OPKO Health Loss Widens - Update

(RTTNews) - OPKO Health Inc (OPK), a biopharmaceutical and diagnostics company, on Monday reported a wider loss for the second quarter, hurt mainly by operating expenses and a marginal drop in revenue.

OPKO posted a second-quarter net loss of $25.5 million or $0.06 per share, compared with a loss of $3.4 million or $0.01 per share last year.

On average, four analysts polled by Thomson Reuters estimated a loss of $0.09 per share for the quarter. Analysts' estimates typically exclude special items.

Results for the recent quarter included $10 million of non-recurring expense, while the prior year recorded gains of $8.5 million.

Revenue for the second quarter edged down to $23.5 million from $23.8 million in the prior year. Analysts estimated revenue of $23.73 million for the quarter.

Expenses for the quarter increased to $51.4 million from $41.8 million last year.

OPKO said it continued to increase its investment in research activities related to ongoing Phase 3 programs for Rayaldee and hGH-CTP.

At June 30,, OPKO had cash and cash equivalents of $134 million providing it with adequate liquidity to continue the development of its product candidates.

Separately, OPKO announced positive top-line results from the first pivotal phase 3 trial of Rayaldee, a first-in-class oral vitamin D prohormone treatment being developed for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

The trial met all primary efficacy and safety endpoints, and safety and tolerability data were comparable in both treatment groups, OPKO said. The trial is one of two randomized, double-blind, placebo-controlled studies to establish the safety and efficacy of Rayaldee.

Top-line data from the second, identical pivotal phase 3 trial are expected to be available in September, and a New Drug Application submission to the U.S. FDA is on track for the end of 2014.

OPK closed Monday at $9.36, down $0.10 or 1.06%, on a volume of 3 million shares on the NYSE. In after hours, the stock dropped $0.03 or 0.32%.