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Stock Market & Financial Investment News

News Breaks
March 18, 2013
09:11 EDTNUVANuVasive says received FDA warning letter related to San Diego facility
On March 13, NuVasive received a warning letter dated March 12 from the FDA related to an inspection of the company’s San Diego, California facility that occurred from October 29, 2012 through November 2, 2012. The inspection did not result in any 483 observations and the warning letter does not cite any quality system concerns.The FDA letter identifies specific labeling claims related to the company’s ILIF procedure, indicating that one of the indications noted is not cleared through any of the company’s Affix Spinous Process Plate system 510(k)s. The letter only relates to this promotional claim and the company does not anticipate a disruption in the distribution of these products. The company takes this matter seriously and has already begun to respond to the FDA’s requests. The company is giving the matter the highest priority in order to fully address the FDA’s concerns to our mutual satisfaction. As this is an administrative process to address the warning letter, the company believes the FDA’s concerns can be resolved without an impact on the company’s financial results or operations. Comments taken from an 8-K filing.
News For NUVA From The Last 14 Days
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February 26, 2015
12:15 EDTNUVANuVasive management to meet with Piper Jaffray
Meetings to be held in New York on March 3 and in Denver on March 4 hosted by Piper Jaffray.
February 24, 2015
16:30 EDTNUVANuVasive announces updated Non-GAAP definition
NuVasive announced that it will implement an updated non-GAAP definition in Q1. NuVasive will redefine its non-GAAP cost of goods sold, gross margin, operating expenses, operating margin and earnings per share financial measures from its existing non-GAAP definition to include the impact of non-cash stock-based compensation and certain intellectual property related litigation expenses, both of which had previously been excluded in the company's calculation of these non-GAAP financial measures. In addition to GAAP results, these non-GAAP measures are intended to provide additional information to enable investors to assess the Company's operations in the same way management assesses operations. Management uses non-GAAP measures to budget, evaluate and measure the company's performance and sees these results as an indicator of the company's ongoing business performance. The company believes these changes in non-GAAP reporting increase transparency and better reflect the underlying financial performance of the business. CFO Quentin Blackford said, "This update allows us to provide investors with a meaningful non-GAAP measurement that represents the performance of our core business on a more inclusive, comprehensive basis. Importantly, this change does not impact NuVasive's plan to deliver at least 100 basis points of operating margin expansion each year, as well as improved EBITDA margins for the next several years as we rapidly scale the business in the U.S. and internationally and capture well-identified opportunities to drive profitability."
16:18 EDTNUVANuVasive sees FY15 adjusted EPS approximately $1.10, consensus $1.53
Sees FY15 revenue approximately $810M, consensus $811.03M, which includes an approximate $10M of currency headwinds.
16:16 EDTNUVANuVasive reports Q4 adjusted EPS 39c, consensus 37c
Reports Q4 revenue $204.3M, consensus $201.39M.

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