Novartis raises 2013 sales and profit forecast for 2nd time

Swiss drug major Novartis AG has raised its 2013 sales and profit forecast for a second consecutive quarter. Announcing its Q3 2013 financial results, Novartis said it continues to benefit from the delay in entry of generic competition for its hypertension pill Diovan monotherapy in the US market. The US Food & Drug Administration is yet to approve Ranbaxy 's generic version of Diovan, where the Indian drug maker has a 180 day marketing exclusivity.

Novartis now expects yearly sales losses of USD 2.3 billion due to generic competition versus the earlier forecasts. Novartis had, in January 2013, forecasted to make losses of USD 3.5 billion and later in July quarter lowered it to USD 2.7 billion.

Novartis' blockbuster drug Diovan lost patent protection in August 2012 and its variant Diovan HCl is already facing generic competition. However, other version Diovan monotherapy, which has annual US sales of USD 1.2 billion, still has no generic competitor.

Novartis in its Q3 2013 earnings statement also said that for guidance modeling the company assumes that the launch of a generic Diovan monotherapy in the US will not happen in the fourth quarter of 2013.

Continued regulatory troubles and a strict vigil from the US FDA on Ranbaxy has delayed the approval. Ranbaxy had paid a USD 500 million fine to US Department of Justice to settle charges of felony in May this year and currently has all its three Indian plants under an import ban in the US and a strict vigil over its other facilities.

However, recently the US FDA gave a clean-chit to Ranbaxy's Ohm Laboratories in New Jersey, which is the Indian drug maker's only plant approved for supplies to the US market. And this latest clearance has brought hopes for fresh approval for drugs filed from Ohm Labs, including the long pending one for Diovan.

But in the mean time, Novartis is benefitting from the lack of competition. Swiss drug major expects full-year sales to grow by a low to mid single-digit percentage in constant currencies and core earnings to be in line or better than previous year. Novartis had earlier forecasted mid-single-digit percentage decline in profit this year. However, cautioning that the benefits accruing from delay in Diovan generic will reverse and result in higher generic erosion in 2014. Also indicating that the company expects Ranbaxy to be able to launch generic version in 2014 only.

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