Puma Biotechnology (PBYI) TD Cowen 46th Annual Health Care Conference summary

Commercial performance and financial outlook

• NERLYNX net revenue reached $59.9 million in Q4 2025, up from $54.4 million in Q4 2024 and $51.9 million in Q3 2025.

• 3,298 bottles sold in Q4 2025, an increase from 2,964 in Q4 2024 and 2,949 in Q3 2025.

• 75% of new U.S. patients started NERLYNX at a reduced dose in Q4 2025 to improve tolerability.

• 2026 full-year revenue guidance for NERLYNX is $194–$198 million, with total revenue projected at $214–$221 million and net income of $10–$13 million.

• Q1 2026 revenue expected at $38–$42 million, with a small net loss of $8–$10 million.

Pipeline and clinical development updates

• Alisertib is in two phase II trials: ALISCA-Breast1 (HR-positive, HER2-negative metastatic breast cancer) and ALISCA-Lung1 (small cell lung cancer).

• Interim data from both ALISCA-Breast1 and ALISCA-Lung1 expected in 2026, with full data from ALISCA-Breast1 anticipated in Q4 2026.

• Ongoing study of neratinib with T-DXd (Enhertu) shows promising tumor shrinkage in multiple cancer types, including those not typically HER2-driven.

• Alisertib has demonstrated clinical activity in HR-positive, HER2-negative breast, triple-negative breast, and small cell lung cancer.

• Biomarker-driven strategies are being pursued for potential accelerated approval pathways.

Regulatory, intellectual property, and strategic considerations

• NERLYNX holds U.S. commercial rights and is partnered internationally with multiple distributors.

• Key patents for NERLYNX extend to 2031, and for alisertib to 2034, with ongoing efforts to extend IP life.

• Patent litigation with AstraZeneca resulted in an initial $107.5 million award, later overturned; appeal is ongoing.

• FDA approval for new indications will likely require randomized trials, especially in ER-positive breast cancer.

• Financial discipline is prioritized, with a focus on maintaining profitability and minimizing the need for new equity raises.