Puma Biotechnology PBYI reported fourth-quarter 2025 adjusted earnings of 29 cents per share, beating the Zacks Consensus Estimate of 24 cents. In the year-ago quarter, the company had reported adjusted earnings of 43 cents per share.
The adjusted earnings exclude the impact of stock-based compensation expenses. Including the same, earnings per share were 26 cents compared with earnings of 39 cents in the year-ago quarter.
Total revenues in the fourth quarter were $75.5 million, which beat the Zacks Consensus Estimate of $68 million. Revenues increased 28% year over year due to higher net product sales and growth in royalty revenues from ex-U.S. partners.
Total revenues comprised net product sales of Nerlynx (neratinib), PBYI’s only marketed drug in the United States and royalty revenues. Nerlynx is indicated for the treatment of early-stage HER2-positive breast cancer.
PBYI was added to the Nasdaq Biotechnology Index in December 2025.
PBYI's Q4 Earnings in Detail
Product revenues from Nerlynx totaled $59.9 million in the fourth quarter, up nearly 10% year over year. This metric beat the Zacks Consensus Estimate and our model estimate of $54 million.
Royalty revenues surged 232% year over year to $15.6 million.
Total operating costs (including stock-based compensation expense) in the quarter were $58.4 million, up 28% year over year.
Selling, general and administrative (SG&A) expenses (including stock-based compensation expense) rose 11% year over year to $18.4 million.
Research and development (R&D) expenses (including stock-based compensation expense) totaled $16.8 million, up 11% year over year.
As of Dec. 31, 2025, PBYI had cash, cash equivalents, restricted cash and investment securities of $97.5 million compared with $94.4 million as of Sept. 30, 2025.
PBYI's Full-Year 2025 Results
For 2025, Puma Biotechnology reported total revenues of $228.4 million, compared with $230.5 million recorded in the prior year.
For full-year 2025, the company recorded adjusted net earnings of 75 cents, down 3.8% year over year.
PBYI's Guidance 2026
Puma Biotechnology issued its financial guidance for 2026.
For full-year 2026, net product revenues are projected to be between $194 million and $198 million, while royalty revenues are expected to range from $20 million to $23 million, with no contribution from license revenues. Total revenues for this year are forecasted in the range of $214 million to $221 million. The Zacks Consensus Estimate for 2026 is pegged at $235.7 million.
The lower-than-expected 2026 revenue guidance dampened investor sentiment and led the stock to decline 14% in after-hours trading on Thursday despite the fourth-quarter beat.
Over the past year, PBYI’s shares have surged 154.2% compared with the industry’s rise of 19.9%.
Image Source: Zacks Investment ResearchThe company expects to generate net income of $10 million to $13 million for the full year.
PBYI anticipates that SG&A expenses will increase by 3% to 5% in 2026. R&D expenses are expected to rise by 30% to 35% year over year, driven by the progress of clinical studies.
For the first quarter of 2026, the company expects net product revenues to range between $36 million and $39 million, along with royalty revenues of $2 million to $3 million. Total projected revenues are expected to be between $38 million and $42 million. The company anticipates reporting a net loss of approximately $8 million to $10 million for the quarter.
PBYI's Pipeline Updates
Puma Biotechnology in-licensed 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).
PBYI is conducting ALISCA-Lung1, a phase II study evaluating alisertib as a monotherapy for the treatment of patients with extensive-stage SCLC. Additional interim data from this study is expected to be announced in the second quarter of 2026.
Puma Biotechnology is also conducting a phase II ALISCA-Breast1 study on alisertib in combination with endocrine treatment for the treatment of patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer. Initial data from the study is also expected in the second quarter of 2026.
Puma Biotechnology, Inc. Price, Consensus and EPS Surprise
Puma Biotechnology, Inc. price-consensus-eps-surprise-chart | Puma Biotechnology, Inc. Quote
PBYI’s Zacks Rank & Stocks to Consider
Puma Biotechnology currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Castle Biosciences CSTL, which currently sports a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals ANIP and Assertio Holdings ASRT, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 96 cents. CSTL shares have risen 30.6% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 66.11%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $8.08 to $8.22 for 2026. Over the past year, shares of ANIP have surged 41.7%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.
Over the past 60 days, estimates for Assertio’s 2026 loss per share have narrowed from 30 cents to 28 cents. ASRT shares have gained 0.2% over the past year.
Assertio’s earnings beat estimates in one of the trailing four quarters and missed in the remaining three quarters, with the average negative surprise being 35.21%.
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Puma Biotechnology, Inc. (PBYI): Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis Report Assertio Holdings, Inc. (ASRT): Free Stock Analysis Report Castle Biosciences, Inc. (CSTL): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).
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