Puma Biotechnology
PBYI
reported a loss of 38 cents per share for the fourth quarter of 2020, significantly wider than the Zacks Consensus Estimate of a loss of 18 cents and also the year-ago quarter’s loss of 29 cents.
Total revenues consisted of net product sales of Nerlynx (neratinib), Puma Biotech’s only marketed drug, and royalty fees from sublicensees.
Nerlynx is indicated for extended adjuvant treatment of HER2-positive early-stage breast cancer in patients, previously treated with
Roche
’s
RHHBY
Herceptin-based adjuvant therapy.
In the fourth quarter, total revenues were $52.6 million, down 16.4% year over year on lower Nerlynx sales and no license revenues compared with the year-ago quarter. Sales slightly beat the Zacks Consensus Estimate of $52 million.
Product revenues from Nerlynx were $50.0 million, down 14.8% year over year due to business disruptions caused by the COVID-19 situation. Generally, Puma Biotech sees a decline in Nerlynx’s new patients starts in the fourth quarter of each year as some patients prefer not to initiate new therapies around the holiday season. Royalty revenues from licensing partners were $2.6 million in the quarter.
Total operating costs in the quarter were $63.9 million, down 10.6% year over year. Research and development expenses were $24.4 million in the quarter, down almost 20% from the year-ago period. Selling, general and administrative expenses declined 7.7% year over year to $28.8 million.
Puma Biotech’s shares have risen 2.8% this year so far compared with the
industry
’s increase of 6%.
2021 Guidance
In 2021, Puma Biotech expects Nerlynx’s net sales in the range of $205 million to $210 million. Royalty revenues are expected to be in the range of $16 million to $17 million. License revenues are expected to be in the range of $30 million to $32 million. However, pandemic-related disruptions may continue to hurt the company’s revenues in 2021.
Meanwhile, Nerlynx’s net revenues are expected in the range of $42-$43 million in the first quarter of 2021.
Pipeline & Other Updates
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. The company expects to complete enrolment in the randomized cohort of the study in HER2-positive breast cancer in the second quarter and report data from this cohort later in the year. Additionally, the company plans to report data from another cohort of the SUMMIT study, which is evaluating Nerlynx in non-small cell lung cancer patients with EGFR exon 18 mutations in the second half of 2021
Meanwhile, Puma Biotech plans to release results from the phase II TBCRC-022 study on Nerlynx in combination with Roche’s Kadcyla in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla in the second half of 2021.
Zacks Rank and Stocks to Consider
Puma Biotech currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the biotech sector include
Moderna
MRNA
and
Acorda Therapeutics
ACOR
. While Moderna sports a Zacks Rank #1 (Strong Buy), Acorda has a Zacks Rank #2 (Buy). You can see
the complete list of today’s Zacks #1 Rank stocks here
.
Moderna’s earnings per share estimates have moved up from $11.24 to $14.74 per share for 2021 in the past 30 days. The stock has risen 42% so far this year.
Acorda’s stock is up 46.1 this year so far.
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