Another troubled biotech giant, or a positive quarter of growth? Investors from both sides of the debate over Genentech's (NYSE: DNA) future found things to cheer about in its fourth-quarter financial results, announced yesterday.
Ever since an FDA advisory panel recommended against approving Genentech's lead drug, Avastin, as a treatment for metastatic breast cancer in December, investors have fretted about where Genentech's top-line growth will come from in future quarters. In the fourth quarter, though, revenue was up 9% year over year, and adjusted earnings per share gained 13% to $0.69 per share. For all of 2007, earnings were $2.94 per share.
As even Genentech acknowledges, any near-term improvements to its top and bottom lines are going to be predicated on the upcoming FDA review of whether to include approval for front-line metastatic breast cancer in the Avastin label. Whether Genentech can reach the top of its non-GAAP 2008 EPS guidance of $3.30-$3.45 is based on Avastin getting this FDA approval by its Feb. 23 PDUFA date.
After looking over the FDA's thoughts -- as channeled in its advisory-panel briefing documents on Avastin, as well as in the negative panel hearing -- it would be quite an unexpected coup if the agency approved Avastin for the breast cancer indication in the coming month. Instead, expect the FDA to issue a non-approval letter, which Genentech can overcome if overall survival data from the two upcoming Avastin breast cancer studies are positive.
Can Avastin's proven efficacy overcome its potential toxicity, or will the toxicity reign supreme in the breast cancer indication? We'll find out soon enough; Genentech expects data from the first of these two studies in the first half of 2008, and the other study's results in the second half of the year.
Unless the FDA gives it a late holiday gift in February, it looks like Genentech is going to have a tough 2008 financially. It could still be a positive year for Genentech on the development front, with more Rituxan data coming for the treatment of lupus and as a treatment for a large subpopulation of multiple sclerosis patients. But without that positive FDA review, expect Genentech to look more and more like Amgen (Nasdaq: AMGN), at least in the near term.
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