DVAX - NASDAQ

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Fourth Quarter and Full Year 2022 Financial Results. As a reminder, this conference call is being recorded. At the end of the Company’s prepared remarks, we will open the call 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.

Thank you, operator. Good afternoon, and welcome to the Dynavax fourth quarter and full year 2022 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 on the Events section of our 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 and market share, ACIP recommendation impact, market trends, growth perspective and rates, manufacturing plans, seasonality, financial guidance and trends, including revenue, profitability and efficiency of current capitalization timing and results of clinical trial starts and data readouts and potential future uses of 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 Factors section of our SEC filings, including today’s annual report on Form 10-K. Our forward-looking statements speak as of today and we undertake no obligation to update such statements. Joining me on the call today are Ryan Spencer, Chief Executive Officer; Donn Casale, Senior Vice President of Commercial; Rob Janssen, Chief Medical Officer; and Kelly MacDonald, Chief Financial Officer. I will now turn the call over to Ryan.

Thanks, Nicole, and thank you all for joining us today. We’re excited to have the opportunity to discuss the tremendous progress we made in 2022 and with respect as we look to our future. We built a valuable and scalable company on the foundation of our first product, HEPLISAV-B, which continues to generate increasing revenue year-over-year. In 2022, as a result of the overall market growth and continued market adoption of the product, HEPLISAV-B revenues doubled compared to 2021. This continued progress reinforced our confidence in the product and our ability to capture additional market share. Looking forward to 2023, we anticipate HEPLISAV-B annual revenue growth in the range of 30% to nearly 50% with sustained and meaningful annual growth expected for the coming years. Additionally, throughout the pandemic, we delivered CpG 1018 adjuvant for nearly 1 billion COVID-19 vaccine doses across all five of our commercial supply partnerships, completing our obligations under our commercial supply agreement to support the pandemic response. Our efforts resulted in $588 million of revenue in 2022 and further validated the safety and efficacy of CpG 1018 adjuvant across a variety of protein-based vaccine platforms around the world. And then finally, for 2022, we made great progress in executing on our clinical development plans, delivering robust Phase 1 data for both our shingles and Tdap vaccine candidates and completing Part 1 of the Phase 2 clin trial that’s funded by the DoD, which, as you’ll hear from Rob shortly, met its primary endpoint. We are now exiting the pandemic era in a stronger position than when it began. As a result of this team’s commitment, resolve, agility and professionalism. During this period, HEPLISAV-B has made major market share gains, even though the health care system faced unprecedented disruption. Our success generating over -- generating almost $1 billion of CpG 1018 revenue during this time was made possible by the impressive teamwork and collaboration across the company. We have successfully built a pipeline in preclinical and clinical assets, focused on leveraging our proven adjuvant to drive long-term value. All of our success was accomplished while also strengthening our corporate infrastructure, governance and overall capabilities across our fully integrated organization, allowing us to run a successful business while managing our growth. I’m incredibly proud and confident in our team. And considering the results that have been delivered in this particularly challenging environment, I believe this organization’s combined capability is a tremendous set that we will leverage as we advance and grow our business. In 2023, we will build on a strong foundation laid in ‘22. With continued product revenue growth from HEPLISAV-B and advance of our clinical development and preclinical pipeline, leveraging our CpG 1018 adjuvant. Additionally, we are prioritizing our business development efforts with the goal of adding late-stage or commercial assets to further leverage our comprehensive organizational capability and to accelerate value creation. We will continue to take a highly disciplined approach to identifying opportunities that we believe can make an even greater impact on our mission to help protect the world against infectious diseases. I’ll now turn the call over to Donn to provide more details on HEPLISAV-B performance.

Thank you, Ryan. I am thrilled to share the incredible progress and strong results for HEPLISAV-B and details about the exciting future and growth opportunities for the brand. 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 high levels of protection. In an era of universal hepatitis B recommendation, two dose HEPLISAV-B make series completion easier and protect more patients faster than a three-dose regimen. In 2022, full year net product revenue for HEPLISAV-B grew 104% from 2021. This significant revenue growth in the U.S. was driven by continued gains in market share. We estimate HEPLISAV-B’s total market share increase to 35% compared to 25% during the same period last year, while prioritized Integrated Delivery Networks and Clinics increased to 47%, up from 33% during the fourth quarter of 2021. Strong performance in the fourth quarter was driven by two critical segments: Retail Pharmacy and Integrated Delivery Networks, or IDNs. Within the Retail segment, we continue to receive positive feedback from customers about the ACIP universal recommendation. Additionally, we saw increases in initial purchases and reordering across several large national chains. Likewise, in the IDNs segment, several customers began implementing processes to adopt the ACIP universal recommendation, which led to meaningful increases in their hepatitis B purchases that far exceeded 2019 levels. The momentum in both segments led to our strong performance in the fourth quarter, despite the typical end of year seasonality. The ACIP’s recommendation that all adults 19 to 59 years of age receive hepatitis B vaccination, significantly expands the number of adults in the U.S. who are recommended to be vaccinated against hepatitis B. In fact, hepatitis B vaccination now has the second highest addressable adult population across vaccines, more than shingles and pneumococcal vaccination and is second only to flu. We continue to believe this recommendation will be a significant catalyst for growth and estimate the hepatitis B market opportunity could grow to over $800 million by 2027, with HEPLISAV-B well positioned to secure a majority market share. We believe the IDN and Retail segments will see most of the market growth from the ACIP universal recommendation. Both segments have the required institutional control, infrastructure, capabilities and patient volumes that can drive universal uptake. We expect these two segments will represent approximately 60% of the hepatitis B market by 2027 compared to approximately 44% in 2022. We are well positioned in both segments with established long-term relationships with key vaccine decision makers along with a deep understanding of the buying process and operational levers that can help us drive ACIP universal recommendation update. Additionally, HEPLISAV-B is approaching 50% market share across these two segments, with most of the nation’s top IDNs and several national retail chains making HEPLISAV-B their preferred hepatitis B vaccine. This exciting progress has supported our shift in strategy from a market share only approach to increasing our focus on market expansion in the Retail and IDN segments. In 2023, we forecast the hepatitis B market opportunity will grow 15% to 25% from 2022 levels and exceed 2019 utilization. In addition to market growth, we expect HEPLISAV-B will continue to increase its market share across all segments, most notably, IDN and retail. With a proven clinical profile and our team’s strong commercial execution, we remain confident in our ability to generate momentum and look forward to continuing to drive long-term growth for the brand. I will now turn the call over to Rob to take you through our clinical pipeline.

Thank you, Donn. We believe there’s a tremendous amount of potential in our pipeline, focusing on best-in-class products, targeting large markets by combining our CpG 1018 adjuvant with established antigens. We’re currently advancing programs for 3 adjuvanted vaccines, Tdap, shingles and plague. We believe CpG 1018 adjuvant has the potential to improve the durability of protection against pertussis by redirecting T cell responses and enhancing protective antibody responses in the booster vaccine. We recently completed a Phase 1 clinical trial, evaluating an improved tetanus, diphtheria and pertussis or Tdap vaccine that utilizes our CpG 1018 adjuvant. Adult and adolescent safety from this study demonstrated the vaccine candidate was well tolerated without observed safety concerns. Adult immunogenicity results were consistent with our expectations and they support continued advancement of the vaccine antedate. This year, we’re completing a nonhuman primate pertussis challenge study that we designed to assess the impact on prevention of disease symptoms and nasal colonization as well as T cell responses with data anticipated mid-2023. At the same time, our collaborator in Canada is identifying the appropriate challenge dose of pertussis bacteria to be used in our human challenge study with planned initiation by the end of this year. This will be the first-ever vaccine pertussis human challenge study, and it’s designed to assess the feasibility of such a study to evaluate vaccine prevention of pertussis symptoms, effect on these colonization and immune responses, including pertussis toxin neutralization and T cell responses. In addition to Tdap, we continue to advance our shingles vaccine program. We believe the CpG 1018 adjuvant mechanism of action is ideal for an improved shingles vaccine due to its demonstrated good tolerability and its ability to generate high levels of antibodies in CD4-positive T cells, which are key in controlling reactivation of the zoster virus in preventing shingles. In January, we reported promising top line results from our Phase 1 clinical trial designed to evaluate our investigational shingles vaccine utilizing different regimens of CpG 1018 adjuvant. High antibody and CD4 positive T cell vaccine response rates were seen in all arms, and they were similar to the comparator. Robust increases in CD4-positive T cells were observed in all the CpG 1018 adjuvanted arms as well, although lower than comparator. In the first half of this year, we plan to submit an abstract with a full set of data for presentation at an upcoming medical meeting, and we plan on meeting with FDA to discuss the regulatory path forward. Over the course of the year, we expect to complete GMP manufacturing of gE antigen to support initiation of subsequent clinical trials. Based on our initial data, we plan to advance our shingles vaccine candidate with CpG 1018 adjuvant into a Phase 1/2 study in early 2024 to evaluate various dose levels of the gE antigen and further evaluate immune responses over a longer period of time. Now transitioning to our third program, we’re conducting a Phase 2 trial evaluating the immunogenicity, safety and tolerability of an rF1V plague vaccine candidate adjuvanted with CpG 1018 in collaboration with and funded by the U.S. Department of Defense. The CpG 1018 adjuvanted vaccine candidate’s mechanism of action has the potential to speed up time to protection with fewer doses compared to the three-dose vaccine under development by the DoD. In January, we successfully completed Part 1 of the clinical trial. Both CpG 1018 adjuvanted arms met the Part 1 primary endpoint and demonstrated a greater than twofold increase in antibodies over the alum adjuvanted control arm after two doses. DoD has approved continuing to Part 2 of the study using a bedside mix of CpG 1018 with the alum adjuvanted rF1V plague vaccine. The advancement of our clinical candidate is a core Dynavax priority. We’re confident in our strategy to leverage the proven profile of CpG 1018 to develop new and improved vaccine candidates that provide significant opportunities to address important unmet medical needs. I’ll now turn the call over to Kelly to review our financial results.

Thank you, Rob. I’m very happy to report another quarter and full year of strong financial performance. I’ll highlight the key annual financial results and then share our full year 2023 guidance and provide a few closing thoughts. Please note that all financial comparisons are versus the prior year period, unless otherwise noted. Please also refer to our press release and Form 10-K for detailed financial information. Starting with revenue. Total revenue for 2022 was $723 million compared to $439 million for 2021, representing an annual increase of about 64%, which was driven both by HEPLISAV-B as well as CpG 1018 adjuvant sales as we successfully executed all five of our COVID-19 pandemic commercial supply agreements. Starting with HEPLISAV-B. We reported full year net product revenue of $126 million compared to $62 million in the prior year, representing annual growth of 104%. What is equally impressive for the brand is the continued improvement in gross margin, which was approximately 68% for the full year compared to 56% for 2021. Turning to CPG 1018 adjuvant revenue. Revenue recognized under our commercial supply agreements for COVID-19 vaccines totaled $588 million, gross margin of 62% for 2022, achieving the high end of our previously stated guidance range for both revenue and gross margin. Looking ahead to our COVID-19 partnerships, our customers are managing their initial stockpiling of CpG 1018 with forward-looking needs as the global pandemic evolves. Specifically for 2023, we believe our customers have sufficient adjuvant stockpiles to fulfill their near-term demand, translating to minimal to as low as zero COVID-19 related adjuvant sales for Dynavax in 2023. We expect to share additional insight as we execute future commercial supply agreements and gain better clarity around the endemic demand of COVID-19 vaccines for our customers for 2024 and beyond. Now turning to expenses. Our research and development expenses for 2022 were $47 million compared to $32 million in 2021. The increase was primarily driven by continued advancement in our pipeline programs, Tdap and shingles through the completion of Phase 1 clinical trials, also successful top line data plus the continued advancement of our fully funded Phase 2 contract with the DoD for adjuvant plague vaccine. Selling, general and administrative expenses for 2022 were $131 million and at the low end of our previously stated guidance compared to -- and compared to $100 million for 2021. The increase was primarily driven by increased headcount across field sales and G&A, coupled with focused marketing investments, targeting growth in HEPLISAV-B market share as well as market expansion in key segments that we believe will benefit HEPLISAV-B. Moving on to profitability. For the full year 2022, we generated GAAP net income of $293 million or $2.32 per share basic and $1.97 per share diluted compared to GAAP net income of $77 million or $0.62 per share basic and $0.57 per share diluted for the full year 2021. Turning to the balance sheet. We ended the year with cash and investments of approximately $624 million. We continue to believe this level of capital is sufficient to support our core business, enabling us to drive sustainable growth in HEPLISAV-B and bring our R&D portfolio of vaccine candidates forward without needing to return to the capital markets. For 2023 full year financial guidance, we anticipate the following: HEPLISAV-B net product revenue between $165 million and $185 million; R&D expenses to be between $55 million and $70 million; and SG&A expense to be between $135 million and $155 million. Lastly and in closing before we turn to Q&A, we’re very proud of the way that we executed on our priorities throughout 2022. Our strong balance sheet position combined with a disciplined approach to capital allocation enables us to focus on selective investments to drive sustainable top line growth in HEPLISAV-B, thoughtfully advance our clinical pipeline and support our business development objectives, all of which we believe will generate long-term shareholder value. Thank you, everyone, for your attention today. Operator, we would now like to open the Q&A portion of today’s call.

[Operator Instructions] Our first question comes from the line of Phil Nadeau from Cowen & Company.

Good afternoon. Congrats on the successful year. And thanks for taking our question. A couple of commercial questions from us and then one pipeline. On the commercial side, in your prepared remarks and in the press release, you mentioned that you are seeing signs that the ACIP guidelines are growing the market. Can you talk a little bit more detail about what those signs are and what gives you confidence that you’re beginning to see the impact of the guideline change?

Hey Phil, it’s Donn. Absolutely. So within the Integrated Delivery Network segment, so some of the signs we’re seeing is just volume increases. We’re looking at the volume increases in several of these customers that are exceeding 2019 levels. We’re also monitoring implementation. And so, it’s around how they implement the guidelines. So, are they communicating those guidelines out across the clinics? We’re seeing signs of that. Are they evaluating progress against those communications? We’re seeing signs of that as well within the IDN segment. So, those are all positive signals as well as the growth, as I mentioned before. Within Retail, Retail, we continue to engage at the headquarter level within Retail and they continue to want to be -- willing to do different types of initiatives focusing on hepatitis B vaccination, so that’s obviously a very positive sign. Retail fees, the recommendation as an opportunity, certainly, especially in the 30 to 50-year-old age cohorts, as an opportunity to do a companion vaccination strategy. So, that’s been communicated to us by several of the large national retailers. So, all very positive signs as we head into ‘23.

That’s really helpful. Then second commercial question is on CpG 1018. Your guidance for 2023 is pretty clear. But I’m thinking longer term as the pandemic ends. In the past, Dynavax had suggested it was hoping to get 30% to 40% of the economics on vaccines sold using CpG 1018 -- vaccines commercially sold for using CpG 1018. Is that possible under your current supply contracts with the COVID manufacturers, or do you need to renegotiate new contracts for the post-pandemic era, assuming some of those vaccines may eventually be available commercially?

I think it depends on what actually happens in the post-pandemic era. I think when you think of the low to middle income countries, the economics post dynamic and during the pandemic are frankly, probably similar. It’s the middle income and upper middle income and high income countries and how our collaborators will fare in those prime markets that could be different than the way those markets existed during the pandemic, government-sponsored purchasing. So, I actually don’t think we would need to comment any differently on our -- the ability -- the value we can capture. It seems consistent. I think what’s more challenging to understand is how does the 1 billion dose of adjuvant supply get utilized over the next -- through the pandemic -- through ‘23, ‘24, and ‘25 before there’s additional supply to support the endemic market. And at that time, we’ll be able to understand where the endemic pricing has settled out at and volumes to be able to negotiate the appropriate economics -- to figure out basically over the long term. But I don’t think there’s anything -- any major change in how we position the economics...

Okay. That is useful. And then last question on the pipeline. In terms of the 1018, the press release that discussed the top line data noted that the CD4 positive T cells somewhat lower for 1018 than the comparator regimens. What -- any thoughts on the significance of that finding? And do you think those CD4 positive T cell levels could be related to glycoprotein E dose, and therefore, as you go to higher doses, perhaps you get more -- levels more similar to the competition?

Yes. I mean we’re going to be looking at it with our gE protein in our Phase 1/2 trial. So we’ll have to see. I mean we use a reasonably high dose in this one. So, I don’t think that we would highlight that as an expectation, but we’d like to see it in the Phase 1/2 trial. The first question is the importance of it. And as you can tell by our continued interest in the program, it’s unknown, right? And we want to continue to work around that endpoint. But the bottom line is we saw a robust response. And recognizing that it’s lower than the comparator, we still saw a very robust response and believe that that has the opportunity to deliver high levels of efficacy. So, we need to continue to do work and advance the program and think of ways to derisk that ultimate efficacy trial. But, we can’t really comment more than what we said around the fact that they were lower, but we did see robust responses. Rob, anything else you want to add to that?

No, I think you’ve covered it. We certainly will be looking at higher doses of antigen in the new Phase 1 study, and potentially other changes to look at how we can improve those CD4 responses.

Our next question comes from the line of Madhu Kumar from Goldman Sachs.

So I think we’ll start with a financial one, kind of as you think about gross margins for HEPLISAV, you mentioned gross margins of 68%. Should we expect further margin improvements in 2023 and on the forward for HEPLISAV?

Yes. We’re really happy with the continued expansion in margin. We’ve been making some very specific and disciplined investments in our manufacturing facility in Germany. So, we’re happy to see those yield improvements over time. We would like to continue to see some margin expansion through 2023 and 2024, namely as scale continues to improve, I think in the low-70% is a fair -- sort of fair estimate for the next couple of years.

Okay. And then a follow-up question on the CpG 1018 story. So really clear about kind of expectations for CpG 1018 sales in 2023. I guess also, as you think about the kind of long-term opportunities you mentioned in the endemic market, we hear some of your customers talking about plans for the endemic market. If they were to need more adjuvant, in what kind of time frame would you expect them to need to be placing these orders? And when kind of would you have a sense of when that demand might emerge?

Thanks for the question, Madhu. Again, it depends on how fast they burn through their stockpile of adjuvant. But we are in very close contact with our collaborators recognizing that there is lead time meaning the secure the manufacturing supply. We do have inventory I think it’s worth noting that we do have some inventory of adjuvants that we purposely maintain to be able to help navigate the transition from utilizing the stockpile and manage the time line to securing manufacturing spots so that we can be supportive of our collaborators broadly. So, I think we’ll be able to see it coming at the point as they use their -- as the endemic market becomes clearer, more clear as to what the volume and demand will be. And as our collaborators utilize their inventory, I think there will be plenty of time to see any future demand coming to be able to manage their needs for their endemic markets without having to run the risk of not having adjuvants available.

Our next question comes from the line of Matthew Phipps from William Blair.

Congrats on great end to ‘22. Following up on Phil’s question on the antigen dose of gE for shingles vaccine. GSK published a study in 2014 that looked at different doses of antigen and at least in that study, it looked like there was a dose response for the humoral response, but maybe not for the cellular response. Is that what you would expect when you’re changing antigen? Or is there maybe differences in ranges being looked at or something different with the CpG 1018 adjuvant to change that?

Bob, would you have to take that?

Yes. I think it’s hard to know because the adjuvants work in very different ways. So yes, in that paper, GSK’s paper, 50 and 100 looks the same for CD4s. I don’t know that that’s going to be true for us. So, the purpose of the Phase 1 that we completed was just looking at a fixed dose of antigen but various CpG 1018 formulations to see could we get close to the comparator. And I think at this point now, because now what we have to look at is, now we have to look at that antigen dose. I don’t think we can assume that based on the GSK experience, that’s what we’re going to see with 1018.

Got it. Okay, Bob. And you mentioned kind of the prioritizing of BD, which is good to hear, given the balance sheet. And I know you can’t talk too much about it at this point. But should we be thinking about adult vaccines, pharmacist administered? I guess just where do you think there’s the most overlap with kind of your current infrastructure?

I think, practically, Matt, the reality is it’s the sweep opportunities in the industry that it’s going to be more meaningful as opposed to the specific overlap. Well, it would be great to find something that overlaps perfectly with our commercial infrastructure. The reality is it’s the whole combined entity that has value to leverage, including leadership, high-quality manufacturing, pharmacovigilance, clinical development policy, commercialization, medical affairs, commercial leadership, distribution. So I think we’re looking for ways to leverage that entire entity more so than just focusing on leveraging our field footprint, which can be augmented in many directions as needed, depending on the products that are available. So, you’ve heard in our comments, from a business perspective, we believe the best use of our capital as well as our capabilities, focusing on late-stage or commercial assets. That would be obviously within the vaccine business ideally, but we also might have to be open to a little bit broader purview as well. So we’ll have to kind of manage through that over time as we consider all the opportunities.

Our next question comes from the line of Roy Buchanan from JMP Securities.

Kind of handful on the shingles program. I just want to make sure I heard Rob correctly. I think you said meet with the FDA this half. Is that correct? And do you plan to announce the outcome of that meeting outside of, say, an earnings call? And then if that’s true, do you also think you can file the IND this half?

Hey Roy. This is Ryan. Let me just take the cause of the communication. The meeting with the FDA is a pre-IND meeting to move into a clinical trial in the U.S. And so, we will -- the outcome of that meeting will help dictate our future development program, which we will always be transparent about as we continue to refine it. I don’t think you should expect that we have a specific announcement related to the completion of that meeting. So the communication of that outcome will be through how we talk about our programs and our traditional dialogue. So, I think that’s just to be very clear about that. Rob, you can comment on the timing of IND filing.

Yes. Timing, so yes, we do anticipate that we’ll be able to meet with FDA in the first half of the year. We certainly will be submitting our pre-IND meeting request. And then we do anticipate submitting the IND later in the year, it will be the second half of the year.

Got it. Okay. Anything else you guys can say about the potential venue for the data this half. It sounds like maybe you haven’t submitted the abstract. Is that correct? Just any details you can give us on that. And then anything you could say about what you’ve seen as far as the adjuvants. I know you’re looking at with and without alum. Anything you can say at this point whether you expect to go forward with alum or without? Thanks.

Well, let me comment on the abstract. We estimate the abstract has to be accepted before we can commit to where we’re going to present. So I think, frankly, at this point, it’s most appropriate for us to just explain our plan, which we will be submitting the abstract with expectations for a medical meeting that will be held in the first half of this year. I don’t think we can really comment more on that because we don’t -- won’t control the ultimate acceptance of that abstract. And then we haven’t commented on our decision around the adjuvant with or without alum yet. One thing that I will -- just to highlight some of the commentary you saw in our previous press release, all of our comments were around all dose groups. So, there was -- we did see some differences, which will be highlighted in the eventual poster presentation, but they are not so significant to where there is necessarily an obvious decision. So, we will continue to work through that decision as we progress towards our Phase 1/2 trial. There’s just not a lot of urgency to make that decision yet, Roy. So, we haven’t prioritized it.

We have no further questions at this time. I’d like to now turn it back to Ryan Spencer, CEO, for closing remarks.

Thank you, operator, and thank you all for your attention today. The important takeaway for you is that we believe the combination of our revenue-generating assets, a highly experienced and execution-focused team, our strong financial profile, and an emerging pipeline of product candidates based on our proven adjuvant technology provide a solid foundation for our future. Our success this past year and the opportunities we see ahead are made possible by the dedicated team of Dynavax. Our people are everything, and I’d like to thank them for their commitment and effort towards our mission. Thank you for joining us today. We appreciate your time and interest in Dynavax. Operator, you may end the call.