BioNTech - Q4 2025
March 10, 2026
Transcript
Operator (participant)
Welcome to BioNTech's fourth quarter and full year 2025 earnings call. I will now hand the call over to Douglas Maffei, Vice President, Strategy and Investor Relations. Please go ahead.
Douglas Maffei (VP of Strategy and Investor Relations)
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.
Ugur Sahin, Chief Executive Officer and Co-Founder, Özlem Türeci, Chief Medical Officer and Co-Founder, and Ramón Zapata, Chief Financial Officer. With this, I'll hand the call over to Ugur.
Ugur Sahin (CEO and Co-Founder)
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 combinations across solid 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 a result, we anticipate multiple late-stage event-driven readouts in 2026. In parallel, we now have more than 10 novel combination trials with pumitamig in progress. We executed key strategic deals, most importantly with BMS, to strengthen the execution of and help de-risk 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.
Last but 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 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 read out this year. Second is building momentum in our combination-based approach. Multiple data readouts from our 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 ambitions 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 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 stands 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 own 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, 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, 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 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 Özlem for an update on our oncology execution.
Özlem Türeci (CMO and Co-Founder)
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 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 IO penetration tumor backbone of our combination-based development strategy is our PDL1 VEGF-A bispecific antibody, pumitamig. We and our partner BMS are pursuing a three-wave plan to develop pumitamig 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 III trial designed for registration and supported by studies that de-risk dose and setting. Through these trials, we aim to establish pumitamig in foundational first line indications in combination with standard of care chemotherapy through global registration of 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 two 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 three 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 immunomodulators. Wave three 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 waves seek to establish and expand pumitamig in combination with current standard of care. These trials lay the foundation for our 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 eight 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 two 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 PDL1-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 bolster and empower the third wave.
This wave seeks to elevate pumitamig's reach and maximize its clinical impact through 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 base. Across our first four ADC programs, we have generated single-agent clinical data in more than 2,800 patients to date, providing physician-grade insights into activity, durability, and safety, and guiding indication prioritization and combination design. Our primary objective is to combine the ADCs with pumitamig 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 B7-H3 ADC in a broad early-stage development program consistent with the expression profile of B7-H3 across a variety of cancers. BNT324 has demonstrated pan-tumor activity and favorable safety profile across a broad range of tumors, categorized by low single-digit rates of Grade 3 treatment-related adverse events and low rates of any grade ILD 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 apply 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 combos. 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 this indication.
In adjuvant ctDNA-positive stage 2 high-risk or stage 3 colorectal cancer, we have a phase II trial evaluating autogene cevumeran 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 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 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 T-Pam, we expect to present phase II data in endometrial cancer and 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 setting. 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, Ramón Zapata, for the financial update.
Ramón Zapata (CFO)
Thank you, Özlem, 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. 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 non-contingent 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-derived 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 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 IPOs. 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-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 vaccines 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 Shingles program that occurred last year. On COVID-19 vaccines 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 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 phasing similar to last year, with the last four 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-EUR 2.5 billion and adjusted SG&A expenses to be in the range of EUR 700 million-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 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 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 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 Uğur 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 (participant)
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 Daina Graybosch from Leerink Partners. Please go ahead.
Daina Graybosch (Senior Research Analyst)
Well, thank you for the question. Congratulations to Ugur and Özlem on your new pursuit. I'm excited to see where you take it. Certainly it feels like a transition today, and I think I'll ask my question there. 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?
Douglas Maffei (VP of Strategy and Investor Relations)
Okay. Thank you, Daina. Ugur, I think that's one for you in terms of what could potentially go to the new company from mRNA technologies.
Ugur Sahin (CEO and Co-Founder)
Hi, Daina. 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. Yeah. Clinical and everything what 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. What you can imagine, Daina is and you are very close to that the field in the mRNA space is rapidly advancing. Yeah. We are seeing a lot of innovation happening, particularly in combination with AI. Yeah. We together felt really the need to address that.
By Özlem 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. Completely new means really next generation. Yeah. We call the next generation everything that goes beyond the current generation. That's the idea.
Ramón Zapata (CFO)
If you allow me to add on the topic, Ugur, and thank you, Daina, for the question. 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 COMIRNATY. We retain our mRNA oncology programs. What is being discussed, as Ugur 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 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 progress.
Daina Graybosch (Senior Research Analyst)
Great. Thank you.
Operator (participant)
Thank you. We will now take the next question from the line of Tazeen Ahmad from Bank of America. Please go ahead.
Tazeen Ahmad (Managing Director)
Hi. Good morning. Thank you for taking my questions. Another one may be about, you know, how you're thinking about, management of the company. 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? One question about T-Pam. How are you preparing for that launch in endometrial cancer, and is that gonna serve as sort of a, infrastructure build for other launches, or is this just gonna be tailored for this particular launch? Thank you.
Douglas Maffei (VP of Strategy and Investor Relations)
Okay. Thank you, Tazeen. 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.
Ramón Zapata (CFO)
Thank you. Thank you, Tazeen, for the question. On your first part, Ugur and Özlem will remain in their roles 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 Anne-Marie 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.
Operator (participant)
Thank you. We will now take the next question from the line of Asad Haider from Goldman Sachs. Please go ahead.
Asad Haider (Managing Director)
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 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. 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.
Douglas Maffei (VP of Strategy and Investor Relations)
Thanks, Asad. That was a question around timing. It's a critical time for the company, which we recognize getting ready for the launches of certain products and pumitamig. Why make this decision now?
Ugur Sahin (CEO and Co-Founder)
I take over the question and then, Ramón, you can add. I think from timing-wise, we are talking now end of 2026 and not today. Yeah. We have a clear plan for milestones and data read out in 2026, and we believe it's really a perfect timing for transitioning because the company at the time point end of 2026 will already have a number of readouts. Yeah. Important readouts, but also what is the number of phase III studies that we plan end of 2026? 15+ phase III clinical trials. 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.
Ramón Zapata (CFO)
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. As you know, this is spanning innovative immunomodulators, as I was mentioning, ADCs and mRNA candidates. Now you have two companies focusing on these things, right, strategic priorities and to tailor the investment cases. BioNTech expects 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 upside through its minority stake. I hope this provides clarity.
Asad Haider (Managing Director)
Thank you.
Operator (participant)
Thank you. We will now take the next question from the line of Cory Kasimov from Evercore ISI. Please go ahead.
Cory Kasimov (Senior Managing Director)
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? On the pipeline front regarding goti, 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.
Douglas Maffei (VP of Strategy and Investor Relations)
Okay, great. Thank you, Cory. 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 goti, if we were to recapitulate the part one results in part two, what do we anticipate the market opportunity would be?
Ramón Zapata (CFO)
Thank you. Thank you, Cory, for the question. 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 NewCo related 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 further innovation in our key priorities. And then goti part two.
Ugur Sahin (CEO and Co-Founder)
Yeah. I think everyone knows that how difficult second non-small cell lung cancer is. There is more real disruptive innovation in space for almost 30 years now. If the data are replicated with a OS hazard ratio in the range of 0.5, this would be a disruption. It would begin 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 receive the data results.
Cory Kasimov (Senior Managing Director)
All right. Thank you.
Operator (participant)
Thank you. We will now take the next question from the line of Geoff Meacham from Citigroup. Please go ahead.
Speaker 12
Hey, guys. Good morning. This is Jarrod on for Geoff. Maybe a question on the management transition. I know during the call you guys mentioned 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 on gotistobart. You know, if the interim data were positive, could that open an avenue for an accelerated regulatory filing? Thanks.
Douglas Maffei (VP of Strategy and Investor Relations)
Thank you for the question. We have one on the management board transition, and then the second question on portfolio prioritization efforts and current late stage versus mid stage.
Ramón Zapata (CFO)
Thank you. Let me take the first part of the question, and then I'll allow Ugur 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 COMIRNATY and prepare for commercialization. The organization, our governance structures, our scientific leadership that Ugur and Özlem have been building over the past years provides the stability that we need to bring all the pipeline to the next stages of either innovation or development or commercialization.
As Ugur and Özlem will continue to lead the company through the transition period when the supervisory board conducts a search 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, you know, focus and really making this as available as soon as possible to our patients.
Ugur Sahin (CEO and Co-Founder)
Yeah. I can take the second question.
Özlem Türeci (CMO and Co-Founder)
Um-
Ugur Sahin (CEO and Co-Founder)
Oh, Özlem, do you want to talk? Özlem, it's also you.
Özlem Türeci (CMO and Co-Founder)
Yes, yes, I can also take it. Depending obviously on the data we will see later this year from the interim analysis of the GOTI study. 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.
Ugur Sahin (CEO and Co-Founder)
In the second part of the question with regard to the pipeline, we have really built an extremely rich pipeline. The pipeline is not only individual drugs, but we believe it's our establish, expand, and elevate strategy. Yeah. We are building a combination approach that could allow us now, and by rapidly transitioning from phase II into phase III, really address multiple indication spaces with our current pipeline. We have a number of phase I assets, including again next generation IO molecules, including again ADCs that we have in our pipeline but never shared data so far. You will hear also in the early stage clinical.
For the early-stage clinical assets at the end of this year, beginning next year data.
Operator (participant)
Thank you. We will now take the next question from the line of Terence Flynn from Morgan Stanley. Please go ahead.
Speaker 14
Good morning. This is Chris on for Terence, and thanks for taking our question. We have a two-part question for autogene cevumeran's 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.
Ramón Zapata (CFO)
Okay. Thank you, Chris. That was autogene cevumeran in CRC. What level of details in early 2026, and what is the bar for success?
Özlem Türeci (CMO and Co-Founder)
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. 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, will not be the basis for any steps towards based on efficacy data. What our objective is that we want to be statistically significantly and clinically meaningfully better than the standard of care with regard to DFS.
Operator (participant)
Thank you. We will now take the next question from the line of Evan Seigerman from BMO Capital Markets. Please go ahead.
Evan Seigerman (Managing Director and Head of Healthcare Research)
Hi, guys. Thank you so much for taking my question. I wanted to touch on the upcoming phase II 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 six- or 12-month OS data? 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 just want to understand how you're trying to position the product relative on efficacy and safety. Thank you.
Douglas Maffei (VP of Strategy and Investor Relations)
Okay, great. Thank you, Evan. Just to confirm, that was a question on BNT113 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. Ugur, would you like to take that one and then maybe Özlem can add detail?
Ugur Sahin (CEO and Co-Founder)
Yes. This is PFS-based event-based endpoint, and that we expect in the late second half 2026. Its patient population is HPV positive head and neck cancer patients. You know that this is a patient population that is increasing in the industrialized states. Depending on the hazard ratio, this could give us a path towards registration. Also depending on the further readouts that are the later time readouts that are based on OS. This could also give us a path based on a full approval on OS. We are very curious about the outcome of this trial.
We have published strong immunogenicity data in this patient population and so this is a potentially a registrational trial and important result.
Operator (participant)
Thank you. We will now take the next question from the line of Yaron Werber from TD Cowen. Please go ahead.
Yaron Werber (Managing Director and Senior Biotechnology Analyst)
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 1,260 patients from 986 or so, and data is now in fiscal year 2029. Was that one subhistology 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. Also, what data should we expect in the phase II endometrial cancer fam deruxtecan this year? Thank you.
Douglas Maffei (VP of Strategy and Investor Relations)
Okay. Thank you, Yaron. To confirm, these are questions, mostly for Özlem. The first is on ROSETTA Lung-02 on the rationale behind the expanded study across both histologies. Next question was on any potential data from T-Pam in 2Q this year.
Özlem Türeci (CMO and Co-Founder)
Yes. Regarding the sample size 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 bispecific antibody class. Based on this data, we expanded the sample 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 speed. That means the rationale for both amendments is changed statistical consideration and also recalibration of recruitment.
The second question was about T-Pam. I guess specifically about T-Pam 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 confirmatory trial, a phase III trial for this indication, which is ongoing and our plans remain unchanged.
Operator (participant)
Thank you. We will now take the next question from the line of Akash Tewari from Jefferies. Please go ahead.
Speaker 13
Hey, this is Manoj on for Akash. Just one from outside. Are you still planning to take BNT324, BNT327 combo, to registrational studies in lung indication? Also, do you expect any revenues from cancer vaccines, BNT113 and BNT122 in 2026 through any accelerated approval pathways as your base case?
Douglas Maffei (VP of Strategy and Investor Relations)
Okay. Thanks, Manoj. I struggled to hear all of that, but what I gathered from that is on BNT327, any plans to take a combination into registrational lung study? Second question-
Speaker 13
324, sorry.
Douglas Maffei (VP of Strategy and Investor Relations)
324. Okay.
Speaker 13
Yeah. Sorry. Yeah. Okay. Second question was whether we expect any revenue from cancer vaccines in 2026. Ramon, that one could be for you.
Ugur Sahin (CEO and Co-Founder)
Yeah. For BNT324, as you know, BNT324 is evaluated with BNT327 in multiple cancer indications, including lung cancer.
Ramón Zapata (CFO)
Sure.
Ugur Sahin (CEO and Co-Founder)
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 II into a phase III trial.
Ramón Zapata (CFO)
In terms of potential revenues from our cancer vaccines, all these products are still in the clinical development stage, so we do not expect revenue from them in 2026. The value from assets such as BNT113, they are reflected in the clinical milestones and potential approvals we are working towards rather than near-term revenue contribution.
Speaker 13
Thank you.
Operator (participant)
Thank you. We will now take the next question from the line of Asthika Goonewardene from Truist. Please go ahead.
Asthika Goonewardene (Managing Director and Senior Biotech Analyst)
Hi. Good morning, everyone. This is Kari from Asthika Goonewardene. 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? Second, on COVID sales, how large do you expect the 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.
Operator (participant)
Can someone repeat the question?
Asthika Goonewardene (Managing Director and Senior Biotech Analyst)
First question on the new company, would there be any milestone or royalty economics tied to the IP that belong to BioNTech? 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?
Ramón Zapata (CFO)
Thank you for the questions. 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 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 midterm financial impact for BioNTech. Now, in relation to your question around COMIRNATY and COVID-19. 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.
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. Our focus is really on 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.
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 multi-year contract to now a more, seasonal demand of, utilization and revenues. This year specifically, Germany is an important effect because we recognize direct sales of our COVID-19 vaccines directly. 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. That's as much transparency I can give you there.
Asthika Goonewardene (Managing Director and Senior Biotech Analyst)
Got it. Thank you so much.
Operator (participant)
Thank you. We will now take the last question from the line of Mohit Bansal from Wells Fargo. Please go ahead.
Mohit Bansal (Managing Director and Co-Head of Therapeutics Research)
Great. Thank you very much for taking my question. 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? Do you think that there is a lower bar to be successful in squamous trial? That's the first question. Second question for Ramón, 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.
Douglas Maffei (VP of Strategy and Investor Relations)
Thank you, Mohit. Two questions in there. One for Ramón on any thoughts around a potential buyback, share buyback given our cash. Another question for Özlem on ROSETTA Lung-02 on squamous and non-squamous, and is there a lower bar to be successful in squamous?
Ramón Zapata (CFO)
I let Özlem to answer the question also first.
Özlem Türeci (CMO and Co-Founder)
Yes, Mohit, thank you for the question. You ask whether it makes sense to have two different studies. We in fact have in this study in ROSETTA Lung-02 both histologies separated. It's technically like two studies in one, which gives us the best balance between speed and probability of success.
Ramón Zapata (CFO)
Thank you, Özlem. On the capital allocation priority strategy and priorities, this remains focused on advancing our late-stage oncology pipeline, preparing the organization for potential launches, and defending our COMIRNATY launches as well. We believe our pipeline on 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. 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 inorganic transactions so as to strengthen our early science pipeline. No changes there either.
Mohit Bansal (Managing Director and Co-Head of Therapeutics Research)
Helpful. Thank you.
Operator (participant)
Thank you. That's all the time we have for questions. I would like to hand back over to the speakers for closing remarks.
Ramón Zapata (CFO)
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 BMS on late-stage execution, the next combo combinations with pumitamig, and then continue our strong strategy on having this strong balance sheet, focused strategy, and the strength 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.
Operator (participant)
This concludes today's conference call. Thank you for participating. You may now disconnect.