All right, everybody, thank you so much for joining us this afternoon. We've got Ryan and Kelly from Dynavax joining us. Thanks for taking the time and coming down to Miami. Thank you for having us. Let's start with Hep B. Seems reasonable. Reasonable place to start. Evolving market share. You've given and maintained long-term guidance, but can you elaborate on some of the details there? How are you advancing marketing efforts in those key market segments, the retail and IDN that you keep talking about? And where are you in terms of the progress towards the ultimate goal? Yeah, as you noted, we continue to make progress year -over -year. We've provided pretty clear guidance for what we think the long-term opportunity is to achieve 60% market share of a market that has the potential to grow to be over $900 million by 2030, and year -over -year, we continue to chunk away at that goal with steady growth, and we're still on track for that long-term objective. We know there's a couple of big channels that have the biggest impact over the course of the launch and then moving into the future. The retail segment becomes a big part of the growth story from here on out. We have moved to reporting channel-specific share in some of our materials, as well as the makeup of the market by channel. And what you'll notice in those materials is we have a pretty high share in retail already, 63%, about 50% in the IDN segment, which are the two largest opportunities for growth. But another element of the story is continuing to see patients captured in retail over time. So by 2030, we actually think about 50% of the adult vaccination for Hep B will be done within the retail setting, which does a lot of things, including it captures patients where we have the highest share, especially as we expect share to advance in the retail setting. Overall, to hit the 60% goal, we believe that results in over 75% share in the retail segment. And we're tracking very well with those objectives. Let's dive into that retail segment growth a little bit more. What's driving that shift? It looks like it's coming, according to the projections that you've published, at the expense of both IDNs and the other, broadly speaking, other segment. What's driving people into the retail segment and what's sapping the influence of IDNs? It's just a change in how vaccines are delivered. Prior to the pandemic, you did see retailers have certain vaccines that they administered. It started with flu, and then the zoster vaccine, and some others, pneumococcal as well. But it wasn't the main source for adult immunization. During the pandemic, things changed. One, consumers' or patients' confidence and willingness to roll up their sleeve in a retail setting, the retail provider's capacity to administer lots of vaccines and have the right structure for it. Importantly, state legislation allowing pharmacists to administer vaccines broadly. Since the pandemic, the retail setting has figured out this part of their business and continues to leverage that capability. It just continues to expand. And it's much easier to get a patient to originate for things that are age-based vaccines when they come into the retail setting, either for a different vaccine or for other care. So it's a. Point of contact. Yeah, it's just a better point of contact for a provider, a healthcare provider, a pharmacist to say, are you up to date on your vaccination? Versus a wellness visit or other things within a traditional healthcare setting. Sure, and you've mentioned the impact of contracting and IDN setting especially as being a slow-to-shift driver of share there. What's holding back share there? What are the opportunities to drive share in the retail setting where presumably there's less impact of contracting on a broad setting, multiple vaccines are available? At this stage in our launch, it's actually quite straightforward. So the retail segment has, we break it down between monovalent products, which is our vaccine plus the other two monovalent competitors, and then combo products, which is Twinrix, which is a Hep A, Hep B combo product. The reality is that combo product is probably 25%-30% of the doses administered in the retail setting when we talk about total Hep B. And so we have 63% share, which means we have a remarkably high percentage of monovalent usage. So really expanding share there is all about addressing the population that's being served by the combo product. And those are two distinct populations. Combo vaccine for patients or subjects who want A and B, but we believe there's a large opportunity for patients who are on Medicare, and the combo product is being used to satisfy their Hep B vaccination because previously that was the only product that was reimbursed in the pharmacy by Medicare, and so that provides. There's about 25% of the Hep B market in pharmacy is patients over 65. So there's a large portion of that market that we still have to capture as the Medicare reimbursement gets cleaned up. How does that overlap there? It's just a 25% that's over 65, potentially Medicare patients, 25%-ish. That's the Twinrix population. What's the overlap there and what% of your current sales are covered? Yeah, we probably actually get about 25% in the 65+ of that share. So you can see Twinrix has some travel, some Medicare. So obviously we're not targeting 100% share in retail because they're still competitive brands, but we are confident that we can deliver very high share. And going back to our long-term guide, to hit that long-term guide, if you think about how the market is going to evolve to have more patients in retail, we're targeting over 75% share of the retail setting over time. And we're at 63 now. So we think that's over the next number of years very reasonable. The drive into the retail setting is going to be true for Medicare patients as well as for the broader population. Yeah. Again, it aligns with retailers' goals of growing that part of their business. So they're very well incentivized through just the business model to identify appropriate patients for vaccination. They want to be driving. They want to be driving it. Sure. All right. Now we've had a little bit more time now in fourth quarter this year. Rather than talk about long-term trends, let's talk about near-term trends. We've had a little bit more time this year talking about seasonality. I'd love to hear your take on how that's continuing to evolve. We heard a little bit on the earnings call that maybe we were expecting to see over time a reduction in that seasonal impact. I don't think looking at IMS that we've tracked so far in the quarter that we can see that. So I'm curious where you're seeing the seasonality evolve and what your observations have been so far this quarter. Sure, so without commenting specifically on the quarter's numbers to date, I think the concept from the earnings call on seasonality is seasonality has changed from pre-pandemic to post-pandemic because you're seeing a fundamental shift of where people are getting vaccinated, which has different dynamics that are evolving. In retail, one, there's a desire to have non-flu vaccination in other parts of the year to spread out their capabilities. But two, there's significant patient origination with flu vaccines. And so a common practice is to give more than one vaccine. What's happening in the background is there's this opportunity for non-flu vaccination to have decent volumes during the flu vaccine season. But that can be filled with different brands. When you talk about seasonality, there's a complexity that's evolving over the last couple of years on what does normal look like. We used to talk about there being vaccine fatigue during flu shot season. In the IDN setting, it was less likely that you were going to get, or if you got your flu vaccine at your workplace or other settings, it was less likely you're going to get a combo vaccine there. Retailers have a lot more controlled practice around doing that. And so they see that as an opportunity to leverage the patient capture probably more efficiently than other channels. And so that's the big delta. They have a number of products they can use to fulfill that. One was COVID. We saw flu COVID, pneumococcal, RSV. But these things all change over time. And so HEPLISAV-B is continuing and will continue to be an option there when it's ready to be that product. When the retailers identify a patient that is eligible, they can drive usage at their own volume. There's a few products that fit. Over a course of time, it'll be your turn. Makes sense. All right. Let's move on a little bit. I'd love to talk about the recent acquisition, oral COVID vaccines. This is obviously a topic that people don't particularly want to talk about. Except for you, Ryan, you want to talk about it, and that's why I'm talking to you. There's been a lot of news in the press about vaccines in general, obviously COVID vaccines in particular, get a lot of heated discussion. What is the real opportunity in COVID vaccines right now with existing products waning in adoption? Yeah, I mean, I don't think we need to pick apart the dialogue in the press right now, except to say focusing on the highest need, which is patients over 65 or people with other comorbidities that are at highest risk of severe outcomes from COVID infection. That is not necessarily, I mean, there is maybe some waning uptake there, but that's still a very large market and a very appropriate place to vaccinate. And we believe that the current products, they offer good protection for long-term risk, but severe outcomes, I'm sorry, over a long period, but they do wane very rapidly and they have some room for improvement. Actually, we think there's significant room for improvement. And so the recent transaction with Vaxart for their oral COVID vaccine was really to address some of the things that are causing a lot of the dialogue in the marketplace today, as opposed to just kind of going in the face of it. So for example, when we talk about the oral vaccine, the pill is nice. That's a very helpful tool for access and convenience. It's secondary, though, to the mechanism of action. This is a fundamentally different mechanism of action, delivering a viral vector to mucosal surfaces with the goal of having a fundamentally different level of protection, which we believe that if it hits that mark, that can be very meaningful in improving the utility of COVID vaccines and addressing specifically a number of the concerns that exist with the current products. I do think that the driver in the market right now is end-user demand. It's not necessarily the unmet need, although obviously those things are not fully decoupled. Right, but the demand, the big change to the marketplace obviously is reduction of the broad utilization of COVID vaccines. They're still recommended and utilized. I think the current market's trending 15% down from last year. It's still a multi-billion-dollar market and has high utility for preventing severe outcomes, so we still see it as a highly valuable opportunity, recognizing we do believe there's room for improvement in the profile. Now the deal structure gave you some good optionality there. It doesn't cost you too much upfront and gives you a nice entry point next year after the data. Can we talk a little bit about different scenarios we might run into as we start getting into the data, what it would mean for your spend, timeline to profitability, and what you would take on as a co-sponsor? Yeah, I'll talk about a little bit what we're looking to see. And Kelly, if you have any comments on the financials. We're not playing for a me-too product here. So we view this readout as being very meaningful. Remember, this is an efficacy readout. So on all this dialogue about what's going on, this is an efficacy readout, which we believe will be a true proof of concept for a differentiated vaccine. Obviously, you'll still have to go through Phase 3 development, which will be costly, as expected, but the value you'd be driving from this result should warrant that investment. So it's very clear to highlight that we're not looking for a me-too product that's oral. That's not what the strategy is. The strategy is to build a product that has. If you're not differentiated, at least on efficacy, if not on headline. Primary endpoint is comparable efficacy. Now, there will be other pieces of information that can be very supportive, like medically attended COVID events. Maybe symptomatic infection, medically attended events, hospitalization, even severity of underlying symptoms are going to be very interesting and supportive details. But the primary endpoint is head-to-head comparison on symptomatic infection. Yeah, just to sort of add on to that, with respect to the financial profile of the company, one of the things that was unique about this deal structure is it does enable us the opportunity to not only see that top-line data before making a decision, but also to get the regulatory pathway forward too, which given all of the dialogue around COVID vaccines and then other adult vaccines and all vaccines right now is a really critical thing for us to make sure that we have clarity on. With respect to deployment of capital, our strategy hasn't changed. We've remained balanced in how we think about deploying capital to drive near-term and long-term shareholder value. If these data are successful and supportive of advancing a truly differentiated product in COVID, which will be a multi-billion-dollar opportunity, I think we'll be happy to drive that as a value catalyst and we'll be happy to deploy capital to advance that into a registrational trial. I think the other thing just to add on, we do have balance sheet capacity to support this, and I think with the way that we've structured the deal, we're really pleased with our ability to balance the risk with the opportunity to drive value. But fair to assume that this would change the runway to profitability and if you're going to a Phase 3 program. What would be required to push through to commercial product in COVID at this point? Obviously, you still have to have regulatory discussions, but what are you anticipating? We know it'll be in efficacy. I mean, it'll definitely be an efficacy study. I think we've heard very clearly from the various communications from the administration that you have to study in the efficacy studies in the population that you want to be indicated and recommended. But with the level of disease that exists, it's very approachable. So I think that's the key for vaccine development. Efficacy studies can be incredibly complex and expensive when there's not significant disease. When there's significant disease, the N drops, you have a higher likelihood of success of having enough cases to demonstrate efficacy. And I think if we know what the framework looks like with the agency, we can go into this in a very contemporary way with the right support from the agency to develop the study. So. Now, symptomatic disease is relatively common. I imagine you have no trouble getting events there. But if you had to run a hospitalization or a mortality study, that would be much challenging. Right. And I think that's where the trick is going to be, what's the utility of the product? And so are there other things you could do to demonstrate severity? So for example, again, this will be supportive information, not necessarily power to test, but severity of symptoms. Just because you have chills doesn't mean that's the same COVID case you had if you were laid up for three days. Okay? Those are big differences. If you have consistent differences there, that could be helpful. But again, the efficacy trial will not likely be head-to-head. It'll be placebo-controlled for safety. So we'll have to manage those things with the agency on what the right label claims are and what would also then support recommendation for the right population. Efficacy against protection against infection is definitely the gold standard. And given this modality with the fact that it's mucosal, we're hopeful that that will be what we're hanging our hat on. So I think we'll have to be really thoughtful about what is the regulatory pathway, what's the level of evidence that can be generated, and how will that be supported within the marketplace in making the decision to go forward. Okay, great. Makes sense. Let's move to shingles, I guess, as we come into the last couple of minutes here. What's your expectation for the market opportunity by the time it could potentially come to market? We've discussed this in the past, getting through the bolus and having an incidence population. But can you break down to us what the incidence market looks like in the United States and how much of a prevalence market would still remain ex-U.S.? Yeah, I mean, the prevalence market ex-U.S. is hard to pinpoint given the fact that there's so many different countries and a lot of ex-U.S. There's seven billion people or something, and so I think the prevalence ex-U.S. will be high still. This is going to take a long time to shoot through that. It's going to be more methodical. It's not going to go as fast as the U.S. The U.S. market, by the time we launch, I think the safest bet is you're essentially at the aging cohort plus some people on the sidelines because they didn't like the profile of the current option. Up until the point where there is a booster recommendation, if there's ever a booster recommendation, I think one thing that's important to consider, you can't necessarily claim it because it doesn't exist yet, but as we move the age range down, now at 50, you're recommended to get your shingles vaccine. We know that as effective as the current product is, we do know it wanes over time. I think the data is out 10 years or 12 years now, but as you move that down, imagine if you got vaccinated when you're 50, what happens when you're 70? Your need is, that's where you were indicated for having a need in the first place. In the first place. So I think there's a reasonable potential for there to be also a booster market. Now, obviously, you have to be careful about building plans around that, which is why we're so focused on sharing some of the risk of development with a partner who can more appropriately tackle the ex-U.S. opportunity and generate value there, help support the clinical work from a financial perspective, because obviously the U.S. market, absent a booster recommendation, has its own limitations being anchored to the aging cohort. But we still think it'd be a very good portfolio product in a suite of products for a vaccine company like us. From a commercial standpoint, is this driven by the same points of contact as HEPLISAV-B? It's driven by the same sorts of commercial. It's retail pharmacy. Yeah. This is the same kind of product. It's the same, same, same. I mean, obviously, it's virtually the same. It's easy for us. We would do a great job with this product, with this profile, and it'd be highly synergistic, which is why my comment was a portfolio asset for us or others like us who are in this space. So for any partnership that you'd get, presumably ex-U.S., you would want to maintain that U.S. control of the U.S. market for the portfolio. Honestly, we would be thrilled to launch the product in the U.S. because our team would kill it. We're talking about early 2030s here. So if, depending on what was the right thing to extract value for the program and ensure we get value for the program now, we'll be open to any deal structures. I mean, we're pretty flexible on that, but we'd like to launch it. Okay. Well, can we talk about the expectations for the Part 2 study next year? How do we expect to translate from Part 1 to Part 2 and any nuances we should be paying attention to? I think we've gotten it down to be pretty clear. Vaccine response rate in this population that's theoretically harder to protect. I expect that we'll have a lower vaccine response rate in the 70+ study than we had in the prior study. I expect shingles will as well. So that's the primary thing to look at. The supportive data beyond that will be vaccine response rate, both for T cells and antibodies, because we want to show that we activated an immune response. Then we'll have the supportive data, the long-term follow-up on antibodies and T cells, which I think, honestly, I think we're expecting will just be supportive, but it'll come down to the vaccine response rate as well as obviously the tolerability profile. But again, I think we're pretty confident that 1018 has a favorable tolerability profile. So excited to see the data. Anything else to learn from full data from Part 1 when you present that on other doses? I don't think so. I mean, we presented the data recently at ID Week, and you can see within the error bars, they were all relatively similar. So it wasn't like we got lucky on one formulation or anything. No, I don't think so. I think we should hopefully see similar antibodies over time, similar T cells over time to Shingrix, and then we'll have the 70+ data to support the vaccine response rate in that challenging age cohort. Fair. Last question then as we're wrapping up on pandemic flu. There's top-line safety and immunogenicity data coming next year from that program as well. Another market where demand waxes and wanes. Yeah. How are you thinking about interpretation of that data and what we should be expecting from your opportunities? Yeah. Look, there's certain levels for seroconversion and seroprotection that are known and established for sort of how you assess pandemic flu vaccine. So we're excited about the data we generated from Part 1. So we're advancing into Part 2. We look forward to sharing that data. But like you said, it's an enablement study. We expect it to be positive. We had good data from Part 1, and we selected a couple of doses. We even have a potential single-dose option, which is not actually existing in pandemic. That could provide a different kind of BD opportunity with the U.S. government or other agencies. But we expect we'll have very reasonable data to support dose sparing using the adjuvant for pandemic response. And then it becomes a BD tool globally to make sure Dynavax's adjuvant is in the mix when we need to be prepared for the next flu pandemic. Excellent. Well, that's it on time, but thank you so much for joining us and really appreciate you speaking with us. Thank you. Thank you.