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Exelixis, Inc. Message Board

  • commonwealthinc commonwealthinc May 8, 2013 9:46 AM Flag

    Off label revenue

    Why did they refuse to give out the off label revenue? It was one of the things I was most interested in because it measures how aware/interested in Cabo doctors' are whose specialty may not be MTC. It was one of the first things mentioned so I know they were aware it was a hot topic.

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    • "Why did they refuse to give out the off label revenue?"

      Off label use of an approved drug is a very touchy subject for the FDA. Regulations forbid off label promotion and FDA recently sponsored the prosecution of a sales rep (U.S. v Coronia) for this offense and all he did is truthfully answer questions posed to him by a potential customer who turned out to be an undercover informant. Breaking out the off label revenue for Cabo would not violate any statutes or regulations, but it would open the topic and invite questions from the participating financial analysts. EXEL's success or failure could hinge on a harmonious relationship with FDA and avoiding any facet of the off label topic is one way for EXEL to maintain a good working relationship with the agency.

    • I thought it was a bit curious too. However, it has to be recorded somewhere - lumped in with license/milestone revenue - so take total revenue, remove Cometrix sales, approximate what license/milestone revenue should have been - and boom - there's your off label. I think you could reasonably proxy in 500K-1.5K.

      Off-label is not a reliable or forecastable item, influenced largely on approved indications and existing studies. Given the single sales data point for the approved indication, I guess it is fair for them to essentially set aside the off label as irrelevant to the ongling business.

      Sentiment: Strong Buy

 
EXEL
2.93+0.2400(+8.92%)Feb 26 4:00 PMEST

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