Vertex Pharmaceuticals (VRTX) shares dropped some 20% premarket as of this writing on news that the company's VX-809/Kalydeco Cystic Fibrosis combination therapy data was inflated. Instead of 46% of patients in Phase II studies showing lung function improvement of 5% or more, the actual number was 35%. Once reported that 30% of patients received a 10% function improvement, the number was revised down to 19%. The error has been attributed to misinterpretation of data by the outside firm contracted by Vertex. This morning's CNBC Opening Bell has Jim Cramer chiming in that despite his early excitement on the original data, he questions now if Vertex is the "real deal." So what is an investor to think?
Vertex's meteoric rise in 2012 was bound for a correction at some point, but not many could see that correction coming at the hands of the company itself. The positives include that the company still insists it is on track for VX-809 to enter Phase III trials and its revised data still shows statistical improvement. The drug has FDA orphan and fast track status, which has not changed despite the ancillary data analysis issue. Kalydeco helped this money making pharmaceutical pop this year, despite the fact that the drug only serves a small sliver of the cystic fibrosis (CF) population. The Kalydeco/VX-809 combination therapy has potential to target a much larger population. Nearly half of the world's population of CF suffers have the mutation type targeted by the combination therapy. Look for the company to organize a larger sample set study soon to corroborate its faith in the Kalydeco/VX-809 therapy.
Should investors buy in on this dip? No doubt Vertex's market cap has taken a hit, but this money-making pharmaceutical can withstand this storm. Its versatility of pipeline and place in the Hepatitis C and non-VX-809 CF markets diversify Vertex between development and revenue generation. For example, its Hepatitis C drug Incivek, partnered in Europe with Johnson & Johnson (JNJ) subsidiary Janssen Pharmaceuticals, shows the company is capable of growing gains into future quarters. In Q1 2012, Incivek brought in nearly $360 million. The total revenue for Q1 2012 was $438 million, which is six times greater than that of Q1 2011. The company has a total of five drugs for a variety of diseases ranging from inflammation to epilepsy in Phase II trials. It has 12 preclinical trials for diseases ranging from cancer to MS. Vertex is not a one-trick pony and it is certainly not a fly-by-night smaller pharmaceutical that lives and dies by news.
A data blip, provided it is managed well and corrected with some solid studies, should not scare current investors into selling. Indeed, this happenstance may offer an entry point for new investors. Trading just north of $50 down from its mid-$60s share price before Memorial Day, the dust should settle for Vertex and by week's end I wouldn't be surprised to see the stock tick back up toward the high $50s. As the name Vertex implies, if there is a dip, the company will rise again.