Earnings

Puma Lifts 2026 Net Income Outlook After NERLYNX Demand

The Tip Desk · November 11, 2026 · 3 min read

The biopharmaceutical company now expects full-year 2026 net income of $20 million to $22 million, up from a prior $17 million to $20 million range, after third-quarter product sales of $54.1 million.

Puma Biotechnology, Inc. (PBYI), a biopharmaceutical company, raised its full-year 2026 net income outlook to $20 million to $22 million from a prior $17 million to $20 million range after third-quarter NERLYNX demand increased year over year.

Product revenue, net, which consists entirely of sales of NERLYNX, Puma’s first commercial product, was $54.1 million in the third quarter ended September 30, 2026, compared with $51.9 million a year earlier. Total revenue was $55.1 million, of which $1.0 million was royalty revenue, versus $54.5 million total in the year-ago quarter.

GAAP net income was $6.0 million, or $0.12 a share basic and $0.11 a share diluted, compared with $8.8 million, or $0.18 a share basic and $0.17 a share diluted, a year earlier. Non-GAAP adjusted net income, which excludes stock-based compensation, was $8.0 million, or $0.15 a share, compared with $10.5 million, or $0.21 a share. Income from operations was $5.3 million, down from $9.6 million.

Chairman, Chief Executive Officer and President Alan H. Auerbach said third-quarter U.S. NERLYNX sales were positively impacted by increased year-over-year demand and negatively impacted by higher than expected gross to net due to an increase in Medicaid and 340B sales, as well as a delay in sales to Puma’s ex-U.S. commercial partners that shifted from the third quarter to the fourth quarter. The company said it continues to anticipate increased year-over-year demand for NERLYNX.

Cost of sales was $15.2 million, compared with $12.2 million a year earlier, which the company attributed primarily to higher product sales to an international partner. Selling, general and administrative expenses were $16.3 million. Research and development expenses were $18.3 million, compared with $15.9 million a year earlier. Total other income was $0.9 million, versus total other expenses of $0.4 million a year earlier, as interest expense was zero after Puma paid down its debt principal in May 2026.

The third quarter and first nine months of 2026 included a $2.1 million reduction to royalty revenue as a change in accounting estimate after third-party market data confirmed that the market share of generic versions of NERLYNX in China reached a specified threshold.

Net cash provided by operating activities was $14.6 million, compared with $9.7 million a year earlier. Cash, cash equivalents and marketable securities were $108.5 million at September 30, 2026, compared with $97.5 million at December 31, 2025.

For the fourth quarter of 2026, Puma expects net product revenue of $56 million to $58 million, royalty revenue of $11 million to $12 million, total revenue of $67 million to $70 million, and net income of $10 million to $12 million, with a 28% to 29% gross-to-net adjustment. Full-year net product revenue is now forecast at $206 million to $208 million, from a prior $205 million to $209 million range, and total revenue at $224 million to $227 million, from a prior $224 million to $231 million range. The outlook does not include any potential adjustments for tax valuation allowance.

In September 2026, Puma initiated ALISCA-Lung2, a Phase II trial of alisertib in combination with paclitaxel in patients with advanced small cell lung cancer, adding a new study to the ALISCA-Breast1 and ALISCA-Lung1 programs. The company said it anticipates presenting updated ALISCA-Breast1 data at the San Antonio Breast Cancer Symposium in December 2026 and initiating discussions with global regulatory agencies on a Phase III trial design for alisertib in combination with endocrine treatment in chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer in the first half of 2027.

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PUMA BIOTECHNOLOGY, INC. — all coverage and financials