Dynavax Technologies Corporation

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.

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.

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.