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): August 25, 2016
Akorn, Inc.
(Exact Name of Registrant as Specified in Charter)
| Louisiana | 001-32360 | 72-0717400 |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) |
| 1925 W. Field Court, Suite 300 , Lake Forest, Illinois 60045 |
| (Address of Principal Executive Offices) (Zip Code) |
(847) 279-6100
(Registrant's telephone number, including area code)
(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: | ||
| [ ] | 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 7.01. Regulation FD Disclosure.
On August 25, 2016, Akorn, Inc. announced its relaunching of Ofloxacin Otic Solution 0.3%, a sterile aqueous anti-infective solution for otic use. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated by reference into this Item 7.01. The information in this Item 7.01, including exhibit 99.1 attached hereto, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. See attached exhibit index.
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.
| Akorn, Inc. | ||
| Date: August 25, 2016 | By: | /s/ Duane A. Portwood |
| Duane A. Portwood | ||
| Chief Financial Officer | ||
Exhibit Index
| Exhibit Number | Description of Exhibit | |
| 99.1 | Press release dated August 25, 2016, issued by Akorn, Inc. entitled “Akorn Relaunches Ofloxacin Otic Solution.” |
EXHIBIT 99.1
Akorn Relaunches Ofloxacin Otic Solution
LAKE FOREST, Ill., Aug. 25, 2016 (GLOBE NEWSWIRE) -- Akorn, Inc. (Nasdaq:AKRX), a leading specialty pharmaceutical company, today announced that it has relaunched Ofloxacin Otic Solution 0.3%, a sterile aqueous anti-infective solution for otic use.
About Ofloxacin Otic Solution
Ofloxacin Otic Solution is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
According to IMS Health, sales of Ofloxacin Otic Solution were approximately $33 million for the twelve months ended June 30, 2016.
About Akorn
Akorn, Inc. is a specialty generic pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois; Somerset, New Jersey; Amityville, New York; Hettlingen, Switzerland and Paonta Sahib, India that manufacture ophthalmic, injectable and specialty sterile and non-sterile pharmaceuticals. Additional information is available on Akorn’s website at www.akorn.com.
Forward Looking Statements
This press release includes statements that may constitute "forward looking statements", including statements regarding Akorn's goals and strategy. When used in this document, the words “continue,” “anticipate,” “plan,” “will,” “believe,” “estimate” and “expect” and similar expressions are generally intended to identify forward looking statements. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the susceptibility of our generic and off patent pharmaceutical products to competition, substitution policies and reimbursement policies of the government; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations; the continuing consolidation of our customer base, which could adversely affect sales of our products; our dependence on a small number of distributors, the loss of any of which could have a material adverse effect; changes in the laws and regulations and such other risks and uncertainties outlined in Akorn's public filings with the SEC. Except as expressly required by law, Akorn disclaims any intent or obligation to update these forward looking statements.
Investors/Media:
Stephanie Carrington
ICR, Inc.
(646) 277-1282
Stephanie.carrington@icrinc.com