Puma Biotechnology (PBYI) investor relations material

Product pipeline and commercial performance

• NERLYNX is FDA-approved for extended adjuvant and metastatic HER2-positive breast cancer, sold in the US via specialty pharmacy and distributor channels, and internationally through partners with royalty agreements.

• Q2 2025 net revenue reached $49.2 million, up from $44.4 million year-over-year and $43.1 million sequentially, with 2,608 bottles sold, reflecting consistent growth.

• Dose titration strategies have improved NERLYNX tolerability, with 71% of patients starting at a reduced dose, enhancing patient experience.

• US market includes about 28,300 early stage HER2-positive breast cancer patients, but guidelines recommend use in a high-risk HR-positive subset (~6,000 patients); EU label is more restrictive.

• Q3 2025 guidance: $46–48M NERLYNX revenue, $2–3M royalties, $2–4M net income; full-year 2025 guidance: $192–198M sales, $20–24M royalties, $23–28M net income.

Clinical development and trial updates

• NERLYNX is in a phase 1 trial combined with T-DXd (ENHERTU), showing promising tumor regressions, including in pancreatic cancer; more data expected next year.

• Alisertib, an Aurora kinase A inhibitor, is in phase 2 for hormone receptor-positive, HER2-negative metastatic breast cancer and small cell lung cancer, with prior trials showing notable response rates and PFS improvements, especially in biomarker-defined populations.

• Ongoing Alysca breast phase 2 trial is enrolling ahead of expectations, targeting patients post-CDK4/6 inhibitor and endocrine therapy; interim data expected late 2025 or early 2026.

• In small cell lung cancer, alisertib plus paclitaxel showed PFS and OS benefits in biomarker-positive subgroups (MYC expression, RB1 loss), guiding future biomarker-driven development.

• Alysca lung study is optimizing dosing with GCSF prophylaxis, aiming for higher exposure and safety, with a focus on biomarker selection for future enrollment.

Intellectual property and legal matters

• NERLYNX patents extend to 2030–2031 for composition, use, and combinations; alisertib patents extend to 2029–2034, with potential for five-year extensions.

• Legal action against AstraZeneca for EGFR T790M patent infringement resulted in a $107.5M award, but a subsequent ruling invalidated the patents; an appeal is ongoing.