Yaron Werber: Great. Thanks for taking my questions. I just have two. The first one, can you give us a little bit of a sense? We’re hearing that not now, but potentially later on apheresis slots might become more of a bottleneck as you’re ramping up capacity. I don’t know if you can give us a little bit of a sense how much capacity there is now and what can you do to enhance it. And then secondly, it looks like the facility in Europe, in Belgium, has now got approved on a local basis and you’re noting that you need to wait for an Investigational Medicinal Product Dossier approval and local authorities. Is that not centralized to the EMA or is it sort of different, done differently in Europe? And just reaffirm that you’re not foreseeing any sort of limitation on how many slots you’re going to have in that plant in Europe? Thank you.
Steve Gavel: Hi, there. Steve again. Why don’t I take a crack at the apheresis question? The apheresis question really varies by site. I know we’ve been having a number of conversations with our sites as we work collaboratively to on-board them and certify them. So the apheresis question really is being upfront addressed by our sites because what they are doing is forecasting what the volume looks like for them, whether it be for, obviously, the CARTITUDE-1 launch. But they have a pretty good idea, obviously, by now. But more importantly, CARTITUDE-4. So, as I keep mentioning, you know, we are addressing this in a number of different ways, this question around capacity. And right now, like I said, the number that I was guiding earlier in terms of roughly to 90 to 100 that I gave earlier in terms of number of sites, is in response to a number of these capacity questions to ensure that the marketplace has enough aggregate capacity to pull this indication through.
Ying, do you want to take the second question?
Ying Huang: Hey, Yaron. I’ll take the question about the European facility. So we did receive a GMP certificate issued by the local FAG, which is the counterpart of FDA in Belgium, and that is sufficient for us to start the clinical production next month in the US, sorry, in Belgium. And then specifically on your question about the US FDA. So right now, our plan is to start clinical production by end of this year in Belgium for certain clinical trials. And then about mid-year, next year in 2024, we’re planning to seek regulatory approval for our Obelisc Ghent facility to start produce commercial CARVYKTI. Initially, we’re planning to supply only the European market. So at this point, we would not need FDA approval. In the future, in the case where we do have excess capacity that we could use from the Ghent facilities, then we plan to come back and ask FDA approval.
So you’re right, in the case of commercial production for US patients, we would need sBLA approval by the FDA. But right now, in the very near future, we’re only designating the Ghent facilities for our European commercial demand and also clinical trial demand. But still that does help our supply in the US because, as you know, right now, we’re only producing both clinical trial material and commercial CARVYKTI from our New Jersey facility. So whenever we can divert some of the demand from European market and also clinical trials to Ghent that will free up more slots from our Raritan New Jersey facility. I hope that answers your question.
Operator: Thank you. One moment please for our next question. And our next question coming from the line of Linhai Zhao from Goldman Sachs. Your line is open.
Linhai Zhao: Hi. Thanks for taking my question. Two quick questions on the financials. The first one is, as we are still enrolling for CARTITUDE-5 and now starting to enroll for CARTITUDE-6, and the R&D expenses remain flat quarter-over-quarter, how should we see the R&D spending in fourth quarter and in 2024? And the second question is, it seems that the gross profit margin slightly decreased quarter-over-quarter. And can you share with us any colors on the potential gross profit margin improvements in the near term? Thanks.
Lori Macomber: Hi. This is Lori. In regards to the R&D spend, I think, you’ll see a consistent quarter-over-quarter. I mean, the activities itself have been pretty consistent with our investment in frontlines for the CARVYKTI program, as well as our pipeline. So we continue — going into 2024, we expect to see continual spend consistent with our historic. I’m sorry, can you repeat the second question?
Linhai Zhao: Yeah, sure. The second question is about the gross profit margin. When do we expect to see a further decrease — increase on the profit margin?
Lori Macomber: So, from a gross margin perspective, we have been seeing improvements from a product perspective. As a reminder, for gross margins, we have the product gross margin in there, as well as the OpEx related to facility investments. So that’s why it’s hard for you to see the continual improvement in gross margins, because as we’ve talked about, we continue to expand our capacity with manufacturing, so we continue to have expenses hitting in that gross margin line. But as our volumes have increased and as we’ve made also some process improvements, our margins are improving from a product perspective, but we don’t give specific guidance on those actual percentages.
Linhai Zhao: Got it. Thanks.
Operator: Thank you. One moment for our next question. And our next question coming from the line of Jonathan Miller from Evercore ISI. Your line is open.
