... Good afternoon. Thank you all for joining, and welcome to the Dynavax Technologies Fireside Chat at the Wells Fargo Healthcare Conference. My name is Jason Ellis. I am Managing Director on our healthcare investment banking team. I have the distinct pleasure today of having with me Ryan Spencer, Chief Executive Officer, and Kelly MacDonald, CFO of Dynavax. Ryan, Kelly, thanks for being here. Thank you. Thank you. Thank you so much for having us. So it'd be great if we could, you know, just kinda get started with some perspectives on the company at a high level for those who may not be as familiar with the story, and really just articulating what you'd like investors to know and understand about the company and how it's positioned, and, like, what success looks like, based on who Dynavax is and where you're trying to take the company. Okay, great. So again, thank you for having us. It's a great place to start. So Dynavax is a commercial-stage vaccine company focused on developing improved vaccines, leveraging our novel adjuvant technology, which basically enhances the immune response. We are at a very key inflection point in our journey, with our lead asset generating significant revenue on its continued growth path, and our pipeline has had some recent advancement and continuing to advance in the coming years. So, you know, I think the key takeaways to get started from an investor perspective is recognizing that we continue to make significant progress with HEPLISAV-B, our lead asset. We do see this as an opportunity for us to continue to expand earnings based on the revenue growth of that asset, but also importantly, start to generate value from this emerging pipeline, leveraging our core technology, while we also maintain a appropriate financial position to be able to opportunistically evaluate, you know, basically high-value business development or corporate development transactions. So we think we have a very balanced approach, and high capability in the organization to execute it. Now, that's excellent. Could you talk to us a little bit about HEPLISAV-B? So HEPLISAV-B, I'm sorry, Hepatitis B market is obviously showing strong growth, continues to expand, and you've been able to capitalize on that with HEPLISAV-B. At the same time, you've increased market share, so not just riding the tailwinds of the industry, but really taking more share. Could you just talk to us about, you know, how we should better appreciate the weighting of the various puts and takes around HEPLISAV-B, whether it's, you know, the product differentiation, whether it's the commercial execution that you're able to, drive, that's really kind of, leading to that market share change? Yeah. So there's a couple things to understand about HEPLISAV-B and our growth. You know, we do have a differentiated product based on our adjuvant technology, and there's also been some important market developments that have happened recently. So in twenty twenty-two, the ACIP recommended that all adults be vaccinated against hepatitis B, making it one of the largest addressable populations in the U.S. adult vaccine business. And so since then, we've been working to drive the market growth in and around that recommendation. That actually has a pretty big impact on overall market share because we've been very successful at driving growth while also leveraging kind of this market event for adult vaccination to highlight the benefits of our product, and which has led us to, you know, drive growth as well as take share. Importantly, we've taken increased share across key aspects of our business in IDNs and the retail setting. When we think about why we've been successful, beyond just having this expanding market opportunity, it's a variety of things. One, our product profile is quite strong, which goes back to our overall premise for all of our assets, leveraging 1018, is to deliver meaningful clinical differentiation. In HEPLISAV, that shows up as two doses compared to three doses of the competitor vaccines over a shorter timeframe, so over one month versus six months with the competitor vaccines. And importantly, even with fewer doses, we generate in our phase III trials, higher levels of seroprotection across all populations studied. So the clinical differentiation is quite significant and is a key tool for us to leverage in driving market share. In addition, our commercial execution has been quite important in the whole journey as well. We've been able to constantly shift and flex our how we attack the market from when we first launched and then into the advancement of the retail setting post-COVID. And now you can see, like a lot of our public comments, that the retail setting continues to be a key aspect of future growth and where we have our strongest share, and that's been not only the product profile, but the commercial execution has been a very important part of that of those gains. That's, that's really helpful. So, you know, as you think about how you've performed commercially and, and where the product is, you know, what do you think has gone really well, and, and where do you think some of the challenges are, the things that you'd like to continue to work through? You know, so, so really just building off of Ryan's comments around not only the clinical profile of the program and the continued commercial success of the launch, we really do have a best-in-class commercial team pulling through execution on both market share shift towards HEPLISAV-B from competitor vaccines, as well as growing and expanding the market. So we're really, we're really the primary and predominant voice in the space, doing both of those things at once. One of the key segments that Ryan highlighted is retail. In retail, we're projecting will grow, will double in size by 2030. Right now, it represents about a quarter of the market of the adult Hep B market, and we're projecting that it will represent approximately 50% of the adult Hep B market by the time we get to 2030. We already have leading market share position in the retail space, exiting Q2, just under 60% market share. A true testament to our commercial team and our, you know, capable footprint there. But one of the exciting things as we think about the trajectory, particularly in that segment, between where we are today and the path to 2030, is, you know, our ability to penetrate the Medicare population. Where only earlier this year, you know, we've been able to, you know, see the benefit of unlocking reimbursement access to that population, which represents about a quarter of the retail segment. So we're really looking forward to pulling that through in 2026 and beyond, and expect that to be a nice tailwind on our trajectory to, you know, our 2030 guidance. Great. With the Q2 earnings, you started to provide more granularity around, you know, the performance within the four key kinda hepatitis B market segments. Can you just walk us through each of those segments and comment on kind of the key levers and opportunities that Dynavax is focused on and any challenges to overcome within those? Yeah, the expansion of those or the change, I'll say, of how we've talked about the segments, as well as we provide some additional clarity as well on top of it, was really intended to provide opportunity for the investment community to understand the business, for us to talk about the business where we're actually providing, you know, we're focusing our efforts. And so the four segments that you mentioned are the IDN segment, which is the top 500 largest systems in the country, regardless of our targeting effort, just really understanding where the business is. The retail channel setting, those are our two primary segments, the in dialysis setting and then other. So other is another big one in that mix. So when we think about the challenges across the settings and the opportunity, the greatest opportunity exists in the IDN segment and retail, which is where we focus the vast majority of our commercial effort. The dialysis segment, we've also provided the fact that we have market share in each of those segments is available on our corporate deck, is in and around 50%. So we already have a very large share in that setting. There's two main customers in that space, so clearly we have one. And so it just kinda highlights the opportunity to capture more share there will kinda come with the next national provider. In the other space, that is a mix of DoD, corrections, public health, and then the large number of very small offices that only use five to 10 doses of hepatitis B vaccine a year. That segment is not approachable with a promotional effort, and so what our market share over that segment is varies across those different components, but because we don't put as much focus there, we bundle them in one segment. So we can really talk to the investors around the places where we're putting that energy and where we really expect to drive growth. And Kelly already highlighted, the primary sector for growth will be the retail setting, as we find more patients moving out of other or IDN into retail because it's a capture point that exists nationally. We do believe that ultimately we will see this expansion of the retail setting, which it also favors us because not only do we have very high share there currently, as Kelly noted, there's 25% of the market that we haven't been able to access, and we already have, you know, almost 60% share. So we're feeling very positive about our ability to drive growth in that setting in particular. Yeah, I'm glad you mentioned retail. I mean, it seems to be a big part of the opportunity set going forward. Maybe we can drill down on that a little bit more. You know, can you provide any more perspectives around just the velocity of the retail shift? And, you know, when you say 50% of the market by 2030, is that middle of the fairway, maybe even a little bit conservative or aggressive? We would love to just kind of understand that shift a little bit more. Yeah, it'll depend a little bit on, like, to your point, to the speed. If you think about the reality is, there's patients that are seen in the IDN segment, there's patients that are seen in the small providers, clinic segments that's under other, that are also captured in retail pharmacy. They all go to a pharmacy, and so all of the arrows point in one direction. Patients move from those segments into retail as retail captures patients. There's a big balloon of patients, if you think about it, so we're confident in the ability for that segment to expand to that level by 2030. I think the reality is, it's possible that it happens sooner or you get, you know, you get to 28 per... or, you know, you get more growth in the next few years, and it slows down a little bit. But we'll just have to wait and see how it plays out and how fast that transition happens. But, you know, we try to take our projections pretty seriously to try to hit the middle-of-the-road type projections. But with market size, there is some variableness there to where it could happen a little bit sooner. So it does provide a growth opportunity for us, or a way for us to potentially accelerate, depending on how the market behaves. And can you talk a little bit more about just kinda how you're adjusting the strategy and the investments that you're making to really take advantage of that shift to retail? Yeah, we are. You know, we're ahead of the game on it, I think is the key, is we've seen this coming for quite some time. Our team has had a lot of familiarity with this segment from their prior experiences, and so it allowed us to position ourselves very effectively there. And it- there's unique investments that you can make in that setting. Oftentimes in the physician access setting, so if you think about a traditional field team, one of your biggest tools is your people. The retail settings, our people are quite valuable, but there's also elements around how do you work within the retail's marketing channels to drive patient awareness and support? And that... That is everything from the ads you hear when you're shopping to what happens when you're online on your social accounts. Sometimes you'll have things coming from the retail set, the retail banner itself, which could be unbranded awareness of the need to be vaccinated against hep B. There's other things like that that we can do, which provides very targeted and efficient spend in that setting. So we do look to leverage all of those tools to, one, build awareness of the need for adults to be vaccinated against hepatitis B, and two, drive support for HEPLISAV-B in the marketplace. When you think about just the knowledge and awareness of hepatitis, and you think about some of the shifts and changes and news we've seen around, you know, policy and regulatory and administration, can you just talk a little bit about, you know, the political environment and what impact that has on hepatitis vaccination and what you expect going forward? Yeah, there's obviously a lot of dialogue on vaccine policy in the United States currently. Ultimately, when we think about our business, we know that there is, you know, a significant public health threat with hepatitis B. There is no cure for hepatitis B, but it can be prevented with vaccination, so we're lucky that we have this tool. We believe that HEPLISAV-B provides a unique opportunity to help achieve that public health goal of eliminating the threat of viral hepatitis, and so we think there's gonna be tremendous support for that. You know, vaccines are good interventions from our perspective. We have a very robust safety database, both with our initial clinical trials as well and our real-world evidence study. So we feel very confident that the product is has the opportunity to deliver significant value, and is safe in doing so. So, you know, I think ultimately we're gonna keep our head down and focused on executing on our plans, and we don't feel like there's too much risk to that as based on some of the current dialogue in the policy world currently. Got it. And talk a little bit about the competitive environment. I mean, you've mentioned, you know, you guys are really out there, the ones really promoting and educating a lot of the market. Can you just kinda give us some... a sense of, you know, what that looks like from a competitive standpoint? And are you really able to control the dialogue around the space because you are out there? And, you know, how are the other products getting attention? I mean, Kelly kind of already hit on that point. We actually are controlling the narrative for sure, and this gets back down to the concept of focus. What we make up, what we kinda lose in size to some of our competitors, we have in, we make up in focus. So we have one thing to do commercially. You can imagine, you know, our team is not distracted by other things. We don't have other products in the bag to take us off our efforts here. And so I think that ultimately allows us to control the narrative pretty substantially. The competition has portfolio of products to manage, and at any point in time, I'm sure they have other things to focus on. So, you know, I think that's allowed us to, you know, really own the voice in the marketplace, which has been helpful in a lot of ways because, you know, I do like to think that Dynavax has had an impact on driving awareness of the universal recommendation. So beyond just our product impact that it can deliver, I do think our effort and our existence in the space has helped get more people vaccinated. So that's another, you know, another thing we can hang our hat on. Yeah ... and be proud of. No, that's great. Maybe we can shift a little bit more to the pipeline and some of the development opportunities so we saw the release of the top-line results from part one of the phase 1/2 trial for Z-1018. Mm-hmm. You know, what are the most important takeaways from and for investors as you're coming out of that data release, that you'd like them to appreciate about the opportunity set? You know, we thought that was a very successful trial. We met our goals. The goals there were to basically establish the product profile that we believe will be competitive, and provide the right information to select the dose to advance into the next part of the study. So, just as a quick reminder, the goal of this product is to deliver a similar efficacy profile to the market-leading vaccine, right now, Shingrix, and do so with improvement in the tolerability profile. And so in this trial, what you'll see, and you've seen our press release, and will be supported by hopefully a publication or scientific conference, later in the year, is that the selected dose as well as the other doses generated similar immunogenicity as Shingrix as measured by the vaccine response rates for both antibodies and T cells. And it did so with improved tolerability in post-injection site reactions, both local and systemic. We would focus on moderate to severe post-injection site reactions. That's because those are both identified as having an impact or stopping you from daily activity. So we believe ultimately, that's the right measure to focus on. These severe adverse events that have an impact on your daily activity, we think is a good target to demonstrate an improved profile. So we think the data was quite positive. Very excited to move forward into this next stage of the program, where we will test the product in a group of patients that are over 70 years old, which will allow us to assess the vaccine response rate in a tougher population, compared again to Shingrix, in a trial that'll be about 300 subjects. So it'll have more statistical power than what we saw in this study, and that will be with our optimized dose. ... Got it. I mean, I know it's still early in the development pathway, still a lot to learn, but as you look outward toward more the commercial opportunity, you know, obviously, Shingrix has marketing capability and investment put behind that. Yeah. You know, is it really kind of the tolerability and some of the clinical profile elements that is gonna allow you to be successful commercially and differentiate from Shingrix and take some of that market share? Or can you just talk a little bit about, you know, what makes you think you can be successful in that environment? Yeah, I think generally there's room for competition in sort of any environment. I think the key is when you're dealing with an entrenched competitor, being really thoughtful about why you think you can actually break into that reality is important. You know, we never undertook this development effort with a me-too strategy because of that. We've always wanted to build best-in-class vaccines, and like we said, we expect to be comparable on efficacy. I don't think you can really improve on efficacy, but we do think there's reasonable room for improvement on tolerability. And that's enough, given the fact that this is pretty well known within the patient cohort that gets vaccinated. I think if you were to go talk to ten people who got a shingles vaccine, you're gonna get a few stories. Mm. And so there's a high awareness of this issue, and we think as long as we have a meaningful enough improvement. I mean, it has to be a clinically meaningful improvement. It just can't be a nominal improvement, and which was what we saw in our trial to date, that is a big enough tool to leverage with the patient population who have to elect to get this vaccine. So we do believe that tolerability offers us an ability to compete, especially given where the vaccine's administered, at least in the United States and internationally, every market's gonna have different competitive dynamics. But in the U.S. in particular, the retail setting is very focused on the patient. They wanna be able to have what the patient needs. You go to your retailer, and you have a script. What's the first thing? Is this in stock or is it not in stock? Can I service your need? Is the first thing, so if you have a patient group that comes in asking for something, the retailers will want to provide it. And so we do believe this is a unique opportunity for us to be able to create that demand from the patient perspective, that will then support a preferential position within the retail banners. And we've demonstrated the ability to compete in that setting already with HEPLISAV-B, so we do think there's a good opportunity to leverage the tolerability profile to the extent that you can also provide the same level of efficacy. Yep. That's great. Maybe shifting a little bit to, I know that there's a program coming right behind that, around plague vaccine, something that you're doing with the DoD. Haven't provided a lot of clarity around that, but I'm just curious, you know, how should investors think about the importance of that program to the overall equity narrative? Is this an example of something you can do more of with the DoD in terms of, you know, finding these important kind of countermeasure-type opportunities and being able to stockpile that? Or is this kind of a one-off opportunity that's more, you know, value-oriented within itself? Yeah, I mean, look, it's a great example of how we work to find value for Z-1018, to leverage the value of our adjuvant. And so in this case, it showed up with the opportunity to advance this into the plague vaccine, where the DoD had the antigen already, but it had a three-dose regimen that didn't have significant durability. So there's a desire to improve on that, which just goes back to our whole strategy on how we leverage this, and we found ways to be involved. It. In addition to that, it provides us an opportunity to continue to do meaningful R&D, provide profit and overhead offset through just the financial metrics of this relationship and build strong relationships within the USG as a good partner to help them achieve their goals with our adjuvant. So I do think there's a bigger story here than just, you know, what's the economics gonna be for the eventual plague vaccine, which could, you know, be a nice little piece of revenue in a book of business that allows us to generate profit and overhead offset during the course of this development program. But it also provides evidence of ways that we can leverage our collaborative approach to 1018 to drive value for that technology platform within the DoD or other collaborators, frankly. So, you know, it's both. But we do value the relationship with DoD, and we think it's, you know, it's been a very collaborative and high-value relationship for both parties. So we look to continue to find ways to work with the U.S. government as appropriate. Okay. And I know you have some other programs as well, Lyme disease. You just comment on, you know, some of the key highlights around the rest of the pipeline that investors should be aware of. I think the strategy to leverage known antigens where the biology for the antigen has already been established, that this is a good approach to be protective so that we can then leverage our adjuvant to deliver best-in-class products. I mean, that's the story that we've been managing here. So Lyme disease is another example of that, where we think the biological premise for the Lyme disease vaccine is sound. We think that there could be an opportunity to improve somewhat against some of the products in current late-stage development with our program. And so we have a non-human primate model that we're running now, which is gonna be very interesting, given that it's a challenge model. It'll allow us to establish, you know, the impact of the adjuvant against some of the competitor products that are in a later stage development now. So we think that could be another good opportunity commercially for us. Need to generate the data in the preclinical model first, but so far, you know, we generally have a good sense that our adjuvant will show up and perform. Now, we've just got to refine it in this model, so excited about that, and then our pandemic influenza program, I think a key point there is. This is a discrete R&D investment to run this one study, which will enable long-term BD investment to sell adjuvant as part of a pandemic preparedness or pandemic response globally, so this is not an ongoing R&D effort. This is a street investment in late 2025 and early 2026 or through 2026, that will then enable years of BD activity to be prepared for the next pandemic that could come whenever. So, you know, again, thoughtful deployment of capital to generate value or effort to generate value for the CpG 1018 platform. Great. Maybe switching a little bit to balance sheet, capital allocation. You know, strong balance sheet, you know, strong financial profile. You know, as you consider business development investments, you know, how do you think about leveraging the balance sheet and what your capacity is to really invest in other assets? Sure, so yeah, we would agree. It's our balance sheet and our capital structure are absolutely a strategic asset, and that's how we look at maintaining both elements of, you know, our financial profile from a balance sheet and a capital structure perspective. Our capital allocation priorities are predominantly focused on driving forward HEPLISAV-B, making sure we're doing everything we can to maximize the value of the product, driving growth importantly, and then also looking at ways to optimize profitability as appropriate. Also, we have exciting progress in our pipeline, which Ryan's highlighted. From an organic pipeline perspective, as it relates to capital allocation, what we're really looking to do here is advance those assets towards, you know, a point of value accretion, or like a clear inflection, where we believe that those programs can be valuable. Then, you know, constantly assess, are we the right owner of them? Should they be partnered? What's the right way to pull through those assets in order to maximize the value of those assets? We spend a lot of time debating all the variety of ways to do that as well, particularly as we approach important and meaningful value inflection points, like the one we have, for example, coming up in the second half of next year with shingles. Thirdly, we are always looking for opportunities to leverage our fully integrated and highly scalable and extremely capable organization through evaluating business development opportunities or corporate development opportunities. We continue to prioritize assets and opportunities that are de-risked from a clinical perspective, and, you know, ones where we believe we can leverage our infrastructure and our unique capabilities and our unique know-how to bring forward a real value creation potential for those assets. To the extent that, you know, all of the above, who have resulted in a, you know, balance sheet that has excess capital, I think we've already demonstrated also that we are more than willing to return capital to shareholders, should that be the right tactic to, you know, relative to everything else we have to deploy our cash to, in order to drive value. A very balanced approach overall, this- Yeah. Sort of in summary. Absolutely. So when you think about some of those BD opportunities and what could make sense, are you mainly focused on, you know, vaccine opportunities? Is it, are there things that you can-- outside of that, that you are focused on? Is it infectious disease focused? Like, really, how broad are you willing to go? Sure. So, so certainly, adult vaccines are middle of the fairway, but I also think that, and Ryan's commented on this, you know, throughout the last, you know, sort of year, year and a half, that we do have a very leverageable capability that can be deployed towards assets and other modalities outside of vaccines. Yeah, I think infectious diseases remains our scientific and clinical expertise, but we do have a very broad commercial footprint and broad strategic know-how within our organization that can be definitely reasonably deployed outside of vaccines. So we're being creative, but very prudent and thoughtful as well as we evaluate different corporate development ideas and targets. And you mentioned kind of returning capital to shareholders. You know, how much emphasis are you getting on that from investors, and really, how do you prioritize? You know, there's clearly BD opportunities out there. There's clearly a desire to grow. You know, how do you think about really kind of giving capital back when there's that opportunity set? Sure. So we get a lot of, I don't want to call it emphasis, I think curiosity in terms of wanting to understand how-- what our philosophy is with respect to returning capital to shareholders, and rightfully so. We've earned a very stable and, you know, financially sound, balance sheet and, you know, our deployment and our track record of deploying capital. While it has been very, you know, prudent and disciplined, I think for investors, making sure that they continue to understand what the forward looks like and what all the different opportunities to drive growth are, is really important. So, we-- listen, we certainly have a bias towards growing this organization and what we've built and where we've built excellence and expertise throughout the org. But we also appreciate that there comes a point in time, you know, sometimes, and it's a great tool in the toolkit to be able to return capital to shareholders when that, you know, when that circumstance arises. And we have very robust frameworks to go through that evaluation and, you know, sort of a real-time, you know, real-time basis. But I think, you know, to sort of summarize it, one thing that you can definitely expect from this management team is, you know, decisions that are not only strategic but also will be highly synergistic to the extent we do deploy capital to business development and, you know, certainly that we would hold as financially sound. Got it. Maybe we'll break here and see if there are any questions from the audience. If not, maybe if we could kind of summarize, you know, when you think about the value proposition and when you think about the unique position that you hold in the market, there's not a lot of companies that look like Dynavax. You know, what's the value proposition that investors should be focused on, that really kind of sets you apart as a good investment opportunity relative to some of the other things that are out there? Yeah, I mean, look, we're a little different than companies in our space. We take risk management very seriously, which is, you know, sometimes hard to do in clinical development. But if you look at the profile of the assets that we're advancing, and it's based off the technology that we're working with, that we have here with CpG 1018, as well as the late-stage focus of our company. We've been very thoughtful in how we built this business and what we're doing to generate growth and value creation with de-risked assets, both from one, how we manage stage gating of our R&D pipeline, but two, taking forward technologies where we know the biology works. That's inherently different than many, many, many other biotech objectives. We have an asset that has, at this point now, crested a very important milestone in the... You know, we expect to be over $300 million of revenue for this year. Specifically, our last earnings call, we had guidance at $315-$325 million. So it's a significant asset on a continued growth trajectory with a track record of delivering on the promises that we've made. You know, so we're on the right track there. It's gonna offer significant earnings. We've demonstrated sound financial management, and we have a pipeline of opportunities and additional ways to exploit the technology as well as our capabilities. This investment, in particular, gives you an opportunity to grow a growing revenue line and an opportunity to expand earnings while having the ability to also have clinical exposure to key portfolio assets, as well as the ability for us to leverage that more comprehensively through BD and corp dev, which I'd say a relatively well-managed downside risk exposure, given the way we run the business and the particular fundamentals of our business, which is somewhat unique for a biotech-type investment so of our size. Kind of proud of that fact, honestly, that we've been able to create that balancing act, and we look forward to continuing to run that strategy and cultivate additional investor interest. Great. Well, we really appreciate the insights on the business and for being here today. Thank you for sharing your time with us. Thank you so much.