Puma Biotechnology is a small oncology-focused biopharmaceutical company built around a single commercial product: NERLYNX (neratinib), an oral HER2 inhibitor for HER2-positive breast cancer. NERLYNX is approved in the U.S. for extended adjuvant treatment of early-stage HER2-positive breast cancer following trastuzumab therapy — the primary revenue driver — and for metastatic breast cancer in combination with capecitabine. Puma sells NERLYNX in the U.S. through a small direct sales force of roughly 35 oncology specialists, distributing through specialty pharmacy and distributor networks. Outside the U.S., Puma licenses rights to regional partners across more than 40 countries, generating product supply revenue and royalties. Revenue runs at approximately $195-200M annually in the U.S., with gross-to-net deductions of roughly 23-24% from Medicaid rebates, Medicare Part D discounts, and other chargebacks. Puma pays royalties to Pfizer on U.S. net sales. In the pipeline, Puma is developing alisertib, licensed from Takeda, in two Phase II trials: one in small cell lung cancer and one in hormone receptor-positive, HER2-negative breast cancer, both targeting biomarker-selected patients. Puma's strategy is to sustain NERLYNX profitability, retire its remaining debt by mid-2026, and fund alisertib development internally, while also exploring in-licensing or acquisitions to leverage its existing commercial infrastructure.
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