secwatch.observer — SEC 8-K summary
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Issuer:     DYNAVAX TECHNOLOGIES CORP (—)
CIK:        0001029142
Form:       8-K
Filed at:   2024-05-08T23:59:59+00:00
Accession:  0000950170-24-055612
Event type: earnings
Sentiment:  positive
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1029142/000095017024055612/0000950170-24-055612-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1029142/000095017024055612/dvax-20240508.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-055612

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