BioNTech SE Q4 FY2025 earnings call

BioNTech's vision is translating science into survival with focus on oncologies. 2025 had key achievements: maintained COVID vaccine market leadership, advanced oncology programs with registrational nucleus in lung and breast, executed strategic deals like with BMS and acquisitions, exceeded 2025 revenue guidance. 2026 priorities include accelerating oncology asset late-stage development, building momentum in combination-based approach, evolving to tumor-centric clinical development. In oncology, executing synergy-driven development strategy across modalities, advancing novel-novel combination strategy with Pumitamic as core, progressing assets as monotherapy or combination, expecting key late-stage data readouts in 2026. Also, plans to pursue next-generation mRNA innovations in a new independent company.

2026 total revenues expected in range of 2 - 2.3 billion euros. Adjusted R&D expenses expected in range of 2.2 - 2.5 billion euros, adjusted SG&A expenses in range of 700 - 800 million euros. COVID-19 vaccine revenues anticipated to be lower than 2025 due to declines in European and US markets. 613 million euro BMS payment recognition expected in third quarter of 2026.

Q: Can you help us better understand how you'll split the mRNA therapeutics, what remains in the parent beyond tech, and what kind of innovation will you take to pursue in the new company?

A: Hi, Dana. Great to hear you. So first of all, there is nothing that is going to change from the BioNTech perspective. Everything what is visible today will stay with BioNTech. Clinical, clinical, and everything what we have communicated so far. I don't want to speak too much about a new upcoming company because this is not disclosed and it is still under discussion. But what you can imagine, Dina, and you are very close to that, that the field in the MRN space is rapidly advancing. And we are seeing a lot of innovation happening, particularly in combination with AI. Yes. And we together felt really the need to address that. And by Ersam and I focusing on this chapter, on this type of endeavor to ensure that we can use basic technologies and basic IT that comes from BioNTech to build something completely new. And completely new means means really next generation. And we call the next generation everything that goes beyond the current generation. So that's the idea. If you allow me to add on on the topic, and thank you, Raina, for the question. So I think it's just to confirm that there is no split for BioNTech's core mRNA capabilities. Our strategy and pipeline remains unchanged. We retain Comirnaty. we retain our mRNA oncology programs. And what is being discussed, as Uwe was just mentioning, with this new company relates to certain rights and mRNA technologies to advance next-gen innovation, while BioNTech continues to focus on executing its late-stage pipeline and, of course, preparing all of these for commercialization. I think it's also worth mentioning that we will continue to innovate in BioNTech. We have our innovation engines in Germany, in China, and in the U.S., and we will continue to deepen our efforts and pipeline in our immunomodulators, our ADCs, and our mRNA technologies and programs.

Q: Another one may be about, um, you know, how you're thinking about, um, management at the company. So the search for the new CEO, are you looking at internal candidates or do you think that you would want somebody external? Um, what is the profile that we should be thinking about for who you think should be leading the company into its next phase? And then one question about CPAM, how are you preparing for that launch? and endometrial cancer, and is that going to serve as sort of an infrastructure build for other launches, or is this just going to be tailored for this particular launch?

A: Thank you, Tazeem. So, just to confirm, we've got one question on the search for replacement CEO and CMO. and the criteria, and then on TPAN, PREP, or EC, and whether the infrastructure is just for that launch or for future launches as well. Thank you. Thank you, Tatin, for the question. So your first part, Google and Auslan will remain in the role through the transition period, and the supervisory board has already initiated executive searches to identify the next leadership and their successors. The focus is on leaders with strong experience in late-stage development and commercial execution, which reflects BioNTech's next phase of growth. At the same time, as you know, with NMRE and all of our commercial teams, we are already preparing the organization for these potential launches, including endometrial cancer and other programs, and we are building the commercial, medical, and market access capabilities needed to support all of this pipeline coming through.

Q: high level, just on the timing of the departure. It just seems like it's a very critical time for the company for a transition given all the repositioning in recent months and the momentum in the late stage pipeline. So I guess the question I have to ask is why now ahead of very important readouts and the need for very precise execution during this important time?

A: Thanks, Asad. So that was a question around timing. So it's a critical time for the company, which we recognize, getting ready for the launches of certain products and cumulatively. So why make this decision now? I take over the question and then come on. I think from timing, we are talking now end of 2026 and not today. So it's We have a clear plan for milestones and data readouts in 2026. And we believe it's really perfect timing for transition, transitioning because the company at the time point end of 2026 will already have a number of readouts, important readouts, but also a number of phase three studies that we plan end of 2026. 15 plus phase three clinical trials. And this is really about industrialization and we need to get people on board who connect this with the scale that is needed at that moment. So if I would add to the answer, I think the plan aligns with BioNTech's continued efforts to sharpen our strategic focus on our growing late stage pipeline. And as you know, this is spanning innovative immunomodulators, as I was mentioning, ADCs and mRNA candidates. So now you have two companies focusing on these strategic priorities and two tailored investment cases. And BioNTech expects to maximize value for patients and shareholders alike. And in terms of our collaboration and contribution to the new course, we also retain the possibility to participate in UCOS Upside through its minority stake. So I hope this provides clarity.

Q: Does BioNTech contribute any capital to this new company, or is it just planning to be a minority investor. And then on the pipeline front regarding goatee, if you were to replicate the results you saw in part one in part two of the study, how do you think about the market opportunity in second line plus squamous non-small cell lung cancer?

A: Thank you, Corey. So just to clarify, First question was whether BioNTech plans to contribute any capital to the new company or whether it's a minority stake. Second question on GOTY, if we were to recapitulate the part one results in part two, what do we anticipate the market opportunity would be? Thank you. Thank you, Corey, for the question. So let me answer the first one. I think the short answer would be no, based on what is contemplated today. BioNTech's contribution to the new correlates to certain rights and mRNA technologies, not cash. The new company will have the ability to pursue funding from other resources, while BioNTech remains focused on advancing our late-stage pipeline and keep preparing for commercialization and for the innovation in our key priorities. And then, Batul? Yeah. I think everyone knows how difficult second-hand and frontal lung cancer is. real disruptive innovation in space for almost 30 years now. And if the data are replicated to the OSS station in the range of 0.5, this would be a disruption. It would begin changing for patients. And as you know, this is a very sizable patient population in non-sensory lung cancer. So we will come up with this market market projections once we see the data results.

Q: Maybe a question on the management transition. I know during the call you guys mentioned the prioritization of R&D efforts, and I guess given the upcoming transition, you know, how should we feel about the current late-stage pipeline prioritization and mid-stage pipeline prioritization versus, I guess, stability of it looking ahead? And then maybe another question I'm going to ask to Bart. You know, if the interim data were positive, could that open an avenue for an accelerated regulatory filing?

A: Thank you for the question. So we have one on the management board transition and then the second question on portfolio prioritization efforts and current late stage versus mid stage. So, thank you. Let me take the first part of the question and then I allow to take the second one. In terms of priorities, and particularly strategic priorities, this transition does not change any of this at all. BioNTech remains focused on advancing, again, the late-stage pipeline and our mRNA oncology programs, where we continue to defend Comirnaty and prepare for commercialization. We organization, our governance structures, our scientific leadership that Uber and Ozem have been building over the past years provides the stability that we need to bring this next, to bring all the pipeline to the next stages of either innovation or development or commercialization. And we will continue to lead the company through the transition period when the supervisory board conducts research for these successors. I believe that the company is well positioned to continue to move these programs through the different stages at speed and with the rights know focus and uh and really making this as available as soon as possible to our patients okay i i can take the second question uh so uh do you want to talk yes yes i can also take it uh so um depending obviously on the on the data we will see later this year from the interim analysis of the GOATI study. And if we can replicate the data we have shown in the initial part of the study, there's absolutely a potential regulatory path forward for an accelerated approval. The second part of the question with regard to the pipeline We have really built an extremely rich pipeline, and the pipeline is not only individual drugs, but we believe it's our establish, expand, and elevate strategy. We are building a combination approach that could allow us now, by rapidly transitioning from phase two into phase three, really address multiple indication spaces. with our current pipeline. We have a number of phase one assets, including, again, next-generation IO molecules, including, again, ADCs that we have in our pipeline but never shared data so far. So you will hear also in the early-stage clinical assets in the end of this year, beginning next year, late after.

Q: just kind of wondering what level of details are you planning to give for the update in early 2026? And then for the DFS primary endpoint, how do you define the bar of success?

A: So our final analysis will be later. We have just updated the projections based on the current accrual rate or event rate, to be more precise, for early 2027. And this is the time point where we expect to have robust data. Our earlier analysis, which is an interim analysis, will just guide us to continue the trials. However, will not be the basis for any steps based on efficacy data. And our objective is that we want to be statistically significantly and clinically meaningfully better than the standard of care with regard to DFS.

Q: I wanted to touch on the upcoming phase two to interim data for BMT113 in first line head and neck HNSTC. Can you talk about some expectations for this interim analysis? Could we potentially see six- or 12-month OS data? And more importantly, how are you thinking about the potential tradeoffs on efficacy and safety here? I know there's been a lot of development in head and neck, so I just want to understand how you're trying to position the product relative on efficacy and safety.

A: This is... CFS-based, event-based endpoint that we expect in the late second half of 2026. And its patient population is HPV positive. In cancer patients, you know that this is a patient population that is increasing in the industrial states. And depending on the hazard ratio, this could give us a path towards registration. And also depending on the further readouts that are the later times readouts that are based on OS, this could also give us a path based on a full approval on OS. So we are very curious about the outcome of this trial. We have published strong immunogenicity data in the patient population, and so this is potentially a biggest patient trial and important .

Q: The first one on Rosetta Lung 02, I see the study was now expanded to 1260 patients from 986 or so and data is now in fiscal year 29. Was that, is one sub-histology expanded or are both of them equally expanded and what was the reason to do so? i think it makes sense given the the extension in from your competitor and also what data should we expect in the phase two um endometrial cancer femur tcan this year A: Regarding the synthesized increase in our non-small cell lung cancer study, we are constantly assessing available data or emerging data from our trials and also from other trials with this specific antibody class and based on this data. we expanded the center size also to increase speed. It was an increase for both histologies. We also amended the trial design with regard to the endpoints. We have PFS now as primary endpoint and OS as key secondary endpoint, which also helps with the speech. That means the rationale for both amendments is changed statistical considerations and also recalibration of recruitment. The second question was about TPAM. I guess specifically about TPAM in endometrial cancer, second-line endometrial cancer, our data package, which we plan to submit for BLA this year. We have also, in parallel, initiated a confirmational trial, a phase three trial, for this indication, which is ongoing and our plans remain unchanged.

Q: Are you still planning to take BNT324-B7S3-ADC combo to registration studies in lung indication? And also, do you expect any revenues from cancer vaccines BNT113 and BNT122 in 2026 through any accelerated approval pathways as your base case?

A: For 3 to 4, as you know, 3 to 4 is evaluated with 3 to 7 in multiple cancer indications, including lung cancer. We are expecting data here in the second half of 2026. And of course, we are prepared if we see a strong signal to transition from phase 2 into a phase 3 trial. And then in terms of potential revenues from our cancer vaccines, they are still, all these programs are still in the clinical development stage, so we do not expect revenue from them in 2026. The value from assets such as EMT-113, they are affected in the clinical milestones and potential approvals we are working towards rather than near-term revenue contribution.

Q: For the Rosetta Lung 2 trial, Does this make sense to do separate trials for squamous and non-squamous? And do you think that there is a lower bar to be successful in squamous trials? That's the first question. And second question for Ramon, what is your thought process here to do a buyback or some kind of special dividend there given that cash position and your cash requirements going forward?

A: You asked whether it makes sense to have two different studies. We, in fact, have in this study, in Rosetta Long 2, both histologies separated. So it's technically like two studies in one, which gives us the best balance between speed and probability of success. And then on the capital allocation strategy and priorities. So this remains focused on advancing our late-stage oncology pipeline, preparing the organization for potential launches, and defending our community as well. We believe our pipeline and all of these programs can really drive the next stage of growth for BioNTech and should get the resources they need when they need it. And outside of that, as we have done in the past, if there are assets or technologies that could help our late-stage programs be best positioned, we may look at ways to access those assets or technologies through strategic and organic transactions to strengthen our early science pipeline. So no changes there either.