On August 6, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the second quarter ended June 30, 2026. Unless otherwise stated, all comparisons are for the second quarter 2026 compared to the second quarter 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 second quarter of 2026 was $53.6 million, compared to product revenue, net of $49.2 million in the second quarter of 2025. Product revenue, net in the first six months of 2026 was $95.5 million, compared to $92.3 million in the first six months of 2025.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $8.2 million, or $0.16 per basic and diluted share, for the second quarter of 2026, compared to net income of $5.9 million, or $0.12 per basic and diluted share, for the second quarter of 2025.

Net income for the first six months of 2026 was $4.4 million, or $0.09 per basic and diluted share, compared to net income of $8.8 million, or $0.18 per basic and diluted share, for the first six months of 2025.

Non-GAAP adjusted net income was $10.1 million, or $0.20 per basic share and $0.19 per diluted share, for the second quarter of 2026, compared to non-GAAP adjusted net income of $7.5 million, or $0.15 per basic and diluted share, for the second quarter of 2025. Non-GAAP adjusted net income for the first six months of 2026 was $8.3 million, or $0.16 per basic and diluted share, compared to non-GAAP adjusted net income of $12.4 million, or $0.25 per basic and diluted share, for the first six 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 second quarter of 2026 was $1.6 million, compared to $14.1 million in the second quarter of 2025. Net cash provided by operating activities for the first six months of 2026 was $17.0 million, compared to net cash provided by operating activities of $17.7 million in the first six months of 2025. As previously reported, on May 4, 2026, Puma remitted the final payment of principal, interest and exit fees under its 2021 Note Purchase Agreement, which reduced outstanding debt to zero and terminated all remaining obligations, other than customary continuing indemnification obligations. At June 30, 2026, Puma had cash, cash equivalents and marketable securities of $93.9 million, compared to cash, cash equivalents and marketable securities of $97.5 million at December 31, 2025.

"We are pleased with our commercial execution in the second quarter and the continued increase in year-over-year demand for NERLYNX. We are also pleased with our continued progress across our clinical development programs during the second quarter," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We remain focused on both continuing our commercial execution in the second half of the year as well as with continuing to advance alisertib in the respective ALISCA clinical trials in HER2-negative, hormone receptor-positive metastatic breast cancer and small cell lung cancer."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) initiation of enrollment in ALISCA-Lung2, a Phase I/II trial of alisertib in combination with paclitaxel for the treatment of patients with extensive stage small cell lung cancer (Q3 2026); (ii) 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 (H2 2026); (iii) 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 (iv) 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 second quarter ended June 30, 2026, total revenue was $56.5 million, of which $53.6 million was net product revenue and $2.9 million was royalty revenue. This compares to total revenue for the second quarter of 2025 of $52.4 million, of which $49.2 million was net product revenue and $3.2 million was royalty revenue. For the first six months of 2026, total revenue was $101.3 million, of which $95.5 million was net product revenue and $5.8 million was royalty revenue. This compares to total revenue for the first six months of 2025 of $98.4 million, of which $92.3 million was net product revenue and $6.1 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $48.9 million for the second quarter of 2026, compared to $45.8 million for the second quarter of 2025. Operating costs and expenses in the first six months of 2026 were $97.5 million, compared to $87.8 million in the first six months of 2025, primarily attributable to an increase in research and development (R&D) expenses, including an increase in clinical trial expense of approximately $7.4 million and an increase in internal R&D expense of approximately $2.0 million.

Cost of Sales

Cost of sales was $12.5 million for the second quarter of 2026, compared to $12.3 million for the second quarter of 2025. Cost of sales was $22.9 million for the first six months of 2026, virtually unchanged from the first six months of 2025, while year-over-year sales of our product bottles were higher.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $17.5 million for the second quarter of 2026, compared to $18.0 million for the second quarter of 2025. SG&A expenses for the first six months of 2026 were $35.9 million, compared to $35.6 million for the first six months of 2025.

Research and Development Expenses

Research and development (R&D) expenses were $18.9 million for the second quarter of 2026, compared to $15.5 million for the second quarter of 2025. R&D expenses for the first six months of 2026 were $38.7 million, compared to $29.3 million for the first six months of 2025. The $9.4 million year-over-year increase for the first six months resulted primarily from an increase in clinical trial expense of approximately $7.4 million, which reflects increased alisertib study activity, and an increase in internal R&D expense of approximately $2.0 million, which includes increased employee compensation and the hiring of a new executive.

Total Other Income (Expenses)

Total other income was $0.6 million for the second quarter of 2026, compared to total other expenses of $0.4 million for the second quarter of 2025. Total other income was $1.0 million for the first six months of 2026, compared to total other expenses of $1.2 million for the first six months of 2025. The $2.2 million year-over-year increase in other income for the first six months of 2026 resulted primarily from a decrease in interest expense, which reflects a lower debt balance as we paid down our debt principal in the three months ended June 30, 2026.

Third Quarter and Full Year 2026 Financial Outlook

Third Quarter 2026

New Full Year 2026

Prior Full Year 2026

Net Product Revenue

$54–$56 million

$205–209 million

$202–$206 million

Royalty Revenue

$2–$3 million

$19–$22 million

$20–$23 million

Total Revenue

$56–$59 million

$224–$231 million

$222–$229 million

Net Income*

$2–$3.5 million

$17–$20 million

$16–$19 million

Gross to Net Adjustment

26%–27%

26.5%–27.5%

26.5%–27.5%

Conference Call

Puma Biotechnology will host a conference call to report its second quarter 2026 financial results and provide an update on its business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 6, 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, AUG 6, 2026, View Source [SID1234669803])