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): December 26, 2013
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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 December 26, 2013 (the "Effective Date"), ANI Pharmaceuticals, Inc., a Delaware corporation (the "Company" or "ANI"), Teva Pharmaceuticals USA, Inc., a Delaware corporation, and certain affiliates of Teva Pharmaceuticals USA, Inc. (collectively, "Teva"), entered into an Asset Purchase Agreement pursuant to which the Company agreed to acquire all of Teva's right, title and interest, within the United States and its territories, in 31 Abbreviated New Drug Applications (collectively the "ANDAs" and each a "Product ANDA") and certain documents relating thereto (together with the ANDAs, the "Purchased Assets") for a total purchase price of $12.5 million to be paid in cash by the Company in two installments (the "Up-Front Payments"). The first installment will be a non-refundable payment in the amount of $8.0 million (the "Initial Payment") no later than five (5) business days following the Effective Date upon the execution by the Company and Teva of a bill of sale relating to and delivery to the Company of all of the Purchased Assets that are in electronic form as well as certain Purchased Assets that are in hardcopy (the "Initial Purchased Assets"). The second installment will be a non-refundable payment in the amount of $4.5 million (the "Second Payment") no later than ninety (90) calendar days following the Effective Date upon the execution by the Company and Teva of a second bill of sale relating to and delivery to the Company of all of the Purchased Assets other than the Initial Purchased Assets. In addition to the Up-Front Payments, the Company has agreed to pay, for each product manufactured by the Company pursuant to a Product ANDA (a "Product"), a royalty on future gross profits from product sales.
Under the Asset Purchase Agreement, the Company assumes all liabilities and obligations for the Purchased Assets from and after the date such Purchased Assets are acquired following payment of the Initial Payment and Second Payment.
The Asset Purchase Agreement contains various representations, warranties and covenants, as well as provisions relating to insurance, confidential information and confidentiality and other matters. Except as set forth in the Asset Purchase Agreement, Teva is selling the Purchased Assets on an "as is" and "where is" basis and makes no further representation or warranty with respect to the Purchased Assets.
| Item 9.01 | Financial Statements and Exhibits |
| (d) | Exhibits |
| 99.1 | Press release of ANI Pharmaceuticals, Inc., dated December 26, 2013. |
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 and Chief Financial Officer | ||
| Dated: December 26, 2013 | ||
| FOR IMMEDIATE RELEASE | NASDAQ: ANIP |
ANI Pharmaceuticals Acquires 31 Generic Drug Products from Teva Pharmaceuticals
Baudette, MN (December 26, 2013) – ANI Pharmaceuticals, Inc. (NASDAQ: ANIP), an emerging generic pharmaceutical company, today announced that it has acquired 31 previously marketed generic drug products from Teva Pharmaceuticals for $12.5 million in cash and a percentage of future gross profits from product sales. The acquisition includes 20 solid-oral immediate release products, 4 extended release products and 7 liquid products. ANI will begin work immediately on transferring these products into its manufacturing facilities in anticipation of product launches beginning in the fourth quarter of 2014. All of these products have been previously approved by FDA as abbreviated new drug applications (ANDAs). The total current annual market for these products is $860 million per IMS Health.
Arthur S. Przybyl, President and CEO of ANI Pharmaceuticals, stated, “This acquisition is a significant opportunity for ANI to expand our generic product portfolio beyond our current seven marketed products. When launched, these products will strengthen our business by growing our revenue base and leveraging our manufacturing capabilities. We are excited that this transaction extends the ANI-Teva relationship beyond the existing generic testosterone gel partnership.”
Robert W. Schrepfer, VP of New Business Development, commented, “This transaction demonstrates ANI’s commitment to diversify our marketed product portfolio and supplement our internal product development efforts through a business development plan that includes partnerships, acquisitions and in-licensing.”
About ANI
ANI is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. In two facilities with combined manufacturing, packaging and laboratory capacity totaling 173,000 square feet, ANI manufactures oral solid dose products, as well as liquids and topicals, including narcotics and those that must be manufactured in a fully contained environment due to their potency and/or toxicity. ANI also performs contract manufacturing for other pharmaceutical companies. Over the last two years ANI has launched three new products and has twelve products in development. ANI’s targeted areas of product development include narcotics, anti-cancers and hormones (potent compounds), and extended release niche generic product opportunities. ANI’s other products include an FDA-approved testosterone gel, which is licensed to Teva Pharmaceuticals USA. 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 under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the potential benefits of the merger, the combined company’s plans, objectives, expectations and intentions with respect to future operations and products, the anticipated financial position, operating results and growth prospects of the combined company 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. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause the combined company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include the risk that the Company may in the future be required to seek FDA approval for its unapproved products or withdraw such products from the market; the Company may fail to meet NASDAQ listing requirements; general business and economic conditions; the Company’s need for and ability to obtain additional financing; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; and the marketing success of the Company’s licensees or sublicensees. 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 this quarterly report on Form 10-Q, as well as its proxy statement/prospectus, filed with the Securities and Exchange Commission on May 8, 2013. All forward-looking statements in this release speak only as of the date made and are based on the Company’s current beliefs 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.