Puma Biotechnology, Inc. Q2 FY2025 earnings call

Clinical Review - Alan Auerbach

• Puma has 2 ongoing Phase II trials of alisertib: ALISCA-Breast (alisertib + endocrine treatment in HER2-negative hormone receptor-positive metastatic breast cancer) and ALISCA-Lung1 (alisertib monotherapy in small cell lung cancer).
• ALISCA-Breast trial has 33 US and 18 European sites activated, 62 patients enrolled, 10 in screening, with interim data expected later in 2025.
• ALISCA-Lung1 trial amended to increase alisertib dose to 60-milligram b.i.d., 52 patients enrolled, 3 in screening, with interim data expected later in 2025.

Marketing Initiatives - Heather Blaber

• Focused on creating awareness of NERLYNX clinical messaging and recently published data on reducing recurrence risk in HER2-positive early breast cancer.
• Adjusted messaging based on market research, rolled out new patient resource for NERLYNX therapy, reached 99.7% of oncologists through nonpersonal promotion.

Commercial Performance - Roger Storms

• Q2 2025 NERLYNX net product revenue was $49.2 million, an increase from Q1 2025 and Q2 2024.
• Distribution model: ~63% in specialty pharmacy channel, ~37% in specialty distributor channel; stronger growth in distributor channel due to increased 340B purchasing and GPO sales.
• NERLYNX ex-factory bottle sales 2,608 in Q2 2025, 12% Q/Q increase, 4% Y/Y increase. Inventory decreased by ~$1.3 million in Q2 2025.

Total revenue for the second quarter of 2025 was $52.3 million. Product revenue net, consisting entirely of NERLYNX sales, was $49.2 million in Q2 2025, an increase from $43.1 million in Q1 2025 and $44.4 million in Q2 2024. Royalty revenue was $3.2 million in Q2 2025. NERLYNX sold 2,608 bottles in Q2 2025, an increase from 2,338 bottles sold in Q1 2025. Inventory decreased by 72 bottles in Q2 2025. New prescriptions were down approximately 3% compared to Q1 2025, while total prescriptions were up approximately 3% compared to Q1 2025. Approximately 63% of the business was purchased through the specialty pharmacy channel and 37% through the specialty distributor channel in Q2 2025.

Fiscal Year 2025

• Net NERLYNX product revenue expected to be in the range of $192 million to $198 million.
• Gross to net adjustment for full year 2025 between 21.5% and 22% (higher due to increase in government chargeback expenses).
• Royalties expected to be $20 million to $24 million (lower than 2024 due to fewer shipments to China).
• Net income expected to be in the range of $23 million to $28 million.

Q3 2025

• NERLYNX product revenue net expected to be $46 million to $48 million.
• Royalty revenues expected to be $2 million to $3 million.
• Gross to net adjustment in Q3 2025 approximately 22.5% to 23.5%.
• Net income anticipated between $2 million and $4 million.
• SG&A expenses expected to decrease 5% to 10%, R&D expenses expected to increase 20% to 25% year-over-year.

• Shifting trade policies in the United States and other countries, although currently not expected to have a material impact on product cost or results of operations.
• Risks associated with clinical trial outcomes and regulatory approvals for alisertib.

Q: About the venue and bar for advancement of R&D data disclosures later this year.

A: Likely to be a corporate update, with venue around November/December. For the small cell lung study, ~40 patients at 50mg would be discussed for safety, efficacy, and biomarkers; for the breast study, ~40-45 patients across 3 arms. The bar for advancement is seeing progression-free survival (PFS) and overall survival (OS) benefit similar to the previous randomized study.

Q: If the bars are met, interest in in-licensing additional products.

A: The company is profitable and fiscally responsible, would be selective, and does not want to make the company unprofitable, so would be cautious about in-licensing additional products without ensuring fiscal responsibility