Correspondence 0001104659-23-084560 from RVL Pharmaceuticals plc (RVLPQ) (CIK 0001739426)
RVL Pharmaceuticals plc (RVLPQ) (CIK 0001739426)
Date: July 27, 2023 · CIK: 0001739426 · Accession: 0001104659-23-084560
AI Filing Summary & Sentiment
File numbers found in text: 001-38709
Referenced dates: June 15, 2023
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CORRESP
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filename1.htm
July 27, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F. Street, N.E.
Washington, D.C. 20549
Attention:
Mary Mast
Angela Connell
Re:
RVL Pharmaceuticals plc
Form 10-K for the Fiscal Year Ended December 31, 2022
Filed March 20, 2023
File No. 001-38709
Ladies and Gentlemen:
RVL Pharmaceuticals plc (the
“Company”) is submitting this letter to the Securities and Exchange Commission (the “SEC”) via EDGAR
in response to the comment letter from the staff of the SEC (the “Staff”), dated June 15, 2023 (the “Comment
Letter”), pertaining to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022,
filed with the SEC on March 20, 2023 (the “Annual Report”).
The Staff’s comments,
as reflected in the Comment Letter, are reproduced in italics below, and the corresponding responses of the Company are shown below each
comment.
Form 10-K for the Fiscal Year Ended December 31,
2022
Notes to the Consolidated Financial Statements
Note 5. Revenue, page 91
1. Refer to your response to comment 3. You state that Eversana assumes legal title to the product at
the time of shipment to the end customer practitioner while the product is in transit to the end customer practitioner. Please address
the following:
· With respect to identifying the customer,
· Clarify to us when title of the product transfers from you to Eversana.
· Tell us why transfer of title does not preclude Eversana from being considered the customer pursuant
to ASC 606-10-15-3.
· Tell us the nature of the contract the end customer practitioner enters into with you to purchase the
product.
· Confirm to us that Eversana does not pay you for the goods shipped to them or is not obligated to pay
you if the end practitioner does not pay.
· Tell us if Eversana has inventory risk before the product is transferred to the end customer practitioner.
Refer to ASC 606-10-55-39b.
· Tell us who has primary responsibility for fulfilling the order and why. Refer to ASC 606-10-55-39a.
· Tell us when your performance obligations under the contract have been satisfied and why.
· Provide us a detailed example of each step of the process from how the end customer practitioner places
the order to how the end customer practitioner pays for the order. In particular, tell us Eversana's role in the process. Address if the
end customer practitioner places the order directly with you or through Eversana.
Response
to Comment 1:
In response to the Staff’s comment,
please see below for an enhanced discussion of the accounting considerations made under Financial Accounting Standards Board, Accounting
Standards Codification 606, Revenue from contracts with customers (“ASC 606”), with respect to the Company’s
Direct Dispense model, building on portions of the Company’s response to comment 3 included in its response letter submitted to
the SEC on May 25, 2023.
Direct Dispense - Background
In September 2021, the Company
initiated its Direct Dispense program to eye care practices. In early 2022, the Company expanded the offering to medical aesthetics professionals,
and, in the second half of 2022, the Company further expanded the offering to select telemedicine partners (telemedicine partners together
with eye care practices and medical aesthetics professionals, the “practitioners”). Pursuant to the Direct Dispense
model, practitioners can purchase case quantities of Upneeq directly from the Company and then resell and dispense Upneeq directly from
the practitioner’s office to patients who are diagnosed with acquired blepharoptosis and prescribed Upneeq by the practitioner.
The
Direct Dispense model relies upon a third-party logistical partner, Eversana Life Science Services (“Eversana”) as
an authorized distributor of record, to satisfy certain regulatory requirements (including, but not limited to, the Prescription
Drug Marketing Act) and ship product to the practitioner on behalf of the Company.
Direct Dispense – Detailed
Process Example
The following section is intended to
respond to the portion of the Staff’s comment that includes the following:
Provide
us a detailed example of each step of the process from how the end customer practitioner places the order to how the end customer practitioner
pays for the order. In particular, tell us Eversana's role in the process. Address if the end customer practitioner places the order directly
with you or through Eversana.
The
Company refers the Staff to Exhibit A for a detailed illustration of each step of the Direct Dispense process that includes,
among other things, how the end customer practitioner places the order, how the end customer practitioner pays for the order and Eversana’s
role in the process.
Direct Dispense – Requested
Clarifications
The following section is intended to
respond to the portions of the Staff’s comment that include the following:
Clarify to
us when title of the product transfers from you to Eversana
Confirm to us that Eversana does
not pay you for the goods shipped to them or is not obligated to pay you if the end practitioner does not pay.
As
detailed in Exhibit A, legal title to the product transfers from the Company to Eversana when Eversana engages a third-party
shipping intermediary on the Company’s behalf. Eversana retains legal title until the third-party shipping intermediary delivers
the product to the end customer practitioner. This title arrangement was implemented because Eversana, and not the Company, possessed
the necessary state licenses to affect a legally compliant sale transaction. Eversana earns a fee from the Company for its temporary acceptance
of title to the product in order to effect a legally compliant sale transaction. Such a fee is based on the product cost incurred by the
Company and is not based on the selling price of the product or any other economics determined between the Company and the practitioner.
In
no event is Eversana obligated to compensate the Company, whether by direct payment or offset payment, for the goods shipped. Eversana
is never obligated to pay the Company in the event the practitioner does not pay the Company for the product.
Direct Dispense – Determining
the Customer
The following section is intended to
respond to the portion of the Staff’s comment that includes the following:
Tell us why transfer of title does
not preclude Eversana from being considered the customer pursuant to ASC 606-10-15-3.
The
Company concluded that the end customer practitioner, and not Eversana, meets the definition of a customer under ASC 606-10-15-3, which
states: “a party that has contracted with an entity to obtain goods or services that are an output of the entity’s
ordinary activities in exchange for consideration.” This conclusion was based on the fact that the end customer practitioner
enters into a contract with the Company to purchase the product and is the ultimate beneficiary of the product. There is no basis on which
to conclude that Eversana is the customer pursuant to ASC 606-10-15-3 because Eversana has not contracted to obtain any goods or services;
rather, Eversana has contracted to provide specified channel management services to the Company. The Company believes that Eversana’s
temporary acceptance of title to the product solely to effect a legally compliant sale transaction is not indicative that Eversana is
the customer as Eversana is not contracting for the purchase of product; rather, it is contracting to provide the service of fulfilling
the Company’s obligation to the end customer practitioner. This conclusion is further supported by the principle of control in ASC
610-10-25-25 and the principal vs. agent considerations in ASC 610-10-55-39 (a) and (b) discussed further below.
Direct Dispense – Nature of
the Contract
The following section is intended to
respond to the portion of the Staff’s comment that includes the following:
Tell us the nature of the contract
the end customer practitioner enters into with you to purchase the product.
Under
ASC 606-10-25-2, “a contract is an agreement between two or more parties that creates enforceable rights and obligations.”
As detailed in Exhibit A, the end customer practitioner enters into a contract with the Company by submitting a purchase order via
a standardized website portal, which creates a legally enforceable agreement with rights and obligations.
The following considerations from ASC
606-10-25-1 were made to ensure the above referenced contract falls in the scope of ASC 606:
· Both parties to the contract (the Company and practitioner) have approved the contract and are committed
to perform their respective obligations. The Company has designed the website portal to receive orders under its specifications and invited
the practitioner to submit its order within the portal. The Company demonstrates its commitment by accepting payment and promptly activating
Eversana as its agent to ship the product. The practitioner has agreed to the Company’s Upneeq program sales terms and conditions
as a part of the terms of use of the portal and demonstrates its commitment by remitting payment to the Company in full in advance.
· The Company can unambiguously identify each party’s rights regarding the pharmaceutical product
to be transferred. The practitioner has the right to receive and control the product, and the Company has the right to receive payment
for the product.
· The Company can clearly identify the payment terms for the goods to be transferred 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 that will
be transferred to the practitioner. As explained further in Exhibit A, upon submission of an order, the practitioner delivers payment
in full, typically via credit card, directly to the Company. On the occasion when the Company offers credit terms to a practitioner, the
Company assesses the practitioner’s ability and intention to pay all of the consideration.
· The contract has commercial substance. The Company’s cash flow changes as a result of the arrangement.
Direct Dispense – Principal vs. Agent
The following section is intended to
respond to the portion of the Staff’s comment that includes the following:
Tell us who has primary responsibility
for fulfilling the order and why. Refer to ASC 606-10-55-39a.
Tell us if Eversana has inventory
risk before the product is transferred to the end customer practitioner. Refer to ASC 606-10-55-39b.
The Company concluded that it has primary
responsibility for fulfilling the order and is the principal in the arrangement with the end customer practitioner and that Eversana acts
in the capacity as an agent for the Company.
This conclusion is based on the fact
that the Company retains control over the product prior to the transfer to the end customer practitioner, with “control” being
defined by ASC 606-10-25-25 to refer to “the ability to direct the use of, and obtain substantially all of the remaining benefits
from, the asset … the ability to prevent other entities from directing the use of, and obtaining the benefits from, an asset.”
As
illustrated in Exhibit A, the Company consistently exhibits its control over the product during the Direct Dispense lifecycle,
including when the product resides in Eversana’s custody during their delivery of channel management services and also when the
product resides in the custody of the third-party shipping intermediary during the product delivery. Only the Company determines to whom
the product is sold and at what price. The Company obtains the product order from the practitioner, conveys the product order details
to Eversana, determines the third-party shipping intermediary to fulfil the product shipment and directs Eversana to provide the channel
management services on its behalf. Further, the end customer practitioner interacts solely with the Company and pays only the Company
directly for the purchase of the product. Lastly, Eversana is ultimately compensated by the Company for the channel management services
rendered, including a fee for Eversana’s temporary acceptance of title to the product in order to effect a legally compliant sale
transaction. Such a fee is based on the product cost incurred by the Company and is not based on the selling price of the product or any
other economics determined between the Company and the practitioner.
Additionally, the Company considered
each of the following relevant indicators found in ASC 606-10-55-39, which in aggregate reinforce the conclusion that the Company is the
principal in the arrangement:
· Pursuant to ASC 606-10-55-39a, “The entity is primarily responsible for fulfilling the promise to
provide the specified good or service. This typically includes responsibility for the acceptability of the specified good or service (for
example, primary responsibility for the good or service meeting customer specifications). If the entity is primarily responsible for fulfilling
the promise to provide the specified good or service, this may indicate that the other party involved in providing the specified good
or service is acting on the entity's behalf.” The Company is primarily responsible for fulfilling the promise to provide the specified
good to the practitioner as evidenced by the Company being solely responsible for ensuring the delivered product meets the specifications
as had been conveyed to and established with the practitioner. In no circumstances would the practitioner have a basis to assert that
Eversana would be required to fulfil the promise. The practitioner’s only recourse would be to compel the Company to act. Such an
arrangement is indicative that Eversana, being directed by the Company to ship specified quantities to specified customers, is simply
acting as an agent on the Company’s behalf.
· Pursuant to ASC 606-10-55-39b, “The entity has inventory risk before the specified good or service
has been transferred to a customer or after transfer of control to the customer (for example, if the customer has a right of return).
For example, if the entity obtains, or commits to obtain, the specified good or service before obtaining a contract with a customer,
that may indicate that the entity has the ability to direct the use of, and obtain substantially all of the remaining benefits from, the
good or service before it is transferred to the customer.” The Company substantively maintains inventory risk at all times prior
to delivery of the product to the practitioner, including prior to obtaining the contract and while the product is in the custody of Eversana
and any third-party shipping intermediary tasked with delivering the product to a practitioner. In the event of a product loss experienced
during transit from Eversana to the practitioner, the Company, despite Eversana accepting legal title during such time for purposes of
effectuating a legally compliant sale transaction, remains solely responsible for making a freight loss claim with the third-party shipping
intermediary. Such an arrangement is highly indicative that the Company has the sole ability to direct the use of, and obtain substantially
all of the remaining benefits from, the product before it is delivered to the practitioner. Furthermore, Eversana never obtains the title
to the product prior to the establishment of the contract by the practitioner and the Company or the Company’s direction to Eversana
to ship the product.
Direct Dispense –
Performance Obligations
The following section is intended to
respond to the portion of the Staff’s comment that includes the following:
Tell us when your performance obligations
under the contract have been satisfied and why.
The Company’s performance obligations
under a contract with an end customer practitioner are satisfied when the third-party shipping intermediary deliv