Executive Summary

Q4 2024 delivered solid growth with total revenues of $72.0M (+30% Y/Y) and HEPLISAV-B net product revenue of $71.1M (+39% Y/Y); GAAP diluted EPS was $0.05 versus $0.00 a year ago, while Q/Q seasonality drove a sequential step-down from Q3’s $80.6M total revenue and $0.12 diluted EPS .
2025 guide introduced: HEPLISAV-B net product revenue $305–$325M (midpoint +17% Y/Y) and adjusted EBITDA ≥$75M, underpinned by Medicare Part B retail access and HEDIS inclusion that should support retail and IDN adoption; HEPLISAV-B gross margin expected “around 80%” in 2025 .
Strategic catalysts: shingles readout in Q3 2025 (Phase 1/2 top-line) and initiation of a DoD‑funded plague vaccine Phase 2 in Q3 2025; $200M buyback program with $100M ASR completed in Q1 2025 and the remainder targeted by year-end 2025 .
S&P Global consensus estimates for Q4 were not retrievable due to access limits; comparison to Street is unavailable (see Estimates Context) [Functions:GetEstimates error].

What Went Well and What Went Wrong

What Went Well
- Strong commercial execution: HEPLISAV-B net product revenue grew 39% Y/Y to $71.1M; full-year HEPLISAV-B revenue grew 26% to $268.4M; U.S. total HBV market share reached ~44% at 2024 year-end .
- Policy-driven tailwinds: management highlighted two 2025 levers—Medicare Part B roster billing enabling retail pharmacy access and HEDIS inclusion emphasizing series completion—expected to support share gains in retail and IDN .
- Margin and profitability progress: FY24 HEPLISAV-B gross margin reached 82% vs 76% in 2023; company delivered FY24 profitability (net income $27.3M) and Q4 adjusted EBITDA of $13.4M .
What Went Wrong
- Sequential revenue decline: Q4 total revenue ($72.0M) fell from Q3’s $80.6M on typical holiday seasonality and retail cadence shifts, despite strong Y/Y growth .
- Operating expense intensity: Q4 R&D rose to $18.7M (+32% Y/Y) as pipeline progressed; FY25 R&D is guided to increase by a high-teens percentage, which will weigh on near-term earnings leverage as trials advance .
- Estimates visibility: Street consensus was unavailable via S&P Global at time of analysis, limiting precision on beat/miss diagnostics for traders (see Estimates Context) [Functions:GetEstimates error].

Financial Results

Metric	Q4 2023	Q3 2024	Q4 2024
Total Revenues ($M)	$55.6	$80.6	$72.0
HEPLISAV-B Net Product Revenue ($M)	$51.1	$79.3	$71.1
Other Revenue ($M)	$4.5	$1.3	$1.0
GAAP Diluted EPS ($)	$0.00	$0.12	$0.05
Adjusted EBITDA ($M)	$4.1	N/A	$13.4
Adjusted EBITDA Margin (%)	7.4% (4.1/55.6)	N/A	18.7% (13.4/72.0)
Cost of Sales – Product ($M)	$8.7	$13.1	$13.4

Notes: Adjusted EBITDA margin is computed from reported values; see citations in each cell.

Segment breakdown

Revenue Breakdown ($M)	Q4 2023	Q3 2024	Q4 2024
HEPLISAV-B Net Product Revenue	$51.1	$79.3	$71.1
Other Revenue	$4.5	$1.3	$1.0
Total Revenues	$55.6	$80.6	$72.0

KPIs

KPI	FY 2023	FY 2024
HEPLISAV-B U.S. Market Share (end of period)	~42%	~44%
HEPLISAV-B Net Product Revenue ($M)	$213.3	$268.4
HEPLISAV-B Gross Margin (%)	76%	82%
Cash, Cash Equivalents & Marketable Securities ($M)	$742.3	$713.8
Share Repurchase Authorization ($M)	—	$200 authorized; $100 ASR completed in Q1’25

Vs S&P Global consensus (Q4 2024)

Metric	Consensus	Actual	Surprise
Revenue ($M)	N/A	$72.0	N/A
Diluted EPS ($)	N/A	$0.05	N/A

Note: S&P Global consensus values were unavailable due to access limits at query time (see Estimates Context).

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
HEPLISAV-B Net Product Revenue	FY 2025	N/A	$305–$325M	New
Adjusted EBITDA (ex-SBC)	FY 2025	N/A	≥$75M	New
HEPLISAV-B Gross Margin	FY 2025	~80% (qualitative)	~80% (qualitative)	Maintained
R&D Expense	FY 2025	N/A	High-teens % increase vs 2024	New
SG&A Expense	FY 2025	N/A	Roughly flat vs 2024	New

Context: In Q3, DVAX narrowed 2024 HEPLISAV-B revenue guidance to $265–$270M and reiterated ~80% gross margin, then delivered $268.4M and ~82% gross margin for FY24 .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024, Q3 2024)	Current Period (Q4 2024)	Trend
HEPLISAV-B market growth & share	Q2: Record revenue; share ~42% . Q3: Share ~44%; retail 55%/IDN 56%; double-digit growth outlook .	End-2024 share ~44%; 2025 tailwinds from Medicare Part B roster billing and HEDIS inclusion .	Strengthening; policy support to drive adoption.
Capital allocation	Q3: $200M repurchase announced; intent to execute within 12 months .	$100M ASR completed in Q1’25; remainder expected by YE25; openness to more after execution .	Active return of capital alongside growth.
Shingles (Z‑1018)	Q2: Phase 1/2 initiated; H2’25 data expected . Q3: Enrollment completing; aim for ≥75% of Shingrix CD4 median; tolerability focus .	Enrollment completed in Q4; top-line Q3’25; ex‑US BD to share Phase 3 cost/risk; durability to be assessed at 6–12 months .	Advancing toward proof-of-concept; partner-minded path.
Regulatory/label	Q2: CRL for dialysis regimen; plan to engage FDA . Q3: FDA feedback on retrospective cohort; pregnancy label update approved .	FDA feedback received; observational study path under consideration for sBLA .	Ongoing dialogue; potential sBLA resubmission.
Macro/policy drivers	—	Medicare Part B retail roster billing and HEDIS measure inclusion expected to lift access/series completion .	Positive structural policy tailwinds for 2025.

Management Commentary

“In 2024, we successfully executed on our strategic growth initiatives, achieving record HEPLISAV-B product revenue… Looking ahead to 2025, we plan to drive significant top-line growth… and pursue external opportunities to generate sustainable long-term value” – Ryan Spencer, CEO .
“Medicare patients gained access to hepatitis B vaccines at retail pharmacies… and adult hepatitis B vaccination will be included in the HEDIS measure… These changes are likely to enhance focus and utilization in IDNs and large clinics” – Donn Casale, CCO .
“HEPLISAV-B gross margin was 82% for the full year 2024… and we expect [it] to continue at around 80% in 2025… we expect R&D expenses to increase by high teens percent [in 2025], and SG&A to be roughly flat” – Kelly MacDonald, CFO .
“Z‑1018 showed favorable tolerability compared to Shingrix… we seek to demonstrate a CD4+ T cell frequency similar to Shingrix… results at 1 month after the second dose are expected in the third quarter” – Robert Janssen, CMO .

Q&A Highlights

Market share drivers: Management emphasized 2025 catalysts—Medicare Part B roster billing for retail pharmacies and HEDIS inclusion—which should favor HEPLISAV-B’s two‑dose completion and support share gains in retail/IDN .
Shingles immunogenicity bar: Team reiterated the ~75% of Shingrix median CD4+ T‑cell response (plus quality/durability) as a guidepost for Phase 3 probability, while noting Phase 1/2 is not powered for statistical NI on immunologic markers .
Durability and elderly extension: 1‑month readout in Q3’25 won’t determine durability; 6‑ and 12‑month follow-up plus a 70+ extension study will inform dose selection and Phase 3 design .
Capital returns and BD: $200M repurchase remains on track (ASR $100M completed); willingness to consider additional buybacks after completing the current program, balanced against internal pipeline and external BD opportunities .
Phase 3 shingles funding strategy: Preference to secure an ex‑US partner to validate the profile and share Phase 3 cost/risk, with high willingness to proceed if immunogenicity profile is supportive .

Estimates Context

S&P Global consensus revenue and EPS for Q4 2024 were unavailable due to data access limits at query time; therefore, we cannot determine a beat/miss versus consensus for the quarter [Functions:GetEstimates error].
2025 guidance implies ~17% Y/Y HEPLISAV-B revenue growth at the midpoint and ≥$75M adjusted EBITDA; given policy tailwinds (Medicare Part B, HEDIS) and management’s ~80% gross margin expectation, models may need to align with the $315M midpoint if previously below that level .

Key Takeaways for Investors

HEPLISAV-B growth remains durable with structural policy catalysts in 2025 (Medicare Part B roster billing; HEDIS inclusion) likely to support retail/IDN share and series completion—key commercial levers for accelerating revenue at stable ~80% product gross margin .
Sequential Q4 seasonality is typical; underlying Y/Y growth (+30% total revenue, +39% HEPLISAV-B) and FY profitability (net income $27.3M) confirm operating discipline and earnings power into 2025 .
2025 guide ($305–$325M HEPLISAV-B; ≥$75M adj. EBITDA) sets a clearer baseline for Street models; execution against retail access and IDN quality metrics is the near-term KPI to watch .
Shingles Phase 1/2 top-line in Q3’25 is a pivotal mid‑year catalyst; if CD4+ T‑cell/antibody/durability and tolerability align with the targeted profile, an ex‑US partnership could de‑risk Phase 3 and broaden the LT thesis .
Capital returns are material: $200M repurchase authorized, $100M ASR completed, remainder targeted by YE25—supportive to EPS and share count, with optionality for incremental buybacks as execution continues .
Balance sheet remains strong ($713.8M cash/securities), enabling simultaneous investment in pipeline milestones and shareholder returns without compromising commercial execution .

Supporting detail and source documents

Q4/FY24 press release and financials, including reconciliation and 2025 guidance .
Q4 2024 earnings call transcript (prepared remarks and Q&A) .
8‑K (Item 2.02) furnishing the Q4/FY24 press release and financial statements .
Prior quarters for trend: Q3 2024 results and call (record HEPLISAV-B, buyback authorization, pregnancy label update) ; Q2 2024 results (record HEPLISAV-B, share ~42%, pipeline progress) .

DYNAVAX TECHNOLOGIES CORP (DVAX)·Q4 2024 Earnings Summary