Dynavax Technologies Corporation

and our details in our risk factors section of our current 10Q and 10K periodic reports filed with the SEC, which we encourage you to review. I will now turn the call over to Ryan Spencer, CEO of Dynavax.

Thank you, Nicole, and thank you all for joining us today. I'm excited to share results from the second quarter, which reflect continued successful execution and reinforce our belief that 2021 is a transformational year for Dynavax. We continue to execute on our core priorities, driving growth of HEPLIS FB, enabling our CPG 1018 adjuvant partnerships in the fight against COVID-19, developing our pipeline, and strengthening our financial profile. I will touch on each of these briefly, then turn it over to the team to provide a bit more detail. First, we generated $13.7 million in HEPLIS FB product revenue, which is our highest quarterly revenue for HEPLIS FB since launch. In addition to revenue growth, we continue to grow field-targeted market share, achieving 30% share, and we finalized an agreement with Bavarian Nordic for the commercialization of HEPA-Sav-B in Germany. we continue to believe HEPLISAB-B has the potential to be the standard of care adult hepatitis vaccine in the United States. And we are very excited to welcome an additional 35 members to our sales team that will help us make this goal a reality. This investment in the growth of HEPLISAB-B highlights our confidence in the product and the value of the commercial opportunity. Secondly, our vaccine adjuvant, CPG-1018, provides a variety of opportunities for Dynabats, either as a vaccine developer or as a supplier of adjuvant through commercial supply agreements. We continue to make tremendous progress with the execution of multiple supply agreements to provide CPG-1018 to partners developing COVID-19 vaccines. Additionally, we continue to progress our internal efforts. to leverage the proven capabilities of CPG1018 to develop innovative new vaccines. We are currently enrolling patients in a phase one trial for our next product candidate, which is a Tdap vaccine adjuvanted with CPG1018, focused on improving the response to the pertussis component of the combination vaccine. Lastly, and importantly, We are pleased to report that we've generated positive gap net income for the second quarter in a row. Our financial performance during the first half of 2021 reflects the benefit of continued growth of HEPA-SAP-B revenue and the disciplined approach and strategy we implemented to respond to the COVID-19 pandemic. As I've said before, We believe this is a transformational time in Dynavax's history, and we will set the foundation for continued growth into the future. We are focused on identifying the best ways to deliver value to our shareholders by leveraging our development and commercialization strengths in vaccines. I am proud of the progress we've made so far. To take you through the update on HEPA-SAP-B, I will now turn the call over to Don Casal, Senior Vice President of Commercials.

Thank you, Ryan. Hepatitis B continues to make significant progress on its path to becoming the standard of care for hepatitis B prevention in the United States, with a potential market of over $600 million, with additional opportunities for expansion beyond that. Hepatitis B is the only two-dose, one-month hepatitis B vaccine that delivers higher rates of protection across all patient types in a shorter period of time. Hepatitis B vaccine series completion is essential to achieve protection. Unfortunately, three-dose hepatitis B vaccine regimens have proven to be challenging with low completion rates. Fortunately, based on real-world data, twice as many adults complete the HEPOSAB B series than those starting on Ngerix B. As Ryan mentioned, second quarter net product revenue for HEPOSAB B was $13.7 million. the highest quarterly revenue since our commercial launch. This revenue milestone was achieved despite the hepatitis B market remaining far below historical norms due to the ongoing pandemic, with vaccine utilization during the quarter at approximately 61% of pre-pandemic levels, consistent with prior quarter utilization of 59%. Market share in field targeted accounts increased to 30% in the quarter. an increase of 9.5% from the second quarter of last year. We are very excited by this outcome and remain confident in our ability to continue to drive market share quarter-over-quarter in field-targeted accounts. In the retail segment, there were several large purchases from national customers, plus significant increases in the number of new stores ordering HEPLASAB-B. The retail segment has started to shift its focus from COVID-19 vaccination back to routine adult vaccines such as hepatitis B. We believe this shift has provided a great opportunity to accelerate adoption of hepatitis B in the second half of this year. Additional progress in the quarter included increases in DOD purchases as large accession bases prepared for the surge of new recruits over the summer months. We continue to make progress with the remaining non-converted accession bases and remain on track to convert at least one additional base by year end. Looking ahead, with a high hope that we can quickly overcome the concerning resurgence of COVID-19 cases due to the Delta variant, we expect the hepatitis B market to continue its steady recovery back to pre-pandemic levels. This ongoing recovery, coupled with increased awareness around the importance of vaccines provides a terrific opportunity to capitalize on the strong clinical profile of Hepatitis B. Additionally, we anticipate the CDC Advisory Committee on Immunization Practices, or ACIP, will vote on a universal Hepatitis B recommendation for all previously unvaccinated adults in October. We believe a positive decision will be an important driver of long-term value for Hepatitis B. Based on the increased awareness around the importance of vaccines, continued recovery of the hepatitis B market, and market expansion opportunities, including a potential ACIP universal hepatitis B recommendation, we made the decision to expand our commercial footprint. In July, we hired additional 35 sales professionals, which increased our sales team to approximately 100 field-based professionals, and expect deployment of these resources to drive increased awareness of the clinical benefits of HEPLISA-B and market share. An additional highlight for HEPLISA-B was finalizing a commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISA-B in Germany. We look forward to Bavarian Nordic's launch of HEPLISA-B in Germany in the first half of 2022 and updating you on progress in Europe. As we continue to see a steady return in vaccine utilization, increasing market share in field targeted accounts, progress in national accounts, potential for significant market expansion, and a planned launch in Europe, we are very excited about both the near and long-term prospects for HEPA-SAB-B. I will now return the call back over to Ryan to walk through the progress we made in our CPG-1018 adjuvant business. Thanks, Don.