On November 6, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the third quarter ended September 30, 2025. Unless otherwise stated, all comparisons are for the third quarter of 2025 compared to the third quarter of 2024.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Product revenue, net in the third quarter of 2025 was $51.9 million, compared to $56.1 million in the third quarter of 2024. Product revenue, net in the first nine months of 2025 was $144.2 million, compared to $140.8 million in the first nine months of 2024.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $8.8 million, or $0.18 per basic share and $0.17 per diluted share, for the third quarter of 2025, compared to net income of $20.3 million, or $0.41 per basic and diluted share, for the third quarter of 2024. Net income for the first nine months of 2025 was $17.7 million, or $0.35 per basic and diluted share, compared to net income of $11.0 million, or $0.23 per basic share and $0.22 per diluted share, for the first nine months of 2024.

Non-GAAP adjusted net income was $10.5 million, or $0.21 per basic and diluted share, for the third quarter of 2025, compared to non-GAAP adjusted net income of $22.4 million, or $0.46 per basic share and $0.45 per diluted share, for the third quarter of 2024. Non-GAAP adjusted net income for the first nine months of 2025 was $23.0 million, or $0.46 per basic and diluted share, compared to non-GAAP adjusted net income of $17.5 million, or $0.36 per basic and diluted share, for the first nine months of 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 third quarter of 2025 was $9.7 million, compared to $11.0 million in the third quarter of 2024. Net cash provided by operating activities for the first nine months of 2025 was $27.4 million, compared to net cash provided by operating activities of $23.3 million in the first nine months of 2024. At September 30, 2025, Puma had cash, cash equivalents and marketable securities of $94.4 million, compared to cash, cash equivalents and marketable securities of $101.0 million at December 31, 2024.

"We are very happy to report the continuation of our positive earnings trend, which is driven by increased demand for NERLYNX," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "According to our current projections, 2025 will mark the first year-over-year demand increase for NERLYNX in the United States since 2018 and we are very pleased with our commercial execution, which contributed to this. We are also pleased with our continued clinical progress in the advancement of alisertib for patients facing chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer in ALISCATM-Breast1 and for patients with extensive-stage small cell lung cancer in ALISCATM-Lung1, where there continues to be a need for new treatment."

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 (H1 2026) and (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 (H1 2026)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the third quarter of 2025, total revenue was $54.5 million, of which $51.9 million was product revenue, net and $2.6 million was royalty revenue. This compares to total revenue of $80.5 million for the third quarter of 2024, of which $56.1 million was product revenue, net and $24.4 million was royalty revenue. This decrease in product revenue, net, compared to the three months ended September 30, 2024, was attributable to a decrease in product supply revenue to our international licensees (reduction in China sales), and higher Gross to Net reduction, partially offset by an increase in U.S. sales resulting from an 8% increase in bottles of NERLYNX sold in the U.S. market and an increase in net selling price. For the first nine months of 2025, total revenue was $152.9 million, of which $144.2 million was product revenue, net and $8.7 million was royalty revenue. This compares to total revenue of $171.4 million for the first nine months of 2024, of which $140.8 million was product revenue, net and $30.6 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $44.9 million for the third quarter of 2025, compared to $58.4 million for the third quarter of 2024. Operating costs and expenses in the first nine months of 2025 were $132.7 million, compared to $153.8 million in the first nine months of 2024.

Cost of Sales

Cost of sales was $12.2 million for the third quarter of 2025, compared to $29.1 million for the third quarter of 2024. Cost of sales was $35.0 million for the first nine months of 2025, compared to $50.5 million for the first nine months of 2024. The year-to-date decrease was primarily due to timing of sales made into China by our sub-licensee and the related cost of products shipped and royalty expense.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $16.8 million for the third quarter of 2025, unchanged from the third quarter of 2024. SG&A expenses for the first nine months of 2025 were $52.5 million, compared to $63.5 million for the first nine months of 2024. The $11.0 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 $15.9 million for the third quarter of 2025, compared to $12.5 million for the third quarter of 2024. R&D expenses for the first nine months of 2025 were $45.2 million, compared to $39.8 million for the first nine months of 2024. The $5.4 million year-over-year increase in R&D expenses resulted primarily from increased alisertib study activity.

(Press release, Puma Biotechnology, NOV 6, 2025, View Source [SID1234659586])