Dynavax Reports 3rd Quarter 2022 Financial Results.

EMERYVILLE, Calif: Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today reported financial results and provided a business update for the quarter ended September 30, 2022.

"For the third quarter, we demonstrated another quarter of successful execution on our key priorities and remain on track for profitability with record revenues anticipated for both HEPLISAV-B and our CpG 1018 adjuvant in 2022," commented Ryan Spencer, Chief Executive Officer of Dynavax. "We believe we are well capitalized to invest in driving revenue growth for HEPLISAV-B and to deliver progress across our clinical pipeline, focusing on high value vaccine programs where our proven adjuvant may provide meaningful differentiation."

THIRD-QUARTER CORPORATE HIGHLIGHTS

HEPLISAV-B(r) [Hepatitis B Vaccine (Recombinant), Adjuvanted]

HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S. and EU that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S.

HEPLISAV-B vaccine achieved net product revenue of $37.5 million for the third quarter of 2022, up 65% compared to $22.7 million for the third quarter of 2021.

Market share in the accounts targeted by the Dynavax field sales team increased to approximately 43%, with total market share increasing to approximately 32% in the third quarter of 2022, up from approximately 32% and 25%, respectively, in the third quarter of 2021.

CpG 1018(r) Adjuvant Supply for COVID-19 Vaccines

Dynavax has established a global portfolio of CpG 1018 adjuvant commercial supply agreements (CSAs) currently supporting the development of COVID-19 vaccines across a variety of vaccine platforms.

CpG 1018 adjuvant revenue for the third quarter of 2022 was $126.3 million, up 50% compared to $84.3 million for the third quarter of 2021.

The Company reiterates its expectation of 2022 full-year CpG 1018 adjuvant COVID-19 supply revenue to be between $550 million and $600 million, based on committed orders under our CSAs, with an anticipated full-year gross margin of approximately 60%.

Clinical Pipeline

Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018 adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and...