On August 7, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the second quarter ended June 30, 2025 (Press release, Puma Biotechnology, AUG 7, 2025, View Source [SID1234654995]). Unless otherwise stated, all comparisons are for the second quarter 2025 compared to the second quarter 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 second quarter of 2025 was $49.2 million, compared to product revenue, net of $44.4 million in the second quarter of 2024. Product revenue, net in the first six months of 2025 was $92.3 million, compared to $84.6 million in the first six months of 2024.
Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $5.9 million, or $0.12 per basic and diluted share, for the second quarter of 2025, compared to a net loss of $4.5 million, or $0.09 per share, for the second quarter of 2024. Net income for the first six months of 2025 was $8.8 million, or $0.18 per basic and diluted share, compared to a net loss of $9.3 million, or $0.19 per share, for the first six months of 2024.
Non-GAAP adjusted net income was $7.5 million, or $0.15 per basic and diluted share, for the second quarter of 2025, compared to a non-GAAP adjusted net loss of $2.5 million, or $0.05 per share, for the second quarter of 2024. Non-GAAP adjusted net income for the first six months of 2025 was $12.4 million, or $0.25 per basic and diluted share, compared to a non-GAAP adjusted net loss of $4.9 million, or $0.10 per share, for the first six months of 2024. Non-GAAP adjusted net income (loss) 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 second quarter of 2025 was $14.1 million, compared to $1.0 million in the second quarter of 2024. Net cash provided by operating activities for the first six months of 2025 was $17.7 million, compared to net cash provided by operating activities of $12.3 million in the first six months of 2024. At June 30, 2025, Puma had cash, cash equivalents and marketable securities of $96.0 million, compared to cash, cash equivalents and marketable securities of $101.0 million at December 31, 2024.
"We are pleased to report both the growth in revenues in the second quarter as well as the positive net income for the quarter," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We are pleased to see the year over year growth being driven by NERLYNX demand and we are also pleased with the progress in the clinical development of alisertib in both chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer and small cell lung cancer as well."
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 (Q4 2025) 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 (Q4 2025)."
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, 2025, total revenue was $52.4 million, of which $49.2 million was net product revenue and $3.2 million was royalty revenue. This compares to total revenue for the second quarter of 2024 of $47.1 million, of which $44.4 million was net product revenue and $2.7 million was royalty revenue. For the first six months of 2025, total revenue was $98.4 million, of which $92.3 million was net product revenue and $6.1 million was royalty revenue. This compares to total revenue for the first six months of 2024 of $90.8 million, of which $84.6 million was net product revenue and $6.2 million was royalty revenue.
Operating Costs and Expenses
Total operating costs and expenses were $45.8 million for the second quarter of 2025, compared to $49.3 million for the second quarter of 2024. Operating costs and expenses in the first six months of 2025 were $87.8 million, compared to $95.3 million in the first six months of 2024.
Cost of Sales
Cost of sales was $12.3 million for the second quarter of 2025, compared to $10.7 million for the second quarter of 2024. Cost of sales was $22.9 million for the first six months of 2025, compared to $21.4 million for the first six months of 2024. The increase in the first six months of 2025 was due to higher royalty expense and product costs resulting from increased worldwide net sales.
Selling, General and Administrative Expenses
Selling, general and administrative (SG&A) expenses were $18.0 million for the second quarter of 2025, compared to $25.0 million for the second quarter of 2024. SG&A expenses for the first six months of 2025 were $35.6 million, compared to $46.7 million for the first six months of 2024. The $11.1 million year-over-year decrease for the first six months resulted primarily from legal fees associated with the AstraZeneca litigation in the prior year.
Research and Development Expenses
Research and development (R&D) expenses were $15.5 million for the second quarter of 2025, compared to $13.6 million for the second quarter of 2024. R&D expenses for the first six months of 2025 were $29.3 million, compared to $27.2 million for the first six months of 2024. The $2.1 million year-over-year increase for the first six months resulted primarily from increased alisertib study activity.
Total Other Income (Expenses)
Total other income/expenses were $0.4 million for the second quarter of 2025, compared to total other expenses of $2.0 million for the second quarter of 2024. Total other income/expenses were $1.2 million for the first six months of 2025, compared to total other expenses of $4.2 million for the first six months of 2024. The $3.0 million year-over-year decrease in other expenses for the first six months of 2025 was primarily due to a lower debt balance as we continue to pay down our principal.
Third Quarter and Full Year 2025 Financial Outlook
Third Quarter 2025
Full Year 2025 (current)
Full Year 2025 (previous)
Net Product Revenue
$46-$48 million
$192–$198 million
$192–$198 million
Royalty Revenue
$2-$3 million
$20–$24 million
$20–$24 million
License Revenue
$0 million
$0 million
$0 million
Total Revenue $48-$51 million $212–$222 million $212–$222 million
Net Income/(Loss)*
$2-$4 million
$23–$28 million
$23–$28 million
Gross to Net Adjustment
22.5%–23.5%
21.5%–22.0%
20.5%–21.5%
*The outlook above does not include any adjustments for tax valuation allowance.
Conference Call
Puma Biotechnology will host a conference call to report its second quarter 2025 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PT/4:30 p.m. ET on Thursday, August 7, 2025. 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.