BioNTech SE (NASDAQ:BNTX) Q3 2023 Earnings Call Transcript

Ryan Richardson : Thank you, Jess. I’ll start. [Multiple Speakers]

Ugur Sahin: Okay. Ryan, please go ahead. Please go ahead.

Ryan Richardson: On the pipeline update, I was just going to say on the pipeline update that we do expect data on BNT116 at SITC just around the corner. And of course, tomorrow we will have — we do expect to give a pretty wholesome update across our late stage oncology pipeline as well.

Jessica Fye: And then what about on the new iNest trial in adenopancreatic? Can you talk about what drove the decision to start that up and the SG&A flexibility question?

Ozlem Tureci: Maybe I can take this one. We’ll also talk about that trial tomorrow in our Innovation Day set up. We had an IIT, an investigator-initiated trial, a small one, which, however, showed very promising results in terms of the immune responses and the magnitude of immune responses in pancreatic cancer patients, which are traditionally always seen as immune suppressed. We also could see that the success of inducing immune responses in half of this population was correlated with prolonged time to recurrence. And this data has motivated us to now set up a Phase 2 trial which has already dosed first patients.

Jens Holstein: And then on the SG&A question, Jessica, we have reduced the cost here as well. Of course, we need to support the growth of the business going forward. Here specifically in the years to come, we need to set up a sales marketing organization for our parts where we commercialize on our own. So in that respect, we need to invest as well, but you see, I mean, the scale of costs here is relatively small in comparison to what you see at competitive levels and therefore if you look at the basis currently that we’re having here I think we’re already relatively lean. But most important really is to set up a sales and marketing organization so that will be something where we have to invest going forward some money.

Operator: Thank you. We’ll now move to our next question. Please stand by. This is from the line of Bill Maughan from Canaccord Genuity. Please go ahead.

Bill Maughan: Hi, thank you. So looking at the ongoing evolution of SARS-CoV-2, do you expect the virus evolution to slow down to the point where annual strain updates aren’t necessary? And if that does happen, how strong is the proposition for annual boosters if a strain update isn’t needed? And then a second question, looking more broadly, with the broad — the multiplicity of platforms that you have, how do you think about bringing a specific modality into the clinic against the tumor target when you have the option of using an ADC or a bi-specific or anything or several different options here. Thank you.

Ugur Sahin: Thank you. I can take the question. So with regard to the evolution of SARS-CoV-2, we have to consider two rough mutational patterns. We have the typical mutation of an existing variant, which is continuing in more or less changing of single spike protein amino acids in various positions. This is what we have observed for the alpha, beta variant and now observing for the omicron variant. But there is also a second mutation pattern which is — which are variants that evolved with dozens of additional mutations. We have seen that for the first time, but we have also seen it most recently with a variant which is called BA286, which is actually covering more than 30 additional mutations as compared to the Omicron strain.

It is still called Omicron, but if we look closer, it is actually really a new variant. And this is something that we would also expect in future. So this pattern will continue also in future. And we asked the mutations based on single changes based on single changes will not foster the generation of a new variant-adapted vaccine. I expect that the major changes will require variant adapted vaccines. And we have also to consider that the antibody titers decline over time. So we have two mechanisms. One is the erosion of the immune response itself, which is associated with a higher rate of infections and also associated with a higher severity. And the second is the evolvement of new variants. So in short, yes, we expect that also in future we have to look at two variants, and this pattern, this space might differ from season to season like we are seeing that for flu infections.

And the second question was about our interest in ADC technology and whether we would like to combine that with our expertise in target identification and antibody generation. And the answer is yes. This is something we are working on.

Bill Maughan: Thank you.

Operator: Thank you. We’ll now take our next question. Please stand by. This is from the line of Simon Baker from Redbird Atlantic. Please go ahead.

Simon Baker: Thank you very much for taking my questions. Two very quick ones, if I may. Just going back to R&D spend, from what I can gather from what you were saying, it sounds like essentially you’re doing the same for less rather than delaying or deferring. But I wonder if you could just give us a little bit more color on CapEx, whether that’s savings driven or whether there are some deferrals in there? And then secondly on PM8002, you highlight the non-small cell lung indication, but that molecule is in, I think, about half a dozen other tumour types. So I was just wondering what your interest in the other tumour types is for PM8002. Is that something you’re looking to develop and do you indeed have rights across all tumours? Thanks so much.

Jens Holstein: Yes, let me maybe quickly start with the CapEx question. So indeed here we have some savings, but we also have to some extent some shifts here. So we’re delaying some investments going forward, specifically in terms of the production area where we anticipated to invest maybe a bit more in 2023 given where we stand with COVID, the activities around other programs in the infection disease area, we said we watch how and when we actually invest and in that respect we have some lower spend than anticipated. But of course also when you go through the cost base, you try to figure out if there are some savings here and there.

Ugur Sahin: Can you shortly repeat on which compound you referred in your question in the first part?

Simon Baker: Yes, it was the Biotheus PM8002.

Ugur Sahin: Oh, yes. Yes. Biotheus PM002 is a bispecific antibody which combines a neutralizing anti-VEGF with a blocking PDL1 arm. The antibody has been evaluated in more than 500 patients and shows very favorable safety profile and has shown activity in multiple indications, also combination therapies with chemotherapy. And we see this molecule indeed as an opportunity — as an opportunity, a new generation IO, which combines bispecific activity for multiple indications. And we are seeing particularly an opportunity to combine this with our ADC portfolio. It’s well known that anti-VEGF treatment is synergistic with chemotherapy by improving the penetration of chemotherapy and modifying the tumor microenvironment and thereby increasing the efficacy of chemotherapy. And this is something that we are also expecting [indiscernible] partner for our ADCs.