SEC Comment Letter 0000000000-23-003961 to RVL Pharmaceuticals plc (RVLPQ) (CIK 0001739426)
RVL Pharmaceuticals plc (RVLPQ) (CIK 0001739426)
Date: April 20, 2023 · CIK: 0001739426 · Accession: 0000000000-23-003961
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File numbers found in text: 001-38709
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United States securities and exchange commission logo
April 20, 2023
Brian Markison
Chief Executive and Director and Principal Financial Officer
RVL Pharmaceuticals plc
400 Crossing Boulevard
Bridgewater, NJ 08807
Re:RVL Pharmaceuticals plc
Form 10-K for the Years Ended December 31, 2022
Filed March 20, 2023
Form 8-K dated March 20, 2023
File No. 001-38709
Dear Brian Markison:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comments. In some of our comments, we may ask you to
provide us with information so we may better understand your disclosure.
Please respond to these comments 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
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Years Ended December 31, 2022
Management's Discussion and Analysis
Results of Operations
Comparison of Years Ended December 31, 2022 and 2021, page 66
1.You disclose a gross profit and gross profit percentage in your table of revenues and
expenses from continuing operations which includes both Net product sales and Royalty
and licensing revenue. Please confirm you will revise in future filings to separately
calculate gross profit and gross profit percentage based on net product sales and revise the
narrative on page 67 accordingly. In this regard, please confirm that the cost of sales
relates solely to Net product sales.
FirstName LastNameBrian Markison
Comapany NameRVL Pharmaceuticals plc
April 20, 2023 Page 2
FirstName LastName
Brian Markison
RVL Pharmaceuticals plc
April 20, 2023
Page 2
Revenues, page 66
2.You state on pages 9 and 22 that Upneeq exclusivity from the FDA expires on July 8,
2023. You state on page 26 that after the regulatory exclusivity period expires in July
2023, manufacturers may gain approval of generic versions of Upneeq. If you may be
subject to generic competition after July 2023, provide proposed additional disclosure to
be included in future filings to enhance Management's Discussion and Analysis and
throughout the filing, as necessary, relating to the effect loss of exclusivity may have on
your results of operations.
Notes to the Consolidated Financial Statements
Note 5. Revenue, page 91
3.You state in your Form 8-K dated March 20, 2023 that since inception of your Direct
Dispense model, you recognized sales upon shipment from the third-party logistics
company. You state that you will now record Direct Dispense revenues upon delivery to
the end customer, starting with the fourth quarter of 2022. As a result, $2.3 million of net
product sales that were included in your preliminary estimates of the fourth quarter and
full year 2022 UPNEEQ net product sales will now be recognized in the first quarter of
2023. Please address the following:
•Clarify whether this change represents a change in accounting principle or change in
accounting estimate. If the former, tell us if you have received a preferability letter
from your auditors. Refer to ASC 250.
•Tell us where this fourth quarter change is disclosed in your 10-K.
•Tell us the effect the change was to each previously reported period.
•Provide us an analysis under ASC 606 of your accounting treatment before and after
the change. In this regard, clarify your use of any third-party logistical partners and
explain your determination of whether they are acting as principal or agent in their
capacity as distributor and the resulting impact on the timing of your revenue
recognition.
4.You state on page 22 that you made the decision to dispense Upneeq exclusively through
a wholly-owned mail order pharmacy, RVL Pharmacy LLC, which appears to conflict
with your discussion on pages 63 and 64 that patients may purchase Upneeq either from
eye care or medical aesthetic professionals, or exclusivity through RVL Pharmacy, LLC,
your wholly-owned pharmacy. Please revise to clarify in future filings. In addition, you
discuss on page 23 your Direct Dispense and Virtual Inventory programs, which you state
were introduced in September 2021 and January 2022, respectively. Please tell us the
accounting treatment for each distribution model for all periods presented. Provide us the
basis for your accounting treatment and proposed disclosure to be included in future
filings.
FirstName LastNameBrian Markison
Comapany NameRVL Pharmaceuticals plc
April 20, 2023 Page 3
FirstName LastName
Brian Markison
RVL Pharmaceuticals plc
April 20, 2023
Page 3
5.You state on page 23 that eye care practices can purchase case quantities of Upneeq.
Please tell us what your return policy is and whether or not returns have been significant.
Also tell us whether or not returns are considered in determining variable consideration.
In this respect, we note a reference on page 86 to returns on product sales related to
licensing revenue, but no reference to returns under Product Sales.
Form 8-K dated March 20, 2023
GAAP to Non-GAAP Reconciliation, page 12
6.Please tell us how you determined the following adjustments to calculate Adjusted
EBITDA are consistent with the Non-GAAP C&DI 100.1:
•Licensing-related revenues, net of transaction costs,
•Divestiture-related contingent milestone payments, net of fees, and
•Gain on sales of product rights
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.
You may contact Mary Mast at 202-551-3613 or Angela Connell at 202-551-3426 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences