Record Net Product Sales and Accelerating Growth
Net product sales of $44.6 million in FY2025 versus $29.6 million in FY2024 (+50% year-over-year). Fourth quarter net product sales of $13.8 million versus $7.9 million in Q4 2024 (≈+75% year-over-year). Fifth consecutive quarter of net product sales growth, driven by increased patient treatment and account expansion.
Strong Q4 Operational Performance and Fennec HEARS Results
Fennec HEARS (patient support program) achieved record performance in Q4 with all‑time highs in patient enrollments, prescribed and infused vials, active patients and improved conversion rates. Conversion improved from ~50% in Q1 to ~70% in Q4 (increase of 20 percentage points, +40% relative), supporting better conversion of prescriptions into infused patients.
Balance Sheet Strengthened — Capital Raise and Debt Elimination
Raised over $42 million in net proceeds from public offerings during 2025 and used proceeds to fully redeem debt (approximately $21.5 million debt paydown). Cash and cash equivalents of $36.8 million as of Dec 31, 2025. Company expects positive cash flow in Q1 2026 following receivable collections.
U.S. Patent Litigation Settlement Extending Exclusivity
Settlement with Cipla prevents Cipla from entering the U.S. market with a generic sodium thiosulfate product until September 1, 2033 (or earlier under select circumstances). Company expects this to preserve market exclusivity, save multiple millions annually in G&A, and support long-term commercial value.
Advancing Clinical Evidence and KOL Engagement
Initiation of investigator‑sponsored/initiated studies with City of Hope (adult testicular germ cell tumors) and Tampa General Hospital (AYA/adult real‑world utility). Japan STS‑J01 Phase II/III progressing. New retrospective head & neck data (15 adults) presented at MHNCS showing safe 6‑hour post‑cisplatin administration without observed disruption to curative intent treatment — evidence that supports broader adoption and guideline consideration.
International Commercial Progress (Norgine Partnership)
Norgine launched PEDMARQSI in the U.K. and Germany in 2025 and received approval in Switzerland. U.K. price set at ~GBP 8,000. Norgine plans 8–10 additional launches in 2026; Fennec expects material royalty/milestone contributions beginning in the second half of 2026.
Strong Reimbursement and Increasing Provider Adoption
Top three payers show reimbursement rates of ~95%–100% for PEDMARK. Company reports increasing repeat prescribers and adoption across both academic and community oncology practices, supporting sustained commercial growth.