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PBYI reported a narrower Q1 loss as revenues reached $44.8M, topping analyst estimates.
Nerlynx product sales fell 2.6% year over year in Q1 2026. Royalty revenues also declined.
Puma Biotechnology raised 2026 revenue guidance to $222M-$229M from $214M-$221M.
Puma Biotechnology (PBYI - Free Report) reported first-quarter 2026 adjusted loss of 4 cents per share, narrower than the Zacks Consensus Estimate of a loss of 13 cents. In the year-ago quarter, the company had reported adjusted earnings of 10 cents per share.
Total revenues in the first quarter were $44.8 million, which beat the Zacks Consensus Estimate of $39 million. Revenues, however, decreased 2.6% year over year due to lower net product sales.
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.
Year to date, shares of Puma Biotechnology have rallied 22% against the industry’s decline of 0.2%.
Image Source: Zacks Investment Research
PBYI’s Q1 Earnings in Detail
Product revenues from Nerlynx totaled $42 million in the first quarter, down 2.6% year over year. This metric beat our model estimate of $36.7 million.
Royalty revenues declined 3.4% year over year to $2.8 million.
Total operating costs (including stock-based compensation expense) in the quarter were $48.6 million, up 15.7% year over year.
Selling, general and administrative (SG&A) expenses (including stock-based compensation expense) rose 4.5% year over year to $18.4 million, owing to higher compensation and marketing costs.
Research and development (R&D) expenses (including stock-based compensation expense) totaled $19.8 million, up 43.5% year over year, reflecting higher costs associated with clinical studies on alisertib.
As of March 31, 2026, PBYI had cash, cash equivalents, restricted cash and investment securities of $101.5 million compared with $97.5 million as of Dec. 31, 2025.
PBYI's Guidance
Puma Biotechnology raised its financial guidance for 2026.
For full-year 2026, total revenues are now forecasted in the range of $222-$229 million compared with the previous projection of $214-$221 million. The Zacks Consensus Estimate for the metric is pegged at $219.5 million.
Net product revenues are now projected in the band of $202-206 million versus the earlier expectation of $194-$198 million.
Meanwhile, royalty revenues are expected to range from $20 million to $23 million, with no contribution from license revenues, which is unchanged from the previous expectation.
The company now expects to generate net income of $16-$19 million compared with the earlier projection of $10-$13 million for 2026.
For the second quarter of 2026, the company expects net product revenues to range between $50 million and $52 million and royalty revenues in the range of $2 million to $3 million. Total revenues are expected to be between $52 million and $55 million. The company anticipates reporting a net income of approximately $2 million to $4 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.
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.
The company plans to expand enrollment in both these studies in the second half of 2026.
Puma Biotechnology, Inc. Price, Consensus and EPS Surprise
Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 54 cents to $1.30, while loss per share estimates for 2027 have narrowed from $1.91 to $1.52 during the same time. AGEN shares have surged 19.7% year to date.
Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%.
Over the past 60 days, 2026 loss per share estimates for Amarin have narrowed from $7.01 to $6.36, while the same for 2027 have narrowed from $5.50 to $4.64 during the same time. AMRN stock has risen 5.9% year to date.
Amarin's earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 50.02%.
Over the past 60 days, 2026 loss per share estimates for AnaptysBio have narrowed from $3.61 to $1.30, while estimates for 2027 have moved from a loss of $4.59 per share to earnings of $3.01 during the same time. ANAB stock has surged 38.1% year to date.
AnaptysBio’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 59.70%.
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PBYI Q1 Earnings & Sales Beat Estimates, 2026 Guidance Raised
Key Takeaways
Puma Biotechnology (PBYI - Free Report) reported first-quarter 2026 adjusted loss of 4 cents per share, narrower than the Zacks Consensus Estimate of a loss of 13 cents. In the year-ago quarter, the company had reported adjusted earnings of 10 cents per share.
Total revenues in the first quarter were $44.8 million, which beat the Zacks Consensus Estimate of $39 million. Revenues, however, decreased 2.6% year over year due to lower net product sales.
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.
Year to date, shares of Puma Biotechnology have rallied 22% against the industry’s decline of 0.2%.
Image Source: Zacks Investment Research
PBYI’s Q1 Earnings in Detail
Product revenues from Nerlynx totaled $42 million in the first quarter, down 2.6% year over year. This metric beat our model estimate of $36.7 million.
Royalty revenues declined 3.4% year over year to $2.8 million.
Total operating costs (including stock-based compensation expense) in the quarter were $48.6 million, up 15.7% year over year.
Selling, general and administrative (SG&A) expenses (including stock-based compensation expense) rose 4.5% year over year to $18.4 million, owing to higher compensation and marketing costs.
Research and development (R&D) expenses (including stock-based compensation expense) totaled $19.8 million, up 43.5% year over year, reflecting higher costs associated with clinical studies on alisertib.
As of March 31, 2026, PBYI had cash, cash equivalents, restricted cash and investment securities of $101.5 million compared with $97.5 million as of Dec. 31, 2025.
PBYI's Guidance
Puma Biotechnology raised its financial guidance for 2026.
For full-year 2026, total revenues are now forecasted in the range of $222-$229 million compared with the previous projection of $214-$221 million. The Zacks Consensus Estimate for the metric is pegged at $219.5 million.
Net product revenues are now projected in the band of $202-206 million versus the earlier expectation of $194-$198 million.
Meanwhile, royalty revenues are expected to range from $20 million to $23 million, with no contribution from license revenues, which is unchanged from the previous expectation.
The company now expects to generate net income of $16-$19 million compared with the earlier projection of $10-$13 million for 2026.
For the second quarter of 2026, the company expects net product revenues to range between $50 million and $52 million and royalty revenues in the range of $2 million to $3 million. Total revenues are expected to be between $52 million and $55 million. The company anticipates reporting a net income of approximately $2 million to $4 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.
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.
The company plans to expand enrollment in both these studies in the second 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 Agenus (AGEN - Free Report) , Amarin (AMRN - Free Report) and AnaptysBio (ANAB - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 54 cents to $1.30, while loss per share estimates for 2027 have narrowed from $1.91 to $1.52 during the same time. AGEN shares have surged 19.7% year to date.
Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%.
Over the past 60 days, 2026 loss per share estimates for Amarin have narrowed from $7.01 to $6.36, while the same for 2027 have narrowed from $5.50 to $4.64 during the same time. AMRN stock has risen 5.9% year to date.
Amarin's earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 50.02%.
Over the past 60 days, 2026 loss per share estimates for AnaptysBio have narrowed from $3.61 to $1.30, while estimates for 2027 have moved from a loss of $4.59 per share to earnings of $3.01 during the same time. ANAB stock has surged 38.1% year to date.
AnaptysBio’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 59.70%.