Puma Biotechnology PBYI reported a loss of $1.09 per share for the third-quarter of 2021, wider than 79 cents in the year-ago quarter. The Zacks Consensus Estimate for loss was pegged at 23 cents per share.
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 Puma’s sub-licensees.
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 third quarter, total revenues were $46.2 million, down 9.1% year. Sales missed the Zacks Consensus Estimate of $53 million.
Product revenues from Nerlynx were $43.4 million, down 12% year over year as business disruptions caused by the COVID-19 situation limited access to health care providers. Inventory reduction at Puma’s specialty pharmacies and specialty distributors also hurt sales in the quarter. Nerlynx net revenues fell short of the company’s guidance of $49 million to $50 million.
Royalty revenues from licensing partners were $2.8 million in the quarter compared with $1.5 million in the year-ago quarter.
Total operating costs in the quarter were $55.2 million, down 12.2% year over year. Research and development expenses were $18.8 million in the quarter, down 21.9% from the year-ago period. Selling, general and administrative expenses declined 11.8% year over year to $26.1 million.
Puma lowered its 2021 Nerlynx sales guidance for the second time this year.
For 2021, Puma Biotech expects Nerlynx’s net sales in the range of $180 million-$182 million, which is less than the prior guidance of $200 million to $205 million. Slower-than-anticipated improvement in access to health care led to the cut in guidance. The company expects significant uncertainty regarding the time when access to healthcare providers will improve.
Shares were down 18% in after-hours trading following the earnings release and the guidance cut. Puma Biotech’s shares have declined 37.7% this year so far compared with the industry’s decrease of 6.9%.
Image Source: Zacks Investment Research
Royalty revenues are expected to be in the range of $13 million to $14 million (previously $13 million to $15 million). License revenues are expected to be in the range of $50 million to $52 million (maintained).
Nerlynx’s net revenues are expected in the range of $42 million to $44 million in the fourth quarter of 2021. Royalty revenues will be in the range of $3.5 million to $4.5 million
On the conference call, Nerlynx announced that it had taken actions to reduce the overall commercial footprint by approximately 40%. It is reducing the number of sales representatives and consequently adjusting the size of its territories to better account for the new hybrid environment, which consists of both live and virtual interactions.
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 present data from the randomized cohort of the study in ER-positive HER2-negative breast cancer patients who have a HER2 mutation in the fourth quarter. 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 first half of 2022. The company also expected to report phase II data from the SUMMIT study of Nerlynx in cervical cancer patients with HER2 mutations in the first half of 2022.
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 first half of 2022.
Zacks Rank and Stocks to Consider
Puma Biotech currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks from the same sector include Alkermes ALKS and Regeneron REGN, each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Alkermes’ 2021 earnings per share have increased from 61 cents to 68 cents in the past 60 days. The same for 2022 has risen from $1.06 to $1.11 in the past 60 days. The stock has rallied 52.1% in the year so far.
Estimates for Regeneron’s earnings pershare have moved north from $54.28 to $63.53 for 2021 and from $44.11 to $46.69 for 2022 in the past 60 days. The stock has risen 34% so far this year.
Puma Biotechnology, Inc. Price, Consensus and EPS Surprise
Puma Biotechnology, Inc. price-consensus-eps-surprise-chart | Puma Biotechnology, Inc. Quote
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Alkermes plc (ALKS) : Free Stock Analysis Report
Puma Biotechnology, Inc. (PBYI) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research