Q4 2023 Dynavax Technologies Corp Earnings Call

Operator: Good morning, ladies and gentlemen, and welcome to the Dynavax Technologies fourth quarter and full year 2023 Financial Results Conference call. As a reminder, this call is being recorded.

Good day, ladies and gentlemen, and welcome to the tie backs technologies fourth quarter and full year 2023 financial results Conference call.

As a reminder, this call is being recorded at the end of the company's prepared remarks, we'll open the call for questions and provide specific.

Operator: At the end of the company's prepared remarks, we'll open the call for questions and provide specific instructions at that time. I would now like to turn the call over to Paul Cox, Vice President of Investor Relations and Corporate Communications. You may begin.

Instructions at that time, I would now like to turn the call over to Paul Cox, Vice President Investor Relations and corporate Communications you may begin.

Paul Cox: Thank you for participating in today's call. Joining me from Dynavax are Ryan Spencer, Chief Executive Officer, Don Casale, Chief Commercial Officer, Rob Jansen, Chief Medical Officer, and Kelly McDonald, Chief Financial Officer. Earlier today, Dynavax released financial results for the fourth quarter and full year ended December 31st, 2023.

Paul Cox: Thank you for participating in today's call.

Paul Cox: Joining me from dying of Axa, Ryan Spencer, Chief Executive Officer, Don Casals, Chief Commercial officer.

Paul Cox: Jan Stange, Chief Medical Officer, and Kelly Macdonald, Chief Financial Officer.

Speaker Change: Earlier today <unk> released financial results for the fourth quarter and full year ended December 31, 2020 three.

Paul Cox: 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, These statements involve risks and uncertainties, and our actual results may differ materially.

Speaker Change: Copies of the press release and a supplementary slide presentation are available on <unk> website.

Speaker Change: Before we begin I advise you that we will be making forward looking statements today based on our current expectations and beliefs.

Speaker Change: <unk>, but not limited to potential market sizes market segmentation effective marketing efforts future expected market share and related growth rates and related ACI P recommendation impact on each financial guidance and trends, including revenue profitability cash flow and sufficiency of current capital.

Speaker Change: <unk> timing and results of FDA submissions clinical trial starts and data readouts and potential future uses of or demand for our CPG 10 18 adjuvant.

Speaker Change: These statements involve risks and uncertainties and our actual results may differ materially these.

Paul Cox: These risks are summarized in today's press release and detailed in the risk factors section of our SEC filings, including today's annual report on Form 10-K. Our forward-looking statements speak as of today, and we undertake no obligation to update such statements. And with that, I will now turn the call over to Ryan. Good afternoon, everyone, and thank you for taking the time to join us to review Dynavax's results for 2023. 2023 was characterized by record revenue growth for Apple 70, delivering 69% growth year over year, and becoming the market share leader in the two largest growth segments, which are retail pharmacies and integrated delivery networks, making HEPO7B the leading vaccine in the U.S. adult hepatitis B vaccine market. We expect 2024 to be an important year in building our vaccine portfolio of best-in-class products, including further growing the Apple Satelite brand and advancing our pipeline programs into clinical trial initiations and data readouts. For FSEP-B, we are again forecasting continued growth with net product revenue in the range of $265 to $280 million for the year.

Speaker Change: These risks are summarized in today's press release and detailed in the risk factors section of our SEC filings, including today's annual report on Form 10-K.

Speaker Change: Our forward looking statements speak as of today, and we undertake no obligation to update such statements.

Speaker Change: And with that I will now turn the call over to Ryan.

Ryan Spencer: Thanks, Paul Good afternoon, everyone and thank you for taking the time to join US to review <unk> results for 2023.

Ryan Spencer: 2023 was characterized by record revenue growth for FY, 17, delivering 69% growth year over year.

Ryan Spencer: And coming to market the market share leader in the two largest growth segments, which are retail pharmacies and integrated delivery networks, making networks that these leading vaccine in the U S adult hepatitis B vaccine market.

Ryan Spencer: We expect 2024 to be an important year in building our vaccine portfolio of best in class products.

Ryan Spencer: <unk> further growing the Saturday brand and advancing our pipeline programs.

Ryan Spencer: Clinical trial initiations and data Readouts.

Ryan Spencer: Perhaps a b, we're again forecasting continued growth with net product revenue in the range of $265 million to $280 million for the year.

Ryan Spencer: In a few minutes, Don will provide some additional commentary on how the U.S. hepatitis B vaccine market is evolving due to an active winter respiratory disease season and why we continue to be very confident in another year of growth for the brand and in the long term prospects for hepatitis B in a vaccine market with one of the largest total addressable populations in the United States. For our development pipeline, we expect to achieve important milestones in the coming months, including our PDUFA action date for the HEPLISAV-B SPLA for hemodialysis, expected in May, clearing our shingles IND, currently being reviewed by FDA, to begin our Phase I-II trial, advancing our TDAP program, in delivering Phase 2 clinical and non-human primate challenge study data for our plague program under collaboration with the US Department of Defense.

Ryan Spencer: A few minutes Donald provide some additional commentary on how the U S. Hepatitis B vaccine market is evolving.

Ryan Spencer: Through an active winter respiratory disease season, and why we continue to be very confident in another year of growth for the brand and in the long term prospects for <unk> and a vaccine market with one of the largest total addressable population in the United States.

Ryan Spencer: For our development pipeline, we expect to achieve important milestones in the coming months, including our <unk> action date for <unk> for hemodialysis expected in Bay clearing our shingles indie currently being reviewed by FDA to begin our phase one two trial.

Ryan Spencer: Advancing our <unk> program.

Ryan Spencer: And delivering phase III clinical and nonhuman Primate Challenge study data for our <unk> program under our collaboration with U S Department of defense.

Ryan Spencer: Importantly, our strong financial position of $742 million cash provides us with the optionality to continue to build value across our business, such as three incremental investments to drive the MLSB market opportunity, continuing to advance R&D efforts, and pursuing new opportunities to accelerate our growth. As we've discussed previously, we continue to evaluate strategic opportunities to further diversify our clinical and commercial product portfolio. We remain committed to disciplined capital allocation to generate significant value and accelerate growth.

Ryan Spencer: Importantly, our strong financial position of $742 million of cash provides us with the optionality to continue to build value across our business.

Ryan Spencer: As to the incremental investments to drive the <unk> market opportunity.

Ryan Spencer: To advance R&D efforts and pursuing new opportunities to accelerate our growth.

Ryan Spencer: As we've discussed previously we continue to evaluate strategic opportunities to further diversify our clinical and commercial product portfolio.

Ryan Spencer: We remain committed to disciplined capital allocation to generate significant value and accelerate growth. We look forward to providing updates on these efforts in the future.

Ryan Spencer: We look forward to providing updates on these efforts in the future. I'll now turn the call over to Don to provide more details on the HEPA Step-B results and our guidance for the future. Thank you, Ryan.

Ryan Spencer: I'll now turn the call over to Don to provide more details on the <unk> results and our guidance looking forward.

Don Casals: Thank you Brian and.

Don Casale: In 2023, we will achieve record net product sales and market share. Heplisav-D is the leading adult hepatitis D vaccine in the U.S. market. Additionally, we drove significant hepatitis B market growth by effectively pushing through the ACIP Universal Recommendation. Our success in 2023 reaffirms our confidence in a sizable market opportunity and long-term revenue growth potential for Heplisav-B. The U.S. adult hepatitis B market continued to grow in 2023, following the ACIP Universal Recommendation for Hepatitis B vaccination, which now represents one of the largest vaccine market opportunities for adults. We believe this recommendation will continue to be a significant catalyst for growth and estimate the Hepatitis B vaccine market opportunity for HEPLISAV grew to approximately $525 million in 2023 on a clear path to approximately $800 million by 2027, with HEPLISAV-B achieving a majority market share by that time.

Don Casals: In 2020, we achieved record net product sales and market share.

Don Casals: Obviously <unk> is the leading adult hepatitis b vaccine in the U S market.

Don Casals: We drove significant hepatitis b market growth by effectively pulling through the ACI P Universal recommendation.

Don Casals: Our success in 2023, reaffirms, our confidence and a sizable market opportunity and long term revenue growth potential for hapless abbvie.

Don Casals: The U S adult hepatitis B market continued to grow in 2023, following the <unk> universal recommendation for hepatitis B vaccination.

Don Casals: So that represents one of the largest vaccine market opportunities for adults.

Don Casals: We believe this recommendation will continue to be a significant catalyst for growth in.

Don Casals: And estimate the hepatitis b vaccine market opportunity, perhaps a fab.

Don Casals: Moving to approximately $525 million in 2023 on a clear path to approximately $800 million by 2027 with <unk>, achieving a majority market share by that time.

Don Casale: During the fourth quarter, we continued to see indicators of U.S. market expansion from the ASEC Universal Recommendation, despite softness in the market related to reduced wellness visits and an increased focus by health care providers on respiratory disease vaccines, including typical flu campaigns and the launches of RSV and endemic COVID-19 vaccines. Headless FB continues to increase its total US market share, achieving 42% at the end of 2023, compared to 35% at the end of 2022; net product revenue in 2023 increased 69% year over year.

Don Casals: During the fourth quarter, we continued to see indicators of use market expansion from the ACI Universal recommendations.

Don Casals: Despite softness in the market related to reduced wellness visits and an increased focus by health care providers on respiratory disease vaccines.

Don Casals: Including typical flow campaign, and the launches of RSV and endemic COVID-19 vaccine.

Don Casals: <unk> continues to increase its total U S market share achieving 42% at the end of 2023 compared to 35% at the end of 2022.

Don Casals: Net product revenue in 2023 grew 69% year over year.

Don Casals: This sales growth continues to be driven by <unk> strong performance in two critical segment.

Don Casale: This sales growth continues to be driven by HITLTEPI's strong performance in two critical segments: retail pharmacy and integrated delivery networks, or IDN. We continue to focus our sales and marketing efforts on the retail, pharmacy, and IDM segments, as we expect to see most of the anticipated market growth from the ACIP Universal Recommendation in these segments, estimating that both will grow to represent over 60% of the total hepatitis D market by 2027. Headless Abby is now the market share leader in both of these key segments.

Don Casals: Retail pharmacy, and integrated delivery networks or <unk>.

Don Casals: We continue to focus our sales and marketing efforts on the retail pharmacy segment as.

Don Casals: As we expect to see most of the anticipated market growth from the <unk> recommendation in these segments.

Don Casals: Estimated both will grow to represent over 60% of the total hepatitis D market by 2027.

Don Casals: <unk> is now the market share leader in both of these key segments.

Don Casals: And at the end of the year <unk> market share increased to approximately 56% compared to approximately 47% at the end of 2022.

We are focused on working with large health systems at the C suite and clinical level to pull through ongoing adoption of the universal recommendation.

Don Casale: Friday end, at the end of the year, Teplicev's market share increased to approximately 56%, compared to approximately 47% at the end of 2022. We are focused on working with large health systems at the C-suite and clinic level to pull through ongoing adoption of the Universal Recommendation. Customers continue to respond positively to the ACIP change and recognize the need to adopt and implement the recommendation.

Don Casals: Customers continue to respond positively to the ACP changed and recognized the need to adopt and implement the recommendation.

Full year hepatitis B vaccine market growth in the <unk> segment was 41%.

Don Casals: In the retail pharmacy segment, we have made significant progress with several large national chain, making <unk> the preferred adult hepatitis B vaccine.

Don Casals: At the end of the year <unk> achieved approximately 58% market share in the retail pharmacy segment compared to approximately 42% at the end of 2022.

Don Casale: Full-year hepatitis B vaccine market growth in the IDN segment was 41%. In the retail pharmacy segment, we made significant progress in several large national chains, making HEPLISAV-B the preferred adult hepatitis B vaccine. At the end of the year, HEPA 70 achieved approximately 58% market share in the retail pharmacy segment, compared to approximately 42% at the end of 2022.

Don Casals: We continue to see and expect significant growth from the retail pharmacy segment.

Don Casals: Full year hepatitis B vaccine market growth was 78%.

Don Casals: As Ryan noted we are providing full year 2024, net product revenue guidance for <unk> to be in the range of 265 million to $280 million.

Don Casals: This guidance reflects our momentum in the market, while factoring in the evolving market landscape and emerging quarterly patterns of non respiratory vaccination.

Don Casals: We expect to see in 2024.

Don Casals: Based on feedback from customers cough cold and flu season has extended much further into January than expected, reducing the number of wellness visits and vaccination opportunities.

Don Casale: We continue to see and expect significant growth from the retail pharmacy segment. Full year hepatitis B vaccine market growth was 78%. As Ryan noted, we are providing full year 2024 net product revenue guidance for HEPAFAB-B in the range of $265 to $280 million. This guidance reflects our momentum in the market while factoring in the evolving market landscape and emerging quarterly patterns of non-respiratory vaccination that we expect to see in 2024. Based on feedback from customers, the cough, cold, and flu season extended much further into January than expected, reducing the number of wellness visits and vaccination opportunities.

Don Casals: Due to the softness in January we anticipate little to no growth in the hepatitis B vaccine market for Q1 as compared to Q4 of 2023.

Don Casals: Encouragingly, we expect the market to strengthen for the remainder of Q1 into Q2 as the focus of healthcare providers and retail pharmacy shifted back to prioritizing non respiratory vaccine.

Don Casals: As a result, we expect to recognize up to 60% of our full year revenue range in the second and third quarters with typical Q4 seasonality expected.

Don Casals: We are extremely confident in the long term expansion of the U S. Hepatitis b vaccine market and forecast annual market growth of approximately 10% to 15% over the next several years with <unk> gaining meaningful increases in total market share over that time.

Don Casals: In summary, we had a tremendous 2023 reaffirming our confidence that <unk> will strengthen its position as the clear market leader in the expanding hepatitis b vaccine market.

Don Casale: Due to the softness in January, we anticipate little to no growth in the hepatitis B vaccine market for Q1 as compared to Q4 2023. However, encouragingly, we expect the market to strengthen for the remainder of Q1 into Q2 as the focus of health care providers and retail pharmacies shifts back to prioritizing non-respiratory vaccines. As a result, we expect to recognize up to 60% of our full-year revenue range in the second and third quarters, with typical Q4 seasonality expected.

We are very proud of our commercial team's execution and encouraged by the progress and momentum for <unk> be establishing a majority market share in the key segments of retail pharmacy and IBM.

Don Casals: I will now turn the call over to Rob to take you through our clinical pipeline.

Rob: Thank you dawn.

Rob: As a reminder, in our development pipeline, we are advancing innovative and diversified vaccines that leverage our CPG <unk> adjuvant with proven and of tunes.

Rob: We also continue to identify new opportunities to leverage our CPG 2018, adjuvant through multiple innovative preclinical and discovery efforts with leading collaborators.

Rob Jansen: We are extremely confident in the long-term expansion of the U.S. peptidase B vaccine market and forecast annual market growth of approximately 10-15% over the next several years, with Hepatitis B gaining meaningful increases in total market share over that time. In summary, we had a tremendous 2023, reaffirming our confidence that Hepatitis B will strengthen its position as a clear market leader in the expanding hepatitis B We are very proud of our commercial team's execution and encouraged by the progress and momentum for Heplisav-B, establishing a majority market share in the key segments of retail, pharmacy, and IDM. I will now turn the call over to Rob to take you through our clinical pipeline. Thank you, Don.

Rob: Starting with our shingles vaccine program <unk> T.

Rob: Currently there is a successful licensed vaccine on the market, but we believe there is an opportunity to develop an improved vaccine given the challenging tolerability profile of the current market leading product.

Rob: One of the unique advantages, we believe our CPG <unk> adjuvant is it safety and Tolerability profile combined with its ability to induce strong CD four positive T cell responses, which we believe are critical to preventing the reactivation of the zoster virus.

Rob: Results from our phase one trials support the continued development of <unk> as they demonstrate the opportunity to develop a shingles vaccine with an improved tolerability profile and comparable efficacy.

Rob: Late last year, we received type B meeting feedback from the FDA on the <unk> program, which we believe is supportive of our proposed clinical development plan that includes a pivotal placebo controlled efficacy study.

Rob Jansen: As a reminder, in our development pipeline, we're advancing innovative and diversified vaccines that leverage our CPG-1018 adjuvant with proven antigens. We also continue to identify new opportunities to leverage our CPG-1018 adjuvant through multiple innovative preclinical and discovery efforts with leading collaborators. Starting with our shingles vaccine program, Z1018. Currently, there is a successful licensed vaccine on the market, but we believe there is an opportunity to develop an improved vaccine given the challenging tolerability profile of the current market leading product. One of the unique advantages of our CPG1018 adjuvant is its safety and tolerability profile combined with its ability to induce strong CD4 positive T cell responses, which we believe are critical to preventing the reactivation of the zoster virus. Results from our Phase 1 trial support the continued development of Z1018 as they demonstrate the opportunity to develop a shingles vaccine with an improved tolerability profile and comparable efficacy.

Rob: We recently submitted an investigational new drug application or indeed to the U S. FDA to support the initiation of a phase one two trial of <unk> in the first half of 2024.

Rob: We will be evaluating escalating doses of our G protein, our selected dose of <unk> with or without anthem.

Rob: And different vaccinations schedules.

Rob: We plan to enroll approximately 400 subjects and anticipate topline immunogenicity data in the second half of 2025.

Rob: Now turning next to our <unk> program.

Rob: This is an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria and pertussis were TDAP.

Rob: Current TDAP vaccines have limitations, including waning effectiveness, we believe theres an opportunity to improve the duration of protection using our CPG $2 18, adjuvant to generate the th one bias to immune response.

Rob: We've completed both the phase one clinical trial in adults and adolescence as well as a pertussis challenge study in non human primates. We've.

We recently received type B pre IMD meeting feedback from the FDA on the <unk> clinical development and regulatory pathways.

Rob Jansen: Late last year, we received type B meeting feedback from the FDA on the Z1018 program, which we believe is supportive of our proposed clinical development plan that includes a pivotal placebo-controlled efficacy trial. We recently submitted an Investigational New Drug Application, or IND, to the US FDA to support the initiation of a Phase I-II trial of Z1018 in the first half of 2024. We will be evaluating escalating doses of our GE protein, our selected dose of CpG-1018 with or without alum, and different vaccination schedules. We plan to enroll approximately 400 subjects and anticipate top-line immunogenicity data in the second half of 2025. Now turning next to our TDAP1018. This is an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria, and pertussis, or Tdap.

Rob: Together results from our phase one study our nonhuman primate study and the feedback from FDA all support proceeding to a human challenge study this year.

Rob: We plan to submit an IND to the U S. FDA to support the initiation of this phase II Human Challenge study of <unk> in the second half of the year. Upon completion of the independent study being conducted by the Canadian Centre for Vaccinology to establish the human challenge dose, which we will utilize in our phase II study.

Thanks.

Rob: Moving onto the <unk> program. This is a collaboration with and funded by the U S Department of defense.

Rob: We are conducting a phase two trial evaluating the immunogenicity safety and Tolerability of a kudos plagued vaccine candidate that is adjuvant and with CPG 2018.

Rob: The CPG <unk> adjuvant vaccine candidates mechanism of action has the potential to speed up time to protection with fewer doses compared to the three dose alum adjuvant in vaccine previously developed by the department of Defense.

Rob Jansen: Current Tdap vaccines have limitations, including waning effectiveness; we believe there's an opportunity to improve the duration of protection using our CPG1018 adjuvant to generate a Th1 bioimmune response. We've completed both a phase one clinical trial in adults and adolescents, as well as a pertussis challenge study in non-human primates. We recently received type B pre-IND meeting feedback from the FDA on the Tdap1018 clinical development and regulatory pathway. Together, results from our Phase 1 study, our non-human primate study, and the feedback from the FDA all support proceeding to a human challenge study this year. We plan to submit an IMD to the U.S. FDA to support the initiation of this phase two human challenge study of Tdap1018 in the second half of the year, upon completion of the independent study being conducted by the Canadian Center for Vaccinology to establish the human challenge dose, which we will utilize in our phase two study.

Rob: We're currently conducting a randomized active controlled phase II clinical trial evaluating immunogenicity safety and Tolerability of the plagued vaccine candidate and in parallel we're conducting a nonhuman primate challenge study.

Rob: We expect top line data from both of these studies by the end of 2024 and these data will inform next steps for the program.

Now in addition to these development programs. We've also filed a supplemental BLA for Hep Lasalle B vaccination of adults on hemodialysis, which the FDA has accepted with a <unk> action date in May of 2024.

Rob: If approved this would allow us to promote a four dose regimen of <unk> b to the dialysis population.

Rob: We look forward to continuing to make progress across these programs in the months ahead.

Rob: And we're excited to initiate the next clinical trials for both our shingles and teed up programs in the coming year.

Rob: I'll now turn the call over to Kelly to review our financial results.

Rob Jansen: Moving on to the PLEG program, this is a collaboration with and funded by the U.S. Department of Defense. We are conducting a Phase 2 trial evaluating the immunogenicity, safety, and tolerability of a two-dose plague vaccine candidate that is adjuvanted with CPG1018. The CPG1018 adjuvanted vaccine candidate's mechanism of action has the potential to speed up time to protection with fewer doses compared to the three-dose alum adjuvanted vaccine previously developed by the Department of Defense.

Kelly Macdonald: Thank you Rob.

Kelly Macdonald: Thanks to report another quarter and full year of strong financial performance I'll review the key financial results for 2023, as well as our financial guidance for 2024.

Kelly Macdonald: Please note that all financial comparisons are versus the prior year period, unless otherwise noted.

Kelly Macdonald: Please also refer to our press release and Form 10-K for more detailed financial information.

Kelly Macdonald: Starting with topical therapy.

Kelly Macdonald: Product revenue grew 69% year over year to $213 million in 2023, another record year for the franchise.

Kelly Macdonald: We are also pleased with our continued trend in our margin profile, perhaps lasalle fee, but gross margin of approximately 76% in 2023, consistent with our guidance of mid 70 percentage for the full year and.

Rob Jansen: We're currently conducting a randomized active controlled phase two clinical trial evaluating immunogenicity, safety, and tolerability of the plague vaccine candidate. And, in parallel, we're conducting a non-humid primate challenge study. We expect top-line data from both of these studies by the end of 2024, and these data will inform next steps for the program. Now, in addition to these development programs, we've also filed a supplemental BLA for HEPLISAV-B vaccination of adults on hemodialysis, which the FDA has accepted with a BDUFA action date in May of 2024. If approved, this would allow us to promote a four-dose regimen of Heplisav-B to the dialysis population. We look forward to continuing to make progress across these programs in the months ahead. And we're excited to initiate the next clinical trial for both our shingles and Tdap programs in the coming year. I'll now turn the call over to Kelly to review our financial results. Thank you, Rob.

Kelly Macdonald: A significant improvement compared to about 68% in the prior year.

Kelly Macdonald: Looking forward, we expect gross margins of approximately 80% for the full year 2024, which is consistent with our long term expectations and margin profile for this brand.

Kelly Macdonald: Other revenue was $19 million in 2023 compared to $9 million in the prior year period, representing revenue related to the play vaccine program in collaboration with and funded by the U S Department of defense.

Kelly Macdonald: The increase was primarily driven by the.

Kelly Macdonald: And the advancement into a nonhuman primate challenge study as well as continued progress throughout our phase III clinical contract for the vaccine candidate.

Kelly Macdonald: Turning to our expenses.

Kelly Macdonald: Search and development expenses for 2023 increased to $55 million compared to $47 million from the prior year period with the increases reflecting continued advancements in our clinical and preclinical development programs.

Kelly Macdonald: Selling general and administrative expenses for 2023 or $153 million.

Kelly Macdonald: Compared to $131 million from the prior year period, with the increase primarily driven by higher compensation and related personnel costs.

Kelly McDonald: I'm pleased to report another quarter and full year of strong financial performance. I'll review the key financial results for 2023, as well as our financial guidance for 2024. Please note that all financial comparisons are versus the prior year period, unless otherwise noted. Please also refer to our press release in Form 10-K for more detailed financial information, starting with HEPLISAV-B. That product revenue grew 69% year over year to $213 million in 2023, another record year for the franchise.

Kelly Macdonald: In an overall increase in targeted commercial investments.

Kelly Macdonald: And to drive help us that would be market share and maximize the opportunities presented by the CIP is universal recommendation.

Kelly Macdonald: These results generated GAAP net loss of $6 4 million in 2023 compared to a GAAP net income of $293 million during 2022.

Kelly Macdonald: Moving to the balance sheet.

Kelly Macdonald: We ended the year with cash cash equivalents in marketable securities of approximately $742 million, which we believe is sufficient to progress our current pipeline assets and support our organic base business without the need to raise additional capital.

Kelly McDonald: We are also pleased with our continued trend in the margin profile for HEPLISAV-B with gross margin of approximately 76% in 2023, consistent with our guidance of mid-70s percentage for the full year and a significant improvement compared to about 68% in the prior year. Looking forward, we expect gross margins of approximately 80% for the full year 2024, which is consistent with our long-term expectations of margin profile for this brand. Other revenue was $19 million in 2023, compared to $9 million in the prior year period, representing revenue related to the Plague Vaccine Program in collaboration with and funded by the U.S. Department of Defense. The increase was primarily driven by the advancement into a non-human primary challenge study, as well as continued progress throughout our phase two clinical trial for the vaccine candidates.

Kelly Macdonald: Turning towards 2024, we are providing the following full year financial guidance.

Kelly Macdonald: <unk> net product revenue is expected to be between approximately 265 and $280 million.

Kelly Macdonald: Approximately $3 million in ex U S sales through our commercialization agreement with Bavarian Nordic in Germany.

Kelly Macdonald: We expect to happen is that the gross margin of approximately 80% for full year 2024.

Kelly Macdonald: We expect R&D expenses to be between approximately 60 and $75 million.

Kelly Macdonald: We expect SG&A expenses to be between approximately 168 and $180 million.

And we also expect to be cash flow positive for the full year ended December 31st 2024, reflecting our continued discipline towards allocating capital to drive topline revenue growth, while thoughtfully advancing our research programs.

Kelly Macdonald: In closing, we believe that with our strong financial profile, we are well positioned to drive sustainable growth in our core <unk> business capture.

Kelly Macdonald: Capture a majority market share and lead the expansion of the adult hepatitis B vaccine market.

Kelly McDonald: Turning to our expenses, Research and development expenses for 2023 increased to $55 million compared to $47 million for the prior year period, with the increases reflecting continued advancement in our clinical and preclinical development programs. Selling general and administrative expenses for 2023 were $153 million, compared to $131 million in the prior year period, with the increase primarily driven by higher compensation and related personnel costs, and an overall increase in targeted commercial investments designed to drive HEPLISAV-B market share and maximize These results generated a gap net loss of $6.4 million in 2023 compared to a gap net income of $293 million in 2022.

Kelly Macdonald: We look forward to progressing our R&D portfolio of vaccine candidates, while continuing to be extremely thoughtful and how we allocate our capital to accelerate growth and build beyond our current base business.

Kelly Macdonald: We are excited about our progress to date and we look forward to continuing to deliver on our goals for this year and beyond.

Speaker Change: Thank you everyone for your attention today, operator, we would now like to open the Q&A portion of today's call.

Speaker Change: To ask a question you will need to press star one on your telephone to withdraw your question. Please press star one again, please wait for your name to be announced please standby, while we compile the Q&A roster one moment for your first question.

Speaker Change: Our first question comes from the line of Matthew Phipps with William Blair. Your line is now open.

Matthew Phipps: Hi, good afternoon. Thanks for taking my question Congrats on a great 2003.

Matthew Phipps: Last year I, just wanted to visit last year than you initially gave guidance.

Matthew Phipps: Sure.

Matthew Phipps: There was lower 165 or something like that and throughout the year you raised it 20 over 20%.

Kelly McDonald: Moving to the balance sheet, we ended the year with cash, cash equivalents, and marketable securities of approximately $742 million, which we believe is sufficient to progress our current pipeline assets and support our organic business without the need to raise additional capital. Turning towards 2024, we are providing the following full-year financial guidance. Peplicev-B net product revenue is expected to be between approximately $265 and $280 million, including approximately $3 million in ex-U.S. sales through our commercialization agreement with Bavarian Nordic in Germany.

Matthew Phipps: An update.

Matthew Phipps: What were the factors you think that drove greater than expected sales from your initial point last year was it greater growth of the total market or market share gains just kind of wondering what factors might influence where your guidance goes from today and 2024.

Speaker Change: Hey, Matt.

Matt: Thanks for the question.

Speaker Change: I think we have to remember 2023 was the first year first full year coming out of both.

Speaker Change: A reconciliation of pandemic demand as well as the AIP Universal recommendation.

Speaker Change: So one of the things we said I think we were pretty clear about this as I recall from our prior earnings calls is that the market growth in 2003 outpaced our original expectations. When we originally provided guidance.

Kelly McDonald: We expect Tesla's gross margin to be approximately 80% for the full year 2024. We expect R&D expenses to be between approximately $60 and $75 million. We expect SG&A expenses to be between approximately $160 and $180 million.

Speaker Change: Earlier in the year. So we also had fairly successful growth and market share throughout the year.

Speaker Change: Those two factors, but dominated by <unk>.

Better market growth than originally projected.

Speaker Change: Yes, okay. Thanks.

Speaker Change: And does your guidance for this year include any contribution from the dialysis segment.

Kelly McDonald: And we also expect to be cashflow positive for the full year ended December 31st, 2024, reflecting our continued discipline towards allocating capital to drive top-line revenue growth while thoughtfully advancing our research program. In closing, we believe that with our strong financial profile, we are well positioned to drive sustainable growth in our core Heplis FD business, capture a majority market share, and lead the expansion of the adult hepatitis B vaccine market. We look forward to progressing our R&D portfolio of vaccine candidates while continuing to be extremely thoughtful in how we allocate our capital to accelerate growth and build beyond our current-based business. We are excited about our progress to date, and we look forward to continuing to deliver on our goals for this year and beyond. Thank you, everyone, for your attention today.

Speaker Change: Yes, I mean, we.

Speaker Change: Don't really provide guidance segment by segment. So we want to run a feature that our guidance for the year takes into account a lot of different puts and takes on how the year could evolve.

Speaker Change: So we're not going be able to comment on one specific segment.

Speaker Change: Okay.

Speaker Change: Great. Thanks for taking my questions.

Speaker Change: Thank you one moment for our next question. Please.

Speaker Change: Our next question comes from the line of Jonathan Miller with Evercore ISI. Your line is now open.

Jonathan Miller: Hey, guys. Thanks for taking the question and also congrats on 23, Greg.

Jonathan Miller: Wanted to drill down a little bit into that comment you made on little growth in the heavy market. In Q1 do you still have an opportunity to grow share in Q1 to what extent is share growth tied to market overall market expansion I guess.

Speaker Change: And then secondly.

Speaker Change: What are your expectations on the regular regulatory requirements for plague beyond the phase II in the NSP studies. This year, what do you expect from regulators and what do you expect from Doj.

Operator: Operator, we would now like to open the Q&A portion of today's call. Thank you. To ask a question, you'll need to press star 1-1 on your telephone.

Why do we take the hit thanks, John Thanks for the questions I'm going to have on top of your first question and I'll pick up the second one hey, Jonathan regarding share actually.

Speaker Change: We're excited about our ability to continue to take market share.

Operator: To withdraw your question, please press star 1-1 again. Please wait for your name to be announced. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question comes from the line of Matthew Phipps with William Blair. Your line is now open. Good afternoon. Thanks for taking my questions. Congratulations on a great 23.

Speaker Change: This quarter is no different but I think the consistent around is the ability to take market share. So.

Speaker Change: We like our position and our ability to take market share in first quarter, even with the market being what it is.

Speaker Change: Okay.

Speaker Change: And then the second question regarding the plague plan the regulatory plan.

Speaker Change: I think it's important to know the reason we're doing the nonhuman Primate studies is because that's a key part of the regulatory path for a product like the C utilize the animal rule and so what we don't know yet the specific path on whether or not there will be additional work required.

Ryan Spencer: Last year, you know, just wanted to visit last year, and you initially gave guidance of, you know, there was a lower 165, 185, something like that. And throughout the year, you raised it 20, over 20% with subsequent updates. What were the factors you think that drove greater than expected sales from your initial point last year? Was it greater growth in the total market or market share gains? Just kind of wondering what factors might influence where your guidance goes from today in 2024. Hey, Matt.

Speaker Change: To satisfy the filing needed under that under that pathway with the agency.

Speaker Change: Rob I don't know if you have any other comments you want to make around plague.

Rob: I think you covered it I don't think we know what will be required safe room EUA versus a full approval not at this point.

Rob: Okay. It makes sense a little bit what the data will also be an important aspect of that so we really need to see that data before we can confirm the pathway.

Rob: And then just one more on gross margin.

Rob: You said, 80% plus for help with that but.

Ryan Spencer: Thanks for the question. I think we have to remember 2023 was the first year, the first full year coming out of both reconciliation of pandemic demand, as well as the ACIP universal recommendation. So, one of the things we said, I think we were pretty clear about this, as I recall from our prior earnings calls, is that the market growth in 23 outpaced our original expectations when we originally provided guidance earlier in the year. So, we also had fairly successful growth in market share throughout the year. And so, those two factors, but dominated by better market growth than originally projected. Yep.

Rob: How does the potential Vod collaboration revenue and other revenue line.

Rob: Tie into that could total gross margin over overall gross margin.

Rob: Still be in the mid <unk> and higher.

So the guidance. So thanks for the question the guidance is approximately 80% for the full year for <unk>.

Rob: Other revenue line item.

Rob: Predominantly our plague our.

Rob: Play contract reimbursement, which doesn't carry significant margin.

Sorry significant cost of goods at all obviously it doesn't carry any cost to get that also so the extent, we continue recognizing which we expect to continue recognizing other revenue through that contract.

Ryan Spencer: Okay, thanks, Ryan. And does your guidance for this year include any contribution from the dialysis segment? Yeah, I mean, we don't really provide guidance segment by segment. So we want to, we want to stay true to that our guidance for the year takes into account a lot of different opinions and takes on how the year can evolve. So we're not gonna be able to comment on one specific segment. Okay? Great, thanks very much. Thank you. Take care.

Rob: Our total company gross margins would be slightly higher than the 80%.

Speaker Change: Thanks, so much.

Speaker Change: Thank you Sean.

Speaker Change: One moment for our next question comes from the line of Paul Choi with Goldman Sachs. Your line is now open.

Paul Choi: Thanks, Jay and good afternoon.

Paul Choi: That's on the strong finish to 2003 from us as well.

Paul Choi: I want to maybe just ask Andre thinking with regard to the guidance.

Paul Choi: If you think about the macroeconomic environment, we're in and.

Paul Choi: People's price sensitivity.

Paul Choi: Sensitivity in terms of thinking about health care spending versus the <unk>.

Operator: One moment for our next question. Our next question comes from the line of Jonathan Miller with Evercore ISI. Your line is now open.

Paul Choi: High inflation environment, how do you think about maybe sort of the puts and takes of that in terms of.

Andre: Demand growth over the course of the year.

Operator: Hey guys, thanks for taking the question and also congrats on the 23 percent growth. I wanted to drill down a little bit into that comment you made on little growth in the HEPB market in Q1. Do you still have an opportunity to grow share in Q1? To what extent is share growth tied to overall market expansion, I guess?

Andre: Would that is that something youre thinking about.

Andre: In terms of your guidance and then I had a follow up on capital allocation.

Speaker Change: Thanks for the question Paul.

Speaker Change: Our guidance, obviously is very specific to the market dynamics <unk> vaccination and we.

Speaker Change: We don't see some of those macro factors, having a big impact here at all on the FSP market. It's a very the reimbursement for that segment is incredibly well theres first dollar coverage required required.

Don Casale: And then secondly, what are your expectations of regulatory requirements for plague beyond phase 2 and the NHP studies this year? What do you expect from regulators, and what do you expect from DOD? Hey, why don't we take it?

Speaker Change: Under under the Affordable Care Act. So we think we're in a good position as it relates to some of those macro factors to continue to grow the vaccine market through 2024 and beyond.

Ryan Spencer: Hey, thanks, John. Thank you for the questions. I'm going to have Don tap me on the first question, and I'll pick up the second one. Hey, Jonathan.

Speaker Change: Okay. Thanks for that and then.

Speaker Change: As a follow up.

Don Casale: Yeah, regarding share, actually, we're excited about our ability to continue to take market share. This quarter is no different. That's one of the things we've been consistent about, the ability to take market share. So we like our position and our ability to take market share in this first quarter, even with the market being what it is. And then the second question regarding the plague plan, the regulatory plan, I think it's important to know the reason we're doing the non-human primate study is because that's a key part of the regulatory path for a product like this to utilize the animal rule. And so what we don't know yet is the specific path on whether or not there will be additional work required to satisfy the filing needed under that pathway with the agency.

Speaker Change: I know you and the team talked about.

Speaker Change: <unk> and <unk> partnering here, but I guess as you sort of survey the landscape.

Speaker Change: Sort of.

Speaker Change: Potential bid ask spreads are perhaps risk appetites are I guess.

Speaker Change: This partnership where BD opportunities don't materialize in the let's say in the next 12 to 18 months.

Speaker Change: How would you think about then rank ordering your capital allocation outside of investing in to help us out business. Thanks, so much for taking our questions.

Paul: Alright, Thanks, Paul Yes.

Speaker Change: Yes, no I think I appreciate you highlighting the fact that there's a lot of flexibility and identifying the right asset for <unk>.

Speaker Change: Kelly why don't you provide some commentary on overall capital allocation strategy sure. So our exceptional commercial execution for helpless SPE.

Ryan Spencer: Rob, I don't know if you have any other comments you want to make about plague. No, I think you covered that. I don't think at this point we know what will be required, say, for an E-Way versus a full approval. Not at this point, and a little bit more.

Kelly Macdonald: Along with our adjuvant supply business questions created this.

Kelly Macdonald: Strengthening of our financial profile.

We certainly believe in a strong position will help us drive further growth, including first and foremost looking for opportunities to invest in driving growth in <unk>.

Kelly McDonald: The data will also be an important aspect of that. So we really need to see that data before we can confirm the pathway. And then just one more on gross margin, you said 80% plus for HEPLISAV, but how does substantial DOD collaboration revenue and other revenue lines tie into that? Could total gross margin, overall gross margin still be in the mid-80s and higher?

Kelly Macdonald: As well as advancing our organic clinical stage assets as well as our preclinical portfolio.

Kelly Macdonald: As we reflect on opportunities outside of that the Ryan's comments.

Kelly Macdonald: Around corporate development, we do continue to evaluate strategic opportunities to diversify our commercial and clinical product portfolio and then beyond that.

Kelly Macdonald: We do we do evaluate and consider other opportunities to return capital to shareholders, if and when appropriate as.

Kelly McDonald: So the guidance, so thanks for the question. The guidance is approximately 80% for the full year for Heplisav. Our other revenue line item is predominantly our plague, our plate contract reimbursement, which doesn't carry a significant margin or, sorry, a significant cost of goods at all. Actually, it doesn't carry any cost of goods at all.

Kelly Macdonald: As well as other ways to generate value for our shareholders.

Kelly Macdonald: So I'd say, that's sort of the rank ordering.

Where we stand today.

Speaker Change: Thanks, Paul.

Paul: Thank you. Thank you.

Paul: One moment for our next question.

Paul: Our next question comes from the line of Ernesto Rodriguez <unk> with Cowen. Your line is now open.

Ernesto Rodriguez: Hi, everybody, thanks for taking our questions and congrats on a great year.

Kelly McDonald: So yes, to the extent we continue recognizing, which we expect to continue recognizing other revenues through that contract, our total company gross margins would be slightly higher than that 80%. All right, thanks so much. Thank you. One moment for our next question comes from the line of Paul Choi with Goldman Sachs. The line is now open. Hi, good afternoon, and congratulations on the strong finish to 23 from us as well.

<unk>.

Ernesto Rodriguez: I have a question about the.

Speaker Change: The effect that you described from the longer than expected.

Ernesto Rodriguez: Respiratory vaccine season in the Q4 seasonality our dose effect over <unk> during Q4, and Q3 or do you have to like internally adjust your estimates for 2020 forward based on on that.

Ernesto Rodriguez: And then.

Ernesto Rodriguez: Second question.

Ernesto Rodriguez: Regarding the.

Ryan Spencer: Um, I want to maybe just ask you about your thinking with regard to the guidance and as you think about the macroeconomic environment we're in and people's price sensitivity and sensitivity in terms of thinking about health care spending versus the high inflation environment. How do you think about maybe sort of the puts and takes of that in terms of demand growth over the course of the year? And is that something you're thinking about in terms of framing your guidance? And then I had to follow up on capital allocation. Thanks for the question, Paul. You know, our guidance is obviously very specific to the market dynamics for adult vaccination, and we don't see some of those macro factors having a big impact here at all on the FDIC market. It's very, the reimbursement for that segment is incredibly well. There's first-dollar coverage required under the Affordable Care Act.

Ernesto Rodriguez: The gross margin or what.

Ernesto Rodriguez: What's driving the improvement in gross margin you said.

Ernesto Rodriguez: Economies of scale and lower cost or are you.

Ernesto Rodriguez: Expecting to have more pricing power.

Speaker Change: Yeah, I'll take the first one and Kelly if you can handle the second one.

Kelly Macdonald: As far as.

Kelly Macdonald: Thanks for the question I interpreted the first part of the question, let's say.

Kelly Macdonald: Because what we see in Q1 impact how we think about the rest of the year to change how we update our guidance.

Kelly Macdonald: Ultimately, we we only provide one guidance number when we're ready to provide it. So it's kind of hard to think about how individual factors impacted.

Kelly Macdonald: But like we said in the call script, we know that Q2, and Q3 will continue to be the strongest quarters of the year.

Ryan Spencer: So we think we're in a good position as it relates to some of those macro factors to continue to grow the vaccine market through 2024 and beyond. Okay, thanks for that. And then as a follow-up, I know you and the team have talked about BD and or partnering here, but I guess as you sort of survey the landscape and sort of where potential bid-ask spreads or perhaps risk appetites are, I guess if partnership or BD opportunities don't materialize in the, let's say, the next 12 to 18 months, you know, how would you think about ranking your capital allocation outside of, you Right, thanks, Paul.

Ryan Spencer: Um, yeah, no. I think I appreciate you highlighting the fact that there's a lot of flexibility and identifying the right asset for Dynavax. So Kelly, why don't you provide some commentary on our overall capital allocation strategy? Sure.

Speaker Change: Okay very helpful. Thank you.

Speaker Change: February.

Speaker Change: Thank you one moment for next question.

Speaker Change: And next question comes from the line of Edward White with H C. Wainwright phone line is now open.

Speaker Change: Hey, this is Steve on for at what.

Steve: Few questions.

Ed White: For the shingles vaccine do you have expected timing to market.

Ed White: Oh, we haven't commented on a on a long term.

Kelly McDonald: So, you know, our exceptional commercial execution for Heplisav-B, along with our adjuvant supply business, of course, has created this strengthening of our financial profile. We certainly believe this strong position will help us drive further growth, including, you know, first and foremost, looking for opportunities to invest in driving growth in Heplisav-B, as well as advancing our organic clinical stage assets, as well as our preclinical portfolio. As we reflect on opportunities outside of that, you know, to Ryan's comments around corporate development, we do continue to evaluate strategic opportunities to diversify our commercial and clinical product portfolio. And then beyond that, certainly, we do evaluate and consider other opportunities to return capital to shareholders if and when appropriate, as well as other ways to generate value for our shareholders.

Ed White: Staticity of of our launch obviously, it's a it's a.

Ed White: Clinical development program. So we're taking the kids take multiple years to move forward. We have we have commented on the phase two trial and the specifications of that data in 2025, and then we'll have to roll forward from there Steven on Uhm expectations from the moving into the next study site in the study.

Ed White: Rolling it that dynamics to figure out when that would be able to to read out. So it's a little premature for us to predict the specific timing of filing the ultimate approval.

Ed White: We have provided general commentary that it's.

Ed White: Traditional vaccine development pathway.

Ed White: Good reference points for prior trials conducted in the space to get a sense of timelines taken for the study.

Speaker Change: Okay. Thank you.

Speaker Change: And so there are no adjuvant sale this year right.

Speaker Change: No I didn't fail this year and we don't we don't contemplate additional agent sales for a COVID-19 partnerships in 2024 at this time.

Kelly McDonald: So I'd say that's sort of the rank ordering where we stand today. Thanks all. Great. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Ernesto Rodriguez Dumont with Cowen. Your line is now open. Hi, everybody.

Speaker Change: Okay, and what about in 2025 and going forward.

It's unclear depends on how the market demand how the market is evolving how our individual collaborators products are are utilized in the efficacy flip yawn behind keeping up with the shifting landscape, including stream management.

Ryan Spencer: Thanks. Thank you for taking our questions and congratulations on a great year. I have a question about the effects that you described from the longer-than-expected respiratory vaccine season and the Q4 seasonality. Are those effects overcome during Q4 and Q3? Or do you have to internally adjust your estimates for 2024 based on that? And then there is a second question regarding gross margins. What's driving the improvement in gross margin? Is it economies of scale and lower cost, or are you expecting to have more pricing power? Thank you. Yeah, I'll take the first one, and Kelly, if you can handle the second one.

Speaker Change: So obviously will be supportive of our partners in their initiatives.

Speaker Change: Vaccination will continue globally for years to come in as an important product in the market place. So we will be there to support them as needed.

Speaker Change: Alright, thank you.

Speaker Change: Thank you.

Speaker Change: One moment for our next question please.

Avoid Buchanan: And next question comes from the line avoid Buchanan with citizens JMP. Your line is now open.

Ava Buchanan: Hey, Thanks for taking the questions. It's a couple of quick ones on the <unk> are you going to announce the results are they're not here and challenge trial on the safe too at the same time later this year.

Buchanan: Remind me are you, making any <unk> mediated immunity assessments in the in the <unk>, you think that might be important any thoughts on that.

Ryan Spencer: As far as I'm concerned, Ernie, thank you for the question. I interpreted the first part of the question to mean, does what we see in Q1 impact how we think about the rest of the year? Does it change how we update our guidance? I mean, ultimately, we only provide one guidance number when we're ready to provide it. So I don't, it's kind of hard to think about how individual factors impact it.

Speaker Change: I'll take the first one and then I'll try to follow up on a second one of the things you have to realize with the with the study with the funded by the D. O. D. Is this is data that is we have to work with it our duty partners on on the release data release, and so that has not been clarified yet on exactly what the opportunity will be.

Ryan Spencer: But like we said in the call script, we know that Q2 and Q3 will continue to be the strongest quarters of the year. And our continued interactions with our customers are incredibly positive. So we're excited to get out of the respiratory season and the respiratory vaccine season and start working with our customers in the non-respiratory part of the year to really drive growth in this market. Kelly, can you handle the gross margin? Sure. On gross margins for Heplisav-B, these margin improvements have been driven by a couple of things, but mainly, you know, just decreasing our per-unit manufacturing costs.

Speaker Change: Sure the data and what forum for either try also he needed basically complete these trials first Roy and we'll be able to make some top line comments like we have in the past, but we don't have data release plan across both trials together that will we will work to be able to present clarity on how the program is.

Speaker Change: Progressing in partnership with the D. O D. The primary 10 point is antibodies the raw that police tried any other commentary you have around some idiot immunity and play program. Yeah. The the primary is looking to antibodies because that's been that's D. O D is used to previously received develop this vaccine.

Kelly McDonald: We made a number of investments in our antigen manufacturing facility in Germany, and I'm really, really proud of the way that we've been able to pull through those improving yields over time to realize, you know, an estimate of approximately 80% gross margin for 2024. To reiterate a point that I made in the prepared remarks, we do expect this 80% gross margin range to represent levels that are consistent with our long-term expectations for this brand. Okay, very helpful. Thank you. Thank you, Ernie.

Speaker Change: Particularly with respect to looking antibodies nonhuman primates, and then applying those to humans, we weren't looking at so immediate immune to your T cells in our in the space to study.

Speaker Change: Okay. Thank you.

Speaker Change: Thank you.

Speaker Change: At this time I'd like to hand, the conference back over to Mister Ryan Spencer for closing remarks.

Ryan Spencer: Thank you operator, and thank you all for joining US today. We appreciate your interest in <unk>. We're excited about our recent accomplishments and the strength of our position overall, we look forward to update you on our progress focused on protecting the world against infectious diseases.

Kelly McDonald: Thank you. Thank you. One moment for our next question. Our next question comes from the line of Edward White with H.C. Wainwright. The line is now open. Hey, this is Steve on behalf of Edward White. A few questions.

Speaker Change: Operator, you may end the call.

Speaker Change: Ladies and gentlemen, thank you for joining US today. This concludes today's conference call. You may now disconnect everyone have a wonderful.

Speaker Change: Mmm Mmm mmm.

Speaker Change: [music].

Ryan Spencer: For the shingles vaccine, do you have an expected timing to market? Oh, we haven't commented on the long-term specificity of our launch. Obviously, it's a full clinical development program, so it would take multiple years to move forward. We have commented on the Phase I-II trial and the expectation of that data in 2025, and then we'll have to roll forward from there, Steven, on expectations for moving into the next study, citing the study, looking at enrollment dynamics to figure out exactly when that would be able to read out. So it's a little premature for us to predict the specific timing of filing an ultimate approval, but we have provided general commentary that this is a traditional vaccine development pathway, and there are good reference points for prior trials conducted in this space to get a sense of the timelines taken for those. Okay, thank you. And so there were no adjuvant sales this year, right?

Ryan Spencer: No adjunct sales this year, and we don't we don't contemplate additional adjunct sales for our co-lead partnerships in 2024 at this time. Okay, and what about in 2025 and going forward? It's unclear, depending on how the markets evolve and how our individual collaborators' products are utilized and the efforts they put behind keeping up with the shifting landscape, including stream management.

Ryan Spencer: So, obviously, we'll be supportive of our partners and their initiatives. We believe COVID vaccination will continue globally for years to come and is an important product in the marketplace, and so we will be there to support them as needed. All right, thank you. Thank you. One moment for our next question. Our next question comes from the line of Roy Buchanan with Citizens JMP. The line is now open. Hey, thanks for taking the question. Just a couple quick ones on the plague.

Ryan Spencer: Are you going to announce the results of the non-human challenge trial in phase two at the same time later this year? And can you remind me, are you making any cell-mediated immunity assessments in the plague phase two? And do you think those might be important? Any thoughts on that?

Rob Jansen: I'll take the first one, and then I'll ask Rob to follow up on the second. One of the things you have to realize with the study, with the funding by the DoD, is this is data that we have to work with our DoD partners on the release. And so that has not been clarified yet on exactly what the opportunity will be to share the data and in what forum for either trial. Also, we need to basically complete these trials first, Roy, and we'll be able to make some top-line comments like we have in the past, but we don't have a data release plan across both trials together. But we will work to be able to provide as much clarity on how the program is progressing in partnership with the DoD.

Rob Jansen: The primary endpoint is antibodies, but Rob, please provide any other commentary you have around cell-mediated immunity in the PLAIN program. Yeah, the primary endpoint is looking at antibodies because that's what DoD has used previously as they've developed this vaccine, particularly with respect to looking at antibodies in non-human primates and then applying those to humans. We aren't looking at cell-mediated immunity or T-cells in this Phase 2 study.

Speaker Change: [music].

Rob Jansen: Thank you. At this time, I'd like to hand the conference back over to Mr. Ryan Spencer for closing remarks. 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 overall. We look forward to updating you on our progress focused on protecting the world against infectious disease. Operator, you may end the call. Ladies and gentlemen, thank you for joining us today. This concludes today's conference call. You may now disconnect. Everyone have a wonderful day, www. ElectricUnicycles.eu ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? Go to Beadaholique.com for all of your beading supply needs!