Good morning, everyone. Thank you for joining us for the next session of the Barclays Healthcare Conference on the Spec Pharma track. My name is Balaji Prasad. I'm the Senior Analyst for the Specialty Pharmaceutical sector. Delighted to have with us Ryan Spencer, the CEO of Dynavax, with us. Ryan, thank you so much for joining us and welcome to the conference. Thank you very much for having me. Yeah. Ryan, you recently reported Q4 results. Can you maybe just as a prelude to our discussions, walk us through the key points and highlights and what's been the focus of these results, especially from an investor perspective? How to dig into some of these? Sure. Yeah, we again, thank you for having us at your conference. Appreciate the chance to talk. We recently reported our Q4 earnings, or the full-year earnings, where we had, again, demonstrated really solid top-line revenue growth, reporting $268 million of total revenue, product revenue for Heplisav-B, which is, you know, another year of great progress. As part of this, you know, long-term view of the world, we're really excited about the opportunity to continue to focus on our mission to help protect the world against infectious diseases through our novel adjuvant technology, which is the backbone for our emerging pipeline. In addition to our product revenue for Heplisav, we've also shared continued focus on growth with projection of overall revenue for next year for product revenue of $305-$325 million, as well as continued growth and demonstrated $75 million of adjusted EBITDA for 2025. Pretty excited for not only our earnings and progress in Q4, but what we have looking forward into 2025. Great. Thank you for that, Ryan. As you think about your mission to protect the population, I do want to take that and discuss a broader level overarching question around vaccines, companies, and all. Clearly, there have been some issues that have been weighing on the vaccine space in general. I would love to get your thoughts around the new administration, its policies on vaccines, and how do you see the risk to vaccine recommendations, if any, to development, to public perception of vaccines? Kind of touching on a lot of things there, but I think it's important to address that. Yeah. It's a common question. I think it's top of mind to everybody. I, you know, the reality is we can only focus on the things that we know and what we know. And I probably should have mentioned in our opening remarks. Mm-hmm. Our core asset or our lead asset is an adult hepatitis B vaccine. We know that there's no cure for hepatitis B, but you can prevent it with effective vaccination. Yeah. We know that vaccines are one of the biggest and most valuable medical advancements for prevention in human history, really. We also are very confident in the data that we generated to support our approval. We know the importance of eliminating hepatitis B as a public health threat. We believe all of these things will continue to support our progress against our goals. With that, you know, we're pretty confident around the value of vaccines in general, as well as specifically, you know, how excited we are to continue to grow and penetrate the adult market with our adult hepatitis B vaccine. Got it. Do you think that you'll need to articulate this message, or the company needs to get the message out there, and if you're doing anything towards that? Yeah. We can, I mean, constantly. I mean, we have executed very well commercially, and we continue to drive the market growth, which we've been doing since the ACIP approved the, Mm-hmm. Broad recommendation back in 2022. Continued penetration of market share, as well as driving the growth. Independent of administration changes, we do not see that trajectory changing. Got it. I mean, touching upon the core asset, Heplisav. Clearly, it's done very well over the last few years. You recently mentioned that you expect the market, the hepatitis B vaccines market, to continue to expand to a peak of over $900 million by 2030. Within that, of course, Heplisav would have at least 60% of market share over the time. Help us better understand the key dynamics driving this expansion and also your own confidence in reaching this goal of 60% market share within this growing market. Yeah. We're pretty confident. The items that are driving it really, it starts with the ACIP recommended. Mm-hmm. That all adults, who have not been previously vaccinated should get vaccinated against Hep B. This was back in 2022. This was, 18- to 60-year-olds, as well as a permissive recommendation for those over 60 with risk factors. That fundamentally changed the hepatitis B market. That is the opportunity for growth, as you noted in our long-term guidances, over $900 million by 2030. We believe we can achieve a 60% market share in that setting. You know, the key drivers of that growth really are two major main market segments, which is. Mm-hmm. The retail pharmacy, which has seen significant growth for our product, but for its capabilities overall, since the pandemic, as well as integrated delivery networks, where we see continued consolidation of healthcare services. Those two markets, we believe, are the main growth drivers, given this, the institutional nature and the systems they have available to continue to identify patients that are appropriate for vaccination. We believe those markets will continue to grow and ultimately, by 2030, be approximately 70% of the overall adult hepatitis B vaccine market. The fact that we're able to target those markets very efficiently and effectively with our field sales team, as well as, like I said, the supportive recommendation by the ACIP, gives us confidence that we can drive the growth as well as continue to drive that meaningful market share growth. Got it. For those not familiar with the narrative, can you help us understand how IDNs, or integrated delivery networks, help you achieve that goal and what you need to do to tap into the potential there? Yeah. One, so again, IDN versus retail pharmacy, integrated delivery networks operate with a lot of systems. They have, there's a lot of systems overarching that versus independent clinics. Now, independent clinics also, you know, if it's a very large clinic, it could be a call point. The reality is the majority of large clinics are part of the integrated delivery networks. Sure. It provides an opportunity for us to leverage system-level information sharing and organization. Mm-hmm. to help, again, like I said, identify appropriate patients, whether it's through effective utilization of electronic medical records or health systems that can influence care all the way down to the provider level, formulating decisions, appropriate contracting, and things like that to allow us to really just leverage the institution and the one control where available, but also the institution's ability to share knowledge down to their providers. We believe that's a critical piece to help drive this growth. Got it. Maybe on the market itself, can you help remind us what proportion of the key eligible populations within these adult segments are vaxxed already? As we discussed about these longer-term goals, how much market penetration are you assuming in these, in these, long-term patterns? Adult Hep B has a relatively low vaccine coverage rate. Mm-hmm. Given the prior recommendation was a risk-based recommendation. We are seeing expansion of those coverage rates. The reality is there's about 130 million adults that were recommended for vaccination that were not previously vaccinated. Mm-hmm. Out of the adult market. That is in that 18 to 60-year-old bucket. There is even more when you go 60-plus. It is a pretty large number of people that need to still be vaccinated. It is one of the highest recommended, largest recommended population. Sure. Within the adult vaccine market, kind of behind flu and COVID, but higher than even pneumococcal, given the relatively low vaccine coverage rates. We look at analog products to project reasonable coverage rates that support our long-term projections. Again, we're pretty confident that we have the right dynamics in place to drive those long-term projections. Notably, just this year, actually, Medicare added hepatitis B to the roster billing for retail pharmacies. Now Medicare patients can receive hepatitis B vaccine in the retail setting, just like they can for pneumococcal and flu. Previously, prior to January 1, that was not paid for by Medicare. Twinrix was utilized in that setting, and that was reimbursed under pharmacy services. Now, all monovalent adult Hep B products can be utilized there as well, which provides a great opportunity for Dynavax to leverage its capabilities and infrastructure to drive utilization in that setting for Medicare patients. Additionally, recently, Hep B was added as a HEDIS measure, which is very important for overall IDNs. Mm-hmm. HEDIS is a nationally recognized quality measure. Many IDNs build process and protocols around these quality measures to, you know, demonstrate appropriate care for their patients. We see that as another lever, basically highlighting the importance of Hep B prevention to these systems. This all kind of helps us build our confidence around being able to penetrate that large unvaccinated population. Got it. Maybe a final question around this. I think you recently mentioned that you received FDA feedback regarding a potential to conduct a real-world evidence study to support, sBLEON5. Can you walk us through the journey for this expansion up until now, and what are the next steps, and how significant would an expansion to the hemodialysis segment be? Sure. As we had ran a clinical trial in this population and submitted it to the agency to kind of update our label for the hemodialysis population using a four-dose regimen. Mm-hmm. Of Heplisav, we received a CRL on that initial filing and have been working with the agency since to respond with, you know, our goal is to run a retrospective study. There has been utilization of Heplisav in the dialysis segment utilizing a four-dose regimen. Mm-hmm. This provides a unique opportunity to look at real-world evidence comparing patient populations prior to adopting Heplisav-B and then post, post-adoption. We are working with the agency on the suitability of that database to generate a clinical, a retrospective trial that would be label-enabling. Right now, we are in the process of working with the agency on that. Mm-hmm. To make sure the database is suitable and that we can align on a protocol that would achieve our goal of getting this important information into our label. There is already utilization, as I mentioned, in dialysis that we don't actively promote to that segment, but they can, you know, they can choose to use the product. We do expect with the label update, we will continue to be able to expand market share in that important setting. Got it. Shifting towards the pipeline side of things, I mean, a couple of programs there, the shingles vaccine. I know we are expecting top-line data in 3Q 2025. Help us understand the opportunity for this program and how excited are you about it? Yeah. It's a great opportunity. Currently, you know, shingles product is a multi-billion-dollar market. Mm-hmm. With one real player globally. We see this as a very unique opportunity. The value in the product that's on the market is basically an adjuvant and a protein, which is a very reasonable approach for us, given that our core technology is an adjuvant. One of the hallmarks of our adjuvant is very favorable tolerability. Mm-hmm. Across all the clinical trials that we've conducted, evidenced by Heplisav even. You know, we wouldn't have the success we have with Heplisav if the product was very reactogenic. We believe there's a great opportunity to improve on the existing vaccine, which has a fairly reactogenic profile driving, Okay. You know, high levels of adverse local and systemic adverse events. Ultimately, we believe there's an opportunity to have a product that can improve the tolerability profile, meet the current product where it is on efficacy, to really make an impact on this patient population. Understood. When we see the top-line data towards, in the second half of this year, and if the data looks supportive of a commercially differentiated profile, how quickly can you advance this to a late stage? From there, how long would development take place for we to see this as a commercial launch? Right. Where we are right now is we conducted a phase I study a couple of years ago. We're doing a phase I/II now to select the final adjuvant formulation as well as the concentration of antigen in the product. Mm-hmm. That trial we noted will read out in Q3, the first part of that trial. And so once we have that information, that will actually unlock further development for our 70-year-old plus extension study, as well as an opportunity to engage with regulators. Mm-hmm. and business development partners to determine, you know, with regulators, the long-term plan and the final clinical trial design. The data from the 70-plus extension study will be a great, it, it'll, it's a phase two extension, essentially using the finalized dose and regimen. That's really the key next step in the program. Got it. What do you expect to see in the top line that will potentially help you position this as a possible best-in-class product? Yeah. We believe the key there is no correlate. This is an important element. Mm-hmm. We're running an immunogenicity study. Sure. There's no correlate for efficacy, like we had with Heplisav-B. The proof of concept study that we're running now is really focused on immunogenicity, as well as the tolerability profile. Mm-hmm. What we'll be looking at, we've already demonstrated a very tolerable profile in our last study, as well as good immunogenicity. What we'll be looking at in this study is both antibody responses and CD4-positive T-cell responses. We believe the CD4-positive T-cell responses are critical to demonstrating, you know, a likelihood of efficacy. Mm-hmm. Having the Shingrix product as a head-to-head comparison in the study will be very helpful. Got it. We'll look to that. We'll look forward to it. Maybe shifting from shingles towards the plague vaccine program, walk us through the opportunity for this program and the recent developments. What are the recent developments being, and, more importantly, key upcoming milestones for this? The plague program is a program that's fully partnered with the Department of Defense to develop a improved, really, plague vaccine using our adjuvant. The concept for this program would be to support stockpile for Department of Defense. Mm-hmm. To protect against a bio threat for pneumonic plague, basically. Sure. If we can develop a vaccine that would protect our troops, that would be very useful in certain scenarios. We have conducted a phase two study previously, and based on some of the data that we had there, the DOD decided to extend the program to conduct another phase two study. We will be working on that. That actually came with a $30 million contract. Mm-hmm. That runs, we signed at the very end of last year, and it runs until the first part of 2027. Got it. Maybe a quick, some, comments around the balance sheet side of things and your capital allocation. Remind us currently of your balance sheet strength. Also, I know that you recently started your $200 million share repurchase program in November. How is the program likely to evolve in 2025? What are your goals with this capital allocation program? Yeah. The balance sheet, we ended the year at $714 million. You already noted the $200 million share buyback, which the end-of-year number actually included the first $100 million of that share buyback. Mm-hmm. That was already accounted for there, and the balance sheet's very healthy. Our capital allocation strategy continues to be one that's balanced, focused first on Heplisav, making sure we're allocating appropriate capital and focusing attention. Sure. To that key asset. Next are organic R&D pipeline, which, as we already talked about, is kind of led by our shingles advancement, as well as some other plague and some other preclinical efforts. Then continuing to focus capital allocation on, again, as you noted, the share buyback, completing the share buyback. Mm-hmm. As well as, supporting our pursuit for external, inorganic opportunities to leverage our fully integrated commercial capabilities for late-stage, infectious disease assets. Got it. Maybe I'll just pick up on the last part of your capital allocation priority. In terms of BD, again, can you give us more color around the kind of assets that you're looking for, commercial or just close to commercial stage assets? What kind of areas? And what is your comfort level in terms of the ticket size that you're comfortable with? Sure. I mean, like I've said before, I think we've been pretty clear about we believe that the company's demonstrated significant capability from a commercial execution and strategy perspective. Additionally, we have a fully integrated organization around regulatory, clinical development. We manufacture our own products, so high-quality manufacturing, consistent high-quality manufacturing. This all plays into demonstrating our late-stage capabilities on the back of a commercial company platform. We believe that provides an opportunity for us to leverage that with, again, a focus on late-stage assets in the infectious disease area. Obviously, adult vaccines is ideal. Sure. We also recognize that, you know, what we've demonstrated and learned as from our experience with Heplisav can be applied to other, niche infectious disease opportunities as well. As far as price tag, I mean, that depends on the underlying asset to the extent it has any sort of execution risk in. Mm-hmm. Regulatory or clinical development. That's very different than an on-market product, depending on the current size of the product. We really can't comment on specifics, but, you know, we've always been fairly disciplined here. We have a very, very high bar for something that we would consider being accretive that makes sense for us. And so we, you know, we're judicious in how we approach those activities and those opportunities, recognizing that we're very confident with the risk profile of the company currently, and we want to strengthen that, and not weaken it through excessively. Sure. Aggressive corporate development. Great. Thank you. You went through most of our questions there, Ryan. Very helpful. Would you want to leave with some closing comments for, for? Always, always. Any chance to add more. Mm-hmm. I was pretty light on my opening comments, so I'll be a little heavier on my closing comments. Obviously, the company has, in my view, done a really good job growing into our vaccine focus. The way we've, the current activities to leverage our adjuvant, with very reasonable and valuable R&D efforts, our balanced capital allocation strategy, continuing to run this organization with tremendous financial discipline while creating opportunities for long-term growth, beyond just what our current, you know, very successful and continuing to grow asset in Heplisav is. We really feel confident that the company is well-positioned to run this balanced approach to growing our business inorganically and organically. I think we're capitalized to do it. I think the team is built and ready to go. It's a pretty exciting time for Dynavax. I see 2025 as being a transformational year for us. Thank you for giving us a chance to share our story. Of course. Fantastic. Thank you for attending our conference, and I wish you a very productive conference, Ryan. Thank you. Look forward to hearing more of your progress. Thank you.