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.