Exhibit 99.3
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
F-1
Report of Independent Registered Public Accounting Firm
To the Shareholders and Board of Directors of Osmotica Pharmaceuticals plc
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Osmotica Pharmaceuticals plc (the Company) as of December 31, 2020 and 2019, the related consolidated statements of operations and comprehensive loss, changes in shareholders’ equity and cash flows for each of the two years in the period ended December 31, 2020, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2020 and 2019, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2020, in conformity with U.S. generally accepted accounting principles.
The Company's Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the financial statements, the Company has suffered recurring losses from operations, has a working capital deficiency, and has stated that substantial doubt exists about the Company’s ability to continue as a going concern. Management's evaluation of the events and conditions and management’s plans regarding these matters are also described in Note 3. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2019.
Iselin, New Jersey
March 30, 2021
except for Note 3, as to which the date is September 8, 2021, and except for the effects of the discontinued operations described in Note 4, as to which the date is September 8, 2021
F-2
OSMOTICA PHARMACEUTICALS PLC
Consolidated Balance Sheets
(In thousands, except share and per share data)
| December 31, 2020 |
| December 31, 2019 | |||
Assets |
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Current assets: |
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Cash and cash equivalents | $ | | $ | | ||
Trade accounts receivable, net |
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Inventories, net |
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Prepaid expenses and other current assets |
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Assets held for sale | | | ||||
Total current assets |
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Property, plant and equipment, net |
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Operating lease assets | | | ||||
Intangibles, net |
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Goodwill |
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Other non-current assets | | | ||||
Assets held for sale |
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Total assets | $ | | $ | | ||
Liabilities and Shareholders' Equity |
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Current liabilities: |
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Trade accounts payable | $ | | $ | | ||
Accrued liabilities |
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Current portion of obligation under finance leases | |
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Current portion of lease liability | | | ||||
Income taxes payable - current portion |
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Liabilities held for sale | | | ||||
Total current liabilities |
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Long-term debt, net of non-current deferred financing costs |
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Long-term portion of obligation under finance leases |
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Long-term portion of lease liability | | | ||||
Deferred taxes |
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Liabilities held for sale | | | ||||
Total liabilities |
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Commitments and contingencies (See Note 16) |
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Shareholders' equity: |
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Ordinary shares ($0.01 nominal value | | | ||||
Preferred shares ($ | — | — | ||||
Euro deferred shares (€ | — | — | ||||
Additional paid in capital | | | ||||
Accumulated deficit | ( | ( | ||||
Accumulated other comprehensive loss |
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Total shareholders' equity |
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Total liabilities and shareholders' equity | $ | | $ | |
See accompanying notes to consolidated financial statements.
F-3
OSMOTICA PHARMACEUTICALS PLC
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
Year Ended December 31, | ||||||
| 2020 |
| 2019 | |||
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Net product sales | $ | | $ | | ||
Royalty revenue |
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Licensing revenue |
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Total revenues |
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Cost of goods sold |
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Gross profit |
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Selling, general and administrative expenses |
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Research and development expenses |
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Impairment of intangibles | | | ||||
Total operating expenses |
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Operating loss | ( | ( | ||||
Interest expense and amortization of debt discount |
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Other non-operating (gain) loss |
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Total other non-operating expense |
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Loss before income taxes | ( |
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Income tax benefit |
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Loss from continuing operations | ( | ( | ||||
Income (loss) from discontinued operations before income tax expense | | ( | ||||
Income tax expense (benefit) - discontinued operations | | ( | ||||
Income (loss) from discontinued operations, net of tax |
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Net and other comprehensive loss | $ | ( | $ | ( | ||
Other comprehensive loss, net | ||||||
Change in foreign currency translation adjustments | — | ( | ||||
Comprehensive loss | $ | ( | $ | ( | ||
(Loss) income per share attributable to shareholders: | ||||||
Basic and Diluted, continuing operations | $ | ( | $ | ( | ||
Basic and Diluted, discontinued operations | | ( | ||||
Basic and Diluted loss per share | $ | ( | $ | ( | ||
Weighted average shares basic and diluted: |
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Basic and Diluted |
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See accompanying notes to consolidated financial statements.
F-4
OSMOTICA PHARMACEUTICALS PLC
Consolidated Statements of Changes in Shareholders’ Equity/Partners’ Capital
(In thousands, except share data)
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other | ||||||||||||||||||
Ordinary shares | Additional | Accumulated | comprehensive | |||||||||||||||
Shares | Amount | paid in capital | deficit | loss | Total | |||||||||||||
Balance at January 1, 2019 | | $ | | $ | | $ | ( | $ | ( | $ | | |||||||
Repurchase of ordinary shares | ( | ( | ( | — | — | ( | ||||||||||||
Share compensation | — | — | | — | — | | ||||||||||||
Net loss | — | — | — | ( | ( | |||||||||||||
Change in foreign currency translation | — | — | — | — | ( | ( | ||||||||||||
Balance at December 31, 2019 | | | | ( | ( | | ||||||||||||
Repurchase of ordinary shares | ( | ( | ( | — | — | ( | ||||||||||||
Proceeds from issuance of ordinary shares, net of offering costs | | | | — | — | | ||||||||||||
Payments for taxes relatd to the net share settlement of equity awards | — | — | ( | — | — | ( | ||||||||||||
Share compensation | | | | — | — | | ||||||||||||
Net loss | — | — | — | ( | — | ( | ||||||||||||
Balance at December 31, 2020 | | $ | | $ | | $ | ( | $ | ( | $ | |
See accompanying notes to consolidated financial statements.
F-5
OSMOTICA PHARMACEUTICALS PLC
Consolidated Statements of Cash Flows
(In thousands)
Year Ended December 31, | ||||||
| 2020 |
| 2019 | |||
Cash Flows from Operating Activities: |
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Net loss from continuing operations | $ | ( | $ | ( | ||
Net income (loss) from discontinued operations | | ( | ||||
Net loss | ( | ( | ||||
Adjustments to reconcile net loss to net cash provided by operating activities: |
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Depreciation and amortization |
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Share compensation | | | ||||
Impairment of intangibles | | | ||||
Deferred income tax benefit |
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Loss on sale of fixed and leased assets | | | ||||
Bad debt provision |
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Amortization of deferred financing and loan origination fees | | | ||||
Write off of deferred financing fees in connection with prepayment | | — | ||||
Change in operating assets and liabilities: |
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Trade accounts receivable, net |
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Inventories, net |
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Prepaid expenses and other current assets |
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Trade accounts payable |
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Accrued and other current liabilities |
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Net cash provided by operating activities |
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Cash Flows from Investing Activities: |
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Proceeds from sale of fixed and leased assets | | | ||||
Payments on disposal of leased assets | ( | ( | ||||
Purchase of property, plant and equipment | ( | ( | ||||
Net cash used in investing activities |
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Cash flows from Financing Activities: |
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Payments on finance lease obligations |
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Proceeds from public offering, net of issuance costs | | — | ||||
Proceeds from purchases of stock under ESPP | | — | ||||
Debt repayment | ( | — | ||||
Repurchases of ordinary shares | ( | ( | ||||
Payments for taxes related to net share settlement of equity awards | ( | — | ||||
Proceeds from insurance financing loan |
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Repayment of insurance financing loan | — | ( | ||||
Net cash provided by (used in) financing activities |
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Net change in cash and cash equivalents -continuing operations |
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Effect on cash of changes in exchange rate | — | | ||||
Cash and cash equivalents, beginning of period |
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Cash and cash equivalents, end of period | $ | | $ | | ||
Supplemental disclosure of cash and non-cash transactions: |
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Cash paid for interest | $ | | $ | | ||
Cash paid for taxes | $ | | $ | |
See accompanying notes to consolidated financial statements.
F-6
OSMOTICA PHARMACEUTICALS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1. Organization and Nature of Operations
Osmotica Pharmaceuticals plc, an Irish public limited company (the “Company”), together with its subsidiaries, is a specialty pharmaceutical company focused on the development and commercialization of products that target markets with underserved patient populations. In July 2020, the Company received regulatory approval from the FDA for RVL-1201, or Upneeq, (oxymetazoline hydrocholoride ophthalmic solution, 0.1%), for the treatment of acquired blepharoptosis, or droopy eyelid, in adults. Upneeq was commercially launched September 2020 to a limited number of eye care professionals with commercialization operations expanded in 2021 among ophthalmology, optometry and oculoplastic specialties.
On June 24, 2021, the Company entered into an agreement for the divestiture of the Company’s portfolio of branded and non-promoted products and its Marietta, Georgia manufacturing facility (the “Legacy Business”) to certain affiliates of Alora Pharmaceuticals, or Alora, for total consideration of approximately $
With the divestiture of the Legacy Business the Company’s commercial operations will be conducted by its wholly-owned subsidiaries, RVL Pharmaceuticals, Inc. and RVL Pharmacy, LLC, or RVL. RVL operates pharmacy operations dedicated to the processing and fulfillment of prescriptions for Upneeq.
Note 2. Basis of Presentation and Summary of Significant Accounting Policies
Significant Accounting Policies
Basis of Presentation—The accompanying consolidated financial statements included herein have been prepared by the Company in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
Principles of Consolidation—The accompanying consolidated financial statements include the accounts of Osmotica Pharmaceuticals plc and its wholly-owned domestic and foreign subsidiaries. All inter-company transactions and balances have been eliminated in consolidation. The Company is not involved with variable interest entities.
Discontinued Operations— Upon divestiture of a business, the Company classifies such business as a discontinued operation, if the divested business represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results. The divestiture of the Legacy Business qualifies as a discontinued operation nd therefore have been presented as such. The results of businesses that have qualified as discontinued operations have been presented as such for all reporting periods. Results of discontinued operations include all revenues and expenses directly derived from such businesses; general corporate overhead is not allocated to discontinued operations.
Use of Estimates—The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the condensed consolidated financial statements and accompanying notes. Management bases it estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.
Foreign Currency Translation—The financial position and results of operations of the Company’s non-U.S. subsidiaries are generally determined using U.S. Dollars as the functional currency. Our subsidiary in Argentina is currently operating in a highly inflationary environment, as a result, we account for translation in accordance with US GAAP.
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Foreign currency transaction gains and losses are included in selling, general and administrative expenses in the Company’s statements of operations.
Cash and Cash Equivalents—The Company considers all highly liquid investments with an original maturity date of three months or less to be cash equivalents.
Fair Value of Financial Instruments—The Company applies Accounting Standards Committee or ASC 820, Fair Value Measurement (“ASC 820”), which establishes a framework for measuring fair value and clarifies the definition of fair value within that framework. ASC 820 defines fair value as an exit price, which is the price that would be received for an asset or paid to transfer a liability in the Company’s principal or most advantageous market in an orderly transaction between market participants on the measurement date. The fair value hierarchy established in ASC 820 generally requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s judgments about the assumptions that market participants would use in pricing the asset or liability and are to be developed based on the best information available in the circumstances.
The Company’s financial instruments include cash and cash equivalents, accounts receivable, accounts payable and short and long-term debt. The fair values of these financial instruments approximate book value because of the short maturity of these instruments.
The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below:
Level 1 — Assets and liabilities with unadjusted, quoted prices listed on active market exchanges. Inputs to the fair value measurement are observable inputs, such as quoted prices in active markets for identical assets or liabilities.
Level 2 — Inputs to the fair value measurement are determined using prices for recently traded assets and liabilities with similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals.
Level 3 — Inputs to the fair value measurement are unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities.
Inventories—Inventories are stated at the lower of cost or net realizable value at approximate costs determined on the first-in first-out basis. The Company maintains an allowance for excess and obsolete inventory as well as inventory where the cost is in excess of its net realizable value (“NRV”) based on management’s assessments. The Company capitalizes inventory costs associated with its products prior to regulatory approval when, based on management judgement, future commercialization is considered probable and future economic benefit is expected to be realized. As of December 31, 2020 and 2019, there were no capitalized inventory costs associated with products that had not yet achieved regulatory approval. The Company assesses the regulatory approval process and where the product stands in relation to that approval process including any known constraints or impediments to approval. The Company also considers the shelf life of the product in relation to the product timeline for approval. Sample inventory utilized for promoting the Company’s products are expensed and included in cost of goods sold when the sample units are purchased or manufactured.
Property, Plant and Equipment—Property, plant and equipment is stated at cost, less accumulated depreciation. Maintenance and repairs are charged to expense when incurred. Additions and improvements that extend the economic useful life of the asset are capitalized and depreciated over the remaining useful lives of the assets. The cost and accumulated depreciation of assets sold or retired are removed from the respective accounts, and any resulting gain or
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loss is reflected in current earnings. Depreciation is provided using the straight-line method in amounts considered to be sufficient to amortize the cost of the assets to operations over their estimated useful lives or lease terms, as follows:
Asset category |
| Depreciable life |
Leasehold improvements |
| Lesser of the useful life of the improvement or the terms of the underlying lease |
Machinery |
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Furniture, fixtures and equipment |
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Computer hardware and software |
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Long-Lived Assets, Including Definite-Lived Intangible Assets—Intangible assets are stated at cost less accumulated amortization. Amortization is generally recorded on a straight-line basis or based on the expected pattern of cash flows over estimated useful lives ranging from
Long-lived assets, other than goodwill and other indefinite-lived intangibles, are evaluated for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable through the estimated undiscounted future cash flows derived from such assets.
Factors that the Company considers in deciding when to perform an impairment review include significant changes in the Company’s forecasted projections for the asset or asset group for reasons including, but not limited to, significant under-performance of a product in relation to expectations, significant changes, or planned changes in the Company’s use of the assets, significant negative industry or economic trends, and new or competing products that enter the marketplace. The impairment test is based on a comparison of the undiscounted cash flows expected to be generated from the use of the asset group. If impairment is indicated, the asset is written down by the amount by which the carrying value of the asset exceeds the related fair value of the asset with the related impairment charge recognized within the statements of operations.
The Company recorded impairment charges of
million and million, in regard to definite-lived and indefinite-lived intangible assets for the years ended December 31, 2020 and 2019, respectively (see Note 9).Goodwill and Indefinite Lived Intangible Assets—Goodwill, which represents the excess of purchase price over the fair value of net assets acquired, is carried at cost. Goodwill is not amortized; rather, it is subject to a periodic assessment for impairment by applying a fair value-based test. The Company is organized in
In-Process Research and Development (“IPR&D”) intangible assets represent the value assigned to acquired Research & Development (“R&D”) projects that principally represent rights to develop and sell a product that the Company has
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acquired which have not yet been completed or approved. These assets are subject to impairment testing until completion or abandonment of each project. Impairment testing requires the development of significant estimates and assumptions involving the determination of estimated net cash flows for each year for each project or product (including net revenues, cost of sales, R&D costs, selling and marketing costs and other costs which may be allocated), the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of each asset’s life cycle, the potential regulatory and commercial success risks, and competitive trends impacting each asset and related cash flow stream as well as other factors. The major risks and uncertainties associated with the timely and successful completion of the IPR&D projects include legal risk, market risk and regulatory risk. If applicable, upon abandonment of the IPR&D product, the assets are reduced to zero. IPR&D is assessed for impairment on an annual basis as of October 1st of each year or more frequently if events or changes in circumstances indicate that the asset might be impaired. If the fair value of the IPR&D is less than its carrying amount, an impairment is recognized for the difference. The Company recognized an impairment charge to IPR&D of $
Product Sales—Revenue is recognized at the point in time when the Company’s performance obligations with the applicable customers have been satisfied. At contract inception, the Company determines if the contract is within the scope of ASC Topic 606 and then evaluates the contract using the following five steps: (1) identify the contract with the customer; (2) identify the performance obligations; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations; and (5) recognize revenue at the point in time when the entity satisfies a performance obligation.
Revenue is recorded at the transaction price, which is the amount of consideration the Company expects to receive in exchange for transferring products to a customer. The Company considered the unit of account for each purchase order that contains more than one product. Because all products in a given purchase order are generally delivered at the same time and the method of revenue recognition is the same for each, there is no need to separate an individual order into separate performance obligations. The Company determines the transaction price based on fixed consideration in its contractual agreements, which includes estimates of variable consideration, and the transaction price is allocated entirely to the performance obligation to provide pharmaceutical products. In determining the transaction price, a significant financing component does not exist since the timing from when the Company delivers product to when the customers pay for the product is less than one year and the customers do not pay for product in advance of the transfer of the product.
The Company records product sales net of any variable consideration, which includes estimated chargebacks, certain commercial rebates, and discounts and allowances. The Company utilizes the expected value method to estimate all elements of variable consideration included in the transaction price. The variable consideration is recorded as a reduction of revenue at the time revenues are recognized. The Company will only recognize revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration amount received and the Company will re-assess these estimates each reporting period to reflect known changes in factors.
Royalty Revenue—For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all the royalty has been allocated has been satisfied (or partially satisfied).
Licensing Revenue— We recognize development and regulatory milestone revenue from milestone events under our license agreement that have been achieved and the Company is reasonably certain such revenues would not have to be reversed (see Note 5). Sales deductions, such as returns on product sales, government program rebates, price adjustments, and prompt pay discounts in regard to licensing revenue is generally the responsibility of the Company’s licensee partners and not recorded by the Company.
Freight—The Company records amounts billed to customers for shipping and handling as revenue, and records shipping and handling expenses related to product sales as cost of goods sold. 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
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shipping and handling costs are incurred after a customer obtains control of the products, the Company also has elected to account for these as costs to fulfill the promise and not as a separate performance obligation.
Business Combinations—The Company accounts for its business combinations under the provisions of ASC Topic 805, Business Combinations (“ASC 805”), which requires that the purchase method of accounting be used for all business combinations. Assets acquired, and liabilities assumed, are recorded at the date of acquisition at their respective fair values. Amounts allocated to acquire IPR&D are capitalized at the date of an acquisition and are not amortized. As products in development are approved for sale, amounts are allocated to product rights and licenses and amortized over their estimated useful lives. Definite-lived intangible assets are amortized over the expected life of the asset. Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.
Goodwill represents the excess purchase price over the fair value of the tangible net assets and intangible assets acquired in a business combination. Acquisition-related expenses are recognized separately from business combinations and are expensed as incurred. If the business combination provides for contingent consideration, the Company records the contingent consideration at fair value at the acquisition date. Changes in fair value of contingent consideration resulting from events after the acquisition date, such as earn-outs, are recognized as follows: 1) if the contingent consideration is classified as equity, the contingent consideration is not re-measured and its subsequent settlement is accounted for within equity, or 2) if the contingent consideration is classified as a liability, the changes in fair value are recognized in earnings.
Purchases of developed products and licenses that are accounted for as an asset acquisition are capitalized as intangible assets and amortized over an estimated useful life. IPR&D assets acquired as part of an asset acquisition are expensed immediately if they have no alternative future uses. There were
In-Process Research and Development—In-process research and development represent the fair value assigned to incomplete research projects that the Company acquires through business combinations or developed internally which, at that time, have not reached technological feasibility. Intangible assets associated with IPR&D projects are not amortized until regulatory approval is obtained and product is launched, subject to certain specified conditions and management judgment. The useful life of an amortizing asset generally is determined by identifying the period in which substantially all of the cash flows are expected to be generated. During the years ended December 31, 2020 and 2019, there was $
Research and Development Costs—Research and development costs are expensed as incurred. These expenses include the costs of proprietary efforts, as well as costs incurred in connection with certain licensing arrangements. Upfront payments are recorded when incurred, and milestone payments are recorded when the specific milestone has been achieved.
Advertising—Advertising expense consists primarily of print media promotional materials. Advertising costs are expensed as incurred. Advertising expense for the years ended December 31, 2020 and 2019 amounted to $
Share-based Compensation—The Company recognizes share-based compensation expense for all options and other arrangements within the scope of ASC 718, Stock Compensation. Share-based compensation expense is measured at the date of grant, based on the fair value of the award. Compensation for share-based awards with vesting conditions other than service are recognized at the time that those conditions will be achieved. Forfeitures are recognized as they are incurred.
Income Taxes—Income taxes are accounted for under the asset and liability method. 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. Deferred tax assets and liabilities are
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measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. Where applicable, the Company records a valuation allowance to reduce any deferred tax assets that it determines will not be realizable in the future.
The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position. These tax benefits are measured based on the largest benefit that has a greater than
Comprehensive income (loss)—Comprehensive income (loss) refers to revenues, expenses, gains and losses that under U.S. GAAP are included in comprehensive loss but are excluded from net loss as these amounts are recorded directly as an adjustment to accumulated other comprehensive income (loss). The Company’s other comprehensive loss is comprised of foreign currency translation adjustments.
Basic and Diluted Loss per Share—Basic and diluted net loss per share is determined by dividing net loss by the weighted average ordinary shares outstanding during the period. For all periods presented with a net loss, the shares underlying the common share options have been excluded from the calculation because their effect would have been anti-dilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per share are the same for periods with a net loss.
Segment Reporting—The Company operates in
Recently Adopted Accounting Standards
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which introduces a new methodology for accounting for credit losses on financial instruments, including available-for-sale debt securities. The guidance establishes a new “expected loss model” that requires entities to estimate current expected credit losses on financial instruments by using all practical and relevant information. The estimate of credit losses must be based on all relevant information including historical information, current conditions, and reasonable and supportable forecasts that affect the collectability of the amounts. The Company adopted this standard on January 1, 2020, and there was no material impact to the Company’s consolidated financial statements. The Company has provided additional disclosures as required by the standard upon adoption. Refer to Note 6 for additional details.
Note 3. Going Concern Evaluation
As of December 31, 2020, the Company’s cash and cash equivalents totaled $
As a result of the Transaction, the Company divested substantially all its revenue generating assets and the Company’s business plan is focused on the launch of its commercial product, Upneeq, which will diminish the Company’s cash flows in at least the near term, in particular cash inflows from product sales. The Company will require additional capital
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to repay the remaining portion of its term loans, fund its operating needs, including the commercialization of Upneeq and other activities. Accordingly, the Company expects to incur significant expenditures and increasing operating losses in the future. As a result, the Company’s current sources of liquidity will not be sufficient to meet its obligations for the 12 months following the date the consolidated financial statements contained in this Current Report on Form 8-K are issued. These conditions give rise to substantial doubt as to the Company’s ability to operate as a going concern. The Company’s ability to continue as a going concern will require the Company to obtain additional funding, generate positive cash flow from operations and/or enter into strategic alliances or sell assets.
The Company’s plans to address these conditions include pursuing one or more of the following options to secure additional funding, none of which can be guaranteed or are entirely within our control:
There can be no assurance that the Company will receive cash proceeds from any of these potential resources or, to the extent cash proceeds are received, such proceeds would be sufficient to support the current operating plan for at least the next 12 months from the date the consolidated financial statements contained in this Current Report on Form 8-K are issued. The sale of additional equity or convertible debt securities may result in additional dilution to our stockholders. If the Company raises additional funds through the issuance of debt securities or preferred stock or through additional credit facilities, these securities and/or the loans under credit facilities could provide for rights senior to those of our ordinary shares and could contain covenants that would restrict our operations. Additional funds may not be available when we need them, on terms that are acceptable to us, or at all.
Our audited consolidated financial statements have been prepared on a going concern basis, which assumes the realization of assets and settlement of liabilities in the normal course of business. The Company’s ability to continue as a going concern is dependent on the ability to obtain the necessary financing to meet the Company’s obligations and repay liabilities arising from the normal business operations when they become due. The outcome of these matters cannot be predicted with any certainty at this time and raise substantial doubt that the Company will be able to continue as a going concern. The audited consolidated financial statements do not include any adjustments to the amount and classification of assets and liabilities that may be necessary should the Company be unable to continue as a going concern.
Note 4. Discontinued Operations
On August 27, 2021, we closed the divestiture of our Legacy Business and received total cash consideration of approximately $
We have determined the divestiture of the Legacy Business represents a strategic shift that will have a major effect on our business and therefore met the criteria for classification as discontinued operations at December 31, 2020. Accordingly, the assets and liabilities associated with the Legacy Business have been classified as held for sale in the accompanying Consolidated Balance Sheets at December 31, 2020 and December 31, 2019. The operations and cash flows of the Legacy Business are presented as discontinued for all periods presented.
F-13
Unless otherwise indicated or required by the context, references throughout to "Osmotica," or the "Company", refer to our continuing operations following the sale of the Legacy Business to Alora. A description of our business prior to the consummation of the transaction is included in Item 1. "Business", in Part I of the Annual Report on Form 10-K for the year ended December 31, 2020 that was previously filed with the Securities and Exchange Commission ("SEC") on March 30, 2021. The continuing operations reflect the results of the product Osmolex ER, as discussed in Note 16, the global rights of which were sold in January, 2021; however, as the sale did not qualify for presentation as a discontinued operation, the financial results of Osmolex ER are included within the continuing operations herein.
The following table presents the results of the discontinued operations for the years ended December 31, 2020 and 2019:
Year Ended | ||||||
December 31, | ||||||
| 2020 |
| 2019 | |||
Total revenues | $ | | $ | | ||
Cost of goods sold (exclusive of depreciation and amortization shown separately below) |
| |
| | ||
Selling, general and administrative expense |
| |
| | ||
Depreciation and amortization |
| |
| | ||
Impairment of intangibles |
| |
| | ||
Research and development expenses |
| |
| | ||
Income (loss) from operations |
| |
| ( | ||
Interest expense |
| |
| | ||
Other income, net |
| ( |
| | ||
Income (loss) from discontinued operations before costs of disposal and provision for income taxes |
| |
| ( | ||
Income tax expense (benefit) |
| |
| ( | ||
Income (loss) from discontinued operations before gain on disposal | $ | | $ | ( |
The following table summarizes the carrying amounts of major classes of assets and liabilities of discontinued operations for each of the periods presented.
| December 31, 2020 |
| December 31, 2019 | |||
Cash and cash equivalents | $ | — | $ | — | ||
Accounts receivable, net |
| |
| | ||
Inventories |
| |
| | ||
Prepaid expenses and other current assets |
| |
| | ||
Total current assets of discontinued operations |
| |
| | ||
Property, plant and equipment, net |
| |
| | ||
Operating lease right-of-use assets |
| |
| | ||
Goodwill |
| |
| | ||
Intangible assets, net |
| |
| | ||
Total non-current assets of discontinued operations |
| |
| | ||
Total assets of discontinued operations | $ | | $ | | ||
Accounts payable |
| |
| | ||
Accrued liabilities |
| |
| | ||
Current portion of operating lease liabilities |
| |
| | ||
Total current liabilities of discontinued operations |
| |
| | ||
Operating lease liabilities, net of current portion |
| |
| | ||
Total non-current liabilities of discontinued operations |
| |
| | ||
Total liabilities of discontinued operations |
| |
| | ||
Net assets of discontinued operations | $ | | $ | |
F-14
The following table presents the significant non-cash items and purchases of property, plant and equipment for the discontinued operations for the Legacy Business that are included in the accompanying consolidated statements of cash flows.
Year Ended | ||||||
December 31, | ||||||
Cash flows from operating activities: |
| 2020 |
| 2019 | ||
Depreciation and amortization | $ | | $ | | ||
Share compensation |
| |
| | ||
Impairment of intangibles |
| |
| | ||
Cash flows from investing activities: |
|
|
|
| ||
Purchase of property, plant and equipment | $ | ( | $ | ( |
Note 5. Revenues
The Company’s performance obligations are to provide its pharmaceutical products based upon purchase orders from distributors. The performance obligation is satisfied at a point in time, typically upon delivery, when the customer obtains control of the pharmaceutical product. The Company either collects payment in advance from its customers or invoices after the products have been delivered and invoice payments are generally due within
The following table disaggregates revenue from contracts with customers by pharmaceutical products (in thousands):
Year Ended December 31, | ||||||
Pharmaceutical Product |
| 2020 |
| 2019 | ||
Upneeq net product sales | $ | | $ | — | ||
Osmolex | | | ||||
Net product sales |
| |
| | ||
Royalty revenue |
| |
| | ||
Licensing revenue | | — | ||||
Total revenues | $ | | $ | |
On July 28, 2020, the Company entered into a License Agreement with Santen Pharmaceutical Co. Ltd, granting Santen exclusive development, registration, and commercialization rights to RVL-1201 in Japan, China, and other Asian countries as well as Europe, the Middle East and Africa (“EMEA”) countries. Under the agreement the Company is entitled to certain development and regulatory milestone payments. The Company is also entitled to royalty payments on net sales of RVL-1201 in Santen commercialization territories. During the year ended December 31, 2020, the Company received a $
When the Company receives consideration from a customer, or such consideration is unconditionally due from a customer prior to the transfer of products to the customer under the terms of a contract, the Company records a contract liability. The Company classifies contract liabilities as deferred revenue. The Company had an immaterial amount of deferred revenue as of December 31, 2020 and 2019. The Company has elected to apply the exemption under paragraph 606-10-50-14(a) related to remaining performance obligations as all open purchase orders are expected to be satisfied with a period of one year from the date of the purchase order.
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, 2020 and 2019, respectively. The Company has
costs to obtain or fulfill contracts meeting the capitalization criteria under ASC Topic 340, Other Assets and Deferred Costs.F-15
Note 6. Accounts Receivable, Sales and Allowances
Accounts receivable result primarily from sales of pharmaceutical products, amounts due under revenue sharing, license and royalty arrangements.
The Company is exposed to credit losses primarily through sales of its products. Prior to January 1, 2020, accounts receivable were recorded at cost less an allowance for doubtful accounts. Subsequent to January 1, 2020, accounts receivable are recorded at amortized cost less an allowance for expected credit losses that are not expected to be recovered. The Company’s expected loss methodology for accounts receivable is developed using historical collection experience, a review of the current status of customer’s trade receivables, and current and future market conditions. Due to the short-term nature of such receivables, the estimate of accounts receivable that may not be collected is based on the aging of accounts receivable balances and the financial condition of customers. The Company’s monitoring activities include timely account reconciliations, dispute resolution, payment confirmation, consideration of customers’ financial condition and macroeconomic conditions. Balances are written-off when determined to be uncollectible. The Company considered the current and expected future economic and market conditions surrounding a novel strain of the coronavirus, referred to as 2019-ncov, COVID-19 coronavirus epidemic, or COVID-19, and determined that the estimate of credit losses was not significantly impacted.
With the exception of the allowance for credit losses, which is reflected as part of selling, general and administrative expense, the provisions for the following customer reserves are reflected as a reduction of revenues in the accompanying Consolidated Statements of Operations and Comprehensive Loss.
Trade accounts receivable, net consists of the following (in thousands):
| December 31, |
| December 31, | |||
2020 | 2019 | |||||
Gross trade accounts receivable: |
|
|
|
| ||
Trade accounts receivable | $ | | $ | | ||
Royalty accounts receivable | | | ||||
Other receivable |
| |
| | ||
Less reserves for: |
|
| ||||
Commercial rebates | ( | ( | ||||
Discounts and allowances | ( | ( | ||||
Total trade accounts receivable, net | $ | | $ | |
For the years ended December 31, 2020 and 2019, the Company recorded the following adjustments to gross product sales (in thousands):
Year Ended December 31, | ||||||
| 2020 |
| 2019 | |||
Gross product sales | $ | | $ | | ||
Less provisions for: |
|
| ||||
Chargebacks |
| ( |
| — | ||
Government and managed care rebates |
| ( |
| ( | ||
Commercial rebates |
| ( |
| ( | ||
Product returns |
| ( |
| ( | ||
Discounts and allowances |
| ( |
| ( | ||
Advertising and promotions |
| ( |
| ( | ||
Net product sales | $ | | $ | |
F-16
For the years ended December 31, 2020 and 2019, the activity in the Company’s allowance for customer deductions against trade accounts receivable is as follows (in thousands):
|
| Discounts |
| ||||||
Commercial | and | ||||||||
Rebates | Allowances | Total | |||||||
Balance at December 31, 2018 | $ | — | $ | — | $ | — | |||
Provision | | | | ||||||
Charges processed | ( | ( | ( | ||||||
Balance at December 31, 2019 | $ | | $ | | $ | | |||
Provision | | | | ||||||
Charges processed | ( | ( | ( | ||||||
Balance at December 31, 2020 | $ | | $ | | $ | |
Note 7. Inventories
The components of inventories, net of allowances, are as follows (in thousands):
| December 31, |
| December 31, | |||
2020 | 2019 | |||||
Finished goods | $ | | $ | | ||
Work in process |
| |
| - | ||
Raw materials and supplies |
| |
| | ||
$ | | $ | |
Note 8. Property, Plant and Equipment, Net
Property, plant and equipment consist of the following (in thousands):
| Year Ended | |||||
December 31, | December 31, | |||||
2020 |
| 2019 | ||||
Leasehold improvements | $ | | $ | | ||
Machinery | | | ||||
Furniture, fixtures and equipment | | | ||||
Computer hardware and software | | | ||||
| |
| | |||
Accumulated depreciation | ( | ( | ||||
| | |||||
Construction in progress | | | ||||
$ | | $ | |
Depreciation expense was $
F-17
Note 9. Goodwill and Other Intangible Assets
The Company tests goodwill and indefinite-lived intangible assets for impairment annually as of October 1st, or more frequently whenever events or changes in circumstances indicate that the asset might be impaired. The assessment of goodwill has been based on the historical goodwill for the continuing and discontinued operations of the business on a combined basis which was $
| Goodwill | ||
January 1, 2019 | $ | | |
Impairments | — | ||
December 31, 2019 | | ||
Impairments | — | ||
December 31, 2020 | $ | |
The following tables sets forth the major categories of the Company’s intangible assets and the weighted-average remaining amortization period as of December 31, 2020 and 2019, for those assets that are not already fully amortized (in thousands):
December 31, 2020 | ||||||||||||||
|
|
|
|
| Weighted | |||||||||
Average | ||||||||||||||
Gross | Net | Remaining | ||||||||||||
Carrying | Accumulated | Carrying | Amortization | |||||||||||
Amount | Amortization | Impairment | Amount | Period (Years) | ||||||||||
IPR&D | $ | | $ | — | $ | ( | $ | |
| Indefinite Lived | ||||
$ | | $ | — | $ | ( | $ | |
|
|
December 31, 2019 | ||||||||||||||
|
|
|
|
| Weighted | |||||||||
Average | ||||||||||||||
Remaining | ||||||||||||||
Gross | Net | Amortization | ||||||||||||
Carrying | Accumulated | Carrying | Period | |||||||||||
Amount | Amortization | Impairment | Amount | (Years) | ||||||||||
Product Rights | $ | | $ | ( | $ | ( | $ | — |
| — | ||||
IPR&D | $ | | $ | — | $ | — | $ | | Indefinite Lived | |||||
$ | | $ | ( | $ | ( | $ | |
|
|
Changes in intangible assets during the years ended December 31, 2019 and 2020, were as follows (in thousands):
| Intangible Assets |
| Total | |||
January 1, 2019 | $ | | $ | | ||
Amortization | ( | ( | ||||
Impairments | ( | ( | ||||
December 31, 2019 | | | ||||
Amortization | — | — | ||||
Impairments | ( | ( | ||||
December 31, 2020 | $ | | $ | |
As part of the Company’s goodwill and intangible asset impairment assessments performed on the annual assessment date, when indicators of impairment are identified and when IPR&D assets are put into service, when a qualitative assessment is performed, the Company estimates the fair values of the intangible assets using an income approach that utilizes a discounted cash flow model, or, where appropriate, a market approach. The discounted cash flow models are
F-18
dependent upon our estimates of future cash flows and other factors. These estimates of future cash flows involve assumptions concerning (i) future operating performance, including future sales, long-term growth rates, operating margins, variations in the amounts, allocation and timing of cash flows and the probability of achieving the estimated cash flows and (ii) future economic conditions. These assumptions are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. As of October 1, 2020, the Company performed a qualitative assessment for goodwill and for the IPR&D assets and concluded that the assets were not impaired. The discount rates applied to the estimated cash flows for the Company’s 2019 annual goodwill and indefinite-lived intangible assets impairment test was
Impairments of intangible assets for the year-ended December 31, 2020 was $
During 2019, we recognized an impairment of finite-lived intangible assets of
million, consisting primarily of the write-off of Osmolex ER. Osmolex ER was impaired due to underperforming revenue expectations subsequent to the launch of the product.Amortization expense was $
Note 10. Accrued Liabilities
Accrued liabilities consist of the following (in thousands):
| December 31, |
| December 31, | |||
2020 | 2019 | |||||
Accrued chargeback | $ | | $ | | ||
Accrued product returns | | | ||||
Accrued royalties | | — | ||||
Accrued compensation |
| |
| | ||
Accrued government and managed care rebates | | | ||||
Accrued research and development | | | ||||
Accrued expenses and other liabilities |
| |
| | ||
Customer coupons | | | ||||
Total | $ | | $ | |
Note 11. Leases
The Company leases office space in Bridgewater, New Jersey for its principal offices under
We assess whether an arrangement is a lease or contains a lease at inception. For arrangements considered leases or that contain a lease that is accounted for separately, we determine the classification and initial measurement of the right-of-
F-19
use asset and lease liability at the lease commencement date, which is the date that the underlying asset becomes available for use. The Company has elected to account for non-lease components associated with our leases and lease components as a
lease component.The Company recognizes a right-of use asset, which represents the Company’s right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments arising over the lease term. The present value of the lease payments are calculated using either the implicit interest rate in the lease or an incremental borrowing rate.
Our lease assets and liabilities were classified as follows on our Condensed Consolidated Balance Sheet at December 31, 2020 (in thousands):
Leases | Classification | Balance at | Balance at | |||||
Assets | ||||||||
Operating | Operating Lease Assets | $ | | $ | | |||
Finance | | | ||||||
Total leased assets | $ | | $ | | ||||
Liabilities | ||||||||
Current | ||||||||
Operating | Current portion of lease liability | $ | | $ | | |||
Finance | Current portion of obligations under finance leases | | | |||||
Non-current | ||||||||
Operating | Long-term portion of lease liability | | | |||||
Finance | Long-term portion of obligations under finance leases | — | | |||||
Total lease liabilities | $ | | $ | |
The Company recognizes lease expense on a straight-line basis over the lease term. The components of lease cost are as follows (in thousands):
Lease Cost | Classification | Year Ended | Year Ended | |||||
Operating lease cost | SG&A expenses | $ | | $ | | |||
R&D expenses | | | ||||||
Cost of goods sold | | — | ||||||
Finance lease cost | ||||||||
Amortization of leased assets | Depreciation and amortization | | | |||||
Interest on lease liabilities | Interest expense | | | |||||
Total lease cost | $ | | $ | |
F-20
The table below shows the future minimum rental payments, exclusive of taxes, insurance and other costs, under the leases as follows (in thousands):
Years ending December 31 |
| Operating Leases | |
2021 | $ | | |
2022 |
| | |
2023 |
| | |
Total lease payments | | ||
Less: interest | | ||
Present value of lease payments | $ | |
The Company has future minimum lease payments required under the finance leases of less than $
The weighted-average remaining lease term and the weighted-average discount rate of our leases were as follows (in thousands):
Lease Term and Discount Rate | December 31, 2020 | December 31, 2019 | |||||
Weighted average remaining lease term (years) | |||||||
Operating leases | |||||||
Finance leases | |||||||
Weighted average discount rate | |||||||
Operating leases | % | % | |||||
Finance leases | % | % | |||||
Other Information | December 31, 2020 | December 31, 2019 | |||||
Cash paid for amounts included in the measurement of lease liabilities: | |||||||
Operating cash flows for operating leases | $ | ( | $ | ( | |||
Operating cash flows for finance leases | ( | ( | |||||
Financing cash flows for finance leases | ( | ( |
For the years ended December 31, 2020 and 2019, the Company recorded $
Note 12. Financing Arrangements
The composition of the Company’s debt and financing obligations are as follows (in thousands):
| December 31, |
| December 31, | |||
2020 | 2019 | |||||
CIT Bank, N.A. Term Loan, net of deferred financing costs of $ | $ | | $ | | ||
Total debt |
| |
| | ||
Less: current portion |
| — |
| — | ||
Long-term debt | $ | | $ | |
F-21
Term Loan
Concurrent with the closing of the Company's acquisition of Osmotica Holdings Corp Limited, the Company entered into a $
The Term Loan Agreement required quarterly principal repayments equal to
On November 10, 2016, the Company amended the Term Loan Agreement (the "First Amendment to the Term Loan Agreement") in conjunction with the reacquisition of venlafaxine distribution rights. Pursuant to the First Amendment to the Term Loan Agreement, CIT Bank and certain other lenders agreed to make available to the Company, an Incremental Term Loan in the aggregate principal amount of $
On April 28, 2017, the Company amended the Term Loan Agreement (the "Second Amendment to the Term Loan Agreement"), in which the due date of the Company's annual financial statements was modified for the first fiscal year after the closing of the Second Amendment to Term Loan Agreement.
On December 21, 2017, the Company amended the Term Loan Agreement (the "Third Amendment to the Term Loan Agreement"). Pursuant to the Third Amendment to the Term Loan Agreement, CIT Bank and certain other lenders agreed to increase the principal amount of the Term Loan to an aggregate principal amount of $
On December 11, 2020, the Company amended the Term Loan Agreement (the "Fourth Amendment to the Term Loan Agreement"). Pursuant to the Fourth Amendment to the Term Loan Agreement, the Term Loan Agreement was amended to, among other things, remove a limit on the exercise of the Company’s right to cure a breach of the financial covenant under the Term Loan Agreement and providing that any proceeds received by the company as a result of the exercise of such cure right will be applied to repay term loans under the Term Loan Agreement.
The Term Loan Agreement requires quarterly principal repayments to
At the Company's election, for the Term A Loan, interest accrues on a Prime Rate/Federal Funds Effective Rate ("ABR Loan") or a LIBOR ("LIBOR Loan") rate in which the applicable rate per annum set forth below under the caption "ABR Spread" or "LIBOR Rate Spread," based upon the Total Leverage Ratio (as defined in the Term Loan Agreement) as of last day of the most recently ended fiscal quarter is as follows:
Total Leverage Ratio |
| LIBOR Rate Margin |
| ABR Margin |
|
Category 1 |
| | % | | % |
Greater than | |||||
Category 2 |
| | % | | % |
Equal to or less than |
F-22
For Term B Loan, interest accrues with respect to any ABR Loan,
The Term Loan Agreement contains covenants that require the Company to deliver quarterly and annual financial statements along with certain supplementary financial information and schedules and ratios. The Term Loan Agreement also contains covenants that limit the ability of the Company to, among other things: incur additional indebtedness; incur liens; make investments; make payments on indebtedness; dispose of assets; enter into merger transactions; and make distributions. In addition, the Company shall not permit the total leverage ratio to be greater than
:1.00 until March 31, 2020 at which time the total leverage ratio remains constant at a required :1.00. The total leverage ratio is the ratio, as of any date of determination, of (a) consolidated total debt, net of unrestricted cash and cash equivalents as of such date to (b) consolidated adjusted earnings before income taxes, depreciation and amortization ("Consolidated EBITDA") for the test period then most recently ended for which financial statements have been delivered. Also, the Company will not permit the fixed charge coverage ratio to fall below :1.0 beginning on March 31, 2018 through the final maturity date. The fixed charge coverage ratio, as of the date of determination, is the ratio of (x) Consolidated EBITDA net of capital expenditures and cash taxes paid to (y) interest payments, scheduled principal payments, restricted payments and management fees paid to related parties. The Company obtained a waiver from CIT Bank in regard to its non-compliance of its covenant to deliver annual financial statements by April 2, 2018. The Company did not incur a waiver fee as a condition to the waiver. The Company was in compliance with all covenants of the Term Loan Agreement as of December 31, 2020 and 2019.As a result, of payments made in 2018, as of both December 31, 2020 and 2019, there are no remaining scheduled installments of principal due in respect of the Term Loans until the final maturity date.
During the year ended December 31, 2020, the Company prepaid $
In accordance with ASC 470, when debt is prepaid within its contractual terms and the terms of the remaining debt are not modified, the prepayment should be treated as a partial extinguishment rather than a modification. This conclusion is reached without regard to consideration of the 10% cash flow test since no change to terms of the original debt instrument was modified in connection with the prepayment. The Third Agreement allows for partial prepayments without creating changes to the terms of Term Loan A or Term Loan B.
The Company incurred debt issuance costs associated with the Third Amendment. Pursuant to ASC 835-30-35-2, with respect to a note for which the imputation of interest is required, the difference between the present value and the face amount shall be treated as a discount or premium and amortized as interest expense or income over the life of the note in such a way as to result in a constant rate of interest when applied to the amount outstanding at the beginning of any given period. As such, in accordance with ASC 835-30-35-2, the Company deferred and amortized the debt issuance costs amortized over the length of the Term Loan using the effective interest method.
As a result of the partial extinguishment, the Company has elected, as an accounting policy in accordance with ASC 470-50-40-2, to write off a proportionate amount of the unamortized fees at the time that the financing was partially settled in accordance with the terms of the Third Amendment. The unamortized debt issuance costs are allocated between the remaining original loan balance and the portion of the loan paid down on a pro-rata basis. The Company wrote off $
F-23
Revolving Facility
Concurrent with the closing of the Company's acquisition of Osmotica Holdings Corp Limited, the Company entered into a Revolving Facility in an aggregate amount of $
On December 21, 2017, the Company amended the Revolving Facility (the "Amended Revolving Facility"). Pursuant to the Amended Revolving Facility, CIT Bank and certain other lenders agreed to increase the revolving credit commitments up to $
The total amount available under the Revolving Facility includes a Swingline Loan and Letter of Credit subfacility, respectively, in an aggregate principal amount at any time outstanding not to exceed the lesser of
The Company will be required to repay the Revolving Facility upon its expiration
Total Leverage Ratio |
| LIBOR Rate Margin |
| ABR Margin |
| Commitment Fee |
|
Category 1 |
| | % | | % | | % |
Greater than | |||||||
Category 2 |
| | % | | % | | % |
Equal to or less than |
At December 31, 2020 and 2019, there were no outstanding borrowings or outstanding letters of credit. Availability under the Revolving Facility as of December 31, 2020, was $
Note 13. Concentrations and Credit Risk
The Company does not have significant concentrations of credit risk with its customers.
Purchasing
The Company does not have significant purchase agreements with third parties.
Sales by Product
For the years ended December 31, 2020 and 2019,
F-24
Royalty Sales
The Company does not have significant concentrations of royalty sales.
Note 14. Shareholders’ Equity
Osmotica Pharmaceuticals plc 2018 Equity Incentive Plan
Prior to the IPO, the Company adopted the 2018 Incentive Plan (the "2018 Plan") which became effective upon our IPO and allows for the issuance of up to
Osmotica Holdings S.C.Sp. 2016 Equity Incentive Plan
Effective February 3, 2016, Osmotica Holdings S.C.Sp. adopted the 2016 Equity Incentive Plan (the "2016 Plan") which allows for the issuance of up to
Amended and Restated Osmotica Pharmaceuticals plc. 2016 Equity Incentive Plan
On August 14, 2018, the board of directors amended and restated the 2016 Plan in connection with the Reorganization. The Amended and Restated 2016 Equity Incentive Plan (the “Amended 2016 Plan”) became effective upon our IPO which closed on October 22, 2018. In connection with the Reorganization, options to purchase common units of Osmotica Holdings S.C.Sp. were converted into options to purchase shares of the Company and existing sales restriction was removed. In connection with the IPO, the number of shares issuable pursuant to the Amended 2016 Plan and the corresponding exercise prices of options were adjusted to reflect a stock split initiated prior to the IPO. Additionally, effective upon the IPO, the Amended 2016 Plan modified the terms of Performance Awards previously issued under the 2016 Plan by converting these awards to time based awards vesting in equal annual installments on the first anniversaries of the IPO, subject to continuous employment. There were
Ordinary Share Repurchase Program
In September 2019, the Company’s board of directors authorized the repurchase of up to
F-25
ordinary shares acquired under the repurchase program. For the years ended December 31, 2020 and 2019, the Company repurchased
2019 Employee Share Purchase Plan
In September 2019, the Company’s board of directors adopted and approved, the Employee Share Purchase Plan (the “ESPP”). The ESPP allows each eligible employee who is participating in the plan to purchase shares by authorizing payroll deductions of up to $
The Company accounts for employee stock purchases made under its ESPP using the estimate grant date fair value of accounting in accordance with ASC 718, Stock Compensation. The purchase price discount and the look-back feature cause the ESPP to be compensatory and the Company to recognize compensation expense. The compensation cost is recognized on a straight-line basis over the requisite service period. The Company recognized $
As of December 31, 2020 and 2019, there were no unrecognized ordinary share compensation expense related to the ESPP. There were
Share-based Compensation
The compensation cost that has been charged against income for all incentive plans was $
F-26
modification where the fair value of such awards determined on a modification date, or the IPO date is being recognized over their remaining vesting period.
Share-Based Award Activity
The following tables of share based activity are based on the historical activity of the continuing and discontinuing operaations of the Company on a combined basis. A summary of option activity granted under the 2016 Plan and the Amended 2016 Plan as of December 31, 2020, and changes during the year then ended is presented below:
2016 Equity Incentive Plan | Weighted | Weighted | |||||||
Average | Average | ||||||||
Number of Shares | Exercise | Contractual | |||||||
| Time |
| Price | Term | |||||
Outstanding at January 1, 2019 | | $ | | ||||||
Granted | — | — | |||||||
Exercised | — | — | |||||||
Expired / Forfeited | ( | $ | | ||||||
Outstanding at December 31, 2019 | | $ | | ||||||
Vested Options at December 31, 2019 | |
| $ | | |||||
Granted | — | — | |||||||
Exercised | — | — | |||||||
Expired / Forfeited | ( | $ | | ||||||
Outstanding at December 31, 2020 | | $ | | ||||||
Vested Options at December 31, 2020 | |
| $ | |
There were
A summary of option activity granted under the 2018 Plan as of December 31, 2020, and changes during the year then ended is presented below:
2018 Equity Incentive Plan | Weighted | Weighted | |||||
Average | Average | ||||||
Number of Shares | Exercise | Contractual | |||||
| Time |
| Price |
| Term | ||
Outstanding at January 1, 2019 |
| | $ | |
| ||
Granted | — | — | |||||
Exercised | — | — | |||||
Expired / Forfeited | ( | $ | | ||||
Outstanding at December 31, 2019 | | $ | | ||||
Vested Options at December 31, 2019 | — | ||||||
Granted | |||||||
Exercised | |||||||
Expired / Forfeited | ( | $ | | ||||
Outstanding at December 31, 2020 | | $ | | ||||
Vested Options at December 31, 2020 | — | — |
There were
The estimated fair value of the options is expensed over the requisite service period, which is generally the vesting period on a graded vesting basis. As of December 31, 2020 and 2019, there was $
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unrecognized compensation cost related to nonvested options granted under the Incentive Plans. That cost is expected to be recognized over a weighted-average period of
The fair value of option awards is estimated using the Black-Scholes option-pricing model. Exercise price of each award is generally not less than the per share fair value in effect as of that award date. The determination of fair value using the Black-Scholes model is affected by the Company’s share fair value as well as assumptions regarding a number of complex and subjective variables, including expected price volatility, risk-free interest rate and projected employee share option exercise behaviors. There were no options granted during 2020 and 2019, respectively.
For all periods prior to the IPO, our Board of Directors has determined the fair value of the common unit underlying our option with assistance from management and based upon information available at the time of grant. Prior to our IPO, given the absence of a public trading market for our common units, estimating the fair value of our common units was based on the actual operational and financial performance, current business conditions and discounted cash flow projections. The estimated fair value of our common units, prior to our IPO was adjusted for lack of marketability and control existing at the grant date.
Restricted and Performance Stock Units
On May 18, 2020 and May 20, 2020, the Company granted performance stock units (“PSUs”) under its existing 2018 Incentive Plan (the “2018 Plan”) to certain key employees of the Company that gives holders the potential to receive a certain number of earned PSUs at the end of a pre-determined term. Unless earlier terminated, forfeited, relinquished or expired, the earned PSUs will vest in full on the vesting date, subject to the grantee remaining in continuous employment from the date of grant through the vesting date. The vesting date is the third anniversary from the grant date for the PSUs granted on May 18, 2020 and the fifth anniversary from the grant date for the PSUs granted on May 20, 2020. The number of PSUs that become earned PSUs as of the end of the performance period shall be equal to the number of PSUs multiplied by the applicable percentage based on Stock Price Hurdle attainment, as set forth in the PSU Award Agreement and 2018 Plan. The fair value of these market-based awards is estimated on the date of grant using a Monte Carlo simulation model with the following assumptions:
Years Ended | |||
| December 31, |
| |
| 2020 |
| |
Expected volatility |
| | % |
Risk-free interest rate |
| % | |
Expected dividend yield |
| — | % |
Performance period in years |
|
The Company estimates its expected volatility by using a combination of historical share price volatilites of similar companies within our industry. The risk-free interest rate assumption is based on observed interest rates for the appropriate term of the Company’s options on a grant date.
As of December 31, 2020 total compensation cost not yet recognized related to unvested PSUs $
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The following table summarizes the information as of December 31, 2020 and activity during 2020 related to our PSUs:
Weighted- | |||||||||
Weighted- | Average Remaining | ||||||||
Number of | Average Grant | Contractual Term | |||||||
PSUs | Date Fair Value | (Years) | |||||||
Outstanding at January 1, 2020 | — | $ | — | — | |||||
PSUs granted | | | — | ||||||
PSUs vested | — | — | — | ||||||
PSUs forfeited | ( | | — | ||||||
Outstanding at December 31, 2020 | | $ | |
During 2020 and 2019 we granted restricted stock units, or RSUs, covering an equal number of our ordinary shares to employees and certain directors with a weighted average grant date fair value of $
The following table summarizes the information as of December 31, 2020 and activity during 2020 related to our RSUs:
Weighted- | |||||||||
Weighted- | Average Remaining | ||||||||
Number of | Average Grant | Contractual Term | |||||||
RSUs | Date Fair Value | (Years) | |||||||
Outstanding at January 1, 2019 | — | $ | — | — | |||||
RSUs granted | | | — | ||||||
RSUs vested | — | — | — | ||||||
RSUs forfeited | ( | | — | ||||||
Outstanding at December 31, 2019 | | $ | | ||||||
RSUs granted | | | — | ||||||
RSUs vested | ( | | — | ||||||
RSUs forfeited | ( | | — | ||||||
Outstanding at December 31, 2020 | | $ | |
2020 Equity Offering
On January 13, 2020 we completed a follow-on equity offering and allotted
On July 16, 2020 we completed a follow-on equity offering and allotted
Note 15. Earnings (Loss) per Ordinary Share
Basic net income (loss) per ordinary share is computed by dividing net income (loss) by the weighted-average number of shares of ordinary shares outstanding during the period. Diluted net income per ordinary shares is computed by dividing net income by the weighted average number of shares of ordinary shares and potentially dilutive outstanding shares of
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ordinary shares during the period to reflect the potential dilution that could occur from ordinary shares issuable through contingent share arrangements, share options and warrants.
The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares and units outstanding as they would have been anti-dilutive at December 31, 2020 and 2019:
Year Ended | ||||
December 31, | ||||
| 2020 |
| 2019 | |
Performance and restricted stock units | | |||
Options to purchase ordinary shares | | |||
Shares to be purchased through employee stock purchase plan | | |
Note 16. Commitments and Contingencies
Contingent Milestone Payments
The Company has entered into strategic business agreements for the development and marketing of finished dosage form pharmaceutical products with various pharmaceutical development companies. Each strategic business agreement includes a future payment schedule for contingent milestone payments and in certain strategic business agreements, minimum royalty payments. The aggregate amount of future potential milestone payments payable in connection with such agreement are currently not material to the Company’s financial statements. The Company will be responsible for contingent milestone payments and minimum royalty payments to these strategic business partners based upon the occurrence of future events. Each strategic business agreement defines the triggering event of its future payment schedule, such as meeting product development progress timelines, successful product testing and validation, successful clinical studies, and various U.S. Food and Drug Administration and other regulatory approvals. The aggregate amount of future potential milestone payments are currently not material to our financial statements.
Royalty Obligations
The Company does not have agreements with third parties that require the Company to make minimum royalty payments.
Supply Agreement Obligations
The Company is engaged in various supply agreements with third parties which obligate the Company to purchase various API or finished products at contractual minimum levels. None of these agreements are individually in the aggregate material to the Company. Further, the Company does not believe at this time that any of the purchase obligations represent levels above that of normal business demands.
The Company has no enforceable and legally binding purchase obligations as of December 31, 2020.
Defined Contribution Plan
Vertical/Trigen and Legacy Osmotica both had a defined contribution plan under Section 401(k) of the Internal Revenue Code ("IRC") as of December 31, 2016 pursuant to the Merger (the "Contribution Plans"). The employees of the respective companies are eligible to participate in the Contribution Plans. Participants may contribute amounts through payroll deductions not to exceed IRC limitations. For the year ended December 31, 2016, the Vertical/Trigen Plan provided for nonelective employer contributions equal to
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Legal Proceedings
The Company is a party in legal proceedings and potential claims arising from time to time in the ordinary course of its business. The amount, if any, of ultimate liability with respect to such matters cannot be determined. Despite the inherent uncertainties of litigation, management of the Company believes that the ultimate disposition of such proceedings and exposures will not have a material adverse impact on the financial condition, results of operations, or cash flows of the Company.
On February 16, 2018, the Company received FDA approval for its amantadine extended release tablets under the trade name Osmolex ER. On that same date the Company filed in the Federal District Court for the District of Delaware a Complaint for Declaratory Judgment of Noninfringement of certain patents owned by Adamas Pharmaceuticals, Inc. (Osmotica Pharmaceutical US LLC and Vertical Pharmaceuticals, LLC vs. Adamas Pharmaceuticals, Inc. and Adamas Pharma, LLC). Adamas was served with the Complaint on February 21, 2018. Adamas filed an answer on April 13, 2018 denying the allegations in the Complaint and reserving the ability to raise counterclaims as the litigation progresses. On September 20, 2018, Adamas filed an amended answer to the Company’s Complaint for Declaratory Judgment of Noninfringement, with counterclaims alleging infringement of certain patents included in the Company’s Complaint and requesting that the court grant Adamas damages, injunctive relief and attorneys’ fees. On December 2, 2020, we entered into an agreement to settle the litigation with Adamas. Under the terms of the agreement, both parties agreed to drop their respective claims relating to the patent litigation, and Adamas agreed to acquire the global rights to Osmolex ER from the Company for $
Additionally, in connection with the settlement and the sale of the global rights to Osmolex ER, the parties entered into a supply agreement pursuant to which the Company agreed to supply Adamas with amantadine extended release tablets for a
On April 30, 2019, the Company was served with a complaint in an action entitled Leo Shumacher, et al., v. Osmotica Pharmaceuticals plc, et al., Superior Court of New Jersey, Somerset County No. SOM-L-000540-19. On May 10, 2019, a Complaint entitled Jeffrey Tello, et al., v. Osmotica Pharmaceuticals plc, et al., Superior Court of New Jersey, Somerset County No. SOM-L-000617-19 was filed in the same court as the Shumacher action. The complaints named the Company, certain of the Company’s directors and officers and the underwriters of the Company’s initial public offering as defendants in putative class actions alleging violations of Sections 11 and 15 of the Securities Act of 1933 related to the disclosures contained in the registration statement and prospectus used for the Company’s initial public offering of ordinary shares. On July 22, 2019, the plaintiffs filed an amended complaint consolidating the
Note 17. Income Taxes
Osmotica Pharmaceuticals plc (formerly known as Lilydale Limited and Osmotica Pharmaceuticals Limited) is an Irish public limited company. Osmotica Holdings S.C.Sp. acquired Osmotica Pharmaceuticals plc on April 30, 2018 for the purpose of facilitating an offering of ordinary shares in an initial public offering. On October 22, 2018, Osmotica Pharmaceuticals plc completed its initial public offering (the “IPO”). Immediately prior to the IPO and prior to the commencement of trading of Osmotica Pharmaceuticals plc’s ordinary shares on the Nasdaq Global Select Market, Osmotica Holdings S.C.Sp. undertook a series of restructuring transactions that resulted in Osmotica Pharmaceuticals plc being the direct parent of Osmotica Holdings S.C.Sp. Osmotica Holdings S.C.Sp. is a Luxembourg special limited partnership, formed on January 28, 2016. Osmotica Holdings US LLC, a subsidiary of Osmotica Holdings S.C.Sp. entered into a
partnership (the “Merger”), effective , pursuant to a definitive agreementF-31
between Vertical/Trigen Holdings, LLC (“Vertical/Trigen”) and members, and Osmotica Holdings Corp Limited and Subsidiaries. Osmotica Holdings S.C.Sp. and several other holding companies and partnerships were formed as a result of the Merger. Vertical/Trigen Holdings, LLC became a wholly-owned subsidiary of certain U.S. corporations that are directly or indirectly owned by Osmotica Holdings U.S. LLC. These subsidiaries are included in the consolidated financial statements and are designated as C Corp filers for U.S. tax purposes. As such, the activity of Vertical/Trigen Holdings, LLC is subject to federal income tax at the level of its U.S. corporate parents beginning in 2016. In addition, the Company’s foreign entities are subject to income tax in various foreign jurisdictions.
The Company follows the Income Taxes topic of ASC 740, which prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return, as well as guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The loss before income taxes and the related tax benefit from continuing operations are as follows (in thousands):
December 31, | December 31, | |||||
2020 | 2019 | |||||
Loss before income taxes |
|
|
|
| ||
U.S. operations | $ | ( | $ | ( | ||
Non-U.S. operations |
| ( |
| ( | ||
Total loss before income taxes |
| ( |
| ( | ||
Current tax (benefit) provision |
|
|
|
| ||
Federal |
| ( |
| ( | ||
State |
| |
| ( | ||
Foreign |
| |
| ( | ||
Total current tax (benefit) expenses |
| ( |
| ( | ||
Deferred tax benefit |
|
|
|
| ||
Federal |
| ( |
| ( | ||
State |
| ( |
| ( | ||
Foreign |
| ( |
| | ||
Total deferred tax benefit |
| ( |
| ( | ||
Total benefit for income taxes | $ | ( | $ | ( |
A reconciliation of the statutory federal income tax rate to the Company’s effective tax rate from continuing operations for the years ended December 31, 2020 and 2019 respectively are as follows:
December 31, | December 31, |
| |||
2020 | 2019 |
| |||
Federal tax at |
| | % | | % |
State and local income taxes, net of federal benefit |
| | % | | % |
Differences in tax effects on foreign income |
| ( | % | ( | % |
Federal tax credits |
| | % | | % |
Uncertain tax positions |
| | % | | % |
NOL carryback rate differential | | % | | % | |
Tax audit adjustment | ( | % | | % | |
Change in valuation allowance |
| ( | % | ( | % |
Permanent adjustments |
| ( | % | | % |
Other |
| ( | % | | % |
Effective tax rate |
| | % | | % |
Deferred taxes reflect the tax effects of the differences between the amounts recorded as assets and liabilities for financial statement purposes and the comparable amounts recorded for income tax purposes. Significant components of
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the deferred tax assets (liabilities) from continuing operations at December 31, 2020 and 2019 respectively are as follows (in thousands):
December 31, | December 31, | |||||
2020 | 2019 | |||||
Deferred tax assets: |
|
|
|
| ||
Accounts receivable | $ | — | $ | | ||
Accrued expenses |
| |
| | ||
Inventory |
| |
| | ||
Investment in partnership |
| |
| | ||
Net operating losses |
| | | |||
Operating lease liabilities |
| |
| | ||
Tax credits | | | ||||
Share compensation | | | ||||
Intangible assets | | — | ||||
Other |
| |
| | ||
Less: valuation allowance |
| ( |
| ( | ||
Deferred tax liabilities: |
|
| ||||
Prepaid expenses |
| ( |
| ( | ||
Property plant & equipment |
| ( |
| ( | ||
Operating lease assets | ( | ( | ||||
Other |
| ( |
| ( | ||
Total deferred income taxes | $ | ( | $ | ( |
Included in the deferred tax balances above is a net deferred tax asset of $
As of December 31, 2020 and 2019, the Company had a federal and state net operating loss carryover of $
The Coronavirus Aid Relief, and Economic Security Act (CARES Act) was enacted on March 27, 2020 in the United States. The CARES Act and related notices include several significant provisions, including delaying certain payroll tax payments, mandatory transition tax payments under the Tax Cuts and Jobs Act, and estimated income tax payments that we expect to defer to future periods. The Cares Act provides a five year carryback for losses generated in 2018-2020, The Company incurred losses in the current period that will be carried back to the earliest year, 2015. The loss generated in 2020 will be carried back to a tax year with a higher tax rate providing a benefit of $
The Company files income tax returns in U.S. federal, state and certain international jurisdictions. For federal and certain state income tax purposes, the Company's 2015 through 2018 tax years remain open for examination by the tax
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authorities under the normal statute of limitations. For certain international income tax purposes, the Company's 2015 through 2019 tax years remain open for examination by the tax authorities under the normal statute of limitations.
No provision is made for foreign withholding or income taxes associated with the cumulative undistributed earnings of the foreign subsidiaries. Any future foreign withholding or income taxes associated with the undistributed earnings are not anticipated to be material.
A reconciliation was completed of the beginning and ending amounts of unrecognized tax benefits, excluding accrued interest, for
December 31, | December 31, | |||||
2020 | 2019 | |||||
Unrecognized tax benefits beginning balance | $ | | $ | | ||
Additions related to current period tax positions | | | ||||
Releases related to prior period tax positions | ( | — | ||||
Unrecognized tax benefits ending balance | $ | | $ | |
The Company classifies interest expense related to unrecognized tax benefits as components of the tax provision for income taxes. Interest and penalties recognized in the consolidated income statement as of December 31, 2020 resulted in an immaterial amount of interest and penalties as of December 31, 2020 and in a decrease of $
Note 18. Related Parties
On August 22, 2018, the Company entered into a Master Service Agreement with United Biosource, LLC or UBC, an Avista portfolio company, for prescription processing and patient access services. In November 2018, the Company and UBC entered into a Statement of Work for services through the end of 2019 valued at approximately $
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