Dynavax Q1 HEPLISAV-B revenue up 10% to $47.8M; reaffirms 2024 guidance; FDA clears IND for shingles vaccine

DYNAVAX TECHNOLOGIES CORP

2024-Q1 EPS reported -$0.07 revenue$50,790,000

HEPLISAV-B net product revenue $47.8M (+10% YoY); total revenue $50.8M; GAAP net loss $8.7M ($0.07/share) vs loss $24.3M ($0.19) YoY.
Reaffirms FY2024 guidance: HEPLISAV-B revenue $265-280M, gross margin ~80%, R&D $60-75M, SG&A $160-180M, cash to increase.
U.S. FDA cleared IND for Z-1018 shingles vaccine; Phase 1/2 trial expected Q2 2024 with top-line data H2 2025.
HEPLISAV-B U.S. market share ~41% (up from 37% YoY); sBLA for hemodialysis under review with PDUFA May 13.
Cash, equivalents, marketable securities $723.5M; plague vaccine contract modification adds $4M from DoD; Phase 2 data Q4 2024.

item 2.02 item 9.01

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

DYNAVAX TECHNOLOGIES CORP reported the quarter ended March 31, 2024 results: revenue $50.8 million. Guidance reaffirmed.

Period: the quarter ended March 31, 2024
Revenue: $50.8 million
Guidance: reaffirmed
Result: reported results

Exact text from the filing

Total revenues for the first quarter of 2024 were $50.8 million

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Source: SEC EDGAR

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