Dynavax Technologies Corporation

Good day, ladies and gentlemen, and welcome to the DynaVax Technologies Second Quarter 2024 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 Vaux, 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 Casale, Chief Commercial Officer, Rob Jansen, Chief Medical Officer, and Kelly McDonnell, our Chief Financial Officer. Earlier today, Dynavax released financial results for the second quarter ended June 30th, 2024. 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 CPG1018 adjuvants. 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 10Q. Our forward-looking statements speak as of today, and we undertake no obligation to update such statements. And with that, I will now turn the call over to Ryan.

Thanks, Paul. Good afternoon, everyone, and thank you for taking the time to join us to review our second quarter 2024 results. We've achieved another record quarter for APLISAP-B net product sales as we strengthen our leadership position in the U.S. adult hepatitis B vaccine market, notching continued year-over-year market share gains for the total market and in key market segments. Based on our strong results in Q2 and the continued strengthening of the hepatitis B vaccine market across Q2 and into early Q3, we are reaffirming our Hepatitis B product revenue guidance for the full year 2024. Longer term, we are highly optimistic about the adult hepatitis B vaccine market of over 130 million eligible patients, which is one of the largest addressable patient populations for vaccines in the U.S. We expect the market opportunity for HEPA-CEPV to grow to over $800 million by 2027, with continued growth in both market share and market size through the end of the decade. We also anticipate long-term demand for HEPA-CEPV beyond 2030 as a result of the continued penetration of the unvaccinated cohort, as well as expanding market share, providing a substantial long-term revenue opportunity for HEPA-CEPV. For our pipeline development, we are pleased to have recently initiated our Phase 1-2 trial for our novel shingles vaccine program and remain excited for several upcoming milestones, including readouts from the shingles study, as well as our Tdap and plague vaccine programs expected across 2024 and 2025. In addition to this progress, and bolstered by our strong financial position, we continue to evaluate strategic opportunities to grow beyond our internal organic pipeline within the infectious disease space, which we believe would enable us to further diversify our product portfolio and create future commercial opportunities. We look forward to providing updates on these efforts in the future. I'll now turn the call over to Don and Rob, who will provide more details on the HEPA-SAPI results and our pipeline progress, respectively, before Kelly reviews our financial results for the second quarter. Don?