Q3 2025 BioNTech SE Earnings Call
Welcome to BioNTech, Sir, Quarter 2025 earnings call. I will now hand the call over to Doug Murphy.
Vice President, Strategy and Investor Relations. Please go ahead.
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 will use during the call and the corresponding press release can be found in the investor section of our website on the next slide. You will see our forward-looking statement disclaimer.
Additional information about these statements and other risks is 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 the Bontex management team.
Ugur Sahin, Chief Executive Officer and Co-Founder.
Osam Teti, Chief Medical Officer and co-founder, and Ramn Zapata, Chief Financial Officer.
With this, I'll hand the call over to UGA.
Thank you, duck 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 bio for a pharmaceutical company with the science.
scale capabilities and the aim to deliver multiple approved therapies and reach patients in need.
Cancer remains a systems problem; it is heterogeneous across patients and valuable with an individual tumor.
We believe the future lies in rational design combinations.
Pairing potent and precise mechanism of action. They create biological synergies to this aim, we have purpose-built at Diversified clinical pipeline.
Spending on mRNA immunotherapies; next-generation immunomodulators, ADCs, and other targeted agents that enable the development of potent personalized precision medicine and novel combinations across tumors.
Our goal is to address the full continuum of cancer, from recurrent high-risk tumors in the adjuvant setting to advanced and metastatic disease, as well as treatment-resistant and refractory cancer.
Our strategy concentrates capital on two priority plant tumor programs that are designed to anchor various combinations. One is Pramac, formerly BNT, Free to 7, a PDL1 VGSA by specific that unites checkpoint inhibition with vascular normalization in one molecule.
We believe Pumac is particularly suited as a next-generation IO backbone to combine the Shamo ADC and other immuno-modulators.
Immune system disposition.
Our mRNA can say immunotherapy self, advanced in randomized, late stage, price is focused on the actual 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. This program provides breadth, optionality, and scalable registration of part because Solid 2 months.
We are investing deliberately.
Scaling, clinical development building, and manufacturing that ranges from personalized to large-scale production, while preparing for commercialization in key markets to reach patients in need.
Now turning to how our achievements in the quarter related to our vision and strategy.
We see Pramukh as a potential standard of care, a cost-divers tumor type.
Spending settings, already treated with checkpoint inverters, and those that checkpoint in with us have not demonstrated benefits.
Is our partner BMF. We are executing a boat registration program.
This quarter, we made significant progress in advancing. Pumac taking concrete steps toward our registration plan.
In Crew 3, we progressed enrollment in 2 global registrations, trials in lung cancer, and remained on track to initiate the PNDC Phase 3.
This year.
This keeps us aligned with our target of first potential launches before the end of the decade.
The cost of the portfolio is more than a dozen thicknesses. Seeking studies progress.
Either with Shamo backbone to expand in the additional indications, or as normal novel combinations with BioNTech props.
Importantly we Advanced clinical mono agent profiling of potential combination Partners helping to deal with those schedule and safety assumptions for future registration designs.
This steps including phase 3 recruitment, momentum initiation of new combination, cohorts and deeper combination partner. Characterization are all about informing your next slave of registration cards plans with DMS from now onwards turning to Omni can the immunotherapy platform in October? We presented Phase 2, trial updates for BNT, 111 our 6, second candidate in
Melan.
Our data, reinforces our view that accurate settings that tumor burden is low and immune control is most effective represents their mRNA immunotherapy. Can deliver the most significant benefits to patients
A shared details on how the sweet out shopping our development Focus, this quarter. We hosted our second AI day.
It underscored 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 showcase 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 the interpretation heterogeneity and intra-tuna variability, and driving precision and potency in our treatment approaches with regard to our COVID-19 vaccine franchise, which is partnered with Cyber, is successfully launched. Our variant-adapted vaccines for the current season are following regulatory approval.
The system is in a major market, with a strong balance sheet of over €16 billion in total cash equivalents and securities. We have the resources and the flexibility to fund the oncology transition by maintaining a disciplined P&L.
Simply put, we are transforming scientific advances into late-stage progress. In our priority oncology program,
Cost indications. In parallel, we are building the capabilities and the financial strengths to translate positive data into market opportunities. And most importantly, into patient benefit.
Our clinical execution and near-term data laid out.
I'll start with a topline status of the programs that are heading our pipeline before moving to specifics.
Firstly, with our pdl1 V GFA by specific, anti-body Puma M. We are executing a broad, registrational program in partnership with Bristol Myers script.
Second, for our mRNA cancer immune of Europe piece, we have recently provided two Phase 2 updates that support and inform our current development strategy.
And third for trust or TPM or her two targets: targeted ADC known previously as PNT-323 that we developed with our partner Duality. We continue to progress towards the first BLA submission, now planned for 2026, subject to regulatory feedback. We are evaluating TPM as a monotherapy in Europe into randomized Phase 3 trials, one in metastatic endometrial cancer and one in breast cancer.
For both studies, we expect data in 2026.
We have also initiated a sigma seeking trial, evaluating the novel combination of Tam with pom.
Let me recap the clinical development framework.
Our refined Freewave plan that we are pursuing with our partner BMS.
Wave 1 aims to establish promec in free foundational first-line indications: small cell lung cancer, non-small cell lung cancer, and triple-negative breast cancer through global registrational Phase 3 trials.
With 2 and 3, aim to expand the opportunity of pom 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, for novel combinations, notably with our ADCs that enhance efficacy. We have delivered tangible progress on all these three waves in Q3.
Regarding Wave 1 in small cell lung cancer, the global phase 3 is recruiting, and the phase 3 dose is locked based on the dose optimization data set, with a safety profile consistent with known PDF1. DGF chemo experience.
In non small cell, lung, cancer, The Phase 2, part of the seamless face to free, trial achieved full enrollment and the phase 3 portion is recruiting.
In TNBC, we remain on track to initiate the global Phase 3 this year, targeting the PD-L1 low segment, where unmet need is highest. This slide shows additional studies; these are supportive studies for those findings.
Setting refinement and regional programs that contribute to the body of evidence supporting our free foundational global Phase 3.
Wave 2 serves as our expansion engine. We now have more than a dozen chemo-based Cigna-seeking studies across tumor types and lines of therapy. In Q3, we opened new cohorts and continued to mature data sets that will feed into our pivotal planning. This helps to ensure that the next registration 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.
Spare heading. This next round of pivotal trials, we are initiating two trials in partnership with BMS with registrational intent for.
Wave 3, elevates, the potential of pumel Novel combinations, the maximize its clinical impact, reinforced class differentiation and set up a multi-year pathway to system. The value and the longevity of a drug into the new decade.
Here are several combo cards of
Partners to set. Clear Baseline for those safety and Seekers.
Taken together, Q3 was a quarter of strong clinical execution that strengthened our registrational core, widened our expansion engine, and advanced the novel combination rationale that we believe will further distinguish and elevate PERCY over time.
Let me now highlight two Q3 focal points. First, our first-line small cell lung cancer registration 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 diseased, 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 2 studies and first and second lines. More cell lung cancer, initially in China and now globally, is showing encouraging activity and a manageable safety profile.
This quarter at WCLC, we reported the first global data from our Phase 2 optimization study in untreated extensive stage small cell lung cancer, evaluating two dose levels of.
All patients, irrespective of those who had Disease Control at 20 MC per kick, were observed to have a confirmed objective response rate of 85%, with a median progression-free survival of 6.3 months.
30 MC per kick yielded, a confirmed objective response, rate of 66% and the median, PFS of 7 months,
Median overall survival data were not yet mature.
Safety remained consistent and manageable, with low discontinuation rates and no new signals beyond those typically seen with chemo and PD-L1 VGF agents. Two points are worth emphasizing.
First, those clarity, which is a critical de-risking step for any registrational program. The global dose optimization readout allowed us to lock the Phase 3 regimen at 20 mg per kick 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 due free data are consistent with those findings, which further strengthens our confidence. In pomf Cross patient populations and practice patterns together these results. Support our ongoing Global phase 3 Rosetta lung o1 trial which Compares pumitik plus chemotherapy against a sollatuma plus chemotherapy and untreated small lung cancer in parallel. In China, we continue with second line, randomised phase 3 trial of ohmic plus chemo where this chemo alone
This quarter, we expanded our POM mix in the small lung cancer program to include novel testing, and we launched signal-seeking studies of Puma, our B7H. ADC, the Entry 324 in both first and second lines of small cell lung cancer.
SA3 readouts and Phase 1/2 ADC combination data sets mature, we will be well positioned to select and advance additional regimens. This is designed to establish a long-standing presence in small cell lung cancer.
This brings me to our strategy for advancing combinations of.
For our B7 A3, ADCB, and 324. Our mono agent database has expanded significantly over the last 12 months. The 783 Road expression profile aligns well with Promet expansion, presenting more opportunities.
And non-squamous disease, including an egfr mutant subset with an objective response rate of 21%.
In heavily pre-treated metastatic, castration-resistant prostate cancer, we observe meaningful tumor shrinkage with BNT324 and a durable radiographic response.
Progression-free survival with a manageable safety profile recently. At as more, we reported data for our top 2 ADC, the entry 325 in second line plus tnbc with an objective response rate around 35% Disease, Control control control rate of roughly 81% and medium progression free, survival of about 5.5 months. Also in Q3 for our 2 Adcock, conducts in China, that met its primary end point of PFS Improvement, versus trusted sum up and tanzine in pre-treated patients with her to positive unresectable or metastatic breast cancer Tam. Is another promising, combination partner.
With the potential to expand Pumita's therapeutic reach into the HER2-expressing tumor spectrum, taken together, these data provide a clear model of European baseline and help us set the bar for add-on benefit from Fumic Plus, ADC combinations.
Across these programs, the mechanistic rationale is consistent bgf. A blockade can normalize vasculature to improve, ADC delivery while pdl1 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 two key advances in Q3: continued mono-agent profiling to refine those, and the sequence and codification of our add-on benefit threshold.
And the expansion of FOMIC 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 way, other key factors to ensure every decision aligns with our mission to deliver transformative benefits, for patients moving. Now to our second oncology, Cornerstone mRNA cancer, immune of Europe.
Inist is individually manufactured per patient to Target personal neuro antigens.
The biology and our clinical experience point to the greatest relevance in earlier disease settings, where there is a lower tumor burden. Allow the immune system to consolidate control. Our ongoing randomized Phase 2 trials are designed to test that premise in a rigorous way off the shelf. This includes BNT1 111, BNT1 134 for HPV16 positive head and neck cancer, and BNT1 16 for non-small cell lung cancer.
Targets shared antigens and this 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 fix sack is best positioned longer term.
This quarter at WCLC, we presented results for BNT1 16 plus similar as consolidation treatment in unresectable stage 3 non-small cell lung cancer. We also presented data at ASCO from two randomized Phase 2 trials in melanoma: one with BNT1 116 and the other for autologous T cells in the NEST trial. I will briefly walk you through the melanoma readouts and their implications.
Starting with BNT1 116 back in the high medical. Need the population of patients who had relapsed or not responded to PD-1 treatment.
PD-1 treatment in this setting, the study included two 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 crossarm, efficacy claims in the moon of therapy chords on progression edition of the second agent was permitted.
More than half of the patients in each arm opted for this edition.
After a median duration of Iva, Moon of therapy, treatment of brown formats.
The study met its pre-specified primary endpoint by rejecting the null hypothesis of an ORR of 10% with statistical significance.
The ORR also combination was 18%, including deep and durable responses.
Notably 2/3 of the responses were complete responses supporting the depth of activity.
Follow-up shows the positive impact on long-term survival: 37% of patients were still alive after 24 months, and 21% were free of tumor progression.
Safety was manageable, driven largely by expectations. Mostly Grade 1-2 cytokine-related events were consistent with the mRNA platform.
The NT1 11 moon of Europe. You also demonstrated objective responses and a consistent safety profile.
Taken together, these results support that BNT1 11 is active in this difficult environment.
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 2 trial evaluating autogene therapy.
In combination with the Piso map, where the SPA released them up alone: in the 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 in overall survival in the combination arm at 12 months.
Overall survival was 88% at 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 perceived the combination at progression for the overall survival analysis. Patients remained in their originally assigned arm, which can dilute the observed treatment effect over time.
We observed robust new antigen specific T Cell responses in the majority of a valuable patients with multi epitope breath and Persistence of key cell clones. Well Beyond induction, indicating that the MRNA of therapy is mediating. The intended biological activity that we want to achieve the translational readouts, give us 3 actionable. Insights first, T Cell response of breath correlates with activity within the combination. Arm patients. Who mounted? A broader? Neo antigen specific T Cell response. Experienced longer progression-free survival, supporting our ongoing efforts to maximize antigen reps 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.
All together, these mechanistic insights support our ongoing randomized Phase 2 trials.
Both a specific indication: we have chosen pancreatic and bladder cancer, as well as our focus on the adjuvant setting where tumor burden and heterogeneity are critical.
Now looking ahead, what comes next?
We will continue to generate and present new clinical data across our oncology pipeline, with a direct list here and late-stage decisions.
For.
From our ADC platform, we expect additional updates on your IP from B&T 324 in cervical cancer and platinum-resistant ovarian cancer, from B&T 325 in triple-negative breast cancer (TNBC), and from BNC 326 in HER2-null and low hormone receptor-positive breast cancer. These studies explore indications, defined dose, and sequence start trails.
And set the add-on benefit bar for Promex novel, novel combinations.
For the randomized, phase 2 trial, evaluating autogenerate treatment. Where this watchful waiting in eduin ctdna positive stage to high risk or stage 3 colorectal cancer. We expect an interim update in early 2026.
The efficacy evaluation of a primary endpoint of disease-free survival.
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 on C4 from the non-registration. First part of the ongoing Global phase 3 trial, evaluating our anti-ctla for anti-body got his provide versus chemotherapy as a second line treatment for squamous non smaller, lank cancer,
Overall, these upcoming data points advance the same theme—evidence-led prioritization—by establishing those findings and mono ADC baselines to further refine Pumicestone.
And leverage randomized settings 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 Ramen, sobota for the financial update. Thank you olim and I welcome to everyone who has joined today's call. I will Begin by reviewing our financial results. For the 3 months. Ended September 30th 2025 note that all figures are in Euros unless otherwise specified the total revenue reported for the period where 1 billion 519 million.
An increase from the same quarter in 2024, which was 1 billion 245 million.
This increase was mainly driven by the recognition of $700 million as part of the VMS collaboration in the third quarter of 2025.
For context in total we expect to receive 3.5 billion US dollars in upfront and non-contingent cash payments from BMS between 2025 and 2028.
For the third quarter, 2025 we reflected 700 million US dollars in our revenues.
Moving to cost of sales. This amounted to approximately 148 million for the third quarter of 2025 compared to approximately 179 million for the same period last year, driven by lower inventory write Downs.
Research and development expenses were approximately 50065 million for the third quarter of 2025 compared to approximately 550 million for the same period last year.
R&D expenses were mainly driven by the initiation of late stage trials for our immuno modulators and ABC programs.
And partly offset by cost savings resulting from active portfolio management. Towards our priority programs, SDNA, expenses amounted.
approximately 148 million in the third quarter of 2025 compared to 150 million for the same period last year.
Was mainly driven by lower external costs?
Partially compensated by our ongoing commercial buildout. Our other operating result amounted to approximately negative 75 million in the third quarter of 2025 compared to approximately negative 355 million for the same period last year.
Our other operating result 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 29 million compared to a net income of 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 12 cents compared to basic earnings per share of 82 cents and diluted earnings per. Share of 81 cents for the comparative prior year period. At the end of the third quarter of 2025 our cash cash equivalents and security Investments, totaled, 16.7 billion Euro including the 1.5 billion US Dollars up from payment. Received from BMS, our strong financial position and Powers continued investments in our late stage priority, programs and preparations. For commercialization of our d.
Testify 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 to 2.2 billion. And today, we are increasing it to 2.6 to 2.8 billion. This is mainly driven by the recognition of 700 million US dollars from our VMS collaboration.
Other guidance considerations such as those related to our Co coid, 19 vaccine business, including inventory, write downs from coid, 19. Vaccine sales in 530 territories, as well as expected revenues from the pandemic. Preparedness, contracts with the German government and revenues from our service businesses remain on changed.
Turning to expenses, we are lowering our prior 2025 Financial year around the expense guidance, by 600 million, to a new range of 2 to 2.2 billion.
These 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 this 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 disciplines and sustainable growth. We are also improving our full year guidance for sgna and capital expenditure for operating activities.
We are reducing our full year sgna expense, guidance by 100 million, to a range of 550 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 arrange of 200, 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 a sub outline. We continue to focus on executing our strategy around, stop and tumor product opportunities pumi. And our mRNA canceling in. We currently have multiple ongoing Phase 2 and 3 trials, across these programs reflecting our strategy to bring novel combinations to patients. We expect to generate additional meaningful data for this program.
In the months ahead.
Before concluding, I would like to invite you to watch our annual Innovation series R&D Day event on November 11th. During the R&D day, we plan to provide a deeper dive into our oncology strategy, including plans for pumita make and our mRNA monotherapy candidates.
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.
Thank you. To ask a question, please press *1, 1 on your telephone, and wait for your name to be announced.
To withdraw your question, please press star 1 and 1 again.
We kindly ask you to limit yourselves to 1 question per person and ask you to ask speak loudly and clearly into your microphone.
We will now take our first question.
From the line of testing, Ahmed, from Bank of America Securities. Please go ahead.
Hi guys. Good morning. Uh thank you for taking my question. Um I wanted to get a sense about how you're thinking about the market opportunity for MSS CRC and first line gastric cancer. Um can you just talk about how your product can be particularly differentiated from what's currently used, thanks?
Hi. This is Zen. Thank you for the question. We lost your audio there, a little bit. Could you just sorry. Could you just repeat that question? Just want to make sure we get it correct? Yeah, sorry about that.
Um, I wanted to ask a question about the market opportunity for MSS BRC, and for first-line, gastric. Um, I wanted to get a sense of how you think about the opportunity. Um, relative to the competition. Thanks,
Thank you to Zayn. We got it that 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 osm would you like to take that question?
Yes, I I can take that question. Um, both indications MSS CRC and gastric first liner, still high medical need um, indications and uh, we think that the combination of uh, vgf a and uh, pdl1 blocking uh, from a biology point of view. Uh, has a rationale for development and has a potential of uh, improving the uh the the clinical benefit for these patients population.
Thank you.
From the line of Terren fleeing from Morgan Stanley, please go ahead.
Hi, thanks for taking the question. Um, I had uh 1 uh question and 1 just clarification so for BNT 323 was just wondering if you can share any more color on the delay in the bla filing in terms of the, the gating Factor here. And then, on the new R&D Guidance, just want to clarify that, that reflects the Assumption of, um, some of the 327 expenses by Bristol Meyers and that, that was the driver of the, um, the change here. If there's other prioritization that, that fed into this, thank you so much.
Yep. Okay. Thank you Terrence. So 2 2 clarifications in there. So maybe if we do the R&D guidance first and and I'll direct that 1 to Ramen and then also um I'll direct the uh, 323 bla progress, question to you after that.
Thank you for the question, parents. Uh, I would say that the lower guidance on R&D is not about reducing spending on $327. We are updating this guidance to reflect, uh,
The uh, you know, lower around these expenses for the for the, the reduction is mainly driven by the facing of certain programs and are delivered focus on archist strategic priorities, meaning 327. As you rightly mentioned, these demonstrate discipline, portfolio management, what I would say is too early to say, whether this represents a structural shift, depending on the face of our late stage programs, including the expanded efforts and Pam.
Around this spending could remain at a similar level 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.
and also,
Just uh, now in 20 in 26 because we have continued discussions and conversations with uh, the FDA to further understand additional data needs and are generating this information.
The plan is still to um submit in uh 26. And in 26, we will also get for this program data from our ongoing breast cancer study.
Thank you.
We will not take the next question.
From the line of Dina gray bush from leaving.
Partners, please go ahead.
Hey guys, thank you for the question.
I have a question on the overall strategy uh with to make to make of established and Elevate as 2 steps.
And while you're taking that approach versus in some indications doing um simultaneously let's say in multi-arm Phase 3 studies, with ADC, Combos and permit to make on top of traditional standard of care chemo, to Leap Frog, particularly where you have some early data uh, with the ADC and an indication. And uh the competition is fierce. Thank you.
Thank you, thank you, Dana for that question. Um, so so that's a question about our strategy for permit and the various, um, stages, the the various steps, to our, to our strategy, with establish and Elevate. So um, I would direct that question to osam.
Sure, thank you question. Uh, you are actually right? Uh, we have the 3 wave strategy established, expand Elevate, and even though we call it, uh, freeway, uh, these are activities which are going on in parallel. We have a certain focus on the um, chemo combination. So combinations with standard of care because these studies can be simply started, much faster. And we have a focus on speech to be really first to Market in certain indications. However, there is data generation in combination studies ongoing in these indications. Um, with our adc's, for example and uh, will come very soon. Also following this uh, established way
Thank you.
From the line of Assad. Haider from Goldman Sachs, please go ahead.
Hi, thanks. This is Nick Jennings on for Assad and the Goldman team. Um, given that the BNT 327 phase 3 trial in triple negative breast cancer is initiating this year. Could you provide any insights as to what we can expect to see in the phase 2 details coming up at sabcs and um is there any new information? We can expect that provides additional confidence in the phase 3 success. Thanks.
Thank you, Nick, for that question. It's a good one. So, um, just to recap that from our commitment to make the Phase 3 triple-negative breast cancer trial, which is initiating. And also, um, the specific question is whether we can provide any additional details on the Phase 2 results that we'll be presenting at SABCS.
So, we will present some more efficacy data, safety data, and also those data.
Thank you.
We will now take the next question.
From the line of Akash to worry from Jeffrey's, please go ahead.
Okay. Uh, this is managed for August. Uh, just 1 question. So we recently saw Harmony 3 trial in first line and the CLC, making some changes to look at primary pfos and oil static analysis separately for scammers and known scammers populations. So, considering these changes. Do you still think Rosetta 02, uh, trial in BMT, 327 plus chemo? Is sufficiently powered for PFS and Os end points in the uh, phase 3 portion. Will there be any trial change? Uh, any trial design changes based on these uh, new information.
Yeah, thank you for that question. So it was a little hard to hear some of the details on that, but I heard you talking about Harmony 3 um and whether that may have any read through or effect on the way that we're conducting our trials for a few Mig. So I'll direct that question to osam.
Yes, we are constantly moving forward with upcoming.
uh,
And that has been for ongoing trials. We'll also look into this.
Specific trial.
Thank you.
Thank you.
We will now take the next question.
From the line of Yaron. Wherever from TD Cohen, please go ahead.
Great. Uh, thank you so much and I had a quick follow up for Osa on 3:23. Just didn't need to generate more data to support filing. Um, can you be maybe a little bit more explicit? Do 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, then file for breast cancer next year and what, what was the feedback for endometrial cancer? And do you, do you still plan to file for that or maybe just give us better clarity? Thank you. Uh, yes, may maybe I I uh uh, was misleading. Uh, so the endometrial cancer discussions with FDA have nothing to do with the breast ongoing breast cancer.
Study, uh, it's not about generating new data. Uh, it's about follow up data and further analysis.
So that, uh, pushes the timelines a bit, uh, into 2026. But, uh, does not um change our submission strategy and our plans for Q3 overall.
Okay. And that's and that's for for breast cancer. And then what about endometrial cancer? What's the plan there? Thank you. No no, no endometrium.
Uh, what we said all along, uh, originally, uh, it was set for 2025. Uh, this is pushed out to 2026 because, as I said, we are in discussions with, uh, uh, in PBL discussions with the FDA, uh, and providing for the data, uh, breast cancer. The breast cancer Phase 3 study is ongoing. We'll read out later, uh, in 2026.
Thank you.
We will now take the next question.
From the line of Mohit bansal from Wells, Fargo, please go ahead.
Great, thank you very much for taking my question. Uh, so, uh, again, question as of pd1, uh, 1 key comment, we get from kols or experts is that, uh, with these by specifics, it does look like that. They are better with Jeff, uh Inhibitors. But uh, it doesn't look like that. The pd1 is component is better. So, I mean, how do you think about that? And in the context of these, uh, this by specific showing an OS benefit in lung cancer trials, how important it is for pd1 to be better at this point. Uh, given that we are seeing good PFS benefit but OS is kind of on borderline. So would love to love to get your thoughts on that. Thank you.
Okay, thank you. Move it. So, uh, question generally around how much confidence we or others have in the by specific class. And you mentioned that, uh, that Jeff, uh, Binding is maybe better, but PD-1, you’re saying, maybe not a good invoice specifics and specifically the OS benefit in lungs. So, direct that question to.
Also, I can pay the second part. First of all, I think is that okay? Yeah, sure. Please go ahead.
Yeah, let's let's start with our confidence. Our confidence is increasing into this into this graph class. And and um, and the confidence is not based on better ETFs or we a better PDR 1. But what the entire body? Really does the best specific molecule. Yeah. And we are seeing now that this is uh getting more and more clinical data that this is not only calling PSS but also have an impact in in, in uh, in OS. Maybe a 7. If you would like to add mechanistic understanding,
It could also be helpful. Uh yes. Uh mechanistically in principle, our pre-clinical data and that was also part of uh uh develop of of of uh, pre-clinical development, and selection process for this anti-body shows that, uh, blocking of pd1 pdl1 pathway as well as the GFA blocking in, uh, the respective pre-clinical settings. Uh, is is robust. Uh, and is not inferior to what you would see with the individual antibodies. Uh, having said that, uh, we also think that, uh, the fact that we have a pdl1, uh, not a pd1 arm here at an additional, um, uh, uh, element to the mode of action named the targeting of this molecule into the tumor micro environment. And this again, uh, is uh very good condition.
To amplify, uh, both on the pd1 pdl1 side, but also on the vgf, uh, receptor signaling aside, uh, all the, um, uh, uh, effects on canonical and noncon effects of these 2 targets. So this is the pre-clinical piece and mode of action piece but um, the clinical data uh, has to uh, to have a Truth uh, from the
Data, we have across uh, 2 more indications. This is uh, um, not yet phase 3 data. We are very confident that um uh, the activity uh, has uh, PFS, if effect in certain, um, in certain, um, indications and and also duration of progression, free survival, uh, starts with a good.
Thank you.
Thank you.
We will now take the next question.
From the line of Haven desktop from BMO. Please go ahead.
Hi. This is MM, MM, for Evan from the MMO. I appreciate you taking our question. Thinking about the guidance rates 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, UK government agreements? I know you mentioned most of this was tied to the collaboration, but I was curious if there were.
Uh, any minor changes on the code front would be helpful to think about the relative contribution zero appreciate it.
Thank you, and welcome. Um, so let let us uh, talk a little bit about the, the revenue and I will I will refer to your commentary question, but I also think it would be helpful for
The audience to understand that a little bit of the BMS Revenue. So,
So, we continue to see a stable position with a strong market share and stable pricing.
Us 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 with the 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 Varian adaptation. And we do expect to close the year in lines with our Outlook.
Now, if we talk about the VMS revenues,
The the updated Revenue guidance mainly reflect the collaboration with BMS as you rightly point out and on the this agreement, we will receive a total of 3.5 billion US dollars in upfront and not contingent cash payments within 2025 and 2028.
While the timing of cash inflows and revenue recognition, deferred revenues will be recognized in broadly equal amounts over the next three years, with the remaining balance recognized together with the final payment in 2028. This will provide a clear and predictable contribution over the next several years.
Thank you.
We will not take the next question.
From the line of Joshua tesaro from evercore isi, please go ahead.
Hi. This is Josh on for Corey kasimov. Thanks for taking our question.
And you're in your partner's decision to push permit, egg into gastric cancer. Did you see compelling clinical data? Not sure if this has been presented or not or is this pushed into this new indication based off your understanding of the mechanism of action. Thank you.
Um, announced decision to move into gastric cancer. What? What was that based on have we seen any data that we can speak to that supports that decision?
So Google would you like to take that question? Yes, the emerging data for for cancer
And, uh, and uh, as an indication there, uh, which uh, which uh, for which checkpoint located is approved, its indication there, and we have seen seen, uh, um, a responses in in combination with chemotherapy and, uh, and this indication where we see, uh, based on on the data that we got in other GI indications, uh, uh, uh, a clear rule for improving over standard of care.
And and, and, and also the me mechanism, uh, mechanistic rationale that uh, anti-angiogenic and uh, pd1 targeting approaches, um, are validated, approaches in gastric.
Thank you.
We will now take the final question.
From the line of J. Also from open Hymer, please go ahead.
Oh hey, thanks so much for taking our questions. We're curious about your collaboration with Bristol Myers Squibb. Can you talk about the governance structure? Which party makes the decisions for new trials? And who leads the new clinical trials when you initiate them? Thank you.
Yeah. Okay.
Thanks for that question. It's an interesting 1 about how our collaboration would be Ms. Works me. Mechanic. Mechanic listing? I can't say that word. Um so also I'll pass that over to you who makes decisions or or Ruger who makes decisions on clinical development. Yeah, uh, but, uh, it's um, it's a classical classical approach with with multiple multiple collaborative arms, the fjsc, the industry discussed all the all the indications so far. All indicate all decisions that are made up based on input of Partners. But both Partners have the opportunity to do combination combination cars with their products. Yes, we got this with the the other partner is uh, is interested to join directly or not, so we have a lot of flexibility in the collaboration and ready to do.
All kinds of studies and to exploit the pipeline of the other partner as exhausted as possible.
Great. Thank you.
Thank you.
This concludes today's conference call, thank you for participating. You may now disconnect