On November 5, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the third quarter ended September 30, 2026. Unless otherwise stated, all comparisons are for the third quarter of 2026 compared to the third quarter of 2025.
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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the third quarter of 2026 was $54.1 million, compared to product revenue, net of $51.9 million in the third quarter of 2025. Product revenue, net in the first nine months of 2026 was $149.6 million, compared to $144.2 million in the first nine months of 2025.
Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $6.0 million, or $0.12 per basic share and $0.11 per diluted share, for the third quarter of 2026, compared to net income of $8.8 million, or $0.18 per basic share and $0.17 per diluted share, for the third quarter of 2025.
Net income for the first nine months of 2026 was $10.4 million, or $0.20 per basic and diluted share, compared to net income of $17.7 million, or $0.35 per basic and diluted share, for the first nine months of 2025.
Non-GAAP adjusted net income was $8.0 million, or $0.15 per basic and diluted share, for the third quarter of 2026, compared to non-GAAP adjusted net income of $10.5 million, or $0.21 per basic and diluted share, for the third quarter of 2025. Non-GAAP adjusted net income for the first nine months of 2026 was $16.3 million, or $0.32 per basic share and $0.31 per diluted share, compared to non-GAAP adjusted net income of $23.0 million, or $0.46 per basic and diluted share, for the first nine months of 2025. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.
Net cash provided by operating activities for the third quarter of 2026 was $14.6 million, compared to $9.7 million in the third quarter of 2025. Net cash provided by operating activities for the first nine months of 2026 was $31.6 million, compared to net cash provided by operating activities of $27.4 million in the first nine months of 2025. At September 30, 2026, Puma had cash, cash equivalents and marketable securities of $108.5 million, compared to cash, cash equivalents and marketable securities of $97.5 million at December 31, 2025.
"Third quarter U.S. NERLYNX sales were positively impacted by increased year-over-year demand and were 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," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We continue to anticipate increased year-over-year demand for NERLYNX, while we continue to advance alisertib across our ALISCA clinical development programs. During the quarter, we initiated ALISCA-Lung2, a Phase II trial evaluating alisertib in combination with paclitaxel in patients with advanced small cell lung cancer, further expanding our clinical development program in this area, while we are continuing to enroll the ALISCA-Breast1 and ALISCA-Lung1 trials."
Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of updated data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (San Antonio Breast Cancer Symposium, December 2026); (ii) initiation of discussions with global regulatory agencies regarding the Phase III trial design for alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (H1 2027); (iii) continued
enrollment in ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer to obtain more data in biomarker focused populations (H2 2026); (iv) continued enrollment of ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer and ALISCA-Lung2, a Phase II trial evaluating alisertib in combination with paclitaxel in patients with advanced small cell lung cancer (Q4 2026); and (v) presentation of updated data from ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (2027)."
Revenue
Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the third quarter ended September 30, 2026, total revenue was $55.1 million, of which $54.1 million was net product revenue and $1.0 million was royalty revenue. This compares to total revenue for the third quarter of 2025 of $54.5 million, of which $51.9 million was net product revenue and $2.6 million was royalty revenue. For the first nine months of 2026, total revenue was $156.4 million, of which $149.6 million was net product revenue and $6.8 million was royalty revenue. This compares to total revenue for the first nine months of 2025 of $152.9 million, of which $144.2 million was net product revenue and $8.7 million was royalty revenue. The third quarter and first nine months of 2026 included a $2.1 million reduction to royalty revenue as a change in accounting estimate, reflecting the receipt of new third-party market data confirming that the market share of generic versions of NERLYNX in China reached a specified threshold during the period.
Operating Costs and Expenses
Total operating costs and expenses were $49.8 million for the third quarter of 2026 , compared to $44.9 million for the third quarter of 2025. Operating costs and expenses in the first nine months of 2026 were $147.4 million, compared to $132.7 million in the first nine months of 2025. The year-to-date increases were primarily attributable to increases in R&D expenses and cost of sales.
Cost of Sales
Cost of sales was $15.2 million for the third quarter of 2026, compared to $12.2 million for the third quarter of 2025. Cost of sales was $38.1 million for the first nine months of 2026, compared to $35.0 million for the first nine months of 2025. The increases in cost of sales for the third quarter and first nine months of 2026 were due primarily to higher product sales to an international partner.
Selling, General and Administrative Expenses
Selling, general and administrative (SG&A) expenses were $16.3 million for the third quarter of 2026, compared to $16.8 million for the third quarter of 2025. SG&A expenses for the first nine months of 2026 were $52.3 million, compared to $52.5 million for the first nine months of 2025, and were virtually unchanged year over year.
Research and Development Expenses
Research and development (R&D) expenses were $18.3 million for the third quarter of 2026, compared to $15.9 million for the third quarter of 2025. R&D expenses for the first nine months of 2026 were $57.0 million, compared to $45.2 million for the first nine months of 2025. The $11.8 million year-over-year increase for the first nine months resulted primarily from an $8.9 million increase in clinical trial expense, reflecting increased alisertib study activity, and an increase of approximately $2.9 million in internal R&D expense, primarily due to increased employee compensation including the hiring of a new executive.
Total Other Income (Expenses)
Total other income was $0.9 million for the third quarter of 2026, compared to total other expenses of $0.4 million for the third quarter of 2025. Total other income was $2.0 million for the first nine months of 2026, compared to total other expenses of $1.5 million for the first nine months of 2025. The $3.5 million year-over-year increase in other income for the first nine months of 2026 resulted primarily from a decrease in interest expense, reflecting a lower debt balance, as Puma paid down its debt principal in May 2026, partially offset by the termination of subleases as of March 31, 2026 and unfavorable exchange rates on Euro-denominated transactions.
Fourth Quarter and Full Year 2026 Financial Outlook
Fourth Quarter 2026
New Full Year 2026
Prior Full Year 2026
Net Product Revenue
$56–$58 million
$206–$208 million
$205–$209 million
Royalty Revenue
$11–$12 million
$18–$19 million
$19–$22 million
Total Revenue
$67–$70 million
$224–$227 million
$224–$231 million
Net Income*
$10–$12 million
$20–$22 million
$17–$20 million
Gross to Net Adjustment
28%–29%
27.5%–28%
26.5%–27.5%
Conference Call
Puma Biotechnology will host a conference call to report its third quarter 2026 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PT/4:30 p.m. ET on Thursday, November 5, 2026. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.
(Press release, Puma Biotechnology, NOV 5, 2026, View Source [SID1234674340])