I'm here with Dynavax, Ryan and Kelly from Dynavax. Really appreciate the time you're spending with us this afternoon. Welcome to sunny Miami and to our conference. Before we dive into the nitty-gritty, please just give us the lay of the land. How are you feeling coming into 2024, and what should we be focused most on as we look ahead to the new year? Great. Well, first, thanks for having us. We really appreciate it. But first, we want to finish out 2023 strong. We're not in 2024 yet, so- Right. We're, we're focused on continuing to generate, market share, growth, throughout the end of the year. But as we move forward to 2024, you know, the story continues to be focused on HEPLISAV, which is our lead asset, our adult hepatitis B vaccine. Looking, specifically at growing the market, we do believe there's good opportunity for continued market growth, along with capturing additional share. Also in 2024, our pipeline programs are advancing to the next stage of development for both of our two lead assets. Our Tdap vaccine and our shingles vaccine will be moving into the next stage of development in sort of the middle part of next year. So really excited to be able to continue to advance the pipeline. Excellent. Well, let's start, maybe for those in the room who aren't as in the weeds, with a brief overview. What is your... what is your addition here? Well, obviously, you're in Hep B. There are existing Hep B vaccines. What makes your adjuvant best, and what's changing the standard of care? What's the magic? What's the magic? So, as you highlighted, it's our adjuvant. So the company was founded on TLR biology, so toll-like receptor biology, specifically with this product, Toll-like receptor 9, which is a critical receptor found on plasmacytoid dendritic cells, which basically stimulates the innate immune response with invading pathogens. And so the adjuvant mimics the natural immune response within the presence of vaccine antigen. We find that it stimulates a Th1-biased response, which is somewhat different than the most commonly used adjuvant of alum. Mm-hmm. and that can provide a number of benefits, as we saw with HEPLISAV, where we were able to demonstrate very high levels of seroconversion, seroprotection, and doing it with an incredible tolerability profile, which isn't necessarily always the case with an adjuvant. Sure. And so that, that gave us a great opportunity with HEPLISAV, which we're looking to leverage in other products. We, we were able to use it for a, a pretty, interesting COVID-19 response, where we, ended up getting, I think, five products approved, either through emergency use or full approval globally, and saw really great data that continued to show the, the ability to stimulate the immune response and do so with a very favorable tolerability profile. Now, you're not the only CpG-based adjuvant out there, too. This is a class of adjuvant that's been known for a little while. What makes your version of the class a little different? Well, I think it's the focus. We are the only TLR9 adjuvant out there, and we've demonstrated that that's a very useful mechanism and pathway. Great. For Hep B, for the ongoing launch, you've been taking market share. You've been talking throughout the year about increasing revenue guidance and increasing market share. What's driving your recent momentum, and where are you seeing the biggest opportunity for a near-term share gains? Sure. So a couple of things, and, and first, we're really, really excited about the performance of the brand throughout the year. In Q3, we pulled in $62 million of top-line net sales from the brand, which was another record-breaking quarter. We did raise guidance expectations for the year to be between $210 million and $220 million, driven really by, by two different things. First, we're seeing tremendous growth in the underlying size of the market as a result of the ACIP universal recommendation, that got implemented in 2022, which I know we'll go into a little bit, more in detail here in a minute. So we're seeing nice, nice growth in the market. In Q3, we saw just under 30% total market growth in terms of Hep B utilization. And while that market is growing in size, we're also continuing to capture market share over time. In Q3, we exited Q3 with just over 41% total market share, and importantly, we're pulling through over 50% in some of the key segments that are very promotionally responsive and which we expect to grow disproportionately in line with the universal recommendation. You've been talking, you just mentioned market segmentation there. You've been giving great, granularity on market segmentation in recent quarters here. But obviously, where the growth is coming from has evolved over time, and it seems set to continue to shift, both in terms, as you just said, in terms of the market shares that are susceptible to being sold and also to the growth of those underlying segments. Can we get into that a little bit more granularity- with a little more, with more granularity? Where are we expecting to see market share changes or market size changes more near term, and what does the tail of that curve look like as we look out towards 2027, which is about where you talk about peak guidance? Yeah, I, I can take that one. So, the key segments that we're talking about are retail, pharmacy, and integrated delivery network. So if you think about what has happened with the universal recommendation, we moved from a risk-based recommendation, which is prior to that, prior to 2022, we were in many different segments, from occupational health clinics, travel clinics, correctional facilities, DoD, public health, retail pharmacy, integrated delivery networks. But what the universal recommendation has done is it said healthy adults should be getting vaccinated, not just people with inherent risk factors, and that, that favors the, the two key segments of retail pharmacy and integrated delivery networks, where there's high level of institutional control and ability to implement new recommendations broadly across the segment. And so what's really important is our field model allows us to target those segments very effectively.... Frankly, because we've been at it for a few years as well, we've gotten great traction within the IDN segment, which is very useful. And with COVID, you've seen a lot of movement in the retail segment on how they are able to basically universally across the country now be a source for significant vaccination. Yeah. That gives us a great opportunity to be able to focus on IDN, where traditional healthcare is generally encountered, and then also use retail as another site to pick up the rest of the market. So those patients who aren't in an IDN where HEPLISAV is primarily available or in small providers, retail is another setting where we can capture those patients. Basically, better concentration. That's right. And so they also have certain mechanisms through their communication pathways to their pharmacies or initiatives, whether it's pharmacist-driven or marketing-driven, that allow us to help educate consumers around the recommendations and the need to get vaccinated. So it can also be a very efficient model to get the word out and drive vaccination. So we do believe that those two segments are gonna be critical for expanding the market on the back of the universal recommendation. They happen to be the two segments where we have our highest share, and they happen to be the two segments that we are organized to focus around. So I think we're very well positioned to drive, not only benefit from the growth, but drive the growth as well. As a fraction of total market, where does that peak out? You know, assuming the ACIP recommendation runs its course, and you're seeing a peak penetration in those healthy adult segments that previously might not have been getting vaccinated at all, where does focus on retail and IDN cap for you as you get towards the back end of the decade? Yeah, if we add up both those percentages, it's probably in the 50% range as far as the overall market that will come out of that segment, if that's the question. Yeah ... as it grows. Yeah, it's probably in that range. I mean, currently, about 25% of the market is in independent physician offices, so I think 40,000 outlets where they use 10 doses a year or something. So there's still this, like, chunk of the market that is the independent physician. That's very hard to get to. That's going to shrink 'cause we don't see a lot of-- we don't see that group being very proactive with the universal recommendation. They're probably gonna be more just kinda going about their business. Mm-hmm. So, and then the other segments where public health is still gonna matter to some degree. There'll still be Occ Health and. Yeah ... in other settings. Prisons and DoD. It'll still be there. So I think ultimately, we have it in our actual slide deck. There's a nice breakdown on the pie chart, but it's gonna be a very sizable component. Makes sense. Now, competitors argue that they have a pricing edge over HEPLISAV. To what extent is that a driver in these various different segments? Is it more relevant in retail, say, than an IDN, or what's your sense for the relative impact of that competitive dynamic? Sure. So in the U.S., we have a number of segments, and the pricing works differently segment to segment, as you alluded to, John. I think importantly, we, you know, believe that we have a best-in-class product, and we do have a premium price strategy. With respect to, you know, hearing sort of anecdotally from folks that pricing is problematic, we really haven't heard that at all. In fact, you know, for our customers, I think they really do appreciate that we have a premium price or a premium product, that's not only operationally more efficient, but also, you know, sort of clinically has a profile that'll support a premium price in the U.S. Of course, as we think about international markets, it's really on a case-by-case basis. You know, every single market has its own pricing dynamics, and, you know, sort of how public health works in each market could vary significantly country to country to country. So we take that into consideration, of course, as we think about expanding, you know, the value proposition of HEPLISAV outside of the U.S. Mm-hmm. Makes sense. Another big headwind that comes up in our conversations with investors is the likelihood for vaccine fatigue. Obviously- Mm ... we're seeing a lot of folks tired of interminable COVID shots, but with the expansion of universal recommendations to Hep B, but also seeing greater recommendations for RSV, for pneumococcal, potential expansions in the adult market for pneumococcal, how do you anticipate handling vaccine fatigue overall, seasonal vaccine fatigue? To what extent is that gonna be an impact, and, and do you have any strategies there? Yeah, get out of 2023. Yeah. I think that's a strategy. I think that 2023 is a particular- Mm. It's a very, very unique year. We're coming off the back of pandemic COVID vaccine, which was kind of all over the place, and moving into that endemic reality, so it's, you know, it's a new product that, that is recommended for everybody. But then RSV was introduced with multiple products very rapidly- Mm-hmm ... frankly, and around the same time that we're navigating the respiratory season with flu and COVID. So I do think this is a bit of a perfect storm of events that was unparalleled in recent history to have this many things kind of thrust on us at the same season. I do think this will settle out a little bit. One, we don't know yet what the RSV long-term recommendations will be. Will it be annual? Will it be every- Biannual. Or every five years? I mean, we really don't know yet. Mm-hmm. I think we- It will certainly be recurrent at some point. We would expect, but again, it doesn't have the same shift and drift issues of flu and COVID, so we'll have to see. But, with COVID and flu, I do think that we're gonna find a little bit less... It'll still be an important part of the season, of the year, but I don't think it's gonna be as, disruptive in that you had RSV and this unknown COVID season coming. So from a retail, especially the retail channel, there was a lot of distraction, right? And, and so they had to figure out how to manage that, and we do think that that's gonna cause some seasonality here in Q4. But from- But it sounds like you're suggesting coming into 2024, that it could be a tailwind? ... Well, there's two things. So you—that's from a retail perspective, yes, because they, this whole channel has built a model around being able to provide significant vaccination services. It doesn't just go away because it's Q1. Mm-hmm. They still have bandwidth- Mm. That they just demonstrated they could use. So there's the other products, there's room for them to be administered through the retail channel, and there's infrastructure to support it. As far as a patient perspective on vaccine fatigue, you know, I... Yes, there is definitely some, but we're still seeing a lot of people get vaccinated. And I do think 2024 will feel quite a bit different than 2023, with everything that's going on. So I think it's a bit of a temporary reality. Mm-hmm. Sure. Moving forward with Hep B, you are expecting a label expansion into dialysis indication coming next year. What impact is that label expansion gonna have? Does it change strategy at all, or is it just one more segment to tack on? No, I think really, it's, it's part of the life cycle management. It's been... You know, we're very proud of the product. We're very, very proud of this product, and it's been a little frustrating that we can't bring our full, you know, engagement to all customers in the segment. Mm. So being able to proactively engage with the dialysis segment will be useful to us. There's already some utilization in that segment. We don't talk about it much because we're not proactive in that segment, but we can contract. There is utilization. And so we're excited to be able to engage with our customers and engage with that segment proactively to one, continue to grow share there, and two, make sure we can hang on to the share that we have, 'cause we do think it's an important product for that segment. Let's move beyond Hep B and talk about some of the downstream products- Great. -that you mentioned earlier. Obviously, you have INDs coming and, yeah, or I'm sorry, the trial starts coming- Both. -both, uh, Yeah in shingles and Tdap next year. But we also have data coming from the plague study. That's right ... which maybe is a smaller market, but a very interesting one, given it's a government contract. Remind us what the endpoints are there that you're looking for. What are the key metrics you expect to report, and where does the program go from there? Sure. So very briefly, the key metrics for that phase II data that will come out in 2024 is comparing the titers for two doses of the CpG- 1018 adjuvanted plague antigen, compared to the three doses or the two doses and three doses of the non-CpG- 1018 adjuvanted arm. What we expect to see is, based on the original run-in data, we expect to see higher titers for the two doses with the adjuvant than two without. But what's gonna be really critical is, and this is where the expansion to non-human primates is so important, that the DoD has already expanded the contract to include the non-human primate study. That's how you interpret the data, 'cause there is no correlate. Mm-hmm. And so what we'll be doing in the non-human primate study is demonstrating the efficacy of that two-dose regimen. So we've already seen enough... You know, the DoD already saw enough to try to want to expand the contract. So this will be a larger data set to help us really understand the magnitude of the difference in the phase II- with the phase II data. And then, I think the real important point will be getting through the non-human primate challenge study- Got it ... which is fundamental to approval under the Animal Rule. You can't conduct a- Plague. Plague. You can't conduct a plague efficacy study. Not even on soldiers. Not even on soldiers, no, 'cause there is no plague. Yeah. Which is a weird disease to vaccinate against, but it's a bio threat. It's a bioweapon that they're concerned of, and so we'll really looking forward to continuing to expand that contract to include the NHP work and get those studies done. Well, what does that market look like with the DoD? Obviously, it's a very different market- It's very different. ... from a typical vaccine market. Sure. There's some analogues. If you look at strategic national stockpile contracts, there's a few different vaccines that are stockpiled, either smallpox and anthrax. And then I think the question is ultimately gonna come down to: What is the defined need? Is it for the strategic stockpile for the U.S. population? Is it only focused for the troops? Which will have a very big difference on order of magnitude. So you know, depending on that, it'll drive the ultimate revenue opportunity. At what point do you expect to have clarity on that from the DoD? I don't think we'll see anything on that discussion till after we have non-human primate results. So this is a good, it's a good business for us. It's profitable, and they support all the work. We believe it demonstrates 1018's capability very cleanly and well. They're great partners. We wanna be a great partner to DoD to expand the U.S. government business, if available. So... And we'll roll with the opportunity as it presents itself. Great. Maybe on shingles, obviously, we've seen updated data there from competitors. Where are the opportunities for a novel approach to shingles, and how do you expect to see... Where do you expect to see the clearest differentiation? Tolerability, period. There's not... You're not- Yeah. You can't beat that product on efficacy. It's a tremendous product, tremendous efficacy. Just has some challenges with tolerability and, and reactogenicity, and so we're looking... This is the 1018 story. Adjuvant, the protein with our adjuvant, to see if we can create a similar, efficacy with much improved tolerability. Similar story to Tdap? Tdap is different. Tdap is longevity, durable protection from acellular pertussis. Yeah. Acellular pertussis with adjuvant, with alum, is known to not be as effective as whole-cell pertussis. Mm. We're looking to see if the adjuvant and stimulating a Th1-biased response can actually provide a difference immunologically that will provide more durable protection for pertussis. You're contemplating a challenge vaccine, a challenge study for that. How does a challenge study get designed to answer that particular question? It doesn't. It answers whether or not that your antigens can protect against a challenge of pertussis in the very near term. Right. So what's going to have to happen is a couple things. One, the immunological endpoints through our, the duration of our trial, even over time, we will be looking at those compared to the an active comparator, and assessing the durability or the potential durability of the vaccine based on the immunological endpoints. And then- Separate from a challenge then. Separate from a challenge study and clinical evidence, and then through real-world evidence, I suspect we'll have to support that ultimate viewpoint on durability. Mm-hmm. Makes sense. Obviously, there's a lot of focus on possibility for further BD. The shingles Tdap programs are interesting, but a very early stage, and people are interested in later stage opportunities or later stage development. You've guided to the potential for BD- Mm-hmm. But you've also suggested that you're not in a rush and that you're going to wait to find the right opportunity. Can you talk a little bit about what the current landscape looks like to you from this perspective, and what you're looking for in the right acquisition? Sure. So yeah, from a BD perspective, we have over $720 million of cash on the balance sheet, largely thanks to our execution during the COVID pandemic with our adjuvant supply business. We also know that HEPLISAV-B is positive from a free cash flow perspective on a brand standalone basis. So for us, you know, as a priority, we wanna leverage our fully integrated organization. We have a commercial footprint that, of course, includes a sales force, as well as, you know, full commercial capability, as well as manufacturing facility and manufacturing capability. So, you know, making sure that we're prioritizing those, those opportunities and that opportunity set that can, that can leverage, whether it's adding scale or, you know, creating capability where there, where there are other opportunities down the line, I think is, you know, first and foremost what we're, prioritizing. Of course, looking at vaccines, and then, there are also some potential adjacencies beyond vaccines that we would consider. Mm-hmm. with that profile. Have you considered or have you made any suggestions about size of potential deal or what the stage of development you're most interested in? Yeah, I mean, I think Kelly highlighted that it's gonna depend, right? On the size of a commercial deal will be larger than the size of an early-stage development deals. I think ultimately, it's gonna depend on the opportunity. The stage of development, taking on excessive clinical risk outside of prophylactic approaches would be fairly risky for us, given where we're at, so I think we lean towards later-stage adjacencies. Mm-hmm ... you know, whether they've already demonstrated clinical viability and/or are on market. We are also looking at novel approaches to other disease targets within vaccines, outside of leveraging the adjuvant. Mm-hmm. Those would be earlier-stage, smaller transactions, license deals, or something like that. So we're kind of open to leveraging all aspects of our core business, our vaccine infrastructure and capability, as well as the fact that we are a late-stage company in a market where there's a lot of companies that aren't, you know... They, they could use that support, so we might be able to opportunistically leverage it. Should we be expecting multiple deals, potentially? if, if they were... Depending on the size If they presented themselves. Yeah. I think and the structure would matter. If there's a deal where we fund the next stage of development, but we're not taking it on, that changes the bandwidth- Mm that we could then deploy on something else, and the capital is there. It gets back down to a sound capital allocation strategy and managing our bandwidth. We're not throwing money at anything. We are very disciplined with capital allocation against trying to drive long-term shareholder value, so. All right. Makes sense. Any closing thoughts, before I let you go? No, thank you for having us. I'm very excited for, you know, what we've been able to do, with our, with our asset and what the team's been able to accomplish. And like I said already, we're focused on accelerating growth through expanding our pipeline, taking more share and growing the Hep B market, and looking for unique opportunities, to leverage our capabilities more broadly.