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United States securities and exchange commission logo
December 7, 2023
Shoshana Shendelman
President and Chief Executive Officer
Applied Therapeutics Inc.
545 Fifth Avenue, Suite 1400
New York, NY 10017
Re: Applied
Therapeutics Inc.
Form 10-K for the
Fiscal Year Ended December 31, 2022
Filed March 23,
2023
Form 10-Q for the
Nine Months Ended September 30, 2023
Filed November 9,
2023
File number
001-38898
Dear Shoshana Shendelman:
We have limited our review of your filing to the financial
statements and related
disclosures and have the following comment.
Please respond to this letter 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
the comment applies to your facts and circumstances, please tell us why
in your response.
After reviewing your
response to this letter, we may have additional comments.
Form 10-Q for the Nine Months Ended September 30, 2023
Notes to the Financial Statements
15. Revenue
License Agreement with Advanz Pharma, page 30
1. You disclose on page
F-32 of the 10-K that under the agreement with
ADVANZ PHARMA you
remain responsible for development of the Licensed Product,
and must conduct such
development in the Territory. You state that you retain sole
responsibility for the
conduct of all clinical trials (subject to cost sharing with ADVANZ
PHARMA), unless the
company provides ADVANZ PHARMA prior consent to conduct
certain studies
following marketing authorization, or ADVANZ PHARMA exercises
certain step-in rights.
The company is also responsible for the manufacture and supply of
the Licensed Product to
ADVANZ PHARMA. You state on page 31 of the 10-Q that you
identified two
performance obligations, the exclusive license to commercialize the
Shoshana Shendelman
Applied Therapeutics Inc.
December 7, 2023
Page 2
Licensed Product, that was satisfied on the date of the execution of
the
ADVANZ Agreement when control of the license was transferred, and the
obligation to
manufacture and supply ADVANZ with the Product. Please address the
following:
Tell us why you have not identified the development of the
Licensed Product and
performance of the clinical trials as a performance obligation.
Clarify to us if you believe the license is distinct from the
other performance
obligations and provide your accounting basis for your conclusion.
Tell us why you have not allocated some of the upfront payment to
the manufacture
and supply of the License Product as well as the obligation to
develop the Licensed
Product and perform the clinical trials.
Clarify to us, and in future filings, how you account for the
cost-sharing with
ADVANZ PHARMA and tell us the basis for your accounting treatment.
In closing, we remind you that the company and its management are
responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review,
comments, action or
absence of action by the staff.
Please contact Mary Mast at 202-551-3613 or Daniel Gordon at
202-551-3486 with any
questions.
FirstName LastNameShoshana Shendelman Sincerely,
Comapany NameApplied Therapeutics Inc.
Division of
Corporation Finance
December 7, 2023 Page 2 Office of Life
Sciences
FirstName LastName