This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk03: Good day, ladies and gentlemen, and welcome to Dynavex Technologies' first quarter 2024 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 participation instructions at that time. I would now like to turn the call over to Paul Cox, Vice President, Investor Relations and Corporate Communications. Please begin, sir.
spk10: Thank you for participating in today's call. Joining me from Dynavax are Ryan Spencer, Chief Executive Officer, Don Cassell, Chief Commercial Officer, Rob Jansen, Chief Medical Officer, and our Interim Head of Finance, Rita O'Connor. Earlier today, Dynavax released financial results for the first quarter ended March 31st, 2024.
spk09: Copies of the press release and a supplementary slide presentation are available on Dynavax's website. Before we begin, I advise you that we will be making forward-looking statements today based on our current expectations and beliefs, including but not limited to potential market sizes, market segmentation, effective marketing efforts, future expected market share, and related growth rates, and related ACIP recommendation impact on each. Financial guidance and trends, including revenue, profitability, cash flow, and sufficiency of current capitalization, timing and results of FDA submissions, clinical trial starts and data readouts, and potential future uses of or demand for our CPG-1018 adjuvant. These statements involve risks and uncertainties, and our actual results may differ materially. These risks are summarized in today's press release and detailed in the risk factor section of our SEC filings, including today's quarterly report on Form 10-Q. Our forward-looking statements speak as of today, and we undertake no obligation to update such statements. And with that, I will now turn the call over to Ryan. Thanks, Paul. Good afternoon, everyone. Thank you for taking the time to join us to review our Q1 2024 results. The first quarter of 2024 saw continued year-over-year growth in quarterly HFL-7b net product revenue, despite a slight decrease in the U.S. hepatitis B vaccine market during the first quarter. due to an extended cough, cold, and flu season, which reduced the number of vaccination opportunities, a dynamic which was observed across other non-restrictory vaccine markets beyond hepatitis B. Even with the slow start to the year, we remain very encouraged about the adult hepatitis B vaccine market opportunity, both in 2024 and over the longer term. We are seeing a pickup in the market in recent weeks as providers have begun to shift to non-restrictory vaccine campaigns. and as our retail pharmacy partners and top IDN systems launch new hepatitis B-focused initiatives. Hepatitis B became the market share leading hepatitis B vaccine for adults in the U.S. last year, and we plan to build on that position in 2024. We continue to expect record hepatitis B sales in 2024 with net product revenue expected in the range of $265 to $280 million for the year. Longer term, the U.S. adult hepatitis B vaccine opportunity remains significant with over 130 million patients eligible, one of the largest addressable patient populations in the U.S., with a vast majority remaining unvaccinated. We believe this translates to a market opportunity for HEPA-Sav-B of over $800 million by 2027, with HEPA-Sav-B poised to achieve a majority market share. We're also excited for several upcoming milestones from our novel vaccine pipeline, including the initiations of our Phase 1-2 trial for our shingles vaccine candidate, long-term follow-up data for our Phase 1 Tdap trial, and data readouts from our plague program. As a reminder, we look forward to our PDUFA action date on May 13th for the, for HEPLIS-FB supplemental BLA for vaccination of adults on hemodialysis, which is currently under review by the US FDA. In addition to this continued execution and bolstered by our strong financial position, we continue to assess opportunities to grow beyond our internal organic pipeline within the infectious disease space, which we believe would enable us to further diversify our product portfolio and create future commercial opportunities. As we've discussed previously, we remain committed to disciplined capital allocation focused on generating significant value and driving growth. We look forward to providing updates on these efforts in the future. I'll now turn the call over to Dawn and Rob, who will provide more details on the EPOSAB-B results and our pipeline progress, respectively, before Rita O'Connor reviews our financial results for the first quarter. As previously announced, our CFO, Kelly MacDonald, is currently on maternity leave, as Rita has stepped in as interim head of finance. supporting me in my temporary appointment as principal financial officer until Kelly's expected return in August. Don, can you take it away? Thank you, Ryan. In the first quarter of 2024, HEPLIS-IV achieved strong net product sales despite headwinds that affected the non-respiratory vaccine markets, including hepatitis C. On our last call, we said that growth in the U.S. hepatitis C vaccine market was expected to be flat during the first quarter, due to an extended cough, cold, and flu season. As expected, these dynamics played out, ultimately reducing the opportunity for adult vaccination in Q1, leading to a slight decrease in the hepatitis B vaccine market compared to the fourth quarter of last year, and a flat year-over-year growth compared to the first quarter of 2023. This dynamic has been observed across other non-respiratory vaccine markets as well. Headless FBE continued to increase its total U.S. market share year-over-year, achieving an estimated 41% market share in the first quarter compared to 37% during the same period last year. Net product revenue in the quarter grew 10% year-over-year compared to the first quarter of 2023. This sales growth continues to be driven by Headless FBE's strong performance in two critical segments, retail pharmacy and integrated delivery networks, or IDN. We estimate these segments will drive significant growth and represent over 60% of the total adult hepatitis B market in the U.S. by 2027. In both segments, Hepatitis B's first quarter estimated market share increased to approximately 55% compared to approximately 49% during the same period last year. Despite the softness in the market in the first quarter, we continue to see indicators of U.S. market expansion from the ACIP universal recommendation for adult Hepatitis B vaccination, reaffirming our confidence in a sizable market opportunity and long-term revenue growth potential for Hepatitis B. Large health systems and providers are gaining awareness and agree they need to act on the ACIP universal recommendation. Many large systems have committed to launching new Hepatitis B focused initiatives over the next several quarters to effectively implement the recommendation. over half of our targeted IDN universe has increased hepatitis B dose volume year over year. While system-level changes take time to enact, we are encouraged by the progress we see as our systems work to implement operational changes to support routine adoption of the ACIP universal recommendation. In the retail pharmacy segment, we have made meaningful progress with several large national chains, slicing hepatitis B in a preferred position among adult hepatitis B vaccines. Despite the slow start in Q1, retail customers are mobilizing around the opportunity of hepatitis B vaccination. Several customers have indicated a clear shift away from respiratory vaccines to a focus on non-respiratory vaccines, such as hepatitis B. Given these positive trends and customers' commitment to prioritize hepatitis B vaccination for the rest of the year, We are forecasting the retail segment to meet our annual expectations for 2024 and make a considerable impact to HEPA-Savvy's success this year. As Ryan noted, we are reaffirming our full-year 2024 net product revenue guidance for HEPA-Savvy to be in the range of $265 to $280 million. As mentioned, We've already seen signs of the market strengthening early on in Q2 as the focus of healthcare providers and retail pharmacies shifts back to prioritizing non-respiratory vaccines. 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 hepatitis B gaining meaningful increases in total market share over that time. We continue to expect the hepatitis B vaccine market opportunity for Hepatitis B to grow to over $800 million in the U.S. by 2027 from approximately $525 million in 2023. In summary, we are reaffirming our confidence that Hepatitis B will strengthen its position as a clear market share leader in the expanding hepatitis B vaccine market, and we expect 2024 will be another year of record sales and continued growth. We are very proud of our commercial team's execution in establishing headless FBE as the market share leader in the U.S., and we look forward to continuing this momentum in the remainder of 2024. I will now turn the call over to Rob to take you through our clinical pipeline.
spk07: Thank you, Don. We continue to make progress advancing our innovative vaccine pipeline, which is focused on leveraging our CPG1018 adjuvant with proven antigens. Starting with our shingles vaccine program, Z1018. As a reminder, we believe there's an opportunity to develop and improve shingles vaccine given the challenging tolerability profile of the current market-leading product. One of the unique advantages, we believe, 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. We previously conducted a phase one trial of Z1018 in 150 subjects at clinical sites in Australia. We believe the results from this 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. Late last year, we received type B meeting feedback from FDA on the Z1018 program, which we believe is supportive of our proposed clinical development plan that includes a pivotal placebo-controlled efficacy study. During the second quarter of 2024, we plan to initiate a randomized active controlled phase 1-2 trial to evaluate the safety, tolerability, and immunogenicity of Z1018 compared to the licensed recombinant vaccine. We plan to enroll approximately 440 healthy adults aged 50 to 69 years at trial sites in Australia. We will be evaluating escalating doses of our GE protein, our selected dose of CPG1018 with or without alum, and different vaccination schedules. We anticipate top-line immunogenicity and safety data in the second half of 2025, which will include a comparison of CB4 positive T cells one month after the last vaccine dose. In March, we received FDA clearance of our IND application for this trial. Turning next to the Tdap1018 program, this is an investigational vaccine candidate that's intended for active booster immunization against tetanus, diphtheria, and pertussis, or Tdap. Current Tdap vaccines have limitations, including waning effectiveness, and we believe there's an opportunity to improve the duration of protection using our CPG1018 adjuvant to generate a Th1-biased immune response. In 2022, Dynavax reported top-line results from a Phase I clinical trial, evaluating the immunogenicity and safety of a booster dose of Tdap1018 compared to an active control. The results demonstrated that Tdap1018 was generally well-tolerated and induced similar or higher antipertussis antibodies and booster response rates than the active control. Prior to advancing Tdap1018 into a previously announced phase two human challenge trial, DynaVax plans to evaluate the persistence of pertussis immunogenicity of Tdap1018 through a long-term follow-up study of participants who completed our phase one trial. The extension study is expected to follow participants for up to approximately three years following vaccination. Topline results are expected in the fourth quarter of 2024. These data will provide us with a view of how the TIDAP-1018 immunogenicity response over time compares to the active control and will help establish our views on the potential benefits that can be achieved with our vaccine candidates. Moving on to the plague vaccine program, which is in collaboration with and funded by the US Department of Defense. In March, we executed a contract modification with DOD to add approximately $4 million to support CMC work for the plague vaccine candidate, with the agreement now totaling $38 million through 2025. We anticipate top line data from both the randomized active control phase two clinical trial, as well as the non-human primate challenge study of the plague vaccine candidate in the fourth quarter of 2024. These data will inform next steps for the program. We're pleased with this progress across our pipeline, and we look forward to executing on these upcoming milestones in the coming months. We also continue to identify new opportunities to leverage our CPG 1018 adjuvant through multiple innovative programs with biotech and academic collaborators. I'll now turn the call over to Rita to review our financial results.
spk00: Thank you, Rob. I'll review the key financial results for the first quarter of 2024, as well as our financial guidance for the full year of 2024. Please note that all financial comparisons are versus the prior year period, unless otherwise noted. Please refer to our press release and Form 10-Q for more detailed financial information. Starting with HEPLIS FB, net product revenue grew 10% year-over-year to $48 million in the first quarter of 2024. Cost of product sales for HEPLIS FB in the first quarter of 2024 decreased to $11 million compared to $15 million for the prior year period. The decrease was primarily due to lower per unit manufacturing costs as a result of previous process improvements partially offset by a $1 million inventory write-off charge recorded during the first quarter of 2024. We continue to be pleased with the HEPA-Sav-B margin profile trend with growth margin of about 77% in Q1 of 2024, a significant improvement over the 66% in the first quarter of 2023. We continue to expect growth margins of approximately 80% for the full year of 2024, which is consistent with our long-term expectations of margin profile for HEPA-SATB. Other revenue is about $3 million for both the first quarter of 2024 and 2023. representing revenue related to the plague vaccine program in collaboration with and funded by the U.S. Department of Defense. Turning to our expenses, research and development expenses were $14 million for both the first quarters of 2024 and 2023. Expenses in 2023 included the completion of clinical trials for our pipeline programs, whereas the first quarter of 2024 reflected activities for planned clinical trials as well as increases related to investments in our CPG-1018 preclinical and clinical collaborations. Selling general and administrative expenses for the first quarter of 2024 were $44 million compared to approximately $37 million for the prior year period. The increase was primarily driven by increased headcount and other investments supporting our strategic growth, including an overall increase in targeted commercial and marketing efforts designed to increase HEPA SABB market share and maximize the opportunities presented by the ACIP's universal recommendation. Sublease expense was $1.6 million in the first quarter of 2024, compared to sublease income of $1.6 million in the prior year period. This change reflected the termination of our original lease with a non-cash charge of $3.5 million, partially offset by income of $1.9 million during the period. Including this one-time non-cash charge, we expect to record approximately $5 million of net sublease income for the full year of 2024. These results generated a net loss of $9 million in the first quarter of 2024 compared to $24 million during the prior year period. Moving to the balance sheet, we ended the first quarter of 2024 with cash, cash equivalents, and marketable securities of $724 million, which we believe is sufficient to progress our current pipeline assets and support our organic-based business without the need to raise additional capital. And now to summarize our financial guidance. we are reaffirming our prior full year 2024 financial guidance as follows. HEPLIS FB net product revenue expected to be between approximately $265 and $280 million, including approximately $3 million in ex-US sales through our commercialization partnership in Germany. We expect HEPLIS FB gross margin of approximately 80% for the full year of 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. And we also expect cash, cash equivalents, and marketable securities to be higher at the end of 24 as compared to December 31st of 23. reflecting our continued discipline towards allocating capital to drive top-line revenue growth while thoughtfully advancing our research programs. I would now like to turn the call back over to Ryan before we start the Q&A section.
spk09: Thanks, Rita. In closing, we believe that our strong financial position and proven ability to execute, we are well-positioned to drive sustainable growth in our core HEPA-Sub-B business by capturing majority U.S. market share. and leading 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 base 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. Operator, we would now like to open the Q&A portion of the call.
spk03: Thank you. To ask a question, you'll need to press star 11 on your telephone. To withdraw your question, please press star 11 again. Please wait for your name to be announced. Please stand by while we compile the Q&A roster.
spk01: One moment for our first question, please. Our first question will come from the line of Matthew Phipps with William Blair.
spk03: Your line is now open.
spk10: Good afternoon. Thanks for taking my question. First, I guess the retail market share looks like it did dip a little bit from Q4 to Q1, 58% to 55%. I realize, one, these are somewhat assumptions, but just wondering if there's anything lumpy in there, or did anything else change with any contracts that caused that to happen?
spk09: Hey, Matt. It's Don. Nothing really changed. I mean, you know, market share, there will be slight variations in market share. I mean, it's related to purchasing patterns of some of our larger customers. But, you know, for us, you know, we continue to expect to take market share both in retail and as well in IDN. So it's really more so around these, you know, purchasing patterns of some of the larger customers.
spk10: Yeah, that makes sense. And then, Rob, a question on the shingles program. One, could you just maybe tell us how many total arms are in the trial? Just kind of wondering how many patients will be in each trial to get a sense of, you know, powering you might have for the immunogenicity endpoint. And then also, did you, I can't tell if you confirmed that a potential pivotal trial would be placebo controlled or that's just kind of still the hope and you need to still have those conversations.
spk07: So, Matt, We will be enrolling 10 arms to receive Z1018 and then a Shingrix arm. So there will be 11 arms with 40 subjects in each arm. And, you know, which is a reasonably large number for a phase one study, but it's really so we can get a good sense of what CD4 responses are. Now, with respect to placebo-controlled, we have communicated with the FDA and heard from them that that placebo-controlled efficacy study would be acceptable for review for a license.
spk10: Great. And then maybe one last one for Ryan. Do you almost hesitate to make any real big decisions with regards to your cash balance until you see that immunogenicity data from the Shingles program in the second half of next year? Is that almost a, you know, you just kind of want to make sure you have all your options open until you get to that data? Or is that not the case?
spk09: No, it's certainly one of the elements on how we think about managing our capital position. One, you know, we've talked a lot about this. we're in a favorable position to be able to fund our development programs, as well as the opportunity to settle our convert when it comes due in 26. And so we like to be able to maintain all of our optionality as it relates to being able to advance our pipeline. So it's definitely a factor in how we manage our capital structure overall.
spk02: Great. Thanks for taking my questions.
spk01: Thank you.
spk02: Thanks, Matt.
spk03: One moment for our next question. Our next question comes from the line of Paul Cho with Goldman Sachs. Your line is now open.
spk08: Hi. Good afternoon, team, and thanks for taking my question. I also want to follow up on shingles as well. And can you maybe comment on, you know, how you thought about the trial design for your study, particularly in the context of recent data from Curvo, you know, which showed 100% immunogenicity? Any thoughts on patient selection and or trial design? endpoints and such that you can comment on and just where you think you can possibly show the most differentiation, either on efficacy and or safety. And secondly, just with regard to HEPLICEV, can you maybe just comment on just sort of retail chain behavior, that share gains continue to look good, but just curious if you're seeing more activity, if you could elaborate a little bit more on the activity levels in the retail channel in particular. Thank you very much.
spk09: Thanks, Paul. Rob, why don't you take the first question on shingles, and Don, you can address the retail question. Yep.
spk07: Right. So the study really is designed to identify the antigen, the GE antigen. This is the first time our GE antigen, this is the first in humans, first time it's been in people. So we'll be looking at different levels of antigen. So the trial is designed to look at different levels of antigen to increase CD4 counts. and we'll also be looking at different regimens. We're looking at a couple of different regimens in terms of time between doses, again, to increase CD4 counts. Now, to look at reactogenicity we're developing, and we've been communicating with FDA about it and how to go about doing it, and that is reactogenicity and how can we design future studies that would be label-enabling to put reactogenicity data in the label. And we're looking at, you know, sort of standard global impression of severity changes in symptoms, health-related quality of life, those types of already instruments that already exist. But we'll also be looking to develop potentially our own instrument in this study and then to validate it for use in a phase three study.
spk09: And Paul, just to put a finer point on it, when we think about the ways to measure immunogenicity, we've been very clear and transparent that we believe that CD4s are critical for this vaccine. And so, when we think about the way we've talked about our data, it's been very deliberate to be focused on what we think is some of the most critical endpoints. There's a variety of ways to measure immunogenicity with percentages of response to different measures. But for our trials, we've been very clear about the importance of CD4s, and that's what we will continue to focus on as we progress.
spk08: Got it. And on the retail front?
spk09: Hey, Paul. It's Don. To put a bit more color on the retail behavior, there's been a dramatic shift, if you will, in the retail segment as it relates to non-respiratory vaccines and focus on those vaccines coming off the respiratory season.
spk08: You're seeing certainly a lot of focus by those retailers as it relates to various tactics to increase awareness, to continue to run initiatives, both not only awareness for the pharmacists themselves, but also advertising out to consumers.
spk09: They're all rallying around the fact, you know, it may is Hepatitis B Awareness Month, but there's a lot of focus, again, on setting up the infrastructure, if you will, to take advantage of that opportunity as well. Again, a drastic shift, if you will, on focus by the retail chains as it relates to hepatitis B vaccination.
spk08: Great. Thanks for the caller. I'll jump back in queue.
spk03: Thank you. One moment for our next question. Our next question comes from the line of John Miller with Evercore ISI. Your line is now open.
spk05: Oh, hi. This is from John. Thanks for taking our question. I guess the first one, how is the seasonality profile developing as the market gets more penetrated? When do you expect to see the biggest growth for the remaining of the year? And I guess second, on TDAP, I guess why delaying the TDAP phase two trial, and how will the phase two design change based on learning from the extension of phase one? Thanks.
spk09: Okay, let me comment on seasonality first, and Dawn, if you have anything to add, please feel free. It's pretty clear that Q2 and Q3 we expect will continue to be the largest quarters in the adult hepatitis B vaccine market for a variety of reasons. And I think the market growth doesn't really change. the belief that we still believe Q2 and Q3 will be the largest quarters of the year and the years in the future, recognizing that we do expect there will always be seasonality due to the fact that significant respiratory vaccine is given in the Q4, Q1 time period. So we expect that seasonality to continue even as we see market growth. Don, good? Yeah, it's good. And then I think the other question, just at a high level, on Tdap. I'll take that to, and Rob, please add any color that you feel is important. But the decision here to delay the phase two challenge study was as a response to the regulatory feedback that we received related to the PRN positive versus PRN negative strain for pertussis recognizing that the FDA is interested in the PRN-negative strain that we would conduct in the future. We didn't need to conduct a positive pilot study now, and we decided to make the decision to focus on the PRN-negative strain in the future when available, which also happened to allow us to see the results of this Phase I extension study. So it doesn't have an impact on the overall timeline, but it does allow us to have you know, insight into the durability of our product prior to advancing into any other clinical studies. All right. Thanks, Mike. All in all, I think it's actually a very favorable opportunity to be able to increase our understanding of the product before investing further in additional clinical trials.
spk05: All right. Thank you.
spk03: Thank you. One moment for our next question, please. Our next question comes from the line of Ed White with HC Wainwright. Your line is now open.
spk10: Good evening. Thanks for taking my questions.
spk02: Just to stay with the Tdap, so how is the timing of the Phase II going to be affected? When do you expect to start that study?
spk09: As the phase two we started, it really is still kind of up in the air. We do need to have the PRN negative strain available, and that's being developed, so it depends on the availability of that strain. I think the key point, though, is that study is one component of the overall development plan. The longer lead times in this development plan will be the immunogenicity data, which in our view is going to be critical to have that data develop over time to show durability. that can be part of our submission. So the Tdap challenge study is not on the critical path, I think, is the way to think about it. It's a very valuable study because it'll show the antigens are efficacious, which we have a high confidence that they will be, and that with the presence of our adjuvant, we expect to improve over existing vaccines. So ultimately, what will gate that timing will be the availability of the PRN-negative strain.
spk02: Okay, thanks, Ryan.
spk09: And as you have the BLA, excuse me, the PDUFA on May 13th for hemodialysis patients, I'm just wondering if you can quantify, you know, what that means to them, what the impact could potentially be, you know, not only this year, but going forward. Yeah, I mean, we talked about this a little bit in the past, that the yeah, you already noted that May 13th is the PDUFA date. It's too really purely to comment on the impact of any revenue expectations, but we will know, like we've said in the past, obviously it does take time to engage customers, and merely having the PDUFA, it gives us that license to hunt and actually engage them commercially, so we'd expect it's going to take time, like with any other customer, to be able to engage them and in an effective manner. So we made no comment on the revenue expectations from this particular regulatory event, but we will continue to provide updates as we progress.
spk02: Okay. Thanks, Ryan, for taking my questions.
spk01: Thank you.
spk03: One moment for our next question. Our next question comes from the line of Phil Nadeau with TD Cowan. Your line is now open.
spk04: Good afternoon. Thanks for taking our questions. One follow-up question on seasonality, appreciating, it's probably a hard question since we're all dealing with imperfect information, but do you have a sense as to whether this year the seasonality was particularly bad given that it was early in the availability of RSV vaccines and people are still getting shots for COVID? Is there any reason to think that the seasonality and the decline in the HPV market in Q4 and Q1 won't be as bad in future years, or is that just hard to know at this point?
spk09: Hey Phil, it's Don. I think it's a little hard to know, a little early to kind of call it, but, you know, certainly, and the feedback we've been receiving from our retail customers in particular is, you know, learning new vaccines, RSV, COVID, a lot was thrown at the retailers all at once. Now that, you know, they've gone through it once, you know, going into this year, they'll be better prepared to understand, you know, what's going to be in store for that, you know, respiratory season. So, you know, we sort of see that as an opportunity moving forward. But probably too early to tell how it looks every year thereafter, but certainly we expect this year to be a little bit different because our customers are a little bit more prepared for anticipating the onslaught of all these different vaccines in the space.
spk04: Okay.
spk09: And then on the . Sorry, yeah. Just one, just to add on to that is also remember the winter season and how cough, cold, and flu, COVID, other things, Those are variables as well as how they impact wellness visits or opportunities for vaccination. So that's going to always be variable across the season. So we just have to keep that in mind that it's not only market dynamics, there's also disease dynamics at play that will be variable.
spk04: Do the RSV vaccines have a requirement that patients not be vaccinated for something else like HPV for weeks before or weeks after receiving the RSV vaccine?
spk09: Did you say the RSV vaccine?
spk04: Yeah, specifically for RSV. Is there required to be a window of no other vaccinations around that vaccine?
spk09: No, not in particular. Okay. Just be aware, Phil, concomitant data is very rare for there to be specific information around how to treat other vaccines within one vaccine's label. Phil, it's more around the operational hurdles, quite frankly, about just operationalizing a new vaccine and vaccine launches versus concomitant administration as being the barrier for our retailers in particular.
spk04: Got it. In terms of hemodialysis, I think in the past you've suggested that there is some use of HEPA-SAV already in the market. Do you mind if that's true and if you have any estimates of penetration in the hemodialysis market currently?
spk09: Yeah, no, there's definitely utilization in the marketplace. So, yeah, and you're right. We have commented on that before. We have not commented on specific penetration or share other than our comments on retail and IDN. And like we have said before, until we have our SBLA approved, we're going to refrain from getting into too many details on this segment.
spk04: Great. Thanks for taking our questions.
spk09: Thanks, Phil.
spk03: Thank you. Thank you, Phil.
spk01: One moment for our next question. Our next question will come from the line of Roy Buchanan with Citizens JMP.
spk03: Your line is now open.
spk06: Hey, thanks for taking the question. Just a quick follow-up on PDEP. I guess, how many patients are you expecting in the extension trial? And it says in the press release versus active control. So you're going to be looking at both the Tdap 1018 and the Boostrix arms. It seems like a lot of patients have probably been off the trial for a while, maybe gone on to other things. Are you going to look at both the adults and the adolescents?
spk07: We'll just be looking at the young adults, Roy. We won't be looking at adolescents who are too few. And the number of subjects we were looking to try to enroll was up to 50. And we'll be comparing TDAP 1018 to boosters.
spk06: Thanks.
spk09: Yeah, and Roy, just a couple elements there. You already noted the trial was conducted a while ago, so we'll have two to three years of follow-up on these patients, and the ultimate number is going to be depending on how many we can get to return, given some of the challenging factors you noted. But we expect that we'll be able to have some interesting data from the follow-up.
spk06: Okay, very good. Thank you.
spk03: Thank you. We have no further questions at this time. I would now like to turn the call over to Mr. Ryan Spencer, Chief Executive Officer, for closing remarks.
spk09: Thank you, operator, and thank you all for joining us today. We appreciate your interest in Dynavax. We are excited about our recent accomplishments and the strength of our position. We look forward to updating you on our progress focused on protecting the world against infectious diseases. Operator, you may end the call.
spk03: Ladies and gentlemen, thank you for joining us today. This concludes today's conference call. You may now disconnect, everyone. Have a wonderful day.
Disclaimer