BioNTech SE (NASDAQ:BNTX) Q4 2023 Earnings Call Transcript

Ryan Richardson: Yes, thank you for the question. So we believe that we still performed very strong in 2023, and having globally above a 50% market share for the COVID franchise, we did see some market share pressure in a couple of markets like the United States. As you point out, we’ve also had market share gains in a number of other geographies. We maintained a very high market share above 85% in Europe, and also grew our market share in countries like Japan, which have actually been pretty sizable from a volume perspective over the last 12 months. Going into 2024, we do feel confident that we can continue to maintain a leadership position above the 50% mark globally. To your question on competition, yes, we do expect there to be some new entrants, mostly niche players in some of the peripheral markets.

I think that you pointed out also the role of pre-filled syringes, which is an important point. I think last year it is fair to say that part of the reduction in market share in the United States that we experienced was due to a lack or limited supply of pre-filled syringes. Last year, we did have some supply in the United States, but we also had single dose vials as well. And clearly, the market preference was for pre-filled syringes. As we go into 2024, we have taken steps with Pfizer to dramatically increase our supply of pre-filled syringes. In the United States, but also elsewhere.

Bill Maughan: Thank you.

Operator: Thank you. Your next question comes from the line of Akash Tewari from Jefferies. Please go ahead.

Ivy Wang: Good morning. This is Ivy on for Akash. Thanks for taking our questions. We have two. The first one is on COVID. So for COVID vaccines gross margin given that Pfizer reported $5.4 billion for revenue versus your €1.5 billion, and that your exploiting growth, perfect, 50-50 with Pfizer. It seems to imply a gross margin of 60% which is lower than previous levels of around 80%. So, is this just because of the additional write-offs Pfizer had in Q4? Additionally, I think, what’s your view on gross margin in ’24 and beyond for your COVID business, especially when the competitors seems to talk about a higher GTN discount. And my second question is quickly for pipeline. I guess how encouraged are you with the early signals of BNT122 in other consumers outside of pancreatic? And is there any read-across from the pancreatic data that will be presented at AACR soon? Thanks.

Jens Holstein: Yes. So, let me take the first question. Thanks for the question. To just clarify, Pfizer is, as you know, responsible for the commercialization of COMIRNATY in most markets with the exception of Germany and Turkey. And we have a gross profit share. And that methodology works in a way that, of course, you know whatever Pfizer is writing-off on in the — in write-off on inventories or something that is — will grow in the gross profit share and will reduce our revenue figure, that is what we are trying to highlight for the — for the last quarters, because we have been hit by round about €900 million due to that procedure. This means for us, this is basically a 100% profit for us before COGS that come across, due to the manufacturing activities that we are responsible for, and they are limited.

And if you compare the margin development that we’ll have in ’23 versus ’22, you will see that we are above 80% margin. So, you can’t really read-through from what Pfizer’s reporting really to our numbers that we report.

Victoria Meissner: With regard to your question to our BNT122 and its performance in PDAC, we are very encouraged, not surprised, but really encouraged, and this is also the reason why following the Data Disclosure of our Phase 1 PDAC trial, we have initiated a Phase 2 PDAC trial in the adjuvant setting with BNT122 which is enrolling of patients. The results we saw in this cancer type, which is considered as immune suppressive and cold and low in tumor mutational load is encouraging us also to go into other cancer indications with this type of immunological profile. And in fact in our Phase 1 trials in other such indications, we have collected data which supports the PDAC findings and which we currently are compiling to be published as manuscripts.

Ivy Wang: Thanks.

Operator: Thank you. Your next question comes from the line of Yaron Werber from TD Cowen. Please go ahead.

Yaron Werber: Right. Good morning, and thanks for taking that. I have a couple of questions as well. So maybe the first one is on 323, the ongoing Phase 3 study, the DYNASTY-Breast02. Can you talk a little bit about the powering and the PFS, and it sounds like, if I remember correctly, Chemo, the ORR, the — historically is 11% to 36%, PFS is about 3% to 8%, you show they are 39% ORRs [indiscernible]. It depends how chemo is going to do, which is kind of will determine kind of how the study works. So maybe if you can talk about the powering of the study and maybe a little bit, if you can share any Phase 1/2 data on PFS, so we can kind of just get a sense of what you’re expecting. And then secondly, just curious, you have such a huge pipeline already. And you’ve executed and you obviously continue to execute and you need to grow the company a lot to continue to execute. What’s the purpose to doing potentially more BD, given that you have so much already? Thank you.

Ryan Richardson: Thanks Yaron. So, I’ll start with the second question, and then we’ll come into the first. So I think, we were obviously very active last year on the BD front, bringing in-house six clinical stage or near clinical-stage assets. We are going to continue to be active. But Yaron, I think we would agree that we feel that we already have actually now a very broad toolkit that allows us to do a lot. And so, we are focused increasingly on execution. So, I do think that, we’re going to continue to be active in BD, but probably not as active in terms of the number of clinical-stage assets that we’re looking to bring on-board. We’re looking — the focus this year is going to be more on executing and getting the pivotal trials initiated and enrolled.