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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)

MetricQ4 2024Q1 2025Q2 2025
Total Revenues$72.0 $68.2 $95.4
HEPLISAV-B Net Product Revenue$71.1 $65.0 $91.9
Other Revenue$1.0 $3.2 $3.6
GAAP Net Income (Loss)$7.1 $(96.1) $18.7
Diluted EPS ($)$0.05 $(0.77) $0.14
Adjusted EBITDA$13.4 $(4.4) $37.3

Margins (S&P Global consensus-calculated)

Values retrieved from S&P Global.

MetricQ4 2024Q1 2025Q2 2025
Net Income Margin %9.79%*-140.98%*19.62%*
EBIT Margin %0.80%*-31.40%*17.45%*
EBITDA Margin %2.44%*-29.68%*18.75%*

Segment/Revenue Breakdown

MetricQ2 2024Q1 2025Q2 2025
Total Revenues ($MM)$73.8 $68.2 $95.4
Product Revenue, net ($MM)$70.2 $65.0 $91.9
Other Revenue ($MM)$3.6 $3.2 $3.6

KPIs

KPIQ4 2024Q1 2025Q2 2025
HEPLISAV-B U.S. Market Share (%)~44% ~43% ~45%
Cash & Marketable Securities ($MM)$713.8 $661.3 $613.7
Cost of Sales – Product ($MM)$13.4 $13.8 $14.0
Share Repurchases Executed ($MM)$100 (ASR completed) $172 (cum. to 5/5/25) $200 (program completed)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
HEPLISAV-B Net Product RevenueFY 2025$305–$325M $315–$325M Raised lower end
Adjusted EBITDAFY 2025≥$75M ≥$75M Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
HEPLISAV-B market share & retail momentumQ4: ~44% share; strong retail/IDN execution . Q1: Retail volume +~70% y/y; share ~43% .Record Q2 sales; share ~45% as momentum continued .Improving
Medicare Part B roster billing accessQ4: Medicare access at retail highlighted . Q1: Broader Medicare Advantage access likely H2’25 .Execution ongoing; retail remains growth lever .Rolling out
Shingles program (Z-1018)Q4: Pursues best-in-class tolerability; Phase 1/2 readout planned; durability focus . Q1: Stage gates; 6- and 12-month CD4 durability emphasized .Top-line Part 1 readout expected August 2025 .On track
Pandemic influenza adjuvantQ1: Initiate Phase 1/2 in Q2’25 .Completed Part 1 dosing in Phase 1/2 .Progressed
Plague vaccine (DoD-funded)Q4/Q1: $30M agreement through H1’27; Phase 2 to initiate in H2’25 .Phase 2 initiation expected in H2’25 .Advancing
Capital allocation/buybacksQ4: $200M authorization; ASR done . Q1: $172M executed .$200M program completed as of 6/30/25 .Completed

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.

MetricQ2 2025 Estimate*Q2 2025 Actual
Revenue ($USD Millions)$86.7*$95.4
EPS (Primary/Diluted, $)$0.09*$0.14
  • 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.