Puma Biotechnology NASDAQ: PBYI reported second-quarter 2026 total revenue of $56.5 million, including $53.6 million in net product revenue from NERLYNX and $2.9 million in royalty revenue. The company posted GAAP net income of $8.2 million, or $0.16 per diluted share, compared with a net loss of $3.8 million, or $0.07 per share, in the first quarter.
Chief Executive Officer Alan Auerbach said net NERLYNX product revenue increased from $42 million in the prior quarter and $49.2 million in the second quarter of 2025. Reported NERLYNX revenue includes U.S. net sales and product supply revenue to ex-U.S. partners. International product supply revenue was approximately $23,000 during the quarter, meaning nearly all of the reported product revenue came from U.S. sales.
NERLYNX Demand and Commercial Performance
Puma sold 2,929 NERLYNX bottles in the second quarter, up from 2,328 bottles in the first quarter. The company estimated that inventory declined by 57 bottles during the quarter, compared with a decline of 439 bottles in the first quarter.
Senior Vice President of Sales Roger Storms said U.S. demand reached 2,986 bottles, representing an 8% sequential increase and an 11% year-over-year increase. Ex-factory bottle sales increased approximately 26% from the first quarter and 12% from a year earlier.
The specialty pharmacy channel accounted for about 61% of the company’s business in the second quarter, while specialty distributors and in-office dispensing represented the remaining 39%. Storms said growth was stronger in the specialty distributor channel, supported by increased group purchasing organization activity and greater 340B purchasing.
- Total prescriptions increased 7% sequentially and 3% year over year.
- New prescriptions declined about 6% from the first quarter.
- Commercial new-patient starts fell 6% sequentially but rose 8% from a year earlier.
- Patient enrollments increased 1% sequentially and 12% year over year.
- About 73% of patients began NERLYNX at a reduced dose, reflecting the company’s focus on dose escalation and patient support.
Senior Vice President of Marketing Heather Blaber said Puma remains focused on expanding awareness of NERLYNX’s dual indication in HER2-positive breast cancer, including its role in reducing recurrence risk in early-stage disease and helping protect against progression in the metastatic setting. The company also launched NERLYNX in Thailand during the first quarter for the extended adjuvant setting.
Alisertib Clinical Development Plans
Puma is advancing two ongoing Phase II trials of investigational drug alisertib: ALISCA-Breast1 in HER2-negative hormone receptor-positive recurrent or metastatic breast cancer, and ALISCA-Lung1 in small cell lung cancer.
Auerbach said interim data from ALISCA-Breast1 have provided what the company views as a preliminary indication of potentially better activity among patients with biomarkers associated with the Aurora kinase pathway. Following feedback from breast-cancer key opinion leaders, Puma amended the study to continue enrollment only in the 40 mg and 50 mg twice-daily dose groups. The amendment has been submitted to the FDA and European authorities and is being submitted to institutional review boards. Puma expects enrollment under the amended protocol to begin in the third quarter and plans to provide updated interim data, including longer-term follow-up, in the fourth quarter.
In ALISCA-Lung1, Puma is evaluating alisertib monotherapy in small cell lung cancer. The study has enrolled 92 patients, including 36 patients at the 60 mg twice-daily dose and four patients at the 70 mg dose. The company is currently enrolling at 70 mg twice daily.
Puma also expects to begin enrolling patients in ALISCA-Lung2 during the third quarter. That study will evaluate alisertib in combination with paclitaxel in small cell lung cancer. The company expects additional interim data from ALISCA-Lung1 and initial data from ALISCA-Lung2 in 2027.
During the question-and-answer session, Auerbach said Puma believes it could fund potential Phase III studies in both ER-positive breast cancer and small cell lung cancer based on its current projections, though it may stagger the trials to maintain positive net income. He also said the company continues to evaluate commercial-stage and development-stage business-development opportunities, including assets beyond breast and lung cancer.
Updated 2026 Outlook and Balance Sheet
Chief Financial Officer Maximo Nougues said Puma raised its full-year net NERLYNX product revenue outlook to $205 million to $209 million, from prior guidance of $202 million to $206 million. The company raised its full-year net-income outlook to $17 million to $20 million, compared with prior guidance of $16 million to $19 million.
Puma lowered its expected 2026 royalty revenue range to $19 million to $22 million from $20 million to $23 million. Nougues said royalty rates under the company’s China sublicense agreement could decline if generic NERLYNX market share reaches a specified threshold, which Puma believes could occur in late 2026 or 2027.
For the third quarter, Puma expects net NERLYNX product revenue of $54 million to $56 million, royalty revenue of $2 million to $3 million, and net income of $2 million to $2.5 million. The company expects third-quarter gross-to-net adjustments of approximately 26% to 27%.
Second-quarter SG&A expenses were $17.5 million, down from $18.4 million in the first quarter, while research and development expenses were $18.9 million, down from $19.8 million. Puma expects 2026 SG&A expense to increase 1% to 2% year over year and R&D expense to increase 34% to 37%, driven by progress in its clinical trials.
Puma ended the quarter with approximately $93.9 million in cash equivalents and marketable securities. The company made its final $11.1 million quarterly principal payment on its Athyrium obligation during the quarter and is now debt-free, Nougues said.
About Puma Biotechnology (NASDAQ:PBYI)
Puma Biotechnology, Inc is a late‐stage biopharmaceutical company dedicated to the development and commercialization of targeted therapies for oncology patients. Founded in 2010 and headquartered in Los Angeles, California, the company focuses on advancing molecularly defined cancer treatments that address significant unmet medical needs.
The company's lead product is neratinib, marketed under the brand name Nerlynx in the United States. Neratinib is an irreversible small‐molecule tyrosine kinase inhibitor designed to target the HER2 receptor, and it received FDA approval in 2017 for extended adjuvant treatment of early‐stage HER2-positive breast cancer.
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