Puma Biotechnology, Inc. PBYI delivered earnings of 8 cents per share in the second quarter of 2020, rebounding from the year-ago quarter’s loss of 97. The Zacks Consensus Estimate was of a loss of 26 cents.
The bottom line includes an impact of stock-based compensation expense. Excluding the same, adjusted earnings per share were 36 cents versus a loss of 57 cents in the year-ago quarter.
Total revenues consisted of net product sales of Nerlynx, Puma Biotech's only marketed drug, and license and royalty revenues. In the second quarter, the top line was $70.6 million, comprising $48.8 million of product revenues from Nerlynx, $1.1 million of royalty revenues from licensing partners and license revenues worth $20.7 million. Sales comprehensively beat the Zacks Consensus Estimate of $56 million. Moreover, the top line improved from the year-ago figure of $54 million on higher license revenues.
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.
Sales of Nerlynx decreased 9.3% year over year but increased slightly on a sequential basis. Sales in the quarter were hurt by business disruptions due to the COVID-19 situation as well as a significant inventory drawdown by specialty pharmacies in the quarter.
Total operating costs in the quarter were $63.5 million, down 20.3% year over year. Research and development expenses (including stock-based compensation expense) were $24.7 million in the quarter, down 33.1% from the year-ago period. Selling, general and administrative expenses (including stock-based compensation expense) declined 12.2% year over year to $29.4 million.
Meanwhile, last month, Puma Biotech’s licensing partner Specialised Therapeutics Asia received a marketing approval for Nerlynx in Malaysia. Nerlynx is already approved in Argentina, Singapore, Hong Kong and China where it is marketed by its partners Pint Pharma, Specialised Therapeutics Asia and CANbridge, respectively. Puma Biotech receives royalties from the sales of Nerlynx in these territories.
Shares of Puma Biotech have rallied 18.7% so far this year compared with the industry’s increase of 5.8%.
On the second-quarter conference call, management stated that for the full year, it anticipates Nerlynx net sales in the range of $200-$210 million. Additionally, Nerlynx net revenues are expected in the $48 - $50 million band for the third quarter of 2020.
Pipeline & Other Updates
Several studies on Nerlynx targeting different types of breast cancer patient populations and in earlier-line settings 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. Puma Biotech plans to report data in the fourth quarter of 2020 from the HER-positive breast and cervical cancer cohort of the SUMMIT study on Nerlynx in patients with HER2 mutations.
It also aims to release results from the phase II TBCRC-022 study on Nerlynx in combination with Roche’s Kadcyla in the first half of 2021for patients with HER2 positive breast cancer involving brain metastases who have history of being treated with Kadcyla. Additionally, the company intends to conduct a pre-NDA meeting with the FDA officials to discuss the accelerated approval pathway for Nerlynx to address HER2 mutated hormone receptor positive breast cancer during the first half of 2021.
Puma Biotechnology, Inc. Price, Consensus and EPS Surprise
Puma Biotechnology, Inc. price-consensus-eps-surprise-chart | Puma Biotechnology, Inc. Quote
Zacks Rank & Stocks to Consider
Puma Biotech currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the healthcare sector include Emergent BioSolutions Inc. EBS and Horizon Therapeutics Public Limited Company HZNP, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have moved 96.4% and 99.1% north for 2020 and 2021, respectively, over the past 60 days. The stock has skyrocketed 135.3% year to date.
Horizon’s earnings estimates have been revised 13% and 12.1% upward for 2020 and 2021 each over the past 60 days. The stock has rallied 103.5% year to date.
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