Dynavax Technologies (DVAX) The 44th Annual William Blair Growth Stock Conference summary

Commercial performance and market opportunity

• HEPLISAV-B, a two-dose adult hepatitis B vaccine, is approved in the US, Europe, and Great Britain, offering a compliance advantage over three-dose competitors.

• Q1 2024 HEPLISAV-B net product revenue was $47.8M, with 10% year-over-year growth and a 41% overall market share, reaching 55% in retail and IDN/large clinic segments.

• Year-over-year growth for HEPLISAV-B reached 69% from 2022 to 2023, with projected 25%-30% growth for 2023-2024.

• The US adult hepatitis B vaccine market is expected to expand from $525 million in 2023 to over $800 million by 2027, driven by updated ACIP recommendations for universal adult vaccination under 60.

• Commercial focus is on retail pharmacies and large health systems, which are expected to drive the majority of future growth.

Product pipeline and development updates

• Pipeline includes shingles, Tdap, and plague vaccines, all leveraging the CpG 1018 adjuvant used in HEPLISAV-B.

• The shingles vaccine (Z-1018) received FDA IND clearance, with a Phase 1/2 trial to start in Q2 2024 and top-line data expected in H2 2025.

• Tdap program aims to improve durability of pertussis protection; a Phase 1 extension study will report antibody durability data in Q4 2024.

• The plague vaccine program expanded via a $38M contract with the Department of Defense, with Phase II and non-human primate data expected in Q4 2024.

• Multiple collaborations are ongoing, providing CpG 1018 to external vaccine programs at both preclinical and clinical stages.

Industry analysis and market outlook

• HEPLISAV-B is positioned as the market share leader in key growth segments, with the U.S. hepatitis B vaccine market projected to grow significantly.

• Shingles and Tdap vaccine markets represent significant opportunities, with global market sizes of $4.4B and $1.2B, respectively, and unmet needs in efficacy and tolerability.

• Dynavax leverages proprietary CpG 1018 adjuvant technology across its pipeline, targeting large indications with high unmet need.