Dynavax Technologies Corp

NASDAQ:DVAX

Earnings Call Transcript 2021-Q4

[Operator]

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Fourth Quarter and Full Year 2021 Financial Results Call. At this -- as a reminder, this conference call is being recorded. At the end of the competitor'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.

[Nicole Arndt, Senior Manager, Investor Relations]

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 recommendation, 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 Factors section of our 10-K filed today with the SEC, which I 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, Ryan Spencer, our CEO, will provide an overview of our 2021 corporate performance. and strategic priorities. Donn Casale will -- Senior Vice President of Commercial, will review the commercial performance of HEPLISAV-B; Rob Janssen, our Chief Medical Officer will provide an overview of our current clinical pipeline; and Kelly MacDonald, our CFO, will review our 2021 results and provide financial guidance for 2022. I'll now turn the call over to Ryan Spencer.

[Ryan Spencer, Chief Executive Officer]

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 capital staff growth, advancing our CpG 1018 adjuvant supply business for COVID-19 vaccine, 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 HEPLISAV-B 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 HEPLISAV-B's performance in 2021, achieving $62 million of net product sales, which represents 72 [ph] -- sales growth compared to the previous year. Looking forward, we expect continued revenue growth from increased market share and growth in the US adult hepatitis B vaccine market as health care services return to normal operations and as a result of the recent action by the CDC to expand the recommendation for hepatitis B vaccination, all adults aged 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 HEPLISAV-B 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, Dynavax 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 agreement to which Dynavax generated CpG 1018 adjuvant 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 vaccine, which has led 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 vaccines. This includes additional clinical trials to support homologous and heterologous boosters and elderly and pediatric indications. Based on the impressive Phase 3 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 profile as the COVID-19 vaccine landscape evolves to an endemic market. These data reinforce our belief that CpG 1018 is a unique and valuable adjuvant for the development of improved and novel vaccines. Beyond COVID-19, we are leveraging CpG 1018's profile in our clinical pipeline to develop new and improved vaccines. We've identified and advanced two programs into the clinic, Tdap and shingles that, if successful, could provide significant US 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 1018 adjuvant supply business, COVID-19 vaccine and from increasing HEPLISAV-B sale. With $546 million in cash and equivalents at year end, we are well capitalized to invest in driving growth from our 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 Donn Casale to provide more details on HEPLISAV-B performance.

[Donn Casale, Senior Vice President, Commercial]

Thank you, Ryan. 2021 was an exceptional year for HEPLISAV-B. I'm excited to share that despite the ongoing impact of pandemic, HEPLISAV-B achieved record performance in all-time highs in revenue and market share growth. HEPLISAV-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. This series completion is more critical now than ever in the era of universal adult hepatitis B vaccination. Two-dose HEPLISAV-B can make series completion easier and protect more patients faster. In 2021, HEPLISAV-B achieved $52 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. Despite these headwinds, HEPLISAV-B 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 HEPLISAV-B 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, HEPLISAV-B 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 HEPLISAV-B as 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 this prior risk-based recommendation and significantly expands the number of adults in the US who should be vaccinated against hepatitis B. With the ACIP universal recommendation, HEPLISAV-B vaccines have the potential to become one of the most widely used adult back phase across health care systems. We believe that the ACIP recognition will be a significant catalyst for growth, and we estimate that market opportunity could grow to over $800 million by 2027, with HEPLISAV-B well positioned to secure a majority of the market shareholder 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. Take you through our clinical pipeline, I will now turn the call over to Rob Janssen, our Chief Medical Officer.

[Rob Janssen, Chief Medical Officer]

Thank you, Don. CpG 1018 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 CpG 1018 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 TDEV vaccine program. Since 1991, when acellular pertussis vaccines replaced wholesale vaccines, whooping cough cases increased by 85% in the United States due to waning efficacy and asymptomatic transmission. Last year, we initiated a Phase I clinical trial, evaluating an improved Tdap vaccine that uses our CpG 1018 adjuvant. Top line safety, tolerability and immunogenicity data in adults are expected in the first half of 2022, with the adolescent data expected in the second half of 2022. Second is our CpG 1018 adjuvant shingles vaccine program. Singles is a painful condition that results from the reactivation of a latent varicella zoster virus infection, more commonly known as chickenpox, but with attacks leading to potential complications, including chronic pain, which can be debilitating. 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 CpG 1018, which has demonstrated its ability to enhance the immune response without excessive reactive genicity in both HEPLISAV-B and multiple COVID-19 vaccines. Additionally, we believe the CpG 1018 mechanism of action is ideal for an improved shingles vaccine, as it's been shown to illicit CD4 T cell responses, which are key in controlling reactivation of the zoster virus and preventing singles. In late January, we dosed the first patient in a Phase I 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 US 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.

[Kelly MacDonald, Chief Financial Officer]

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 SEC this afternoon. Overall, 2021 marked a historically strong year for Dynavax. 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 HEPLISAV-B for long-term growth, and we exited the year with an established and focused clinical pipeline, including our recently announced shingles Phase I trial. This strong execution led to Dynavax's first ever full year of profitability with GAAP net income of $77 million. And now I'll move on to financial highlights for the year, starting with revenue. We delivered total revenue of $439 million for 2021. For the full year 2021, HEPLISAV-B generated net sales of $62 million, up 72% from $36 million in 2020. Additionally, Dynavax delivered $375 million in CpG 1018 adjuvant revenue in 2021, an exceptional year and achieving our previously issued 2021 financial guidance. In the fourth quarter of 2021, we reported $17 million in HEPLISAV-B revenue, up nearly 50% compared to $12 million in the fourth quarter of 2020. And we recorded $177 million adjuvant sales under our COVID 19 commercial supply agreements in the fourth quarter, representing approximately half of this 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 HEPLISAV-B field sales team. Moving on to profitability and cash. For the full year 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 basis and a 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 GAAP 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 revenue to be at least $550 million for the year, with corresponding gross 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 HEPLISAV-B and in support of our core business processes. We anticipate R&D expenses to be between $55 million 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 contracts with the Department of Defense for a Phase 2 clinical trial in place. Expenses related to the plague clinical trial will be fully funded by the US Department of Defense with such offsetting revenues to be reported top line and other revenue. 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 of 2021 interest expense. We believe that continued execution on our priorities, coupled with our cash balance, and the numerous steps taking 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 HEPLISAV-B market share, executing on our CpG 1018 adjuvant supply partnerships and the disciplined allocation of capital to advance our clinical pipeline, leveraging our adjuvants. 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. Thank you. [Operator Instructions] Our first question comes from the line of Phil Nadeau of Cowen. Your line is open.

[Phil Nadeau, Cowen]

Good afternoon. Congratulations on a very productive year. A couple of 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 future demand?

[Ryan Spencer, Chief Executive Officer]

Thanks, Phil. The guidance we provided was based on our binding commitments. We have, as you know, from our prior discussions and calls are collaborators have to place orders well in advance. That's obviously filling products and delivering their final dose. So we have good line of sight into that $550 million.

[Phil Nadeau, Cowen]

Perfect. And then in terms of milestones, are there any important guideposts that you'd point us to as we evaluate the collaborative product -- collaborative programs to determine if there could be upside beyond the $550 million 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?

[Ryan Spencer, Chief Executive Officer]

Yes. 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 will be watching the collaborators progress.

[Phil Nadeau, Cowen]

Perfect. Then one last question from us on HBV. You're very clear as to where you think the HBV 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 we've seen with diabetes? And is there anything that Dynavax can do to facilitate the understanding of the new guidelines?

[Ryan Spencer, Chief Executive Officer]

Donn, do you want to take that?

[Donn Casale, Senior Vice President, Commercial]

Yes, sure, Phil. We believe actually what it's going to do, quite frankly, for a lot of customers is it may 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 it's going to be an opportunity for us to continue to get around and with to drive market share. To the question of how fast? It's going to take time, as it catalyst really around market share growth for HEPLISAV-B more so than more sort of an expanding here in the near-term as it relates to the size of the market.

[Phil Nadeau, Cowen]

Great. Thanks for taking my question.

[Ryan Spencer, Chief Executive Officer]

Let me add to that quickly, Phil. The difference between that is a pretty stark difference compared to what we saw at these recommendations, which frankly still hasn't really had much uptick, which makes this one so valuable because it's much easier to identify patients with age-based recommendation and not risk recommendation.

[Phil Nadeau, Cowen]

Yes, got it. Thanks again for taking my questions and congrats on a productive year.

[Ryan Spencer, Chief Executive Officer]

Thanks Phil.

[Operator]

Thank you. Our next question comes from Madhu Kumar of Goldman Sachs. Your line is open.

[Unidentified Analyst]

Hi, this is Omar on for Madhu. So, for our first question, what's the path for helps to get majority HPC market share?

[Ryan Spencer, Chief Executive Officer]

I'm sorry, the path to get the majority market share, is that what you said?

[Unidentified Analyst]

That's right.

[Ryan Spencer, Chief Executive Officer]

Donn, why don't you go ahead and think about kind of review our long-term plan and how we're structured?

[Donn Casale, Senior Vice President, Commercial]

Yes, absolutely. And the path really starts obviously key segments, Integrated Delivery Network segment 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 HEPLISAV-B. 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 US market.

[Ryan Spencer, Chief Executive Officer]

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 what we -- our commentary all along the way has been this is a trend that we're going to have to -- 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 that -- 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.

[Unidentified Analyst]

Then how should we think about the first half 2022 Tdap data?

[Ryan Spencer, Chief Executive Officer]

So, well, I think let's take the whole picture. I think you really need to look at the whole picture. 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 1 trial was run to start with adults and then follow-up in adolescent,. 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's what the hopes are not supportive of the profile that we hope to move forward as we continue development.

[Unidentified Analyst]

Great. Thanks. And then one last question. how should we consider the rollout of adjuvant payments through 2022?

[Ryan Spencer, Chief Executive Officer]

How do we expect the adjuvant payments to roll out 2022?

[Unidentified Analyst]

Great. How should we consider the rollout of adjuvant payments through 2022?

[Ryan Spencer, Chief Executive Officer]

I assume this means adjuvant revenue by quarter. We haven't really guided to revenue by quarter, so I don't know if there's any comments I just want to provide?

[Kelly MacDonald, Chief Financial Officer]

So we -- as a reminder, we do structure our arrangements such that we do get a chunk of payment up front when we secure the manufacturing facilities, and then we do secure the additional -- the final payment upon delivery of adjuvant to our customers. So you will see some amount on the balance sheet reflecting the amount that we 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.

[Unidentified Analyst]

Great. Thanks.

[Operator]

Thank you. Our next question comes from Ed White of H.C. Wainwright. Your line is open.

[Ed White, H.C. Wainwright]

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 had mentioned potential DTC advertising. I'm just wondering if you can give us any general thoughts of what that would look like.

[Ryan Spencer, Chief Executive Officer]

Sure. Donn, why don't you go -- sorry, the details?

[Donn Casale, Senior Vice President, Commercial]

Yes. 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.

[Ryan Spencer, Chief Executive Officer]

Highly focused DTC efforts. I think, the risk of that term generally could lead you down the path of magazine and TV commercial. That's -- that is not the focus here. It's just -- it's still a very highly focused marketing campaign, just not focused on decision-makers and physicians part.

[Ed White, H.C. Wainwright]

Great. Thank you. And maybe just to drill down a little bit on the opportunities from your various partners. With Valneva, there was a -- 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.

[Ryan Spencer, Chief Executive Officer]

Sure. Nothing has changed about what we said in the past. 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 neat thing about position. You mentioned Valneva in Europe, and how they have secured the contract with EC for 27 million this year, plus an option for delivery 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 a similar diversification across other geographies with our other collaborators. So Valneva provides us good access into Europe, but we also with Bio E in India, Clover in China, and Medigen in Taiwan, have what I would say, a rich portfolio of geographies to allow us continue to build this business.

[Ed White, H.C. Wainwright]

Okay. And just you had mentioned earlier again about the binding commitments that you're looking for the $550 million revenue this year. If you do see a termination notices like you did with Valneva in the U.K., does that change the contract? Are you no longer bound to deliver those -- that adjuvant that potential client?

[Ryan Spencer, Chief Executive Officer]

One of the -- we filed our commercial supply agreements adjuvant agreement. So you can reference these in more detail. But Valneva was our first agreement. And at the time, we had purposely built in flexibility around the U.K. 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 turn that existed in that contract and that contract alone. So the remainder of our contracts do not have the same flexibility for canceling orders that existed in the Valneva contract that was tied specifically to the U.K. obligation.

[Ed White, H.C. Wainwright]

Okay. Great. Thanks for taking my questions.

[Ryan Spencer, Chief Executive Officer]

Sure. Thanks, Ed.

[Operator]

Thank you. Our next question comes from Matt Phipps of William Blair. Your line is open.1

[Matt Phipps, William Blair]

Hey, good afternoon. Thanks. Thanks for taking my question and congrats on a great year. Donn, you gave us market share in Q4 -- or I'm sorry, utilization in Q4 COVID impact. Wondering if you can just comment anything on trends you're seeing here to start this year. 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're not giving us guidance on HEPLISAV, but it seems to consist is maybe around $100 million. Just wondering how you feel about that?

[Donn Casale, Senior Vice President, Commercial]

Yes, yes. Okay. Hey, Matt, let's do it. So regarding the impact of utilization here in Q1, obviously, with the discrete impact of Omicron and the variance, it certainly had an impact on health care operations, widespread, especially in the month of January into February. We are seeing that start to reverse a little bit, whereas the thick 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 from the standpoint of looking ahead, we see obviously it came back from the standpoint of health care operations, which allows to continue to drive market share and revenue in 2022, as we mentioned before.

[Ryan Spencer, Chief Executive Officer]

No, 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 Donn's comments around Q1 Omicron impact. We see that being very discrete, and we're very excited to see help your operations return normal and frankly, to begin the initiative now that the schedule was 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 market. I think that's something that we don't -- we're not alone in this is within the adult vaccine space broadly. So, we look forward to being into a position where we can provide you more detailed updates in the future.

[Matt Phipps, William Blair]

Sure. I appreciate that and thank you. And then this has been -- you talked about a couple of questions. But as far as the -- again, the committed $550 million you feel comfortable with, is that -- is there temporal flexibility in those contracts just given some of the comments from at CDC and ACIP, just almost meaning more spacing in some of the donations, any, I guess, risk for those contractual deliveries that your partners to asked for those to be pushed into 2023?

[Ryan Spencer, Chief Executive Officer]

Well, I think there's -- 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 worked very collaboratively with our customers within reason to support their business and the success of their programs. But obviously, we have to manage this business appropriately. So like I said, the rationale that underpins the $550 million revenue guidance. Makes our contracts that we have in hand, and that we expect to receive deliver product for.

[Matt Phipps, William Blair]

Okay. Great. Thanks for taking the question.

[Ryan Spencer, Chief Executive Officer]

Great. Thanks Matt.

[Donn Casale, Senior Vice President, Commercial]

Thanks Matt.

[Operator]

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.

[Ryan Spencer, Chief Executive Officer]

Thank you, operator. We have made tremendous progress with our three strategic priorities, HEPLISAV-B 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 to further enable our corporate mission of protecting the world against infection. We expect continued revenue growth for HEPLISAV-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 adult CpG 1018, 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 a Phase 2 set 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 Diamondback. Operator, you may end the call.

[Operator]

Ladies and gentlemen, thank you for joining us today. This concludes today's conference call. You may now disconnect.