Executive Summary

Q4 revenue accelerated to $15.1M (vs. $11.2M in Q3 and $0.5M in Q4’23), driven by U.S. HEPZATO KIT sales; gross margin reached 86% and adjusted EBITDA turned positive at $4.6M, while net loss narrowed to $3.4M .
Commercial execution strengthened: 16 U.S. centers active by early Q1’25 (up from 12 at Q3-end), with ~“slightly under 2” treatments/site/month and 8 additional centers accepting referrals; management targets 30 active centers by YE25 .
Balance sheet inflected: YE cash and investments of $53.2M, no debt, and Q4 operating cash burn of ~$1.0M; warrant exercises contributed ~$41.3M during 2024 .
2025 outlook (qualitative): SG&A to rise ~30–40% YoY as sales coverage expands; R&D to ramp to $35–40M for new indications (mCRC/mBC) while management still expects 2025 to be cash-flow positive; gross margin could approach 90% by YE25 .
Potential stock drivers: continued center activation and throughput, validation from CHOPIN/SCANDIUM data readouts in 2025, reimbursement progress ex-U.S., and pipeline initiation (mCRC IND cleared; trial start 2H25) .

What Went Well and What Went Wrong

What Went Well
- Commercial ramp: HEPZATO U.S. revenue of $13.7M in Q4 with gross margin at 86% and positive adjusted EBITDA of $4.6M; YE cash/investments $53.2M, no debt .
- Network expansion: 16 active U.S. centers by early Q1’25 (from 12 at Q3-end), with marquee academic centers in the mix; average treatments/site ~“slightly under 2” per month .
- Strategic validation: NCCN guidelines updated to include liver‑dominant disease; FDA cleared mCRC Phase 2 IND; management appointed SVP of Interventional Oncology to drive R&D .
- Quote: “In 2024, the successful launch of HEPZATO drove strong financial and operational results, including positive adjusted EBITDA in the fourth quarter.” — CEO Gerard Michel .
What Went Wrong
- Profitability still GAAP-negative: Q4 GAAP net loss of $3.4M despite strong revenue and margin; full-year net loss was $26.4M .
- Operating leverage build required: SG&A to rise ~30–40% in 2025 to support expansion; R&D expected to increase to $35–40M for new trials, which could temper near-term EPS even as cash flow trends improve .
- EU revenue remains modest vs. U.S.: strategy is to run Europe near breakeven with growth hinging on market-by-market reimbursement; step-ups are “binary” and timing uncertain .

Financial Results

Income statement summary (USD, millions except per-share). Periods left→right are chronological.

Metric	Q1 2024	Q2 2024	Q3 2024	Q4 2024
Revenue	$3.139	$7.766	$11.200	$15.100
Gross Profit	$2.236	$6.247	$9.560	$12.974
Gross Margin %	71.3% (calc)	80.4% (calc)	85.0%	86.0%
Total OpEx	$12.514	$10.159	$10.819	$9.935
Net Income (Loss)	$(11.111)	$(13.741)	$1.864	$(3.398)
Diluted EPS ($)	$(0.45)	$(0.48)	$0.06	$(0.11)

Notes: Q1 and Q2 gross margin percentages are computed from reported revenue and gross profit in company statements; Q3 and Q4 gross margins are management disclosures .

Segment revenue breakdown (USD, millions)

Metric	Q2 2024	Q3 2024	Q4 2024
HEPZATO KIT Revenue	$6.6	$10.0	$13.7
CHEMOSAT Revenue	$1.2	$1.2	$1.4
Total Revenue	$7.8	$11.2	$15.1

KPIs and balance sheet

KPI	Q1 2024	Q2 2024	Q3 2024	Q4 2024
Active U.S. Centers (end/point)	4 activated in Q1	8 active total	12 active total	16 active total (early Q1’25)
Avg Treatments/Site/Month	—	—	~“just under 2”	~“slightly under 2”
Cash & Investments ($M)	$27.2	$19.9	$14.0	$53.2
Operating Cash Burn ($M)	—	—	$3.6	$1.0
Adjusted EBITDA ($M)	—	—	—	$4.6

YoY highlights for Q4: Revenue $15.1M vs $0.5M in Q4’23; net loss $(3.4)M vs $(11.1)M; GM 86% vs GM implied by prior-year data; EPS $(0.11) vs $(0.48) in Q4’23 .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Active U.S. Centers	FY2025 YE	30 by YE25 (reiterated)	30 by YE25 (reaffirmed)	Maintained
Gross Margin %	FY2025	n/a	Expect ~mid‑80s to “probably reach 90% by end of 2025”	New commentary
SG&A	FY2025	n/a	+30–40% YoY as team expands to 6 regions	New commentary
R&D Expense	FY2025	n/a	$35–$40M for trials/new indications	New
Cash Flow	FY2025	n/a	Expect cash‑flow positive in 2025; not promising to maintain thereafter	New
Pricing	2025	n/a	HEPZATO price increased to ~$187,500 in early Feb; cadence tied to inflation constraints (CMS)	New

No formal revenue/EPS guidance was issued in the Q4 materials.

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024 and Q3 2024)	Current Period (Q4 2024)	Trend
Center activation & throughput	Q2: 8 active centers ; Q3: 12 active, avg <2 tx/site/month; holiday seasonality expected to elongate cycles	16 active by early Q1’25; ~“slightly under 2” tx/site/month; goal 30 by YE25	Improving capacity; expanding coverage
EU strategy & reimbursement	Breakeven approach, CHEMOSAT volumes +137% YoY in 2024; expansion into FR/IT/ES; reimbursement is key driver	Expect “modest” growth; step changes contingent on reimbursement (UK/NL in focus)	Gradual; catalyst‑dependent
Clinical pipeline (mCRC/mBC)	Plans for two Phase 2 RCTs; timelines guided for 2025 starts	mCRC IND cleared; start 2H25; breast trial planned 4Q25; endpoints/timelines reiterated	Advancing per plan
Gross margin trajectory	—	GM 85% in Q3	GM 86% in Q4; could reach ~90% by YE25; leverage on fixed infra
Pricing	—	—	Early Feb price to ~$187,500; increases limited by inflation caps (CMS)
Referrals & network	—	Building referral networks; seasonality in 4Q	Referral pipeline developing; need more centers to reduce travel friction
Guidelines/regulatory	—	—	NCCN updated to include liver‑dominant disease; supports TAM alignment with label

Management Commentary

Strategic posture: “We are well positioned to continue to grow revenue while investing in high‑impact R&D initiatives. The future for Delcath has never been brighter.” — CEO Gerard Michel .
Commercial cadence: “In Q4, the average treatment rate per site was slightly under 2 per month, a rate expected to continue in 2025 as we bring on new centers…” — CEO Gerard Michel .
Profitability path: “We achieved $4.6 million in positive adjusted EBITDA [in Q4]… and ended the year with $53.2 million in cash and investments with no debt.” — CEO Gerard Michel .
Expense outlook: “SG&A… about a 30% to 40% increase [YoY] into 2025… fully staffed by midyear.” — CFO Sandra Pennell .
Margin outlook: “We ended Q4 with 86% gross margin and we do expect that to continue into 2025 and probably could reach 90% by the end of 2025.” — CFO Sandra Pennell .

Q&A Highlights

Treatment cycles per patient: Label allows up to 6; real‑world trajectory appears at least consistent with FOCUS’ 4.1 average; tolerability and anecdotally strong responses could support ≥4 cycles over time .
Opex cadence: SG&A +30–40% in 2025 on sales expansion; R&D to $35–40M to fund mCRC/mBC programs and IITs .
Pricing: HEPZATO increased to ~$187,500 in early Feb; future adjustments constrained to inflation under CMS rules .
Network/referrals: Pareto remains (top accounts drive mix but concentration decreasing); more centers needed to reduce travel friction and capture patients locally .
Profitability stance: Management expects to be cash‑flow positive in 2025 but will invest in high‑return R&D; no commitment to maintain CF+ beyond 2025 if opportunities warrant .

Estimates Context

S&P Global consensus for Q4 2024 revenue/EPS was not available for retrieval at the time of analysis due to data access limits; therefore, we cannot provide a vs. consensus comparison for Q4 results at this time. Values would be retrieved from S&P Global if available.
On the call, one analyst cited a 2025 revenue consensus of ~$77M; management declined to characterize it as conservative or aggressive .
Given the inflection in revenue and GM, and the planned expansion of active centers and sales coverage, street models may need to adjust SG&A (higher) and R&D (higher) for 2025 while contemplating improving gross margins and cash‑flow positivity in 2025 .

Key Takeaways for Investors

Commercial flywheel: Sequential revenue acceleration (+35% Q/Q in Q4) with expanding center footprint and stable utilization (~<2 tx/site/month) supports continued top‑line momentum into 2025 .
Margin power: Structural gross margin in the mid‑80s with a credible path toward ~90% by YE25 enhances operating leverage as volumes scale .
Investment mode: Expect 2025 opex to rise (SG&A +30–40%; R&D $35–40M) to fund field expansion and new indications; cash‑flow positive in 2025 is still expected despite higher spend .
Clinical catalysts: mCRC Phase 2 initiation (2H25); breast (4Q25); CHOPIN/SCANDIUM readouts in 2025 could accelerate adoption and shape sequencing with IO therapies .
U.S. first, EU strategic: U.S. remains the growth engine; EU run at breakeven pending reimbursement step‑ups (UK/NL priority markets) .
Reimbursement/Guidelines tailwinds: NCCN update to liver‑dominant mUM aligns with label and should support community referrals and broader adoption .

Appendix: Additional Relevant Press Releases for Q4 2024 Context

Preliminary Q4 & FY 2024 results announced Jan 13, 2025: Q4 rev ~$15.1M, FY rev ~$37.2M; YE cash/investments ~$53.2M; GM 80–85% prelim .
Q3 2024 results (Nov 8, 2024): revenue $11.2M; indicated center activations and publications; cash/investments $14.0M; warrant exercises added ~$25M proceeds .
Q2 2024 results (Aug 5, 2024): revenue $7.8M (HEPZATO $6.6M; CHEMOSAT $1.2M); NTAP secured Aug 1; 8 active centers .

Citations

Q4 2024 8‑K press release and financials:
Q4 2024 earnings call transcript (full):
Q3 2024 press release and transcript:
Q2 2024 press release and financials:
Q1 2024 press release and financials:
IND clearance for mCRC Phase 2:

DELCATH SYSTEMS, INC. (DCTH)·Q4 2024 Earnings Summary