BioNTech SE

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. 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. 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. Ugo Shaheen, Chief Executive Officer and Co-Founder, Oslem Tureci, Chief Medical Officer and Co-Founder, and Ramon Zapata, Chief Financial Officer. With this, I'll hand the call over to Ugar.

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 oncologies. 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 end, we have purpose-built a diversified clinical pipeline, spending 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 progress towards realizing our ambitions. 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 II and Phase III studies. As I've said, we anticipate multiple late-stage event-driven readouts in 2026. In parallel, we now have more than 10 novel-novel combination trials with Prometamic in progress. We executed key strategic deals most importantly with BMS, to strengthen the execution of and help de-risk our Prometamic programs. We acquired Bioceus, thus gaining full rights to our cornerstone acid Prometamic, and completed the acquisition of CureVac, 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 disciplined 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 assets, 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 thrombotomic combination trials are expected this year and will inform our first thrombotomic plus ADC pivotal trials. Third is to continue our evolution from our platform-centric approach to a tumor-centric clinical development program centered around high-incidence 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 registrational 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 types from 2026 to 2030. Our clinical program provides multiple approval opportunities, and we are building launch readiness now, deepening indication-specific expertise, and advancing commercial and market access capabilities in the tumor types 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 Aslam and me, and we are both excited at the prospect of this new chapter on our personal journey towards our vision to translate our science into meaningful advances for patients. In order to do this, our new company will be built with distinct resources, operations, and funding options. BioNTech plans to contribute related rights and mRNA technologies to the new company. In exchange, BioNTech will hold a minority stake 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 first 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 mRNA candidates. Combination approaches are a core part of BioNTech's strategy to maximize the value of our next-generation immune oncology backbone candidate, Pumetamic. 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, world leading expertise and the focus on their respective strategic priorities to maximize value for patients and shareholders. Over the past 18 years, we have built BioNTech from a startup 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 vaccine helping to protect people worldwide. None of this would have been possible without the extraordinary dedication of our teams, the trust of our shareholders and supervisory board, 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 Esten 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 care. We also gained a better understanding of how to prioritize, sequence, and stage-gate 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 IAO pent-rumor backbone of our combination-based development strategy is our PD-L1 VEGF-A bispecific antibody, Pumitamic. We and our partner, BMS, are pursuing a three-wave plan to develop Pumitamic broadly, deeply, and in a differentiated manner across indications, disease areas, and treatment lines. Wave one is anchored in three foundational first-line programs, SCLC, NSCLC, and TNBC. each with a global phase three trial designed for registration and supported by studies that de-risk dose and setting. Through these trials, we aim to establish in foundational first-line indication in combination with standard of care chemotherapy for global registration of phase three trials. Speed to the initial label is the key value inflection point, and it creates the platform for evidence-led expansion thereafter. In parallel, Wave 2 expands into additional indications. Alongside trials with registration intent, we are running an expanding set of signal-seeking studies across tumor types to quantify effect size and guide evidence-led selection of the next registrational opportunities. Wave 3 comprises novel-novel combinations, beginning with our in-house ADCs. You can already see this happening, and we are also starting to combine humetomic with our other next-generation immunomodulator. Wave 3 is designed to build durable differentiation and lifecycle options, and wherever biology supports it, to increase depth and durability of response. The first two waves seek to establish and expand humetomic 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 progress. 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 three trials running by the end of this year, and depending on data from some of the signal-seeking phase two trials listed here, we may further expand our phase three programs. Two of the most recently announced phase three 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 sumitamix 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 Pumitamic 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 signs empower the third wave. This wave seeks to elevate Pumicamic's reach and maximize its clinical impact through novel-novel asset combinations. 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 Pumicamic in combination with our in-house ADCs, supported by an 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 insight into activity, durability, and safety, and guiding indication prioritization and combination design. Our primary objective is to combine the ADCs with Pumicamic with registrational pathways, In parallel, where monotherapy activity is compelling and clinically meaningful, we will advance an ADC as a stand-alone 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 a variety The NT324 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 any grade IOD pneumonitis. One area of particular interest is metastatic castration-resistant prostate cancer, where we observe strong activity in heavily pretreated patients. With the goal of moving to earlier lines of treatment, we have designed a phase three trial in the first line of this indication. We expect recruitment to begin in the coming weeks. We believe the NG324 is well positioned to address the need for an easily administered, well-tolerated treatment option with the potential for a more durable response. The progress and wealth of insights we have generated on our ADCs as monotherapy and on Pumichamic in combination with chemotherapy has informed our evaluation of Pumichamic plus ADC combination in a number of phase 1, 2 trials in certain tumor types. 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-sebumeran, 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 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 orophilia carcinoma. The reason for this decision is the rapidly emerging treatment landscape and shifting standard of care. Our other randomized Phase II clinical trials evaluating autogenous ovumoron in adjuvant pancreatic ductal adenocarcinoma and adjuvant colorectal cancer continue to ascend, and we and our partner, Roche Genentech, remain committed to a development and advancement of autogen to address the high unmet medical needs in these indications. In adjuvant ctDNA positive stage two high risk of stage three colorectal cancer, We have a phase two trial evaluating autogen-sevumaran monotherapy against watchful waiting. The final analysis with DFS as primary endpoint is event-driven and according to updated projections to be expected in 2027. For FIXVEC and first-line HCV16-positive PD-L1 high head-neck cancer, we have a phase two free trial in combination with PEM-RODI tumor. Recruitment is ongoing, and a Phase III 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 TPEM, we expect to present Phase II data in endometrial cancer and Phase III interim analysis in HR-positive her to low breast cancer later this year. For gotistobar, we expect a phase III interim analysis in the second line and beyond, grayness, non-small cell lung cancer. For prumetamic, 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 groups for patients is immense. With that, I will now turn the presentation over to our CFO, Amon Zapata, for the financial update.

Thank you, Oslem, 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. Adjustments we will be making to our reporting and guidance going forward. And third, our full year 2026 guidance. Financially, 2025 was a strong year for BioNTech. 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 programs. Our total revenues in 2025 were 2.9 billion euro, 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 euro in revenue derived from the non-contingent upfront and anniversary payments from our BMS collaboration. R&D expenses were approximately 2.1 billion euro, 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 commitment 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 euro in cash, cash equivalent, and security investments. Our strong financial position and dynamic R&D cost discipline will empower continued investments 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. are intended to provide complementary information and context to understand the company's underlying business performance and will be reflected in our guidance metrics. 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 sales, R&D, and mainly our other operating results on the IFRS. When excluded, we ended 2025 with an adjusted non-IFRS net loss of 117 million euros. On the four-quarter figures, revenues were lower than in the same period previous year, driven by reduced demand for our COVID-19 vaccines. 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 VMS. Turning to the next slide, let me highlight our financial outlook for 2026. All guidance we provide will be on an adjusted basis. 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 pandemic preparedness contract with the German government and from our services business. However, we do not expect any one-time positive revenue effect such as the payments from Pfizer's opt-out of our singles 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 markets. 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 contracts. 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 SENA expenses to be in the range of 700 to 800 million euros. We expect to increase investment into our priority late-stage programs in 2026, compared to the prior year, namely , 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 this 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, reserve cash, and have strategic flexibility to assess inorganic opportunities as they come through. Our SD&A 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 risking our R&D investments and efforts. We progressed key programs into pivotal stage, established our partnership with VMS, all while maintaining a strong balance. 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 OSLIM 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 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. We will now take the first question from the line of Dinah Graybosh from Living Partners. Please go ahead.

Wow, thank you for the question. Congratulations to Ugar and Aslam 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, 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. So first of all, there is nothing that is going to change from the BioNTech perspective. Everything what is visible today will stay with BioNTech. Clinical, clinical, and everything what we have communicated so far. I don't want to speak too much about a new upcoming company because this is not disclosed and it is still under discussion. But what you can imagine, Dina, 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. Yes. And we together felt really the need to address that. And by Ersam 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 means really 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 confirm that there is no split for BioNTech's core mRNA capabilities. Our strategy and pipeline remains unchanged. We retain Comirnaty. we retain our mRNA oncology programs. And what is being discussed, as Uwe 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 U.S., and we will continue to deepen our efforts and pipeline in our immunomodulators, our ADCs, and our mRNA technologies and programs.

Great. 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. Uh, thank you for taking my questions. Um, another one may be about, um, you know, how you're thinking about, um, management at 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? Um, 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? and 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, Tazeem. So, just to confirm, we've got one question on the search for replacement CEO and CMO. and the criteria, and then on TPAN, PREP, or 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 supervisory board has already initiated executive searches 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 NMRE 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 this pipeline coming through.

Thank you.

We will now take the next question from the line of Asad Haider 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 departure. It 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 cumulatively. So why make this decision now?

I take over the question and then come on. I think from timing, we are talking now end of 2026 and not today. So it's We have a clear plan for milestones and data readouts in 2026. And we believe it's really perfect timing for transition, transitioning because the company at the time point end of 2026 will already have a number of readouts, important readouts, but also a number of phase three studies that we plan end of 2026. 15 plus phase three clinical trials. And this is really about industrialization and we need to get people on board who 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 efforts 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 mRNA candidates. So now you have two companies focusing on these strategic priorities and two tailored investment cases. And BioNTech expects to 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 UCOS 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. 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 goatee, 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? Thank you.

Okay, great. Thank you, Corey. So just to clarify, 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 resources, while BioNTech remains focused on advancing our late-stage pipeline and keep preparing for commercialization and for the innovation in our key priorities. And then, Batul?

Yeah. I think everyone knows how difficult second-hand and frontal lung cancer is. real disruptive innovation in space for almost 30 years now. And if the data are replicated to the OSS station in the range of 0.5, this would be a disruption. It would begin changing for patients. And as you know, this is a very sizable patient population in non-sensory lung cancer. So we will come up with this market market projections once we see the data results.

All right. Thank you.

Thank you. We will now take the next question from the line of Jeff Meacham from Citigroup. Please go ahead.

Hey, guys. Good morning. This is Jarwe on for Jeff. 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 current late-stage pipeline prioritization and mid-stage pipeline prioritization versus, I guess, stability of it looking ahead? And then maybe another question I'm going to ask to Bart. You know, if the interim data were positive, could that open an avenue for an accelerated regulatory filing?

Thanks. 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 allow to take the second one. 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 Comirnaty and prepare for commercialization. We organization, our governance structures, our scientific leadership that Uber and Ozem 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 board conducts research for these successors. I believe that the company is well positioned to continue to move these programs through the different stages at speed and with the rights

know focus and uh and really making this as available as soon as possible to our patients okay i i can take the second question uh so uh do you want to talk yes yes i can also take it uh so um depending obviously on the 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's absolutely a potential regulatory path forward for an accelerated approval.

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 establish, expand, and elevate strategy. We are building a combination approach that could allow us now, by rapidly transitioning from phase two into phase three, really address multiple indication spaces. with our current pipeline. We have a number of phase one assets, including, again, next-generation IO molecules, including, again, ADCs that we have in our pipeline but never shared data so far. So you will hear also in the early-stage clinical assets

in the end of this year, beginning next year, late after. Thank you.

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

Good morning. This is Chris An for Terence, 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 the bar of success? Thank you.

Okay. So thank you, Chris.

So 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 accrual 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 trials. However, will not be the basis for any steps based on efficacy data. And 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 Sagerman from BMO Capital Markets. Please go ahead.

Hi, guys. Thank you so much for taking my question. I wanted to touch on the upcoming phase two to interim data for BMT113 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 how you're trying to position the product relative on efficacy and safety. Thank you.

Okay, great. Thank you, Evan. So just to confirm, that was a question on 1.1.3, frontline head and neck, and our expectations for the data from the interim analysis, and also any perspective that we have on the trade-off of efficacy and safety. Luca, would you like to take that one? Then maybe we can add details. Yes, yes.

So this is... CFS-based, event-based endpoint that we expect in the late second half of 2026. And its patient population is HPV positive. In cancer patients, you know that this is a patient population that is increasing in the industrial states. And depending on the hazard ratio, this could give us a path towards registration. And also depending 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 outcome of this trial. We have published strong immunogenicity data in the patient population, and so this is potentially a biggest patient trial 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 02, I see the study was now expanded to 1260 patients from 986 or so and data is now in fiscal year 29. Was that, 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 the extension in from your competitor and also what data should we expect in the phase two um endometrial cancer femur tcan this year thank you okay thank you you're wrong so to confirm um these are questions uh most mostly for for osm

And so the first is on Rosetta Lung 02 on the rationale behind the expanded study across both histologies. And then next question was on any potential data from TPAM in HBC this year.

Yes.

Regarding the synthesized increase in our non-small cell lung cancer study, 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. That means the rationale for both amendments is changed statistical considerations and also recalibration of recruitment. The second question was about TPAM. I guess specifically about TPAM in endometrial cancer, second-line endometrial cancer, our data package, which we plan to submit for BLA this year. We have also, in parallel, initiated a confirmational trial, a phase three trial, for this indication, which is ongoing and our plans remain unchanged.

Thank you.

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

This is Manoj for Akash. Just one from outside. Are you still planning to take BNT324-B7S3-ADC combo to registration studies in lung indication? And also, do you expect any revenues from cancer vaccines BNT113 and BNT122 in 2026 through any accelerated approval pathways as your base case?

Okay. 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 registrational lung study? And 324, sorry. 324. Okay. Sorry. Yeah. Okay. And then second question was whether we expect any revenue from cancer vaccines in 2026. So Ramon, that one could be for you.

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 see a strong signal 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 EMT-113, they are affected in the clinical milestones and potential approvals we are working towards rather than near-term revenue contribution.

Thank you.

Thank you. We will now take the next question from the line of Artika Kunewardane from Churis. Please go ahead.

Hi, good morning, everyone. This is Kari on for Africa for Churis. Just a couple of questions from us. First, for this new company, would there be any milestone or 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 we think about the relative pressure coming from U.S.

versus Europe and versus Germany? Thank you. Can someone repeat the question?

um yeah uh 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 covet sales how large do you expect the step down to be versus 2025 how should we think about the relative pressure coming from the us versus eu versus germany

So 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 NUCU 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 midterm financial impact for BioNTech. Now, in relation to your question around Comirnaty and COVID-19, so we do expect lower COVID-19 vaccine revenues in 2026 compared with prior years as the market continues to normalize and demand becomes more seasonal. And saying that Comirnaty 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. is 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 the anticipated 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 split with our partner Pfizer.

And that's 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 I may. One from the science side. So 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 trials? That's the first question. And second question for Ramon, what is your thought process here to do a buyback or some kind of special dividend there given that cash position and your cash requirements going forward? Thank you.

Okay, great. Thank you, Mohit. So two questions in there. One for Ramon on any thoughts around a potential buyback, share buyback, given our cash. And then another question for Oslem on Rosetta Lung 2, on 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, Marit, 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 Long 2, 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 as well. We believe our pipeline and all of these programs can really drive the next stage of growth for BioNTech 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 be best positioned, we may look at ways to access those assets or technologies through strategic and organic transactions to strengthen our early science pipeline. So no changes there either.

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.

Well, I think 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 readouts ahead. Pumitamig is the backbone of all of these efforts. Our strong collaboration with VMS on late-stage execution, the next combo combinations with Pumitamig, and then continue our strategy on having this strong balance sheet, focused 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 BioNTech 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.