UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 8-K

 

CURRENT REPORT PURSUANT

TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

January 5, 2015

Date of Report (Date of Earliest Event Reported)

 

HOSPIRA, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

1-31946

 

20-0504497

(Commission File Number)

 

(I.R.S. Employer Identification No.)

 

275 N. Field Drive

Lake Forest, Illinois 60045

(Address of Principal Executive Offices, including Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (224) 212-2000

 

Not Applicable

(Former Name or Former Address, If Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 8.01 Other Events

 

On January 8, 2015, Hospira, Inc. distributed the attached press release regarding Hospira’s devices, including information regarding notification on January 5, 2015, from the U.S. Food and Drug Administration (“FDA”) that the FDA had lifted an import alert that previously prohibited U.S. importation of infusion pump devices manufactured in Hospira’s Costa Rica device manufacturing facility.

 

*              *              *              *

 

This Current Report may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including projections of certain measures of Hospira’s results of operations; projections of certain charges, expenses, and cash flow; and other statements regarding Hospira’s goals, plans and strategy.  Hospira cautions that these forward-looking statements are subject to risks and uncertainties, including adequate and sustained progress on Hospira’s quality initiatives, continuous improvement activities, and device strategy that may cause actual results to differ materially from those indicated in the forward-looking statements.  Factors that may affect Hospira’s operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings “Forward-Looking Statements,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Hospira’s latest Annual Report on Form 10-K, and as updated by Hospira’s Reports on Form 10-Q, filed with the U.S. Securities and Exchange Commission.  Readers are cautioned not to place undue reliance on these forward-looking statements, which apply only as of the date of this Current Report.  Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments, other than as required by law.

 

Item 9.01                                           Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.

 

Description of Exhibit

 

 

 

99.1

 

Press Release regarding Hospira’s devices, dated January 8, 2015

 

2



 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

HOSPIRA, INC.

 

 

Date: January 8, 2015

/s/ Royce Bedward

 

By:

Royce Bedward

 

Its:

Senior Vice President, General Counsel and Secretary

 

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EXHIBIT INDEX

 

Exhibit No.

 

Exhibit

 

 

 

99.1

 

Press Release regarding Hospira’s devices, dated January 8, 2015

 

4




Exhibit 99.1

 

GRAPHIC

 

For Immediate Release

 

 HOSPIRA ANNOUNCES SIGNIFICANT PROGESS ON

GLOBAL DEVICE STRATEGY

 

— Quality systems, significant investment credited for import alert lift —

 

LAKE FOREST, Ill., Jan. 8, 2015 — Hospira, Inc. (NYSE: HSP), the world’s leading provider of injectable drugs and infusion technologies, today unveiled significant progress on its global device strategy. The global device strategy, initiated in 2013, establishes a streamlined and modernized device portfolio to address customer needs and to position the company for future innovation and growth, all while supporting continued advancement of device remediation, including quality improvement efforts. Progress announced today includes the lifting of the import alert on the company’s portfolio of infusion devices by the U.S. Food and Drug Administration (FDA), the introduction of next-generation pumps and details on future technology development.

 

On January 5, the FDA notified Hospira that it lifted the import alert that previously prohibited U.S. importation of infusion pump devices manufactured in Hospira’s Costa Rica device manufacturing facility, including Hospira’s Plum A+™ and LifeCare PCA™ infusion pumps. Hospira is now able to sell these infusion devices to new and existing customers without medical necessity certificates, and will resume the importation of these devices into the United States immediately.

 

Globally, we know our customers depend upon Hospira’s products and we are pleased to be returning these devices to the market. We strive to continuously improve the performance of our products and meet the expectations of both customers and regulatory agencies. This is an important milestone in that process,” said David J. Endicott, president, Hospira Medical Devices. “In 2015, we expect that our continued efforts to streamline and modernize our portfolio will result in a number of key product launches, with Hospira ultimately providing the most advanced and intuitive pumps in the industry.”

 



 

Progress in Hospira’s global device strategy is reflected in the following areas:

 

·                  Quality systems: Hospira’s investments continue to strengthen its global device quality systems and promote continuous improvement to better meet evolving regulatory standards.

 

·                  New Product Launches: In 2015, Hospira expects to offer its customers new next-generation pump technology, including:

 

·                  SapphirePlusTM — Hospira’s partner Q Core Medical recently received FDA clearance on this Hospira MedNetTM-ready general-infusion device, which features unique patented technology, innovative design, wireless capability and an intuitive touch screen to help improve the safety and efficiency of I.V. medication administration.

 

·                  Plum 360TM — Hospira is awaiting FDA clearance on this new infusion system, which builds on its unique air management and concurrent delivery features, while expanding its drug library and wireless capability.

 

·                  Hospira MedNet 6.1 — The latest update to the Hospira MedNet safety software enables MedNet to operate with all Hospira pump platforms, building on its leadership position in I.V. Clinical Integration and helping hospitals improve I.V. administration productivity and prevent medication errors.

 

The anticipated launches of these new pumps in 2015, along with ongoing efforts to replace and retire past technologies, are critical in bringing Hospira customers the most advanced medication management systems.

 

·                  Future technology: Hospira and partner Q Core Medical recently enhanced their collaboration to develop a next-generation platform of pumps, building on both the Sapphire and Plum cassette technologies. The partnership continues to strengthen and supplement Hospira’s own research and development efforts. Together, Hospira and Q Core will launch a full spectrum of pumps, including general infusion, PCA, syringe and ambulatory devices that build on the intuitive design of Sapphire and leverage the proven Hospira MedNet software.

 

The development of next generation Plum and Sapphire platforms continues to demonstrate Hospiras long-term commitment to the I.V. infusion market and is a critical part of the company’s strategy to build future growth.

 

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About Hospira

 

Hospira, Inc. is the world’s leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill.  Learn more at www.hospira.com.

 

Private Securities Litigation Reform Act of 1995 —
A Caution Concerning Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Hospira’s goals, plans and strategy related to Hospira’s global devices. Hospira cautions that these forward-looking statements are subject to risks and uncertainties, including adequate and sustained progress on the company’s quality initiatives and device strategy that may cause actual results to differ materially from those indicated in the forward-looking statements. Other factors that may affect Hospira’s operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Hospira’s latest Annual Report on Form 10-K and subsequent Forms 10-Q, filed with the U.S. Securities and Exchange Commission, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments, except as required by law.

 

Contacts:

 

Media
Lindsey Negaard
(224) 212-2656

 

Tareta Adams
(224) 212-2535

 

Financial Community
Karen King
(224) 212-2711

 

Ruth Venning
(224) 212-2774

 

###

 

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