BioNTech SE (NASDAQ:BNTX) Q3 2025 Earnings Call Transcript

BioNTech SE (NASDAQ:BNTX) Q3 2025 Earnings Call Transcript November 3, 2025

BioNTech SE misses on earnings expectations. Reported EPS is $-0.14 EPS, expectations were $0.75.

Operator: Welcome to BioNTech’s Third Quarter 2025 Earnings Call. I will now hand the call over to Doug Maffei, Vice President, Strategy and Investor Relations. Please go ahead.

Douglas Maffei: Thank you, operator. Good morning and good afternoon, everybody, and thank you for joining BioNTech’s Third Quarter 2025 Earnings Call. As a reminder, the slides we’ll use during the call and the corresponding press release can be found in the Investors section of our website. On the next slide, you will see our forward-looking statement disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission, or SEC. Forward-looking statements on this call are subject to significant risks and uncertainties and speak only as of the date of this conference call. We undertake no obligation to update or revise any of these statements.

On Slide 3, you can find the agenda for today’s call. I’m joined by the following members of BioNTech’s management team: Ugur Sahin, Chief Executive Officer and Co-Founder; Ozlem Tureci, Chief Medical Officer and Co-Founder; and Ramon Zapata, Chief Financial Officer. With this, I’ll hand the call over to Ugur.

Ugur Sahin: Thank you, Doug, and warm welcome to you all as you join us today. As BioNTech has grown, our vision has remained constant, namely translating science into survival. We are building a global immunotherapy powerhouse, a fully integrated biopharmaceutical company with the science, scale, capabilities and the aim to deliver multiple approved therapies and reach patients in need. Cancer remains a systems problem, heterogeneous across patients and variable within individual tumors. We believe the future lies in rationally designed combinations, pairing potent and precise mechanism of action that create biological synergies. To this aim, we have purpose built a diversified clinical pipeline spanning mRNA immunotherapies, next-generation immunomodulators, ADCs and other targeted agents that enable development of potent, personalized precision medicines and novel-novel combinations across solid tumors.

Our goal is to address the full continuum of cancer from resected high-risk tumors in the adjuvant setting to advanced and metastatic disease to treatment-resistant and refractory cancer. Our strategy concentrates capital on 2 priority pan-tumor programs that are designed to anchor various combinations. One is Pumitamig, formerly BNT327, a PD-L1 VEGF-A bispecific that unites checkpoint inhibition with vascular normalization in 1 molecule. We believe Pumitamig is particularly suited as a next-generation IO backbone to combine with chemo ADC and other immunomodulators. The other is mRNA cancer immunotherapy that is designed to activate and educate the immune system with precision. Our mRNA cancer immunotherapies have advanced in randomized late-stage trials with focus on the adjuvant setting.

Both approaches have disruptive potential and align with our vision. We believe these programs could establish new standards of care and improve survival outcomes. Together, these programs provide breadth, optionality and scalable registrational path across solid tumors. We are investing deliberately scaling clinical development, building manufacturing that ranges from personalized to large-scale production and preparing for commercialization in key markets to reach patients in need. Now turning to how our achievements in the quarter relate to our vision and strategy. We see Pumitamig as a potential standard of care across diverse tumor types, spanning settings already treated with checkpoint inhibitors and those where checkpoint inhibitors have not demonstrated benefit.

With our partner, BMS, we are executing a broad registrational program. This quarter, we made significant progress in advancing Pumitamig, taking concrete steps towards our registrational plan. In Q3, we progressed enrollment in 2 global registrational trials in lung cancer and remain on track to initiate the TNBC Phase III this year. This keeps us aligned with our target of first potential launches before the end of the decade. Across the portfolio, more than a dozen signal-seeking studies progressed. Either with chemo backbones to expand into additional indications or at novel-novel combinations with BioNTech proprietory assets. Importantly, we advanced clinical mono agent profiling of potential combination partners, helping to derisk dose, schedule and safety assumptions for future registrational design.

These steps, including Phase III recruitment momentum, initiation of new combination cohorts and deeper combination partner characterization are all about informing the next wave of our registrational trials planned with BMS from now onwards. Turning to our mRNA cancer immunotherapy platform. In October, we presented Phase II trial updates for BNT111, our fixed candidate in anti-PD-1 resistant refractory melanoma and for Autogene cevumeran, our fully personalized mRNA cancer immunotherapy in first-line treatment of metastatic melanoma. Our data reinforces our view that adjuvant settings, where tumor burden is low and immune control is most effective represents, where mRNA immunotherapy can deliver the most significant benefit to patients. Ozlem will share details on how this readout sharpening our development focus.

This quarter, we hosted our second AI Day. It underscores that we are not only pioneers in new pharmaceutical technologies, but a fully integrated AI-tech bio company with AI tools that enable discovery and development of innovative medicines. We showcased AI-based approaches designed to convert complex dimensions of data diversity into personalized therapy development. We demonstrated 2 distinct strengths of our AI capabilities, addressing inter-patient heterogeneity and intra-tumor variability and driving precision and potency in our treatment approaches. With regard to our COVID-19 vaccine franchise, which is partnered with Pfizer, we successfully launched our variant adapted vaccine for the current season following regulatory approval. With these launches in major markets and with a strong balance sheet, over EUR 16 billion in total cash, equivalents and securities, we have the resources and the flexibility to fund the oncology transition, while maintaining a disciplined P&L.

Simply put, we are transforming scientific advances into late-stage programs in our priority oncology program across indications. In parallel, we are building the capabilities and the financial strength to translate positive data rapidly into market opportunities and most importantly, into patient benefit. With that, I will hand over to Ozlem to discuss our clinical execution and near-term data readouts.

Özlem Türeci: Thank you, Ugur. I’m glad to be speaking with everyone today. I’ll start with a top line status of the programs that are heading our pipeline before moving to specifics. Firstly, with our PD-L1 VEGF-A bispecific antibody Pumitamig, we are executing a broad registrational program in partnership with Bristol-Myers Squibb. Second, for our mRNA cancer immunotherapies, we have recently provided 2 Phase II updates that support and inform our current development strategy. And third, for Trastuzumab-Pamirtecan or TPAM, our HER2-targeted ADC known previously as BNT323 that we developed with our partner, Duality, we continue to progress towards first BLA submission now planned for 2026, subject to regulatory feedback. We are evaluating TPAM as a monotherapy into a randomized Phase III trials, 1 in metastatic endometrial cancer and 1 in breast cancer.

For both studies, we expect data in 2026. We have also initiated a signal-seeking trial evaluating the novel combination of TPAM with Pumitamig. For Pumitamig, let me recap the clinical development framework, our refined 3 wave plan that we are pursuing with our partner, BMS. Wave 1 aims to establish Pumitamig in 3 foundational first-line indications, small cell lung cancer, non-small cell lung cancer and triple-negative breast cancer through global registrational Phase III trials. Wave 2 and 3 aim to expand the opportunity of Pumetamic by amplifying its differentiation, and we do this in 2 dimensions: first, through signal-seeking studies in combination with standard of care across tumors that inform our indication strategy and prioritization; and second, through novel-novel combinations, notably with our ADCs that enhance efficacy.

We have delivered tangible progress on all these 3 waves in Q3. Regarding Wave 1, in small cell lung cancer, the global Phase III is recruiting and the Phase III dose is locked based on the dose optimization data set with a safety profile consistent with known PD-L1 VEGF chemo experience. In non-small cell lung cancer, the Phase II part of the seamless Phase II/III trial achieved full enrollment and the Phase III portion is recruiting. In TNBC, we remain on track to initiate the global Phase III this year, targeting the PD-L1 low segment, where unmet need is highest. This slide shows additional studies. These are supportive studies for dose finding, setting refinement and regional programs that contribute to the body of evidence supporting our 3 foundational global Phase IIIs. Wave 2 serves as our expansion engine.

We now have more than a dozen chemo-based signal-seeking studies across tumor types and lines of therapy. In Q3, we opened new cohorts and continue to mature data sets that will feed into our pivotal planning. This helps to ensure that the next registrational wave is evidence-led and prioritized by benefit risk profiles, patient population size, well-informed study design and commercial opportunity alongside other key factors in our decision matrix. Spearheading this next round of pivotal trials, we are initiating 2 trials in partnership with BMS with registrational intent for Pumitamig in combination with chemotherapy in first-line microsatellite stable colorectal cancer and first-line gastric cancer. Wave 3 elevates the potential of Pumitamig through novel-novel combinations to maximize its clinical impact, reinforce class differentiation and set up a multiyear pathway to sustain the value and the longevity of the drug into the new decade.

Here, several combo cohorts of Pumitamig with our ADCs or other novel compounds are already enrolling and have gained momentum in Q3. Initial data over the next year will inform decision-making for our first pivotal combinational regimen. In parallel, we are continuing mono-agent profiling of potential combination partners to set clear baseline for dose safety and sequence. Taken together, Q3 was a quarter of strong clinical execution that strengthened our registrational core, widened our expansion engine and advanced the novel-novel combination rationale that we believe will further distinguish and elevate Pumitamig over time. Let me now highlight 2 Q3 focal points. First, our first-line small-cell lung cancer registrational program and why the recent updates are catalytic.

And second, our advances in mono agent profiling for refining our combination strategy. Small cell lung cancer remains a challenging immunologically cold disease in which responses to immune checkpoint therapy tend to be short-lived, resulting in modest gains over chemotherapy alone and low long-term survival. Over the last 18 months, we have built a cohesive evidence base across multiple Phase II studies in first- and second-line small cell lung cancer initially in China and now globally, showing encouraging activity and a manageable safety profile. This quarter, at WCLC, we reported the first global data from our Phase II dose optimization study in untreated extensive-stage small cell lung cancer, evaluating 2 dose levels of Pumitamig plus chemotherapy.

All patients irrespective of dose had disease control at 20 mg per kg we observed a confirmed objective response rate of 85% and a median progression-free survival of 6.3 months. 30 mg per kg yielded a confirmed objective response rate of 66% and a median PFS of 7 months. Median overall survival data were not yet mature. Safety remained consistent and manageable with low discontinuation and no new signals beyond those typically seen with chemo and PD-L1 VEGF agents. 2 points are worth emphasizing. First, dose clarity, which is a critical derisking step for any registrational program. The global dose optimization readout allowed us to lock the Phase III regimen at 20 mg per kg every 3 weeks. Second, consistent performance across regions. Earlier China data sets in first-line extensive stage small cell lung cancer showed robust activity and manageable safety.

The global Q3 data are consistent with those findings, which further strengthens our confidence in Pumitamig’s benefit across patient populations and practice patterns. Together, these results support our ongoing global Phase III ROSETTA LUNG-01 trial, which compares Pumitamig plus chemotherapy against atezolizumab plus chemotherapy in untreated small cell lung cancer. In parallel, in China, we continue with second-line randomized Phase III trial of Pumetamic plus chemo versus chemo alone. This quarter, we expanded our Pumetamic small cell lung cancer program to include novel-novel testing, and we launched signal-seeking studies of Pumetamic plus our B7H3 ADC, BNT324 in both first- and second-line small cell lung cancer. As Phase III readouts and Phase I/II ADC combination data sets mature, we will be increasingly well positioned to select and advance additional regimens designed to establish long-standing presence in small cell lung cancer.

This brings me to our strategy for advancing combinations of Pumetamic with other novel agents, one of our key differentiation approaches. The cornerstone is establishing mono agent evidence of activity, durability and safety before we decide to pair with Pumetamic. For our B7H3 ADC, BNT324, our mono agent database has expanded significantly over the last 12 months. B7-H3’s broad expression profile aligns well with Pumitamig’s expand tumor opportunity. In small cell lung cancer, BNT324 as monotherapy achieved an objective response rate of 56% with deep tumor shrinkage across the waterfall, an unusually strong single-agent signal in this setting. In non-small cell lung cancer, activity was observed in both squamous and non-squamous disease, including an EGFR mutant subset with an objective response rate of 21%.

In heavily pretreated metastatic castration-resistant prostate cancer, we observed meaningful tumor shrinkage with BNT324 and a durable radiographic progression-free survival with a manageable safety profile. Recently at ESMO, we reported data for our TROP2 ADC, BNT325 in second-line plus TNBC with an objective response rate around 35%, disease control rate of roughly 81% and median progression-free survival of about 5.5 months. Also in Q3 for our HER2 ADC T-PAM, we saw a substantial expansion of the monotherapy data base by the DYNASTY-Breast02 Phase III trial, our partner DualityBio conducts in China that met its primary endpoint of PFS improvement versus trastuzumab emtansine in pretreated patients with HER2-positive un-resectable or metastatic breast cancer.

T-PAM is another promising combination partner with the potential to expand Pumitamig’s therapeutic reach into the HER2-expressing tumor spectrum. Taken together, these data provide a clear monotherapy baseline and help us set the bar for add-on benefit from Pumitamig plus ADC combinations. Across these programs, the mechanistic rationale is consistent. VEGF-A blockade can normalize vasculature to improve ADC delivery, while PD-L1 inhibition can convert ADC-mediated cytotoxicity and antigen release into a broader durable immune response, aiming for deeper debulking plus immune control. These represent complementary mechanisms that single agents cannot engage simultaneously. So operationally, we made 2 key advances in Q3, continued mono-agent profiling to refine dose and sequence and codification of our add-on benefit threshold and expansion of Pumitamig plus ADC cohorts across prioritized settings.

Of note, our go/no-go decision-making process is driven by a holistic evaluation that goes beyond efficacy signals and safety profiles. We strategically assess market opportunity, unmet needs, competitive dynamics and weigh other key factors to ensure every decision aligns with our mission to deliver transformative benefit for patients. Moving now to our second oncology cornerstone, mRNA cancer immunotherapy. iNeST is individually manufactured per patient to target personal neoantigens. The biology and our clinical experience point to greatest relevance in earlier disease settings, where lower tumor burden allow the immune system to consolidate control. Our ongoing randomized Phase II trials are designed to test that premise in a rigorous way.

Off-the-shelf FixVac that includes BNT111 for melanoma, BNT113 for HPV16 positive head and neck cancer and BNT116 for non-small cell lung cancer targets shared antigens and is intended to pair with checkpoint inhibitors and increasingly our next-gen backbones. We continue to advance execution and evidence generation across multiple tumor settings, while keeping optionality around where and how FixVac is best positioned longer term. This quarter at WCLC, we presented results for BNT116 plus cemiplimab as consolidation treatment in unresectable Stage III non-small cell lung cancer. We also presented data at ESMO from 2 randomized Phase II trials in melanoma, 1 with BNT111 FixVac and the other for Autogene cevumeran iNeST. I will briefly walk you through the melanoma readouts and their implications.

Starting with BNT111 FixVac in the high medical need population of patients who had relapsed or not responded to PD-1 treatment. The Phase II study evaluated BNT111 plus cemiplimab against a historical control objective response rate of 10% reported for anti-PD-1 treatment in this setting. The study included 2 calibrator monotherapy cohorts to characterize the safety of each agent and its activity on objective response rate. The objective of this design was signal characterization, not cross-arm efficacy claims. In the monotherapy cohorts on progression addition of the second agent was permitted. More than half of the patients in each arm opted for this addition, after a median duration of [ IVA ] monotherapy treatment of around 4 months. The study met its prespecified primary endpoint by rejecting the null hypothesis of an ORR of 10% with statistical significance.

The ORR of the combination was 18%, including deep and durable responses. Notably, 2/3 of the responses were complete responses, supporting the depth of activity. Follow-up showed a positive impact on long-term survival. 37% of patients were still alive after 24 months, 21% were free of tumor progression. Safety was manageable, driven largely by expected mostly grade 1, 2 cytokine-related events consistent with the mRNA platform. BNT111 monotherapy also demonstrated objective responses and a consistent safety profile. Taken together, these results support that BNT111 is active in this difficult post-IO setting and provide us useful footing to guide setting selection and optimal combinations going forward. Turning to iNeST. The data presented at ESMO come from our randomized Phase II trial evaluating Autogene cevumeran in combination with pembrolizumab versus pembrolizumab alone in first-line metastatic advanced melanoma.

As previously disclosed, the trial did not meet the primary endpoint of a statistically significant improvement in progression-free survival. That said, we observed a numerical trend favoring the combination and overall survival. In the combination arm, 12 months overall survival was 88% and 24 months overall survival was 74% compared to 71% and 63% in the pembrolizumab arm, respectively. Of note, crossover was allowed and patients randomized to pembrolizumab received the combination at progression. For the overall survival analysis, those patients remain in their originally assigned arm, which can dilute the observed treatment effect over time. We observed robust neoantigen-specific T-cell responses in the majority of evaluable patients with multi-epitope breadth and persistence of T-cell clones well beyond induction, indicating that the mRNA therapy is mediating the intended biological activity that we want to achieve.

The translational readouts give us 3 actionable insights. First, T cell response breadth correlates with activity. Within the combination arm, patients who mounted a broader neoantigen-specific T-cell response experienced longer progression-free survival, supporting our ongoing efforts to maximize antigen breadth and to target early and low tumor burden disease with still proficient immune cell priming capacity. Second, immune cell PD-L1 matters. We saw a trend of improved overall survival for the combination in tumors, where immune cell PD-L1 was high, while tumor cell PD-L1 did not discriminate overall survival in this data set, supporting that low tumor cell PD-L1 should not exclude tumor types from vaccine PD-1 strategies. Third, signal in IO-insensitive biology.

There was a trend of improved overall survival with the combination in tumor mutational burden low patients. Precisely the population that typically gains less from IO. This is consistent with the concept that the vaccine can supply immunogenic targets, when endogenous mutation load is limited and further encourages development in settings such as pancreatic cancer and MSS colorectal cancer with low tumor mutational burden and unresponsiveness to IO. Altogether, these mechanistic insights support our ongoing randomized Phase II trials, both the specific indications we have chosen, which is colorectal, pancreatic and bladder cancer as well as our focus on the adjuvant setting, where tumor burden and heterogeneity is lowest and T-cell proficiency is still high.

Now looking ahead, what comes next? We will continue to generate and present new clinical data across our oncology pipeline, data that directly steer late-stage decisions. For Pumitamig, we will share early data from our TNBC program in December, including from our dose optimization cohorts, which are central to defining the Phase III regimen. From our ADC platform, we expect additional monotherapy updates from BNT324 in cervical cancer and platinum-resistant ovarian cancer, from BNT325 in TNBC and from BNT326 in HER2-null and low hormone receptor positive breast cancer. These studies explore indications defined dose and sequence guardrails and set the add-on benefit bar for Pumitamig’s novel-novel combinations. For the randomized Phase II trial evaluating Autogene Cevumeran monotherapy treatment versus watchful waiting in adjuvant ctDNA-positive Stage II high-risk or Stage III colorectal cancer, we expect an interim update in early 2026.

The efficacy evaluation of the primary endpoint of disease-free survival is projected for the end of 2026, when the data set will have reached the intended maturity. Then later this year, we plan to present data together with our partner, Onco C4 from the nonregistrational first part of the ongoing global Phase III trial evaluating our anti-CTLA-4 antibody, Gotisrobart versus chemotherapy as a second-line treatment for squamous non-small cell lung cancer. Overall, these upcoming data points advance the same theme. Evidence-led prioritization by establishing dose finding and mono ADC baselines to further refine Pumitamig registrational path and leverage randomized setting-specific readouts to position our mRNA immune therapies where they are most likely to succeed.

With that, I will now turn the presentation over to our CFO, Ramon Zapata, for the financial update.

Ramón Zapata-Gomez: Thank you, Ozlem, and a warm welcome to everyone who has joined today’s call. I will begin by reviewing our financial results for the 3 months ended September 30, 2025. Note that all figures are in euros unless otherwise specified. The total revenues reported for the period were EUR 1.519 billion, an increase from the same quarter in 2024, which was EUR 1.245 billion. This increase was mainly driven by the recognition of USD 700 million as part of the BMS collaboration in the third quarter of 2025. For context, in total, we expect to receive USD 3.5 billion in upfront and noncontingent cash payments from BMS between 2025 and 2028. We expect to recognize this as revenue in increments annually over the development phase of Pumitamig.

For the third quarter 2025, we reflected USD 700 million in our revenues. Moving to cost of sales. This amounted to approximately EUR 148 million for the third quarter of 2025 compared to approximately EUR 179 million for the same period last year, driven by lower inventory write-downs. Research and development expenses were approximately EUR 565 million for the third quarter of 2025, compared to approximately EUR 550 million for the same period last year. R&D expenses were mainly driven by the initiation of late-stage trials for our immunomodulators and ADC programs and partly offset by cost savings resulting from active portfolio management towards our priority programs. SG&A expenses amounted to approximately EUR 148 million in the third quarter of 2025 compared to EUR 150 million for the same period last year.

The decrease was mainly driven by lower external costs, partially compensated by our ongoing commercial build-out. Our other operating results amounted to approximately negative EUR 705 million in the third quarter of 2025 compared to approximately negative EUR 355 million for the same period last year. Our other operating results for the third quarter of 2025 was primarily influenced by the settlement of a contractual dispute. For the third quarter of 2025, we reported a net loss of EUR 29 million compared to a net income of EUR 198 million for the comparative prior-year period. This was mainly driven by the effect of settlement disputes. Our basic and diluted loss per share for the third quarter of 2025 was EUR 0.12 compared to basic earnings per share of EUR 0.82 and diluted earnings per share of EUR 0.81 for the comparative prior-year period.

At the end of the third quarter of 2025, our cash, cash equivalents and security investments totaled EUR 16.7 billion, including the USD 1.5 billion upfront payment received from BMS. Our strong financial position empowers continued investments in our late-stage priority programs and preparations for commercialization of our diversified oncology portfolio. Turning to the next slide. We are updating the company’s financial guidance for the 2025 financial year. Our previously issued revenue guidance range for 2025 was $1.7 billion to $2.2 billion. And today, we are increasing it to $2.6 billion to $2.8 billion. This is mainly driven by the recognition of USD 700 million from our BMS collaboration. Further guidance considerations, such as those related to our COVID-19 vaccine business, including inventory write-downs from COVID-19 vaccine sales in Pfizer’s territories as well as expected revenues from the pandemic preparedness contract with the German government and revenues from our service businesses remain unchanged.

Turning to expenses. We are lowering our prior 2025 financial year R&D expense guidance by EUR 600 million to a new range of EUR 2 billion to EUR 2.2 billion. This updated guidance reflects our active portfolio management that has enabled significant R&D efficiencies. As part of that, we follow a rigorous go/no-go decision-making across all development stages as part of the prioritization efforts. This allows us to focus on the programs in our portfolio, which we believe represents the largest opportunities. Consistent with our commitment to disciplined and sustainable growth, we are also improving our full-year guidance for SG&A and capital expenditure for operating activities. We are reducing our full year SG&A expense guidance by $100 million to a range of $550 million to $650 million as a result of ongoing cost optimization initiatives.

We are also reducing our full-year guidance for capital expenditures for operating activities to a range of $200 million to $250 million to better reflect our targeted investment in manufacturing. Aligned with our disclosures earlier in the year, we expect to report a loss for the 2025 financial year as we continue to invest in our transition to become a fully integrated commercial oncology company. As Ugur outlined, we continue to focus on executing our strategy around 2 pan-tumor product opportunities, Pumitamig and our mRNA cancer immunotherapies. 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 in the months ahead.

As we advance, we will continue to maintain rigorous financial discipline and remain focused on achieving long-term sustainable growth. Before concluding, I would like to invite you to watch our annual Innovation Series R&D Day event on November 11. During the R&D Day, we plan to provide a deeper dive into our oncology strategy, including plans for Pumitamig and our mRNA immunotherapy candidate. Thank you for your ongoing support and interest as we continue to create value for cancer patients, society and shareholders. With that, we would like to open the floor for questions.

Q&A Session

Operator: [Operator Instructions] We will now take our first question. From the line of Tazeen Ahmad from Bank of America Securities.

Tazeen Ahmad: I wanted to get a sense about how you’re thinking about the market opportunity for MSS CRC and first-line gastric cancer. Can you just talk about how your product can be particularly differentiated from what’s currently used?

Douglas Maffei: Tazeen, thank you for the question. We lost your audio there a little bit. Could you just — sorry, could you just repeat that question? I just want to make sure we get it correct.

Tazeen Ahmad: I wanted to ask a question about the market opportunity for MSS CRC and for first-line gastric. I wanted to get a sense of how you think about the opportunity relative to the competition?

Douglas Maffei: Thank you, Tazeen. We got it this time. So that was a question about how we think about the CRC first-line opportunity in gastric and how it compares to the competitive field. So Ozlem, would you like to take that question?

Özlem Türeci: Yes, I can take that question. Both indications as CRC and gastric first-line are still high medical need indications. And we think that the combination of VEGF-A and PD-L1 blocking from a biology point of view, has a rationale for development and has the potential of improving the clinical benefit for these patient populations.

Operator: We will now take the next question from the line of Terence Flynn from Morgan Stanley.

Terence Flynn: I had 1 question and then 1 just clarification. So for BNT323, was just wondering, if you can share any more color on the delay in the BLA filing in terms of the gating factor here? And then on the new R&D guidance, just want to clarify that, that reflects the assumption of some of the BNT327 expenses by Bristol-Myers and that, that was the driver of the change here, if there’s other prioritizations that fed into this?

Douglas Maffei: Yes. Okay. Thank you, Terence. So 2 clarifications in there. So maybe if we do the R&D guidance first, and I’ll direct that one to Ramon. And then Ozlem, I’ll direct the BNT323 BLA progress question to you after that.

Ramón Zapata-Gomez: Thank you for the question, Terence. I would say that the lower guidance on R&D is not about reducing spending on BNT327. We are updating this guidance to reflect the lower R&D expenses for the year. The reduction is mainly driven by the phasing of certain programs and a deliberate focus on our key strategic priorities, meaning BNT327 as you rightly mentioned. We demonstrate disciplined portfolio management, but I would say it’s too early to say whether this represents a structural shift. Depending on the pace of our late-stage programs, including the expanded efforts on Pumitamig, R&D spending will remain at similar levels or increase again next year. I think what really matters is that we continue to allocate resources with focus and flexibility to maximize long-term value and support our key strategic priorities and programs.

Douglas Maffei: And Ozlem, would you now like to take BNT323?

Özlem Türeci: I can take the second question, Terence. The reason why we — originally, we guided towards end of ’25 for BNT323 BLA submission. This moves now into ’26 because we have continued discussions and conversations with the FDA to further understand additional data needs and are generating this information. The plan is still to submit in ’26. And in ’26, we will also get for this program data from our ongoing breast cancer study.

Operator: We will now take the next question from the line of Daina Graybosch from Leerink Partners.

Daina Graybosch: Thank you for the question. I have a question on the overall strategy with Pumitamig of Establish and Elevate as 2 steps. And why you’re taking that approach versus in some indications doing them simultaneously let’s say, in multi-arm Phase III studies with ADC combos and Pumitamig on top of traditional standard-of-care chemo to leapfrog, particularly where you have some early data with the ADC in an indication and the competition is fierce.

Douglas Maffei: Thank you, Daina, for that question. So that’s a question about our strategy for Pumitamig and the various stages, the various steps to our strategy with Establish and Elevate. So I’ll direct that question to Ozlem.

Özlem Türeci: You are actually right. We have this 3-wave strategy, Establish, Expand, Elevate. And even though we call it 3 waves these are activities, which are going on in parallel. We have a certain focus on the chemo combination or combinations with standard-of-care because these studies can be simply started much faster, and we have a focus on speed to be really first to market in certain indications. However, there is data generation in combination studies ongoing in these indications with our ADCs, for example, and will come very soon also following this established waves.

Operator: We will now take the next question from the line of Asad Haider from Goldman Sachs.

Nick Jennings: This is Nick Jennings on for Asad and the Goldman team. Given that the BNT327 Phase III trial in triple-negative breast cancer is initiating this year, could you provide any insight as to what we can expect to see in the Phase II details coming up at SABCS. And is there any new information we can expect that provides additional confidence in the Phase III success?

Douglas Maffei: Thank you, Nick, for that question. It’s a good one. So just to recap that from Pumitamig the Phase III triple-negative breast cancer, which is initiating and Ozlem, the specific question is whether we can provide any additional details on the Phase II results that we’ll be presenting SABCS.

Özlem Türeci: So we will present some more efficacy data, safety data and also dose data.

Operator: We will now take the next question from the line of Akash Tewari from Jefferies.

Manoj Eradath: This is Manoj for Akash. Just 1 question. So we recently saw HARMONi-3 trial in first line and the CLC making some changes to look at primary PFS and OS statistical analysis separately for squamous and non-squamous populations. So considering these changes, do you still think ROSETTA-02 trial in BNT327 plus chemo is sufficiently powered for PFS and OS endpoints in the Phase III portion. Will there be any trial change, any trial-design changes based on these new information?

Douglas Maffei: So it’s a little hard to hear some of the details on that, but I heard you talking about HARMONi-3 and whether that may have any read-through or effect on the way that we’re conducting our trials for Pumitamig. So I’ll direct that question to Ozlem.

Özlem Türeci: Yes, we are constantly with upcoming new data, reevaluating our statistical analysis plans for ongoing trials, and we’ll also look into this specific trial.

Operator: We will now take the next question from the line of Yaron Werber from TD Cowen.

Yaron Werber: Great. And I had a quick follow-up for Ozlem on BNT323. Just that the need to generate more data to support filing, can you be — maybe a little bit more explicit? Do you need to generate — it sounds like you’re going to have more data, as you noted, in breast cancer next year. And so is the thought to then file for breast cancer next year. And what was the feedback for endometrial cancer? And do you still plan to file for that? Or maybe just give us better clarity.

Özlem Türeci: Yes, maybe I was misleading for the endometrial cancer discussions with FDA, have nothing to do with the ongoing breast cancer study. It’s not about generating new data. It’s about follow-up data and further analysis. So that pushes the time line a bit into ’26, but does not change our submission strategy and our plans for BNT323 overall.

Yaron Werber: Okay. And that’s for breast cancer. And then what about endometrial cancer? What’s the plan there?

Özlem Türeci: No, no, no. Endometrial cancer is our first submission. This is what we said all along. Originally, it was planned for ’25. We — this is pushed out to ’26 because, as I said, we are in discussions with — it’s in pre-BLA discussions with the FDA and providing further data breast cancer, the breast cancer study, Phase III study is ongoing, will readout later in 2026.

Operator: We will now take the next question from the line of Mohit Bansal from Wells Fargo.

Mohit Bansal: So again, a question on VEGF PD-1. One key comment we get from KOLs or experts is that with these bispecifics, it does look like that they are better VEGF inhibitors, but it doesn’t look like that the PD-1 is — the component is better. So I mean, how do you think about that? And in the context of these — this bispecific showing an OS benefit in lung cancer trials, how important it is for PD-1 to be better at this point, given that — we are seeing good PFS benefit, but OS is kind of on border line. So I would like to get your thoughts on that.

Douglas Maffei: Thank you, Mohit. So a question generally around how much confidence we or others have in the bispecific class. And you mentioned that VEGF binding is maybe better, but PD-1, you’re saying maybe not as good in bispecifics. And specifically, that OS benefit in lung. So direct that question to — Ozlem?

Ugur Sahin: I can start and Ozlem can take the second part. Is it okay, Ozlem.

Özlem Türeci: Yes, sure, please. Go ahead.

Ugur Sahin: Yes. Let’s start with our confidence. Our confidence is increasing into this drug class. And the confidence is not based on better VEGF better PD-L1s, but what the antibody really does as a bispecific molecule and we are seeing now that this is getting more and more clinical data that this is not only called on PFS, but also have an impact in OS. And maybe, Ozlem, if you would like to add mechanistic understanding how that could also be helpful.

Özlem Türeci: Yes. Mechanistically, in principle, our preclinical data, and that was also part of develop of — preclinical development and selection process for this antibody shows that blocking of PD-1, PD-L1 pathway, as well as the VEGF-A blocking in the respective preclinical settings is robust and it’s not inferior to what you would see with the individual antibodies. Having said that, we also think that the fact that we have a PD-L1, not a PD-1 arm here as an additional elements to the mode of action, namely targeting of this molecule into the tumor micro environment. And this, again, is a very good condition to amplify both on the PD-1, PD-L1 side, but also on the VEGF receptor signaling side all the effects on economical and non-economical effects of these 2 targets.

So this is the preclinical piece and mode of action piece, but the clinical data has to — to tell the truth from the data we have across tumor indications. This is not yet Phase III data. We are very confident that the activity has PFS effect in certain important indications and also duration of progression-free survival starts to look good.

Operator: We will now take the next question from the line of [indiscernible] from BMO.

Malcolm Hoffman: This is actually Malcolm Hoffman for Evan from BMO. Thinking about the guidance range for this quarter, could you quantify how much of this reflects the relatively stronger quarter for COVID versus just general updates for the BMS collaboration and U.K. government agreements. I know you mentioned most of this was tied to the collaboration, but I was curious, if there were any minor changes on the COVID front would be helpful to think about the relative contributions there. I appreciate it.

Ramón Zapata-Gomez: Thank you, Malcolm. So let us talk a little bit about the revenues. And I will refer to your COVID-19 question, but I also think it would be helpful for the audience to understand that bit of the BMS revenue. So on COVID-19. So for COVID-19, we continue to see a stable position with a strong market share and stable pricing. U.S. vaccination rates are roughly 20%, which is in line with what we had anticipated. We have always assumed lower volumes versus last year. So overall, the business is performing within our expectations for the year. While the broader market remains uncertain, we continue to lean on our strengths like strong brand recognition, reliable supply and rapid variant adaptation, and we do expect to close the year in line with our outlook.

Now if we talk about the BMS revenues, the updated revenue guidance mainly reflects the collaboration with BMS, as you rightly point out. And under this agreement, we will receive a total of USD 3.5 billion in upfront and on continuing cash payments between 2025 and 2028. While the timing of cash inflows and revenue recognition deferred revenues will be recognized in broadly equal amounts over the next 3 years, with the remaining balance recognized together with a final payment in 2028. This will provide a clear and predictable contribution over the next several years.

Operator: We will now take the next question from the line of Joshua Chazaro from Evercore ISI.

Mario Joshua Chazaro Cortes: This is Josh on for Cory Kasimov. On your and your partner’s decision to push Pumitamig into gastric cancer, did you see compelling clinical data, not sure if this is presented or not? Or is this push into this new indication based off your understanding of the mechanism of action?

Douglas Maffei: Thanks, Josh, for that question. So it was a question about Pumitamig and our announced decision to move into gastric cancer, what was that based on? Have we seen any data that we can speak to that support that decision. So Ugur, would you like to take that question?

Ugur Sahin: Yes. We have emerging data for Pumitamig in gastric cancer and as an indication, which — for which checkpoint blockade is approved. It’s an indication that we have seen responses in combination with chemotherapy and an indication where we see based on the data that we’ve got in other GI indications. A clear room for improving over standard of care.

Özlem Türeci: And also the mechanistic rationale that anti-angiogenic and PD-1 targeting approaches are validated approaches in gastric.

Operator: We will now take the final question from the line of Jay Olson from Oppenheimer.

Jay Olson: We’re curious about your collaboration with Bristol-Myers Squibb. And can you talk about the governance structure and which party makes the decisions for new trials and who leads the new clinical trials when you initiate them?

Douglas Maffei: Yes. Okay. Thank you, Jay. Thanks for that question. It’s an interesting one about how our collaboration with BMS works mechanically. I can’t say that word. So Ozlem, I’ll pass that over to you, who makes decisions for [ Auriga ], who makes decisions on clinical development.

Özlem Türeci: But it’s a classical approach with multiple collaborative arms. We have a JSC in which we discussed all the indications so far or indicate all decisions that are made are based from interest of both partners, but both partners have the opportunity to do combination trials with their products. Yes, regardless whether the other partner is interested to join directly or not. So we have a lot of flexibility in this collaboration aiming really to do all kind of studies and to exploit the pipeline of the other partner as exhausted as possible.

Operator: Thank you. This concludes today’s conference call. Thank you for participating. You may now disconnect.