Fennec Pharmaceuticals (FENC) Q3 2024 earnings summary

Executive summary

• Net product sales for Q3 2024 reached $7.0 million, up from $6.5 million in Q3 2023, driven by increased adoption and >90% reimbursement in the AYA segment for PEDMARK.

• PEDMARK is the only FDA-approved therapy for cisplatin-induced ototoxicity in pediatric patients, with European launch preparations for PEDMARQSI underway and a fully enrolled trial in Japan.

• Strategic imperatives include market expansion, academic endorsements, educational investments, operational efficiencies, and leadership strengthening, with new CMO, CCO, and CSO appointed.

• Exclusive licensing agreement with Norgine for PEDMARQSI in Europe, New Zealand, and Australia, with $43.2M upfront and up to $230M in milestones and royalties.

• Cash, cash equivalents, and investment securities totaled $40.3 million at quarter end, expected to fund operations into at least 2026.

Financial highlights

• Q3 2024 net product sales were $7.0 million, a 7.1% increase year-over-year; nine-month net product sales reached $22 million.

• Licensing revenue of $17.96 million recognized in 2024 from the Norgine agreement.

• Q3 2024 net loss was $5.74 million; nine-month net income was $1.55 million, reversing a $13.36 million loss in the prior year period.

• General and administrative expenses for Q3 2024 were $6.1 million, up from $3.8 million in Q3 2023, mainly due to non-cash stock compensation, CEO severance, and IP litigation.

• Selling and marketing expenses were $4.6 million in Q3 2024, compared to $3.4 million in Q3 2023, with increased focus on AYA initiatives.

Outlook and guidance

• Cash and equivalents of $40.3 million are expected to fund planned operations into at least 2026.

• PEDMARQSI launch in Europe anticipated to generate additional revenue starting in 2025.

• Results from the fully enrolled STS-J01 clinical trial in Japan expected in 2025, with potential for PEDMARK registration in Japan.