Puma Biotechnology (NASDAQ:PBYI) reported fourth-quarter 2025 total revenue of $75.5 million, driven by NERLYNX product revenue and a sharp increase in royalty revenue, according to management’s comments on the company’s earnings call held February 26, 2026.
Product revenue net, which management said consists entirely of NERLYNX sales, totaled $59.9 million in the fourth quarter, up from $51.9 million in the third quarter of 2025 and $54.4 million in the fourth quarter of 2024. Royalty revenue rose to $15.6 million, compared with $2.6 million in Q3 2025 and $4.7 million in Q4 2024.
Quarterly sales trends and inventory dynamics
Commercial metrics were mixed quarter over quarter. Auerbach said new prescriptions were down about 11.4% versus Q3 2025, while total prescriptions increased about 1.4%.
During the question-and-answer session, management addressed the quarter-end inventory build. Auerbach said Puma tends to see inventory building in the fourth quarter “since launch,” and attributed much of the pattern to channel purchasing ahead of an assumed price increase at the start of the year. Chief Financial Officer Maximo Nougues added that Puma typically expects that inventory to burn off in the first quarter, which is one reason management described Q1 as “usually the lowest quarter of the year” for net product revenue.
Commercial execution and channel mix
Senior Vice President of Sales Roger Storms said the sales team remains focused on expanding healthcare provider reach and engagement, particularly when treatment decisions are being made. Storms reported Q4 2025 call activity increased 23% year over year but decreased 13% sequentially, citing more vacant territories and fewer opportunities around the holiday period. He said he expects call activity to improve as vacancies are filled.
Storms also outlined Puma’s distribution mix in the quarter:
- Approximately 63% of Q4 2025 business was purchased through the specialty pharmacy (SP) channel.
- The remaining 37% was purchased through the specialty distributor/in-office dispensing (SD) channel.
He said Puma continues to see stronger growth in the SD channel, driven by increased sales in group purchasing organizations and increased 340B purchasing. Storms also noted that in Q4 2025, NERLYNX demand increased about 7% quarter over quarter and about 7% year over year, while SD demand grew about 17% sequentially and about 46% year over year.
On product revenue composition, Storms emphasized that reported NERLYNX sales include U.S. net sales plus product supply revenue to ex-U.S. partners. He said product supply revenue was about $4.7 million in Q4 2025 versus roughly $840,000 in Q4 2024, and that U.S. net sales were $55.2 million in Q4 2025 compared with $53.5 million in Q4 2024.
Senior Vice President of Marketing Heather Blaber said the marketing team is focused on increasing awareness of NERLYNX clinical data and the “continued unmet need” in HER2-positive early-stage breast cancer after adjuvant therapy. She added that the strategy emphasizes NERLYNX’s “dual indication” and aims to expand adoption among new prescribers.
Storms also provided an update on dose escalation practices, stating that approximately 75% of patients started NERLYNX at a reduced dose in Q4 2025, compared with 77% in Q3 2025. He said the company views dose escalation, paired with patient education resources, as important for persistence and compliance.
Internationally, Storms said NERLYNX was launched in Algeria in Q4 2025 in the extended adjuvant setting, and that it was launched in Thailand in Q1 2026, also in the extended adjuvant setting.
Clinical development: alisertib trials in breast cancer and SCLC
Auerbach reviewed progress in Puma’s two ongoing Phase II alisertib programs. In breast cancer, the ALISCA-Breast1 trial is evaluating alisertib in combination with endocrine therapy in patients with HER2-negative, hormone receptor-positive recurrent or metastatic breast cancer. He said the study was initiated in late November 2024 and is enrolling ahead of expectations.
Management said the trial originally targeted 150 patients with full enrollment anticipated in December 2026, but enrollment reached 150 patients in February 2026. As of the call, Puma reported 164 patients enrolled and 15 additional patients in screening, with screening now closed. Auerbach said interim data are anticipated in Q2 2026, based on a protocol-defined interim analysis after approximately 75 randomized patients have completed at least two tumor assessments or had documented progression or death.
In small cell lung cancer, Puma’s ALISCA-Lung 1 Phase II trial is evaluating alisertib monotherapy and examining activity in biomarker subgroups tied to the Aurora kinase pathway. Auerbach said preliminary data to date suggest potentially better activity in patients with relevant biomarkers.
He also said Puma observed lower pharmacokinetics (PK) in ALISCA-Lung 1 compared with a prior Phase II monotherapy study published in The Lancet Oncology, prompting a protocol amendment to increase dosing from 50 mg BID to 60 mg BID. Puma is currently enrolling at 60 mg BID, with 79 patients enrolled overall, including 27 at 60 mg BID and three in screening. Based on a preliminary review of data from the 60 mg cohorts, Auerbach said the company believes safety at 60 mg is acceptable and that Puma is submitting an amendment to the FDA to increase dosing to 70 mg in the trial.
Auerbach also said Puma plans to initiate a second small cell lung cancer trial combining alisertib with paclitaxel, similar to a previously published randomized trial in the Journal of Thoracic Oncology. He said additional interim data from ALISCA-Lung 1 are expected in Q2 2026, with an interim analysis including safety and efficacy for approximately 60 patients meeting protocol criteria.
Financial results, guidance, and balance sheet items
Nougues reported fourth-quarter 2025 GAAP net income of $13.4 million, or $0.20 per basic share and $0.26 per diluted share, compared with GAAP net income of $8.8 million in Q3 2025. He said Q4 included a net change in valuation allowance that unfavorably impacted net income by $3.2 million. On a non-GAAP basis, Puma reported net income of $15.1 million, or $0.30 per basic share and $0.29 per diluted share, excluding stock-based compensation.
Gross revenue from NERLYNX sales was $82.9 million in Q4 2025, up from $70.0 million in Q3 2025. Nougues said the quarter-over-quarter increase in net revenue was primarily driven by increased NERLYNX demand and the $5.7 million inventory build, partially offset by higher gross-to-net expense. He reported gross-to-net adjustments of about 27.8% in Q4 2025 versus 25.9% in Q3 2025, driven mostly by higher Medicare and Medicaid share and higher government chargebacks.
Cost of sales was $23.2 million in Q4 2025, including $2.4 million of amortization of intangible assets related to the neratinib license, compared with $12.2 million in Q3 2025. Nougues said Puma expects to continue recognizing approximately $2.4 million per quarter of amortization of milestones to the licensor as cost of sales.
For 2026, Puma guided to net NERLYNX product revenue of $194 million to $198 million and full-year gross-to-net adjustments of 27.5% to 28.5%, which Nougues said is expected to be “significantly higher than 2025” due to anticipated government chargebacks. The company also guided to royalties of $20 million to $23 million and said it does not expect any license revenue. Nougues guided to full-year net income of $10 million to $13 million, noting the guidance does not include any potential release of additional tax asset valuation allowance.
For Q1 2026, management projected net NERLYNX product revenue of $36 million to $39 million, royalty revenue of $2 million to $3 million, and no license revenue. Nougues guided to a gross-to-net adjustment of approximately 29.5% to 30.5% and a Q1 net loss of $8 million to $10 million.
Operating expenses increased sequentially in Q4 2025, with SG&A of $18.4 million versus $16.8 million in Q3 and R&D of $16.8 million versus $15.9 million. Looking ahead, Nougues said the company expects 2026 SG&A to increase 3% to 5% year over year and R&D to increase 30% to 35%, driven by clinical trial progress.
On cash and debt, Nougues said Puma generated approximately $3.1 million of cash in Q4 2025, compared with cash burn of about $1.6 million in Q3, while also making an $11.1 million quarterly principal payment tied to its Athyrium obligation. As a result, he said outstanding principal debt declined to approximately $22 million. Puma ended 2025 with about $97.5 million in cash, cash equivalents, and marketable securities, compared with about $101 million at year-end 2024.
In closing remarks, Auerbach said Puma achieved positive net income for full-year 2025, marking the company’s third consecutive year of profitability, and said management remains focused on maintaining positive net income while advancing commercialization efforts and the alisertib development program.
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.
