Dynavax Technologies Corporation

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies' third quarter 2021 conference call. As a reminder, this conference call 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 Nicole Arndt, Senior Manager, Investor Relations. You may begin.

Thank you very much. Good afternoon and welcome to the DynaVax Third Quarter 2021 Financial Results and Corporate Update Conference Call. Before I begin, I advise you that we will be making forward-looking statements today, including but not limited to statements regarding market size, impact of ACIP recommendations, customer buying patterns, financial guidance and trends, and potential future uses of CPG 1018. These statements involve risks and insurgencies that could cause actual results to differ materially. These risks are summarized in today's press release and are detailed in our risk factors section of our current 10Q reports filed with the SEC, which we encourage you to review. Our forward-looking statements speak as of today, and we undertake no obligation to update such statements at a later date. Joining me on the call today from DynaVax are Ryan Spencer, Chief Executive Officer, Kelly McDonald, Chief Financial Officer, Robert Jansen, Chief Medical Officer, and Don Casal, Senior Vice President, Commercials. Go ahead, Ryan.

Thank you, Nicole, and thank you all for joining us today. I'm pleased to report that we continue to make strong progress on each of our core priorities, including accelerating momentum with our lead commercial asset, Hevelstam V., advancing our COVID-19 vaccine collaborations, and continuing to add to our development efforts to leverage our vaccine adjuvant, CPG1018, to generate long-term value. Hepatitis B, our two-dose adult hepatitis B vaccine approved in the U.S. and in Europe, achieved another record this quarter with net product revenue of $22.7 million, up significantly from $13.7 million in the prior quarter. I'm also excited to report that yesterday the ACIP voted unanimously to adopt an upgraded recommendation greatly expanding the number of adults recommended to be vaccinated against hepatitis B in the United States. With this upgraded recommendation, we believe the U.S. hepatitis B market opportunity has the potential to grow to over $800 million annually over time. We believe hepalsab B is progressing to become the standard of care adult hepatitis B vaccine in the U.S. Hepalsab B provides an important foundation for our company as our lead commercial asset, generating durable, long-term revenue growth. The opportunity for our CPG1018 adjuvant has also advanced rapidly. Our collaborators have generated significant data demonstrating its efficacy, immunogenicity, and safety in COVID-19 vaccines, which is expected to lead to multiple emergency use authorizations. Additionally, our commercial supply agreements for CPG 1018 have generated $84 million in revenue this quarter alone. As a result of the progress made by our collaborators, and our growing CPG-1018 capacity, we now expect to generate approximately $375 to $425 million in aggregate CPG-1018 product revenue in 2021, an increase to our previously estimated range of $300 to $400 million. I will turn the call over to Rob Jansen to review the current status of each collaboration before we move on to HEPA-SAT-B and our financial results. Rob?