Good afternoon, everybody. Thank you so much, Ryan and Kelly, for joining me this afternoon from Dynavax here in Miami. Thanks for taking the time. Yeah, thanks for having us. Great to be back. Good to see you again. Before we launch into the Dynavax-specific stuff, I feel like I should start by asking about policy. There are obviously some issues that have been weighing on the vaccine space in general recently. What are your thoughts on some noted vaccine skeptics poised to take some leadership positions in public health? And how do you see the risk to vaccine recommendations, to development, and to public perception of vaccines in the next couple of years? Yeah, it's a little too soon to comment, really, on the nomination and confirmation process. I think to speculate what the agenda will be or what's actually going to happen there with the nomination, I think it's probably just too soon to tell. I think as it relates to the, I guess, the concept, we think HEPLISAV-B is pretty well insulated. HEPLISAV-B is an adult vaccine, obviously. We had the recommendation for universal vaccination in 2022, which, you know, that recommendation came out of a fairly intentional data review that had been put together for some time to support the goal of eliminating viral hepatitis, which is very supportive of a pro-health agenda. So ultimately, we think we're pretty insulated from any volatility that could exist from one administration to the next. We have a very robust safety database. We had a long and disciplined approval process, so we feel like HEPLISAV-B data stands on its own. So I think we're feeling reasonably secure in our continued progress. With a lot of your growth coming from retail channel, though, it is, even given the universal recommendation, it is a voluntary vaccine. Have you contemplated changes in language from the top driving retail behavior, driving voluntary behavior in adults? Nothing specific related to any change in the administration. I mean, I think staying true to our message and our belief that HEPLISAV-B is the right product for adults to achieve the ultimate public health goal of elimination of viral hepatitis as a public health threat. We'll continue to do everything we've been doing to support the uptake in retail and other settings with all of our promotional tactics and marketing tactics, and we will keep a close eye on the policy environment, as we have done since launch, to deal with all the different policy opportunities and challenges that have continued to exist, and there will always be some that continue to exist. But we're well positioned to manage it and stay on track with our long-term guidance and expectation for growth. Great. Well, so let's talk about that growth. Obviously, market share growth is a key driver for you moving forward. And it slowed in 2024 relative to where you exited 2023. Remained strong, but growth slowed a little bit. Obviously, quarter to quarter, there's seasonality, lumpiness. But how are the overall trends in the market developing through 2024 relative to how you were feeling about them exiting last year? Fine. I mean, I think we've had, we continue, you mentioned quarterly fluctuations. That's why we tend to compare everything annually, so 44% total share exiting Q3 compared to 41% for the prior year, so still showing reasonably annual year-over-year growth, which we expect to continue. You know, when we think about market share, one metric we use to kind of highlight how we're progressing, ultimately, we pay a lot of attention to our specific progress by customer, customer targets, and within the channels, and so we have another level of information below just the quantifiable metrics that make us feel very confident about our long-term trajectory. We did, you know, update our long-term guidance that included a market share figure to say we expect to be at least 60% share by 2030. If you look at where we are and kind of where we think we'll be, obviously, it shows confidence that we'll continue to find ways to grow. You obviously reiterated the long-term guidance that you'd previously given. You extended that out to 2030, as you just said. Something is giving you confidence in your ability to keep growing market share from these mid-40 numbers pretty dramatically out to 60% by 2030. So what are you seeing that's giving you the confidence to say that now? I think one thing you have to look at is our share in the key segments that will drive growth. Currently, I think Q3 we had reported 55%-56% share in both retail and IDNs, 55% for retail, I think 56% for IDN percent share in those channels. That's obviously higher than the overall market. That's also the channels where we'll see growth. We're not stopping there in those channels either. As we drive continued share increases in those channels and we drive growth through those channels, it obviously will help us continue to increase overall share. And on top of that, with continued expansion of utilization along with awareness, we do believe that in the sort of small clinics and the other part of the business, we'll continue to have market share increases over time, although it'll be much slower than where we specifically promote. So I think all in all, you know, it all kind of hangs together with just continued progress year over year. Now, you've seen some dramatic overall growth in the market with universal rec. You've guided the continued growth in the overall market through the end of the decade. But one thing that I hear from investors who are nervous about the ability to get there is the one-and-done nature of the shot is about using up the eligible population, but at least using up the population that are enthusiastic about getting a vaccine. So maybe just can you lay out for us what proportion of the key eligible populations have been vaxxed already? How much market penetration are you assuming in those long-term guidances? Yeah, that's a great way to frame the question because it does help support understanding where does, you know, what's the believability of the long-term guide, which we think is all very credible assumptions. We weren't, I don't think we pushed the envelope necessarily. So if you go back to the data that's available, the CDC does a survey that helps you understand vaccine coverage rates. They do it across the number of vaccines. They do it for hepatitis B. It's evolved a little bit over the last few years because of the introduction of HEPLISAV-B and our dosing regimen. But historically, they would check in on the adult population and ask who's been vaccinated and then how many doses have you received. They sort of changed their survey questions in the recent years because the dosing doesn't line up. But in the most recent survey, they also adjusted the question to only ask it to those people who are over 31 or 32 years old because that's the cutoff point. So this gets back to your point around a one-and-done and the catch-up cohort. So people born before 1991 represent this opportunity for catch-up. People born after 1991 were most likely vaccinated as infants. I'm pretty sure I haven't been vaccinated yet. I'm sorry. Okay, well, there you go. I'll drive your growth in 2025. There you go. you go. We're going to go out to the pharmacy after this meeting. But the survey data now focuses on those people over 32 years old. And it showed that 28% of adults over 32 have been vaccinated. Now, if you look back to when they asked the question around how many doses have you received, you realize that when they answer the vaccination question, about 80% have been fully vaccinated. So, you know, when you adjust these figures, you get somewhere between probably 20-25% of people in that sort of over 32 years old have been vaccinated. That means 75% of them or 80% haven't. Just to give you a sense of the long-term value. And when we think about our guide, we basically took analog curves for recommendation changes for vaccines to understand how long, what's the shape of that growth curve. It's sort of long and slow. It doesn't happen overnight, but it doesn't also just end either. That's what we applied to HEPLISAV-B as well as a view of where do we think that the cumulative coverage rate would top out. For our long-term guide, we kind of assume we end in sort of that 40%-50% range of total coverage. That's $900 million in 2030. That's $900 million in 2030 is based on, you know, continued price advancement as well as hitting about somewhere in the 40%-50% overall range, cumulative vaccine coverage rates. Plus, and this is a really important point as it relates to the long-term nature of the product, we know that there's revaccination practices that happen in the marketplace. So for example, we know that when someone goes to medical school or other settings where there's occupational health risk, oftentimes they'll get their titers checked if they're going to work in a hospital, for example. And if they don't have titers, they'll be revaccinated even if they were under 30 years old. There's an established revaccination practice that exists that we believe will, is driven towards the highest risk populations, so occupational health risk and other settings that we think will offer a long-term market opportunity even beyond just that initial catch-up cohort, plus the ability to continue to penetrate the unvaccinated populations for many, many years to come. Of course. Now, you know, one thing that you mentioned in there in passing almost was the number of vaccinations, people who have been partially vaccinated versus fully vaccinated, and obviously, there's a place where you're a little differentiated from the competitors. How do you view that population of patients who are partially vaccinated who, for whatever reason, didn't go back for their boosters? Is that a capturable patient population? Is that for those people that you're assuming that you'll have access to? Yes, yes. Because here's what it feels like. So you go into your pharmacy and they say, "Oh, have you been vaccinated against hepatitis B?" "Oh, I don't know." Or, "Oh, I got one." "Well, you know, you recommended to be vaccinated, so why don't we start you on the series here?" And that's it. Because if you didn't complete the series, you're not vaccinated. Like, that's just, you had a vaccine, but you are not vaccinated. You're not necessarily protected. And frankly, with the protection rates after one and two doses of the competitor product, you should assume you're not vaccinated or not protected. And so that's how it'll play out. If you don't have a record of completing the series, then you are an eligible patient. All right, Kelly, let's get to you. I'm done. Go ahead. All right. Substantial share repo got started last month. I think this is something that folks reacted relatively positively to. How is that program going to evolve heading into next year? You announced an accelerated share repo plan. Can you get a little bit more granular about your goals with the program as opposed to alternative possible uses of capital? Sure. Thanks, John, so just as a reminder, we had authorized the $200 million share repurchase program, which was announced in connection with our Q3 earnings update. Shortly thereafter, we executed the first $100 million of that program under an accelerated share repurchase plan, and we expect that ASR to go through the first part of Q1, and, you know, then we'll have, we've also guided that we expect the full $200 million authorized plan to be executed within the first 12 months, you know, subject to market conditions, of course, and it's an important part of our capital allocation strategy. This is a new piece of our capital allocation strategy, but we've always held ourselves really responsible for balancing near-term value creation and long-term value creation, especially as we continue to invest in the growth of the brand. You know, to a lot of Ryan's points, we're seeing really tremendous uptake in HEPLISAV-B. We look for opportunities to continue maximizing that growth. A couple of the other decisions that we took in connection with Q3 that helped add some clarity to our capital allocation strategy overall beyond the continued growth of HEPLISAV-B, where we discontinued one of our clinical programs, our Tdap program, because we didn't think it was going to be competitive in the marketplace, and then, you know, we also have a really good line of sight into what the costs are going to look like to support our shingles program through this next important catalyst and the data readout for the Phase I/II study, which we expect in the second half of 2025. So really the culmination of all of those elements of our organic-based business and understanding exactly what it's going to take to drive value through all of them gave us the confidence to be able to return some capital to shareholders, you know, which was all capital we earned during the pandemic and we're really proud of. And then also, you know, we continue to aspire to bring on, you know, late-stage corporate development assets that we believe we can rapidly progress into, you know, in a creative way to commercial stage and leverage this organization that we've built that we're really proud of. Let's definitely talk a little bit more about BD. We'll talk about strategy. First, let's talk about dry powder and size range here. Obviously, you do have a fairly substantial amount of cash that you can put to use here. You've announced $200 million for repo. What does that leave you in terms of the size range that you're most interested in and the sorts of assets in that size class? Sure. So an important piece to think about with respect to the amount of dry powder we have access to is, of course, our balance sheet. But we also guided and are excited about crossing that threshold to profitability for not only the quarter, but for 2024 and the near term. I mean, having a disciplined series of a set of investments that, you know, allow us to create cash flow and create additional dry powder in future years and expand our margin on the back of growth, top-line growth will be an important element to how we think about the size and structure, frankly, of what kinds of business development or corporate development assets that we can address or that we can act on. I think, you know, just to put a finer point on it, you know, we think we would be most effective with sub-$1 billion market share products or market-sized products. You know, we have a great footprint in retail and IDN that can be leveraged. We have fully integrated capabilities across development, manufacturing, CMC, and of course, commercial, not to mention, you know, throughout the clinical and regulatory expertise as well. And IDN, but not just vaccines. And IDN, but not just vaccines. Yeah. And I think we'll take every opportunity on its own merits, you know, opportunity by opportunity. And we'll look at the TPP and look at, you know, what could make sense for us and what could be synergistic and leverageable. You're looking at things like antivirals. You mentioned a size range of target, but what about size range of market? Would you be interested in potentially large market opportunities? Yeah, I mean, I think, Kelly, the point there is being realistic of what products are likely to land with Dynavax. We have to be able to add value in a way that's unique to us, right? What's our, why do we win? So very large markets are fine, I think, as far as market size. But if it's products that are going to have $2 billion revenue objectives that are later stage, it's not, that's probably not a product Dynavax is likely to win because it probably makes more sense somewhere else. So I think those products that may be targeting a large market that have the right profile or niche to where their sub-billion dollar revenue opportunities is more likely. IDN driven. Right. I think that gets down to the call point and target, like something that's digestible, right? If you think about that, our IDN team is probably more leverageable than our retail team outside of vaccines because of where they are, right? Retail, there's not a lot of products that get commercialized in retail like vaccines do. But the IDN team could support, you know, a variety of different call points and things within that setting or within specialties. So, but ultimately, Kelly kind of hit on this. We want to focus on things where we can add value to support why they make sense for us to actually be taking them forward. That can be across our commercial footprint, but as well as our late-stage focus where other companies may not need to be focused on ID or our earlier stage and they're not really ready to go into. Late-stage development. That late-stage development. They might have a more robust earlier stage pipeline assets where they want to maintain focus on early-stage R&D, you know, those kinds of things. So we're just trying to really stay true to where we can add value and take on for this first step, something focused mostly on execution risk as opposed to substantial clinical risk. Okay. And maybe we'll spend a few minutes on the internal pipeline. Starting with the DoD plague proposal, obviously that was submitted. But can you share anything about the data that supported the proposal that you recently submitted and maybe when you could expect to hear more back from it? Obviously, it is in the DoD's hands, but any clarity you can provide us about that? Sure. Yeah, I can provide clarity on the fact that we didn't share the data because it's not our data to share. And this gets a little tricky when working with the DoD, especially on things like this, just given their whole focus is national defense. But the important point is that we're continuing to work with them for the next step of advancing the program. And so we, in collaboration with them, have put together a proposal for additional work across both clinical and CMC. And now we're waiting to hear on their response. And so once we have that, then we can provide more clarity on expectations for the program because obviously the contract is the program. Do you have a sense for what their typical turnaround time would be on a proposal like this? Yeah, we're expecting something in the relative near term, but as far as weeks slash months. Months, whatever they like. We can't really. There is no defined timeline. I don't think it's reasonable that they would sit on the proposal for months and months and months and months and months because otherwise, you know, it's just stale at that point. So, but I can't pinpoint it. Fair enough. Shingles data coming out next year head- to- head, obviously probably the biggest remaining internal pipeline readout that people are anticipating here. If data looks supportive of a commercially differentiated profile, as you've discussed in the past on tolerability, how rapidly can you advance to late-stage studies and how long would development from there take in your opinion? Yeah, I mean, we're getting a lot out of this readout. It's, as you noted, key data. It helps us validate the patient-reported outcome tool. It'll also be the data set that helps support our international business development efforts. And so one of the things, a key element of this strategy of this program is we recognize this is the stage gate that will then unlock fairly sizable and long-term investment to advance the program. And so we have a stated strategy to partner this program to help obviously defer some of the risk or share some of the risk around the cost of continuing to advance it. So we need some time to actually do some of that work as well. Plus unlocking additional CMC investment to support moving into phase two, three studies, which is kind of the trial design now. You wouldn't move into a late-stage study without a partner and to do additional investment in CMC? We think it's going to be important to have a global plan here to unlock the full value of the product. I think the other thing that a partnership will do will provide some validation on our, not that we necessarily need it, but I think from a market perspective, you know, we're going to be making, you know, advancing a program on the back of this relatively early data on immunogenicity. So there is some validation that would come from an external partner also being willing to take on some of that risk. I think that could be a very important indicator for the market as well that it's a reasonable investment to make. Obviously, so having a partner for international is going to be pretty important to the overall path for the program. That makes sense. Obviously, last question, I promise, but discontinuing that Tdap program seems like a very responsible decision to me in light of expected differentiation, or is it lack of expected differentiation? But obviously now we're looking at early pipeline. You've mentioned new potential INDs in the future. How do you think about internal pipeline development from those early-stage assets from here? Yeah, I mean, like we have a few things we're working on. We don't really talk about them until we get through the pre-IND enabling studies, so we know that what we're going to discuss actually has some legs to move forward into the clinic, so we can, you know, we're excited to continue to leverage 1018 in assets that we think have, you know, reasonable opportunities. I mean, you can tell by our Tdap decision, we take these things very seriously, right? We could have probably developed that Tdap vaccine and got it approved and had a reasonable profile, just not confident it was going to win in the marketplace to justify the resources and effort, and we take that same thing with anything that's coming out of the earlier stage work. So we're excited to talk about some things as they advance, but not until they're ready to be discussed. I'll be patient then. Thank you guys so much for joining us this afternoon. I appreciate all your commentary. Look forward to seeing how the launch progresses in Hep B, obviously, and all the news on BD that I'm sure is coming soon. All right. Thank you so much.
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