Puma (PBYI) Posts Narrower Loss in Q2, Focus on Neratinib

Puma Biotechnology, Inc. PBYI reported a second-quarter 2016 loss of $2.05 per share, much narrower than the Zacks Consensus Estimate of $2.20 but wider than the year-ago loss of $2.01.

With no approved product in Puma Biotech’s portfolio at the moment, the company does not generate revenues yet.

In the second quarter of 2016, research and development (R&D) expenses were $54.2 million, down 8.8% from the year-ago quarter. General and administrative expenses shot up 123.6% year over year to $12.3 million.

Neratinib in Focus

Puma Biotech has made significant progress with its lead candidate, neratinib (PB272). The company has submitted regulatory applications for neratinib both in the U.S. and EU for the extended adjuvant treatment of HER2-positive early stage breast cancer based on positive ExteNET phase III study data.

Meanwhile, the company reported positive phase II data from an investigator-sponsored study on neratinib in patients with HER2 mutated, non-amplified breast cancer this June. Additionally, phase II study on neratinib for the front-line treatment of HER2-positive metastatic breast cancer (NEfERT-T) was published in JAMA Oncology in April, and positive results from the I-SPY 2 phase II study on neratinib for the neoadjuvant treatment of breast cancer was published in the New England Journal of Medicine.

Puma Biotech expects to report data from ongoing studies on neratinib throughout the second half of 2016 and beyond. Though the company is exploring the possibility of developing an intravenous formulation of neratinib, it is currently focused on the development of the oral version of neratinib.

Meanwhile, the company expects net loss to narrow in subsequent quarters due to continued reduction in clinical trial expenses and expenses associated with the completion of regulatory filings for neratinib. The company also expects its R&D expenses to decrease in subsequent quarters for the same reasons.

Given that Puma Biotech has no approved product in its portfolio at the moment and neratinib is its lead candidate, we expect investor focus to remain on updates pertaining to its development.

PUMA BIOTECHNLG Price and EPS Surprise

PUMA BIOTECHNLG Price and EPS Surprise | PUMA BIOTECHNLG Quote

Puma Biotech is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Corcept Therapeutics Inc. CORT, ANI Pharmaceuticals, Inc. ANIP and Geron Corp. GERN. All three stocks sport a Zacks Rank #1 (Strong Buy).

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