Dynavax Technologies Corporation

Good day and welcome to the Dynavox Technologies second quarter 2022 financial results call. As a reminder, this conference call is being recorded. At the end of 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 for Investor Relations. You may begin.

Thank you. Good afternoon and welcome to the DynaVac second quarter 2022 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 and market share, market trends, impact of ACIP recommendations, and timing of such impact, financial guidance and trends including revenue, profitability, and sufficiency of current capitalization, timing and results of clinical trials, starts, and data readouts, and potential future uses of CPG 1018 adjuvant. These statements involve risks and uncertainties, and our actual results may differ materially. These results, these risks are summarized in today's press release and detailed in the risk factor section of our SEC filing, 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 Casal, Senior Vice President of Commercial, Rob Jansen, Chief Medical Officer, and Kelly McDonald, Chief Financial Officer. I will now turn the call over to Ryan.

Thank you, Nicole, and thank you all for joining us today. I'm excited to have the opportunity to review the progress we've made during the second quarter. I'll start by providing a brief overview of our highlights before turning it over to Don, Rob, and Kelly, who will provide a bit more insight into their respective areas. The short summary of the quarter is that we continue to execute well on our core priorities. which has us on track for a second consecutive year of profitability with record revenues expected for HEPA-LSAB-B and our CPG-1018 adjuvant. Based on strong execution from the team, the total revenue for the quarter grew 386% compared to the second quarter of last year. Importantly, we continue to see market adoption of HEPA-LSAB-B driven by successful engagement across our customer segments, resulting in increased market share and revenue. We achieved over $32 million in HEPA-Sav-B net product sales in the second quarter, supporting our expectations for another year of growth for HEPA-Sav-B revenues. We're also paying close attention to the evolving landscape for COVID-19 vaccines globally. New COVID-19 variants have driven increases in infections. However, vaccines continue to provide protection against severe disease that lead to hospitalization and death. Our collaborators have demonstrated that their COVID-19 vaccine platforms adjuvanted with CPG1018 can provide a combination of high efficacy and immunogenicity with favorable safety and tolerability. In the second quarter, our global portfolio of CPG1018 adjuvant supply agreements for COVID-19 vaccines generated over $220 million of revenue. we anticipate full-year 2022 revenue for CPG1018 to be between $550 and $600 million, which represents the remainder of orders from our partners under our commercial supply agreement. We continue to work with each of our partners to understand and clarify potential demand for 2023 and beyond. Now, beyond COVID-19, we are leveraging our proven CPG1018 adjuvant to advance our pipeline of new and improved vaccines. Our current clinical programs are focused on delivering meaningful improvement over existing vaccines by adding our CPG1018 adjuvant to establish antigens. We expect our Tdap and shingles program will generate initial phase one data this year, which we anticipate will highlight the value of our pipeline and strategy to produce best in class products targeting large markets. In reflecting on the past few years, We are extremely proud of the execution on our strategy to grow HEPA-SAPB revenue and broadly develop our CPG-1018 adjuvant to build a strong foundation for future growth. Over a relatively short period of time, we have drastically expanded the long-term opportunity for our CPG-1018 adjuvant, transformed our financial profile, and have demonstrated our ability to successfully commercialize HEPA-SAPB. We are proud of our progress and equally excited for our future where we will continue to provide advancements to benefit of public health and drive value for our shareholders. I'll now turn the call over to Don to provide more details on HEPA-SAV-B performance.