Mayank Mamtani: Yeah. Super helpful, very comprehensive. And then maybe just sticking on that regulatory milestones that I think was noted also in your Q, including for under 18 year old, maybe for higher dose that you’re looking at for the elderly. Could you just fill update on what all is going on there for the updated ’23, ‘24 vaccine? And then also a similar roadmap for the CIC program, what sort of those optimization work remains. And also if you anticipate any ex-U.S. regulatory guidance to also come along with all the discussions we’re having with the FDA?
John Jacob: Mayank, why don’t we ask Filip to address some of your questions on the clinical programs and the related regulatory milestones there. Filip?
Filip Dubovsky: Thanks. You managed to squeeze a lot into that once run on sentence, Mayank. So we laid out the regulatory timings for CIC in the U.S. We think that’s going to be most important market force right. It’s product that we see demand from consumers as well as from health care providers and that’s our focus. The time once we laid out was their potential regulatory filing in 2025 with potential regulatory approval and in the market in ’26. Now as far as a high dose of product that this program was supported by U.S. government, we’ve finish enrolling that study or we will today. So the timelines of that aren’t going to be available until the following year. Pediatric data, we previously said that we would be filing the – or we would have data available in the first quarter of next year. And we think that older age group will be relevant for the following season.
John Jacob: I think we have time for one or two more questions here.
Mayank Mamtani: Okay. I’ll jump back into you. Thanks for the taking the question.
John Jacob: Thank you, Mayank.
Operator: And our next question comes from Alec Stranahan of Bank of America. Your line is open.
John Jacob: Hi, Alec.
Alec Stranahan: Hey, guys. Great. Thanks for taking our questions. A couple from us as well. The first is on the multi-dose format, given the demand kinetic you’ve seen to date. Do you see a risk of some doses in a vial not being used and what happens to those doses? Are they shipped back to you guys and how does that feed into the price or reimbursement to pharmacies? And then I’ve got a follow-up.
John Jacob: Yeah. Good question, Alec. I’ll let John Trizzino address that one on returns.
John Trizzino: Yeah, Alec. Look, we’re in a five-dose vial, and I think, of course, it would, anticipated for future we’d be in some kind of unit-dose presentation and that’s what the marketplace wants, and we’re moving in that direction. As far as the use of those vials, we’ve made sure that there’s flexibility to the healthcare provider in the use of that vial. So if not all five doses are used, there’s an opportunity to return partial vials, and we’re tracking that through a third-party provider of that returns process. So it’s been made clearly communicated that our intent is to provide access getting product on the shelf and available that then it’s good utilization of whatever is available and that period of time and that there is a returns provision in place that allows for that with no cost and economic disadvantage to the health care provider and then we monitored that on our end.
Filip Dubovsky: And then quick comment on [indiscernible] pharma products highly common to have a return provision services far from uncharted territory will have the regular gross in that entry will make an estimate we’ve got visibility on our return rate as we seek to close the books for the fourth quarter based on both actual returns come in and then visibility through the channel. So this will be an important part of our revenue recognition go forward.
John Jacob: And Alec, you said you had another question.
Alec Stranahan: Yes. Just a quick one. I noticed some new language in the queue around the withholding the installment payment to Fujifilm. Is this due to a breach of contract or something else? Are there other vendors that you may seek to withhold payments to for similar reasons and just high level how you see the arbitration playing out? Thanks.
John Jacob: Kelly, you want to take that one?
James Kelly: So absolutely. Alec, you’re exactly right. We have disclosed that with respect to the remaining two payments that were targeted for the third and fourth quarter, that’s $68 million total, that we are currently in a dispute or difference of opinion with Fuji at this time, it’s a legal matter, so I can’t speak too much about it. You might remember that those payments were each subject to commercially reasonable effort to mitigate our exposure, and I think that’s all I can say at this time.
Alec Stranahan: Thank you.
John Jacob: And time for one more question.
Operator: And our last question comes from Vernon Bernardino, a Private Investor. Your line is open.
Vernon Bernardino: Hi. Thanks for taking my question from H.C. Wainwright. Can you comment on what regulatory concurrence is being discussed for a final clinical study design for the combination vaccine? And I’ll just throw the follow-up now. For the ‘24-‘25 season, can you give us your thoughts on what dynamics you expect regarding authorization of your updated vaccine and its role after that season? Thank you.
John Jacob: Hey, Filip, you want to take the first part of Vernon’s question?
Filip Dubovsky: Sure. So, the major focus with us is going to be with the FDA, and this is really going to be part of a pre-IND discussion with them. Since we’re filing an IND in the U.S. to support the U.S. study. That’s an interaction that we have planned for the first quarter. We are going into that with a lot of data to bring to them, and that’s why the timing is in the first quarter of 2024.
John Trizzino: Yeah. So let me follow up on that next question, Vernon, on plans for ‘24-‘25. We’re intending to have an updated profile for the vaccine that’s being offered. We’re looking at a unit dose presentation available on a more timely basis than we were able to this year, so earlier in the season availability. And then, of course, it’s our reasonable expectation that we would be under BLA for the ‘24-‘25 season as well. So I think those are significant factors that are driving an improved uptake in market share and presentation to the marketplace.
John Jacob: Thank you, Vernon and operator, I believe, we’re at time at this point.
Operator: And this will conclude our question-and-answer session. I’d like to turn the conference back over to John for any closing remarks.
John Jacob: I want to thank everyone for their time and energy and for your questions and wish you a great close to your week. Appreciate you all, thank you.
Operator: The meeting has now concluded. Thank you for joining and have a pleasant day.
