Puma Biotechnology (PBYI) Q4 2025 earnings summary

Executive summary

• Q4 2025 total revenue reached $75.5 million, with net product revenue from NERLYNX at $59.9 million, up 10% year-over-year and 15% sequentially from Q3 2025.

• Royalty revenue surged to $15.6 million in Q4 2025, mainly due to shipments to a partner in China, though full-year royalty revenue declined to $24.3 million from $35.3 million in 2024.

• Achieved third consecutive year of profitability, with Q4 2025 GAAP net income of $13.4 million and full-year net income of $31.1 million.

• Ongoing clinical trials for alisertib in breast and lung cancer are progressing ahead of schedule, with key milestones expected in 2026.

• Approximately 75% of patients in Q4 2025 started at a reduced dose, continuing a multi-year trend.

Financial highlights

• Q4 2025 GAAP net income was $13.4 million ($0.20 per basic share, $0.26 per diluted share), with non-GAAP net income at $15.1 million ($0.30 per basic share, $0.29 per diluted share).

• Gross revenue from NERLYNX sales was $82.9 million in Q4 2025, with U.S. net sales at $55.2 million.

• Inventory increased by $5.7 million in Q4 2025, with 343 more bottles in inventory and 3,298 ex-factory bottles sold, up 11% year-over-year.

• Cost of sales for Q4 2025 was $23.2 million, including $2.4 million in amortization of intangible assets.

• SG&A expenses were $18.4 million in Q4 2025, and R&D expenses rose to $16.8 million, reflecting increased alisertib study activity.

Outlook and guidance

• FY 2026 net NERLYNX product revenue expected between $194 million and $198 million, with total revenue guidance of $214–$221 million and net income of $10–$13 million.

• FY 2026 gross-to-net adjustment anticipated at 27.5%-28.5%, higher than 2025.

• Q1 2026 net product revenue expected at $36 million-$39 million, with a net loss of $8 million-$10 million.

• SG&A expenses projected to rise 3%-5% and R&D expenses to increase 30%-35% in 2026.

• Key clinical milestones for alisertib trials expected in Q2 and Q4 2026.