Ugur Sahin: Yes. To your second question. I think the second question can be — can be better answered with the powering for hazard ratio, which we usually do at around 0.7, 0.65. And with that, we have a power of 90%. And this gives rise to a study of around 530 patients that we will onboard.
Operator: Thank you. I will now go to the next question. And your next question comes from the line of Etzer Darout from BMO Capital. Please go ahead.
Etzer Darout: Great. Thanks for taking the question. Just one question from me. On BNT327 VEGF PD-L1, you highlighted the program sort of prominently, a couple of slides. And looking at sort of Phase 3 2024 and beyond. Just wondered if you would be providing any clinical updates for this program in 2024, what we could expect to see there. And any more specifics as well on sort of the potential path to Phase 3 and what programs or what indications specifically, you made, be able to sort of pursue with this molecule. Thank you.
Ugur Sahin: Yes. Thank you for the question. Indeed, we will see a number of clinical trial updates on this molecule in multiple indications. Just to remind everyone, this is a bispecific molecule, which has a PD-L1 for PD-1 blocking and anti-VEGF arm. What we have seen so far consistently, and in a number of cohorts is then the objective response rate which are very encouraging in various indications, and what we have also reported already first two — first combination size and small-cell lung cancer and in triple-negative breast cancer, cancer patients, and what is really exciting in this indications is, it’s not only the high response rate in the range of 60% to 75% in triple-negative breast cancer patients, but also the response rate in the patient population who are – are negative for immune infiltrate which is unusual, yes, for checkpoint blockade.
So, we believe that this molecule — that we can replicate this molecule, not only in these two indications, small cell lung cancer and triple-negative breast cancer, but also in a wider range of indications. This results allowing us to position the molecule as a combination partner for classical chemotherapy and even more importantly for our ADC portfolio.
Etzer Darout: Thank you.
Operator: Thank you. Your next question comes from the line of Jessica Fye from JPMorgan. Please go ahead.
Jessica Fye: Hi guys, good morning. Thanks for taking my questions. First on the topline guidance. I think you’ve previously talked about roughly a €3 billion topline, just a couple months ago, and, I appreciate you highlighting the variables that factor into the guidance, but can you just expand on which of those assumptions drove the change? And then second, on the pipeline related to the HER2 space. What are you guys going to be watching for in the DESTINY Breast-06 readout, as it relates to your HER2 ADC? Thank you.
Jens Holstein: So yes, let me take the first question. So we broadened the range. We felt that the top line guidance should reflect the assumptions that we’ve made with respect to the vaccination rates and the price levels that we currently have seen, where COMIRNATY of course is significantly relevant. We also have made assumptions related to the inventory write offs that hit us back in ’23. And there will be some write offs that we got to anticipate going forward. So we’ve done some included here some assumptions. And of course, there are also some additional anticipated revenues related to our service business and the German pandemic preparedness contract that we have in-hand, or we are finalizing currently with the government. So therefore, we feel we have — that was driving basically, the broadening of that range.
Jessica Fye: So each of those really factored into the broadening.
Jens Holstein: This is — there are some upsides, there are some downside that I mentioned and we’ll try to work it in with of course current assumptions. That could vary over-time, but that’s what we’ve done, yes.
Jessica Fye: Got it.
Ozlem Tureci: Yes, with regards to our HER2 ADC, the concept of her HER2 ADCs and the molecules which are around, that’s a great concept, that’s very obvious. And we are very excited about our HER2 two ADC, the molecule BNT-323 which we have partnered with Duality. And as Ugur pointed out earlier, in HRE2-low breast cancer are looking for making a difference in this high medical need population. You also have heard about our target hazard ratio which we are targeting.
Ugur Sahin: And we can’t of course comment on the clinical price of third parties.
Jessica Fye: Thank you.
Operator: Thank you. Your next question comes from the line of Simon Baker from Redburn. Please go ahead.
Simon Baker: Thank you for taking my question. Two quick ones if I may. The 2024 R&D guidance of €2.4 billion to €2.6 billion is a step-up on ’23 and against the plethora of studies you’re running. That makes perfect sense, but I was wondering is this the new normal? I was wondering what you could say about the anticipated levels of R&D expense beyond 2024? And finally, there’s been an awful lot of deal activity in the radiopharmaceutical space of late, I’d be interested to get your thoughts on the attractiveness of that modality? Thanks very much.
