Puma Biotechnology, Inc. Q1 FY2026 earnings call

Alan presented interim data from Phase II trials of Allocertib. Heather Blaber discussed marketing initiatives focusing on awareness of Neuralink's clinical data and unmet need in HER2-positive breast cancer. Roger Storms reviewed commercial performance: Q1 2026 call activity increased 44% YOY and 14% QOQ; narrow-link ex-factory bottle sales 2,328, down 29% QOQ but flat YOY; inventory decreased 439 bottles; new prescriptions up 25% QOQ, total prescriptions down 4% QOQ; SD demand decreased 9% QOQ but up 28% YOY. Maximo reviewed financial results: net loss $3.8 million in Q1 2026 vs net income $13.4 million in Q4 2025; Netlink product revenue $42 million, down from $59.9 million in Q4 2025; royalty revenue $2.8 million, down from $15.6 million in Q4 2025; anticipates Netlink product revenue $202 - $206 million in 2026, higher than prior guidance; Q2 2026 Narlinx product revenue expected $50 - $52 million, royalties $2 - $3 million, net income $2 - $4 million.

Total revenue for Q1 2026 was $44.8 million. Product revenue net was $42 million, down from $59.9 million in Q4 2025 and $43.1 million in Q1 2025. Royalty revenue was $2.8 million, down from $15.6 million in Q4 2025 and $2.9 million in Q1 2025. Product revenue was impacted by $7.9 million inventory drawdown. Neuralink bottles sold in Q1 2026 were 2,328 vs 3,298 in Q4 2025. New prescriptions up ~25% Q4 2025, total prescriptions down ~4% Q4 2025. For ALISCA Lung 1 trial, 50 mg arm had 11.5% partial response, median PFS 1.7 months; 60 mg arm had 6.7% partial response, median PFS 4.2 months. For ALISCA Breast 1 trial, 30 mg arm median PFS 2.04 months, 40 mg arm 5.45 months, 50 mg arm 5.59 months.

PUMA anticipates Net Nearlink's product revenue in 2026 to be in the range of $202 to $206 million, higher than prior guidance of 194 to 198 million. Anticipates gross to net adjustment for 2026 between 26.5% and 27.5%. Anticipates net income for full year 2026 in the range of 16 to 19 million, higher than prior guidance of 10 to 13 million. Anticipates Q2 2026 Narlinx product revenue in range of $50 to $52 million, royalties $2 to $3 million, net income $2 to $4 million.

Q: Given the emerging signal in CMIC-positive patients in both lung and breast, how are thinking about incorporating systemic biology into future trial designs and if registational strategy will evolve into biomarker-enriched program?

A: Alan said in small cell lung likely need form of CMIC positive, in ER-positive breast, benefit of enrichment of CMIC in categories where disease is already being determined, path is down biomarker-focused approach.

Q: Looking ahead to next updates in both programs, what specific outcomes would give confidence to advance or keep progressing programs?

A: Alan said at this juncture, no data telling not to continue into phase three, looking for more patient numbers and duration.