On August 1, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the second quarter ended June 30, 2024 (Press release, Puma Biotechnology, AUG 1, 2024, View Source [SID1234645269]). Unless otherwise stated, all comparisons are for the second quarter 2024 compared to the second quarter 2023.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the second quarter of 2024 was $44.4 million, compared to product revenue, net of $51.6 million in the second quarter of 2023. Product revenue, net in the first six months of 2024 was $84.6 million, compared to $98.3 million in the first six months of 2023.
Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $4.5 million, or $0.09 per share, for the second quarter of 2024, compared to net income of $2.1 million, or $0.05 per basic and diluted share, for the second quarter of 2023. Net loss for the first six months of 2024 was $9.3 million, or $0.19 per share, compared to net income of $3.5 million, or $0.08 per basic share and $0.07 per diluted share, for the first six months of 2023.
Non-GAAP adjusted net loss was $2.5 million, or $0.05 per share, for the second quarter of 2024, compared to non-GAAP adjusted net income of $4.6 million, or $0.10 per basic and diluted share, for the second quarter of 2023. Non-GAAP adjusted net loss for the first six months of 2024 was $4.9 million, or $0.10 per share, compared to non-GAAP adjusted net income of $8.8 million, or $0.19 per basic and diluted share, for the first six months 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 second quarter of 2024 was $1.0 million, compared to $3.3 million in the second quarter of 2023. Net cash provided by operating activities for the first six months of 2024 was $12.3 million, compared to net cash provided by operating activities of $5.9 million in the first six months of 2023. At June 30, 2024, Puma had cash, cash equivalents and marketable securities of $96.8 million, compared to cash, cash equivalents and marketable securities of $96.0 million at December 31, 2023.
Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma, said, "We were pleased to see promising efficacy signals from the Phase I/Ib study of alisertib in combination with osimertinib in advanced osimertinib-resistant EGFR-mutated lung cancer, which was presented at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). The trial has been amended such that future enrollment will be limited to patients who are tp53 wild type and we look forward to further studying this combination in this biomarker directed cohort of patients. In addition, the biomarker analysis from the Phase II randomized clinical trial of alisertib alone vs. alisertib + fulvestrant for the treatment of patients with endocrine and CDK4/6 inhibitor (CDK 4/6i) resistant, human epidermal growth factor receptor 2-negative (HER2-negative), hormone receptor-positive metastatic breast cancer, presented at the same conference, may provide clarity into the subset of patients who may derive the greatest benefit from treatment with alisertib."
Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) 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 (ii) 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 second quarter ended June 30, 2024, total revenue was $47.1 million, of which $44.4 million was net product revenue and $2.7 million was royalty revenue. This compares to total revenue for the second quarter of 2023 of $54.6 million, of which $51.6 million was net product revenue and $3.0 million was royalty revenue. For the first six months of 2024, total revenue was $90.8 million, of which $84.6 million was net product revenue and $6.2 million was royalty revenue. This compares to total revenue for the first six months of 2023 of $107.3 million, of which $98.3 million was net product revenue and $9.0 million was royalty revenue.
Operating Costs and Expenses
Total operating costs and expenses were $49.3 million for the second quarter of 2024, compared to $49.7 million for the second quarter of 2023. Operating costs and expenses in the first six months of 2024 were $95.3 million, compared to $98.0 million in the first six months of 2023.
Cost of Sales
Cost of sales was $10.7 million for the second quarter of 2024, compared to $11.9 million for the second quarter of 2023. Cost of sales was $21.4 million for the first six months of 2024, compared to $25.1 million for the first six months of 2023. The $3.7 million decrease in the first six months of 2024 resulted primarily from lower royalty expense resulting from decreased worldwide net sales.
Selling, General and Administrative Expenses
Selling, general and administrative (SG&A) expenses were $25.0 million for the second quarter of 2024, compared to $24.4 million for the second quarter of 2023. SG&A expenses for the first six months of 2024 were $46.7 million, compared to $46.8 million for the first six months of 2023. The decrease was primarily due to lower payroll costs related to lower headcount and recruiting related expenses, a decrease in credit losses due to collection on an overdue receivable, a decrease in stock-based compensation expense and a decrease in marketing costs, partially offset by an increase in legal fees.
Research and Development Expenses
Research and development (R&D) expenses were $13.6 million for the second quarter of 2024, compared to $13.4 million for the second quarter of 2023. R&D expenses for the first six months of 2024 were $27.2 million, compared to $26.1 million for the first six months of 2023. The $1.1 million year-over-year increase for the first six months resulted primarily from an increase in clinical trial expenses related to alisertib drug product procurement, as well as a one-time payroll-related expense.
Total Other Income (Expenses)
Total other expenses were $2.0 million for the second quarter of 2024, compared to $2.6 million for the second quarter of 2023. Total other expenses were $4.2 million for the first six months of 2024, compared to $5.4 million for the first six months of 2023. The $1.2 million year-over-year decrease in other expenses for the first six months of 2024 resulted primarily from higher interest income associated with higher interest rates in the current year.
Third Quarter and Full Year 2024 Financial Outlook
Third Quarter 2024
Full Year 2024
Net Product Revenue
$50 -53 million
$183 – $190 million
Royalty Revenue
$20 – $22 million
$30 – $33 million
License Revenue
$0 million
$1 – $2 million
Net Income
$11 – $13 million
$12 – $15 million
Gross to Net Adjustment
18.5% – 19.5%
21% – 22%
Conference Call
Puma Biotechnology will host a conference call to report its second quarter 2024 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 1, 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 shortly after completion of the call and will be archived on Puma’s website for 90 days.