Dynavax Technologies Corporation Q3 FY2024 earnings call

• HEPLISAV-B delivered a record quarter with $79M net product sales, making Dynavax profitable. - Discontinued Tdap program as Phase I results didn't show sufficient differentiation. - Z1018 shingles vaccine program is actively enrolling in Phase I/II trial, expecting top-line data in H2 2025. - Regulatory update: FDA approved sBLA to include pregnancy info in HEPLISAV-B label; feedback received on sBLA for hemodialysis 4-dose regimen. - Financial results: Q3 net income $18M, HEPLISAV net sales guidance for 2024 $265M-$270M, gross margin ~80% for the year, updated R&D and SG&A expense guidance. - Board authorized $200M share repurchase plan.

HEPLISAV-B was the key driver, with net product sales of $79 million in the third quarter. HEPLISAV-B achieved 44% market share in the third quarter, up from 41% the prior year. The hepatitis B market dose volume grew 23% year-over-year in Q3, while HEPLISAV-B dose volume grew 27%. The Tdap program was discontinued as Phase I results didn't meet differentiation thresholds. The Z1018 shingles vaccine program is in Phase I/II trial, enrolling and expecting top-line data in H2 2025. The plague vaccine program is in collaboration with the US DoD, with a proposal submitted regarding additional clinical and manufacturing activities.

• HEPLISAV-B net product revenue guidance for 2024 narrowed to $265M-$270M. - HEPLISAV-B gross margin expected ~80% for the year. - R&D expenses expected $55M-$65M, SG&A expenses $170M-$180M for 2024. - Long-term outlook: HEPLISAV-B market opportunity in US to expand to over $900M by 2030 with at least 60% market share. - Board approved $200M share repurchase plan to be executed within 12 months subject to market conditions.

Forward-looking statements involve risks and uncertainties, including potential market size, marketing efforts, FDA submissions, clinical trial outcomes, etc. These risks are detailed in SEC filings, including the quarterly report on Form 10-Q.

Q: Matt Phipps asked about the 2030 market view, growth between 2027-2030, and market share goals.

A: Ryan Spencer and Donn Casale responded that the 2030 view extends previous guidance, retail pharmacy is the predominant growth driver, and they expect to take market share in critical segments like retail pharmacy and IDN to reach 60% market share.

Q: Jon Miller inquired about gross margin variability, share repurchase priority vs external BD, and share repurchase cadence.

A: Kelly MacDonald said there's quarter-to-quarter variability in gross margin, share repurchase is part of balanced capital allocation, and the plan will be executed within 12 months subject to market conditions.

Q: Ernie Rodriguez asked about RSV vaccination impact on HEPLISAV and pipeline learnings from Tdap.

A: Donn Casale mentioned retail pharmacy has opportunity from ACIP Universal, and Ryan Spencer stated no read-through from Tdap program to other vaccine programs as each is different.

Q: Paul Choi asked about Z1018 pipeline and single-dose candidate.

A: Rob Janssen responded that single-dose is challenging, but Z1018 has better reactogenicity than Shingrix and they'll look at dose optimization.

Q: Roy Buchanan asked about plague vaccine dose optimization, DoD response timeline, and sBLA for HEPLISAV dialysis label.

A: Ryan Spencer said they're waiting for DoD response on plague vaccine, and Rob Janssen mentioned ongoing discussions on sBLA for hemodialysis label with FDA, proposing real-world evidence study.