There's a new sheriff in town. Or at least, as a sort of proxy, one receiving more attention from medical device companies and public firms in general.
The name is Sarbanes-Oxley – legislation intended to hold upper executives more directly responsible for their firms' financial reports.
References to Sarbanes-Oxley were frequent this week, the legislation given considerably more potential punch with the guilty verdict against former WorldCom CEO Bernie Ebbers (and that decision probably not boding well for Richard Scrushy, founder and former CEO of HealthSouth [Birmingham, Alabama], and other indicted upper-level executives, according to many commentators.)
Several companies have issued statements reporting delays in their financial filings with the Securities and Exchange Commission (SEC), most citing Sarbanes-Oxley as a contributing factor.
• Bruker BioSciences (Billerica, Massachusetts) reported that it has been "made aware" of several FY04 audit adjustments, saying the adjustments are "expected to have a negative impact" on previously reported financial results for 2004. Bruker said it also has received a higher tax assessment from German tax authorities following its March 2005 release of 2004 financial results.
The company is seeking a 15-day extension of its 2004 SEC Form 10-K filing and will schedule a conference call to discuss the revised statements when filed.
Bruker said it now expects to report, "in accordance with the Sarbanes-Oxley Act, a material weakness in its internal controls at one of its subsidiaries" and that its independent accountants "will concur with management's assessment."
The subsidiary was not named.
Bruker BioSciences is the parent company of Bruker Daltonics (Billerica), a developer and provider of life science tools based on mass spectrometry, and Bruker AXS (Madison, Wisconsin), a provider of life science and advanced materials research tools.
William Knight, CFO of Bruker BioSciences, said: "We had previously reported a net loss of $0.06 per diluted share for the year ended Dec. 31, 2004. . . . we now expect that the combined effect of these audit adjustments and the higher tax assessment in Germany will increase our 2004 GAAP net loss to $0.07 to $0.09 per diluted share, with audit adjustments affecting several quarterly results during 2004. These adjustments should not have any effect on our 2005 goals and first quarter 2005 guidance."
• TriPath Imaging (Burlington, North Carolina) filed for an extension of its FY04 annual report filing with the SEC, saying it needs more time to complete assessment of its reporting in accordance with Sarbanes-Oxley. It expects to make the annual report filing "no later than March 31" and sees no "significant changes" in its previously announced financial results for 4Q and full-year 2004.
TriPath manufactures systems for the detection, diagnosis, staging and treatment of cancer.
• Referencing a need to "execute against its Sarbanes-Oxley . . . project plan," plus changes in internal controls, RITA Medical Systems (Mountain View, California) has filed for more time to file its report for the year ended Dec. 31, 2004. It projected making the filing "by the end of the two-week extension period," expecting no changes in 4Q and year-end results.
RITA manufactures products for the oncology sector, including radio frequency ablation systems, as well as percutaneous vascular and spinal access systems.
• While not citing Sarbanes-Oxley, Osteotech (Eatontown, New Jersey) reported the need for an extension of Form 10-K filing to March 31, due to "extensive and complex activities required . . . to complete internal control review" of financial statements for 2004. The company said it expects to make the filing "no later" than that date.
Osteotech is a provider of human bone and connective tissue for transplantation used in musculoskeletal surgery.