DCTH

Delcath is at a genuine inflection. Revenue has gone from $2.06M (FY2023) to $37.2M (FY2024) to $85.2M (FY2025, +129.1%), and FY2025 is the first profitable year in the company's history (net income $2.70M) after an accumulated deficit of -$529M. This is not accounting sleight-of-hand: operating cash flow was $22.5M (+220.5%), far exceeding net income, and gross margin is an 86.2% drug/device profile. HEPZATO KIT (FDA-approved Aug 2023 for uveal-melanoma liver metastases) is clearly gaining commercial traction, with the FOCUS Trial's 36.3% ORR vs. a 5.5% historical control underpinning adoption and reimbursement momentum for CHEMOSAT in Europe.

The balance sheet is pristine and de-risks the story: $43.5M cash, $111M equity, only $12.4M total liabilities (0.11x liabilities/equity), and zero long-term debt. Management is confident enough to run a $25M buyback (authorized Nov 2025, ~$19M remaining, 628,572 shares bought at ~$9.53) — a signal, though note that repurchase level sits well below today's $13.20. Layered on top is meaningful pipeline optionality funded by heavy R&D ($29.2M, +110.8%): Phase 2 trials expanding HEPZATO into liver-dominant metastatic colorectal cancer (US TAM cited at 6,000–10,000 third-line patients annually) and HER2-negative metastatic breast cancer. The current mUM indication is small, so this label-expansion is the real growth engine — the mCRC hPFS readout by end-2027 is the pivotal proof point.