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DYNAVAX TECHNOLOGIES CORP (DVAX)·Q1 2025 Earnings Summary

Executive Summary

  • Record HEPLISAV-B net product revenue of $65.0M (+36% YoY) drove total revenue of $68.2M (+34% YoY); management said this puts the company “on track to achieve the top half” of FY25 HEPLISAV-B guidance ($305–$325M). However, GAAP EPS was impacted by a non-cash extinguishment loss from March’s convertible refinancing .
  • Q1 GAAP net loss of $96.1M ($-0.77 per share) was driven primarily by $82.1M loss on debt extinguishment, $11.0M bad debt expense related to Clover, and proxy contest costs; adjusted EBITDA improved to -$4.4M vs -$6.8M last year .
  • New pipeline programs announced: pandemic influenza adjuvant (Phase 1/2 initiation in Q2) and Lyme disease vaccine (IND-enabling now; clinic in 2027), plus shingles Phase 1/2 Part 1 top-line in Q3 and plague Phase 2 initiation in Q3, broadening longer-term optionality .
  • Commercial momentum: U.S. market share ~43% in Q1 (vs ~41% last year), retail dose volume up ~70% YoY; management reiterated long-term view of >$900M U.S. market by 2030 with ≥60% share for HEPLISAV-B .
  • Stock reaction catalysts: strong unit and share momentum, reaffirmed guidance with “top half” commentary, and multiple 2025 readouts; balanced by GAAP EPS optics from debt accounting and Clover bad debt .

What Went Well and What Went Wrong

What Went Well

  • Record Q1 HEPLISAV-B revenue ($65.0M, +36% YoY) and total revenue ($68.2M, +34% YoY); CFO noted HEPLISAV-B gross margin improved to 79% (vs 77% Q1’24) and reiterated ~80% for FY25 .
  • Market execution: U.S. market share ~43% (vs ~41% last year), and retail segment dose volume up ~70% YoY; CEO: “2025 is off to a strong start… puts us on track to achieve the top half of our full-year… guidance” .
  • Pipeline breadth: shingles Part 1 top-line in Q3, plague Phase 2 in Q3, pandemic influenza Phase 1/2 in Q2, and Lyme IND-enabling—“banner year” framing for 2025 (leveraging CpG 1018) .

What Went Wrong

  • GAAP optics: $96.1M net loss and $-0.77 EPS, largely due to $82.1M loss on extinguishment from convertible refinancing; also $11.0M Clover bad debt provision and proxy contest costs .
  • Clover exposure: allowance for doubtful accounts ($11.0M) tied to Clover/Gavi dynamics and Clover’s CpG 1018 write-down/liquidity—raises credit risk and non-core noise in results .
  • No formal guidance raise: despite strong start, management kept ranges (HEPLISAV-B $305–$325M; adj. EBITDA ≥$75M), citing prudence one quarter into the year .

Financial Results

Headline Financials vs prior quarters and consensus

MetricQ3 2024Q4 2024Q1 2025
Total Revenues ($USD)$80.630M $72.032M $68.164M
HEPLISAV-B Net Product Revenue ($USD)$79.345M $71.053M $64.959M
GAAP EPS (Basic) ($USD)$0.13 $0.06 $-0.77
Revenue Consensus Mean ($USD)$84.166M*$72.703M*$68.387M*
Primary EPS Consensus Mean ($USD)$0.11*$0.0425*$0.02*
Primary/Normalized EPS Actual ($USD)$0.12*$0.05*$-0.0091*

Estimates marked with * are values retrieved from S&P Global.

Commentary:

  • Q1 2025 revenue essentially inline vs consensus (slight miss ~$0.22M); GAAP EPS a large miss vs consensus due to refinancing accounting; normalized EPS shows a modest shortfall vs modest positive consensus . Estimates marked with * are from S&P Global.

Margins (HEPLISAV-B)

MetricQ1 2024Q1 2025
HEPLISAV-B Gross Margin %77% 79%

Segment/Revenue Breakdown

Revenue Line ($USD)Q3 2024Q4 2024Q1 2025
HEPLISAV-B Net Product Revenue$79.345M $71.053M $64.959M
Other Revenue$1.285M $0.979M $3.205M
Total Revenues$80.630M $72.032M $68.164M

KPIs

KPIQ1 2025
U.S. HEPLISAV-B Market Share (%)~43%
Retail Segment Dose Volume YoY~+70%
Cash, Cash Equivalents & Marketable Securities$661.3M
Share Repurchases Executed (since authorization)$172.0M

Non-GAAP reconciliation and adjustments are provided in the press release; adjusted EBITDA was -$4.4M in Q1 2025 vs -$6.8M in Q1 2024 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
HEPLISAV-B Net Product RevenueFY 2025$305–$325M $305–$325M Maintained; management expects top half
Adjusted EBITDAFY 2025≥$75M ≥$75M Maintained; “grow adj. EBITDA >2x revenue rate”

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3’24, Q4’24)Current Period (Q1’25)Trend
HEPLISAV-B market leadership, share, retail~44% U.S. share at end-2024; record Q3 revenue; share repurchase announced ~43% share Q1; retail dose volume +70% YoY; momentum continuing Stable-to-Positive
Guidance stanceNarrowed 2024 ranges; set 2025 HEPLISAV-B $305–$325M and EBITDA ≥$75M Reaffirmed ranges; “top half” commentary Positive tone, unchanged ranges
Shingles programOngoing Ph1/2; top-line expected 2H’25 Top-line Part 1 in Q3’25; stage-gated decision, durability at 6/12 months critical Advancing; clarity on decision criteria
Plague vaccine (DoD-funded)Phase 2 program updates proposed; DoD agreement discussions Phase 2 initiation expected Q3’25; $30M agreement through 1H’27 Advancing
New programs (pandemic influenza, Lyme)N/APandemic influenza Phase 1/2 initiation Q2’25; Lyme IND-enabling, clinic 2027 Pipeline expanding
Regulatory environment (placebo)N/APrepared to balance placebo and head-to-head where ethical; shingles efficacy placebo study feasible Monitoring, pragmatic
Capital allocationShare repurchase program initiated >85% executed by May 5; refinancing extended maturities, lowered cost of capital Shareholder returns + optimized capital

Management Commentary

  • CEO: “2025 is off to a strong start… delivering our highest ever first quarter net revenue for HEPLISAV-B of $65 million… on track to achieve the top half of our full year HEPLISAV-B guidance” .
  • CCO: “HEPLISAV-B’s estimated U.S. market share rose to 43% in Q1… retail segment delivered strong year-over-year growth… market volume increasing approximately 70%” .
  • CMO: “Top line readout… Part 1 [shingles] in the third quarter… goals: similar immunogenicity to Shingrix based on vaccine response rate… improved tolerability… durability of CD4+ T cells at 6 and 12 months” .
  • CFO: “GAAP net loss… primarily due to the GAAP accounting treatment of our debt refinancing… adjusted EBITDA improved to negative $4 million… we reiterate… HEPLISAV-B… $305–$325 million… adjusted EBITDA… at least $75 million” .

Q&A Highlights

  • Guidance policy: PMs pressed for a raise; management kept ranges, citing prudence this early, but emphasized “top half” expectation based on strong start .
  • Shingles decision gateposts: Q3 readout informs advancement into Part 2; ultimate pivotal decision depends on 6/12-month CD4 durability and response in ≥70-year-old cohort (stringent efficacy proxy) .
  • FDA and placebo: Team expects feasibility of placebo-controlled shingles efficacy study; will balance placebo vs head-to-head arms as appropriate and ethical .
  • Market share dynamics and Medicare: Management cautioned against quarter-over-quarter share comparisons due to channel mix; expects year-over-year share gains; Medicare access broadening likely in 2H’25, a growth lever in retail .
  • Capital allocation: Balanced approach—>85% of $200M buyback executed; refinancing extended maturities and lowered cost of capital while reducing share count .

Estimates Context

  • Revenue: Q1 2025 essentially inline (Actual $68.164M vs Consensus $68.387M*); prior quarters: Q4 2024 essentially inline (Actual $72.032M vs $72.703M*), Q3 2024 below consensus (Actual $80.630M vs $84.166M*) .
  • EPS: Q1 2025 GAAP EPS -$0.77 vs Consensus +$0.02*—miss explained by the $82.1M extinguishment loss; normalized EPS Actual -$0.0091* vs Consensus +$0.01–$0.02*, still a shortfall; Q4 2024 beat (Actual $0.05 vs $0.0425*), Q3 2024 beat (Actual $0.12 vs $0.11*) .
MetricQ3 2024Q4 2024Q1 2025
Revenue Actual ($USD)$80.630M $72.032M $68.164M
Revenue Consensus Mean ($USD)$84.166M*$72.703M*$68.387M*
GAAP EPS Actual ($USD)$0.13 $0.06 $-0.77
Primary/Normalized EPS Consensus Mean ($USD)$0.11*$0.0425*$0.02*
Primary/Normalized EPS Actual ($USD)$0.12*$0.05*$-0.0091*

Estimates marked with * are values retrieved from S&P Global.

Implications: Expect sell-side models to adjust Q2–Q4 EPS trajectories given normalized shortfall and higher R&D cadence (shingles Part 2, pandemic influenza, plague Phase 2), while revenue trajectory remains intact with share gains and retail momentum .

Key Takeaways for Investors

  • Commercial engine remains robust: Q1 HEPLISAV-B revenue +36% YoY, share ~43%, retail volume +70%; supports confidence in top-half of FY25 revenue guidance .
  • GAAP EPS optics are transitory: the refinancing-driven extinguishment loss ($82.1M) and Clover provision ($11.0M) skew Q1 GAAP; adjusted EBITDA improved YoY and guidance (≥$75M) maintained .
  • Pipeline catalysts ahead: shingles Part 1 top-line (Q3), pandemic influenza Phase 1/2 initiation (Q2), plague Phase 2 initiation (Q3)—multiple shots on goal leveraging CpG 1018 .
  • Shingles decision framework emphasizes durability and tolerability: management set clear stage gates; pivotal decision likely post-2026 readouts (6/12-month CD4 durability, ≥70 cohort) .
  • Medicare expansion likely adds tailwinds in 2H’25, especially in retail; expect continued year-over-year share gains, but be cautious on quarter-to-quarter share comparisons due to mix .
  • Capital allocation constructive: >85% of $200M buyback executed; refinance lowered cost of capital, extended maturities, reduced share count—supports medium-term EPS leverage once one-offs pass .
  • Trading angle: near-term narrative may hinge on Q3 shingles tolerability/immunogenicity readout and confirmation of top-half revenue trajectory; medium-term thesis tied to durable share gains and pipeline validation .