Correspondence 0001104659-24-006710 from Applied Therapeutics, Inc. (APLT) (CIK 0001697532)
Applied Therapeutics, Inc. (APLT) (CIK 0001697532)
Date: Jan. 25, 2024 · CIK: 0001697532 · Accession: 0001104659-24-006710
AI Filing Summary & Sentiment
File numbers found in text: 001-38898
Referenced dates: December 7, 2023
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APLT SEC Comment Letter
Response – Advanz
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, DC 20549
Attn: Mary Mast and Daniel Gordon
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
Ladies and Gentlemen:
On behalf of Applied Therapeutics, Inc.
(the “Company”, “we,” and “our”), set forth below is the Company’s response to the comment
letter dated December 7, 2023 provided by the staff of the Office of Life Sciences of the Division of Corporation Finance (the “Staff”)
of the U.S. Securities and Exchange Commission (the “Commission”) to the Company regarding the Company’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2022 (the “Form 10-K”), filed on March 23,
2023 and the Company’s Quarterly Report on From 10-Q for the nine months ended September 30, 2023, filed on November 9,
2023.
For the Staff’s convenience, we have
repeated the comment in full.
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 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.
The Company respectfully acknowledges the
Staff’s comment and has reviewed its position in light of the Staff’s comment. In future filings, the Company
will revise its accounting analysis of the arrangement with ADVANZ PHARMA (“ADVANZ”) and related revenue recognition,
as detailed below. In particular, the Company has concluded that additional promises exist within the ADVANZ License and Development
Agreement (the “Agreement” or the “Contract”).
The Company considered ASC 606-10-25-14 through 25-22 in evaluating the promises in the Contract. The Company identified the following
promises to ADVANZ (the “Customer”): (1) delivery of the exclusive license to commercialize the Licensed Product; (2) commitment
to provide research and development of the product pre- and post-marketing authorization; (3) participation in the pricing and market
access committee (“PMAC”); (4) the commitment to manufacture and supply ADVANZ with the product at its cost; and (5) granting
ADVANZ a right of negotiation and “most-favored nation” rights with respect to acquiring the European commercialization rights
for any additional indications.
The Company concluded the following with respect to each identified
promise:
(1) Delivery of the exclusive license to commercialize the Licensed
Product – as discussed below, the Company has concluded that the license is distinct
from the other promises and is considered a performance obligation.
(2) Commitment to provide research and development of the product pre-
and post-marketing authorization – as discussed below, the Company has concluded that
this promise is distinct from the other promises in the Contract and is considered a performance
obligation.
(3) Participation in the PMAC – The Company has considered that while
both parties are required to participate in the PMAC, this participation is considered to be informative in nature and the time and value
of the promise is not material to the Company or the Agreement, quantitatively or qualitatively. As a result, consistent with the guidance
in ASC 606-10-25-16A, the Company did not assess this promise as a performance obligation.
(4) The commitment to manufacture and supply ADVANZ with product at its
cost – Under the terms of the agreement, the Company is obligated to manufacture and supply ADVANZ for any optional purchases of
product by ADVANZ post marketing authorization. While the purchases by ADVANZ are optional, the Company concluded that the pricing (at
cost) represented a material right, consistent with the guidance in ASC 606-10-55-42.
(5) The right of negotiation and “most-favored nation” rights
with respect to acquiring the European commercialization rights for any additional indications is purely an option provided to the Customer
which allows it to submit a pricing proposal that the Company may or may not accept. As such, it does not represent a right to acquire
a license at a discount to the standalone selling price. The Company will account for this option if and when it is exercised as a separate
contract. The Company concluded that this is a marketing offer and not a performance obligation.
The Company confirms that it will provide expanded disclosure of all
performance obligations related to the Agreement in its future annual and quarter reports filed pursuant to under the Securities Exchange
Act of 1934, as amended, beginning with the Company’s upcoming filing on Form 10-K for the year ended December 31, 2023. See Appendix
A for expanded disclosure.
· Clarify
to us if you believe the license is distinct from the other performance obligations and provide
your accounting basis for your conclusion.
In accordance with ASC 606-10-25-19, the Company first assessed whether
the Customer could benefit from the license either on its own or together with other resources that are readily available to the customer
(that is, the good or service is capable of being distinct). Upon the delivery of the license, the Customer had the ability to benefit
from the intellectual property (“IP”) by executing its right to sublicense the IP. The Customer also has the ability and resources
to complete the development itself or with the assistance of a contract research organization, without changing the licensed IP given
that all of the requisite knowledge and information had been conveyed to the Customer as part of the license transfer. Further, the Customer,
and certain third-party providers, have the requisite knowledge, experience and capabilities to perform the associated manufacturing and
commercialization activities. As a result, the license is considered to have stand-alone value and the Customer could derive full utility
from the delivered license. The promise to deliver the license was capable of being distinct, satisfying the criterion set forth in ASC 606-10-25-19(a).
After concluding that the license was capable of being distinct, the
Company assessed whether the license was distinct in the context of the contract in accordance with ASC 606-10-25-19(b). In assessing
whether the Company’s promises to transfer the license and the other promises are separately identifiable, the Company considered
the factors in ASC 606-10-25-21. The Company concluded that the license and the other promises in the contract, including the commitment
to perform research and development of the product, are not inputs to a combined item in the Contract. The Customer could separately purchase
the license without significantly affecting its ability to benefit from the license (i.e., the Customer could sub-license). Neither the
license nor the other promises in the Contract are significantly modified or customized by the other since the product is in a Phase 3
trial and the underlying IP is not expected to be modified. In addition, entity is not providing a significant service of integrating
those items into a combined output. Further, the license and the other promises are not highly interdependent or highly interrelated
because the Company was able to fulfill its promise to transfer the license independent of fulfilling its other promises in the Contract.
Therefore, the Company concluded that the performance obligation to deliver the license was distinct in the context of the Contract, satisfying
the criterion set forth in ASC 606-10-25-19(b) .
· 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.
In our revised analysis, we allocated the total transaction price to
the following performance obligations on a relative standalone selling price basis and determined whether the transaction price allocated
to each performance obligation should be recognized at a point in time or over time:
Performance
Obligation
Allocated
Transaction Price
(in millions) at Contract Inception
Recognition
Delivery
of the exclusive license to commercialize the Licensed Product
$9.3
Point
in time – upon delivery
Commitment
to provide research and development of the Licensed Product pre- and post-marketing authorization
1.3
Over time - The Company recognizes revenue related to research and
development services performed using an input method based on costs incurred relative to total costs expected to be incurred as this measure
of progress best depicts our performance in transferring control to the Customer.
Commitment
to manufacture and supply Advanz with the product – material right
0.1
The Company will recognize revenue when the future supply is transferred
or when the option expires
Total
$10.7
With respect to the 2023 annual financial statements, the Company will
record a deferral of revenue of approximately $667,000 at December 31, 2023, related to the performance obligations not yet satisfied
as of year-end 2023. We evaluated the materiality of the error from a quantitative and qualitative perspectives with respect to the Company’s
2023 quarterly financial statements and concluded that the error was not material to any period.
The Company confirms that it will provide expanded disclosure related
to the Agreement in its future annual and quarter reports filed pursuant to the Securities Exchange Act of 1934, as amended, beginning
with the Company’s upcoming filing on Form 10-K for the year ended December 31, 2023. See Appendix A for expanded disclosure.
· 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.
Thank you for your comment. As described above, the Company has concluded
that the promise to provide research and development of the product pre- and post-marketing authorization represents a performance obligation
that is recognized over time. Any consideration received under the cost-sharing arrangement represents variable consideration and is subject
to the constraint guidance in ASC 606-10-32-11 and ASC 606-10-32-12. The Company estimated the amount of the variable consideration using
the expected value method in accordance with ASC 606-10-32-8 at contract inception and will update its estimate at the end of each of
the reporting period (including our assessment of whether the estimate of variable consideration is constrained) in accordance with ASC
606-10-32-14.
Appendix A
Revised Footnote Disclosure
Accounting Policy Footnote:
Under ASU 2014-09, Revenue from Contracts with Customers (Topic
606), or ASC 606, as amended by ASU 2016-08, 2016-10, 2016-12 and 2016-20, the Company recognizes revenue in an amount that reflects
the consideration to which it expects to be entitled in exchange for the transfer of promised goods or services to customers. To determine
revenue recognition for contracts with customers that are within the scope of ASC 606, the Company performs the following steps: (1) identifies
the contract with the customer, (2) identifies the performance obligations in the contract, (3) determines the transaction
price, (4) allocates the transaction price to the performance obligations in the contract, and (5) recognizes revenue when
(or as) the entity satisfies a performance obligation.
The Company has entered into an agreement to license its
intellectual property, or IP, related to Galactosemia and SORD to develop, manufacture and/or commercialize drug products with
Mercury Pharma Group Limited, trading as Advanz Pharma Holdings, (“Advanz Pharma”). The agreement contains multiple
performance obligations, including licenses of IP, research and development services, and the manufacturing and supply material
right. Payments to the Company under this agreement may include nonrefundable fees, payments for research activities, payments based
upon the achievement of certain milestones and royalties on any resulting net product sales.
The Company identifies agreements as contracts that create enforceable
rights and obligations when the agreement is approved by the parties, the Company can identify the rights of the parties and the payment
terms, the contract has commercial substance and it is probable that the Company will collect substantially all of the consideration to
which it will be entitled in exchange for the goods and services that will be transferred to the customer. The counterparty is considered
to be a customer when it has contracted with the Company to obtain goods and services that are the output of the Company’s ordinary
activities (i.e., development of pharmaceutical products) in exchange for consideration.
A performance obligation is a promise to transfer distinct goods or
services to a customer. Performance obligations that are both capable of being distinct and distinct within the context of the contract
are considered to be separate performance obligations. Performance obligations are capable of being distinct if the counterparty is able
to benefit from the good or service on its own or together with other resources that are readily available to it. Performance obligations
are distinct within the context of the contract when each performance obligation is separately identifiable. In assessing whether the
Company’s promises to transfer goods or services to the customer are separately identifiable, the Company considers factors in ASC
606, including whether the Company uses the goods or services as inputs to produce or deliver a com