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Puma Biotechnology (PBYI) investor relations material

Puma Biotechnology H.C. Wainwright 27th Annual Global Investment Conference summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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H.C. Wainwright 27th Annual Global Investment Conference summary8 Sep, 2025

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.

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Frequently asked questions

Puma Biotechnology Inc. is a biopharmaceutical company focused on the development and commercialization of therapies for the treatment of cancer. The company specializes in targeted oncology, developing drugs that aim to improve outcomes for patients with specific types of cancer by addressing unmet medical needs. It collaborates with healthcare professionals, researchers, and regulatory bodies to advance its clinical and commercial objectives. The company is headquartered in Los Angeles, California, and its shares are listed on the NASDAQ.

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