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 1, 2014
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. |
The information set forth below under “Item 2.01 Completion of Acquisition or Disposition of Assets” is incorporated herein by reference.
| Item 2.01 | Completion of Acquisition or Disposition of Assets. |
On August 1, 2014, (the "Closing Date"), ANI Pharmaceuticals, Inc., a Delaware corporation, (the "Company") acquired the rights to manufacture, promote, distribute and sell the drug product Vancocin® in the United States and certain Abbreviated New Drug Applications relating to the injectable and oral forms of vancomycin hydrochloride, which are currently non-marketed products, from Shire ViroPharma Incorporated ("ViroPharma") pursuant to that certain Asset Purchase Agreement (the "ViroPharma Agreement"), dated as of the Closing Date by the Company and ViroPharma.
In consideration for the acquisition of the U.S. rights to Vancocin and the ANDAs relating to the injectable and oral forms of vancomycin hydrochloride, the Company paid ViroPharma $11,000,000 on the Closing Date.
The ViroPharma Agreement contains customary representations, warranties and covenants from the Company and ViroPharma, as well as provisions relating to indemnity, confidentiality and other matters.
| Item 9.01 | Financial Statements and Exhibits. |
(c) Exhibits.
|
Exhibit No. |
Description | |
99.1 |
Press release of ANI Pharmaceuticals, Inc., dated August 1, 2014 |
| 2 |
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.
| ANI PHARMACEUTICALS, INC. | ||
| By: | /s/ Charlotte C. Arnold | |
| Charlotte C. Arnold | ||
| Vice President, Finance and Chief Financial Officer | ||
| Dated: August 1, 2014 | ||
| 3 |
ANI Pharmaceuticals Acquires Vancocin® Capsules and Additional Vancomycin Assets from Shire
BAUDETTE, Minn., Aug. 1, 2014 /PRNewswire/ -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) today announced that it has acquired the US rights for Vancocin® 125 mg and 250 mg capsules from Shire plc, a global biopharmaceutical company. In addition, ANI acquired from Shire approved ANDAs for the currently non-marketed products vancomycin hydrochloride injectable 500 mg, 1 gm and 10 gm ($45 million in 2013 market value, per IMS Health) and vancomycin hydrochloride oral solution 250 mg and 500 mg. ANI paid $11 million in cash for the rights to Vancocin® together with existing inventories on hand. Following a transition period, ANI intends to launch Vancocin® capsules under its own label during the fourth quarter of 2014. The transaction is immediately accretive and sales of Vancocin® capsules are expected to generate approximately $5.4 million in revenues and $4 million in non-GAAP EBITDA annually.
Arthur S. Przybyl, ANI's President and CEO stated, "We are excited to add Vancocin® capsules to our portfolio of mature brand products. In addition, we will immediately begin exploring opportunities to launch both vancomycin injectable and vancomycin oral solution. Year to date we have invested $23 million in two mature brand acquisitions that will contribute a combined $9.4 million in annual revenues and $8 million in annual non-GAAP EBITDA. At the same time, we are continuing to advance our internal generic product development pipeline while selectively pursuing acquisitions and partnerships that augment those efforts."
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:
Arthur S. Przybyl
(218) 634-3608
arthur.przybyl@anipharmaceuticals.com