\nPuma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the first quarter ended March 31, 2023. Unless otherwise stated, all comparisons are for the first quarter of 2023 compared to the first quarter of 2022.<\/p>\n
\nProduct revenue, net consists entirely of revenue from sales of NERLYNX\u00ae, Puma\u2019s first commercial product. Product revenue, net in the first quarter of 2023 was $46.8 million, compared to product revenue, net of $40.7 million in the first quarter of 2022.<\/p>\n
\nBased on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $1.4 million, or $0.03 per basic and diluted share, for the first quarter of 2023, compared to net loss of $3.4 million, or $0.08 per share, for the first quarter of 2022.<\/p>\n
\nNon-GAAP adjusted net income was $4.2 million, or $0.09 per basic and diluted share, for the first quarter of 2023, compared to non-GAAP adjusted net loss of $0.3 million, or $0.01 per share, for the first quarter of 2022. 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.<\/p>\n
\nNet cash provided by operating activities for the first quarter of 2023 was $2.6 million, compared to net cash used in operating activities of $26.9 million in the first quarter of 2022. At March 31, 2023, Puma had cash, cash equivalents and marketable securities of $71.2 million, compared to cash, cash equivalents and marketable securities of $81.1 million at December 31, 2022.<\/p>\n
\n\u201cWe are pleased to deliver positive net income for the first quarter of 2023. We are additionally pleased to see the recently published results from the TBCRC-041 trial evaluating alisertib in patients with ER-positive HER2-negative metastatic breast cancer that were published in JAMA Oncology in March,\u201d said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. \u201cWe look forward to meeting with the U.S. Food and Drug Administration and discussing the next steps for the development of alisertib in both small cell lung cancer and ER-positive HER2-negative metastatic breast cancer during 2023. Additionally, we will continue to focus our efforts toward achieving our goal of increasing awareness of and access to NERLYNX as an option for patients battling HER2-positive breast cancer.\u201d<\/p>\n
\nMr. Auerbach added, \u201cWe anticipate the following key milestones over the next 12 months: (i) reporting biomarker data from the randomized trial of alisertib plus paclitaxel versus paclitaxel alone in hormone receptor positive, HER2-negative breast cancer (Q2 2023); (ii) reporting data from an ongoing investigator sponsored Phase I\/II trial of alisertib plus pembrolizumab for the treatment of patients with Rb-deficient head and neck squamous cell cancer (2023); (iii) conducting a meeting with the FDA to discuss the registration pathway for alisertib in small cell lung cancer (Q2 2023); and (iv) conducting a meeting with the FDA to discuss the registration pathway for alisertib in hormone receptor positive, HER2-negative breast cancer (Q4 2023).\u201d<\/p>\n
Revenue<\/b><\/p>\n
\nTotal revenue consists of product revenue, net from sales of NERLYNX, Puma\u2019s first commercial product, license revenue from Puma\u2019s sub-licensees and royalty revenue. For the first quarter ended March 31, 2023, total revenue was $52.8 million, of which $46.8 million was net product revenue and $6.0 million was royalty revenue. This compares to total revenue of $45.7 million in the first quarter of 2022, of which $40.7 million was net product revenue and $5.0 million was royalty revenue.<\/p>\n
Operating Costs and Expenses<\/b><\/p>\n
\nTotal operating costs and expenses were $48.4 million for the first quarter of 2023, compared to $46.4 million for the first quarter of 2022.<\/p>\n
Cost of Sales<\/i><\/p>\n
\nCost of sales was $13.2 million for the first quarter of 2023, compared to $10.8 million for the first quarter of 2022. The $2.4 million increase resulted primarily from higher royalty expense related to increased net product sales, as well as increased intangible amortization related to the $12.5 million paid to Pfizer for meeting a commercial sales milestone as of December 31, 2022.<\/p>\n
Selling, General and Administrative Expenses<\/i><\/p>\n
\nSelling, general and administrative expenses were $22.5 million for the first quarter of 2023, compared to $20.4 million for the first quarter of 2022. The $2.1 million increase resulted primarily from an increase in payroll and related costs of approximately $1.6 million, primarily due to salary increases beginning in 2023 as well as higher headcount, and higher travel and meeting expenses.<\/p>\n
Research and Development Expenses<\/i><\/p>\n
\nResearch and development expenses were $12.7 million for the first quarter of 2023, compared to $15.2 million for the first quarter of 2022. The $2.5 million decrease resulted primarily from a decrease in clinical trial expense of approximately $3.2 million, primarily due to the reduction and closing of SUMMIT clinical trial sites, and was partially offset by an increase in internal R&D of approximately $0.8 million, primarily due to an increase in payroll-related expenses in 2023.<\/p>\n
Total Other Income (Expenses)<\/b><\/p>\n
\nTotal other expenses were $2.8 million for the first quarter of 2023, compared to total other expenses of $2.7 million for the first quarter of 2022. The increase resulted primarily from higher interest rates.<\/p>\n
Second Quarter and Full Year 2023 Financial Outlook<\/b><\/p>\n
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