Given posts record revenue on path to FDA nod

The PillCam Colon--Courtesy of Given Imaging

Israel's Given Imaging ($GIVN) notched a best-ever second quarter, nearly doubling its net profit and increasing revenue by 11% as it wins more and more approvals for the PillCam.

In Q2, Given posted $49.5 million in sales and $5.2 million in net income, besting $44.5 million and $3 million from the same period last year. Worldwide, sales of Given's banner PillCam SB technology increased by 6%, as a 13% jump in European, Middle Eastern and Asian sales propped up a 2% drop in revenue from the Americas.

Given's non-PillCam revenue increased 22% to $15.2 million, including the integration of SmartPill, which Given bought for $6 million last year.

But the record quarter is just a prelude to what Given believes is soon to come, CEO Homi Shamir said. Last month, Given won Japanese approval for the next-generation PillCam Colon, and the company expects to win FDA approval for the device next quarter. 

The pill, already CE marked, is a capsule with two tiny color video cameras on each end, a battery and an LED light source, administered to patients for whom colonoscopy isn't ideal. After a patient swallows the device, it records and transmits up to 35 frames per second for 10 hours, allowing physicians to better spot early signs of colon cancer.

In data submitted to the FDA, PillCam Colon was equivalent to CT colonography in 98% of patients, posting 95% sensitivity to colon inflammation and 100% specificity in ruling it out.

Given's shares jumped about 3.5% on Tuesday, trading at $16.05 after hours. The company has had an up-and-down year on the Street, peaking at $18.40 in January, when rumor had it the Israeli devicemaker was set to be sold, and then gradually slipping about 30% before last month's Japanese approval sparked a rally.

- read Given's results

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