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.

• Full-year 2026 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 $36–39 million, with a small net loss of $8–10 million.

• Cash and cash equivalents at year-end were $97.5 million, with two remaining debt payments before becoming debt-free.

Product pipeline and clinical development

• NERLYNX is FDA-approved for HER2-positive breast cancer in both extended adjuvant and metastatic settings.

• Alisertib is in phase II trials for HER2-positive/negative metastatic breast cancer and small cell lung cancer (ALISCA-Breast and ALISCA-Lung).

• Ongoing studies include neratinib combined with T-DXd, showing promising tumor shrinkage in various cancer types.

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

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

Market access, partnerships, and IP

• NERLYNX is commercialized in the US directly and through partners internationally, covering major global markets.

• US label includes both HR-positive and HR-negative; EU label is HR-positive only.

• NERLYNX patents extend to 2030–2031, with additional use and combination patents.

• Alisertib patents extend to 2034 for breast cancer and 2033 for small cell lung cancer, with ongoing efforts to extend IP.

• Patent litigation with AstraZeneca resulted in an initial $107.5 million award, but the patent was later ruled invalid; appeal is ongoing.