SEC Company Response from AVADEL PHARMACEUTICALS PLC (AVDL) (CIK 0001012477) — Nov 24, 2020
AVADEL PHARMACEUTICALS PLC (AVDL) (CIK 0001012477)
Date: Nov. 24, 2020 · CIK: 0001012477 · Accession: 0001104659-20-129084
AI Filing Summary & Sentiment
File numbers found in text: 001-37977
Referenced dates: October 29, 2020
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Avadel Pharmaceuticals plc
10 Earlsfort Terrace
Dublin 2, Ireland
November 24, 2020
Ms. Nudrat Salik
Mr. Ameen Hamady
Office of Life Sciences
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: Avadel
Pharmaceuticals plc
Form
10-Q for the Period Ended June 30, 2020
Filed August 10, 2020
File No. 001-37977
Dear Ms. Salik and Mr. Hamady:
Avadel Pharmaceuticals
plc (the “Company,” “we” or “us”) is submitting this letter in response
to comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange
Commission (the “Commission”) with respect to our quarterly report on Form 10-Q filed on August 10, 2020 (the
“10-Q”), as set forth in the Staff’s letter dated October 29, 2020 to Thomas McHugh, Senior Vice President
and Chief Financial Officer (the “Comment Letter”).
For reference purposes,
the text of the Comment Letter has been reproduced and italicized herein with responses below each numbered comment. All capitalized
terms used and not otherwise defined herein shall have the meanings set forth in the 10-Q.
Form 10-Q for the
Period Ended June 30, 2020
Note 4. Disposition
of the Hospital Business, page 13
1. We note your response to comment
1. You state that the sterile injectable drugs (the “Products”) do not represent a product line, and therefore are
not a distinguishable component of the company. Please tell us if you believe that the Products meet the definition of a component
of an entity as defined in ASC 205-20. If not, please explain. In your response, please address your presentation of the unaudited
pro forma financial information you presented in exhibit 99.2 of Form 8-K dated July 2, 2020, which gives effect to the sale of
the Products. Based on this presentation, it appears that, at a minimum, the operations of the Products can be clearly distinguished,
operationally and for financial reporting purposes, from the rest of the entity.
Response to Comment No. 1.
ASC 205-20-20 defines a component as:
“A component of an
entity comprises operations and cash flows that can be clearly distinguished, operationally and for financial reporting
purposes, from the rest of the entity. A component of an entity may be a reportable segment or an operating segment, a
reporting unit, a subsidiary, or an asset group.”
The Products do not meet the definition
of a component because the operations and cashflows related to the Products are not clearly distinguishable from the rest of the
Company. We have always managed the Company as one operating segment, one reporting unit, and one asset group and therefore one
component. We do not separately report the expenses related to the Products due to the small, centralized nature of our operations
involved in developing, marketing, distributing, and selling drugs. Avadel has one leased office and approximately 30 employees,
the same as both prior to and subsequent to the sale of the Products. All of our employees supported both the Products and the
development of FT218. No positions were eliminated and none of our employees were terminated upon the sale of the Products, and
we did not reduce the size of our facilities as a result of the sale.
The pro forma financial information included
in the Form 8-K filed on July 2, 2020 was based on Regulation S-X, Article 11, Rule 11-01 requirements which focuses on the quantitative
aspect of the disposition and not the qualitative. The Company provided this information in the interest of providing our shareholders
with timely information about the transaction. The Company had to prepare this information for the Form 8-K, as the Company does
not operate or financially report the business in this manner. In our Form 10-Q for the quarter ended June 30, 2020, we added a
reference to this Form 8-K if our investors wanted additional information related to the transaction. EY’s Financial reporting
development: Pro Forma, states “Article 11 pro forma financial information also may be necessary if the disposition is
material, even if the disposed operations do not meet the criteria in ASC 205-20, Discontinued Operations.” Therefore, we
believe it is inappropriate to draw the conclusion from our presentation of pro forma financial information that the Products represent
a component.
The financial information that was disclosed
within the Form 8-K was primarily based on either contractual or regulatory obligations that the Company is required to comply
with, rather than because the financial information was distinguishable within the Company’s operations. In our previous
letter on October 14, 2020, we discussed that only gross profit and certain operating expenses are truly distinguishable for the
Products. The significant majority of the other costs and expenses to support the Products were not clearly distinguishable. The
adjustments reflected in Exhibit 99.2 of the Form 8-K were identified through our accounting records in order to prepare the information
provided but is not representative of how the Company operated.
We note that the significant majority of
the Company’s centralized operating expenses that also supported the Products were not adjusted for in the Form 8-K as they
are not distinguishable from the rest of the entity. Although the pro forma adjustments included nearly 100% of our product sales
and cost of products sold, less than 5% of our combined Research and Development and Selling, General and Administrative expenses
were adjusted, clearly indicating the significance of the indistinguishable costs related to the Products in those line items.
For example, we do not maintain separate personnel, departments, functions, or for that matter operating divisions for the Products
for activities such as procurement, marketing, distribution, and selling. Therefore, we believe that the fact that we comply with
the Form 8-K disclosure requirements does not imply that the Products were distinguishable for operational purposes from the rest
of the entity in applying ASC 205-20.
Our facts are comparable to the
interpretive examples in the KPMG Handbook: Discontinued Operations, Example 3.3.10 and Question 3.3.50 (refer
to Appendix A). In those examples, it is not appropriate to present all or almost all of an entity’s assets or
activities as discontinued operations, as they would not be clearly distinguishable from the rest of the entity. Since the
Products represent all of our revenue-generating assets, and therefore all of our revenue and costs of product sold, we
believe that presenting the disposition of the Products as a discontinued operation would not provide meaningful information
to the users of the financial statements and instead could be confusing.
Our facts are also similar to Illustration
2-1: Component of an entity from EY’s Financial reporting developments: Discontinued Operations (refer to Appendix
B). Since the brands in this example are part of a larger cash-flow-generating group, the disposed brands do not represent a group
that on its own is a component of the entity. As discussed above, none of our products had or have separately identifiable and
distinct cash flows due to the small size of our workforce and centralized costs involved at a company our size, and therefore
were part of the larger cash-flow-generating group that is the whole Company and are not a component of the entity on their own.
2. We note from your response to comment
1 that you do not believe the sale of the sterile injectable drugs represented a strategic shift as contemplated by ASC 205-20-45.
We continue to believe that the disposal may have represented a strategic shift. Please help us better understand your conclusion.
In your response, please address the statements made in the press release announcing the sale of the Products on July 1, 2020.
We note that in that press release, the company articulated that the sale of the sterile injectable drug portfolio was a significant
milestone for the company, as it further reflected your commitment to strategically focus on advancing FT218 through the regulatory
review process and, if approved, bringing your formulation of sodium oxybate to patients. We also note the statement made by Mr.
Greg Divis, your Chief Executive Officer, in which he stated, “By divesting our portfolio of sterile injectable drugs, we
are now singularly focused on supporting the regulatory approval process, market planning and maximizing shareholder value for
FT218.” Please also tell us how you considered the fact that the Products sold and FT218 are based on different technologies.
Response to Comment No. 2.
A strategic shift did
not occur because our strategy both prior to and subsequent to the sale of the Products remains unchanged. The Company was founded
in France in 1990 as Flamel Technologies as an organization focused on drug development and commercialization. Over the past 30
years, the Company has evaluated numerous products. The Company has not focused on a particular indication or technology, nor has
it focused on curing specific diseases. Our products, whether internally developed or acquired from a third party, have represented
improved medical applications of already existing drugs, including increasing the bioavailability, stability, ease of use or safety
of a drug, among other things. Our strategy can be trifurcated into three primary stages: 1) identification, assessment and development
of targeted drug candidates; 2) creation and execution of a plan to successfully formulate, develop and obtain FDA approval for
the drug candidate; and 3) maximize the value of those drugs for our shareholders through either strategic partnerships, licensing
arrangements, commercialization, or outright asset sales. This has been the Company’s strategy since inception and is the
strategy both before and after the sale of the Products.
The Products represented
improved medical applications of already existing, unapproved drugs for which the Company was able to obtain FDA approval. The
same is true for FT218 if it is approved. FT218 is an investigational, once-nightly formulation
of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. If approved,
we believe once-nightly FT218 has the potential to offer a meaningful treatment alternative
for patients to switch from twice-nightly sodium oxybate, a product that has been on the market for nearly 20 years.
Throughout our
history, we have had several drug candidates in different stages of our strategy. Prior to June 30, 2020, we had three drugs
in the third stage (Bloxiverz®, Vazculep®, and AkovazTM), one that had completed the second stage
(NouressTM), and one at the completion of the first stage (FT218) of our strategy. The history of the development
of FT218 is contemporary with the 2013 acquisition of the drug candidates that became Bloxiverz, Vazculep, and Akovaz. The
Company has been investigating the development of FT218 for many years and pre-dates the Company’s 2014 announcement of
positive results from two clinical studies for the treatment of narcolepsy. Our current, primary focus on the development of
FT218 is not new and is consistent with the long-standing strategy of the Company.
In considering technology, we are agnostic
to the drug-delivery technology used to deliver the medicine in our products and drug candidates. The Company does not sell drug-delivery
technologies, we develop and sell drug products that sometimes utilize our internally developed patented delivery technologies,
formulations, and processes. We own four different drug-delivery technologies that we evaluate for use in potential additional
drug candidates (Micropump®, LiquiTime®, MedusaTM, and Trigger LockTM). While FT218 uses the Micropump
drug-delivery technology and the Products do not, it was not a consideration in our determination that the sale did not represent
a strategic shift. As demonstrated in the Company’s history in Appendix C, each of our drug candidates is different from
the last. We have developed drug candidates using a variety of drug-delivery technologies or using none at all. Due to the competitive
and innovative nature of the pharmaceutical industry, we continuously evaluate opportunities for additional drug candidates to
add to our pipeline or product portfolio. However, alternative drug-delivery technologies can also be obtained through strategic
partnerships, license arrangements or outright acquisition. Additionally, we have developed drugs that do not use a drug-delivery
technology as was the case with the Products.
Our drug-delivery technologies
are not a prerequisite for determining our next drug candidates. The fact that one of our drug delivery technologies is used in
FT218 does not make it an inherent part of our strategy going forward. Nor does it dictate that a strategic shift occurs every
time a different drug-delivery technology (whether it is one we own or not) is used or not used in our past, present or future
drug candidates. To suggest otherwise is to suggest that the Company potentially undergoes a strategic shift every time an additional
product is developed, which is unreasonable. Additionally, as noted in Appendix C, we have divested several drugs in our history.
If each divestiture of a drug was to be considered a strategic shift, we would have presented discontinued operations in each of
the last three years (2018-2020) with the divestitures of AcipHex® SprinkleTM, Karbinal TM, Cefaclor
for Oral Suspension, Flexichamber TM, Noctiva, and the Products.
We plan to continue to
develop and obtain FDA approval for FT218, and then elect a method of monetization that maximizes value to our shareholders. Depending
on the method of monetization, as we continue to develop additional drugs, we could potentially enter a cycle of presenting substantially
all of the Company as discontinued operations every few years with each divestiture. Per ASU 2014-08, the FASB issued updates to
the discontinued operations guidance in Subtopic 205-20 for this reason. Too many disposals of groups of assets qualified for discontinued
operations presentation, which resulted in financial statements that were “less decision useful” for users. We agree
with the FASB that such a cycle of financial statement presentation would not provide value to the users of the financial statements
and believe that it instead has the potential to mislead.
Regarding our CEO’s statements
you reference, the statement is absolutely affirmative of the Company’s strategy and not at all indicative of a
strategic shift. The fact that Mr. Divis describes the transaction in this way is evidence that our strategy continues,
unchanged, after the sale of the Products. The sale was significant in that it accelerated the future cash flows from mature
drugs in the amount of $42 million, a material amount to shareholders of a company our size. Mr. Divis is simply
communicating the fact that accelerating $42 million of cash flow from the Products is a significant event to support the
continued development of FT218, which has been ongoing for over six years and is now approaching submission to the FDA
following our just-completed Phase 3 trials. The Company has communicated in past press releases that we have historically
used the cash flow from the Products to fund the development of FT218. Additionally, the word “milestone” is
commonly used by many companies in shareholder communications when describing significant events, as was the case in this
instance. For the Products, the disposal represented the completion of the third stage to our strategy of developing and
maximizing the value of these Products to our shareho