CS First Boston downgrades ImClone Systems (IMCL) to neutral from outperform.
Analyst Mark Augustine asys ImClone announced Erbitux supplemental Biologics License Application for squamous carcinoma of head and neck (SCCHN) to be filed before year-end 2005, vs. prior guidance for second-quarter 2005.
He cuts 2005 to 2008 Erbitux U.S. sales estimates. The company now sees $1.60 2005 earnings per share, $2.35 2006 earnings per share, and $1.84 2007 earnings per share (moved a $250 million milestone payment from Bristol-Meyers Squibb to 2006).
Augustine estimates off-label SCCHN Erbitux use accounts for 10% or more of Erbitux use today, the company does not expect this to accelerate near-term. He says risk of further approval delays/non-approvability is raised. He cuts his $62 target to $37.