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spk08: Good day, ladies and gentlemen, and welcome to the DynaVax Technologies third quarter 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 now begin.
spk03: Thank you. Good afternoon and welcome to the DynaVax third quarter 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 in 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 impact, market trends, growth perspectives, seasonality, financial guidance and trends, including revenue, profitability, and sufficiency of current capitalization. Timing and results of clinical trials starts in data readouts and potential future uses of CPG 1018 adjuvant. These statements involve risks and uncertainties, and our actual results may differ materially. These results are summarized in today's press release and detailed in the risk factor section of our SEC filings, including today's quarterly report on Form 10-Q. Our forward-looking statements speak as of today, and we undertake no obligation to update such statements. Joining me on the call today are Ryan Spencer, Chief Executive Officer, Don Casal, Senior Vice President of Commercial, Rob Jansen, Senior Medical Officer, and Kelly McDonald, Chief Financial Officer. I will now turn the call over to Ryan.
spk02: Thank you, Nicole, and thank you all for joining us today. I'm delighted to have the opportunity to discuss the progress we've made this quarter and to review how far we've come over the last few years. It was just three years ago we made a strategic pivot to focus on building a leading vaccine company by committing to drive value through HEPA-SAP-B commercialization and leveraging our CPG-1018 adjuvant to develop new vaccines. At that time, HEPA-SADB revenue for the full year of 2019 ended up at $35 million. Since then, we have seen significant growth as a result of strong execution from our commercial team. HEPA-SADB generated nearly $38 million in revenue in this third quarter alone, keeping us on track for record HEPA-SADB revenues for the full year of 2022 and providing us confidence in the expected continued revenue growth for the future. Also in 2019, we began to focus on broadening utilization of CPG1018 for the development of new vaccines. Today, in addition to HEPACEPV, CPG1018 is used globally in five COVID-19 vaccine programs, which have generated over $800 million in cumulative revenues for DynaVax through the third quarter of this year. Additionally, CPG1018 is the foundation of our expanding development pipeline.
spk13: for the development of new vaccines today, in addition to hepatitis C shingles in place. COVID-19 is used globally in five COVID-19 vaccine programs, which have generated over $800 million in cumulative revenues for 9 1⁄2 This is tremendous progress in the short term time is a testament to our strategic plan and the team's ability to successfully execute it.
spk02: As we near the end of 2022, we continue to expect between $550 million and $600 million in revenue from our CPG 2018 business for the full year. Our success in navigating the pandemic highlights the organization's execution abilities underscores the scientific rationale supporting the use of CPG1018 for broader vaccine development and has transformed our financial profile. As we look to our future, our strong financial position supports continued investment in the commercialization of hepicep B and expanding and advancing our clinical programs. With the recent data from our Tdap Phase 1 trial and data from the Phase 1 shingles clinical trial anticipated before year end, We believe we have the opportunity to highlight the value of our pipeline and strategy to produce best-in-class products targeting large markets. Additionally, we are advancing efforts to build on our vaccine portfolio by leveraging our capabilities in commercialization, development, and manufacturing through the addition of late-stage or commercial assets. We are beginning the process of carefully identifying and evaluating opportunities with a high bar for potential transactions that we may consider. We believe this approach will further enable our success by leveraging our core organizational capabilities to strengthen our financial profile. I'll now turn the call over to Don to provide more details on Heplis AB performance.
spk12: Thank you, Ryan. I'm thrilled to share the third quarter results for Heplis AB. The dedication and perseverance of our commercial team has resulted in another record quarter of product revenue and market share for Heplis ABB. HEPLISAB-B is the first and only FDA-approved adult hepatitis C 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 HEPLISAB-B can make series completion easier and protect more patients faster. In the third quarter, HEPLISAB-B generated net product revenue of just under $38 million. its highest single revenue quarter since launch, and an increase of 65% from $23 million in Q3 of last year. This significant revenue growth in the U.S. was largely driven by our continued gains in market share. We estimate HEPA's total market share increased to 32% compared to 25% during the same period last year, while field targeted market share increased to 43%, up from 32% during the third quarter of last year. Strong performance in Q3 was driven by two critical segments, retail pharmacy and integrated delivery networks, or IDNs. In Q3, retail pharmacy had significant increases in the number of new ordering and reordering locations. We are encouraged by this trend and the positive feedback we are receiving from customers about the ACIP universal recommendation. During the quarter, several top retail chains expressed a desire to make hepatitis B vaccine a priority focus for their immunization strategies moving forward. In addition to our success in retail, there has been considerable progress in the IDN segment. Many of our customers have expanded their use and increased reordering of HEPLASAB B. Like in retail, we have received positive feedback from customers about the ACIP universal recommendation and their desire to enter this new era with a two-dose vaccine for hepatitis B. In Q3, several large IDN customers updated their vaccine protocols and capabilities to reflect the policy change. The ACIP's recommendation that all adults 19 to 59 years of age should receive hepatitis B vaccination significantly expands the number of adults in the U.S. who should receive or should be vaccinated against hepatitis B. We continue to believe that the universal recommendation will be a significant catalyst for growth and estimate the hepatitis B market opportunity could grow to approximately $800 million by 2027, with hepatitis B well-positioned to secure a majority market share over time. In Q3, we continue to see positive trends in hepatitis B market recovery. During the quarter, the market was down only 7% from pre-pandemic levels. This positive recovery was due to the market continuing its return to normal pre-pandemic operations, coupled with expanded growth from customers implementing the universal recommendation. Looking ahead to this quarter, we anticipate the hepatitis B market will remain flat or slightly below the level seen in Q3. This likely outcome is due to the typical Q4 seasonality, which has historically reduced the market by 10 to 15% quarter over quarter. With a proven clinical profile and our team's strong commercial execution, we expect further market share gains and continued annual revenue growth for HEPA-SAPB. 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.
spk06: Thank you, Don. We believe there's a tremendous amount of potential in our pipeline focusing on best-in-class products targeting large markets by combining our CPG1018 adjuvant with established antigens. We recently completed a phase one clinical trial evaluating an improved tetanus diphtheria and pertussis or Tdap vaccine that utilizes our CPG1018 adjuvant. Adult and adolescent safety data from this study demonstrated the vaccine candidate was well tolerated without safety concerns. Adult immunogenicity results were consistent with our expectations and support continued advancement of the vaccine candidate. We're also conducting a non-human primate pertussis challenge study to assess the impact on prevention of disease symptoms and nasal colonization of the pertussis bacteria. Our second development area is the shingles vaccine program. The last participant visit has been completed in the phase one study evaluating safety, tolerability, and immunogenicity compared with Shingrix, a commercially available shingles vaccine in the U.S. and other countries. We believe that our vaccine candidate adjuvanted with CPG1018 has the potential to elicit strong CD4 T cell responses, which are key in controlling reactivation of the zoster virus, while also providing improved tolerability compared to the current marketed product. Data from this proof of concept clinical trial are anticipated by year end. The advancement of our clinical candidates is a core priority. We're confident in our strategy to leverage the proven profile of CPG1018 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 third quarter financial results.
spk04: Thank you, Rob. I'm happy to report on another quarter of strong financial performance. I'll touch on some key financial items and then review our full year 2022 guidance and provide a few closing thoughts. Please note that all financial comparisons are versus the prior year period unless otherwise noted. Please additionally refer to our press release and 10Q for detailed financial information. Starting with revenue. Total revenue for the third quarter was $168 million, up 55% year-over-year. This quarter marked another record-breaking quarter for HEPLIS FD with total net sales of $38 million, representing 65% year-over-year growth. What is equally impressive for the brand is the continued improvement in gross margin, which was approximately 69% for the third quarter and 70% year-to-date, compared to 56% for the full year of 2021. Turning to CPG 1018 adjuvant revenue. Revenue recognized under our commercial supply agreements for COVID-19 vaccines totals $126 million for the third quarter, bringing CPG 1018 adjuvant revenues to $440 million year to date. We had two unique items to highlight in the third quarter relating to our CPG 1018 COVID-19 partnerships. We have recently amended our commercial supply agreements with both Clover Biopharmaceuticals as well as Biological E to reflect a reduction in demand as the COVID landscape evolves. During the third quarter, in connection with the Clover Amendment, we recognized approximately $24 million in one-time revenue for cancellation fees covering the cost of raw materials and CMO-related fees incurred. Additionally, we wrote down approximately $14 million in corresponding inventory in connection with the reduction in demand. We are working closely with our CPG-1018 adjuvant commercial supply customers as they manage their initial stockpiling of CPG-1018 with forward-looking demand as the global pandemic evolves. We continue to expect between $550 and $600 million in full-year 2022 CPG 1018 revenue, with corresponding gross margins approximating 60%, and are very proud of the collective efforts with our collaborators to be an important part of the response to the COVID-19 pandemic during a very dynamic period. As we look ahead to 2023, We believe our customers will likely have sufficient adjuvant stockpile as of the end of 2022 to service their initial commercial agreements, translating to substantially lower adjuvant sales expected in 2023. Beyond 2023, we expect to provide additional guidance as we execute future commercial supply agreements and gain better line of sight into the endemic demand of COVID-19 vaccines for our customers. Now, turning to expenses. Our research and development expenses for the third quarter of 2022 were $13 million, compared to $6 million in the same period last year, reflecting continued advancement of our ongoing pipeline programs in TDAP and shingles, as well as our funded phase two contract with the DOD for an adjuvanted plague vaccine. Selling general and administrative expenses for the third quarter of 2022 increased to $32 million, compared to $27 million for the third quarter of last year, primarily driven by increased headcount, cross-field sales, and G&A, coupled with focused marketing investments to drive growth in Hefflesap B. Moving on to profitability. For the third quarter of 2022, we generated gap net income of $64 million, or 50 cents per share basic and 43 cents per share diluted. Turning to the balance sheet, we ended the third quarter with cash equivalents and investments of $587 million, and we continue to believe this level of capital is sufficient to support our core business, including our R&D portfolio, without the need to raise additional funds. Lastly, I'm pleased to reiterate our 2022 full-year financial guidance, including CPG 1018 adjuvant revenues, expected to be between $550 and $600 million, with approximately 60% growth margin for the year, reflecting the economics associated with the remaining firm orders under our commercial supply agreements, R&D expenses in the range of $50 to $60 million, SG&A expenses in the range of $130 to $140 million, and interest expense of approximately $7 million. In summary, with another quarter of strong commercial and financial performance, we remain on track for another great year with anticipated record revenues, continued progress and meaningful catalysts across our clinical portfolio, positive cash flow, and a second consecutive year of profitability. Our strong balance sheet position, combined with a disciplined approach to capital allocation, enables us to focus on selective investments to drive growth in HEPA-Sav-B and thoughtfully advance our clinical pipeline to drive 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.
spk08: Thank you. At this time, we will conduct the question and answer session. To ask a question, you will need to press star, 1, one on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A roster. Our first question comes from Roy Buchanan from JMP Securities. Your line is open.
spk10: Great. Thanks for taking the questions. I guess the first one is on HEPLISAV. Good quarter. Do you know the market share and retail segment specifically? And if you do, is it consistent across the top 10 retailers where you have the contracts, or is there a variation between the retailers?
spk02: Don, do you want to go ahead and take that?
spk12: Yeah, so market share across the segment is just under 50% for the entire segment. We do see different market shares across the different retail chains. With a few of them where we have majority market share, so it's kind of a blend. But overall, we like the momentum we have seen as it relates to our market share as well as growth within that segment.
spk10: Okay, great. And then the improvements in gross margin is impressive, you know, given all that we've heard about inflation. I guess, any thoughts on the impact of inflation? May we see that impact the gross margins going forward?
spk02: Thanks, Roy. Kelly, you want to take that one?
spk04: Sure. So, yeah, thanks, Roy, for the question. Appreciate it. We've made substantial improvements in investments in our manufacturing facility in Germany and are really excited to be able to pull through some of the financial benefits of those investments over the last couple of years. We don't expect inflation to have a meaningful impact to our gross margins and, in fact, in the 70% range is where we expect gross margins to settle and at this level of volume.
spk10: Great. Thanks. And then I had a quick one on the shingles data coming up later in the year. Are you going to have T cell data for all the patients? And then I know you're looking at the CD4 cells as a secondary endpoint. Are you also going to look at CD8 cells?
spk06: Thanks. Rob, you want to take that? CD4s are what are associated with protection against reactivation of zoster, so we'll be predominantly focusing on CD4s. For all patients. For all patients.
spk07: Yeah, yeah, for all patients in the study. Thank you. Thanks, Roy.
spk09: Please stand by for the next question. Our next question comes from Matthew Fitz of William Blair.
spk08: Your line is open.
spk11: Hi, everyone. Thanks for having me, and congrats on continued great momentum with Pebbleswap. I guess on the shingles update in comparison to Shingric, and it's maybe tough to answer this, but how much better do you want to be in the tolerability your new deck has on that Shingrick side effect profile? And are there any particular side effects you think are more impactful than others when you think about kind of patient preference and adoption?
spk02: Thanks, Matt. We want to have Rob answer that one.
spk06: Yeah, so what I anticipate that is that we would be able to demonstrate statistically significantly lower rates of post-injection reactions in Shingrix. We're currently in the process of evaluating if any of the individual reactions would be more important than any other or whether we would use essentially a composite term, which is all of, you know, any of the either local or systemic post-injection reactions. But it's something that we're looking into right now. Interesting. Okay. Thanks, Rob.
spk11: A question about the IRA, Inflation Reduction Act. Obviously, it's caused some headaches for other drug development companies, but there is some benefit for adult vaccine coverage as far as co-pays and things like that. Is that impact any of your development calculus for pipeline programs?
spk02: Yeah, well, I mean, the benefits are relative compared to other products. I mean, the reality is for Hep B, for example, it's incredibly favorable because of the impacts on Part D coverage. But with Hep B specifically being called out on the Medicaid rebate program as not having to participate, And then not, we do not expect given the level of Medicare spend on hepatitis B vaccine that it would ever be a negotiated drug. So from a relative perspective, you know, I think, you know, our long-term revenue potential is comparatively strong compared to other products possibly. Different, the calculus would be different depending on the product. If you had a product that was focused on the over 65 population that could result in larger spend for Medicare, then it might be, It might have an impact, but I will say that one of the benefits is that it's somewhat limited given the IRA limited the negotiation down to 25% impact, which is less for vaccines, which is less than what you could see in other classes. So ultimately, you know, I think being a vaccine manufacturer, the IRA doesn't have the same level of impact as other, you know, parts of our industry.
spk11: Thanks, Ryan. And I guess maybe lastly, obviously mentioning significant maybe slowdown in CPG revenues next year, but I guess that implies at least there is still some you expect next year. Is that kind of flow through of currently signed contracts or is that you do see potential for some contracts in 2023?
spk02: Yeah, I mean, I think the way we're, we're, we're, what we're trying to provide is an overview of what we know now. And what we, what we know now is the market's changed pretty significantly over the last year as it relates to demand. It's really, it is a, and there's a decent amount of stockpiles of adjunct within our, our, uh, collaborators. And so it really would come down to, uh, how do we need shipments from the end of this year roll into next year, which would be minor. And then how will the market evolve towards the end of next year, which we don't have a ton of visibility into now. And so there is a potential for additional revenue in the second half of the year, depending on how the market evolves, which we currently are not contracted for at the moment. So, you know, we're going to have to let you know as we know as those contracts evolve, which will be dependent on the line of sight as far as demand for our collaborator vaccines.
spk11: Got it. That's helpful. Thanks, Ryan. That's all. That's all for me. Great. Thank you.
spk09: Please stand by for the next question. Our next question comes from Madhu Kumar from Golden Sex.
spk08: Your line is open.
spk05: Hey, guys. This is Rob on for Madhu. Thanks for taking our question. I guess we were just wondering from a high level, how should we think about the year-end shingles data? And then also, I guess, how should we be thinking about modeling the adjuvant revenues, like, in 2023 and on the forward?
spk02: So, for the shingles data, we expect to have the data in hand by the end of the year, and we will be We expect to issue a top-line press release shortly thereafter with more robust reporting of the data to follow at a scientific meeting or publication. And then the other question as far as how to think about the long-term adjuvant revenue, I mean, I think Rob, the key is you got to watch the market. And what we keep saying is there's been significant evolution of the COVID market during the course of this year. We think we're well positioned as it relates to the global need, recognizing that we have, you know, collaborators targeting very many different markets around the globe. But as far as what that ultimate demand will be, I think that's still kind of left to be determined as we move into this. So, you know, we're very pleased with how we positioned ourselves to be able to participate in the long-term demand. Being able to quantify it at this moment is difficult.
spk05: That makes a lot of sense. Thanks for taking our question.
spk09: Stand by for the next question. And the next question comes from Ernesto Rodriguez Dumont from Cali.
spk08: Your line is open.
spk01: Hi, thank you for taking the question. Congrats on the quarter. You highlighted the progress that you've had on the retail space and with hospital systems. They seem to be aware of their universal recommendation and that's going to be a catalyst for growth. What do you expect then to be the hurdle there? Is it the logistics of them applying the recommendation or are they going to wait for the demand to to assist or they're going to try to push it or what is it? What is, I guess, the next step there? And a second question, if you can give also any color on the launch in Europe, any progress on other markets outside of Germany? Thanks.
spk02: Okay, Don, why don't you take that? Spoken on the hurdle of the uptake of Universal, I think was the question, not spoken on market share, but let's start with the uptake in Universal.
spk12: So, you know, right now, as I mentioned before, in our cell, we see quite a few of our hospitals that have implemented a flag within their EMR system. So it's a passive flag. That's a first great step. It gives us quite a bit of confidence as we think about the market opportunities. We communicated $800 million opportunity. Those types of signs are signs that we like to see, and we'll continue to see that happening throughout the marketplace. Our role will be to pull that through with the customer to increase the awareness at the provider level of those set flags. On the retail segment, we've engaged with all of our top retail customers. From their point of view, as I mentioned before, they see hepatitis D vaccine and universal recommendation as an opportunity, especially for those age 30 to 50, to use a plus one strategy, especially going into 2023. So they've been engaging us around opportunities to go after that patient population and really see it as a strategic priority moving forward. So that's why we're really excited about the opportunities as it relates to universal both in retail and IDN.
spk02: Yeah, if I can just add a little bit of cover onto that as it relates to clearing hurdles. I actually would say we've cleared a small hurdle already this year. And Dawn's commentary around what we've seen with certain IDN customers turning on a flag, which basically prompts physicians when a patient has not been vaccinated, we've actually seen uptake. And that seems obvious, but that is a hurdle to clear that when physicians do have the prompts in front of them, patients are actually accepting of the recommendation. And we've already seen evidence that that's taken place. So I would argue that we've cleared the first hurdle in expanding the market. Now, obviously, that has to be done much more broadly, as Don highlighted, but we are seeing evidence that patients are going to be willing to accept a recommendation for hepatitis B vaccine. So that's an important step in the journey. And then Don, do you want to provide some commentary on the launch in Germany?
spk12: Yeah, so the launch is going well. As you would expect with most launches, it takes time. But we're excited about the progress that's been made thus far. We'll continue to update as we get more information. But thus far, the launch is going as we expected. And these launches, they take time.
spk09: Please stand by for the next question.
spk08: Our next question is from Roy Buchanan from JMP Securities. Your line is open.
spk10: Thanks for taking the follow-ups. I had a couple more. So what's the status of HEPLISAVA in dialysis patients? I think you're expecting to meet with the FDA. around this time. Just curious if that happened and where that's at.
spk02: Yeah, no, we've had good engagement. It was a little delayed due to the FDA's focus on COVID over the last few years, but we are working on the SBLA for dialysis, which we expect to file probably early next, very early next year, and to get that data into the label upon approval of the SBLA.
spk10: Okay, great. And then the Back to the shingles, I guess it's a little early. You're just finishing up the phase one. You're going to need to talk to the FDA, et cetera. But how do you picture the registrational path for that candidate at this point? Are you going to likely have to go head-to-head with Shingrix and need an efficacy trial? And then how do you think about the path ex-US and the market opportunity there? Thanks.
spk02: Sure. We'll just take the first point. It's probably worth hitting head-on, which is that When you have products with this level of efficacy that we expect, you know, over 90, 95% efficacy, a head-to-head trial just doesn't make sense. You'll never be able to feasibly demonstrate actual efficacy. And so we still obviously need to continue to advance our engagement with the agency, given that we're in phase one, to really fine-tune what the expectations are for the full regulatory plan. But we do not expect, it's just not feasible to do a head-to-head efficacy study in this case. So, there could be a placebo-controlled efficacy study or even potential accelerated approval on immunogenicity, but we haven't been able to fine-tune that path just yet in U.S.
spk07: or in other markets.
spk10: Okay, great. And then on the XUS, do you see that as a viable? I mean, Shingrix does pretty well XUS, especially this last quarter. How are you guys thinking about the opportunity there? Thanks.
spk02: Oh, well, I mean, like any product, we would expect to, we'd want to launch it broadly into all markets that would support the infrastructure cost of bringing the product into that region. So that's part of the, the strategy is a global strategy for shingles.
spk07: Okay, perfect. Thank you.
spk09: Thank you.
spk08: We have no further questions at this time. I would now like to turn the call over to Ryan Spencer, CEO for closing remarks. You may begin.
spk02: Thank you, operator. And thank you all for your attention today. As we have reiterated on multiple occasions, we believe that the combination of our revenue generating assets, a highly experienced team, our strong financial profile, and an emerging pipeline of product candidates based on our proven adjuvant technology provide a solid foundation for DynaVax's future. Our success this year and opportunities we see ahead are made possible by the dedicated team here at Dynavax. Our people are everything and I would 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.
spk08: Ladies and gentlemen, thank you for joining us today. This concludes today's conference call. You may now disconnect.
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