DELCATH SYSTEMS, INC. (DCTH)·Q3 2025 Earnings Summary

Executive Summary

• Q3 revenue was $20.563M with diluted EPS of $0.02; gross margin expanded to 87% as HEPZATO KIT revenue reached $19.3M and CHEMOSAT $1.3M .
• EPS beat S&P Global consensus (−$0.06* vs $0.02 actual); Q3 revenue consensus was unavailable*, while Q1 and Q2 both beat on revenue and EPS* [Values retrieved from S&P Global].
• FY25 guidance was lowered to $83–$85M revenue (from $93–$96M in August) while gross margin guidance was raised to 85–87%; management reiterated positive adjusted EBITDA and positive cashflow each quarter .
• NDRA/340B participation and summer seasonality pressured average kit price (~13% step-down vs Q2) and new patient starts; site activations accelerated to 25 REMS-certified centers with plans for 26–28 by year-end and ~40 by end of 2026 .

What Went Well and What Went Wrong

What Went Well

• HEPZATO KIT revenue of $19.3M drove total revenue to $20.6M; gross margin expanded to 87% and adjusted EBITDA reached $5.291M, with operating cash flow of $4.8M .
• Active centers reached 25, and first patient was dosed in the global Phase 2 trial for liver-dominant metastatic colorectal cancer; CHOPIN trial results presented at ESMO showed significant efficacy .
• CEO tone confident: “We are confident that the growing clinical validation of HEPZATO positions us well to drive continued progress and long-term value for patients and shareholders” .

What Went Wrong

• Sequential revenue declined vs Q2 ($24.156M → $20.563M) with management citing NDRA discounts (~13% lower average revenue per kit) and summer seasonality impacting new patient starts .
• Operating expenses rose YoY (R&D $8.0M; SG&A $10.3M) to support clinical programs and commercial expansion, compressing net income to $0.83M vs $1.864M in Q3’24 .
• FY25 revenue guidance cut to $83–$85M from $93–$96M, reflecting pricing and pacing headwinds despite strong gross margin trajectory .

Financial Results

Guidance Changes

Context: Earlier May 22 guidance was $94–$98M revenue and 83%–85% gross margins with “≥200%” volume increase expectation prior to NDRA adoption . Guidance was reduced following NDRA pricing and seasonality, while margin outlook improved .

Earnings Call Themes & Trends

Management Commentary

• CEO: “While revenue results in the quarter reflected the impact of NDRA discounts and seasonal factors, our fundamentals remain strong.”
• CEO on clinical momentum: “Compelling positive CHOPIN results and first-patient dosing in our global Phase 2 trial in liver-dominant metastatic colorectal cancer.”
• CFO: “Forecast for 2025 gross margins are expected to be between 85%-87%, with continued positive non-GAAP adjusted EBITDA and positive cash flow for the rest of the year.”
• CEO on NDRA and profitability: “This is a one-time step down…we do not anticipate…a dramatic change in average revenue per kit…with our healthy cash balance, I just don’t see any need to raise capital.”

Q&A Highlights

• Q4 setup: Management assumed modest winter seasonality and sustained clinical trial competition in guidance .
• Site additions: Expect acceleration in H2’26 as sales regions expand; indicative 40/60 split for additions across the year .
• Utilization lift at low-volume sites: Build referral networks; shift physician prescribing behavior using CHOPIN data; manage capacity constraints by sequencing systemic therapy .
• NDRA impact: One-time average price step-down; gross margin outlook remains 85%–87% in 2026 with potential high-80s thereafter; no capital raise anticipated .
• Clinical programs: CRC combo trial hematologic toxicity managed via standard supportive care (G-CSF, dosing adjustments) per protocol ; Thomas Jefferson single-center trials enrolling 109 patients noted as a competitive factor .

Estimates Context

Notes: Consensus values marked with * are retrieved from S&P Global. Q3 revenue consensus was unavailable*. EPS beat in Q1, Q2, and Q3; revenue beat in Q1 and Q2* [Values retrieved from S&P Global].

Key Takeaways for Investors

• Sequential softness driven by NDRA pricing and summer scheduling; gross margin strength and positive cash flow/EBITDA underscore resilient unit economics .
• FY25 revenue guidance reset to $83–$85M, but margin guidance raised to 85–87%; near-term narrative hinges on Q4 seasonality and center activation pace .
• CHOPIN results and CRC first patient dosing are catalysts for utilization; expect CHOPIN-driven adoption to become more visible through 2026 as data disseminates .
• Watch the cadence of REMS-certified center additions and referral network development to lift low-volume sites—key drivers of mix and volume .
• NDRA impact appears as a one-time average price step-down; management does not foresee further dramatic pricing changes and sees no need for capital raise given ~$88.9M cash/investments .
• Monitoring competitive trial enrollment (e.g., RP2, Thomas Jefferson) remains important to forecast patient flows; management expects competition to ebb and flow .
• Near-term trading bias: focus on Q4 seasonality commentary and any CHOPIN publication timing; medium-term thesis centers on center expansion, margin durability, and multi-indication pipeline progression .

Citations:
Financials and guidance:
Earnings call commentary and Q&A:
Additional press release (real-world evidence context):
S&P Global consensus data noted with asterisks and disclaimer above.