Document and Entity Information - USD ($) $ in Millions |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2019 |
Mar. 24, 2020 |
Jun. 30, 2019 |
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| Document and Entity Information | |||
| Document Type | 10-K | ||
| Document Period End Date | Dec. 31, 2019 | ||
| Entity Registrant Name | Zyla Life Sciences | ||
| Entity Well-known Seasoned Issuer | No | ||
| Entity Voluntary Filers | No | ||
| Entity Current Reporting Status | Yes | ||
| Entity Interactive Data Current | Yes | ||
| Entity Filer Category | Non-accelerated Filer | ||
| Entity Small Business | true | ||
| Entity Emerging Growth Company | false | ||
| Entity Shell Company | false | ||
| Entity Public Float | $ 20.6 | ||
| Entity Common Stock, Shares Outstanding | 9,522,096 | ||
| Entity Central Index Key | 0001586105 | ||
| Current Fiscal Year End Date | --12-31 | ||
| Document Fiscal Year Focus | 2019 | ||
| Document Fiscal Period Focus | FY | ||
| Amendment Flag | false |
Consolidated Balance Sheets - USD ($) $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended | 13 Months Ended | ||||
|---|---|---|---|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Jan. 31, 2019 |
Feb. 01, 2019 |
Jan. 30, 2019 |
Dec. 31, 2017 |
|
| Consolidated Balance Sheets | ||||||||
| Predecessor Successor Fixed list | Predecessor | Successor | Successor | Predecessor | Predecessor | |||
| Current assets: | ||||||||
| Cash and cash equivalents | $ 36,785 | $ 11,965 | $ 11,965 | $ 35,323 | $ 36,785 | $ 17,047 | ||
| Marketable securities, available for sale | 4,994 | 4,988 | 4,994 | 4,994 | ||||
| Accounts receivable, net | 4,141 | 25,697 | 25,697 | 8,006 | 4,141 | 4,141 | ||
| Inventory | 2,299 | 9,049 | 9,049 | 2,639 | 2,299 | 33,838 | ||
| Prepaid expenses and other current assets | 2,497 | 4,102 | 4,102 | 2,715 | 2,497 | 3,943 | ||
| Other receivables | 133 | 815 | 815 | 846 | 133 | 133 | ||
| Total current assets | 50,849 | 51,628 | 51,628 | 54,517 | 50,849 | 64,096 | ||
| Intangible assets, net | 4,109 | 110,482 | 110,482 | 4,281 | 4,109 | 123,306 | ||
| Restricted cash | 400 | 400 | 400 | 400 | 400 | 400 | ||
| Property and equipment, net | 1,027 | 3,316 | 3,316 | 1,059 | 1,027 | 4,074 | ||
| Right of use assets | 1,854 | 2,672 | 2,672 | 1,854 | 1,854 | |||
| Goodwill | 58,747 | 58,747 | 58,747 | |||||
| Deposits and other assets | 1,676 | 3,142 | 3,142 | 1,676 | 1,676 | 1,676 | ||
| Total assets | 59,915 | 230,387 | 230,387 | 61,933 | 59,915 | 254,153 | ||
| Current liabilities: | ||||||||
| Accounts payable | 9,839 | 12,752 | 12,752 | 8,561 | 9,839 | 8,339 | ||
| Accrued expenses | 26,617 | 50,357 | 50,357 | 24,584 | 26,617 | 46,800 | ||
| Debt - non-current portion, net | 8,177 | 8,177 | 1,492 | |||||
| Acquisition-related contingent consideration | 3,500 | 3,500 | 1,200 | |||||
| Other current liabilities | 1,030 | 985 | 985 | 1,030 | 1,030 | |||
| Total current liabilities | 37,538 | 75,771 | 75,771 | 33,145 | 37,538 | 58,861 | ||
| Debt - non-current portion, net | 91,710 | 91,710 | 93,371 | |||||
| Acquisition-related contingent consideration | 14,400 | 14,400 | 13,600 | |||||
| Credit agreement | 4,050 | 4,050 | ||||||
| Other liabilities | 1,463 | 2,065 | 2,065 | 560 | 1,463 | 1,360 | ||
| Total liabilities not subject to compromise | 39,025 | 187,996 | 187,996 | 33,705 | 39,025 | 167,216 | ||
| Liabilities subject to compromise | 138,884 | 139,588 | 138,884 | |||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock | 55 | 9 | 9 | 55 | 55 | 9 | ||
| Additional paid-in capital | 276,880 | 89,027 | 89,027 | 276,569 | 276,880 | 86,928 | ||
| Accumulated other comprehensive (loss) income | 866 | (5) | (5) | 869 | 866 | |||
| Accumulated deficit | (395,795) | (46,640) | (46,640) | (388,853) | (395,795) | |||
| Total stockholders' equity (deficit) | 86,937 | 42,391 | 42,391 | (111,360) | 86,937 | 86,937 | $ (117,994) | $ (39,375) |
| Total liabilities and stockholders’ equity (deficit) | $ 59,915 | $ 230,387 | $ 230,387 | $ 61,933 | $ 59,915 | $ 254,153 | ||
Consolidated Balance Sheets (Parenthetical) - $ / shares |
Dec. 31, 2019 |
Feb. 01, 2019 |
Jan. 31, 2019 |
Dec. 31, 2018 |
Feb. 28, 2018 |
Dec. 31, 2017 |
|---|---|---|---|---|---|---|
| Consolidated Balance Sheets | ||||||
| Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||
| Common stock, authorized | 100,000,000 | 100,000,000 | 275,000,000 | 275,000,000 | 275,000,000 | 75,000,000 |
| Common stock, issued | 9,437,883 | 4,774,093 | 56,547,101 | |||
| Common stock, outstanding | 9,437,883 | 56,547,101 |
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended |
|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
|
| Consolidated Statements of Comprehensive Loss | |||
| Predecessor Successor Fixed list | Predecessor | Successor | Predecessor |
| Net (loss) income | $ 107,240 | $ (46,640) | $ (95,454) |
| Other comprehensive (loss) income: | |||
| Unrealized loss on available for sale securities | 45 | ||
| Foreign currency translation adjustments | (5) | (184) | |
| Comprehensive (loss) income | $ 107,240 | $ (46,645) | $ (95,593) |
Consolidated Statements of Cash Flows (Parenthetical) |
Dec. 31, 2019 |
Dec. 31, 2018 |
Jan. 31, 2017 |
Aug. 31, 2016 |
|---|---|---|---|---|
| 13% Notes | ||||
| Interest rate (as a percent) | 13.00% | 13.00% | 13.00% | 13.00% |
Organization and Description of the Business |
12 Months Ended |
|---|---|
Dec. 31, 2019 | |
| Organization and Description of the Business | |
| Organization and Description of the Business | 1. Organization and Description of the Business Zyla Life Sciences (the “Company”) is a commercial-stage life science company committed to bringing products to patients and healthcare providers and is focused on marketing its portfolio of medicines for pain and inflammation. Zyla’s portfolio includes six products: SPRIX® (ketorolac tromethamine) Nasal Spray, ZORVOLEX® (diclofenac), VIVLODEX® (meloxicam), INDOCIN® (indomethacin) suppositories, INDOCIN® oral suspension and OXAYDO® (oxycodone HCI, USP) tablets for oral use only —CII. SPRIX Nasal Spray is a nonsteroidal anti-inflammatory drug indicated in adult patients for the short‑term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level. VIVLODEX and ZORVOLEX are SOLUMATRIX® Technology non-steroidal anti-inflammatory products. The Company acquired two forms of INDOCIN, an oral solution and a suppository, from Iroko Pharmaceuticals, Inc. and its subsidiaries (collectively, “Iroko”) in January 2019. Both products are approved for many indications including: moderate to severe rheumatoid arthritis including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis. OXAYDO is an immediate release (“IR”) oxycodone product designed to discourage abuse via snorting, indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. To augment its current product portfolio, the Company is seeking to acquire additional product candidates or approved products to develop and/or market. Emergence from Voluntary Reorganization Under Chapter 11 Proceedings Chapter 11 Cases On October 30, 2018, the Company entered into a definitive asset purchase agreement (the “Purchase Agreement”) to acquire the SOLUMATRIX products and INDOCIN products and one development product from Iroko. To facilitate the transactions contemplated by the Purchase Agreement (the “Iroko Products Acquisition”) and to reorganize its financial structure, the Company and its wholly-owned subsidiaries filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”) and a related Joint Plan of Reorganization (“the Plan”) on October 30, 2018. The Company requested that the Chapter 11 cases (the “Chapter 11 Cases”) be jointly administered for procedural purposes only under the caption “In re Egalet Corporation, et al., Case No. 18-12439”. Upon filing, the Company continued to operate its business as a “debtor-in-possession” under the jurisdiction of the Bankruptcy Court and in accordance with the applicable provisions of the Bankruptcy Code and orders of the Bankruptcy Court. The Company continued ordinary course operations substantially uninterrupted during the Chapter 11 Cases and sought approval from the Bankruptcy Court for relief under certain “first day” motions authorizing the Company to continue to conduct its business in the ordinary course. On January 14, 2019, the Bankruptcy Court entered the Confirmation Order confirming the Plan under Chapter 11 of the Bankruptcy Code. On January 31, 2019 (the “Effective Date”), and substantially concurrent with the consummation of the acquisition of the Iroko products named below pursuant to the Purchase Agreement (the “Iroko Products Acquisition”), the Plan became effective. The Company divested assets related to TIVORBEX in November 2019. Liquidity and Substantial Doubt in Going Concern Substantial Doubt Regarding Going Concern The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred recurring operating losses since inception. As of December 31, 2019, the Company had an accumulated deficit of $46.6 million and a working capital deficit of $24.1 million. Even though the Company emerged from bankruptcy, it continues to have significant indebtedness and its ability to continue as a going concern is contingent upon the successful integration of the Iroko Products Acquisition, increasing its revenue, managing its expenses and complying with the terms of its new debt agreements. Refer to Note 12—Debt for additional details of these debt agreements. These factors, in combination with others described above, resulted in the conclusion that there is substantial doubt about the ability of the Company to continue as a going concern for the one-year period after the date that these financial statements are issued. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. |
Summary of Significant Accounting Policies and Basis of Accounting |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Significant Accounting Policies and Basis of Accounting | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Significant Accounting Policies and Basis of Accounting | 2. Summary of Significant Accounting Policies and Basis of Accounting
Basis of Accounting
The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company’s consolidated financial statements include the accounts of Zyla Life Sciences and its wholly‑owned subsidiaries, Zyla Life Sciences US Inc. and Egalet Limited. All intercompany balances and transactions have been eliminated in consolidation.
Upon emergence from bankruptcy, the Company adopted fresh start accounting in accordance with the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 852, Reorganizations, which resulted in the Company becoming a new entity for financial reporting purposes on February 1, 2019.
References to "Successor" or "Successor Company" relate to the financial position and results of operations of the reorganized Company subsequent to January 31, 2019. References to "Predecessor" or "Predecessor Company" relate to the financial position and results of operations of the Company prior to, and including, January 31, 2019.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires the Company to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances, the results of which form its basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates under different assumptions or conditions. The Company believes the following critical accounting policies reflect the more significant judgements and estimates used in the preparation of its consolidated financial statements. Segment and Geographic Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision‑making group, in deciding how to allocate resources and in assessing performance. The Company globally manages the business within one reportable segment. Segment information is consistent with how management reviews the business, makes investing and resource allocation decisions and assesses operating performance. As of December 31, 2019, long‑lived assets were located in the United States and net revenue from product sales was derived entirely from the United States.
Concentrations of Credit Risk and Off‑Balance Sheet Risk
Cash, cash equivalents and accounts receivable are financial instruments which potentially subject the Company to concentrations of credit risk. The Company maintains its cash balances in accounts with financial institutions that management believes are creditworthy. The Company invests cash that is not currently being used for operational purposes in accordance with its investment policy. The policy allows for the purchase of low-risk debt securities issued by U.S. government agencies and very highly rated corporations, subject to certain concentration limits. The Company believes its established guidelines for investment of its excess cash maintain safety and liquidity through its policies on diversification and investment maturity.
The following table reflects the Company’s accounts receivable concentration by customer at December 31, 2019 and 2018:
Cash, Restricted Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash balances of $12.2 million and $0.2 million were maintained at financial institutions in the United States and Denmark, respectively, at December 31, 2019. Bank deposits are insured up to approximately $0.3 million and $0.1 million for U.S. and Danish financial institutions, respectively.
Marketable Securities, Available-for-Sale
Marketable securities consist of securities with original maturities greater than three months and are composed of securities issued by U.S. government agencies and corporate debt securities. Marketable securities have been classified as current assets in the accompanying Consolidated Balance Sheets based upon the nature of the securities and their intended use to fund operations.
Management determines the appropriate classification of securities at the time of purchase. The Company has classified its investment portfolio as available-for-sale in accordance with FASB ASC 320, Investments—Debt and Equity Securities. The Company’s available-for-sale securities are carried at fair value with unrealized gains and losses reported in other comprehensive income (loss). Realized gains and losses are determined using the specific identification method and are included in interest expense. Marketable securities are evaluated periodically for impairment. If it is determined that a decline of any investment is other than temporary, then the carrying amount of the investment is written down to fair value and the write-down is included in the Consolidated Statements of Comprehensive Loss as a loss.
Fair Value Measurements
The carrying amounts reported in the Company’s consolidated financial statements for cash and cash equivalents, accounts receivable, accounts payable and accrued expenses approximate their respective fair values because of the short-term nature of these accounts. The carrying value of the derivative liabilities are the estimated fair value of the liability as further described in Note 6 – Fair Value Measurements.
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
Fair value should be based on the assumptions that market participants would use when pricing an asset or liability and is based on a fair value hierarchy that prioritizes the information used to develop those assumptions. The fair value hierarchy gives the highest priority to quoted prices in active markets (observable inputs) and the lowest priority to the Company’s assumptions (unobservable inputs). Fair value measurements should be disclosed separately by level within the fair value hierarchy. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with established fair value hierarchy.
Financial assets that the Company measures at fair value on a recurring basis include cash equivalents and marketable securities. These financial assets are generally classified as Level 1 or 2 within the fair value hierarchy. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable, such as quoted prices (adjusted), interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability. The fair value hierarchy level is determined by the lowest level of significant input.
The Company’s financial assets have been initially valued at the transaction price and subsequently valued at the end of each reporting period, typically utilizing third-party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market-based approaches, and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validates the prices provided by its third-party pricing services by reviewing their pricing methods and matrices, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. The Company did not adjust or override any fair value measurements provided by its pricing services as of December 31, 2019 or 2018.
Financial liabilities that the Company measures at fair value on a recurring basis include derivative liabilities consisting of the interest make whole feature of the 5.50% and 6.50% Notes, the conversion feature of the 6.50% Notes and the warrant liability associated with the July 2017 Equity offering. Acquisition related contingent consideration is also measured at fair value. These financial liabilities are classified as Level 3 within the fair value hierarchy. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability. The fair value hierarchy level is determined by the lowest level of significant input.
The Company’s financial liabilities have been initially and subsequently valued at the end of each reporting period, typically utilizing third-party valuation services. The valuation services utilize industry standard valuation models, including both income and market-based approaches and observable market inputs for similar instruments to determine value, if available. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validates the valuations provided by its third-party valuation services by reviewing their pricing valuation and matrices and confirming the relevant markets are active. The change in fair value of the contingent consideration during the period ending December 31, 2019 was primarily due to changes in the net product sales forecast and discount rates as there were no other significant changes in key assumptions. The Company did not adjust or override any fair value measurements provided by its valuation services as of December 31, 2019 and December 31, 2018.
During the years ended December 31, 2019 and 2018, there were no transfers between Level 1, Level 2, or Level 3 financial assets or liabilities. The Company did not have any non-recurring fair value measurements on any assets or liabilities at December 31, 2019 and December 31, 2018.
Stock-Based Compensation
The Company uses the Black-Scholes valuation model in determining the fair value of equity awards. For stock options granted to employees and directors with only service-based vesting conditions, the Company measures stock-based compensation cost at the grant date based on the estimated fair value of the award and recognizes it as expense over the requisite service period on a straight-line basis. The Company records the expense of services rendered by non-employees based on the estimated fair value of the stock option as of the respective vesting date. Further, the Company expenses the fair value of non-employee stock options that contain only service-based vesting conditions over the requisite service period of the underlying stock options.
The fair value for restricted stock awards is determined based on the closing market price of the Company’s common stock on the grant date of the awards. The expense is recognized over the requisite service period on a straight-line basis.
Property and Equipment
Property and equipment consist primarily of laboratory and manufacturing equipment, furniture, fixtures, and other property, all of which are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight‑line method over the estimated useful lives of the assets. Maintenance and repairs are expensed as incurred. The following estimated useful lives were used to depreciate the Company’s assets:
Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is charged to income.
Goodwill
Goodwill is calculated as the excess of the reorganization equity value over the fair value of tangible and identifiable intangible assets pursuant to ASC 852, Reorganizations. Goodwill is not amortized but is tested for impairment at the reporting unit level at least annually or when a triggering event occurs that could indicate a potential impairment by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that the fair value of net assets are below their carrying amounts. A reporting unit is the same as, or one level below, an operating segment. Our operations are currently comprised of a single, entity wide reporting unit.
Intangible and Long-Lived Assets
Intangible and long-lived assets consist of in‑process research and development (“IP R&D”) and product rights. IP R&D is considered an indefinite‑lived intangible asset and is assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets would be written‑off and the Company would record a non‑cash impairment loss on its Consolidated Statement of Operations. For those product candidates that reach commercialization, the IPR&D asset will be amortized over its estimated useful life.
Long-lived intangible assets acquired as part of the SPRIX Nasal Spray acquisition, OXAYDO license and INDOCIN product rights are being amortized on a straight-line basis over their estimated useful lives of 9 years, 3 years and 9 years, respectively. The Company estimated the useful life of the assets by considering competition by products prescribed for the same indication, the likelihood and estimated future entry of non-generic and generic competition for the same or similar indication and other related factors. The factors that drive the estimate of the life are often uncertain and are reviewed on a periodic basis or when events occur that warrant review.
The Company assesses the recoverability of its long‑lived assets, which include property and equipment and product rights whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset and a charge to operating results. During the year ended December 31, 2018, the Company recorded a charge of $0.1 million to restructuring and other charges to write off the remaining IP R&D intangible asset related to its Guardian Technology due to the Company’s decision to discontinue the manufacturing and promotion of ARYMO ER.
Net Product Sales
The Company recognizes revenue in accordance with FASB ASC 606, Revenue from Contracts with Customers, at the time it ships its products to its customers (primarily wholesalers and specialty pharmacies).
The Company sells SPRIX Nasal Spray in the United States to a single specialty pharmaceutical distributor. The Company recognizes revenue from sales of SPRIX Nasal Spray upon delivery of the product to its distributor. The Company sells INDOCIN suppositories and oral suspension in the United States through third-party wholesalers, subject to rights of return, with revenue recognized upon delivery of the product to the wholesaler. The Company sells its SOLUMATRIX products in the United States through third-party wholesalers, subject to rights of return, with revenue recognized upon delivery of the product to the wholesaler. The Company sells OXAYDO in the United States to several wholesalers, all subject to rights of return. The Company recognizes revenue of OXAYDO upon delivery of the product to its customers.
Product Sales Allowances
The Company recognizes product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of the Company’s agreements with customers and third-party payors that may result in future rebates or discounts taken. In certain cases, such as patient discount programs, the Company recognizes the cost of patient discounts as a reduction of revenue based on estimated utilization. If actual future results vary, the Company may need to adjust these estimates, which could have an effect on product revenue in the period of adjustment. The Company’s product sales allowances include:
Specialty Pharmacy Fees. The Company offers a discount to a certain specialty pharmaceutical distributor based on a contractually determined rate. The Company records the fees on shipment to the distributor and recognizes the fees as a reduction of revenue in the same period the related revenue is recognized.
Wholesaler and Title Fees. The Company pays certain pharmaceutical wholesalers and its third-party logistics provider fees based on a contractually determined rate. The Company accrues these fees on shipments to the respective wholesalers and recognizes the fees as a reduction of revenue in the same period the related revenue is recognized.
Prompt Pay Discounts. The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the prompt pay discount amount and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized.
Patient Discount Programs. The Company offers co-pay discount programs for each of its products to patients, in which patients receive a co-pay discount on their prescriptions. The Company utilizes data provided by independent third parties to determine the total amount that was redeemed and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized.
Rebates and Chargebacks. Managed care rebates are payments to governmental agencies and third parties, primarily pharmacy benefit managers and other health insurance providers. The reserve for these rebates is based on a combination of actual utilization provided by the third party and an estimate of customer buying patterns and applicable contractual rebate rates to be earned over each period. The Company recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. Inventories and Cost of Sales
Inventories are stated at the lower of cost or net realizable value, net of reserve for excess and obsolete inventory and cost is determined using the average-cost method. At December 31, 2019 and December 31, 2018, inventory consisted of raw materials, work in process, and finished goods.
Cost of sales includes the cost of inventory sold or reserved, which includes manufacturing and supply chain costs, product shipping and handling costs, and product royalties. Acquisition-related contingent consideration Pursuant to the Iroko Products Acquisition, the Company has obligations relating to contingent payment consideration for future royalty obligations to Iroko based upon annual INDOCIN product net sales over $20.0 million. The Company recorded the acquisition-date fair value of these contingent liabilities, based on the likelihood of contingent earn-out payments. The earn-out payments are subsequently remeasured to fair value each reporting date. The fair value of the acquisition-related contingent consideration is remeasured each reporting period, with changes in fair value recorded in the Company’s Consolidated Statements of Operations. The royalty term commenced on the Effective Date and ends on the tenth anniversary of the Effective Date, January 31, 2029. Long Term Debt For a description of the Company’s debt obligations outstanding at December 31, 2019, see Note 12 – Debt.
Former 5.50% Notes
In April and May 2015, the Company issued through a private placement $61.0 million in aggregate principal amount of the 5.50% Notes in two separate closings. Interest on the 5.50% Notes is payable semi-annually in arrears on April 1 and October 1 of each year, commencing October 1, 2015. The 5.50% Notes are convertible at 67.2518 shares per $1,000 principal amount of the 5.50% Notes (equivalent to an initial conversion price of approximately $14.87 per share of common stock).
In December 2017, the Company closed exchange agreements with certain holders of the outstanding 5.50% notes for $36.4 million in principal value of the 5.50% Notes. The total face value of the outstanding 5.50% notes was reduced from $61.0 million to $24.6 million as a result of the Exchange. As part of the exchange, the Company issued $23.9 million in principal amount of new 6.50% convertible notes due December 31, 2024. See below for further information.
Former 13.0% Notes
In August 2016, the Company completed the initial closing (the “Initial Closing”) of its offering (the “Offering”) of up to $80.0 million aggregate principal amount of its 13.0% senior secured notes and entered into an indenture governing the Notes with the guarantors party thereto (the “Guarantors”) and U.S. Bank National Association, a national banking association, as trustee (the “Trustee”) and collateral agent (the “Collateral Agent”). The Company issued $40.0 million aggregate principal amount of the 13% Notes at the Initial Closing and issued an additional $40.0 million aggregate principal amount of the Notes on approval from the Food and Drug Administration (“FDA”) of ARYMO ER in January 2017 (the “Second Closing”). Net proceeds from the Initial Closing and Second Closing were $37.2 million and $38.3 million respectively, after deducting offering expenses. The Notes were sold only to qualified institutional buyers within the meaning of Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).
Former 6.50% Notes
In December 2017, the Company issued $23.9 million in principal amount of the 6.50% Notes. The 6.50% notes were issued to existing 5.50% Note holders in exchange for $36.4 million in face value of the 5.50% Notes. Interest on the 6.50% Notes is payable semi-annually in arrears on January 1 and July 1 of each year, commencing July 1, 2018. The 6.50% Notes are convertible at 749.6252 shares per $1,000 principal amount of the 6.50% Notes (equivalent to an initial conversion price of approximately $1.33 per share of common stock).
Liabilities Subject to Compromise
The Predecessor Company’s financial statements include amounts classified as Liabilities Subject to Compromise, which represent liabilities that existed prior to the effectiveness of its bankruptcy plans and that were restructured under the Plan of Reorganization. These amounts include amounts related to (i) the 5.50% Notes, (ii) the 6.50% Notes and (iii) the 13.0% Notes, including the accrued interest thereon, and accrued vendor liabilities. Refer to Note 11–Liabilities Subject to Compromise for additional details.
Interest Make-Whole Derivative
The former 5.50% Notes included an interest make-whole feature whereby if a noteholder converted any of the 5.50% Notes prior to April 1, 2018, subject to certain restrictions, the noteholder would be entitled, in addition to the other consideration payable or deliverable in connection with such conversion, to an interest make-whole payment equal to the sum of the present value of the remaining scheduled payments of interest that would have been made on the notes to be converted had such notes remained outstanding from the conversion date through April 1, 2018, computed using a discount rate equal to 2%. The Company has determined that this feature is an embedded derivative and has recognized the fair value of this derivative as a liability on the Company’s Consolidated Balance Sheet, with subsequent changes to fair value recorded through earnings at each reporting period on the Company’s Consolidated Statements of Operations and Comprehensive Loss as change in fair value of derivative liabilities. The fair value of this embedded derivative was determined based on a binomial tree lattice model.
The former 6.50% Notes included an interest make-whole feature whereby if a noteholder converted any of the 6.50% Notes prior to January 1, 2021, subject to certain restrictions, they were entitled, in addition to the other consideration payable or deliverable in connection with such conversion, to an interest make-whole payment equal to the sum of the present value of the remaining scheduled payments of interest that would have been made on the notes to be converted had such notes remained outstanding from the conversion date through January 1, 2021, computed using a discount rate equal to 2%. The Company has determined that this feature is an embedded derivative and has recognized the fair value of this derivative as a liability on the Company’s Consolidated Balance Sheets, with subsequent changes to fair value recorded through earnings at each reporting period on the Company’s Consolidated Statements of Operations and Comprehensive Loss as change in fair value of derivative liabilities. The fair value of this embedded derivative was determined based on a binomial tree lattice model.
Warrant Liability
On July 6, 2017, the Company entered into an underwriting agreement with Cantor Fitzgerald & Co. relating to an underwritten public offering (the “July 2017 Equity Offering”) of 16,666,667 shares of the Company’s common stock and accompanying warrants to purchase 16,666,667 shares of common stock, at a combined public offering price of $1.80 per share and accompanying warrant, for gross proceeds of $30.0 million. Each warrant was issued at an exercise price of $2.70, subject to adjustment in certain circumstances. The shares of common stock and warrants were issued separately. The warrants could be exercised at any time on or after the date of issuance and expired five years from the date of issuance.
The Company accounted for the warrants using ASC 480 – Distinguishing Liabilities from Equity and determined that the warrants were a freestanding financial instrument that are subject to liability classification. Pursuant to the terms of the agreement, the Company could be required to settle the warrants in cash in the event of an acquisition of the Company, and as a result the warrants are required to be measured at fair value and reported as a current liability in the Company’s Consolidated Balance Sheet, with subsequent changes to fair value recorded through earnings at each reporting period on the Company’s Consolidated Statements of Operations and Comprehensive Loss as change in fair value of derivative liabilities. The warrants were cancelled in connection with the emergence from bankruptcy.
Foreign Currency Translation
The reporting currency of the Company is the U.S. dollar. The functional currency of the Company’s non‑U.S. operations is the Danish Krone. Assets and liabilities of foreign operations are translated into U.S. dollars based on exchange rates at the end of each reporting period. Revenues and expenses are translated at average exchange rates during the reporting period. Gains and losses arising from the translation of assets and liabilities are included as a component of accumulated other comprehensive loss or income on the Company’s Consolidated Balance Sheets. Gains and losses resulting from foreign currency transactions are reflected within the Company’s Consolidated Statements of Operations. The Company has not utilized any foreign currency hedging strategies to mitigate the effect of its foreign currency exposure.
Intercompany payables and receivables are considered to be long-term in nature and any change in balance due to foreign currency fluctuation is included as a component of the Company's Consolidated Statements of Comprehensive Loss and Accumulated Other Comprehensive Loss within the Company's Consolidated Balance Sheets.
Comprehensive Loss
Comprehensive loss is defined as changes in stockholders’ deficit exclusive of transactions with owners (such as capital contributions and distributions). Comprehensive loss is composed of net loss, foreign currency translation adjustments and unrealized gains or losses on marketable securities classified as available for sale.
Income Taxes
The Company uses the asset and liability method of accounting for income taxes. Current tax liabilities or receivables are recognized for the amount of taxes the Company estimates are payable or refundable for the current year. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is provided when it is more likely than not that some portion or the entire deferred tax asset will not be realized. The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on its income tax return if such a position is more likely than not to be sustained. Then, the tax benefit recognized is the largest amount of benefit, determined on a cumulative probability basis, which is more likely than not to be realized upon ultimate settlement. The Company recognizes interest and penalties related to unrecognized tax benefits within the income tax expense line in the Company’s Consolidated Statements of Operations and Comprehensive Loss. Accrued interest and penalties are included within the related tax liability line in the Company’s Consolidated Balance Sheets. The Company did not have any accrued interest or penalties associated with any unrecognized tax positions at December 31, 2019 and 2018, and there were no such interest or penalties recognized during the period from February 1, 2019 through December 31, 2019 (Successor), the period from January 1, 2019 through January 31, 2019 (Predecessor) or the year ended December 31, 2018 (Predecessor).
Basic and Diluted Net Loss Per Share of Common Stock
Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted‑average number of common shares outstanding during the period. Diluted net loss per share of common stock is computed by dividing the net loss applicable to common stockholders by the sum of the weighted‑average number of common shares outstanding during the period plus the potential dilutive effects of common stock options and warrants outstanding during the period calculated in accordance with the treasury stock method, plus the potential dilutive effects of the 5.50% and 6.50% Notes using the if-converted method. Because the impact of these items is anti‑dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of common stock for the period February 1, 2019 through December 31, 2019 (Successor), the period January 1, 2019 through January 31, 2019 (Predecessor) and the year ended December 31, 2018 (Predecessor).
Recent Accounting Pronouncements
In February 2016, the Financial Accounting Standards Board FASB issued ASU No. 2016-02 Leases (ASC 842). In July 2018, the FASB issued ASU No. 2018-10, "Codification Improvements to Topic 842, Leases" (ASU 2018-10), which provides narrow amendments to clarify how to apply certain aspects of the new lease standard, and ASU No. 2018-11, "Leases (Topic 842)-Targeted Improvements" (ASU 2018-11), which addressed implementation issues related to the new lease standard. These and certain other lease-related ASUs have generally been codified in ASC 842. ASC 842 supersedes the lease accounting requirements in Accounting Standards Codification Topic 840, Leases (ASC 840). ASC 842 establishes a right-of-use model that requires a lessee to record a right-of-use ("ROU") asset and a lease liability on the balance sheet for all leases. Under ASC 842, leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The standard also requires disclosures to help investors and other financial statement users better understand the amount, timing and uncertainty of cash flows arising from leases. The Company adopted ASC 842 using the modified retrospective transition approach as of the effective date, which allows the Company to not adjust the comparative periods presented. The Company has elected to adopt the package of transition practical expedients and, therefore, has not reassessed whether existing or expired contracts contain a lease, the lease classification for existing or expired leases or the accounting for initial direct costs that were previously capitalized. The Company did not elect the practical expedient to use hindsight for leases existing at the adoption date. Further, the Company does not expect the amendments in ASU 2018-01: Land Easement Practical Expedient to have an effect on its financial position because it did not enter into land easement arrangements. The Company has elected, as an accounting policy, to not recognize ROU assets and lease liabilities for all short-term leases that have a lease term of 12 months or less. Upon adoption, the Predecessor Company recorded a lease liability of $2.5 million with a corresponding ROU asset of $1.9 million for its operating leases. As of the adoption date, the Company had a $0.6 million deferred rent liability which was reversed. The adoption of ASC 842 did not have a material impact on the Company’s Consolidated Statements of Operations or Consolidated Statements of Cash Flows.
In January 2016, the FASB issued ASU 2016-01, Financial Instruments - Overall (Subtopic 825-10), Recognition and Measurement of Financial Assets and Financial Liabilities, which addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. ASU 2016-01 was effective for annual periods and interim periods within those annual periods beginning after December 15, 2017. The Company adopted the standard in the first quarter of 2018 and determined there to be no material impact of the adoption in the year ended December 31, 2018.
In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” This guidance applies to all entities and impacts how entities account for credit losses for most financial assets and other instruments. ASU 2016-13 requires financial assets measured at amortized cost to be presented at the net amount expected to be collected. The measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amounts. An entity must use judgment in determining the relevant information and estimation methods that are appropriate in its circumstances. For trade receivables, loans and held-to-maturity debt securities, entities will be required to estimate expected credit losses over the lifetime of the asset. For available-for-sales debt securities, entities will be required to recognize an allowance for credit losses rather than an other-than-temporary impairment that reduces the cost basis of the investment. Further, an entity will recognize any improvements in credit losses on its available-for-sale debt securities immediately in earnings.
The FASB also released clarifying guidance in April 2019 within ASU 2019-04, “Codification Improvements to Topic 326, Financial Instruments – Credit Losses,” in May 2019 within ASU 2019-05, “Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief,” and in November 2019 within ASU 2019-10, “Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842),” and ASU 2019-11, “Codification Improvements to Topic 326, Financial Instruments – Credit Losses.” The updates provide guidance on estimating credit losses, including transition relief by allowing for election of the fair value methodology on an instrument-by-instrument basis for eligible financial instruments within the scope of ASC 825-10, and valuation of receivables from customers with troubled debt. This guidance is effective for fiscal years beginning after December 15, 2019 and interim periods therein. Elections under ASU 2019-05 require a modified retrospective application through a cumulative-effect adjustment in the opening balance of retained earnings upon adoption. The Company is currently analyzing the impact of the credit losses standard and does not anticipate the adoption of this ASU on January 1, 2020 to have a material impact on its consolidated financial statements.
In August 2018, the FASB issued ASU 2018-13, “Fair Value Measurement (Topic 820)” which modifies the disclosure requirements of fair value measurements in Topic 820, Fair Value Measurement. For public companies the ASU removes disclosure requirements for transfers between Level 1 and Level 2 of the fair value hierarchy, the policy for timing of transfers between levels and the valuation process for Level 3 fair value measurements. The ASU modifies the disclosure requirements for investments in certain entities that calculate net asset value and clarifies that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date. The ASU adds the disclosure requirement for changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2019 including interim periods within that fiscal year. Early adoption is permitted. The Company does not plan to early adopt this ASU and the Company does not believe there will be a material impact on its consolidated financial statements as a result of adopting this ASU. In December 2019, the FASB issued ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes.” This guidance is effective for fiscal years beginning after December 15, 2020 and interim periods therein. Early adoption is permitted for any annual periods for which financial statements have not been issued and interim periods therein. The Company is currently analyzing the impact of ASU 2019-12 and does not anticipate the adoption of this ASU to have a material impact on the Company’s consolidated financial statements. |
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Fresh Start Accounting |
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| Fresh Start Accounting | 3. Fresh Start Accounting Upon emergence from bankruptcy, the Company adopted fresh start accounting as (i) the reorganization value of the assets of the Successor Company immediately before the date of confirmation of the Plan was less than the total of all post-petition liabilities and allowed claims and (ii) the holders of the Predecessor Company’s voting shares immediately before confirmation of the Plan received less than 50 percent of the voting shares of the emerging entity. U.S. GAAP requires the adoption of fresh start accounting on the later of (i) the Plan confirmation date, or (ii) when all material conditions precedent to the Plan’s becoming effective are resolved, which occurred on January 31, 2019. Accordingly, the Company selected January 31, 2019 as the fresh start reporting date. Upon the application of fresh start accounting, the Company allocated the reorganization value to its individual assets based on their estimated fair values. Reorganization value represents the fair value of the Successor Company’s assets before considering liabilities. The excess reorganization value over the fair value of identified tangible and intangible assets is reported as goodwill. The Bankruptcy Court confirmed the Plan based upon an estimated enterprise value of the Company between $162 million and $200 million, which was estimated using various valuation methods, including (i) comparable public company analysis, a method to estimate the value of a company relative to other publicly traded companies with similar operations and financial characteristics; (ii) discounted cash flow analysis, a calculation of the present value of the future cash flows to be generated by the asset or business based on its projection, and (iii) precedent transaction analysis, a method to estimate the value of a company by examining comparable public merger and acquisition transactions. Based upon a reevaluation of relevant factors used in determining the range of enterprise value and updated expected cash flow projections, the Company concluded the enterprise value, or fair value, was $196.6 million. The basis of the discounted cash flow analysis used in developing the enterprise value was based on Company prepared projections that included a variety of estimates and assumptions. While the Company considers such estimates and assumptions reasonable, they are inherently subject to significant business, economic and competitive uncertainties, many of which are beyond the Company’s control and, therefore, may not be realized. Changes in these estimates and assumptions may have had a significant effect on the determination of the Company’s enterprise value. The assumptions used in the calculations for the discounted cash flow analysis, which had the most significant effect on the estimated enterprise value, included the following: forecasted revenue, costs and free cash flows through 2023, discount rate of 15.1 %. A terminal value of $217.3 million was established, which was determined using a perpetual long-term growth rate of 3%. The four-column consolidated statement of financial position as of January 31, 2019, included herein, applies effects of the Plan and fresh start accounting to the carrying values and classifications of assets or liabilities. Upon adoption of fresh start accounting, the recorded amounts of assets and liabilities were adjusted to reflect their estimated fair values. Accordingly, the reported historical financial statements of the Predecessor Company prior to the adoption of fresh start accounting for periods ended on or prior to January 31, 2019 are not comparable to those of the Successor Company. In applying fresh start accounting, the Company followed these principles:
The following four-column consolidated statement of financial position table identifies the adjustments recorded to the Predecessor Company’s January 31, 2019 Consolidated Balance Sheets as a result of implementing the Plan and applying fresh start accounting:
Effects of Plan Adjustments
Fresh Start Adjustments
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| Revenue From Contracts with Customers | 4. Revenue from Contracts with Customers Revenue Recognition Under ASC 606, revenue is recognized when, or as, performance obligations under the terms of a contract are satisfied, which occurs when control of the promised products or services is transferred to customers. To recognize revenue pursuant to the provisions of ASC 606, the Company performs 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 Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect substantially all the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses whether the goods or services promised within each contract are distinct to determine those that are performance obligations. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer (“transaction price”). 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. To the extent that the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price to which the Company expects to be entitled after giving effect to returns, rebates, sales allowances and other variable elements with contracts between the Company and its customers. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance under the contract and all information (historical, current and forecasted) that is reasonably available. Sales taxes and other taxes collected on behalf of third parties are excluded from revenue. When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the significant financing practical expedient, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of December 31, 2019. The Company’s existing contracts with customers contain only a single performance obligation and, as such, the entire transaction price is allocated to the single performance obligation. Should future contracts contain multiple performance obligations, those would require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on observable prices or a cost-plus margin approach when one is not available. The Company’s performance obligations are to provide pharmaceutical products to several wholesalers or a single specialty pharmaceutical distributor. All of the Company's performance obligations, and associated revenue, are generally transferred to customers at a point in time. Revenue is recognized at the time the related performance obligation is satisfied by transferring control of a promised good to a customer, which is typically upon delivery. Payments for invoices are generally due within 30 to 65 days of invoice date. Disaggregation of Revenue The following table reflects net revenue by revenue source for the periods indicated:
Reserves for Variable Consideration Revenues from product sales are recorded at the transaction price, which includes estimates of variable consideration for which reserves are established and which result from returns, rebates and sales allowances that are offered within or impacted by contracts between the Company and its customers. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual 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 of the amount of consideration to which it is entitled based on the terms of the contract as of the date of determination. The amount of variable consideration which is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration 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 net product revenue and earnings in the period such variances become known. Product Returns Consistent with industry practice, the Company generally offers customers a limited right of return for its products. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company estimates product return liabilities using the expected value method based on its historical sales information and other factors that it believes could significantly impact its expected returns, including product discontinuations, product recalls and expirations, of which it becomes aware. These factors include its estimate of actual and historical return rates for non-conforming product and open return requests. Specialty Pharmacy Fees The Company offers a discount to a certain specialty pharmaceutical distributor based on a contractually determined rate. The Company records the fees on shipment to the distributor and recognizes the fees as a reduction of revenue in the same period the related revenue is recognized. Wholesaler and Title Fees The Company pays certain pharmaceutical wholesalers and its third-party logistics provider fees based on a contractually determined rate. The Company accrues these fees on shipment to the respective wholesalers and recognizes the fees as a reduction of revenue in the same period the related revenue is recognized. Prompt Pay Discount The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. The Company estimates cash discounts using the mostly likely amount method by reducing accounts receivable by the prompt pay discount amount. The discount is recognized as a reduction of revenue in the same period as the related revenue. Patient Discount Programs The Company offers co-pay discount programs to patients for each of its products, in which patients receive a co-pay discount on their prescriptions. For discount amounts that are not immediately available, the Company estimates the total amount that will be redeemed using the expected value method based on the quantity of product shipped. The Company recognizes the discount as a reduction of revenue in the same period as the related revenue. As a result of actual co-pay experience related to Oxaydo product sales being more favorable than originally estimated, the Company reduced the Oxaydo co-pay sales allowance by $3.3 million during the year ended December 31, 2019. Rebates and Chargebacks The Company contracts with various commercial and government payor organizations for the payment of rebates and/or chargebacks with respect to utilization of its products. The Company estimates these rebates and chargebacks using the expected value method and records such estimates in the same period the related revenue is recognized, resulting in a reduction of net product sales and the establishment of an accrued expense. The following table reflects activity in each of the net product sales allowance and reserve categories for the periods indicated:
Transaction Price Allocated to Future Performance Obligations ASC 606 requires that the Company disclose the aggregate amount of transaction price that is allocated to performance obligations that have not yet been satisfied as of December 31, 2019. The guidance provides certain practical expedients that limit this requirement including performance obligations that are part of a contract that has an original expected duration of one year or less. All of the Company’s contracts are eligible for the practical expedient provided by ASC 606, therefore the Company elected not to disclose any remaining performance obligations. Contract Balances from Contracts with Customers When the Company receives consideration from a customer, or such consideration is unconditionally due from a customer prior to the transfer of goods or services to the customer under the terms of a contract, the Company records a contract liability. Contract liabilities are recognized as revenue after control of the products is transferred to the customer and all revenue recognition criteria have been met. The Company classifies contract liabilities as deferred revenue. The Company had no deferred revenue as of December 31, 2019 or December 31, 2018. Contract assets primarily relate to rights to consideration for goods or services transferred to the customer when the right is conditional on something other than the passage of time. Contract assets are transferred to accounts receivable when the rights become unconditional. The Company had no contract assets as of December 31, 2019 or December 31, 2018. Costs to Obtain and Fulfill a Contract The Company accounts for shipping and handling activities related to contracts with customers as costs to fulfill the promise to transfer the associated products. When shipping and handling costs are incurred after a customer obtains control of the products, the Company has elected to account for these as costs to fulfill the promise and not as a separate performance obligation. Shipping and handling costs associated with the distribution of finished products to customers are expensed as incurred and are recorded in costs of goods sold in the accompanying Consolidated Statements of Operations. The Company expenses incremental costs of obtaining a contract with a customer (for example, commissions) when incurred as the period of benefit is less than one year. |
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| Investments | 5. Investments The Company owned no marketable securities as of December 31, 2019. The following table reflects marketable securities of the Predecessor Company as of December 31, 2018:
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Fair Value Measurements |
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| Fair Value Measurements | 6. Fair Value Measurements The Company measures certain assets and liabilities at fair value in accordance with ASC 820, Fair Value Measurements and Disclosures. ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The guidance in ASC 820 outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, the Company maximizes the use of quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from independent sources. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:
Cash equivalents – Cash equivalents primarily consisted of money market funds with overnight liquidity and no stated maturities. The Company classified cash equivalents as Level 1, due to their short-term maturity, and measured the fair value based on quoted prices in active markets for identical assets.
Acquisition-related contingent consideration – As of December 31, 2019, the Company had obligations to make contingent payment consideration for future royalties to Iroko based upon annual INDOCIN product net sales over $20.0 million. Pursuant to the Iroko Products Acquisition, the Company recorded the acquisition-date fair value of these contingent liabilities, based on the likelihood of contingent earn-out payments. The earn-out payments are subsequently measured to fair value each reporting date. The Company classified the acquisition-related contingent consideration liabilities to be settled in cash as Level 3, due to the lack of relevant observable inputs and market activity. Changes in assumptions described above could have an impact on the payout of contingent consideration.
The following table reflects the fair value hierarchy information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis, for the periods indicated:
The 5.50% Notes included and 6.50% Notes include an interest make-whole feature whereby if a noteholder had converted any of the 5.50% Notes prior to April 1, 2018, or converts any of the 6.50% Notes prior to July 1, 2021, the Company will, in addition to the other consideration payable or deliverable in connection with such conversion, make an interest make-whole payment to the converting holder equal to the sum of the present value of the remaining scheduled payments of interest that would have been made on the notes to be converted had such notes remained outstanding from the conversion date through April 1, 2018 (5.50% Notes), or July 1, 2021 (6.50% Notes), computed using a discount rate equal to 2%.
The embedded conversion options in the 6.50% Notes are required to be separately accounted for as derivatives as the Company did not have enough available authorized shares to cover the conversion obligation as of the date of issuance as of December 31, 2017. In February 2018, the Company held a special meeting of stockholders (the “Special Meeting”). At the Special Meeting, the Company’s stockholders approved an amendment to the Company’s Third Amended and Restated Certificate of Incorporation to increase the number of shares of the Company’s authorized common stock from 75,000,000 to 275,000,000 shares. As the Company had reserved sufficient shares of its common stock to satisfy the conversion provisions of the 6.50% Notes, the conversion feature was considered indexed to its stock and the fair value of the conversion feature was reclassified from a liability into stockholders’ deficit in the first quarter of 2018.
The Company has determined that the above features are embedded derivatives and has recognized the fair value of the derivatives as liabilities in the Company’s Consolidated Balance Sheet, with subsequent changes to fair value recorded through earnings at each reporting period on the Company’s Consolidated Statements of Operations and Comprehensive Loss as change in fair value of derivative liabilities.
The following table reflects a rollforward of the Company’s Level 3 liabilities for the Successor period February 1, 2019 through December 31, 2019:
The following tables reflects a summary of changes in the fair value of Level 3 liabilities for the year ended December 31, 2018:
The fair value of the contingent consideration was determined using an income approach based on projected INDOCIN product net sales and appropriate discount rates. The fair value of the contingent consideration is remeasured each reporting period, with changes in fair value recorded in the Consolidated Statements of Operations. The change in fair value of the contingent consideration during the period ended December 31, 2019 was primarily due changes in the product net sales forecast and discount rates.
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| Inventory | 7. Inventory Inventories are stated at the lower of cost or net realizable value using actual cost net of reserve for excess and obsolete inventory. The following table represents the components of inventory as of December 31, 2019 and 2018.
As a result of the discontinuation of manufacturing and promotion of ARYMO ER effective September 28, 2018, the Company recognized a write-down of the remaining inventory of ARYMO ER of $0.7 million in the year ended December 31, 2018, which is included in Restructuring and other charges on the Company’s Consolidated Statements of Operations. Three was no reserve for excess and obsolete inventory as of December 31, 2019. As of December 31, 2018, the Company recorded a reserve for excess and obsolete inventory of $0.1 million. |
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| Property and Equipment | 8. Property and Equipment The following table reflects property and equipment and related accumulated depreciation as of December 31, 2019 and 2018:
Depreciation expense, including amortization of leasehold improvements, was $0.8 million, $32,000 and $2.1 million for the Successor period February 1, 2019 through December 31, 2019, the Predecessor period January 1, 2019 through January 31, 2019 and the Predecessor year ended December 31, 2018, respectively. As a result of the discontinuation of manufacturing and promotion of ARYMO ER effective September 28, 2018, the Company recognized a write-down of equipment related to the manufacture of ARYMO ER of $6.8 million in the year ended December 31, 2018, which is included in Restructuring and other charges on the Company’s Consolidated Statements of Operations. |
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| Intangible Assets and Goodwill | 9. Intangible Assets and Goodwill The following table reflects intangible assets of the Successor Company as of December 31, 2019:
The following table reflects intangible assets of the Predecessor Company as of December 31, 2018:
As a result of fresh start accounting, the OXAYDO and SPRIX Nasal Spray product rights and their remaining useful lives were revalued. The value of the OXAYDO product rights were reduced to $1.3 million and the remaining useful life decreased to 3 years as of January 31, 2019. The SPRIX Nasal Spray product rights were increased to $31.9 million and the remaining useful life increased to 9 years as of January 31, 2019. As a result of the Iroko Products Acquisition, the Company acquired the product rights to the INDOCIN products. The fair value of the INDOCIN product rights was determined to be $90.1 million and the remaining useful life to be 9 years as of January 31, 2019. On January 31, 2019, the Company recognized $58.7 million of goodwill as a result of fresh start accounting adjustments. See Note 3—Fresh Start Accounting for additional details.
The following table reflects estimated amortization of the intangible assets for the five years subsequent to December 31, 2019 is as follows:
The Company recognized amortization expense of $9.2 million related to the INDOCIN product rights intangible asset during the Successor period February 1, 2019 through December 31, 2019.
The Company recognized amortization expense related to the OXAYDO product right intangible asset of $0.4 million during the Successor period February 1, 2019 through December 31, 2019. The Company recognized amortization expense related to the OXAYDO product right intangible asset of $0.1 million and $1.1 million during the Predecessor periods January 1, 2019 through January 31, 2019 and year ended December 31, 2018, respectively. The Company recognized amortization expense related to the SPRIX Nasal Spray product rights intangible asset of $3.2 million during the Successor period February 1, 2019 through December 31, 2019 The Company recognized amortization expense related to the SPRIX Nasal Spray product rights intangible asset of $0.1 million and $1.0 million during the Predecessor periods January 1, 2019 through January 31, 2019 and year ended December 31, 2018, respectively. Refer to Note 21—Acquisitions and License and Collaboration agreements for additional details regarding the Company’s intangible assets and related intellectual property. |
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| Accrued Expenses | 10. Accrued Expenses The following table reflects accrued expenses as of December 31, 2019 and 2018:
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| Liabilities Subject to Compromise | 11. Liabilities Subject to Compromise There were no liabilities subject to compromise as of December 31, 2019. As of December 31, 2018, the Company had segregated liabilities and obligations whose treatment and satisfaction were dependent on the outcome of its reorganization under the Chapter 11 Cases and has classified these items as liabilities subject to compromise. Generally, all actions to enforce or otherwise effect repayment of prepetition liabilities of the Debtors, as well as all pending litigation against the Debtors, were stayed while the Company is subject to the Chapter 11 Cases. The ultimate amount and treatment for these types of liabilities will be subject to the claims resolution processes in the Chapter 11 Cases and the terms of the Plan confirmed by the Bankruptcy Court in the Chapter 11 Cases. Liabilities subject to compromise may vary significantly from the stated amounts of claims filed with the Bankruptcy Court. Although prepetition claims are generally stayed, at hearings held on November 1, 2018, the Bankruptcy Court approved the Debtors’ “first day” motions generally designed to stabilize the Debtors’ operations and cover, among other things, human capital obligations, supplier relations, customer relations, business operations, tax matters, cash management, utilities and retention of professionals. The following table reflects liabilities subject to compromise as of December 31, 2018:
In December 2018, the Company made an adequate protection payment of $0.9 million to the holders of the Senior Secured Debt that reduced the outstanding principal balance of the Notes as of December 31, 2018. The payment was made as part of the First Lien Cash Distribution arrangement required by the Plan of Reorganization. On the Effective Date of the Company’s Plan of Reorganization on January 31, 2019, the accrued interest was cancelled, the Convertible Notes were converted to equity and the Senior Secured Debt was converted to newly issued notes, equity and partially repaid in cash. |
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| Debt | 12. Debt Successor Company Debt
The following table reflects the Successor Company’s debt as of December 31, 2019:
13% Senior Secured Notes Indenture Due 2024
On the Effective Date, the Company issued $95.0 million aggregate principal amount of its 13% senior secured notes (the “13% Notes”) and entered into an indenture (the “Indenture”) governing the 13% Notes with the guarantors party thereto (the “Guarantors”) and Wilmington Savings Fund Society, previously held by U.S. Bank National Association, as trustee (the “Trustee”) and collateral agent (the “Collateral Agent”). The 13% Notes were issued in two series: (x) $50.0 million of “Series A-1 Notes”, issued pursuant to the Plan to former holders of First Lien Secured Notes Claims (the “former 13% Notes”) and which was subject to an interest holiday from the Effective Date through November 1, 2019 and (y) $45.0 million of “Series A-2 Notes,” issued to Iroko and certain of its affiliates and which are subject to the rights of set-off and recoupment and related provisions set forth in the Purchase Agreement. On the Effective Date, the Company recorded a discount associated with the interest holiday on the Series A-1 Notes of $4.6 million. The obligations of the Company under the Indenture and the 13% Notes are unconditionally guaranteed on a secured basis by the Guarantors. Interest on the 13% Notes accrues at a rate of 13% per annum and is payable semi-annually in arrears on May 1 and November 1 of each year (each, a “Payment Date”) commencing on May 1, 2019 (subject to the interest holiday referred to above with respect to the Series A-1 Notes). On each Payment Date, the Company will also pay an installment of principal on the 13% Notes in an amount equal to 15% of the aggregate net sales of OXAYDO (oxycodone HCI, USP) tablets for oral use only —CII, SPRIX (ketorolac tromethamine) Nasal Spray, ARYMO ER, Egalet-002, the SOLUMATRIX® products and the INDOCIN products for the two consecutive fiscal quarter period most recently ended, less the amount of interest paid on the 13% Notes on such Payment Date. The 13% Notes are senior secured obligations of the Company and will be equal in right of payment to all existing and future pari passu indebtedness of the Company, will be senior in right of payment to all existing and future subordinated indebtedness of the Company, will have the benefit of a security interest in the 13% Notes collateral and will be junior in lien priority in respect of any collateral that secures any first priority lien obligations incurred from time to time in accordance with the Indenture. The stated maturity date of the 13% Notes is January 31, 2024. Upon the occurrence of a Change of Control, subject to certain conditions, or certain Asset Sales events (each, as defined in the Indenture), holders of the 13% Notes may require the Company to repurchase for cash all or part of their 13% Notes at a repurchase price equal to 101% of the principal amount of the 13% Notes to be repurchased, plus accrued and unpaid interest to the date of repurchase. The Company may redeem the 13% Notes at its option, in whole or in part from time to time, prior to January 31, 2020, at a redemption price equal to 100% of the principal amount of the 13% Notes being redeemed, plus accrued and unpaid interest, if any, through the redemption date, plus a make-whole premium computed using a discount rate equal to the treasury rate in respect of such redemption date plus 1%. The Company may redeem the 13% Notes at its option, in whole or in part from time to time, on or after January 31, 2020, at a redemption price equal to: (i) from and including January 31, 2020 to and including January 30, 2021, 103% of the principal amount of the 13% Notes to be redeemed and (ii) from and including January 31, 2021 and thereafter, 100% of the principal amount of the 13% Notes to be redeemed, in each case, plus accrued and unpaid interest to the redemption date. In addition, prior to January 31, 2020, the Company may redeem, at its option, up to 35% of the aggregate principal amount of the 13% Notes with the proceeds of one or more public or private equity offerings at a redemption price equal to 113.50% of the aggregate principal amount of the 13% Notes to be redeemed, plus accrued and unpaid interest to the date of redemption in accordance with the Indenture; provided that at least 65% of the aggregate principal amount of 13% Notes issued under the Indenture remains outstanding immediately after each such redemption and provided further that each such redemption occurs within 90 days of the date of closing of each such equity offering. No sinking fund is provided for the 13% Notes, which means that the Company is not required to periodically redeem or retire the 13% Notes. Pursuant to the Indenture, the Company and its restricted subsidiaries must also comply with certain affirmative covenants, such as furnishing financial statements to the holders of the 13% Notes, and negative covenants, including limitations on the following: the incurrence of debt; the issuance of preferred and/or disqualified stock; the payment of dividends, the repurchase of shares and under certain conditions making certain other restricted payments; the prepayment, redemption or repurchase of subordinated debt; the merger, amalgamation or consolidation involving the Company; engaging in certain transactions with affiliates; and the making of investments other than those permitted by the Indenture. In addition, commencing December 31, 2019, the Company must maintain a minimum level of consolidated liquidity, based on unrestricted cash on hand and availability under any revolving credit facility, equal to the greater of (1) the quotient of the outstanding principal amount of the Notes divided by 9.5 and (2) $7.5 million. The Indenture governing the 13% Notes contains customary events of default with respect to the 13% Notes (including the Company’s failure to make any payment of principal or interest on the 13% Notes when due and payable or the Company’s failure to comply with the minimum consolidated liquidity covenant described above), and upon certain events of default occurring and continuing, the Trustee by notice to the Company, or the holders of at least 25% in principal amount of the outstanding 13% Notes by notice to the Company and the Trustee, may (subject to the provisions of the Indenture) declare 100% of the principal of and accrued and unpaid interest, if any, on all the 13% Notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, as well as the then-applicable optional redemption premium under the Indenture, will be due and payable immediately. In the case of certain events of bankruptcy, insolvency or reorganization involving the Company or a Restricted Subsidiary (as defined in the Indenture), the Notes will automatically become due and payable. With respect to any event of default due to the Company’s non-compliance with the minimum liquidity covenant, the Company may, within ten business days, cure such default through the issuance of equity securities, subordinated debt securities or certain other capital contributions. Preemptive Rights Agreements On the Effective Date, the Company entered into preemptive rights agreements (the “Preemptive Rights Agreements”) with certain of the holders of the former 13% Notes. The Preemptive Rights Agreements provide for customary preemptive rights in favor of the parties thereto with respect to certain future issuances of debt or equity securities by the Company, subject to certain exceptions, for so long as such party continues to hold at least 2.5% of the outstanding shares of the Company’s common stock. Collateral Agreement On the Effective Date and in connection with its entry into the Indenture, the Company entered into a collateral agreement, dated as of the Effective Date, with the Collateral Agent and the subsidiary parties from time to time party thereto (the “Collateral Agreement”). Pursuant to the terms of the Collateral Agreement, the Notes and the related guarantees are secured by a first priority lien on substantially all of the Company’s and the Guarantors’ assets, in each case, subject to certain prior liens and other exclusions, and a pledge of 65% of the voting equity interests and 100% of the non-voting equity interests of the Company’s foreign subsidiaries (other than Egalet Limited and any Specified IP Subsidiary (as defined in the Indenture), of which 100% of the voting equity interests have been pledged) to the extent and only for so long as the Company determines in good faith that permitting a pledge of 100% of such voting Equity Interests would result in material adverse tax consequences for the Company or any of its subsidiaries, it being understood that, if a percentage less than 100% but greater than 65% of such voting equity interests may be pledged without any such material adverse tax consequences, then such percentage shall be pledged. Royalty Rights Obligation In connection with 13% Notes, the Company entered into royalty rights agreements (the “Royalty Rights”) with each of the holders of the 13% Notes pursuant to which the Company will pay the holders of the 13% Notes an aggregate 1.5% royalty on Net Sales (as defined in the Indenture) from the Effective Date through December 31, 2022. The Royalty Rights were determined to be a freestanding element with respect to the 13% Notes and the Company is accounting for the Royalty Rights obligation relating to future royalties as a debt instrument. The Company has Royalty Rights obligations of $5.2 million as of December 31, 2019, which are classified as current and non-current debt in the Company’s Consolidated Balance Sheets. The accounting for the 13% Notes requires the Company to make certain estimates and assumptions about the future net sales. The estimates of the magnitude and timing of net sales are subject to significant variability due to the extended time period associated with the financing transaction, and are thus subject to significant uncertainty. Therefore, these estimates and assumptions are likely to change, which may result in future adjustments to the portion of the debt that is classified as a current liability, the amortization of debt issuance costs and discount as well as the accretion of the interest expense. Any such adjustments could be material. On the Effective Date, the fair value of the Royalty Rights obligation associated with net product sales was estimated to be approximately $5.7 million using a probability-weighted present value analysis. On the Effective Date, the Royalty Rights obligation was recorded with an offsetting discount recognized on the 13% Notes. On March 20, 2019, (the “Closing Date”), the Company entered into a credit agreement (the “Credit Agreement”) with Cantor Fitzgerald Securities as administrative agent and collateral agent (in such capacities, the “Agent”) and certain funds managed by Highbridge Capital Management, LLC, as lenders (collectively, the “Lenders”), which Credit Agreement consists of a $20.0 million revolving line of credit. The Company drew $5.0 million on the Closing Date and must maintain at least 25% of the commitment amount outstanding at all times. The Company will use the proceeds of the loans under the Credit Agreement for working capital purposes and to pay costs and expenses incurred by the Credit Agreement and related transactions. This arrangement is recognized as a related party transaction as the Lenders are holders of a portion of the Company’s 13% Notes that were issued on January 31, 2019 and are also holders of the Company’s common stock. Advances under the Credit Agreement bear interest at the Company’s option at either the LIBOR Rate (as defined in the Credit Agreement) plus 5.00% or the Base Rate (as defined in the Credit Agreement) plus 4.00%. The Credit Agreement matures on March 20, 2022. The obligations of the Company under the Credit Agreement are unconditionally guaranteed on a senior secured basis by the Company’s wholly-owned subsidiaries, Zyla Life Sciences US Inc. and Egalet Ltd. (collectively, the “Guarantors”). As security for the Company’s obligations under the Credit Agreement, the Company and the Guarantors have granted to the Agent, for the benefit of the Lenders and other secured parties, a first priority lien on substantially all of their tangible and intangible personal property (other than certain specified excluded assets), including proceeds and accounts related to this property and the capital stock of the Guarantors, pursuant to the terms of that certain Collateral Agreement, dated as of the Closing Date (the “Collateral Agreement”), among the Company and the Guarantors in favor of the Agent for the benefit of the Lenders and other secured parties. The Credit Agreement will (i) be equal in right of payment to all existing and future pari passu indebtedness of the Company, (ii) be senior in right of payment to the obligations of the Company pursuant to that certain Indenture, dated as of January 31, 2019 (the “Indenture”), among the Company, the Guarantors and U.S. Bank National Association, as trustee and collateral agent, and (iii) be senior in right of payment to all existing and future subordinated indebtedness of the Company. The Company may terminate the commitments under the Credit Agreement at its option, in whole or in part from time to time, subject to a termination fee equal to (x) 1.0% from the Closing Date through March 20, 2020 and (y) 0.50% from March 20, 2020 through March 20, 2021. Pursuant to the Credit Agreement, the Company and its subsidiaries must also comply with certain customary affirmative covenants, such as furnishing financial statements to the Lenders, and negative covenants, including limitations on the following: incurring debt; issuing preferred and/or disqualified stock; paying dividends, repurchasing shares and, under certain conditions, making certain other restricted payments; prepaying, redeeming or purchasing subordinated debt; conducting a merger or consolidation involving the Company; engaging in certain transactions with affiliates; disposing of assets under certain circumstances; and making certain investments, in each case, other than those permitted by the Credit Agreement. In addition, commencing with the fiscal quarter ending on December 31, 2019, the Company must maintain a minimum level of consolidated liquidity, based on unrestricted cash on hand and availability under any revolving credit facility, equal to the greater of (1) the quotient of the outstanding principal amount of the senior secured notes issued pursuant to the Indenture divided by 9.5 and (2) $7,500,000. As of December 31, 2019 the Company’s minimum level of consolidated liquidity is $10.0 million. The Credit Agreement contains customary events of default (including the Company’s failure to make any payment of principal or interest when due and payable, the failure to comply with the minimum consolidated liquidity covenant or other covenants described above, or upon a Change of Control (as defined in the Credit Agreement)), and, upon such events of default occurring and continuing, the Lenders may accelerate the loans. In the event of certain events of bankruptcy, insolvency or reorganization involving the Company or its subsidiaries, the obligations under the Credit Agreement will automatically become due and payable. With respect to any event of default due to the Company’s non-compliance with the minimum liquidity covenant (described above), the Company may, within ten business days, cure such default through the issuance of equity securities, subordinated debt securities or certain other capital contributions. On the Closing Date and in connection with its entry into of the Credit Agreement, the Company and the Guarantors entered into the Collateral Agreement, which granted a first priority lien on substantially all of the Company’s and the Guarantors’ assets, in each case subject to certain existing liens and other exclusions. Interim Promissory Note On the Effective Date, pursuant to the Purchase Agreement, the Company issued a $4.5 million promissory note to an affiliate of Iroko in respect of certain inventory purchases by Iroko as a part of the Iroko Products Acquisition (the “Interim Promissory Note”). The Interim Promissory Note bears interest at a rate of 8% per annum (payable by way of increasing the principal amount of the Interim Promissory Note on each interest payment date) and matures on July 31, 2020. The following table reflects unamortized discounts and deferred financing fees on Successor Company debt as of December 31, 2019:
Future Payments The following table reflects the Company’s estimated future principal payments as of December 31, 2019, and excludes payments to be made under the Royalty Rights Obligation, which are included in the carrying value of the Company’s current and non-current debt on the Company’s Consolidated Balance Sheet as of December 31, 2019:
Predecessor Company Debt Former 13% Senior Secured Notes In August 2016 and January 2017, the Company issued a total of $80.0 million aggregate principal amount of the 13% Notes (the “former 13% Notes”). The former 13% Notes were sold only to qualified institutional buyers within the meaning of Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The former 13% Notes were senior secured obligations of the Company and equal in right of payment to all existing and future pari passu indebtedness of the Company (including the 5.50% Notes), were senior in right of payment to all existing and future subordinated indebtedness of the Company, had the benefit of a security interest in the Notes collateral and are junior in lien priority in respect of any collateral that secures any first priority lien obligations incurred, which includes intellectual property, from time to time in accordance with the indenture governing the former 13% Notes. On the Effective Date, in addition to the cash settlement of $20.0 million, the outstanding 13% Notes were converted into the number of shares of common stock of the Company (or Warrants) representing, in the aggregate, 19.4% of the shares outstanding as of the Effective Date and the issuance of the Series A-1 Notes of $50.0 million. As of December 31, 2018, a total of $80.0 million in principal amount of the former 13% Notes remained outstanding. Refer to Note 3 – Fresh Start Accounting for further details. Former 5.50% Convertible Senior Notes In April and May 2015, the Company issued through a private placement $61.0 million in aggregate principal amount of the 5.50% Convertible Senior Notes (the “5.50% Notes”). The 5.50% Notes were general, unsecured and unsubordinated obligations of the Company and ranked senior in right of payment to all of the Company’s indebtedness that was expressly subordinated in right of payment to the 5.50% Notes. The 5.50% Notes were effectively subordinated to any secured indebtedness of the Company to the extent of the value of the assets securing such indebtedness. On the Effective Date, the outstanding 5.50% Notes were cancelled and the 5.50% noteholders received shares of common stock of the Successor Company (or warrants) representing, in the aggregate, 16.1 % of the shares of common stock outstanding as of the Effective Date. As of December 31, 2019, the 5.50% Notes were no longer outstanding. As of December 31, 2018, a total of $24.7 million in principal amount of the 5.50% Notes remained outstanding. Refer to Note 3 – Fresh Start Accounting for further details. Former 6.50% Convertible Notes In December 2017, the Company entered into exchange agreements (the “Exchange Agreements”) with certain holders (the “Holders”) of the Company’s 5.50% Notes pursuant to which the Holders agreed to exchange, in the aggregate, approximately $36.4 million of outstanding principal amount of the 5.50% Notes for, in the aggregate, (i) approximately $23.9 million of 6.50% Convertible Senior Notes due 2024 (the “6.50% Notes”) issued by the Company, (ii) a warrant exercisable for 3,500,000 shares of the Company’s common stock at an exercise price of $0.01 per share and (iii) payments, in cash, of all accrued but unpaid interest as of the closing on the 5.50% Notes exchanged in the transaction (the “Exchange”). At the closing of the Exchange, 2,500,000 warrants were exercised. The remaining 1,000,000 warrants were exercised in January 2018. On the Effective Date, the outstanding 6.50% Notes were cancelled, and the 6.50% noteholders received shares of common stock of the Successor Company (or warrants) representing, in the aggregate, 15.5% of the shares of common stock outstanding as of the Effective Date. As of December 31, 2019, the 6.50% Notes were no longer outstanding. As of December 31, 2018, a total of $23.9 million in principal amount of the 6.50% Notes remained outstanding. Refer to Note 3 – Fresh Start Accounting for further details. |
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| Leases | 13. Leases The Company leases office space, vehicles and office equipment under operating lease arrangements. The leases have initial lease terms ranging from one to five years. Certain of the Company’s leases contain renewal options to extend the lease, which if the Company determined it is reasonably certain to exercise, that renewal option would be included in the total lease term. The Company accounts for its leases in accordance with ASC 842. The Company determines if an arrangement is a lease at contract inception. A lease exists when a contract conveys to the Company the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) the Company has the right to control the use of the identified asset and to obtain substantially all of the economic benefits from using the underlying asset. Right-of-use assets represent the Company’s right to control the use of an explicitly or implicitly identified fixed asset for a period of time and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating leases where the Company is the lessee are included in ROU assets, Other current liabilities and Other long-term liabilities on the Company’s December 31, 2019 Consolidated Balance Sheet. The lease liabilities are measured at the present value of the unpaid lease payments at the lease commencement date. Key estimates and judgments include how the Company determined the incremental borrowing rate (“IBR”) it uses to present value the unpaid lease payments, the lease term and lease payments. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its IBR. The Company’s leases do not provide an implicit rate, therefore, management uses its IBR based on the information available at commencement date in determining the present value of lease payments. The lease term for all of the Company’s leases includes the noncancelable period of the lease. Lease payments included in the measurement of the lease asset or liabilities comprised of fixed payments. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company recognizes lease expense associated with its short-term leases as an expense on a straight-line basis over the lease term. Variable lease payments are presented in the Company’s Consolidated Statements of Operations in the same line item as expense arising from fixed lease payments for operating leases. The following table reflects the components of lease expense as of the periods indicated:
The following table reflects supplemental balance sheet information related to leases as of December 31, 2019:
The following table reflects supplement lease term and discount rate information related to leases as of December 31, 2019:
The following table reflects supplemental cash flow information related to leases as of the periods indicated:
The following table reflects future minimum lease payments under noncancelable leases as of December 31, 2019:
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Stock-Based Compensation |
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| Stock-Based Compensation | 14. Stock-Based Compensation Expense Predecessor On the Effective Date of the Company’s Plan of Reorganization (January 31, 2019) all of its outstanding equity interests and, accordingly, the 2013 Stock-Based Incentive Compensation Plan, the 2017 Inducement Plan and the Employee Stock Purchase Plan were terminated in accordance with the terms of the Reorganization Plan. Refer to Note 3—Fresh Start Accounting for additional details. The Predecessor Company had granted stock-based awards that were cancelled upon emergence from bankruptcy. In conjunction with the cancellation, the Predecessor Company accelerated the unrecognized stock-based compensation expense and recorded $4.1 million of compensation expense in the period from January 1, 2019 to January 31, 2019. Successor 2019 Stock-Based Incentive Compensation Plan In March 2019, the Company adopted its 2019 Stock-Based Incentive Compensation Plan (the “2019 Stock Plan”) for the benefit of employees, non-employee directors and consultants of the Company and its subsidiaries and affiliates. The 2019 Stock Plan is designed to attract and retain valued employees, consultants and non-employee directors by offering them a greater stake in the Company’s success and a closer identity with it, and to encourage ownership of the Company’s stock. Under the 2019 Stock Plan, 2,150,000 shares of the Company’s common stock are reserved for issuance, including 1,433,333 shares reserved for grants to executives and 716,667 shares reserved for persons other than executives, subject to equitable adjustment based on the effect of certain corporate transactions. The 2019 Stock Plan is administered by the Compensation Committee of the Company’s Board of Directors (the “Compensation Committee”). In the discretion of the Compensation Committee, the right of a 2019 Stock Plan participant to exercise or receive a grant or settlement of any award, and the timing thereof, may be subject to performance goals as may be specified by the Compensation Committee. Awards granted to executives that are forfeited or otherwise terminate will once again be available for issuance to executives under the 2019 Stock Plan. Similarly, awards granted to persons other than executives that are forfeited or otherwise terminate will once again be available for issuance to persons who are not executives under the 2019 Stock Plan. Any award granted under the 2019 Stock Plan, including a common stock award, will be subject to mandatory repayment by the participant to the Company pursuant to the terms of any “clawback” or recoupment policy that is directly applicable to the 2019 Stock Plan and set forth in an award agreement or as required by applicable law.
For restricted stock awards and restricted stock units that vest subject to the satisfaction of service requirements, stock-based compensation expense is measured based on the fair value of the award on the date of grant and is recognized as expense on a straight-line basis over the requisite service period. All of the restricted stock awards and restricted stock units reflected below vest based on performance conditions or over time as stipulated in the individual award agreements. In the event of a change in control, the unvested awards will be accelerated and fully vested immediately prior to the change in control. The following table reflects the Company’s shares that are reserved under its 2019 Stock Plan of December 31, 2019:
The estimated grant-date fair value of the Company’s stock-based awards is amortized ratably over the award’s service periods. The following table reflects stock-based compensation expense recognized for the periods indicated:
Stock Option Grants The following table reflects stock option activity under the 2019 Stock Plan during the Successor period ended December 31, 2019:
The intrinsic value of the Company’s 534,500 stock options outstanding as of December 31, 2019 was $0.1 million based on a per share price of $2.50, the Company’s closing stock price on that date, and a weighted-average exercise price of $2.69 per share. The Company uses the Black-Scholes valuation model in determining the fair value of equity awards. For stock options granted to employees with only service-based vesting conditions, the Company measures stock-based compensation expense on the grant date based on the estimated fair value of the award and recognizes the expense over the requisite service period on a straight-line basis. The Company records the expense of services rendered by non-employees based on the estimated fair value of the stock option as of the respective vesting date. Further, the Company expenses the fair value of non-employee stock options that contain only service-based vesting conditions over the requisite service period of the underlying stock options. The weighted-average grant date fair value of the options granted to employees during the Successor period ended December 31, 2019 was estimated at $1.88 per share on the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions:
The weighted-average valuation assumptions were determined as follows:
As of December 31, 2019, there was $0.8 million of total unrecognized compensation expense, related to unvested options granted under the Plan, which will be recognized over the weighted-average remaining period of 2.4 years. Restricted Stock Awards
Time-Based Restricted Stock Unit Award Agreement
Time-based restricted stock units granted under the 2019 Stock Plan are awarded pursuant to a time-based restricted stock unit agreement with the Company. On March 26, 2019, the Compensation Committee approved a form of time-based Restricted Stock Unit Award Agreement (the “Time RSU Agreement”). The Time RSU Agreement provides for grants of restricted stock units (“RSUs”), with two potential vesting schedules: (i) 1/3 of the RSUs vesting on each of the first three anniversaries of the date of grant; and (ii) 100% of the RSUs vesting on the first anniversary of the date of grant, in each case subject to the participant’s continued employment with the Company through each such anniversary date. In the event of a change of control (as defined in the 2019 Stock Plan) prior to a termination of the participant’s service, any remaining unvested time-based RSUs will vest and be settled immediately prior to the change of control.
Performance-Based Restricted Stock Unit Award Agreement
Performance-based RSUs granted under the 2019 Stock Plan are awarded pursuant to a performance-based restricted stock unit agreement with the Company. On March 26, 2019, the Compensation Committee approved a form of performance-based Restricted Stock Unit Award Agreement (the “Performance RSU Agreement”). The Performance RSU Agreement provides for grants of RSUs, which only vest if the Company achieves at least 75% of its 2019 Corporate Goals, as set by the Company’s Board of Directors in March 2019, with the exact number of performance-based RSUs vesting pro-rated based on the level of achievement between 75% and 100%. 2019 Corporate Goals include financial performance, business development goals and other corporate metrics. Assuming those parameters are satisfied, the performance-based RSUs have two potential issuance schedules: (i) one with 50% of the performance-based RSUs eligible for issuance on each of March 1, 2020 and March 1, 2021 and (ii) one with 100% of the performance-based RSUs eligible for issuance on March 1, 2020, in each case subject to the participant’s continued employment with the Company through each such anniversary date. In the event of a change of control (as defined in the 2019 Stock Plan) prior to a termination of the participant’s service, any remaining unvested performance-based RSUs will vest and be settled immediately prior to the change of control.
The following table reflects RSU activity under the 2019 Plan for the Successor period ended December 31, 2019:
For stock awards that vest subject to the satisfaction of service requirements, compensation expense is measured based on the fair value of the award on the date of grant and is recognized as expense on a straight-line basis (net of estimated forfeitures) over the requisite service period. In the event of a change in control of the Company, the unvested awards will be accelerated and fully vested immediately prior to the change in control. RSUs that vested during 2019 were the result of acceleration of vesting in accordance with terms upon the separation the Company’s former Chief Executive Officer. As of December 31, 2019, unrecognized stock-based compensation expense related to RSUs under the 2019 Plan was $2.8 million which will be recognized over the weighted-average remaining period of 1.8 years.
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Income Taxes |
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| Income Taxes | 15. Income Taxes The following table reflects the Company’s (loss ) income before income taxes for the period February 1, 2019 through December 31, 2019 (Successor), the period January 1, 2019 through January 31, 2019 (Predecessor) and the year ended December 31, 2018 (Predecessor):
The following table reflects the benefit for income taxes for the periods February 1 through December 31, 2019 (Successor), the period January 1, 2019 through January 31, 2019 (Predecessor) and the year ended December 31, 2018 (Predecessor):
For the years ended December 31, 2019 and 2018, the Company had no interest or penalties accrued related to unrecognized tax benefits. Any interest and penalties relating to unrecognized tax benefits will be recorded as a component of income tax expense. The following table reflects the changes to the Company’s unrecognized tax benefits for the period from February 1, 2019 through December 31, 2019 (Successor), the period from January 1, 2019 through January 31, 2019 (Predecessor) and the year ended December 31, 2018 (Predecessor):
Of the Company’s unrecognized tax benefits, none would affect the Company’s effective tax rate in the period recognized due to the offsetting impact of the valuation allowance recorded against the Company’s net operating losses. The Company does not expect its unrecognized tax benefit liability to change significantly over the next 12 months. The following table reflects the principal components of the Company’s deferred tax assets and liabilities as of December 31, 2019 and 2018:
As of December 31, 2019, the Company had foreign net operating loss (“NOL”) carry forwards of $90.3 million from its operations in Denmark, which are available to reduce future foreign taxable income. The NOL carry forwards are not subject to future expiration and may be carried forward indefinitely. However, if there is a more than a 50% change of stockholders by value or vote at the end of the tax year as compared to the beginning of the tax year, these existing foreign NOLs may not be available to offset certain types of future foreign income (generally, “net financial income”, which includes interest income net of interest expense, dividends, and capital gains and losses). The Company files income tax returns in the U.K., because Egalet Limited (“Egalet UK”) was incorporated in that jurisdiction; however, Egalet UK has no business operations in the U.K. and the Company has no plans to commence operations in that jurisdiction in the foreseeable future. As such, the Company has determined that it will not record U.K. NOLs as a component of their deferred tax inventory, since there is currently no expectation that the NOLs will ever be realized. As of December 31, 2019, the Company had federal net operating loss carryforwards for income tax purposes of approximately $184.2 million. Due to the limitation on NOLs as more fully discussed below, the Company had U.S. federal and state NOLs of $130.3 and $155.0 million, respectively. Upon emergence from bankruptcy, the Company completed an Internal Revenue Code Section 382 (“Section 382”) analysis in order to determine the amount of losses that are currently available for potential offset against future taxable income, if any. It was determined that the utilization of the Company’s NOL and certain carryforwards generated in tax periods up to and including December 2019 were subject to limitations under Section 382 due to ownership changes that occurred at various points from the Company’s original organization through January 2019. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of stockholders that own, directly or indirectly, 5% or more of a corporation’s stock, in the stock of a corporation by more than 50 percentage points over a testing period (usually 3 years). The Company continues to track all of its NOLs and carryforwards but has provided a full valuation allowance to offset those amounts. These federal and state NOLs will begin to expire in 2033 and through 2037. As a result of the Tax Act, the Federal NOL incurred in 2018 and 2019 will have an indefinite life. ASC 740 – Tax Provisions requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance against its net deferred tax assets at December 31, 2019 and 2018, respectively, because the Company has determined that is it more likely than not that these assets will not be fully realized. The Company experienced a net change in valuation allowance of $13.4 million and $19.4 million, which includes the impact of the Tax Reform for the years ended December 31, 2019 and 2018, respectively. At December 31, 2019, no provision has been made for U.S. federal and state income taxes of foreign earnings due to the history of foreign losses and the Company does not expect to incur any future United States federal and state income tax with respect to its foreign companies. The Company files income tax returns in Denmark, the U.K., the United States, and in various U.S. states. The foreign tax returns are subject to tax examinations for the tax years ended July 31, 2013 through December 31, 2019. The domestic tax returns are subject to tax examinations for the tax years ended December 31, 2016 through December 31, 2019. However, to the extent the Company utilizes in the future any tax attribute NOL carry forwards from a tax period that may otherwise be closed to examination, the Internal Revenue Service, state tax authorities, or other governing parties may still adjust the NOL upon their examination of the future period in which the attribute was utilized.
The following table reflects a reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the financial statements for the period February 1, 2019 through December 31, 2019 (Successor), the period January 1, 2019 through January 31, 2019 (Predecessor) and the year ended December 31, 2018 (Predecessor):
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Employee Benefit Plans |
12 Months Ended |
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Dec. 31, 2019 | |
| Employee Benefit Plans | |
| Employee Benefit Plans | 16. Employee Benefit Plans The Company's 401(k) Employee Savings Plan (the "401(k) Plan") is available to all U.S. employees meeting certain eligibility criteria. As the Company has elected a Safe-Harbor provision for the 401(k) Plan, participants are always fully vested in their employer contributions. The Company matches 100% of the first 3% of participating employee contributions and 50% of the next 2% of participating employee contributions. The Company contributed approximately $0.6 million, $38,000, and $0.6 million to the 401(k) Plan in the period February 1, 2019 through December 31, 2019 (Successor), the period January 1, 2019 through January 31, 2019 (Predecessor) and the year ended December 31, 2018 (Predecessor), respectively. The Company's contributions are made in cash. The Company's common stock is not an investment option available to participants in the 401(k) Plan. For its employees based in Denmark, the Company subscribes to a state plan for which the expense for the financial year is equal to the contributions called by, and thus payable to, such plan. Under Denmark’s state plan, contributions paid by the Company are in full discharge of the Company’s liability and are recognized as an expense for the period. For the period February 1, 2019 through December 31, 2019 (Successor), the period January 1, 2019 through January 31, 2019 (Predecessor) and the year ended December 31, 2018 (Predecessor) the Company recorded $24,000, $7,000 and $0.1 million respectively, for contributions under its state plan for Denmark employees. |
Restructuring and Other Charges |
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| Restructuring and Other Charges | 17. Restructuring and Other Charges The following table reflects a summary of the Company’s restructuring and other charges for the periods indicated:
Restructuring and other charges for the Successor period February 1, 2019 through December 31, 2019 reflect severance costs related to the reduction of executive officers. Restructuring and other charges for the Predecessor period January 1, 2019 through January 31, 2019 primarily reflect severance costs related to the closure of the Denmark facility. Restructuring and other charges for the year ended December 31, 2018 reflect the write-down of assets related to the discontinuation of ARYMO ER, a termination payment to Halo Pharmaceuticals also related to the discontinuance of ARYMO ER and legal and professional fees relating to, but incurred prior to the bankruptcy filing. |
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Reorganization items |
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| Reorganization items | 18. Reorganization items The following table reflects reorganization items for the periods indicated. See Note 3—Fresh Start Accounting for further details.
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Commitments and Contingencies |
12 Months Ended |
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Dec. 31, 2019 | |
| Commitments and Contingencies | |
| Commitments and Contingencies | 19. Commitments and Contingencies Legal Proceedings On January 27, 2017 and February 10, 2017, respectively, two putative securities class actions were filed in the U.S. District Court for the Eastern District of Pennsylvania that named as defendants Egalet Corporation and former officers Robert S. Radie, Stanley J. Musial and Jeffrey M. Dayno (the “Officer Defendants” and together with Egalet Corporation, the “Defendants”). These two complaints, captioned Mineff v. Egalet Corp. et al., No. 2:17-cv-00390-MMB and Klein v. Egalet Corp. et al., No. 2:17-cv-00617-MMB, assert securities fraud claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) on behalf of putative classes of persons who purchased or otherwise acquired Egalet Corporation securities between December 15, 2015 and January 9, 2017 and seek damages, interest, attorneys’ fees and other expenses. On May 1, 2017, the Court entered an order consolidating the two cases (the “Securities Class Action Litigation”) before it, appointing the Egalet Investor Group (consisting of Joseph Spizzirri, Abdul Rahiman and Kyle Kobold) as lead plaintiff and approving their selection of lead and liaison counsel. On July 3, 2017, the plaintiffs filed their consolidated amended complaint, which named the same Defendants and also asserted claims for purported violations of Sections 10(b) and 20(a) of the Exchange Act. Plaintiffs brought their claims individually and on behalf of a putative class of all persons who purchased or otherwise acquired shares of Egalet between November 4, 2015 and January 9, 2017 inclusive. The consolidated amended complaint based its claims on allegedly false and/or misleading statements and/or failures to disclose information about the likelihood that ARYMO ER would be approved for intranasal abuse-deterrent labeling. The Defendants moved to dismiss the consolidated amended complaint on September 1, 2017 (the “Motion to Dismiss”), the plaintiffs filed their opposition on October 31, 2017, and the Defendants filed their reply on December 8, 2017. The Court heard oral arguments on the Motion to Dismiss on February 20, 2018 and entered an order pursuant to which the plaintiffs filed a motion for leave to file a second amended complaint on March 6, 2018. The Defendants responded on March 20, 2018 and the plaintiffs filed their reply on March 27, 2018. The Court heard oral arguments on the plaintiffs’ motion for leave to file a second amended complaint on July 12, 2018. On August 2, 2018, the Court granted the Defendants’ Motion to Dismiss and dismissed the Securities Class Action Litigation with prejudice. On August 31, 2018, plaintiffs filed their notice of appeal with the United States Court of Appeal for the Third Circuit. On November 7, 2018, the Defendants filed a notice of suggestion of bankruptcy and unopposed motion to stay the appeal as to the Officer Defendants (the appeal was automatically stayed as to the Company upon the Chapter 11 filing). On February 6, 2019, the Officer Defendants filed a Notice of Lifting of Automatic Stay of Proceedings and Discharge of Subordinated Claims, as plaintiffs’ claim against the Company was extinguished as part of the bankruptcy, which restarted the appellate process. On April 22, 2019, plaintiffs filed their brief with the United States Court of Appeals for the Third Circuit. Defendants filed their brief on May 22, 2019 and Plaintiffs filed their reply on June 12, 2019 and the parties are currently awaiting the Court’s decision. The Company disputes the allegations in the lawsuit and intend to defend these actions vigorously. The Company cannot determine the likelihood of, nor can it reasonably estimate the range of, any potential loss, if any, from these lawsuits. In March 2018, Novitium Pharma LLC (“Novitium”) notified iCeutica Pty Ltd. and Iroko Pharmaceuticals, LLC that Novitium had submitted an ANDA to FDA requesting permission to manufacture and market a generic version of VIVLODEX® (meloxicam). In the notice, Novitium alleges that its generic product will not infringe any claim of U.S. Patent Nos. 9,526,734; 9,526,734; and 9,649,318. On April 20, 2018, Plaintiffs iCeutica Pty Ltd and Iroko Pharmaceuticals, LLC filed a complaint in the District Court for the District of Delaware alleging infringement of United States Patent Nos. 9,526,734, 9,649,318, and 9,808,468 by Novitium under 35 U.S.C. sections 271(e)(2) and 271(a)-(c). With the Company’s acquisition of certain assets of Iroko and the assignment of Iroko’s exclusive license to U.S. Patent Nos. 9,526,734; 9,526,734; and 9,649,318 to the Company, Egalet was substituted for Iroko as a Plaintiff in this matter. The parties settled the lawsuit, with no cash payment required by the Company, and Plaintiffs filed a motion to dismiss the case. The Court dismissed the suit on January 22, 2020.
On May 1, 2019, the Company was served in a lawsuit entitled International Brotherhood of Electrical Workers Local 728 Family Healthcare Plan v. Allergan, PLC, et al., which was filed in the Philadelphia County Court of Common Pleas (and subsequently coordinated with similar cases and transferred to the Delaware County Court of Common Pleas) on March 29, 2019 in which the Company was named as a defendant. In the lawsuit, plaintiff alleges that the Company, along with numerous other named defendants, manufactured, promoted, sold and distributed branded and generic opioid pharmaceutical products in the Commonwealth of Pennsylvania, State of Florida and the City of Philadelphia. Plaintiffs assert that the defendants’ conduct has exacted a financial burden on the plaintiff which has unnecessarily spent considerably more on costs directly attributable to opioid use and over-use in the Commonwealth of Pennsylvania and City of Philadelphia. On December 18, 2019, Plaintiffs filed a Stipulation of Dismissal, which has not yet been signed by the judge and ordered by the Court as the matter is currently stayed. The Company cannot determine the likelihood of, nor can it reasonably estimate the range of, any potential loss, if any, from this lawsuit.
On August 7, 2019, the Company filed a lawsuit in the Court of Chancery of the State of Delaware against iCeutica Inc. and iCeutica Pty Ltd. (together, the “Defendants”) seeking, among other things, declaratory and injunctive relief relating to the Defendants’ demand under the iCeutica License Agreement described below, for reimbursement for patent activities in countries outside the United States which the Company has expressly told the Defendants are unreasonable in light of the Company’s current plans. The Company asked the Court to prohibit the Defendants from terminating the license agreement and to toll the cure period under the License Agreement pending resolution of the dispute. On August 30, 2019, the Court granted a Status Quo Order that extended the cure period until 30 days after the date of the Court’s decision on the merits in the case. On January 27, 2020, the parties entered into a settlement that provided for, among other things, (i) the dismissal of the lawsuit with prejudice, (ii) the reimbursement by the Company of certain costs incurred by Defendants during 2019 to prepare, prosecute and maintain certain patent applications and patents; (iii) the entry by the parties into a Second Amended and Restated Nano-Reformulated Compound License Agreement; and (iv) the entry into mutual releases related to the subject matter of the lawsuit. On January 28, 2020, the suit was dismissed with prejudice.
Cosette Pharmaceuticals Supply Agreement On January 31, 2019, as part of Asset Purchase Agreement to acquire products from Iroko, the Company assumed a Collaborative License, Exclusive Manufacture and Global Supply Agreement with Cosette Pharmaceuticals, Inc. (formerly G&W Laboratories, Inc.) (the “Supply Agreement”) for the manufacture and supply of INDOCIN Suppositories to Zyla for commercial distribution in the United States. The Company is obligated to purchase all of its requirements for INDOCIN Suppositories from Cosette Pharmaceuticals, Inc., and are required to meet minimum purchase requirements for the calendar years 2019 and 2020. The term of the Supply Agreement extends through July 31, 2023, and there are no minimum requirements in any of the other subsequent years. Total commitments to Cosette Pharmaceuticals, Inc are $6.5 million in 2020. Catalent Pharma Solutions Commercial Supply Agreement On January 31, 2019, as part of the Iroko Products Purchase Agreement, the Company assumed a Commercial Supply Agreement (“CSA”) with Catalent Pharma Solutions (“Catalent”) for the manufacture of certain SOLUMATRIX products. Based on the CSA, the Company is obligated to purchase certain minimum amounts of manufacturing and product maintenance services on an annual basis for the term of the contract (“Minimum Requirement”) through September 2021. Total commitments to Catalent are $1.0 million through the period ending September 2021. Jubilant HollisterStier Manufacturing and Supply Agreement On July 30, 2019, the Company entered into a Manufacturing and Supply Agreement (the “Agreement”) with Jubilant HollisterStier LLC (“JHS”) pursuant to which the Company engaged JHS to provide certain services related to the manufacture and supply of SPRIX® (ketorolac tromethamine) Nasal Spray for the Company’s commercial use. Under the Agreement, JHS will be responsible for supplying a minimum of 75% of the Company’s annual requirements of SPRIX through July 30, 2022. The Company has agreed to purchase a minimum number of batches of SPRIX per calendar year from JHS over the term of the Agreement. Total commitments to JHS are $3.6 million through the period ending July 30, 2022. |
Net Loss (Income) Per Common Share |
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| Net Loss (Income) Per Common Share | 20. Net Loss (Income) Per Common Share On the Effective Date the Predecessor Company's equity was cancelled and new equity was issued. Additionally, the Predecessor Company's 5.50% and 6.50% Convertible Notes were cancelled. See Note 22 – Stockholders' Deficit and Note 18 – Reorganization Items for further details. Basic net loss per common share excludes dilution for potential common stock issuances and is computed by dividing net loss by the weighted-average number of shares of common stock outstanding for the period. The 4,972,364 shares of common stock issuable upon the exercise of warrants are included in the number of outstanding shares used for the computation of basic and diluted loss per share. See Note 22 – Stockholders’ Deficit. The following table reflects the computation of basic and diluted weighted average shares outstanding and net income (loss) per share for the periods indicated:
The calculation for diluted net loss per share is identical to that used for basic loss per share. The exercise of common stock options would have the effect of reducing the loss per share and are excluded since not dilutive.
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Acquisitions and License and Collaboration Agreements |
12 Months Ended |
|---|---|
Dec. 31, 2019 | |
| Acquisitions and License and Collaboration Agreements | |
| Acquisitions and License and Collaboration Agreements | 21. Acquisitions and License and Collaboration Agreements Purchase Agreement with Iroko On October 30, 2018, the Company entered into the Purchase Agreement with Iroko pursuant to which, upon the terms and subject to the conditions set forth therein, the Company acquired certain assets and rights of Iroko, referred to in the Purchase Agreement as the “Transferred Assets,” and assumed certain liabilities of Iroko, referred to in the Purchase Agreement as the “Assumed Liabilities,” including assets related to Iroko’s marketed products, the SOLUMATRIX products under the iCeutica License Agreement and the INDOCIN products. The Iroko Products Acquisition was completed on January 31, 2019. iCeutica License Agreement Pursuant to the Purchase Agreement, on the Effective Date, the Company assumed the rights and obligations of Iroko and its subsidiaries pursuant to the Amended and Restated Nano-Reformulated Compound License Agreement, dated October 30, 2018 (the “iCeutica License”), with iCeutica Inc. and iCeutica Pty Ltd. (collectively, “iCeutica”) to license certain technology and intellectual property related to iCeutica’s SOLUMATRIX® technology, meloxicam and certain other rights of iCeutica. Pursuant to the iCeutica License, iCeutica granted to the Company (as the assignee of Iroko) a sole and exclusive, world-wide right and license under certain iCeutica intellectual property to make, use, sell, offer and import certain products made from the compounds indomethacin, diclofenac, naproxen and meloxicam. In consideration of the grant of the iCeutica License, the Company is obligated to pay to iCeutica a mid-single digit royalty on all Net Sales of any licensed products, including pro rata portions of any combination products that include a licensed product. The iCeutica License will terminate on a country-by-country basis upon the expiration of the last-to-expire of any licensed patent rights in such country, and otherwise twenty years after the date of the first commercial introduction of a licensed product in such country. Either party may terminate the license in its entirety if the other party materially breaches the License Agreement, subject to applicable cure periods. The iCeutica License also contains customary provisions for an agreement of this type related to intellectual property matters, confidentiality, representations and warranties and indemnification. Iroko Royalty Arrangement Pursuant to the Purchase Agreement, on the Effective Date, the Company was also obligated to pay to Iroko a 5% royalty payment on Net Sales of TIVORBEX, ZORVOLEX and the development product acquired. In May 2019, the Company agreed to pay approximately $0.8 million to satisfy the royalty payment terminating any obligation for future payments with respect to this agreement.
Collaboration and License Agreement with Acura
In January 2015, the Company entered into the OXAYDO License Agreement with Acura Pharmaceuticals, Inc. (“Acura”) to commercialize OXAYDO tablets containing Acura’s Aversion Technology. OXAYDO (formerly known as Oxecta®) is currently approved by the FDA for marketing in the United States in 5 mg and 7.5 mg strengths, but was not actively marketed at the time of the OXAYDO License Agreement Under the terms of the OXAYDO License Agreement, Acura transferred the approved New Drug Application(“NDA”) for OXAYDO to the Company and the Company was granted an exclusive license under Acura’s intellectual property rights for development and commercialization of OXAYDO worldwide in all strengths.
Under the OXAYDO License Agreement, Acura will be entitled to a one-time $12.5 million milestone payment when OXAYDO net sales reach a level of $150.0 million in a calendar year.
In addition, Acura receives from the Company, a tiered royalty percentage based on sales thresholds. Based on the Company’s current level of net sales, the royalty percentage payable to Acura is in the mid-single digits; however, the percentage may increase in future years in the event the Company achieves the higher sales thresholds set forth in the License Agreement. In addition, in any calendar year in which net sales exceed a specific threshold, Acura is entitled to receive a double-digit royalty on all OXAYDO net sales in that year. The Company’s royalty payment obligations commenced on the first commercial sale of OXAYDO and expire, on a country-by-country basis, upon the expiration of the last to expire valid patent claim covering OXAYDO in such country (or if there are no patent claims in such country, then upon the expiration of the last valid claim in the United States). Royalties will be reduced upon the entry of generic equivalents, as well for payments required to be made by the Company to acquire intellectual property rights to commercialize OXAYDO, with an aggregate minimum floor. The term of the Acura license agreement expires, in its entirety, upon the final expiration of any such patent claim in any country. OXAYDO is currently sold in the United States and is covered by six U.S. patents that expire between 2023 and 2025. Patents covering OXAYDO in foreign jurisdictions expire in 2024. Either the Company or Acura may terminate the license agreement for certain customary reasons, including cause, insolvency or patent challenge. The Company may terminate the license agreement upon 90 days prior written notice.
Purchase Agreement with Luitpold
In January 2015, the Company entered into and consummated the transactions contemplated by the SPRIX Purchase Agreement with Luitpold (the “SPRIX Purchase Agreement”), pursuant to which the Company acquired certain assets and liabilities associated with SPRIX Nasal Spray and the Company was assigned an exclusive license with Recordati Ireland Ltd. (“Recordati”) for intranasal formulations of ketorolac tromethamine (the “Licensed Product”), the active ingredient in SPRIX Nasal Spray. The Company is required to pay a fixed, single-digit royalty to Recordati on net sales of the Licensed Product. The exclusive term of the license agreement expires, on a country-by-country basis, on the later of the final expiration of any patent right in such country that contains a valid claim covering the Licensed Product, or ten years from the date of the first commercial sale of the Licensed Product in such country, and thereafter the Company will retain a non-exclusive, perpetual license in such country. In addition, during the exclusivity period with respect to the United States, Canada and Latin America, the royalty payable to Recordati is decreased if no patent containing a valid claim is in force in the country at the time of sale. SPRIX Nasal Spray is currently sold in the United States and the patent expired in December 2018 and the first commercial sale of SPRIX Nasal Spray in the United States occurred in May 2011.
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Stockholders' Deficit |
12 Months Ended |
|---|---|
Dec. 31, 2019 | |
| Stockholders' Deficit | |
| Stockholders’ Deficit | 22. Stockholders’ Deficit Successor Preferred Stock The Successor Company’s certificate of incorporation authorizes it to issue up to 5,000,000 shares of preferred stock with a par value of $0.001 per share. As of December 31, 2019, there were no preferred shares outstanding. Common Stock The Successor Company’s certificate of incorporation authorizes it to issue up to 100,000,000 shares of common stock with a par value of $0.001 per share. As of December 31, 2019, there were 9,437,883 shares issued and outstanding. Outstanding shares were issued to holders of Predecessor first lien obligations and convertible notes claims of 4,774,093 shares, to Iroko and its affiliates of 4,586,875 shares and 76,915 shares through the Company’s 2019 Plan. Amended and Restated Charter and Bylaws On February 1, 2019, in accordance with the Plan, the Company’s Fourth Amended and Restated Certificate of Incorporation (as amended and restated, the “A&R Charter”) was filed with the Secretary of State of the State of Delaware, at which time the A&R Charter became effective. Among other things, the A&R Charter decreases the number of shares of authorized common stock of the Company from 275,000,000 to 100,000,000 and decreases the maximum number of directors that may serve on the Company’s Board of Directors to seven. On the Effective Date, pursuant to the Plan, the Company’s Second Amended and Restated Bylaws (the “A&R Bylaws”) became effective. Among other things, the A&R Bylaws provide for special director nomination procedures, related party transaction approval procedures and independence requirements with respect to certain directors appointed by the Supporting Noteholders pursuant to the Plan (or such directors successors), in each case, for a two-year period following the Effective Date. Effective June 3, 2019, the Company changed its name to Zyla Life Sciences by filing an amendment to the A&R Charter. A copy of the amendment to the Charter is filed as Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q filed on August 13, 2019. In addition, the A&R Bylaws were amended to reflect the name change to Zyla Life Sciences and to expressly permit communications between and among stockholders and directors of the Company by means of electronic transmissions. Stockholders’ Agreement On the Effective Date, the Company entered into a stockholders’ agreement (the “Stockholders’ Agreement”) with Iroko and certain of its affiliates. Pursuant to the Stockholders’ Agreement, Iroko and the other stockholder parties agreed to a customary lock-up with respect to their shares of common stock for a period of 90 days following the Effective Date and a customary standstill provision for a period of 24 months following the Effective Date, in each case, subject to certain exceptions. In addition, pursuant to the Stockholders’ Agreement, the stockholder parties are entitled to designate two nominees to the Company’s Board of Directors for so long as such entities hold at least 25% of the equity consideration received on the Effective Date. The Stockholders’ Agreement also provides for customary preemptive rights in favor of the stockholder parties with respect to future issuance of equity securities by the Company, subject to certain exceptions. Warrant Agreements On the Effective Date, the Company entered into warrant agreements (the “Warrant Agreements”) with Iroko, certain of Iroko’s affiliates and certain other parties entitled to receive shares of the Company’s common stock as consideration pursuant to the Purchase Agreement or in satisfaction of certain claims pursuant to the Plan. Pursuant to the Warrant Agreements, the Company issued warrants to purchase up to an aggregate of 4,972,365 shares of the Company’s common stock. The warrants are exercisable at any time at an exercise price of $0.001 per share, subject to certain ownership limitations including, with respect to Iroko and its affiliates, that no such exercise may increase the aggregate ownership of the Company’s outstanding common stock of such parties above 49% of the number of shares of its common stock then outstanding for a period of 18 months. All of the Company’s outstanding warrants have similar terms whereas under no circumstance may the warrants be net-cash settled. As such, all warrants are equity-classified. Predecessor In connection with the Company’s Plan of Reorganization and emergence from bankruptcy, all equity interests in the Predecessor Company were cancelled, including common stock and equity-based awards. Registration Rights Agreement On the Effective Date, the Company entered into a registration rights agreement (the “Registration Rights Agreement”) with Iroko pursuant to which the Company agreed to file with the SEC, upon Iroko’s request at any time following the date which is 180 days following the date on which any equity securities of the Company are accepted for listing on any national securities exchange, a registration statement on Form S-1 or Form S-3, and thereafter to use its commercially reasonable efforts to cause to be declared effective as promptly as practicable, one or more registration statements for the offer and resale of the Company’s common stock held by Iroko and certain of its affiliates. The Registration Rights Agreement contains other customary terms and conditions, including, without limitation, provisions with respect to blackout periods, underwriter cutbacks, reimbursement of expenses and indemnification. |
Subsequent Events |
12 Months Ended |
|---|---|
Dec. 31, 2019 | |
| Subsequent Events | |
| Subsequent Events | 23. Subsequent Events Subsequent to year-end on March 16, 2020, the Company entered into an Agreement and Plan of Merger (the ”Merger Agreement”) by and among the Company, Assertio Therapeutics, Inc. (“Assertio”), Alligator Zebra Holdings, Inc. (“Parent”), Zebra Merger Sub, Inc., a wholly owned subsidiary of Parent (“Merger Sub”) and Alligator Merger Sub, Inc. The Merger Agreement provides that, upon the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will be merged with and into Zyla, with Zyla continuing as the surviving corporation and a wholly-owned subsidiary of Parent. Pursuant to the terms of the Merger Agreement, at the time the merger is effective, each outstanding share of common stock, par value $0.001 per share, of the Company (the “Common Stock”) (other than Excluded Shares (as defined below) and Dissenting Shares (as defined below)) will be converted into the right to receive 2.5 shares (the “Exchange Ratio”) of common stock, par value $0.0001 per share, of Parent (“Parent Common Stock”). Each share of Common Stock that is held by the Company as treasury stock or that is owned, directly or indirectly, by Parent, the Company, Merger Sub, or any subsidiary of the Company (collectively, “Excluded Shares”), immediately prior to the effective time of the Merger (the “Effective Time”) will cease to be outstanding and will be cancelled and retired and will cease to exist, and no consideration will be delivered in exchange therefor. “Dissenting Shares” are shares of the Common Stock (other than Excluded Shares) outstanding immediately prior to the Effective Time and held by a holder who is entitled to demand and has properly demanded appraisal for such shares of the Common Stock in accordance with Section 262 of the Delaware General Corporation Law. Consummation of the Merger is subject to certain conditions to closing, including, among others, including (1) requisite approvals of the Company’s and Assertio’s stockholders; (2) the absence of certain legal impediments to the consummation of the Merger; (3) the approval of shares of Parent Common Stock to be issued as consideration in the Merger for listing on the Nasdaq Stock Market, (4) effectiveness of the registration statement on Form S-4 registering the shares of Parent Common Stock and other equity instruments to be issued in the Merger, (5) subject to certain exceptions, the accuracy of the representations, warranties and compliance with the covenants of each party to the Merger Agreement, and (6) Assertio, Parent and their respective Subsidiaries having minimum cash and cash equivalents equal to $25 million in the aggregate (as calculated pursuant to the Merger Agreement). The Company is working toward completing the Merger as quickly as possible and currently expects to consummate the merger in the second calendar quarter of 2020. |
Summary of Significant Accounting Policies and Basis of Accounting (Policies) |
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| Summary of Significant Accounting Policies and Basis of Accounting | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Basis of Accounting | Basis of Accounting
The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company’s consolidated financial statements include the accounts of Zyla Life Sciences and its wholly‑owned subsidiaries, Zyla Life Sciences US Inc. and Egalet Limited. All intercompany balances and transactions have been eliminated in consolidation.
Upon emergence from bankruptcy, the Company adopted fresh start accounting in accordance with the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 852, Reorganizations, which resulted in the Company becoming a new entity for financial reporting purposes on February 1, 2019.
References to "Successor" or "Successor Company" relate to the financial position and results of operations of the reorganized Company subsequent to January 31, 2019. References to "Predecessor" or "Predecessor Company" relate to the financial position and results of operations of the Company prior to, and including, January 31, 2019.
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| Use of Estimates | Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires the Company to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances, the results of which form its basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates under different assumptions or conditions. The Company believes the following critical accounting policies reflect the more significant judgements and estimates used in the preparation of its consolidated financial statements. |
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| Segment and Geographic Information | Segment and Geographic Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision‑making group, in deciding how to allocate resources and in assessing performance. The Company globally manages the business within one reportable segment. Segment information is consistent with how management reviews the business, makes investing and resource allocation decisions and assesses operating performance. As of December 31, 2019, long‑lived assets were located in the United States and net revenue from product sales was derived entirely from the United States.
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| Concentrations of Credit Risk and Off-Balance Sheet Risk | Concentrations of Credit Risk and Off‑Balance Sheet Risk
Cash, cash equivalents and accounts receivable are financial instruments which potentially subject the Company to concentrations of credit risk. The Company maintains its cash balances in accounts with financial institutions that management believes are creditworthy. The Company invests cash that is not currently being used for operational purposes in accordance with its investment policy. The policy allows for the purchase of low-risk debt securities issued by U.S. government agencies and very highly rated corporations, subject to certain concentration limits. The Company believes its established guidelines for investment of its excess cash maintain safety and liquidity through its policies on diversification and investment maturity.
The following table reflects the Company’s accounts receivable concentration by customer at December 31, 2019 and 2018:
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| Cash, Restricted Cash and Cash Equivalents | Cash, Restricted Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash balances of $12.2 million and $0.2 million were maintained at financial institutions in the United States and Denmark, respectively, at December 31, 2019. Bank deposits are insured up to approximately $0.3 million and $0.1 million for U.S. and Danish financial institutions, respectively.
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| Marketable Securities, Available-for-Sale | Marketable Securities, Available-for-Sale
Marketable securities consist of securities with original maturities greater than three months and are composed of securities issued by U.S. government agencies and corporate debt securities. Marketable securities have been classified as current assets in the accompanying Consolidated Balance Sheets based upon the nature of the securities and their intended use to fund operations.
Management determines the appropriate classification of securities at the time of purchase. The Company has classified its investment portfolio as available-for-sale in accordance with FASB ASC 320, Investments—Debt and Equity Securities. The Company’s available-for-sale securities are carried at fair value with unrealized gains and losses reported in other comprehensive income (loss). Realized gains and losses are determined using the specific identification method and are included in interest expense. Marketable securities are evaluated periodically for impairment. If it is determined that a decline of any investment is other than temporary, then the carrying amount of the investment is written down to fair value and the write-down is included in the Consolidated Statements of Comprehensive Loss as a loss. |
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| Fair Value Measurements | Fair Value Measurements
The carrying amounts reported in the Company’s consolidated financial statements for cash and cash equivalents, accounts receivable, accounts payable and accrued expenses approximate their respective fair values because of the short-term nature of these accounts. The carrying value of the derivative liabilities are the estimated fair value of the liability as further described in Note 6 – Fair Value Measurements.
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
Fair value should be based on the assumptions that market participants would use when pricing an asset or liability and is based on a fair value hierarchy that prioritizes the information used to develop those assumptions. The fair value hierarchy gives the highest priority to quoted prices in active markets (observable inputs) and the lowest priority to the Company’s assumptions (unobservable inputs). Fair value measurements should be disclosed separately by level within the fair value hierarchy. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with established fair value hierarchy.
Financial assets that the Company measures at fair value on a recurring basis include cash equivalents and marketable securities. These financial assets are generally classified as Level 1 or 2 within the fair value hierarchy. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable, such as quoted prices (adjusted), interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability. The fair value hierarchy level is determined by the lowest level of significant input.
The Company’s financial assets have been initially valued at the transaction price and subsequently valued at the end of each reporting period, typically utilizing third-party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market-based approaches, and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validates the prices provided by its third-party pricing services by reviewing their pricing methods and matrices, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. The Company did not adjust or override any fair value measurements provided by its pricing services as of December 31, 2019 or 2018.
Financial liabilities that the Company measures at fair value on a recurring basis include derivative liabilities consisting of the interest make whole feature of the 5.50% and 6.50% Notes, the conversion feature of the 6.50% Notes and the warrant liability associated with the July 2017 Equity offering. Acquisition related contingent consideration is also measured at fair value. These financial liabilities are classified as Level 3 within the fair value hierarchy. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability. The fair value hierarchy level is determined by the lowest level of significant input.
The Company’s financial liabilities have been initially and subsequently valued at the end of each reporting period, typically utilizing third-party valuation services. The valuation services utilize industry standard valuation models, including both income and market-based approaches and observable market inputs for similar instruments to determine value, if available. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validates the valuations provided by its third-party valuation services by reviewing their pricing valuation and matrices and confirming the relevant markets are active. The change in fair value of the contingent consideration during the period ending December 31, 2019 was primarily due to changes in the net product sales forecast and discount rates as there were no other significant changes in key assumptions. The Company did not adjust or override any fair value measurements provided by its valuation services as of December 31, 2019 and December 31, 2018.
During the years ended December 31, 2019 and 2018, there were no transfers between Level 1, Level 2, or Level 3 financial assets or liabilities. The Company did not have any non-recurring fair value measurements on any assets or liabilities at December 31, 2019 and December 31, 2018. |
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| Stock-Based Compensation | Stock-Based Compensation
The Company uses the Black-Scholes valuation model in determining the fair value of equity awards. For stock options granted to employees and directors with only service-based vesting conditions, the Company measures stock-based compensation cost at the grant date based on the estimated fair value of the award and recognizes it as expense over the requisite service period on a straight-line basis. The Company records the expense of services rendered by non-employees based on the estimated fair value of the stock option as of the respective vesting date. Further, the Company expenses the fair value of non-employee stock options that contain only service-based vesting conditions over the requisite service period of the underlying stock options.
The fair value for restricted stock awards is determined based on the closing market price of the Company’s common stock on the grant date of the awards. The expense is recognized over the requisite service period on a straight-line basis. |
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| Property and Equipment | Property and Equipment
Property and equipment consist primarily of laboratory and manufacturing equipment, furniture, fixtures, and other property, all of which are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight‑line method over the estimated useful lives of the assets. Maintenance and repairs are expensed as incurred. The following estimated useful lives were used to depreciate the Company’s assets:
Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is charged to income. |
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| Goodwill | Goodwill
Goodwill is calculated as the excess of the reorganization equity value over the fair value of tangible and identifiable intangible assets pursuant to ASC 852, Reorganizations. Goodwill is not amortized but is tested for impairment at the reporting unit level at least annually or when a triggering event occurs that could indicate a potential impairment by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that the fair value of net assets are below their carrying amounts. A reporting unit is the same as, or one level below, an operating segment. Our operations are currently comprised of a single, entity wide reporting unit. |
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| Intangible and Long-Lived Assets | Intangible and Long-Lived Assets
Intangible and long-lived assets consist of in‑process research and development (“IP R&D”) and product rights. IP R&D is considered an indefinite‑lived intangible asset and is assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets would be written‑off and the Company would record a non‑cash impairment loss on its Consolidated Statement of Operations. For those product candidates that reach commercialization, the IPR&D asset will be amortized over its estimated useful life.
Long-lived intangible assets acquired as part of the SPRIX Nasal Spray acquisition, OXAYDO license and INDOCIN product rights are being amortized on a straight-line basis over their estimated useful lives of 9 years, 3 years and 9 years, respectively. The Company estimated the useful life of the assets by considering competition by products prescribed for the same indication, the likelihood and estimated future entry of non-generic and generic competition for the same or similar indication and other related factors. The factors that drive the estimate of the life are often uncertain and are reviewed on a periodic basis or when events occur that warrant review.
The Company assesses the recoverability of its long‑lived assets, which include property and equipment and product rights whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset and a charge to operating results. During the year ended December 31, 2018, the Company recorded a charge of $0.1 million to restructuring and other charges to write off the remaining IP R&D intangible asset related to its Guardian Technology due to the Company’s decision to discontinue the manufacturing and promotion of ARYMO ER.
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| Net Product Sales | Net Product Sales
The Company recognizes revenue in accordance with FASB ASC 606, Revenue from Contracts with Customers, at the time it ships its products to its customers (primarily wholesalers and specialty pharmacies).
The Company sells SPRIX Nasal Spray in the United States to a single specialty pharmaceutical distributor. The Company recognizes revenue from sales of SPRIX Nasal Spray upon delivery of the product to its distributor. The Company sells INDOCIN suppositories and oral suspension in the United States through third-party wholesalers, subject to rights of return, with revenue recognized upon delivery of the product to the wholesaler. The Company sells its SOLUMATRIX products in the United States through third-party wholesalers, subject to rights of return, with revenue recognized upon delivery of the product to the wholesaler. The Company sells OXAYDO in the United States to several wholesalers, all subject to rights of return. The Company recognizes revenue of OXAYDO upon delivery of the product to its customers. |
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| Product Sales Allowances | Product Sales Allowances
The Company recognizes product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of the Company’s agreements with customers and third-party payors that may result in future rebates or discounts taken. In certain cases, such as patient discount programs, the Company recognizes the cost of patient discounts as a reduction of revenue based on estimated utilization. If actual future results vary, the Company may need to adjust these estimates, which could have an effect on product revenue in the period of adjustment. The Company’s product sales allowances include:
Specialty Pharmacy Fees. The Company offers a discount to a certain specialty pharmaceutical distributor based on a contractually determined rate. The Company records the fees on shipment to the distributor and recognizes the fees as a reduction of revenue in the same period the related revenue is recognized.
Wholesaler and Title Fees. The Company pays certain pharmaceutical wholesalers and its third-party logistics provider fees based on a contractually determined rate. The Company accrues these fees on shipments to the respective wholesalers and recognizes the fees as a reduction of revenue in the same period the related revenue is recognized.
Prompt Pay Discounts. The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the prompt pay discount amount and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized.
Patient Discount Programs. The Company offers co-pay discount programs for each of its products to patients, in which patients receive a co-pay discount on their prescriptions. The Company utilizes data provided by independent third parties to determine the total amount that was redeemed and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized.
Rebates and Chargebacks. Managed care rebates are payments to governmental agencies and third parties, primarily pharmacy benefit managers and other health insurance providers. The reserve for these rebates is based on a combination of actual utilization provided by the third party and an estimate of customer buying patterns and applicable contractual rebate rates to be earned over each period. The Company recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. |
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| Inventories and Cost of Sales | Inventories and Cost of Sales
Inventories are stated at the lower of cost or net realizable value, net of reserve for excess and obsolete inventory and cost is determined using the average-cost method. At December 31, 2019 and December 31, 2018, inventory consisted of raw materials, work in process, and finished goods.
Cost of sales includes the cost of inventory sold or reserved, which includes manufacturing and supply chain costs, product shipping and handling costs, and product royalties. |
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| Acquisition-related contingent consideration | Acquisition-related contingent consideration Pursuant to the Iroko Products Acquisition, the Company has obligations relating to contingent payment consideration for future royalty obligations to Iroko based upon annual INDOCIN product net sales over $20.0 million. The Company recorded the acquisition-date fair value of these contingent liabilities, based on the likelihood of contingent earn-out payments. The earn-out payments are subsequently remeasured to fair value each reporting date. The fair value of the acquisition-related contingent consideration is remeasured each reporting period, with changes in fair value recorded in the Company’s Consolidated Statements of Operations. The royalty term commenced on the Effective Date and ends on the tenth anniversary of the Effective Date, January 31, 2029. |
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| Long Term Debt | Long Term Debt For a description of the Company’s debt obligations outstanding at December 31, 2019, see Note 12 – Debt.
Former 5.50% Notes
In April and May 2015, the Company issued through a private placement $61.0 million in aggregate principal amount of the 5.50% Notes in two separate closings. Interest on the 5.50% Notes is payable semi-annually in arrears on April 1 and October 1 of each year, commencing October 1, 2015. The 5.50% Notes are convertible at 67.2518 shares per $1,000 principal amount of the 5.50% Notes (equivalent to an initial conversion price of approximately $14.87 per share of common stock).
In December 2017, the Company closed exchange agreements with certain holders of the outstanding 5.50% notes for $36.4 million in principal value of the 5.50% Notes. The total face value of the outstanding 5.50% notes was reduced from $61.0 million to $24.6 million as a result of the Exchange. As part of the exchange, the Company issued $23.9 million in principal amount of new 6.50% convertible notes due December 31, 2024. See below for further information.
Former 13.0% Notes
In August 2016, the Company completed the initial closing (the “Initial Closing”) of its offering (the “Offering”) of up to $80.0 million aggregate principal amount of its 13.0% senior secured notes and entered into an indenture governing the Notes with the guarantors party thereto (the “Guarantors”) and U.S. Bank National Association, a national banking association, as trustee (the “Trustee”) and collateral agent (the “Collateral Agent”). The Company issued $40.0 million aggregate principal amount of the 13% Notes at the Initial Closing and issued an additional $40.0 million aggregate principal amount of the Notes on approval from the Food and Drug Administration (“FDA”) of ARYMO ER in January 2017 (the “Second Closing”). Net proceeds from the Initial Closing and Second Closing were $37.2 million and $38.3 million respectively, after deducting offering expenses. The Notes were sold only to qualified institutional buyers within the meaning of Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).
Former 6.50% Notes
In December 2017, the Company issued $23.9 million in principal amount of the 6.50% Notes. The 6.50% notes were issued to existing 5.50% Note holders in exchange for $36.4 million in face value of the 5.50% Notes. Interest on the 6.50% Notes is payable semi-annually in arrears on January 1 and July 1 of each year, commencing July 1, 2018. The 6.50% Notes are convertible at 749.6252 shares per $1,000 principal amount of the 6.50% Notes (equivalent to an initial conversion price of approximately $1.33 per share of common stock).
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| Liabilities Subject to Compromise | Liabilities Subject to Compromise
The Predecessor Company’s financial statements include amounts classified as Liabilities Subject to Compromise, which represent liabilities that existed prior to the effectiveness of its bankruptcy plans and that were restructured under the Plan of Reorganization. These amounts include amounts related to (i) the 5.50% Notes, (ii) the 6.50% Notes and (iii) the 13.0% Notes, including the accrued interest thereon, and accrued vendor liabilities. Refer to Note 11–Liabilities Subject to Compromise for additional details. |
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| Interest Make-Whole Derivative | Interest Make-Whole Derivative
The former 5.50% Notes included an interest make-whole feature whereby if a noteholder converted any of the 5.50% Notes prior to April 1, 2018, subject to certain restrictions, the noteholder would be entitled, in addition to the other consideration payable or deliverable in connection with such conversion, to an interest make-whole payment equal to the sum of the present value of the remaining scheduled payments of interest that would have been made on the notes to be converted had such notes remained outstanding from the conversion date through April 1, 2018, computed using a discount rate equal to 2%. The Company has determined that this feature is an embedded derivative and has recognized the fair value of this derivative as a liability on the Company’s Consolidated Balance Sheet, with subsequent changes to fair value recorded through earnings at each reporting period on the Company’s Consolidated Statements of Operations and Comprehensive Loss as change in fair value of derivative liabilities. The fair value of this embedded derivative was determined based on a binomial tree lattice model.
The former 6.50% Notes included an interest make-whole feature whereby if a noteholder converted any of the 6.50% Notes prior to January 1, 2021, subject to certain restrictions, they were entitled, in addition to the other consideration payable or deliverable in connection with such conversion, to an interest make-whole payment equal to the sum of the present value of the remaining scheduled payments of interest that would have been made on the notes to be converted had such notes remained outstanding from the conversion date through January 1, 2021, computed using a discount rate equal to 2%. The Company has determined that this feature is an embedded derivative and has recognized the fair value of this derivative as a liability on the Company’s Consolidated Balance Sheets, with subsequent changes to fair value recorded through earnings at each reporting period on the Company’s Consolidated Statements of Operations and Comprehensive Loss as change in fair value of derivative liabilities. The fair value of this embedded derivative was determined based on a binomial tree lattice model. |
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| Warrant Liability | Warrant Liability
On July 6, 2017, the Company entered into an underwriting agreement with Cantor Fitzgerald & Co. relating to an underwritten public offering (the “July 2017 Equity Offering”) of 16,666,667 shares of the Company’s common stock and accompanying warrants to purchase 16,666,667 shares of common stock, at a combined public offering price of $1.80 per share and accompanying warrant, for gross proceeds of $30.0 million. Each warrant was issued at an exercise price of $2.70, subject to adjustment in certain circumstances. The shares of common stock and warrants were issued separately. The warrants could be exercised at any time on or after the date of issuance and expired five years from the date of issuance.
The Company accounted for the warrants using ASC 480 – Distinguishing Liabilities from Equity and determined that the warrants were a freestanding financial instrument that are subject to liability classification. Pursuant to the terms of the agreement, the Company could be required to settle the warrants in cash in the event of an acquisition of the Company, and as a result the warrants are required to be measured at fair value and reported as a current liability in the Company’s Consolidated Balance Sheet, with subsequent changes to fair value recorded through earnings at each reporting period on the Company’s Consolidated Statements of Operations and Comprehensive Loss as change in fair value of derivative liabilities. The warrants were cancelled in connection with the emergence from bankruptcy. |
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| Foreign Currency Translation | Foreign Currency Translation
The reporting currency of the Company is the U.S. dollar. The functional currency of the Company’s non‑U.S. operations is the Danish Krone. Assets and liabilities of foreign operations are translated into U.S. dollars based on exchange rates at the end of each reporting period. Revenues and expenses are translated at average exchange rates during the reporting period. Gains and losses arising from the translation of assets and liabilities are included as a component of accumulated other comprehensive loss or income on the Company’s Consolidated Balance Sheets. Gains and losses resulting from foreign currency transactions are reflected within the Company’s Consolidated Statements of Operations. The Company has not utilized any foreign currency hedging strategies to mitigate the effect of its foreign currency exposure.
Intercompany payables and receivables are considered to be long-term in nature and any change in balance due to foreign currency fluctuation is included as a component of the Company's Consolidated Statements of Comprehensive Loss and Accumulated Other Comprehensive Loss within the Company's Consolidated Balance Sheets.
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| Comprehensive Loss | Comprehensive Loss
Comprehensive loss is defined as changes in stockholders’ deficit exclusive of transactions with owners (such as capital contributions and distributions). Comprehensive loss is composed of net loss, foreign currency translation adjustments and unrealized gains or losses on marketable securities classified as available for sale.
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| Income Taxes | Income Taxes
The Company uses the asset and liability method of accounting for income taxes. Current tax liabilities or receivables are recognized for the amount of taxes the Company estimates are payable or refundable for the current year. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is provided when it is more likely than not that some portion or the entire deferred tax asset will not be realized. The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on its income tax return if such a position is more likely than not to be sustained. Then, the tax benefit recognized is the largest amount of benefit, determined on a cumulative probability basis, which is more likely than not to be realized upon ultimate settlement. The Company recognizes interest and penalties related to unrecognized tax benefits within the income tax expense line in the Company’s Consolidated Statements of Operations and Comprehensive Loss. Accrued interest and penalties are included within the related tax liability line in the Company’s Consolidated Balance Sheets. The Company did not have any accrued interest or penalties associated with any unrecognized tax positions at December 31, 2019 and 2018, and there were no such interest or penalties recognized during the period from February 1, 2019 through December 31, 2019 (Successor), the period from January 1, 2019 through January 31, 2019 (Predecessor) or the year ended December 31, 2018 (Predecessor).
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| Basic and Diluted Net Loss Per Share of Common Stock | Basic and Diluted Net Loss Per Share of Common Stock
Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted‑average number of common shares outstanding during the period. Diluted net loss per share of common stock is computed by dividing the net loss applicable to common stockholders by the sum of the weighted‑average number of common shares outstanding during the period plus the potential dilutive effects of common stock options and warrants outstanding during the period calculated in accordance with the treasury stock method, plus the potential dilutive effects of the 5.50% and 6.50% Notes using the if-converted method. Because the impact of these items is anti‑dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of common stock for the period February 1, 2019 through December 31, 2019 (Successor), the period January 1, 2019 through January 31, 2019 (Predecessor) and the year ended December 31, 2018 (Predecessor). |
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| Recent Accounting Pronouncements | Recent Accounting Pronouncements
In February 2016, the Financial Accounting Standards Board FASB issued ASU No. 2016-02 Leases (ASC 842). In July 2018, the FASB issued ASU No. 2018-10, "Codification Improvements to Topic 842, Leases" (ASU 2018-10), which provides narrow amendments to clarify how to apply certain aspects of the new lease standard, and ASU No. 2018-11, "Leases (Topic 842)-Targeted Improvements" (ASU 2018-11), which addressed implementation issues related to the new lease standard. These and certain other lease-related ASUs have generally been codified in ASC 842. ASC 842 supersedes the lease accounting requirements in Accounting Standards Codification Topic 840, Leases (ASC 840). ASC 842 establishes a right-of-use model that requires a lessee to record a right-of-use ("ROU") asset and a lease liability on the balance sheet for all leases. Under ASC 842, leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The standard also requires disclosures to help investors and other financial statement users better understand the amount, timing and uncertainty of cash flows arising from leases. The Company adopted ASC 842 using the modified retrospective transition approach as of the effective date, which allows the Company to not adjust the comparative periods presented. The Company has elected to adopt the package of transition practical expedients and, therefore, has not reassessed whether existing or expired contracts contain a lease, the lease classification for existing or expired leases or the accounting for initial direct costs that were previously capitalized. The Company did not elect the practical expedient to use hindsight for leases existing at the adoption date. Further, the Company does not expect the amendments in ASU 2018-01: Land Easement Practical Expedient to have an effect on its financial position because it did not enter into land easement arrangements. The Company has elected, as an accounting policy, to not recognize ROU assets and lease liabilities for all short-term leases that have a lease term of 12 months or less. Upon adoption, the Predecessor Company recorded a lease liability of $2.5 million with a corresponding ROU asset of $1.9 million for its operating leases. As of the adoption date, the Company had a $0.6 million deferred rent liability which was reversed. The adoption of ASC 842 did not have a material impact on the Company’s Consolidated Statements of Operations or Consolidated Statements of Cash Flows.
In January 2016, the FASB issued ASU 2016-01, Financial Instruments - Overall (Subtopic 825-10), Recognition and Measurement of Financial Assets and Financial Liabilities, which addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. ASU 2016-01 was effective for annual periods and interim periods within those annual periods beginning after December 15, 2017. The Company adopted the standard in the first quarter of 2018 and determined there to be no material impact of the adoption in the year ended December 31, 2018.
In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” This guidance applies to all entities and impacts how entities account for credit losses for most financial assets and other instruments. ASU 2016-13 requires financial assets measured at amortized cost to be presented at the net amount expected to be collected. The measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amounts. An entity must use judgment in determining the relevant information and estimation methods that are appropriate in its circumstances. For trade receivables, loans and held-to-maturity debt securities, entities will be required to estimate expected credit losses over the lifetime of the asset. For available-for-sales debt securities, entities will be required to recognize an allowance for credit losses rather than an other-than-temporary impairment that reduces the cost basis of the investment. Further, an entity will recognize any improvements in credit losses on its available-for-sale debt securities immediately in earnings.
The FASB also released clarifying guidance in April 2019 within ASU 2019-04, “Codification Improvements to Topic 326, Financial Instruments – Credit Losses,” in May 2019 within ASU 2019-05, “Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief,” and in November 2019 within ASU 2019-10, “Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842),” and ASU 2019-11, “Codification Improvements to Topic 326, Financial Instruments – Credit Losses.” The updates provide guidance on estimating credit losses, including transition relief by allowing for election of the fair value methodology on an instrument-by-instrument basis for eligible financial instruments within the scope of ASC 825-10, and valuation of receivables from customers with troubled debt. This guidance is effective for fiscal years beginning after December 15, 2019 and interim periods therein. Elections under ASU 2019-05 require a modified retrospective application through a cumulative-effect adjustment in the opening balance of retained earnings upon adoption. The Company is currently analyzing the impact of the credit losses standard and does not anticipate the adoption of this ASU on January 1, 2020 to have a material impact on its consolidated financial statements.
In August 2018, the FASB issued ASU 2018-13, “Fair Value Measurement (Topic 820)” which modifies the disclosure requirements of fair value measurements in Topic 820, Fair Value Measurement. For public companies the ASU removes disclosure requirements for transfers between Level 1 and Level 2 of the fair value hierarchy, the policy for timing of transfers between levels and the valuation process for Level 3 fair value measurements. The ASU modifies the disclosure requirements for investments in certain entities that calculate net asset value and clarifies that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date. The ASU adds the disclosure requirement for changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2019 including interim periods within that fiscal year. Early adoption is permitted. The Company does not plan to early adopt this ASU and the Company does not believe there will be a material impact on its consolidated financial statements as a result of adopting this ASU. In December 2019, the FASB issued ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes.” This guidance is effective for fiscal years beginning after December 15, 2020 and interim periods therein. Early adoption is permitted for any annual periods for which financial statements have not been issued and interim periods therein. The Company is currently analyzing the impact of ASU 2019-12 and does not anticipate the adoption of this ASU to have a material impact on the Company’s consolidated financial statements. |
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Summary of Significant Accounting Policies and Basis of Accounting (Tables) |
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| Customer Concentration | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of estimated useful lives |
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| Schedule of concentration |
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Fresh Start Accounting (Tables) |
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| Fresh Start Accounting | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of consolidated balance sheets as a result of implementing the Plan and applying fresh start accounting |
Effects of Plan Adjustments
Fresh Start Adjustments
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Revenue from Contracts with Customers (Tables) |
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| Schedule of disaggregation of revenue |
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| Schedule of net product sales allowance and reserve |
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Investments (Tables) |
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| Investments | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of marketable securities |
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Fair Value Measurements (Tables) |
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| Fair Value Measurements | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of information about each major category of financial assets and liabilities measured at fair value on a recurring basis |
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| Summary of changes in the fair value of Level 3 liabilities | The following table reflects a rollforward of the Company’s Level 3 liabilities for the Successor period February 1, 2019 through December 31, 2019:
The following tables reflects a summary of changes in the fair value of Level 3 liabilities for the year ended December 31, 2018:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventory | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of components of inventory |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Property and Equipment | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of property and equipment and related accumulated depreciation and amortization |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible Assets and Goodwill (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Intangible Assets | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of indefinite-lived intangible assets | The following table reflects intangible assets of the Successor Company as of December 31, 2019:
The following table reflects intangible assets of the Predecessor Company as of December 31, 2018:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of estimated amortization expense |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accrued Expenses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of accrued expenses |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Liabilities Subject to Compromise (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||
| Liabilities Subject to Compromise | |||||||||||||||||||||||||||||||||||||||||
| Summary of liabilities subject to compromise |
|
||||||||||||||||||||||||||||||||||||||||
Debt (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of the Successor Company's debt |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of unamortized discounts and deferred financing fees on debt |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Company's estimated future principal payments |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Leases | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of components of lease expense |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of supplemental balance sheet information |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of supplemental lease term and discount rate information |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of supplemental cash flow information |
|
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| Schedule of future minimum lease payments |
|
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Stock-Based Compensation (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-Based Compensation | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of common stock reserved for issuance |
|
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| Schedule of stock-based compensation expense recognized |
|
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| Schedule of stock options outstanding under equity compensation plans |
|
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| Schedule of weighted-average assumptions |
|
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| Summary of status and change in restricted stock awards |
|
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Income Taxes (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Income Taxes | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of income (loss) before income tax expense |
|
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| Schedule of provision (benefit) for income taxes |
|
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| Schedule of changes in unrecognized tax benefits |
|
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| Schedule of principal components of the Company's deferred tax assets and liabilities |
|
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| Schedule of the reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes |
|
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Restructuring and Other Charges (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Restructuring and Other Charges | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of restructuring and other charges |
|
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Reorganization items (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Reorganization items | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of reorganization items |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss (Income) Per Common Share (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss (Income) Per Common Share | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of computation of basic and diluted net loss per share |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization and Description of the Business (Details) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
|
Dec. 31, 2019
USD ($)
product
|
Jan. 31, 2019
USD ($)
|
Dec. 31, 2018
USD ($)
|
|
| Liquidity [Abstract] | |||
| Number of Products | product | 6 | ||
| Working capital | $ 24,100 | ||
| Accumulated deficit | $ (46,640) | $ (395,795) | $ (388,853) |
| Substantial doubt about going concern of the company within one year | true |
Summary of Significant Accounting Policies and Basis of Accounting - Segment and Geographic Information and Cash Restricted Cash and Cash Equivalents (Details) $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended | ||
|---|---|---|---|---|---|
|
Jan. 31, 2019
USD ($)
|
Dec. 31, 2019
USD ($)
|
Dec. 31, 2019
USD ($)
segment
|
Dec. 31, 2018
USD ($)
|
Feb. 01, 2019
USD ($)
|
|
| Segment and Geographic Information | |||||
| Number of reportable segments | segment | 1 | ||||
| Revenue from Contract with Customer, Excluding Assessed Tax | $ 1,775 | $ 79,527 | $ 30,353 | ||
| Property and equipment, net | $ 1,027 | 3,316 | $ 3,316 | $ 1,059 | $ 4,074 |
| United States | |||||
| Segment and Geographic Information | |||||
| Cash balances | 12,200 | 12,200 | |||
| United States | Maximum | |||||
| Segment and Geographic Information | |||||
| Cash, FDIC Insured Amount | 300 | 300 | |||
| Denmark | |||||
| Segment and Geographic Information | |||||
| Cash balances | 200 | 200 | |||
| Denmark | Maximum | |||||
| Segment and Geographic Information | |||||
| Cash, FDIC Insured Amount | $ 100 | $ 100 | |||
Summary of Significant Accounting Policies and Basis of Accounting - Concentrations of Credit Risk and Off Balance Sheet Risk (Details) - Accounts receivable - Credit Concentration Risk |
12 Months Ended | |
|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
| Concentration of credit risk | ||
| Concentration risk (as a percent) | 95.50% | 93.50% |
| Customer A | ||
| Concentration of credit risk | ||
| Concentration risk (as a percent) | 44.30% | 70.20% |
| Customer B | ||
| Concentration of credit risk | ||
| Concentration risk (as a percent) | 34.30% | |
| Customer C | ||
| Concentration of credit risk | ||
| Concentration risk (as a percent) | 6.20% | |
| Customer D | ||
| Concentration of credit risk | ||
| Concentration risk (as a percent) | 6.00% | 14.30% |
| Customer E | ||
| Concentration of credit risk | ||
| Concentration risk (as a percent) | 4.70% | 9.00% |
Summary of Significant Accounting Policies and Basis of Accounting - Fair Value Measurements (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
| Fair value measurements | |||
| Transfer of assets from level 1 to level 2 | $ 0 | $ 0 | |
| Transfer of assets from level 2 to level 1 | 0 | 0 | |
| Transfer of liabilities from level 1 to level 2 | 0 | 0 | |
| Transfer of liabilities from level 2 to level 1 | 0 | 0 | |
| Fair Value, asset transfers out of Level 3 | 0 | 0 | |
| Fair Value, asset transfers into of Level 3 | 0 | 0 | |
| Fair Value, liability transfers into of Level 3 | 0 | 0 | |
| Fair Value, liability transfers out of Level 3 | $ 0 | $ 0 | |
| 5.50% Notes | |||
| Fair value measurements | |||
| Stated interest rate (as a percent) | 5.50% | 5.50% | |
| 6.50% Notes | |||
| Fair value measurements | |||
| Stated interest rate (as a percent) | 6.50% | 6.50% | 6.50% |
Summary of Significant Accounting Policies and Basis of Accounting - Property and Equipment and Intangible and Long-Lived Assets (Details) - USD ($) $ in Millions |
12 Months Ended | |
|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
| IPR&D | Restructuring & other charges | ||
| Intangible Asset | ||
| Impairment of intangible assets | $ 0.1 | |
| Laboratory and manufacturing equipment | Minimum | ||
| Property and Equipment | ||
| Useful life | 3 years | |
| Laboratory and manufacturing equipment | Maximum | ||
| Property and Equipment | ||
| Useful life | 10 years | |
| Furniture, fixtures and other property | Minimum | ||
| Property and Equipment | ||
| Useful life | 3 years | |
| Furniture, fixtures and other property | Maximum | ||
| Property and Equipment | ||
| Useful life | 7 years | |
| SPRIX Nasal Spray | ||
| Impairment of Long-Lived Assets | ||
| Useful life of intangible asset | 9 years | |
| OXAYDO tablets | ||
| Impairment of Long-Lived Assets | ||
| Useful life of intangible asset | 3 years | |
| INDOCIN | ||
| Impairment of Long-Lived Assets | ||
| Useful life of intangible asset | 9 years | |
Summary of Significant Accounting Policies and Basis of Accounting - Product Sales Allowances (Details) |
12 Months Ended |
|---|---|
Dec. 31, 2019 | |
| Summary of Significant Accounting Policies and Basis of Accounting | |
| Discount Percentage | 2.00% |
Summary of Significant Accounting Policies and Basis of Accounting - Income Taxes (Details) - USD ($) |
1 Months Ended | 11 Months Ended | 12 Months Ended | |
|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
|
| Income Taxes | ||||
| Interest and penalties | $ 0 | $ 0 | ||
| Federal income tax at the statutory rate | 21.00% | 21.00% | 21.00% | |
Summary of Significant Accounting Policies and Basis of Accounting - Acquisition and Recent Accounting Pronouncements (Details) - USD ($) $ in Thousands |
1 Months Ended | ||
|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Feb. 01, 2019 |
|
| New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
| Right of use assets | $ 1,854 | $ 2,672 | $ 1,854 |
| Lease Liability | $ 3,026 | ||
| Accounting Standards Update 2016-02 | Measurement period adjustments | |||
| New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
| Right of use assets | 2,500 | ||
| Lease Liability | 1,900 | ||
| Deferred Rent | 600 | ||
| Iroko | |||
| New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
| Threshold Net Sales for Future Royalty Payments | $ 20,000 |
Fresh Start Accounting (Details) $ in Millions |
Jan. 31, 2019
USD ($)
|
|---|---|
| Fresh-Start Adjustment [Line Items] | |
| Percentage of voting shares of emerging entity to qualify for fresh-start accounting | 50.00% |
| Enterprise value | $ 196.6 |
| Terminal Value | $ 217.3 |
| Discount rate | |
| Fresh-Start Adjustment [Line Items] | |
| Percentage of voting shares of emerging entity to qualify for fresh-start accounting | 15.10% |
| Growth rate | |
| Fresh-Start Adjustment [Line Items] | |
| Percentage of voting shares of emerging entity to qualify for fresh-start accounting | 3.00% |
| Maximum | |
| Fresh-Start Adjustment [Line Items] | |
| Enterprise value | $ 200.0 |
| Minimum | |
| Fresh-Start Adjustment [Line Items] | |
| Enterprise value | $ 162.0 |
Fresh Start Accounting - Cash and cash equivalents (Details) $ in Millions |
Jan. 31, 2019
USD ($)
|
|---|---|
| Fresh-Start Adjustment [Line Items] | |
| Cash and cash equivalents | $ 18.2 |
| Iroko | |
| Fresh-Start Adjustment [Line Items] | |
| Cash and cash equivalents | $ 1.5 |
Fresh Start Accounting - Iroko Acquisition (Details) - USD ($) $ in Thousands |
1 Months Ended | ||
|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Feb. 01, 2019 |
|
| Business Combination, Recognized Identifiable Assets Acquired, Goodwill, and Liabilities Assumed, Net [Abstract] | |||
| Goodwill attributable to Iroko acquisition | $ 58,747 | $ 58,747 | |
| Iroko | Plan Effects Adjustments | |||
| Iroko Purchase Price Allocation | |||
| Iroko Promissory Note | $ 45,000 | ||
| Iroko Equity Value in Reorganization | 41,630 | ||
| Fair Value of Contingent Consideration | 14,800 | ||
| Total Iroko Purchase Price | 105,930 | ||
| Business Combination, Recognized Identifiable Assets Acquired, Goodwill, and Liabilities Assumed, Net [Abstract] | |||
| Inventory | 28,364 | ||
| Prepaid expenses | 1,446 | ||
| Fixed Assets | 3,047 | ||
| Intangible - Indocin | 90,106 | ||
| Product Liability | (17,033) | ||
| Total Iroko Purchase Price | 105,930 | ||
| Iroko | Plan Effects Adjustments | Unsecured Promissory Note | |||
| Iroko Purchase Price Allocation | |||
| Iroko Promissory Note | $ 4,500 |
Fresh Start Accounting - Adjustments to accrued expense (Details) $ in Thousands |
Jan. 31, 2019
USD ($)
|
|---|---|
| Transaction Fees to be Paid [Member] | |
| Fresh-Start Adjustment [Line Items] | |
| Adjustments to accrued expense | $ 1,000 |
| Iroko | Plan Effects Adjustments | Success Fees to be Paid [Member] | |
| Fresh-Start Adjustment [Line Items] | |
| Adjustments to accrued expense | 2,150 |
| Iroko | Plan Effects Adjustments | Product Related Liabilities [Member] | |
| Fresh-Start Adjustment [Line Items] | |
| Adjustments to accrued expense | $ 17,030 |
Fresh Start Accounting - Obligations (Details) $ in Millions |
1 Months Ended |
|---|---|
|
Jan. 31, 2019
USD ($)
| |
| Iroko | |
| Fresh-Start Adjustment [Line Items] | |
| Threshold net sales for future royalty payments | $ 20.0 |
| Plan Effects Adjustments | |
| Fresh-Start Adjustment [Line Items] | |
| Long term debt | $ 90.3 |
| Interest rate (as a percent) | 13.00% |
| Percentage of royalty right payment to aggregate net sale | 1.50% |
| Contingent consideration | $ 14.8 |
| Royalty | 1.2 |
| Plan Effects Adjustments | Iroko | |
| Fresh-Start Adjustment [Line Items] | |
| Threshold net sales for future royalty payments | 20.0 |
| Plan Effects Adjustments | First lien | |
| Fresh-Start Adjustment [Line Items] | |
| Contingent consideration | 1.1 |
| Plan Effects Adjustments | Unsecured Promissory Note | |
| Fresh-Start Adjustment [Line Items] | |
| Long term debt | 4.5 |
| Contingent consideration | $ 0.4 |
Fresh Start Accounting - Inventory (Details) $ in Thousands |
Jan. 31, 2019
USD ($)
|
|---|---|
| Fresh Start Adjustments | |
| Fresh-Start Adjustment [Line Items] | |
| Inventory | $ 3,175 |
| Iroko | |
| Fresh-Start Adjustment [Line Items] | |
| Inventory | $ 3,200 |
Fresh Start Accounting - Goodwill (Details) - Fresh Start Adjustments $ in Thousands |
Jan. 31, 2019
USD ($)
|
|---|---|
| Fresh-Start Adjustment [Line Items] | |
| Enterprise value | $ 196,600 |
| Add: Fair value of liabilities excluded from enterprise value | 57,552 |
| Less: Fair value of tangible assets | (72,099) |
| Less: Fair value of identified intangible assets | (123,306) |
| Reorganization value of assets in excess of amounts allocated to identified tangible and intangible assets (Successor company goodwill) | 58,747 |
| Total Successor Goodwill | $ 58,747 |
Fresh Start Accounting - Adjustment to Stockholders' Deficit (Details) - Fresh Start Adjustments $ in Thousands |
1 Months Ended |
|---|---|
|
Jan. 31, 2019
USD ($)
| |
| Fresh-Start Adjustment [Line Items] | |
| Establish Successor goodwill attributable to emergence from Chapter 11 | $ 58,747 |
| Intangible fair value adjustments | 29,091 |
| Inventory fair value adjustments | 3,175 |
| Deferred revenue and product advance adjustments | 155 |
| Gain on fresh start adjustment for revaluation of assets and liabilities | 91,168 |
| Eliminate Predecessor Company Other comprehensive income | 866 |
| Total adjustment to stockholders' deficit | $ 92,034 |
Revenue from Contracts with Customers - Transaction Price Allocated to Future Performance Obligations (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2019 |
Jan. 31, 2019 |
Dec. 31, 2018 |
|
| Costs to Obtain and Fulfill a Contract | |||
| Practical expedient performance obligation | true | ||
| Deferred revenue | $ 0 | $ 52 | $ 0 |
| Contract assets | $ 0 | $ 0 |
Revenue from Contracts with Customers - Costs to Obtain and Fulfill a Contract (Details) |
12 Months Ended |
|---|---|
Dec. 31, 2019 | |
| Costs to Obtain and Fulfill a Contract | |
| Practical expedient, incremental costs of obtaining contracts as an expense when incurred as the period of benefit is less than one year | true |
Investments (Details) - USD ($) $ in Thousands |
Feb. 01, 2019 |
Jan. 31, 2019 |
Dec. 31, 2018 |
|---|---|---|---|
| Marketable Securities | |||
| Cost Basis | $ 4,990 | ||
| Unrealized Losses | (2) | ||
| Fair Value | $ 4,994 | $ 4,994 | 4,988 |
| Corporate notes and bonds | |||
| Marketable Securities | |||
| Cost Basis | 4,990 | ||
| Unrealized Losses | (2) | ||
| Fair Value | $ 4,988 |
Inventory (Details) - USD ($) $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended | 13 Months Ended | ||
|---|---|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Jan. 31, 2019 |
Feb. 01, 2019 |
|
| Raw materials | $ 1,257 | $ 1,257 | $ 1,374 | |||
| Work in process | 4,864 | 4,864 | 665 | |||
| Finished goods | 2,928 | 2,928 | 600 | |||
| Total | $ 2,299 | $ 9,049 | $ 9,049 | $ 2,639 | $ 2,299 | $ 33,838 |
| Predecessor Successor Fixed list | Predecessor | Successor | Successor | Predecessor | Predecessor | |
| Reserve for excess and obsolete inventory | $ 0 | $ 0 | $ 100 | |||
| ARYMO ER | ||||||
| Write-down of the remaining inventory | $ 700 | |||||
Property and Equipment (Details) - USD ($) |
1 Months Ended | 11 Months Ended | 12 Months Ended | |
|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Feb. 01, 2019 |
|
| Property and Equipment | ||||
| Less: Accumulated depreciation | $ (745,000) | $ (1,239,000) | ||
| Property and equipment, net | $ 1,027,000 | 3,316,000 | 1,059,000 | $ 4,074,000 |
| ARYMO write down of equipment | 8,184,000 | |||
| Depreciation expense, including amortization of leasehold improvements | $ 32,000 | 800,000 | 2,100,000 | |
| ARYMO ER | ||||
| Property and Equipment | ||||
| ARYMO write down of equipment | 6,800,000 | |||
| Leasehold improvements | ||||
| Property and Equipment | ||||
| Property and equipment, gross | 736,000 | 1,431,000 | ||
| Laboratory and manufacturing equipment | ||||
| Property and Equipment | ||||
| Property and equipment, gross | 2,997,000 | |||
| Furniture, fixtures and other property | ||||
| Property and Equipment | ||||
| Property and equipment, gross | $ 328,000 | $ 867,000 |
Intangible Assets - Estimated Amortization Expense (Details) - USD ($) $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended |
|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
|
| 2020 | $ 13,990 | ||
| 2021 | 13,990 | ||
| 2022 | 13,592 | ||
| 2023 | 13,556 | ||
| 2024 | 13,556 | ||
| OXAYDO tablets | |||
| Amortization [Abstract] | |||
| Depreciation, Depletion and Amortization | $ 100 | 400 | $ 1,100 |
| SPRIX Nasal Spray | |||
| Amortization [Abstract] | |||
| Depreciation, Depletion and Amortization | $ 100 | 3,200 | $ 1,000 |
| INDOCIN | |||
| Amortization [Abstract] | |||
| Depreciation, Depletion and Amortization | $ 9,200 |
Accrued Expenses (Details) - USD ($) $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended | 13 Months Ended | ||
|---|---|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Jan. 31, 2019 |
Feb. 01, 2019 |
|
| Accrued Expenses | ||||||
| Predecessor Successor Fixed list | Predecessor | Successor | Successor | Predecessor | Predecessor | |
| Sales allowances | $ 38,615 | $ 38,615 | $ 17,174 | |||
| Payroll and related | 3,086 | 3,086 | 3,567 | |||
| Interest | 2,520 | 2,520 | 1,049 | |||
| Restructuring | 1,659 | 1,659 | 81 | |||
| Sales and marketing | 683 | 683 | ||||
| Professional services | 656 | 656 | 1,847 | |||
| Royalties | 493 | 493 | 34 | |||
| Manufacturing services | 426 | 426 | ||||
| Other | 2,219 | 2,219 | 832 | |||
| Total | $ 26,617 | $ 50,357 | $ 50,357 | $ 24,584 | $ 26,617 | $ 46,800 |
Debt - Summary of company's debt (Details) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Jan. 31, 2019 |
|---|---|---|
| Debt Instrument [Line Items] | ||
| Long-term debt, Gross | $ 109,736 | |
| Unamortized debt discounts | (5,007) | |
| Unamortized deferred financing fees | (792) | |
| Carrying value | 103,937 | |
| Less: current portion of long-term debt | (8,177) | |
| Net, long-term debt | 95,760 | |
| Series A-1 Notes | ||
| Debt Instrument [Line Items] | ||
| Long-term debt, Gross | 50,000 | |
| Unamortized debt discounts | (2,297) | $ (4,600) |
| Series A-2 Notes | ||
| Debt Instrument [Line Items] | ||
| Long-term debt, Gross | 45,000 | |
| Royalty rights obligation | ||
| Debt Instrument [Line Items] | ||
| Long-term debt, Gross | 5,236 | |
| Unamortized debt discounts | (2,553) | |
| Credit agreement | ||
| Debt Instrument [Line Items] | ||
| Long-term debt, Gross | 5,000 | |
| Unamortized debt discounts | (157) | |
| Unamortized deferred financing fees | (792) | |
| Interim promissory note | ||
| Debt Instrument [Line Items] | ||
| Long-term debt, Gross | $ 4,500 |
Debt - Revolving Credit Agreement (Details) - USD ($) |
Sep. 30, 2019 |
Mar. 20, 2019 |
|---|---|---|
| LIBOR | ||
| Subsequent Events | ||
| Basis spread (as a percent) | 5.00% | |
| Base rate | ||
| Subsequent Events | ||
| Basis spread (as a percent) | 4.00% | |
| Revolving Credit Agreement | ||
| Subsequent Events | ||
| Maximum borrowings | $ 20,000,000 | |
| Amount of line of credit drawn | $ 5,000,000 | |
| Interest rate (as a percent) | 13.00% | |
| Percent of termination fee from the Closing Date through March 20, 2020 | 1.00% | |
| Percent of termination fee from March 20, 2020 through March 20, 2021 | 0.50% | |
| Minimum amount of consolidated liquidity | $ 10,000,000 | |
| Threshold period within which the entity has to cure default | 10 days | |
| Revolving Credit Agreement | Minimum | ||
| Subsequent Events | ||
| Percent of commitment amount outstanding to be maintained | 25.00% | |
| Maintenance of consolidated liquidity | 9.5 | |
| Denominator of consolidated liquidity | $ 7,500,000 |
Debt - Interim Promissory Note (Details) - USD ($) $ in Thousands |
1 Months Ended | |
|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
|
| Debt Instrument [Line Items] | ||
| Discounts | $ 5,007 | |
| Deferred Financing Fees | 792 | |
| Series A-1 Notes | ||
| Debt Instrument [Line Items] | ||
| Discounts | $ 4,600 | 2,297 |
| Royalty rights obligation | ||
| Debt Instrument [Line Items] | ||
| Discounts | 2,553 | |
| Credit agreement | ||
| Debt Instrument [Line Items] | ||
| Discounts | 157 | |
| Deferred Financing Fees | $ 792 | |
| Asset Purchase Agreement | Unsecured Promissory Note | Iroko | ||
| Debt Instrument [Line Items] | ||
| Principal amount of notes issued as consideration | $ 4,500 | |
| Interest rate (as a percent) | 8.00% |
Debt - Estimated Future Principal Payments (Details) $ in Thousands |
Dec. 31, 2019
USD ($)
|
|---|---|
| Long-term Debt, Fiscal Year Maturity [Abstract] | |
| 2020 | $ 6,803 |
| 2021 | 6,006 |
| 2022 | 12,237 |
| 2023 | 10,111 |
| 2024 | $ 69,343 |
Leases - (Details) |
11 Months Ended |
|---|---|
Dec. 31, 2019 | |
| Leases | |
| Renewal options to extend | true |
| Minimum | |
| Leases | |
| Initial lease terms | 1 year |
| Maximum | |
| Leases | |
| Initial lease terms | 5 years |
Leases - Components of lease expense (Details) - USD ($) $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended | 13 Months Ended | |
|---|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Jan. 31, 2019 |
|
| Components of lease expense | |||||
| Predecessor Successor Fixed list | Predecessor | Successor | Successor | Predecessor | Predecessor |
| Fixed lease cost | $ 69 | $ 850 | |||
| Total operating lease expense | $ 69 | $ 850 | |||
Leases - Balance sheet information (Details) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Feb. 01, 2019 |
Jan. 31, 2019 |
|---|---|---|---|
| Balance sheet information: | |||
| Operating lease ROU asset | $ 2,672 | $ 1,854 | $ 1,854 |
| Financial position | us-gaap:OperatingLeaseRightOfUseAsset | ||
| Current operating lease liabilities | $ 985 | ||
| Financial position | us-gaap:OtherLiabilitiesCurrent | ||
| Non-current operating lease liabilities | $ 2,041 | ||
| Financial position | us-gaap:OtherLiabilitiesNoncurrent | ||
| Total operating leas liability | $ 3,026 | ||
| Financial position | us-gaap:OtherLiabilitiesCurrent us-gaap:OtherLiabilitiesNoncurrent |
Leases - Lease term and discount rate information (Details) |
Dec. 31, 2019 |
|---|---|
| Leases | |
| Weighted-average remaining lease term | 2 years 11 months 12 days |
| Weighted-average discount rate | 8.00% |
Leases - Cash flow information (Details) - USD ($) $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended | 13 Months Ended | |
|---|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Jan. 31, 2019 |
|
| Leases | |||||
| Predecessor Successor Fixed list | Predecessor | Successor | Successor | Predecessor | Predecessor |
| Operating cash flows from operating leases | $ 1,164 | ||||
| Right-of-use assets obtained in exchange for lease obligations - New operating leases | $ 2,478 | ||||
| New Operating Lease Fleet Vehicles | |||||
| Leases | |||||
| Right-of-use assets obtained in exchange for lease obligations - New operating leases | 2,216 | ||||
| Termination Of Operating Lease Fleet Vehicles | |||||
| Leases | |||||
| Right-of-use assets obtained in exchange for lease obligations - Termination of operating lease | $ (677) | ||||
Leases - Future minimum lease payments (Details) $ in Thousands |
Dec. 31, 2019
USD ($)
|
|---|---|
| Future minimum lease payments: | |
| 2020 | $ 1,274 |
| 2021 | 1,227 |
| 2022 | 634 |
| 2023 | 231 |
| Total lease payments | 3,366 |
| Less: Imputed interest | (340) |
| Total minimum lease payments | $ 3,026 |
Stock-Based Compensation - Equity Compensation Plans (Details) - 2019 Stock Plan - shares |
12 Months Ended | |
|---|---|---|
Dec. 31, 2019 |
Mar. 31, 2019 |
|
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
| Shares initially reserved under the 2019 Plan | 2,150,000 | 2,150,000 |
| Stock options granted under the Plan | (597,500) | |
| Stock options forfeited | 63,000 | |
| Restricted stock units forfeited | 713,000 | |
| Remaining shares available for future grant | 818,500 | |
| Time-Based Restricted Stock Unit | ||
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
| Restricted stock units granted under the 2019 Plan | (1,001,000) | |
| Performance-Based Restricted Stock Unit | ||
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
| Restricted stock units granted under the 2019 Plan | (509,000) |
Stock-Based Compensation - Restricted Stock (Details) - Unvested Restricted Stock Awards |
11 Months Ended |
|---|---|
|
Dec. 31, 2019
$ / shares
shares
| |
| Shares | |
| Restricted stock units granted under the 2019 Plan | shares | 1,510,000 |
| Forfeited | shares | (713,000) |
| Restricted stock units released | shares | (132,000) |
| Unvested balance at the end of the period (in shares) | shares | 665,000 |
| Weighted-average Grant Date Fair Value per Share | |
| Granted | $ / shares | $ 6.07 |
| Forfeited | $ / shares | 6.07 |
| Restricted stock units released | $ / shares | 6.07 |
| Outstanding balance at the end of the period (in dollars per share) | $ / shares | $ 6.07 |
Income Taxes - Provision (Benefit) (Details) - USD ($) $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended | 13 Months Ended | |
|---|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Jan. 31, 2019 |
|
| Income (loss) before income tax expense: | |||||
| Predecessor Successor Fixed list | Predecessor | Successor | Successor | Predecessor | Predecessor |
| Domestic operations | $ 109,275 | $ (46,351) | $ (91,262) | ||
| Foreign operations | (2,035) | (289) | (4,192) | ||
| Loss before provision for income taxes | $ 107,240 | $ (46,640) | $ (95,454) | ||
Income Taxes - Net Operating Loss (Details) - USD ($) $ in Millions |
12 Months Ended | |
|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
| Net operating loss | ||
| Increase in valuation allowance | $ 13.4 | $ 19.4 |
| Foreign | ||
| Net operating loss | ||
| Net operating loss | $ 90.3 | |
| Federal | ||
| Net operating loss | ||
| Net operating loss | $ 184.2 | |
Employee Benefit Plans (Details) - USD ($) |
1 Months Ended | 11 Months Ended | 12 Months Ended | |
|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
|
| Contribution amount to 401(k) plan | $ 38,000 | $ 600,000 | $ 600,000 | |
| State Plan Member | Denmark | ||||
| Payment for pension contributions | $ 7,000 | $ 24,000 | $ 100,000 | |
| First 3% | ||||
| Company's matching contribution | 100.00% | |||
| Participating employee contribution matching by company | 3.00% | |||
| Next 2% | ||||
| Company's matching contribution | 50.00% | |||
| Participating employee contribution matching by company | 2.00% | |||
Restructuring and Other Charges (Details) - USD ($) $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended | 13 Months Ended | |
|---|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Jan. 31, 2019 |
|
| Restructuring and Other Charges | |||||
| Predecessor Successor Fixed list | Predecessor | Successor | Successor | Predecessor | Predecessor |
| Severance | $ 776 | $ 1,920 | |||
| Professional fees | 23 | $ 1,428 | |||
| Legal Fees | 4,331 | ||||
| ARYMO write down of equipment | 8,184 | ||||
| Halo termination fee | 3,100 | ||||
| Total restructuring and other costs | $ 799 | $ 1,920 | $ 17,043 | ||
Reorganization items (Details) - USD ($) $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended | 13 Months Ended | |
|---|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Jan. 31, 2019 |
|
| Reorganization items | |||||
| Predecessor Successor Fixed list | Predecessor | Successor | Successor | Predecessor | Predecessor |
| Professional Fees | $ 2,612 | $ 337 | $ 528 | ||
| Iroko acquisition related fees | 2,138 | 50 | |||
| Legal fees | 713 | 1,003 | |||
| Other reorganization expenses | 473 | 77 | |||
| Bankruptcy fees | 42 | 606 | 214 | ||
| 13% Notes redemption premium | 7,200 | ||||
| Gain on extinguishment of debt | (29,976) | ||||
| Revaluation of assets and liabilities | (91,171) | ||||
| Total reorganization items | $ (115,169) | $ 993 | $ 9,022 | ||
Commitments and Contingencies (Detail) $ in Millions |
Aug. 30, 2019 |
Jul. 30, 2019
USD ($)
|
Feb. 10, 2017
security
|
Jan. 27, 2017
security
|
Jan. 31, 2019
USD ($)
|
|---|---|---|---|---|---|
| Loss Contingencies [Line Items] | |||||
| Number of putative securities | security | 2 | 2 | |||
| Cosette Pharmaceuticals Supply Agreement | |||||
| Loss Contingencies [Line Items] | |||||
| Purchase obligation | $ 6.5 | ||||
| Catalent Pharma Solutions Commercial Supply Agreement | |||||
| Loss Contingencies [Line Items] | |||||
| Purchase obligation | $ 1.0 | ||||
| Jubilant HollisterStier Manufacturing and Supply Agreement | |||||
| Loss Contingencies [Line Items] | |||||
| Percentage of requirements to be purchased under the agreement | 75.00% | ||||
| Purchase obligation | $ 3.6 | ||||
| Pending Litigation | I Ceutica Inc. and I Ceutica Pty Ltd | Maximum | |||||
| Loss Contingencies [Line Items] | |||||
| Cure period | 30 days |
Net Loss (Income) Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
1 Months Ended | 11 Months Ended | 12 Months Ended | 13 Months Ended | ||
|---|---|---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Jan. 31, 2019 |
Dec. 31, 2017 |
|
| Basic and diluted net loss per common share calculation: | ||||||
| Predecessor Successor Fixed list | Predecessor | Successor | Successor | Predecessor | Predecessor | |
| Shares excluded from the calculation of diluted weighted average shares outstanding, as they would be anti-dilutive | 4,972,364 | |||||
| Net (loss) income | $ 107,240 | $ (46,640) | $ (95,454) | |||
| Weighted-average common stock outstanding | 56,547,101 | 14,333,562 | 52,775,116 | |||
| Net (loss) income per share of common stock, basic and diluted (in dollars per share) | $ 1.90 | $ (3.25) | $ (1.81) | |||
| 5.50% Notes | ||||||
| Basic and diluted net loss per common share calculation: | ||||||
| Interest rate (as a percent) | 5.50% | 5.50% | 5.50% | |||
| 6.50% Notes | ||||||
| Basic and diluted net loss per common share calculation: | ||||||
| Interest rate (as a percent) | 6.50% | 6.50% | 6.50% | 6.50% | ||
Stockholders' Deficit (Details) - $ / shares |
Dec. 31, 2019 |
Feb. 01, 2019 |
Jan. 31, 2019 |
Dec. 31, 2018 |
Feb. 28, 2018 |
Dec. 31, 2017 |
|---|---|---|---|---|---|---|
| Preferred shares authorized | 5,000,000 | |||||
| Preferred shares, par value | $ 0.001 | |||||
| Preferred shares outstanding | 0 | |||||
| common stock shares authorized | 100,000,000 | 100,000,000 | 275,000,000 | 275,000,000 | 275,000,000 | 75,000,000 |
| Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||
| Common stock, issued | 9,437,883 | 4,774,093 | 56,547,101 | |||
| Common stock, outstanding | 9,437,883 | 56,547,101 | ||||
| Iroko and affiliates | ||||||
| Common stock, issued | 4,586,875 | |||||
| 2019 Stock Plan | ||||||
| Common stock, issued | 76,915 |
Stockholders' Deficit - Amended and Restated Charter and Bylaws (Details) |
Feb. 01, 2019
director
$ / shares
shares
|
Dec. 31, 2019
shares
|
Jan. 31, 2019
shares
|
Dec. 31, 2018
shares
|
Feb. 28, 2018
shares
|
Dec. 31, 2017
shares
|
|---|---|---|---|---|---|---|
| Equity [Abstract] | ||||||
| Common Stock, Shares Authorized | shares | 100,000,000 | 100,000,000 | 275,000,000 | 275,000,000 | 275,000,000 | 75,000,000 |
| Number of board of directors | director | 7 | |||||
| Term of the changes under A&R Charter | 2 years | |||||
| Lock up period | 90 days | |||||
| Standstill period | 24 months | |||||
| Number of nominee to board of directors | director | 2 | |||||
| Percentage of equity consideration received on effective date | 25.00% | |||||
| Warrants issued | shares | 4,972,365 | |||||
| Exercise price (in dollars per share) | $ / shares | $ 0.001 | |||||
| Percentage of increase in aggregate ownership | 49.00% | |||||
| Outstanding period | 18 months | |||||
| Terms of registration right agreement | 180 days |
Subsequent Events (Details) $ / shares in Units, $ in Thousands |
Mar. 16, 2020
USD ($)
$ / shares
|
Dec. 31, 2019
USD ($)
$ / shares
|
Feb. 01, 2019
USD ($)
|
Jan. 31, 2019
USD ($)
|
Dec. 31, 2018
USD ($)
$ / shares
|
|---|---|---|---|---|---|
| Subsequent Event [Line Items] | |||||
| Common stock, par value | $ 0.001 | $ 0.001 | |||
| Cash and cash equivalents | $ | $ 11,965 | $ 17,047 | $ 36,785 | $ 35,323 | |
| Subsequent events | |||||
| Subsequent Event [Line Items] | |||||
| Common stock, par value | $ 0.0001 | ||||
| Exchange Ratio | 2.5 | ||||
| Subsequent events | Mergersub | |||||
| Subsequent Event [Line Items] | |||||
| Common stock, par value | $ 0.001 | ||||
| Subsequent events | Mergersub | Minimum | |||||
| Subsequent Event [Line Items] | |||||
| Cash and cash equivalents | $ | $ 25,000 |