BioNTech SE American Depositary Share 2026 Q2 Earnings Call

Please go ahead. Thank you, operator.

Good morning and good afternoon. Thank you for joining BioNTech second quarter 2026 earnings call. As a reminder, the slides we will be using during this call and the corresponding press release can be found in the investor section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission, or SEC. Forward-looking statements on this call are subject to significant risks and uncertainties and speak only as of the date of this conference call. We undertake no obligation to update or revise any of these statements. On slide three, you can see the agenda for today's call.

I am joined by the following members of BioNTech's management team: Ugur Sahin, Chief Executive Officer and co-founder, Özlem Türeci, Chief Medical Officer and co-founder, and Ramon Zapata, Chief Financial Officer. Also available for the Q&A portion of the call is Anne Marie Hannekamp, Chief Commercial Officer. Related to yesterday's Chief Executive Officer announcement, we will also be joined today by Helmut Jeggle, Chairman of BioNTech Supervisory Board. With this, I will hand the call over to Helmut.

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

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

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

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

Notably, in our GU tumor area, we dosed the first patient in our phase III trial, evaluating our B7-H3 ADC, elfetabart drozuntecan, formerly known as BNT324, in metastatic castration-resistant prostate cancer. BioNTech is well-positioned for the next phase. With a growing pipeline of potentially registrational trials, strong partnerships, and financial strength, we are on track to become a diversified multi-product company by 2030. We are targeting more than 17 late-stage and pivotal trial readouts through 2030 and beyond, spanning multiple tumor types and different lines of treatment. Our progress to date sets us up for an impactful second half of 2026. We enter the remainder of this year with momentum and diligent execution as we continue to progress towards our long-term vision. With this, I will hand over to Özlem for an update on our oncology execution.

Thank you, Ugur. I'm glad to be speaking with everyone today. Our ambition is to address the full continuum of cancer, utilizing the approaches that Ugur outlined. We have defined a tumor-focused strategy to address significant unmet medical need where our novel combinations can extend survival outcomes for patients and maximize the potential of our pipeline. As such, we are advancing multiple assets from our multimodal oncology pipeline into late-stage development. During the first half of 2026, we made progress across our pipeline, and I'll cover some of these updates today. I'll begin with lung cancer, which is one of the cancers of highest unmet medical need in the tumor area where we have the broadest and most diverse coverage. We are aiming to tackle unmet medical needs at every stage of the lung cancer patient journey. Our lung cancer strategy covers various disease stages, settings, and enlists various modalities.

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

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

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

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