Fennec Pharmaceuticals (FENC) Piper Sandler 37th Annual Healthcare Conference summary

Product overview and clinical data

• Pedmark is the first and only FDA-approved product to prevent Cisplatin-induced ototoxicity in patients aged 1–18, with proven efficacy and safety from Phase III trials and recent supportive data from a Japanese study.

• NCCN 2A Guidelines recommend use in patients aged 15–39, expanding the addressable market to about 20,000 AYA patients annually in the U.S., including 4,000 testicular cancer patients.

• Pedmark is administered as a 15-minute IV infusion six hours after Cisplatin, acting as a scavenger to prevent hearing loss, which is irreversible once it occurs.

• Recent Japanese trial met its primary endpoint, showing efficacy and no interference with Cisplatin's anti-tumor activity, supporting plans for approval and partnership in Japan.

• Three similar trials have demonstrated clinical efficacy and safety, with ongoing discussions for further investigator-initiated trials in metastatic disease and adult populations.

Commercial strategy and market expansion

• Commercial infrastructure includes under 40 employees, with half customer-facing, and recent doubling of medical science liaisons and addition of key account directors to target large oncology networks.

• Growth in the AYA market has driven quarterly net product sales from $7 million to $12.5 million, with 2024 sales largely from pediatric use and recent expansion into AYA.

• Awareness among community oncologists remains low, prompting ongoing educational and promotional efforts, with plans to further expand outreach in 2026.

• Partnerships enable home health administration for about 33–40% of patients, addressing logistical challenges in community settings.

• European launch is underway through a licensing deal with Norgine, covering Europe, UK, Australia, and New Zealand, with initial launches in the UK and Germany and milestone payments expected.

Pricing, reimbursement, and intellectual property

• Pedmark's U.S. WAC price is $11,000 per vial, with actual patient cost depending on Cisplatin dose and patient size; gross-to-net adjustment is about 20% due to discounts and rebates.

• Achieved 100% reimbursement from major U.S. payers, reflecting recognition of the product's value in preventing lifelong hearing loss.

• In the UK, pricing is set at GBP 10,000 per vial, closely aligned with U.S. pricing; German pricing is forthcoming.

• Orphan drug exclusivity in the U.S. extends to September 2029, with six Orange Book patents potentially protecting the product until July 2039; ANDA litigation with a generic manufacturer is ongoing.

• Proactive antiemetic protocols are in place to manage nausea associated with both Cisplatin and Pedmark, ensuring patients can complete their treatment.