Puma Biotechnology PBYI reported earnings of 10 cents per share in the fourth quarter of 2021 compared to a loss of 38 cents in the year-ago quarter. Zacks’ consensus estimate was pegged at a loss of 11 cents per share.
Adjusted earnings (excluding stock-based compensation expense) were 21 cents per share for the fourth quarter of 2021. In the prior year quarter, Puma Biotech reported an adjusted loss of 14 cents per share.
In the fourth quarter, total revenue was $55.4 million, up 5.3% year-over-year. Sales also exceeded Zacks’ consensus estimate of $47.7 million. Total revenues included net sales of products from Nerlynx (neratinib), the only drug marketed by Puma Biotech in the United States, as well as license fees and royalties from PBYI sublicensees.
The shares rose 11.6% after the close of trading following the earnings release. Puma Biotech shares are down 23.4% so far this year, compared to 15.9% for the industry.
Quarter in detail
Nerlynx is indicated for the prolonged adjuvant treatment of HER2-positive early breast cancer in patients previously treated with Herceptin-based adjuvant therapy.
Nerlynx’s product revenue was $51 million, up 2% year-over-year. Puma Biotech typically sees an increase in inventory purchases in the fourth quarter of each year and estimates that approximately $5 million of net product revenue for the last quarter is attributed to this factor. Nerlynx’s net revenue also exceeded management’s forecast of $42 million to $44 million.
Royalty revenue from licensing partners was $2.9 million in the quarter, compared to $2.6 million in the prior year quarter. Puma Biotech also recorded $1.5 million in licensing revenue in the fourth quarter.
Total operating expenses for the quarter were $48.6 million, down 23.9% year-over-year. Research and development spending was $14.2 million in the quarter, down 41.3% from the number reported a year ago. Selling, general and administrative expenses decreased 21.9% year over year to $22.5 million.
For 2021, Puma Biotech reported adjusted earnings of 8 cents per share, rebounding from an adjusted loss of 59 cents a year ago. Zacks’ consensus estimate was a loss of 93 cents.
Revenue was $253.2 million for 2021, which exceeded Zacks’ consensus estimate of $245.5 million and the prior year’s figure of $225.1 million.
In 2022, Puma Biotech expects net sales of Nerlynx to be between $180 million and $190 million. Royalty revenue is expected to be between $27 million and $34 million. Licensing revenue is expected to be between $0 and $1.5 million. However, pandemic-related disruptions could continue to hurt PBYI’s revenue in 2022.
Nerlynx’s net revenues are expected to be between $35 million and $39 million in the first quarter of 2022.
Several additional studies of Nerlynx targeting different types of breast cancer patient populations as well as other cancers are currently underway.
A key Nerlynx analysis is the Phase II SUMMIT basket study for the treatment of solid tumors in patients with EGFR, HER2 or HER4 mutated cancers. While Puma Biotech plans to report data from a cohort of the SUMMIT study, which is evaluating the drug for HR-positive HER2-mutated breast cancer in the first half of 2022, it also intends to publish the results of another cohort. It is evaluating Nerlynx in patients with non-small cell lung cancer with EGFR exon 18 mutations in the second half of 2022. PBYI aims to schedule a meeting with the FDA later this year to discuss the path to Nerlynx fast-track approval for both indications.
Puma Biotech also plans to report data from the SUMMIT study evaluating Nerlynx for cervical cancer patients with HER2 mutations in the second half of 2022.
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Zacks Ranking and Stocks to Consider
Puma Biotech currently has a Zacks rank of #3 (Hold). Top-ranked stocks across the healthcare industry include Adaptimmune Therapeutics ADAP, Biodelivery Science BDSI and Vertex Pharmaceuticals VRTX, each carrying a Zacks Rank #2 (Buy) at present. You can see the full list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Adaptimmune Therapeutics’ 2022 loss-per-share estimates fell from 99 cents to 91 cents in the past 30 days. Earnings for Adaptimmune Therapeutics have exceeded estimates in three of the last four quarters and missed the target on only one occasion, with the average surprise being 0.9%.
BioDelivery Sciences’ earnings per share estimates for 2022 have fallen from 33 cents to 38 cents in the past 30 days. Shares of BDSI have jumped 79.7% since the start of the year.
Earnings for BioDelivery Sciences have exceeded estimates in three of the last four quarters and missed the target on only one occasion, with the average surprise being 33.7%.
Vertex Pharmaceuticals earnings per share estimates for 2022 have fallen from $14.33 to $14.52 in the past 30 days. Shares of VRTX are up 7.3% year-to-date.
Earnings for Vertex Pharmaceuticals have exceeded estimates in each of the past four quarters, averaging 10%.
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