And then we make an estimate based on the shots and arms that we have through IQVIA for what may be eligible, and we estimate would be eligible for return upon the end of the season. It is simply an estimate at this time. We will monitor it closely as the year goes on. But our net revenue, in the case of the United States for the fourth quarter, is a function of that return estimate that you’re seeing in our roll forward financials. It is net of that amount.
Eric Joseph : Okay, great. That’s very helpful.
John Jacobs: Filip, do you want to take Eric’s second question? Or Eric, did you have a follow-up there?
Eric Joseph : No, no, that’s fine. Thank you. Yes. The follow-up question on the development side.
Filip Dubovsky: Yes, we have a couple of lines of evidence to give us confidence. I mean, as you know, we’ve had a prior Phase 3 study that was actually granted the accelerated approval pathway by the FDA [ph]. So we know what endpoints and how we need to achieve that. And certainly the immune responses that I shared in the slides today would be adequate to achieve the same ones we used in our prior Phase 3 study. We also know the competitors are talking about timelines which would indicate that they’re pursuing accelerated approval pathway. But I think most importantly, the FDA told us, right. So they reviewed our plans in our study, and what they told us was that if we achieve the agreed upon endpoints and we are able to demonstrate meaningful therapeutic benefit, then there’s a pathway forward to accelerate approval.
Now, they also said that they would have to wait to see the data before they took the final determination. But the strength of the immune responses we’re seeing compared to the comparators, as well as our prior experience, gives us confidence that we have a pathway forward.
John Jacobs: Thank you, Jim and Filip. Thanks, Eric. Eric, did you have a follow-up?
Operator: Thank you.
Unidentified Analyst: One more follow-up if I could, on full year 2024 guidance, the non-APA portion of that. What – to what extent is that guidance sort of conditioned or dependent on additional regulatory approvals or recommendations in the U.S., UK and Europe?
John Jacobs: Jim, did you want to take that one? And then John Trizzino can add color if needed. Go ahead.
Jim Kelly: Well, hey, certainly. So the non-APA revenue guidance, $300 million to $400 million, is virtually all except for that small portion related to R21, concentrated on the fall vaccination season. And so the regulatory authorizations that would be supportive of recognizing that outcome are all linked to our updated variant, speed the market and regulatory authorizations to support that commercial market performance.
John Jacobs: Thank you, Jim. Thanks, Eric.
Operator: Thank you. Your next question comes from the line of Brendan Smith from TD Cowen. Please proceed.
Brendan Smith: Hi, guys. Thanks very much for taking the questions. Quick one from us, actually. Apologies if I missed it in your comments. But I think you mentioned that you saw up to about 10% share in the U.S. in retail outlets, where you were carried on an even playing field. Just wondering if you could maybe expound on that a little bit really kind of what that looks like? If there’s something about those areas where you could expand even further this year and into next year, maybe what your plans for that would look like? And then just maybe quickly, what kind of the important steps between now and a potential approval would look like if you are to prioritize that prefilled syringe and any meaningful differences you’d expect to that process versus last year? Thanks.
John Jacobs: John Trizzino, do you want to take Brendan’s question and maybe discuss what’s different in our intentions for 2024 versus 2023?
John Trizzino: Yes, sure. So that was a great example of the 10%. And we also had in another instance where we had 4% to 5% share in similar circumstances. As we said, we came to the market a little bit late. So vaccinations were underway and five-dose vial created some challenges. And so as we look forward to this, the benefit of having a well-informed pharmacy population and pharmacist educated is going to help in that regard of timely availability of product, prefilled syringe is going to make it much more convenient for use. And so, as we’ve mentioned, three critical elements here for success in 2024 is early September on time availability of product in front of the vaccination season. BLA, which is in process right now through rolling submission and prefilled syringe making it easy and convenient use for the pharmacists. We believe that these will make dramatic difference in what we see as our performance in 2024.
John Jacobs: And John, just a little bit of additional commentary. Well said, but I think that 10%, Brendan, that you mentioned in a key retailer, when we say even playing field, we were still several weeks behind the competition in a five-dose vial. And we were able to achieve that in just a few weeks being on the market. So we’re confident that should we execute on the plans we intend to execute upon, which include a prefilled syringe, an on time launch in the marketplace, being on an even playing field when it comes to the pharmacy schedulers, that consumers can go in and schedule their shots, which wasn’t the case in 2023 in our first year in the U.S. market. And we’re encouraged by the early dialogue we had starting this past fall with retailers, and I think it was a surprise to everyone that the COVID market in the United States was over like John said in our earlier commentary, 95% plus retail, nothing really coming out of the IDNs of the physician offices.
So we’ve recalibrated, reorganized our internal team and our focus on retail started those conversations in the fall, are very encouraged by where those are headed right now, and that makes us more optimistic for it to be much better positioned for success in 2024. Thank you.
