Puma Biotechnology (PBYI) Q1 2026 earnings summary

Executive summary

• Q1 2026 total revenue was $44.8 million, down from $46.0 million in Q1 2025, with NERLYNX net product revenue at $42.0 million, impacted by a $7.9 million inventory drawdown and a 3% year-over-year decline.

• Net loss (GAAP) for Q1 2026 was $3.8 million ($0.07/share), compared to net income of $3.0 million in Q1 2025, mainly due to higher R&D expenses.

• NERLYNX remains the primary commercial product, with ongoing global commercialization and launches, including Thailand in Q1 2026.

• 78% of patients in Q1 2026 started NERLYNX at a reduced dose.

• All debt was fully repaid by May 2026, resulting in a debt-free balance sheet.

Financial highlights

• Net NERLYNX revenue for Q1 2026 was $42.0 million, down from $43.1 million in Q1 2025 and $59.9 million in Q4 2025, with ex-factory bottle sales at 2,328, down 29% sequentially.

• Royalty revenue was $2.8 million, flat year-over-year.

• Cost of sales was $10.4 million, including $2.4 million amortization of intangible assets.

• SG&A expenses were $18.4 million, and R&D expenses rose to $19.8 million due to increased clinical trial activity.

• Cash, cash equivalents, and marketable securities totaled $101.5 million at quarter end.

Outlook and guidance

• FY 2026 net product revenue guidance raised to $202–206 million, with total revenue guidance at $222–229 million.

• FY 2026 net income guidance increased to $16–19 million.

• Q2 2026 net product revenue expected at $50–52 million; Q2 net income guidance is $2–4 million.

• Expansion and interim data updates for alisertib clinical trials expected in H2 and Q4 2026.

• Existing cash and expected proceeds projected to cover operating needs for at least one year.