Current Report Filing (8-k)
June 25 2019 - 7:42AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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):
June 25, 2019
Akorn,
Inc.
(Exact Name of Registrant as Specified in
Charter)
Louisiana
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001-32360
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72-0717400
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification Number)
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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:
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Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company
¨
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act.
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Securities registered pursuant to Section
12(b) of the Act:
Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, No Par Value
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AKRX
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The NASDAQ Global Select Market
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Item 7.01. Regulation FD Disclosure.
On June 25, 2019, Akorn,
Inc. (“Akorn” or the “Company”) issued a press release announcing that it received a warning letter from
the U.S. Food and Drug Administration (FDA) related to an inspection of its Somerset, New Jersey manufacturing facility in July
and August of 2018. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
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.
Cautionary Note Regarding Forward-Looking Statements
This report and press release
may include forward-looking statements about, among other things, the Company’s expectations regarding quality systems, action
plans, operations, initiatives, continued production of product, and other statements regarding Akorn's goals and strategy that
are subject to substantial risks and uncertainties which could cause actual results to differ materially from those expressed or
implied by such statements. These risk factors include, but are not limited to: (i) the effect of the Delaware court’s recent
decision against the Company on the Company’s ability to retain and hire key personnel, its ability to maintain relationships
with its customers, suppliers and others with whom it does business, or its operating results and business generally, (ii) the
risk that ongoing or future litigation related to the court’s decision may result in significant costs of defense, indemnification
and/or liability, (iii) the outcome of the investigation conducted by the Company with the assistance of outside consultants, into
alleged breaches of FDA data integrity requirements relating to product development at the Company and any actions taken by the
Company, third parties or the FDA as a result of such investigations, (iv) the difficulty of predicting the timing or outcome of
product development efforts, including FDA and other regulatory agency approvals and actions, if any, (v) the timing and success
of product launches, (vi) difficulties or delays in manufacturing, (vii) the Company’s increased indebtedness and compliance
with certain covenants and other obligations under the Standstill Agreement, which create material uncertainties and risks to its
growth and business outlook, (viii) the Company’s obligation under the Standstill Agreement to enter into a Comprehensive
Amendment that is satisfactory in form and substance to the Lenders, (ix) the Company’s obligation under the Standstill Agreement
to pay certain fees and expenses and increased interest margin, (x) such other risks and uncertainties outlined in the risk factors
detailed in Part I, Item 1A, “Risk Factors,” of the Company’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2018 (as filed with the Securities and Exchange Commission (“SEC”) on March 1, 2019), detailed in
Part II, Item 1A, “Risk Factors,” of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended
March 31, 2019 (filed with the SEC on May 7, 2019) and other risk factors identified from time to time in the Company’s subsequent
reports on Form 8-K and in other Company filings with the SEC. Readers should carefully review these risk factors, and should not
place undue reliance on the Company’s forward-looking statements. These forward-looking statements are based on information,
plans and estimates at the date of this report. The Company undertakes no obligation to update any forward-looking statements to
reflect changes in underlying assumptions or factors, new information, future events or other changes or developments.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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.
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Akorn, Inc.
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Date: June 25, 2019
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By:
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/s/ Duane A. Portwood
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Duane A. Portwood
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Chief Financial Officer
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