Puma Biotechnology's Q1 Earnings and Revenues Beat

Puma Biotechnology, Inc. PBYI reported first-quarter 2024 adjusted loss of 5 cents per share, which was narrower than the Zacks Consensus Estimate of a loss of 16 cents. In the year-ago quarter, the company had reported adjusted earnings of 9 cents.

The above-adjusted loss excludes the impact of stock-based compensation expense. Including the same, reported loss per share was 10 cents in the first quarter of 2024 against earnings of 3 cents reported in the year-ago quarter.

In the first quarter, total revenues were $43.8 million, which beat the Zacks Consensus Estimate of $42 million.

Revenues, however, decreased around 17% year over year. Total revenues comprised net product sales of Nerlynx (neratinib), Puma Biotechnology'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 14.6% so far this year against the industry's 8.8% decline.

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Quarter in Detail

Product revenues from Nerlynx were $40.3 million in the reported quarter, down 13.9% year over year, as sales were negatively impacted by inventory drawdown at specialty pharmacies and specialty distributors. However, Nerlynx's product sales were higher than the guidance range of $38-$40 million.

Product revenues also beat the Zacks Consensus Estimate of $38.6 million, as well as our model estimate of $38.5 million. Nerlynx revenues decreased 24.2% sequentially.

On the first-quarter conference call, management stated that overall demand for Nerlynx declined around 18% year over year and 8% sequentially. Nerlynx total prescriptions decreased 16% year over year and 3% sequentially in the first quarter. New prescriptions increased 27% sequentially but declined 15% year over year.

Royalty revenues were $3.5 million, down almost 41.7% from the year-ago quarter. Royalty revenues decreased 81.5% on a sequential basis due to the timing of shipments to PBYI's partner in China. Royalty revenues beat our model estimate of $2.9 million.

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

Total operating costs (including stock-based compensation expense) in the quarter were $46.1 million, down 4.8% year over year.

Selling, general and administrative expenses (including stock-based compensation expense) were down 3.1% year over year to $21.8 million.

Research and development expenses (including stock-based compensation expense) were $13.6 million in the quarter, up 7.1% year over year.

Cash, cash equivalents and marketable securities were $107.2 million as of Mar 31, 2024, compared with $96 million as of Dec 31, 2023.

2024 Guidance

Puma Biotechnology expects Nerlynx's product sales to be in the range of $183-$190 million in 2024, unchanged from the previous guidance range. In the second quarter of 2024, Nerlynx product sales are expected in the band of $43-$45 million.

Royalty revenues are expected to be in the $30-$33 million range in 2024, also unchanged from the previous guidance range. In the second quarter of 2024, royal revenues are expected in the band of $2.5-$3.0 million.

The company expects license revenues to be in the range of $1-$2 million in 2024.

Net income is expected to be in the range of $12-$15 million in 2024. PBYI expects to report net loss in the range of $6-$9 million in the second quarter of 2024.

Pipeline Update

Puma Biotechnology in-licensed the global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan's Takeda in 2022.

In March 2024, the FDA notified the company that its investigational new drug application has been reviewed and that it can proceed with the clinical development of alisertib for the treatment of patients with human epidermal growth factor receptor 2-negative, hormone receptor-positive metastatic breast cancer in the phase II ALISCA-Breast1 trial study. The study is likely to be initiated in the fourth quarter of 2024.

PBYI is already conducting ALISCA-Lung1, a phase II study (PUMA-ALI-4201) evaluating alisertib as monotherapy for the treatment of patients with extensive stage small cell lung cancer. Interim data from the study is expected in the fourth quarter of 2024.

Meanwhile, alisertib is also being studied in combination with Tagrisso (osimertinib) in patients with metastatic EGFR-mutant non-small cell lung cancer who have developed Tagrisso resistance. Updated data from this study is expected later in the second quarter of 2024.

Zacks Rank & Stocks to Consider

Puma Biotechnology currently has a Zacks Rank #3 (Hold).

Some top-ranked stocks in the healthcare sector are Voyager Therapeutics, Inc. VYGR, Ligand Pharmaceuticals Incorporated LGND and ANI Pharmaceuticals, Inc. ANIP, each sporting a Zacks Rank #1 (Strong Buy) at present.

In the past 60 days, estimates for Voyager Therapeutics' 2024 loss per share have narrowed from $1.89 to $1.64. Year to date, shares of VYGR have increased 1.1%.

VYGR's earnings beat estimates in three of the trailing four quarters and missed the same once, the average surprise being 545.93%.

In the past 60 days, estimates for Ligand's 2024 earnings per share have improved from $4.42 to $4.56. Year to date, shares of LGND have risen 1.3%.

Earnings of LGND beat estimates in each of the trailing four quarters, the average surprise being 84.81%.

In the past 60 days, estimates for ANI Pharmaceuticals' 2024 earnings per share have improved from $4.25 to $4.44. Year to date, shares of ANIP have jumped 21.7%.

Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.

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