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):  January 4, 2016

 

ANI PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-31812   58-2301143
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (I.R.S. Employer
Identification Number)

 

210 Main Street West

Baudette, Minnesota

  56623
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code:  (218) 634-3500

 

 

(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 2.01Completion of Acquisition or Disposition of Assets.

 

On January 4, 2016, ANI Pharmaceuticals, Inc. (the "Company" or "ANI") and Merck Sharp & Dohme B.V. ("Merck") completed the previously announced acquisition of certain assets (the "Acquisition") pursuant to the Asset Purchase Agreement, dated September 18, 2015, between ANI and Merck (the "Agreement"). Pursuant to Agreement, the Company acquired Merck's right, title and interest in NDA #008975 for purified corticotropin gel and NDA #009854 for corticotropin-zinc hydroxide (collectively, the "NDAs") and certain documentation and trademark rights relating to the products under the NDAs (the "Acquired Assets"). The Company also received a non-exclusive, irrevocable, perpetual right and license (with the right to grant sublicenses) to certain manufacturing technology relating to the manufacture of the products under the NDAs.

 

In consideration for the purchase of the Acquired Assets, the Company paid Merck an aggregate purchase price of $75 million and will pay to Merck a percentage of future net sales of the products under the NDAs.

 

The Company assumed all liabilities and obligations for the Acquired Assets, except for any liabilities arising from the manufacture or sale of products under the NDAs prior to the closing of the acquisition.

 

A press release announcing the closing of the Acquisition is filed with this Current Report on Form 8-K as Exhibits 99.1 and incorporated into this Item 2.01 by reference.

 

 

Item 9.01   Financial Statements and Exhibits.

 

(d) Exhibits

 

No.   Description
     
99.1   Press release, dated January 5, 2016.

 

 

 

 

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.

 

  ANI PHARMACEUTICALS, INC.  
     
  By: /s/ Charlotte C. Arnold  
    Charlotte C. Arnold  
    Vice President, Finance, and Chief Financial Officer  
Dated:  January 5, 2016    

  

 

Exhibit 99.1
 

ANI Pharmaceuticals Closes Transaction to Acquire Two NDAs from Merck for $75 Million



-         NDA #008975 Purified Cortrophin Gel, 40 units/mL and 80 units/mL

-         NDA #009854 Cortrophin-Zinc hydroxide, 40 units/mL

BAUDETTE, Minn., Jan. 5, 2016 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today announced that it has completed the acquisition of the NDAs for purified corticotropin gel and corticotropin zinc hydroxide from Merck (known as MSD outside of the United States and Canada) for $75 million in cash and a percentage of future net sales. The acquisition was funded through cash on hand.

The assets were acquired from a Dutch subsidiary of Merck by ANI Pharmaceuticals C.V., a Netherlands based wholly owned indirect subsidiary of ANI.

Arthur S. Przybyl, President and CEO of ANI Pharmaceuticals stated, "Having now closed the acquisition of the corticotrophin NDAs, we look forward to advancing our re-commercialization plan."

About ANI

ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website www.anipharmaceuticals.com.

Forward-Looking Statements

To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about price increases, the Company's future operations, products financial position, operating results and prospects , the Company's pipeline or potential markets therefore, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "plans," "potential," "future," "believes," "intends," "continue," other words of similar meaning, derivations of such words and the use of future dates.

Uncertainties and risks may cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; increased competition; delays or failure in obtaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory and other approvals and marketing.

More detailed information on these and additional factors that could affect the Company's actual results are described in the Company's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as its proxy statement. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company's current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticals.com