Immucor Inc., F4Q09 (Qtr End 05/31/09) Earnings Call Transcript

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2009-07-24 10:52:19.0

Tags: FDA, U.S. Bancorp Piper Jaffray Inc., Call Transcript, Earnings, Immucor Inc., Federal Government, Manufacturing, Government, Seeking Alpha

Question-and-Answer Session

Operator

(Operator Instructions). Our first question comes from William Quirk - Piper Jaffray.

William Quirk - Piper Jaffray

First question is over to Rick, of the 80% of the Echo orders that you received in May month, how does this compare with previous quarters?

Richard A. Flynt

Bill, it varies; I mean, instrument orders are rather lumpy, sometimes they’re spread evenly over quarters, but in our fourth quarter, they just happened to come in the last month of the quarter.

William Quirk - Piper Jaffray

And then just a quick question on the manufacturing correction, outside of the publicly stated dollars that you’ve committed to the corrective action, what should we be thinking about in terms of ongoing expenses? Obviously you guys shifted some resources internally but still created a new department.

Dr. Gioacchino Eatz De Chirico

Yes, we’ve allocated some of the people in this new department, they were already in our organization but they were not focused on this product surveillance department. In our original forecast, we already included some additional headcounts that were to address this quality project; the number already included our original number, already included some additional ongoing expenses. We are adding additional people, but overall, the impact of this expenses will not change our guidance.

William Quirk - Piper Jaffray

And then lastly, again another manufacturing question; of the discrepancies that were identified by the FDA in either or one of the letters you received, anything in particular that you expect to take more time than anything else, or said another way, are you planning to shut down production at all to implement some of the corrections?

Dr. Gioacchino Eatz De Chirico

No, there is no implication of any shutdown. I don’t want to go much more in detail about the corrections we are taking; we are looking at our overall quality system, not just what the FDA suggested in their letters. We are looking at all the components of the system like design control, kappa system, and we are doing a truly gap analysis of all the systems, and from there we will go where the system should be basically; and it’s a much more bigger project to address the things that were in the warning letters.

Operator

Our next question is from Jim Quentin - Barrett & Co.

Jim Quentin - Barrett & Co.

Just had one question regarding where you started talking about the FDA at the beginning of the call, I know that still the investigation is going on and so forth, but did you mention anything about the FDA looking into the price increases in reagents 5 or 6 years ago or is that part of the ongoing investigation?

 

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