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
Date of Report (Date of earliest event reported): September 23, 2013
LANTHEUS MEDICAL IMAGING, INC.
(Exact name of registrant as specified in its charter)
Delaware | | 333-169785 | | 51-0396366 |
(State or other jurisdiction of
incorporation) | | (Commission File Number) | | (IRS Employer Identification
No.) |
331 Treble Cove Road, North Billerica, MA 01862
(Address of principal executive offices) (Zip code)
Registrant’s telephone number, including area code: (978) 671-8001
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 (see General Instruction A.2. below):
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 September 23, 2013, we sent our first shipments of newly-manufactured Neurolite® to customers. Barring any unforeseen circumstances, we will work to rebuild our inventory levels of Neurolite® manufactured by Ben Venue Laboratories, Inc. (“BVL”) to fill our customer needs until our new manufacturer, Jubilant HollisterStier (“JHS”), has been fully qualified to manufacture, and is supplying, Neurolite®. We can give no assurances, however, that additional Neurolite® recently manufactured by BVL will successfully complete the quality review and commercial release process, or that BVL will be able to manufacture Neurolite® for us on a timely basis prior to the expiration of our BVL manufacturing and service contract on December 31, 2013. We can also give no assurances as to when the technology transfer at JHS will be completed and when we will actually receive supply of Neurolite® from JHS.
Cautionary Note Regarding Forward-Looking Statements
Some of the statements contained in this Current Report on Form 8-K are forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, in particular, statements about our plans, strategies and prospects. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. The matters referred to in the forward-looking statements contained in this Current Report on Form 8-K may not in fact occur. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions and other factors that are discussed in other documents we file with the Securities and Exchange Commission, such as those set forth in our Annual Report on Form 10-K for the year ended December 31, 2012, including, without limitation, our dependence upon third parties for the manufacture and supply of a substantial portion of our products, and risks associated with BVL’s manufacturing of our products and the regulatory requirements related thereto.
Any forward-looking statement made by us in this Current Report on Form 8-K speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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SIGNATURES
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.
| LANTHEUS MEDICAL IMAGING, INC. |
| |
| By: | /s/ Michael P. Duffy |
| Name: | Michael P. Duffy |
| Title: | Vice President and General Counsel |
Date: September 23, 2013
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