On November 7, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the third quarter ended September 30, 2024 (Press release, Puma Biotechnology, NOV 7, 2024, View Source [SID1234647945]). Unless otherwise stated, all comparisons are for the third quarter of 2024 compared to the third quarter of 2023.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Product revenue, net in the third quarter of 2024 was $56.1 million, compared to $51.6 million in the third quarter of 2023. Product revenue, net in the first nine months of 2024 was $140.8 million, compared to $149.9 million in the first nine months of 2023.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $20.3 million, or $0.41 per basic and diluted share, for the third quarter of 2024, compared to a net income of $5.8 million, or $0.12 per basic and diluted share, for the third quarter of 2023. Net income for the first nine months of 2024 was $11.0 million, or $0.23 per basic share and $0.22 per diluted share, compared to net income of $9.3 million, or $0.20 per basic and diluted share, for the first nine months of 2023.

Non-GAAP adjusted net income was $22.4 million, or $0.46 per basic share and $0.45 per diluted share, for the third quarter of 2024, compared to $8.3 million, or $0.18 per basic share and $0.17 per diluted share, for the third quarter of 2023. Non-GAAP adjusted net income for the first nine months of 2024 was $17.5 million, or $0.36 per basic and diluted share, compared to non-GAAP adjusted net income of $17.1 million, or $0.36 per basic and diluted share, for the first nine months of 2023. Non-GAAP adjusted net income excludes stock-based compensation expenses. For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the third quarter of 2024 was $11.0 million, compared to $10.7 million in the third quarter of 2023. Net cash provided by operating activities for the first nine months of 2024 was $23.3 million, compared to net cash provided by operating activities of $16.6 million in the first nine months of 2023. On September 30, 2024, Puma had cash, cash equivalents and marketable securities of approximately $97 million, compared to cash, cash equivalents, and marketable securities of approximately $96 million at December 31, 2023.

"We are pleased to announce both positive net income and positive operating cash flow for the third quarter of 2024," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "In addition to our focus on the commercialization of NERLYNX, we are also continuing to make progress with the clinical development of alisertib for patients with extensive stage small cell lung cancer and patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) initiation of ALI-1201/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); (ii) presentation of interim data from ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (2025); and (iii) 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 (2025)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product and royalty revenue. For the third quarter of 2024, total revenue was $80.5 million, of which $56.1 million was product revenue, net and $24.4 million was royalty revenue. This compares to total revenue of $56.1 million in the third quarter of 2023, of which $51.6 million was product revenue, net and $4.5 million was royalty revenue. For the first nine months of 2024, total revenue was $171.4 million, of which $140.8 million was product revenue, net and $30.6 million was royalty revenue. This compares to total revenue of $163.5 million for the first nine months of 2023, of which $149.9 million was product revenue, net, and $13.6 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $58.4 million for the third quarter of 2024, compared to $47.5 million for the third quarter of 2023. Operating costs and expenses in the first nine months of 2024 were $153.8 million, compared to $145.7 million in the first nine months of 2023.

Cost of Sales

Cost of sales was $29.1 million for the third quarter of 2024, compared to $13.3 million for the third quarter of 2023. Cost of sales was $50.5 million for the first nine months of 2024, compared to $38.4 million for the first nine months of 2023. The increase was primarily due to royalty expense related to the timing of sales made in China by our sub-licensee and an increase in units shipped to China.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $16.8 million for the third quarter of 2024, compared to $22.8 million for the third quarter of 2023. SG&A expenses for the first nine months of 2024 were $63.5 million, compared to $69.7 million for the first nine months of 2023. The $6.2 million decrease in SG&A expenses for the first nine months of 2024 compared to the first nine months of 2023 resulted from a decrease in payroll and related costs of approximately $2.4 million, primarily due to lower headcount, partially offset by annual salary increases; and a decrease in professional fees and expenses of approximately $1.2 million, primarily due to decreases of approximately $3.2 million in marketing expenses and $0.4 million in insurance and other expenses. These decreases were partially offset by an increase of approximately $2.3 million in legal fees; a decrease in stock-based compensation expense of approximately $1.1 million, primarily due to lower headcount; a decrease in provision for credit loss of $0.6 million, due to a customer payment on an overdue receivable; and a decrease in loss on impairment of asset expense of approximately $0.6 million in connection with our decision to sublease a portion of our office space in 2023.

Research and Development Expenses

Research and development (R&D) expenses were $12.5 million for the third quarter of 2024, compared to $11.4 million for the third quarter of 2023. R&D expenses for the first nine months of 2024 were $39.8 million, compared to $37.6 million for the first nine months of 2023. The $2.2 million year-over-year increase in R&D expenses resulted primarily from an increase in clinical trial expenses of approximately $1.8 million, primarily due to the procurement of alisertib drug product and increased alisertib study activity, partially offset by fewer clinical milestones being achieved, and an increase in internal R&D expenses of approximately $0.8 million, primarily due to one-time payroll and severance related expenses.

Total Other Income (Expenses)

Total other expenses were $1.5 million for the third quarter of 2024, compared to $2.6 million for the third quarter of 2023. Total other expenses of $5.7 million for the first nine months of 2024 were down from $8.0 million for the first nine months of 2023 due primarily to an increase in interest income.

Fourth Quarter and Full Year 2024 Financial Outlook

Fourth Quarter 2024

Full Year 2024 (previous)

Full Year 2024 (new)

Net Product Revenue

$46–$48 million

$183–$190 million

$187–$190 million

Royalty Revenue

$3.5–$5 million

$30–$34 million

$34–$36 million

License Revenue

$1–$2 million

$1–$2 million

$1–$2 million

Net Income

$4–$6 million

$12–$15 million

$15–$17 million

Gross to Net Adjustment

21%–22%

21%–22%

20.5%–21.5%

Conference Call

Puma Biotechnology will host a conference call to report its third quarter 2024 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, November 7, 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.