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