UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 15, 2011
THE COOPER COMPANIES, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 1-8597 | 94-2657368 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
6140 Stoneridge Mall Road, Suite 590, Pleasanton, California 94588
(Address of principal executive offices)
(925) 460-3600
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| ITEM 8.01. | Other Events. |
The Cooper Companies, Inc. announced that its subsidiary CooperVision has expanded its recall on limited lots of Avaira® Toric contact lenses to include limited lots of Avaira Sphere contact lenses. In continued collaboration with the United States Food and Drug Administration, CooperVision is expanding the recall because it identified certain lots of Avaira Sphere lenses that did not meet its updated quality requirements due to the level of a silicone oil residue. CooperVision intends to replace the recalled product with available Avaira Sphere inventory.
The Cooper Companies, Inc. and its subsidiary CooperVision both issued press releases informing customers. A copy of each release is attached and incorporated by reference.
Internet addresses are for information purposes only and are not intended to be hyperlinks to other The Cooper Companies, Inc. information.
FORWARD-LOOKING STATEMENTS
This news release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Statements relating to plans, prospects, goals, strategies, future actions, events or performance and other statements which are other than statements of historical fact, including all statements regarding resuming shipments and expectations as to inventory levels are forward-looking. To identify these statements look for words like “believes,” “expects,” “may,” “will,” “should,” “could,” “seeks,” “intends,” “plans,” “estimates” or “anticipates” and similar words or phrases. Forward-looking statements necessarily depend on assumptions, data or methods that may be incorrect or imprecise and are subject to risks and uncertainties.
The factors that could cause our actual results and future actions to differ materially from those described in forward-looking statements include an expansion of the scope of the Avaira recall or taking additional actions that may be requested by a regulatory agency that would impede our ability to complete the recall and are described in our Securities and Exchange Commission filings, including the “Business” and “Risk Factors” sections in the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2010, as such Risk Factors may be updated in quarterly filings.
We caution investors that forward-looking statements reflect our analysis only on their stated date. We disclaim any intent to update them except as required by law.
| ITEM 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit |
Description | |
| 99.1 | Press Release dated November 15, 2011, of The Cooper Companies, Inc. | |
| 99.2 | Press Release dated November 15, 2011, of CooperVision, Inc., a subsidiary of The Cooper Companies, Inc. | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| THE COOPER COMPANIES, INC. | ||||
| By | /s/ Carol R. Kaufman | |||
| Carol R. Kaufman | ||||
| Executive Vice President, Secretary and | ||||
| Chief Administrative Officer | ||||
Dated: November 15, 2011
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 |
Press Release dated November 15, 2011, of The Cooper Companies, Inc. | |
| 99.2 |
Press Release dated November 15, 2011, of CooperVision, Inc., a subsidiary of The Cooper Companies, Inc. | |
Exhibit 99.1
|
| |
| NEWS RELEASE | ||
| CONTACT: Kim Duncan Director, Investor Relations The Cooper Companies, Inc. ir@cooperco.com |
6140 Stoneridge Mall Road Suite 590 Pleasanton, CA 94588 925-460-3663 www.coopercos.com | |
THE COOPER COMPANIES ANNOUNCES ITS SUBSIDIARY COOPERVISION HAS EXPANDED ITS RECALL TO INCLUDE THE REPLACEMENT OF LIMITED LOTS OF AVAIRA SPHERE
PLEASANTON, Calif., November 15, 2011 – The Cooper Companies, Inc. (NYSE: COO) today announced that its subsidiary CooperVision has expanded its recall on limited lots of Avaira® Toric contact lenses to include limited lots of Avaira Sphere contact lenses. In continued collaboration with the United States Food and Drug Administration, CooperVision is expanding the recall because it identified certain lots of Avaira Sphere lenses that did not meet its updated quality requirements due to the level of a silicone oil residue. CooperVision intends to replace the recalled product with available Avaira Sphere inventory.
Avaira Sphere was launched in April 2008 and represents approximately 4% of CooperVision’s fiscal 2011 revenue. The Avaira Sphere product to be replaced represents less than 1% of CooperVision’s fiscal 2011 revenue. The Company notes that no other product line uses silicone oil in the manufacturing process other than Avaira Sphere and Avaira Toric.
The Company will establish a reserve for costs associated with the expanded recall and additional costs associated with the Avaira Toric recall of approximately $9.0 million. This reserve will be taken as a charge in the Company’s fiscal fourth quarter 2011 GAAP earnings. The total cost of the Avaira recall is now expected to be approximately $23.2 million, including the $14.2 million taken in the fiscal third quarter. Further details will be discussed on the Company’s fiscal fourth quarter 2011 earnings conference call on December 8, 2011.
About The Cooper Companies
The Cooper Companies, Inc. (“Cooper”) is a global medical device company publicly traded on the NYSE Euronext (NYSE:COO). Cooper is dedicated to serving the needs of the healthcare professional, improving the quality of life for its employees and customers and providing market leading products. Cooper’s commitment to health and wellness is reflected through its corporate culture and global initiatives to promote healthy life choices for its employees. Cooper operates through two business units, CooperVision and CooperSurgical. CooperVision brings a refreshing perspective on vision care with a commitment to crafting quality lenses for contact lens wearers and providing focused practitioner support. CooperSurgical focuses on supplying women’s health clinicians with market leading products and treatment options to improve the delivery of healthcare to women. Both companies provide superior product range and quality, along with friendly customer service and a drive to continually innovate. Cooper and CooperVision are headquartered in Pleasanton, CA, and CooperSurgical is headquartered in Trumbull, CT.
Forward-Looking Statements
This news release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Statements relating to plans, prospects, goals, strategies, future actions, events or performance and other statements which are other than statements of historical fact, including all statements regarding resuming shipments and expectations as to inventory levels are forward-looking. To identify these statements look for words like “believes,” “expects,” “may,” “will,” “should,” “could,” “seeks,” “intends,” “plans,” “estimates” or “anticipates” and similar words or phrases. Forward-looking statements necessarily depend on assumptions, data or methods that may be incorrect or imprecise and are subject to risks and uncertainties.
The factors that could cause our actual results and future actions to differ materially from those described in forward-looking statements include an expansion of the scope of the Avaira recall or taking additional actions that may be requested by a regulatory agency that would impede our ability to complete the recall and are described in our Securities and Exchange Commission filings, including the “Business” and “Risk Factors” sections in the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2010, as such Risk Factors may be updated in quarterly filings.
We caution investors that forward-looking statements reflect our analysis only on their stated date. We disclaim any intent to update them except as required by law.
COO-G
###
Exhibit 99.2
CooperVision Announces Expanded Recall of Avaira Line of Contact Lenses
Expanded Recall Involves Limited Number of Lots of Avaira Sphere Lenses
PLEASANTON, CA USA– CooperVision announced today that it is expanding its worldwide recall of the Avaira brand product line of contact lenses to include a limited number of lots of Avaira Sphere contact lenses. In continued collaboration with the United States Food and Drug Administration, CooperVision is expanding the recall because it identified certain lots of Avaira Sphere lenses that did not meet its updated quality requirements due to the level of a silicone oil residue.
The presence of the residue (silicone oil) on Avaira Sphere contact lenses may cause hazy vision or discomfort, severe eye pain or eye injuries requiring medical treatment. Not everyone experiences the same symptoms.
“The company is confident we found the problem and have taken corrective action to fix the problem,” said Christine Moench, Vice President, Global Regulatory Affairs and Quality Assurance. “The health and safety of our customers is our top priority.”
If you wear Avaira Sphere contact lenses and experience any symptoms, CooperVision recommends that you stop wearing the lenses immediately. Contact your eye care practitioner for advice.
Avaira Sphere contact lens wearers should:
| • | CooperVision will launch a recall site www.coopervision.com/international-recall on Wednesday November 16th for wearers to enter the package lot number found on the contact lens carton or blister label to determine if their lenses have been recalled. |
| • | Alternatively, contact CooperVision on a toll-free consumer hotline at 1-855-526-6737. |
| • | If you discover your lenses are among the recalled lots, return them to the point of purchase or to your eye care practitioner. |
In August 2011, CooperVision announced a recall of limited lots of Avaira Toric contact lenses. CooperVision has identified the issue and has corrected it through its quality system process.
CooperVision will continue to supply Avaira Sphere lenses that are not affected by this recall.
As part of the expanded recall, CooperVision is notifying its customers and requests that eye care practitioners contact their patients regarding this recall. Communication efforts are focused at eye care professional and distributors to effectively reach lens wearers. CooperVision recall efforts include:
| • | Sending worldwide recall notifications to Avaira Sphere CooperVision customers. |
| • | Issuing a press release via PR Newswire and Globe Newswire regarding the recall of limited lots of CooperVision Avaira Sphere lenses. |
| • | Providing information on the CooperVision website for lens wearers to check if their lenses are impacted (www.coopervision.com/international - recall). |
| • | An information notice has been posted on www.coopervision.com. |
| • | Offering a toll-free consumer hotline (1-855-526-6737). |
| • | Providing retailers and distributors access to patient communications materials. |
| • | Providing support and detailed information to eye care practitioners to remove recalled lots of Avaira Sphere lenses from the market place. |
| • | Offering customer care resources to answer questions from patients. |
The total number of Avaira Sphere lenses manufactured that are affected by the recall is 6.6M, of which 4.9M were shipped to customers globally. CooperVision intends to replace the recalled product with available Avaira Sphere inventory.
About CooperVision
CooperVision, a unit of The Cooper Companies, Inc. (NYSE: COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of monthly, two-week and daily disposable contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges; such as astigmatism, presbyopia and ocular dryness; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, thereby creating real advantages for customers and wearers. For more information, visit www.coopervision.com.