2025 Q4 and Full Year Earnings Call

Welcome to Biontech's fourth quarter and full year 2025 earnings call. I will now hand the call over to Doug Maffei, Vice President, Strategy Investor Relations. Please go ahead.

Thank you, operator. Welcome to Biontech's fourth quarter and full year 2025 earnings call. As a reminder, the slides we will be using during this call and the corresponding press release can be found in the investor 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. 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. On slide three, you will see the agenda for today's call. I'm joined today by the following members of BioNTech's management team. Uga Shaheen, Chief Executive Officer and Co-Founder, Oslam Sureci, Chief Medical Officer and Co-Founder, and Ramon Zapata, Chief Financial Officer. With this, I'll hand the call over to Uga.

Thank you, Doug, and a warm welcome to everyone as you join us today. As BioNTech has grown, our vision has remained constant, namely translating science into survival. Our focus is on oncology. Cancer remains a complex systems problem, varying between patients and further with an individual tumor. We believe that the future lies in rationally designed therapeutic combinations that pair potent precise mechanisms of action to achieve biological synergies. To this aim, we have purpose-built a diversified clinical pipeline spanning next-generation immunomodulators, antibody drug conjugates, and mRNA immunotherapies that enable effective personalized precision medicine and novel novel combinations across soda tumors. In 2025 and early 2026, we have made strong focus towards realizing our ambition. The year was marked by important achievements in four key areas. We have maintained our leadership in the COVID vaccine market and launched our variant-adapted vaccine in partnership with Pfizer. Our vaccine is now distributed in over 180 countries with more than 50% market share in major markets. Second, we have advanced our oncology programs with a registrational nucleus advancing in lung and breast, supported by a bold clinical evidence base with more than 4,000 patients enrolled across phase 2 and phase 3 studies. As a result, we anticipate multiple late-stage, event-driven readouts in 2026. In parallel, we now have more than 10 novel-novel combination tribes with Pumitamik in progress. We executed key strategic deals, most importantly with BMS, to strengthen the execution of and help the risk of our Pumitamik programs. We acquired BioSeus, thus gaining full rights to our cornerstone as a Pumitamik, and completed the acquisition of QVAC, strengthening our position in the MRNA field. And last but not least, we exceeded our already increased 2025 revenue guidance and ended the year in a strong financial position with more than 17 billion euros in cash, cash equivalents and securities. We maintained discipline resource allocation with active portfolio management, focusing on late stage programs that provide a clear potential to drive value appreciation. For 2026, we are focused on three key priorities. The first is to accelerate the late stage development of our first wave of oncology efforts, and we anticipate key late stage data readouts this year. Second is building momentum in our combination-based approach. Multiple data readouts from our novel novel prometamic combination trials are expected this year and will inform our first prometamic plus ADC pivotal trial. Third is to continue our evolution from our platform-centric approach to a tumor-centric clinical development program centered around high-incident cancers, including lung cancer, breast cancer, and other tumors. The foundation of this matrix approach is leveraging our diverse clinical assets for combination strategies, which will allow us to address several lines of treatment with different combinations. Our current late-stage pipeline illustrates the broad and robust approach we are taking to advance our ambition to become a multi-product company. Today, we have a growing set of late-stage and pivotal programs across high-incidence tumors with a clear registration path and stage expansion options where we believe we can make meaningful difference for patients. We expect a sustained cadence of event-driven late-stage readouts across different tumor tests from 2026 to 2030. Our clinical program provides multiple approval opportunities and we are building launch readiness now, deepening indication-specific with expertise and advance in commercial and market access capabilities in the two more tasks where we anticipate first launches. Earlier today, we announced plans to pursue next-generation mRNA innovations in a new independent company as BioNTech advances towards becoming a multi-product company by 2030. The new company will be founded and led by SM and me and we are both excited at the prospect of this new chapter on our personal journey towards our vision to translate our son into meaningful advances for patients. In order to do this, our new company will be built with distinct resources, operations and funding options. BioNTech stands to contribute related RISE and mRNA technologies to the new company. In exchange, BioNTech will hold a minority state in the company. This will enable and support prioritized development of these innovative technologies. A binding agreement is expected to be signed by the end of the third half of this year. Özlem and I will transition to lead our new company by the end of 2026, when our current BioNTech service agreements end. As BioNTech founders and significant shareholders, we will remain close to the company. BioNTech will continue to sharpen its strategic focus on the development and commercialization of its growing late-stage pipeline spanning innovative immunomodulators, ADCs, and AMANI candidates. Combination approaches are a core part of BioNTech's strategy to maximize the value of our next generation immune oncology backbone candidate Pumitamik. BioNTech's potential stake in the new company will provide both organizations with opportunities to collaborate on combination approaches involving their candidates with the potential to create new complementary or synergistic treatment strategies. BioNTech and our new company will each have unique capabilities, will be in expertise and will focus on their respective strategic priorities to maximize value for patients and shareholders. Over the past 18 years, we have built BioNTech from a start-up into a global biopharmaceutical company with a strong and diversified pipeline. During the COVID-19 pandemic, we expanded beyond oncology to develop the first approved mRNA vaccines, helping to protect people worldwide. None of this would have been possible without the extraordinary dedication of our team, the trust of our shareholders and the commitment of the partners who have supported us along the way. Today, BioNTech is well positioned to advance its mission and become a commercial multi-product company. I look forward to updating you on our progress throughout this year. Thank you all. With this, I will hand over to FDM for an update on our oncology execution.

Thank you, Ugo. I'm glad to be speaking with everyone today. 2025 was a year where we laid important foundational elements to enable us to execute our strategy in 2026 and beyond. We are executing a synergy-driven development strategy across three modalities in oncology. At the core of our approach is the rationale. The combination across these modalities can help prevent and address resistance and create conditions for more durable treatment responses, ideally translating into better outcomes for cancer patients from early to late stage. Last year, we progressed the development of assets across these modalities, as monotherapy or in combination with current standard of change. We also gained a better understanding of how to prioritize, sequence and investigate our development plans based on evidence, feasibility and potential impact. During 2026, we expect to meaningfully advance our novel novel combination strategy with multiple data sets expected the io pen tumor backbone of our combination based development strategy is our pdl1 vgfa by specific antibody kumitamik we and our partner bms are pursuing a free wave plan to develop kumitamik broadly deeply and in a differentiated manner across cross-indications, disease areas, and treatment lines. Wave 1 is anchored in three foundational first-line programs, SCSC, NSCSC, and TNBC, each with a global phase 3 trial designed for registration and supported by studies that dearest dose and testing. Through these trials, we aim to establish Bumitamik and foundational first-line indication in combination with standard of care chemotherapy through global registration of phase 3 trials. Speed to the initial label is the key value inflection point, and it creates the platform for stage evidence-less expansion thereafter. In parallel, wave 2 expands into additional indications. Alongside trials with registrational intent, we are running an expanding set of signal-seeking studies across tumor types to quantify effect size and guide evidence-led collection of the next registrational opportunity. Wave3 comprises novel-novel combinations, beginning with our in-house ADC. You can already see this happening, and we are also starting to combine ComitaMix with our other next-generation immunomodulator. Wave3 is designed to build durable differentiation and life cycle options and where the biology supports it to increase depth and durability of response. The first two ways seek to establish and expand HUMOTAMIC in combination with current standard of care. These trials lay the foundation for our novel novel combination. In 2025 we announced many of these indications and made significant development programs. For non-small cell lung cancer, small cell lung cancer and triple negative breast cancer, we completed our global phase 2 program, selected phase 3 doses, and initiated each global phase 3 trial. With our partner BMS, we were able to accelerate the expansion into other tumor types and settings. In January, we announced our intention to have eight global phase 3 trials running by the end of this year and depending on data from some of the signals seeking phase 2 trials listed here we may further expand our phase 3 programs two of the most recently announced phase 3 programs further expand our focus in non-small cell lung cancer an area of high unmet need lung cancer has a significant incidence and the majority of patients are diagnosed with late stage disease leading to poor long-term survival, despite the treatment advances with checkpoint inhibitors. Our Rosetta Lung O2 trial, which is evaluating schematomix in combination with chemotherapy as a first-line treatment for patients with metastatic non-small cell lung cancer whose tumors do not have any actionable genomic alteration is well underway. We are expanding our registration program with two new non-small cell lung cancer trials. The first, Rosetta Lung 201, is evaluating Pumitamix as a treatment for patients with stage 3 unresectable non-small cell lung cancer who have not progressed after platinum-based concurrent chemoradiation therapy. The second Rosetta Lung 202 is evaluating Pumitermix as a monotherapy in first-line treatment for patients with PD-L1 high metastatic non-small cell lung cancer. We and BMS expect these two trials will initiate this year. Progress and insights from the first two waves both sides empower the third wave. This wave seeks to elevate Pumitamik's reach and maximize its clinical impact through novel-novel acid combination. This is where we believe we can have the most meaningful clinical impact and are expecting to make significant progress in 2026. We are well positioned to advance Pumitamik in combination with our in-house ADC, supported by extensive monotherapy evidence. Across our first four ADC programs, we have generated single-agent clinical data in more than 2,800 patients to date, providing decision-grade insights into activity, durability, and safety, and guiding indication prioritization and combination design. Our primary objective is to combine the ADCs with Comitermic with registrational pathways. In parallel, where monotherapy activity is compelling and clinically meaningful, we will advance an ADC as a standalone opportunity, and there are in fact a couple of signals which we are encouraged about. For instance, we have evaluated activity and safety of BNT324 or B7H3 ADC in a broad early stage development program consistent with the expression profile of B7H3 across The NG324 has demonstrated pan-tumor activity and favorable safety profiles across a broad range of tumors, categorized by low single-digit rates of grade-free treatment-related adverse events and low rates of N-grade ILD pneumonitis. One area of particular interest is metastatic castration-resistant prostate cancer, where where we observe strong activity in heavily pre-treated patients. With the goal of moving to earlier lines of treatment, we have designed a phase 3 trial in the first line of this indication. We expect recruitment to begin in the coming weeks. We believe BNT324 is well positioned to address the need for an easily administered, well-tolerated treatment option with the potential for more durable responses. The progress and wealth of insights we have generated on our ADC as monotherapy and on umitermic in combination with chemotherapy has informed our evaluation of umitermic plus ADC combination in a number of phase 1, 2 trials in certain tumor trials. We apply a multi-factor screen, not signal alone, including effect size, tolerability, Headroom, Addressable Population, Competitive Context, Operational Feasibility, and CMC Readiness to nominate the first pivotal combo. Moving now to our portfolio of innovative mRNA cancer immunotherapies which aim to activate and educate the immune system with precision. Our personalized approach includes Autogen Saboomaran which is partnered with Roche Genentech. In 2025 and early this year, we published data from multiple trials that support our focus on the adjuvant setting where tumor burden and heterogeneity is lower. The biology and our clinical experience point to greatest relevance in earlier disease settings where the lower tumor burden allows the immune system to consolidate control. Recently, we and our partner, Roche, the sponsor of the trial, decided to discontinue the trial in high-risk muscle-invasive orophilic carcinoma. The reason for this decision is the rapidly emerging treatment landscape and shifting standard of care. Our other randomized phase 2 clinical trials, evaluating autogenous abumaran, in adjuvant pancreatic ductal adenocarcinoma and atjuvant colorectal cancer continue to extend and we and our partner Roche Genentech remain committed to the development and advancement of autogen subumaran to address the high unmet medical needs in these indications. In atjuvant ctDNA positive stage 2 high risk of stage 3 colorectal cancer, we have a phase 2 trial evaluating autogen subumaran monotherapy against watchful weighting. The final analysis with DFS as primary endpoint is event-driven and according to updated projections to be expected in 2027. For fix-back and first-line HPV16 positive PDA1 high head-neck cancer, we have a phase 2 free trial in combination with pembrolizumab. Recruitment is ongoing and a phase 3 interim analysis is expected in 2026. 2026 will be a year packed with potentially value-creating readouts and catalysts. In summary, I'd like to highlight a few of our late-stage potential registrational trials. For T-Pen, we expect to present phase 2 data in endometrial cancer in phase 3 interim analysis in HR positive for low breast cancer later this year. For gotistobat, we expect a phase 3 interim analysis in the second line and beyond squamous non-smart cell lung cancer study. For Pumitermic, we expect a Phase III interim analysis from our CHINA trial in first-line TNBC. In total, we anticipate six readouts from late-stage trials. Looking across our pipeline, we believe the potential to lift survival growth for patients is immense. With that, I will now turn the presentation over to our CFO, Amon Zapata, for the financial update.

Thank you, Uslem, and a warm welcome to everyone who's joining us today. Today, I will be covering three main topics. First, our full year and fourth quarter 2025 financial results. Second, adjustments we will be making to our reporting and guidance going forward. And third, our full year 2026-10. Financially, 2025 was a strong year for biome. We exceeded our revenue guidance, which we had raised during the year. We were also in line with our already reduced R&D and SG&A expenses guidance for the year. These results were informed by our active portfolio management and strategy, where we are focusing our resources on programs that have the biggest potential to elevate patient outcomes and deliver value for our shareholders. Also important is our tailored innovative partnership model, which contributed meaningful revenue and cost sharing across multiple problems. Our total revenues in 2025 were €2.9 billion, a slight increase from the prior year despite the year-over-year decrease in COVID-19 vaccine revenues. This decline was offset in part by the recognition of 613 million euros in revenue, derived from the non-contingent upfront and anniversary payments from our BMS collaboration. R&D expenses were approximately 2.1 billion euros, which is a slight decrease from prior year despite the acceleration of our late-stage oncology program. This was enabled by cost savings resulting from our active portfolio management, as well as positive effects resulting from our permit amid cost sharing with BMS. We continue to drive value creation through active portfolio management, shifting towards later stage to risk programs that have the potential to really deliver a new era of growth for Biontech. We ended 2025 with €17.2 billion in cash, cash equivalents, and security investments. Our strong financial position and dynamic R&D cost discipline will empower continued investment in our late-stage priority programs and preparations for commercialization of our diversified oncology portfolio. Starting today, we will be supplementing our IFRS reporting with certain adjusted non-IFRS measures, as you can see on the slide. These adjustments are intended to provide complementary information and context to understand the company's underlying business performance and will be reflected in our guidance methods. These non-IFRS measures will exclude expenses and income from legal proceedings, impairments and reversals, employee-related expenses from restructuring, and income from bargain purchase, and income and expenses from divestiture-related items. In 2025, these factors impacted our cost of sale, R&D, and mainly our other operating results under IFRS. when excluded we ended 2025 with an adjusted non-ifrs net loss of 117 million euros on the fourth quarter figures revenues were lower than in the same period previous year driven by reduced demand for our covet 19 vaccine our r d expenses were also lower in the last quarter of 2025 compared to Q4 2024. Again, this was mainly driven by cost savings resulting from active portfolio management and positive effects resulting from our cost sharing with VMA. Turning to the next slide, let me highlight our financial outlook for 2026. All guidance we provide will be on an adjusted stage. We expect total revenues for 2026 in the range of 2 to 2.3 billion euros. Compared to 2025, we expect the same amount and quarterly timing of revenue from our BMS collaboration, but expect lower COVID-19 vaccine revenues. On other revenues, we expect similar revenues in 2026 from the epidemic preparedness contract with the German government and from our services business. However, we do not expect any one-time positive revenue effects, such as the payments from prices opt-out of our shingles program that occurred last year on COVID-19 vaccines revenues we anticipate lower community revenues compared to 2025 driven by declines in both the european and united states market the united states continues to be a competitive and dynamic market where we expect lower revenues this year as a result of this in europe we expect lower revenues as we defend our market share and begin managing the transition of multi-year contract. In Germany specifically, we recognize direct sales of our COVID-19 vaccines as revenue. Hence, the anticipated declines in our sales of COVID-19 vaccines in the country will have a direct impact to our top line, whereas revenues outside of Germany only affect our top line as part of the 50% gross profit split with our partner Pfizer. In terms of revenue cadence, we anticipate COVID-19 vaccine revenues facing similar to last year, with the last four months of the year driving the full year revenue figure. As in 2025, the 613 million euro BMS payment recognition is expected in the third quarter of 2026. Comirnaty remains a strong brand and a leading global COVID-19 vaccine franchise. Given the lean structure of the business under the collaboration with Pfizer, we have in Comirnaty a cash-generative franchise with favorable economics, which we expect to continue as markets adjust to the endemic environment. Turning to operating expenses, in 2026, we expect adjusted R&D expenses to be in the range of 2.2 to 2.5 billion euros, and adjusted SG&A expenses to be in the range of 7 to 800 million euros. We expect to increase investment into our priority late-stage programs in 2026 compared to the prior year, namely, furmitamide, our ADC pipeline, mRNA immunotherapies, and respective combinations. Consistent with our portfolio prioritization strategy, we also expect to lower R&D spend outside of our priority areas. We will continue to follow the data generated by our pipeline. As part of these prioritization efforts, we follow a rigorous go-no-go decision-making process across all development stages. This allows us to focus on the programs which we believe represent the strongest opportunities, preserve cash, and have strategic flexibility to assess inorganic opportunities as they come through. our sdna spend will be driven by our commercial build out for oncology and preparations for our first oncology launch 2025 was a year of great progress during which we advanced important components to empower the execution of our strategy we advanced our pipeline while the risking our r d investments and efforts we progressed key programs into pivotal stage established our partnership with BMS, all while maintaining a strong balance sheet. During 2026, we will continue to focus on driving our execution at scale and speed by accelerating pivotal trials, advancing combination therapies, and continuing to build indication-specific oncology portfolios. We are energized as we look towards a phase of sustained clinical data output from 2026 to 2029. By 2030, we envision BioNTech as a diversified, multi-product company focused on achieving long-term sustainable growth and generating value for patients and shareholders. Lastly, before opening the call for the Q&A, on behalf of the Management Board, I would like to thank UGUR and Auslan for what they have built here at BioNTech. Your vision, talent, dedication, and relentless pursuit of excellence has had a lasting impact on the world and all of us. We are excited to see and support what comes next. BioNTech is in an optimal position to execute this next phase of growth. You have truly inspired us all to be bold and to continue to push the boundaries of what we believe is possible.

With that, we would like to open the floor for questions. thank you to ask a question please press star one one on your telephone and wait for your name to be announced to withdraw your question please press star one and one again we will now take the first question from the line of Dinah Kraybosch from leaving partners please go ahead well thank you for the question.

Congratulations to Ugar and Oslim on your new pursuit. I'm excited to see where you take it, but certainly it feels like a transition today. And I think I'll ask my question there. So can you help us better understand how you'll split the mRNA therapeutics? You know, what remains in the parent beyond tech, and what kind of innovation will you take to pursue in the new company?

Okay. Thank you, Dana. So, Ugar, I think that's one for you in terms of what could potentially go to the new company from mRNA technologies. Hi, Dana.

Great to hear you. First of all, there is nothing that is going to change from the Biontech perspective. Everything that is visible today will stay with Biontech, clinical, clinical, and everything that we have communicated so far. I don't want to speak too much about the new upcoming company, because this is not disclosed and it is still under discussion, but what you can imagine, Dina, is, and you are very close to that, that the field in the MRN space is rapidly advancing, and we are seeing a lot of innovation happening, particularly in combination with AI. and we together felt really the need to address that by us and I focusing on this chapter on this type of endeavor to ensure that we can use basic technologies and basic IT that comes from BioNTech to build something completely new and completely new means really the next generation, and we call the next generation everything that goes beyond the current generation. So, that's the idea.

If you allow me to add on on the topic, and thank you, Raina, for the question. So, I think it's just to reconfirm that there is no split for IOMTEX core mRNA capabilities. Our strategy and pipeline remains unchanged. We retain ComisNAPI, we retain our mRNA oncology programs, and what is being discussed, as I was just mentioning, with this new company relates to certain rights and mRNA technologies to advance next-gen innovation, while BioNTech continues to focus on executing its late-stage pipeline and, of course, preparing all of these for commercialization. I think it's also worth mentioning that we will continue to innovate in BioNTech. we have our innovation engines in Germany, in China, and in the US, and we will continue to deepen our efforts and pipeline in our immunomodulators, our ADCs, and our mRNA technologies and progress.

Thank you.

Thank you. We will now take the next question from the line of Tasin Atmat from Bank of America. Please go ahead.

Hi. Good morning. Thank you for taking my questions. Another one maybe about, you know, how you're thinking about management of the company. So the search for the new CEO, are you looking at internal candidates or do you think that you would want somebody external? What is the profile that we should be thinking about for who you think should be leading the company into its next phase? And then one question about CPAM. How are you preparing for that launch in endometrial cancer? And is that going to serve as sort of an infrastructure build for other launches, or is this just going to be tailored for this particular launch? Thank you.

Okay. Thank you, Tazine. So just to confirm, we've got one question on the search for replacement CEO and CMO and the criteria, and then on T-PAM prep for EC, and whether the infrastructure is just for that launch or for future launches as well.

Thank you. Thank you, Tatin, for the question. So your first part, Google and Auslan will remain in the role through the transition period, and the The supervisory board has already initiated to identify the next leadership and their successors. The focus is on leaders with strong experience in late-stage development and commercial execution, which reflects BioNTech's next phase of growth. At the same time, as you know, with an MRE and all of our commercial teams, we are already preparing the organization for these potential launches, including endometrial cancer and other programs, and we are building the commercial, medical, and market access capabilities needed to support all of these pipeline coming through thank you we will now take the next question from the line of Assad hi there from Goldman Sachs please go ahead great thanks for taking the question and congratulations on the move and best of luck I guess just one

question high level just on the timing of the of the departure just seems like It's a very critical time for the company for a transition given all the repositioning in recent months and the momentum in the late-stage pipeline. So I guess the question I have to ask is why now ahead of very important readouts and the need for very precise execution during this important time? Thank you.

Thanks, Asad. So that was a question around timing.

So it's a critical time for the company, which we recognize getting ready for the launches of certain products and humidity. make so why make this decision now uh i i take over the question and then and then you can you can add i think from timing wise we are talking now uh end of 2026 and not uh today yeah so so we have a clear plan for my phones and uh and uh data read out in 2026 and we believe it's really perfect timing for for transition transitioning because the company company at the time time end of 2026 will already have a number of reports important results but also also uh what is the number of phase three studies that you plan end of 20 15 plus uh phase three clinical trials and This is really about industrialization, and we need to get people on board who connect that, connect this with the scale that is needed at that moment.

So if I would add to the answer, I think the plan aligns with BioNTech's continued effort to sharpen our strategic focus on our growing late-stage pipeline. And as you know, this is spanning innovative immunomodulators, as I was mentioning, ADCs and other candidates. So now you have two companies focusing on these things, right, three priorities, and two tailored investment cases. And I have expressed two maximize value for patients and shareholders alike. And in terms of our collaboration and contribution to the new course, we also retain the possibility to participate in new course upside through its minority stake. So I hope this provides clarity.

Thank you.

Thank you. We will now take the next question from the line of Corey Casano from Evercore ISI. Please go ahead.

Hey, guys. I appreciate you taking the question. First, just a quick clarification question. I just want to be clear. Does Biontech contribute any capital to this new company, or is it just planning to be a minority investor? And then on the pipeline front regarding GOTY, if you were to replicate the results you saw in part one in part two of the study, how do you think about the market opportunity in second-line-plus squamous non-small-cell lung cancer?

Okay, great. Thank you, Corey. So just to clarify, the first question was whether BioNTech plans to contribute any capital to the new company or whether it's a minority stake. Second question on GOTY. If we were to recapitulate the part one results in part two, what do we anticipate the market opportunity would be?

Thank you. Thank you, Corey, for the question. So let me answer the first one. I think the short answer would be no. Based on what is contemplated today, BioNTech's contribution to the new correlates to certain rights and mRNA technologies, not cash. The new company will have the ability to pursue funding from other sources, while BioNTech remains focused on advancing our late-stage pipeline and keep preparing for commercialization and further innovation in our key priorities. And then, Bautista, Bartogu?

Yeah, I think everyone knows that how difficult second-hand response to lung cancer is. There is no real, real disruptive innovation in space for almost 30 years now. And if the data are replicated with an OAS registration range of 0.5, this would be a disruption. It would be game-changing for patients, and as you know, this is a very sizable patient population in non-smartal lung cancer.

So we will come up with market projections once we receive the data we talk. all right thank you thank you we will now take the next question from the line of jeff mitchum from citigroup please go ahead hey guys good morning this is jarway on for jeff um maybe a question on the management transition i know during the call you guys mentioned the prioritization of r&d efforts and i guess given the upcoming transition you know how should we feel about the currently staged pipeline prioritization and mid-stage pipeline prioritization versus, I guess, stability of it looking ahead. And then maybe another question I'm going to go to is to Bart. If the interim data were positive, could that open an avenue for accelerated regulatory filing?

Okay. Thank you for the question. So we have one on the management board transition, and then the second question on portfolio prioritization efforts and current late-stage versus mid-stage.

So, thank you. Let me take the first part of the question, and then I'll allow everyone to take the second one.

I think in terms of priorities, and particularly strategic priorities, this transition does not change any of this at all. BioNTech remains focused on advancing, again, the late-stage pipeline and our mRNA oncology programs, where we continue to defend and prepare for commercialization. The organization, our governance structures, our scientific leadership that Uber and Odden have been building over the past years provides the stability that we need to bring this next, to bring all the pipeline to the next stages of either innovation or development or commercialization. And we will continue to lead the company through the transition period when the supervisory both conduct research for the successors. I believe that the company is well positioned to continue to move these programs through the different stages at speed and with the right focus and really making this available as soon as possible to our patients.

Hi, I can take a second question, so Elton, do you want to talk, Elton, also you?

Yes, yes, I can also take it. So, depending, obviously, on the data we will see later this year from the interim analysis of the GOATI study and if we can replicate the data we have shown in the initial part of the study, there is absolutely a potential regulatory path forward for an accelerated improvement.

The second part of the question with regard to the pipeline, we have really built an extremely rich pipeline. And the pipeline is not only individual drugs, but we believe it's our established, expand, and elevate strategy. We are building a combination approach that could allow us now, by rapidly transitioning from Phase 2 into Phase 3, really address multiple communication spaces with our current pipeline. We have a number of phase one acids, including, again, next-generation IO molecules, including, again, ADCs that we have in our pipeline but never shared data so far. So you will see also in the early stage clinical, for the early stage clinical assets, in the end of this year, beginning next year.

Thank you. We will now take the next question from the line of Terrence Flynn from Morgan Stanley. Please go ahead.

This is Chris on for Terrence, and thanks for taking our question. We have a two-part question for autogenous trial in colorectal cancer. Just kind of wondering what level of details are you planning to give for the update in early 2026? And then for the DFS primary endpoint, how do you define a bar of success?

That was in CRC, so what level of details in early 2026, and what is the bar for success?

So our final analysis will be later. We have just updated the projections based on the current cool rate or event rate, to be more precise, for early 2027. And this is the time point where we expect to have robust data. our earlier analysis, which is an interim analysis, will just guide us to continue the trial. However, it will not be the basis for any steps based on efficacy data. And what we, our objective is that we want to be statistically significantly and clinically meaningfully better than the standard of care with regard to DFS.

Thank you. We will now take the next question from the line of Evan Seigerman from BMO Capital Markets. Please go ahead.

All right, guys. Thank you so much for taking my question. I wanted to touch on the upcoming phase two through interim data for BNT 113 in first-line head and neck HNSTC. Can you talk about some expectations for this interim analysis? Could we potentially see six- or 12-month OS data? And more importantly, how are you thinking about the potential tradeoffs on efficacy and safety here? I know there's been a lot of development in head and neck, so I just want to understand and how you're trying to position the product relative on efficacy and safety. Thank you.

Great. Thank you, Evan. So just to confirm, that was a question on 113, frontline head and neck, and our expectations for the data from the interim analysis, and also any perspective that we have on the trade-offs of efficacy and safety.

This is an event-based endpoint that we expect in the late second half of 2026, and the patient population is HPV-positive. cancer patients you know that this is a patient population that is increasing in the in the industrial state and and depending on the on the hazard ratio this could give us a path a path to work towards towards registration and also depending on on the on the on the further readouts that are the later times readouts that are based on OS. This could also give us a path based on a full approval on OS. So we are very curious about the data in the station population and so this is a potentially a It takes place in a time and important.

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

Great. Thanks so much. I just have a couple of questions. The first one on Rosetta Lung O2, I see the study was now expanded to 1260 patients from 986 or so, and data is now in fiscal year 29. Is one sub-histology expanded, or are both of them equally expanded, and what was the reason to do so? I think it makes sense, given the expansion from your competitor. And also, what data should we expect in the Phase II endometrial cancer, femuritikin, this year? Thank you.

Thank you, Yaron. So to confirm, these are questions mostly for OSLAM and so the first is on Rebecca Lung O2 on the rationale behind the expanded study across both histologies and then next question was on any potential data from TPAM in DC this year.

Yes, regarding the sample size increase in We are constantly assessing available data or emerging data from our trials and also from other trials with this specific antibody class. And based on this data, we expanded the center size also to increase speed. It was an increase for both histologies. We also amended the trial design with regard to the endpoints. we have PFS now as primary endpoint and OS as key secondary endpoint which also helps with the speech. Now for both amendments is changed statistical consideration and also recalibration of TPEM in industrial cancer. Our data package which we plan to submit for BLA This will, in parallel, initiate a confirmational trial, a phase three trial for this indication, which is ongoing and our...

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

Hey, this is Mano John for ADAS, just one from outside. Are you still planning to take BNT 324, B7 and HVADC combo to registrational studies in LEN indication? And also, do you expect any revenues from cancer vaccines, BNT 113 and BNT 122, in 2026 through any accelerated approval pathways of your base case?

Thanks, Manil. So I struggled to hear all of that. but what I thought you, what I gathered from that is on 327, any plans to take a combination into registration or lung study? And then a second question was whether we expect any revenue from cancer vaccines in 2026. So Ramon, that could be for you.

Yes, for 3 to 4, as you know, 3 to 4 is evaluated with 3 to 7 in multiple cancer indications, including lung cancer. We are expecting data here in the second half of 2026, and of course we are prepared if we choose to transition from phase 2 into a phase 3 trial.

And then, in terms of potential revenues from our cancer vaccines, they are still, all these programs are still in the clinical development stage, so we do not expect revenue from them in 2026. The value from assets such as VNT113, they are affected in the clinical milestones and potential approvals we are working towards rather than near-time revenue contribution.

Thank you.

Thank you. We will now take the next question from the line of Ashitika Kounir-Boardane from Truist. Please go ahead.

Hi, good morning, everyone. This is Kari on to Africa for Truist. There's a couple of questions from us. First, for this new company, would there be any milestone of royalty economics tied to the IP that belongs to BioNTech? And second, on COVID sales, how large do you expect to step down to be versus 2025, and how should you think about the relative pressure coming from U.S. versus Europe and versus Germany? Thank you.

Can someone repeat the question?

Yeah. First question on the new company, would there be any milestone or royalty economics tied to the IP that belong to BioNTech? And second, on COVID sales, how large do you expect a step-down to be versus 2025? How should we think about the relative pressure coming from the U.S. versus EU versus Germany?

Thank you for the questions. So on your first questions, we are not providing any specific financial guidance related to the potential transfer of the related rights and mRNA technologies to the nuclear at this stage. The terms of the transaction, including any potential IP-related consideration, are still under negotiation and will be defined as part of the binding agreement expected by the end of the first half of 2026. What we can say is that we do not expect a material short or mid-term financial impact for BioNTech. Now, in relation to your question around COVID-19, so we do expect lower COVID-19 vaccine revenues in 2026 compared with prior years as the market continues to normalize and the amount becomes more seasonal. And so saying that COVID-19 remains an important franchise for us, we continue to generate meaningful cash flows, we continue to have very meaningful market shares, and it's helping us to fund ongoing R&D investments in a big way. So our focus is really to managing this transition while we continue to advance our oncology pipeline and prepare for potential launches. If I would go a little bit more in detail to your question, the United States, the U.S. sees a competitive and a very dynamic market where we expect lower revenue this year as a result of all of this. Then in Europe, as I was mentioning during the presentation, we expect lower revenues as we are defending now our market share and begin the managing of the transition from multiyear contracts to now a more seasonal demand of utilization and revenues. And then this year, specifically, Germany is an important effect because we recognize direct sales of our COVID-19 vaccines directly. So we anticipate the declines in our top line in the country. will have a direct impact on our overall top line, whereas the revenues that are coming outside of Germany only hit our top line as part of the 50% gross profit spread, you know, and that's not as much transparency I can give you.

Got it. Thank you so much.

Thank you.

We will now take the last question from the line of Mohit Bansai from Wells Fargo. please go ahead okay thank you very much for taking my question I have two if you if I may one from the science side so so for the for the Rosetta Lung 2 trial does this make sense to do separate trials for squamous and non squamous and do you think that there is a lower bar to be successful in squamous trial that's first question and second question for Ramon how what is your thought process here to do a buyback

or some kind of special dividend there given that cash position and and your cash requirements going forward thank you two questions in there one for Ramon on any thoughts around the potential buyback share buyback, given our cash. And then another question for Oslem on Rosetta Lung 2 on squamous squamous and non-squamous, and is there a lower bar to be successful in squamous?

Sorry, let Oslem answer the question on Rosetta first.

Yes, Mari, thank you for the question. You asked whether it makes sense to have two different studies. We, in fact, have, in this study, in Rosetta Lang, two, both histologies separated. So, it's technically like two studies in one, which gives us the best balance between speed and probability of success.

Thank you, Moslem, and then on the capital allocation strategy and priorities. So this remains focused on advancing our late-stage oncology pipeline, preparing the organization for potential launches, and defending our community launches as well. We will leave our pipeline and all of these programs can really drive the next stage of growth for biotech and should get the resources they need when they need it. And outside of that, as we have done in the past, if there are assets or technologies that could help our late-stage programs see best positions, we may look at ways to access those assets or technologies through strategic and organic transactions, but to strengthen our early science pipeline. So no changes there.

Thank you.

Thank you. That's all the time we have for questions. I would like to hand back over to the speakers for closing remarks.

So, it was, of course, an important day of announcements. I would like to, of course, thank all of you for your continued interest in BioNTech. As you have heard today, we are entering an important phase for the company with multiple late-stage programs progressing and key real-outs ahead. Bumita may give you the backbone of all of these efforts. Our strong collaboration with VMS on late-stage execution. the next combo combination with and then continue our strategy on having this strong balance sheet, focus strategy, and the strengthening of our teams, our partners, and our governance, so that we remain confident in our ability to advance our pipeline and move by on tech towards becoming a multi-product oncology company by 2030. We really appreciate your time today and really looking forward to updating you on the progress in the quarters ahead.

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