BioNTech Q2 2026 Earnings Call Transcript

Quartr
Provided by Quartr
August 4, 2026

Key Takeaways

  • Positive Sentiment: Oncology pipeline advanced with multiple pivotal programs underway, including the first Phase III trial for the B7-H3 ADC elfetabart drozuntecan (BNT324) in metastatic castration-resistant prostate cancer. BioNTech expects three additional late-stage readouts in 2026.
  • Positive Sentiment: Pumitamig plus chemotherapy produced a confirmed response rate of 62.5% in global Phase II first-line NSCLC, including a 47.6% response rate among patients with PD-L1 expression below 1%; the results support ongoing Phase III development across lung cancer settings.
  • Neutral Sentiment: BioNTech appointed Guido Oelkers as CEO effective by February 1, 2027, positioning the company for its transition from a research-focused organization to a multi-product commercial biopharmaceutical company while co-founder Ugur Sahin supports the leadership transition.
  • Negative Sentiment: 2026 revenue guidance was reduced to €1.6 billion–€1.9 billion, primarily due to weaker-than-expected COVID-19 vaccine demand and Germany’s use of existing inventory; first-half revenue was €224 million, down substantially year over year.
  • Positive Sentiment: BioNTech ended the quarter with €16.6 billion in cash and investments and has repurchased $152 million of shares under its authorized $1 billion buyback program, while maintaining funding for priority pipeline programs and potential external opportunities.
AI Generated. May Contain Errors.
Earnings Conference Call
BioNTech Q2 2026
00:00 / 00:00

Transcript Sections

Skip to Participants
Operator

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.

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 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.

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

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.

Helmut Jeggle
Helmut Jeggle
Chairman of the Supervisory Board at BioNTech

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.

Helmut Jeggle
Helmut Jeggle
Chairman of the Supervisory Board at BioNTech

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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Operator

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.

Cory Kasimov
Cory Kasimov
Analyst at Evercore ISI

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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

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

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.

Cory Kasimov
Cory Kasimov
Analyst at Evercore ISI

Great. Thank you very much.

Operator

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

Tazeen Ahmad
Tazeen Ahmad
Analyst at Bank of America

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.

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

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.

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

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?

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

Control.

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

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.

Operator

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

David Dai
David Dai
Analyst at UBS

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?

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Operator

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

Daina Graybosch
Daina Graybosch
Analyst at Leerink Partners

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?

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

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.

Operator

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

Geoff Meacham
Geoff Meacham
Analyst at Citigroup

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Geoff Meacham
Geoff Meacham
Analyst at Citigroup

Great. Thank you.

Operator

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

Akash Tewari
Akash Tewari
Analyst at Jefferies

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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Operator

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

Terence Flynn
Terence Flynn
Analyst at Morgan Stanley

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.

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

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.

Operator

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

Jessica Fye
Jessica Fye
Analyst at JPMorgan

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Ramon Zapata
Ramon Zapata
CFO at BioNTech

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.

Jessica Fye
Jessica Fye
Analyst at JPMorgan

Thank you.

Operator

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

Yaron Werber
Yaron Werber
Analyst at TD Cowen

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.

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

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.

Yaron Werber
Yaron Werber
Analyst at TD Cowen

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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Operator

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

Analyst at BMO Capital Markets

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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Operator

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

Mohit Bansal
Mohit Bansal
Analyst at Wells Fargo

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.

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

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.

Ugur Sahin
Ugur Sahin
CEO and Co-Founder at BioNTech

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.

Operator

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

Executives
    • Doug Maffei
      Doug Maffei
      VP of Strategy and Investor Relations
    • Helmut Jeggle
      Helmut Jeggle
      Chairman of the Supervisory Board
    • Ugur Sahin
      Ugur Sahin
      CEO and Co-Founder
    • Özlem Türeci
      Özlem Türeci
      Chief Medical Officer and Co-Founder
    • Ramon Zapata
      Ramon Zapata
      CFO
Analysts
Powered by Quartr