On May 7, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2026. Unless otherwise stated, all comparisons are for the first quarter 2026 compared to the first quarter 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the first quarter of 2026 was $42.0 million, compared to product revenue, net of $43.1 million in the first quarter of 2025.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $3.8 million, or $0.07 per basic and diluted share, for the first quarter of 2026, compared to net income of $3.0 million, or $0.06 per basic and diluted share, for the first quarter of 2025.

Non-GAAP adjusted net loss was $1.9 million, or $0.04 per basic and diluted share, for the first quarter of 2026, compared to non-GAAP adjusted net income of $5.0 million, or $0.10 per basic and diluted share, for the first quarter of 2025. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the first quarter of 2026 was $15.4 million, compared to net cash provided by operating activities in the first quarter of 2025 of $3.6 million. At March 31, 2026, Puma had cash, cash equivalents and marketable securities of $101.5 million, compared to cash, cash equivalents and marketable securities of $97.5 million at December 31, 2025. Total debt at March 31, 2026 was $11.3 million, compared to total debt of $22.5 million at December 31, 2025. On May 4, 2026, Puma remitted the final payment of principal, interest and exit fees due under its 2021 Note Purchase Agreement, which reduced outstanding debt to zero and terminated all remaining obligations, other than customary continuing indemnification obligations.

"We are very pleased that the first quarter of 2026 marked another quarter of year-over-year demand increase resulting in our raising revenue guidance for 2026. According to our current forecasts, FY 2026 will mark our second consecutive year of NERLYNX demand increase year over year," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "We are also pleased with the interim data from ALISCA-Breast1 and ALISCA-Lung1, which appear to demonstrate an increased clinical effect of alisertib in biomarker subgroups where aurora kinase A appears to be playing a role. We look forward to continuing the development of alisertib in ALISCA-Breast1 and ALISCA-Lung1 while carefully managing our resources to achieve positive net income for this year."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) expansion of 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); (ii) expansion of ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H2 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 first quarter ended March 31, 2026, total revenue was $44.8 million, of which $42.0 million was net product revenue and $2.8 million was royalty revenue. This compares to total revenue of $46.0 million in the first quarter of 2025, of which $43.1 million was net product revenue and $2.9 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $48.6 million for the first quarter of 2026, compared to $42.0 million for the first quarter of 2025.

Cost of Sales

Cost of sales was $10.4 million for the first quarter of 2026, compared to $10.6 million for the first quarter of 2025. Cost of sales was relatively consistent year-over-year as our product bottle sales were relatively consistent.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $18.4 million for the first quarter of 2026, compared to $17.6 million for the first quarter of 2025. The $0.8 million increase resulted primarily from a $0.9 million increase in employee compensation and a $0.4 million increase in marketing and market access costs, partially offset by decreases in provision for credit losses, facility and equipment costs, and stock-based compensation expense totaling $0.4 million.

Research and Development Expenses

Research and development expenses were $19.8 million for the first quarter of 2026, compared to $13.8 million for the first quarter of 2025. The $6.0 million increase resulted primarily from an increase of approximately $5.2 million in clinical trial expense, primarily due to increased alisertib study activity, and an increase of approximately $0.7 million in employee compensation expense.

(Press release, Puma Biotechnology, MAY 7, 2026, View Source [SID1234665344])