Puma Biotech (PBYI) Q4 Earnings Beat Mark, Revenues Rise Y/Y

Puma Biotechnology PBYI reported fourth-quarter 2021 earnings of 10 cents per share against a loss of 38 cents in the year ago quarter. The 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 fourth-quarter 2021. In the year-ago quarter, Puma Biotech reported an adjusted loss of 14 cents per share.

In the fourth quarter, total revenues were $55.4 million, up 5.3% year over year. Sales also beat the Zacks Consensus Estimate of $47.7 million. Total revenues consisted of net product sales of Nerlynx (neratinib), Puma Biotech's only marketed drug in the United States, and license fees and royalties from PBYI’s sub-licensees.

Shares were up 11.6% in after-hours trading following the earnings release. Puma Biotech’s shares have declined 23.4% this year so far compared with the industry’s 15.9% decrease.

Quarter in Detail

Nerlynx is indicated for extended adjuvant treatment of HER2-positive early-stage breast cancer in patients previously treated with Herceptin-based adjuvant therapy.

Product revenues from Nerlynx were $51 million, up 2% year over year. Generally, Puma Biotech sees an increase in inventory buy-in in the fourth quarter of each year and estimates that approximately $5 million of the net product revenues for the final quarter is attributed to this factor. Nerlynx’s net revenues also beat management’s guidance of $42-$44 million.

Royalty revenues from licensing partners were $2.9 million in the quarter compared with $2.6 million in the year-ago quarter. Puma Biotech also recorded $1.5 million of license revenues in the fourth quarter.

Total operating costs in the quarter were $48.6 million, down 23.9% year over year. Research and development expenses were $14.2 million in the quarter, down 41.3% from the year-ago period’s reported number. Selling, general and administrative expenses declined 21.9% year over year to $22.5 million.

Full-Year Results

For 2021, Puma Biotech reported adjusted earnings of 8 cents per share, rebounding from the year-ago adjusted loss of 59 cents. The Zacks Consensus Estimate was of a loss of 93 cents.

Revenues were $253.2 million for 2021, which beat the Zacks Consensus Estimate of $245.5 million and the year-ago figure of $225.1 million.

2022 Guidance

In 2022, Puma Biotech expects Nerlynx’s net sales in the band of $180-$190 million. Royalty revenues are expected in the range of $27-$34 million. License revenues are expected in the range of $0-$1.5 million. However, pandemic-related disruptions may continue to hurt PBYI’s revenues in 2022.

Nerlynx’s net revenues are expected in the range of $35-$39 million in the first quarter of 2022.

Pipeline Update

Several additional studies on Nerlynx targeting different types of breast cancer patient populations as well as other cancers are currently underway.

A key analysis of Nerlynx is the phase II SUMMIT basket study for treating solid tumors in patients with activating 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 HER2-mutated HR-positive breast cancer in first-half 2022, it also intends to release the outcomes from another cohort. It is evaluating Nerlynx in non-small cell lung cancer patients with EGFR exon 18 mutations in second-half 2022. PBYI aims to hold a meeting with the FDA later this year to discuss the path for an approval of Nerlynx under the accelerated pathway for both indications.

Puma Biotech also expects to report data from the SUMMIT study evaluating Nerlynx for cervical cancer patients with HER2 mutations in second-half 2022.

Puma Biotechnology, Inc. Price

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Zacks Rank & Stocks to Consider

Puma Biotech currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the overall healthcare sector include Adaptimmune Therapeutics ADAP, BioDelivery Sciences BDSI and Vertex Pharmaceuticals VRTX, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Adaptimmune Therapeutics’ loss per share estimates for 2022 have narrowed from 99 cents to 91 cents in the past 30 days. Earnings of Adaptimmune Therapeutics beat estimates in three of the last four quarters and missed the mark on a single occasion, the average surprise being 0.9%.

BioDelivery Sciences’ earnings per share estimates for 2022 have increased from 33 cents to 38 cents in the past 30 days. Shares of BDSI have surged 79.7% year to date.

Earnings of BioDelivery Sciences beat estimates in three of the last four quarters and missed the mark on a single occasion, the average surprise being 33.7%.

Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 7.3% year to date.

Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, with the average being 10%.

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