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Puma Biotechnology posted Q3 adjusted EPS of $0.21, which topped estimates but fell from last year's $0.45.
Q3 revenues of $54.5 million beat expectations but declined 32.3% year over year on weaker royalty income.
PBYI raised 2025 revenue guidance to $220-$223 million, while increasing Nerlynx product sales outlook.
Puma Biotechnology (PBYI - Free Report) reported third-quarter 2025 adjusted earnings of 21 cents per share, which beat the Zacks Consensus Estimate of 9 cents. In the year-ago quarter, the company had reported adjusted earnings of 45 cents per share.
The above-adjusted earnings exclude the impact of stock-based compensation expense. Including the same, earnings per share were 17 cents compared with earnings of 41 cents in the year-ago quarter.
Total revenues in the third quarter were $54.5 million, which beat the Zacks Consensus Estimate of $48 million. Revenues, however, declined 32.3% year over year due to a decrease in product supply revenues to international licensees (lower sales in China) and a higher gross-to-net reduction.
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 treating early-stage HER2-positive breast cancer.
Shares of Puma Biotechnology have rallied 60.7% year to date compared with the industry’s rise of 11.5%.
Image Source: Zacks Investment Research
PBYI's Q3 Earnings in Detail
Product revenues from Nerlynx totaled $51.9 million in the third quarter, down almost 7.5% year over year. Nerlynx’s product sales, however, were above management’s guidance of $46-$48 million.
Product revenues from Nerlynx beat our model estimate of $46.2 million. Nerlynx sales increased 5.5% sequentially.
Royalty revenues amounted to $2.6 million compared with $24.4 million reported in the year-ago quarter. Royalty revenues beat our model estimate of $2.2 million and were within the guided range of $2-$3 million.
Total operating costs (including stock-based compensation expense) in the quarter were $44.9 million, down 23.1% year over year.
Selling, general and administrative expenses (including stock-based compensation expense) remained flat year over year at $16.8 million.
Research and development expenses (including stock-based compensation expense) totaled $15.9 million, up almost 27.2% year over year.
As of Sept 30, 2025, PBYI had cash, cash equivalents, restricted cash and investment securities of $94.4 million compared with $96 million as of June 30, 2025.
PBYI's Guidance for Q4 and Full-Year 2025
Puma Biotechnology raised its financial guidance for 2025.
The company now expects total revenues in the range of $220-$223 million compared with the previous expectation of $212–$222 million.
Nerlynx’s product sales are now expected to be in the range of $198-$200 million compared with the earlier projection of $192-$198 million.
Royalty revenues are now expected to be in the $22-$23 million range versus the previous expectation of $20-$24 million.
Net income is now expected to be in the range of $27-$29 million in 2025 compared with the previous expectation of $23-$28 million.
For the fourth quarter of 2025, total revenues are expected in the band of $67-$70 million. Nerlynx product sales are expected to be in the range of $54-$56 million. Royalty revenues are expected to be in the band of $13-$14 million.
In the fourth quarter, net income is expected to be in the range of $9-$11 million.
PBYI's Pipeline Updates
Puma Biotechnology in-licensed the 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 first half of 2026.
Puma Biotechnology is also conducting a phase II ALISCA-Breast1 study on alisertib in combination with endocrine treatment for treating patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer. Initial data from the study is also expected in the first half of 2026.
Puma Biotechnology, Inc. Price, Consensus and EPS Surprise
In the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $7.25 to $7.29 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.74 to $7.81. Year to date, shares of ANIP have surged 63.2%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 9 cents to 41 cents. Year to date, shares of ARQT have rallied 80.1%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.
In the past 60 days, estimates for Syndax Pharmaceuticals’ loss per share have narrowed from $3.18 to $3.11 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.45 to $1.20. Year to date, shares of SNDX have gained 11%.
Syndax Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 6.58%.
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PBYI's Q3 Earnings & Revenues Beat Estimates, 2025 Sales View Raised
Key Takeaways
Puma Biotechnology (PBYI - Free Report) reported third-quarter 2025 adjusted earnings of 21 cents per share, which beat the Zacks Consensus Estimate of 9 cents. In the year-ago quarter, the company had reported adjusted earnings of 45 cents per share.
The above-adjusted earnings exclude the impact of stock-based compensation expense. Including the same, earnings per share were 17 cents compared with earnings of 41 cents in the year-ago quarter.
Total revenues in the third quarter were $54.5 million, which beat the Zacks Consensus Estimate of $48 million. Revenues, however, declined 32.3% year over year due to a decrease in product supply revenues to international licensees (lower sales in China) and a higher gross-to-net reduction.
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 treating early-stage HER2-positive breast cancer.
Shares of Puma Biotechnology have rallied 60.7% year to date compared with the industry’s rise of 11.5%.
Image Source: Zacks Investment Research
PBYI's Q3 Earnings in Detail
Product revenues from Nerlynx totaled $51.9 million in the third quarter, down almost 7.5% year over year. Nerlynx’s product sales, however, were above management’s guidance of $46-$48 million.
Product revenues from Nerlynx beat our model estimate of $46.2 million. Nerlynx sales increased 5.5% sequentially.
Royalty revenues amounted to $2.6 million compared with $24.4 million reported in the year-ago quarter. Royalty revenues beat our model estimate of $2.2 million and were within the guided range of $2-$3 million.
Total operating costs (including stock-based compensation expense) in the quarter were $44.9 million, down 23.1% year over year.
Selling, general and administrative expenses (including stock-based compensation expense) remained flat year over year at $16.8 million.
Research and development expenses (including stock-based compensation expense) totaled $15.9 million, up almost 27.2% year over year.
As of Sept 30, 2025, PBYI had cash, cash equivalents, restricted cash and investment securities of $94.4 million compared with $96 million as of June 30, 2025.
PBYI's Guidance for Q4 and Full-Year 2025
Puma Biotechnology raised its financial guidance for 2025.
The company now expects total revenues in the range of $220-$223 million compared with the previous expectation of $212–$222 million.
Nerlynx’s product sales are now expected to be in the range of $198-$200 million compared with the earlier projection of $192-$198 million.
Royalty revenues are now expected to be in the $22-$23 million range versus the previous expectation of $20-$24 million.
Net income is now expected to be in the range of $27-$29 million in 2025 compared with the previous expectation of $23-$28 million.
For the fourth quarter of 2025, total revenues are expected in the band of $67-$70 million. Nerlynx product sales are expected to be in the range of $54-$56 million. Royalty revenues are expected to be in the band of $13-$14 million.
In the fourth quarter, net income is expected to be in the range of $9-$11 million.
PBYI's Pipeline Updates
Puma Biotechnology in-licensed the 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 first half of 2026.
Puma Biotechnology is also conducting a phase II ALISCA-Breast1 study on alisertib in combination with endocrine treatment for treating patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer. Initial data from the study is also expected in the first half 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 #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) , Arcutis Biotherapeutics (ARQT - Free Report) and Syndax Pharmaceuticals (SNDX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $7.25 to $7.29 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.74 to $7.81. Year to date, shares of ANIP have surged 63.2%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 9 cents to 41 cents. Year to date, shares of ARQT have rallied 80.1%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.
In the past 60 days, estimates for Syndax Pharmaceuticals’ loss per share have narrowed from $3.18 to $3.11 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.45 to $1.20. Year to date, shares of SNDX have gained 11%.
Syndax Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 6.58%.