Puma Biotechnology Beats Q1 Estimates, Advances Alisertib Development

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Puma Biotechnology Beats Q1 Estimates, Advances Alisertib Development

Key Takeaways

Adjusted loss of 5 cents per share, narrower than the Zacks Consensus Estimate of a loss of 16 cents.

Adjusted earnings of 9 cents.

10 cents (including stock-based compensation expense).

Earnings of 3 cents.

Total revenues: $43.8 million, exceeding the Zacks Consensus Estimate of $42 million.

17%.

Comprised of Nerlynx net product sales and royalty revenues.

Product sales: $40.3 million, down 13.9% year-over-year.

Impacted by inventory drawdown at specialty pharmacies and distributors.

Exceeded guidance range of $38-$40 million.

Beat Zacks Consensus Estimate of $38.6 million and model estimate of $38.5 million.

24.2%.

Decreased 18% year-over-year and 8% sequentially.

Decreased 16% year-over-year and 3% sequentially.

Increased 27% sequentially but decreased 15% year-over-year.

$3.5 million, down 41.7% year-over-year.

Decreased 81.5% sequentially due to shipment timing to PBYI's partner in China.

Beat model estimate of $2.9 million.

No license revenues recorded in the first quarter.

$46.1 million, down 4.8% year-over-year.

Down 3.1% year-over-year to $21.8 million.

Up 7.1% year-over-year to $13.6 million.

$107.2 million as of March 31, 2024.

Nerlynx product sales: Expected to be in the range of $183-$190 million in 2024.

Expected in the band of $43-$45 million.

Expected to be in the $30-$33 million range in 2024.

Expected in the band of $2.5-$3.0 million.

Expected to be in the range of $1-$2 million in 2024.

Expected to be in the range of $12-$15 million in 2024.

Expected in the range of $6-$9 million.

Puma Biotechnology in-licensed global development and commercialization rights to alisertib from Takeda in 2022.

FDA approved IND application for alisertib in March 2024 for the treatment of HER2-negative, hormone receptor-positive metastatic breast cancer.

Phase II ALISCA-Breast1 trial study likely to be initiated in the fourth quarter of 2024.

Phase II ALISCA-Lung1 study evaluating alisertib as monotherapy for extensive stage small cell lung cancer ongoing.

Interim data from ALISCA-Lung1 study expected in the fourth quarter of 2024.

Updated data from study of alisertib in combination with Tagrisso expected later in the second quarter of 2024.

This summary excludes all advertising sentences and focuses solely on the key takeaways from Puma Biotechnology's first-quarter 2024 results.