Fennec Pharmaceuticals (FENC) Q1 2025 earnings summary

Executive summary

• Q1 2025 net product sales reached $8.8 million, up 18% year-over-year, driven by expanded PEDMARK adoption, especially in the AYA segment, and international launches in Germany, the UK, and SMC approval in Scotland.

• Enhanced commercial focus and revamped patient support programs, including Fennec HEARS, improved provider and patient experiences and supported further growth.

• The STS-J01 trial in Japan completed enrollment, with results expected in H2 2025, potentially opening further registration and partnership opportunities.

• PEDMARK is the only FDA- and EMA-approved therapy for cisplatin-induced ototoxicity in pediatric patients, benefiting from orphan drug exclusivity in the U.S. and pediatric use authorization in Europe.

• The Norgine licensing agreement provided a $43 million upfront payment and potential for $230 million in future milestones and royalties.

Financial highlights

• Net product sales for Q1 2025 were $8.8 million, up from $7.4 million in Q1 2024; total revenue in Q1 2024 included $17.96–$18.0 million in licensing revenue from the Norgine deal, not repeated in 2025.

• Net loss for Q1 2025 was $1.2 million, compared to net income of $12.8 million in Q1 2024, reflecting the absence of licensing revenue.

• Selling and marketing expenses declined to $2.9 million in Q1 2025 from $5.2 million in Q1 2024, mainly due to the completion of European pre-commercialization activities.

• G&A expenses rose to $6.1 million in Q1 2025 from $5.9 million in Q1 2024, primarily due to higher non-cash stock-based compensation.

• Cash and cash equivalents stood at $22.6 million as of March 31, 2025, down from $26.6 million at year-end 2024, with a $4 million cash burn in Q1.

Outlook and guidance

• Most significant quarterly growth in net product sales is anticipated in H2 2025 as foundational initiatives mature.

• Full-year 2025 cash operating expenses are expected to be similar to 2024, around $33 million, with higher expenses in H1 due to spending patterns.

• Cash flow break-even is targeted at $8.5–$9 million in quarterly sales, with a focus on achieving this as sales grow.

• Management expects continued growth in PEDMARK adoption, supported by targeted sales strategies and enhanced patient support.

• The company believes current funds, including the Norgine upfront payment, are sufficient to support planned activities and commercialization for at least the next twelve months.