DYNAVAX TECHNOLOGIES CORP Q2 FY2024 earnings call

HEPLISAV-B Performance - Record Q2 sales of over $70M, with year-over-year market share growth to 42%. - Reaffirmed 2024 HEPLISAV-B product revenue guidance. - Long-term optimism about the adult hepatitis B vaccine market, expecting it to grow to over $800M by 2027. ### Pipeline Progress - Initiated Phase I/II trial for novel shingles vaccine program Z1018, expecting top-line data in H2 2025. - Tdap-1018 Phase I extension study results expected in Q4 2024. - Plague vaccine program to provide update in Q4 2024 based on Phase II trial and nonhuman primate challenge study. - Addressing FDA comments on HEPLISAV-B hemodialysis dosing regimen, planning to meet with FDA in H2 2024. ### Financials - Record quarterly revenue for HEPLISAV-B, improved product gross margins to 83% in Q2 2024. - Cash, cash equivalents, and marketable securities at $736M at end of Q2 2024, with sufficient capital to prosecute organic pipeline.

HEPLISAV-B achieved over $70 million in net product revenue in Q2 2024, a 24% year-over-year increase and 47% sequential increase. It had an estimated 42% market share in the U.S. adult hepatitis B vaccine market in Q2 2024, up from 39% in the same period last year. HEPLISAV-B's revenue contribution is significant, driven by growth in the hepatitis B vaccine market and increased market share in retail pharmacy and IDN segments.

HEPLISAV-B - Reaffirmed 2024 product revenue guidance. - Expect HEPLISAV-B market opportunity to reach over $800M by 2027. ### Financial - Reiterated all 2024 financial guidance, with cash guidance on track. - Longer-term, refining work on long-term guidance to provide update later this year, including peak opportunity and post-peak context.

Forward-looking statements involve risks and uncertainties, including potential market size, marketing efforts, FDA submissions, clinical trial results, etc. Actual results may differ materially from forward-looking statements, as detailed in the press release and SEC filings.

Q: Matthew Phipps asked about market share expectations and seasonality.

A: Ryan Spencer mentioned no refined market share guidance but reaffirmed long-term majority share expectation by 2027. Kelly MacDonald noted Q4 is expected to contract at ~15% relative to Q3, with Q3 being strong.

Q: Phil Nadeau asked about data points supporting market growth to $800M by 2027.

A: Ryan Spencer mentioned tracking towards projections based on increasing coverage rates similar to other vaccines, and Donn Casale noted retail pharmacy trends and additional vaccination opportunities.

Q: Jon Miller asked about market share drivers and gross margin noise.

A: Ryan Spencer and Donn Casale mentioned expanding utilization in IDN and disproportionate share of market expansion. Kelly MacDonald said minor quarter-to-quarter fluctuations expected but in line with guidance.

Q: Paul Choi asked about guidance for back half and plague program milestones.

A: Kelly MacDonald and Donn Casale said they feel confident in upper end of guidance due to retail pull-through and opportunities. Ryan Spencer noted no defined milestone structure for plague program, update in Q4 will include future expectations.

Q: Roy Buchanan asked about longer-term guidance preview.

A: Ryan Spencer said refining work on long-term guidance to provide update later this year, including peak opportunity and post-peak context based on additional insights.