BNTX

Welcome to BioNTech's first quarter 2026 earnings call. I will now hand the call over to Douglas Maffei, Vice President, Strategy and Investor Relations. Please go ahead.

Thank you, operator. Good morning and good afternoon. Thank you for joining BioNTech's 1st quarter 2026 earnings call. As a reminder, the slides we will use 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 or SEC. 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 can find the agenda for today's call.

I'm joined 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 Zapatero, Chief Financial Officer. Also available for the Q&A portion of today's call is Annemarie Hanekamp, our Chief Commercial Officer. With this, I'll hand the call over to Ugur.

Thank you, Doug, and a warm welcome to everyone joining us today. As BioNTech has grown, our vision has remained constant, translating science into survival. Cancer is a complex systems disease with heterogeneity across patients and variability within individual tumors. The future of cancer treatment will therefore center around rationally designed therapeutic combinations, pairing potent and precise mechanisms of action that create biological synergies. To address this, BioNTech has built a diversified toolkit of modalities comprising immunomodulators, ADCs, and mRNA cancer immunotherapy. We believe that combination approaches will be key to elevate patient outcomes meaningfully across solid tumors. To execute against that vision in 2026, we have 3 priorities. First, accelerate the late-stage development of our oncology assets. Key late-stage data readouts are anticipated from our first wave of oncology programs this year. Second, build momentum in combination therapy.

In 2026, we are expanding our novel combination strategy centered around pumitamab as potential next-generation IO backbone. This includes the first expected readouts of combination trials with our ADCs as well as with other next-generation targeted therapies, including the recently announced partnership with Boehringer Ingelheim to combine pumitamab with opicitumab. Third, shift from a platform-centric to a tumor-centric clinical development approach around high-incidence cancers such as lung cancer, breast cancer, and other tumor types. The foundation of this matrix approach is our combination strategy, which allows us to address several lines of treatment with different asset combinations. In March, we announced plans to pursue next-generation mRNA innovations in a new independent company founded and led by Özlem and I. With BioNTech and our new company focusing on their respective strategic priorities, we aim to maximize value for patients and shareholders.

Planning at arm's length is ongoing. We expect to share details of an agreement later this year. BioNTech is well-positioned for this next phase. With a growing late-stage pipeline, strong partnerships, and financial strength, we are on track to become a diversified multi-product oncology company by 2030. We are targeting more than 17 late-stage and pivotal trial readouts through 2030, spanning multiple tumor types and different lines of treatment. We enter the remainder of this year with momentum, solid execution, and a rich set of catalyst opportunities ahead. With this, I will hand over to Özlem for an update on our oncology execution.

Thank you, Ugur. I'm glad to be speaking with everyone today. BioNTech's clinical development strategy seeks to address the full continuum of cancer, from resected high-risk tumors in the early setting to advanced and metastatic disease, as well as treatment-resistant and refractory cancers. We have defined a set of key tumor focus areas with high incidence and high unmet need, including lung cancer, breast cancer, and others. Across these tumor focus areas, our goal is to leverage novel combinations to maximize the potential of our pipeline and to elevate solid tumor treatment outcomes. We are advancing multiple assets from our multimodal oncology pipeline into late-stage development. During the first quarter of 2026, we continued to make progress here, and I look forward to speaking to some of these updates today. I'll begin with lung cancer, which is our most advanced example of our disease area-focused approach.

Our lung cancer strategy is built as a matrix across, firstly, disease stages and settings from resectable tumors to unresectable stage 3 disease through metastatic first line and later lines of therapy. Second, clinical and molecular subgroups, including patients with and without actionable alterations and with different PD-L1 expression levels. Third, treatment backbones and combinations with pumitamab at the core. This quarter, we continued to add to the body of evidence for our lung cancer approach, including the presentation of new data at the European Lung Cancer Congress. Starting with pumitamab, our PD-L1 VEGF-A bispecific antibody and the IO backbone of our combination-based development strategy. In March, we presented phase I-B/II-A data at the ELCC. This trial evaluated pumitamab as a monotherapy in patients with previously untreated advanced non-small cell lung cancer, enrolling both squamous and non-squamous histologies. The results are encouraging.

In an overall patient population with PD-L1 expression of at least 1%, we observed a confirmed objective response rate of 46%, a median progression-free survival of 13.6 months, and a median overall survival of 27 months. The disease control rate was 96%. Two features of these data deserve particular emphasis. First, the activity observed across PD-L1 subgroups is noteworthy, and second, the particularly strong response rate of 71% in PD-L1 high squamous disease. The tolerability profile was manageable, with a low rate of treatment discontinuation. These data support the ongoing global phase III program for pumitamab in lung cancer. The ROSETTA LUNG-02 trial is currently recruiting in its phase III portion, comparing pumitamab plus chemotherapy to pembrolizumab plus chemotherapy in first-line non-small cell lung cancer. Phase II data from this trial are expected to be presented at ASCO 2026.

As Ugur mentioned in his opening remarks, another component of our lung strategy is our recently announced collaboration with Boehringer Ingelheim. The study combines DLL3-targeting T-cell engager Obrixtamig with Pumitamig. The clinical trial aims to develop a novel treatment regimen that delivers more sustained tumor control in extensive-stage small cell lung cancer, one of the most aggressive and underserved forms of cancer. Small cell lung cancer progresses rapidly, metastasizes early, and almost always recurs within a year after initial treatment. While the addition of immune checkpoint inhibitors to chemotherapy has led to improved survival outcomes for patients with extensive stage disease, most patients progress within months after treatment, and the prognosis remains poor. The collaboration combines two complementary immunotherapeutic mechanisms to explore a potential new path to enhance and sustain antitumor immunity.

Obrixumab redirects T-cells to kill DLL3-expressing tumor cells, while pumitamab aims to restore T-cells' ability to recognize and destroy tumor cells while cutting off the blood and oxygen supply that feeds the tumor with the intention of preventing it from growing and proliferating. As you can see on our lung cancer slide, we are deploying multiple modalities, next-generation immune modulators, ADCs, and mRNA immunotherapy. gotistobart is a critical component of that picture. gotistobart is our selective TREC modulator targeting CTLA-4, developed in collaboration with our partner, OncoC4, and it is designed to precisely address the patient population that sits beyond pumitamab's current focus. Namely, patients with metastatic squamous non-small cell lung cancer whose disease has progressed following platinum-based chemotherapy and PD-1, PD-L1 inhibitor treatment. This is a setting with very few effective options and poor prognosis.

Gotistobart's differentiated mechanism, selective regulatory T-cell depletion in the tumor microenvironment, is designed to re-engage the immune system even after prior checkpoint inhibitor exposure. In January, gotistobart received orphan drug designation from the FDA for squamous non-small cell lung cancer, building on its existing fast-track designation. In March, at the ELCC, we presented updated data from the non-pivotal dose confirmation stage of PRESERVE-003, our global phase III trial. The data are very encouraging. The 12-month PFS rate of 25% for gotistobart versus 0 for docetaxel is a signal of durable disease control. Gotistobart reduced the risk of death in this IO-pretreated patient population by 54% compared to docetaxel with a hazard ratio of 0.46. The median OS in the gotistobart arm has not yet been reached compared to approximately 10 months with docetaxel.

At 12 months, 63% of patients treated with gotistobart were alive, whereas 30% in the docetaxel arm. The safety profile was consistent with the previously established profile for gotistobart, with no new signals of concern. These encouraging data are derived from a small patient population and require further validation. Based on current event accrual projections, we expect interim data from the pivotal stage of PRESERVE-003 later this year. This program reinforces the breadth and depth of what we are building in lung cancer. I now turn to gynecologic cancers, another of our tumor-focused areas, and 1 where we have a late-stage asset, trastuzumab pamirtecan, or T-Pam, our HER2-targeted ADC developed in collaboration with our partner, DualityBio. Updated T-Pam data were presented at the Society of Gynecologic Oncology annual meeting in April in patients with HER2-expressing previously treated advanced or metastatic endometrial cancer.

Including patients who had received prior immunotherapy, T-Pam demonstrated a confirmed objective response rate of 49% with a median duration of response of 9.9 months and a disease control rate of 79%. Responses were observed across all HER2 expression levels, IHC 1+, 2+, and also 3+. The safety profile was manageable and consistent with what has been previously reported for ADCs and HER2-targeted agents in this setting. The confirmatory for an EC01 phase III trial continues to enroll. In addition to our studies of T-Pam in endometrial cancer, the ADC is also being evaluated in a phase III clinical trial in HR-positive, HER2-low metastatic breast cancer, the DYNASTY-Breast02 trial. A phase III interim analysis for this trial is expected later this year based on current event accrual projections.

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. Updated long-term follow-up data from the PDAC phase I trial were presented at the AACR annual meeting this year. Among the 8 patients who mounted an immune response to the immunotherapy, 7 remained alive for up to 6 years after surgery and demonstrated persistent cytotoxic cancer-killing lymphocytes.

In contrast, of the 8 patients who did not exhibit an immune response, only 2 were still alive, with a median overall survival of 3.4 years. 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 disease-free survival as primary endpoint is event-driven and according to projections to be expected in 2027. For FixVac in first-line HPV 16-positive PD-L1 high HNSCC, we have a phase II-III trial in combination with pembrolizumab. Recruitment is ongoing. The phase III interim analysis is expected in 2026. In Q1, we generated additional data and evidence to support lung and gynecological cancer, 2 of our tumor disease focus areas in particular. Looking ahead, the catalyst calendar for the remainder of the year remains rich. In our late-stage programs, we anticipate 5 more readouts.

In parallel, early data from our pumitamig ADC combination trials will begin to inform the design of our first pivotal combination trials, a milestone that marks the next chapter of our novel strategy. We are in the midst of a sustained evidence-led data generation phase. Each readout is designed to advance our pipeline, de-risk our programs, and bring us closer to our goal of delivering meaningful new treatment options for patients with cancer. With that, I will now turn the presentation over to our CFO, Ramon Zapatero, for the financial update.

Thank you, Özlem, and a warm welcome to everyone joining us. Today, I will cover three topics. To begin, our first quarter 2026 financial results. Second, our reaffirmed full year 2026 financial guidance. Third, an update on our capital allocation strategy, where I will speak to our planned share buyback program and our manufacturing footprint consolidation initiative. Note that all figures will be in euros unless otherwise stated. Our first quarter performance is in line with our expectations and reflects the seasonal demand pattern we expect across quarters for COVID-19 vaccines. Revenues for the first quarter of 2026 were EUR 118 million. This compares to EUR 183 million in the same period last year. The decrease was primarily driven by lower demand from our COVID-19 vaccines as expected.

R&D expenses were EUR 557 million compared to EUR 526 million in the prior year period. The increase was driven by higher spending on our immuno-oncology and ADC programs, in particular, pumitamab and gotistobart, as well as R&D costs from BioNTech China, previously named Biotheus and CureVac, which were acquired in 2025. These increases were partly offset by lower expenses from our COVID-19 vaccine collaboration with Pfizer. On an adjusted basis, R&D expenses were EUR 527 million, excluding an impairment charge for an intangible asset. SG&A expenses were EUR 151 million compared to EUR 121 million in the prior year period. The increase was mainly driven by our ongoing commercial build-up and the post-acquisition inclusion of operations from BioNTech China and CureVac. Adjusted SG&A expenses were identical to the results under IFRS accounting standards.

We ended the first quarter with EUR 16.8 billion in cash equivalents, and security investments. Our strong financial position continues to support sustained investment across our pipeline, late-stage oncology programs, and our preparations for commercialization. Turning to the next slide, we are reaffirming our previously disclosed full year 2026 financial guidance. All guidance is provided on an adjusted non-IFRS basis. We expect total revenues for 2026 in the range of EUR 2 billion-EUR 2.3 billion. As stated at the beginning of the year, we anticipate lower COVID-19 vaccine revenues compared to 2025, driven by declines in both the U.S. and European markets. The U.S. market continues to be competitive and dynamic. In Europe, we expect lower revenues as we defend our market share and begin managing the transition away from multi-year contracts.

In Germany, specifically, we recognize direct sales of our COVID-19 vaccines as revenue. The anticipated declines in our sales of COVID-19 vaccines in the country will have a direct impact to our top line. Revenues outside of Germany only affect our top line as part of the 50% gross profit split with our partner, Pfizer. Revenues from our collaboration with VMS, from the pandemic preparedness contract with the German government, and from our services businesses are expected to remain stable. On revenue cadence, we anticipate COVID-19 vaccine revenue phasing to be similar to last year, with the last four months of the year driving the majority of the full year revenue figure. The VMS collaboration payment of EUR 613 million is expected to be recognized in the third quarter of 2026.

We expect adjusted R&D expenses in the range of EUR 2.2 billion-EUR 2.5 billion. Investment will be concentrated on our priority late-stage programs. We will continue applying disciplined portfolio prioritization across all development stages. We expect adjusted SG&A expenses in the range of EUR 700 million-EUR 800 million, reflecting our continued commercial build-out in oncology. Turning to capital allocation, let me highlight three key components of our approach to create long-term shareholder value. The first component is focused R&D investments to maximize the potential of our pipeline. We actively manage our portfolio, focusing our resources on programs that have the greatest potential to elevate patient outcomes. This means increasing investment into our late-stage priority programs, namely pumitamab, our ADC assets, mRNA immunotherapies, and their respective combinations, while reducing spend outside of those areas.

The second component see us mobilizing our strong balance sheet as a statement of confidence in the business. We plan to initiate a share repurchase program of American depository shares of up to $1 billion US dollars over the coming 12 months. Let me walk you through some principles that guided this decision. One is opportunistic flexibility. This program gives us the ability to deploy capital during times when our share price may be disconnected from intrinsic company value. Another principle is that our pipeline remains the primary driver of value. The buyback is supportive of the share price, but it is not determinative. The real value creation story at BioNTech remains the clinical execution of our oncology pipeline. Also, disciplined capital management. This program complements our R&D investment. We retain full optionality to advance our pipeline, execute partnerships, and corporate development opportunities.

Our balance sheet, with EUR 16.8 billion in cash equivalents, and security investments, gives us the capacity to do all of this simultaneously. In short, the share repurchase program reflects confidence in our science, capital management discipline, and a commitment to delivering long-term value for our shareholders. The third key component of our capital allocation strategy relates to the optimization of operational efficiency and commitment to sustainable value creation. To this end, we plan to continue aligning and consolidating our manufacturing network, focusing on sites where capacities will become underutilized or idle in the next 24 months. Excess capacity can be driven by evolving supply needs, mergers and acquisitions, BioNTech's partners manufacturing capacities, and completion of contracts. Specifically, we plan to exit operations at our manufacturing site in either Idar-Oberstein, Marburg, and Singapore, as well as contract sites. This will affect just over 1,800 positions.

For each of these manufacturing sites, we are exploring divestment options through the end of Q3 2026. This includes a partial or total sale. We expect cost savings to ramp up over time. Once the measures are fully implemented, we expect approximately EUR 500 million in recurring annual savings. In alignment with our capital allocation approach, these savings are intended to further support the advancement of our oncology pipeline towards commercialization. This is a decision we have taken after careful assessment. Our commercial and R&D drug supply will be covered by our broader manufacturing network. Supply of our COVID-19 vaccine will be fully handled by our partner, Pfizer, via their established manufacturing capacities beginning at the end of 2026. These plans underline our commitment to continuously steer our capacities in support of our strategy to become a multi-product company by 2030.

As we look across these three horizons on the slide, we are energized by the progress we have made to date and the path ahead. We are making progress towards our strategy. We are progressing key programs into pivotal stage, leveraging our partnership with BMS and our fortified balance sheet to fund our pipeline. From 2026 through 2029, we will drive execution at scale and speed, advancing combination therapy studies, accelerating pivotal trial execution, building tumor indication-specific portfolios, and executing our first oncology launches. By 2030, our goal is to be a diversified, multi-product, global biopharmaceutical company addressing the high unmet medical needs of cancer patients worldwide. BioNTech's robust financial position empowers us to pursue that goal. We remain fully committed to translating our science into survival for patients. With that, I will hand back to the operator to open the call for questions. Thank you.

Our first question comes from the line of Daina Graybosch from Leerink Partners. Please go ahead. Your line is open.

Hi. Thanks for the question. We're excited to see the initial data from ROSETTA LUNG-02 at ASCO. I wonder, and although, I have a question more about the statistical design of that study. We've all noticed, and I think you shared in the last earnings call, that you changed the primary endpoint from a dual PFS OS to a single PFS primary, and I wonder if you could talk more about why you made that change, including any conversations you've had with BMS and with FDA. Thank you.

Okay, great. Thanks. First question from Daina about ROSETTA LUNG-02, which is coming at ASCO, and a question about the rationale behind the endpoint change, which we announced, I believe, about two months ago.

Yes, I can take that, Doug. Hi, Daina. Thank you for the question. We have made this change because PFS is a well-accepted endpoint in non-small cell lung cancer and we expect the largest and earliest benefit signal in this endpoint and wanted to make sure that we allocate the full alpha on this endpoint and have a statistically robust readout. This does not mean that we neglect overall survival. Overall survival is, in fact, a key secondary endpoint and will also be assessed. As you know, this is a well-trodden regulatory path in particular for non-small cell lung cancer which has also been extensively used by KEYTRUDA.

Thank you. Our next question comes from the line of Jessica Fye from JP Morgan. Please go ahead. Your line is open.

Great. Good morning. Thanks for taking my question. Just thinking ahead to DYNASTY-Breast02, the HR-positive HER2-low trial for T-Pam. On what metric or endpoint do you expect the data to best underscore differentiation from ENHERTU?

Okay. Question from Jess at JPM on essentially, how we see differentiation of T-Pam versus ENHERTU.

The You asked for the endpoint metrics. The primary endpoint is objective re-response rate in connection with duration of response. We have provided the data from the largest recurrent endometrial cancer population at SGO, which you might have seen, where we demonstrate the objective response rate and duration of response together with a manageable safety profile. The differentiation is that we have now a dataset which shows that our ADC has also clinically meaningful benefit in the lower HER2 population and the one plus and two plus population, which is a differentiator.

I was asking for DYNASTY-Breast02, the HER2-low trial where we have benchmark data from ENHERTU.

This is Yes. This is Ugur Sahin. This is a trial of T-Pam with chemotherapy. There's not a direct comparison of with ENHERTU. Of course, there are data where you can benchmark the results of this trial with ENHERTU. We have to see the readout. Ensure it's first of all that there's a positive study. Then whether we can make a cross-comparisons to other trials.

I'll add. Hello, this is Annemarie, Chief Commercial Officer for BioNTech. We've always signaled that TPAM is an important asset for BioNTech also predominantly as a strategic asset, not just for building out our commercial engine, which will be the first time for BioNTech in the oncology space, but also as a combination partner. To Ugur Sahin's point, we will wait for the data readout. The physicians we spoke to always signal that they like to have more than one option. We do see a meaningful place for TPAM in the breast cancer space as well. Again, a strategic asset that we predominantly also focus on in combination therapy.

Thank you.

Thank you. We'll now move on to our next question. Our next question comes from the line of Tazeen Ahmad from Bank of America. Please go ahead. Your line is open.

Hi, guys. Thanks for taking my question. For the upcoming data that you're expecting to show at ASCO for PUMI plus chemo in the frontline non-small cell setting, how can we best frame expectations? What would be good data there?

Okay. Thank you. That question was on our upcoming data that we're presenting at ASCO, PUMI frontline non-small cell lung cancer. What are our expectations in terms of that dataset? Özlem Türeci, would you like to take that one?

Yes, I can take that. The data we will present at ASCO is from the phase II part of this trial. What we will show is the efficacy profile and the safety profile of 2 different doses of pumitamig in the combination with chemo in this patient population. That data might help to inform about what to expect then from the ongoing pivotal phase III part of the trial.

Thank you. We'll now move on to our next question. Our next question comes from the line of Akash Tewari from Jefferies. Please go ahead. Your line is open.

Hey, this is Manoj on for Akash. Just one from my end. Given the recent disclosures around the PFS interim from the HARMONi-3 global trial, do you think any changes in effect size assumptions or design changes needed to be considered for the Rosetta Lung trials? Also, the Ocutrop lung-04 trial showed interim overall survival hazard ratio around 0.6. Do you still think the chemo combos are the optimal approach, market entry approach in the setting?

Okay. Thank you, Manoj. I caught that. First question is on HARMONi-3.

Yeah.

If that changes our perspective on the space. Second question, it was a little tricky to hear the audio. Was it about best option for chemo combinations?

Could you just clarify the question?

Yes. Merck, Optitrope, Lang 04 from the fact TMD showed like hazard ratio of 0.6, overall hazard ratio of 0.6. Just wondering like whether chemo combos are still the option or like going for the ADC combos will be the most optimal option to enter the market first.

Okay, great. Thank you for clarifying. Awesome. Should we pass over to you for the HARMONi-3 data? Ugur, if you could offer some context on the second question, please.

Yeah. Yeah, sure. The recent disclosure of HARMONi-3 data is about interim analysis of PFS, which was a late edit, early look into PFS. But we don't know much about the metrics behind it, so we cannot co-comment extensively. However, summit management has signaled that, quote-unquote, where they have deliberately used a minimal alpha to set the bar high, which is a very valid approach at that. In this case, however, it also means that statistically this interim analysis is uninformative on the hazard ratio. We have to wait for the next analysis, which will be later this year.

Yeah. In, in short, no, we are, this does not change anything for our overall strategy. We would like to remind everyone that our overall strategy has several ways of development. The first way of development is pumitamig-trastuzumab. We have already started more than a year ago with first combinations, ADC combination. At the moment we have more than 10 clinical trials ongoing to assess the combination of pumitamig with our ADCs BNT324, BNT323, BNT324, BNT325, BNT326. We will report on the studies end of or in the second half of 2026.

These studies, of course, provide our differentiation strategy, what comes next as a second phase, which will be a combination of pumitamab with selected ADCs in different type of indications.

Thank you so much.

Thank you. We will now move on to our next question. Our next question comes from the line of David Day from UBS. Please go ahead. Your line is open.

Great. Thanks for taking my questions. I just wanted to come back to ROSETTA LUNG-02, where you changed the primary endpoint from dual PFS OS to PFS as primary endpoint. How do you think this will help with regulatory pathway? Does that mean that you're able to potentially get approved just on PFS with accelerated approval, and then full approval on the OS? Just also think a little bit around how should we think about regulatory path using PFS as the primary endpoint.

Okay, great. Thank you, David. Also maybe if I pass to you with the question, a follow-on question on ROSETTA LUNG-02 on the endpoint changing from dual to primary, on the rationale for that, specifically what it helps us to do with the development.

Yes. First of all, this decision was discussed with our partner BMS and also with regulators. The point is, in fact, that PFS is the earliest potential readout. We know that this type of next gen IOs, that PFS is the earliest and also the largest endpoint to cover the mechanism of action of this next gen IOs. With having PFS as only primary endpoint, we can put the entire alpha on this PFS and ensure that it has the highest readout power. This is the rationale behind that.

Still overall survival is a key secondary endpoint, and having it as a secondary endpoint allows us to get a clean path to approval with even a delayed or soft OS.

Thank you. We'll now move on to our next question. Our next question comes from the line of Asad Haider from Goldman Sachs. Please go ahead. Your line is open.

Great. Thanks for taking the question, and thanks for all the updates on the trial progress. Maybe just shifting gears quickly for Ramon, on capital allocation. Just given the substantial cash balance, it would be helpful to hear your updated thoughts on deployment and what the considerations were that went into the $1 billion share program you repurchase program you announced this morning. Just on the revenue guidance reaffirmation, despite the seasonally lower COVID in 1Q that you're calling out, just talk us through how you're thinking about the revenue progression through the rest of the year. Thank you.

Okay, great. Thank you, Asad.

Yeah.

Thank you, Asad. I appreciate the questions. First, talking about our capital allocation. I think our capital allocation strategy remains the same. We acknowledge that we are in a In an investment phase as we are building BioNTech into a commercial stage multiprotocol oncology company by 2030. The good thing is that the strength of our balance sheet allows us to invest in the pipeline, continue to build our commercial capabilities and preserve flexibility for targeted opportunities in the M&A or the BD space. Additionally, now it also allow us to return capital to shareholders. The report sharing program is not at the expense of our innovation efforts or pipeline, but is more to be seen as an element of our overall capital allocation strategy. If I move to the revenue guidance and the dynamics of the COVID vaccines revenues. I would say that our current guidance already assumes lower COVID-19 vaccine revenues versus last year.

As you rightly point out, so the regulatory and the recommendation landscape remains dynamic. As you can expect, we are monitoring these developments very closely. Now, based on the information available today and including the expected seasonal profile of COMIRNATY revenues, we are reaffirming our 2026 revenue guidance.

Thank you. We'll now move on to our next question. Our next question comes from the line of Terence Flynn from Morgan Stanley. Please go ahead.

Great. Thanks so much. Just two for me. I was wondering if there's any update on the CEO search and if you can provide a timeline for when that might be finalized. With respect to your T-Pam FDA discussions, similar type question, just any update there and expected timeline for visibility. Thank you.

Hi, Terence. Thank you for the question on the succession process. This is being led by the supervisory board, so I cannot comment on specific timing or process details. What I can tell you is that both Hugo and Özlem, together with the full management board and the overall organization, we remain committed to delivering our 2026 priorities. Our operating focus and strategy has not changed. We will update the market as appropriate when we have more information on that.

Okay, great. Thank you, Ramon. Now on T-Pam, maybe if we pass to Özlem, first of all, and then, Anne-Marie, you could add some color, if possible.

This time it's about the endometrial cancer study, right?

Yes.

Sorry for missing that for the other question. This transfer phase II cohort is fully enrolled, and we have presented the data. The confirmatory phase III trial, the Fern EC-01, continues to enroll, and we are in discussion with the FDA. We haven't changed our plans to submit.

Yeah. I would add to that what I stated before. T-Pam continues to be an important asset for us to lay our groundwork for commercial stage biopharmaceutical company. We continue to see the start of launch as a very strategic opportunity to build our commercial infrastructure and prepare for potential future launches where, as you know, especially in the United States, time to peak for oncology assets go around timelines of potentially 9 months. We don't have time to learn on the fly sort of saying. Especially if we look at the potential for pumitamig, where we also partner with Bristol Myers Squibb on the commercialization. This together would set us up nicely for success, even though currently we're not experienced in oncology launches as of yet.

Thank you. We will now move on to our next question. Our next question comes from the line of Evan Seigerman from BMO Capital Markets. Please go ahead. Your line is open.

Thank you so much for taking my question. We're looking forward to the data at ASCO. I want to follow up on Terence's question. As you think about the management change, can you talk to the profile of a new executive team that you might want to bring in? Is it still R&D focused, or are we going to shift more towards commercial as you transform the company? Thank you very much.

Thank you. Thank you, Evan. Again, sorry if I am not gonna be able to give many specifics and details because the management board is not running this process. It's our supervisory board. Having said that, our Chairman, Helmut Jeggle, has shared some characteristics last quarter when we disclosed the change in the management board. I think it's So what we are looking is for skills and capabilities in late stage development as well as, you know, commercialization, production and commercialization of scale of pharmaceutical products. I think I would be close to what Helmut would be commenting on that.

Thank you. We'll now move on to our next question. Our next question comes from the line of Cory Kasimov from Evercore. Please go ahead. Your line is open.

Hey, it's Cory. Thanks for taking the question. I do have 1 question. Upcoming ASCO is like competitor, bispecific data shows like an OS benefit. How does that change the bar for ROSETTA LUNG-02? Like would a strong like PFS and just OS trend here be enough, or does that kind of just the entire class needs like a clear OS benefit?

I'm sorry, The audio was not so clear on that. Would you mind clarifying? Were you talking about Pfizer's data or a different dataset?

No, no, I'll say, I'll say ASCO's competitor biospecific data, the PD-1 Bejet space here. That does show like a clear OS benefit. How does that change or raise the bar for your studies?

Oh, okay. Yeah, understood. We get that now. I'll pass over to.

Can you repeat? It's about HARMONi-6. Did I get that right?

It's HARMONi-6 was positive.

Yeah.

Yeah. With OS.

Okay.

How this would change our view.

Oh, okay. We are also excited to see the data at ASCO because it could be for the validation of the class as such and the data we have seen earlier from HARMONi-6 with a very good PF-PFS was already validation. However, I would like to remind you that this is a China study, which means that the comparator is Tislel plus chemo, not pembro plus chemo. It would not have a direct read-through for our ROSETTA LUNG-02 study.

Got it. Thank you.

Thank you. We'll now move on to our next question. Our next question comes from the line of Mohit Bansal from Wells Fargo.

Great. Thank you very much for taking my question. Given the HARMONi-3 versus HARMONi-6, and we don't know the data in Idar-Oberstein on HARMONi-3, but there has been some questions around the translatability of China data to the global data. I'm not asking you to comment on HARMONi-3, but would love to understand when you are seeing your own China data versus global data, what gives you confidence that you would be able to replicate what you saw in China into a global trial? Thank you.

Generally speaking, there are datasets, for example, pumitamab, small cell lung cancer, pumitamab, TNBC data, ivosidenib, second-line EGFR mutated non-small cell lung cancer data, which are reproductions of previous China data on a global level. We continue to be very positive about the regional reproducibility of this data. Having said that, with regard to the molecules, to this molecule class, there seems to be reproducibility of data. However, there could be still setting specific frictions on data reproducibility in populations or indications in which there are major differences between global and regional populations. For example, small cell lung cancer or non-small cell lung cancer, where in China the smokers rates are different to global.

That means we have to continue to monitor and follow the data, and we'll see from the data which comes out whether such setting specific frictions on reproducibility will show up.

Okay.

Thank you. We'll now move on to our next question. Our next question comes from the line of Yaron Werber from TD Securities. Please go ahead. Your line is open.

Hi, this is Gina in for Yaron. Thanks for taking our question. Please make this decision to pretty catalyst-rich year with five more late-stage pipeline data readouts across gotistobart, T-Pam, BNT113, et cetera. Besides the upcoming pumitamig dataset at ASCO, how should we think about the order and the timing for the rest of these key late-stage readouts? Secondly, on pumitamig, beyond your three lead indications, obviously you have a bunch of other phase III trials starting this year. How are you and Bristol evaluating where pumitamig has the most potential? Thanks so much.

Okay, thank you for that. I caught that that is essentially around timing and cadence of our late-stage data readouts. I would imagine that in the coming year, because that's what we've disclosed. Also how discussions are going with BMS in terms of which indications to prioritize. Özlem Türeci, shall I pass over to you for these? And then, Annemarie.

Yes, I can start with the second one. From a scientific and clinical and medical point of view, I can say that BMS and we are very aligned in the understanding of the potential of pumitamig, and that it is a very broad opportunity. And we are deciding on the sequence and on the specific indications together based on data and all the other dimensions which are relevant for making strategic decisions for a pumitamig portfolio. With regard to data readouts, we will have a couple of data readouts on pumitamig over the last over the next, yeah, 12 to 18 months.

One of these readouts, for example, at ASCO, the R-Rifateran 02 trial. Later this year, multiple readouts from phase I, II studies of combinations with our ADCs, with pumitamig, and additional readouts will follow in the next year.

Yeah, I would just add on the BMS and Pomi-T strategy is that we have a very deep and strong governance ongoing with BMS at different levels. From a scientific, from a clinical perspective, and also we're looking of course at where can we address unmet medical needs the most. As you know, the oncology space is in constant evolution, providing more options for patients and making sure that by the time our designs or trials read out, we're still relevant in what the current standard of practice clinical practice is. That is something where we can leverage both BMS' and BioNTech's capabilities as we're coming together to make those decisions. Sometimes that also includes changing some of our initial thinking to maximize the opportunity for Pomi-T for both BioNTech and Roche.

Thank you so much.

Thank you. We'll now move on to our next question. Our next question comes from the line of Geoff Meacham from Citigroup. Please go ahead. Your line is open.

Hey, good morning, guys. Thanks for the question. This is Jarway on for Geoff. Maybe just following up on earlier questions on T-Pam. Are there any outstanding data maturation requirements for T-Pam that could push the timeline beyond the current 2026 submission? Then earlier on, the comments on T-Pam having efficacy in low HER2 as well, is the strategy to pursue a broad pan HER2 label? Thanks so much.

Okay, great. Thanks. We caught whether T-Pam has any outstanding data requests that could impact regulatory pathway, and then clarification on HER2 low, and what our approach might be there. Özlem Türeci, would you like to take the data question?

Yes. I can take both, and thereafter, we can also get the commercial input here. No, we don't have outstanding data questions around TPAM. What we are currently monitoring is the enrollment of a confirmatory trial to ensure a harmonized timing of the BLA submission and the timelines for data to come out of this confirmatory trial. With regard to the populations, we are interested in a broad label. We, that's our goal, given that we have a large data set for all HER2 IHC levels, including the low expression ones.

I would add from a commercialization perspective that I mentioned this before in talking to our customers or treating physicians that a secondary option is always welcome. I think T-Pam, apart from our commercialization strategic launch and making sure that physicians start to get familiar with T-Pam itself as we're also moving forward with combination strategy, it's going to be important for us to understand where we can leverage the strategic launch for T-Pam specifically and then move through in commercialization.

Thank you. We'll move on to our next question. Our next question comes from the line of Harry Gillis from Berenberg. Please go ahead. Your line is open.

Thank you very much for taking the questions. I have a follow-up on catalyst timings. I was wondering, based on the latest event accrual projections you have, can you be any more specific on the timing of the stage 2 portion of the gotistobart reading? Also on the FixVac head and neck trial, when we might expect those within 2026. Following on from that, for each of these, if they were to be positive, should we just expect a press release at the time, you know, stating that, or would we expect any specific data? Given gotistobart's interim, and I believe the FixVac is as well, if these were to pass the interim readout, would we just hear nothing, and then maybe get an update at the next quarterly results?

Just exactly, when we might expect those and how we should expect an update. Thank you.

Okay. Thank you, Harry, for those questions. First question on stage II Goti data and then FixVac head and neck and whether each would be likely to have interim data readouts or not. Luca, I'll pass over to you for this one.

Okay. Yes. Yes. I think from the timing, nothing changed. We had guided to the second half of 2026 for both studies. Yes. We are on track with regard to the enrollment in the study, and we are also on track with regard to the event count in the study. Yes. This will be interim readout in both studies with challenging hazard ratios. It is a first interim readout. If the interim readout is positive, of course, we will document that. Yes.

If the study continues to go, we will also inform the market that the interim readout was performed and the study will continue to go on.

Very clear. Thank you very much.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.

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.

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.

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.

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.

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.

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.

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?

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.

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.

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.

Great. Thank you.

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

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.

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.

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.

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

Great. Thanks for taking the question and congratulations on the move and best of luck. I guess just one question, high level, just on the timing of the departure. It 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.

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?

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.

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.

Thank you.

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

Hey, guys. Appreciate you taking the question. First, just a quick clarification question. I just want to be clear. Does BioNTech contribute any capital to this new company, or is it just planning to be a minority investor? 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.

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?

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.

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.

All right. Thank you.

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

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.

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.

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.

Yeah. I can take the second question.

Um-

Oh, Özlem, do you want to talk? Özlem, it's also you.

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.

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.

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

Good morning. This is Chris 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.

Okay. Thank you, Chris. That was autogene cevumeran in CRC. What level of details in early 2026, and what is the bar for success?

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.

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

Hi, guys. Thank you so much for taking my question. I wanted to touch on the upcoming phase 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.

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?

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.

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

Great. Thanks so much. I just have a couple of questions. The first one on ROSETTA Lung-02. I see the study was now expanded to 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.

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.

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.

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

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?

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-

324, sorry.

324. Okay.

Yeah. Sorry. Yeah. Okay. Second question was whether we expect any revenue from cancer vaccines in 2026. Ramon, that one could be for you.

Yeah. For BNT324, as you know, BNT324 is evaluated with BNT327 in multiple cancer indications, including lung cancer.

Sure.

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.

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.

Thank you.

Thank you. We will now take the next question from the line of Asthika Goonewardene from Truist. Please go ahead.

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.

Can someone repeat the question?

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?

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.

Got it. Thank you so much.

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

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.

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?

I let Özlem to answer the question also first.

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.

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.

Helpful. Thank you.

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

Well, I think it was, of course, an important day of announcements. I would like to, of course, thank all of you for your continued interest in BioNTech. As you have heard today, we are entering an important phase for the company with multiple late-stage programs progressing and key readouts ahead. pumitamig is the backbone of all of these efforts. Our strong collaboration with 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.

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