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Puma (PBYI) Reports Wider Loss in Q1, Neratinib in Focus

Puma Biotechnology, Inc. PBYI reported a first-quarter 2016 loss of $2.19 per share, much wider than the Zacks Consensus Estimate of $1.86 per share and the year-ago loss of $1.66.

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

Quarterly Details

In the first quarter of 2016, research and development (R&D) expenses were $60.2 million, up 34.7% from the year-ago quarter. The increase was mainly due to higher stock-based compensation expense, clinical trial expenses, internal R&D and related expenses, and consultants and contractors expenses.

General and administrative expenses were up 39.2% year over year to $11 million, primarily due to higher stock-based compensation expense, professional fees, payroll and related costs, and facility and equipment costs.

Puma Biotech plans to submit a new drug application to the FDA in mid 2016 and a marketing authorization application in the EU during the second quarter of 2016 for neratinib (PB272) for the extended adjuvant treatment of HER2-positive early stage breast cancer based on positive ExteNET phase III study results.

Moreover, several phase II combination studies on neratinib are currently in progress for the treatment of patients with HER2 non-amplified breast cancer that has a HER2 mutation and 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.

Puma Biotech expects to report data from its ongoing studies through 2016. 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 anticipates its net loss to decrease in subsequent quarters due to an expected reduction in clinical trial expenses and the completion of regulatory filings both in the U.S. and EU for neratinib. The company also expects its R&D expenses to decrease in subsequent quarters for the same reasons mentioned above.

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 #2 (Buy) stock. Other favorably ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP, Retrophin, Inc. RTRX and Bristol-Myers Squibb Company BMY. All three stocks sport a Zacks Rank #1 (Strong Buy).

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