Fennec Pharmaceuticals Reports Record FY2025 Results and Major Strategic Advancements

Key Highlights for Investors

• Record Annual Revenue: Fennec Pharmaceuticals (NASDAQ/TSX: FRX) delivered all-time high net product sales of \$44.6 million for the full year 2025, representing a 50% increase year-over-year. Q4 2025 alone saw net product sales reach \$13.8 million, up 75% from Q4 2024.
• Strong PEDMARK^® Adoption: The company saw accelerating adoption of PEDMARK^® across key accounts, with notable success in conversion and adherence, and increasing penetration among Adolescent and Young Adult (AYA) cancer patients and across several tumor types.
• Expansion of Commercial Team: Fennec expanded its field force in Q4 2025 to capitalize on positive sales momentum and to deepen engagement with oncology centers and the AYA population.
• Clinical & Real-World Validation: New real-world data presented at the 2026 Multidisciplinary Head and Neck Cancers Symposium support PEDMARK^®‘s use in adults with head and neck cancer. Institution-led studies were initiated at City of Hope and Tampa General Hospital to further evaluate PEDMARK^® in additional patient populations.
• International Progress: Positive topline results from the investigator-initiated Phase 2/3 STS-J01 trial in Japan showed PEDMARK^® significantly reduced cisplatin-induced hearing loss without compromising efficacy or introducing notable side effects. Fennec is pursuing regulatory registration and potential partnerships in Japan.
• Strengthened Financial Position: Fennec completed oversubscribed equity offerings, raising \$42 million with participation from both new and existing investors, and fully redeemed its debt (\$21.5 million paid down in November 2025). The company ended 2025 with \$36.7 million in cash and no debt outstanding.

Detailed Financial Performance

• Net Product Sales:
  • Q4 2025: \$13.8 million (vs \$7.9 million in Q4 2024; +75%)
  • FY 2025: \$44.6 million (vs \$29.6 million in FY 2024; +50%)
• Selling and Marketing Expenses:
  • Q4 2025: \$6.1 million (up from \$3.9 million in Q4 2024)
  • FY 2025: \$18.6 million (slightly up from \$18.4 million in FY 2024, with increased payroll and marketing offset by discontinued European expenses post-Norgine transaction)
• General & Administrative Expenses:
  • Q4 2025: \$8.9 million (vs \$4.2 million in Q4 2024)
  • FY 2025: \$28.8 million (vs \$23.1 million in FY 2024), reflecting higher legal, payroll, and equity-based compensation costs.
• Cash Position: \$36.7 million as of Dec 31, 2025 (up \$10.2 million year-over-year), fueled by equity raises and product sales, offset by operating expenses and debt repayment.
• Net Loss:
  • Q4 2025: \$5.1 million (vs \$1.6 million in Q4 2024)
  • FY 2025: \$10.1 million (vs \$0.4 million in FY 2024)
• No Debt Outstanding: The company is now debt-free, having fully redeemed its prior term loan and related interest/discounts.

Strategic and Clinical Developments

• Key Account Expansion: PEDMARK^® adoption continues to accelerate across new and existing accounts, with particular strength in the AYA segment and multiple tumor types. This demonstrates strong market confidence and may drive further sales increases.
• Clinical Pipeline: Multiple investigator-led studies are underway or under review, expanding the potential patient base for PEDMARK^® (including adults and AYA patients, and new tumor types).
• International Progress: The positive results from Japan’s large-scale AYA/pediatric trial open the door to new regulatory filings, potential partnerships, and licensing deals in Asia.
• European Commercialization: Following the exclusive licensing agreement with Norgine in March 2024, PEDMARK^® (as PEDMARQSI^®) is now approved and commercially available in the UK and Germany. The deal brings upfront and future milestone/royalty payments to Fennec.
• Intellectual Property: PEDMARK^® is protected by Orphan Drug Exclusivity in the US and Pediatric Use Marketing Authorization in Europe (8+2 years market protection), plus patents running to 2039.

Upcoming Events

• Piper Sandler Spring Biopharma Symposium (April 15–16, 2026): Management will host one-on-one investor meetings.

Product and Market Overview

PEDMARK^® (sodium thiosulfate injection) is the only FDA-approved therapy to reduce the risk of cisplatin-induced ototoxicity in pediatric patients (1 month and older) with localized, non-metastatic solid tumors. PEDMARK^® is also recommended for AYA patients by NCCN, with a 2A endorsement. The US sees ~500,000 new cancer diagnoses annually that could involve platinum-based chemotherapy, and hearing loss from such treatments is common, impacting quality of life and long-term outcomes.

PEDMARK^® is supported by two Phase 3 trials (COG ACCL0431 and SIOPEL 6) and has demonstrated efficacy and safety in reducing hearing loss without compromising cancer treatment efficacy.

Notably, there were no preventative agents for cisplatin-induced hearing loss prior to PEDMARK^®. The product is now positioned as standard of care for eligible pediatric and AYA patients.

Risks and Considerations

• Ongoing expansion and validation in new patient populations and tumor types carries regulatory and clinical risks.
• Reimbursement, market access, and adoption rates in new geographies (e.g., Japan, Europe) may affect future revenues.
• Increased expenses in G&A and marketing relate to commercial expansion and legal/IP protection, which may impact near-term profitability.
• Forward-looking statements are subject to risk factors described in the company’s SEC filings, including market, regulatory, and clinical uncertainties.

Summary for Shareholders

Fennec Pharmaceuticals is entering a phase of strong commercial execution and geographic expansion, driven by continued growth of PEDMARK^® sales, new clinical data broadening its use, and a solid financial position with no debt. The company’s ability to deliver record sales, raise non-dilutive capital, and reduce liabilities is a positive signal for investors.

Key potential share price movers include further positive clinical data, regulatory approvals (especially in Japan), new partnership/licensing deals, and continued sales growth in the US and Europe. The company’s participation in high-profile investor events and strong cash position also underscore a bullish outlook.

Disclaimer

This article contains forward-looking statements based on Fennec Pharmaceuticals’ Q4 and FY2025 financial report and public disclosures. Actual results may differ materially due to risks described in Fennec’s SEC filings. This summary is provided for informational purposes only and does not constitute investment advice. Investors are encouraged to review the full financial statements and consult their own advisors before making investment decisions.

View FENNEC PHARMACEUTICALS INC. Historical chart here