BioNTech Q4 2024 Earnings Report

BioNTech EPS Results

• Actual EPS: $1.08
• Consensus EPS: $0.38
• Beat/Miss: Beat by +$0.70
• One Year Ago EPS: $1.90

BioNTech Revenue Results

• Actual Revenue: $1.19 billion
• Expected Revenue: $1.24 billion
• Beat/Miss: Missed by -$45.66 million
• YoY Revenue Growth: -19.50%

BioNTech Announcement Details

• Quarter: Q4 2024
• Date: 3/10/2025
• Time: Before Market Opens
• Conference Call Date: Monday, March 10, 2025
• Conference Call Time: 8:00AM ET

BioNTech (NASDAQ:BNTX), a biotechnology company, develops and commercializes immunotherapies for cancer and other infectious diseases. The company is developing FixVac product candidates, including BNT111, which is in Phase II clinical trial for advance melanoma; BNT112 that is in Phase I/IIa clinical trial for prostate cancer; BNT113, which is in Phase II clinical trial to treat HPV 16+ head and neck cancers; BNT114 to treat triple negative breast cancer; BNT115, which is in Phase I clinical trial in ovarian cancer; and BNT116, which is in Phase I clinical trial for non-small cell lung cancer. It develops BNT122, which is in Phase II clinical trial for first-line melanoma and in Phase I clinical trial to treat multiple solid tumors; BNT131 that is in Phase I clinical trial for multiple solid tumors; BNT141 and BNT142 that are in Phase I clinical trial to treat multiple solid tumors; BNT151, BNT152, and BNT153 to treat solid tumors; BNT211 to treat multiple solid tumors, and BNT221 for pancreatic and other cancers; BNT311 which are in Phase II clinical trial to treat metastatic non-small cell lung cancer and Phase I/II clinical trial to treat multiple solid tumors; and BNT312, which is in Phase 2 clinical trial to treat multiple solid tumors, as well as ONC-392, which is in Phase III clinical trial to treat ovarian cancer and Phase I/II clinical trial to treat multiple solid tumors. It develops BNT321, an IgG1 monoclonal antibody in Phase I clinical trial for pancreatic cancer; BNT411, a small molecule immunomodulator product candidate in Phase I clinical trial for solid tumors; BNT322, which is in Phase I/Ib clinical trial for multiple solid tumors; and prophylactic vaccine for shingles, malaria, tuberculosis, HSV-2, and other infectious diseases. It has collaborations with Genentech, Inc.; Sanofi S.A.; Genmab A/S; Pfizer Inc.; Shanghai Fosun Pharmaceutical (Group) Co., Ltd; and Ryvu Therapeutics S.A. BioNTech SE was incorporated in 2008 and is based in Mainz, Germany.

BioNTech Q4 2024 Earnings Call Transcript

Presentation

[Operator]

Welcome to BioNTech's Fourth Quarter and Full Year twenty twenty four Earnings Call. I would like to hand the call over to Michael Horovitz, Director, Investor Relations. Please go ahead.

[Michael Horowicz, Director - IR at BioNTech]

Thank you. Good morning and good afternoon. Thank you for joining Viontech's fourth quarter and full year twenty twenty four 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.

[Michael Horowicz, Director - IR at BioNTech]

Additional information about these statements and other risks are described in our filings with The U. S. Securities And Exchange Commission. 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.

[Michael Horowicz, Director - IR at BioNTech]

On Slide three, you can find the agenda for today's call. Today, I'm joined by the following members of BioNTech's management team: Uber Zaheem, Chief Executive Officer and Co Founder Ozlem Torechi, Chief Medical Officer and Co Founder Jan Polstein, Chief Financial Officer and Ryan Richardson, Chief Strategy Officer. With this, I would like to hand over to Ugor.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

Thank you, Michael. 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 02/2008, 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.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

In 2024, we made significant progress on this mission, 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 has the potential to improve outcomes for patients across a wide range of tumor types. In oncology, we have identified two key PANT tumor programs. Our mRNA cancer immunotherapy Zixak and INIT and our bispecific anti PD L1 anti VQF antibody we interviewed to seven.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

We believe that these programs have disruptive potential and aligns with our vision. If successfully developed and approved, these programs could establish a new standard of care and enhance patient outcomes in multiple cancer indications globally. We are significantly investing in the clinical development of these programs across various cancer types, building up commercial functions for their future commercialization in key markets and enhancing manufacturing capabilities to support both clinical trial and commercial supply. In the infectious disease sector, we are advancing the development of our next generation COVID-nineteen 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.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

Consequently, as outlined in our 20 F filing today, we are prioritizing areas with disruptive potential for value generation. Moreover, we are planning to adjust our resources in manufacturing, administrative functions and preclinical research over the next three years to further solidify efficient execution. Let me continue with a look back at what we have achieved in 2024. For our mRNA cancer immunotherapies, we initiated a third Phase II trial evaluating autogen serumiran in adjuvant setting, namely in bladder cancer. In early twenty twenty five, we also published two manuscripts describing our insights from two Phase I trials for autogenecilumorab.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

For three of the CHF Sig SAG programs, we reported data including the announcement that SicSAT candidate BNT11 met the primary endpoint in a randomized Phase II trial in patients with anti PD1 relapse or refractory melanoma. We presented multiple datasets for our next generation IO 20 three-seven, a PD L1 VGF bispecific antibody and initiated Phase III and Phase IIIII trials in small cell lung cancer and non small cell lung cancer. We plan to initiate a Phase III trial in triple negative breast cancer this year. We announced our intention to acquire BioPhios to secure global control over BNT-three twenty seven and expand our immunotherapy capabilities. This transaction closed earlier this year and we are thrilled to welcome BioPhios as a new arm of our operations in China.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

With regard to our COVID-nineteen vaccine, we and Pfizer maintained our leading market share globally. We also continued to progress several data programs in our early stage infectious disease pipeline. Lastly, we were able to achieve all this while maintaining our strong financial position. We believe these achievements positions us well for further progress in 2025. 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 programs.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

First, our personalized mRNA cancer immuno therapies, encoding mutant neoantigens for application primarily for the early stage, including adjuvant setting and our fixed site immunotherapies targeting tumor associated antigen in combination with checkpoint immunotherapy, respectively. Second, our PD L1 VGF bispecific antibody BNT3U7, which we believe has the potential to become a next generation I O backbone for the treatment of advanced cancers. We believe that both programs have planned tumor potential and could be combined with different modalities to address large patient population with high unmet medical needs. 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 strategy.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

I want to take a moment to highlight our recently completed acquisition of BioSears. We are excited to now formally welcome BioPhiose team to BioNTech. Having worked for a year with the highly skilled and dedicated team at BioPhiose, 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. However, there are other factors of this acquisition, which are also strategically important for us.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

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. With the acquisition of BioceoSafe, 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 launches. Lastly, Biofuels comes with leading antibody engineering technology and expertise.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

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. With that, I will turn the call over to Esther.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

Thank you, Ugur. Glad to be speaking with everyone today. Before talking about our focus programs introduced by Ugur, I wanted to take a minute to show our pipeline progress in 2024. If you compare our oncology pipeline today to previous years, you can see that we have significantly increased the number of Phase II and III 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.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

As Ugur pointed out, our mRNA immunotherapies and our BN three twenty seven centered clinical development program are dominantly represented in our pipeline and particularly so in the advanced clinical stages with BNT three twenty seven becoming our platform for unique combinations with several of our other assets, in particular our ADCs. As Ugo mentioned, 2025 will be an important year for both of our priority programs. BNT327 by KULA localizing the blockade of PD L1 and VEGFA signaling to the tumor is designed to deliver superior antitumor, immune modulatory and anti angiogenic effects compared to the individual targeting of PD L1 and VEGFA with the potential to minimize adverse events associated with systemic anti VEGFA therapy. With the anti PD L1 and anti VEGFA 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.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

The first wave is focused on lung cancer and TNBC as key indications to establish BNT-three twenty seven combined with standard of care chemotherapy with first approvals in first line settings of these indications. We have completed enrollment in our global Phase II dose optimization studies in small cell lung cancer and TNBC. In small cell lung cancer, we have begun enrolling patients in the global randomized Phase III trial. In TNBC, we will start a global registrational study later this year. In non small cell lung cancer, we have begun enrolling patients in our global Phase II preregistrational clinical trial.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

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 BNT-three twenty seven with four ADCs directed against TROP2HER3 B7H3 from our partnerships with Duality and MediLink and informed by a robust database of single agent data for these ADC. A BNT327 ADC combination study with our TROP2 ADC, BNT325 is already enrolling patients. In the coming months, we expect to dose the first patients combining BNT-three twenty seven with our HER2 ADC-three twenty three and our B7H380. Throughout this year, we will 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 BNT-three twenty seven.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

With this focused clinical development program, we aim to leverage BNT-three twenty seven's full potential. As previously mentioned, we expect 2025 to be a data rich year across our whole pipeline and especially for BNT327. 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. 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 three percent.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

Based on our emerging data, we believe that BNT327 has the potential to improve clinical outcomes for patients with small cell lung cancer. At ESMO twenty twenty three, 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. We plan to present three data sets from trials in small cell lung cancer this year, including data from two separate single arm Phase II trials, evaluating BNT327 plus chemotherapy as a first or second line treatment for extensive stage small cell lung cancer. These datasets continue to support our enthusiasm for evaluating the NT-three twenty seven for the potential treatment of first line small cell lung cancer in our ongoing global Phase III trial. As Ryan will cover later, we expect to share additional important clinical data updates throughout the year.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

Our mRNA cancer immune therapy platforms, INS and SigVac are the other cornerstone of our oncology portfolio. Autogen's zuvumeran, a. K. A. BNT122, developed in partnership with Genentech, is based on the Ines platform.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

Ines targets neoantigens, unique tumor specific mutations and is manufactured on demand for each individual patient. FICC track in contrast targets shared non mutated tumor antigens and is an off the shelf approach. Both platforms utilize our proprietary Uridine mRNA LPX delivery technology. 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 INES and FICC FACT trials across various tumor types.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

These data consistently demonstrate that uridine mRNA LPX based immunotherapies have manageable safety profile whereby used as single agents in combination with anti PD-onePD L1 inhibitors or with chemotherapy. 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 activity. We have multiple trials with both FICC FACT and INEST ongoing and have had multiple data reports in the past years and in particular in 2024. Today, I would like to focus on INESTS and recent data we have obtained in the trial highlighted here from which we recently published data in Nature Medicine.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

This is our first Phase I clinical trial of autogen ziruvumiran published in Nature Medicine, which included over 200 patients with resistant refractory advanced and metastatic solid tumors. This trial evaluated autogen zuvumiran both with and without the checkpoint inhibitor atezolizumab. It is known that only a small fraction one percent to two percent of cancer mutations spontaneously elicit an anti tumor immune response. Our mRNA cancer immunoFRP approach aims to significantly increase these anti tumor immune responses. In this Phase one trial, autogen sevumran successfully induced T cell responses across multiple cancer types, converting a high portion of patients into immune responders.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

The majority of these responses were fully epitopic 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 neoantigen specific T cells. Furthermore, in several patients, we detected newly induced anti tumor T cells infiltrating the tumor of treated patients. These findings demonstrate the potent immunogenicity of autogen ziruvimiran even in patients with advanced rapidly progressing cancers, which is a prerequisite for clinical activity. In our ongoing Phase II clinical trials, we aim to confirm these data and evaluate in which treatment setting and indications where immune responses translate best into clinical activity.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

While we saw strong immune responses in this Phase I trial, we observed modest signals of clinical activity, which was expected given that the Phase I trial was conducted in heavily pretreated resistant refractory fast growing advanced cancer. We recently also received top line data from the ENCODE one Phase two trial marked here on this slide. This was the first randomized proof of concept Phase II trial of an INIST candidate evaluating autogen zuvumiran in combination with pembrolizumab versus pembrolizumab alone as first line treatment for patients with metastatic or advanced melanoma. This trial is part of a broader ENCODE study program initiated in 2017 by our partner Genentech and us designed to identify optimal treatment settings and patient populations for individualized mRNA cancer immunotherapies, including early and late stage cancers. Fibro initial data confirm our observations that autogen sorumaran induces high magnitude immune responses against encoded neoantigens in this advanced treatment setting.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

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 sorumaran with PD-one blockade was well tolerated with adverse events consistent with the known safety profiles of the individual treatment. We are continuing to analyze the results, including exploratory endpoints and biomarker correlation. We and our partner Genentech will share these data with the scientific community at an upcoming medical conference.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

The outcome confirms what we have observed in our Phase I trial in patients with heavily pretreated resistant refractory fast growing advanced cancers and provides valuable insights. 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. This experience combined with our extensive translational data reconfirm our strategic focus on using I NIST in the adjuvant setting where patients have resectable cancers and minimal residual disease.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

We believe this setting offers a strong biological rationale for success due to several reasons. Atruent therapy targets a much smaller number of residual tumor cells after surgery. The slower disease progression in the Atruent 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 established. Patients in the adjuvant setting often have healthier immune systems and less compromised T cell function, increasing the likelihood of a clinically meaningful response.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

This rationale is the reason why we strategically focused our advanced INS program on the adjuvant setting. We currently have three ongoing randomized Phase II trials of autogen zevoomiran, 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 this study either late this year or in early twenty twenty six. These data will be critical for informing the next stages of development and regulatory discussion.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

We are also evaluating autogen sevumiran as an adjuvant treatment for pancreatic cancer. This Phase II is informed by a small Phase I trial in which we showed strong immune responses induced by autogen sevumiran and their correlation with significant improvement of recurrence free survival. A randomized controlled Phase II 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 or cancer metastases. 2025 will be an important year for BioNTech.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at 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 IO combinations for the treatment of advanced rapidly progressing high volume tumors. We look forward to providing updates on our progress. With that, I will now pass the presentation to our CFO, Jens Holstner.

[Jens Holstein, CFO at BioNTech]

Thank you, Erzlem, and a warm welcome to everyone who has dialed in today's call. I'll start with our fourth quarter and full year results 2024. Then I'll share our 2025 financial guidance. In terms of our financial results, we executed the year according to our plans. We recognized around EUR 2,800,000,000.0 in revenues, meeting the approximate midpoint of our full year 2024 revenue guidance and with this slightly better than our previously announced expectation.

[Jens Holstein, CFO at BioNTech]

Driven by effective cost management, we limited our full year 2024 losses before taxes to approximately EUR $678,000,000 and a diluted loss per share of EUR 2.77. Our cash position, including cash equivalents and investments and securities, amounted to EUR 17,400,000,000.0 at the end of twenty twenty four. This leaves us financially well positioned to continue with the execution of our strategy in 2025. Please note that this year end cash position has not yet reflected the closed acquisition of BioThius to the amount of approximately USD 800,000,000 and payments derived from the settlement of the contractual disputes with NIH at the University of Pennsylvania to the amount of USD $792,000,000 and USD $467,000,000, respectively. We expect that the BioThius acquisition payment and the NIH payment totaling approximately USD 1,600,000,000.0 will be reflected in our first quarter twenty twenty five financial position.

[Jens Holstein, CFO at BioNTech]

We expect that the University of Pennsylvania settlement payment will be reflected in our second quarter twenty twenty five financial position. With respect to the settlements, we also expect a reimbursement of approximately USD $535,000,000 from our partner, Pfizer, during 2025 and 2026. 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 12/31/2024, we recognized total revenues of approximately EUR 1,200,000,000.0 compared to approximately EUR 1,500,000,000.0 in the prior year period. For the full year, we recognized around EUR2.8 billion compared to around EUR3.8 billion in 2023.

[Jens Holstein, CFO at BioNTech]

The reduction was primarily driven by a lower COVID-nineteen vaccine market demand. In addition, write downs by our collaboration partner Pfizer reduced our gross profit share and hence negatively influenced our revenues for 2024. Research and development expenses reached

[Jens Holstein, CFO at BioNTech]

EUR $612,000,000 for

[Jens Holstein, CFO at BioNTech]

the fourth quarter of twenty twenty four compared to EUR $578,000,000 for the comparative period in 2023. For 2024, R and D expenses amounted to approximately EUR 2,300,000,000.0 compared to roughly EUR 1,800,000,000.0 in 2023. The increase was mainly influenced by the planned advancing of our priority programs, including BNT327 towards late stage development. SG and A expenses amounted to approximately EUR 132,000,000 for the fourth quarter of twenty twenty four compared to EUR142 million in the same period of the previous year. For the 2024 financial year, SG and A expenses amounted to approximately EUR591 million compared to EUR568 million in 2023.

[Jens Holstein, CFO at BioNTech]

The increase in SG and A expenses is primarily attributable to the build out of our commercial organization. With respect to the company's other operating results, we reported negative EUR $671,000,000 for the 2024 financial year as compared to negative EUR188 million in 2023. This was mainly due to payments and expenses related to the above mentioned contractual disputes with NIH and UPenn. Net of aforementioned related reimbursement by our collaboration partner, Pfizer. For the fourth quarter of twenty twenty four, we reported a net profit of approximately EUR $260,000,000 compared to around EUR $458,000,000 for the comparative period in 2023.

[Jens Holstein, CFO at BioNTech]

For the full year 2024, we reported a net loss of EUR $665,000,000 compared to a net profit of EUR $930,000,000 in the prior year. Our diluted earnings per share for the fourth quarter of twenty twenty four amounted to EUR 1.08 compared to EUR 1.88 in the comparative period in 2023. For the 2024 financial year, our diluted loss per share amounted to EUR 2.77 compared to EUR 3.83 for the prior year. 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.

[Jens Holstein, CFO at BioNTech]

Starting from the top, we achieved roughly the midpoint of our full year 2024 revenue guidance of EUR 2,500,000,000.0 to EUR 3,100,000,000.0. During our third quarter twenty twenty four earnings call, we stated that we expected full year 2024 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. On R and D, we reported roughly EUR 2,300,000,000.0 in expenses for 2024, slightly below the low end of our full year 2024 financial guidance range of EUR 2,400,000,000.0 to EUR 2,600,000,000.0.

[Jens Holstein, CFO at BioNTech]

This was in part driven by our active portfolio management and the shifting of some registrational study costs from 2024 into 2025. On SG and A and capital expenditures for operating activities, we ended at the lower end of our 2024 expectations from our last earnings call. Meeting these lower guidance ranges is a result of our continued cost monetary and financial discipline. 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 EUR 1,700,000,000.0 to EUR 2,200,000,000.0 for 2025.

[Jens Holstein, CFO at BioNTech]

Our revenue guidance assumes relatively stable vaccination rate 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 figure. 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-nineteen vaccine sales in Pfizer's territory. We also expect revenues related to our service business as well as revenues from the German Pandemic Preparedness Agreement to contribute to our overall group revenues. 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-nineteen vaccine revenues and financial results.

[Jens Holstein, CFO at BioNTech]

Turning to operating expenses. In 2025, we expect R and D expenses to be in the range

[Jens Holstein, CFO at BioNTech]

of EUR 2,600,000,000.0 to EUR

[Jens Holstein, CFO at BioNTech]

2,800,000,000.0. As compared to 2024, we expect to see an increase in investment into our priority late stage programs in 2025, in MBNT327, our mRNA cancer immunotherapies and our LVC pipeline. Consistent with our portfolio prioritization strategy, we also expect to decrease our R and 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 and A.

[Jens Holstein, CFO at BioNTech]

We expect SG and A expenses to be in the range of EUR $650,000,000 to EUR $750,000,000. 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

[Jens Holstein, CFO at BioNTech]

of EUR $250,000,000

[Jens Holstein, CFO at BioNTech]

to EUR $350,000,000. 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 technologies. In summary, 2025 will be another year of continued transition for BioNTech with the aim to become a multiproduct commercial oncology company. We will continue to diligently invest in our long term growth strategy while maintaining strict financial discipline.

[Jens Holstein, CFO at BioNTech]

With that, we remain focused on achieving long term sustainable growth and generating value for patients and shareholders. 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.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

Thank you, Jens. 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, BNT-three twenty seven and our mRNA cancer immunotherapies. Each of these programs are in Phase II or Phase III trials and will generate data updates over the course of the year. We will continue to build out our commercial capabilities in oncology to support our goal of becoming a fully integrated biopharmaceutical company.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

In infectious disease, we will continue to invest to maintain our and Pfizer's global leadership position in the COVID-nineteen vaccine market, while continuing to advance next generation and combination vaccines in the clinic. 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 BNT327, we plan to share data updates for our mRNA cancer immunotherapies, INEST and VIXPAC.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

And with regards to our first potential oncology product in HER2 ADC BNT-three 23, 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. 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 16. We are excited to once again host two innovation series events this year. The first will be another AI event on October 1.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

The second will be our R and D Day on November 18. We will share further details on both events later in the year. With that, we would like to

[Ryan Richardson, Chief Strategy Officer at BioNTech]

open the floor for questions.

[Operator]

Thank you. You. We will now take the first question from the line of Daina Kravos from Leerink Partners. Please go ahead.

[Daina Graybosch, Senior Managing Director, Biotechnology Analyst at Leerink Partners]

Hi. Thank you for the 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 quarters and this year?

[Daina Graybosch, Senior Managing Director, Biotechnology Analyst at Leerink Partners]

Thank you.

[Jens Holstein, CFO at BioNTech]

Thanks, Dana, 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 20 F, where we have explained the circumstances in detail, and I can't comment more than what we have published in the 20 F.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

Yes. I think, David, just to add to that, I think as we've said in the 20 F as well that we're confident in the strength of our IP estate. Some of these sometimes these processes can go through multiple appeals processes, but we think we're in a good position and are going to continue to defend our IP estate along with our partner Pfizer.

[Daina Graybosch, Senior Managing Director, Biotechnology Analyst at Leerink Partners]

Great. And maybe one more because that was quick. On the six pack data that you're going to share this year of simlopumab, can you just remind us of the context going into that or recall that that was a top line success? And so how we should be thinking about a vaccine in relapsedrefractory melanoma in context of Aslam, you sharing that the personalized vaccine didn't work in a metastatic melanoma setting? Thank you.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

Thank you for the question. I'm not sure whether I got it correctly. So the question was with regard to our melanoma fix sec, the NT-one 11, right, where we have reported top line results that we have that it was a successful trial and that we have achieved the endpoint. 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.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

As you pointed out, yes, we observe that for our EyeNEST, the first line setting seems that it's not the right one. So metastatic setting with advanced cancers and higher tumor burden is not optimal, and which actually is not surprising. I have described the reasons for this, which can explain a couple in my talk today. That's also why we are focusing our INES approach, our individualized cancer approach on the adjuvant setting and have initiated three trials in this setting. We believe that here the probability of getting robust clinical benefit is much higher due to synthetic biology of atrivant cancer.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

Dana, one of the key differences between the INES approach and the FICCAC approach is the FICC VAC can be applied immediately without any delay. And for the IVAC approach, at the time point of the clinical trial, we had a turnaround time in the range of six to eight 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 sent into the adjuvant stage, the patients before they progress have three, six, nine, twelve months before PFS event is occur.

[Operator]

Great. Thank you. Thank you. We will now take the next question from the line of Akash Tavares from Jefferies. Please go ahead.

[Akash Tewari, Managing Director at Jefferies]

Hey, thanks so much. Just on 03/27, 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 is talking about running a lot of different Phase three trials over time. And you guys have hinted at a potential fiftyfifty partnership. Where does BioNTech currently stand on the partnership question on 03/27 and what clinical or commercial capabilities would you be looking at for an external partner? Thank you.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

Yes. 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 three twenty seven 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.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

So that's really the focus for 2025. What we have said though is that we recognize that with such a very 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 BNT327. 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 partnerships over the next twelve to eighteen months.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

I won't comment beyond that at this point, 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 to potentially speed up and expand the program.

[Operator]

Thank you. We will now take the next question from the line of Chris Shibutani from Goldman Sachs. Please go ahead.

[Chris Shibutani, Analyst at Goldman Sachs]

Good morning. Thank you so much. With your plan for 03/27, obviously, the scope of opportunity is considerable. And as we think about the other leading player developing some at Akesho, they're mapping out a pretty broad plan. Can you clarify how you see what you think will be differentiating in your approach?

[Chris Shibutani, Analyst at Goldman Sachs]

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.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

So I can start and maybe Renasant 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-onePD L1 therapies have been successful, but also potentially in patient segments where PD-onePD 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. 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.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

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, Uwe, do you want

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

to know? No, just it's really about the execution of this trial. If you really consider the full spectrum, will take many years in multiple indications. So then you revisit what has happened in the I OCA for anti PD-one treatment. This was a process which went and is still ongoing in the last ten years.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

And this is something which we expect also for the next generation of an entire PD-one blockade

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

with

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

the bispecific 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 BNP3-seven alone.

[Chris Shibutani, Analyst at Goldman Sachs]

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.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

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 specific effects on our trials and have actually very good enrollment in particular into the three twenty seven trials, which seems to be a compound where investigators are very enthusiastic about.

[Chris Shibutani, Analyst at Goldman Sachs]

Thank you. I appreciate the follow-up.

[Operator]

Thank you. We will now take the next question from the line of Tazeen Ahmad from Bank of America Securities. Please go ahead.

[Tazeen Ahmad, MD - US Equity Research at Bank of America]

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 03/23 for the endometrial data that you're expecting this year that would be able to support the filing this year? And then related to that, maybe the second part of the question is for Ryan. How are you preparing for the launch of 03/23 if in fact you're able to do so in 2026?

[Tazeen Ahmad, MD - US Equity Research at Bank of America]

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.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

Yes. Thanks, Tazeen. So on the first question, just to clarify, I think you're asking the efficacy bar for BNT-three twenty three and endometrial cancer, correct?

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

Yes. Yes. So as you know, endometrial cancer is an indication where patients can be categorized into HER2 plus and HER2 load 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, the standard of care SHAML therapy with a very short PFS and OS.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

As you know, the compound if we receive breakthrough designation in this indication. So we are confident that the results will fulfill the requirements for potential registration.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

Yes. And to Uwe's point, I mean, we've seen within HER2 response rates are around fifty percent, 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 bevacizumab plus chemo, we're seeing response rates far lower than that in terms of standard of care. So in the sort of twenty percent range.

[Operator]

Thank you.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

Could

[Ryan Richardson, Chief Strategy Officer at BioNTech]

you just repeat the second question please?

[Terence Flynn, Equity Research Analyst at Morgan Stanley]

Oh my God, I mean this is crazy.

[Operator]

Sorry, we will now take the next question from the line of Terence Flynn from Morgan Stanley. Please go ahead.

[Terence Flynn, Equity Research Analyst at Morgan Stanley]

Hi, thanks for taking the question. I know you mentioned you're going to have some three twenty seven Phase II 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, etcetera? Thank you.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

So I think in the first instance, I'll start and maybe also Nubir can join. So we've already published some data in small cell lung cancer where we showed response rates in the seventy percent range for with a combination with chemotherapy. We're expecting that these datasets 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. And so that's been built on the the previous data sets that we put out there.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

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. You will get follow-up data, but also new data from our dose justification clinical trial, which we have initiated.

[Operator]

Thank you. We will now take the next question from the line of Harry Gillies from Berenberg. Please go ahead.

[Harry Gillis, Vice President - Pharmaceuticals Equity Research at Berenberg]

Hi. Thank you for taking the question. Just on the 2025 revenue guidance, you talked about relative stability in vaccination rates, pricing and market share. I was just 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 U. S.

[Harry Gillis, Vice President - Pharmaceuticals Equity Research at Berenberg]

Vaccination rates and any impacts from Sanofi's commercialization of the Novavax bag? Thank you.

[Jens Holstein, CFO at BioNTech]

Yes, thanks very much. Happy to take the question. So of course, as you pointed out, 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 think about Pfizer's guidance, that we have some write offs to reflect product returns or write offs that consist out of write offs on material like we've seen in 2024. We had JN1, we

[Jens Holstein, CFO at BioNTech]

had KP2 variance introduced and we had to

[Jens Holstein, CFO at BioNTech]

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 U. S.

[Jens Holstein, CFO at BioNTech]

In 2025, reflecting a little bit potential competitive pressure here to the point of philosophy. And thirdly, 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 why we are at the midpoint at this range.

[Operator]

Thank you. We will now take the next question from the line of Cory Kasimov from Evercore. Please go ahead.

[Cory Kasimov, Senior Managing Director at Evercore]

Hey guys, thanks for taking the question. I wanted to follow-up on Terrence'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.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

So we will have PFS data. I cannot say from the top of my head what the follow-up time within this study is, but we will have CFS data on our small cell lung cancer trial.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

And emerging OS data.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

And emerging OS data, yes. No median OS, but emerging OS data.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

Yes. And in terms of the standard of care, it continues to be in first line setting, it continues to be TID CENTRIC plus chemotherapy. That's the benchmark.

[Cory Kasimov, Senior Managing Director at Evercore]

Great. Thank you.

[Operator]

Thank you.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

It's the IMPALA-one 33 trial as a benchmark if that helps.

[Operator]

Thank you. We will now take the next question from the line of Mohit Bansal from Wells Fargo. Please go ahead.

[Analyst]

Hi, this is Sadie Arman on for Mohit. Thanks for taking our questions. So another question on 03/27, with a competitor expected to read out their OS data in lung cancer later this year, how would you view read through from those results to 03/27 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?

[Analyst]

Thank you.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

Okay. Our non small lung cancer study is actually two studies in one study, addressing the complete population

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

of

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

AGA negative first line lung cancer patients. That means the PD L1 high, PD L1 low and PD L1 negative population in squamous and nonscamous patients. Our comparator is pembrolizumab plus chemotherapy. And the treatment group received BNP57 plus chemotherapy. And endpoints are as usual PFS and OS.

[Operator]

Thank you. We will now take the next question from the line of Architkar Gunewardena from Chur Securities. Please go ahead.

[Asthika Goonewardene, Analyst at Truist Securities]

Hi guys. Thanks for taking my question. Aslam, you mentioned that you started recruiting patients to the Phase twothree trial in non small cell lung cancer. Could you give a little bit more color on the size of that Phase tw cohort? And if you plan on reporting that data and maybe a little bit of guidelines on expectations that are enrolling that Phase two portion.

[Asthika Goonewardene, Analyst at Truist Securities]

And then sort of related to this guys, could you maybe comment on the statistical analysis of this study? And I believe you're considering the non squamous and squamous population separately, which is different from how your competitor summit is doing their analysis of HARMONITY III. So why do you prefer your method? Thank you.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

So what's the question, the size of our study? There were several questions, I think, regarding the non small cell lung cancer study. As Ugo has pointed out, this is in principle like two studies in one because we want to explore in our Phase twothree 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 sample size, which is around nine fifty plus patients. And we expect based on earlier data, we have seen that all these that these histologies and also different PD L1s and strata can benefit from the NT327.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

This is why we have them all covered in our study.

[Ugur Sahin, Co-Founder, CEO & Chair of the Management Board at BioNTech]

And we discussed also all kind of options how to structure this clinical trial, including also having a single cohort. Based on the discussion also with the FDA, we decided to have two indications, particularly with the observations. And recently recently in some of the clinical trials, there are non small cell lung cancer and squamous non squamous and squamous did show different type of results for some of the compounds. There is now more attention of on the different histology.

[Asthika Goonewardene, Analyst at Truist Securities]

Got it. Guys, can I also just double click into this a little bit please? Because the study, the Phase twothree recruiting nine eighty something patients, what proportion of that target enrollment is specifically for the Phase II component?

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

So the Phase II component is around 40 patients. The Phase III component is nine forty something. So I was basically reflecting the Phase III component with the sample size. And this is equally distributed across non squamous and squamous non small cell lung cancer sub studies, so to say.

[Michael Horowicz, Director - IR at BioNTech]

Got it. Thanks so much for the color.

[Operator]

Thank you. We will now take The first

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

place, as you can imagine, is about further optimizing the dose or justifying the dose. So it's more a technical part of the development.

[Operator]

We will now take the next question from the line of Yaron Werber from TD Cowen. Please go ahead.

[Yaron Werber, Managing Director, Senior Biotechnology Analyst at Cowen and Company]

Great. I have a quick question. Actually, I want to maybe shift to the ACIP latest decision not to hold an ACIP not meeting this time it was flu. 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?

[Yaron Werber, Managing Director, Senior Biotechnology Analyst at Cowen and Company]

And I don't know whether you have any sort of communication so far sort of what to expect? Thank you.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

Yes. Thanks, Yaron. Not too much to say at this stage. Obviously, we're following very closely the policy environment for COVID-nineteen vaccines in The United States. 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.

[Ryan Richardson, Chief Strategy Officer at BioNTech]

But I'm afraid that at this point that's pretty much all we can say.

[Operator]

Thank you. We will now take the next question from the line of Jessica Fye from JPMorgan. Please go ahead.

[Jessica Fye, Managing Director & Equity Research Analyst - Biotechnology at JP Morgan]

Hey guys, good morning. Thanks for taking my questions. So beyond the small cell lung data coming up imminently for 03/27, can you just take us through what specifically the next 03/27 data releases will be and where we should look out for them? I realize there's a number listed

[Jessica Fye, Managing Director & Equity Research Analyst - Biotechnology at JP Morgan]

on the slide, but it

[Jessica Fye, Managing Director & Equity Research Analyst - Biotechnology at JP Morgan]

just says 2025 plus. Thank you.

[Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech]

So the question was about next upcoming BNP-three twenty seven data after small cell lung cancer. One data package will be TNBC in which we also have a Phase II 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 three twenty seven, including also the first cohorts where we combine with our ADCs, specifically our trial where we combine three twenty seven with three twenty five, our top two ADC.

[Operator]

Thank you. That's all the time we have for questions today. This concludes today's conference call. Thank you for participating. You may now disconnect.

Participants

Executives

• Michael Horowicz, Director - IR
• Ugur Sahin, Co-Founder, CEO & Chair of the Management Board
• Özlem Türeci, Co-Founder, Chief Medical Officer & Member of Management Board
• Jens Holstein, CFO
• Ryan Richardson, Chief Strategy Officer

Analysts

• Daina Graybosch, Senior Managing Director, Biotechnology Analyst at Leerink Partners
• Akash Tewari, Managing Director at Jefferies
• Chris Shibutani, Analyst at Goldman Sachs
• Tazeen Ahmad, MD - US Equity Research at Bank of America
• Terence Flynn, Equity Research Analyst at Morgan Stanley
• Harry Gillis, Vice President - Pharmaceuticals Equity Research at Berenberg
• Cory Kasimov, Senior Managing Director at Evercore
• Analyst
• Asthika Goonewardene, Analyst at Truist Securities
• Yaron Werber, Managing Director, Senior Biotechnology Analyst at Cowen and Company
• Jessica Fye, Managing Director & Equity Research Analyst - Biotechnology at JP Morgan