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Replies to #32266 on Biotech Values
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daved

11/15/06 7:40 PM

#37515 RE: DewDiligence #32266

I am new here. I bought some GTCB recently after reading the Nature article and doing limited DD and noting the recent U.S. patent and the LFB deal. I sold it for a minor profit a few days later. I have concerns regarding the LEO deal.

At the end of Q3 2005 we wrote off the entirety of the ATryn inventory on hand for a charge of $466K.

The needed product for the first approved indication are agreed to be miniscule due to the few patients suffering from that indication. It won't be needed until Leo is named and each country buys in. Phase II trials usually involve 50 to 100 patients. Again, I see little need for massive amounts of product.

Since Q4 2005 we've spent 12 million manufacturing and writing off inventories of ATryn despite starting with 0 inventory.

The 10 K says that:

"In our collaboration with LEO we will continue to be responsible for the production of ATryn. LEO will pay for all product used in clinical studies as well as for commercial sale. For product that sold for approved therapeutic use, LEO will pay us a royalty on all commercial sales, as well as a transfer price that we believe will provide us a margin on our cost of production. LEO will pay us at cost for all product used in clinical studies and will be responsible for all other clinical study costs for approval in Europe."

From the sound of this clinical product should not be subject to the transfer price provision. Fully burdened cost should be the criteria.

Why are we making so much?

In the Q3 2006 conference call Cox seemed to back off earlier statements that a profit margin could be made at significant production levels.

I call 12 mil significant.

What's your take on this concern? This may still be a good investment but I'd want to hear more from Cox about this first.




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daved

01/02/07 6:56 PM

#40140 RE: DewDiligence #32266

With all Dew respect you left GTCB/LEO update unchanged despite recent 10Qs.

Do you feel comfortable about that?

Dave
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daved

01/03/07 6:58 PM

#40213 RE: DewDiligence #32266

Re call to GTCB and LEO. This morning's PR confirmed my "baseless" fears.

"GTC said it expects to use $26 million to $29 million of cash in 2007 for forecasted sales of ATryn in the approved indication as well as to LEO for its Phase II study for severe clotting associated with sepsis. "

Add this to the 20 odd mil spent on the LEO progam in 2006. All this for production scale-up. For the 200 patients to be enrolled in the Phase II DIC trial that means a cost of over $200,000 in GTCB clinical product cost per patient.

Per Tom Newberry the enrollment process will take a year. When results are evaluated this "scale up" may have to be renewed for Phase III. It's too early to tell.

Dave