, considering the non squamous non squamous population separately, which is different from how you can better summit is doing their analysis of harmony III. So why do you prefer your message. Thank you.
Ugur Sahin: Thank you. So one more question besides of our study, we have several questions. regarding the As Ugur has pointed out, this is in principle like two studies in one, because we want to explore in our Phase II-III both non-squamous and squamous small cell lung cancer across all PD-L1 status settings. That means with these different patient populations covered, we have a sample size which is around 950-plus patients, and we expect, based on earlier data, we have seen that all these And we discussed also all kinds of options how to structure this clinical trial, including also having a single, single, big cohort.
Speaker Change: So that was the question of the size of the study.
Speaker Change: Devon, who haven't suffered several questions.
Speaker Change: Regarding the non small cell lung cancer study.
Speaker Change: Go ahead, you wanted offices.
Speaker Change: In principle like two studies and one because we want to explore a in our phase II free both non squamous and <unk>.
Speaker Change: Glamis Smith small cell lung cancer.
Speaker Change: Across all PD one status.
Speaker Change: Setting.
Speaker Change: That means with these different patient.
Speaker Change: Patient population, how about we have a.
Speaker Change: Center size, which is around 900.
Speaker Change: 50, plus Ah patients.
Speaker Change: We expect based on already of data we have seen that all.
Speaker Change:
Speaker Change: His policy that.
Speaker Change: These histology.
Speaker Change: And also a different PD other ones to end strains have Ken Ken.
Speaker Change: Can benefit.
Speaker Change: Benefits from the BMT pre 2007 and that is why we have been Oh, I'll cover and all that stuff.
Speaker Change: And the biggest cost also or so or kind.
Speaker Change: Kind of options how to structure this clinical.
Speaker Change: Hi, including also.
Speaker Change: Having a singer singer cohort.
Ugur Sahin: Based on the discussion also with the FDA, we decided to have two indications, particularly with observations. And recently, in some of the monosquamous and squamous, did show different type of results for some of the compounds. There is now more, more attention on the different histology. Got it. Guys, but can I also just double click into this a little bit, please? Because the study, the phase two, three, recruiting nine hundred and eighty something patients. What proportion of that target enrollment is specifically for the phase two component? So the phase two component is around 40 patients. The phase three component is 940 something.
Speaker Change: Based on the discussion also with the FDA decided anthrax two indications, particularly with observations recently.
Speaker Change: In some of the clinical cut.
Speaker Change: Non small cell lung cancer.
Speaker Change: And.
Speaker Change: And.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Non squamous non squamous and squamous.
Speaker Change: So different type of hit side for some of the components is now more and more attention.
Speaker Change: On the defensive policy.
Speaker Change: Got it guys.
Speaker Change: And I'll just double click into this a little bit please because the.
Speaker Change: The study, it's a phase II III recruiting 980, septic patients what proportion of that target enrollment is specifically for the phase two component.
Speaker Change: So the phase.
Speaker Change: Phase two component is around 40 patients.
Speaker Change: Sweet component is 940, something so I was basically reflecting will faithfully component, what's the sense of size.
Ugur Sahin: So I was basically reflecting the phase three component with the sample size. And this is equally distributed across non-squamous and squamous non-small cell lung cancer sub-studies, so to speak. Got it. Thanks so much for the follow-up. As you can imagine, it is about further optimizing the dosage. Justifying the Doors. It's more a technical part.
Speaker Change: Well equally distributed.
Speaker Change: This trip you would cut across non squamous and squamous non small cell.
Speaker Change: So lung cancer studies.
Speaker Change: Studies sort of thing.
Speaker Change: Got it thanks, so much good color.
Speaker Change: Thank you we.
We will nowadays.
Speaker Change: As you can imagine is about optimizing but don't suggest it.
Speaker Change: Adjusted buying but also what's in it.
Speaker Change: It's more attention at the technical part of that development.
Yaron Werber: We will now take the next question from the line of Yaron Werber from TD Cohen. Please go ahead. Great. I have a quick question.
Speaker Change: We will now take the next question from the line of Yaron Werber from TD Cowen. Please go ahead.
Speaker Change: Great.
Speaker Change: Quick question.
Yaron Werber: Actually, I want to maybe shift to the ACIP latest decision, not to hold an ACIP meeting. This time it was for flu. I'm just curious. I know it's kind of early, but how would you handle this? Would you, at the end of the day, with Pfizer, just use the World Health Organization recommendation for the COVID strains? And I don't know whether you have any sort of communication so far, sort of what to expect. Thanks. Yeah, thanks, Yaron. Not too much to say at this stage. Obviously, we're following very closely the policy environment for COVID-19 vaccines in the United States.
Speaker Change: I want to maybe shift to the CIP.
Speaker Change: Latest decision not to hold on ACP.
Speaker Change: Meeting this time it was so slow.
Just curious I know, it's early but how would you handle this would do at the end of the day with Pfizer just use the world Health organization recommendation for the corporate strength and I don't know, whether you have any sort of communication, so far sort of what to expect thank you.
Speaker Change: Yes, Thanks, you Robyn not too much to say at this stage.
Speaker Change: You can see we're following very closely the policy environment for COVID-19 vaccines in the United States.
Yaron Werber: Our expectation is that there will eventually be a strain selected, and we're going to be in a position to respond very quickly, as we have done over the last couple of years. But I'm afraid that at this point, that's pretty much all we Thank you.
Speaker Change: Our expectation is that there will eventually be a strain selected and we're going to be in a position to respond very quickly as we have done over the last couple of years, but I'm afraid at this point that's pretty much all we can say.
Jessica Fye: We will now take the next question. From the line of Jessica Fye from J.P. Morgan, please go ahead.
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: From the line of Jessica Fye from J P. Morgan. Please go ahead.
Ryan Richardson: Hey guys, good morning. Thanks for taking my question. So beyond the small cell long data coming up imminently for 327, can you just take us through what specifically the next 327 data releases will be and where we should look out for them? I realize there's a number listed on the slide, but it just says 2025 plus. Thank you.
Jessica Fye: Hey, guys. Good morning, Thanks for taking my question, so beyond small cell lung data coming up imminently for three to seven can you just take us through what specifically the next three to seven data releases will be and where we should look out for them I realize theres a number listed on the slide but it just is 2025 plus.
Speaker Change: Thank you.
Ryan Richardson: So the question was about next upcoming BNT-327 data after small cell lung cancer. One data package will be TNVC, in which we also have a phase two study ongoing, and follow-up data on a previous study, which we have presented last year at the San Antonio conference, where you will learn a bit more about further maturing OS. Additional reports could be about other indication cohorts we have with 327, including also the first cohorts where we combine with our ADCs, specifically our trial where we combine 327 with 325, our top two ADCs. Thank you.
Speaker Change: So the question was about next I mean, our next upcoming.
<unk> hundred 27 data after small cell lung cancer.
Speaker Change: One data package will be <unk>.
Speaker Change: NBC and which we also have a phase two.
Speaker Change: Study ongoing and follow up data on.
Speaker Change: On a previous study, which we have presented last year at the San Antonio Conference well.
Speaker Change: You will learn a bit more about program maturing O S.
Speaker Change: Additionally, our reports are could be about other indication cohorts, we have with from 2007, including.
Speaker Change: Including also the first cohorts, where we combine with our Abcs are specifically our try our when we combine 327 with 325, Oh I talked to ADC.
Speaker Change: Thank you.
Unknown Executive: That's all the time we have for questions today.
Speaker Change: Thank you that's all the time, we have for questions today.
Unknown Executive: This concludes today's conference call. Thank you for participating. You may now disconnect.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
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Speaker Change: [music].