Dynavax Technologies Corporation

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Second Quarter 2025 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.

Thank you for participating in today's call. Joining me from DynaVax are Ryan Spencer, Chief Executive Officer, Don Cassell, Chief Commercial Officer, Rob Jansen, Chief Medical Officer, and Kelly MacDonald, our Chief Financial Officer. Earlier today, DynaVax released financial results for the second quarter ended June 30th, 2025. Copies of the press release and a supplementary slide presentation are available on 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 of or demand for our CPG-1018 adjuvant. These statements involve risks and uncertainties, and our actual results may differ materially. These risks are summarized in today's press release and detailed in the risk factors section of our SEC filings, including today's quarterly report on Form 10-Q. Our forward-looking statements speak as of today, and we undertake no obligation to update such statements. Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations, on the investor section of our corporate website at dynavax.com. And with that, I will now turn the call over to Ryan.

Thanks, Paul. Thank you all for joining us this afternoon. We continued our momentum in the second quarter of 2025 by delivering our highest ever revenue quarter for hepatitis B. We recorded $92 million in Q2 net product revenue, representing an increase of 31% year over year. We also continued to grow our market leading position in the U.S. adult hepatitis B vaccine market with 45% estimated market share in Q2 compared to 42% for the prior year quarter, demonstrating our ability to continue growing share in this expanding market, putting us on track to achieve our long-term goal of at least 60% total market share in the U.S. by 2030. Based on our strong performance for the first half of the year, we are updating our full-year 2025 HEPA Sub B Net Product Revenue Guidance to $315 million to $325 million, bringing up the prior low end of the range of $305 million. Beyond Hepatitis B, our vaccine pipeline remains on track with key clinical milestones achieved or expected this year across multiple programs. We look forward to reporting initial top-line immunogenicity and safety results from our Phase I-II trial for our novel shingles program in the coming weeks. We are excited to have an opportunity to advance a potential best-in-class profile for this program with the goal of disrupting the multibillion-dollar shingles vaccine market. We're also excited to continue advancing our earlier stage development pipeline, which leverages our vaccine adjuvant technology, CPG1018. As we announced last quarter, we are developing two new programs in pandemic influenza and Lyme disease. We believe our pandemic influenza adjuvant program is an attractive opportunity to leverage our expertise and capabilities as a supplier of CPG1018. Given the global shortage of proven vaccine adjuvants, for potential pandemic responses. This program is on track to report the safety and immunogenicity Phase 1-2 data next year, which would support our business development efforts with global flu manufacturers, governments, and non-government organizations focused on global pandemic preparedness and response efforts. We continue to focus on building an optimal product portfolio and development pipeline with a disciplined capital allocation approach. First and foremost, supporting our lead asset, Peplicev B. Second, advancing our internal pipeline programs, which are evolving and maturing. While third, also continuing to assess attractive opportunities that would complement our existing portfolio. We believe this performance year date continues to set us up for a banner year for Dynabats. I look forward to providing you with updates on the progress along the way. Now I'd like to turn the call over to Don.