Puma Biotechnology, Inc. (PBYI Quick QuotePBYI - Free Report) reported third-quarter 2024 adjusted earnings of 45 cents per share, which beat the Zacks Consensus Estimate of 35 cents. In the year-ago quarter, the company had reported adjusted earnings of 17 cents per share.

The above-adjusted earnings exclude the impact of stock-based compensation expense. Including the same, the reported earnings per share were 41 cents in the third quarter of 2024 compared with earnings of 12 cents reported in the year-ago quarter.

In the third quarter, total revenues were $80.5 million, which also beat the Zacks Consensus Estimate of $71 million.

Revenues increased around 43.5% year over year. 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 were up 12.2% in after-hours trading on Nov. 7 owing to the better-than-expected results and the sales performance of Nerlynx. The stock has plunged 30% so far this year compared with the industry’s 2.4% decrease.

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More on PBYI's Q3 Results

Product revenues from Nerlynx were $56.1 million in the third quarter, up almost 8.7% year over year, as sales were driven by inventory increase at specialty pharmacies and specialty distributors. Nerlynx’s product sales were above the guidance range of $50-$53 million.

Product revenues from Nerlynx beat the Zacks Consensus Estimate of $50 million, as well as our model estimate of $50.4 million. Nerlynx revenues increased 26.4% sequentially.

Nerlynx total prescriptions were flat sequentially and decreased 8% year over year in the third quarter. However, new prescriptions increased around 3% on a sequential basis and around 8% year over year.

Overall demand for Nerlynx increased by around 1.5% sequentially but declined by about 5% year over year during the reported quarter.

Royalty revenues were $24.4 million, significantly up from the year-ago quarter, owing to the expected sales to China by PBYI’s offshore partner, Pierre Fabre. Royalty revenues beat our model estimate of $20.9 million.

Puma Biotechnology did not record any license revenues in the third quarter.

Total operating costs (including stock-based compensation expense) in the quarter were $58.4 million, up 22.9% year over year.

Selling, general and administrative expenses (including stock-based compensation expense) were down 26.3% year over year to $16.8 million.

Research and development expenses (including stock-based compensation expense) were $12.5 million in the quarter, up 9.6% year over year.

Cash, cash equivalents and marketable securities were $97 million as of Sept 30, 2024, compared with $96.8 million as of June 30, 2024.

2024 Guidance

Puma Biotechnology updated its financial guidance for 2024. The company now expects Nerlynx’s product sales to be in the range of $187-$190 million in 2024, compared with the earlier projection of $183-$190 million.

Royalty revenues are expected to be in the $34-$36 million range in 2024 compared with the previous guidance range of $30-$34 million.

The company expects license revenues to be in the range of $1-$2 million in 2024, unchanged from the previous guidance.

Net income is now expected to be in the range of $15-$17 million in 2024 compared with the earlier projection of $12-$15 million.

Q4 View

For the fourth quarter of 2024, Nerlynx product sales are expected in the band of $46-$48 million. Royalty revenues are expected in the range of $3.5-$5 million.

PBYI expects to report net income in the range of $4-$6 million in the fourth quarter of 2024.

PBYI's Recent 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.

PBYI plans to begin the phase II ALISCA-Breast1 study on alisertib in combination with endocrine treatment for treating patients with chemotherapy-naive HER2-negative, hormone receptor-positive metastatic breast cancer later in the fourth quarter of 2024.

PBYI is also studying ALISCA-Lung1 in a phase II study evaluating alisertib as a monotherapy for the treatment of patients with extensive stage small cell lung cancer. Interim data from this study is expected to be presented in 2025.

PBYI's Zacks Rank & Key Picks

Puma Biotechnology currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the biotech sector are Immunocore Holdings plc (IMCR Quick QuoteIMCR - Free Report) , Amicus Therapeutics, Inc. (FOLD Quick QuoteFOLD - Free Report) and Castle Biosciences, Inc. (CSTL Quick QuoteCSTL - Free Report) , each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.67 to $1.60. Loss per share estimates for 2025 have narrowed from $2.35 to $2.33 during the same time. Year to date, shares of IMCR have declined 49.8%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.

In the past 60 days, estimates for Amicus’ 2024 earnings per share have moved up from 20 cents to 22 cents. Earnings per share estimates for 2025 have improved from 49 cents to 53 cents during the same time. Year to date, shares of FOLD have declined 22.6%.

FOLD’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 27.09%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 54.4%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.