BioNTech Q1 2026 Earnings Call Transcript

Quartr
Provided by Quartr
May 5, 2026

Key Takeaways

  • Positive Sentiment: BioNTech is pivoting to a tumor‑centric, combination‑first oncology strategy with a focus on high‑incidence cancers and aims for more than 17 late‑stage/pivotal readouts through 2030 and five additional late‑stage readouts in 2026, signaling large future catalyst potential.
  • Positive Sentiment: Early clinical data support the approach — pumitamab Phase I‑B/II‑A showed a 46% confirmed ORR (median PFS 13.6 months, median OS 27 months) and a 71% ORR in PD‑L1 high squamous NSCLC, underpinning the ongoing global Phase III ROSETTA LUNG‑02 program.
  • Positive Sentiment: Gotistobart’s non‑pivotal data are encouraging — PRESERVE‑003 interim showed a 54% reduction in risk of death versus docetaxel (HR 0.46) and a 12‑month PFS of 25% vs 0, but management notes the sample is small and requires validation in the pivotal stage later this year.
  • Positive Sentiment: Strong balance sheet and shareholder returns — BioNTech ended Q1 with EUR 16.8 billion in cash/securities, reaffirmed 2026 guidance (EUR 2.0–2.3bn revenues) and announced an opportunistic $1 billion ADS share buyback, supporting capital allocation alongside R&D investment.
  • Neutral Sentiment: Management plans to consolidate manufacturing (potentially exiting sites in Idar‑Oberstein, Marburg and Singapore), affecting ~1,800 positions while targeting about EUR 500 million in recurring annual savings; near‑term execution risks and one‑time charges are possible even as long‑term efficiency improves.
AI Generated. May Contain Errors.
Earnings Conference Call
BioNTech Q1 2026
00:00 / 00:00

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Operator

Welcome to BioNTech's First Quarter 2026 Earnings Call. I will now hand the call over to Doug Maffei, Vice President, Strategy and Investor Relations. Please go ahead.

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

Thank you, operator. Good morning and good afternoon. Thank you for joining BioNTech's First 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 three, you can find the agenda for today's call.

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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 Zapata, 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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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 three 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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

In 2026, we are expanding our novel combination strategy centered around pumitamig 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 pumitamig with obrixtamig. 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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

Our lung cancer strategy is built as a matrix across, firstly, disease stages and settings from resectable tumors to unresectable stage III 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 pumitamig 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 pumitamig, 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 pumitamig 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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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 pumitamig in lung cancer. The ROSETTA LUNG-02 trial is currently recruiting in its phase III portion, comparing pumitamig 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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

Obrixtamig redirects T-cells to kill DLL3-expressing tumor cells, while pumitamig 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 Treg modulator targeting CTLA-4, developed in collaboration with our partner, OncoC4, and it is designed to precisely address the patient population that sits beyond pumitamig'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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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 zero 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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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 one 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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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 EC-01 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 Breast-02 trial. A phase III interim analysis for this trial is expected later this year based on current event accrual projections.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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 eight patients who mounted an immune response to the immunotherapy, seven remained alive for up to six years after surgery and demonstrated persistent cytotoxic cancer-killing lymphocytes.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

In contrast, of the eight patients who did not exhibit an immune response, only two were still alive, with a median overall survival of 3.4 years. In adjuvant ctDNA positive stage II 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 HPV16-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, two 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 five more readouts.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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 Zapata, for the financial update.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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, pumitamig 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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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 United States 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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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 BMS, 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 BMS collaboration payment of EUR 613 million is expected to be recognized in the third quarter of 2026.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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 pumitamig, our ADC assets, mRNA immunotherapies, and their respective combinations, while reducing spend outside of those areas.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Operator

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

Daina Graybosch
Daina Graybosch
Analyst at Leerink Partners

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.

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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.

Operator

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

Jessica Fye
Jessica Fye
Analyst at JPMorgan

Great. Good morning. Thanks for taking my question. Just thinking ahead to DYNASTY Breast-02, 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?

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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.

Jessica Fye
Jessica Fye
Analyst at JPMorgan

I was asking for DYNASTY Breast-02, the HER2-low trial where we have benchmark data from ENHERTU.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

This is yes. This is Ugur. 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.

Annemarie Hanekamp
Annemarie Hanekamp
Chief Commercial Officer at BioNTech

I'll add. Hello, this is Annemarie, Chief Commercial Officer for BioNTech. We've always signaled that T-Pam 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'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 T-Pam in the breast cancer space as well. Again, a strategic asset that we predominantly also focus on in combination therapy.

Jessica Fye
Jessica Fye
Analyst at JPMorgan

Thank you.

Operator

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.

Tazeen Ahmad
Tazeen Ahmad
Analyst at Bank of America

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

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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 two 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.

Operator

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.

Manoj Eradath
Manoj Eradath
Analyst at Jefferies

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 OptiTROP-Lung04 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?

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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

Manoj Eradath
Manoj Eradath
Analyst at Jefferies

Yeah.

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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?

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

Could you just clarify the question?

Manoj Eradath
Manoj Eradath
Analyst at Jefferies

Yes. Merck, OptiTROP-Lung04 from the fact TMT 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.

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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 plus chemo. 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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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

Manoj Eradath
Manoj Eradath
Analyst at Jefferies

Thank you so much.

Operator

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

David Dai
David Dai
Analyst at UBS

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.

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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.

Operator

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.

Asad Haider
Asad Haider
Analyst at Goldman Sachs

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.

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

Okay, great. Thank you, Asad.

Asad Haider
Asad Haider
Analyst at Goldman Sachs

Yeah.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Operator

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.

Terence Flynn
Terence Flynn
Analyst at Morgan Stanley

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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 Ugur 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.

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

Yes.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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.

Annemarie Hanekamp
Annemarie Hanekamp
Chief Commercial Officer at BioNTech

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 nine 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.

Operator

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.

Evan Seigerman
Evan Seigerman
Analyst at BMO Capital Markets

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Operator

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.

Cory Kasimov
Cory Kasimov
Analyst at Evercore

Hey, it's Cory. Thanks for taking the question. I do have one 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?

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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?

Cory Kasimov
Cory Kasimov
Analyst at Evercore

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

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

It's HARMONi-6 was positive.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

Yeah.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

Yeah. With OS.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

Okay.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

How this would change our view.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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 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.

Cory Kasimov
Cory Kasimov
Analyst at Evercore

Got it. Thank you.

Operator

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

Mohit Bansal
Mohit Bansal
Analyst at 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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

Generally speaking, there are datasets, for example, pumitamig, small cell lung cancer, pumitamig, TNBC data, IVO, 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.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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.

Mohit Bansal
Mohit Bansal
Analyst at Wells Fargo

Okay.

Operator

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.

Analyst at TD Securities

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 gotis, 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.

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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, shall I pass over to you for these? And then, Annemarie.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

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, 12-18 months.

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

One of these readouts, for example, at ASCO, the ROSETTA Lung-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.

Annemarie Hanekamp
Annemarie Hanekamp
Chief Commercial Officer at BioNTech

Yeah, I would just add on the BMS and pumtamig 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 pumitamig for both BioNTech and Bristol Myers.

Analyst at TD Securities

Thank you so much.

Operator

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.

Jarwei Fang
Jarwei Fang
Analyst at Citigroup

Hey, good morning, guys. Thanks for the question. This is Jarwei 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.

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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, would you like to take the data question?

Özlem Türeci
Özlem Türeci
Chief Medical Officer and Co-Founder at BioNTech

Yes. I can take both, and thereafter, we can also get the commercial input here. No, we don't have outstanding data questions around T-Pam. 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.

Annemarie Hanekamp
Annemarie Hanekamp
Chief Commercial Officer at BioNTech

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.

Operator

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.

Harry Gillis
Harry Gillis
Analyst at Berenberg

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 II 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?

Harry Gillis
Harry Gillis
Analyst at Berenberg

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

Doug Maffei
Doug Maffei
VP of Strategy and Investor Relations at BioNTech

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. Ugur, I'll pass over to you for this one.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Harry Gillis
Harry Gillis
Analyst at Berenberg

Very clear. Thank you very much.

Operator

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

Executives
    • Annemarie Hanekamp
      Annemarie Hanekamp
      Chief Commercial Officer
    • Doug Maffei
      Doug Maffei
      VP of Strategy and Investor Relations
    • Ramon Zapata
      Ramon Zapata
      CFO
    • Ugur Sahin
      Ugur Sahin
      CEO and Co-Founder
    • Özlem Türeci
      Özlem Türeci
      Chief Medical Officer and Co-Founder
Analysts
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