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PBYI posted Q2 adjusted EPS of $0.15, beating estimates and reversing the year-ago loss.
Nerlynx product sales rose 10.8% year over year to $49.2M, within management's guidance.
2025 revenue outlook remains $212M-$222M, with Nerlynx sales expected to be in the range of $192M-$198M.
Puma Biotechnology (PBYI - Free Report) reported second-quarter 2025 adjusted earnings of 15 cents per share, which beat the Zacks Consensus Estimate of 11 cents. In the year-ago quarter, the company had incurred an adjusted loss of 5 cents per share.
The above-adjusted earnings exclude the impact of stock-based compensation expense. Including the same, earnings per share were 12 cents against a loss of 9 cents in the year-ago quarter.
Total revenues in the second quarter were $52.4 million, which also beat the Zacks Consensus Estimate of $50 million.
Revenues rose 11.2% year over year due to higher product revenues. 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 increased 7.9% year to date against the industry’s decline of 1.2%.
Image Source: Zacks Investment Research
PBYI's Q2 Earnings in Detail
Product revenues from Nerlynx totaled $49.2 million in the second quarter, up around 10.8% year over year. Nerlynx’s product sales were within management’s guidance of $48-$50 million.
Product revenues from Nerlynx beat our model estimate of $48.1 million. Nerlynx sales increased 14.2% sequentially.
In the reported quarter, Nerlynx demand increased 2% year over year and 4% on a sequential basis.
Royalty revenues amounted to $3.2 million, increasing around 18.5% on a year-over-year basis. Royalty revenues beat our model estimate of $2.1 million and came ahead of the guided range of $2-$3 million.
Total operating costs (including stock-based compensation expense) in the quarter were $45.8 million, down 7.1% year over year.
Selling, general and administrative expenses (including stock-based compensation expense) declined 28% year over year to $18 million.
Research and development expenses (including stock-based compensation expense) totaled $15.5 million, up almost 14% year over year.
PBYI's Guidance for Q3 and Full-Year 2025
Puma Biotechnology maintained its previously issued financial guidance for 2025. The company expects total revenues in the range of $212–$222 million, while Nerlynx’s product sales are expected to be in the range of $192-$198 million.
Royalty revenues are expected to be in the $20-$24 million range.
Net income is expected to be in the range of $23-$28 million in 2025.
For the third quarter of 2025, total revenues are expected in the band of $48-$51 million. Nerlynx product sales are expected to be in the range of $46-$48 million. Royalty revenues are expected to be in the band of $2-$3 million.
In the third quarter, net income is expected to be in the range of $2-$4 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 fourth quarter of 2025.
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 fourth quarter of 2025.
Puma Biotechnology, Inc. Price, Consensus and EPS Surprise
In the past 60 days, estimates for Exact Sciences’ earnings per share have increased from 5 cents to 16 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.13 to $1.23. Year to date, shares of EXAS have declined 23.2%.
Exact Sciences’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 329.87%.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from 93 cents to 97 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.64 to $1.65. Year to date, shares of CRMD have rallied 33.4%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 25.82%.
In the past 60 days, estimates for Immunocore’s 2025 loss per share have narrowed from 86 cents to 68 cents. Loss per share estimates for 2026 have narrowed from $1.34 to $1.10 during the same period. IMCR stock has risen 8.3% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 76.18%.
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PBYI's Q2 Earnings Beat Estimates, Nerlynx Sales Drive Revenues
Key Takeaways
Puma Biotechnology (PBYI - Free Report) reported second-quarter 2025 adjusted earnings of 15 cents per share, which beat the Zacks Consensus Estimate of 11 cents. In the year-ago quarter, the company had incurred an adjusted loss of 5 cents per share.
The above-adjusted earnings exclude the impact of stock-based compensation expense. Including the same, earnings per share were 12 cents against a loss of 9 cents in the year-ago quarter.
Total revenues in the second quarter were $52.4 million, which also beat the Zacks Consensus Estimate of $50 million.
Revenues rose 11.2% year over year due to higher product revenues. 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 increased 7.9% year to date against the industry’s decline of 1.2%.
Image Source: Zacks Investment Research
PBYI's Q2 Earnings in Detail
Product revenues from Nerlynx totaled $49.2 million in the second quarter, up around 10.8% year over year. Nerlynx’s product sales were within management’s guidance of $48-$50 million.
Product revenues from Nerlynx beat our model estimate of $48.1 million. Nerlynx sales increased 14.2% sequentially.
In the reported quarter, Nerlynx demand increased 2% year over year and 4% on a sequential basis.
Royalty revenues amounted to $3.2 million, increasing around 18.5% on a year-over-year basis. Royalty revenues beat our model estimate of $2.1 million and came ahead of the guided range of $2-$3 million.
Total operating costs (including stock-based compensation expense) in the quarter were $45.8 million, down 7.1% year over year.
Selling, general and administrative expenses (including stock-based compensation expense) declined 28% year over year to $18 million.
Research and development expenses (including stock-based compensation expense) totaled $15.5 million, up almost 14% year over year.
PBYI's Guidance for Q3 and Full-Year 2025
Puma Biotechnology maintained its previously issued financial guidance for 2025. The company expects total revenues in the range of $212–$222 million, while Nerlynx’s product sales are expected to be in the range of $192-$198 million.
Royalty revenues are expected to be in the $20-$24 million range.
Net income is expected to be in the range of $23-$28 million in 2025.
For the third quarter of 2025, total revenues are expected in the band of $48-$51 million. Nerlynx product sales are expected to be in the range of $46-$48 million. Royalty revenues are expected to be in the band of $2-$3 million.
In the third quarter, net income is expected to be in the range of $2-$4 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 fourth quarter of 2025.
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 fourth quarter of 2025.
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 Exact Sciences (EXAS - Free Report) , CorMedix (CRMD - Free Report) and Immunocore (IMCR - Free Report) . While Exact Sciences sports a Zacks Rank #1 (Strong Buy), CorMedix and Immunocore currently carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Exact Sciences’ earnings per share have increased from 5 cents to 16 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.13 to $1.23. Year to date, shares of EXAS have declined 23.2%.
Exact Sciences’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 329.87%.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from 93 cents to 97 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.64 to $1.65. Year to date, shares of CRMD have rallied 33.4%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 25.82%.
In the past 60 days, estimates for Immunocore’s 2025 loss per share have narrowed from 86 cents to 68 cents. Loss per share estimates for 2026 have narrowed from $1.34 to $1.10 during the same period. IMCR stock has risen 8.3% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 76.18%.