Puma Biotechnology, Inc. Q4 FY2025 earnings call

Alan Auerbach discussed total revenue, product revenue, royalty revenue, and NERLYNX sales details. He provided a clinical review including updates on Phase II trials of alisertib (ALISCA-Breast1 and ALISCA-Lung1). Heather Blaber focused on marketing initiatives to create awareness of NERLYNX clinical data and reinforce unmet need in HER2-positive early-stage breast cancer. Roger Storms reviewed commercial performance, including call activity, distribution model, NERLYNX net product revenue, inventory changes, bottle sales, enrollment and prescription metrics, demand, dose escalation adoption, and strategic collaborations. Maximo Nougues summarized financial results, including net income, gross revenue, royalty revenue, gross to net adjustment, cost of sales, SG&A and R&D expenses, cash burn, debt balance, cash and receivables, and inventory levels. Alan Auerbach also emphasized senior management's focus on NERLYNX sales trends and fiscal responsibility, and commitment to finding more effective ways to help cancer patients.

Total revenue for the fourth quarter of 2025 was $75.5 million. Product revenue net was $59.9 million in Q4 2025, an increase from Q3 2025 and Q4 2024. Royalty revenue was $15.6 million in Q4 2025 compared to $2.6 million in Q3 2025 and $4.7 million in Q4 2024. NERLYNX net product revenue in Q4 2025 was $59.9 million, an increase from Q3 2025 and Q4 2024. In Q4 2025, about 63% of business was through the specialty pharmacy channel and 37% through the specialty distributor channel. NERLYNX ex-factory bottle sales were 3,298 in Q4 2025, an approximate 12% increase quarter-over-quarter and 11% increase year-over-year. Inventory increased by about 343 bottles in Q4 2025. Enrollments, new patient starts, and total prescriptions had certain quarter-over-quarter and year-over-year changes. Approximately 75% of patients started NERLYNX at a reduced dose in Q4 2025. NERLYNX was launched in Algeria and Thailand in the extended adjuvant setting in Q4 2025 and Q1 2026 respectively.

For fiscal year 2026, Puma anticipates net NERLYNX product revenue in the range of $194 million to $198 million. Gross to net adjustment for full-year 2026 is between 27.5% and 28.5%. Anticipates royalties from partners in the range of $20 million to $23 million in 2025. Net income for full year expected to be in the range of $10 million to $13 million. Q1 2026 NERLYNX product revenue net expected to be in the range of $36 million to $39 million. Q1 royalty revenue expected to be in the range of $2 million to $3 million. Anticipates Q1 net loss between $8 million and $10 million. SG&A expenses to increase by 3% to 5% in 2026, R&D expenses to increase by 30% to 35% year-over-year.

Q: Can you maybe speak to some of the dynamics around the inventory build this fourth quarter as well as how it relates to build in previous quarters? Is there any sort of overall trend that you're starting to see, and kind of what can we expect going forward?

A: Alan Auerbach said they tend to always see an inventory build at the end of the year, especially in the fourth quarter, since launch, often due to assumption of price increase at beginning of year. Maximo Nougues added they usually see inventory build in Q4 and burn off in first quarter, so Q1 guidance is usually lower in terms of quarter-by-quarter comparison. Alan Auerbach also mentioned they're near 9 of launch with a lot of history, seeing inventory buildup in Q4 and burn off in first quarter