Fennec Pharmaceuticals (FENC) investor relations material

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 two phase III trials and recent positive data from a Japanese study.

• The product is administered six hours after cisplatin infusion and is indicated for ages 1–18, with NCCN guidelines recommending use up to age 39.

• The NCCN 2A endorsement allows broader use in the adolescent and young adult (AYA) population, expanding the addressable market.

• The AYA market includes about 20,000 patients annually, with 4,000 being germ cell/testicular cancer patients, a key early adopter group.

• Recent Japanese trial results confirmed efficacy and safety, with no interference in cisplatin’s anti-tumor activity, supporting plans for regulatory submission in Japan.

Commercial strategy and market expansion

• The company has under 40 employees, with half in customer-facing roles, including sales reps, medical science liaisons, and key account directors focused on large oncology networks.

• Commercial infrastructure has expanded, doubling MSL presence and adding key account directors to drive awareness, especially in the AYA market.

• Home health administration is growing, now accounting for 33–40% of PEDMARK infusions, addressing logistical challenges in community oncology centers.

• Sales growth has shifted from pediatric to AYA markets, with quarterly net product sales rising from $7 million to $12.5 million.

• Awareness campaigns target thousands of community oncology locations, with ongoing efforts to educate practitioners about prophylactic use and product availability.

Financials, pricing, and reimbursement

• PEDMARK’s wholesale acquisition cost is $11,000 per vial, with patient usage ranging from 6 to 30 vials depending on cisplatin dose and patient size.

• Gross-to-net price is reduced by about 20% due to discounts and government rebates.

• The company reports 100% reimbursement from major U.S. payers, reflecting strong payer support.

• In Europe, the product is licensed to Norgine for $43 million upfront and up to $200 million in milestones, with launches underway in the UK and Germany.

• UK pricing is set at GBP 10,000 per vial, closely aligned with U.S. pricing.