Dynavax Technologies Corporation

Good day, ladies and gentlemen, and welcome to Dynavax Technologies' first quarter 2023 financial results conference call. 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 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, Norma. Good afternoon and welcome to the DynaVax first quarter 2023 financial results and corporate update conference call. In addition to our press release issued today, a supplementary slide presentation that accompanies today's call is available in the events section of our 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, future expected market share and related growth rates, and related ACIP recommendation impact on each, financial guidance and trends, including revenue, profitability, and sufficiency of current capitalization, timing and results of 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 factor 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. Joining me on the call today are Ryan Spencer, Chief Executive Officer Don Cassell, Chief Commercial Officer, Rob Jansen, Chief Medical Officer, and Kelly McDonald, Chief Financial Officer. I'll now turn the call over to Ryan.

Thank you, Paul, and thank you all for joining us today. We're excited to update you on our continued progress in the first quarter as we execute across our core strategic priorities. First and foremost, we are focused on driving growth for our commercial product, Hepatitis B, our adult vaccine for hepatitis B. In the first quarter, We are pleased to achieve record quarterly net product revenue once again for HEPA-SATV and continued market share gains, both in total market share and in the key market segments that are expected to drive the long-term growth. The tremendous results this quarter even exceeded our own expectations. We are encouraged by the continued market adoption of HEPA-SATV, driven in part by the expanded ACIP recommendation for adult hepatitis B vaccination, and look forward to demonstrating continued revenue and market share growth this year. Last year, HEPA-CEV revenue doubled compared to 2021, and we anticipate continued annual revenue growth for HEPA-CEV in 2023 in the range of 30 to nearly 50%. With Q1 revenue increasing 109% compared to Q1 of last year, we are already on track to achieve a fourth year of record revenue for HEPA-CEV. Don will review our commercial progress in more detail in a few minutes. We continue to build on the strong executional foundation laid in 2022 through further advancement of our pipeline as we progress our three adjuvanted vaccine clinical stage candidates for Tdap, shingles, and plague, and continue to identify new opportunities to leverage CPG1018 in our preclinical efforts, both internally and through our collaboration. Rob will walk through our expected progress for our clinical programs this year in detail later on in the call. Based on our strong execution, we are in a financial position that enables us to support our efforts to maximize the opportunity while making the appropriate investments to advance our clinical stage portfolio. In addition, backed by the continued growth and our strong cash position, we are actively working to identify and review strategic opportunities to accelerate our growth. Our initial prioritization of external opportunities includes the following two categories. commercial or late stage assets in the vaccine space to leverage our expertise in the field and our fully integrated capability, and high synergy commercial assets within the infectious disease space that would broaden our focus to include therapeutic modalities outside of vaccines. We remain focused on a 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 to provide more details on the tremendous HEPALSAT-B performance in the first quarter. Thank you, Ryan.