BioNTech SE Q3 2024 Earnings Call Transcript

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

Question: Tazeen Ahmad - BofA Securities - Analyst : I appreciate your time. I wanted to ask you about one of the data catalysts that you mentioned that's upcoming in 2025. Perhaps we'll talk about this more in detail next week but for 323, specifically, I believe you've got data coming for endometrial cancer. Can you talk about the level of data you expect to show next year for that program and what you're looking for in order to move forward?

Question: Tazeen Ahmad - BofA Securities - Analyst : And also what would be positive data in your mind for that program?

Question: Tazeen Ahmad - BofA Securities - Analyst : What would be positive data for that study in your mind data? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 04, 2024 / 1:00PM, BNTX.OQ - Q3 2024 BioNTech SE Earnings Call

Question: Daina Graybosch - Leerink Partners - Analyst : I have one on the VEGF PD-L1, BNT327. I think we're all aware of a similar bispecific that has a PD-1 side, whereas you have a PD-L1 side and in small trials in similar indications like triple-negative breast cancer, the two bispecifics look to have similar outcomes, was that expected? And what does that tell you about the mechanism? And do you believe BNT327 could be differentiated in any indications?

Question: Suzanne van Voorthuizen - Kempen & Co. N.V. - Analyst : This is Suzanne. Maybe I missed it, but can you clarify what the exact amount is that you have taken as a provision for contractual disputes this year? Is this it? Or will there be more and can you indicate what this relates to, if this is the ongoing patent dispute with other mRNA players on the COVID vaccine? Or if there are other contractual disagreements you are dealing with?

Question: Terence Flynn - Morgan Stanley - Analyst : I was just wondering if you can tell us what you think the relevant benchmark is for survival for the upcoming BNT327-TNBC data that we're going to see at the San Antonio conference in December? Were you able to hear my question? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 04, 2024 / 1:00PM, BNTX.OQ - Q3 2024 BioNTech SE Earnings Call

Question: Terence Flynn - Morgan Stanley - Analyst : Survival benchmarks for the upcoming BNT327-TNBC data at the San Antonio conference in December. And then the second part of the question is, is it reasonable to expect some interim data from your global Phase II lung cancer trial next year?

Question: Yaron Werber - TD Cowen - Analyst : Great. Maybe just a follow-on Terence's question. on TNBC is the starting Phase IIIs to go for CPS less than 10 specifically in that cohort? Or would you go across all CPS levels in Phase III. And then secondly, on small cell, is the primary going to be head-to-head against chemo to centric or is it going to be against chemo alone? Thank you so much.

Question: Yaron Werber - TD Cowen - Analyst : Yeah. And just switching to small cell lung cancer is the Phase III going to be head-to-head against chemo or against chemo to centric. Thank you in small cell lung cancer.

Question: Jessica Fye - JPMorgan Chase & Co. - Analyst : Two first on guidance of the various assumptions factoring into your guidance what changed to lead you to guide the low end of the range, even though Pfizer, I believe, maintained its community guidance last week? And then on the pipeline for BNT327, the VEGF PD-L1 bispecific, what do you see as the fastest to market indications? And what's the right way to think about R&D spend as the company expands trials for this product?

Question: Jessica Fye - JPMorgan Chase & Co. - Analyst : Yes.

Question: Cory Kasimov - Evercore ISI - Analyst : So your Trop-2 ADC BNT325 looks like an important part of your emerging combination strategy with 327, looking at the clinical trial posting shows that you're evaluating a variety of different dosing combinations. So wondering if you can add some color on the dosing strategies in your content level. that all three mechanisms together will not compromise safety?

Question: Eliana Merle - UBS Investment Bank - Analyst : So the flu COVID combo program, I guess, what's the latest on this program after the Phase III missed d1 of the endpoints? And what's your latest thinking around the time lines for the second-gen program with the trivalent mRNA flu vaccine just given Moderna expects to launch its combo next year, curious dilutes on your strategy with your combination? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 04, 2024 / 1:00PM, BNTX.OQ - Q3 2024 BioNTech SE Earnings Call

Question: Yifeng Liu - HSBC - Analyst : I have one on your oncology portfolio. Just wondered for the other assets, apart from BNT327, 325 especially on the IO space. In the next 12 months, what are we going to hear your update on specifically things like 312 or 314, those early stage -- early mid-stage assets.

Question: Simon Baker - Redburn (Europe) Limited - Analyst : Another one on BNT327. And going back to Terence's question. I just wanted to double check that the comments you made with respect to trial

Question: Manos Mastorakis - Deutsche Bank AG - Analyst : Since my question was stolen. Basically, I just wanted to ask on your ongoing confidence on your TROP-2 program, but also your nest meal program as well? Thank you very much.

Question: Jay Olson - Oppenheimer & Co. Inc. - Analyst : Congrats on the progress, and thank you for providing this update. Can you comment on the approximate level of R&D spending increase you expect in the next few years considering how rapidly you're expanding the number of Phase III programs in oncology? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 04, 2024 / 1:00PM, BNTX.OQ - Q3 2024 BioNTech SE Earnings Call And is there an ideal number of Phase III trials that would optimize your organizational and financial resources?