Puma Biotechnology, Inc. Q3 FY2025 earnings call

• Clinical: ALISCA-Breast1 Phase II trial enrolling ahead of expectations with 98 patients enrolled, 14 in screening, interim analysis expected in H1 2026. ALISCA-Lung1 Phase II trial amended dose to 60mg BID, plans to meet FDA for dose escalation.
• Marketing: Focus on NERLYNX clinical messaging, revised messaging, patient education resources, reached 99.7% of oncologists via nonpersonal promotion.
• Commercial: Call activity up 22% YOY and 17% QOQ, distribution model: 65% specialty pharmacy channel, 35% specialty distributor channel, SD demand growth 11% QOQ and 25% YOY. Dose escalation adoption at 77% in Q3 2025.

Puma Biotechnology reported total revenue for the third quarter of 2025 as $54.5 million. Product revenue net, consisting entirely of NERLYNX sales, was $51.9 million in Q3 2025, an increase from $49.2 million in Q2 2025 but a decrease from $56.1 million in Q3 2024. U.S. net sales of NERLYNX in Q3 2025 were $51.8 million compared to $48.8 million in Q3 2024. Royalty revenue in Q3 2025 was $2.6 million, down from $3.2 million in Q2 2025 and $24.4 million in Q3 2024. Bottles of NERLYNX sold in Q3 2025 were 2,949, an increase from 2,608 in Q2 2025. Inventory increased by 172 bottles in Q3 2025. New prescriptions were down ~3% and total prescriptions down ~1% compared to Q2 2025.

• Fiscal year 2025 net NERLYNX product revenue expected in range of $198 million to $200 million.
• Q4 2025 NERLYNX product revenue net expected in range of $54 million to $56 million, royalty revenue $13 million to $14 million.
• SG&A expenses anticipated to decrease 7% to 10% YOY, R&D expenses to increase 20% to 25% YOY.
• Cash burn in Q3 2025 was approximately $1.6 million, debt balance decreased to ~$33 million, cash at 9/30/2025 was ~$94 million.

• Forward-looking statements subject to risks and uncertainties detailed in SEC filings.
• Shifts in trade policies could impact product cost.
• Dependence on NERLYNX sales and clinical trial outcomes for future performance.

Q: Mark Frahm asks about the breast cancer interim and profitability.

A: Alan Auerbach states the ALISCA-Breast1 trial will be compared to TBCRC41 trial, mentions staggered indications to control burn, and notes manageable pivotal program within profitability while remaining net income positive.