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):  March 11, 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 1.01.Entry into a Material Definitive Agreement.

 

On March 10, 2016, ANI Pharmaceuticals, Inc. (the "Company" or "ANI") and Cranford Pharmaceuticals, LLC ("Cranford") entered into an asset purchase agreement (the "Cranford Agreement") pursuant to which the Company agreed to acquire Cranford's right, title and interest in the NDA for Inderal® LA (the "NDA") and certain documentation, trademark rights and finished goods inventory relating to the NDA (the "Acquired Assets").

 

In consideration for the purchase of the Acquired Assets, the Company will pay Cranford (i) an aggregate purchase price of $60 million upon the closing of the acquisition and (ii) annual milestone payments. The closing of the purchase is expected to occur in the second quarter of 2016.

 

The Cranford Agreement contains various customary representations, warranties, covenants and closing conditions, as well as customary provisions relating to insurance, indemnity, confidentiality and other matters.

 

Item 7.01.Regulation FD Disclosure.

 

On March 11, 2016, the Company issued a press release to announce the execution of the Cranford Agreement.

 

The press release is available on the Company's website, www.anipharmaceuticals.com, and is furnished with this Current Report on Form 8-K as Exhibit 99.1 and incorporated into this Item 7.01 by reference.

 

In accordance with General Instruction B.2 of Form 8-K, the information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

No.   Description
     
99.1   Press release, dated March 11, 2016

 

 

 

 

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:  March 11, 2016  

 

 

 



 

Exhibit 99.1

ANI Pharmaceuticals Agrees to Acquire Inderal® LA Assets from Cranford Pharmaceuticals

BAUDETTE, Minn., March 11, 2016 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has agreed to acquire a portfolio of Inderal® LA assets from Cranford Pharmaceuticals, LLC. The acquired portfolio will include the NDA and trademark for Inderal® LA as well as finished goods inventory. Cranford Pharmaceuticals, LLC owns the NDA for Inderal® LA 60mg, 80mg, 120mg and 160mg sustained release capsules as well as the authorized generic, propranolol ER capsules, both of which are indicated for hypertension, angina pectoris, migraine and hypertrophic subaortic stenosis. According to IMS Health, Inderal® LA and the authorized generic generated combined sales of $30M in calendar year 2015.

The transaction is expected to close in the second quarter of 2016, subject to certain closing conditions. Following the close of the transaction ANI will immediately begin distributing Inderal® LA as well as the authorized generic propranolol ER.

Arthur S. Przybyl, ANI's President and CEO stated, "We are excited to add these extended release products to the ANI commercial portfolio. The acquisition, which is consistent with our strategy of pursuing limited competition generic products and mature brands, will be material to our revenue and EBITDA in 2016. We plan to provide updated financial guidance upon closing the transaction."

About Inderal® LA capsules

Hypertension

Inderal® LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal® LA is not indicated in the management of hypertensive emergencies.

Angina Pectoris Due to Coronary Atherosclerosis

Inderal® LA is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.

Migraine

Inderal® LA is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.

Hypertrophic Subaortic Stenosis

Inderal® LA improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.

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 therefor, 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; acquisitions; delays or failure in obtaining product approvals 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



ANI Pharmaceuticals (NASDAQ:ANIP)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more ANI Pharmaceuticals Charts.
ANI Pharmaceuticals (NASDAQ:ANIP)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more ANI Pharmaceuticals Charts.