NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except per share data)
NOTE 1: Summary of Significant Accounting Policies
Nature of Operations. Avadel Pharmaceuticals plc (Nasdaq: AVDL) (“Avadel,” the “Company,” “we,” “our,” or “us”) is a biopharmaceutical company. Our lead product candidate, FT218, is an investigational once-nightly, extended-release formulation of sodium oxybate for the treatment of excessive daytime sleepiness (“EDS”) and cataplexy in adults with narcolepsy. We are primarily focused on the development and potential United States (“U.S.”) Food and Drug Administration (“FDA”) approval of FT218. In December 2020, the Company submitted a New Drug Application (“NDA”) to the FDA for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.The NDA for FT218 was accepted by the FDA in February 2021 and assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of October 15, 2021.
Outside of our lead product candidate, we continue to evaluate opportunities to expand our product portfolio. As of December 31, 2020, we do not have any approved and commercialized products in our portfolio.
We are registered as an Irish public limited company. Our headquarters are in Dublin, Ireland and we have operations in St. Louis, Missouri, U.S.
FT218
FT218 is a once-nightly formulation of sodium oxybate that uses our Micropump controlled release drug-delivery technology for the treatment of EDS and cataplexy in adults suffering from narcolepsy. Sodium oxybate is the sodium salt of gamma hydroxybutyrate, an endogenous compound and metabolite of the neurotransmitter gamma-aminobutyric acid. Sodium oxybate is approved in the U.S. for the treatment of EDS and cataplexy in patients with narcolepsy and is approved in Europe for the treatment of cataplexy in patients with narcolepsy. Since 2002, sodium oxybate has only been available as a formulation that must be taken twice nightly, first at bedtime, and then again 2.5 to 4 hours later.
On December 16, 2020, we announced the submission of our NDA to the FDA for FT218. On February 26, 2021, the FDA notified us of formal acceptance of the NDA with an assigned PDUFA target action date of October 15, 2021.
The REST-ON trial was a randomized, double-blind, placebo-controlled study that enrolled 212 patients and was conducted in clinical sites in the U.S., Canada, Western Europe and Australia. The last patient, last visit was completed at the end of the first quarter of 2020 and positive top line data from the REST-ON trial was announced on April 27, 2020. Patients who received 9 g of once-nightly FT218, the highest dose administered in the trial, demonstrated a statistically significant and clinically meaningful improvement compared to placebo across the three co-primary endpoints of the trial: maintenance of wakefulness test, or MWT, clinical global impression-improvement, or CGI-I, and mean weekly cataplexy attacks. The lower doses assessed, 6 g and 7.5 g also demonstrated a statistically significant and clinically meaningful improvement on all three co-primary endpoints compared to placebo. We observed the 9 g dose of once-nightly FT218 to be generally well tolerated. Adverse reactions commonly associated with sodium oxybate were observed in a small number of patients (nausea 1.3%, vomiting 5.2%, decreased appetite 2.6%, dizziness 5.2%, somnolence 3.9%, tremor 1.3% and enuresis 9%), and 3.9% of the patients who received 9 g of FT218 discontinued the trial due to adverse reactions.
In January 2018, the FDA granted FT218 Orphan Drug Designation, which makes the drug eligible for certain development and commercial incentives, including potential U.S. market exclusivity for up to seven years. Additionally, several FT218-related U.S. patents have been issued, and there are additional patent applications currently in development and/or pending at the U.S. Patent and Trademark Office (“USPTO”), as well as foreign patent offices.
In July 2020, we announced that the first patient was dosed initiating an open-label extension (“OLE”)/switch study of FT218 as a potential treatment for EDS and cataplexy in patients with narcolepsy. The OLE/switch study is examining the long-term safety and maintenance of efficacy of FT218 in patients with narcolepsy who participated in the REST-ON study, as well as dosing and preference data for patients switching from twice-nightly sodium oxybate to once-nightly FT218 regardless if they participated in REST-ON or not. We anticipate that the study will enroll up to 250 patients, many of which will be enrolled in North American clinical trial sites that participated in the REST-ON study.
Previously Approved FDA Products
On June 30, 2020 (the “Closing Date”), Avadel Legacy Pharmaceuticals, LLC (the “Avadel Seller”) announced the sale of the portfolio of sterile injectable drugs used in the hospital setting (the “Hospital Products”), which included our three commercial products, Akovaz, Bloxiverz and Vazculep, as well as Nouress, which was approved by the U.S. FDA to Exela Sterile Medicines LLC (“Exela Buyer”) pursuant to an asset purchase agreement by and among the Avadel Seller, Avadel US Holdings, Inc., the Exela Buyer and Exela Holdings, Inc. This sale included the following FDA approved products:
•Bloxiverz (neostigmine methylsulfate injection) - Bloxiverz is a drug used intravenously in the operating room to reverse the effects of non-depolarizing neuromuscular blocking agents after surgery.
•Vazculep (phenylephrine hydrochloride injection) - Vazculep is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
•Akovaz (ephedrine sulfate injection) - Akovaz was the first FDA approved formulation of ephedrine sulfate, an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
•Nouress (cysteine hydrochloride injection) - Nouress is a sterile injectable product for use in the hospital setting to provide parenteral nutrition to neonates.
See Note 4: Disposition of the Hospital Products.
Basis of Presentation. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP). The consolidated financial statements include the accounts of the Company and all subsidiaries. All intercompany accounts and transactions have been eliminated.
Our results of operations for the period January 1, 2019 through February 6, 2019 and for year ended December 31, 2018 include the results of Avadel Specialty Pharmaceuticals, LLC (“Specialty Pharma”) prior to its February 6, 2019 voluntary petition for reorganization under Chapter 11 of the U.S. Bankruptcy Code. See Note 3: Subsidiary Bankruptcy and Deconsolidation.
Our results of operations for the period January 1, 2018 through February 16, 2018 include the results of FSC Therapeutics and FSC Laboratories, Inc., (collectively “FSC”), prior to its February 16, 2018 disposition date. See Note 18: Divestiture of the Pediatric Assets, for additional information.
Reclassifications
Certain reclassifications are made to prior year amounts whenever necessary to conform with the current year presentation. Certain adjustments have been made to the Consolidated Statements of Cash Flows for the fiscal year ended December 31, 2020 and balances within Note 16: Other Assets and Liabilities for the year ended December 31, 2019 to condense line items of the same nature into a single line. This change does not affect previously reported net cash flows used in operating activities in the Consolidated Statements of Cash Flows. We made certain reclassifications within Note 10: Goodwill and Intangible Assets, to the gross value and total accumulated amortization balances of the Vazculep intangible asset as of December 31, 2019. We made certain adjustments to Note 24: Company Operations by Product, Customer, and Geographic Area to include comparable information for customers that became significant for the year ended December 31, 2020.
Revenue. Prior to June 30, 2020, revenue included sales of pharmaceutical products, licensing fees, and, if any, milestone payments for research and development (“R&D”) achievements.
Effective January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” (“ASC 606”) using the modified retrospective transition method applied to all open contracts as at December 31, 2017. The adoption of the new standard did not have a material effect on the overall timing or amount of revenue recognized when compared to prior accounting standards. See Note 5: Revenue Recognition.
ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, an entity recognizes revenue when the performance obligations to the customer have been satisfied through the transfer of control of the goods or services. To determine the appropriate revenue recognition for arrangements that the Company believes are within the scope of ASC 606,
we perform the following five steps: (i) Identify the contract(s) with a customer; (ii) Identify the performance obligations in the contract; (iii) Determine the transaction price; (iv) Allocate the transaction price to the performance obligations in the contract; and (v) Recognize revenue when (or as) the entity satisfies a performance obligation. The Company applies the five-step model to contracts only when the Company and its customer’s rights and obligations under the contract can be determined, the contract has commercial substance, and it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. For contracts that are determined to be within the scope of ASC 606, the Company identifies the promised goods or services in the contract to determine if they are separate performance obligations or if they should be bundled with other goods and services into a single performance obligation. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Product Sales
Prior to June 30, 2020, we sold products primarily through wholesalers and considered these wholesalers to be our customers. Under ASC 606, revenue from product sales is recognized when the customer obtains control of our product, which occurs typically upon receipt by the customer. Our gross product sales are subject to a variety of price adjustments in arriving at reported net product sales. These adjustments include estimates of product returns, chargebacks, payment discounts, rebates, and other sales allowances and are estimated based on analysis of historical data for the product or comparable products, future expectations for such products and other judgments and analysis.
License and Milestone Revenue
From time to time we may enter into out-licensing agreements which are within the scope of ASC 606 under which it licenses to third parties certain rights to its products or intellectual property. The terms of these arrangements typically include payment to us of one or more of the following: non-refundable, upfront license fees; development, regulatory, and commercial milestone payments; and sales-based royalty payments. Each of these payments results in license revenue.
For a complete discussion of the accounting for net product revenue and license revenues, see Note 5: Revenue Recognition.
Research and Development (“R&D”). R&D expenses consist primarily of costs related to clinical studies and outside services, personnel expenses, and other R&D expenses. Clinical studies and outside services costs relate primarily to services performed by clinical research organizations and related clinical or development manufacturing costs, materials and supplies, filing fees, regulatory support, and other third-party fees. Personnel expenses relate primarily to salaries, benefits and share-based compensation. Other R&D expenses primarily include overhead allocations consisting of various support and facilities-related costs. R&D expenditures are charged to operations as incurred. Raw materials used in the production of pre-clinical and clinical products are expensed as R&D costs.
We recognize R&D tax credits received from the French and Irish government for spending on innovative R&D as an offset of R&D expenses.
Advertising Expenses. We expense the costs of advertising as incurred. Advertising expenses were $312, $372 and $17,562 for the years ended December 31, 2020, 2019 and 2018, respectively. The decrease in advertising for the years ended December 31, 2020 and 2019 is due to Specialty Pharma’s bankruptcy and deconsolidation. See Note 3: Subsidiary Bankruptcy and Deconsolidation.
Share-based Compensation. We account for share-based compensation based on the estimated grant-date fair value. The fair value of stock options and warrants is estimated using Black-Scholes option-pricing valuation models (“Black-Scholes model”). As required by the Black-Sholes model, estimates are made of the underlying volatility of AVDL stock, a risk-free rate and an expected term of the option or warrant. We estimated the expected term using a simplified method, as we do not have enough historical exercise data for a majority of such options and warrants upon which to estimate an expected term. We recognize compensation cost, net of an estimated forfeiture rate, using the accelerated method over the requisite service period of the award.
Income Taxes. We account for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, we determine deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.
We recognize deferred tax assets to the extent that we believe that these assets are more likely than not to be realized. In making such a determination, we consider all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If we determine that we would be able to realize our deferred tax assets in the future in excess of their net recorded amount, we would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.
We record uncertain tax positions in accordance with ASC 740 on the basis of a two-step process in which (1) we determine whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, we recognize the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority.
We recognize interest and penalties related to unrecognized tax benefits in the income tax expense line in the accompanying consolidated statements of income (loss). Accrued interest and penalties are included on the related tax liability line in the consolidated balance sheets.
Cash and Cash Equivalents. Cash and cash equivalents consist of cash on hand, cash on deposit and fixed term deposits which are highly liquid investments with original maturities of less than three months.
Marketable Securities. The Company’s marketable securities are considered to be available for sale and are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive (loss) income (“AOCI”) in shareholders’ equity, with the exception of unrealized gains and losses on equity instruments and unrealized losses believed to be other-than-temporary, if any, which are reported in earnings in the current period. The cost of securities sold is based upon the specific identification method.
Accounts Receivable. Prior to the sale of the Hospital Products on June 30, 2020, accounts receivable were stated at amounts invoiced net of allowances for credit losses and certain other gross to net variable consideration deductions. An allowance for credit losses is established based on expected losses. Expected losses are estimated by reviewing individual accounts, considering aging, financial condition of the debtor, payment history, current and forecast economic conditions and other relevant factors. A majority of our accounts receivable were due from four significant customers.
Inventories. Prior to the sale of the Hospital Products on June 30, 2020, inventories consisted of raw materials and finished products, which were stated at lower of cost or net realizable value, using the first-in, first-out (“FIFO”) method. The Company established reserves for inventory estimated to be obsolete, unmarketable or slow-moving on a case by case basis.
Property and Equipment. Property and equipment is stated at historical cost less accumulated depreciation. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives:
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Software, office and computer equipment
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3 years
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Leasehold improvements, furniture, fixtures and fittings
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5-10 years
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Goodwill. Goodwill represents the excess of the acquisition consideration over the fair value of assets acquired and liabilities assumed. We have determined that we operate in a single segment and have a single reporting unit associated with the development and commercialization of pharmaceutical products. We test goodwill for impairment annually and when events or changes in circumstances indicate that the carrying value may not be recoverable. We performed our required impairment test of goodwill and have determined that no impairment of goodwill existed at December 31, 2020 and 2019.
Long-Lived Assets. Long-lived assets include fixed assets and intangible assets. Prior to the sale of the Hospital Products on June 30, 2020, intangible assets consisted primarily of purchased licenses and intangible assets recognized as part of the Éclat Pharmaceuticals acquisition. Acquired in-process research and development (“IPR&D”) had an indefinite life and was not amortized until completion and development of the project, at which time the IPR&D became an amortizable asset, for which amortization of such intangible assets was computed using the straight-line method over the estimated useful life of the assets.
Long-lived assets are reviewed for impairment whenever conditions indicate that the carrying value of the assets may not be fully recoverable. Such impairment tests are based on a comparison of the pretax undiscounted cash flows expected to be generated by the asset to the recorded value of the asset or other market-based value approaches. If impairment is indicated, the asset value is written down to its market value if readily determinable or its estimated fair value based on discounted cash flows. Any significant changes in business or market conditions that vary from current expectations could have an impact on the fair value of these assets and any potential associated impairment. During the fourth quarter of 2018, we recorded a $66,087 impairment charge to the entire acquired developed technology related to Noctiva. We determined that no impairment existed
at December 31, 2019. On June 30, 2020, we transferred our remaining intangible asset to the Exela Buyer as part of the disposition of the Hospital Products. We determined that no impairment existed at December 31, 2020 on our remaining long-lived assets.
Lease Obligations. On January 1, 2019, the Company adopted ASU 2016-02, “Leases” which supersedes ASC 840 “Leases” and creates a new topic, ASC 842 “Leases”. The Company adopted ASU 2016-02 using the modified retrospective transition approach and elected the transition option to recognize the adjustment in the period of adoption rather than in the earliest period presented. Results and disclosure requirements for reporting periods beginning after January 1, 2019 are presented under Topic 842, while prior period amounts have not been adjusted and continue to be reported in accordance with our historical accounting under Topic 840. Upon adoption, we recognized total ROU assets of $5,046, with corresponding lease liabilities of $5,131 on the consolidated balance sheets. The adoption did not impact our beginning retained earnings, or our prior year consolidated statements of income (loss) and statements of cash flows.
The Company elected the package of practical expedients permitted under the transition guidance, which allowed us to carryforward our historical lease classification, our assessment on whether a contract was or contains a lease, and our initial direct costs for any leases that existed prior to January 1, 2019. The Company also elected to combine our lease and non-lease components and to keep leases with an initial term of 12 months or less off the balance sheet and recognize the associated lease payments in the consolidated statements of income (loss) on a straight-line basis over the lease term.
Under ASU 2016-02, the Company determines if a contract is a lease at the inception of the arrangement. Right-of-use assets and operating lease liabilities are recognized at commencement date based on the present value of remaining lease payments over the lease term. For this purpose, the Company considers only payments that are fixed and determinable at the time of commencement. The Company reviews all options to extend, terminate, or purchase its right-of-use assets at the inception of the lease and will include these options in the lease term when they are reasonably certain of being exercised. The Company’s lease contracts do not provide a readily determinable implicit rate. The Company’s estimated incremental borrowing rate is based on information available at the inception of the lease. Our lease agreements may contain variable costs such as common area maintenance, insurance, real estate taxes or other costs. Variable lease costs are expensed as incurred on the consolidated statements of income (loss).
Acquisition-related Contingent Consideration. Prior to the sale of the Hospital Products on June 30, 2020, the acquisition-related contingent consideration payables arising from the acquisition of Éclat Pharmaceuticals (i.e., our hospital products) and FSC (our pediatrics products), which was assumed by the buyer as part of the disposition of the pediatrics products on February 16, 2018, were accounted for at fair value (see Note 13: Contingent Consideration Payable and Note 18: Divestiture of the Pediatric Assets). The fair value of the warrants issued in connection with the Éclat acquisition were estimated using a Black-Scholes model. A portion of these warrants were exercised on February 23, 2018 and the remaining warrants expired on March 12, 2018. See Note 13: Contingent Consideration Payable. The fair value of acquisition-related contingent consideration payable is estimated using a discounted cash flow model based on the long-term sales or gross profit forecasts of the specified hospital or pediatric products using an appropriate discount rate. There are a number of estimates used when determining the fair value of these earn-out payments. These estimates include, but are not limited to, the long-term pricing environment, market size, market share the related products are forecast to achieve, the cost of goods related to such products and an appropriate discount rate to use when present valuing the related cash flows. These estimates can and often do change based on changes in current market conditions, competition, management judgment and other factors. Changes to these estimates can have and have had a material impact on our consolidated statements of income (loss) and balance sheets. Changes in fair value of these liabilities are recorded in the consolidated statements of income (loss) within operating expenses as changes in fair value of contingent consideration.
Financing-related Royalty Agreements. We were previously a party to two royalty agreements in connection with certain financing arrangements. We elected the fair value option for the measurement of the financing-related contingent consideration payable associated with the royalty agreements with certain Deerfield and Broadfin entities (the “Deerfield and Broadfin Royalty Agreements”) (see Note 13: Contingent Consideration Payable). Prior to the sale of the Hospital Products on June 30, 2020, the fair value of financing-related royalty agreements was estimated using the same components used to determine the fair value of the acquisition-related contingent consideration noted above, with the exception of cost of products sold. Changes to these components can also have a material impact on our consolidated statements of income (loss) and balance sheets. Changes in the fair value of this liability are recorded in the consolidated statements of income (loss) as other (expense) income - changes in fair value of contingent consideration payable. In connection with the disposition of the Hospital Products on June 30, 2020 as discussed in Note 4: Disposition of the Hospital Products, the Deerfield and Broadfin Royalty Agreements were assigned to the Exela Buyer and the Exela Buyer assumed and shall pay, perform, satisfy and discharge the liabilities and obligations of the Company under the Deerfield and Broadfin Royalty Agreements.
Use of Estimates. The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including marketable securities and contingent liabilities at the date of the consolidated financial statements and the reported amounts of sales and expenses during the periods presented. These estimates and assumptions are based on the best information available to management at the balance sheet dates and depending on the nature of the estimate can require significant judgments. Changes to these estimates and judgments can have and have had a material impact on our consolidated statements of income (loss) and balance sheets. Actual results could differ from those estimates under different assumptions or conditions.
NOTE 2: Newly Issued Accounting Standards
Recently Adopted Accounting Guidance
In August 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework— Changes to the Disclosure Requirement for Fair Value Measurement” which amends certain disclosure requirements over Level 1, Level 2 and Level 3 fair value measurements. The amendments in ASU 2018-13 are effective for fiscal years beginning after December 15, 2019, with early adoption permitted. We adopted ASU 2018-13 in the first quarter of 2020.
In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”).” This standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. ASU 2016-13 will be effective for the Company for fiscal years beginning on or after January 1, 2020, including interim periods within those annual reporting periods and early adoption is permitted. We adopted the provisions of ASU 2016-13 in the first quarter of 2020. Adoption of the new standard did not have any impact on our consolidated financial statements.
Recent Accounting Guidance Not Yet Adopted
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. The FASB’s amendments primarily impact ASC 740, Income Taxes, and may impact both interim and annual reporting periods. ASU 2019-12 will be effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years and early adoption is permitted. We are currently evaluating the impact of adopting ASU 2019-12; however, the impact is expected to be immaterial to our consolidated financial statements.
In August 2020, the FASB issued ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging- Contracts in Entity’s Own Equity (Subtopic 815-40), to reduce the complexity associated with applying U.S. GAAP principles for certain financial instruments with characteristics of liabilities and equity. The amendments in this ASU reduce the number of accounting models for convertible instruments and expand the existing disclosure requirements over earnings per share as it relates to convertible instruments. This ASU will be effective for our fiscal year beginning January 1, 2022 and interim periods therein. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The amendments may be adopted through either a modified retrospective method, or a fully retrospective method. We are currently evaluating the impact of adopting ASU 2020-06.
NOTE 3: Subsidiary Bankruptcy and Deconsolidation
Bankruptcy Filing and Deconsolidation
As a result of Specialty Pharma’s bankruptcy filing on February 6, 2019, Avadel ceded authority for managing the business to the Bankruptcy Court, and Avadel management could not carry on Specialty Pharma’s activities in the ordinary course of business without Bankruptcy Court approval. Prior to Bankruptcy Court approval, Avadel managed the day-to-day operations of Specialty Pharma but did not have discretion to make significant capital or operating budgetary changes or decisions and purchase or sell significant assets, as Specialty Pharma’s material decisions were subject to review by the Bankruptcy Court. For these reasons, we concluded that Avadel had lost control of Specialty Pharma, and no longer had significant influence over Specialty Pharma during the pendency of the bankruptcy. Therefore, we deconsolidated Specialty Pharma effective with the filing of the Chapter 11 bankruptcy in February 2019.
In order to deconsolidate Specialty Pharma, the carrying values of the assets and certain liabilities of Specialty Pharma were removed from our unaudited condensed consolidated balance sheet as of February 5, 2019, and we recorded our investment in Specialty Pharma at its estimated fair value of $0. As the estimated fair value of our investment in Specialty Pharma was lower than its net book value immediately prior to the deconsolidation, we recorded a non-cash charge of approximately $2,678 for the year ended December 31, 2019 associated with the deconsolidation of Specialty Pharma. Subsequent to the deconsolidation of Specialty Pharma, we are accounting for our investment in Specialty Pharma using the cost method of accounting because Avadel does not exercise significant influence over the operations of Specialty Pharma due to the Chapter 11 filing.
On April 26, 2019, Specialty Pharma sold its intangible assets and remaining inventory to an unaffiliated third party in exchange for aggregate cash proceeds of approximately $250, pursuant to an order approving such sale which was issued by the Bankruptcy Court on April 15, 2019. As a result of such sale, Specialty Pharma has completed its divestment of the assets of the Noctiva business.
On July 2, 2019, Specialty Pharma was made aware of a $50,695 claim made by the Internal Revenue Service (“IRS”) as part of the bankruptcy claims process against Specialty Pharma. On October 2, 2019 the IRS amended the original claim filed in July, reducing the claim to $9,302. Specialty Pharma filed its U.S. federal tax return as a member of the Company’s consolidated U.S. tax group. As such, the IRS claim was filed against Specialty Pharma in the bankruptcy proceedings due to IRS tax law requirements for joint and several liability of all members in a consolidated U.S. tax group. On November 19, 2019, Specialty Pharma and the IRS resolved their dispute, subject to the Bankruptcy Court’s approval of Specialty Pharma's Chapter 11 plan, and without prejudice to the claims, rights and defenses of the IRS and other Avadel entities outside of the bankruptcy case. The resolution provided for allowance of the IRS claim as a priority claim but for the IRS to receive a distribution of 50% of the proceeds, but in no event less than $125 from Specialty Pharma following confirmation of its disclosure statement and Chapter 11 plan of liquidation.
On July 24, 2020, Specialty Pharma sought bankruptcy court approval of a settlement agreement by and between it, Avadel US Holdings, Inc. and Serenity Pharmaceuticals, LLC (“Serenity”) (the “Serenity Settlement Agreement”). Before the commencement of Specialty Pharma's bankruptcy case, Serenity asserted claims against Specialty Pharma and Avadel US Holdings collectively in an amount no less than $50,000, and after the commencement of the bankruptcy case, Serenity asserted a $3,096 claim against Specialty Pharma and voted to reject its Chapter 11 plan of liquidation. The Serenity Settlement Agreement provides for a global resolution of these disputes by way of an $800 payment from Avadel US Holdings to Serenity, a mutual exchange of general releases, and the withdrawal of Serenity's claim and vote in Specialty Pharma's bankruptcy case. The Serenity Settlement Agreement was approved by order of the Bankruptcy Court on August 12, 2020.
At a hearing conducted on October 6, 2020, the Bankruptcy Court granted final approval of Specialty Pharma’s disclosure statement and confirmed its Chapter 11 plan of liquidation. Pursuant to the plan, the appointment of a Plan Administrator was also approved. The Plan Administrator will be responsible for making distributions to creditors, managing the final windup and dissolution of Specialty Pharma, and taking other steps in accordance with the plan of liquidation. The plan of liquidation became effective on October 21, 2020. Subsequent to the finalization of the bankruptcy, we recognized a non-cash gain of $3,364 from the release of certain liabilities that had been retained following the deconsolidation of Specialty Pharma. This gain is including in "Gain from release of certain liabilities" within non-operating income (loss) for the year ended December 31, 2020.
Debtor in Possession (“DIP”) Financing – Related Party Relationship
In connection with the bankruptcy filing, Specialty Pharma entered into a Debtor in Possession Credit and Security Agreement with Avadel US Holdings (“DIP Credit Agreement”) dated as of February 8, 2019, in an aggregate amount of up to $2,700, of which the funds are to be used by Specialty Pharma solely to fund operations through February 6, 2020. During the year ended December 31, 2019, the Company funded $407 under the DIP Credit Agreement. As the Company assessed that it is unlikely that Specialty Pharma will pay back the loan to Avadel, the $407 was recorded as part of the loss on deconsolidation of subsidiary within the consolidated statements of income (loss) during the year ended December 31, 2019. No amounts were funded under the DIP Credit Agreement during the year ended December 31, 2020. We do not expect any additional further liabilities from the DIP Credit Agreement.
NOTE 4: Disposition of the Hospital Products
On June 30, 2020 (the “Closing date”), we announced the sale of our Hospital Products to the Exela Buyer pursuant to the Purchase Agreement (the “Transaction”).
Pursuant to the Purchase Agreement, the Exela Buyer agreed to pay a total aggregate consideration amount of $42,000, of which $14,500 was paid on the Closing Date and an additional $27,500 is to be paid in ten equal monthly installments. During the year ended December 31, 2020, we collected four installment payments, totaling $11,000. Subsequent to the year ended December 31, 2020 but prior to the filing of this Annual Report, we collected an additional $5,500 in installment payments. In connection with the sale of the Hospital Products, the parties also agreed to cause the dismissal of the pending civil litigation related to Nouress in the District Court for the District of Delaware.
We were party to a Membership Interest Purchase Agreement, dated March 13, 2012, by and among us, Avadel Legacy, Breaking Stick Holdings, LLC, Deerfield Private Design International II, L.P. (“Deerfield International”), Deerfield Private Design Fund II, L.P. (“Deerfield Fund”) and Horizon Santé FLML, Sarl (“Horizon”) (the “Deerfield MIPA”) and a Royalty Agreement, dated February 4, 2013, by and among us, Avadel Legacy, the Deerfield Fund and Horizon (the “Deerfield Royalty Agreement”). In connection with the closing of the sale of the Hospital Products, the Deerfield MIPA (with respect to certain sections thereof) and the Royalty Agreement were assigned to the Exela Buyer. Pursuant to the Purchase Agreement, the Exela Buyer assumed and will pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy under the Deerfield Royalty Agreement for obligations that arise after the Closing date.
We were also party to a Royalty Agreement, dated December 3, 2013, by and between us, Avadel Legacy and Broadfin Healthcare Master Fund, Ltd. (the “Broadfin Royalty Agreement”). In connection with the closing of the sale of the Hospital Products, the Broadfin Royalty Agreement was assigned to the Exela Buyer and the Exela Buyer assumed and shall pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy under the Broadfin Royalty Agreement for obligations that arise after the Closing Date.
We recorded a net gain on the sale of the Hospital Products of $45,760 during the year ended December 31, 2020 which has been recorded on the consolidated statement of income (loss). The $45,760 gain represents the aggregate consideration of $42,000, less transaction fees of $2,928, plus the assets and liabilities either transferred to the Exela Buyer or eliminated by us due to the sale of the Hospital Products, which are listed below.
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December 31, 2020
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Prepaid expenses and other current assets
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$
|
(134)
|
|
Inventories
|
|
(4,922)
|
|
Goodwill
|
|
(1,654)
|
|
Intangible assets, net
|
|
(407)
|
|
Other non-current assets
|
|
(1,095)
|
|
Total long-term contingent consideration payable
|
|
14,900
|
|
Net liabilities disposed of
|
|
6,688
|
|
Aggregate consideration
|
|
42,000
|
|
Less transaction fees
|
|
(2,928)
|
|
Net gain on the sale of the Hospital Products
|
|
$
|
45,760
|
|
Subsequent to the disposition of the Hospital Products, the Company entered into a separate and distinct agreement with the Exela Buyer, whereby the Exela Buyer assumed all future returns of the Hospital Products in exchange for cash consideration paid by the Company. The Company recorded a $518 gain from this transaction, which is recorded in “Selling, general and administrative expenses” for the year ended December 31, 2020.
We evaluated various qualitative and quantitative factors related to the disposition of the Hospital Products and determined that it did not meet the criteria for presentation as a discontinued operation.
The unaudited pro forma condensed combined financial statements included below are being provided for information purposes only and are not necessarily indicative of the results of operations or financial position that would have resulted if the Transaction had actually occurred on the date indicated. The pro forma adjustments are based on available information and assumptions that the Company believes are attributable to the sale.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited Pro Forma Condensed Combined Balance Sheet
|
|
|
As of December 31, 2019
|
|
|
As Reported
|
|
Pro Forma Adjustments
|
|
Notes
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
9,774
|
|
|
$
|
12,935
|
|
|
(a)
|
|
$
|
22,709
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventories
|
|
3,570
|
|
|
(3,570)
|
|
|
(b)
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
4,264
|
|
|
27,500
|
|
|
(c)
|
|
31,764
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
18,491
|
|
|
(1,654)
|
|
|
(d)
|
|
16,837
|
|
Intangible assets, net
|
|
813
|
|
|
(813)
|
|
|
(e)
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Other non-current assets
|
|
39,274
|
|
|
(9,702)
|
|
|
(f)
|
|
29,572
|
|
Total assets
|
|
$
|
151,436
|
|
|
$
|
24,696
|
|
|
|
|
$
|
176,132
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of long-term contingent consideration payable
|
|
$
|
5,554
|
|
|
$
|
(5,054)
|
|
|
(g)
|
|
$
|
500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued expenses
|
|
19,810
|
|
|
2,800
|
|
|
(h)
|
|
22,610
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term contingent consideration payable, less current portion
|
|
11,773
|
|
|
(11,773)
|
|
|
(g)
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
180,635
|
|
|
(14,027)
|
|
|
|
|
166,608
|
|
|
|
|
|
|
|
|
|
|
Shareholders’ equity (deficit):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated deficit
|
|
(391,215)
|
|
|
38,723
|
|
|
(i)
|
|
(352,492)
|
|
|
|
|
|
|
|
|
|
|
Total shareholders’ (deficit) equity
|
|
(29,199)
|
|
|
38,723
|
|
|
|
|
9,524
|
|
Total liabilities and shareholders’ equity (deficit)
|
|
$
|
151,436
|
|
|
$
|
24,696
|
|
|
|
|
$
|
176,132
|
|
Adjustments to the pro forma unaudited condensed combined balance sheet
(a) This adjustment represents the receipt of $14,500 cash consideration from the Exela Buyer at the closing of the Transaction less $1,565 placed into escrow for the estimated earn outs and royalties payable to Breaking Stick Holdings L.L.C., Horizon Santé FLML, Sarl, Deerfield Private Design Fund II, L.P., all affiliates of Deerfield Capital L.P. ("Deerfield") and Broadfin Healthcare Master Fund ("Broadfin") for the current year ended.
(b) This adjustment reflects the elimination of Inventories that were purchased as part of the Transaction.
(c) This adjustment reflects the Transaction consideration in the form of ten monthly installment payments of $2,750 (totaling $27,500) beginning 90 days from the Closing date.
(d) This adjustment reflects the elimination of $1,654 of Goodwill based on the relative fair value of the Hospital Products as a portion of the overall value of the Company.
(e) This adjustment reflects the elimination of the unamortized balance of the Intangible asset on acquired developed technology for Vazculep.
(f) This adjustment reflects the elimination of $1,228 of other long-term assets and $8,474 of deferred tax assets at December 31, 2019. The eliminated deferred tax assets are tax attributes of the Hospital Products.
(g) This adjustment reflects the elimination of short and long term related party payables, less the expected amounts due to Deerfield and Broadfin after taking into consideration the escrow discussed in Note (a). As part of the Transaction, the buyer
agreed to assume the quarterly earn-out and royalty payments for periods after the close of the Transaction. The Company will no longer be responsible for these payments.
(h) This adjustment reflects the estimated transaction fees payable related to the Transaction.
(i) This adjustment reflects the estimated gain of $38,723 arising from the Transaction for the year ended December 31, 2019. This estimated gain has not been reflected in the pro forma unaudited condensed combined statements of loss as it is considered to be nonrecurring in nature. No adjustment has been made to the sale proceeds to give effect to any potential post-closing adjustments under the terms of the Purchase Agreement.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited Pro Forma Condensed Combined Statement of Income (Loss)
|
|
|
Year Ended December 31, 2020
|
|
|
As Reported
|
|
Pro Forma Adjustments
|
|
Notes
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
22,334
|
|
|
$
|
(22,175)
|
|
|
(j)
|
|
$
|
159
|
|
Total operating expense
|
|
16,519
|
|
|
(8,392)
|
|
|
(k)
|
|
8,127
|
|
Operating income (loss)
|
|
5,815
|
|
|
(13,783)
|
|
|
|
|
(7,968)
|
|
Loss before income taxes
|
|
$
|
(5,082)
|
|
|
$
|
(13,348)
|
|
|
(l)
|
|
$
|
(18,430)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited Pro Forma Condensed Combined Statement of Income (Loss)
|
|
|
Year Ended December 31, 2019
|
|
|
As Reported
|
|
Pro Forma Adjustments
|
|
Notes
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
59,215
|
|
|
$
|
(59,273)
|
|
|
(j)
|
|
$
|
(58)
|
|
Total operating expense
|
|
83,327
|
|
|
(16,092)
|
|
|
(m)
|
|
67,235
|
|
Operating income (loss)
|
|
(24,112)
|
|
|
(43,181)
|
|
|
|
|
(67,293)
|
|
Loss before income taxes
|
|
$
|
(38,582)
|
|
|
$
|
(42,803)
|
|
|
(n)
|
|
$
|
(81,385)
|
|
Adjustments to the pro forma unaudited condensed combined statements of income (loss)
(j) This adjustment reflects Product sales attributable to the Hospital Products.
(k) This adjustment reflects the following estimated expenses attributable to the Hospital Products:
•Cost of products of $3,540.
•R&D expenses of $322.
•Selling, general and administrative expenses of $797.
•Intangible asset amortization on acquired development technology for Vazculep of $406.
•Changes in fair value of related party contingent consideration of $3,327. The Company will no longer be responsible for these payments.
(l) This amount reflects the adjustments noted in (j) and (k) above, as well as estimated Changes in fair value of related party payable of $435 attributable to the Hospital Products. The Company will no longer be responsible for these payments.
(m) This adjustment reflects the following estimated expenses attributable to the Hospital Products:
•Cost of products of $11,368.
•R&D expenses of $1,960.
•Selling, general and administrative expenses of $1,102.
•Intangible asset amortization on acquired development technology for Vazculep of $816.
•Changes in fair value of related party contingent consideration of $845. The Company will no longer be responsible for these payments.
(n) This amount reflects the adjustments noted in (j) and (m) above, as well as the reversal of estimated Changes in fair value of related party payable of $378 attributable to the Hospital Products. The Company will no longer be responsible for these payments.
NOTE 5: Revenue Recognition
Prior to June 30, 2020, the Company generated revenue primarily from the sale of pharmaceutical products to customers. On June 30, 2020, the Company sold the Hospital Products. See Note 4: Disposition of the Hospital Products.
Product Sales and Services
Prior to June 30, 2020, we sold products primarily through wholesalers and considered these wholesalers to be our customers. Revenue from product sales was recognized when the customer obtained control of our product and our performance obligations were met, which occurred typically upon receipt of delivery to the customer. As is customary in the pharmaceutical industry, our gross product sales were subject to a variety of price adjustments in arriving at reported net product sales. These adjustments included estimates for product returns, chargebacks, payment discounts, rebates, and other sales allowances and were estimated when the product is delivered based on analysis of historical data for the product or comparable products, as well as future expectations for such products.
Reserves to reduce Gross Revenues to Net Revenues
Revenues from product sales were recorded at the net selling price, which included estimated reserves to reduce gross product sales to net product sales resulting from product returns, chargebacks, payment discounts, rebates, and other sales allowances that are offered within contracts between the Company and its customers and end users. These reserves were based on the amounts earned or to be claimed on the related sales and were classified as reductions of accounts receivable if the amount is payable to the customer, except in the case of the estimated reserve for future expired product returns, which are classified as a liability. The reserves are classified as a liability if the amount is payable to a party other than a customer. Where appropriate, these estimated reserves take into consideration relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates to reduce gross selling price to net selling price to which it expects to be entitled based on the terms of its contracts. The actual selling price ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect earnings in the period such variances become known.
Product Returns
Consistent with industry practice, the Company maintains a returns policy that generally offers customers a right of return for product that has been purchased from the Company. The Company estimated the amount of product returns and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company estimated product return liabilities based on analysis of historical data for the product or comparable products, as well as future expectations for such products and other judgments and analysis.
Chargebacks, Discounts and Rebates
Chargebacks, discounts and rebates represent the estimated obligations resulting from contractual commitments to sell products to its customers or end users at prices lower than the list prices charged to our wholesale customers. Customers charge the Company for the difference between the gross selling price they pay for the product and the ultimate contractual price agreed to between the Company and these end users. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargebacks, discounts and rebates are estimated at the time of sale to the customer.
Revenue from licensing arrangements
The terms of the Company’s licensing agreements may contain multiple performance obligations, including certain R&D activities. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments. Each of these payments are recorded as license revenues. The Company did not have any license revenue during the years ended December 31, 2020 and 2019. License revenue during the year ended December 31, 2018 was $1,846.
License of Intellectual Property
If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up-front fees allocated to the license when the
license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Disaggregation of revenue
The Company’s primary source of revenue was from the sale of pharmaceutical products, which are equally affected by the same economic factors as it relates to the nature, amount, timing, and uncertainty of revenue and cash flows. For further detail about the Company’s revenues by product, see Note 24: Company Operations by Product, Customer and Geography.
Contract Balances
The Company does not recognize revenue in advance of invoicing its customers and therefore has no related contract assets.
A receivable is recognized in the period the Company sells its products and when the Company’s right to consideration is unconditional.
There were no material deferred contract costs at December 31, 2020 and 2019.
Transaction Price Allocated to the Remaining Performance Obligation
For product sales, the Company generally satisfies its performance obligations within the same period the product is delivered. Product sales recognized in 2020 from performance obligations satisfied (or partially satisfied) in previous periods were immaterial.
For certain licenses of intellectual property, specifically those with performance obligations satisfied over time, the Company allocates a portion of the transaction price to that performance obligation and recognizes revenue using an appropriate measure of progress towards development of the product. In December 2018, we reached an agreement to exit a contract and our remaining performance obligations and recognized the remaining $1,600 of deferred revenue, which represented the unsatisfied performance obligations associated with a license agreement. At December 31, 2020 and 2019, the deferred revenue balance related to this obligation is $0.
The Company has elected certain of the practical expedients from the disclosure requirement for remaining performance obligations for specific situations in which an entity need not estimate variable consideration to recognize revenue. Accordingly, the Company applies the practical expedient in ASC 606 to its stand-alone contracts and does not disclose information about variable consideration from remaining performance obligations for which we recognize revenue.
NOTE 6: Fair Value Measurements
The Company is required to measure certain assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting. For example, we use fair value extensively when accounting for and reporting certain financial instruments, when measuring certain contingent consideration liabilities and in the initial recognition of net assets acquired in a business combination. Fair value is estimated by applying the hierarchy described below, which prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon the lowest level of input that is available and significant to the fair value measurement.
ASC 820, “Fair Value Measurements and Disclosures,” defines fair value as a market-based measurement that should be determined based on the assumptions that marketplace participants would use in pricing an asset or liability. When estimating fair value, depending on the nature and complexity of the asset or liability, we may generally use one or each of the following techniques:
•Income approach, which is based on the present value of a future stream of net cash flows.
•Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities.
As a basis for considering the assumptions used in these techniques, the standard establishes a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value as follows:
•Level 1 - Quoted prices for identical assets or liabilities in active markets.
•Level 2 - Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means.
•Level 3 - Unobservable inputs that reflect estimates and assumptions.
The following table summarizes the financial instruments measured at fair value on a recurring basis classified in the fair value hierarchy (Level 1, 2 or 3) based on the inputs used for valuation in the accompanying consolidated balance sheets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2020
|
|
As of December 31, 2019
|
Fair Value Measurements:
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable securities (see Note 7)
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity securities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,404
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Money market and mutual funds
|
|
104,672
|
|
|
—
|
|
|
—
|
|
|
38,799
|
|
|
—
|
|
|
—
|
|
Corporate bonds
|
|
—
|
|
|
22,155
|
|
|
—
|
|
|
—
|
|
|
4,098
|
|
|
—
|
|
Government securities - U.S.
|
|
—
|
|
|
18,999
|
|
|
—
|
|
|
—
|
|
|
5,446
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other fixed-income securities
|
|
—
|
|
|
3,854
|
|
|
—
|
|
|
—
|
|
|
1,637
|
|
|
—
|
|
Total assets
|
|
$
|
104,672
|
|
|
$
|
45,008
|
|
|
$
|
—
|
|
|
$
|
43,203
|
|
|
$
|
11,181
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration payable (see Note 13)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
17,327
|
|
Total liabilities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17,327
|
|
A review of fair value hierarchy classifications is conducted on a quarterly basis. Changes in the observability of valuation inputs may result in a reclassification for certain financial assets or liabilities. During the fiscal year ended December 31, 2020, there were no transfers in and out of Level 1, 2, or 3. During the twelve months ended December 31, 2020, 2019 and 2018, we did not recognize any other-than-temporary impairment loss.
Some of the Company’s financial instruments, such as cash and cash equivalents, accounts receivable and accounts payable, are reflected in the balance sheet at carrying value, which approximates fair value due to their short-term nature.
Debt
We estimate the fair value of our $143,750 aggregate principal amount of 4.50% exchangeable senior notes due 2023 (the “2023 Notes”), a Level 2 input, based on interest rates that would be currently available to the Company for issuance of similar types of debt instruments with similar terms and remaining maturities or recent trading prices obtained from brokers. The estimated fair value of the 2023 Notes at December 31, 2020 is $128,210, which is the same as book value.
See Note 12: Long-Term Debt for additional information regarding our debt obligations.
NOTE 7: Marketable Securities
The Company has investments in equity and available-for-sale debt securities which are recorded at fair market value. The change in the fair value of equity investments is recognized in our consolidated statements of income (loss) and the change in the fair value of available-for-sale debt investments is recorded as other comprehensive income (loss) in shareholders’ equity (deficit), net of income tax effects. As of December 31, 2020, we considered any decreases in fair value on our marketable securities to be driven by factors other than credit risk, including market risk.
The following tables show the Company’s available-for-sale securities’ adjusted cost, gross unrealized gains, gross unrealized losses and fair value by significant investment category as of December 31, 2020 and 2019, respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2020
|
Marketable Securities:
|
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market and mutual funds
|
|
$
|
103,404
|
|
|
$
|
1,288
|
|
|
$
|
(20)
|
|
|
$
|
104,672
|
|
Corporate bonds
|
|
21,811
|
|
|
350
|
|
|
(6)
|
|
|
22,155
|
|
Government securities - U.S.
|
|
18,849
|
|
|
155
|
|
|
(5)
|
|
|
18,999
|
|
|
|
|
|
|
|
|
|
|
Other fixed-income securities
|
|
3,839
|
|
|
22
|
|
|
(7)
|
|
|
3,854
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
147,903
|
|
|
$
|
1,815
|
|
|
$
|
(38)
|
|
|
$
|
149,680
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019
|
Marketable Securities:
|
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
|
|
|
|
|
|
|
|
|
Equity securities
|
|
$
|
4,234
|
|
|
$
|
170
|
|
|
$
|
—
|
|
|
$
|
4,404
|
|
Money market and mutual funds
|
|
38,028
|
|
|
771
|
|
|
—
|
|
|
38,799
|
|
Corporate bonds
|
|
4,021
|
|
|
77
|
|
|
—
|
|
|
4,098
|
|
Government securities - U.S.
|
|
5,341
|
|
|
110
|
|
|
(5)
|
|
|
5,446
|
|
|
|
|
|
|
|
|
|
|
Other fixed-income securities
|
|
1,614
|
|
|
23
|
|
|
—
|
|
|
1,637
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
53,238
|
|
|
$
|
1,151
|
|
|
$
|
(5)
|
|
|
$
|
54,384
|
|
We determine realized gains or losses on the sale of marketable securities on a specific identification method. We reflect these gains and losses as a component of investment and other income in the accompanying consolidated statements of income (loss).
We recognized gross realized gains of $474, $483, and $317 for the twelve months ended December 31, 2020, 2019, and 2018, respectively. These realized gains were offset by realized losses of $912, $151, and $565 for the twelve-months ended December 31, 2020, 2019, and 2018, respectively.
The following table summarizes the estimated fair value of our investments in marketable debt securities, accounted for as available-for-sale securities and classified by the contractual maturity date of the securities as of December 31, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturities
|
Marketable Debt Securities:
|
|
Less than 1 Year
|
|
1-5 Years
|
|
5-10 Years
|
|
Greater than 10 Years
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate bonds
|
|
$
|
6,054
|
|
|
$
|
14,468
|
|
|
$
|
1,633
|
|
|
$
|
—
|
|
|
$
|
22,155
|
|
Government securities - U.S.
|
|
—
|
|
|
13,827
|
|
|
2,038
|
|
|
3,134
|
|
|
18,999
|
|
|
|
|
|
|
|
|
|
|
|
|
Other fixed-income securities
|
|
1,017
|
|
|
2,837
|
|
|
—
|
|
|
—
|
|
|
3,854
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
7,071
|
|
|
$
|
31,132
|
|
|
$
|
3,671
|
|
|
$
|
3,134
|
|
|
$
|
45,008
|
|
We have classified our investment in available-for-sale marketable securities as current assets in the consolidated balance sheets as the securities need to be available for use, if required, to fund current operations. There are no restrictions on the sale of any securities in our investment portfolio.
Total gross unrealized losses of our available-for-sale debt securities at December 31, 2020 were immaterial. The unrealized losses are driven by factors other than credit risk and have been in a unrealized loss position for less than one year. We do not intend to sell the investments and it is not more likely than not that we will be required to sell the investments before recovery of their amortized cost bases.
NOTE 8: Inventories
The principal categories of inventories, net of reserves of $0 and $914 at December 31, 2020 and 2019, respectively, are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory:
|
|
2020
|
|
2019
|
|
|
|
|
|
Finished goods
|
|
$
|
—
|
|
|
$
|
3,020
|
|
Raw materials
|
|
—
|
|
|
550
|
|
Total
|
|
$
|
—
|
|
|
$
|
3,570
|
|
The decrease in inventory at December 31, 2020 is a result of the June 30, 2020 disposition of the Hospital Products. See Note 4: Disposition of the Hospital Products.
NOTE 9: Property and Equipment, net
The principal categories of property and equipment, net at December 31, 2020 and 2019, respectively, are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and Equipment, net:
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
Software, office and computer equipment
|
|
$
|
1,443
|
|
|
$
|
1,258
|
|
Furniture, fixtures and fittings
|
|
300
|
|
|
300
|
|
Less - accumulated depreciation
|
|
(1,384)
|
|
|
(1,014)
|
|
Total
|
|
$
|
359
|
|
|
$
|
544
|
|
Depreciation expense for the years ended December 31, 2020, 2019 and 2018 was $287, $459 and $811, respectively.
NOTE 10: Goodwill and Intangible Assets
The Company’s amortizable and unamortizable intangible assets at December 31, 2020 and 2019, respectively, are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2020
|
|
2019
|
Goodwill and Intangible Assets:
|
|
Gross
Value
|
|
Accumulated
Amortization
|
|
Net Carrying Amount
|
|
Gross
Value
|
|
Accumulated
Amortization
|
|
Net Carrying Amount
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired developed technology - Vazculep (1)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
12,061
|
|
|
$
|
(11,248)
|
|
|
$
|
813
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unamortizable intangible assets - Goodwill (2)
|
|
$
|
16,836
|
|
|
$
|
—
|
|
|
$
|
16,836
|
|
|
$
|
18,491
|
|
|
$
|
—
|
|
|
$
|
18,491
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) This intangible asset was assumed by the Exela Buyer as part of the disposition of the Hospital Products on June 30, 2020. See Note 4: Disposition of the Hospital Products.
(2) In connection with the disposition of the Hospital Products (see Note 4: Disposition of the Hospital Products), the Company allocated goodwill of $1,655 on a relative fair value basis to the Hospital Products and included this amount in the net gain on the disposition of the Hospital Products on the consolidated statement of income (loss) during the year ended December 31, 2020.
The Company recorded amortization expense related to amortizable intangible assets of $406, $816 and $6,619 for the years ended December 31, 2020, 2019 and 2018, respectively.
No impairment loss related to goodwill or intangible assets was recognized during the years ended December 31, 2020 or 2019.
NOTE 11: Leases
On January 1, 2019, the Company adopted ASU 2016-02, “Leases”, using the modified retrospective transition approach and elected the transition option to recognize the adjustment in the period of adoption rather than in the earliest period presented. At December 31, 2020, the balances of the operating lease right-of-use asset and total operating lease liability were $2,604 and $2,314, respectively, of which $474 of the operating lease liability is classified as a current liability.
All of the Company’s office spaces are leased. The Company also leases a production suite. All leased facilities are classified as operating leases with remaining lease terms between one and five years. The Company determines if a contract is a lease at the inception of the arrangement. The Company reviews all options to extend, terminate, or purchase its right-of-use assets at the inception of the lease and will include these options in the lease term when they are reasonably certain of being exercised. For all of the Company’s leases, lease and non-lease components are accounted for as a single lease component, as all non-lease components are immaterial.
The components of lease costs, which are included in selling, general and administrative expenses in the consolidated statements of income (loss) of years ended December 31, 2020 and 2019 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lease cost:
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
Operating lease costs (1)
|
|
|
|
$
|
1,133
|
|
|
$
|
1,515
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sublease income (2)
|
|
|
|
(336)
|
|
|
(276)
|
|
Total lease cost
|
|
|
|
$
|
797
|
|
|
$
|
1,239
|
|
(1) Variable lease costs were immaterial for the years ended December 31, 2020 and 2019.
(2) Represents sublease income received for various office leases.
During the years ended December 31, 2020 and 2019, the Company reduced its operating lease liabilities by $769 and $1,480 for cash paid. During the year ended December 31, 2020, there were no new operating or finance leases entered into. As of December 31, 2020, the Company is aware of one additional potential embedded lease that has not yet commenced and will not commence until certain conditions are met. If these conditions are met and the start date is determined, annual fees would commence and at that time an operating lease right-of-use asset and corresponding operating lease liability will be recorded.
As of December 31, 2020, our operating leases have a weighted-average remaining lease term of 4.3 years and a weighted-average discount rate of 5.3%. Avadel’s lease contracts do not provide a readily determinable implicit rate. Avadel’s estimated incremental borrowing rate is based on information available at the inception of the lease.
Maturities of the Company’s operating lease liabilities were as follows:
|
|
|
|
|
|
|
|
|
Maturities:
|
|
Operating Leases
|
|
|
|
2021
|
|
$
|
578
|
|
2022
|
|
590
|
|
2023
|
|
602
|
|
2024
|
|
614
|
|
2025
|
|
206
|
|
Thereafter
|
|
—
|
|
Total lease payments
|
|
2,590
|
|
Less: interest
|
|
276
|
|
Present value of lease liabilities
|
|
$
|
2,314
|
|
NOTE 12: Long-Term Debt
Long-term debt is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2020
|
|
December 31, 2019
|
Principal amount of 4.50% exchangeable senior notes due 2023
|
|
$
|
143,750
|
|
|
$
|
143,750
|
|
Less: unamortized debt discount and issuance costs, net
|
|
(15,540)
|
|
|
(22,064)
|
|
Net carrying amount of liability component
|
|
128,210
|
|
|
121,686
|
|
Less: current maturities
|
|
—
|
|
|
—
|
|
Long-term debt
|
|
$
|
128,210
|
|
|
$
|
121,686
|
|
|
|
|
|
|
Equity component:
|
|
|
|
|
Equity component of exchangeable notes, net of issuance costs
|
|
$
|
(26,699)
|
|
|
$
|
(26,699)
|
|
2023 Notes
On February 16, 2018, Avadel Finance Cayman Limited, a Cayman Islands exempted company (the “Issuer”) and an indirect wholly-owned subsidiary of the Company, issued $125,000 aggregate principal amount of 4.50% exchangeable senior notes due 2023 (the “2023 Notes”) in a private placement (the “Offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act. In connection with the Offering, the Issuer granted the initial purchasers of the 2023 Notes a 30-day option to purchase up to an additional $18,750 aggregate principal amount of the 2023 Notes, which was fully exercised on February 16, 2018. Net proceeds received by the Company, after issuance costs and discounts, were approximately $137,560. The 2023 Notes are the Company’s senior unsecured obligations and rank equally in right of payment with all of the Company’s existing and future senior unsecured indebtedness and effectively junior to any of the Company’s existing and future secured indebtedness, to the extent of the value of the assets securing such indebtedness.
The 2023 Notes will be exchangeable at the option of the holders at an initial exchange rate of 92.6956 ADSs per $1 principal amount of 2023 Notes, which is equivalent to an initial exchange price of approximately $10.79 per ADS. Such initial exchange price represents a premium of approximately 20% to the $8.99 per ADS closing price on The Nasdaq Global Market on February 13, 2018. Upon the exchange of any 2023 Notes, the Issuer will pay or cause to be delivered, as the case may be, cash, ADSs or a combination of cash and ADSs, at the Issuer’s election. Holders of the 2023 Notes may convert their 2023 Notes, at their option, only under the following circumstances prior to the close of business on the business day immediately preceding August 1, 2022, under the circumstances and during the periods set forth below and regardless of the conditions described below, on or after August 1, 2022 and prior to the close of business on the business day immediately preceding the maturity date:
•Prior to the close of business on the business day immediately preceding August 1, 2022, a holder of the 2023 Notes may surrender all or any portion of its 2023 Notes for exchange at any time during the five business day period immediately after any five consecutive trading day period (the “Measurement Period”) in which the trading price per $1 principal amount of 2023 Notes, as determined following a request by a holder of the 2023 Notes, for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the ADSs and the exchange rate on each such trading day.
•If a transaction or event that constitutes a fundamental change or a make-whole fundamental change occurs prior to the close of business on the business day immediately preceding August 1, 2022, regardless of whether a holder of the 2023 Notes has the right to require the Company to repurchase the 2023 Notes, or if Avadel is a party to a merger event that occurs prior to the close of business on the business day immediately preceding August 1, 2022, all or any portion of a the holder’s 2023 Notes may be surrendered for exchange at any time from or after the date that is 95 scheduled trading days prior to the anticipated effective date of the transaction (or, if later, the earlier of (x) the business day after the Company gives notice of such transaction and (y) the actual effective date of such transaction) until 35 trading days after the actual effective date of such transaction or, if such transaction also constitutes a fundamental change, until the related fundamental change repurchase date.
•Prior to the close of business on the business day immediately preceding August 1, 2022, a holder of the 2023 Notes may surrender all or any portion of its 2023 Notes for exchange at any time during any calendar quarter commencing after the calendar quarter ending on June 30, 2018 (and only during such calendar quarter), if the last reported sale
price of the ADSs for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the exchange price on each applicable trading day.
•If the Company calls the 2023 Notes for redemption pursuant to Article 16 to the Indenture prior to the close of business on the business day immediately preceding August 1, 2022, then a holder of the 2023 Notes may surrender all or any portion of its 2023 Notes for exchange at any time prior to the close of business on the second business day prior to the redemption date, even if the 2023 Notes are not otherwise exchangeable at such time. After that time, the right to exchange shall expire, unless the Company defaults in the payment of the redemption price, in which case a holder of the 2023 Notes may exchange its 2023 Notes until the redemption price has been paid or duly provided for.
We considered the guidance in ASC 815-15, Embedded Derivatives, to determine if this instrument contains an embedded feature that should be separately accounted for as a derivative. ASC 815 provides for an exception to this rule when convertible notes, as host instruments, are deemed to be conventional, as defined by ASC 815-40. We determined that this exception applies due, in part, to our ability to settle the 2023 Notes in cash, ADSs or a combination of cash and ADSs, at our option. We have therefore applied the guidance provided by ASC 470-20, Debt with Conversion and Other Options which requires that the 2023 Notes be separated into debt and equity components at issuance and a value be assigned to each. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected our non-convertible debt borrowing rate for similar debt. The equity component of the 2023 Notes was recognized as a debt discount and represents the difference between the proceeds from the issuance of the 2023 Notes and the fair value of the liability of the 2023 Notes on its issuance date. The excess of the principal amount of the liability component over its carrying amount (the “Debt Discount”) is amortized to interest expense using the effective interest method over the term of the 2023 Notes. The equity component is not remeasured as long as it continues to meet the conditions for equity classification.
NOTE 13: Contingent Consideration Payable
Contingent consideration payable and related activity are reported at fair value and consist of the following at December 31, 2020 and 2019, respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Activity during the Twelve Months Ended December 31, 2020
|
|
|
|
|
|
|
|
|
Changes in Fair Value of
Contingent Consideration Payable
|
|
|
|
|
|
|
Balance,
December 31, 2019
|
|
Payments
|
|
Operating Expense
|
|
Other
Expense
|
|
Disposition of the Hospital Products
|
|
Balance,
December 31, 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition-related contingent consideration:
|
|
|
|
|
|
|
|
|
|
|
|
|
Earn-out payments - Éclat Pharmaceuticals (a) (d)
|
|
$
|
15,472
|
|
|
$
|
(5,323)
|
|
|
$
|
3,327
|
|
|
$
|
—
|
|
|
$
|
(13,476)
|
|
|
$
|
—
|
|
Financing-related:
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty agreement - Deerfield (b) (d)
|
|
1,251
|
|
|
(587)
|
|
|
—
|
|
|
272
|
|
|
(936)
|
|
|
—
|
|
Royalty agreement - Broadfin (c) (d)
|
|
604
|
|
|
(279)
|
|
|
—
|
|
|
163
|
|
|
(488)
|
|
|
—
|
|
Total contingent consideration payable
|
|
17,327
|
|
|
$
|
(6,189)
|
|
|
$
|
3,327
|
|
|
$
|
435
|
|
|
$
|
(14,900)
|
|
|
—
|
|
Less: current portion
|
|
(5,554)
|
|
|
|
|
|
|
|
|
|
|
—
|
|
Total long-term contingent consideration payable
|
|
$
|
11,773
|
|
|
|
|
|
|
|
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) In March 2012, the Company acquired all of the membership interests of Éclat from Breaking Stick Holdings, L.L.C. (“Breaking Stick”, formerly Éclat Holdings), an affiliate of Deerfield. Breaking Stick is majority owned by Deerfield, with a minority interest owned by the Company’s former CEO, and certain other current and former employees. As part of the consideration, the Company committed to provide quarterly earn-out payments equal to 20% of any gross profit generated by certain Éclat products. These payments will continue in perpetuity, to the extent gross profit of the related products also continue in perpetuity. In connection with the disposition of the Hospital Products on June 30, 2020 as discussed in Note 4: Disposition of the Hospital Products, the Deerfield MIPA (with respect to certain sections thereof) and the Royalty Agreement were assigned to the Exela Buyer. Pursuant to the Purchase Agreement, the Exela Buyer assumed and will pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy and the Company under the Deerfield Royalty Agreement.
(b)As part of a February 2013 debt financing transaction conducted with Deerfield, the Company received cash of $2,600 in exchange for entering into a royalty agreement whereby the Company shall pay quarterly a 1.75% royalty on the net sales of certain Éclat products until December 31, 2024. In connection with such debt financing transaction, the Company granted Deerfield a security interest in the product registration rights of the Éclat Pharmaceuticals products. In connection with the disposition of the Hospital Products on June 30, 2020 as discussed in Note 4: Disposition of the Hospital Products, the Deerfield MIPA (with respect to certain sections thereof) and the Royalty Agreement were assigned to the Exela Buyer. Pursuant to the Purchase Agreement, the Exela Buyer assumed and will pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy and the Company under the Deerfield Royalty Agreement.
(c)As part of a December 2013 debt financing transaction conducted with Broadfin Healthcare Master Fund, a former related party and shareholder, the Company received cash of $2,200 in exchange for entering into a royalty agreement whereby the Company shall pay quarterly a 0.834% royalty on the net sales of certain Éclat products until December 31, 2024. In connection with the disposition of the Hospital Products on June 30, 2020 as discussed in Note 4: Disposition of the Hospital Products, the Broadfin Royalty Agreement was assigned to the Exela Buyer and the Exela Buyer assumed and shall pay, perform, satisfy and discharge the liabilities and obligations of the Company under the Broadfin Royalty Agreement.
(d)Deerfield and Broadfin Healthcare Master Trust disposed of their 2023 Notes and ordinary shares in the Company during the year ended December 31, 2020 and are no longer considered related parties.
Prior to the sale of the Hospital Products on June 30, 2020, the fair value of each contingent consideration payable listed in (a), (b) and (c) above was estimated using a discounted cash flow model based on estimated and projected annual net revenues or gross profit, as appropriate, of each of the specified Éclat products using an appropriate risk-adjusted discount rate of 14%. These fair value measurements are based on significant inputs not observable in the market and thus represent a level 3 measurement as defined in ASC 820. Subsequent changes in the fair value of the acquisition-related contingent consideration payables, resulting primarily from management’s revision of key assumptions, will be recorded in the consolidated statements of income (loss) in the line items entitled “Changes in fair value of contingent consideration” for items noted in (b) above and in “Other (expense) income - changes in fair value of contingent consideration payable” for items (b) and (c) above. See Note 1: Summary of Significant Accounting Policies under the caption Acquisition-related Contingent Consideration and Financing-related Royalty Agreements for more information on key assumptions used to determine the fair value of these liabilities.
Prior to June 30, 2020, the Company chose to make a fair value election pursuant to ASC 825, “Financial Instruments” for its royalty agreements detailed in items (b) and (c) above. These financing-related liabilities were recorded at fair market value on the consolidated balance sheets and the periodic change in fair market value is recorded as a component of “Other expense – change in fair value of contingent consideration payable” on the consolidated statements of income (loss).
The following table summarizes changes to the contingent consideration payables, a recurring Level 3 measurement, for the twelve-month periods ended December 31, 2020, 2019 and 2018:
|
|
|
|
|
|
|
|
|
Contingent Consideration Payable:
|
|
Balance
|
|
|
|
Balance at December 31, 2017
|
|
$
|
98,925
|
|
Payments of related party payable
|
|
(22,951)
|
|
Fair value adjustments (1)
|
|
(24,630)
|
|
Expiration of warrants
|
|
(2,167)
|
|
Disposition of the pediatrics assets
|
|
(20,337)
|
|
Balance at December 31, 2018
|
|
28,840
|
|
Payments of related party payable
|
|
(12,736)
|
|
Fair value adjustments (1)
|
|
1,223
|
|
Balance at December 31, 2019
|
|
17,327
|
|
Payments of contingent consideration payable
|
|
(6,189)
|
|
Fair value adjustments (1)
|
|
3,762
|
|
Disposition of the Hospital Products
|
|
(14,900)
|
|
Balance at December 31, 2020
|
|
$
|
—
|
|
(1) Fair value adjustments are reported as changes in fair value of contingent consideration and other expense - changes in fair value of contingent consideration payable in the consolidated statements of income (loss).
NOTE 14: Income Taxes
The components of (loss) income before income taxes for the years ended twelve months ended December 31, are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) Income Before Income Taxes:
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
Ireland
|
|
$
|
(27,205)
|
|
|
$
|
(50,134)
|
|
|
$
|
(42,604)
|
|
U.S.
|
|
22,335
|
|
|
10,401
|
|
|
(70,340)
|
|
France
|
|
(212)
|
|
|
1,151
|
|
|
(253)
|
|
Total loss before income taxes
|
|
$
|
(5,082)
|
|
|
$
|
(38,582)
|
|
|
$
|
(113,197)
|
|
The income tax (benefit) provision consists of the following for the years ended December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income Tax (Benefit) Provision:
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
Current:
|
|
|
|
|
|
|
U.S. - Federal
|
|
$
|
(12,810)
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S. - State
|
|
20
|
|
|
97
|
|
|
330
|
|
|
|
|
|
|
|
|
Total current
|
|
(12,790)
|
|
|
97
|
|
|
330
|
|
|
|
|
|
|
|
|
Deferred:
|
|
|
|
|
|
|
Ireland
|
|
—
|
|
|
(1,256)
|
|
|
—
|
|
U.S. - Federal
|
|
680
|
|
|
(4,093)
|
|
|
(19,503)
|
|
U.S. - State
|
|
—
|
|
|
(104)
|
|
|
1,280
|
|
|
|
|
|
|
|
|
Total deferred
|
|
680
|
|
|
(5,453)
|
|
|
(18,223)
|
|
|
|
|
|
|
|
|
Income tax benefit
|
|
$
|
(12,110)
|
|
|
$
|
(5,356)
|
|
|
$
|
(17,893)
|
|
The reconciliation between income taxes at the statutory rate and the Company’s benefit for income taxes is as follows for the years ended December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation to Effective Income Tax Rate:
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
Statutory tax rate
|
|
12.5
|
%
|
|
12.5
|
%
|
|
12.5
|
%
|
Differences in international tax rates
|
|
(34.5)
|
%
|
|
3.2
|
%
|
|
8.0
|
%
|
Nondeductible changes in fair value of contingent consideration
|
|
(19.4)
|
%
|
|
(0.3)
|
%
|
|
4.0
|
%
|
Intercompany asset transfer
|
|
—
|
%
|
|
21.2
|
%
|
|
—
|
%
|
Change in valuation allowances
|
|
(83.3)
|
%
|
|
(19.1)
|
%
|
|
(5.3)
|
%
|
Nondeductible stock-based compensation
|
|
(20.9)
|
%
|
|
(2.7)
|
%
|
|
(1.3)
|
%
|
Hospital Products sale
|
|
183.5
|
%
|
|
—
|
%
|
|
—
|
%
|
Unrealized tax benefits
|
|
5.4
|
%
|
|
0.7
|
%
|
|
(1.3)
|
%
|
State and local taxes (net of federal)
|
|
(0.4)
|
%
|
|
—
|
%
|
|
(0.3)
|
%
|
Change in U.S. tax law
|
|
179.5
|
%
|
|
—
|
%
|
|
(0.2)
|
%
|
Nondeductible interest expense
|
|
(34.0)
|
%
|
|
(2.5)
|
%
|
|
(1.1)
|
%
|
Orphan drug and R&D tax credit
|
|
55.0
|
%
|
|
—
|
%
|
|
—
|
%
|
Other
|
|
(5.1)
|
%
|
|
0.9
|
%
|
|
0.7
|
%
|
Effective income tax rate
|
|
238.3
|
%
|
|
13.9
|
%
|
|
15.7
|
%
|
|
|
|
|
|
|
|
Income tax benefit - at statutory tax rate
|
|
$
|
(636)
|
|
|
$
|
(4,823)
|
|
|
$
|
(14,149)
|
|
Differences in international tax rates
|
|
1,755
|
|
|
(1,218)
|
|
|
(9,039)
|
|
Nondeductible changes in fair value of contingent consideration
|
|
988
|
|
|
121
|
|
|
(4,559)
|
|
Intercompany asset transfer
|
|
—
|
|
|
(8,190)
|
|
|
—
|
|
Change in valuation allowances
|
|
4,231
|
|
|
7,379
|
|
|
5,998
|
|
Nondeductible stock-based compensation
|
|
1,060
|
|
|
1,039
|
|
|
1,499
|
|
Hospital Products sale
|
|
(9,328)
|
|
|
—
|
|
|
—
|
|
Unrecognized tax benefits
|
|
(274)
|
|
|
(261)
|
|
|
1,440
|
|
State and local taxes (net of federal)
|
|
20
|
|
|
(7)
|
|
|
299
|
|
Change in U.S. tax law
|
|
(9,124)
|
|
|
—
|
|
|
274
|
|
Nondeductible interest expense
|
|
1,728
|
|
|
982
|
|
|
1,269
|
|
Orphan drug and R&D tax credit
|
|
(2,793)
|
|
|
—
|
|
|
—
|
|
Other
|
|
263
|
|
|
(378)
|
|
|
(925)
|
|
Income tax benefit - at effective income tax rate
|
|
$
|
(12,110)
|
|
|
$
|
(5,356)
|
|
|
$
|
(17,893)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In 2020, the income tax benefit increased by $6,754 when compared to the same period in 2019. The increase in the income tax benefit in 2020 was primarily driven by the tax benefits from the sale of our hospital products and passage of the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) in the U.S. The Company recorded additional tax benefit in 2020 from the Orphan Drug and R&D tax credit in the U.S. Tax benefit from the intercompany asset transfer recorded in 2019 did not recur, resulting in a partial offset of tax benefits described above.
In 2019, the income tax benefit decreased by $12,537 when compared to the same period in 2018. The decrease in the income tax benefit in 2019 was primarily driven by the impairment of the Noctiva intangible asset in 2018, which did not recur in 2019. In addition to the non-recurring impairment, an increase in the valuation allowance in 2019, when compared to the same period in 2018 also contributed to the decrease in tax benefit recorded in 2019. As a part of a corporate reorganization, the Company entered into an internal sale transaction in December 2019. The internal sale transaction included transfer of intangible assets from an Irish entity to a U.S. entity. The internal sale transaction resulted in a decrease of $5,536 to Irish deferred tax asset with corresponding decrease of $5,536 to valuation allowance, an increase of $8,190 to U.S. deferred tax asset associated with amortization of intangible assets, and a $8,190 deferred tax benefit.
Unrecognized Tax Benefits
The Company or one of its subsidiaries files income tax returns in Ireland, France, U.S. and various states. The Company is no longer subject to Irish, French, U.S. Federal, and state and local examinations for years before 2016. During 2020, the Company completed the 2015 through 2017 U.S. Federal Tax Audit. Completion of the audit resulted in an assessment of $1,937 for the 2015 through 2017 U.S. Federal Tax Returns compared to the IRS Claims of $50,695 made on July 2, 2019 and the updated IRS Claims of $9,302 on October 2, 2019 made as part of the Specialty Pharma bankruptcy proceedings, which at this time does not include interest and penalties. The Company settled the $1,937 assessment. The French tax authority completed an examination of the Company's French tax returns for 2017 and 2018 during 2020, noting no change.
The following table summarizes the activity related to the Company’s unrecognized tax benefits for the twelve months ended
December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrecognized Tax Benefit Activity
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
Balance at January 1:
|
|
$
|
6,465
|
|
|
$
|
5,315
|
|
|
$
|
3,954
|
|
Additions based on tax positions related to the current year
|
|
—
|
|
|
—
|
|
|
1,087
|
|
Increases for tax positions of prior years
|
|
—
|
|
|
2,416
|
|
|
274
|
|
Statute of limitations expiration
|
|
—
|
|
|
(1,266)
|
|
|
—
|
|
Settlements
|
|
(3,322)
|
|
|
—
|
|
|
—
|
|
Balance at December 31:
|
|
$
|
3,143
|
|
|
$
|
6,465
|
|
|
$
|
5,315
|
|
The Company expects that within the next twelve months the unrecognized tax benefits could decrease by an immaterial amount and the interest could increase by an immaterial amount.
At December 31, 2020, 2019 and 2018, there are $2,483, $3,806 and $4,597 of unrecognized tax benefits that if recognized would affect the annual effective tax rate.
The Company recognizes interest and penalties accrued related to unrecognized tax benefits in income tax expense. During the years ended December 31, 2020, 2019 and 2018, the Company recognized approximately $203, $555 and $725 in interest and penalties. The Company had approximately $1,475 and $1,612 for the payment of interest and penalties accrued at December 31, 2020 and 2019, respectively.
Deferred Tax Assets (Liabilities)
Deferred income tax provisions reflect the effect of temporary differences between consolidated financial statement and tax reporting of income and expense items. The net deferred tax assets (liabilities) at December 31, 2020 and 2019 resulted from the following temporary differences:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Deferred Tax Assets and Liabilities:
|
|
2020
|
|
2019
|
|
|
|
|
|
Deferred tax assets:
|
|
|
|
|
Net operating loss carryforwards
|
|
$
|
31,302
|
|
|
$
|
30,275
|
|
Amortization
|
|
3,701
|
|
|
11,602
|
|
Stock based compensation
|
|
2,626
|
|
|
3,577
|
|
Accounts receivable
|
|
—
|
|
|
53
|
|
Fair value contingent consideration
|
|
—
|
|
|
264
|
|
Orphan drug and R&D tax credit
|
|
2,793
|
|
|
—
|
|
Other
|
|
423
|
|
|
901
|
|
Gross deferred tax assets
|
|
40,845
|
|
|
46,672
|
|
|
|
|
|
|
Deferred tax liabilities:
|
|
|
|
|
Amortization
|
|
—
|
|
|
(172)
|
|
Prepaid expenses
|
|
(75)
|
|
|
(35)
|
|
Other
|
|
(890)
|
|
|
—
|
|
Gross deferred tax liabilities
|
|
(965)
|
|
|
(207)
|
|
|
|
|
|
|
Less: valuation allowances
|
|
(21,624)
|
|
|
(17,038)
|
|
|
|
|
|
|
Net deferred tax assets
|
|
$
|
18,256
|
|
|
$
|
29,427
|
|
At December 31, 2020, the Company had $118,070 of net operating losses in Ireland that do not have an expiration date and $46,003 of net operating losses in the U.S. Of the $46,003 of net operating losses in the U.S., $10,365 were acquired due to the acquisition of FSC and $35,638 are due to the losses at US Holdings. The portion due to the acquisition of FSC will expire in 2034 through 2035. The Company also has $2,793 of U.S. tax credits available to reduce future income tax payable that have no expiration date. A valuation allowance is recorded if, based on the weight of available evidence, it is more likely than not that a deferred tax asset will not be realized. This assessment is based on an evaluation of the level of historical taxable income and projections for future taxable income. For the year ended December 31, 2020, the Company recorded $4,171 of valuation allowances related to Irish net operating losses and $60 of valuation allowances related French net operating losses. The U.S. net operating losses are subject to an annual limitation as a result of the FSC acquisition under Internal Revenue Code Section 382 and will not be fully utilized before they expire.
We recorded a valuation allowance against all of our net operating losses in Ireland and France as of December 31, 2020, and all of our net operating losses in Ireland as of December 31, 2019. We intend to continue maintaining a full valuation allowance on the Irish net operating losses until there is sufficient evidence to support the reversal of all or some portion of these allowances. In 2019, the Company removed $3,259 of French net operating losses and the corresponding valuation allowance as a result of the 2019 restructuring activities in France. See Note 19: Restructuring Costs.
While the Company believes it is more likely than not that it will be able to realize the deferred tax assets in the U.S., the Company continues to monitor any unfavorable changes that could ultimately impact our assessment of the realizability of our U.S. deferred tax assets. If the Company experiences an ownership change under Internal Revenue Code Section 382, the U.S. net operating losses could also be limited in their utilization.
At December 31, 2020, the Company has unremitted earnings of $3,725 outside of Ireland as measured on a U.S. GAAP basis. Whereas the measure of earnings for purposes of taxation of a distribution may be different for tax purposes, these earnings, which are considered to be invested indefinitely, would become subject to income tax if they were remitted as dividends or if we were to sell our stock in the subsidiaries, net of any prior income taxes paid. It is not practicable to estimate the amount of deferred tax liability on such earnings, if any.
R&D Tax Credits Receivable
The French and Irish governments provide tax credits to companies for spending on innovative R&D. These credits are recorded as an offset of R&D expenses and are credited against income taxes payable in years after being incurred or, if not so utilized, are recoverable in cash after a specified period of time, which may differ depending on the tax credit regime. As of December 31, 2020, our net research tax credit receivable amounts to $6,771 and represents a French gross research tax credit of $6,396 and an Irish gross research tax credit of $375. As of December 31, 2019, our net Research tax credit receivable amounts to $8,429 and represents a French gross research tax credit of $7,608 and an Irish gross research tax credit of $821.
In 2020, the Company recorded $2,793 for the U.S. Orphan Drug Tax Credit and the U.S. Research & Development Tax Credit. These credits are recorded as an income tax benefit in the year and are currently recorded as deferred tax assets because the credits are not recoverable in cash.
2020 CARES Act
The Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”), enacted on March 27, 2020, includes significant business tax provisions. In particular, the CARES Act modified the rules associated with net operating losses (“NOLs”). Under the temporary provisions of the CARES Act, NOL carryforwards and carrybacks may offset 100% of taxable income for taxable years beginning before 2021. In addition, NOLs arising in 2018, 2019 and 2020 taxable years may be carried back to each of the preceding five years to generate a refund. During the twelve months ended December 31, 2020, the income tax benefit includes a discrete tax benefit of $9,124 as a result of our ability under the CARES Act to carry back NOLs incurred to periods when the statutory U.S. Federal tax rate was 35% versus our current U.S. Federal tax rate of 21%. During the twelve months ended December 31, 2020, the Company received $3,351 in cash tax refunds from carryback claims related to the CARES Act from the carryback of 2018 tax losses. The Company filed refund claims for $18,753 associated with the carryback of 2019 tax losses and estimates it will file refund claims associated with the carryback of 2020 tax losses.
2017 Tax Cuts and Jobs Act
On December 22, 2017, the U.S. government enacted the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act includes significant changes to the U.S. corporate income tax system including: a federal corporate rate reduction from 35% to 21%; limitations on the deductibility of interest expense and executive compensation; creation of the base erosion anti-abuse tax (“BEAT”) and a new minimum tax. As a result of the Tax Act being signed into law, we recognized a provisional charge of $274 in 2018 related to the re-measurement of its U.S. net deferred tax assets and certain unrecognized tax benefits at the lower enacted corporate tax rates. A majority of the provisions in the Tax Act were effective January 1, 2018.
NOTE 15: Post-Retirement Benefit Plans
Retirement Indemnity Obligation – France
French law requires the Company to provide for the payment of a lump sum retirement indemnity to French employees based upon years of service and compensation at retirement. The retirement indemnity has been actuarially calculated on the assumption of voluntary retirement at a government-defined retirement age. Benefits do not vest prior to retirement. Any actuarial gains or losses are recognized in the Company’s consolidated statements of income (loss) in the periods in which they occur.
During the second quarter of 2019, the Company initiated a plan to substantially reduce all of its workforce at its Vénissieux, France site (“2019 French Restructuring”). As a result of this decision, the Company reversed the French retirement indemnity obligation and recorded a curtailment gain of $1,000 during the year ended December 31, 2019. At December 31, 2020, there are no future expected retirement indemnity benefits to be paid. See Note 19: Restructuring Costs.
NOTE 16: Other Assets and Liabilities
Various other assets and liabilities are summarized for the years ended December 31, as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid Expenses and Other Current Assets:
|
|
2020
|
|
2019
|
|
|
|
|
|
Valued-added tax recoverable
|
|
$
|
341
|
|
|
$
|
1,051
|
|
Prepaid and other expenses
|
|
1,018
|
|
|
2,116
|
|
Guarantee from Armistice
|
|
318
|
|
|
454
|
|
Income tax receivable (see Note 14)
|
|
18,615
|
|
|
536
|
|
Receivable from Exela (see Note 4)
|
|
16,500
|
|
|
—
|
|
Short-term deposit
|
|
1,477
|
|
|
—
|
|
Other
|
|
457
|
|
|
107
|
|
Total
|
|
$
|
38,726
|
|
|
$
|
4,264
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Non-Current Assets:
|
|
2020
|
|
2019
|
|
|
|
|
|
Deferred tax assets
|
|
$
|
18,256
|
|
|
$
|
29,427
|
|
Long-term deposits
|
|
—
|
|
|
1,477
|
|
Guarantee from Armistice
|
|
1,050
|
|
|
1,367
|
|
Right of use assets at contract manufacturing organizations
|
|
5,201
|
|
|
6,428
|
|
Other
|
|
432
|
|
|
575
|
|
Total
|
|
$
|
24,939
|
|
|
$
|
39,274
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued Expenses:
|
|
2020
|
|
2019
|
|
|
|
|
|
Accrued compensation
|
|
$
|
1,697
|
|
|
$
|
3,944
|
|
|
|
|
|
|
Accrued restructuring (see Note 19)
|
|
520
|
|
|
2,949
|
|
Customer allowances
|
|
1,030
|
|
|
6,470
|
|
Accrued outsourced contract costs
|
|
473
|
|
|
2,833
|
|
|
|
|
|
|
Other
|
|
2,781
|
|
|
3,614
|
|
Total
|
|
$
|
6,501
|
|
|
$
|
19,810
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Current Liabilities:
|
|
2020
|
|
2019
|
|
|
|
|
|
Accrued interest
|
|
$
|
2,695
|
|
|
$
|
2,695
|
|
Due to Exela
|
|
2,026
|
|
|
—
|
|
Guarantee to Deerfield
|
|
319
|
|
|
455
|
|
Other
|
|
160
|
|
|
725
|
|
Total
|
|
$
|
5,200
|
|
|
$
|
3,875
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Non-Current Liabilities:
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
Customer allowances
|
|
$
|
—
|
|
|
$
|
981
|
|
Unrecognized tax benefits
|
|
3,143
|
|
|
6,465
|
|
Guarantee to Deerfield
|
|
1,053
|
|
|
1,372
|
|
Other
|
|
16
|
|
|
55
|
|
Total
|
|
$
|
4,212
|
|
|
$
|
8,873
|
|
NOTE 17: Contingent Liabilities and Commitments
Litigation
The Company is subject to potential liabilities generally incidental to our business arising out of present and future lawsuits and claims related to product liability, personal injury, contract, commercial, intellectual property, tax, employment, compliance and other matters that arise in the ordinary course of business. The Company accrues for potential liabilities when it is probable that future costs (including legal fees and expenses) will be incurred and such costs can be reasonably estimated. At December 31, 2020, there were no contingent liabilities with respect to any litigation, arbitration or administrative or other proceeding that are reasonably likely to have a material adverse effect on the Company’s consolidated financial position, results of operations, cash flows or liquidity.
Subsidiary Bankruptcy and Deconsolidation
There is currently no pending or threatened litigation or disputes to which Specialty Pharma is or would be a party. All prior litigation and disputes involving Specialty Pharma have been dismissed or resolved. See Note 3: Subsidiary Bankruptcy and Deconsolidation.
Material Commitments
At December 31, 2020, we have one commitment with a contract manufacturer related to facility upgrades and the purchase and validation of equipment to be used in the manufacture of FT218. The total cost of this commitment is estimated to be approximately $4,000 and is expected to be started and completed during the year ending December 31, 2021.
The Company also has a commitment with a contract manufacturer related to the construction and preparation of a production suite at the contract manufacturer’s facility, which is substantially complete at December 31, 2020. Subsequent to the initial build and preparation of the production suite, this commitment also includes annual fees which would commence at the start of production of validation batches and continue thereafter for five years.
NOTE 18: Divestiture of the Pediatric Assets
On February 12, 2018, the Company, together with its subsidiaries Avadel Pharmaceuticals (USA), Inc., Avadel Pediatrics, Inc., FSC Therapeutics, LLC (“FSC Therapeutics”), and Avadel US Holdings, Inc. (“Holdings”), as the “Sellers,” entered into an asset purchase agreement (the “Purchase Agreement”) with Cerecor, Inc. (“Cerecor”). The transaction closed on February 16, 2018 wherein Cerecor purchased from the Sellers four pediatric commercial stage assets – Karbinal™ ER, Cefaclor, Flexichamber™ and AcipHex® Sprinkle™, together with certain associated business assets – which were held by FSC. The Company acquired FSC in February 2016 from Deerfield and certain of its affiliates. Pursuant to the Purchase Agreement, Cerecor assumed the Company’s remaining payment obligations to Deerfield under the Membership Interest Purchase Agreement, dated as of February 5, 2016, between Holdings, Flamel Technologies SA (the predecessor of the Company) and Deerfield and certain of its affiliates, which payment obligations consisted of the following (collectively, the “Assumed Obligations”): (i) a quarterly payment of $263 beginning in July 2018 and ending in October 2020, amounting to an aggregate payment obligation of $2,625; (ii) a payment in January 2021 of $15,263; and (iii) a quarterly royalty payment of 15% on net sales of the FSC products through February 5, 2026 (“FSC Product Royalties”), in an aggregate amount of up to approximately $10,300. Cerecor also assumed certain contracts and other obligations related to the acquired assets, and in that connection Holdings agreed to pay Cerecor certain make-whole payments associated with obligations Cerecor is assuming related to a certain supply contract related to Karbinal™ ER.
In conjunction with the divestiture, the Company also entered into the following arrangements:
License and Development Agreement
Flamel Ireland Limited, an Irish private limited company operating under the trade name of Avadel Ireland and a wholly-owned subsidiary of the Company, and Cerecor entered into a license and development agreement (the “License and Development Agreement”) pursuant to which, among other things:
•Avadel Ireland will provide Cerecor with four product formulations utilizing Avadel Ireland’s LiquiTime™ technology, and will complete pilot bioequivalence studies for such product formulations within 18 months;
•Cerecor will reimburse Avadel Ireland for development costs of the four LiquiTime™ products in excess of $1,000 in the aggregate;
•Upon transfer of the four product formulations, Cerecor will assume all remaining development costs and responsibilities for the product development, clinical studies, NDA applications and associated filing fees; and
•Upon regulatory approval and commercial launch of any LiquiTime™ products, Cerecor will pay Avadel Ireland quarterly royalties based on a percentage of net sales of any such products in the mid-single digit range.
Effective October 25, 2019, Cerecor and Avadel Ireland agreed to terminate the License and Development Agreement.
Deerfield Guarantee
The Company and Holdings provided their guarantee (the “Deerfield Guarantee”) in favor of Deerfield. Under the Deerfield Guarantee, the Company and Holdings guaranteed to Deerfield the payment by Cerecor of the Assumed Obligations under the Membership Interest Purchase Agreement between the Company and Deerfield dated February 5, 2016. The Assumed Obligations include (i) a quarterly payment of $263 beginning in July 2018 and ending in October 2020, amounting to an aggregate payment obligation of $2,625; (ii) a payment in January 2021 of $15,263; and (iii) a quarterly royalty payment of 15% on net sales of the FSC products through February 6, 2026 (“FSC Product Royalties”), in an aggregate amount of up to approximately $10,300. In addition, under the Deerfield Guarantee, the Company and Holdings guaranteed that Deerfield would receive certain minimum annual FSC Product Royalties through February 6, 2026 (the “Minimum Royalties”). Given the Company’s explicit guarantee to Deerfield, the Company recorded the guarantee in accordance with ASC 460. A valuation was performed, which was based largely on an analysis of the potential timing of each possible cash outflow described above and the likelihood of Cerecor’s default on such payments assuming an S&P credit rating of CCC+. The result of this valuation identified a guarantee liability of $6,643. This liability is being amortized proportionately based on undiscounted cash outflows through the remainder of the contract with Deerfield.
On October 10, 2019, Cerecor entered into a purchase and sale agreement with Aytu BioScience, Inc (“Buyer”) pursuant to which the Buyer will purchase certain assets from Cerecor and assume certain of Cerecor’s liabilities, including all of Cerecor’s liabilities assumed as part of the Purchase Agreement noted above. As part of this transaction, on November 1, 2019, Armistice has agreed to deposit $15,000 in an escrow account governed by an escrow agreement between Armistice and Deerfield having the purpose of securing the $15,000 balloon payment due January 2021 as part of the Membership Interest Purchase Agreement. As part of the Cerecor transaction with the buyer, Deerfield contractually acknowledges and agrees that it will seek payment from the escrow funds before requesting payment from the Company pursuant to the Deerfield Guarantee discussed above. Due to the change in circumstances, a new valuation was performed based on an analysis of the possible timing of the updated possible cash flow which excludes the $15,000 that Armistice has deposited in an escrow account. The updated valuation identified an updated guarantee liability of $1,827 at December 31, 2019, which is being amortized proportionately based on undiscounted cash outflows through the remainder of the contract with Deerfield. The balance of this guarantee liability was $1,372 at December 31, 2020.
Armistice Guarantee
Armistice Capital Master Fund, Ltd., the majority shareholder of Cerecor, guaranteed to Holdings the payment by Cerecor of the Assumed Obligations, including the Minimum Royalties. A valuation of the guarantee asset was performed in accordance with ASC 460 “Guarantees” and a guarantee asset of $6,620 was recorded. This asset is being amortized proportionately based on undiscounted cash outflows through the remainder of the contract with Deerfield noted above.
As discussed above, based on the purchase and asset sale between Cerecor and the Buyer, an updated valuation was performed and identified an updated guarantee asset of $1,821 at December 31, 2019. The balance of this guarantee asset was $1,368 at December 31, 2020.
The fair values of the Avadel guarantee to Deerfield and the guarantee received by Avadel from Armistice largely offset and when combined are not material.
Based on management’s review of ASU 2014-08, “Reporting Discontinued Operations and Disclosures of Disposals of Components of an Entity”, the disposition of our pediatric assets and related liabilities did not qualify for discontinued operations reporting. Our results of operations for the year ended December 31, 2018 includes the results of FSC, prior to its February 16, 2018 disposition date.
The net impact of this transaction was not material to the consolidated statements of income (loss).
NOTE 19: Restructuring Costs
2019 French Restructuring
During the second quarter of 2019, the Company initiated a plan to substantially reduce all of its workforce at its Vénissieux, France site (“2019 French Restructuring”). This reduction was part of an effort to align the Company’s cost structure with our ongoing and future planned projects. The reduction in workforce was completed during the year ended December 31, 2020. Restructuring charges associated with this plan of $172 and $4,855 of were recognized during the years ended December 31, 2020 and 2019, respectively. Included in the 2019 French Restructuring charges of $4,855 were charges for employee severance, benefits and other costs of $4,339, charges related to fixed asset impairment of $629, charges related to the early termination penalty related to the office and copier lease terminations of $887, partially offset by a benefit of $1,000 related to the reversal of the French retirement indemnity obligation. The following table sets forth activities for the Company’s cost reduction plan obligations for the years ended December 31, 2020 and 2019:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019 French Restructuring Obligation:
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
Balance of restructuring accrual at January 1,
|
|
$
|
1,922
|
|
|
$
|
—
|
|
|
|
Charges for employee severance, benefits and other costs
|
|
172
|
|
|
4,339
|
|
|
|
Payments
|
|
(1,813)
|
|
|
(2,441)
|
|
|
|
Foreign currency impact
|
|
(33)
|
|
|
24
|
|
|
|
Balance of restructuring accrual at December 31,
|
|
$
|
248
|
|
|
$
|
1,922
|
|
|
|
The 2019 French Restructuring liability of $248 is included in the consolidated balance sheet in accrued expenses at December 31, 2020.
2019 Corporate Restructuring
During the first quarter of 2019, the Company announced a plan to reduce its Corporate workforce by more than 50% (the “2019 Corporate Restructuring”). The reduction in workforce is primarily a result of the exit of Noctiva during the first quarter of 2019 (see Note 3: Subsidiary Bankruptcy and Deconsolidation), as well as an effort to better align the Company’s remaining cost structure at our U.S. and Ireland locations with our ongoing and future planned projects. The reduction in workforce was completed during the year ended December 31, 2020. Restructuring income associated with this plan for the year ended December 31, 2020 was $215, which included a benefit of $421 related to share based compensation forfeitures. Restructuring charges associated with this plan of $1,755 were recognized during the year ended December 31, 2019. Included in the 2019 Corporate Restructuring charges of $1,755 for the year ended December 31, 2019 were charges for employee severance, benefit and other costs of $3,406, charges related to the early termination penalty related to the office lease termination of $288, the write-off of $125 of property, plant and equipment, net, partially offset by a benefit of $2,064 related to share based compensation forfeitures related to the employees affected by the global reduction in workforce.
The following table sets forth activities for the Company’s cost reduction plan obligations for the years ended December 31, 2020 and 2019:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019 Corporate Restructuring Obligation:
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
Balance of restructuring accrual at January 1,
|
|
$
|
1,080
|
|
|
$
|
—
|
|
|
|
Charges for employee severance, benefits and other costs
|
|
206
|
|
|
3,406
|
|
|
|
Payments
|
|
(1,014)
|
|
|
(2,326)
|
|
|
|
|
|
|
|
|
|
|
Balance of restructuring accrual at December 31,
|
|
$
|
272
|
|
|
$
|
1,080
|
|
|
|
The 2019 Corporate Restructuring liability of $272 is included in the consolidated balance sheet in accrued expenses at December 31, 2020.
NOTE 20: Equity Instruments and Transactions
Capital Shares
We have 500,000 shares of authorized ordinary shares with a nominal value of $0.01 per ordinary share. As of December 31, 2020, we had 58,396 ordinary shares issued and outstanding, respectively. The Board of Directors is authorized to issue preferred shares in series, and with respect to each series, to fix its designation, relative rights (including voting, dividend, conversion, sinking fund, and redemption rights), preferences (including dividends and liquidation) and limitations. We have 50,000 shares of authorized preferred shares, $0.01 nominal value, of which 488 are currently issued and outstanding as of December 31, 2020.
Shelf Registration Statement on Form S-3
In February 2020, we filed with the SEC a new shelf registration statement on Form S-3 (the 2020 Shelf Registration Statement) (File No. 333-236258) that allows issuance and sale by us, from time to time, of:
a.up to $250,000 in aggregate of ordinary shares, nominal value US$0.01 per share (the “Ordinary Shares”), each of which may be represented by American Depositary Shares (“ADSs”), preferred shares, nominal value US$0.01 per share (the “Preferred Shares”), debt securities (the “Debt Securities”), warrants to purchase Ordinary Shares, ADSs, Preferred Shares and/or Debt Securities (the “Warrants”), and/or units consisting of Ordinary Shares, ADSs, Preferred Shares, one or more Debt Securities or Warrants in one or more series, in any combination, pursuant to the terms of the 2020 Shelf Registration Statement, the base prospectus contained in the 2020 Shelf Registration Statement (the “Base Prospectus”), and any amendments or supplements thereto (together, the “Securities”); including
b.up to $50,000 of ADSs that may be issued and sold from time to time pursuant to the terms of an Open Market Sale AgreementSM, entered into with Jefferies LLC on February 4, 2020 (the “Sales Agreement”), the 2020 Shelf Registration Statement, the Base Prospectus and the terms of the sales agreement prospectus contained in the 2020 Shelf Registration Statement.
The transactions costs associated with the 2020 Shelf Registration Statement totaled $428 of which $214 was charged against additional paid-in capital during the twelve months ended December 31, 2020 as a result of the May 2020 Public Offering, discussed below. The remaining costs of $214 are recorded as a prepaid asset at December 31, 2020.
February 2020 Private Placement
On February 21, 2020, we announced that we entered into a definitive agreement for the sale of our ADSs and Series A Non-Voting Convertible Preferred Shares (“Series A Preferred”) in a private placement to a group of institutional accredited investors. The private placement resulted in gross proceeds of approximately $65,000 before deducting placement agent and other offering expenses, which resulted in net proceeds of $60,570.
Pursuant to the terms of the private placement, we issued 8,680 ADSs and 488 shares of Series A Preferred at a price of $7.09 per share, priced at-the-market under Nasdaq rules. Each share of non-voting Series A Preferred is convertible into one ADS, provided that conversion will be prohibited if, as a result, the holder and its affiliates would own more than 9.99% of the total number of Avadel ADSs outstanding. The closing of the private placement occurred on February 25, 2020.
Issuance costs of $4,430 have been recorded as a reduction of additional paid-in capital.
May 2020 Public Offering
In connection with the shelf registration statement described above, on April 28, 2020, we announced the pricing of an underwritten public offering of 11,630 Ordinary Shares, in the form of ADSs at a price to the public of $10.75 per ADS. Each ADS represents the right to receive one Ordinary Share. All of the ADSs were offered by us and the gross proceeds to us from the offering were approximately $125,000, before deducting underwriting discounts and commissions and offering expenses, which resulted in net proceeds of $116,924. The offering closed on May 1, 2020.
Retirement of Treasury Shares
In August 2020, the Company retired all of our 5,407 treasury shares, or $49,998 previously repurchased ordinary shares. As a result, we reduced additional paid-in capital by $49,944 and ordinary shares by $54 during the twelve months ended December 31, 2020. The portion allocated to additional paid-in capital is determined pro rata by applying a percentage, determined by dividing the number of shares to be retired by the number of shares issued and outstanding as of the retirement date, to the balance of additional paid-in capital as of the retirement date. Based on this calculation, the entirety of the excess of repurchase price over par of $49,944 was allocated to additional paid-in capital.
NOTE 21: Share-Based Compensation
Compensation expense included in the Company’s consolidated statements of income (loss) for all share-based compensation arrangements was as follows for the periods ended December 31, 2020, 2019 and 2018, respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based Compensation Expense:
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
139
|
|
|
$
|
429
|
|
|
$
|
880
|
|
Selling, general and administrative
|
|
3,281
|
|
|
2,154
|
|
|
6,972
|
|
Restructuring costs
|
|
(421)
|
|
|
(2,064)
|
|
|
—
|
|
Total share-based compensation expense
|
|
$
|
2,999
|
|
|
$
|
519
|
|
|
$
|
7,852
|
|
As of December 31, 2020, the Company expects $12,322 of unrecognized expense related to granted, but non-vested share-based compensation arrangements to be incurred in future periods. This expense is expected to be recognized over a weighted average period of 3.4 years.
The excess tax benefit related to share-based compensation recorded by the Company was not material for the years ended December 31, 2020, 2019 and 2018.
Upon exercise of stock options, or upon the issuance of restricted share awards or performance share unit awards, the Company issues new shares.
At December 31, 2020, there were 4,122,315 shares authorized for stock option grants, restricted share award grants, and performance share unit award grants in subsequent periods.
Determining the Fair Value of Stock Options
The Company measures the total fair value of stock options on the grant date using the Black-Scholes option-pricing model and recognizes each grant’s fair value as compensation expense over the period that the option vests. Options are granted to employees of the Company and become exercisable ratably over four years following the grant date and expire ten years after the grant date. The Company issues stock options to our Board of Directors as compensation for services rendered and generally become exercisable ratably over three years following the grant date, and expire ten years after the grant date.
The weighted-average assumptions under the Black-Scholes option-pricing model for stock option grants as of December 31, 2020, 2019 and 2018, are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Option Assumptions:
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
Stock option grants:
|
|
|
|
|
|
|
Expected term (years)
|
|
6.08
|
|
6.25
|
|
6.25
|
Expected volatility
|
|
75.76
|
%
|
|
56.48
|
%
|
|
56.59
|
%
|
Risk-free interest rate
|
|
0.72
|
%
|
|
2.52
|
%
|
|
2.68
|
%
|
Expected dividend yield
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected term: The expected term of the options represents the period of time between the grant date and the time the options are either exercised or forfeited, including an estimate of future forfeitures for outstanding options. Given the limited historical data, the simplified method has been used to calculate the expected life.
Expected volatility: The expected volatility is calculated based on an average of the historical volatility of the Company’s stock price for a period approximating the expected term.
Risk-free interest rate: The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant and a maturity that approximates the expected term.
Expected dividend yield: We have not distributed any dividends since our inception and have no plan to distribute dividends in the foreseeable future.
Stock Options
A summary of the combined stock option activity and other data for the Company’s stock option plans for the year ended December 31, 2020 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Option Activity and Other Data:
|
|
Number of Stock
Options
|
|
Weighted Average
Exercise Price per Share
|
|
Weighted Average
Remaining
Contractual Life
|
|
Aggregate
Intrinsic Value
|
|
|
|
|
|
|
|
|
|
Stock options outstanding, January 1, 2020
|
|
5,121
|
|
|
$
|
7.51
|
|
|
|
|
|
Granted
|
|
2,551
|
|
|
6.90
|
|
|
|
|
|
Exercised
|
|
(403)
|
|
|
5.08
|
|
|
|
|
|
Forfeited
|
|
(566)
|
|
|
3.24
|
|
|
|
|
|
Expired
|
|
(805)
|
|
|
13.37
|
|
|
|
|
|
Stock options outstanding, December 31, 2020
|
|
5,898
|
|
|
$
|
7.02
|
|
|
7.96 years
|
|
$
|
7,115
|
|
Stock options exercisable, December 31, 2020
|
|
2,172
|
|
|
$
|
9.48
|
|
|
5.58 years
|
|
$
|
1,841
|
|
The aggregate intrinsic value of options exercisable at December 31, 2020, 2019 and 2018 was $1,841, $572, and $0, respectively.
The weighted average grant date fair value of options granted during the years ended December 31, 2020, 2019 and 2018 was $4.63, $1.24 and $3.60 per share, respectively.
Warrants
A summary of the combined warrant activity and other data for the year ended December 31, 2020 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Activity and Other Data:
|
|
Number of
Warrants
|
|
Weighted Average Exercise Price per Share
|
|
Weighted Average Remaining
Contractual Life
|
|
Aggregate Intrinsic
Value
|
|
|
|
|
|
|
|
|
|
Warrants outstanding, January 1, 2020
|
|
291
|
|
|
$
|
13.59
|
|
|
|
|
|
Granted
|
|
—
|
|
|
—
|
|
|
|
|
|
Exercised
|
|
—
|
|
|
—
|
|
|
|
|
|
Forfeited
|
|
—
|
|
|
—
|
|
|
|
|
|
Expired
|
|
(291)
|
|
|
13.59
|
|
|
|
|
|
Warrants outstanding, December 31, 2020
|
|
—
|
|
|
$
|
—
|
|
|
0.00 years
|
|
$
|
—
|
|
Warrants exercisable, December 31, 2020
|
|
—
|
|
|
$
|
—
|
|
|
0.00 years
|
|
$
|
—
|
|
All outstanding warrants expired in August 2020. Each of the above warrants was convertible into one ordinary share. There was no aggregate intrinsic value of warrants exercised during the years ended December 31, 2020, 2019 and 2018.
There were no warrants granted during the years ended December 31, 2020, 2019 and 2018.
Restricted Share Awards
Restricted share awards represent Company shares issued free of charge to employees of the Company as compensation for services rendered. The Company measures the total fair value of restricted share awards on the grant date using the Company’s stock price at the time of the grant. Restricted share awards granted during and after 2017 vest over a three-year period; two-thirds (2/3) vesting on the second anniversary of the grant date and the remaining one-third (1/3) vesting on the third anniversary of the grant date. In 2018, the Company issued restricted share awards to our Board of Directors vesting over a three-year period; one-third (1/3) vesting on each of the three anniversaries of the grant date. Compensation expense for such awards granted during and after 2017 is recognized over the applicable vesting period.
A summary of the Company’s restricted share awards as of December 31, 2020, and changes during the year then ended, is reflected in the table below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted Share Activity and Other Data:
|
|
Number of Restricted Share Awards
|
|
Weighted Average Grant Date
Fair Value
|
|
|
|
|
|
Non-vested restricted share awards outstanding, January 1, 2020
|
|
347
|
|
|
$
|
4.73
|
|
Granted
|
|
186
|
|
|
7.69
|
|
Vested
|
|
(115)
|
|
|
6.01
|
|
Forfeited
|
|
(71)
|
|
|
4.83
|
|
Non-vested restricted share awards outstanding, December 31, 2020
|
|
347
|
|
|
$
|
5.87
|
|
The weighted average grant date fair value of restricted share awards granted during the years ended December 31, 2020, 2019 and 2018 was $7.69, $2.47 and $5.87, respectively.
Performance Share Units Awards
Performance share units awards (“PSUs”) represent Company shares issued free of charge to employees of the Company as compensation for achieving various results. The Company measures the total fair value of performance share unit awards on the grant date using the Company’s stock price at the time of the grant. In 2020, the Company granted performance share awards, of which 50% vest upon the achievement of certain regulatory milestones related to FT218 and the other 50% vest one year following achievement of those milestones. The Company has not yet recognized any PSU-related stock-based compensation expense as the regulatory milestones have not yet been met; however, in the event the performance conditions are met before a certain date, approximately 150% of the outstanding shares, or $2,734 of compensation expense will be recognized by the Company for the PSUs outstanding as of December 31, 2020.
A summary of the Company’s performance share units awards as of December 31, 2020, and changes during the year then ended, is reflected in the table below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Performance Unit Share Activity and Other Data
|
|
Number of Performance Share Awards
|
|
Weighted Average Grant Date
Fair Value
|
|
|
|
|
|
Non-vested performance share awards outstanding, January 1, 2020
|
|
—
|
|
|
$
|
—
|
|
Granted
|
|
257
|
|
|
7.09
|
|
Vested
|
|
—
|
|
|
—
|
|
Forfeited
|
|
—
|
|
|
—
|
|
Non-vested performance share awards outstanding, December 31, 2020
|
|
257
|
|
|
$
|
7.09
|
|
The weighted average grant date fair value of performance share awards granted during the year ended December 31, 2020 was $7.09 per share.
Employee Share Purchase Plan
In 2017, the Board of Directors approved of the Avadel Pharmaceuticals plc 2017 Avadel Employee Share Purchase Plan (“ESPP”). The total number of Company ordinary shares, nominal value $0.01 per share, or ADSs representing such ordinary shares (collectively, “Shares”) which may be issued under the ESPP is 1,000. The purchase price at which a Share will be issued or sold for a given offering period will be established by the Compensation Committee of the Board (“Committee”) (and may differ among participants, as determined by the Committee in its sole discretion) but will in no event be less than 85% of the lesser of: (a) the fair market value of a Share on the offering date; or (b) the fair market value of a Share on the purchase date. During the years ended December 31, 2020 and 2019, the Company issued 49 and 54 ordinary shares to employees, respectively. Expense related to the ESPP for the years ended December 31, 2020, 2019 and 2018 was immaterial.
NOTE 22: Net Income (Loss) Per Share
Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted average number of shares outstanding during each period. Diluted net income (loss) per share is calculated by dividing net income (loss) - diluted by the diluted number of shares outstanding during each period. Except where the result would be anti-dilutive to net income (loss), diluted net income (loss) per share would be calculated assuming the impact of the conversion of the 2023 Notes, the
conversion of our preferred shares, the exercise of outstanding equity compensation awards, and ordinary shares expected to be issued under our ESPP.
We have a choice to settle the conversion obligation under the 2023 Notes in cash, shares or any combination of the two. We utilize the if-converted method to reflect the impact of the conversion of the 2023 Notes, unless the result is anti-dilutive. This method assumes the conversion of the 2023 Notes into shares of our ordinary shares and reflects the elimination of the interest expense related to the 2023 Notes.
The dilutive effect of the warrants, stock options, restricted stock units, preferred shares and ordinary shares expected to be issued under or ESPP has been calculated using the treasury stock method. The dilutive effect of the PSUs will be calculated using the treasury stock method, if and when the contingent vesting condition is achieved.
A reconciliation of basic and diluted net income (loss) per share, together with the related shares outstanding in thousands for the years ended December 31, 2020, 2019 and 2018, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income (Loss) Per Share:
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
7,028
|
|
|
$
|
(33,226)
|
|
|
$
|
(95,304)
|
|
|
|
|
|
|
|
|
Weighted average shares:
|
|
|
|
|
|
|
Basic shares
|
|
52,996
|
|
|
37,403
|
|
|
37,325
|
|
Effect of dilutive securities—employee and director equity awards outstanding
|
|
1,945
|
|
|
—
|
|
|
—
|
|
Diluted shares
|
|
54,941
|
|
|
37,403
|
|
|
37,325
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share - basic
|
|
$
|
0.13
|
|
|
$
|
(0.89)
|
|
|
$
|
(2.55)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share - diluted
|
|
$
|
0.13
|
|
|
$
|
(0.89)
|
|
|
$
|
(2.55)
|
|
Potential ordinary shares of 14,915, 16,740, and 17,529 were excluded from the calculation of weighted average shares for the years ended December 31, 2020, 2019 and 2018, respectively, because either their effect was considered to be anti-dilutive or they were related to shares from PSUs for which the contingent vesting condition had not been achieved. For the years ended December 31, 2019 and 2018, the effects of dilutive securities were entirely excluded from the calculation of net income (loss) per share as a net loss was reported in these periods.
NOTE 23: Comprehensive Loss
The following table shows the components of accumulated other comprehensive loss for the year ended December 31, net of immaterial tax effects:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Loss:
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
Foreign currency translation adjustment:
|
|
|
|
|
|
|
Beginning balance
|
|
$
|
(23,738)
|
|
|
$
|
(23,621)
|
|
|
$
|
(23,202)
|
|
Net other comprehensive income (loss)
|
|
1,111
|
|
|
(117)
|
|
|
(419)
|
|
Balance at December 31,
|
|
$
|
(22,627)
|
|
|
$
|
(23,738)
|
|
|
$
|
(23,621)
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities, net
|
|
|
|
|
|
|
Beginning balance
|
|
$
|
932
|
|
|
$
|
205
|
|
|
$
|
(64)
|
|
Net other comprehensive income, net of $(202), $(43), $(18), tax, respectively
|
|
644
|
|
|
727
|
|
|
269
|
|
Balance at December 31,
|
|
$
|
1,576
|
|
|
$
|
932
|
|
|
$
|
205
|
|
Accumulated other comprehensive loss at December 31,
|
|
$
|
(21,051)
|
|
|
$
|
(22,806)
|
|
|
$
|
(23,416)
|
|
NOTE 24: Company Operations by Product, Customer and Geographic Area
We have determined that we operate in one segment, the development and commercialization of pharmaceutical products, including controlled-release therapeutic products based on our proprietary polymer based technology. The Company’s Chief Operating Decision Maker is the CEO. The CEO reviews profit and loss information on a consolidated basis to assess performance and make overall operating decisions as well as resource allocations. All products are included in one segment because the Company’s products have similar economic and other characteristics, including the nature of the products and production processes, type of customers, distribution methods and regulatory environment.
The following table presents a summary of total revenues by these products for the twelve months ended December 31, 2020, 2019, and 2018:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue by Product:
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
Bloxiverz
|
|
$
|
2,201
|
|
|
$
|
7,479
|
|
|
$
|
20,850
|
|
Vazculep
|
|
10,429
|
|
|
33,152
|
|
|
42,916
|
|
Akovaz
|
|
9,545
|
|
|
18,642
|
|
|
33,759
|
|
Other
|
|
159
|
|
|
(58)
|
|
|
3,898
|
|
Product sales
|
|
22,334
|
|
|
59,215
|
|
|
101,423
|
|
License revenue
|
|
—
|
|
|
—
|
|
|
1,846
|
|
Total revenues
|
|
$
|
22,334
|
|
|
$
|
59,215
|
|
|
$
|
103,269
|
|
Concentration of credit risk with respect to accounts receivable is limited due to the high credit quality comprising a significant portion of the Company’s customers. Management periodically monitors the creditworthiness of our customers and believes that we have adequately provided for any exposure to potential credit loss.
The following table presents a summary of total revenues by significant customer for the twelve months ended December 31, 2020, 2019, and 2018:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue by Significant Customer:
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
McKesson Corporation
|
|
$
|
5,758
|
|
|
$
|
14,900
|
|
|
$
|
26,794
|
|
Cardinal Health
|
|
5,155
|
|
|
15,088
|
|
|
25,413
|
|
AmerisourceBergen
|
|
3,155
|
|
|
12,059
|
|
|
18,620
|
|
QuVa Pharma
|
|
3,117
|
|
|
3,252
|
|
|
2,788
|
|
Others
|
|
5,149
|
|
|
13,916
|
|
|
27,808
|
|
Product sales
|
|
22,334
|
|
|
59,215
|
|
|
101,423
|
|
License revenue
|
|
—
|
|
|
—
|
|
|
1,846
|
|
Total revenues
|
|
$
|
22,334
|
|
|
$
|
59,215
|
|
|
$
|
103,269
|
|
The following table summarizes revenues by geographic region for the twelve months ended December 31, 2020, 2019, and 2018:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue by Geographic Region:
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
22,334
|
|
|
$
|
59,215
|
|
|
$
|
101,423
|
|
|
|
|
|
|
|
|
Ireland
|
|
—
|
|
|
—
|
|
|
1,846
|
|
Total revenues
|
|
$
|
22,334
|
|
|
$
|
59,215
|
|
|
$
|
103,269
|
|
Currently, we are working with contract manufacturing organizations for the manufacture of FT218. Additionally, we purchase raw materials used in FT218 from a limited number of suppliers, including a single supplier for certain key ingredients.
Non-monetary long-lived assets primarily consist of property and equipment, goodwill, intangible assets and operating right-of use-assets. The following table summarizes non-monetary long-lived assets by geographic region as of December 31, 2020, 2019, and 2018:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived Assets by Geographic Region:
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
20,424
|
|
|
$
|
22,254
|
|
|
$
|
27,761
|
|
France
|
|
11
|
|
|
196
|
|
|
1,365
|
|
Ireland
|
|
6,047
|
|
|
7,244
|
|
|
6,028
|
|
Total
|
|
$
|
26,482
|
|
|
$
|
29,694
|
|
|
$
|
35,154
|
|
NOTE 25: Related Party Transactions
As noted in Note 4: Disposition of the Hospital Products, we were party to a Membership Interest Purchase Agreement by and among us, Avadel Legacy, Breaking Stick Holdings, LLC, Deerfield Private Design International II, L.P. (“Deerfield International”), Deerfield Private Design Fund II, L.P. (“Deerfield Fund”) and Horizon Santé FLML, Sarl (“Horizon”) (the “Deerfield MIPA”) and a Royalty Agreement by and among us, Avadel Legacy, the Deerfield Fund and Horizon (the “Deerfield Royalty Agreement”). In connection with the closing of the sale of the Hospital Products, the Deerfield MIPA (with respect to certain sections thereof) and the Royalty Agreement were assigned to the Exela Buyer. Pursuant to the Purchase Agreement, the Exela Buyer assumed and will pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy under the Deerfield Royalty Agreement for obligations that arise after the Closing date.
We were also party to a Royalty Agreement by and between us, Avadel Legacy and Broadfin Healthcare Master Fund, Ltd. (the “Broadfin Royalty Agreement”). In connection with the closing of the sale of the Hospital Products, the Broadfin Royalty Agreement was assigned to the Exela Buyer and the Exela Buyer assumed and shall pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy under the Broadfin Royalty Agreement for obligations that arise after the Closing Date.
Under the terms of the February 5, 2016 acquisition of FSC, which was completed on February 8, 2016, the Company was to pay $1,050 annually for five years with a final payment in January 2021 of $15,000 for a total of $20,250 to Deerfield for all of the equity interests in FSC. The Company would also pay Deerfield a 15% royalty per annum on net sales of the current FSC products, up to $12,500 for a period not exceeding ten years. These obligations were assumed by Cerecor in connection with the divestiture of the Company’s pediatric products on February 16, 2018, as noted in Note 18: Divestiture of the Pediatric Assets.
Deerfield and Broadfin disposed of their 2023 Notes and ordinary shares in the Company during the year ended December 31, 2020 and are no longer considered related parties.