All right. Hi, everyone. My name is Matt Phipps, biotech analyst here at William Blair. Thanks for joining us for a presentation from Dynavax Technologies and CEO, Ryan Spencer. Please consult williamblair.com for any and all disclosures, and also please join us afterwards in Burnham B for the breakout. So with that, Ryan's going to walk us through a presentation on HEPLISAV and commercial growth that they're seeing. Thanks, Ryan. Thanks, Matt, and thank you all for joining us today. I'm Ryan Spencer, the CEO of Dynavax. It's my good fortune to lead an excellent team in our mission to help protect the world against infectious diseases. First off, I will be making some forward-looking statements that are subject to certain risks and uncertainties, more completely detailed on our Forms 10-Q and 10-K, which I encourage you to review. All right, so Dynavax, we are a commercial-stage biopharmaceutical company focused on, as I mentioned, protecting the world against infectious diseases with novel vaccines. We've made pretty good progress over the years, developing and launching our first commercial product, as well as advancing our portfolio of pipeline assets. So I look forward to giving you an overview of the business today and highlighting some opportunities for long-term value creation. Let's start with an overview of the product portfolio. So it's anchored by our commercial product, HEPLISAV-B. It's a two-dose adult hepatitis B vaccine that received approval in the U.S., followed by approval in Europe and then also in Great Britain. Our clinical development programs are a shingles vaccine, a Tdap and plague vaccine, all adjuvanted with the same adjuvant in HEPLISAV-B, which is what we call CpG 1018. Shingles and Tdap are internally funded programs, while the plague program is a collaboration and funded by the Department of Defense. Beyond what you see here on this list, we also have a wide array of collaborations with both preclinical and some clinical assets, where we've provided CpG 1018 to academic and other companies to support their vaccine programs. So Dynavax's core priorities are focused in three areas: number one, continuing to grow HEPLISAV-B, both expanding the market and increasing our overall market share, followed by advancing our development pipeline of clinical and preclinical assets, leveraging CpG 1018, and then lastly, a goal to diversify our product portfolio and accelerate growth through external opportunities. We've had quite a bit of success, as I've noted before, around HEPLISAV continuing to grow, as well as our capital position, which supports our ability to execute on our core priorities. HEPLISAV's year-over-year growth has been impressive with 10% growth in Q1. From 2023 - 2024, we saw 69% growth, and we're projecting about 25%-30% growth in... I'm sorry, for 2023 - 2024, 25%-30% growth. We have seen growth for two reasons. One is expanding market, as well as, as you can see on the slide, continued progress in our overall market share. We exited the year in a strong financial position and are projecting to be cash flow positive for the year. I'm going to spend some time first on HEPLISAV-B to review that product before I move into our pipeline activities. So important thing to understand about HEPLISAV-B is the overall profile of the product, which anchors our belief in the overall strength of the brand and the ability to capture a majority market share. So HEPLISAV-B is the only approved two-dose adult hepatitis B vaccine. This is an important element of the profile. The competitor products are three-dose vaccines, and they're given over six months. So with HEPLISAV-B's profile of two doses over one month, it provides a important option for patients where we know compliance is often a challenge to the three-dose regimen. Importantly, with the two-dose, one-month regimen, you're not giving up any benefit as far as overall sero protection or effectiveness of the product. So you can see from the slide here that even after two doses, HEPLISAV-B obtains higher rates of protection than the comparator product in this trial even after three doses. So it offers a lot more rapid protection, even at higher levels across all patient types that we tested. So very proud of the product that was developed and believe this profile will allow this to be the, majority- take a majority share in the U.S. market. Now, hepatitis B has had a lot of developments, as it relates to, cure or treatments, but there is no cure. The best option is prevention. Recently, due to the overall concern around viral hepatitis, the ACIP, which is the Advisory Committee on Immunization Practices, updated the recommendation to include all adults under 60 to be recommended for a hepatitis B vaccine. This is a big shift from the prior recommendation, which was risk-based, and that provides, a significant, growth opportunity for the, U.S. adult hepatitis B market. As you can see here, as it relates to that recommendation, we believe the market will grow substantially over time. The market size actually saw some growth from the recommendation that was made in 2022 to grow to about $525 million market opportunity in 2023, which we expect to continue to expand to about $800 million by 2027. One of the reasons for this is when you think about the patient population recommended by the ACIP, that's about 130 million adults. This is a very large recommended population. It's even larger than the SHINGRIX or shingles and pneumococcal population. So we do think there's tremendous opportunity for growth. As you can see here on the slide, we have prioritized segments, which are labeled retail and IDN clinics. Those are the retail pharmacy settings and the largest health systems in the country. We believe that these segments offer the best opportunity to support personal promotion, both to capture market share, but they also are the areas where we expect to see the majority of growth, based on the recommendation. And our commercial team is mostly focused on these two segments. So our results to date have been impressive, growing market share year-over-year. You can see we exited Q1 with a 41% share, which has resulted in continued revenue growth year-over-year. As I mentioned, from 2022 - 2023, we grew 69%, and we're projecting, based on our guidance of $265 million-$280 million that we provided during our earnings call last quarter, that would result in a 25%-30% growth this year as well. I'm very excited about not only our progress to date, but the ability to continue to drive revenue increases year over year with this brand. Now, moving past HEPLISAV-B and into our development pipeline, we have development assets leveraging our CpG 1018 adjuvant for shingles, Tdap, and plague. I'll start with a quick overview of our shingles program. So we believe that there's an opportunity to create an improved shingles vaccine focused on matching the current market leader vaccine in efficacy while delivering an improved tolerability profile. We reported data last year on our head-to-head phase I study that showed that our program, which we call Z-1018, was able to generate an improved profile with lower post-injection site reactions compared to SHINGRIX, which is the market-leading product. Additionally, we saw a robust T cell and antibody responses in that trial. So based on what we saw in that trial, we're advancing the product into a phase I/II study using our own gE protein and doing a dose-ranging study to find the optimal dose before we advance into more advanced trials. So a quick review of this trial. This is expected to start in Q2, which would be later this month. It's a phase I/II randomized, active controlled study that will read out in the second half of 2025 top-line data. It's testing the safety and immunogenicity of our product, Z-1018, compared head-to-head to Shingrix, across a number of different dosing arms. And you can see on the slide, we will be evaluating three different doses of g E protein in combination with two different adjuvant formulations, one with CpG 1018 alone and one with CpG 1018 plus alum, as well as some dosing regimens between zero and eight weeks and zero and 12 weeks. And so it'll enroll about 440 subjects in Australia. And we do look forward to report this data in 2025, which will allow us to understand the optimal dose to take forward into future studies. Moving on to Tdap. Our Tdap product, which is tetanus, diphtheria, and acellular pertussis, is built focused on improving the response to the acellular pertussis component of that vaccine. So acellular pertussis vaccines that are currently used are known to be associated with waning immunity, and we believe by adding CpG 1018 to the Tdap products, we will be able to generate higher levels of antibodies to pertussis toxin and thereby extending overall durability of efficacy against pertussis. So we have made the decision recently to conduct an extension study from our original phase I that was completed a number of years ago, and we'll have data from that extension study in Q4, which will allow us to see antibody results for patients that were originally enrolled in the phase I study out 2.5 - 3 years. And so this will be our first look at a comparison of durability against the active control in that trial. The data from that study will then be supportive of us starting a long-term immunogenicity study, which would deliver appropriate data around durability just at the time of licensure of this product, which we think is an important element to have a true differentiation in the market. And then finally, on the development programs, our plague vaccine candidate. This product, as I mentioned previously, is funded and being developed in collaboration with the Department of Defense. This is specifically focused on taking the existing plague antigen that they have already developed and adjuvanting it with CpG 1018, with the goal of reducing the dosing regimen from a zero, one, six-month schedule to a zero, one-month schedule, very similar to what we did with HEPLISAV-B for hepatitis B. So we have data from the controlled study that we'll be reading out in Q4 for the phase II study, as well as non-human primate challenge data, which will be important to establish the overall opportunity for the program. Once we have those data available, we will be able to provide more clarity on the next steps for the program in collaboration with the Department of Defense. So we're pretty proud of the progress we've made over the years, as well as recently as well. Our strong capital position, as well as the continued commercial success of HEPLISAV-B, does provide a unique opportunity for us to focus on strategic opportunities externally that can help accelerate growth and diversify our product portfolio and complement our organic development opportunities with the goal of continuing to drive value for shareholders. I thank you guys for being here today. We look forward to providing an up-
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