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Novo Nordisk A/S Management Discusses Q2 2012 Results - Earnings Call Transcript

As usual, things may turn out completely differently than what we predict, usually not the case, I have to say, at least, when we speak about diabetes, but there are certain uncertainties associated with making predictions and please study this slide to know what the risk factors are. This is the highlight in fact from the front page of the press release that was sent out. Due to a very strong second quarter, we managed to come out the first half with a 12% local currency growth and because of the weakening of the Eurozone, that is translated into 17% growth in first half and in Danish kroner terms, the growth drivers are North America, International Operations, with 19% and 17%. In terms of product, it's Victoza and the modern insulins. They make up for the total growth. The rest is sort of wash up -- up and down. In the regulatory field, there's quite a few new things here. The regulatory process for Tresiba and Ryzodeg is moving along in all major markets. We have gotten a tentative AdCom date, November 8 in the U.S. and the process in Europe and Japan is moving along quite smoothly also.

We just announced a combination trial results where we combine a GLP-1 and an insulin. And as you could see from the data and from the release, they are actually doing what we had anticipated plus some, meaning, that this may present itself as a very attractive treatment option for a variety of different patient categories. And I'm sure we will be discussing the positioning and the potential of this type of combination drug during the Q&A. Then we have one news which is perhaps not so good. We saw in the last parts of the trial with vatreptacog alfa new factor VIIa analogue, potentially neutralizing antibody formation in one patient, and this needs to be started further. The way this is being assessed is in vitro, so we still need to see the efficacy data of whether any truly neutralizing effect clinically has taken place. We don't believe it has, but it's something we need to investigate further, but clearly, not good news. It just basically shows that when you toil around with biologics, if you go too far, you actually run the risk of eliciting antibody formation, and so this is an example of the associated risk with biopharmaceuticals. When we look at the financials, a very strong operating profit growth, 31%; diluted, 26% and we were able to lift our guidance for the year to 9% to 12% and 15% operating profit growth in local currencies. And with this, Kåre Schultz.

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