Delcath Systems (DCTH) Q2 2024 earnings summary

Executive summary

• Q2 2024 revenue reached $7.8M, up from $0.5M in Q2 2023, driven by U.S. HEPZATO KIT launch and increased CHEMOSAT demand in Europe.

• Net loss for Q2 2024 was $13.7M, compared to $7.2M in Q2 2023, reflecting higher operating expenses and warrant liability adjustments.

• Eight U.S. sites have treated at least one patient with HEPZATO KIT since launch, with more activations expected by year-end.

• Published pivotal Phase 3 FOCUS trial results for HEPZATO KIT; further data to be presented at ESMO in September.

• CMS granted NTAP status for HEPZATO, effective October 1, 2024, supporting inpatient reimbursement.

Financial highlights

• Q2 2024 revenue: $7.8M (Q2 2023: $0.5M); HEPZATO U.S. sales: $6.6M; CHEMOSAT Europe sales: $1.2M.

• Gross margin for Q2 2024 was 80–80.5%, with gross profit of $6.2M.

• R&D expenses: $3.4M, down from $3.6M YoY; SG&A expenses: $6.8M, up from $4.8M YoY.

• Cash and investments at June 30, 2024: $19.9M.

• Net loss for Q2 2024: $13.7M; basic and diluted loss per share: $(0.48).

Outlook and guidance

• Expect to reach 12 active U.S. sites by end of Q3, 15 early in Q4, and 20 by year-end.

• Projected average treatments per center for the rest of 2024: 1.5–2 per month.

• Break-even expected at ~$13M quarterly revenue or 60–80 kits per quarter; cash flow positive targeted by Q1 2025.

• Plans to initiate new HEPZATO KIT studies for additional liver cancers in late 2024 or early 2025.

• Liquidity concerns persist if site activation or revenue is delayed.