On May 2, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2024 (Press release, Puma Biotechnology, MAY 2, 2024, View Source [SID1234642595]). Unless otherwise stated, all comparisons are for the first quarter 2024 compared to the first quarter 2023.
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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 first quarter of 2024 was $40.3 million, compared to product revenue, net of $46.8 million in the first quarter of 2023.
Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $4.8 million, or $0.10 per basic and diluted share, for the first quarter of 2024, compared to net income of $1.4 million, or $0.03 per basic and diluted share, for the first quarter of 2023.
Non-GAAP adjusted net loss was $2.4 million, or $0.05 per basic and diluted share, for the first quarter of 2024, compared to non-GAAP adjusted net income of $4.2 million, or $0.09 per basic and diluted share, for the first quarter of 2023. Non-GAAP adjusted net (loss) income excludes stock-based compensation expense. For a reconciliation of GAAP net (loss) income to non-GAAP adjusted net (loss) income and GAAP net (loss) income per share to non-GAAP adjusted net (loss) income 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 2024 was $11.3 million, compared to $2.6 million in the first quarter of 2023. At March 31, 2024, Puma had cash, cash equivalents and marketable securities of $107.2 million, compared to cash, cash equivalents and marketable securities of $96.0 million at December 31, 2023.
"In February, we were pleased to initiate ALISertib in CAncer (ALISCA-Lung1), a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We also look forward to presenting updated data from the clinical trial of alisertib in combination with osimertinib in patients with metastatic EGFR-mutant non-small cell lung cancer who have developed osimertinib resistance, as well as results from the biomarker studies of the randomized trial of alisertib plus fulvestrant versus alisertib alone in hormone receptor-positive, HER2-negative breast cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. We remain committed to our goal to clinically develop alisertib, 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) presentation of biomarker studies from the randomized trial of alisertib plus fulvestrant versus alisertib alone in hormone receptor-positive, HER2-negative breast cancer (Q2 2024); (ii) updated data from the clinical trial of alisertib in combination with osimertinib in patients with metastatic EGFR-mutant non-small cell lung cancer who have developed osimertinib resistance (Q2 2024); (iii) initiation of 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 2024); and (iv) interim data from ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Q4 2024)."
Revenue
Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue from Puma’s sub-licensees and royalty revenue. For the first quarter ended March 31, 2024, total revenue was $43.8 million, of which $40.3 million was net product revenue and $3.5 million was royalty revenue. This compares to total revenue of $52.8 million in the first quarter of 2023, of which $46.8 million was net product revenue and $6.0 million was royalty revenue.
Operating Costs and Expenses
Total operating costs and expenses were $46.1 million for the first quarter of 2024, compared to $48.4 million for the first quarter of 2023.
Cost of Sales
Cost of sales was $10.7 million for the first quarter of 2024, compared to $13.2 million for the first quarter of 2023. The $2.5 million decrease resulted primarily from lower royalty expense reflecting decreased worldwide net sales.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $21.8 million for the first quarter of 2024, compared to $22.5 million for the first quarter of 2023. The $0.7 million decrease resulted primarily from payroll-related expenses and stock-based compensation, partially offset by an increase in professional fees and expenses.
Research and Development Expenses
Research and development expenses were $13.6 million for the first quarter of 2024, compared to $12.7 million for the first quarter of 2023. The $0.9 million increase resulted primarily from an increase in clinical trial expense of approximately $1.0 million, due to a milestone payment associated with a neratinib clinical trial, partially offset by a decrease in neratinib-related consultant and contractors expense.
Total Other Income (Expenses)
Total other expenses were $2.3 million for the first quarter of 2024, compared to total other expenses of $2.8 million for the first quarter of 2023. The $0.5 million decrease resulted primarily from an increase in interest income, which resulted from higher interest rates and increased cash investments.
Second Quarter and Full Year 2024 Financial Outlook
Second Quarter 2024
Full Year 2024
Net Product Revenue
$43 -45 million
$183 – $190 million
Royalty Revenue
$2.5 – $3 million
$30 – $33 million
License Revenue
$0 million
$1 – $2 million
Net Income/(Loss)
$(6) – $(9) million
$12 – $15 million
Gross to Net Adjustment
22% – 23%
21.5% – 22.5%
Conference Call
Puma Biotechnology will host a conference call to report its first quarter 2024 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 2, 2024. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (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 approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.