Biontech SE Q1 2025 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Tazeen Ahmad - BofA Global Research - Analyst : As you prepare for your first launch for endometrial cancer, can you talk to us about how big do you think that particular addressable population is? And then related to that, can you remind us where manufacturing of 327 is expected to take place? And if you expect any impact on those tariffs?

Question: Akash Tewari - Jefferies - Analyst : So this is more long term. In NSCLC, let's say, five years down the road, what do you think is the more likely outcome? The VEGF bispecifics changed standard of care in chemo combo or you really actually needed a novel ADC along with the bispecific to beat pembro chemo? And then kind of as an add-on, how do you expect the safety profile of 327 to evolve in chemo combo versus some of the early data you've seen with the TROP2 ADC?

Question: Akash Tewari - Jefferies - Analyst : We'll go with that.

Question: Daina Graybosch - Leerink Partners - Analyst : CDC's ACIP is going to have a vote in June on the recommendation of COVID boosters. And my interpretation of their pre-meeting was there is a likelihood that they narrow the US recommendation to a risk-based. And I wonder if you could talk about that meeting, what you anticipate the vote will be? And if they do narrow it, what that might -- how that might impact your COVID-19 vaccine sales in the US?

Question: Cory Kasimov - EVERCORE ISI - Analyst : Jens, congratulations on your retirement. So I wanted to -- I recognize it's difficult to comment on programs at another company, but I'd be interested in your perspective on Akeso's preliminary overall survival data that recently came out. I mean, is this something that's in line with your expectations? And maybe more specifically as it relates to 327, does it have any impact at all in how you think about designing your own trials in non-small cell lung cancer? Thank you.

Question: Terence Flynn - Morgan Stanley - Analyst : Two part for me on 327. Thanks for the details on the ROSETTA Lung-02 study. I was just wondering if you could elaborate in terms of the doses that are being studied exactly in the Phase 2 portion and when we might see some of the Phase 2 data? And then can you disclose the powering of the Phase 3 portion of that trial?

Question: Terence Flynn - Morgan Stanley - Analyst : The timing of the data for Phase 2 and the powering of the Phase 3 portion?

Question: Jessica Fye - JPMorgan - Analyst : Ryan, I think earlier in the call, you mentioned minimal impact from current tariffs. But can you speak to how the potential implementation of future biopharma tariffs in the US might impact BioNTech? Is COMIRNATY for the US market made in the US? And second, can you just recap what you guys see as the key similarities or maybe more importantly, the key areas of differentiation of your development plans for 327 relative to the ivonescimab development program?

Question: Evan Seigerman - BMO Capital Markets - Analyst : I wanted to take a higher-level question. With varying views on mRNA technology, how are you thinking about the potential of your therapeutic vaccine franchise? There's a lot of resistance building up in the United States. Do you still see this as a core component of your strategy? Are you more focused on the bispecifics?

Question: Yaron Werber - TD Cowen - Analyst : I have a couple of interrelated questions. The first one is you've been very clear and everything you said made a lot of sense on how you're going to develop 327, small cell TNBC, non-small cell. What about second-line EGFR mutant? Any thoughts on that indication? Obviously, we're waiting for the Phase 3 from the competitor. And then secondly, can you just remind us for 323 for second-line endometrial, what data are we expecting this year and filing for accelerated approval is going to be based on which endpoint specifically? And if you can, just the powering for that study?

Question: Mohit Bansal - Wells Fargo Securities, LLC. - Analyst : Congrats on all the progress. I have two questions. So one is with ROSETTA Lung-02, could you give us some timelines when should we expect Phase 2 portion of the study to be over and you're moving formally into Phase 3? And second one, you get a lot of questions around the differences between -- different bispecifics for your Summit and Merck. And the key difference I see, like one is that you are the only one using a PD-L1. And you also have the very, very heavy chain, so VHH. So could you talk a little bit about these differences and how much could they matter in the

Question: Harry Gillis - Berenberg - Analyst : Could you please comment on the extent of global Phase 2 BNT327 data you've seen internally that informs your decision for Phase 3 entry in small cell lung and TNBC? And then related to that, is Phase 3 entry in TNBC still contingent on any Phase 2 global data? And finally, when could we expect the Phase 2 global data for BNT327 in small cell or TNBC this year? Could we see it at ESMO or World Lung?

Question: John Newman - Canaccord Genuity - Analyst : I'm just curious regarding the development of the COVID-19 vaccine at Pfizer. I wonder if you have any thoughts on some of the recent comments coming out of FDA regarding the possibility of looking at randomized studies for the yearly strain update. I'm wondering if you think that's feasible or likely if it were to move forward, what your strategy might be.