Ryan Spencer: Okay. Let me comment on seasonality first and Donn, if you have anything to add, please feel free. It’s pretty clear that Q2 and Q3 will — we expect will continue to be the largest quarters in the adult hepatitis B vaccine market for a variety of reasons. And I don’t — I think the market growth doesn’t really change the belief that we still believe Q2 and Q3 will be the largest quarters of the year and the years in the future, recognizing that we do expect there will always be seasonality due to the fact there’s significant respiratory vaccine given in the Q4, Q1 time period. So we expect that seasonality to continue even as we see market growth. Donn?
Donn Casale: And then I think the other question, just at a high level, on TdaP. I’ll take that too. And Rob, please add any color that you feel is important. But the decision here to delay the Phase II challenge study was as response to the regulatory feedback that we received related to the PR positive versus PR negative strain for pertussis, recognizing that the FDA is interested in the PR negative strain that we would conduct in the future. We did need to conduct a positive pilot study now, and we decided to make the decision to focus on PR and negative strength in the future when available, which also happen to allow us to see the results of this Phase I extension study. So it doesn’t have an impact on the overall time line, but it does allow us to have insight into the durability of our product.
prior to advancing any other clinical studies. So all in all, I think a pretty — actually a very favorable opportunity to be able to increase our understanding of the product before investing further in additional clinical trials.
Operator: Our next question comes from the line of Ed White with H.C. Wainwright.
Ed White: Just to stay with the TdaP. So how is the timing of the Phase II going to be affected? When do you expect to start that study?
Ryan Spencer: As the Phase II, we started — it really is still kind of up in the air. We do need to have the PR negative strain available and that’s being developed. So it depends on the availability of that strain. I think the key point, though, is that study is one component of the overall development plan. The longer lead times in this development plan will be the immunogenicity data, which, in our view, it’s going to be critical to have that data develop over time to show durability that can be part of our submission. So the TdaP challenge is not on the critical path. I think is the way to think about it. It’s a very valuable study because it will show the antigens are efficacious, which we have a high confidence that they will be — and that with the presence of our adjuvant, we expect to improve over existing vaccines. So ultimately, what will gate that timing will be the availability of the PRN negative strain.
Ed White: Okay. And as you have the BLA — or excuse me, the PDUFA on May 13 for hemodialysis patients, I’m just wondering if you can quantify what that means to the — what the impact could potentially be not only this year but going forward?
Ryan Spencer: Yes. I mean I think we’ve talked about this a little bit in the past that the — yes, you already noted that May 13 is the PDUFA date. It’s too really too early to comment on the impact of any — of revenue expectations. But we will know as we’ve said in the past, obviously, it does take time to engage customers and merely having the PDUFA, it’s the — it gives us that license to hunt and actually engage them commercially. So we’d expect that it’s going to take time, like with any other customer to be able to engage them in an effective manner. So we made no comment on the revenue expectations from this particular regulatory event, but we will continue prior updates as we progress.
Operator: Our next question comes from the line of Phil Nadeau with TD Cowen.
Phil Nadeau: One follow-up question on seasonality. Appreciating — it’s probably a hard question since we’re all dealing with imperfect information. But do you have a sense as to whether this year, the seasonality was particularly bad given that it was early in the availability of RSV vaccines and people are still getting shots for COVID? Is there any reason to think that the seasonality and the decline in the HPB [ph] market in Q4 and Q1 won’t be as bad in future years? Or is that just hard to know at this point?
Donn Casale: Phil, it’s Donn. I think it’s a little hard to know. A little early to kind of call it. But certainly — and the feedback we’ve been receiving from our retail customers, in particular, is learning new vaccines, RSV, COVID, a lot was thrown at the retailers all at once. Now that they’ve gone through it once, going into this year, they’ll be better prepared to understand what’s going to be in store for that respiratory season. So we sort of see that as an opportunity moving forward, but probably too early to tell how it looks every year thereafter. But certainly, we expect this year to be a little bit different because our customers are a little bit more prepared or anticipating the onslaught of all these different vaccines in the space.
I also remember the winter season and how cough, cold and flu, COVID other things, those are variables as well as how they impact wellness and other opportunities for vaccination. So that’s going to always be variable across the season. So we just have to keep that in mind that it’s not only market dynamics. There’s also disease dynamics at play that will be variable.
Phil Nadeau: The RSV vaccines have a requirement that patients not be vaccinated for something else like HBV for weeks before or weeks after receiving the RSV vaccine?
Ryan Spencer: RSV — was that — did you say the RSV vaccine?
Phil Nadeau: Yes. Specifically for RSV, is there required to be a window of no other vaccinations around that vaccine?
Ryan Spencer: No, not in particular. You — just be aware, Phil, the comment data, as you usually doesn’t — specific — how — it’s very rare for there to be specific information around how to treat other vaccines within one vaccines label. So…
