Dynavax Technologies Corporation

Good day, ladies and gentlemen, and welcome to DynaVax Technologies' second quarter 2023 financial results. As a reminder, this conference is being recorded. At the end of the company's prepared remarks, we will open the call for questions and provide specific instructions at that point. 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 second quarter ended June 30th, 2023. 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. 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 DynaVax's results for the second quarter of 2023. We are pleased to share the results of yet another impressive quarter for DynaVax. including outstanding progress for hepatitis B, our adult hepatitis B vaccine, which delivered $56 million in quarterly net product revenue. These results reflect our team's success in driving the expansion of the adult hepatitis B vaccine market and capturing market share. As a result of the strong hepatitis B performance in the first half of 2023, along with the growing enthusiasm that we see in the market, we are significantly raising our revenue expectations for the full year. We now expect HEPA-SAT-B net product revenue to be in the range of $200 to $215 million compared to the prior range of $165 to $185 million. Last year, HEPA-SAT-B revenue doubled compared to 2021, and with our increased guidance range, we now expect growth of 58% to 70% this year. Based on our exceptional commercial execution, we have strengthened our financial position with cash and investments increasing to $682 million at quarter end. And we expect positive free cash flow for 2023 in total. This addition enables us to support our efforts to maximize the opportunity while making the appropriate investments to advance our clinical portfolio. We continue to make progress in advancing our clinical pipeline of three vaccine candidates for Tdap, shingles, and plague. Rob will walk through our achievements and expectations for our clinical programs in a few minutes. Additionally, we continue to identify and review strategic opportunities to help accelerate our growth and further diversify our product portfolio and future commercial opportunities. We are focusing on prioritizing external opportunities in the following two categories. First, commercial or late-stage assets in the vaccine space to leverage our expertise in the field. and our fully integrated capabilities. And second, high synergy commercial assets within the infectious disease space that would broaden our focus to include therapeutic modalities outside of vaccine. We remain focused on disciplined capital allocation strategy in our efforts to generate significant value and accelerate growth. And we look forward to providing updates on this front in the future. I'll now turn the call over to Don so he can provide more details on the tremendous hep Cepi performance in the second quarter.