Puma Biotechnology, Inc. (NASDAQ: PBYI) has announced its financial results for the third quarter of 2024, showcasing a strong performance driven by increased product and royalty revenues. The company reported a net income of $20.3 million, or $0.41 per basic and diluted share, compared to $5.8 million, or $0.12 per basic and diluted share, for the same period in 2023. These results reflect the company's focus on commercializing NERLYNX and advancing its clinical pipeline, particularly alisertib.
Financial Highlights
Total revenue for the third quarter of 2024 was $80.5 million, comprising $56.1 million in net product revenue from NERLYNX and $24.4 million in royalty revenue. This represents a significant increase from the $56.1 million total revenue in Q3 2023, which included $51.6 million in NERLYNX sales and $4.5 million in royalty revenue. For the first nine months of 2024, total revenue reached $171.4 million, compared to $163.5 million for the same period in 2023.
Operating costs and expenses totaled $58.4 million for the third quarter of 2024, compared to $47.5 million for the third quarter of 2023. Research and development expenses increased to $12.5 million, driven by clinical trial expenses related to alisertib. Puma reported net cash provided by operating activities of $11.0 million for the third quarter of 2024, compared to $10.7 million for the third quarter of 2023. As of September 30, 2024, Puma had approximately $97 million in cash, cash equivalents, and marketable securities.
Alisertib Clinical Development
Puma Biotechnology is actively progressing the clinical development of alisertib, a selective, small molecule inhibitor of aurora kinase A. The company anticipates several key milestones over the next 12 months, according to Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma.
These milestones include:
- 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).
- 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).
- 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).
NERLYNX Performance and Indications
NERLYNX (neratinib) is Puma's first commercial product, indicated for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. It is also approved 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.
Financial Outlook
Puma Biotechnology has provided its financial outlook for the fourth quarter and full year 2024, anticipating net product revenue between $46 and $48 million for Q4 2024. The company projects full year 2024 net income to be in the range of $15 to $17 million.
