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.
spk02: Good day, ladies and gentlemen, and welcome to the Dynavax Technologies fourth quarter and full year 2021 financial results call. As a reminder, this conference call is being recorded. At the end of the company's prepared remarks, we will open the call up for questions and provide specific instructions at that point. I would now like to turn the call over to Nicole Arndt, Senior Manager, Investor Relations. You may begin.
spk08: Thank you. Good afternoon and welcome to the DynaVax fourth quarter and full year 2021 financial results and corporate update conference call. In addition to our press release issued today, a supplementary slide presentation that accompanies today's call is available in the events section of our website. Before we begin, I advise you that we will be making forward-looking statements today, including but not limited to statements regarding potential market sizes, impact of ACIP recommendations, financial guidance and trends, and potential future uses of CPG-1018 adjuvant. These statements involve risks and uncertainties that could cause actual results to differ materially. These risks are summarized in today's press release and are detailed in the risk factor section of our 10-K file today with the SEC. We encourage you to review. Our forward-looking statements speak as of today and undertake no obligation to update such statements at a later date. During today's call, Brian Spencer, our CEO, will provide an overview of our 2021 corporate performance and strategic priorities. John Casalvo, Senior Vice President of Commercials, will review the commercial performance of HEPOS-SB. Rob Jansen, our Chief Medical Officer, will provide an overview of our current performance Clinical Pipeline, and Kelly McDonald, our CFO, will review our 2021 results and provide financial guidance for 2022. I'll now turn the call over to Ryan Spencer.
spk07: Thank you, Nicole, and thank you all for joining us today. 2021 was a truly transformative year for DynaVax. We successfully executed on our core priorities, which are driving HEPA-CEP growth, advancing our CPG1018 adjuvant supply business for COVID-19 vaccines, and building a clinical pipeline leveraging our proven adjuvant technology. Strong execution of these core priorities enabled record total revenue of $439 million, our first full year of profitability, and $546 million in cash and investment to end 2021. Importantly, we expect to continue to grow revenue in 2022 for both HEPLIS FB and CPG-1018 adjuvant supply and anticipate another year of profitability. We believe the strength of our current financial position, plus the significant revenue growth expected in 2022, provides a solid foundation for our future success as we continue to advance opportunities to leverage commercial capabilities and our proven adjuvant to deliver value for patients and our shareholders. We are extremely pleased with Heflis FD's performance in 2021, achieving $62 million in net product sales, which represents 70 sales growth compared to the previous year. Looking forward, we expect continued revenue growth from increased market share and growth in the U.S. adult hepatitis B vaccine market as healthcare services return to normal operation and as a result of the recent action by the CDC to expand the recommendation for hepatitis B vaccination to all adults age 19 to 59 years old. We believe the adult hepatitis B vaccine market has the potential to grow to $800 million by 2027, and that HEPLIS-FB has the profile to garner a majority market share. Moving to our next core priority. In support of the global effort to address the ongoing pandemic, DynaVac established multiple CPG-1018 adjuvant supply partnerships to support the development of technologically diverse COVID-19 vaccines. These partnerships have led to a portfolio of global commercial supply agreements to which DynaVax generated CPG-1018 adjunct revenue in 2021, totaling $375 million. Our COVID-19 supply partners have generated significant data demonstrating the efficacy, immunogenicity, and safety of their COVID-19 vaccines, which has led to two emergency use authorizations and multiple additional regulatory applications with responses anticipated in the first half of 2022. our COVID-19 supply partners continue to expand their clinical data to support broad utilization of their vaccine. This includes additional clinical trials to support homologous and heterologous boosters and elderly and pediatric indications. Based on the impressive phase three data sets across our COVID-19 partnership portfolio, we believe the combination of high efficacy and immunogenicity with favorable safety and tolerability could be very competitive profiles as the COVID-19 vaccine landscape evolves to an endemic market. These data reinforce our belief that CPG1018 is a unique and valuable adjuvant for the development of improved and novel vaccines. Beyond COVID-19, we are leveraging CPG1018's profile in our clinical pipeline to develop new and improved vaccines. We've identified and advanced two programs and shingles that, if successful, could provide significant U.S. and global revenue opportunities. Our near-term goal this year is to generate initial clinical data that we anticipate will support meaningful differentiation to establish our high-value pipeline designed to produce best-in-class products targeting large markets. Additionally, we are conducting preclinical efforts to develop candidates utilizing CPG-1018 to improve the immune response to existing vaccine antigens, as well as truly novel products targeting diseases with no current vaccine options. In 2022, we anticipate another profitable year driven by increasing revenue from our CPG-19 adjuvant supply business, COVID-19 vaccines, and from increasing Hepatitis B sales. With $546 million in cash and equivalents at year end, we are well capitalized to invest diverse portfolio of assets. We believe the combination of a strong financial profile, revenue-generating assets, and an emerging pipeline of product candidates based on our proven adjuvant technology provides a solid foundation for DynaVax's future. We are immensely proud of our results this past year. Our achievements in 2021 and the opportunities we believe lie ahead are made possible by the hard work and dedication of our talented team. I will now turn the call over to Don Casal to provide more details on Hepatitis B performance. Thank you, Ryan. 2021 was an exceptional year for Hepatitis B. I'm excited to share that. Despite the ongoing impact of the pandemic, Hepatitis B achieved record performance and all-time highs in revenue and market share growth. Hepatitis B is the first and only FDA-approved adult hepatitis B vaccine that allows series completion with only two doses in one month. Series completion is essential for protection. Unfortunately, most adults never complete a three-dose hepatitis B vaccine series. Efficient series completion is more critical now than ever in the era of universal adult hepatitis B vaccination. Two-dose hepatitis B can make series completion easier and protect more patients faster. In 2021, hepatitis B achieved $62 million in net product revenue, the highest annual revenue since launch. This annual revenue outcome represents a 72% increase compared to 2020 and was achieved despite the hepatitis B market remaining below historical norms due to the pandemic. During the fourth quarter of 2021, total hepatitis B market utilization was at 66% of pre-pandemic levels. Additionally, the hepatitis B market decreased by approximately 25% from third quarter due to seasonal purchasing patterns of key segments and COVID-19 booster administration campaign. This market decline was consistent with the expectations we shared during our last earnings call. By these headwinds, HEPLIS FB's total market share in the fourth quarter increased to 26%, up from 18% during the same period last year. We continue to believe that investing in HEPLIS FB to increase market share will be a meaningful driver of revenue over time as the pandemic begins to subside. In addition to continued growth in total market share, HEPLIS FB field-targeted market share increased to 34% in the fourth quarter, up from 26% during the same period last year. Furthering our positive outlook for HEPLIS FB, the CDC Advisory Committee on Immunization Practices, or ACIP, voted unanimously at their November meeting to recommend that all adults 19 to 59 years of age should receive hepatitis B vaccination. This recommendation simplifies the identification of patients who need a hepatitis B vaccine compared to the prior risk-based recommendation and significantly expands the number of adults in the U.S. who should be vaccinated against hepatitis B. With the ACIP universal recommendation, hepatitis B vaccines have the potential to become one of the most widely used adult vaccines across healthcare systems. We believe that the ACIP recommendation will be a significant catalyst for growth and we estimate that market opportunity could grow to over $800 million by 2027, with HEPLIS-M being well-positioned to secure majority of the market share over time. We remain confident in our ability to generate momentum and look forward to continuing to drive long-term growth for the brand. With a proven clinical profile and strong commercial execution, we expect further market share gains and revenue growth in 2022. Taking you through our clinical pipeline, I will now turn the call over to Rob Janssen, our Chief Medical Officer.
spk03: Thank you, Don. CPG1018 has demonstrated its ability to enhance the immune response with a favorable tolerability profile established through a wide range of clinical trials and real-world commercial use. We're very excited to advance our clinical pipeline leveraging CPG1018 to develop improved vaccines in indications with unmet medical need. During 2022, our studies will generate initial clinical data that we anticipate will begin to support meaningful differentiation from the existing vaccines. First, our improved tetanus diphtheria and pertussis, or Tdap vaccine program. Since 1991, when acellular pertussis vaccines replaced whole cell vaccines, pooping cough cases increased by 85% in the United States due to waning efficacy and asymptomatic transmission. Last year, we initiated a phase one clinical trial evaluating an improved Tdap vaccine that uses our CPG1018 adjuvant. Top line safety, tolerability, and immunogenicity data in adults are expected in the first half of 2022, with adolescent data expected in the second half of 2022. Second is our CPG1018 adjuvanted shingles vaccine program. Shingles is a painful condition that results from the reactivation of a latent varicella zoster virus infection, more commonly known as chickenpox, with attacks leading to potential complications, including chronic pain, which can be debilitating. Now, while an effective vaccine currently exists, we believe there is an opportunity to significantly improve the reactogenicity profile while maintaining comparable efficacy. Our product candidate will be adjuvanted with CPG1018, which has demonstrated its ability to enhance the immune response without excessive reactogenicity in both HEPLIS-MV and multiple COVID-19 vaccines. We believe the CPG1018 mechanism of action is ideal for an improved shingles vaccine, as it's been shown to elicit CD4 T-cell responses, which are key in controlling reactivation of the zoster virus and preventing shingles. In late January, we dosed the first patient in a phase one study designed to evaluate safety, tolerability, and immunogenicity. Data from this trial are expected to be available by the end of 2022. Finally, in the second half of 2022, we anticipate initiating a Phase II clinical trial for a plague vaccine utilizing our CPG-1018 adjuvant. This clinical trial is being conducted in collaboration with and funded by the U.S. Department of Defense. We believe leveraging the proven profile of CPG 1018 enables us to develop vaccine candidates that have significant opportunities with lower development risk. I'll now turn the call over to Kelly to review our 2021 financial results and provide our 2022 financial guidance.
spk09: Thank you, Rob. I'm very excited to highlight our strong financial performance for the fourth quarter and full year 2021 and review our 2022 financial guidance. For additional information, please refer to our press release and our 10-K filed with the SBC this afternoon. Overall, 2021 marked a historically strong year for DynaVac. We took several actions in 2021 to position ourselves for future success and significantly strengthen our financial profile. These steps included the execution of multiple COVID-19 vaccine adjuvant supply agreements, expansion of our commercial footprint by more than 50% to drive market share and position HEPLISA-B for long-term growth. And we exited the year with an established and focused clinical pipeline, including our recently announced shingles phase one trial. This strong execution led to DynaVac's first ever full year of profitability with gap net income of $77 million. And now we'll move on to financial highlights for the year. Starting with revenues. We delivered total revenue of $439 million for 2021. For the full year 2021, Heplicev VH generated net sales of $62 million, up 72% from $36 million in 2020. Additionally, DynaVax delivered $375 million in CTG 1018 adjuvant revenues in 2021, an exceptional year in achieving our previously issued 2021 financial guidance. In the fourth quarter of 2021, we reported $17 million in helpless FB revenue, up nearly 50% compared to $12 million in the fourth quarter of 2020. And we recorded $177 million in adjuvant sales under our COVID-19 commercial supply agreements in the fourth quarter, representing approximately half of the CPG-1018 revenue recorded for the full year in 2021. Looking ahead to 2022, we continue to be bullish on our ability to execute our strategy to supply CPG 1018 to a diverse portfolio of COVID-19 vaccine developers. And based on our existing commercial supply agreement, we expect at least $550 million in CPG 1018 net revenues for 2022. This guidance represents at least 47% growth year-over-year. Moving on to expenses. OUR RESEARCH AND DEVELOPMENT EXPENSES FOR THE FULL YEAR OF 2021 WERE APPROXIMATELY $32 MILLION, COMPARED TO $29 MILLION IN 2020. SELLING GENERAL AND ADMINISTRATION EXPENSES FOR THE FULL YEAR OF 2021 WERE $100 MILLION, COMPARED TO $79 MILLION FOR 2020, WITH THE INCREASE PRIMARILY DRIVEN BY THE MID-YEAR EXPANSION OF OUR HEPLICEV-B FIELD SALE TEAM. MOVING ON TO PROFITABILITY AND CASH. FOR THE FULL YEAR OF 2021, DynaVax generated GAAP net income of $77 million, or $0.62 per share basic and $0.57 per share diluted. This is compared to a net loss of $75 million, or a loss of $0.75 per share basic and loss of $0.78 per share diluted for the full year of 2020. I'd like to take a moment to point out two unique items on our income statement. First, we utilized $158 million in NOLs to reduce 2021 taxable income. And second, our gap net income includes non-cash fair value adjustments for the then outstanding warrants. During the full year 2021, the impact to net income from these fair value adjustments was a loss of $49 million. This is compared to a gain of $4 million in the prior year. We expect these quarterly adjustments to be complete after the first quarter of 2022, given that the warrants recently expired. From a cash perspective, DynaVax generated $336 million in cash from operations for the full year of 2021 and ended the year with a very robust balance sheet, including cash, cash equivalents, and marketable securities on hand of $546 million compared to $165 million as of December 31, 2020. Turning now to our 2022 financial guidance, as mentioned earlier, we expect 2022 CPG 1018 adjuvant revenues to be at least $550 million for the year with corresponding growth margin of approximately 50% with potential fluctuations quarter to quarter depending on customer mix. This guidance represents revenue growth of at least 47% year over year. As we continue to invest in building a durable and sustainable business, we expect SG&A expenses for 2022 to be in the range of $120 million to $140 million for the full year of 2022. reflecting a full year of our expanded sales force supporting the significantly expanded market opportunity for HEPLIS-MV and in support of our core business processes. We anticipate R&D expenses to be between $55 and $70 million, and we expect to deliver multiple clinical catalysts by the end of the year with our Tdap and shingles adjuvanted vaccine programs, as well as our fully funded contract with the Department of Defense for a Phase II clinical trial in place. Expenses related to the plague clinical trial will be fully funded by the U.S. Department of Defense, with such offsetting revenues to be reported top line in other revenues. Lastly, we expect to realize the benefit of a full year of reduced interest expense associated with our 2021 debt refinancing, translating to expected interest expense in 2022 of approximately $7 million, which represents a 40% decrease from full year 2021 interest expense. We believe that continued execution on our priorities, coupled with our cash balance and the numerous steps taken to strengthen our financial profile, position us well for 2022 and beyond. Delivering shareholder value is at the heart of successfully meeting our strategic priorities. This includes driving HEPA-SAB-B market share, executing on our CPG-1018 adjuvant supply partnership, and a disciplined allocation of capital to advance our clinical pipeline, leveraging our adjuvant. Lastly, and in closing, I would like to echo Ryan's comments on the incredible DynaVax team and their commitment and effort towards our mission. I'd like to pass on our sincere thanks to each of our teammates for their hard work and dedication. Thank you, everyone, for your attention today. Operator, we would now like to open the Q&A portion of today's call.
spk02: Thank you. To ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Phil Nadeau of Cohen. Your line is open.
spk01: Good afternoon. Congratulations on a very productive year. A couple questions from us. So first on the CPG guidance, how much of the $550 million in revenue are from binding agreements where – you're very confident that the revenue is going to come in versus how much is a prediction of a future demand.
spk07: Thanks, Phil. The guidance we provided was based on our binding commitments. We have, as you know from our prior discussions and calls, our collaborators have to place orders well in advance of obviously selling the product and delivering their final dose. So we have a good line of sight into that $750 million
spk01: Perfect. And then in terms of milestones, are there any important guideposts that you'd point us to as we evaluate the collaborative programs to determine if there could be upside beyond the 550 from here? Anything in particular that you yourselves are looking towards as you try to gauge the manufacturing capacity and demand that could come above your current funding agreements?
spk07: Yeah, I mean, it's fairly obvious ones, right? It's the product approvals. And then additionally, all of our collaborators have so far shared publicly any of their contracts that they have in the marketplace. So that would be the most obvious ways to identify milestones tied to future demand would be watching the collaborators' progress.
spk01: Perfect. One last question from us on HPV. You're very clear as to where you think the HPV vaccine market could go by 2027. We're curious how quickly you think the ACIP's recommendation could begin to impact the market. Do you think that there'll be a faster increase here than what was seen with diabetes? And is there anything that Dynamax can do to facilitate the understanding of the new guidelines?
spk07: John, you want to take that? Yeah, sure, Phil. believe actually what it's going to do, quite frankly, for a lot of customers is make this something that they're going to actually have to address. In fact, right now we're seeing it with a lot of our large integrated delivery network customers that with the recommendation and actually the schedule being published a few weeks ago, it's actually a reality that we believe, you know, it's going to be an opportunity for us to continue to engage customers around and with to drive market share. To the question of how fast, you know, it's going to take time as it does with anything, certainly, but we see it as a catalyst really around market share growth for Hepatitis B more so than expanding here in the near term as it relates to the size of the market.
spk01: Great. Thanks for taking my questions.
spk07: Let me add to that quickly. So the difference between diabetes, the pretty stark difference compared to what we saw with diabetes recommendation, which frankly still hasn't really had much uptick, which makes this one so valuable because it's it's much easier to identify patients with age-based recommendations than adverse recommendations.
spk01: Yep, got it. Thanks again for taking my questions, and congrats on a productive year. Thanks, Phil.
spk02: Thank you. Our next question comes from Madhu Kumar of Goldman Sachs. Your line is open. Hi, this is Omari from Madhu.
spk04: So for our first question, what's the path for HEPA-SAV to get majority HPV market share?
spk07: I'm sorry, the path to get majority market share, is that what you said?
spk04: Oh, that's right.
spk07: John, why don't you go ahead and think about, you know, kind of review our long-term plan and how we're structured. Yeah, no, absolutely. The path really starts, obviously, you know, key segments, integrated list delivery network segments being a critical one that we put a lot of our marketing and sales resources towards. Retail segment is a critical segment as well, that we continue to engage both the headquarter as well as regional leaders around Atlas FAA. So those are two key segments that we continue to gain market share quarter over quarter and really provide the foundation for us to have the majority market share in the U.S. market. You know, and I think one of the things we can also point to is the continued year-over-year growth in market share that we've demonstrated since launch. And our commentary all along the way has been this is a trend that we're going to see over time. And we expect to stick to the plan and continue to build share. I think the other thing that we should keep in mind is the amount of effort that we're putting in promotion around the expansion. Right now, we expect to be the leading voice in promoting the new recommendation. and identifying channels where we can capture a majority of that share. The vast majority of the new business will help us continue to accelerate market share growth as the market expands.
spk04: And how should we think about the first half 22 TDAP data?
spk07: So, well, I think let's take the whole picture. I think you really need to look at the whole picture for The first half data and the second half data are very similar regarding immunogenicity and safety results just in two separate populations, one being adults and then followed by adolescents. The phase one trial was run to start with adults and then follow up into adolescents. So basically what we're excited to be delivering with clinical data will be the higher levels of immunogenicity with a reasonable tolerability profile. that we hope to move forward as we continue development.
spk04: All right. Thanks. And one last question. How should we consider the rollout of adjuvant payments through 2022?
spk07: How do we expect the adjuvant payments to roll out through 2022?
spk04: Right. How should we consider the rollout of adjuvant payments through 2022?
spk07: So I assume this means revenue by quarter. We haven't really got into revenue by quarter. Kelly, I don't know if there's any comments you want to provide.
spk09: So we, as a reminder, we do structure our arrangements such that we do get a chunk of payment upfront when we secure the manufacturing facility. And then we do secure the additional, the final payments upon delivery of adjuvant to our customers. So you will see some amounts on the balance sheet reflecting amounts that we've collected to date, but have not yet, that are associated with products that we'll deliver in the future. Again, we haven't guided to quarterly deliveries, but that's generally when we would expect to recognize that revenue and pull in the payments. All right, thanks.
spk02: Thank you. Our next question comes from Ed White of HC Wainwright. Your line is open.
spk06: Thanks. Congratulations on a great quarter, and thanks for taking my questions. So the first question I have is just when thinking about the ACIP recommendation, I believe in the past you have mentioned potential DTC advertising. I'm just wondering if you can give us any general thoughts of what that would look like.
spk07: Sure. Don, why don't you go first? So the way we're thinking about it is essentially we see retail pharmacy as a great capture point for the consumer with this expanded recommendation. And so we'll be targeting certain metropolitan areas that have certain characteristics that we feel have a higher probability of success with our DTC efforts, predominantly driving consumer to retail pharmacy around this new recommendation is the strategy. Highly focused ETC efforts. And I think the risk of that term generally could lead you down the path of magazine and TV commercials. That is not the focus here. It's still a very highly focused marketing campaign, just not focused on decision makers and physicians.
spk06: Great. Thank you. And maybe just to drill down a little bit on the – opportunities from your various partners. With Valneva, there was that hiccup in the UK following the termination notice there. I'm just wondering if maybe you can discuss a little bit about Valneva and the potential there for sales. I think they had committed to 27 million doses to be delivered to the European Commission this year with 60 million doses overall. I just wanted to get your thoughts on that contract and what they've said publicly. And going back to another question was how we should think of that going forward. I think it was starting in April, you had mentioned deliveries in the past. Thank you.
spk07: Sure. Nothing's changed about what we said in the past. I mean, I think you highlighted the public nature of that contract with EC very clearly. Ultimately, we're very excited. If you think about our portfolio, this is the unique thing about our position. You mentioned Balneva in Europe and how they issued the contract with EC with $27 million this year, plus an option for delivery of doses next year. So we're positioned to support that contract as it evolves. Obviously, it's going to be dependent on them achieving the approval, and the EU decided to take on that option for doses next year. And then I think the other key point there is, that we have similar diversification across other geographies with our other collaborators. So Galneva provides us good access into Europe, but we also, with BioE in India, Clover in China, and Medellin in Taiwan, have, what I would say, a rich portfolio of geographies to allow us to continue to build this business. Okay.
spk06: Okay. And just, you know, you had mentioned earlier, again, about the binding commitments that you're looking for the $550 million revenue this year. You know, if you do see termination notices like you did with Valneva in the U.K., does that change the contract? Are you no longer bound to deliver that adjuvant to that potential client?
spk07: You know, one of the – we filed our commercial supply agreements as a trailer agreement, so you can reference these in more detail. But the Valneva was our first agreement, and at the time, we had purposely built in flexibility around the UK contract, which allowed for them to cancel. But as you recall, we didn't have to return the funds used to support building the supply. That was a very intentional term that existed in that contract and that contract alone. So the remainder of our contract does not have the same flexibility for canceling orders that existed in the Balneva contract that was tied specifically to the U.K. obligation.
spk06: Okay, great. Thanks for taking my questions.
spk07: Sure. Thanks, Ed.
spk02: Thank you. Our next question comes from Matt Phipps of William Blair. Your line is open.
spk05: Hey, good afternoon. Thanks. Thanks for taking my questions and congrats on a great year. You know, Don, you gave us market share in Q4, or I'm sorry, utilization in Q4, you know, COVID impact. Wondering if you can just comment anything on trends you're seeing here to start this year. You know, hopefully places are opening up a little bit more. I know it's kind of more recent, so maybe it's too early to tell. And, you know, you're not giving us guidance on HEPA-SAV, but, you know, it seems consistent to maybe around 100 million. I'm just wondering how you feel about that.
spk07: Hey, Matt. How are you doing? So, regarding the impact of utilization here in Q1, obviously, with the discrete impact of Omicron and the variant, it certainly had an impact on healthcare operations widespread, especially in the month of January into February. that start to reverse a little bit, whereas the sick outs, whether it be nurses, MAs, physicians, et cetera, are coming back to work. And so, that had a huge impact on operations. And so, with that, we are seeing utilization that's slightly less than what we saw in Q4. It's still, again, early here in the quarter, but that's how we're seeing a trend. But, you know, from the standpoint of looking ahead, we see, you know, obviously, coming back from a standpoint of healthcare operations, which allows you to drive market share and revenue in 2022, as we've mentioned before. Matt, we can't provide any additional commentary on $100 million versus any other number, but with $62 million for this year, we have said very clearly we're confident and expect continued growth of the brand, despite Don's comments around Q1 Omicron impact. We see that being very discreet, and we're very excited to see healthcare operations return to normal and, frankly, to begin the initiative now that the schedule is updated with the universal recommendation. So we will drive hard to expand the market and to capture share and look forward to providing more definition on revenue when we can do so with a certain level of credibility around reduced volatility in the underlying overall markets. I think that's something that we're not alone in. This is within the adult vaccine space broadly. So, you know, we look forward to being into a position where we can provide you more detailed updates in the future.
spk05: Sure. Yeah, appreciate that, man. Thanks. And then, you know, this has been talked about here, a couple questions. But as far as, again, the committed $550 million you feel comfortable with, is there a temporal flexibility in those contracts. Just given some of the comments from AFGUS CDC and CEPI of just, you know, almost needing more spacing in some of their donations, any, I guess, risk for those contractual deliveries to, you know, your partners to ask for those to be pushed into 2023?
spk07: Well, I think there's, you know, the contracts are pretty fine, Matt. with defined delivery dates. Obviously, what's important to understand is when we receive orders, we then place orders, which we have to stand by. And therefore, our customers have to stand by their orders as well. So we work very collaboratively with our customers within reason. to support their business and the success of their programs. But obviously we have to, you know, manage this business appropriately. So, like I said, the rationale that underpins the $550 million revenue guidance is contracts that we have in hand and that we expect to receive, deliver product for.
spk05: Okay. Great. Thanks for taking my questions.
spk06: Great. Thanks, Matt. Thanks, Matt.
spk02: And we have no further questions at this time. I would now like to turn the call over to Ryan Spencer, CEO, for closing remarks.
spk07: Thank you, Operator. We have made tremendous progress with our three strategic priorities, EPLUS FB commercialization, CPG 1018 adjuvant, COVID-19 supply business, and expanding our development pipeline. We believe our successful execution to this point has built a solid foundation for further enable our corporate mission of protecting the world against infectious diseases. We expect continued revenue growth for Hepatitis B driven by increasing market share, and we are excited to begin our initiatives to grow the market through driving implementation of the new expanded universal recommendation for adults 19 to 50 years old, leading to another year of increasing product revenue and strengthening the long-term value of the brand. We will continue to execute on our commitments for our CPG-1018 COVID-19 supply business, driving another year of record product revenue of at least $550 million in adjuvant sales. In our clinical pipeline, we expect multiple proof-of-concept data readouts throughout the year, providing important validation of our pipeline of differentiated vaccines for Tdap and shingles, as well as the initiation of Phase II studies for plague. We look forward to updating you on our progress throughout the year. Thank you for joining us today. We appreciate your time and interest in DynaVac. Operator, you may end the call.
spk02: Ladies and gentlemen, thank you for joining us today. This concludes today's conference call. You may now disconnect.
Disclaimer