BNTX

Welcome to BioNTech second quarter 2026 earnings call. I will hand the call over to Doug Maffei, Vice President of Strategy and Investor Relations. Please go ahead.

Thank you, operator. Good morning and good afternoon. Thank you for joining BioNTech second quarter 2026 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, 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 three, you can see the agenda for today's call.

I am 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 Zapata, Chief Financial Officer. Also available for the Q&A portion of the call is Anne Marie Hannekamp, Chief Commercial Officer. Related to yesterday's Chief Executive Officer announcement, we will also be joined today by Helmut Jeggle, Chairman of BioNTech Supervisory Board. With this, I will hand the call over to Helmut.

Thank you, Doug, and good morning, everyone. Before we begin with a business update from the management board, I would like to provide further color on the appointment of BioNTech's next chief executive officer. As announced yesterday, Guido Oelkers will take office as CEO as of February 1st at the latest. From the outset, the Supervisory Board's CEO search was guided by three clear priorities: proven strategic leadership, the ability to scale a global biopharmaceutical business, and a strong track record of building and growing innovation-driven, science-based organizations. Guido is an excellent fit on all three dimensions. Most recently, as CEO of Sobi, he more than quadrupled the company's revenues over nine years by strengthening its global capabilities and maximizing the value of its late-stage pipeline.

He brings deep expertise in launching and commercializing innovative products with a focus on the U.S. market, as well as extensive leadership experience across Europe and Asia Pacific. The Supervisory Board believes that Guido is the right leader for BioNTech's next phase. His expertise in scaling innovative organizations in a focused and capital-efficient manner, combined with his deep knowledge of the markets most relevant to BioNTech, will position the company well to deliver on its key objectives, evolve into a multi-product biopharmaceutical company, and continue its remarkable success story. With that, I would like to hand over to Ugur and will be available for questions during the Q&A at the end of the call.

Thank you, Helmut, and a warm welcome to everyone joining us today. I believe it is important to note that this transition reflects the natural evolution of BioNTech from a pioneering research organization into a global biopharmaceutical company with multiple commercial products. The next phase of this evolution requires the corresponding leadership skills, and I am confident we have found it in Guido. During our exchanges, I have come to know Guido as a leader who combines a deep understanding of the pharmaceutical industry and strategic acumen with genuine respect for the culture and people of our organization. He understands what we have built, and importantly, he understands what it will take to scale it. To ensure continuity and a seamless transition, I will remain actively engaged in supporting the preparations for Guido's onboarding. As for BioNTech's next phase, our mission remains constant: to translate science into survival.

To achieve this, BioNTech has successfully built a diversified toolkit of modalities, including next generation immunomodulators, ADCs, and mRNA cancer immunotherapies. Our multi-product portfolio has progressed further, and a growing share of it's now in late-stage clinical development and pivotal trials. The second quarter was a period of significant progress for BioNTech towards this. First, we are accelerating the late-stage development of our oncology assets. We shared encouraging global data in first-line NSCLC from the phase II portion of our phase II-III trial at ASCO from our potential next generation IO backbone, pumitamig. Second, our combination therapy strategy is gaining momentum. We have expanded our novel combination programs and presented data from ongoing combination trials with our ADCs, with more to come soon. Third, we continue our shift from platform-centric to a tumor-centric clinical development approach around cancers with greatest unmet medical need.

Notably, in our GU tumor area, we dosed the first patient in our phase III trial, evaluating our B7-H3 ADC, elfetabart drozuntecan, formerly known as BNT324, in metastatic castration-resistant prostate cancer. BioNTech is well-positioned for the next phase. With a growing pipeline of potentially registrational trials, strong partnerships, and financial strength, we are on track to become a diversified multi-product company by 2030. We are targeting more than 17 late-stage and pivotal trial readouts through 2030 and beyond, spanning multiple tumor types and different lines of treatment. Our progress to date sets us up for an impactful second half of 2026. We enter the remainder of this year with momentum and diligent execution as we continue to progress towards our long-term vision. 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. Our ambition is to address the full continuum of cancer, utilizing the approaches that Ugur outlined. We have defined a tumor-focused strategy to address significant unmet medical need where our novel combinations can extend survival outcomes for patients and maximize the potential of our pipeline. As such, we are advancing multiple assets from our multimodal oncology pipeline into late-stage development. During the first half of 2026, we made progress across our pipeline, and I'll cover some of these updates today. I'll begin with lung cancer, which is one of the cancers of highest unmet medical need in the tumor area where we have the broadest and most diverse coverage. We are aiming to tackle unmet medical needs at every stage of the lung cancer patient journey. Our lung cancer strategy covers various disease stages, settings, and enlists various modalities.

Next-generation immunomodulators, ADCs, and mRNA cancer immunotherapy. For certain settings, we have multiple opportunities with the aim to change the standard of care and move forward with our combination strategy. At the core of this tumor-based oncology strategy is pumitamig, our investigational bispecific immunomodulator targeting PD-L1 and VEGF-A, now in development with our partner BMS. In lung cancer, we are now running four registrational programs for pumitamig. ROSETTA-Lung 01 in first-line extensive stage small cell lung cancer, ROSETTA-Lung 02 in first-line non-small cell lung cancer, where global phase II data were presented at ASCO. ROSETTA-Lung 202, our pivotal trial in first-line PD-L1 high non-small cell lung cancer is now enrolling. ROSETTA-Lung 201, our pivotal trial in unresectable Stage 3 non-small cell lung cancer is also underway. We are generating novel combination data to inform the first wave of combination trials with registrational intent. Zooming in on pumitamig.

Here we again have pioneered by delivering the first global phase II data for a PD-L1 VEGF bispecific in first-line non-small cell lung cancer. At ASCO in June, we presented phase II data from ROSETTA-Lung 02, our global randomized phase II/III trial evaluating pumitamig in combination with chemotherapy in patients with previously untreated advanced non-small cell lung cancer. In 40 evaluable patients with both squamous and non-squamous histology, pumitamig plus chemotherapy demonstrated robust clinical activity with unconfirmed and confirmed overall response rates for combined doses of 72.5% and 62.5% respectively. Two features of this data deserve particular emphasis. First, the encouraging activity observed across PD-L1 expression levels is noteworthy. Second, the particularly strong response rate in PD-L1 low disease across histologies. This includes patients with PD-L1 TPS less than 1%, who represented approximately 58% of patients in this cohort, a subgroup typically with poor response to anti-PD-1, PD-L1 treatment.

In that population, the confirmed objective response rate was 47.6%. In patients with TPS between 1% and 49%, it was 77.8%, and all six patients with TPS 50% or above responded. The safety profile was manageable in both histologies with no new safety signals. These data support the ongoing global phase III program for pumitamig in lung cancer. The robust clinical responses across PD-L1 strata align with our expectations. It speaks to the potential of pumitamig to confer benefit in the all-comer patient population, including the PD-L1 low expression levels where unmet medical need is high. The ROSETTA-Lung 02 trial is currently recruiting in its phase III portion, and we look forward to presenting additional phase II data from this trial as the data mature.

The central question in the PD-1, PD-L1, VEGF class has been whether the clinical activity observed in trials conducted in China would be consistent with the data in global populations. We have been able to address that question with our own asset across three key tumor types in phase II trials. Firstly, in first-line small cell lung cancer. The China phase I/II demonstrated a disease control rate of 94% and a confirmed overall response rate of 82%. With the global phase II trial, we showed a disease control rate of 100% and a confirmed objective response rate of 76%. There is the first-line non-small cell lung cancer indication. We observed in the China monotherapy phase I/II, a confirmed objective response rate of approximately 47% in PD-L1 positive patients.

In the global phase II of pumitamig plus chemotherapy, which includes a PD-L1 unselected population, we saw a confirmed objective response rate of approximately 63%. In TNBC, the disease control rate was 92% in both the trials conducted in China and globally. In the China phase I/II, in first-line TNBC, we reported a confirmed objective response rate of approximately 74%, and in the global phase II cohort, which included a heterogeneous population of first- and second-line patients, we reported a confirmed objective response rate of approximately 62%, as expected given the treatment line population. Across these three tumor types of high unmet need, we are observing a meaningful consistency between the data generated in China and globally. While cross-trial comparisons must be interpreted with caution, we are encouraged by this cross-regional consistency. This gives us increased confidence in the global potential of pumitamig.

We are advancing multiple pivotal phase III programs to confirm these signals. As covered here on our tumor map slide, we are deploying multiple modalities to tackle lung cancer. gotistobart is a critical component of that map. As a reminder, gotistobart is our selective TREG-depleting antibody targeting CTLA-4, developed in collaboration with our partner, OncoC4. We are advancing gotistobart through the pivotal Stage 2 of PRESERVE-003, our global phase III in patients with metastatic squamous, non-small cell lung cancer who progressed following platinum-based chemotherapy and PD-L1 inhibitor treatment. This is a setting with very few effective options and poor prognosis. Gotistobart's differentiated mechanism of selectively depleting regulatory T-cells in the tumor microenvironment is designed to re-engage the immune system even after prior checkpoint inhibitor exposure. Earlier this year at ELCC, we presented updated data from the non-pivotal Stage 1 of PRESERVE-003, our global phase III trial.

The data are very encouraging. The 12-month PFS rate of 25% for gotistobart versus zero for docetaxel is a signal of durable disease control. gotistobart reduced the risk of death in this IO pre-treated 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, versus 30% in the docetaxel arm. The safety profile was consistent with the previously established profile for gotistobart, with no new signals of concern. We expect to present longer follow-up data at the World Conference on Lung Cancer next month. Based on current event accrual projections, we expect to conduct the first interim analysis from the pivotal stage of the trial towards the end of this year.

At ASCO this year, we presented overall survival data from the phase II study evaluating gotistobart in combination with pembrolizumab in ovarian cancer patients who had received prior platinum-based chemotherapy. The data showed a compelling and differentiated signal with a median overall survival of 18.9 months. Together, these data reinforce the potential of gotistobart to provide an extended overall survival benefit and serve as a potential chemo-free treatment option for lung patients. I will now turn to LFD, or BNT324, our B7-H3-targeted ADC developed in collaboration with DualityBio. B7-H3 is overexpressed across multiple tumor types, including prostate cancer, non-small cell lung cancer, small cell lung cancer, and others. The target biology, combined with the pharmacology of a Topo 1 inhibitor, ADC with drug to antibody ratio of six, positions LFD as a potentially versatile oncology asset across a wide range of solid tumors.

More than 1,000 patients have now been treated with LFD across more than 10 tumor types, including 400 patients treated with LFD in combination with pumitamig. The growing body of clinical evidence demonstrates anti-tumor activity across multiple indications with a favorable safety profile. This quarter, we dosed our first patient in the phase III clinical trial for LFD, evaluating it against docetaxel in patients with taxane-naive metastatic castration-resistant prostate cancer. Prostate cancer is our first phase III indication for LFD, and it represents one of the strongest B7-H3 expression profiles of any tumor type. The trial targets the patient population with substantial unmet need following progression on second-generation androgen receptor pathway inhibitors. In parallel, LFD is being evaluated in combination with pumitamig across multiple phase I/II programs. These results will help inform the optimal clinical design for upcoming registrational combination trials.

We expect to present some of these data at a medical conference later this year. Moving now to our portfolio of innovative mRNA cancer immunotherapies, which aim to activate and educate the immune system with precision. Our individualized neoantigen-specific immunotherapy, autogene cevumeran, developed in collaboration with Genentech, is advancing into ongoing randomized phase II trials. In adjuvant ctDNA Stage 2 high risk or Stage 3 colorectal cancer, we have a phase II trial evaluating autogene cevumeran monotherapy against the standard of watchful waiting. Enrollment is now complete, and in June, an interim analysis based on the centrally assessed primary endpoint of disease-free survival was reviewed by the independent Data Safety Monitoring Board with the recommendation to continue the trial without modification. The study will continue as planned per protocol, and we will remain masked to the data until the final analysis.

The data readout from the final analysis of this trial is event-driven and expected in 2027. In adjuvant pancreatic cancer, recruitment for the phase II IMcode-003 trial is well underway. Data from a phase I investigator-initiated trial, including a six-year update presented at AACR this year, continue to demonstrate durable immune responses against the encoded neoantigens for up to six years, evidence that supports our therapeutic rationale in the adjuvant and minimal residual disease setting. On our FixVac platform, BNT113, our off-the-shelf HPV16-targeting immunotherapy, is advancing in the AHEAD-MERIT phase II/III trial in combination with pembrolizumab as a first-line treatment for patients with PD-L1-positive, HPV16-positive head neck squamous cell cancer. A phase III interim analysis is expected for PFS this year.

For BNT116, our mRNA immunotherapy targeting multiple non-small cell lung cancer-associated antigens, we expect to present data at WCLC 2026 from Cohort 6 in combination with cemiplimab and chemotherapy. These programs reflect our conviction that mRNA cancer immunotherapy, particularly in combination with checkpoint inhibition, can deliver meaningful benefit in defined patient populations. In closing, today's review underscores the significant progress across our portfolio. We have reached multiple key milestones and continue to execute on plan in 2026 and beyond. Within our late-stage programs, we anticipate three further readouts this year. Gotistobart in squamous non-small cell lung cancer, our FixVac immunotherapy BNT113 in head and neck cancer, and T-PAM in breast cancer. For gotistobart, we expect a first interim analysis in late 2026 based on the projected event accrual rates. This initial review by the independent Data Monitoring Committee is intended as an early checkpoint before the next pre-planned interim analysis.

For BNT113, based on current event accrual projections, we expect a phase III interim analysis for progression-free survival later this year. Overall survival, which is the trial's other core primary endpoint, is not expected to be mature at this interim. T-PAM is currently being advanced in two pivotal clinical trials, one in second-line endometrial cancer and one in HER2-low hormone receptor-positive metastatic breast cancer. The candidate has generated encouraging data to date in both indications. With the primary analysis in breast cancer expected in the fourth quarter of 2026, we will determine the optimal regulatory pathway based on aggregated data across both indications. With this data-driven approach, we aim to pursue a value optimization strategy for T-PAM in an evolving treatment landscape while prioritizing opportunities where we can deliver significant benefit for patients.

Following our mid-year review of upcoming late-stage milestones, we have updated the expected timing for the phase III pumitamig trial in triple-negative breast cancer in China and for the phase II gotistobart trial in second-line castration-resistant prostate cancer, both of which are now expected in 2027. With regards to our earlier-stage novel/novel readouts, we have already published data on some of those combinations and expect more soon. I want to highlight one data set that is strategically significant for our ambitions in lung, the upcoming readout for the phase I/II trial evaluating pumitamig in combination with BNT324, our B7-H3 ADC, across advanced non-small cell lung cancer and small cell lung cancer. This will be the first clinical data for a PD-L1 VEGF-A bispecific antibody in combination with an antibody drug conjugate in lung cancer.

The combination brings together two mechanistically distinct and potentially synergistic approaches, the immune reactivation enabled by pumitamig with the targeted cytotoxic payload of BNT324. We execute these earlier combination studies to provide the signal seeking evidence we need to inform and potentially de-risk our next steps. This data generation will guide the entry of our novel/novel combination strategy into the pivotal stage and it is the foundation of the next chapter towards BioNTech's growing leadership in oncology. With that, I will now turn the presentation over to our CFO, Ramon Zapata, for the financial update.

Thank you, Özlem, and a warm welcome to everyone joining us. I will cover three topics today. Firstly, our second quarter and first half 2026 financials. Secondly, our full year 2026 financial guidance. Lastly, the execution of our share purchase program announced in May this year as part of our capital allocation strategy. Note that all figures will be in EUR unless otherwise stated. Starting with the second quarter financial performance. Revenues for the second quarter of 2026 were EUR 106 million, compared to EUR 261 million in the prior year quarter. This decline mainly reflects lower demand for our COVID-19 vaccine in the U.S. In addition, the prior year quarter was positively impacted by a one-time revenue effect. This related to a compensation payment from Pfizer opting out from our shingles vaccine development program. Moving to R&D.

Adjusted R&D expenses decreased to EUR 477 million from EUR 509 million in the prior year quarter. This change mainly reflects the execution of our disciplined prioritization across the portfolio. Lower spending on unfocused programs, together with favorable cost-sharing effects from our collaboration partners, supported an efficient cost structure. At the same time, we continue to invest in our prioritized immuno-oncology and ADC programs, including pumitamig and gotistobart. Moving to SG&A. SG&A expenses on an adjusted and IFRS basis were EUR 198 million, compared to EUR 137 million in the prior year's quarter. This increase was mainly driven by a global initiative on scaling our processes and ERP infrastructure to strengthen efficient operational execution and our ongoing pre-launch activities for late-stage products. Our cost base in 2026 also reflects the inclusion of CureVac operations post-merger.

At the same time, we continue to realize meaningful savings through pipeline prioritization measures and enhanced cost discipline across the organization. When comparing IFRS and adjusted results overall, the key adjustments are as follows. Within R&D expenses, the difference is driven by impairment charges related to intangible assets outside our focused programs. Within other operating results, the difference relates to actions we are taking following our manufacturing footprint consolidation, the decision we announced in May. The costs are mainly employee-related expenses and impairment charges. These charges reflect our progression from announcing that decision to actively executing it. While these costs weigh on our near-term results, they are a deliberate investment in reshaping our future cost base. We are positioning the company for enhanced operational efficiency and expect sustainable savings going forward.

Importantly, we are acting from a position of strength, allowing us to make these adaptations proactively since we maintain a strong financial position of EUR 16.6 billion in cash equivalents, and security investments at the end of the second quarter, compared to EUR 16 billion as of June 30th, 2025. This empowers sustained investments across our pipeline, our preparations for commercialization, and in our long-term goal to become a global multi-product biopharmaceutical company. Before we go into our full-year guidance, let's first turn from the quarter review to our year-to-date financials, comparing the performance of the first half of 2026 with the prior year period. The drivers are mostly in line with the factors I have described for the quarter. In the first half of 2026, revenues were EUR 224 million.

While we expect the seasonal phasing of the COVID-19 vaccine business throughout the year, as mentioned, this decline mainly reflects lower demand in the U.S. Secondly, lower adjusted R&D expenses of EUR 1,004 million in comparison to the prior year period reflect our focused R&D investments approach in our prioritized programs and positive cost-sharing effects with our collaboration partners. Thirdly, higher adjusted SG&A expenses of EUR 349 million reflect the ongoing pre-launch activities and commercial buildup for our first oncology launches, as well as costs newly incorporated in 2026, like our ERP infrastructure initiative that I already mentioned.

As we look to the second half of the year, we are taking a disciplined view on our full-year outlook. We anticipate changes in some of the factors driving our business and are revising our previously disclosed full-year 2026 financial guidance. We now expect revenues in the range of EUR 1.6 billion-EUR 1.9 billion. Adjusted R&D expenses in the range of EUR 2 billion-EUR 2.3 billion, and adjusted SG&A expenses remaining unchanged in the range of EUR 700 million-EUR 800 million. I will now detail the factors driving our revised revenue guidance. While COVID-19 has been endemic for some time, we continue to monitor the evolving vaccine market and expect softer-than-anticipated global COVID-19 vaccine demand.

In addition, the European Medicines Agency recommendation issued in May allows the use of the previous year's vaccine formula as an alternative to the newly recommended XFG variant-adapted vaccines. This year, for the first time, Germany will utilize previously manufactured on-stock vaccine doses for the upcoming vaccination season. As a result, we expect significantly reduced sales in Germany this week. Also, the timing of milestone related revenues resulting from an out-licensed R&D program, which are no longer expected in 2026. In terms of revenue phasing through the rest of the year, we continue to expect the majority of our 2026 revenues to be realized in the second half of the year, specifically in the third quarter when we expect to recognize the EUR 613 million BMS collaboration payment.

Moving to operating expenses, we have revised our adjusted R&D expenses to the range of EUR 2 billion-EUR 2.3 billion. This reflects our focus on optimizing our R&D resources and continued cost discipline as we prioritize the development of our late-stage clinical pipeline. We expect these cost savings based on prioritization and optimization to continue into future years. Our assumption for adjusted SG&A expenses remain unchanged in the range of EUR 700 million-EUR 800 million as we continue to gradually build out our commercial capabilities. Despite these changes, our strong balance sheet and disciplined cost management position us well to continue investing strategically.

Turning to my final slide, I'm giving you an update on the execution of our capital allocation framework, which we presented during our first quarter earnings call. Our approach remains clear and disciplined, centered on three priorities. First, focus R&D investments. Second, disciplined capital deployment. As well as third, optimized operational efficiency and sustainable value creation. We are executing against these priorities with consistency and intent. As shown on the slide, with respect to the second pillar, we started the execution on our up to $1 billion share repurchase program and repurchased an amount of $152 million so far. This execution reflects our conviction in the intrinsic value of BioNTech, while importantly, we retain full optionality to advance our pipeline, execute on partnerships, and pursue corporate development opportunities.

Taken together, our strong financial position on these three pillars of our capital allocation strategy continue to serve as a clearly defined long-term objective to become a global multi-product company, addressing the high unmet medical needs of cancer patients worldwide. On a final note, regarding the announcement of Ugur and Özlem's new company and potential contributions by BioNTech, the discussions are ongoing, and as with all potential deals, BioNTech's guiding principle in the negotiations is to maximize value for patients and our shareholders. With that, I will hand back to the operator to open the call 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 kindly ask analysts to limit themselves to one question per person. We will now take our first question from the line of Cory Kasimov from Evercore ISI. Please go ahead.

Hey, good morning, everyone. Thank you for taking my question. I wanted to ask on BNT324, the B7-H3 ADC candidate, and what data that you've seen that prompted the decision to choose metastatic CRPC as the first indication for phase III development, and kind of what gives you the confidence that you have a competitive ADC construct here? Thank you very much.

Thank you, Cory. Özlem, will you please care to answer the question from Cory?

Hi, Cory. What is very encouraging for our B7H3 is the combination of durable disease control, plus the so far excellent safety profile that we are seeing for this B7H3. To remind you, various ADCs come either with challenges related to hematosuppression, stomatitis, or ILDs. With our B7H3 ADC, we see a very tolerable safety profile, allowing us not only to get temporary disease control with this compound but enable long-term application. We have a range of patients who have been dosed now for more than a year, without significant ILD events observed so far

If I may add to that, Cory, we have presented this data at ASCO 25 and ASCO GU 26, also follow-up data from our heavily pretreated population which we have tested in a phase I/II study, which is still ongoing.

Great. Thank you very much.

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

Hi, good morning. Thanks for taking my question. Can you just give us a sense about the data updates that are expected for the remainder of the year? Can you just remind us how your updated guidance for what data to expect has changed since earlier in the year? Specifically, are we still expecting pumitamig phase III data for triple-negative breast cancer this year? Should there be any expectation that this data would be presented in a press release versus just released at a medical meeting? Thanks.

With regard to changed milestones and specifically also the China interim analysis testing for first-line TNBC, we are continuously monitoring events, and the data readouts are event-driven. In our China TNBC study, we observed that the events take longer, so the readout is pushed out to 2027, which in principle is also actually a good sign for us. Another study which will come a bit later with regard to its readout is our pumitamig study in first-line CRCC in China, which is a phase II study. Here we have decided to look in more chemo combinations than originally planned, so they are added on top of this. Another readout, which is now projected for 2027, is the gotistobart phase II in second-line positive prostate cancer. The reason is that we want to see more maturity.

Major milestones and readouts this year are the gotistobart interim analysis for part two, meaning the pivotal part of our non-small cell lung cancer study in squamous non-small cell lung cancer, second-line in combination with docetaxel. We are excited about that. Pardon?

Control.

Yes, as a control. We are excited about that. The BNT113 trial, where we expect the phase III interim analysis for progression-free survival later this year, and the T-PAM study in HER2-low hormone receptor-positive metastatic breast cancer.

Thank you. We will now take the next question from the line of David Dai from UBS. Please go ahead.

Great. Thank you, sir, for taking my questions. Just on pumitamig plus chemo in front-line non-small cell lung cancer, we've seen some encouraging phase II data so far, especially showing translation from China to global. I'm just curious, what additional preclinical evidence or, let's say, efficacy, safety, or biomarker features give you confidence that pumitamig can be differentiated versus PD-1 versus other VEGF/PD-1 approaches?

Maybe I take the question. With regard to the bispecific class, they have one thing in common, that they both, due to the bispecific activity, enable either improved binding to PD-1 or to PD-L1. We have one feature which we believe is differentiating with our molecule binding to PD-L1 in the tumor microenvironment. This gives us, in principle, the opportunity to have a double tumor microenvironment-directed compound. Whether this translates at the end of the day to a differentiated efficacy, we have to see. There are, of course, no head-to-head trials here. We believe that the true differentiation will come with the overall portfolio in which we combine pumitamig not only with chemotherapy but with a differentiated set of ADCs and other compounds.

Thank you. We will now take our next question from the line of Daina Graybosch from Leerink Partners. Please go ahead.

Hi, thank you for the question. I wonder if you could help us understand your TPAM comments more. Give us the details. Is there a specific outcome or threshold in the HER2-low breast cancer you're looking to exceed, and how various outcomes from that study could impact your strategy forward with regulators and potentially launching TPAM?

Our TPAM program, as you know, is broader. We are developing TPAM in endometrial cancer, second line, and in breast cancer with our phase III trial in hormone receptor-positive HER2-low. We have, what is also important to note, ongoing signal-seeking studies of TPAM with pumitamig in a different breast cancer patient segment, which is an important part of the strategy. Ultimately, our ADCs are part of our portfolio because of their potential to further elevate pumitamig and allow us to leapfrog. With regard to our breast cancer study, the benchmarks are, if you compare with published benchmarks, median PFS in the range of 9-13 months, and an 18-month median OS of around 85%, according to other studies in this indication and approved treatments.

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

Hey, everyone. Thanks for the question. Just had a bigger picture one on capital deployment. You guys have a substantial cash position, you're also streamlining the pipeline with the cost savings initiative. On the latter, I guess, can you talk a little bit about what your sort of North Star is in this? Is it deprioritizing overlapping indications? Are you eliminating some earlier stuff based on competitive landscape? I just want to get a sense for the strategy there. Thank you.

Hi, thank you for the question. I think because of the cash position that we have and the strength of our balance sheet, we are able to take on the number of pivotal and phase III trials that we are running now with pumitamig. The strategy with our partners is to add on these efforts as much as possible to really widen the net of all the indications where we can use pumitamig and the novel combinations. I would say that our capital allocation priorities remain unchanged. We continue to fully fund our priority pipeline and the commercial capabilities needed to support these upcoming launches. Second, we maintain the flexibility to pursue attractive external opportunities that have the potential to strengthen our portfolio or our capabilities. Third, we continue to return capital to shareholders through the authorized share buyback program that we announced last quarter.

On your comment on portfolio optimization, we continuously review our pipeline to ensure that the resources are focused on the areas with the greatest strategic and value creation potential. That means continuing to invest behind our core programs while reviewing or stopping investments in non-core assets where we feel it's appropriate.

Maybe I can add here another aspect. This year is the year of combination trials where we evaluate pumitamig in combination with our larger ADC portfolio. The results of the studies, of course, will provide further prioritization of the best combinations, thereby reducing maybe the investment in some of the ADCs in certain indications. The overlap at the moment is by purpose, yeah, to identify the winners. In 2027, we expect that we will have identified the winners and engage into several phase III clinical trials, including assets from our partner, BMS.

Great. Thank you.

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

Hey, thanks so much. You have three interim phase II readouts expected in the second half of this year. You have your HER2, your CTLA-4, and your Head and Neck cancer vaccine. Can you talk about your confidence on a positive interim analysis for each of these programs? Is there a particular program where maybe the team's internal view is particularly bullish? Thanks so much.

It's a difficult question. We have to see the data. Yeah. We are positive. We have, of course, positive expectations for each of the trials. If the data for gotistobart that we have seen in the first part of the phase III clinical trial is recapitulated, this would become a game-changing result in this indication. Everyone knows that docetaxel remained unbeaten for decades now, and this would be the first time that if the data are recapitulated, we would have a significant benefit with a mono compound as compared to the standard of care.

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

Hi. Thanks for taking the question. Appreciate the update on your iNeST CRC data coming next year, but was wondering if you could help us think about potential read-through from the Moderna/Merck I.N.T. adjuvant melanoma phase III data that we might get this year. What would you be looking for in that data to give you confidence in your own iNeST program? Thank you.

In terms of biology and indication, we don't see any read-through opportunities. Melanoma versus colorectal cancer, these are very different biologies and indications and responsiveness to immunotherapy and, in particular, antigen-specific T-cell antigens. We remain committed to the way we are conducting together with our partner, Genentech our program focusing on adjuvant settings, focusing also on cancers where checkpoint inhibition immunotherapy has a lower probability of success and does not serve the medical need. You know new antigen vaccines are not created equal. It's difficult to read from one platform to the other.

Thank you. We will now take the next question from the line of Jessica Fye from JPMorgan. Please go ahead.

Great. Good morning, guys. Thanks for taking my question. Ramon, I was hoping you'd help us out with the EUR 400 million reduction to guide to the midpoint. Can you just quantify how much of the change was driven by the milestone pushout versus the German decision to use existing inventory and how much is just softer COVID-19 demand? What specifically was the partner milestone that was pushed out? Thank you.

Thank you for the question. Most of the adjustment of the guidance is a reflection of the weaker COVID-19 vaccination rates and the current regulatory and public health environment. It is really incorporating the latest input from our partners and the teams that are operating in our key markets. I would like to remind you that the COVID revenue is back-end weighted into the late Q3 and Q4. This will only reflect until then. Also that we're expecting approximately EUR 613 million revenues from the BMS collaboration that is also giving us a good uplift for the second half of the year. Based on the information currently available, we believe that this revised range is appropriate.

In relation to the comment of license milestone that we were expecting, yeah, we were expecting that as well at the second half of the year, it's not the key driver of the revenue adjustment. It's mainly lower demand across every market. Specifically for Germany, it impacts us a little bit different because Germany is a direct market versus the other countries that are Pfizer-managed markets. We get the impact on our revenues a little bit more acute than versus the other markets. I would say if you would think about percentage, 80% is COVID-related completely, the rest is the loss of the out-licensed milestones that we would expect.

Thank you.

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

Great, thank you. I wanted to ask about ROSETTA-Lung 02. Clinicaltrials.gov is showing data in 2029, but you changed the endpoint now to PFS and not OS. Is there any chance that we can get this data potentially earlier? Any sense when you might finish enrollment? Thank you.

We can't at the moment, not speculate on when to expect the data. As compared to waiting for OS, it will be obviously earlier that PFS reads out, but we don't have any guidance for the final readout yet.

Maybe can you just remind us when you changed the endpoint, did the interim analysis change in any way? Anything you can share would be great. Thank you.

With the change endpoint and the interim analysis for PFS, they become now an opportunity to file if it's positive. We can't still, so as said, it is expected to read out earlier than the interim OS, okay? We can't at the moment say when we are going to expect, because this is again an event-driven trial, and it's the first time in this indication that we evaluate this large population.

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

Hi, this is Haven on for Evan. Thanks for taking our question. Just one from us. As you think about the broader opportunity for pumitamig, can you discuss how the asset might be differentiated in MSS, CRC given the historically limited efficacy of checkpoint inhibitors in the indication and immune cold phenotype of tumors? Also, what gives you confidence that Pumi's mechanism could overcome these past challenges? Thank you.

To provide, because we do not yet have data in CRC, the strongest evidence that pumitamig or the bispecific class is differentiated comes from the observations of objective response rate, but also durable disease control in patient populations who are PD-L1 negative. For example, in TNBC, we have documented data showing more or less the same rates of objective response in the patient, in PD-L1 positive, PD-L1 low positive, and PD-L1 high positive patient populations. CRC is an indication in which checkpoint blockade was not successful. We have now this combination, and we have to see from our interim analysis, which is coming in 2027. We are going to test, or we are testing at the moment, different chemotherapy combinations, whether this translates to better data as compared to traditional benchmarks, the chemotherapy alone.

The broader pumitamig opportunity again is based on the one side, improving response rate and durable disease control and OS in indications where checkpoint blockade PD-1 is approved. Opening up indications in which PD-1 treatments are not approved. As a third component, combining pumitamig as a potential next standard of care with a new generation of ADCs that allow disease control even in advanced disease with a good safety profile.

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

Great, thank you very much for taking my question. I have a question regarding squamous versus non-squamous. There will be a lot of data coming this year from competitors as well. The first trial that is reading out is for squamous cell lung cancer for VEGF/PD-1. My question is, how much read-through there could be for the non-squamous program if squamous were to be successful, and what specifically you would be looking at the competitor data to gain confidence in your own programs or think about the future trials. Thank you.

With regard to the read-through, in principle, these histologies are like different diseases, right? We would be very cautious to read from data in squamous to non-squamous, or vice versa. We really need to produce the clinical data for both histologies. And in our ROSETTA-Lung 02 trial, for example, we have therefore also separated both histologies in sub-trials.

On the other side, our own data, but also the data coming from ivonescimab indicate that in both indications, PFS is improved. We have seen now in the recent update that the improved PFS appears also to translate into OS signals in other indications. We are cautiously optimistic that we will see in both indications PFS benefit and OS benefit.

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

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.