Arpa Garay: Sure. Yes, I can take the second question. In terms of the total sales, we are anticipating about $2 billion of the $5 billion in the first half of the year, and none of that $2 billion is coming from the U.S. market. The remaining advance purchase agreements that we have of $3 billion will be coming in the second half of this year. Now, that $5 million is just the total that we have from advanced purchase agreements as well as deferrals from 2022. We do anticipate additional sales from the U.S., Japan, EU and other markets, and we believe the majority of these sales will be in the second half of 2023.
Gena Wang: And then your market share regarding the U.S. market?
Arpa Garay: We continue to believe in the strong, differentiated profile of our products. We do not have any updates on market share projections as we are currently in discussions with customers right now for fall 2023 contracting.
Gena Wang: Thank you.
Operator: Next question comes from Matthew Harrison with Morgan Stanley. Your line is open.
Matthew Harrison: Great. Good morning, thanks for taking the question. I was hoping to ask about the regulatory strategy for PCV, and specifically, how you’re thinking about the potential for filing off the Phase 2 data set, as well as how you’re thinking about the time lines for enrollment in the Phase 3 program and how that may impact the time line for potentially filing off the Phase 2 data set? Thanks.
Stephen Hoge: Great. Thank you, Matt for the question. So we’re obviously really pleased yesterday to announce that we received FDA breakthrough designation therapy for the PCV program. And what that allows us to do is very rapidly accelerate our conversations with the FDA and other regulators on the path forward for filing 4157. As you noted, the Phase 2b study that we’ve run is a randomized study compared against, really, the standard of care with KEYTRUDA alone, and has already shown a quite significant benefit of 44% reduction of the rate of recurrence and €“ or death. And that study is ongoing, and so we’re continuing to follow over time and conduct additional interim analyses. And it’s possible that those €“ in fact, we would hope that those data mature and continue to get stronger and stronger.
And so it is entirely possible that in our discussions under breakthrough with the FDA and others that we will come up with a path forward for beginning the filing process based on that Phase 2 and potentially proceeding with accelerated approval. Now as you know, in this country, and I think it’s where your question is coming from, as well globally, if there is a path forward there. We haven’t yet engaged with the FDA on because the breakthrough happened yesterday. But if there is a path forward there, it would require us to rapidly enroll a confirmatory Phase 3 study. And in fact, there is more and more attention on perhaps requiring that those Phase 3 studies be enrolled prior to an accelerated approval. And so for that reason, ourselves and Merck are working really quickly now to try and stand up that confirmatory Phase 3 melanoma study and enroll as fast as possible.
