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Puma (PBYI) Q2 Loss Narrower than Expected, Nerlynx in Focus


Puma Biotechnology, Inc. PBYI reported a loss of $2.10 in the second quarter of 2017 (including the impact of stock-based compensation expenses), narrower than the Zacks Consensus Estimate of a loss of $2.82. The company had reported a loss of $2.05.

Shares of Puma Biotech were down 1.9% on Wednesday. However, so far this year, Puma’s shares have outperformed the industry. Specifically, the company’s shares have risen 159% this year while the industry registered an increase of 8.8%.

Puma Biotechnology’s lead pipeline candidate, neratinib received FDA approval in July as an extended adjuvant treatment for patients with early-stage HER2-overexpressed/amplified breast cancer, who have also been previously treated with Roche Holding AG’s RHHBY Herceptin-based adjuvant therapy. The FDA approval was a huge boost for the company, given the immense commercial potential in the target market.

The drug was launched by the trade name of Nerlynx in early August. However, no sales from the drug will be recorded in the second quarter.

Neratinib is also under review in the EU for the same indication with an opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMA expected in the first quarter of 2018.

With no other approved products in Puma Biotech’s portfolio, the company did not generate any revenues in the second quarter.

In the second quarter, research and development (R&D) expenses were $53.3 million, down 1.7% from the year-ago quarter due to lower clinical trial costs. Selling, general and administrative expenses however increased 102% year over year to $24.9 million due to higher professional fees, payroll costs and other corporate expenses.

Additional Studies on Nerlynx

Several additional studies on Nerlynx targeting different types of breast cancer patient populations and in earlier line settings are currently underway. Puma believes that Nerlynx can also be developed for the treatment of other cancers, including non-small cell lung cancer (NSCLC) and other tumor types, which over-express or have a mutation in HER2. In June, at the annual meeting of American Society of Clinical Oncology (ASCO), the company announced positive results from a single cohort of a three-arm phase II study evaluating neratinib for treating HER2-positive metastatic breast cancer that has metastasized to the brain.

In addition, several phase II combination studies on neratinib for the treatment of breast cancer are ongoing.

Zacks Rank & Stocks to Consider

Puma currently carries a Zacks Rank #3 (Hold).

Puma Biotechnology Inc Price, Consensus and EPS Surprise

Puma Biotechnology Inc Price, Consensus and EPS Surprise | Puma Biotechnology Inc Quote

Some better-ranked stocks in the pharmaceutical sector are Regeneron Pharmaceuticals, Inc. REGN and Alexion Pharmaceuticals, Inc. ALXN both with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of Regeneron have increased 29.1% this year so far while earnings estimates for 2017 have increased 31.3% in the past seven days.

Shares of Alexion have risen 11.9% this year so far while earnings estimates for 2017 have increased 4.8% in the past 30 days.

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