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spk09: Good day and welcome to the Dynavox Technologies second quarter 2022 financial results call. As a reminder, this conference call is being recorded. At the end of 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 for Investor Relations. You may begin.
spk06: Thank you. Good afternoon and welcome to the DynaVac second 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, market trends, impact of ACIP recommendations, and timing of such impact, financial guidance and trends including revenue, profitability, and sufficiency of current capitalization, timing and results of clinical trials, 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 results, these risks are summarized in today's press release and detailed in the risk factor section of our SEC filing, including today's quarterly report on Form 10Q. 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, Chief Medical Officer, and Kelly McDonald, Chief Financial Officer. I will now turn the call over to Ryan.
spk04: Thank you, Nicole, and thank you all for joining us today. I'm excited to have the opportunity to review the progress we've made during the second quarter. I'll start by providing a brief overview of our highlights before turning it over to Don, Rob, and Kelly, who will provide a bit more insight into their respective areas. The short summary of the quarter is that we continue to execute well on our core priorities. which has us on track for a second consecutive year of profitability with record revenues expected for HEPA-LSAB-B and our CPG-1018 adjuvant. Based on strong execution from the team, the total revenue for the quarter grew 386% compared to the second quarter of last year. Importantly, we continue to see market adoption of HEPA-LSAB-B driven by successful engagement across our customer segments, resulting in increased market share and revenue. We achieved over $32 million in HEPA-Sav-B net product sales in the second quarter, supporting our expectations for another year of growth for HEPA-Sav-B revenues. We're also paying close attention to the evolving landscape for COVID-19 vaccines globally. New COVID-19 variants have driven increases in infections. However, vaccines continue to provide protection against severe disease that lead to hospitalization and death. Our collaborators have demonstrated that their COVID-19 vaccine platforms adjuvanted with CPG1018 can provide a combination of high efficacy and immunogenicity with favorable safety and tolerability. In the second quarter, our global portfolio of CPG1018 adjuvant supply agreements for COVID-19 vaccines generated over $220 million of revenue. we anticipate full-year 2022 revenue for CPG1018 to be between $550 and $600 million, which represents the remainder of orders from our partners under our commercial supply agreement. We continue to work with each of our partners to understand and clarify potential demand for 2023 and beyond. Now, beyond COVID-19, we are leveraging our proven CPG1018 adjuvant to advance our pipeline of new and improved vaccines. Our current clinical programs are focused on delivering meaningful improvement over existing vaccines by adding our CPG1018 adjuvant to establish antigens. We expect our Tdap and shingles program will generate initial phase one data this year, which we anticipate will highlight the value of our pipeline and strategy to produce best in class products targeting large markets. In reflecting on the past few years, We are extremely proud of the execution on our strategy to grow HEPA-SAPB revenue and broadly develop our CPG-1018 adjuvant to build a strong foundation for future growth. Over a relatively short period of time, we have drastically expanded the long-term opportunity for our CPG-1018 adjuvant, transformed our financial profile, and have demonstrated our ability to successfully commercialize HEPA-SAPB. We are proud of our progress and equally excited for our future where we will continue to provide advancements to benefit of public health and drive value for our shareholders. I'll now turn the call over to Don to provide more details on HEPA-SAV-B performance.
spk03: Thank you, Ryan. I'm extremely proud of the hard work and dedication of our commercial team and thrilled to share the extraordinary second quarter results for HEPA-SAV-B. Hepatitis B is the first and only FDA-approved adult hepatitis B vaccine that allows series completion with only two doses in one month. Series completion is essential for high levels of protection. Unfortunately, most adults never complete a three-dose hepatitis B vaccine series. Two-dose hepatitis B can make series completion easier and protect more patients faster. In the second quarter, Heplis Appy generated net product revenue of $33 million, its highest single revenue quarter since launch, and an increase of 139% from $14 million in Q2 of last year. This includes approximately $1 million in revenue from the launch in Germany by our commercialization partner, Avera Nordic. This significant revenue growth in the U.S. was driven by our continued gains in market share. We estimate HEPLIS FB's total market share increased to 32%, up from 19% during the same period last year, while field targeted market share increased to 39%, up from 30% during the same period last year. Total market share gains were supported by significant progress in the retail pharmacy segment. Quarter over quarter dose growth in the segment increased by approximately 167%. During Q2, we expanded our commercial engagement with top national retail chains and have now successfully executed purchase contracts with all the top 10 retail pharmacy chains. These top 10 chains represent over 97% of the hepatitis B market opportunity in this segment. Additionally, we executed several sales and marketing initiatives and leveraged the ACIP universal recommendation to drive increased stocking across pharmacy chains. Retail customers view the ACIP universal recommendation as a significant lever for driving expanded vaccination and continue to express an interest in working with us to implement hepatitis B immunization initiatives. We are very excited by our progress in this segment and believe that retail pharmacy will be a critical growth driver to expand the hepatitis B vaccine market. Another important segment that led to significant increases in Q2 market share was the integrated delivery network or IDN segment. In Q2, we were able to convert several top national hospital systems to HEPLASAB-B. We believe the unique clinical profile of HEPLASAB-B as the only two-dose option in an era of universal recommendation is accelerating IDN adoption and conversion to HEPLASAB-B. We are encouraged by the uptake and anticipate continued positive momentum within this segment. In addition to increases in market share, we continue to see a positive trend in the hepatitis B market returning from pandemic mode. In Q2, we estimate that the hepatitis B market utilization was down 19% from pre-pandemic levels. Looking ahead for the remainder of the year, Q3 market utilization will likely remain at or near the same level seen in Q2 due to ongoing COVID-19 booster campaigns. We also anticipate some market utilization impact in the fourth quarter due to typical year-end seasonality. We are focusing our commercial efforts on driving awareness of the expanded ACIP recommendation, which we believe may result in significant market growth over the coming years. 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 be vaccinated against hepatitis B, compared to the prior risk-based recommendation. We continue to believe that the ACIP recommendation will be a significant catalyst for growth and estimates 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. With a proven clinical profile and our team's strong commercial execution, we expect further market share gains and continued annual growth for HEPA-SAV-B. 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.
spk11: Thank you, Don. Our ongoing studies in Tdap and shingles are progressing nicely. These studies are expected to generate early clinical data later this year that we believe will begin to support meaningful differentiation from the existing vaccines. We're currently conducting a phase one clinical trial evaluating an improved tetanus, diphtheria, and pertussis, or Tdap vaccine, that utilizes our CPG1018 adjuvant. Previously, we reported interim adult data from this study that demonstrated the vaccine candidate was well tolerated without safety concerns and that immunogenicity results were consistent with our expectations and support continued advancement of the vaccine candidate. Adolescent data from the same trial are expected in the fourth quarter of 2022. 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. Now moving on to our shingles vaccine program, we recently completed enrollment in our ongoing phase one study evaluating safety, tolerability, and immunogenicity compared with Shingrix, a commercially available shingles vaccine in the United States and other countries. We believe that our vaccine candidate was CPG1018, has the potential to elicit strong CD4 T cell responses, which are key in controlling reactivation of the zoster virus while providing improved tolerability compared to the current marketed product. Top line data from this clinical trial are anticipated in the fourth quarter of 2022. Lastly, we anticipate enrolling this month the first participants in our phase two clinical trial evaluating the immunogenicity, safety, and tolerability of a plague vaccine candidate utilizing CPG1018 adjuvant. The clinical trial is being conducted in collaboration with and funded by the U.S. Department of Defense. We are pleased with the advancement of our clinical candidates and confident in our strategy to leverage the proven profile of CPG1018 to develop new and improved vaccine candidates that have potentially significant opportunities addressing important unmet medical needs. I'll now pass the call over to Kelly to review our second quarter financial results and our 2022 financial guidance.
spk07: Thank you, Rob. I'm very pleased to report on another quarter of strong financial performance. I'll highlight the key financial items and then review our updated 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 refer additionally to our press release and 10-Q for the detailed financial information. Beginning with our revenue performance, we delivered total revenue of $256 million for the second quarter of 2022, up 386% year-over-year. We are extremely excited about the commercial progress of HEPA-SAF-B in the U.S. and now also in Germany. The second quarter marked another record breaking quarter of total HEPA-SAV Bnet sales of $33 million, including approximately $1 million of sales associated with commercialization in Germany, and represents significant year-over-year growth of 139% for the franchise. Additionally, we continue to execute across our global portfolio of CPG-1018 adjuvant commercial supply agreements for COVID-19 vaccines, achieving $223 million in CPG 1018 adjuvant revenues with a gross margin of 67%. Included in this amount is approximately $55 million in revenue at 100% gross margin associated with the final delivery under our commercial supply agreement with Valneva. Now turning to expenses. Our research and development expenses for the second quarter of 2022 were $10 million. 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. Looking ahead, we are very encouraged by the continued progress in our clinical pipeline and look forward to multiple potential data catalysts across our portfolio by the end of the year, as Rob highlighted. Selling general and administrative expenses for the second quarter of 2022 increased to $36 million, compared to $22 million for the second quarter of last year, primarily driven by increased headcount across field sales and G&A, coupled with focused marketing investments to drive growth and help us have B. Moving on to profitability, for the second quarter of 2022, we generated GAAP net income of $129 million, or $1.02 per share basic and 87 cents per share diluted, compared to GAAP net income of $4 million, or $0.04 per share basic and $0.02 per share diluted in the second quarter of 2021. Now turning to the balance sheet. We ended the second quarter with a robust balance sheet including cash, cash equivalents, and investments of $518 million. We believe this level of capital is sufficient to support our core business without the need to raise additional funds. Lastly, I'm pleased to refine our 2022 full-year financial guidance including CPG 1018 adjuvant revenues of between $550 to $600 million with approximately 60% gross margin for the year, which reflects the economics associated with the remaining firm orders under our commercial supply agreements for 2022. R&D expenses in the range of $50 to $60 million. SG&A expenses in the range of $130 to $140 million. and we are reiterating our previously guided interest expense of approximately $7 million. These refinements to our operating expense guidance reflect our disciplined approach to capital allocation, focused on selective investments to drive growth and help us FB, and thoughtfully advance our clinical pipeline to drive long-term shareholder value. We remain on track for another great year with anticipated record revenues for both of our commercial assets, continued progress and meaningful catalysts across our clinical portfolio, and a second consecutive year of profitability. Thank you, everyone, for your attention today. Operator, we would now like to open the Q&A portion of today's call.
spk09: As a reminder, to ask a question, you will need to press star 11 on your telephone.
spk08: Please stand by while we compile the Q&A roster. Your first question comes from the line of Madhu Kumar from Goldman Sachs.
spk09: Your line is open.
spk05: Hey, this is Rob. Thanks for taking our question, and congrats on a good quarter. We were just wondering to what extent were the HEPA-SAT-B revenue gains driven by the CDC ACIP recommendation versus deeper use among prescribers? And additionally, just one more question, like what should we look for from the 4Q Tdap and shingles data in terms of like key markers of immunity?
spk04: Thanks, Rob. I'll answer the first one briefly, given that the gains in HEPA-SAV are primarily tied to market share. The ACIP recommendation will, for market growth, we expect to take some more time. Don, would you like to provide a little bit more commentary on how the ACIP recommendation has supported that increase in market share?
spk03: Yeah, absolutely. What the recommendation has done is really created a market event for the field sales team to leverage with customers. It's allowed us to get back engaged with critical stakeholders, decision makers around driving market share. So at least right now, what that has done is provided that market event. It also allows us to really highlight the true benefit of the two-dose clinical profile of HEPAL-SAPV, and many of our customers are starting to realize how that will be really important in a universal reality. So that's what's driving the market share in folks that are converting to HEPAL-SAPV is really using that market event of universal right now.
spk04: And then, Rob, would you mind providing some context for what expectations around the data releases this year? Yeah.
spk11: Hi, Rob. So for Tdap, what we'll be looking at is antibodies to pertussis antigens induced by our CPG1018 adjuvanted vaccine compared to Boostrix. In addition, we'll be looking at tolerability to be certain that the addition of 1018 induces similar tolerability to that of Boostrix. And that's the first of a package of a comprehensive package of Tdap data that we'll be developing over time. For shingles, what we expect to see will be immunogenicity data, but most importantly, CD4 data compared with Shingrix. In addition, what's going to be critical there and what we think will differentiate us from Shingrix is tolerability data. So Shingrix is notorious for having, you know, challenges with tolerability and and we're very confident that we'll be able to find a formulation that has equal efficacy to shingrix but better tolerability thanks your next question is from the line of ernesto rodriguez from cowan your line is open hi thank you for taking my question and congrats on the quarter
spk01: This is a follow-up to Rob's question. Given that most of the gains are related to the market share, but we should expect the adult vaccine utilization to remain flat for the rest of the year, then what would be the magnitude that you think that effect will have on the growth in the next couple of quarters?
spk04: Thanks, Ernesto, for the question. Obviously, at this point, we're still not comfortable providing financial guidance for the second half of the year for HEPLSEV. I think you've got the points accurately, though, that the market is still a big driver of how we expect revenue to perform. And while we're pleased with the return to date, knowing there's the COVID-19 booster programs out there provides another variable in trying to predict the return to the previous levels. Market share gains are, you know, we're pretty sizable from Q1 to Q2, but we try to draw your attention to the trends we see annually where we focus on driving revenue annually for the brand. We do expect to continue to take market share each quarter, but obviously the trend quarter over quarter can vary.
spk01: Okay, I see. Thank you. That's helpful. I know you're not also not providing guidance for next year for CPG, Do you have, like, thinking about what do you know about your partners and their orders and how they've been progressing in their sales or in their findings or regulatory findings? Do you have any sort of, like, directional prediction? Do you expect it to be more or less the same as this year, less or more?
spk04: Yeah, I can give you a prediction. I mean, I can give you the facts that we know and that I think we all can observe from the COVID landscape, and that is obviously the vaccine landscape continues to evolve, including policies around vaccination and government programs supporting boosters and how future vaccines will evolve with the potential to eventually move variant-based vaccines, and that's all very dynamic at the moment. I think one thing I can draw your attention to is our, and as we noted in our revenue guidance, that revenue guidance represents the orders that we have for 22, and the majority of our contracts, except for the one that we recently executed with PT Biopharma, were only for pandemic supply, which ended in 2022. So we're continuing to work with our collaborators to identify any potential demand in 2023. And I just, directionally, another point to note is there's been a a large amount of adjuncts supplied in 22 that we do believe, if you look across our partners' developments, which I'll get into in a second, can carry them into supplying, satisfying some demand for 23. So it's pretty dynamic, again, across all those factors. But just briefly, Biological E continues to make advancements with their program. The WHO has opened up a pathway for prequalification based on immunogenicity, which BioE has submitted for. And in addition to the progress that they've made within India, where they have also recently got a recommendation to be approved for heterologous boosting. And then Clover Biopharmaceuticals also is continuing to move forward down the regulatory path in the second half of the year to obtain approval where they filed in both EU and China. And they also continue to develop clinical data to support long-term advancement of that program. So, you know, there's definite movement across the collaborators and progress. I think the fact of the matter is it's a very dynamic environment around policy and innovation that will make 23 hard to predict, and I do think that we'll see more settling out of the endemic market as we move forward into 24 and 25.
spk01: Thank you so much. Very helpful, and congrats on the quarter again. Thank you.
spk09: Your next question is from the line of Matthew Fitz from William Blair, and your line is open now.
spk10: Hey, good afternoon. Thanks for taking my question. Congrats on some great numbers in the quarter. Can you maybe just give us a sense of how much revenue in the quarter came from the DoD channel, or at least if you expect a similar level of DoD activity in Q3, and then maybe that
spk04: moderate some key for as typical seasonality um yeah we we're not going to be able to break out revenue by channel um and then i want to make a quick comment on if you have anything to add let me know you know and matt i think some of the commentary is based on our historical uh trends where the dod seasonality had a big impact in our numbers because we had uh early success in a couple key accounts in dod as we grow the the broad book of business the DOD seasonality becomes a little less impactful than it had historically. So I think, you know, there is definitely the summer surge that could take place and drive up some volumes in our DOD accounts, but it won't be seen as discreetly necessarily in our revenue numbers as it has historically when it made up a larger portion of the total percentage. Don, is there anything that you'd like to add to that?
spk03: Hey, Matt. The only thing I'd add is regarding seasonality, it's not so much a DOD piece anymore. It's more so a market piece, a vaccine market piece in the sense of what you see in the fourth quarter. Given the holidays, it's just a few weeks where you don't have as much healthcare utilization. So that would be the typical seasonality that we expect, again, for the heavy market going into Q4, but less so around the concept of, say, DOD to Ryan's point around the fact that it's just less of a contributor to the overall revenue moving forward.
spk10: That's awful, thank you. And then for the new biopharma CPG revenue source, is, I guess, is the, how much is committed for, you know, this course, and is really the upside potential from 550 to 600, is that really coming from options from biopharma?
spk04: No, that is not specific to biopharma, Matt. I mean, obviously, they're in the projections. The reason for that range, and Kelly, please add to this if needed, is that still has, there's still execution of manufacturing and shipments. And, you know, if anything were to slip quarter over quarter, we just have to be careful about making sure we have the right range just to handle just general operations.
spk12: But PT BioPharm is included in that range. Kelly, is there anything you want to add to that? Okay. All right, great. Thanks for my questions.
spk09: Our next question is from the line of Ed White from HC Wainwright. Your line is open.
spk02: Good afternoon. Thanks for taking my questions. Just a question on the plague study. The first patient is to be dosed this month. Perhaps you can give us your thoughts on the timeline to data in the path forward to approval and, you know, any thoughts that you have on potential DOD stockpiling.
spk04: Sure. So the timeline, you know, there's a number of different readouts in this trial. The timeline, I think there will be a potential interim readout towards the end of next year. There's multiple elements to this trial. There's a bedside mix component versus co-administration that we have to get through before we move into the next stage of the trial. So there's some operational elements. I think more importantly is the utility of the overall data eventually for potential revenue for CPG1018. And the way we would view this trial is enabling a discussion around a stockpile or a product purchase in conjunction with antigen. for a stockpiled plague vaccine. There's not a, you know, this is the first step in the process before we could figure out the exact path to what would probably be an emergency use authorization, given that this is not going to necessarily be a commercial vaccine. This would be only used in certain settings where in response to a bio threat. So we would like to get through the data package first, and then we can become more clear
spk12: the path forward to a potential line of revenue. Okay, thanks.
spk02: And then a second question, if I may, just on hepatitis B sales, you recorded sales in Germany. How should we be thinking about what's next up in Europe as far as company rollouts go or, you know, any sales expectations or the market that you can tell us about? Thank you.
spk04: Sure. So obviously Germany is the focus, and our partnership with Bavarian Nordic is really getting underway now with this initial launch. We're very excited about that opportunity, and they're focused in Germany with their sales team. So I think the best opportunity for us to continue to drive revenue is going to be through that collaboration. Beyond that, Europe is challenging from a pricing perspective, which we've been transparent about for a long time here, we do continue to look for opportunities to find new ways to bring the product into different countries. We think the United Kingdom is likely the next best opportunity, particularly because some of the other lower-priced countries within Europe would create a reference price challenge for our pricing strategy in Germany, whereas the UK does not have that challenge. So we're actively looking at opportunities to move forward into the UK. And like I said, excited to see Bavarian Nordics progress with the brand in Germany.
spk12: Okay, great. Thanks, Brian, for taking my questions. Thanks, Ed.
spk09: We have no further questions at this time. I would now like to turn the call over to Ryan Spencer, CEO, for closing remarks.
spk04: Thank you, Operator. We believe that the combination of our revenue-generating assets and 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. Finally, while I may say this repeatedly, it cannot be emphasized enough, our achievements, the opportunities we believe lie ahead, are made possible by the hard work and dedication of the incredible Dynavax team. I'd like to highlight them and thank them for their commitment and effort towards our missions. We look forward to updating you on our progress throughout the remainder of the year. Thank you for joining us today. We appreciate your time and interest in DynaVax. Operator, you may end the call.
spk09: Thank you. Ladies and gentlemen, thank you for joining us today. This concludes today's conference call. You may now disconnect.
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