DVAX - NASDAQ

Good day ladies and gentlemen and welcome to the Dynavax Technologies' First Quarter 2025 Financial Results Conference Call. As a reminder, this call is being recorded. At the end of the company's prepared remarks, we will open the call for questions and provide specific participation instructions at that time. I would now like to hand the call over to Paul Cox, Vice President, Investor Relations and Corporate Communications. You may now begin.

Thank you for participating in today's call. Joining me from Dynavax are Ryan Spencer, Chief Executive Officer; Donn Casale, Chief Commercial Officer; Rob Janssen, Chief Medical Officer and Kelly MacDonald, our Chief Financial Officer. Earlier today, Dynavax released financial results for the first quarter ended March 31, 2025. Copies of the press release and a supplementary slide presentation are available on Dynavax's website. Before we begin, I advise you that we will be making forward-looking statements today based on our current expectations and beliefs including but not limited to potential market sizes, market segmentation, effective marketing efforts, future expected market share and related growth rates and related ACIP recommendation impact on each. Financial guidance and trends including revenue, profitability, cash flow and sufficiency of current capitalization, timing and results of FDA submissions, clinical trial starts and data readouts, and potential future uses of or demand for our CpG-1018 adjuvant. These statements involve risks and uncertainties and our actual results may differ materially. These risks are summarized in today's press release and detailed in the Risk Factors section of our SEC filings, including today's quarterly report on Form 10-Q. Our forward-looking statements speak as of today and we undertake no obligation to update such statements. Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations on the Investors section of our corporate website at dynavax.com. And with that, I will now turn the call over to Ryan.

Thanks Paul. Thank you all for joining us this afternoon. 2025 is off to a strong start including delivering our highest ever first quarter net revenue for HEPLISAV-B of $65 million which was an increase of 36% compared to last year. We believe this performance early in the year puts us on track to achieve the top half of our full year HEPLISAV-B guidance range of net product sales between $305 million to $325 million dollars. We're also excited to advance our development pipeline which leverages our vaccine adjuvant technology CpG-1018. We have key clinical trial milestones this year for our shingles and plague vaccine programs while further broadening our pipeline with new programs announced today in pandemic Influenza and Lyme disease. All of our pipeline programs intentionally follow a similar philosophy of utilizing proven antigens and our CpG-1018 adjuvant, creating lower risk development pathways to advanced products with significant commercial potential. So let's start with our shingles program which is our most advanced clinical program. We see significant opportunity for a differentiated shingles vaccine which is currently a multibillion-dollar global annual market dominated by a single product. To be successful, a differentiated vaccine will require similar efficacy and meaningfully improved tolerability compared to the existing market leading product. As a reminder, we've already completed a dose ranging phase one study where we saw comparable immunogenicity and meaningfully lower rates of post injection reactions compared to Shingrix. For our ongoing Phase I/II study, we expect to report our top line readout for part one of the study in the third quarter which will be based on one month data following the last vaccine dose in the study for the 50- to 69-year-old patient cohort. Turning to our new pandemic influenza adjuvant program. Pandemic influenza remains one of the most persistent and unpredictable global health threats. Yet while vaccine adjuvants play an essential role in the pandemic response, the global supply of proven adjuvants remains limited compared to the global antigen production capacity. Our goal is to generate clinical proof of concept data for pandemic influenza vaccines using CpG-1018. We believe this is an attractive opportunity for us to leverage our expertise and capabilities as a supplier of CpG-1018 and five COVID-19 vaccines used around the world. We are on track to initiate a Phase I/II trial combining third party source flu antigen with CPG-1018 in the coming weeks. This data will allow us to begin business development efforts with global flu manufacturers, government and non-government organizations focused on supplying our adjuvants to support global pandemic preparedness and response. The second new program announced today is an investigational protein subunit vaccine for the prevention of Lyme disease which is a bacterial infection that is the most common vector borne illness in the Northern hemisphere. We see a unique opportunity for Dynavax to develop a best-in-class Lyme disease vaccine. The mechanism of action for Lyme disease vaccines is well understood in which high levels of antibodies are required for protection. Current vaccine candidates in late-stage clinical development require a challenging three to four dose series followed by annual boosters. A lyme disease vaccine adjuvanted to CPG-1018 offers the potential for a differentiated product requiring fewer doses or less frequent boosters. We are excited to progress this program into IND-enabling studies to generate preclinical proof of concept data in non-human primates, with plans to enter the clinic in 2027. Rob will speak in more detail about our clinical pipeline in a few minutes. We continue to focus on maintaining a disciplined approach to capital allocation, including executing on over 85% of our $200 million share repurchase program as of May 5, while evaluating external opportunities that leverage our unique business platform, including our fully integrated commercial stage infrastructure and capabilities to generate additional long-term growth for our shareholders. We are proud of the company we're building around our core assets of HEPLISAV-B and CpG-1018, which have together helped protect millions of people around the world. Our performance thus far sets us up for even greater success in 2025, which we expect to be a banner year for Dynavax. I look forward to providing you with updates on our progress along the way. Next, I'd like to turn the call over to Donn.

Thanks Ryan. At Dynavax, we are proud to be the leader in the U.S. Hepatitis C adult vaccine market. Since its launch in 2018, HEPLISAV-B has disrupted the market due to what we believe is a differentiated and best in class profile, securing its position as the market leader. In 2022, the ACIP universal recommendation transformed the U.S. adult hepatitis B vaccine market, expanding it into one of the largest addressable patient populations for vaccines in the U.S. The market continues to adopt these expanded guidelines with Q1 total market dose volume increasing approximately 16% year-over-year. HEPLISAV-B's strong performance in this expanding market has resulted in record first quarter performance, with net revenue of $65 million, a 36% year-over-year increase. This strong start to the year positions us well to achieve the top half of our annual revenue guidance range for 2025. The retail segment delivered strong year-over-year growth in the first quarter, with market volume increasing approximately 70% compared to Q1 2024. This strong momentum has carried into the second quarter with purchasing and utilization rates surpassing our expectations. Our commercial strategies are resonating with customers and adoption is steadily expanding across the market. We anticipate additional upside during Hepatitis Awareness Month in May as we activate targeted campaigns and collaborations to further accelerate hepatitis B vaccination. HEPLISAV-B's estimated U.S. market share rose to 43% in Q1, up from 41% in the same period last year. This growth was driven by broad based gains including consistent annual market share increases across all major retail customers. We expect to see similar year-over-year market share gains throughout the remainder of 2025, in line with our long-term expectations. Our positive outlook is supported by strong market growth in retail and other key customer segments where HEPLISAV-B holds a leading position. We are encouraged by the ongoing adoption of HEPLISAV-B. Our progress continues to track with our long-term outlook for HEPLISAV-B market opportunity in the U.S. which we expect to peak to over $900 million by 2030 with HEPLISAV-B capturing at least 60% market share. This long-term guidance reflects our expectation of double-digit annual growth in product net sales through 2030. We expect the HEPLISAV-B market opportunity to remain durable beyond 2030 driven by ongoing vaccination of the eligible adult population, observed revaccination practices by healthcare providers and continued market share gains. We are excited about the future for HEPLISAV-B. The strength we see across our business reinforces our belief in the long-term growth opportunity. The execution by our commercial team has been outstanding and the momentum we have built in the first quarter sets a strong foundation for continued success this year and beyond. I will now turn the call over to Rob to take you through our clinical pipeline.

Thank you, Donn. As Ryan summarized earlier, we're very pleased with how our clinical development pipeline continues to advance and expand as we focus on leveraging our core adjuvant technology to develop differentiated vaccines. Our internal R&D programs focus on well-established antigens in biology with clear regulatory pathways where CpG-1018 admin can provide a meaningful improvement. Additionally, we provide CpG-1018 to support external collaborations in a variety of programs. We believe this maximizes the opportunity for CpG-1018 to be utilized in novel vaccine development initiatives. Our Shingles Vaccine program we, previously reported results from our Phase I clinical trial evaluating our investigational shingles vaccine

Thank you, Rob. Before I get started, a reminder to please refer to our press release in Form 10-Q, filed earlier today for more detailed financial information. Financial highlights for the first quarter include HEPLISAV-B net sales of $65 million for the first quarter, up 36% year-over-year, and $68 million in total revenues up 34% year-over-year. Additionally, HEPLISAV-B gross margin was 79% for the first quarter of 2025, an increase compared to 77% in the first quarter of 2024. We continue to expect HEPLISAV-B gross margin of approximately 80% for full year 2025. Turning to expenses, R&D expenses were $19 million for the first quarter, up compared to $14 million in the first quarter last year. Looking ahead for R&D expenses as we continue to progress our clinical stage pipeline through key milestones in 2025, notably our Shingles data readout in Q3, our pandemic influenza clinical initiation in Q2, and our plague program Phase II initiation in Q3, we expect R&D expenses to increase by at least high teens as a percentage compared to 2024. If our Shingles program readout supports moving into part two of the Phase I/II trial, we would expect a further step up in R&D expenses in the second half of the year to reflect investments in launching that study. SG&A expenses were $48 million in the first quarter, up from $44 million in the first quarter of last year, with the increase primarily due to incremental proxy related expenses. Excluding any potential further proxy contest related costs. We expect SG&A expenses to be roughly flat in 2025, reflecting our ongoing commitment to disciplined expense management. During the first quarter we also recorded an allowance for doubtful accounts of $11 million relating to our legacy COVID-19 adjuvant commercial supply agreement with Clover Biopharmaceuticals. This bad debt expense reflects our assessment of heightened credit risk from Clover due to their recently reported liquidity position as of December 31, 2024. We expect to continue to pursue these amounts from Clover in connection with our agreement with CEPI, who as a reminder provided us with a fully forgivable funding to support this arrangement during the pandemic. Moving to the bottom line, we had GAAP net loss of $96 million for the first quarter of 2025 compared to GAAP net loss of $9 million for the first quarter of 2024. The net loss in the first quarter of 2025 was primarily due to the GAAP accounting treatment of our debt refinancing, which required us to recognize the one-time adjustment reflecting the difference between fair value and far value in connection with the extinguishment of our 2026 convertible notes. Lastly, on the P&L, non-GAAP adjusted EBITDA improved to negative $4 million for the first quarter compared to negative $7 million in the first quarter of last year. Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results and accompanying disclosure. Transitioning to the balance sheet we ended the first quarter with cash equivalents and marketable securities of $661 million compared to $714 million at the end of 2024. The decrease in our cash position reflects the continued execution of our stock repurchase program, which included aggressive execution in the open market during periods of significant market volatility during the quarter. To date, the company has repurchased over $172 million worth of common stock under the authorized $200 million share repurchase program or over 85% of the program executed, and we anticipate completing the remaining purchases by the end of the year. In March 2025, we opportunistically refinanced a majority of our outstanding 2026 convertible senior notes which extended the maturity date of most of our existing debt to mid-2030, also lowered our overall cost of capital with meaningfully improved terms, reduced basic and diluted shares outstanding and accelerated the execution of our share buyback program. Following this successful debt refinancing, we believe we have the right size capital structure to support our strategy to protect and deliver long-term value for shareholders. Turning to our financial guidance for the full year 2025, we reiterate our expectation of helpless SAV fee net product revenue to be in the range of $305 million to $325 million, representing 17% year-over-year growth at the midpoint. We do now expect to achieve the top half of that range due to our strong start to the year. We also reiterate our expectation for adjusted EBITDA to be at least $75 million, demonstrating our ability to grow adjusted EBITDA at more than two times the rate of product revenue and further strengthening our ability to deliver on our strategic priorities in 2025. In closing, we are very excited about our strong start to the year consisting of a record first quarter for HEPLISAV-B, our advancing pipeline with key milestones and new programs this year, and our strong financial profile with a balanced capital allocation strategies. We are very proud of this progress and we're also excited about our growth prospects as outlined on the call today. Thank you everyone for your time. Operator we would now like to open the Q&A portion of today's call.

Thank you. At this time, we will conduct the question-and-answer session. [Operator Instructions] Our first question comes from Matthew Phipps from William Blair. Your line is open.

Hi, good afternoon. Thanks for taking my questions and interesting to see the new programs announced, I guess first, just a quick question, talking about hitting the upper half of guidance. Why not officially raise the lower end of guidance then if confidence in that hitting that upper half?

Hey Matt, thanks for the question. At this point we're only one quarter through the year, so we think it's prudent to maintain our overall guidance range as our official guidance and just primary color that we have seen good progress to start the year off is the intention with the commentary around the upper half of the range.

Yeah. Okay. And maybe a higher picture question Ryan, there's obviously been some investor debates on the best path to long term value creation for Dynavax and wondering just particularly if you could share your view around kind of capital allocation and business development? Now that you're almost to the first shingles readout, you obviously had previously discontinued the TDAP program, but now announcing two new preclinical programs just, how do these all fit into the longer-term play and particularly around does this signal maybe less appetite for or less interest in a near term external business development bringing forward kind of two new preclinical programs?

Yeah, I mean look, I mean starting with the capital allocation philosophy, we've been pretty clear about our view that we have a balanced strategy and what underpins that is our desire to create value by leveraging our core assets as you kind of picked up on here Matt, with the pre-clinical programs focusing on leveraging 1018 and also fully leveraging our infrastructure and capabilities which plays into our commentary around value creation through corporate development focused on late stage commercial assets. So and then the sort of the third leg of that picture around our capital allocation strategy is to focus on our existing asset with HEPLISAV-B. And in addition, we also do look for opportunities, as you noted, as we noted with our share buyback program, to return capital to shareholders. So when we balance all these things out, we believe there's room, and we're actually quite proud of this fact that we've been able to return capital to shareholders while also creating enough room for us to advance our internal development programs. And we still believe there's an opportunity for us to identify high value assets to leverage our full commercial capability. So we're going to continue to run that strategy as we advance forward.

Thanks, Ryan. Okay, I'll hop back in the queue.

Thank you for your question. One moment please. Our next question comes from Philip Nadeau from TD Cowen. The floor is yours.

Good afternoon. Thanks for taking our questions. A couple from us too. First, on the quarterly performance, there definitely seemed to be less seasonality in the winter of '24 '25 than in the past. What are you seeing along those lines? Do you expect what we saw this year to be the new normal or was there anything special about this past winter?

Hey Phil, it's Donn. Yeah, thanks for the question. What we saw, particularly in retail, a pretty fast start with focus on non-flu vaccines, including hepatitis B vaccine this year versus in years past. So it was very purposeful by our leading retailers to really prioritize these kind of expanded vaccines for the first quarter. So that really contributed to the growth we saw in Q1. As I, as I mentioned, we saw 70% growth year-over-year in the retail segment alone. So that helped kind of flatten out that seasonality that we typically saw in years past.

Perfect. Then two questions on the pipeline. First on the upcoming Shingles data release, it sounds like, if I interpreted your prepared remarks correctly, that the data we get in Q3 will be informative but not necessarily sufficient to make a go no go decision. You're looking more for the more fulsome data releases, the longer-term data releases in 2026 to fully inform that decision, is that correct? That's the first question. And then second question, just more broadly, a lot of debate on what's happening in Washington with vaccines and the regulatory environment for those. Given that you're starting or talking about starting the development of two new programs, presumably you're having interactions with the FDA. Can you characterize those meetings and whether there's been any issues due to the changes at the FDA and HHS? Thanks.

All right, why don't I take the first one first, Phil. So, this readout is important, but I think you're highlighting the difference between sort of a stage development, decision making and then the ultimate decision making to move into a pivotal program. And so what you can pick up on our remarks today was trying to provide the right clarity for what this initial readout does and then what the longer-term projection is to have a fulsome package to make a decision to go into a pivotal program. So, the first readout this year is important. We need remember we're using our developed antigen here and we're using it to determine the optimized schedule and formulation. We still are going to be looking at that data to ensure that we're delivering a comparable vaccine response rate. And with that positive data that would unlock additional investment to advance CMC activities and clinical development into the next part of that study. So, I want to be very careful here. There is a decision to be made here based on the information like we've said in the past. What we've added to the discussion today is to help you understand the bigger picture and the longer-term decision and the data required to support what I think is the ultimate decision around moving forward into a pivotal study and that information we're going to require more information, including long term durability of the T cell response, which we've consistently highlighted the importance of, as well as a comparable vaccine response rate in the hardest to vaccinate population which is over 70 years old. We think this provides the most stringent analysis to provide confidence in advancing to a pivotal trial. So, there's multiple stage gates in the program ahead of us.

Got it. That is very helpful. And then any issues with your discussions with the FDA?

Yeah, yeah, so I'll comment generally and then Rob, if you have any specifics to add. But we actually find ourselves somewhat insulated for some of the immediate changes right now. If you think about the order of magnitude of our engagement, the next big engagement with the FDA will be end of Phase II on the shingles program and that'll be in the back half of '26. So I do think Dynavax is for whatever reason falling into a good spot there in that the near-term immediate kind of activities will have time to settle out by the time we're engaging with the agency and we're going to have the benefit of engaging with this agency before we embark on critical pivotal programs. As it relates to other, I'll call more operational activities, Rob, do you have any comments?

Yeah, just we haven't had a lot of interactions recently, but those interactions we've had with the review team really haven't been effective at this point.

That's helpful. Thanks for taking our questions.

Thank you for your question. One moment, please. Our next question comes from John Miller from Evercore. The line is open.

Hi guys. Congrats to progress. Thanks for taking my question. I'd love to follow up first on that FDA question. We recently heard that the agency is considering requiring placebo-controlled trials for all new vaccines. Do you think that's going to be relevant to your programs, which obviously are mostly designed head-to-head versus existing vaccines? And what do you think those comments are specifically referring to? And then secondly, on the Lyme vaccine, which I am personally very interested in, how do you conceive of the relevance of the commercial benefits you're going to provide relative to the competitive vaccines given? Pivotal trials from the competitors are coming end of this year and obviously they're well ahead. What do you think that market looks like by the time you're approaching commercialization?

Great. Thanks, John. Let me present framing comments on the FDA and placebo-controlled trials. And Rob, please feel free to jump in if there's more to add, but I think you have to go back to again our latest stage program is Shingles. And if you recall, some of our prior dialogue on shingles was the fact that we are proposing a placebo-controlled study, which was viewed to be a question mark. Will the agency accept it? Which we did get positive feedback prior to the change in the administration around the opportunity to have a placebo-controlled efficacy study for Shingrix -- for Shingles. So I think ultimately for that program there's really no change. It's supportive. We will also conduct a head-to-head study, but that's focused on tolerability and that's an endpoint that we're interested from a commercial labeling perspective. And we expect that would be supported as well. As it relates to additional programs in the future. It's too soon to tell. I think while there was remarks shared on the intention of placebo-controlled trials, I do think there's other elements of development that we have to consider, especially ethical concerns. And so, at this point we don't see it being a major challenge to any of our ongoing programs or future development. We might find ourselves in a situation where we're doing placebo-controlled arms as well as head-to-head arms to support labeling and competition and just figuring out the right balancing act between those. Rob, anything to add to that? Okay. And the Lyme disease product. I'm glad you mentioned this honestly, because while, you know, this is a very interesting evolution where the programs in late-stage development are going to be demonstrating the ability for circulating antibodies to provide a protective response, you have to go through quite a challenging dosing regimen which could significantly limit uptake in the marketplace. So we believe there's a couple elements of our program which is why we're so interested in advancing it. Not only do we believe we can establish the profile very early on in non-human primates to again provide a very valuable, very early-stage step to demonstrate some level of proof of concept, but additionally we believe the product profile would support taking a leading market share position, but also actually grow the market because it creates an opportunity for a regimental that is much more approachable for the population. So, you know, I think ultimately this is a perfect example of where having an adjuvant that is safe and well tolerated can be incredibly beneficial to augment a proven mechanism of action.

Do you guys expect there to be the current Phase IIIs to establish a reliable correlative protection and would you expect then to be able to move forward with that sort of an endpoint in your own program?

No, we're not expecting that. We'll have to see how data plays out over time. But I do think even without a correlative protection, I do think the ongoing data as well as our challenge work will provide an awareness of the level of antibodies needed to be effective or at least a threshold by which you would measure your early-stage studies with. Even though it might fall short of a regulatory approval correlate, I do think it will provide incredible information on being able to measure whether or not we're having a meaningful impact with fewer doses.

Ah, makes sense.

Thank you for your question. One moment please. Our last question comes from Roy Buchanan from Citizens. The floor is yours.

Hey, thanks for taking the questions. Just to make sure I'm clear on the Shingles readout next quarter. You guys have previously said, you know, 75% threshold, median CD4T cell level versus Shingrix. If you do not see that in the one-month data next quarter, are you going to stop the program or what's the thinking there?

Thanks for the question, Roy and Rob again, please comment. But Roy, as we've continued to evaluate the right way to think about the immunogenicity data to support the goal, really here, which is identifying how we compare to Shingrix from an efficacy perspective, we've continued to work with leaders in the space and review the scientific information available. And now you've heard by our comments today, T cell frequency is very important. However, we believe the best measure of that is not at one month but at six and 12 months where you have the opportunity to see the contraction of T cells back to a baseline level that's going to be maintained over time as opposed to the level of rapid expansion. And so, our current plan for this study is to focus on the vaccine response rate, including the CD4 vaccine response rate and frankly importantly, the CD4 vaccine response rate with ultimate T cell frequencies at one month being informative, but not as critical as six months and 12 months. Rob, do you have any other comments around the causes of expansion and contraction and why this is a.

So, Roy, you know CD4s expand very quickly after vaccination, but they also drop very quickly, especially over the first 12 months and then, and then the curve begins to flatten out over that period of time. An example is the Shingrix studies where CD4 counts dropped more than 50% over the first year and at that time the efficacy was 97%. Over a three-year period, they dropped two thirds. Efficacy only dropped 5%. So yeah, we're using CD4 frequency, but it's not a clear direct measure of what's happening with incidents. And it does drop fast. As I said, at 12 months it begins to stabilize and doesn't drop as fast. So, we think a 12-month measurement of CD4 frequency is probably more informative than the one month.

Okay, great, that's very helpful, thanks. And then a couple on Heplisav. Investors have said that the total market share is paused. Maybe it's paused, maybe it's growing less quickly, but either way is there an explanation for the potentially slower growth? It's definitely slower than the growth you've seen in previous quarters. Is GSK pushing back anything there? Then how much of HEPLISAV-B revenue is due to Medicare? Thanks.

Hey Roy, it's Donn. Regarding market share, obviously, when we think about market share year-over-year comparisons are most appropriate given the seasonality of hefty market versus say a quarter-over-quarter assessment of market share. We continue to expect year-over-year growth every quarter in 2025 we're on track exactly how we had planned for market share growth that supports not only 2025 but our long-term view of achieving at least 60% market share. And part of that's due on the back of retail pharmacy. That's going to be the fastest growing segment where we have very high market share and continue to increase that market share. So, we feel very comfortable and very proud where we're at with market share. I continue to expect that market share gain year-over-year.

Don maybe I'll just add to, I mean that's exactly the right answer that the year-over-year comparison. Roy, just to give you some context, why the quarterly we don't do the quarterly comparison when we have different channels and different customers where we have different levels of share. And when we see the channel mix change quarter-over-quarter, for example retail drop in Q1 compared to Q4 where we have very high share, it impacts the overall share for that quarter when lower share parts of the market are more static. And so, we've said this for the last, I don't know how many years, the quarterly fluctuation due to channel mix changes or one off procurement dynamics in the beginning or end of a quarter are not appropriate comparisons and we're going to continue to stand by that. But we are excited when we look at the annual growth each quarter. So happy to continue to show those kinds of details as we progress and for these things that aren't necessarily intuitive. But we do want to continue to draw the comparison to the prior quarter for the same period in the prior year. And then regarding Medicare, it is an important part of the market. Retailers are very excited about having access now to HEPLISAV as well as all Hepatitis B vaccines. It will take some time as it relates to Medicare access through Medicare Advantage plans. We anticipate probably the second half of the year there'll be open access for all HEP B vaccines, including HEPLISAV-B. And so, we're continuing to work with our retailers around prioritizing patients, appropriate patients within the Medicare segment. But it will be an important part of our growth strategy. And the good news, obviously retail is a big part of that where we have a very strong footprint and engagement strategy.

Got it. Thank you.

Thank you for your question. We have no further questions at this time. I would now like to turn the call over to Ryan Spencer, CEO for closing remarks. You may begin.

Thank you, Operator, and thank you all for joining us today. We appreciate your interest in Dynavax. We're excited about our recent accomplishments and the strength of our position. We look forward to updating you on the progress and focused on protecting the world against infectious diseases. Operator, you may end the call.