Analyst here at William Blair. Thank you all for coming. Part of our 45th annual Growth Stock Conference, happy to introduce Dynavax and Ryan Spencer, the CEO. He's going to talk a little bit about the continued growth of Heplisav. It's been becoming a great business for the company and also, I think, a little bit of expansion opportunities that they're evaluating. Please visit williamblair.com for any and all disclosures. With that, I'll turn it over to Ryan. Thanks, Matt, and thank you all. Hi, I'm Ryan Spencer, the CEO of Dynavax. Thank you for joining us today. Before I begin, I'd like to recognize that the presentation contains forward-looking statements that have certain risks and uncertainties that are highlighted in our risk factors in our Form 10Q and SEC filings, which we encourage you to review. The webcast will also include discussion of certain non-GAAP information. You can find a copy of this presentation, including relevant non-GAAP reconciliations, on the investors section of our corporate website at dynavax.com. All right, let's start with a little bit of background of Dynavax, who we are, what we do. We're a commercial-stage biopharmaceutical company focused on developing novel vaccines to protect the world against infectious disease by leveraging our core technology, which is our CpG 1018 adjuvant. The adjuvant has led us down the path of developing our lead asset, our commercial asset, Heplisav-B, which is an adult hepatitis B vaccine approved in the United States, Europe, and Great Britain. Additionally, we leverage the adjuvant to advance our clinical development pipeline, our early-stage programs, as well as a number of preclinical and clinical collaborations. Success with the adjuvant collaborations through COVID-19, plus our commercial success with Heplisav-B, have led us to have a very strong financial position, closing Q1 with just over $660 million in cash and cash equivalents, representing a very strong financial profile that supports the continued progress against our corporate strategy. Just pausing a moment to introduce the adjuvant more completely. CpG 1018 adjuvant is a unique adjuvant. There is only a handful of adjuvants approved in, or that are used in approved vaccines in the United States. CpG 1018 is one of them. It has a well-understood mechanism of action using our toll-like receptor biology, basically stimulating TLR9 on plasmacytoid dendritic cells. It has a very specific mechanism of action. Its clinically proven profile in Heplisav, as well as our COVID collaborations, plus additional work we've done clinically, demonstrates the ability to generate an improved immune response while doing so with less reactogenicity that is typically seen with adjuvanted vaccines. While our business is focused on leveraging the value of the adjuvant, we have three core strategic priorities. The first and foremost being continuing to advance Heplisav-B, its growth in the US market. We have continued to have great sales year- over- year, and we have a long-term projection of being able to achieve over 60% market share in a market that we believe has the ability to grow to over $900 million in the U.S. alone. Beyond Heplisav-B, and I'll get into all of these in a bit more detail here in a second, our clinical pipeline continues to advance. This is a core priority for us to drive the value of the adjuvant through internal development efforts, following a fairly defined R&D strategy, as well as collaborations. To date, we have, or currently we have, over 15 ongoing preclinical and clinical collaborations leveraging CpG 1018. Additionally, the third strategic priority is to leverage our capabilities as a fully integrated commercial company where we manufacture and sell Heplisav-B, to create opportunity to leverage that strength in other products by looking for late-stage vaccines or highly synergistic adjacent products that we can commercialize. Let's start with a little more detail on Heplisav-B. Heplisav-B is a two-dose product delivered over one month, which, that's a pretty big difference than the competitive products, which are three doses over six months. Now, with fewer doses, Heplisav also provides higher levels of seroprotection compared to the competitive vaccines. Not only do you have the benefit of compliance, you actually have higher levels of protection with fewer doses. It's very important because that third dose actually has very low compliance, which has a major impact on overall protection. Hepatitis B is a deadly virus, and it's not curable, but it can be prevented. Completion of the vaccine regimen is critical to generating confident protection. This gives Heplisav-B's profile an edge in the marketplace. That is sort of proven here by the slide you see, the chart you see here on the right, showing our continued growth of revenue since 2020 with a 65% CAGR through 2024. Importantly, we have, in our last earnings call, reiterated our guidance for 2025 of $305-$325 million of revenue for Heplisav-B in the U.S., with current expectations trending towards the top half of that range. I'm very excited about the progress we've made with Heplisav, as well as the value that it'll continue to drive into the future. Here we're showing a view of how we expect the market to develop. You can see the market in 2024 is estimated to be about $615 million in the U.S. That's actually up from $525 million the year before that, which is up from $400 million historically prior to the universal recommendation for all adults to be vaccinated. We believe there's room to continue to drive market growth through continued expansion of the vaccine coverage rates, based on the universal recommendation. We expect the market to peak somewhere around, over $900 million by 2030. We believe there's a long-term, highly valuable market, although declining eventually as we penetrate that cohort. Additional market share and continued penetration provides a very valuable asset over a long period of time. Our commercial efforts are focused on areas of specific areas of growth. As you can see here, we expect the market to continue to grow, as we mentioned, to $900 million, but also the channel mix is expected to change. Growth is likely to come from the prioritized clinics, which are our traditional largest health systems, as well as retail pharmacy. As you can see, we expect the retail pharmacy channel to drive a majority of the growth. This is as a result of the capabilities built, as well as the access hurdles that were removed as a result of the COVID pandemic, provides an opportunity for retail pharmacies to drive significant vaccination in the adult setting. We happen to be very well positioned in retail pharmacy, as you note here on the slide, over 58% market share through Q1 in the retail setting and over 50% share in the prioritized IDN and clinics. This is where we focus most of our effort, and we intend to expand both total product utilization as well as market share in these two key segments over time. Now, turning to our vaccine development portfolio, we've taken a very clear, specific strategy for internally developed and funded programs. Our adjuvant is a proven technology. We know it generates an immune response, and that is what we're trying to leverage. Our development programs that I'll walk through in a minute here share a commonality, and that is they're utilizing well-established antigens. That's the other part of a vaccine that's specific to the disease or bacteria. We are focusing our development efforts on well-established antigens with known biology and clear regulatory pathways. In addition, as I mentioned, we are open to clinical and preclinical collaborations for those who would like to use the adjuvant for other ideas, leveraging their core competencies. Our first program that I will talk about here today is our Shingles program. This is our latest-stage program that we control. I will talk about our plague program second. Our Shingles program is focused on driving an improved tolerability response for Shingles vaccine. The current market leader is a highly efficacious product. However, it has a challenging tolerability profile. You see very high level of post-injection site reactions, both local and systemic. One of the hallmarks of CpG 1018 is its ability to deliver, as I mentioned earlier, an improved immune response while also doing it with a relatively favorable tolerability profile, as evidenced in Heplisav-B. If we had a challenging tolerability profile, I do not believe Heplisav-B would be a market-leading vaccine. We are developing the program through a phase one two study currently. As a reminder, we did conduct a previous phase one study where we studied our adjuvant with a known, available, GE protein and generated the results I am showing you here. The key point being that compared to Shingrix, the active comparator and the market-leading product, we had high vaccine response rates. On the left side of the chart, we had very low or lower post-injection site reactions, both local and systemic. This is sort of the profile of the product that we are looking to develop. The next study that we are advancing currently is with our own Dynavax-developed antigen. In this study, we're evaluating the antigen across three different doses and a couple different dosing schedules to evaluate, to determine the best regimen and dose to move forward into part two of the study. We expect part one will read out here in Q3. That will let us, you know, know if we, with our antigen, delivered similar results to what we showed previously in the phase one. And we'll unlock the next stage of development, which will be advancing to part two, which is a study in patients over 70 years of age. This is an important study because we know that it's harder to vaccinate and generate an immune response in the older population, which gives us a better opportunity to compare the ability for our vaccine to match Shingrix in this population while delivering the tolerability profile that we think is critical to have a market-leading and competitive vaccine. What you should be able to expect is in the near-term data on subjects in the phase part one of the study, and then clarity on timelines for data from part two, which will be the data package that will support eventual phase three development. Importantly, we'll also continue to follow the patients from part one for six and 12 months to demonstrate durability of the antibody response and the CD4 T-cell response. That data will also be available at the same time as the one-month data from the 70-plus extension study. A fairly well-designed and laid out set of information to support our advancement into phase three at the end of 2026. Second program I'll talk about here is our plague vaccine program. This is a collaboration with the Department of Defense. The goal is to build a plague vaccine that provides durable antibodies with as few doses as possible, and our adjuvant provides an opportunity to support both of those goals. This program is funded completely by the Department of Defense. We have the most recent updated contract is for $30 million, and that runs through the middle of 2027. We will be kicking off a phase two study in the second half of this year for this program. We recently also introduced two early-stage programs. Our pandemic influenza program is a very unique program designed to leverage the strengths that we built coming out of the COVID-19 pandemic. As a reminder, during the COVID-19 pandemic, we supplied CpG 1018 to five different vaccine programs globally and generated $950 million of top-line revenue. These programs were mostly focused on the developing world or sort of non-U.S., non-European endeavors. This is an important element because, especially for pandemic flu, while there is a tremendous amount of antigen capacity, there is actually a limit of adjuvant capacity for the global populations. U.S. and Europe are pretty well satisfied as far as pre-existing contracts and relationships with adjuvant manufacturers, but the global populations are not. Through this study, we look to demonstrate significant dose sparing of flu antigen, which is very important in a pandemic setting because the fewer, the less antigen you need, the more patients can be rapidly vaccinated with the available capacity. This is a tried-and-true strategy for pandemic preparedness. We are conducting this study, which will have a couple different parts and should be completed in 2026. Through this effort, we will begin business development activities with non-government agencies, governments, and flu manufacturers to help build global pandemic preparedness and response using CpG 1018. The second program that we introduced recently is our preclinical program for Lyme disease. Lyme disease is a bacterial infection, a vector-borne bacterial infection, which is the most common bacterial or vector-borne infection in the United States, in the northern hemisphere. The current products that are in late-stage development have a very challenging dosing regimen with three to four doses, required over a fairly long period of time, likely followed by annual boosters. So it's a lot of doses. We believe that 1018 has, could have the opportunity to reduce the initial regimen as well as extend the duration between booster doses. And so we have the unique opportunity here to conduct a non-human primate study as part of IND enabling activities, but also to demonstrate the product profile. We're in the, we kicked off a long-term non-human primate study where we'll be able to assess the ability to generate higher antibodies against Lyme disease in the non-human primate model, as well as challenge to demonstrate some level of efficacy with our antigens. This is a very unique opportunity to establish a product profile early on in the development cycle, before advancing into clinical trials, which we would expect to begin in 2027. Moving to some of our financial highlights, we have a capital allocation strategy that follows our core strategic principles, obviously, focusing first and foremost on Heplisav-B, ensuring we have the right capital position to advance, to advance our development pipeline, our internal development pipeline, based on continuing to be successful with the data readouts as they mature. We also focused on, as I said before, accessing late-stage assets to leverage our full capabilities. Finally, also being open to and evaluating return of excess capital through share repurchase programs, which I can remind you all, we've already taken the first step in that process. Late last year, we initiated a $200 million share buyback program. As we reported in our Q1 earnings call, we had at that time completed 85% of that program. We believe this balanced capital allocation strategy serves us very well to be able to continue to focus on driving long-term value for our shareholders through fully leveraging the value of our assets, which are Heplisav-B, our CpG 1018 adjuvant, as well as our capability as a fully integrated, successful manufacturer and commercializing entity for Heplisav-B. For 2025, we did, as I mentioned already, provide product revenue guidance of $305 million-$325 million. At our last earnings call, we reiterated that guidance and provided commentary that, based on the early trend, we believe we're trending towards the top half of that range for this year. We have adjusted EBITDA guidance, which excludes stock-based compensation of over $75 million for the year. We are really proud of the company we are building around our core assets. We have delivered success from this business as we focus on our vaccine business for both patients and investors over the years. The products, it is very exciting, frankly, to have been able to advance the business to a point where we continue to have revenue growth with Heplisav, making that a profitable product, have the ability to put a very reasonable set of high-value development targets into the clinic, while also maintaining a financial position that has allowed us to return capital to shareholders. Very proud of what the company's accomplished over the last few years and believe that 2025 is a very important year in our evolution for us to continue to expand on the assets we have available, and the tremendous work that this company's done along the way. With that, I thank you guys for joining us. We look forward to providing you updates as we progress throughout the year. Thanks. Thanks, Ryan. I appreciate the time. There'll be a breakout session in Burnham B, I believe, if everyone wants to follow us over there. Thank you.
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