Dendreon Posts Widened Loss, Explains Provenge Changes

Updated from 3:41 p.m. EDT

DendreonDNDN reported a widened fourth-quarter loss Thursday, while also giving more details about its recent amendment to the ongoing study for prostate cancer drug Provenge.

The company reported a fourth-quarter loss of $27 million, or 32 cents a share, swelled from $21.5 million, or 28 cents a share, in the comparable 2006 period. Quarterly revenue fell to $28,000 from $86,000 a year earlier.

Analysts surveyed by Thomson Financial had predicted a narrower loss of 25 cents a share, with revenue of $12,000.

For the year, Dendreon reported a loss of $99.3 million, or $1.20 a share, compared with $91.6 million, or $1.27 a share, a year earlier. Revenue for the year rose to $743,000 from $273,000. The results fell shy of analysts' expectations of a loss of $1.13 a share on $830,000 in revenue.

Operating expenses for the year were $102.4 million compared to $97.6 million in 2006. The company said on a Thursday conference call that it projects expenses of $80 million in 2008.

Shares edged down 19 cents, or 3.6%, to $5.10 on Thursday.

The company's quarterly results have less of an impact than any updates it can offer investors on its progress for its prostate cancer drug Provenge. Dendreon said Wednesday that the Food and Drug Administration agreed to amend the special protocol assessment for its IMPACT trial for Provenge.

Under the new conditions, the interim analysis is still scheduled for the second half of 2008 but it will require a greater number of events (deaths) and will have higher statistical powering.

The company said on Thursday's call that the new model -- which includes more deaths to trigger the interim analysis in roughly the same time frame as previously expected -- isn't an indication that patients are dying faster than anticipated. The company said it had assumed it would get the SPA amendment when it originally guided a timeframe for interim data.

In March of last year, an FDA advisory committee unanimously voted that Provenge was reasonably safe and voted 13 to 4 that it was effective. In May, however, the FDA sent the company an approvable letter requesting additional clinical data in support of Provenge's efficacy claim.

The stock, traded as high as $15.19 in May before the approvable letter, but has since retreated to a $5 range.

Dendreon established that the FDA would accept either a positive interim or final analysis of survival from its ongoing IMPACT study to amend its application so that it addressed the agency's request for additional clinical data supporting Provenge's efficacy.

The interim analysis will be performed by an independent data monitoring board, and the data will remained blinded unless the study achieves statistical significance, in which case it will be unblinded, and Dendreon can amend its application.

Per the recent amendment to the SPA, the final analysis will be moved up to second half of 2009 rather than in 2010, will require 304 events, fewer than originally needed.

Know What You Own: Dendreon operates in the biotechnology industry, and some of the other stocks in its field include Cell Genesys CEGE, Targeted Genetics TGEN, Abbott Laboratories ABT, Glaxosmithkline GSK, Genzyme GENZ and Amgen AMGN. These stocks were recently trading at ($2.12, +4.95%), ($0.86, -4.44%), ($52.62, +2.49%), ($41.50, -1.47%), ($73.96, -0.40%) and ($47.26, +5.05%) respectively. For more on the value of knowing what you own, visit TheStreet.com's Investing A-to-Z section.