PUMA-ALI-1201 - (ALISCA-Breast1)

November 6, 2025: Puma Biotechnology, Inc. (NASDAQ: PBYI) reported Q3 2025 financial results and updated 2025 guidance, citing demand trends for its marketed breast cancer drug NERLYNX (neratinib). Q3 2025 product revenue (all NERLYNX) was $51.9M vs $56.1M in Q3 2024; total revenue was $54.5M vs $80.5M, with the year-over-year decline driven largely by lower royalty revenue ($2.6M vs $24.4M) and reduced international product supply revenue (including lower China sales), partially offset by higher U.S. sales (8% increase in bottles sold) and net selling price. GAAP net income was $8.8M ($0.17 diluted EPS) vs $20.3M in Q3 2024.

Catalyst outlook (next 12 months): the company expects interim data presentations in H1 2026 for alisertib in two Phase 2 studies—ALISCA-Breast1 (alisertib + endocrine therapy in chemotherapy-naïve HER2-negative, HR-positive metastatic breast cancer) and ALI-4201/ALISCA-Lung1 (alisertib monotherapy in extensive-stage small cell lung cancer).

Guidance update: full-year 2025 net product revenue raised to $198–$200M (from $192–$198M) and net income to $27–$29M (from $23–$28M); total revenue $220–$223M. A conference call was scheduled for November 6, 2025.