Dynavax at William Blair Conference: Strategic Growth Insights

On Tuesday, 03 June 2025, Dynavax Technologies Corporation (NASDAQ:DVAX) presented at the 45th Annual William Blair Growth Stock Conference. CEO Ryan Spencer outlined the company’s strategic initiatives, highlighting both opportunities and challenges. The focus was on leveraging Dynavax’s core technology, the CpG 1018 adjuvant, and expanding the market share of HEPLISAV B, their adult hepatitis B vaccine. Financial strength and strategic growth were underscored, alongside expected challenges in market penetration.

Key Takeaways

• Dynavax aims to capture over 60% of the U.S. hepatitis B vaccine market, valued at potentially $900 million by 2030.
• The company maintains a strong financial position with over $660 million in cash as of Q1.
• 2025 revenue guidance for HEPLISAV B is set at $305 million to $325 million, trending towards the higher end.
• A $200 million share buyback program has been 85% completed.
• Ongoing vaccine development includes shingles, plague, pandemic influenza, and Lyme disease programs.

Financial Results

Dynavax reported a robust financial position with a Q1 cash balance exceeding $660 million. The company reiterated its 2025 revenue guidance for HEPLISAV B at $305 million to $325 million, expecting results towards the upper range. Adjusted EBITDA is projected to surpass $75 million. The capital allocation strategy remains focused on expanding HEPLISAV B, advancing the pipeline, acquiring late-stage assets, and returning capital to shareholders, evidenced by a nearly completed $200 million share buyback program.

Operational Updates

The company’s strategic priorities include increasing HEPLISAV B’s U.S. market share, currently over 58% in retail settings and over 50% in prioritized clinics. Growth is driven by enhanced vaccine coverage rates and increased access through retail pharmacies post-COVID. Dynavax is also advancing its clinical pipeline with over 15 ongoing collaborations, targeting late-stage vaccine acquisitions and synergistic products.

Future Outlook

Dynavax’s future outlook is positive, with strategic initiatives aimed at expanding market share and advancing its vaccine portfolio. The shingles vaccine program is in Phase 1/2, with promising initial results. A plague vaccine program, funded by the Department of Defense, is set to enter Phase 2. The pandemic influenza program leverages past experience with CpG 1018 and aims to enhance global vaccination capacity by 2026. A preclinical Lyme disease program is underway, with clinical trials expected in 2027.

Q&A Highlights

During the Q&A session, CEO Ryan Spencer emphasized the company’s long-term goal to achieve over 60% market share in the U.S. hepatitis B vaccine market, projected to exceed $900 million by 2030. He highlighted the company’s past success during the COVID-19 pandemic, where CpG 1018 generated $950 million in revenue across five vaccine programs. Spencer expressed pride in the company’s accomplishments and optimism for 2025 as a pivotal year for growth and asset expansion.

For more detailed insights, readers are encouraged to refer to the full transcript below.

Full transcript - 45th Annual William Blair Growth Stock Conference:

Matt, Analyst, William Blair: Analyst here at William Blair. Thank you all for coming, part of our forty fifth Annual Growth Stock Conference. Happy to introduce Dynavax and Ryan Spencer, CEO. We’re 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. And with that, I’ll turn it over to Ryan.

Ryan Spencer, CEO, Dynavax: 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 10 Q 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, so let’s start with a little bit of background of Dynavax, who we are, what we do. So 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 ten eighteen 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 leveraged 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-nineteen plus our commercial success with HEPLISAV have led us to have a very strong financial position, closing Q1 with just over $660,000,000 in cash and cash equivalents, representing a very strong financial profile that supports the continued progress against our corporate strategy. So just pausing a moment to introduce the adjuvant more completely. CpG ten eighteen adjuvant is a unique adjuvant. There’s only a handful of adjuvants approved in or that are used in approved vaccines in The United States. CpG Ten Eighteen 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, so it has a very specific mechanism of action. And 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. So 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 $900,000,000 in The US 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 and D strategy as well as collaborations. To date we have, or currently we have over 15 ongoing preclinical and clinical collaborations leveraging CPG ten eighteen. And 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. So 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 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. So 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. And 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. And importantly, we have in our last earnings call reiterated our guidance for 2025 of 03/2005 to $325,000,000 of revenue for HEPLISAV B in The US with current expectations trending towards the top half of that range. 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 $615,000,000 in The US. That’s actually up from $5.25 the year before that, which is up from $400,000,000 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 $900,000,000 by 02/1930, and we believe there’s a long term, a 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 $900,000,000, 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.

It 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 in 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 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. So 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. And we are focusing our development efforts on well established antigens with known biology and clear regulatory pathways. In addition, as I mentioned, we’re open to clinical and preclinical collaborations for those who would like to use the adjuvant for other ideas leveraging their core competencies.

So our first program that I’ll talk about here today is our shingles program. This is our latest stage program that we control. I’ll talk about our plague program second. But 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.

So you see very high level of post injection site reactions, both local and systemic. One of the hallmarks of CpG ten eighteen 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. And so we’re developing the program through 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’m 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, and on the left side of the chart we had very low or lower post injection site reactions, both local and systemic. So this is sort of the profile of the product that we’re looking to develop. Now the next study that we’re advancing currently is with our own Dynavax developed antigen. So 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 top line data will be in Q3.

That will let us 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. So 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 twelve months to demonstrate durability of the antibody response and the CD4 T cell response, and that data will also be available at the same time as the one month data from the seventy plus extension study.

So a fairly well designed and laid out set of information to support our advancement into phase three at the end of twenty twenty six. Second program we’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 DoD.

We have the most recent updated contract is for $30,000,000 and that runs through the middle of twenty twenty seven. 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-nineteen pandemic. As a reminder, during the COVID-nineteen pandemic, we supplied CPG ten eighteen to five different vaccine programs globally and generated $950,000,000 of top line revenue.

And these programs were mostly focused on the developing world or sort of non US, non European endeavors. This is an important element because while, especially for pandemic flu, while there’s a tremendous amount of antigen capacity, there’s actually a limit of adjuvant capacity for the global populations. US and Europe is pretty well satisfied as far as preexisting contracts and relationship with adjuvant manufacturers, but the global populations are not. And so through this study, we look to demonstrate significant dose sparing of flu antigen, which is very important in a pandemic setting because the less antigen you need, the more patients can be rapidly vaccinated with the available capacity. And this is a tried and true strategy for pandemic preparedness.

So we are conducting this study which we will have a couple different parts and should be completed in 2026. And 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 ten eighteen. And then 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 vector borne infection 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.

It’s a lot of doses. We believe that ten eighteen 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 nonhuman primate study as part of IND enabling activities but also to demonstrate the product profile. So we kicked off a long term nonhuman primate study where we’ll be able to assess the ability to generate higher antibodies against Lyme disease in the nonhuman primate model as well as challenge to demonstrate some level of efficacy with our antigens. So 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.

And then 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 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, and then 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 $200,000,000 share buyback program. And as we reported in our Q1 earnings call, we had at that time completed 85 of that program.

So 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, are HEPLISAV b, our CPG ten eighteen 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, provided product revenue guidance of $3.00 5 to $325,000,000. In 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. And we have adjusted EBITDA guidance, which excludes stock based compensation of over $75,000,000 for the year. So we’re really proud of the company we’re building around our core assets.

We’ve delivered success from this business as we focus on our vaccine business for both patients and investors over the years. The products, it’s 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’s allowed us to return capital to shareholders. So 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 has done along the way. So with that, I thank you guys for joining us. We look forward to providing you updates as we progress throughout the year.

Thanks.

Matt, Analyst, William Blair: Thanks Ryan, I appreciate the time. There’ll be a breakout session in Burnham B I believe, So, wants to follow us over there. Thank you.

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