{"id":873047,"date":"2025-08-07T19:49:15","date_gmt":"2025-08-07T23:49:15","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/puma-biotechnology-reports-second-quarter-financial-results-2\/"},"modified":"2025-08-07T19:49:15","modified_gmt":"2025-08-07T23:49:15","slug":"puma-biotechnology-reports-second-quarter-financial-results-2","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/puma-biotechnology-reports-second-quarter-financial-results-2\/","title":{"rendered":"Puma Biotechnology Reports Second Quarter Financial Results"},"content":{"rendered":"

<\/p>\n

Puma Biotechnology Reports Second Quarter Financial Results<\/b><\/p>\n

LOS ANGELES–(BUSINESS WIRE<\/a>)–
\nPuma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the second quarter ended June 30, 2025. Unless otherwise stated, all comparisons are for the second quarter 2025 compared to the second quarter 2024.<\/p>\n

\nProduct revenue, net consists entirely of revenue from sales of NERLYNX\u00ae, Puma\u2019s 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.<\/p>\n

\nBased 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.<\/p>\n

\nNon-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.<\/p>\n

\nNet 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.<\/p>\n

\n\u201cWe are pleased to report both the growth in revenues in the second quarter as well as the positive net income for the quarter,\u201d said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. \u201cWe are pleased to see the year over year growth being driven by NERLYNX\u00ae demand and we are also pleased with the progress in the clinical development of alisertib in both chemotherapy-na\u00efve HER2-negative, hormone receptor-positive metastatic breast cancer and small cell lung cancer as well.\u201d<\/p>\n

\nMr. Auerbach added, \u201cWe anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA\u2122-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-na\u00efve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2025) and (ii) presentation of additional interim data from the ALI-4201\/ALISCA\u2122-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Q4 2025).\u201d<\/p>\n

Revenue<\/b><\/p>\n

\nTotal revenue consists of product revenue, net from sales of NERLYNX\u00ae, Puma\u2019s 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.<\/p>\n

Operating Costs and Expenses<\/b><\/p>\n

\nTotal 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.<\/p>\n

Cost of Sales<\/b><\/p>\n

\nCost 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.<\/p>\n

Selling, General and Administrative Expenses<\/b><\/p>\n

\nSelling, 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.<\/p>\n

Research and Development Expenses<\/b><\/p>\n

\nResearch 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.<\/p>\n

Total Other Income (Expenses)<\/b><\/p>\n

\nTotal 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.<\/p>\n

Third Quarter and Full Year 2025 Financial Outlook<\/b><\/p>\n\n\n\n\n\n\n\n\n\n
\n

\n\u00a0<\/p>\n<\/td>\n

\n

Third Quarter 2025<\/b><\/p>\n<\/td>\n

\n

Full Year 2025 (current)<\/b><\/p>\n<\/td>\n

\n

Full Year 2025 (previous)<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

Net Product Revenue<\/b><\/p>\n<\/td>\n

\n

$46\u2013$48 million<\/b><\/p>\n<\/td>\n

\n

$192\u2013$198 million<\/b><\/p>\n<\/td>\n

\n

$192\u2013$198 million<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

Royalty Revenue<\/b><\/p>\n<\/td>\n

\n

$2\u2013$3 million<\/b><\/p>\n<\/td>\n

\n

$20\u2013$24 million<\/b><\/p>\n<\/td>\n

\n

$20\u2013$24 million<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

License Revenue<\/b><\/p>\n<\/td>\n

\n

$0 million<\/b><\/p>\n<\/td>\n

\n

$0 million<\/b><\/p>\n<\/td>\n

\n

$0 million<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

Total Revenue<\/b><\/p>\n<\/td>\n

\n

$48\u2013$51 million<\/b><\/p>\n<\/td>\n

\n

$212<\/b>\u2013$222 million<\/b><\/p>\n<\/td>\n

\n

$212<\/b>\u2013$222 million<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

Net Income\/(Loss)*<\/b><\/p>\n<\/td>\n

\n

$2\u2013$4 million<\/b><\/p>\n<\/td>\n

\n

$23\u2013$28 million<\/b><\/p>\n<\/td>\n

\n

$23\u2013$28 million<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

Gross to Net Adjustment<\/b><\/p>\n<\/td>\n

\n

22.5%\u201323.5%<\/b><\/p>\n<\/td>\n

\n

21.5%\u201322.0%<\/b><\/p>\n<\/td>\n

\n

20.5%\u201321.5%<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\n*The outlook above does not include any adjustments for tax valuation allowance.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

Conference Call<\/b><\/p>\n

\nPuma Biotechnology will host a conference call to report its second quarter 2025 financial results and provide an update on Puma\u2019s 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 \u201cPuma Biotechnology Conference Call.\u201d A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at https:\/\/www.pumabiotechnology.com<\/a>. A replay of the call will be available shortly after completion of the call and will be archived on Puma\u2019s website for 90 days.<\/p>\n

About Puma Biotechnology<\/b><\/p>\n

\nPuma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed\/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX\u00ae (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed\/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX\u00ae is a registered trademark of Puma Biotechnology, Inc.<\/p>\n

\nIn September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA\u2122-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA\u2122-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer.<\/p>\n

\nTo help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at https:\/\/www.NERLYNX.com<\/a> or by calling 1-855-816-5421.<\/p>\n

\nFurther information about Puma Biotechnology may be found at https:\/\/www.pumabiotechnology.com<\/a>.<\/p>\n

INDICATIONS<\/b><\/p>\n

\nNERLYNX\u00ae (neratinib) tablets, for oral use, is a kinase inhibitor indicated:<\/p>\n