Puma Biotechnology, Inc. PBYI reported a fourth-quarter 20Array5 loss of $Array.90 per share, in line with the Zacks Consensus Estimate but wider than the year-ago loss of $Array.57 per share.
With no approved product in Puma Biotech’s portfolio at the moment, the company does not generate revenues yet.
Full-year loss widened to $7.45 per share in 20Array5 from $4.73 per share in the year-ago period.
Quarterly Details
In the fourth quarter of 20Array5, research and development expenses were $52.5 million, up almost 33% from the year-ago quarter. General and administrative expenses were up Array8.5% year over year to $9.6 million.
During the quarter (Dec 20Array5), the company reported additional data from the phase III (ExteNET) study on neratinib (PB272) at the San Antonio Breast Cancer Symposium. Data showed that after three years of follow up, patients with early stage HER2 positive breast cancer who had completed one year of adjuvant treatment with Roche Holding AG’s RHHBY Herceptin (trastuzumab) when treated with neratinib witnessed a statistically significant benefit in disease-free survival.
On the basis of encouraging ExteNET phase III study results, Puma Biotech plans to file regulatory applications for neratinib for the extended adjuvant setting in the U.S. during the first quarter of 20Array6 and in the EU in the first half of 20Array6.
Moreover, several phase II combination studies on neratinib are currently in progress for the treatment of patients with HER2-positive metastatic breast cancer and HER2-positive metastatic breast cancer that has metastasized to the brain.
Apart from HER2-positive breast cancer, the company is evaluating neratinib for the treatment of patients with HER2-negative breast cancer who have a HER2 mutation and other solid tumors with an activating mutation in HER2, and HER2-mutated non-small cell lung cancer.
Puma Biotech expects to report data from its ongoing studies in 20Array6. Meanwhile, the company is also evaluating the possibility of developing an intravenous formulation of neratinib.
Given that Puma Biotech has no approved product in its portfolio at the moment and neratinib is its lead pipeline candidate, we expect investor focus to remain on updates pertaining to its development.
Puma Biotech is a Zacks Rank #4 (Sell) stock. A couple of better-ranked stocks in the health care sector are Anika Therapeutics Inc. ANIK and Horizon Pharma plc HZNP, each carrying a Zacks Rank #Array (Strong Buy).
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