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Shares of Puma Biotechnology PBYI have rallied 35.3% in the past six months against the industry’s decline of 9.2%.
The company’s sole marketed product, Nerlynx (neratinib), is approved for treating early-stage HER2-positive breast cancer in patients previously treated with Roche’s RHHBY Herceptin-based adjuvant therapy. Nerlynx is also approved in combination with Xeloda (capecitabine) for treating advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
Nerlynx generated sales worth $195.2 million in 2024. Sales of the drug improved during the second half of 2024 compared to the first half. Overall demand for the drug also rose during the second half of 2024. Nerlynx sales came ahead of management’s expectations during the fourth quarter of 2024.
Management expects Nerlynx product sales to be in the range of $192-$198 million in 2025.
The improved sales of Nerlynx have been the primary reason for the stock’s increase in the past six months.
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Alisertib - A Promising Pipeline Candidate for PBYI
Puma Biotechnology in-licensed the global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda in 2022. It is developing alisertib for hormone receptor-positive breast cancer as well as small-cell lung cancer (SCLC).
The company is conducting ALISCA-Lung1, a phase II study evaluating alisertib as a monotherapy for the treatment of patients with extensive-stage SCLC. Interim data from this study is expected to be announced later in 2025.
Puma Biotechnology initiated the phase II ALISCA-Breast1 study on alisertib in combination with endocrine treatment for treating patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer in November 2024. Initial data from the study is expected later in 2025.
If successfully developed, alisertib has the potential to boost the company’s position in the anticancer drug market and lower its heavy dependence on Nerlynx for revenues.
PBYI Solely Dependent on Nerlynx for Revenues
Puma Biotechnology has no approved product in its portfolio other than Nerlynx. As a result, the company remains heavily dependent on Nerlynx for revenues and overall growth.
While the breast cancer market holds immense commercial potential, Nerlynx faces intense competition in the targeted space. Approved treatments include RHHBY's Herceptin and Novartis' Tykerb. Few other companies are also developing treatments for extensive-stage SCLC. All these factors remain a headwind as alisertib, if successfully developed, is likely to face acute competition in the target market.