Q3 2025 Dynavax Technologies Corp Earnings Call

Speaker #2: Good day , ladies and gentlemen , and welcome to the Dynavax Technologies . Third quarter 2020 Financial Results conference call . As a reminder , this call is being recorded .

Speaker #2: At the end of the company's prepared remarks , we will open the call for questions and provide specific participation instructions . At that time .

Speaker #2: I would now like to turn the call over to Paul Cox Vice President , Investor Relations and Corporate Communications . You may begin .

Speaker #3: Thank you for participating in today's call . Joining me from Dynavax or Ryan Spencer . Chief Executive Officer Donn Casale . Chief Commercial Officer , Robert Janssen .

Speaker #3: Chief Medical Officer and Kelly MacDonald . Our Chief Financial officer . Earlier today , Dynavax released financial results for the third quarter ended September 30th , 2025 .

Speaker #3: Copies of the press release and a supplementary slide presentation are available on Dynavax 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 .

Speaker #3: Impact on each financial guidance and trends , including revenue , profitability , cash flow , and sufficiency of current capitalization , timing and results of FDA submissions .

Speaker #3: Clinical trial starts in data readouts . Potential future uses of or demand for our CPG 1018 adjuvant . Success of our strategic arrangements , including our license agreement with Vaxart and anticipated benefits of our capital allocation strategy in general , including our share repurchase program , our earnings press release and this call will include discussion of certain non-GAAP information .

Speaker #3: You can find our earnings press release , including relevant non-GAAP reconciliations on the investor section of our corporate website at DYNAVAX TECHNOLOGIES CORP .

Speaker #3: And with that , I will now turn the call over to Ryan .

Speaker #4: Thanks , Paul , and thank you all for joining us . This afternoon . I'm excited to review the progress and accomplishments that we've made this quarter .

Speaker #4: We've executed across all areas of our business , including driving another quarter of top line growth and market share expansion for Heplisav-b creating momentum across multiple programs in our clinical stage , pipeline .

Speaker #4: The execution of a strategic deal to access a phase two b Covid 19 oral vaccine candidate from Vaxart , adding another near-term clinical catalyst in an area of high unmet need to our pipeline .

Speaker #4: And lastly , the authorization of a new $100 million share repurchase plan in connection with further clarity on our corporate progress and capital needs .

Speaker #4: This progress is underpinned by our continued commercial execution . With $90 million in net product revenue this quarter from Heplisav-b , representing a 13% increase year over year .

Speaker #4: While also further strengthening its leading market share position in the US . Adult hepatitis B vaccine market , advancing and remains a key focus for the organization , and we are excited to continue to grow the brand and we remain on track to achieve our long term goal of at least 60% total market share in the US by 2030 .

Speaker #4: We've made meaningful progress this quarter , advancing our internal pipeline candidates towards key value inflecting milestones . We are excited to progress our shingles vaccine program into part two of the phase one two study focused on adults aged 70 years and older , which recently began enrolling and dosing .

Speaker #4: We look forward to sharing top line immunogenicity and safety results from part two and the 12 month follow up data from part one .

Speaker #4: In the second half of 2026 . We believe this data set is an important milestone and will provide the opportunity to explore strategic partnerships to realize the global value of this vaccine candidate .

Speaker #4: In addition to shingles . We've made continued advancements across the rest of our pipeline , including a new Department of Defense award for our plague vaccine candidate and the completion of part one of our phase one two study in pandemic flu .

Speaker #4: Rob will discuss the pipeline updates in more detail later on in the call . Beyond our operational success , we are also strategically deploying capital to expand our long term growth opportunities .

Speaker #4: Earlier today , we announced an exclusive license agreement for Vaxart's novel oral Covid 19 vaccine program . The program has enrolled over 5400 subjects and is currently in an ongoing phase two B safety and efficacy study comparing the vaccine candidate to an FDA approved mRNA vaccine .

Speaker #4: Covid 19 remains a significant and ongoing public health challenge in the United States , causing widespread , severe illness . Hundreds of thousands of hospitalizations and tens of thousands of deaths each year .

Speaker #4: Despite the availability of vaccines , millions of adults at increased risk of severe disease remain unprotected , underscoring the continued need for innovation and better options for Covid 19 prevention .

Speaker #4: We're excited to work with Vaxart to advance this potentially transformative vaccine candidate. The Vaxart oral COVID-19 vaccine candidate has the potential to provide improved protection through intestinal delivery, providing both systemic and mucosal immunity through a differentiated mechanism of action.

Speaker #4: Compared to the currently available vaccines . The head to head study is designed to show improvement over an existing mRNA vaccine , providing meaningful data to support disruption of the current vaccine market .

Speaker #4: If successful, this transaction brings a novel vaccine program with high potential upside into our pipeline that will fully leverage our experience in late-stage development and commercialization.

Speaker #4: Importantly , the deal was structured to provide clear de-risking steps before significant future spend on phase three development . Vaxart will continue to run the ongoing study , and we will have the right , but not the obligation , to proceed with development following our review of the phase two B data and end of phase two regulatory feedback , Vaxart expects topline data to be available by the end of 2026 , with the end of phase two meeting occurring thereafter .

Speaker #4: In addition to deploying capital to support long term growth opportunities , we also plan to return capital to shareholders through a new $100 million share repurchase program .

Speaker #4: Reflecting our confidence in the company's long term growth and commitment to enhancing shareholder value . I'm very pleased with how we are executing on our strategic initiatives .

Speaker #4: 2025 continues to be a banner year for Dynavax , and we are excited about how we are setting up 2026 and beyond to drive long term shareholder value through the strength of our base business and multiple opportunities in our pipeline .

Speaker #4: Now , I'd like to turn the call over to Don .

Speaker #5: Thank you . Ryan . I'm excited to walk you through Heplisav-b strong commercial performance and continued progress during the third quarter . The adult hepatitis B market continues to expand under the ACIp Universal recommendation , supported by a large catch up cohort of more than 100 million unprotected adults , we believe Heplisav-b is uniquely positioned to capture this growth driven by its differentiated clinical profile and our proven track record of commercial execution .

Speaker #5: For the third quarter , Heplisav-b generated approximately $90 million in net product revenue . Our estimated US adult hepatitis B vaccine market share reached 46% , up from 44% in the prior year period .

Speaker #5: Within the retail segment , market share grew to 63% , compared with 59% in Q3 last year , highlighting continued expansion in this critical growth segment .

Speaker #5: On a trailing 12 month basis , Heplisav-b achieved 45% total market share , including 59% in retail and 51% in the IDN segment .

Speaker #5: During the quarter . We continued to see strong progress across our two prioritized segments retail and IDN . As we've shared previously , we expect retail to become the dominant channel for adult hepatitis B vaccination by 2030 , representing at least half of all doses administered .

Speaker #5: Vaccines remain a strategic priority for our retail partners, who continue to expand their immunization infrastructure and capabilities to reach more adults and drive growth in adult vaccination. In parallel, we've increased our marketing investments and field sales team support to drive greater provider awareness and consumer activation.

Speaker #5: Together , these efforts position heplisav-b for continued growth and further market share gains . In this critical segment . Across Idns , adoption remained steady as Heplisav-b continues to become embedded within preventative care and employee health programs , with continued disciplined execution and the benefit of the universal adult recommendation .

Speaker #5: We anticipate consistent , recurring volume and steady share gains in this segment . Looking ahead , we're encouraged by the momentum underway , particularly in the retail segment .

Speaker #5: Retail chains continue to leverage flu visits to recommend adult immunizations , including hepatitis B , the later start , and potentially extended flu season this year creates additional opportunities to identify more adults eligible for Heplisav-b , supported by increased retail utilization and ongoing institutional demand .

Speaker #5: We anticipate a strong close to the year and remain confident in achieving our full year 2025 guidance . Our performance continues to track with our long term outlook for Heplisav-b , and we expect the overall market to peak at more than $900 million in the US by 2030 , with Heplisav-b achieving at least 60% market share this long term view reflects our expectation of double digit annual growth and net product sales through 2030 .

Speaker #5: Supported by expanding retail adoption . Sustained ID and performance , and growing awareness of the ACIp . Universal recommendation . In summary , the third quarter demonstrated the strength of our commercial strategy and execution , delivering $90 million in net product revenue and 46% share in total market .

Speaker #5: Our highest market share to date . I want to thank the entire commercial team and the broader Dynavax organization for their continued focus , commitment and execution .

Speaker #5: These results demonstrate that our plan is working and that we are well positioned to drive long term growth . With that , I'll turn the call over to Rob for a pipeline update .

Speaker #6: Thank you . Don . We continue to make consistent progress across our pipeline portfolio , beginning with Z10 , 18 for shingles . We recently had a late breaker oral presentation at Idweek 2025 .

Speaker #6: We presented the previously disclosed part one data from our Z 1018 Phase 1/2 clinical trial. In addition, we presented new data.

Speaker #6: It showed that Z 1018 induced a high proportion of polyfunctional CD4 positive T cell responses exhibiting multiple GE specific activation markers . These results , which were comparable to Shingrix , support the quality and breadth of the Z10 18 cellular immune response .

Speaker #6: Also, we were pleased to report that we've initiated part two of the study in adults 70 years of age and older—a key patient population that's at the highest risk for shingles.

Speaker #6: We anticipate reporting top line part one long term follow up results and part two immunogenicity and safety data . In the second half of 2026 .

Speaker #6: Beyond shingles , our plague vaccine program , which is fully funded by the Department of Defense , is progressing . We were awarded $14 million of additional funding to support nonhuman primate studies .

Speaker #6: We also initiated and completed enrollment in part one of the ongoing Phase 2 trial. Additionally, we recently completed part one of the Pandemic Influenza Adjuvant programs.

Speaker #6: Phase one two study . Based on data from part one that demonstrated high levels of seroconversion and seroprotection and multiple dose levels and regimens were advancing selected optimal formulations of flu antigens and CPG 1018 to advance to part two of the phase one two trial .

Speaker #6: We expect top line immunogenicity and safety data in 2026 . Lastly , with regard to our supplemental Bla for Heplisav-b in adults on hemodialysis , we've continued to engage the FDA to finalize the study protocol needed to support the Bla filing .

Speaker #6: The Sbla filing , we will provide an update once a conclusion has been reached . I'll now turn the call over to Kelly for a review of our financial results .

Speaker #7: Thank you . Rob . Before I get started , a reminder to please refer to our press release in form 10-q filed earlier today .

Speaker #7: For more detailed financial information and for a full reconciliation of GAAP to non-GAAP results and accompanying disclosure . As others have highlighted , Dynavax delivered another strong quarter reflecting sound execution across all aspects of our business .

Speaker #7: We continued to drive commercial growth , advance our pipeline , manage expenses with discipline , execute against our financial guidance , and strategically deploy capital to expand our late stage pipeline , all while maintaining a strong balance sheet .

Speaker #7: We are pleased with the momentum of Heplisav-b with quarterly net sales of approximately $90 million , up 13% year over year , and approximately $95 million in total revenues , up 18% year over year .

Speaker #7: Additionally , Heplisav-b gross margin was 84% and in line with our expectation for Heplisav-b gross margin in the low 80s percent for the year .

Speaker #7: Turning to expenses , quarterly R&D expense was $19 million , up from $14 million in the third quarter last year , reflecting pipeline advancement , most notably , our shingles program and our DoD funded plague program .

Speaker #7: As Rob highlighted , looking forward , we expect R&D expenses to steadily increase through 2026 . In connection with the advancement of our mid to late stage clinical assets , inclusive of our recent deal with Vaxart .

Speaker #7: These anticipated increases in investment are aligned with our expectation to deliver critical value inflection catalysts . In the second half of 2026 . Transitioning to SG&A expenses , we deploy a highly disciplined approach with approximately $40 million in quarterly expenses focused on high ROI investments that drive top line growth and support our core business .

Speaker #7: Accordingly , we reiterate our expectations for SG&A expenses to be consistent with prior year , excluding proxy contest related costs incurred during the first half of this year .

Speaker #7: This prudent management of our line reflects our ongoing commitment to financial discipline as the organization matures , moving to the bottom line . We added GAAP net income of $27 million for the third quarter of 2025 , compared to GAAP net income of $18 million in the third quarter of 2020 .

Speaker #7: For . Additionally , non-GAAP adjusted EBITDA improved to $36 million for the third quarter compared to $25 million in the third quarter of last year .

Speaker #7: Transitioning to the balance sheet , we ended the third quarter with cash and equivalents of $648 million , compared to $714 million at the end of 2020 .

Speaker #7: The decrease in our cash position was primarily driven by the successful execution of our previous $200 million share repurchase program, which was completed earlier this year and retired approximately 17 million shares.

Speaker #7: With continued clarity and advancement across all aspects of our business, I'm pleased to share that our Board of Directors authorized a new $100 million share repurchase program, reinforcing our commitment to utilizing share repurchase tactics when we believe they are the best use of capital.

Speaker #7: We expect the program to be executed within the next 12 months , and it will bring our total capital return to shareholders to $300 million .

Speaker #7: For context , this cumulative capital return represents approximately 25% of our current market capitalization . We believe this balanced approach reflects our confidence in the company's long term growth and commitment to enhancing shareholder value .

Speaker #7: Lastly , and in line with our stated strategy and commitment to deploying capital towards late stage , highly synergistic assets , we entered into a strategic license agreement with Vaxart for its novel oral Covid 19 vaccine program .

Speaker #7: This agreement gives us the exclusive opportunity , but not the obligation , to add the oral vaccine program into our late stage pipeline .

Speaker #7: After seeing the phase two B data readout anticipated in late 2026 . As Ryan highlighted , we have structured this deal in a financially disciplined way with $25 million upfront license payment and future license payments to be made only after results from the phase two B data and regulatory feedback from a subsequent end of phase two meeting with the FDA .

Speaker #7: If we elect to assume responsibility of the program after phase two B data package . Vaxxer is eligible for an additional $50 million payment , as well as potential regulatory approval and commercial milestone payments and royalties on future net sales .

Speaker #7: Turning to our financial guidance for the full year 2025, we reiterate our expectations for Heplisav-B net product revenue to be in the range of $315 million to $325 million. We now expect to achieve adjusted EBITDA of at least $80 million for the year, excluding certain non-recurring expenses.

Speaker #7: Baxter transaction related expenses and stock based compensation . Noting that this is an improvement compared to our prior guidance of adjusted EBITDA of at least $75 million .

Speaker #7: In closing , we are very excited about the continued strength of Heplisav-b coupled with our advancing pipeline with key upcoming milestones in the second half of 2026 .

Speaker #7: From a capital allocation perspective , we are very pleased to authorize another share repurchase program and to deploy capital strategically towards our vaccine license agreement for a highly novel late stage Covid 19 adult vaccine candidate .

Speaker #7: We continue to believe in our balanced capital allocation strategy , investing in innovative growth opportunities while also returning capital to shareholders as appropriate .

Speaker #7: We believe this approach positions Dynavax to deliver long term value and sustainable growth . Thank you everyone for your time . Operator we would now like to open the Q&A portion of today's call .

Speaker #2: Thank you . At this time , we will conduct the question and answer session . To ask a question , you will need to press star one one on your telephone and wait for your name to be announced .

Speaker #2: To withdraw your question , please press star one one again . Please stand by while we compile the Q&A roster . Our first question comes from the line of Matthew Phipps with William Blair .

Speaker #2: Your line is now open .

Speaker #8: Hi . Good afternoon . Thanks for taking my questions . I guess just curious why license a Covid vaccine today ? Do you think success was an oral option ?

Speaker #8: Can return the overall market to growth , particularly with more stringent recent labeling ? And then also , it looks like this trial was originally planned , enrolled 10,000 patients .

Speaker #8: There was obviously some broader issues . So I guess what kind of powering the trial have at 5400 patients . And can you give us a sense of what you need to see to be confident in opting in ?

Speaker #8: I mean , is just trying to see superiority or just , you know , similar efficacy , better tolerability . Just curious what what it is you hope to achieve here .

Speaker #4: Sure , Matt . Thank you . Okay . So let's just take those one at a time . Why now in this market ?

Speaker #4: The reality is this is a very strategic opportunity for us . For a product that fits our capability very well . And the market dynamics that you kind of highlighted to , I think , sort of answer the other part of the question on what we need to see .

Speaker #4: So I'll get to that in a second . But we do believe that an improved vaccine , both with delivery mechanisms but also with underlying efficacy , has the option opportunity to help grow the market .

Speaker #4: And there's lots of room for market growth in Covid compared to other vaccines like flu , that are given annually . We do believe there's opportunities to grow that market over over the long term with improved options .

Speaker #4: And as it relates to the study size , the power of the study was an important consideration . The reality is the study was originally powered with assumptions around the amount of disease that is seen annually , and what we've seen through a number of sources and evidence is that the actual amount of disease is much higher than that , meaning that even though the study is now powered at 5000 subjects or over 5000 subjects , it's adequately powered to demonstrate an improvement over the comparator mRNA vaccine , which is the going to the final question is what would we like to see ?

Speaker #4: We'd like to see just that , that this is an improved option , leveraging the different MOA against the mRNA comparator . And there's there's lots of room for improvement within Covid vaccines .

Speaker #4: We know now that current options , Wayne , very rapidly over the first six month period . And we believe there's room for reduction of symptomatic infection as well as reduction of hospitalizations or severe disease over a longer period of time .

Speaker #4: So we believe the novel mechanism of action and intestinal or mucosal delivery has a real opportunity of making a major difference that can help patients , but also transform the market .

Speaker #8: Thanks , Ryan . I got one quick follow up . By the end of next year , now you'll have kind of full phase two data from the shingles program .

Speaker #8: And you know , this this chance to opt into this , I guess . Do you feel like you are in a position to be able to do registrational studies for both of these , for shingles program and the oral Covid 19 pill ?

Speaker #8: You know , same time , if it ends up both working out to move both forward . You guys have the capacity and everything to do that .

Speaker #4: Yes , we do , Matt , but it's they won't . Obviously they have different readouts of different of different natures . And there's other elements of speed and timing as you move from phase two to phase three .

Speaker #4: And so we will pay attention to the staging of those activities so that we can execute appropriately . But we do believe that we both are capitalized and competent in that way .

Speaker #4: And we can manage the staging of the activities with required , obviously , organizational growth in order to execute those things . But we believe we could or will be well positioned to execute on all of our R&D initiatives .

Speaker #8: Okay , thanks for taking my questions .

Speaker #4: Thank you .

Speaker #2: Thank you . Our next question comes from the line of Phil Nadeau with TD Cohen . Your line is now open .

Speaker #9: Good afternoon . Thanks for taking our questions . A couple from us . First a follow up to Matt's question in terms of what you need to see to advance .

Speaker #9: It sounds like you're saying you won't opt in unless there is something superior about the oral vaccine versus the mRNA vaccine . So non-inferior with oral deliveries not enough .

Speaker #9: Is that fair ? And then second , can you give us some sense of the cost of development for this program ? Should you opt in ?

Speaker #9: How much would that change your profitability profile? And then last question is on Heplisav, actually seasonality. It does seem like guidance is suggesting that there will be a reduction in revenue in Q4 due to seasonality.

Speaker #9: Just want to get your thoughts on how dramatic the seasonality is that you're seeing so far this year. Thanks.

Speaker #4: Great . So going back to what we need to see , the trial is designed to show an improvement . Head to head against an mRNA vaccine .

Speaker #4: So, I mean, that's obviously what we're focused on. There's also other measures beyond just symptomatic COVID-19 that would provide evidence of potential differences.

Speaker #4: So we're going to have to look at the full data package . But the goal is to is to drive a better option forward .

Speaker #4: The the secondary endpoints could be meaningful as well . But like , you know , the intention here is to have a an improved product .

Speaker #4: That's what our goal is as it relates to the overall cost . Kelly , why don't you take that as far as helping , you know , provide some insight as to how we're thinking about this at this stage ?

Speaker #7: Sure . So we would we would expect to have to run for registration purposes , a placebo controlled efficacy study , as you would expect .

Speaker #7: And , you know , so of course , that will come with a very reasonable and potentially pretty hefty price tag . However , as we reflect on our profitability profile with continued growth and progress in Heplisav-b and our stated intention to to seek strategic partners to maximize the value of shingles , especially outside of the US , we'll look forward to continuing to manage our path to profitability despite having , you know , progress , meaningful progress in phase three , Registrational studies to support the Vaxart candidate .

Speaker #4: And then, Don, would you mind handling those questions on seasonality and impact?

Speaker #5: Sure . Yeah . Phil , thanks for the question . I think regarding seasonality , I mean , you're always going to have the holidays , right , as it relates to the fourth quarter .

Speaker #5: So we've got a , you know , put that into consideration . There's always the holidays , which does slow down some demand .

Speaker #5: But what we are seeing certainly , and I've communicated this in the past , is that , you know , vaccines and hepatitis vaccine , hepatitis B vaccine continues to become a priority in the retail segment .

Speaker #5: And so as we continue to move forward , we're going to start to see we believe stronger fourth quarters as retail continues to grow and expand within .

Speaker #5: Adult immunizations , specifically hepatitis B , but there's always the holidays . So I think from the standpoint we will see some seasonality , you probably seen some of that data already with some of the pull .

Speaker #5: But I think , you know , again , it's going to be a quarter where as hep B grows and grows in the retail segment , it continue to smooth out .

Speaker #9: That's very helpful . Thanks for taking our questions .

Speaker #4: Thanks so .

Speaker #2: Thank you. Our next question comes from the line of John Miller with Evercore ISI. Your line is now open.

Speaker #10: Hi , guys . Thanks for taking my questions . Congrats to the progress . I'll start with the Vaxart deal as well . In their first gen Covid vaccine , they did show a lot of mucosal IGA responses .

Speaker #10: Hi , guys . Thanks for taking my questions . Congrats to the progress . I'll start with the Vaxart deal as well . In their

Speaker #10: Have you seen to suggest that you're getting strong serum immunity as well as mucosal immunity? And will we expect to be seeing more durable serum immunity than mRNA?

Speaker #10: In addition to durability on the mucosal side ?

Speaker #4: Yeah . So I don't want to comment on any data that they've generated or haven't generated or haven't shared , John . But I think your point or your question , we can comment on , you know , they they had their first gen product .

Speaker #4: There's also the use of a second-generation construct here, which has demonstrated improved immunogenicity in their norovirus trial. We believe that this is a very meaningful improvement that will translate to COVID as well.

Speaker #4: But you know this is a mucosal delivered vaccine that does have the unique benefit of both systemic and mucosal immunity , although it is not necessarily expected to generate the same level of systemic immunity in IgG , as you referred to , necessarily as injectable vaccines .

Speaker #4: So , you know , I think the reality is we you need to have the efficacy study for a product like this , which is why we think this is such a unique opportunity to opt in to something of this nature prior to having the efficacy studies .

Speaker #4: You're it's you do not have the right level of insight into how effective the mucosal approach will be , and that cannot be measured until we have an efficacy study .

Speaker #4: There's no correlates or other or other measures that can can help you understand that . And so , you know , I think ultimately this is the trial we need to and we need to see how both of those things balance out in the efficacy result , which is why this is such an important study .

Speaker #10: And I guess you just to follow up on an earlier question , you know , you're saying that you think the reduced study size is more than sufficient to show a benefit .

Speaker #10: I understand that , but can you speak to the reason the study was limited in terms of its size ? There does seem to have been a board issue .

Speaker #10: There was a stop work order given by the government , given that this government program , at least primarily historically , do you expect that that current shutdown , the current attitude of the administration is going to cause issues for further development beyond the existing study ?

Speaker #4: So I think you'd have to go back to the Vaxart disclosures . It'd be a good thing to reference , but the the the reduction in trial size was a blanket decision related to any trials using mRNA or stopped .

Speaker #4: And so the but but as part of that , to follow up to your other question , and again I would like to refer you to the Vaxart disclosures based on their communications with Barda for the definitive answer here .

Speaker #4: But but to summarize , they Bartow has been very clear that they are continuing to fund the the patients that were enrolled in the study at that point of that decision to stop utilizing mRNA in clinical development .

Speaker #4: So I think , you know , the reality is it's they continue to have that support from Barda based on their public disclosures .

Speaker #4: And so we should be we're excited to see the results in these 5400 people . Like and like I said , while it started at 10,000 , the amount of disease that's seen in .

Speaker #4: Just seen overall, it indicates that it would be well powered at 55,400.

Speaker #10: Understood . Thank you .

Speaker #2: Thank you . Our next question comes from the line of Karishma Rajaram with Goldman Sachs . Your line is now open .

Speaker #11: Oh , hi . It's actually Paul Choi with Goldman Sachs . Thanks for taking the question . I want to ask on the Heplisav market outlook over the longer term , you guys are having nice performance in the IDN and retail channels , but your overall share is has been relatively steady at 45% .

Speaker #11: But you're targeting 60% share by 2030 . Can you maybe you know you know , tell us how confident you're feeling on the achievability of that longer term target .

Speaker #11: And just sort of what are the how do you bridge the bridge ? The the difference between where you are currently and your longer term aspirations ?

Speaker #11: And my second question is on the on the shingle side with the 1018 , have you started part two of the of of the study there ?

Speaker #11: Can you maybe just update us on where that stands ? Thank you very much .

Speaker #4: Thanks , Paul . So just I'll go backwards on that one . Shingles . Yes . We started part two . We started enrolling and have those patients in that in that program .

Speaker #4: So we're that happened during Q3 that we kicked off that part of the the study . So we look forward to providing those results in the second half of next year .

Speaker #4: And as as it relates to share , I'll provide some high level comments and see if , Don , you have other stat on , but we have you know , I think that we have to kind of adjust the commentary that we've been stuck in , that 40 , 45% range .

Speaker #4: We've been making progress every quarter. This quarter is 46%, which is up from the same quarter last year. And that's what should be expected on the path to 60.

Speaker #4: It's going to be a continued progress between here and there , between the 46% we're at now . And making that progress quarter over quarter all the way to 2030 .

Speaker #4: So you should expect to see those couple percent increases year over year on the path , on the path to 60% . One of the reasons , and this is where we provided some additional insight into our in our slide deck on market share by segment , as well as our views on how the segments will evolve .

Speaker #4: So we're not shy about it . We believe we will continue to see growth in the retail setting , which is also the segment where we have our largest share and where we continue to expect to take additional share .

Speaker #4: So, two things will drive our share increase to 60%: continuing to take additional share across all aspects of our business and volume.

Speaker #4: Moving to the segments of our business where we have the highest share , those two things together will underpin our confidence in driving 60% share by 2030 .

Speaker #4: Don does that . Any other comments ?

Speaker #5: The only thing I'd add to that , Paul , is that the share we have been able to obtain up to this point for total market share , as well as specifically in retail .

Speaker #5: We reported 63% market share are right in line with our expectations and kind of fit our model of how we achieve at least 60% , underpinned by what Ryan just mentioned around the shift to retail .

Speaker #5: We have a lot of momentum in retail . We continue to expect increases in market share within that segment , and the vast majority of the growth coming within that segment .

Speaker #5: So it becomes a math problem and you get there through that , through that approach .

Speaker #11: Okay . Thanks for taking the questions .

Speaker #4: Thanks , Paul .

Speaker #2: Thank you . We have no further questions at this time . I would now like to turn the call over to Ryan , CEO , for closing remarks .

Speaker #2: You may begin .

Speaker #4: Thank you . Operator . And thank you all for joining us today . We appreciate your interest in Dynavax . We're extremely proud of the progress made throughout the quarter , and we're delivering on all of our key growth pillars , maximizing and growing Heplisav-b progressing our internal pipeline , executing on late stage and strategically aligned business development transactions and opportunistically returning capital to shareholders .

Speaker #4: We look forward to updating you on our continued progress . Focus on protecting the world against infectious diseases . Operator . You may end the call .

Q3 2025 Dynavax Technologies Corp Earnings Call

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Dynavax Technologies

Earnings

Q3 2025 Dynavax Technologies Corp Earnings Call

DVAX

Wednesday, November 5th, 2025 at 9:30 PM

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