Puma Biotechnology, Inc. (NASDAQ: PBYI) has announced a significant increase in its third-quarter revenue for 2024, reaching $80.5 million, a notable rise from $51.6 million in the same period last year. The growth was primarily driven by the sales of NERLYNX, the company's flagship product, and a substantial surge in royalty revenue attributed to its performance in the Chinese market.
NERLYNX Sales and Commercial Performance
NERLYNX net revenue in Q3 2024 was $56.1 million, an increase of $11.7 million from the $44.4 million reported in Q2 2024 and a $4.5 million increase from the $51.6 million reported in Q3 2023. The increase was attributed to inventory changes, higher U.S. ex-factory sales, increased product supply revenue to global partners, and a lower gross-to-net adjustment. The company sold 2,723 bottles of NERLYNX in Q3 2024, an increase of 208 from the 2,515 bottles sold in Q2 2024.
Jeff Ludwig, Puma’s Chief Commercial Officer, noted that new patient starts increased by about 3% quarter-over-quarter and about 8% year-over-year. He emphasized the importance of dose escalation, with approximately 65% of patients starting NERLYNX at a reduced dose in Q3, similar to the 66% in Q2. This strategy continues to show improved persistence and compliance.
Alisertib Clinical Trial Updates
Puma is currently conducting a Phase 2 study of alisertib as a monotherapy in patients with small cell lung cancer (SCLC) with biomarkers indicating aurora kinase pathway involvement. The goal is to correlate efficacy in biomarker subgroups in the ALISCA-Lung1 study to previous findings from a randomized trial of paclitaxel plus alisertib versus paclitaxel plus placebo.
Alan Auerbach, CEO of Puma Biotechnology, reported that there are currently 20 patients enrolled in the ALISCA-Lung1 trial, with several in screening and prescreening. Preliminary safety results from the first 18 patients showed a significant reduction in grade 3/4 neutropenia (5.6%) and febrile neutropenia (5.6%). No patient has discontinued alisertib due to adverse events, and only one patient (5.6%) required a dose hold.
Of the 18 patients dosed with alisertib, 16 have had a post-baseline tumor assessment. In the chemotherapy-sensitive patients (relapse more than 90 days, but less than 180 days after primary treatment), one patient (14%) showed stable disease, with a median PFS of 1.2 months. In chemotherapy-resistant or refractory patients (relapse less than 90 days after primary treatment), two patients (22%) had a partial response, and one patient (11%) had stable disease, with a median PFS of 1.4 months. The two refractory or resistant patients with partial responses had biomarkers correlating with aurora kinase pathway activation, including RB1 mutations and MYC gains.
Puma also plans to test alisertib in combination with endocrine treatment in the ALISCA-Breast trial, a Phase II trial for chemotherapy-naive, HER2-negative, hormone receptor-positive metastatic breast cancer. The trial is expected to initiate in Q4 2024.
Financial Highlights and Outlook
Maximo Nougues, Chief Financial Officer, reported a net income of $20.3 million, or $0.41 per share, for Q3 2024, compared to a net loss in Q2 2024 of $4.5 million, or $0.09 per share. On a non-GAAP basis, net income was $22.4 million, or $0.45 per diluted share.
Puma anticipates full-year 2024 net product revenue for NERLYNX to be between $187 million and $290 million. For Q4 2024, NERLYNX net product revenue is expected to be in the range of $46 million to $48 million, with royalties between $3.5 million and $5 million. The company anticipates Q4 net income between $4 million and $6 million.
Strategic Focus and Future Plans
Puma continues to evaluate several drugs to potentially end license, aiming to diversify and leverage its existing R&D, regulatory, and commercial infrastructure. The company remains committed to achieving positive net income and will continue to reduce expenses as needed.
