hospira inc (HSP) Key Developments
Hospira Announces Voluntary Nationwide Recall of One Lot of 0.5% Marcaine
Jun 17 14
Hospira Inc. announced it will initiate a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine., (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial - Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira has attributed the embedded particulate to a supplier's glass defect. Hospira is working with its supplier on implementing corrective and preventive actions. If the particulate goes undetected and solution is administered - depending on the particle size and number - it could block administration of the drug to the patient, causing a delay in therapy. However, this is an unlikely outcome due to the size of the subvisible particulates identified. It is more likely that particulates are able to pass through the catheter and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate. While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage. However, the particulate size identified is considered too small. Therefore, an adverse outcome is extremely unlikely. Marcaine is packaged 10 units per carton/100 units per case in glass fliptop vials. The impacted lot of Marcaine was distributed November 2013 through March 2014 to wholesalers/distributors, hospitals and clinics nationwide.
Ivera Medical Corporation Asserts New Patent Litigation Against Competitors
Jun 10 14
Ivera Medical Corporation announced it has filed patent infringement lawsuits against its competitors in federal court in San Diego. U.S. Patent No. 8,740,864, issued by the US Patent and Trademark Office on June 3, 2014, is owned by BD (Becton, Dickinson and Company). It had been previously announced that Ivera Medical has an exclusive license to this patent. The lawsuits were filed against: Catheter Connections (Salt Lake City, UT) for its DualCap Solo and LB IV-Pole Strip products; Hospira (Lake Forest, IL) for its Lifeshield EffectIV-Cap product; Excelsior Medical (Neptune, NJ) for its SwabCap, SwabFlush, SwabPack, and SwabKit products; and Covidien LP and Covidien Sales LLC (Mansfield, MA) for its Kendall Disinfecting Cap products.
Hospira Announces Investment in McPherson Facility
May 28 14
Hospira Inc. announced an investment in its McPherson, Kansas, facility that will result in 150 jobs and $120 million in capital improvements at the site during the next five years. As part of the McPherson investment, Hospira will be completing capital improvement and modernization projects, including expanding capacity, adding automated visual inspection systems and installing additional production lines at the facility.
Hospira Inc. Reports Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2014; Provides Earnings Guidance for the Year 2014
Apr 30 14
Hospira Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2014. For the quarter, the company reported net sales were $1.1 billion, an increase of 6.3% compared to $884.0 million in the first quarter of 2013. Adjusted net sales were $1,050.8 million compared to $988.3 million a year ago. Adjusted net sales in the first quarter of 2013 exclude the impact of customer sales allowances associated with the company's device strategy, which was launched in 2013 to streamline and modernize Hospira's device portfolio. Adjusted income from operations increased 49.7% to $152 million in the first quarter of 2014, compared to $101 million in the first quarter of 2013. The increase primarily reflects the impact of improved pricing and increased volume in the company's SIP products, partially offset by the device ship-hold, declining docetaxel sales and higher R&D expense. On a GAAP basis, income from operations was $100 million, compared to a loss from operations of $119 million in the first quarter of 2013. Cash flow from operations was $18 million, compared to $21 million in the first three months of 2013. The decrease is primarily due to higher working capital, partially offset by higher income from operations. Capital expenditures were $95 million compared to $69 million for the same period in 2013. The increase reflects capital spending primarily associated with modernization initiatives at several of the company's manufacturing facilities, as well as on the construction of the company's facility in Vizag, India. Income before income taxes was $81.1 million against loss before income taxes of $140.5 million a year ago. Net income was $67.9 million or $0.40 per diluted share against net loss of $76.6 million or $0.46 per diluted share a year ago. Adjusted net income was $101.7 million or $0.60 per diluted share against net income of $86.1 million or $0.52 per diluted share a year ago.
The company continues to expect the change to net sales for full-year 2014 to range between negative 2% and positive 3% on a constant-currency basis, with a flat to negative 1% impact from foreign currency. The company also continues to expect adjusted diluted earnings per share for 2014 to be in a range of $2.00 to $2.25. Diluted earnings per share -GAAP expected to be $0.88 to $1.13. The company continues to project that cash flow from operations in 2014 will range between $100 million and $200 million. Capital expenditure projections remain in a range between $375 million to $425 million. The company continues to expect depreciation and amortization to range between $225 million and $275 million.
Hospira Inc. Agreed to Pay $60 Million to Settle Shareholder Lawsuit
Apr 30 14
Hospira Inc. agreed to pay $60 million to resolve allegations that it misled investors about quality control. The lawsuit, filed in 2011, alleged Hospira-a provider of injectable drugs and infusion technologies-was simultaneously promoting an effort to increase value while cutting costs in quality control. The lawsuit alleged that although that may have given a boost to short-term profitability, it hurt the company in the long run because quality control suffered at the company's large production facility in North Carolina. Hospira was forced to later make revelations about its financial results and a Food and Drug Administration investigation into quality control. That announcement resulted in a significant loss in stock value.