BioNTech Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 4, 2025

Key Takeaways

  • Positive Sentiment: Phase II data for BNT327 in extensive-stage small cell lung cancer showed a median overall survival of 16.8 months, supporting global pivotal Phase III trials in small cell lung, non-small cell lung, and triple-negative breast cancers.
  • Positive Sentiment: Entered a global 50/50 co-development and co-commercialization collaboration with Bristol-Myers Squibb for BNT327, with a $1.5 billion upfront payment and up to $7.6 billion in milestones, bolstering both oncology pipeline and financial resources.
  • Positive Sentiment: Total Q2 revenues rose to €261 million from €129 million year-over-year, driven by higher COVID-19 vaccine collaboration and pandemic preparedness agreements, and the company maintained a strong cash position of €16 billion.
  • Negative Sentiment: The individualized mRNA therapy autogene cevumeran (BNT122) in combination with pembrolizumab did not meet its primary PFS endpoint in a Phase II melanoma trial, although a numerical trend in overall survival was observed.
  • Positive Sentiment: Preparing for the global rollout of the LP8.1 variant-adapted COVID-19 vaccine pending regulatory approvals, with data indicating improved immune responses against dominant and emerging sublineages.
AI Generated. May Contain Errors.
Earnings Conference Call
BioNTech Q2 2025
00:00 / 00:00

Transcript Sections

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Operator

Welcome to BioNTech's Second Quarter twenty twenty five Earnings Call. I would like to hand the call over to Doug Maffei, Vice President, Strategy and Investor Relations. Please go ahead.

Douglas Maffei
Douglas Maffei
VP, Strategy & IR and Head - IR at BioNTech

Thank you, operator. Good morning and good afternoon. Thank you for joining BioNTech's second quarter twenty twenty five earnings call. As a reminder, the slides we will use during this call and the corresponding press release can be found in the Investor Relations section of our website. On the next slide, you will see our forward looking statements disclaimer.

Douglas Maffei
Douglas Maffei
VP, Strategy & IR and Head - IR at BioNTech

Additional information about these statements and other risks are described in our filings with the US 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. I'm joined by the following members of BioNTech's management team, Ugar Shahin, chief executive officer and cofounder, Oslam Tureci, chief medical officer and cofounder, Ramon Zapata, chief financial officer, and Ryan Richardson, Chief Strategy Officer. With this, I'll hand the call over to Ugar.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

Thank you, Dax, and a warm welcome to you all as you join us today. Dag joined BioNTech recently as our new Head of Investor Relations, and I would like to welcome him to the company. As previously announced, Ramon Sataka joined last month as our new Chief Financial Officer and will be speaking on the call today. Ramon is a seasoned financial leader with a wealth of international pharmaceutical experience from companies including Novartis and Zando. With over twenty five years of experience, Ramon has a deep understanding of market and business dynamics, resource optimization, and high performing teams.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

We are delighted to have Ramon on board and look forward to working together in the coming months and years. Our long serving Chief Strategy Officer, Ryan Richardson, will depart BioNTech in September. I would like to thank Ryan for his many contributions and commitment as we develop BioNTech from a private clinical stage biotech into a NASDAQ listed fully integrated biotechnology company. Management board and I wish Ryan all the best as he embarks on the next chapter of his career. I will now continue with our overarching vision and strategy.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

As BioNTech has grown and evolved significantly over the years, our vision has remained unchanged, to translate science into survival by building an immunotherapy powerhouse and becoming a fully integrated biopharmaceutical company with multiple approved therapies. We believe that the future of cancer treatment and the ability to improve cure rates will be driven by combination therapies that combine compounds with synergistic mechanisms of action. Aligned to our vision, we are working to address the full continuum of cancer across different stages, from resected cancers, which are in the adjuvant stage and at risk of recurrence to early stage metastatic cancers, as well as the late stage cancers, which are refractory to multiple treatments. We have built a robust pipeline with compounds from different drug classes that are best suited to achieve this across a broad range of cancers, allowing for novel novel combination of next generation immunomodulators with targeted therapies and mRNA cancer immunotherapies. As a clear focus, we will continue to invest in our technologies and drug candidates that have the potential to improve outcomes for patients across a wide range of tumor types.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

We are focused on two priority pan tumor programs, our mRNA cancer immunotherapies, Sigvec and INEST, and our bispecific antibody BNT327 that targets PDL-one and VGFA. Both approaches have disruptive potential and align to our vision. We believe these programs could establish new standards of care, enhancing patient outcomes in multiple cancer indications globally. We are investing significantly in the clinical development of these programs across various cancer types and stages. At the same time, we are building commercial infrastructure to enable future launches in key markets and enhancing manufacturing capabilities to support both clinical trials and commercial supply.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

Moving now to our key achievements from this quarter related to our outlined strategy and vision. We believe BNT-three twenty seven has the potential to become a standard of care treatment across a broad range of tumor types, including those currently treated with checkpoint inhibitors and those where checkpoint inhibitors have previously not shown benefit. Core to our strategy is developing combinations of BNT327 with a broad range of potentially synergistic therapeutics. With such combinations, we may be able to improve the safety and efficacy profile, thereby unlocking better clinical outcomes for as many patients as possible in areas of high unmet medical need. Earlier this year, we closed the acquisition of BioThese, and with that, fully integrated BNT-two twenty seven into our pipeline.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

In order to significantly accelerate and broaden its clinical development, we entered into a global fiftyfifty co development and co commercialization collaboration with BMS in June. Since the announcement, our teams have collaborated closely to shape joint development plans to unlock BNT-two seven's full potential. We believe BNT-two twenty seven has both potential to be a next generation IO backbone. We will continue to drive its clinical development with the goal to establish a new standard of care for cancer patients across multiple tumor types. In the quarter, we also dosed the first patient in a new cohort evaluating our NS CRC six VAC BNT116 in combination with our B7 H3 antibody drug conjugate, BNT324.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

This is another important source for the company in terms of novel combinations combining an mRNA cancer immunotherapy with an ADC. We see great potential to combine targeted therapies such as ADCs with mRNA cancer immunotherapy. ADCs can debug metastatic tumors and alter the tumor microenvironment, and mRNA cancer immunotherapies may be more effective in creating polyfunctional and tumor associated antigen specific T cell responses once the primary tumor is partially degraded. Also in the quarter, we took steps to strengthen mRNA as one of our platform technologies. We announced a strategic transaction to acquire QVAC in a public exchange offer.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

This planned transaction aims at complementing BioNTech's capabilities and proprietary technologies in mRNA design, delivery formulations, and mRNA manufacturing. With regard to our COVID-nineteen vaccine franchise, which is partnered with Pfizer, we are preparing for the global commercial rollout of our new variant adapted COVID-nineteen vaccine for the upcoming season, pending regulatory approvals. Data recently presented and shared with regulators globally indicated that LP 8.1 strain adapted COVID-nineteen vaccines consider improved immune response against currently dominant and emerging sublineages compared to vaccine formulations used in the twenty twenty four-twenty twenty five vaccination campaigns. Lastly, we expanded our partnership with the UK government to broaden our regional R and D activities for innovative medicines with plans to invest up to £1,000,000,000 over the coming decade. The agreement based on our existing multi year collaboration aimed at accelerating clinical trials for personalized mRNA immunotherapies and focuses on establishing two new R and D centers and our London based UK headquarters.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

We were able to achieve all this while maintaining a strong financial position. Leveraging our COVID-nineteen vaccine business and our progress balance sheet, we will continue to invest significantly in the clinical development of our priority oncology programs across key tumor indications. Now coming to our recent landmark collaboration with BMS. We aim to establish BNT427 broadly as a new standard of care across multiple tumor types. We are currently advancing BNT427 across more than 10 indications, including two global registrational trials with more planned.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

Our early conviction around this modality and BNT57 has put us in a strong position, and if approved, we aim to be the first or second to launch in a number of indications to help patients in need. Our collaboration with BMS aims to strengthen both companies' position in oncology. Our decision to partner reflects our belief in the transformative potential of BNTP-two seventy seven. In recent years, we have built out our capabilities to support the development and planned commercialization of our growing oncology pipeline. To support this goal, we have established a global clinical development organization, international clinical manufacturing capabilities, and have begun to establish a commercial organization.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

Today, we are closer to the goal of becoming a multi product global oncology company and see this partnership as supporting their ambition. With BMS' deep immuno oncology expertise, market presence, commercial capabilities, and global reach, they are the ideal partner for us and this asset. We also see commonality in their science led approach and focus on shaping the oncology market for novel modalities and combinations. There's a clear shared vision in this regard and I look forward to our companies working closely together. I will now turn the call over to Essam to provide more details on select clinical programs.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Thank you, Ugo. I'm glad to be speaking with everyone today. Let me start by highlighting where we stand with the programs that are spearheading our pipeline. With our PD L1BGFA bispecific antibody VNT327, we have initiated two global pivotal clinical trials in first line small cell and non small cell lung cancer and expect to start a third phase three in first line triple negative breast cancer later this year. We aim to further accelerate and expand BND-three twenty seven development with a strategic partnership with Bristol Myers Squibb.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

For our mRNA cancer immunotherapies including six prac and INEST, we anticipate sharing clinical updates in late twenty twenty five and early twenty twenty six. As we look towards becoming a commercial oncology company, we are advancing toward our first oncology BLA submission with BNT323, our HER2 ADC, in HER2 expressing second line endometrial cancer. BNT327 localizes the blockade of PD L1 and VEGF A signaling to the tumor. This bispecific is designed to deliver superior antitumor immune modulatory and anti angiogenic effects compared to the combination of the two individual antibodies and with the potential to minimize adverse events associated with systemic anti VEGF A therapy. We now have data from over twelve hundred patients which show sickness of single agent and combination anti tumor activity across tumor types where checkpoint inhibitors are and are not effective.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Additionally, we have observed a manageable safety and tolerability profile at multiple dose levels with low rates of high grade treatment related adverse events. We have also seen low rates of high grade adverse events typically observed with VEGFA targeted therapies. In totality, the clinical data generated to date further strengthen our conviction in this effort and allow us to make informed and robust decisions for our clinical development strategy. With this clinical database for BMT327 and with the anti PD L1 and anti VEGF A mechanisms having been evaluated and validated across numerous tumor types and in some cases in combination with each other, we have a clear roadmap for development. We aim to develop BMT327 in tumor types where checkpoint inhibitors have been successful for only a group of patients and also in tumor types where checkpoint inhibitors have not yet been successful in improving patient outcomes.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

We are pursuing a three wave development strategy that we refer to as establish combined broaden. We believe that this approach positions us to expand the therapeutic impact across a broader oncology landscape and realize the full potential of this asset. In the last quarter, we have continued to progress in executing this strategy. With our first wave of development, we aim to establish BNT327 combined with chemotherapy as a new standard of care for three key priority indications: small cell lung cancer, non small cell lung cancer, and triple negative breast cancer. This first wave leverages clinical data from multiple Phase I and Phase II clinical trials generated and published in the last twelve months.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

These data have encouraged us to start multiple registrational studies in these indications. Our two global pivotal studies for BNT327 are progressing. The first Rosetta Lung-one is evaluating BNT327 in combination with chemotherapy versus atezolizumab in combination with chemotherapy as a first line treatment of patients with extensive stage small cell lung cancer. The second, rosepla lung O2, is evaluating BNT327 in combination with chemotherapy versus pembrolizumab in combination with chemotherapy as a first line treatment of patients with squamous or non squamous non small cell lung cancer, regardless of PD L1 status. We also plan to start a Phase III trial for Zeta BREST-one in first line triple negative breast cancer later this year.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

The high medical need in these three indications and the clinical data we have seen so far in these tumor types are the reason for choosing these first indications. Extensive stage small cell lung cancer is an immunologically cold tumor for which high unmet need remains. Today, these patients are treated with a combination of atezolizumab and chemotherapy and experience a median overall survival of twelve point three months as observed in the IMPOWER one pre-three clinical trials. Based on our emerging data, we believe that BNT327 has the potential to improve clinical outcomes for patients with small cell lung cancer. Earlier this year at the European Lung Cancer Congress, we disclosed interim data from the Phase II clinical trials evaluating VNT327 in combination with chemotherapy as a first line treatment for patients with extensive stage small cell lung cancer.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Beyond the encouraging response rate and medium progression free survival observed, the ESCC data also included for the first time median overall survival data with a median overall survival of sixteen point eight months. While these data are still immature, we are encouraged by the findings. These data support our decision to evaluate BNT327 in combination with chemotherapy and the ongoing global randomized Phase three clinical trials for zeta lung one. In the last quarter, we completed enrollment in the global Phase two dose optimization trial evaluating VNT327 in combination with chemotherapy in patients with untreated extensive stage small cell lung cancer and in patients with small cell lung cancer that progressed after first or second line treatment, and we'll provide a data update from the clinical trials later this year. Another priority indication is non small cell lung cancer as it's one of the most prevalent cancers globally.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Long term outcomes depend on PD L1 status and histology, but overall remain poor despite improvements in care by checkpoint inhibitors. At the ASCO annual meeting last year, we presented data from the phase one trials evaluating BNT327 as a monotherapy first line treatment in metastatic PD L1 positive non small cell lung cancer. BNT327 monotherapy indicated encouraging antitumor activity across PD L1 low and high tumors and manageable safety in this patient population. These data support our decision to start Rosetta Lung-two, our global Phase III trial that evaluates BNT327 in combination with chemotherapy to improve on survival outcomes when compared to standard of care pembrolizumab in combination with chemotherapy as a first line therapy for non small cell lung cancer patients without actionable genomic alterations. Today, we are enrolling patients in the phase two part and expect to progress to the phase three part later this year.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Triple negative breast cancer is also a priority indication for BNT327 based on the unmet need we see for patients and based on the clinical profile observed to date. Currently, stage four patients depending on their PD L1 status are either treated with checkpoint inhibitor in combination with chemotherapy or with chemotherapy alone. PD L1 positive patients have a median overall survival of twenty three months, while PD L1 negative patients have a median overall survival of fifteen point two months as observed in the KEYNOTE-three 55 study. Data from a study in first line metastatic triple negative breast cancer showed that BNT327 in combination with chemotherapy has an encouragingly high objective response rate irrespective of PD L1 status. We also observed in the trial encouraging landmark overall survival rates, such as sixty nine point seven percent at eighteen months for BND327 in this setting, suggesting that effective control of disease can translate into improved overall survival.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Based on these data, we plan to start a Phase three trial later this year in the first line setting. We have also continued enrollment in our global Phase two dose optimization trial evaluating BNT327 in combination with chemotherapy in the first and second line treatment of patients with locally advanced or metastatic triple negative breast cancer. We plan to share data also from the phase two trial at a medical meeting later this year. Our second wave of development with BNT327 reflects that IO plus ADC combos are an emerging treatment paradigm in oncology. We have started exploring combinations of BNT327 with our ADCs directed against TROP2, HER2, and B7 H3 from our partnerships with duality informed by a robust database of single agent data for these ABCs.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

In the second quarter, we dosed the first patients in two new BNT327 ADC combination studies. The first is a Phase onetwo clinical trial that is evaluating BNT327 in combination with BNT323, however, two targeted ADC in HR positive and negative HER2 low and ultra low metastatic breast cancer patients. The second is a Phase II clinical trial that is evaluating BNT327 in combination with BNT324 our B7 H3 ADC in multiple types of lung cancer, including non small cell and small cell lung cancer patients, patients with known actionable genomic alterations and across treatment lines. In July, we also dosed the first patient in another phase two trial that is evaluating BNT327 in combination with our B7 H3 ADC in additional tumor types, including hepatocellular carcinoma, cervical cancer, melanoma, and head and neck squamous cell carcinoma. Later this year, we plan to initiate our first clinical trial evaluating BNT327 in combination with BNT326, our HER3 targeted ADC.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

The first BNT327 ADC combination trial evaluating BNT327 in combination with BNT325, our Trop-two ADC in multiple tumor types, was initiated a few months ago and we are starting to get initial data. At the AACR Annual Meeting earlier this year, we demonstrated that when dosed in combination, BNT327 and our TROP-two ADC demonstrated superior antitumor effects preclinically compared to each drug alone, our preliminary clinical data and a small sample size suggests that BNT327 plus BNT325 had a manageable safety profile with few overlapping toxicities and clinically meaningful activity. These data provide the first early support for our ambition to combine BNT327 and ADCs with the aim of replacing chemotherapy in some treatment regimens. We believe that combination regimens in which traditional chemotherapy is replaced by targeted chemotherapy in the form of ADCs may be more tolerable and potentially more efficacious, especially when those regimens are combining two synergistic approaches. Over the coming twelve to eighteen months, we will gather preliminary clinical data from these signal seeking VNT327 ADC combination clinical trials to help us define which ADC combinations in which indications to prioritize for late stage development.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

The last wave of our three way strategy aims at further broadening our global clinical development program with BNT327 through additional novel combinations and across additional tumor types. We anticipate that some of the early studies evaluating novel combinations or evaluating new tumor types will begin this year. One clinical trial which we anticipate will begin soon is a Phase onetwo clinical trial evaluating BNT327 in combination with the bispecific we are developing with our partner Genmet that targets both FCM and four-1BB in metastatic colorectal cancer patients. FCM is highly expressed in colorectal cancers. The other arm of the molecule is a potent four-1BB agonist.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

When activated four-1BB signaling promotes T cell activity and provides us. We are excited to bring this and other novel combinations into the clinic soon, and we look forward to updating you on these trials and their rationale as we move forward. As demonstrated in these three ways, we have broad ambitions for BNT327 development that we continue to pursue with focus. Along with our partner BMS, we feel uniquely positioned to fully leverage the complete breadth of potential of this molecule. We will work expeditiously to execute the next global registrational trials and accelerate bringing BNT327 to market in multiple areas.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Moving now to our mRNA cancer immunotherapy platform, which is the other cornerstone of our oncology strategy and includes INES and fixback. Autogen civuliran, also known as BNT122, developed in partnership with Genentech, is based on the INS platform. INS targets neoantigens, which are unique tumor specific mutations and is manufactured on demand for each individual patient. We believe this approach to be best suited for the early stage, including adjuvant setting. Six second contrast targets shared non mutated tumor antigens and is an off the shelf approach in combination with checkpoint immunotherapeutics.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

We believe that these programs have 10 tumor potential and could be combined with different modalities to address large patient populations with high unmet medical needs. While our robust clinical development program continues for our whole mRNA cancer immunotherapy pipeline, we look forward to providing data updates from our trials later in late twenty twenty five and 2026. While we are evaluating our mRNA cancer immune therapies with approved checkpoint inhibitors or chemotherapy, we consider our mRNA cancer immunotherapies as ideal for novel novel combinations and partners for both our immunomodulators and our targeted therapies. We are excited to have recently dosed the first patient in an exploratory cohort evaluating our non small cell lung cancer PIKFEC, BNT116 and our V7 H3 targeted ADC and anticipate dosing the first patient in the exploratory cohort with our HER3 targeted ADC soon. Given they are available off the shelf, we believe that our PIKFAC candidates are uniquely positioned as combination partners in the metastatic setting when patients do not have time to wait for fully personalized approaches.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Turning to the 2025 data update. Earlier this year, we announced that we received data from a Phase II trial evaluating our individualized RNA new therapy, autogen civuniran, in combination with pembrolizumab versus pembrolizumab alone as a first line treatment for patients with metastatic or advanced melanoma. The trial did not meet its primary endpoint of a statistically significant improvement in progression free survival in this advanced patient population. However, we did observe a numerical trend favoring the combination arm in overall survival. We will be presenting the top line data from this trial at the upcoming ESMO Congress in October.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

We believe that these data support our view that our fully individualized mRNA cancer immunotherapies are best positioned in earlier settings such as adjuvant treatment regimens. In early settings, tumor mass is low, resistance and immune suppression mechanisms have not been established and the immune system is much healthier. And this is where all three of our current phase two clinical trials are positioned. Last year, we announced that our six week candidate for melanoma, BNT111, met the primary endpoint in a randomized phase two trial evaluating BNT111 in combination with cemiplimab and also assessing both antibodies alone in patients with anti PD-one relapsed or refractory melanoma. We will also be presenting these data at the upcoming ESMO Congress and we'll discuss the path forward for this program around this. Next, the data update from a cohort evaluating our non small cell lung cancer fixed fact, DND116, in combination with simulizumab as treatment for patients with unresectable, stage three non small cell lung cancer after receiving concurrent chemo radiotherapy will be provided at the twenty twenty five World Conference on Lung Cancer in September.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

We continue to generate clinical data for BNT116 in multiple non small cell lung cancer treatment settings, demonstrating the broad potential of our feedback approach. To conclude, we remain as strongly convinced as ever that our combination based approach offers the potential to positively impact the future outcomes for patients in key indications such as in breast and lung cancer. With that, I will now pass the presentation to our CFO, Ramon Sapater.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

Thank you, Ozlem. It's an honor to be here today for my first earnings call as BioNTech's Chief Financial Officer. Since joining, I've had the opportunity to meet many of our talented teams. I look forward to working with them and the management board to accelerate our common vision, which Ugur and OSLEM just walked us through. As BioNTech navigates its transition towards becoming a multi product company in the oncology field, I will focus on driving sustainable organizational excellence and global execution in financial reporting, accounting, tax, treasury and purchasing with the aim of furthering cost effective value generation.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

As part of my responsibilities, I'm also looking forward to collaborating with Doug, our new Head of Investor Relations. Together, we are serving as your primary points of contact, and I hope to meet many of you in the coming weeks. With that, I will now cover our financial results for the 2025. For the three months ended 06/30/2025, our total revenues reached approximately €261,000,000 compared to €129,000,000 for the 2024. The increase compared to the 2024 is mainly driven by higher revenues derived from our COVID-nineteen vaccine collaboration.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

In addition, parts of our total revenues were also derived from a pandemic preparedness agreement with the German government and from a onetime effect associated with Pfizer's opt out from the development of our shingles program. Research and development expenses were approximately $5.00 €9,000,000 for the 2025, compared to approximately €585,000,000 for the comparative prior year period. The decrease was mainly driven by the reprioritization of clinical trials towards focused programs. SG and A expenses amounted to approximately €138,000,000 in the 2025 compared to €184,000,000 in the comparative prior year period. The decrease was primarily driven by a reduction in external services.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

For the 2025, we reported a net loss of €387,000,000 compared to a net loss of $8.00 €8,000,000 for the comparative prior year period. Our basic and diluted loss per share for the 2025 was 1.6 compared to a basic and diluted loss per share of 3 point euros 3 for the comparative prior year period. During the quarter, we maintained our strong financial position with €16,000,000,000 in cash plus security investments. This strategic cash reserve and robust financial position provides us the flexibility to fully pursue our long term strategy in the coming years. As part of that strategy, we will continue to invest in the development of our immunomodulator and individualized therapies and in the build out of the manufacturing capacities and capabilities to support additional late stage trials and commercialization of our growing oncology portfolio.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

To create long term value, we aim to advance our clinical programs fast, responsibly, and cost efficiently towards potential registration. And with that goal in mind, I would like to guide you through what we anticipate to be the financial effects of the collaboration with BMS. As Ugur highlighted in the key strategic drivers of this partnership, it is a landmark deal that will allow us to broaden the potential clinical utility and global access to VNT327, a key piece of our diversification into oncology. I will now focus on the anticipated financial implications of this deal, which we believe will significantly strengthen our cash position and P and L for the years to come. As part of the agreement, we expect to receive USD 1,500,000,000.0 in an upfront cash payment this year.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

This payment is to be reflected in our cash position as of Q3 twenty twenty five. We also expect to receive US2 billion dollars in total non contingent and anniversary cash payments through 2028. The upfront and non contingent cash payments amounting to $3,500,000,000 are expected to be recognized as revenues over the development phase of BNP 03/27. In addition, we will be eligible to receive up to $7,600,000,000 in development, regulatory, and commercial milestones. The majority of milestone payments are expected to be triggered upon approvals and during commercialization.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

All milestone payments are anticipated to be recognized as revenues following milestone achievement. Also, as part of the agreement, we will share joint BNT327 development and manufacturing costs on a fiftyfifty basis with BMS, subject to certain exceptions. Upon commercialization, global profits and losses will be equally shared between BMS and ourselves. Turning to the next slide, we are reaffirming the company's financial guidance for the 2025 financial year, with revenue expected to be in the range of 1,700,000,000.0 to €2,200,000,000 Research and development expenses expected to be in the range of 2.6 to 2,800,000,000.0 Euro, SG and A expenses expected to be in the range of $6.50 to $750,000,000 Euro, and capital expenditures expected to be in the range of $2.50 to $350,000,000 Euro. We anticipate a revenue phasing weighted towards the last three, four months of the year, driving the full year revenue figure.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

Given the COVID-nineteen vaccine market dynamics and shifting policy, specifically in The United States, we assume lower COVID-nineteen vaccination rates than the prior year. However, we continue to expect similar market share and pricing as compared to 2024. We continue to monitor current and potential further developments in law, public policy, international trade, and public sentiment as they continue to evolve and could further impact our anticipated COVID-nineteen vaccine revenues and expenses. In addition, regarding our revenue outlook, we estimate some inventory write downs and other charges in the range of roughly 15% of BioNTech's share of gross profit from COVID-nineteen vaccine sales in Pfizer's territory. Beyond our COVID-nineteen vaccine business, we also expect revenues from a pandemic preparedness contract with the German government, as well as revenues from our collaborations, now including BMS and our service businesses to contribute to our overall group revenues.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

To conclude, I'm looking ahead, we continue to diligently invest in our growth strategy while maintaining financial discipline. We remain focused on achieving long term sustainable growth and generating value for patients and shareholders. With that, I would like to turn the call over to Ryan for concluding remarks. Thank you.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

Thank you, Ramon. I will close our prepared remarks with a brief summary of our 2025 strategic priorities. As Uber mentioned, we continue to focus on executing against two pan tumor product opportunities, BNT327 and our mRNA cancer immunotherapies, six VAC and INEST. We currently have multiple ongoing Phase II and III trials across these programs, reflecting our strategy to bring novel combinations to patients. We expect to generate additional meaningful data for these programs throughout this and early next year.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

We also continue to build out our commercial capabilities in oncology to support our goal of becoming a fully integrated biopharmaceutical company. These include a broad global commercial leadership team to drive our transition to the commercial stage in oncology, beginning with the potential approval and launch of BNT-three twenty three as early as 2026. In infectious diseases, we have continued to invest to maintain our advisors global leadership position in the COVID-nineteen vaccine market while advancing next generation and combination vaccines in the clinic. On the next slide, I would like to highlight some important investor events we'll be holding this year. Our second AI Day will take place on October 1.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

We also plan to hold our Innovation Series event on November 11, and we'll share more details on both events later in the year. Finally, would like to conclude on a personal note. As Ugar mentioned, I will step down from my executive role at BioNTech at the September. As this is my last earnings call as chief strategy officer, I would like to extend my deepest gratitude to those in the investment and analyst community who have been long term supporters of our efforts to positively impact patients' lives. I would also like to thank my colleagues on the supervisory and management boards, as well as my teams for their dedication collaboration during these crucial and fruitful years.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

It has been a true privilege to support BioNTech's transformation into one of the most exciting disruptors in our industry, and I'm very excited to follow the company's continued growth in the years to come. With that, we would like to open the floor for questions.

Operator

Thank you. To a question you will need to press star one and one on your telephone and wait for your name to be announced. Please limit yourself to one question and speak loud and clearly into your mic. We'll now go to the first question. And your first question today comes from the line of Tazeen Ahmed from Bank of America. Please go ahead.

Tazeen Ahmad
Tazeen Ahmad
Analyst at Bank of America

Can you hear me now? I think I was muted. Good morning. Thanks for taking my question. First of all, Ryan, thanks for all of your help.

Tazeen Ahmad
Tazeen Ahmad
Analyst at Bank of America

Coming IPO onward, and you'll be met. Can I just ask for a little bit of clarity about how you're thinking about vaccine development on a go forward basis? You've talked about continuing to invest in the infectious disease segment of the business. You talked about combination therapies. Just based on where you're seeing vaccination rates now, let's focus on The US, what do you think are going to be the products that are going to motivate people to perhaps increase their rate of vaccinations for ones that, for example, need annual or maybe biannual rates of vaccination, just because it does seem like stats indicate that those rates are tending to flow lower?

Tazeen Ahmad
Tazeen Ahmad
Analyst at Bank of America

And why does it make sense to continue investing in that? Thanks.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

Yeah, thank you Tazeen. I'll start off and appreciate the kind words. In terms of vaccine development, of course, our COVID-nineteen vaccine business is going to continue to be a priority for the company along with building out oncology and entering the commercial stage. And I think in terms of the rates of vaccination, we've seen lower rates of vaccination for COVID-nineteen over the past couple of years and we've guided to a range that we think reflects a similar ballpark this year. We've noted that of course that's still subject to certain policy dynamics and we're continuing to track that, but we feel overall pretty good about the overall value proposition of the COVID-nineteen vaccine franchise.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

And so you know we've seen rates of about twenty percent over the last couple of years. Obviously we're going to track that going in here to the second half of the year which is the main part of the season. But we think we're on track overall to be ready to meet market demand. We do think that even in a market that's focused on the high risk population that's still a substantial number of people approximately 100,000,000 in The United States and this is also going to continue to be a global business. So I think overall we're going to be prepared with Pfizer to continue market leadership in COVID-nineteen.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

And I think as it relates to your question about what's driving demand, think ultimately it's going to continue to be based on the value proposition of these vaccines. And so we're going to continue to work on next generation concepts including exploring combination vaccines that we think could add additional value for patients in the coming years. Beyond COVID-nineteen too, we have a number of vaccine programs that are in either preclinical or phase one development. You know our strategy as it relates to vaccines aside from COVID will remain focused on leveraging partnerships to bring those forward.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

Thank you, Ryan. And thank you Tosin for the question. I also believe that we expect the combination vaccines will gradually complement rather than replace standalone COVID-nineteen vaccine. There are several factors that may sustain demand for monovalent vaccine beyond convenience considerations, such as in monocompromised patients, overwhelming preference of 60 plus population to receive high dose flu plus a mono COVID vaccine, and some asynchronous vaccination schedules where patients need COVID-nineteen boosters.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

So I think as Brian is mentioning, so we still hold a very high market share, more than 50% across worldwide with Pfizer. We are prepared as well to keep developing our combination and keep leading in these markets.

Operator

Thank you. We'll now go to the next question. And your next question comes from the line of Terence Flynn from Morgan Stanley. Please go ahead.

Terence Flynn
Terence Flynn
Equity Research Analyst at Morgan Stanley

Great. Thanks for taking my question and best of luck Ryan in next steps. I was just wondering on the three twenty seven trial ROSETTA Lung-two, if you can tell us the doses that you're exploring in the Phase two portion? And then can you just confirm again that you'd plan to release any top line data here from the Phase II portion before year end? We didn't see that on the slides.

Terence Flynn
Terence Flynn
Equity Research Analyst at Morgan Stanley

We just wanted to confirm the timing of that data release. Thank you.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

Yeah, thank you, Terrence. So I think the question is around doses for the Phase II portion and top line data. Oslo, do you want to take that?

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Yes, yes, I can take that. We will talk to doses actually for both trials, our Lung-one in small cell lung cancer and Lung-two in non small cell lung cancer later this year for the small cell lung cancer study part one. You will hear already more in September on the WCLC.

Operator

Thank you. Your next question comes from the line of Dana Graybosch from Layering Partners. Please go ahead.

Daina Graybosch
Senior MD - Immuno-Oncology at Leerink Partners

Hi. I wonder if you can talk more about BNT three twenty seven and frontline TNBC and how you're thinking about the success of the trope two ADC both in combo with PD-one and without and PD L1 high and low, if you could still do a study without a trope to ADC in frontline in your control arm or in your active arm? And thank you.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

Dana, I can take this question. Yeah, that's right. TNBC provides BN327 several opportunities. We have generated data in TNBC with chemotherapy in combo, reaching a PFS between thirteen to fourteen months and highly encouraging OS data. And of course, the combination with TOP-two or other ADCs, we have also her free ADC, could provide the opportunity to further increase the efficacy.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

And these are, as you might remember, one of the combo studies that we are doing at the moment is BNTP-two 27 and BNTP-two 25, our top two ADC. And based on the data, we might decide also to go for a combo in this indication.

Operator

Thank you. Your next question comes from the line of Cory Kasimov from Evercore. Please go ahead.

Cory Kasimov
Senior Managing Director at Evercore

Hey, guys. First of all, Ryan, been great interacting with you over all these years and best of luck with what's coming up next. I guess I'll go with my first ever question for Ramon. And and thinking about the model, how do you see r and d spend now evolving over the intermediate to long term post your deal with Bristol? This this collaboration should clearly offset a significant amount of future expenses, but is the plan to reallocate the majority of those to other programs or still somewhat TBD there? Thank you.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

Thank you, Corey, for the question. So I think increasing investments into our priority late stage program, of course, the ENTP-five 27 that now are going to be with collaboration, but also in mRNA cancer immunotherapies and ABCs would be some of the key drivers. Now having said that, we will be very consistent with our portfolio prioritization strategy. And we also expect to decrease our R and D spending outside of these priority areas. So we expect R and D to increase in the second half of this year.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

And as we see the starting phases of the work in Phase III BNT327 and BNBC and BNT323 in EC as Oguzlan was alluding to. And as we see how these programs are progressing as well in fixed VAC and INET, we will be, of course, updating you accordingly on how do we see this spending going more towards the two, three year period.

Cory Kasimov
Senior Managing Director at Evercore

Great. Thank you.

Operator

Thank you. Your next question comes from the line of Assad Haydar from Goldman Sachs. Please go ahead.

Asad Haider
Asad Haider
Equity Research Analyst at Goldman Sachs

Great, thanks. And congratulations on all the progress and best of luck, Ryan. Just one quick question back to the COVID question, just your assumption on lower vaccination rates relative to last year. You are keeping revenue guidance the same, recognizing it is a wide range. But any quantification in terms of the pushes and pulls with respect to vaccination uptake would be helpful.

Asad Haider
Asad Haider
Equity Research Analyst at Goldman Sachs

And then second, just in the context of the deal with Bristol, maybe just double click a little bit more on the acceleration strategy, specifically with respect to any new Phase III trials that have been planned since the announcement of the collaboration? And then also just on the development costs, given that they'll be fifty-fifty, how should we be thinking about the cadence of R and D spend going forward? And And then if I can just squeeze one last one on the fixed vax melanoma trial, if you could just double click on what you're planning to present at ESMO and the overall plans for that program going forward. Thank you.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

So, So, think, Ramon, maybe you want to take the first two questions, and then Oslo can take the ESMO question. Yep.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

So, thank you, Asaf. I on the revenue guidance for the COVID-nineteen market. So as I was saying, so we anticipate that this revenue is going to be phased over the last three or four months of this year. Given the COVID-nineteen vaccine market dynamics and shifting policy, we assume that we will have lower COVID-nineteen vaccination rates than previous year, but we also need to take this into consideration with the fact that the vaccination rates in The US are already low at around twenty percent. So, I mean, like this is going to be maybe a couple of points lower, but we are still believing that the pricing and our market share assumptions are going to be broadly in line with previous year.

Ramón Zapata
Ramón Zapata
CFO at BioNTech

So that's what I would say on COVID. And then on the MS Phase three trials, the collaboration, I think it's clear. So it's going to be a fiftyfifty development cost R and D spend. And we will, as these programs progress through the different phases. So we will have transparency on these amounts.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

And of course on the BMS collaboration, new trials are being considered and evaluated right now. And those decisions will be communicated once made.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Yes, and there was, I think, a question for 01/2011, our melanoma fixback, which I can answer, namely what we are going to present at ESMO. This year, we will present the efficacy data. This trial has an objective response rate and duration of objective response rate primary endpoint, and this data will be matured until later this year and will be presented. We will also speak to secondary endpoints like PFS and OS and safety data, and there will be also some translational data characterization of the immune responses.

Operator

Thank you. Your next question comes from the line of Akash Tewari from Jefferies. Please go ahead.

Akash Tewari
Akash Tewari
Global Head - Biopharmaceutical Research at Jefferies

Hey, thanks so much. And Ryan, it was really a pleasure working with you. I'll keep it a little more general. Look, under the new FDA regime, has the BioNTech team seen any shift in, the FDA's willingness to accept Chinese data for your VEGF bispecific or the ADCs? And for 03/27, for NSCLC, small cell, and then TNBC, can you tell us whether when you'd be able to satisfy Project OPTIMAT's regulatory requirements and proceed with a go forward phase three dose for these three indications? Thank you.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

Great. You, Akash. Ubara, Rosalind, do you want to take that?

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Yes. We are discussing and finalizing these discussions currently for all three indications in which we are in phase three trials. The discussions are very positive, because, as you know, we are producing on top of China data, we have in early parts of our phase III resource independent global studies, also some dose data, dose optimization data in the Western population. We think that within the next couple of weeks, we will be able to move ahead in all those three indications.

Operator

Thank you. Your next question comes from the line of Jessica Fey from JPMorgan. Please go ahead.

Jessica Fye
Jessica Fye
MD & Equity Research Analyst - Biotechnology at JP Morgan

Hey, guys. Good morning. Thanks for taking my question. And Ryan, similarly, it's been great working with you over the years. I have a few on the pipeline.

Jessica Fye
Jessica Fye
MD & Equity Research Analyst - Biotechnology at JP Morgan

So with the upcoming global phase two readouts for VNT327, can you remind us when you say, for example, the small cell data and non small cell data is expected this year, will we see that data? And if so, what endpoints will we see, and what are the relevant benchmarks in those settings? Second, for the registrational HER2 positive endometrial cohort, did that slip a bit? I think we were previously expecting a file by year end '25, and now it sounds like data at a conference in '26. So just want to confirm, you know, whether we'll hear top line data this year or what the timeline is.

Jessica Fye
Jessica Fye
MD & Equity Research Analyst - Biotechnology at JP Morgan

And then lastly, for the INEST randomized phase two in ctDNA positive adjuvant colon cancer, can you just share your latest expectation for timing there? Thank you.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

Yeah, thank you, Jess. I think maybe just on the last one, can briefly comment and then hand over to Oslan to speak to the benchmark, to the small cell lung cancer and non small cell. So on adjuvant CRC, we're maintaining our prior guidance that we're expecting data late twenty twenty five or early twenty twenty six and we think we're on track to meet that in terms of the adjuvant CRC data for INEST. Oswin, do you want to address the three twenty seven questions?

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

Yeah, the three twenty seven question, the question was the small cell lung cancer trial and our non small cell lung cancer trial, the benchmark, right? Did I get that right? So for the small cell lung cancer actually for both trials, our aim is to achieve clinically meaningful and statistically significant improvement over the standard of care for the small cell lung cancer trial, Rosetta one, our primary endpoint is OS, and for the non small cell lung cancer trial, we have a dual endpoint PFS and OS, and when I say standard of care, the benchmark trials of a benchmark we are comparing against for small cell lung cancer is MPOWER 133 with median OS outcomes there, and for non small cell lung cancer, you know, we have both non squamous and squamous histologies covered in our phase three trial, and here we refer to KEYNOTE-one 189 and the KEYNOTE-four zero seven studies as benchmarks. And I think there was a question regarding, 03/23, right, when we will show data from that study. The plan is to share data from our single arm second line endometrial cancer study, which will also be the data package for BLA submission data this year.

Özlem Türeci
Özlem Türeci
Co-Founder, Chief Medical Officer & Member of Management Board at BioNTech

This data will be shared in early twenty twenty six. We want to make sure that the data further matures and that the data which will be shared with the community is in sync with the data we are planning to submit to FDA.

Operator

Thank you. We will now take our final question for today. And the final question comes from the line of Yaron Werber from TD Cowen. Please go ahead.

Yaron Werber
MD & Senior Biotechnology Analyst at Cowen and Company

Is going on for Yaron. Congrats on your quarter and thanks for taking our question. On competition for BNT-three twenty seven, Pfizer said that their asset binds to when their asset binds to VEGF, it increases the affinity to PD-one by a hundredfold. Is this kind of cooperative binding also true for BNT-three 27? Are there any other points of differentiation you might note between yours and Pfizer's molecule besides obvious PD-one versus PD L1? Thanks so much.

Ryan Richardson
Ryan Richardson
Chief Strategy Officer at BioNTech

Do you want to take the question on whether or not three twenty seven has a cooperative binding effect and other different points of differentiation?

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

Yes. I can take this question. I think the mechanism is more complicated than this, and we will present the mechanism probably mid next year in a conference. We are evaluating the mechanism for BNTP-two 27. As you know, it's a binder which binds in the tumor microenvironment PD L1, and thereby provides opportunity to bind also in tumor microenvironment to VGFA.

Ugur Sahin
Ugur Sahin
Co-Founder, CEO & Chair of the Management Board at BioNTech

And the combination of both has synergistic activities, but it's not simple. The increase of the affinity It's more complicated.

Operator

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

Executives
    • Douglas Maffei
      Douglas Maffei
      VP, Strategy & IR and Head - IR
    • Ugur Sahin
      Ugur Sahin
      Co-Founder, CEO & Chair of the Management Board
    • Özlem Türeci
      Özlem Türeci
      Co-Founder, Chief Medical Officer & Member of Management Board
    • Ramón Zapata
      Ramón Zapata
      CFO
    • Ryan Richardson
      Ryan Richardson
      Chief Strategy Officer
Analysts
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