Diagnostic equipment provider Hologic Inc. (NSDQ:HOLX) reported adjusted net earnings of $78.2 million, of 30 cents per share, on $420.7 million in revenues, generally in line with Wall Street expectations but falling short of year-ago profit comparisons.
Including amortization costs and charges related to accounting changes at the Bedford, Mass.-based company, net income during the three months ended June 26 was $27.4 million, down from a $30.8 million profit in the year-ago quarter.
Revenues climbed 4.4 percent during Hologic’s fiscal third quarter. The gains were supported by 8.3 percent growth in breast health revenues, primarily due to added numbers of installed Selenia digital mammography systems, coupled with an 8.7 percent jump in GYN surgical revenues. Sales within the diagnostics and skeletal health segments both fell slightly during the quarter.
The company also said Tuesday that its Selenia Dimensions 3-D digital breast tomosynthesis system has been scheduled for a Sept. 24 review by the FDA’s Radiological Devices Panel. Hologix applied for pre-market approval for the device by the U.S. Food and Drug Administration two years ago, seeking approval for both screening and diagnostic use.
During a conference call with analysts Tuesday night, Hologic CEO Robert Cascella described the upcoming review as “a very, very encouraging sign” and stuck with the company’s previous forecast for a 2011 launch but also cautioned against believing approval is a foregone conclusion.
He also said the company — based on its experience bringing the 3-D system to market in Europe — would expect still-unspecified ramp-up expenses connected with an U.S. launch, including costs educating radiologists on how to read tomosynthesis results. “There’s much more sales training that will go into it,” he explained. “But the true incremental cost will be physician training.”
Hologic increased its fiscal 2010 revenue guidance by $5 million to a new range between $1.665 billion to $1.670 billion, reflecting the current level of capital equipment stabilization during the first nine months of fiscal 2010.