Puma Biotechnology (PBYI) TD Cowen 45th Annual Healthcare Conference summary

Product pipeline and clinical development

• NERLYNX (neratinib) is approved for HER2-positive breast cancer in extended adjuvant and metastatic settings, with ongoing trials in combination with trastuzumab deruxtecan for HER2-amplified/mutated solid tumors.

• Alisertib, an Aurora kinase A inhibitor, is being tested in HR+, HER2-negative metastatic breast cancer, EGFR-mutant non-small cell lung cancer, and small cell lung cancer, with a well-characterized safety profile and prior clinical activity.

• Interim data from the NERLYNX and trastuzumab deruxtecan trial is expected in the first half of 2025; ALISCA-Breast1 and ALISCA-Lung1 phase II trials for alisertib are also expected to report interim data in 2025.

• Alisertib trials show promising efficacy, especially in biomarker-defined subgroups such as c-Myc amplification and RB1 mutations, with ongoing enrichment strategies in clinical studies.

• Dose escalation strategies for NERLYNX have improved tolerability, with 74% of Q4 2024 scripts using this approach.

Financial performance and guidance

• Q4 2024 revenue was $54.4 million, up from $53.2 million year-over-year but down from $56.1 million in Q3; 2,964 bottles sold in Q4, an increase from both prior year and prior quarter.

• 2025 U.S. NERLYNX revenue guidance is $192–$198 million, with royalties of $20–$24 million and net income of $23–$28 million; Q1 2025 guidance expects $41–$43 million in U.S. revenue and a slight net loss to break even.

• Revenue guidance reflects flattish to slightly down demand, offset by price increases; commercial budget has been reduced due to the product's maturity.

• Debt has been reduced from $150 million at launch to about $60 million, with $11 million quarterly interest expense impacting net income.

• Cash and cash equivalents at year-end were $101 million; Q4 2024 net income was $19.3 million, including a $7.1 million non-cash tax benefit.

Market access, partnerships, and IP

• NERLYNX is sold directly in the U.S. and through partners internationally, with major partners in Australia, Southeast Asia, Israel, Canada, Latin America, Europe, China, Middle East, and South Korea.

• U.S. market for extended adjuvant HER2-positive breast cancer is about 28,000 patients, with guidelines focusing on high-risk HR+ patients (~6,000); ex-U.S. market is about 37,000 patients, with approval limited to HR+ population.

• NERLYNX patents expire between 2025 and 2031, with possible Hatch-Waxman extensions; alisertib patents expire between 2029 and 2034.

• Litigation over EGFR T790M mutation patents resulted in a $107 million award, later overturned; appeal filed in September 2024.