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Puma Biotechnology Reports Positive Third Quarter 2024 Financial Results and Clinical Development Updates

• Puma Biotechnology announced a net income of $20.3 million for Q3 2024, compared to $5.8 million in Q3 2023, driven by increased product and royalty revenue. • The company's total revenue for Q3 2024 reached $80.5 million, including $56.1 million from NERLYNX sales and $24.4 million from royalty revenue. • Puma is advancing the clinical development of alisertib, with a Phase II trial in small cell lung cancer and plans to initiate a trial in metastatic breast cancer. • Key milestones anticipated include interim data presentations from alisertib trials in small cell lung cancer and metastatic breast cancer in 2025.

Puma Biotechnology, Inc. (NASDAQ: PBYI) has announced its financial results for the third quarter of 2024, reporting a net income of $20.3 million, or $0.41 per basic and diluted share, a significant increase compared to the $5.8 million, or $0.12 per basic and diluted share, reported for the same period in 2023. The company's revenue streams are driven primarily by NERLYNX, its first commercial product, and strategic clinical development programs.

Financial Performance

The company's product revenue, net, which consists entirely of sales revenue from NERLYNX, was $56.1 million in the third quarter of 2024, compared to $51.6 million in the third quarter of 2023. Total revenue for the third quarter of 2024 was $80.5 million, including $24.4 million in royalty revenue, compared to $56.1 million in the third quarter of 2023. Net cash provided by operating activities for the third quarter of 2024 was $11.0 million, 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.

Clinical Development Programs

Puma Biotechnology is actively progressing the clinical development of alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. The company is focusing on the treatment of small cell lung cancer and breast cancer with this drug.
Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma, stated, “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.”

Anticipated Milestones

Puma anticipates several key milestones over the next 12 months, including:
  • 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).

Financial Outlook

Puma Biotechnology has provided its financial outlook for the fourth quarter and full year 2024. The company expects net product revenue of $46-$48 million for the fourth quarter and has updated its full-year net income guidance to $15-$17 million.
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[1]
Puma Biotechnology Reports Third Quarter 2024 Financial Results - BioSpace
biospace.com · Nov 7, 2024

Puma Biotechnology reports Q3 2024 net income of $20.3M, up from $5.8M in Q3 2023, driven by increased product revenue f...

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