0000000000-18-032671.txt : 20181213 0000000000-18-032671.hdr.sgml : 20181213 20181018105952 ACCESSION NUMBER: 0000000000-18-032671 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20181018 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: ANI PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001023024 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 582301143 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 210 MAIN STREET WEST CITY: BAUDETTE STATE: MN ZIP: 56623 BUSINESS PHONE: 2186343500 MAIL ADDRESS: STREET 1: 210 MAIN STREET WEST CITY: BAUDETTE STATE: MN ZIP: 56623 FORMER COMPANY: FORMER CONFORMED NAME: BIOSANTE PHARMACEUTICALS INC DATE OF NAME CHANGE: 19991228 FORMER COMPANY: FORMER CONFORMED NAME: BEN ABRAHAM TECHNOLOGIES INC DATE OF NAME CHANGE: 19991027 PUBLIC REFERENCE ACCESSION NUMBER: 0001144204-18-011197 LETTER 1 filename1.pdf begin 644 filename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end TEXT-EXTRACT 2 filename2.txt October 18, 2018 Stephen P. Carey Vice President, Finance and Chief Financial Officer ANI Pharmaceuticals, Inc. 210 Main Street West Baudette, MN 56623 Re: ANI Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended December 31, 2017 Filed February 27, 2018 File No. 001-31812 Dear Mr. Carey: We have reviewed your September 18, 2018 response to our comment letter and have the following comment. In our comment we ask you to provide us with information so we may better understand your disclosure. Please respond to this comment within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe our comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to the comment, we may have additional comments. Form 10-K for the Fiscal Year Ended December 31, 2017 5. Intangible Assets Definite-lived Intangible Assets Acquisition of New Drug Applications and Product Rights, page 89 1. We acknowledge your response to comment 1 in our letter dated September 7, 2018. With respect to the Product Rights Acquired from AstraZeneca, your response does not consider risks, other than marketing and promotional risks. At a minimum, please address the following potential risks: The drugs are intended to treat significantly different conditions which bear the risk of potentially different long-term side effects. Branded drugs are subject to litigation which may not occur for years after being marketed; Each drug has a significantly different potential customer base with different Stephen P. Carey ANI Pharmaceuticals, Inc. October 18, 2018 Page 2 regulatory risks; Each drug has different risks with respect to being on drug formulary lists; and Although the products have been marketed for more than 17 years, the competition differs for each of the different drugs, despite the lack of promotional activity for the drugs. In light of the risks, other than marketing and promotional risk, please tell us why you believe the product rights acquired from AstraZeneca do not have significantly different risk characteristics and thus meet the "practical screen" test in ASC 805-10-55-5A through 55-5C. If the acquisitions do not meet the "practical screen test" please address each of the criteria in ASC 805-10-55-5E in determining whether or not a substantive process was acquired, that together with the input acquired, significantly contribute to the ability to create outputs. You may contact Vanessa Robertson at 202-551-3649 or Mary Mast at 202-551- 3613 with any questions. FirstName LastNameStephen P. Carey Sincerely, Comapany NameANI Pharmaceuticals, Inc. Division of Corporation Finance October 18, 2018 Page 2 Office of Healthcare & Insurance FirstName LastName