Correspondence 0001104659-23-007254 from ANI PHARMACEUTICALS INC (ANIP) (CIK 0001023024) (ANIP)
ANI PHARMACEUTICALS INC (ANIP) (CIK 0001023024)
Date: Jan. 27, 2023 · CIK: 0001023024 · Accession: 0001104659-23-007254
AI Filing Summary & Sentiment
File numbers found in text: 001-31812
Letter
ANI Pharmaceuticals, Inc.
210 Main Street West
Baudette, Minnesota 56623
January 27, 2023
Division of Corporation Finance
Office of Life Sciences
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: ANI Pharmaceuticals, Inc.
Form 10-K for Fiscal Year Ended December 31, 2021
Filed March 15, 2022
Form 8-K furnished August 8, 2022
File No. 001-31812
Ladies and Gentlemen:
Set forth below are the responses of ANI Pharmaceuticals, Inc. (the “Company,” “ANI,” “we,” “us” or “our”) to the oral comment received from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) on January 12, 2023. For your convenience, our response is prefaced by the exact text of the Staff’s oral comment in bold, italicized text.
We acknowledge your response to comment 3 in your proposed footnote disclosure. Please confirm you will revise your proposed disclosure to eliminate reference to changes being made ‘at the request of the U.S. Securities and Exchange Commission’.
RESPONSE: We acknowledge your comment and would propose the following language in the proposed footnote disclosure, with the proposed change in bold, italicized text:
“Beginning in the fourth quarter of 2022, ANI will no longer exclude expenses for In Process Research & Development or Cortrophin pre-launch charges and sales and marketing expenses from its non-GAAP results. Historically, the company excluded these charges. These changes are being made to align with views expressed by the U.S. Securities and Exchange Commission. Prior periods have been recast to reflect these changes.
- For the period ended December 31, 2022, non-GAAP financial measures have been recast to include $1.15 million of incremental R&D expense and a related reduction in full year Adjusted non-GAAP Diluted Earnings per Share of $0.06 as compared to amount reported in our third quarter 2022 earnings release and associated Form 8-K.
- For the period ended December 31, 2021, non-GAAP results have been recast to include $780K of additional Purified Cortrophin Gel pre-launch charges and $13.4 million of Cortrophin related SG&A expense, and a related reduction in full year Adjusted non-GAAP Diluted Earnings per Share of $0.86, resulting in a revised 2021 Adjusted non-GAAP Diluted Earnings per Share of $2.36.”
* * * * *
Should you have any questions with respect to the foregoing or if any additional supplemental information is required by the Staff, please contact Meredith W. Cook, SVP, General Counsel and Corporate Secretary of ANI Pharmaceuticals, Inc. at 609-759-1810 ext. 1001.
Sincerely,
ANI
Pharmaceuticals, Inc.
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ANI Pharmaceuticals, Inc.
210 Main Street West
Baudette, Minnesota 56623
January 27, 2023
Division of Corporation Finance
Office of Life Sciences
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: ANI Pharmaceuticals, Inc.
Form 10-K for Fiscal Year
Ended December 31, 2021
Filed March 15, 2022
Form 8-K furnished August
8, 2022
File No. 001-31812
Ladies and Gentlemen:
Set forth below are the responses
of ANI Pharmaceuticals, Inc. (the “Company,” “ANI,” “we,” “us” or “our”) to
the oral comment received from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange
Commission (the “Commission”) on January 12, 2023. For your convenience, our response is prefaced by the exact text of the
Staff’s oral comment in bold, italicized text.
We acknowledge your response to comment
3 in your proposed footnote disclosure. Please confirm you will revise your proposed disclosure to eliminate reference to changes being
made ‘at the request of the U.S. Securities and Exchange Commission’.
RESPONSE: We acknowledge your comment and
would propose the following language in the proposed footnote disclosure, with the proposed change in bold, italicized text:
“Beginning in the fourth quarter of 2022,
ANI will no longer exclude expenses for In Process Research & Development or Cortrophin pre-launch charges and sales and marketing
expenses from its non-GAAP results. Historically, the company excluded these charges. These changes are being made to align with
views expressed by the U.S. Securities and Exchange Commission. Prior periods have been recast to reflect these changes.
- For the period ended December 31, 2022, non-GAAP
financial measures have been recast to include $1.15 million of incremental R&D expense and a related reduction in full year Adjusted
non-GAAP Diluted Earnings per Share of $0.06 as compared to amount reported in our third quarter 2022 earnings release and associated
Form 8-K.
- For the period ended December 31, 2021,
non-GAAP results have been recast to include $780K of additional Purified Cortrophin Gel pre-launch charges and $13.4 million of
Cortrophin related SG&A expense, and a related reduction in full year Adjusted non-GAAP Diluted Earnings per Share of $0.86,
resulting in a revised 2021 Adjusted non-GAAP Diluted Earnings per Share of $2.36.”
* * * * *
Should you have any questions
with respect to the foregoing or if any additional supplemental information is required by the Staff, please contact Meredith W. Cook,
SVP, General Counsel and Corporate Secretary of ANI Pharmaceuticals, Inc. at 609-759-1810 ext. 1001.
Sincerely,
ANI
Pharmaceuticals, Inc.
By:
/s/
Stephen P. Carey
Name:
Stephen P. Carey
Title:
Senior Vice President Finance
and Chief Financial Officer
Enclosures
cc: Nikhil Lalwani, ANI Pharmaceuticals, Inc.
Meredith W. Cook, ANI Pharmaceuticals,
Inc.