Puma Biotechnology, Inc. (NASDAQ: PBYI) announced its financial results for the fourth quarter and full year 2024, demonstrating continued profitability and strong commercial execution despite market challenges.
Financial Highlights
For the fourth quarter of 2024, Puma reported net income of $19.3 million, or $0.39 per basic and diluted share, compared to $12.3 million, or $0.26 per share, for the same period in 2023. The 57% increase in quarterly net income was bolstered by a $7.1 million deferred income tax benefit from a partial release of the company's valuation allowance.
Product revenue from NERLYNX® (neratinib) sales reached $54.4 million in Q4 2024, a modest increase from $53.2 million in Q4 2023. Total revenue for the quarter was $59.1 million, which included $4.7 million in royalty revenue.
For the full year 2024, Puma achieved net income of $30.3 million, or $0.62 per share, compared to $21.6 million, or $0.46 per basic share, in 2023. This marks the company's third consecutive year of profitability.
"We are very pleased with our financial results for the fourth quarter of 2024, as well as for the full year 2024, and we are very pleased to be able to report positive net income for the third consecutive year, reflecting our strong execution and disciplined financial management," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma.
Operational Performance
Total operating costs and expenses decreased to $45.7 million for Q4 2024, compared to $57.4 million for Q4 2023. For the full year, operating costs were $199.5 million, down from $203.0 million in 2023.
Selling, general and administrative expenses decreased by $9.7 million for the full year, primarily due to reductions in professional fees, marketing expenses, and payroll costs. Research and development expenses increased by $4.5 million, reflecting investments in the company's alisertib clinical program.
The company ended 2024 with a strong cash position of approximately $101 million in cash, cash equivalents, and marketable securities, compared to $96 million at the end of 2023. Net cash provided by operating activities for the full year 2024 was $38.9 million, a significant improvement from $27.0 million in 2023.
Pipeline Development
Puma made significant progress in advancing its clinical pipeline in 2024, particularly with alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A, which the company in-licensed in September 2022.
In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for patients with extensive-stage small cell lung cancer. More recently, in November 2024, the company launched ALISCA™-Breast1, a Phase II trial evaluating alisertib in combination with endocrine therapy for patients with HER2-negative, hormone receptor-positive metastatic breast cancer.
"The initiation of the ALI-1201/ALISCA™-Breast1 Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer in November is a significant step in our clinical development plan for alisertib," Auerbach noted.
2025 Outlook and Milestones
For the first quarter of 2025, Puma anticipates net product revenue between $41-$43 million and royalty revenue of $1.5-$2.5 million. For the full year 2025, the company projects net product revenue of $192-$198 million, royalty revenue of $20-$24 million, and net income between $23-$28 million.
Key anticipated milestones for the next 12 months include:
- Presentation of interim data from the Phase I trial of neratinib given in combination with trastuzumab deruxtecan in solid tumors with HER2 alterations (H1 2025)
- Presentation of interim data from ALISCA™-Breast1, the Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (2025)
- Presentation of additional interim data from the ALI-4201/ALISCA™-Lung1, the Phase II clinical trial of alisertib monotherapy for patients with extensive stage small cell lung cancer (2025)
Commercial Products
NERLYNX® (neratinib) remains Puma's primary commercial product. It is approved by the U.S. Food and Drug Administration for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. In February 2020, NERLYNX also received FDA approval in combination with capecitabine for treating adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.
The drug has also received marketing authorization from the European Commission for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer who are less than one year from completion of prior adjuvant trastuzumab-based therapy.
To support patient access, Puma has implemented the Puma Patient Lynx support program, which assists patients and healthcare providers with reimbursement support and financial assistance resources.
Despite the year-over-year decrease in full-year product revenue from $203.1 million in 2023 to $195.2 million in 2024, the company's focus on operational efficiency and cost management has enabled it to maintain and grow its profitability.
As Puma continues to execute its commercial strategy for NERLYNX while advancing its pipeline candidates, particularly alisertib, the company appears well-positioned to sustain its financial performance while pursuing new growth opportunities in oncology.
