Biontech SE Q4 2024 Earnings Call Transcript

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

Question: Daina Graybosch - Leerink Partners - Analyst : You had charges related to legal events that you talked about, Jens. There's a lot more IP cases going on and they seem to be accelerating and coming to some conclusions. And I wonder if you could just help give us an overview or road map of any particular ones that we should pay attention to that you think could have outcomes decided in the next quarters in this year. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 10, 2025 / 12:00PM, BNTX.OQ - Q4 2024 Biontech SE Earnings Call

Question: Daina Graybosch - Leerink Partners - Analyst : Great. And maybe one more because I would be quick. On the FixVac data that you're going to share this year of semlipamab. Can you just remind us of the context going into that, I recall that, that was a top line success and how we should be thinking about a vaccine in relapsed/refractory melanoma in context of Ozlem you sharing that the personalized vaccine didn't work in a metastatic melanoma setting.

Question: Akash Tewari - Jefferies - Analyst : Just on 327, I know in the past, your teams alluded to the costs associated with developing an agent like this across different tumor types. And certainly, Merck is talking about running a lot of different Phase 3 trials over time. And you guys have hinted a potential 50-50 partnership. Where REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 10, 2025 / 12:00PM, BNTX.OQ - Q4 2024 Biontech SE Earnings Call does BioNTech currently stand on the partnership question on 327, and what clinical or commercial capabilities would you be looking at for an external partner?

Question: Chris Shibutani - Chris Shibutani - Analyst : With your plan for 327, obviously, the scope of opportunity is considerable. And as we think about the other leading player developing Summit Akeso, they're mapping out a pretty broad plan. Can you clarify how you see what you think will be differentiating in your approach. I think preliminarily, we noticed that you have maybe further along with TNBC, but is there some strategic overlay, whether it's thinking about PD-L1 agnosticism geographies, something that helps discern how your approach may be differentiated to ultimately also demonstrate differentiated clinical data.

Question: Chris Shibutani - Chris Shibutani - Analyst : Can I follow up with a quick related question. Are you seeing any issues with enrollment of trials or competing for sites for enrollment of patients?

Question: Tazeen Ahmad - BofA Global Research - Analyst : Can I just ask you what you're expecting the bar for efficacy to need to be for 323 for the endometrial data that you're expecting this year that would be able to support the filing this year. And then related to that, maybe the second part of the question is for Ryan. How are you preparing for the launch of 323 if, in fact, you're able to do so in 2026? And maybe I wanted to follow up on that previous question a few minutes ago about partnership. How are you thinking about building out commercial organization versus waiting to partner.

Question: Tazeen Ahmad - BofA Global Research - Analyst : Yes. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 10, 2025 / 12:00PM, BNTX.OQ - Q4 2024 Biontech SE Earnings Call

Question: Terence Flynn - Morgan Stanley - Analyst : I know you mentioned you're going to have some 327 Phase 2 data for small cell lung cancer here over the next month or so. I was just wondering if you can help frame expectations there in terms of what you're hoping to see and actually how much data we'll get Will we get anything with respect to PFS, et cetera?

Question: Harry Gillis - Berenberg - Analyst : Just on the 2025 revenue guidance, you talked about relative stability in vaccination rates, pricing and market share. I was just wondering if you could provide maybe some quantification or details on what those metrics look like at the low and high end of your guidance? And perhaps specifically what you're factoring into your forecast for US vaccination rates and any impacts from Sanofi's commercialization of the --

Question: Cory Kasimov - Evercore ISI - Analyst : I wanted to follow up on Terence's question regarding setting the stage for the update later this month at ELCC. Are you able to comment on how much follow-up you will have at the meeting? And what do you see as the appropriate comp at this stage?

Question: Sadia Arman - Wells Fargo - Analyst : This is [Sadia Arman] on for Mohit. So another question on 327. With the competitor expected to read out their OS data in lung cancer later this year, how would you view read-through from those results to 327 in lung cancer? And can you discuss any differences in how you're approaching development, specifically in non-small cell lung cancer from the competitor -- just any differences or similarities that you would highlight?

Question: Asthika Goonewardene - Truist Securities - Analyst : Ozlem, you mentioned that you started recruiting patients with a Phase 2/3 trial in non-small cell lung cancer. Could you give a little bit more color on the size of that Phase 2 cohort. And if you plan on reporting that data and maybe a little bit of guidelines on expectations for enrolling that Phase 2 portion? And then related to this, guys, could you maybe comment on the statistical analysis of the study? And I believe you're considering the nonsquamous and squamous population separately, which is different from how your competitors Summit is doing their analysis of HARMONY3. So why do you prefer your method?

Question: Asthika Goonewardene - Truist Securities - Analyst : Got it. Guys, can I also just double click into this a little bit, please? Because the study, the Phase 2/3 recruiting 980-something patients. What proportion of that target enrollment is specifically for the Phase 2 component.

Question: Yaron Werber - TD Cowen - Analyst : I have a quick question. Actually, I want to maybe shift to the ACIP latest decision not to hold an ACIP, not meeting this time it was flu. Just curious, I know it's early, but how would you handle this? Would you, at the end of the day, with Pfizer just used the World Health Organization recommendation for the COVID strains and I don't know whether you have any communication so far, what to expect.

Question: Jessica Fye - JPMorgan - Analyst : So beyond the small cell lung data coming up imminently for 327, can you just take us through what specifically the next 327 data releases will be and where we should look out for them? I realize there's a number of listed on the slide, but it just says 2025-plus.