BioNTech SE (NASDAQ:BNTX) Q2 2023 Earnings Call Transcript

Brendan Smith: Hi. Thanks very much for taking the question. This is Brendan on for your Yaron. Just really quickly wanted to also ask maybe about the potential flu-COVID combo approach here. First, I guess when you think we might see data from that study but also maybe a little bit more broadly, kind of what the path forward is for the combo. And really, I guess, trying to understand with each updated booster, how this would kind of play out here, just kind of trying to get at, seeing if you could kind of cast some doubt, a little bit on the whole mRNA approach obviously from your own perspective, but really how you’re kind of thinking about mRNA fitting into the whole COVID-flu combo space from what you’re seeing at this point. Thanks.

Ryan Richardson: Yeah. Sure. I’ll start. So as you know, Pfizer currently has an ongoing Phase 1 study of a flu-COVID combo vaccine. And they also have a Phase 3 study ongoing of their flu mRNA flu vaccine, which we’ve licensed the technology to them. We still retain some economics on the program, but they’re in control and driving that program, mono program. So we do see opportunity for a combination vaccine. I think in terms of timelines, Pfizer has guided to a potential Phase 1 data update this year for the combination. And they’ve also guided in near-term Phase 3 data on the flu mono, both of which I think will be relevant data points here to help inform the next stage of development. The last point I would add is just that Pfizer has indicated I think just in the last couple of days, but are they have reiterated that they see a flu — both a flu mono and also flu COVID combo being starting to become relevant from 2024 onwards.

So not something to look at this year. Although, I think positive data could obviously be a helpful catalyst for us as well.

Operator: Thank you. We will now go to our next question. One moment, please. And your next question comes from the line of Terence Flynn from Morgan Stanley. Please go ahead.

Terence Flynn: Great. Good morning and thanks for taking the question. Just I was wondering, if you could elaborate more on the rationale to advance BNT116 into the metastatic setting. Well, in iNeST I know you’ve talked more about the potential there in adjuvant settings. So just wondering if you could kind of compare and contrast those two approaches. Thank you.

Ugur Sahin: Yeah. Thank you. The question is highly relevant. It’s — FixVac approach is based on the off the shelf availability of the vaccines, that means, in the metastatic setting, the disease is rapidly progressing. We would like to get as quickly as possible, an immune response initiated and personalized vaccine in the vaccine approach requires around four to six weeks for preparations of the vaccine and is particularly suited for the adjuvant setting. And because in the adjuvant setting, there is a longer time frame before patients progress. So that gives us opportunity to build an immune response that can counter a potential progression of disease. Therefore, all the adjuvant ties, they have as an endpoint relapse free survival as an endpoint, whereas as in the metastatic setting endpoints will be, for example, progression free survival, OOS.

Operator: Thank you. We will now go to our next question. And your next question comes from the line of Bill Maughan from Canaccord. Please go ahead.

Bill Maughan: Hi. Thank you. So I have a question on self-amplifying RNA. I know that you had to been developing a few programs with your self-amplifying RNA and it’s kind of not center stage anymore, but several other companies that are earlier in their cancer vaccine development are using self-amplifying RNA and kind of singing its praises. So I was just wondering if we could expect self-amplifying RNA to occupy some more of the spotlight and maybe be advanced in some programs coming up in the future. Thanks.