On February 26, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2025. Unless otherwise stated, all comparisons are for the fourth quarter and full year 2025 compared to the fourth quarter and full year 2024.

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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 fourth quarter of 2025 was $59.9 million, compared to $54.4 million in the fourth quarter of 2024. Product revenue, net for the full year 2025 was $204.1 million, compared to $195.2 million in 2024.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $13.4 million, or $0.27 per basic share and $0.26 per diluted share, for the fourth quarter of 2025, compared to net income of $19.3 million, or $0.39 per basic and diluted share, for the fourth quarter of 2024. The fourth quarter of 2025 included a net change in a valuation allowance that unfavorably impacted net income by $3.2 million, or $0.06 per basic and diluted share, compared to the fourth quarter of 2024, which included a partial release of a valuation allowance that favorably impacted net income by $7.1 million, or $0.15 per basic and diluted share. Net income for full year 2025 was $31.1 million, or $0.62 per basic share and $0.61 per diluted share, compared to net income of $30.3 million, or $0.62 per basic and diluted share, for full year 2024.

Non-GAAP adjusted net income was $15.1 million, or $0.30 per basic share and $0.29 per diluted share, for the fourth quarter of 2025, compared to non-GAAP adjusted net income of $21.1 million, or $0.43 per basic and diluted share, for the fourth quarter of 2024. Non-GAAP adjusted net income for full year 2025 was $38.1 million, or $0.76 per basic share and $0.75 per diluted share, compared to non-GAAP adjusted net income of $38.5 million, or $0.79 per basic share and $0.78 per diluted share, for full year 2024. Non-GAAP adjusted net income excludes stock-based compensation expenses. 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 fourth quarter of 2025 was $14.4 million, compared to $15.6 million in the fourth quarter of 2024. Net cash provided by operating activities for full year 2025 was $41.8 million, compared to net cash provided by operating activities of $38.9 million for full year 2024. At December 31, 2025, Puma had cash, cash equivalents, and marketable securities of $97.5 million, compared to cash, cash equivalents, and marketable securities of $101.0 million at December 31, 2024. Total debt at December 31, 2025 was $22.5 million, compared to total debt at December 21, 2024 of $67.0 million.

"Our financial performance in the fourth quarter and full year 2025 demonstrates continued momentum, with net income marking our third consecutive year of profitability, a testament to our disciplined execution and careful fiscal stewardship," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Our current guidance forecasts that we will continue to be profitable in 2026, which we believe is a result of this continued financial discipline. In parallel, we continue to advance alisertib clinically through ALISCA-Breast1 and ALISCA-Lung1, targeting patient populations in chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer and extensive-stage small cell lung cancer."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim 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 (Q2 2026); (ii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Q2 2026); and (iii) 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 (Q4 2026)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the fourth quarter of 2025, total revenue was $75.5 million, of which $59.9 million was product revenue, net and $15.6 million was royalty revenue. This compares to total revenue of $59.1 million for the fourth quarter of 2024, of which $54.4 million was product revenue, net and $4.7 million was royalty revenue. For the year ended December 31, 2025, total revenue was $228.4 million, of which $204.1 million was product revenue, net and $24.3 million was royalty revenue. This compares to total revenue in 2024 of $230.5 million, of which $195.2 million was product revenue, net and $35.3 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $58.4 million for the fourth quarter of 2025, compared to $45.7 million for the fourth quarter of 2024. Total operating costs and expenses were $191.1 million for full year 2025, compared to $199.5 million for full year 2024.

Cost of Sales

Cost of sales was $23.2 million for the fourth quarter of 2025, compared to $13.9 million for the fourth quarter of 2024. Cost of sales was $58.2 million for full year 2025, compared to cost of sales of $64.4 million for full year 2024. The $6.2 million decrease was primarily due to a decrease of product unit sales to our sub-licensees and the related cost of sales (primarily sales in China), partially offset by higher domestic sales.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $18.4 million for the fourth quarter of 2025, compared to $16.6 million for the fourth quarter of 2024. SG&A expenses for full year 2025 were $70.8 million, compared to $80.2 million for full year 2024. The $9.4 million year-over-year decrease in SG&A expenses resulted primarily from legal fees associated with the AstraZeneca litigation in 2024.

Research and Development Expenses

Research and development (R&D) expenses were $16.8 million for the fourth quarter of 2025, compared to $15.2 million for the fourth quarter of 2024. R&D expenses for full year 2025 were $62.1 million, compared to $54.9 million for full year 2024. The $7.2 million year-over-year increase in R&D expenses resulted primarily from increased alisertib study activity.

Total Other Income (Expenses)

Total other income was insignificant for the fourth quarter of 2025, compared to total other expenses of $1.2 million for the fourth quarter of 2024. Total other expenses were $1.5 million for full year 2025, compared to $6.9 million for full year 2024.

Deferred Income Taxes

In the fourth quarter of 2025, Puma recorded a $7.1 million income tax expense, offset by a $3.8 million partial release of a valuation allowance resulting in a non-cash, deferred tax expense of approximately $3.2 million. The valuation allowance was established to offset Puma’s deferred tax assets, which are primarily related to its historical losses. In the fourth quarter of 2024, Puma released a portion of its valuation allowance that resulted in a non-cash, deferred tax benefit of $7.1 million.

First Quarter 2026 and Full Year 2026 Financial Outlook

First Quarter 2026

Full Year 2026

Net Product Revenue

$36–$39 million

$194–$198 million

Royalty Revenue

$2–$3 million

$20–$23 million

License Revenue

$0

$0

Total Revenue

$38–$42 million

$214–$221 million

Net Income/(Loss)*

$(8)–$(10) million

$10–$13 million

Gross to Net Adjustment

29.5%–30.5%

27.5%–28.5%

*The outlook above does not include any potential adjustments for tax valuation allowance.

Conference Call

Puma Biotechnology will host a conference call to report its fourth quarter and full year 2025 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 26, 2026. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (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 approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

(Press release, Puma Biotechnology, FEB 26, 2026, View Source [SID1234663088])