DT
DYNAVAX TECHNOLOGIES CORP (DVAX)·Q2 2025 Earnings Summary
Executive Summary
- Q2 2025 delivered record HEPLISAV-B net product revenue of $91.9M (+31% y/y), total revenue of $95.4M (+29% y/y), GAAP diluted EPS of $0.14, and adjusted EBITDA of $37.3M; U.S. market share for HEPLISAV-B rose to ~45% .
- Results exceeded Wall Street consensus: EPS $0.19 vs $0.09 estimate and revenue $95.4M vs $86.7M estimate; both were meaningful beats, driven by stronger retail adoption and market share gains for HEPLISAV-B; management raised FY25 HEPLISAV-B revenue guidance lower bound to $315–$325M (from $305–$325M) .
- Pipeline milestones remain on track: shingles Phase 1/2 top-line readout expected August 2025; pandemic influenza adjuvant program completed Part 1 dosing; plague Phase 2 to initiate in H2 2025, fully funded by DoD .
- Stock reaction catalyst: despite beats, near-term share moves were muted-to-negative in aftermarket; investors focused on pipeline execution and expense trajectory; after-hours dipped ~1.16% on the print .
What Went Well and What Went Wrong
What Went Well
- Record HEPLISAV-B sales and share: net product revenue $91.9M (+31% y/y), total U.S. market share ~45% (up from ~42% in Q2 2024) .
- Guidance raised: FY25 HEPLISAV-B net product revenue refined to $315–$325M, lifting the lower bound by $10M (confidence in sustained demand and execution) .
- Management tone: “continued our momentum by delivering robust Q2 results…while further growing our market share leading position” — Ryan Spencer, CEO .
What Went Wrong
- Operating expense growth: SG&A rose to $50.4M (+21% y/y), reflecting higher corporate costs; R&D increased to $16.6M (+11% y/y) as pipeline advances .
- Cash drawdown: cash, cash equivalents and marketable securities fell to $613.7M (from $713.8M at 12/31/24), consistent with buybacks and spend; repurchase program reached $200M completed .
- Q1 headwinds context: prior quarter saw GAAP net loss (-$96.1M) largely from debt extinguishment and a ~$11M bad debt reserve; Q2 recovered to profitability, but investors remain sensitive to non-GAAP adjustments and one-time costs .
Financial Results
Summary Financials (USD Millions unless noted)
Margins (S&P Global consensus-calculated)
Values retrieved from S&P Global.
Segment/Revenue Breakdown
KPIs
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- “We continued our momentum by delivering robust Q2 results, achieving our highest net product revenue quarter ever for HEPLISAV-B, while further growing our market share leading position…” — Ryan Spencer, CEO .
- Pipeline message: top-line shingles data “in the coming weeks,” with aim to demonstrate a best-in-class profile in a multibillion-dollar market .
- Financial discipline reiterated alongside growth: guidance refined on revenue; adjusted EBITDA at least $75M maintained .
Q&A Highlights
- Analysts focused on shingles readout and immunogenicity durability metrics (CD4 response rates at 6–12 months), and commercialization pathways; management reiterated stage-gated decision-making and focus on tolerability differentiation vs Shingrix .
- Retail/Medicare dynamics: questions on market share trajectory and Medicare access at retail; management emphasized year-over-year share gains and H2’25 broadening of Medicare Advantage access supporting retail growth .
- Plague (DoD) and pandemic influenza adjuvant: interest in timing and market scope; management highlighted fully funded development and completion of Part 1 dosing in pandemic flu program .
- On the Q2 call, discussions also touched on beat drivers and ongoing retail strength; near-term stock reaction was subdued despite beat .
Estimates Context
Values retrieved from S&P Global.
- Results beat on both revenue and EPS. Upward pressure on FY HEPLISAV-B guidance lower bound reflects sustained demand and share gains; estimates likely to move higher to reflect a stronger retail trajectory and market share expansion .
Key Takeaways for Investors
- HEPLISAV-B remains the growth engine: record Q2, higher market share, and raised revenue guidance lower bound signal sustained execution and demand .
- The quarter de-risks near-term model: strong beat vs consensus, profitability restored after Q1’s debt-extinguishment-related loss; adjusted EBITDA inflects positively .
- Retail/Medicare access and HEDIS inclusion underpin medium-term share gains; watch H2’25 Medicare Advantage rollout for incremental lift .
- Pipeline catalysts: shingles top-line readout (Aug 2025) and pandemic influenza adjuvant progress are next narrative drivers; tolerability vs Shingrix is central to commercial differentiation .
- Balance sheet remains strong despite buybacks; $200M repurchase completed, cash $613.7M supports pipeline and optionality .
- Estimate revisions: expect upward adjustments to FY25 HEPLISAV-B sales and quarterly run-rate assumptions following the beat and guidance raise .
- Trading implications: near-term stock may be data-dependent on shingles readout; operational beats are supportive, but investors will scrutinize opex discipline and non-GAAP adjustments .
S&P Global disclaimer: Asterisked values in margin and estimates tables were retrieved from S&P Global.