BioNTech SE (NASDAQ:BNTX) Q4 2022 Earnings Call Transcript

Yaron Werber: I just have a couple. The first one is on BNT211. What solid tumor data do you anticipate having this year? Is it going to be something outside of the testicular and ovarian and sort of what comes to mind? And then secondly, just to go back on BNT122, the PFS should have potentially read out second half next year. So, as you’re thinking about releasing data in the second half of this year, is it that you’re waiting for the survival data, or sort of what are the gate marks that you’re waiting for you to release that data? Thank you.

Özlem Türeci: Thank you for your question. BNT211, we have a clinical trial ongoing, which recruits patients who have CLDN6-positive cancers, specifically testicular cancer. And as you have already pointed out, we have already reported some of that data. We will have a larger cohort of testicular cancer patients. And this will be one part of the data we will report this year. On top of that, the clinical trial is continuing to enroll patients with ovarian cancer, with endometrial cancer, other rare CLDN6-positive cancer types like gastric and some small cell lung cancer, for example, so that also these indications will be reported.

Ugur Sahin: BNT122, maybe I can take the question. So we are indeed collecting objective response data, PFS data as documenting OS data and potentially read out in the second half of 2023 will be most likely limited to PFS and ORR data.

Operator: And the next question comes from the line of Chris Shibutani from Goldman Sachs.

Unidentified Analyst: This is Steven on for Chris. Thank you for taking our questions. Two for me. So currently, in select territories, BioNTech and Pfizer have a 50-50 gross profit share. Can you speak to what the economics of that might look like for a COVID-flu combo vaccine, if that’s approved in the future? And then with the renegotiations with the European Commission, where there’s potentially lower volume and potential rephasing, could you elaborate on what that might mean for price, could we see a higher price going forward with that contract?

Jens Holstein: Yes. Maybe let me start with this, and then Ryan can chime in. So for the combination of COVID-flu, we can’t give you any details. This is confidential in the discussions with our partner Pfizer. And then in terms of the EC, of course, I mean, these are also ongoing discussions, as you know. We wanted to make sure and be transparent that these outcomes could be the case that the existing 450 million doses contract that we have with the EC could be split over several years or that potentially a certain volume could go down overall. But on the details in terms of pricing, you’ve got to bear with us. Yes, we can’t give any details here. We’re in the middle of negotiations, so we can’t give any more details than what I just said.

Ryan Richardson: Yes. And I would just add the point that — as you know, Steven, for the COVID vaccine, we have a 50-50 gross profit share with Pfizer. We only carry SG&A expenses or S&M expenses in those BioNTech commercial territories, Germany — effective the vast majority of sales and marketing expenses is with Pfizer and outside of our collaboration, which means that our effective economics on the product are well above 50%. I think on flu, that’s different. On the flu mono program, we had licensed that to Pfizer back before COVID-19, as you may recall. So, it’s more of a licensing agreement. We don’t bear any of the development costs for the flu mono program. So it’s a very different structure. We do have — we are eligible to receive milestones and royalties on flu mono.

So I think until we can disclose more on the combo economics, I think it’s safe for you to assume that it’s somewhere in between those two and that we do think it would be economically meaningful to us from a P&L perspective, but that’s all we can say at this point.