Puma Biotechnology (NASDAQ:PBYI) reported third-quarter 2026 revenue of $55.1 million and raised its full-year net income forecast, even as it lowered its outlook for royalties and narrowed its sales guidance for breast cancer drug NERLYNX.
The company also outlined plans to discuss a potential phase III trial of its investigational drug alisertib with global regulators in the first half of 2027. Updated interim data from a phase II breast cancer study is expected in December, Chief Executive Officer Alan Auerbach said on the Nov. 5 earnings call.
NERLYNX Sales Rise, but U.S. Revenue Falls
Net product revenue from NERLYNX was $54.1 million in the third quarter, up from $53.6 million in the second quarter and $51.9 million a year earlier. The figure includes U.S. sales and product supplied to international partners.
Chief Financial Officer Maximo Nougues said international product supply revenue was approximately $3.6 million in the quarter, while U.S. net sales were $50.6 million, down from $53.6 million in the prior quarter. He attributed the U.S. decline to lower demand, a larger inventory decrease and a higher gross-to-net adjustment.
Senior Vice President of Sales Roger Storms said U.S. demand was 2,899 bottles, down approximately 3% from the second quarter but up 5% from a year earlier. Ex-factory sales were 2,818 bottles, down approximately 4% both sequentially and year over year. Inventory in the distribution network decreased by an estimated 82 bottles during the quarter.
Storms said patient enrollments fell 12% sequentially and 6% year over year, while commercial new patient starts declined 13% and 9%, respectively. Call activity also decreased, largely because of a temporary increase in vacancies and time off territory, which he said the company expected to normalize shortly.
Auerbach said Puma’s projections indicate that 2026 will be the second consecutive year of U.S. demand growth for NERLYNX, a first since the drug’s U.S. launch.
China Royalty Adjustment Weighs on Revenue
Royalty revenue was $0.9 million, compared with $2.9 million in the second quarter. Nougues said Puma recorded a $2.1 million cumulative reduction after receiving third-party data in October indicating that generic versions of NERLYNX had reached a market-share threshold in China during 2025. The company will apply a lower royalty rate to China sales going forward.
For the full year, Puma now expects royalties of $18 million to $19 million, down from its prior forecast of $20 million to $23 million. It narrowed its net NERLYNX product revenue guidance to $205 million to $208 million from $205 million to $209 million.
The company raised its full-year net income forecast to $20 million to $22 million from $17 million to $20 million. For the fourth quarter, Puma projected net product revenue of $56 million to $58 million, royalties of $11 million to $12 million and net income of $10 million to $12 million.
Third-quarter net income under generally accepted accounting principles was $6 million, or $0.11 per diluted share, compared with $8.2 million, or $0.16 per share, in the second quarter. Non-GAAP net income, which excludes stock-based compensation expense, was $8 million, or $0.15 per basic and diluted share.
Puma held approximately $108.5 million in cash, cash equivalents and marketable securities as of Sept. 30, up from $97.5 million at the end of 2025. Nougues said the company is debt-free after making its final principal loan payment to Athyrium in the second quarter.
Alisertib Trial Updates
Puma is conducting three phase II studies of alisertib: one in combination with endocrine therapy for certain patients with recurrent or metastatic breast cancer, one as a monotherapy for extensive-stage small cell lung cancer and another in combination with paclitaxel for advanced small cell lung cancer.
Auerbach said Puma amended the breast cancer study to continue enrollment only at the 40 mg and 50 mg dose levels, following feedback from breast cancer experts. Enrollment under the amended protocol began in the third quarter. Updated interim data, including longer patient follow-up, is expected at the San Antonio Breast Cancer Symposium in December.
Based on its initial analysis, Puma believes the breast cancer data support a phase III trial, Auerbach said. He added that the company is seeking to engage regulators about the trial’s design in the first half of 2027.
For the lung cancer monotherapy study, Puma is enrolling patients at a 70 mg twice-daily dose. The company expects additional interim data from that trial and initial data from the paclitaxel combination study in 2027.
Auerbach said Puma also continues to evaluate commercial-stage and development-stage drugs for potential acquisition or in-licensing as it seeks to diversify its business.
About Puma Biotechnology (NASDAQ:PBYI)
Puma Biotechnology, Inc is a biopharmaceutical company focused on developing and commercializing medicines for the treatment of cancer. The company’s lead product is NERLYNX (neratinib), an oral, irreversible tyrosine kinase inhibitor designed to target HER2 and other members of the epidermal growth factor receptor family.
NERLYNX is approved in the United States for the extended adjuvant treatment of adults with early-stage, HER2-positive breast cancer following adjuvant trastuzumab-based therapy.
