Key Developments: Covidien PLC (COV.N)

Covidien PLC's Nellcor Pulse Oximeters Receive FDA 510(k) Clearance With Labeling For Use In Newborn Screening For Critical Congenital Heart Disease
Tuesday, 28 May 2013 08:00am EDT 

Covidien PLC announced that its Nellcor pulse oximetry portfolio facilitates quick, noninvasive screenings for CCHD are U.S. Food and Drug Administration (FDA)-510(k) cleared for use on neonates, so physicians can rely on them for accurate CCHD screenings. As part of a broad effort to educate clinicians on the importance of CCHD screenings and encourage hospitals to implement routine CCHD screening for all newborns Covidien has begun labeling and promoting the use of Nellcor pulse oximetry as a tool to aid healthcare practitioners in CCHD screening.  Full Article

Covidien PLC Approves Separation Of Pharmaceuticals Business And Declares Dividend Of Mallinckrodt Ordinary Shares
Friday, 24 May 2013 07:00am EDT 

Covidien PLC announced that the Board of Directors has approved the separation of the Pharmaceuticals business from the rest of Covidien. The separation will occur by means of the declaration of a dividend in specie of the Pharmaceuticals business, to be effected by the transfer of the Pharmaceuticals business from Covidien to Mallinckrodt plc and the issuance by Mallinckrodt of ordinary shares directly to Covidien's shareholders (the distribution). For every eight ordinary shares of Covidien held, Covidien shareholders will receive one ordinary share of Mallinckrodt plc. No fractional shares of Mallinckrodt will be issued. Shareholders will receive cash in lieu of fractional shares. The distribution is expected to occur on June 28, 2013, to Covidien shareholders of record as of the close of business on June 19, 2013.  Full Article

Covidien PLC Announces Clinical Trial Data Showing Endoscopic Ablation Therapy Eliminates Precancerous Esophageal Tissue And Significantly Reduces Disease Progression
Wednesday, 22 May 2013 06:59am EDT 

Covidien PLC announced that results from a prospective, multicenter, randomized, controlled clinical trial show that endoscopic ablation therapy using the Barrx RF Ablation System is effective at eliminating Barrett`s esophagus, a pre-cancerous condition of the esophagus, and preventing disease progression. The SURF Trial (SUrveillance vs. RadioFrequency ablation) included 136 patients with Barrett`s esophagus containing confirmed low-grade dysplasia. Upon enrollment, patients were randomly assigned to receive either endoscopic ablation therapy and subsequent endoscopic observation (treatment group) or endoscopic observation alone (control group). Tissue samples (biopsies) were obtained at regular intervals after enrollment to assess for the presence of Barrett`s tissue, dysplasia and esophageal cancer. The primary endpoint of the trial was a comparison of the risk of disease progression over time between the ablation and control groups. Disease progression was defined as the development of either high-grade dysplasia or esophageal cancer during follow-up. The authors reported that endoscopic ablation therapy resulted in a 94% relative risk reduction in disease progression, compared to controls (1.5% progression in ablation group vs. 25.0% progression in control group) over a two-year follow-up period. Other endpoints included resolution of Barrett`s tissue and occurrence of adverse events.  Full Article

Covidien PLC Receives FDA 510(k) Clearance For Nellcor Pulse Oximetry Motion Claims
Monday, 20 May 2013 08:00am EDT 

Covidien PLC announced that its Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for motion claims. This makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio that is also compliant with ISO 80601-2-61 (International Organization for Standardization standards for pulse oximetry).  Full Article

Covidien PLC's International Finance S.A Pricing Of $750 Million Senior Notes Offering
Monday, 13 May 2013 09:01am EDT 

Covidien PLC's Covidien International Finance S.A. (CIFSA) announced that it has priced an underwritten offering of $750 million aggregate principal amount of 2.950% senior notes due 2023. The offering is expected to close on May 16, 2013. These notes are fully and unconditionally guaranteed on a senior unsecured basis by Covidien plc and its subsidiary, Covidien Ltd. CIFSA intends to use the net proceeds of this offering to fund the repayment at maturity of all of its outstanding 1.875% senior notes due June 2013 and for general corporate purposes. Barclays Capital Inc., Merrill Lynch, Pierce, Fenner & Smith Incorporated and Morgan Stanley & Co. LLC are acting as joint book-running managers for the offering.  Full Article

Covidien PLC Lowers FY 2013 Revenue Guidance
Friday, 3 May 2013 04:01pm EDT 

Covidien PLC announced that for fiscal 2013, it estimates that net sales 4% to 5% growth. The Company reported revenue of $11.852 billion in fiscal 2012. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $12.492 billion for fiscal 2013.  Full Article

Covidien PLC And VIDA Diagnostics Collaborate To Expand Minimally Invasive Treatment Of Lung Disease
Thursday, 11 Apr 2013 07:00am EDT 

Covidien PLC announced an agreement with VIDA Diagnostics, a pioneer in quantitative pulmonary imaging analysis software. Under the agreement, Covidien will distribute VIDA's Apollo pulmonary imaging software services.  Full Article

Covidien PLC Expands Share Repurchase Program and Declares Quarterly Cash Dividend
Thursday, 21 Mar 2013 07:00am EDT 

Covidien PLC announced that its Board of Directors has authorized a new program to purchase up to $3 billion of the Company's ordinary shares from time to time, based on market conditions. This program is in addition to the $2.0 billion share repurchase program announced in August 2011, which currently has approximately $425 million remaining. The Company also announced that its Board of Directors has declared a quarterly cash dividend of $0.26 per ordinary share. The dividend is payable on May 3, 2013, to shareholders of record on April 4, 2013.  Full Article

Covidien PLC Reaffirms FY 2013 Revenue Guidance-Conference Call
Wednesday, 27 Feb 2013 11:00am EST 

Covidien PLC announced that for fiscal 2013, it expects 5% to 8% revenue growth. The Company reported revenue of $11.852 billion in fiscal 2012. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $12.57 billion for fiscal 2013.  Full Article

Covidien PLC Raises FY 2013 Revenue Guidance
Friday, 25 Jan 2013 06:00am EST 

Covidien PLC updated its fiscal 2013 guidance to reflect the recent U.S. FDA approval of generic CONCERTA, the extension of the R&D tax credit and better operational performance thus far in the fiscal year. The Company now estimates that net sales in fiscal 2013 will be up 5% to 8%, including foreign exchange at current rates. This compares with prior guidance of a 3% to 6% sales increase in 2013. The Company reported revenue of $11.852 billion in fiscal 2012. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $12.39 billion for fiscal 2013.  Full Article

Covidien to acquire CV Ingenuity