As recently as 22 days ago, Merck had predicted a mid-2013 FDA submission for approval of odanacatib, at buy-side Wall Street analysts’ conferences. This, of course, was after a surprisingly positive interim look at a late stage study caused it to be stopped early last July, for odanacatib.
I’ll have an earnings digest below — but this is a truly unwelcome negative surprise, after the positive one of July 2012. This full year delay will reduce the analysts’ models for revenue and EPS in 2014 and 2015 — thus Merck is down around two-to-three percent in the NASDAQ premarket.
Recall that in many ways, Whitehouse Station is counting on odanacatib to replace the beleagured-by-generics (and lawsuits) Fosamax® franchise.
Per the Wall Street Journal, just now:
. . . .The delay in filing for regulatory approval of odanacatib, however, could cause uncertainty about the drug’s potential. Merck said it continues to believe odanacatib has potential to address unmet medical needs in osteoporosis patients. Merck also had a recent R&D setback, dropping cholesterol drug Tredaptive after a negative clinical trial. . .
Merck has recovered a bit at the NYSE open — to be off only around two percent. Still — the Goldman, Sachs & Co., and JP Morgan conferences a month ago held a much sunnier picture of odanacatib’s near-term potential to add revenue and margin.
UPDATED: It looks like Merck will be off about three percent for the day, on the NYSE, on heavy volume — due largely to this.
Earnings and revenue both beat — and the 2013 forecast is in line with what Pfizer said earlier this week. Pfizer rose three percent that day — Merck will fall about the same amount. Wow — that’s a significant difference.