Akorn, Inc. (NASDAQ:AKRX) Files An 8-K Regulation FD Disclosure
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.
| 99.1 | Press release dated June 25, 2019, entitled “Akorn Receives FDA Warning Letter.” |
AKORN INC Exhibit
EX-99.1 2 tv524143_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Investors/Media: (847) 279-6162 Investor.relations@akorn.com Akorn Receives FDA Warning Letter LAKE FOREST,…
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About Akorn, Inc. (NASDAQ:AKRX)
Akorn Inc., together with its subsidiaries, is a specialty pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals, as well as private-label over-the-counter (OTC) consumer health products and animal health pharmaceuticals. The Company operates through two segments: Prescription Pharmaceuticals and the Consumer Health. The Prescription Pharmaceuticals segment is engaged in manufacturing and marketing generic and branded prescription pharmaceuticals, including ophthalmics, injectables, oral liquids, otics, topical, inhalants and nasal sprays. The Consumer Health segment is engaged in manufacturing and marketing branded and private-label animal health and OTC products. The Company’s Akorn Consumer Health division (ACH) markets a portfolio of OTC brands and various formulations of private-label OTC pharmaceutical products. Its OTC brand is TheraTears Therapy for Your Eyes, which is a family of therapeutic eye care products.