Earnings are once again going to steal the spotlight this week, with four of the five can’t-miss stories in the health-care sector revolving around earnings reports. There is, however, one FDA ruling scheduled for the end of the week that could be of interest, so let’s start with that.
Dynavax Technologies Corporation (NASDAQ:DVAX) is expected to face the FDA firing squad on or before Feb. 24 for its hepatitis-B vaccine, Hepislav. Dynavax shares were massacred shortly after the FDA panel released its findings on Hepislav, not because of the data — panel members voted 13-1 in favor of recommending the drug based on efficacy — but because of an 8-5 vote, with one abstention, that there wasn’t enough safety data available to determine that the drug was safe, given a few cases where Hepislav caused rare autoimmune diseases. Although the FDA is under no obligation to side with the panel, it often serves as a good indicator of what to expect. I’d be shocked with an FDA approval next week, but I do expect that, at some point over the next 12-18 months, Dynavax will gain approval for Hepislav.
My personal No. 1 biotech to watch in 2013, Exelixis, Inc. (NASDAQ:EXEL), is scheduled to report fourth-quarter results on Thursday, and it probably won’t include any major surprises. What I’ll be looking for, however, is the company’s updated 2013 sales forecast now that Cometriq, its metastatic medullary thyroid cancer drug, is available in the United States. I’d keep your eye on Exelixis’ cash balance, but I don’t think it’ll dip all too much. Cometriq’s sales forecast could be the factor that causes this company to move up or down in a big way.
Medical-device giant Medtronic, Inc. (NYSE:MDT) is slated to report its third-quarter results on Tuesday, with the expectation that revenue will advance 3% to $4.03 billion and EPS will jump to $0.91 from $0.84 in the year-ago period. For me and investors, this will give us a better look — especially with regard to guidance — at how the medical-device excise tax is affecting Medtronic’s bottom line. Another key point will be how, if at all, St. Jude Medical, Inc. (NYSE:STJ)‘s lead safety issues with regard to defibrillators are affecting Medtronic’s cardiovascular device line. Medtronic is never a report to miss, so keep your eye on this one.