I never would have bought GIVN if I had known that the company won’t submit its PillCam Colon 2 for general screening approval to the U.S. Food and Drug Administration following the completion of an 885-patient clinical trial. I just learned that they made the announcement on August 8 -- did you hear it?--and that's why the stock fell 9.9%. GIVN said they will submit the device for visualizing the colon in patients who are unable to undergo or complete colonoscopies.
According to Maxim, the decision won’t reduce Given’s long-term revenue target.“The stock is oversold as a lot of people don’t understand the entire story,” Bryan Brokmeier, an analyst at Maxim Group, said by phone from New York on Aug. 10. “They were going to have a number of hurdles to use the PillCam as a general screening tool and were anyway going to capture a share of the market in which they are focusing now.”
The PillCam Colon capsule contributed $1.8 million to Given’s total sales of $178 million in 2011. Even with its limited diagnostic patient population,the company expects to reach at least $450 million in revenue by 2016.
I'm not waiting around to find out. Givn should have been clear at the outset that the PillCam was only going to be complementary to colonoscopy and would not replace it. Investors have been shafted with the PillCam already.
Colon Capsule 2 is the first Capsule for Visualization.Over time,better versions will come that will improve visualization to higher success rates compared to Gold Standard Colonoscopy.With 3-D and other enhancements--Colon Capsule will someday become first option. Yes-it is first step-- watch for more Capsules being developed by others.
I'm not familiar with the medical "device" side - if this is approved for a smaller segment of colonoscopy patients, does that prevent doctors from using "off label" for a wider population? Ultimately, if doctors find it useful for a certain patient group and they aren't restricted from using it for general screening (to avoid a colonoscopy), they probably will migrate to that over time? Either way, it was probably going to take a long time for doctors to change their ways, but the company downplaying the change in submission is a little flaky. Beyond that, Maxim is one of the weakest analyst groups out there, so I'm not surprised the stock sold off on their call.
Jeremy Feffer, an analyst at Cantor Fitzgerald, a more respected analyst organization than Maxim (or at least, better known)agreed that the sell-off was overdone. He was quoted as saying:“The reality of this opportunity has not changed. The early revenue opportunity was always going to come from this diagnostic patient population.”
Regardless, GIVN's failure to make this intention known to the general public at the outset was a bum steer.