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spk01: Good day, ladies and gentlemen, and welcome to DynaVac Technologies' third quarter 2023 Financial Results Conference call. As a reminder, this call is being recorded. At the end of the company's prepared remarks, we will open the call for questions and provide specific participation instructions at that time. I would now like to turn the call over to Paul Cox, Vice President, Investor Relations and Corporate Communications. You may begin.
spk09: Thank you all for participating in today's call. Joining me today from Dynavax are Ryan Spencer, Chief Executive Officer, Don Cassell, Chief Commercial Officer, Rob Jansen, Chief Medical Officer, and Kelly McDonald, Chief Financial Officer. Earlier today, Dynavax released financial results for the third quarter ended September 30th, 2023. Copies of the press release and a supplementary slide presentation are available at Dynavax's 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, market segmentation, effective marketing efforts, future expected market share and related growth rates, and related ACIP recommendation impact on each. Financial guidance and trends, including revenue, profitability, cash flow, and sufficiency of current capitalization, timing and results of FDA submissions, clinical trial starts and data readouts, and potential future uses or demand for our CPG1018 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 factor section of our SEC finalists, including today's quarterly report on Forum 10Q. Our forward-looking statements speak as of today, and we undertake no obligation to update such statements. With that, I will now turn the call over to Ryan.
spk02: Thanks, Paul. Good afternoon, everyone, and thank you for taking the time to join us to review Dynavax's results for the third quarter of 2023. We're pleased to report yet another record quarter of HEPA-Sav-B revenue as we progress toward our goal of establishing HEPA-Sav-B as the leading adult hepatitis B vaccine in the U.S. a market opportunity which we believe will continue to expand to over $800 million by 2027. HepacetB delivered $62 million in quarterly net product revenue, which is a 66% year-over-year increase. This record quarter was driven by market share gains in the overall adult hepatitis B vaccine market, and in particular by HepacetB gaining majority market share in both the key market segments of retail pharmacy and integrated delivery networks. As a result of the strong HEPA-SADB performance in the first nine months of the year, we are again raising our revenue expectations for the full year. We now expect HEPA-SADB net product revenue to be in the range of $210 to $220 million, representing up to 75% growth this year. Based on our commercial execution to date, we continue to strengthen our financial position. with cash and investments increasing to $720 million at quarter end. This position enables us to support our efforts to maximize HEPA-7B's opportunity in this growing market, while also advancing our clinical pipeline into the next stage of trials in 2024, which Rob will cover in a few minutes. In addition, as we've discussed on prior calls, we continue to evaluate strategic opportunities to diversify our product portfolio and create future commercial opportunities. We remain committed to discipline capital allocation to generate significant value and accelerate growth. We look forward to providing updates on these efforts in the future. I'll now turn the call over to Don to provide more details on the tremendous HEPA SABV performance in the third quarter.
spk11: Thank you, Ryan. I'm excited to share more details about another very strong quarter for HEPA SABV. We achieved record net product sales and market share in the quarter. The hepatitis B market continues to grow in the U.S. following the ACIP universal recommendation for hepatitis B vaccination, which now represents one of the largest vaccine market opportunities for adults. As a reminder, we believe this recommendation will be a significant catalyst for growth and estimate the hepatitis B vaccine market could grow to over $800 million by 2027, with hepatitis B achieving a majority market share by that time. We continue to see indicators of market expansion from ACIP Universal. In the third quarter, the total hepatitis B vaccine market grew by approximately 29% year over year. Hepatitis B continues to increase its total market share, achieving 41% in the quarter compared to 32% during the same period last year. Net product revenue grew 66% year over year to $62 million in the quarter. This sales growth continues to be driven by Hepatitis B's strong performance in two critical segments, retail pharmacy and integrated delivery networks, or IDN. We continue to focus our sales and marketing efforts on the retail pharmacy and IDN segments, as we expect to see most of the anticipated market growth from the universal recommendations in these segments, estimating both will grow to represent approximately 60% of the total Hepatitis B market by 2027. Right at the end of the third quarter, HEPA-SATB's market share increased to approximately 54% compared to approximately 43% at the end of the third quarter last year. We are focused on working with large health systems at the C-suite and clinic level to pull through ongoing adoption of the universal recommendation. In this segment, we are seeing continued strong conversion and expansion from large customers that are adopting the universal recommendation. driving meaningful increases in their hepatitis B vaccine purchases. In the third quarter, year-over-year hepatitis B vaccine market growth in the IDN segment was approximately 40%. In the retail pharmacy segment, we have made significant progress year-to-date, including several large national chains making hepatitis B the preferred adult hepatitis B vaccine. In the third quarter, hepatitis B achieved a majority share in this important segment, which is expected to drive significant growth in the coming years. Year-over-year hepatitis B vaccine market growth in the retail pharmacy segment was 80%. With hepatitis B market share increasing to approximately 53% compared to approximately 43% at the end of the third quarter last year. During the third quarter, we completed the optimization of our sales force to expand our promotional reach in the retail pharmacy segment, which is intended to further drive market expansion. This expanded Salesforce reach will call on headquarters, divisional, regional, and district leaders across the top retail chain. We are also excited to see the impact of our collaborative marketing initiatives with top national retail chains that launch at the end of the second quarter. We expect these strong collaborative relationships across the top retail chain, plus our expanded Salesforce reach, will enable continued strong market growth and market leadership within this important segment over the years to come. As Ryan noted, based on our progress year to date and these strong results, we are raising our full year 2023 net product revenue guidance for HEPA-SAP-B to be in the range of $210 to $220 million. This updated guidance reflects our tremendous momentum in the market while still factoring in expected fourth quarter seasonality and the impact from customer-focused vaccine efforts on the new RFC vaccine, COVID revaccination, and seasonal flu. We believe the strain on customer bandwidth due to RSV, COVID, and flu vaccination will be temporary and limited to the fourth quarter. We remain extremely confident in the long-term growth of the hepatitis B market, and are forecasting annual growth of approximately 10 to 50% over the next several years, with hepatitis B continuing to gain meaningful increases in total market share over that time. In summary, we had an outstanding third quarter. reaffirming our confidence in Hepatitis B becoming the market leader in the expanding hepatitis B vaccine market. We are very proud of our commercial team's execution and encouraged by the progress and momentum for Hepatitis B, establishing a majority market share in the key segments of retail pharmacy and IDF. I will now turn the call over to Rob to take you through our clinical pipeline.
spk07: Thank you, Don. As a reminder, in our development pipeline, we're advancing innovative and diversified vaccines that leverage our CPG1018 adjuvant with proven antigens. We also continue to identify new opportunities to leverage our CPG1018 adjuvant through multiple innovative preclinical and discovery efforts with leading collaborators. Starting with our shingles vaccine program, Z1018. Currently, there is a blockbuster vaccine on the market, but we believe that there's an opportunity to develop an improved vaccine given the challenging tolerability profile of the current market-leading product. One of the unique advantages, we believe, of our CPG1018 adjuvant is its safety and tolerability profile combined with its ability to induce strong CD4-positive T cell responses, which we believe are critical to preventing the reactivation of the zoster virus. Results from our phase one trial support the continued development of Z1018 as they demonstrate the opportunity to develop a shingles vaccine with an improved tolerability profile and comparable efficacy. Recently, we received type B meeting feedback from FDA on the Z1018 program. We believe the feedback is supportive of our proposed clinical development plan that includes a pivotal phase three placebo-controlled efficacy study. Based on this feedback, we plan to submit an IND application to the FDA to support the initiation of a phase 1-2 trial of Z1018 in the first half of 2024. Turning next to the Tdap1018 program. So this is an investigational vaccine candidate that's intended for active booster immunization against tetanus, diphtheria, and pertussis, or Tdap. Current Tdap vaccines have limitations, including waning effectiveness. And we believe there's an opportunity to improve the duration of protection using our CPG1018 adjuvant to generate a Th1-biased immune response. We've completed both a phase one clinical trial in adults and adolescents, as well as a pertussis challenge study in non-human primates. We recently received type B pre-IND meeting feedback from FDA on the Tdap1018 clinical development and regulatory pathways. Together, results from our phase one study, our non-human primate study, and the feedback from FDA all support proceeding to a human challenge study in mid-2024. Moving on to the plague program. This is in collaboration with and funded by the U.S. Department of Defense. We're conducting a phase two trial evaluating the immunogenicity, safety, and tolerability of a two-dose plague vaccine candidate that's adjuvanted with CPG-1018. The CPG1018 adjuvanted vaccine candidate's mechanism of action has the potential to speed up time to protection with fewer doses compared to the three-dose alum adjuvanted regimen that has been previously evaluated by the DoD. Earlier this year, we successfully completed part one of the phase two study, and subject dosing in part two is now complete. We anticipate top-line data in 2024. DynaVax and the U.S. Department of Defense recently executed a contract modification to support advancement of the plague vaccine candidate into a non-human primate challenge study, which was initiated in August. In addition to these development programs, we've also filed a supplemental BLA for haplizav B vaccination of adults on hemodialysis, which the FDA has accepted with a BDUFA action date in May of 2024. Now, if approved, this would allow us to promote a four-dose regimen of heplizab B for the dialysis population, which comprised about 11% of the total U.S. hepatitis B vaccine market in 2022. We look forward to continuing to make progress across these programs in the months ahead, and we're excited to initiate the next clinical trials for both our shingles and Tdap programs in the coming year. I'll now turn the call over to Kelly to review our financial results.
spk05: Thank you, Rob. I'm excited to report on a strong third quarter. I'll review the key financial results and then share our updated guidance for the full year. 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-Q for detailed financial information. Starting with revenue. Total revenues for the third quarter of 2023 were $70 million, driven by Heplis FD net product revenue of $62 million. Compared to the third quarter of last year, Heplis FB net product revenue grew by 66%. We continue to be excited about the uptake trajectory for Heplis FB with consistent growth in key market segments. Based on the strong results for the first nine months of the year, we are raising our Heplis FB net product revenue guidance for the full year to $210 to $220 million, compared to prior guidance of $200 to $215 million. reflecting our confidence in Heplis FB's continued growth for the full year. We are also pleased with the continued trend in the margin profile for Heplis FB, with gross margin of approximately 79% in Q3, compared to about 69% last year, and we continue to expect gross margins to average in the mid-70s for the full year. Heplis FB margin improvements have been driven by lower per-unit manufacturing costs as a result of the previous investments to drive process development improvement. Other revenue was $7 million for the third quarter, compared to $4 million in the prior year period, representing revenue related to the plague vaccine program in collaboration with and funded by the U.S. Department of Defense. The increase was primarily driven by the advancement into a non-human primate challenge study. Now turning to our research and development expenses for the quarter, which increased to $14 million compared to $13 million for the prior year period. The increase was driven by continued advancement in our clinical and preclinical development programs and collaborations. Selling general and administrative expenses for the quarter were $38 million compared to $32 million for the prior year period. The increase was primarily driven by higher compensation and related personnel costs and an overall increase in targeted commercial and marketing efforts designed to to increase HEPA-SEP B market share and maximize the opportunities presented by the HCIP's universal recommendation. These results generated GAAP net income of $14 million, or $0.11 per share basic, and $0.10 per share diluted in Q3, compared to GAAP net income of $64 million, or $0.50 per share basic, and $0.43 per share diluted for the prior year period. Moving to the balance sheet, we ended the third quarter with cash, cash equivalents and marketable security of approximately $720 million, an increase compared to our year-end balance of $624 million at the end of 2022. Based on our current operating plan, we continue to expect to finish 2023 with a positive free cash flow for the year. We are revising our full year 2023 financial guidance expectations. including raising our HEPLIS FD net product revenue expectations to be between approximately $210 to $220 million, and refining our operating expense guidance, including research and development expenses to be between $50 to $60 million, as well as some general and administrative expenses to be between $145 and $155 million. In closing, we believe that with our strong financial profile, We are well positioned to drive sustainable growth in our core hepatitis B business, capture a majority market share, and lead the expansion of the adult hepatitis B vaccine market. We look forward to progressing our R&D portfolio of vaccine candidates while continuing to be extremely thoughtful in how we allocate our capital to accelerate growth and build beyond our current base business. We are excited about our progress to date, and we look forward to continuing to deliver on our goals for this year and beyond. Thank you, everyone, for your attention today. Operator, we would now like to open the Q&A portion of today's call.
spk01: Thank you. To ask a question, you'll need to press star 11 on your telephone. To withdraw your question, please press star 11 again. Please wait for your name to be announced. Please stand by while we compile the Q&A roster.
spk04: One moment for our first question. Our first question comes from the line of Matthew Phipps with William Blair.
spk01: Your line is now open.
spk03: Good afternoon. Thanks for taking my question. Congrats on another great quarter and great market share gains. Don, real quick, you mentioned, I think you said you expect that the total market to have 10% to 15% annual growth over the next several years. Just want to make sure you're referring to total market there and then you guys' ability to gain market share on top of that.
spk11: Hey, Matt, how you doing? Yeah, so my comments were around the entire FV market would be we expect around 10 to 15% year-over-year growth for the next couple of years, so it's total.
spk03: Yeah, okay, thank you for clarifying that. In the shingles plans, now that you got the feedback, congrats on confirming a placebo-controlled study for Phase III. So is the next step still to evaluate multiple doses of the antigen that you are producing yourselves?
spk02: Hey, Matt. Thank you for the question. Yeah, that's the plan for the Phase 1-2 study, to evaluate a couple different doses of antigen.
spk03: All right. And then lastly, Brian, earlier this year, you talked a little more about potential for external business development. as being a priority, but now I don't really see any mention of that. Is that due to more change and excitement on your end for the internal shingles and TDOT programs, or maybe just a lack of attractive external opportunities?
spk02: No, it's still a priority. I mean, we mentioned it in my opening remarks. It still continues to be a priority for us to find opportunities to accelerate growth.
spk03: All right, great. Thanks for taking the question.
spk04: Thank you. One moment for our next question, please. This question comes from the line of Ernesto Rodriguez-Dumont with Calwin.
spk01: Your line is now open.
spk06: Hi, and congratulations on another great quarter. Thanks for taking our questions. So you can share, Marcus, sharing both segments, the IDN segment and the retail segment, but it seems like the at least a quarter of a quarter share gain was more pronounced in the retail segment than the IBM segment. I was wondering, is that noise or is that maybe reflects more difficulty penetrating the IBM market at this moment or anything like that?
spk11: Hey, Ernie. This is Don. I mean, I think the best way to think about the two segments, you know, IDN is probably more consistent around buying purchases and buying patterns versus within the retail segment. You can see more either seasonality or different types of purchasing patterns that will drive more fluctuation in market share. So there's different types of segments as you think about the heavy market.
spk06: Okay. And then looking into 2024 and the DLA in the dialysis population, should we expect sort of like an inflection point there? Or I guess what's your expectations on further acceleration if and when you get that label expansion?
spk02: Hey, Ernie, this is Ryan. We haven't actually provided any guidance for 24, and I think I understand your point as far as when we're able to start promoting, but we would like to first get through the approval, engage the customer before we're able to make any commentary around specific expectations in that segment. Okay.
spk06: Thanks, and congratulations again. Thank you. Thank you.
spk01: Thank you. One moment for our next question. question comes from the line of Jonathan Miller from Evercore ISI. Your line is now open.
spk08: Hey, guys. Thanks so much for taking the question, and I'll join everybody else in congratulating you on another great quarter. I would love to get some color maybe on gross margin trends. I know you announced earlier this quarter that you had better pricing and your manufacturing contract. How should we expect gross margin to evolve as volumes increase? And then maybe Secondarily, you know, as you're growing market share nicely overall and in those key segments that you've been talking about, is there anywhere that's proving challenging to grow, places where legacy contracting is slowing things down or there's some other headwind? And is there any dynamic related to that that we can expect to change going forward?
spk05: Hi, John. Thanks for the question, Kelly. I'll take the first one and hand it over to John for the second question. We're really proud of the way that we've been able to execute some of the margin improvements. I mean, this is a result of many years of investments and efficiencies that we've made, not only in our Dusseldorf facility, but as we continue to engage with our CMOs for adjuvant manufacture. You can see the improved trends throughout the year, as you noted. Additionally, and I mean, just as a reminder, we did three... issue our guidance or reiterate our guidance that we believe for the full year we're going to have average first margins in the mid-70s. We would expect, you know, next year to continue to see strong margins, more or less consistent with what we've seen in this most recent quarter. I'll hand it to John.
spk11: Yeah, and John, regarding market share, you know, obviously you heard the numbers regarding retail pharmacy and IDN, and we're really proud of the market share gains quarter over quarter. One of the areas that's difficult and always has been difficult is kind of this long tail of customer, which is approximately 40,000 locations that order very little hepatitis C vaccine. So penetrating that universe of customers has been challenging from a market share perspective. But certainly that's why we focus our efforts back to retail, back to IDM, where we believe the vast majority of growth will happen in those two segments. We feel very confident around our growth opportunities as we look ahead. But from a market share perspective, it's been that long tail that's been difficult in the past for market share.
spk08: Great. Thanks so much. And then maybe if I can squeeze one more in there to piggyback on that earlier question about BD. Given that it's still a priority for you, How do you view the current market environment evaluations that are out there as a potential acquirer? I think we've been seeing some motion in that across the industry, but it does feel like there's opportunities from the valuation perspective. How do you view infectious disease relative to the rest of the market?
spk02: Yeah, thanks, Sean. We agree. I mean, I think it's hard to miss that point, but we have to really focus on staying disciplined and finding the right fit for us for our business and our plans going forward. I think that the trap of a good deal is not something we're really going to fall into. We want to really make sure it's the right thing for our business, and it's required us to continue to be disciplined.
spk08: Thanks so much, guys.
spk04: Thank you.
spk01: One moment for our next question, please. Our next question comes from the line of Roy Buchanan with JMP Securities. Your line is now open.
spk10: Hey, thanks for taking the question. I have a few follow-ups on B1018. Just if you could give any more detail around what the FDA said. Do you have the actual minutes back from the meeting? Did they explicitly recognize a correlative protection for the pivotal trial? If there's any other details you can give us around a potential pivotal design, thanks.
spk02: Hey, Roy. This is Ryan. I'll just make a quick high-level comment. Rob, feel free to add to it. I think we still continue to believe that this is a placebo-controlled efficacy study, not a correlative protection for the Z19 program. And the engagement of the FDA in the written response indicated support for that approach. Rob, do you have any other comments to make on top of that?
spk07: Yeah, no, it's an efficacy study, so there was no mention of correlates, nor did we really ask about correlates, and I think the design of the study is going to be pretty typical of, you know, GSK's old design for Shingrix in terms of size, endpoints. We haven't finalized any of that, but, you know, don't be surprised if it looks a lot like that.
spk10: Okay, great. That seems like a pretty big win in my view. And then just a quick one for Kelly. What's driving the decrease in R&D guidance for the year? Thanks.
spk04: Thanks, Roy. Sorry, it's just timing of deployment of our spend here. That's all. Okay. Thank you. Thank you.
spk01: We have no further questions at this time. I would like to turn the call over to Mr. Ryan Spencer, Chief Executive Officer, for closing remarks. You may begin.
spk02: Thank you, operator. And thank you all for joining us today. We appreciate your interest in DynaVax. We're excited about our recent accomplishments and the strength of our position. We look forward to updating you on our progress. Operator, you may end the call.
spk01: Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for joining us. You may now disconnect. Everyone have a wonderful day.
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