Sign in
DT

DYNAVAX TECHNOLOGIES CORP (DVAX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered solid execution: total revenue of $94.9M (+18% YoY), HEPLISAV-B net product revenue of $90.0M (+13% YoY), and diluted EPS of $0.21; management raised full-year Adjusted EBITDA guidance to at least $80M while reiterating HEPLISAV-B revenue guidance of $315–$325M .
  • Versus Wall Street, DVAX posted a modest top-line beat and a material EPS beat: revenue $94.9M vs $94.0M consensus*, diluted EPS $0.21 vs $0.12 consensus*; Q4 2025 consensus implies seasonal moderation (revenue $80.3M*, EPS $0.03*) consistent with management’s commentary .
  • Strategic developments include a new $100M share repurchase program and an exclusive license for Vaxart’s oral COVID-19 vaccine candidate with staged economics (upfront $25M plus $5M equity; option to continue after Phase 2b) .
  • Commercial momentum continues: U.S. total adult hepatitis B market share reached ~46% (retail ~63%); the company still targets ≥60% total share by 2030, with retail mix shift as a key lever .
  • Stock reaction catalysts: EPS beat, buyback authorization, and pipeline progress (shingles Phase 1/2 Part 2 initiation; BARDA-funded plague program) balance near-term seasonal dynamics and medium-term portfolio optionality .

What Went Well and What Went Wrong

What Went Well

  • HEPLISAV-B delivered $90.0M in net product revenue (+13% YoY) and continued share gains (total ~46%; retail ~63%), underscoring execution in prioritized retail and IDN segments .
  • Management raised FY25 Adjusted EBITDA guidance to at least $80M and authorized a new $100M buyback, signaling confidence and disciplined capital allocation .
  • Pipeline progress: shingles Phase 1/2 Part 2 initiated with favorable Part 1 topline (comparable immunogenicity to Shingrix and better tolerability); plague program received ~$14M additional DoD funding .

Quote: “2025 continues to be a banner year for Dynavax… authorization of a new $100 million share repurchase plan… underpinned by continued commercial execution with $90 million in net product revenue this quarter” — CEO Ryan Spencer .

What Went Wrong

  • Seasonal patterns and holiday-related demand softening expected in Q4, with management acknowledging typical fourth-quarter seasonality despite expanding retail vaccination infrastructure .
  • R&D spending stepped up (Q3 R&D $19.1M vs $14.4M YoY) as programs advance, with CFO guiding to steady increases through 2026 to support late-stage assets (including potential COVID oral vaccine) .
  • Q1 2025 revealed capital markets and credit-related items (loss on debt extinguishment; bad debt expense tied to Clover), though largely behind the company by Q3; these episodic items weighed on YTD GAAP profitability .

Financial Results

Consolidated P&L

MetricQ1 2025Q2 2025Q3 2025
Total Revenues ($USD Millions)$68.164 $95.442 $94.876
Net Product Revenue ($USD Millions)$64.959 $91.872 $89.954
Other Revenue ($USD Millions)$3.205 $3.570 $4.922
GAAP Net Income (Loss) ($USD Millions)$(96.099) $18.721 $26.927
Diluted EPS ($USD)$(0.77) $0.14 $0.21
Adjusted EBITDA ($USD Millions)$(4.356) $37.347 $35.532

YoY reference for Q3:

MetricQ3 2024
Total Revenues ($USD Millions)$80.630
Net Product Revenue ($USD Millions)$79.345
GAAP Net Income ($USD Millions)$17.594
Diluted EPS ($USD)$0.12
Adjusted EBITDA ($USD Millions)$24.994

Segment/Revenue Mix

Revenue BreakdownQ1 2025Q2 2025Q3 2025
HEPLISAV-B Net Product Revenue ($USD Millions)$65.0 $91.9 $90.0
Other Revenue ($USD Millions)$3.2 $3.6 $4.9

Margins and Cost Structure

MetricQ1 2025Q2 2025Q3 2025
Cost of Sales – Product ($USD Millions)$13.769 $14.035 $14.403
R&D Expense ($USD Millions)$19.377 $16.619 $19.116
SG&A Expense ($USD Millions)$47.678 $50.359 $40.086
HEPLISAV-B Gross Margin (%)——84% (management commentary)

KPIs

KPIQ1 2025Q2 2025Q3 2025
U.S. Total Market Share (Adult HBV Vaccines)~43% ~45% ~46%
Retail Market Share——~63% (vs ~55% prior-year period per PR; call cited ~59%)

Note on discrepancy: Retail share YoY referenced as ~55% in the press release and ~59% in the call; we highlight this variation for completeness .

Q3 Results vs S&P Global Consensus

MetricConsensus (Q3 2025)Actual (Q3 2025)Surprise
Total Revenue ($USD)$94.0035M*$94.876M +$0.872M (beat)
Diluted EPS ($USD)$0.12*$0.21 +$0.09 (beat)
EBITDA ($USD)—$24.060M (EBITDA per reconciliation) —

Values with asterisk are retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
HEPLISAV-B Net Product RevenueFY 2025$315–$325M (updated from $305–$325M in Q2) $315–$325M Maintained vs Q2 update
Adjusted EBITDAFY 2025≥$75M ≥$80M Raised
Share Repurchase AuthorizationN/A$200M (completed) New $100M program (to be executed within ~1 year) New authorization

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025 and Q2 2025)Current Period (Q3 2025)Trend
HEPLISAV-B market share and retail shiftTotal share ~43% (Q1), ~45% (Q2); emphasis on ACIP universal recommendation and retail/IDN focus Total share ~46%; retail ~63%; targeting ≥60% total share by 2030 Positive momentum; mix shifting to retail
R&D execution (Shingles Z-1018)Part 1 enrollment completed; topline in Q3; plan Part 2 in ≥70-year-olds Positive Part 1 topline; Part 2 initiated; Part 2 and 12-month follow-up data expected 2H26 Advancing; 2026 catalysts
Pandemic influenza (H5N1) adjuvantPart 1 initiated/complete; select optimal formulations; data expected 2026 Advancing optimal formulations; topline in 2026 On track
Plague vaccine (DoD-funded)~$30M agreement through H1’27; Phase 2 initiation planned Additional ~$14M; Phase 2 Part 1 enrollment completed Funding increased; program progressing
Capital allocation$200M buyback progressing/completed; convertible refinancing New $100M buyback; balance sheet $648M cash & equivalents Ongoing capital returns; strong liquidity
Regulatory/label expansion (hemodialysis sBLA)Protocol engagement with FDA; cohort study plan Continued engagement; update pending Steady progress

Management Commentary

  • “We’re excited to work with Vaxart to advance this potentially transformative vaccine candidate… designed to show improvement over an existing mRNA vaccine, providing meaningful data to support disruption of the current vaccine market if successful.” — CEO Ryan Spencer .
  • “Heplisav-B gross margin was 84% and in line with our expectation for the year in the low 80%.” — CFO Kelly MacDonald .
  • “We remain focused on delivering both best-in-class vaccine products and consistent shareholder growth… authorize another $100 million in share repurchases.” — CFO Kelly MacDonald .
  • “Z-1018… well-tolerated and demonstrated… 100% humoral vaccine response rate at the dose selected for advancement, with comparable immunogenicity to Shingrix.” — Company press release .

Q&A Highlights

  • Vaxart oral COVID-19: Management intends to opt in only with evidence of improvement vs mRNA comparator; study (n≈5,400) remains adequately powered given higher-than-assumed disease incidence; topline expected late 2026 .
  • Profitability impact: Registrational efficacy study would carry a “hefty” cost; DVAX plans to manage profitability via continued HEPLISAV-B growth and potential shingles partnership outside the U.S. .
  • Seasonality: Q4 demand typically slows due to holidays; retail’s growing role in adult vaccinations should smooth seasonality over time .
  • Capacity to run multiple registrational programs: Management believes they are capitalized and organizationally capable to stage and execute both shingles and oral COVID-19 phase 3s if warranted .

Estimates Context

  • Q3 2025 comparison to S&P Global: revenue $94.9M actual vs $94.0M estimate*; diluted EPS $0.21 actual vs $0.12 estimate* — both beats .
  • Forward estimates indicate seasonal moderation: Q4 2025 revenue $80.3M* and EPS $0.03*; Q1 2026 revenue $84.7M* and EPS $0.13* — consistent with management commentary on seasonality and steady execution .
  • Consensus target price: $21.8*; consensus recommendation text unavailable*. Values retrieved from S&P Global.

Key Takeaways for Investors

  • Commercial engine is intact: consistent share gains, strong pricing/margins, and raised Adjusted EBITDA guidance point to durable cash generation and disciplined opex .
  • Near-term set-up: Expect typical Q4 seasonality; watch retail activation as a potential offset to historical holiday softness .
  • Capital allocation supports shareholder returns and pipeline breadth: $100M buyback authorization plus option-based Vaxart license structure creates upside without overcommitting capital pre-efficacy readout .
  • Pipeline optionality: Shingles program could be best-in-class on tolerability with comparable immunogenicity to Shingrix; 2H26 readouts are key catalysts .
  • Watch for sBLA progress in hemodialysis and DoD contract milestones; these could expand HEPLISAV-B’s addressable market and add de-risked, funded development .
  • Estimate revisions likely skew positive on EPS for Q3 actuals; monitor Q4 and 2026 updates post-seasonality and as retail mix continues to rise*. Values retrieved from S&P Global.

Citations: All document-based statements and numbers are cited inline using [doc_id:chunk_idx]. Values marked with an asterisk are retrieved from S&P Global.