- **HEPLISAV-B Growth**: $90M Q3 revenue (13% YoY), 46% U.S. market share, targeting 60% by 2030.
- **Vaxart Deal**: $25M upfront for oral COVID-19 vaccine, potential $50M milestone post Phase IIb data review.
- **Pipeline Momentum**: Shingles vaccine (Z-1018) in Phase IIb, plague program awarded $14M DoD funding.
- **Capital Allocation**: $100M share buyback authorized, total capital return $300M (25% of market cap).
- **Financial Health**: Adjusted EBITDA guidance raised to $80M+ for 2025, R&D expenses expected to rise 20-30% YoY in 2026.

**【CEO Summary Section】**
- HEPLISAV-B net product revenue reached $90 million (13% YoY growth), with U.S. total market share at 46% (up from 44% last year). Targeting 60% market share by 2030.
- Announced $25 million upfront license agreement with Vaxart for oral COVID-19 vaccine candidate, with potential $50 million milestone payment post Phase IIb data review.
- Initiated Phase IIb trial for shingles vaccine (Z-1018) in adults ≥70 years, with Part 1 long-term follow-up data expected in H2 2026.

**【CFO Financial Commentary】**
- Total revenue $95 million (18% YoY growth), with HEPLISAV-B gross margin 84%.
- R&D expenses $19 million (14% YoY increase) due to pipeline advancements (shingles, plague programs).
- Authorized $100 million share repurchase program, bringing total capital return to $300 million (25% of current market cap).
- Adjusted EBITDA guidance raised to $80 million+ for 2025 (from $75 million).

**【Q&A Highlights】**
- Vaxart trial powered to demonstrate superiority vs mRNA vaccine, with 5,400 subjects enrolled (originally 10,000 due to BARDA changes). Phase IIb data expected late 2026.
- HEPLISAV-B Q4 seasonality expected due to holiday-related demand slowdown, but long-term retail channel growth offsets.
- Shingles and oral COVID-19 programs could be advanced in parallel if Phase IIb data supports further development.
- CFO expects R&D expenses to rise 20-30% YoY in 2026 as pipeline progresses.


Dynavax Technologies Corporation (DVAX) Q3 2025 Earnings Call Transcript

- **Record Q2 Revenue**: HEPLISAV-B at $92 million (+31% YoY), with 45% U.S. market share.
- **Shingles Trial Milestone**: 1-month data expected August 2025, targeting >75% Shingrix CD4 response.
- **Retail Growth**: 57% share in retail segment, 35% of total doses, projected to 50%+ by 2030.
- **Financial Strength**: $614 million cash, completed $200M share buyback, 85% gross margin.
- **Pipeline Expansion**: Influenza adjuvant data in 2026, Lyme program IND-enabling studies.

**【CEO Summary Section】**
- Q2 2025 net product revenue for HEPLISAV-B reached $92 million, up 31% YoY, with U.S. market share rising to 45% (vs. 42% in Q2 2024). Full-year guidance updated to $315-$325 million.
- Shingles vaccine Phase I/II trial results expected in late August, targeting best-in-class immunogenicity vs. Shingrix.
- Pandemic influenza adjuvant program on track for 2026 Phase I/II data, with Lyme disease program entering IND-enabling studies.
- Long-term HEPLISAV-B market peak projected at $900 million by 2030, with 60%+ U.S. share.

**【Commercial Performance (Donn Casale)】**
- HEPLISAV-B trailing 12-month market share: 44% overall, 57% retail, 53% IDN. Retail segment now 35% of total doses (vs. 25% prior), expected to reach 50%+ by 2030.
- Medicare policy change enabling HEPLISAV-B coverage in retail for >65yo patients, expanding 25% of retail doses.
- Q2 dose volume +13% YoY, with strong execution across all segments.

**【Pipeline Updates (Rob Janssen)】**
- Shingles vaccine: 1-month immunogenicity data expected August 2025, with Part 2 enrollment targeting 2026. Focus on CD4 T-cell response (>75% of Shingrix) and safety.
- Pandemic influenza: H5N1 adjuvant Phase I/II trial completed Q2 2025, with Part 2 formulation selection underway.
- Plague vaccine: DoD-funded Phase II trial to start H2 2025, testing CpG 1018 adjuvant in 70+yo adults.

**【Financial Highlights (Kelly MacDonald)】**
- Q2 2025 HEPLISAV-B gross margin 85% (vs. 83% Q2 2024), with full-year margin ~80%.
- R&D expenses $17 million (up 13% YoY), SG&A $50 million (up 19% YoY) due to proxy contest costs.
- Completed $200 million share buyback program, retiring 16.4 million shares.
- Cash balance $614 million (down $100 million YoY), supporting long-term strategy.

**【Q&A Highlights】**
- Shingles trial: 1-month VRR (CD4 + antibody) vs. Shingrix, with 6-. T12 month durability data to followolerability profile expected to match CpG 1018 safety track record.
- Retail shift: Driven by post-pandemic patient outreach, aligning with zoster and flu trends. Strategy focuses on capturing retail-originating patients.
- BD activity: No immediate plans for new buybacks. Focus on leveraging CpG 1018 adjuvant partnerships for pandemic preparedness.


Dynavax Technologies Corporation (DVAX) Q2 2025 Earnings Call Transcript

- **Revenue Record**: Q1 HEPLISAV-B revenue up 36% YoY to $65M, on track for upper half of $305-325M annual target.
- **Pipeline Momentum**: Shingles vaccine Phase I/II readout in Q3; Lyme disease program targets 2027 clinic entry with simplified dosing.
- **Financial Strength**: 79% gross margin; $172M share buyback completed (85%+ of $200M program); non-GAAP EBITDA improved to -$4M.
- **Strategic Focus**: CpG-1018 adjuvant expansion into influenza, Lyme, and shingles; disciplined R&D spend (~$19M Q1 vs $14M prior year).
- **Market Leadership**: HEPLISAV-B U.S. market share 43% (Q1 2025) vs 41% (Q1 2024), targeting 60%+ by 2030 with $900M+ peak sales.


**【CEO Opening Remarks】**
- Q1 2025 HEPLISAV-B net revenue reached $65 million, up 36% YoY, positioning the company to achieve the upper half of its $305-325 million annual guidance.
- Advanced pipeline initiatives include shingles vaccine Phase I/II readout in Q3 and new programs for pandemic influenza and Lyme disease leveraging CpG-1018 adjuvant technology.
- Capital allocation focus: 85%+ completion of $200 million share repurchase program, disciplined R&D investment, and external collaboration opportunities.

**【CFO Financial Highlights】**
- HEPLISAV-B gross margin improved to 79% (Q1 2025) from 77% (Q1 2024), with full-year gross margin expected ~80%.
- R&D expenses rose to $19 million (Q1 2025) vs $14 million (Q1 2024), driven by clinical trial advancements.
- GAAP net loss of $96 million due to debt refinancing costs; non-GAAP adjusted EBITDA improved to -$4 million (Q1 2025) from -$7 million (Q1 2024).
- Cash position $661 million, with $172 million repurchased under $200 million buyback program.

**【Clinical Pipeline Updates】**
- **Shingles Vaccine (Z1018):** Q3 2025 Phase I/II readout on 50-69yo cohort; Part 2 study in 70+yo planned post data review.
- **Pandemic Influenza:** Q2 2025 Phase I/II trial initiation with third-party flu antigen + CpG-1018.
- **Lyme Disease:** IND-enabling studies underway, targeting clinic entry in 2027 with fewer doses/boosters potential.

**【Q&A Key Takeaways】**
- **Shingles Program:** Q3 readout focuses on antigen dose optimization; pivotal trial decision contingent on 2026 durability data.
- **FDA Interactions:** Agency engagement for shingles program expected in late 2026; no material impact from regulatory changes.
- **Market Share Growth:** HEPLISAV-B U.S. market share 43% (Q1 2025) vs 41% (Q1 2024), targeting 60%+ by 2030.
- **Lyme Vaccine Differentiation:** Potential for 2-dose regimen vs competitors' 3-4 doses, supported by CpG-1018 adjuvant efficiency.
- **Share Repurchase:** 85%+ of $200M program executed; balance sheet strengthened post debt refinancing.


Dynavax Technologies (DVAX)-6 May 25-2025 Q1 Earnings call transcript

- **Revenue Growth**: HEPLISAV-B Q4 2024 sales up 39% YoY, with 2025 guidance of $305-$325 million (17% YoY growth).
- **Shingles Vaccine Progress**: Z1018 Phase I/II trial to report Q3 2025 data, targeting 75% CD4 T-cell response vs. Shingrix. Trial showed 8% vs. 37% moderate-severe reactions vs. Shingrix.
- **Financial Strength**: 2024 net income $27 million, adjusted EBITDA $52 million. 2025 EBITDA ≥$75 million, with $200 million buyback program underway.
- **Strategic Expansion**: $30 million DoD plague vaccine partnership, hemodialysis sBLA resubmission planned. 2030 HEPLISAV-B market share target of 60% ($900 million annual sales).

**【CEO Summary Section】**
- **Record Revenue Growth**: HEPLISAV-B net sales reached $71 million in Q4 2024, up 39% YoY, with full-year sales of $268 million (26% YoY growth). 2025 guidance for HEPLISAV-B revenue is $305-$325 million, reflecting 17% YoY growth at midpoint.
- **Shingles Vaccine (Z1018) Milestones**: Phase I/II trial expected to report 1-month data in Q3 2025, targeting antigen dose and regimen selection. Z1018 showed superior tolerability vs. Shingrix (8% vs. 37% moderate-severe local reactions) in Phase I.
- **Strategic Pipeline Expansion**: $30 million DoD partnership for plague vaccine Phase II trial, initiating in Q3 2025. Hemodialysis sBLA resubmission planned post-FDA feedback.
- **Capital Allocation**: $200 million share buyback program (completed $100M in Q1 2025), with remaining $100M to be executed by end-2025.

**【CFO Financial Commentary】**
- **Profitability**: Full-year 2024 net income of $27 million (vs. $12 million in 2023), with adjusted EBITDA of $52 million (up 300% YoY). 2025 guidance for adjusted EBITDA ≥$75 million.
- **Gross Margin**: HEPLISAV-B gross margin improved to 82% in 2024 (vs. 76% in 2023), expected to remain ~80% in 2025.
- **Expense Management**: R&D expenses of $62 million in 2024 (+12% YoY), SG&A of $170 million (+11% YoY). 2025 R&D growth expected at high teens YoY, SG&A flat.
- **Balance Sheet**: $714 million cash as of Q4 2024, supporting pipeline investments and buybacks.

**【Q&A Highlights】**
- **Market Share Growth Drivers**: Medicare Part B roster billing for retail pharmacies and HEDIS measure inclusion for IDNs expected to boost HEPLISAV-B adoption. 2030 market share target of 60% ($900 million annual sales).
- **Shingles Program Efficacy**: Phase I/II trial evaluating CD4 T-cell response (≥75% of Shingrix median) and durability. Regulatory discussions planned post-Q3 2025 data.
- **Buyback Appetite**: Management prioritizes pipeline and M&A, but open to accelerating buybacks if IRR justifies.
- **Flu Season Impact**: Q1 2025 showing faster non-respiratory vaccine focus in retail, supporting strong start vs. seasonal delays in 2024.

Actual										-0.25	-0.53	0.04	-0.14	0.01	0.02	-0.24	0.55	0.22	0.87	0.43	0.45	-0.19	0.03	0.1	0	-0.07	0.08	0.12	0.05	-0.77	0.14	0.21
Forecast										-0.31	-0.2367	-0.2033	-0.245	-0.025	-0.0367	0.025	0.64	0.28	0.2275	0.2967	0.4118	-0.1325	-0.0929	-0.0378	-0.0106	-0.0236	0.0645	0.1133	0.0418	0.0288	0.105	0.1261
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	+19.35%	-123.91%	+119.68%	+42.86%	+140.00%	+154.50%	-1060.00%	-14.06%	-21.43%	+282.42%	+44.93%	+9.28%	-43.40%	+132.29%	+364.55%	+100.00%	-196.61%	+24.03%	+5.91%	+19.62%	-2773.61%	+33.33%	+66.53%

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DVAX Q3 2025 Earnings

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