John Jacobs: Yes, John, why don’t you take the BLA question first. Yes.
John Trizzino: Yes. Mayank, there’s a couple of pieces to the question there. So first of all, as you all know, we have been intending and have accomplished in fact, the submission of the BLA to FDA. But there was a couple of steps involved with that. So it was the initial approval of the BLA for the XBB strain that was under emergency use authorization last year. We were then going to be adding the prefilled syringe and the strain change into that BLA submission, and having that all tied up in a nice bow in front of the season, right? While that strategy was communicated to the FDA, and it was very thoughtful about the ability for that to get us to the market on time. Reassessing that we in collaboration and conversations with FDA, we felt like if we focused on the strain change and we focused on the prefilled syringe, authorization that the EUA pathway would be the best way to do that, instead of the more formal BLA path.
So as I said in the remarks, we’re going to be pursuing in a parallel path. This parallel pathway ensures our timeliness to the marketplace. And I think that’s most critical. The product is authorized for use. There are no restrictions in how we communicate the benefits of this vaccine. We’re going to have inventory in our 3PL distribution center in mid-August. As soon as authorization is granted, we’re going to be in the market, and I think that’s the most critical component of that strategy.
John Jacobs: And Mayank, as we said in our comments, and I’ll hand it back to John on your market share question, and maybe, John, you could take that as the potential we see in the U.S. marketplace, assuming we are indeed staying on track, which we are now, with our prefilled syringe in a time we launch the season. Because we — Mayank, we’re excited about the opportunity to perform significantly better than we did last season in the U.S. market. But let’s address the PDUFA date question. We will get a PDUFA date from FDA once they formally accept our file. We have completed that file and are waiting for that formal acceptance. John, go ahead on the market share question.
John Trizzino: Yes. So the — yes, the PDUFA date question is part of yet another element of why the timing for EUA and BLA was kind of critical balancing act here. While the FDA could act more quickly if they so desired, the PDUFA date is not the ultimate — they don’t have to fill to the PDUFA date, but it just streamline the activities in a significant way. As far as market share is concerned, again, the critical elements; the new strain, prefilled syringe, on time to the market, awareness of Novavax access, some awareness and access to critical elements. We think that there’s a significant opportunity in the U.S. market, and we’re going to see a dramatic shift from where we were last year. As you recall, in the ’23 season, we relate to the market by almost a full four to five weeks, and almost 50% of the COVID market had been administered by that time.
And we were also in a five-dose presentation. So a dramatic shift in positioning for us. And so I think there will be well established and set up for the ’24 season.
Mayank Mamtani: Very helpful. Makes sense. Thank you. And then on the Phase 3 CIC trial design, obviously, awesome to see the stand-alone flu added. I was just curious since you already have control data from a Phase 3 study with NanoFlu, and I don’t know if this candidate is the same as NanoFlu, but could you just talk about what the key immunogenicity objectives are being agreed upon with the FDA on the different strains and how noninferiority or superiority will have to be relative to the three arms that you’re using?
John Jacobs: Yes, Filip, why don’t you take that one?
Filip Dubovsky: Yes. So you’re right. We’ve kind of tried this ground before. And the real difference in this is twofold. One of them is a specific age population we’re targeting. Because we think that’s where the medical use the greatest and is also the most lucrative market in the U.S. at least. And the second one is the competitors. So the competitors we’re choosing are going to position us to have commercial success going into the future. And I’m not going to give any more details about the specific criteria used to establish superiority or non-inferiority but certainly the non-inferiority criteria that’s also well to ground, which many other sponsors have used in the past.
Mayank Mamtani: Understood. And lastly, I don’t know if it’s too early to comment, but investors care about profitability because you guys do have a real business. So if you could talk about your expectations for breakeven given OpEx ramp down, should it continue into next year. But then obviously, you’re looking to build a broad respiratory pipeline infrastructure long-term. How should we think about that?
John Jacobs: Thank you, Mayank. Go ahead, Jim. And then we’ll need to move on to the next set of questions. Go ahead, Jim.
James Kelly: All right. Guiding principle one. We’re building an enterprise towards cash flow positive and value creation. One of the things you heard John mention earlier is, we believe that the economics and cash flow under this agreement with Sanofi across this portfolio is, in fact, superior to the cash flow we might have been able to drive to ourselves. You are hearing that we are creating and driving to an important value creation platform to increase shareholder value. And so we will continue to give you updates on how our business model evolves to deliver against that guiding principle.
Operator: Your next question comes from Brendan Smith from TD Cowen. Please go ahead.
John Jacobs: Good morning, Brendan.
Brendan Smith: Hi, good morning. Thanks for taking the questions. Huge, huge congrats. It’s really great to see.
John Jacobs: Brendan, thank you very much. Appreciate it.
Brendan Smith: Maybe just a quick one from us first. Apologies if I missed this, but we’ve been hearing a little bit from some of the COVID competitors that FDA might actually be considering authorization the updated boosters even earlier this year, possibly for August. I wanted to see if that’s been part of your conversation, do you think that would impact any of your timing or launch capabilities. And then honestly, just stepping back maybe to the broader opportunity now. I wanted to get your thoughts on strategy and what you’re thinking — how you’re thinking about each of these other non-COVID non-flu areas for you, namely like what strong you were and how you’re thinking about where to go first maybe what makes sense for Novavax alone versus part of the collaboration. Thanks very much.
John Jacobs: Brendan, excellent questions. I’ll take the second question and then hand it over to John Trizzino and Filip to address your question about strain timing and launch timing for the season. So when it comes to strategy, we’re going to continue to crystallize our future pipeline and organic growth strategy from our own tech platform in the coming months and look forward to sharing more detail with you. What we were so excited about sharing with you today was the new science that Filip and his team have been working on new data and approaches to leverage our technology in different ways for months and months now, and we unveiled some of that today to share with the investor community. We’re still working through the best way to optimize some of those assets, and we’re also considering additional early-stage assets that we can work with in our pipeline, and we intend to do so all within the new lean operating model that Jim Kelly started to outline before in his prepared comments and the questions he answered.
So more to come on that. We look forward to sharing more details with you as our thoughts crystallize further, and we’re ready to share them. So why don’t I hand it over to John Trizzino and Filip to answer your first question.
Filip Dubovsky: Right. So you know that the EMA and [indiscernible] have already designated a strain, and we aren’t expecting the strain to be designated from the FDA until early June. And we’ve been in discussions with all those agencies for on a continuous basis. Right now, what we stated is that we’re going to be submitting our supplemental filing immediately after VRBPAC. And I think that John has mentioned before, we anticipate having product available in mid-August. Now none of that matters as much as when the season is — doesn’t get to start by the FDA and by the CDC. So that’s really what we’re targeting. We feel like we’re in a good position to be able to achieve really whatever time frames the season starts. And John?
John Trizzino: I think the variability in there is they’re reviewing three files simultaneously, so the FDA has a bit of work to do. I think they’ve already signaled that they’re going to have a formal kind of campaign kick-off, post the Labor Day holiday in the U.S. and there’s going to be a readiness in front of that. As we said, we’re going to have product availability in the warehouse. It might even be queued up at the distributors or even an staging, awaiting that campaign to kick off. But I think the timing is — it makes a lot of sense, right? We’re coming out of the summer vacation period. We’re coming back to school, back to work, the CDC’s campaign, the other competitors’ campaigns will begin kicking in that September 1 — 1st week in September time frame. And so we’re synchronized around that.
John Jacobs: Yes. And finally, Brendan, and we’ll take final questions next. But finally, to build on John’s point earlier, that’s another reason for the dual pathway for regulatory authorizations this year, the BLA and the EUA John mentioned because it gives us a chance to have — to be more nimble and more quick through the EUA pathway with our prefilled syringe and the updated strains. We believe we’ll be ready and we’re excited about the opportunity in the U.S. this Fall. One last comment when you asked about portfolio, I just want to make sure everyone is clear, that we have a wholly owned independent portfolio and that our combination influenza COVID vaccine is completely ours and completely independent from the vaccine that Sanofi will develop in their pipeline, using our Nuvaxovid. Just want to make sure that, that’s clear to everybody. Thank you. And we’ll take a final questions, Erika, from the final analyst.
Operator: Your next question comes from Vernon Bernardino from H.C. Wainwright. Please go ahead.
Vernon Bernardino: Hi, everyone. And congratulations from me also. And thanks for taking my question. I think one thing that needs to be mentioned is, I think you’ve found a great partner because you both are advancing protein-based vaccines. I think that’s nothing to be recognized. Question I have, just like other analysts and what we tend to do is a three-part question, but maybe it’s just only two now. Regarding the combination vaccine, is there any consideration as far as Sanofi side that you’ll need to have a BLA approved flu vaccine or COVID vaccine for them to actually progress the work on a combination vaccine, that includes their quadrivalent flu vaccine. And then as a follow-up to that, I was just wondering, obviously, the vaccine does not have Matrix-M.
I was wondering if you could remind us the comparison of the [indiscernible] quadrivalent versus yours Fluvax [ph] for example. And with their potential to add Matrix-M to their quadrivalent, what kind of expectancy enhancement do you think they could actually achieve? Thank you.
John Jacobs: Yes. Vernon, I’ll hand the question over to Filip. Excellent questions. We’re not going to comment on Sanofi’s particular technology platform. But Filip, do you want to address the questions about the BLA?
Filip Dubovsky: Yes. Their regulatory path will really involve a standalone BLA. So in that regard, it doesn’t really rely on our regulatory process with Nuvaxovid alone. So they’re going to put together a package, which has to show that their combination of their flu vaccine plus Nuvaxovid is safe and efficacious. And the approach they take, is it going to be really up for them to define and to get approval with the regulators.
