BioNTech SE (BNTX) Q4 2025 Earnings Call Transcript

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 Investors 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 3, you will see the agenda for today's call. I'm joined today by the following members of BioNTech's management team, Ugur Sahin, Chief Executive Officer and Co-Founder; Özlem Türeci, Chief Medical Officer and Co-Founder; and Ramon Zapata, Chief Financial Officer. With this, I'll hand the call over to Ugur.

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 within individual tumors. 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 solid tumors. In 2025 and early 2026, we have made strong progress towards realizing our ambition. The year was marked by important achievements in 4 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 broad clinical evidence base with more than 4,000 patients enrolled across Phase II and Phase III 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 trials with Pumitamig in progress. We executed key strategic deals, most importantly with BMS to strengthen the execution of and help derisk our Pumitamig programs. We acquired Biotheus, thus gaining full rights to our cornerstone asset Pumitamig and completed the acquisition of CureVac, strengthening our position in the mRNA field. And last not least, we exceeded our already increased 2025 revenue guidance and ended the year in a strong financial position with more than EUR 17 billion 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 3 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 Pumitamig combination trials are expected this year and will inform our first Pumitamig 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 multiproduct 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 multiproduct company by 2030. The new company will be founded and led by Özlem 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. The 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 immuno-oncology backbone candidate, Pumitamig. 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 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 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 multiproduct company. I look forward to updating you on our progress throughout this year. Thank you all. With this, I will hand over to Esther for an update on our oncology execution.

Thank you, Ugur. 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 3 modalities in oncology. At the core of our approach is the rationale that 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 a 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 IO pan-tumor backbone of our combination-based development strategy is our PD-L1 VEGFA bispecific antibody, Pumitamig. We and our partner, BMS, are pursuing a 3-wave plan to develop Pumitamig broadly, deeply and in a differentiated manner across indications, disease areas and treatment lines. Wave 1 is anchored in 3 foundational first-line programs, SCLC, NSCLC and TNBC, each with a global Phase III trial designed for registration and supported by studies that derisk dose and setting. Through these trials, we aim to establish Pumitamig in foundational first-line indication in combination with standard of care chemotherapy through global registrational Phase III trials. Speed to the initial label is the key value inflection point, and it creates the platform for stage evidence-led 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 selection of the next registrational opportunities. Wave 3 comprises novel-novel combinations beginning with our in-house ADC. You can already see this happening, and we are also starting to combine Pumitamig with our other next-generation immune modulators. Wave 3 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 2 waves seek to establish and expand Pumitamig 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 II program, selected Phase III doses and initiated each global Phase III 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 8 global Phase III trials running by the end of this year. And depending on data from some of the signal-seeking Phase II trials listed here, we may further expand our Phase III programs. Two of the most recently announced Phase III 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-02 trial, which is evaluating Pumitamig 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 alterations is well underway. We are expanding our registrational program with 2 new non-small cell lung cancer trials. The first, ROSETTA Lung-201, is evaluating Pumitamig 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 Pumitamig as a monotherapy in first-line treatment for patients with PD-L1 high metastatic non-small cell lung cancer. We and BMS expect these 2 trials will initiate this year. Progress and insights from the first 2 waves boost and empower the third wave. This wave seeks to elevate Pumitamig's reach and maximize its clinical impact through novel-novel asset 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 Pumitamig in combination with our in-house ADCs, supported by an extensive monotherapy evidence. Across our first 4 ADC programs, we have generated single-agent clinical data in more than 2,800 patients to date, providing physician-grade insight into activity, durability and safety and guiding indication prioritization and combination design. Our primary objective is to combine the ADCs with Pumitamig with a registrational pathway. In parallel where monotherapy activity is compelling and clinically meaningful, we will advance an ADC as a stand-alone opportunity, and there are a couple of signals which we are encouraged about. For instance, we have evaluated activity and safety of BNT324, our B7H3 ADC, in a broad early-stage development program consistent with the expression profile of B7H3 across a variety of cancers. BNT324 has demonstrated pan-tumor activity and favorable safety profile across a broad range of tumors characterized by low single-digit rates of grade 3 treatment-related adverse events and low rates of any-grade ILD (interstitial lung disease) with 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 III 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 ADCs as monotherapy and on Pumitamig in combination with chemotherapy has informed our evaluation of Pumitamig plus ADC combination in a number of Phase I/II trials in certain tumor types. We applied a multifactor 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 autogene cevumeran, 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 lowest. 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 urothelial 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 autogene cevumeran in adjuvant pancreatic ductal adenocarcinoma and adjuvant colorectal cancer continue as planned, and we and our partner Roche/Genentech remain committed to the development and advancement of autogene cevumeran to address the high unmet medical needs in these indications. In adjuvant ctDNA positive Stage 2 high-risk or Stage III colorectal cancer, we have a Phase II trial evaluating autogene cevumeran monotherapy against watchful waiting. The final analysis with PFS as primary endpoint is event-driven and according to updated projections to be expected in 2027. For FixVac in first-line HPV 16 positive PD-L1 high head and neck cancer, we have a Phase II/III trial in combination with pembrolizumab. Recruitment is ongoing and the 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 T-Pam, we expect to present Phase II data in endometrial cancer and a Phase III interim analysis in HR-positive HER2 low breast cancer later this year. For Gotistobart, we expect a Phase III interim analysis in the second line and beyond squamous non-small cell lung cancer. For Pumitamig, we expect a Phase III interim analysis from our China trial in first-line TNBC. In total, we anticipate 6 readouts from late-stage trials. Looking across our pipeline, we believe the potential to lift survival curves for patients is immense. With that, I will now turn the presentation over to our CFO, Ramon Zapata for the financial update.

Thank you, Özlem, and a warm welcome to everyone who's joining us today. Today, I will be covering 3 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 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 EUR 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 EUR 613 million in revenue derived from the noncontingent upfront and anniversary payments from our BMS collaboration. R&D expenses were approximately EUR 2.1 billion, which is a slight decrease from prior year despite the acceleration of our late-stage oncology programs. This was enabled by cost savings resulting from our active portfolio management as well as positive effects resulting from our Pumitamig cost sharing with BMS. We continue to drive value creation through active portfolio management, shifting towards later-stage de-risked programs that have the potential to really deliver a new era of growth for BioNTech. We ended 2025 with EUR 17.2 billion in cash, cash equivalents 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. 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 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 under IFRS. When excluded, we ended 2025 with an adjusted non-IFRS net loss of EUR 117 million. On the fourth 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 BMS. 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 EUR 2 billion to EUR 2.3 billion. 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 effects such as the payments from Pfizer's opt-out of our shingles program that occurred last year. On COVID-19 vaccine revenues, we anticipate lower COMIRNATY 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 multiyear 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 timing to last year, with the last 4 months of the year driving the full year revenue figure. As in 2025, the EUR 613 million 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 EUR 2.2 billion to EUR 2.5 billion and adjusted SG&A expenses to be in the range of EUR 700 million to EUR 800 million. We expect to increase investment into our priority late-stage programs in 2026 compared to the prior year, namely Pumitamig, 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 this year. We will continue to follow the data generated by our pipeline. As part of this prioritization effort, 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 SG&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 de-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 multiproduct 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 Özlem 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.

Operator provided instructions. We will now take the first question from the line of Daina Graybosch from Leerink Partners.

Well, thank you for the question. Congratulations to Ugur and Özlem 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 BioNTech and what kind of innovation will you take to pursue in the new company?

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

Daina, great to hear you. So 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 programs and everything 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 you can imagine, Daina, and you are very close to this, that the field in the mRNA space is rapidly advancing. We are seeing a lot of innovation happening, particularly in combination with AI. Özlem and I together felt the need to address that by focusing on this type of endeavor to ensure that we can use core technologies and core IT that come from BioNTech to build something completely new. Completely new means really next generation and we call it the next-generation — everything that goes beyond the current generation. So that's the idea.

If you allow me to add on the topic, thank you, Daina, for the question. So I think it's just to reconfirm that there is no split of BioNTech's core mRNA capabilities. Our strategy and pipeline remains unchanged. We retain COVID. We retain our mRNA oncology programs. And what is being discussed, as Ugur was just mentioning, is the new company related 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 this 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 products.

We will now take the next question from the line of Tazeen Ahmad from Bank of America.

Another one, maybe about 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 T-Pam. 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?

Okay. Thank you, Tazeen. 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 endometrial cancer and whether the infrastructure is just for that launch or for future launches as well.

Thank you, Tazeen, for the question. So on your first part, Ugur and Özlem 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 Annemarie 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.

We will now take the next question from the line of Asad Haider from Goldman Sachs.

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?

Thanks, Asad. So that was a question around timing. So it's a critical time for the company, which we recognize given preparations for launches of certain products and Pumitamig. So why make this decision now?

I'll take the question and then Ramon, you can add. I think from a timing perspective, we are talking about a transition at the end of 2026 and not today. So we have a clear plan for milestones and data readouts in 2026. We believe it's a good timing for transitioning because by the end of 2026 the company will already have a number of important readouts, but also the number of Phase III studies that we plan will be in the 15-plus range. This is really about industrialization and we need to get people on board who can connect this with the scale that is needed at that moment.

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. This spans innovative immunomodulators, ADCs and mRNA candidates. Now you will have two companies focusing on these strategic priorities and tailored investment cases. BioNTech steps to maximize value for patients and shareholders alike. In terms of our collaboration and contribution to the NewCo, we also retain the possibility to participate in NewCo's upside through its minority stake. So I hope this provides clarity.

We will now take the next question from the line of Cory Kasimov from Evercore ISI.

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 Gotistobart, if you were to replicate the results you saw in Part 1 and Part 2 of the study, how do you think about the market opportunity in second-line plus squamous non-small cell lung cancer?

Thank you, Cory, for the question. So let me answer the first one. Based on what is contemplated today, BioNTech's contribution to the NewCo relates 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 preparing for commercialization and further innovation in our key priorities. And then Gotistobart...

Yes. I think everyone knows how difficult second-line non-small cell lung cancer is. There has been no real disruptive innovation in the space for almost 30 years now. If the data are replicated with a hazard ratio in the range of 0.5, this would be a disruption. It would be game-changing for patients. As you know, this is a very sizable patient population in non-small cell lung cancer. We will come up with market projections once we really see the data readout.

We will now take question from the line of Geoff Meacham from Citigroup.

This is Jarryd on for Geoff. Maybe a question on the management transition. I know during the call you mentioned the prioritization of R&D efforts. Given the upcoming transition, how should we feel about the current late-stage pipeline prioritization and mid-stage pipeline prioritization versus stability of it looking ahead? And then maybe another question on Gotistobart. If the interim data were positive, could that open an avenue for accelerated regulatory filing?

Let me take the first part of the question, and then I'll allow Ugur to take the second one. In terms of priorities, this transition does not change any of them at all. BioNTech remains focused on advancing the late-stage pipeline and our mRNA oncology programs, where we continue to defend COMIRNATY and prepare for commercialization. The organization, our governance structures and the scientific leadership that Ugur and Özlem have been building over the past years provide the stability that we need to bring this next phase — to bring all the pipeline for the next stages of innovation, development or commercialization. Ugur and Özlem will continue to lead the company through the transition period while the Supervisory Board conducts its search for 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.

Depending on the data later this year from the interim analysis of the Gotistobart study, 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 approval.

In terms of the pipeline, we have built an extremely rich portfolio. The pipeline is not only individual drugs, but our establish, expand and elevate strategy. We are building a combination approach that will allow us, as we transition from Phase II into Phase III, to address multiple indication spaces with our current pipeline. We have a number of Phase I assets, including next-generation IO molecules and ADCs in our pipeline, for which we have not yet shared data. You will hear more about early-stage clinical assets at the end of this year and the beginning of next year.

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

This is Chris on for Terence. We have a 2-part question for autogene's trial in colorectal cancer. Just 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?

Our final analysis will be later. We have just updated the projections based on the current accrual and event rates to be more precise for early 2027. 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. Our objective is that we want to be statistically significantly and clinically meaningfully better than the standard of care with regard to DFS.

We will now take the next question from the line of Evan Seigerman from BMO Capital Markets.

I wanted to touch on the upcoming Phase III interim data for BNT113 in first-line head and neck HNSCC. Can you talk about some expectations for this interim analysis? Could we potentially see 6- or 12-month OS data? And more importantly, how are you thinking about the potential trade-offs 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, Evan. So just to confirm that was a question on BNT113, frontline head and neck, and our expectations for the interim analysis and any perspective on the trade-off of efficacy and safety. Ugur, would you like to take that one and then maybe add detail?

Yes. This is a PFS-based, event-driven endpoint that we expect in the late second half of 2026. This patient population is HPV-positive head and neck cancer patients. This is a patient population that is increasing in incidence. Depending on the hazard ratio, this could give us a path towards registration and, also depending on later readouts that are based on OS, this could also give us a path towards full approval based on OS. We are very curious about the outcome of this trial. We have published strong immunogenicity data in this patient population, so this is potentially a registrational trial and an important readout.

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

I just have a couple of questions. The first one on ROSETTA Lung-02. I see the study was expanded to 1,260 patients from around 986 and data is now expected in fiscal year 2029. Was that expansion for one histology or are both histologies equally expanded? And what was the reason to do so? I think it makes sense given the expansion from your competitor. Also, what data should we expect in the Phase II endometrial cancer T-Pam this year?

Thank you, Yaron. So to confirm, these are questions for Özlem on ROSETTA Lung-02 rationale behind the expanded study across both histologies and the second question on potential data from T-Pam this year.

Regarding the sample size increase in our non-small cell lung cancer study, we are constantly assessing available and emerging data from our trials and also from other trials with this bispecific antibody class. Based on this data, we expanded the sample size 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 speed. The rationale for both amendments is changed statistical considerations and recalibration of recruitment. The second question was about T-Pam. Specifically about T-Pam in endometrial cancer: our data package, which we plan to submit for BLA this year. We have also, in parallel, initiated a confirmatory Phase III trial for this indication, which is ongoing and our plans remain unchanged.

We will now take the next question from the line of Akash Tewari from Jefferies.

This is Manoj on for Akash. Just one from outside. Are you still planning to take BNT324, the B7H3 ADC, combo to registrational 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, Manoj. So I heard the first question was on BNT324 and plans to take a combination to registrational lung studies, and the second was whether we expect any revenue from cancer vaccines in 2026.

For BNT324, as you know, it is being evaluated with other candidates in multiple cancer indications, including lung cancer. We are expecting data here in the second half of 2026. We are prepared, if we see a strong signal, to transition from Phase II into a Phase III trial.

And then in terms of potential revenues from our cancer vaccines, these assets are still in clinical development, so we do not expect revenue from them in 2026. The value from assets such as BNT113 are reflected in the clinical milestones and potential approvals we are working towards rather than near-term revenue contribution.

We will now take the next question from the line of Asthika Goonewardene from Truist.

This is Kari on for Asthika. Just a couple of questions. 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 the step down to be versus 2025? How should we think about the relative pressure coming from the U.S. versus Europe and versus Germany?

Can someone repeat the questions?

Yes. First question on the 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 the 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. On your first question, we are not providing any specific financial guidance related to the potential transfer of certain rights and mRNA technologies to the NewCo 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. Regarding COMIRNATY and COVID-19 vaccines, 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. COMIRNATY remains an important franchise for us. We continue to generate meaningful cash flows and have very meaningful market shares, and it's helping us to fund ongoing R&D investments. Our focus is on managing this transition while we continue to advance our oncology pipeline and prepare for potential launches. To go into a bit more detail, the U.S. is still a competitive and dynamic market where we expect lower revenue this year. In Europe, we expect lower revenues as we defend our market share and manage the transition from multiyear contracts to a more seasonal pattern of demand. Germany is a specific effect for this year because we recognize direct sales of our COVID-19 vaccines there, so anticipated declines in German sales will have a direct impact on our top line, whereas revenues outside of Germany only affect our top line as part of the 50% gross profit split with Pfizer.

We will now take the last question from the line of Mohit Bansal from Wells Fargo.

I have two, if I may. One from the science side. For the ROSETTA Lung-02 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 the squamous trial? 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 given that cash position and your cash requirements going forward?

Okay. Great. Thank you, Mohit. So two questions: one for Ozlem on ROSETTA Lung-02 and whether squamous has a lower bar, and another for Ramon on capital allocation and buybacks.

Yes, Mohit, thank you for the question. You asked whether it makes sense to have two different cohorts. We, in fact, have in this study an approach that allows both histologies to be assessed separately, so it's technically like two studies in one, which gives us the best balance between speed and probability of success.

Thank you, Özlem. On the capital allocation strategy and priorities, our focus remains on advancing our late-stage oncology pipeline, preparing the organization for potential launches and defending COMIRNATY. We believe our pipeline can drive the next stage of growth for BioNTech and should receive the resources it needs when it needs them. Outside of that, as we have done in the past, if there are assets or technologies that could help our late-stage programs, we may look at ways to access those assets or technologies through strategic inorganic transactions to strengthen our early science pipeline. There are no changes to that approach at this time.

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, it was, of course, an important day of announcements. I would like to 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, and our strong collaboration with BMS on late-stage execution, the next combinations with Pumitamig and continued investment in our ADCs are central. We continue to have a strong balance sheet, and we are focused on strategy and strengthening our teams, partners and governance so that we remain confident in our ability to advance our pipeline and move BioNTech towards becoming a multiproduct oncology company by 2030. We really appreciate your time today and look 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.