Puma Biotechnology (PBYI) has experienced a significant stock increase, rallying 24% in the past three months, outperforming the industry's decline. This surge is attributed to the improved sales performance of its marketed product, Nerlynx (neratinib), and the advancement of its pipeline drug, alisertib.
Nerlynx Sales Performance
Nerlynx, approved for treating early-stage HER2-positive breast cancer in patients previously treated with Roche’s Herceptin-based adjuvant therapy, has been a key revenue driver. In the first nine months of 2024, Nerlynx generated sales of $140.8 million. Notably, sales improved in the third quarter of 2024, surpassing management's expectations.
Based on this performance, Puma Biotechnology updated its financial guidance for 2024, projecting Nerlynx product sales to be in the range of $187-$190 million, compared to the earlier projection of $183-$190 million. The company anticipates Nerlynx product sales to be in the band of $46-$48 million in the fourth quarter of 2024.
Alisertib Development
Puma Biotechnology in-licensed global development and commercialization rights for alisertib, an aurora kinase A inhibitor, from Takeda in 2022. The company is currently focusing on developing alisertib for various cancer indications.
Last month, Puma Biotechnology initiated the phase II ALISCA-Breast1 study evaluating alisertib in combination with endocrine therapy for the treatment of patients with HR+, HER2-negative recurrent or metastatic breast cancer. This trial targets patients previously treated with CDK 4/6 inhibitors and who have received at least two prior lines of endocrine therapy in the recurrent or metastatic setting.
The company plans to meet with the FDA to discuss a potential approval pathway for alisertib in HER2-negative, HR+ metastatic breast cancer, contingent on the outcomes of the ALISCA-Breast1 study.
Puma Biotechnology is also conducting ALISCA-Lung1, a phase II study evaluating alisertib as a monotherapy for the treatment of patients with extensive stage small cell lung cancer. Interim data from this study is expected to be presented in 2025. Successful development of alisertib could significantly enhance Puma Biotechnology’s position in the anticancer drug market and reduce its reliance on Nerlynx for revenues.
Market Competition and Future Outlook
While the breast cancer market presents substantial commercial opportunities, Nerlynx faces stiff competition from established treatments like Roche's Herceptin and Novartis' Tykerb. Several other companies are also developing therapies targeting this disease.
Despite these challenges, the improving sales of Nerlynx and the ongoing development of alisertib are expected to sustain the upward trajectory for Puma Biotechnology's stock in 2025.
