Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Jul. 28, 2016 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | ANI PHARMACEUTICALS INC | |
Entity Central Index Key | 1,023,024 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Trading Symbol | ANIP | |
Common Stock [Member] | ||
Document Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 11,514,495 | |
Class C Special Stock [Member] | ||
Document Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 10,864 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Current Assets | ||
Cash and cash equivalents | $ 15,014 | $ 154,684 |
Accounts receivable, net of $23,406 and $13,586 of adjustments for chargebacks and other allowances at June 30, 2016 and December 31, 2015, respectively | 35,562 | 21,932 |
Inventories, net | 25,052 | 13,387 |
Prepaid income taxes | 150 | 1,127 |
Prepaid expenses and other current assets | 4,046 | 1,453 |
Total Current Assets | 79,824 | 192,583 |
Property and equipment, net | 8,911 | 7,131 |
Restricted cash | 5,001 | 0 |
Deferred tax asset, net of valuation allowance | 17,751 | 17,316 |
Intangible assets, net | 194,674 | 66,397 |
Goodwill | 1,838 | 1,838 |
Total Assets | 307,999 | 285,265 |
Current Liabilities | ||
Accounts payable | 4,961 | 2,066 |
Accrued expenses and other | 770 | 617 |
Accrued royalties | 8,110 | 606 |
Accrued compensation and related expenses | 1,071 | 1,188 |
Accrued Medicaid rebates | 6,509 | 4,631 |
Returned goods reserve | 3,309 | 2,648 |
Total Current Liabilities | 24,730 | 11,756 |
Long-term Liabilities | ||
Long-term royalties | 2,500 | 0 |
Convertible notes, net of discount and deferred financing costs | 116,993 | 113,427 |
Total Liabilities | 144,223 | 125,183 |
Commitments and Contingencies (Note 11) | ||
Stockholders' Equity | ||
Common Stock, $0.0001 par value, 33,333,334 shares authorized; 11,513,802 shares issued and outstanding at June 30, 2016; 11,498,228 shares issued and outstanding at December 31, 2015 | 1 | 1 |
Class C Special Stock, $0.0001 par value, 781,281 shares authorized; 10,864 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 0 | 0 |
Preferred Stock, $0.0001 par value, 1,666,667 shares authorized; 0 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 0 | 0 |
Additional paid-in capital | 168,154 | 164,431 |
Accumulated deficit | (4,379) | (4,350) |
Total Stockholders' Equity | 163,776 | 160,082 |
Total Liabilities and Stockholders' Equity | $ 307,999 | $ 285,265 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets [Parenthetical] - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Adjustments for chargebacks and other allowances | $ 23,406 | $ 13,586 |
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred Stock, Shares Authorized | 1,666,667 | 1,666,667 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common stock | ||
Common Stock, Par Value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common Stock, Authorized Shares | 33,333,334 | 33,333,334 |
Common Stock, Issued Shares | 11,513,802 | 11,498,228 |
Common Stock, Outstanding Shares | 11,513,802 | 11,498,228 |
Class C special stock | ||
Common Stock, Par Value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common Stock, Authorized Shares | 781,281 | 781,281 |
Common Stock, Issued Shares | 10,864 | 10,864 |
Common Stock, Outstanding Shares | 10,864 | 10,864 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Earnings - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Net Revenues | $ 31,337 | $ 19,516 | $ 51,892 | $ 38,315 |
Operating Expenses: | ||||
Cost of sales (excluding depreciation and amortization) | 11,795 | 3,141 | 15,205 | 5,892 |
Research and development | 764 | 995 | 1,730 | 1,398 |
Selling, general, and administrative | 7,628 | 5,551 | 13,532 | 10,302 |
Depreciation and amortization | 5,956 | 1,415 | 10,565 | 2,742 |
Total Operating Expenses | 26,143 | 11,102 | 41,032 | 20,334 |
Operating Income | 5,194 | 8,414 | 10,860 | 17,981 |
Other Expense, net | ||||
Interest expense, net | (2,830) | (2,749) | (5,612) | (5,474) |
Other (expense)/income, net | (12) | 0 | (10) | 68 |
Income Before Provision for Income Taxes | 2,352 | 5,665 | 5,238 | 12,575 |
Provision for income taxes | (1,227) | (2,094) | (2,767) | (4,635) |
Net Income | $ 1,125 | $ 3,571 | $ 2,471 | $ 7,940 |
Basic and Diluted Earnings Per Share: | ||||
Basic Earnings Per Share (in dollars per share) | $ 0.10 | $ 0.31 | $ 0.22 | $ 0.7 |
Diluted Earnings Per Share (in dollars per share) | $ 0.10 | $ 0.31 | $ 0.21 | $ 0.68 |
Basic Weighted-Average Shares Outstanding (in shares) | 11,402 | 11,344 | 11,398 | 11,335 |
Diluted Weighted-Average Shares Outstanding (in shares) | 11,541 | 11,549 | 11,514 | 11,556 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Cash Flows From Operating Activities | ||
Net income | $ 2,471 | $ 7,940 |
Adjustments to reconcile net loss to net cash and cash equivalents provided by operating activities: | ||
Stock-based compensation | 3,322 | 1,597 |
Deferred taxes | (435) | 413 |
Depreciation and amortization | 10,565 | 2,742 |
Non-cash interest relating to convertible notes and loan cost amortization | 3,482 | 3,388 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (13,630) | (1,583) |
Inventories, net | (807) | (5,183) |
Prepaid expenses and other current assets | (1,992) | 368 |
Accounts payable | 2,850 | (1,379) |
Accrued royalties | 2,423 | (220) |
Accrued compensation and related expenses | (117) | (504) |
Current income taxes, net | 977 | (5,275) |
Accrued Medicaid rebates | 1,878 | (373) |
Accrued expenses, returned goods reserve, and other | 3,319 | 395 |
Net Cash and Cash Equivalents Provided by Operating Activities | 14,306 | 2,326 |
Cash Flows From Investing Activities | ||
Changes in restricted cash | (5,001) | 0 |
Acquisition of product rights and other related assets | (144,494) | (4,500) |
Acquisition of property and equipment | (2,088) | (310) |
Net Cash and Cash Equivalents Used in Investing Activities | (151,583) | (4,810) |
Cash Flows From Financing Activities | ||
Payment of debt issuance costs | (294) | 0 |
Proceeds from stock option exercises | 504 | 244 |
Excess tax benefit from share-based compensation awards | 19 | 47 |
Repurchase of common stock under the stock repurchase program | (2,500) | 0 |
Treasury stock purchases for restricted stock vestings and forfeitures | (122) | (113) |
Net Cash and Cash Equivalents (Used in)/Provided by Financing Activities | (2,393) | 178 |
Change in Cash and Cash Equivalents | (139,670) | (2,306) |
Cash and cash equivalents, beginning of period | 154,684 | 169,037 |
Cash and cash equivalents, end of period | 15,014 | 166,731 |
Supplemental disclosure for cash flow information: | ||
Cash paid for interest | 2,156 | 2,048 |
Cash paid for income taxes, net | 2,206 | 9,450 |
Supplemental non-cash investing and financing activities: | ||
Accrued royalties related to asset purchase | 3,882 | 0 |
Property and equipment purchased and included in accounts payable | $ 45 | $ 50 |
BUSINESS, PRESENTATION, AND REC
BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS | 6 Months Ended |
Jun. 30, 2016 | |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS | 1. BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS Overview ANI Pharmaceuticals, Inc. and its consolidated subsidiaries (together, “ANI,” the “Company,” “we,” “us,” or “our”) is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. Our targeted areas of product development currently include controlled substances, anti-cancer (oncolytics), hormones and steroids, and complex formulations involving extended release and combination products. We have two pharmaceutical manufacturing facilities located in Baudette, Minnesota that are capable of producing oral solid dose products, as well as liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment. Our strategy is to use our assets to develop, acquire, manufacture, and market branded and generic specialty prescription pharmaceuticals. By executing this strategy, we believe we will be able to continue to grow the business, expand and diversify our product portfolio, and create long-term value for our investors. Basis of Presentation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In our opinion, the accompanying unaudited interim condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations, and cash flows. The consolidated balance sheet at December 31, 2015, has been derived from audited financial statements of that date. The unaudited interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the United States Securities and Exchange Commission. We believe that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim condensed consolidated financial statements are read in conjunction with the audited financial statements and notes previously distributed in our Annual Report on Form 10-K for the year ended December 31, 2015. Certain prior period information has been reclassified to conform to the current period presentation. Principles of Consolidation The unaudited interim condensed consolidated financial statements include the accounts of ANI Pharmaceuticals, Inc. and its subsidiaries. All inter-company accounts and transactions have been eliminated in consolidation. Foreign Currency The company has subsidiaries located outside of the U.S. All existing subsidiaries currently conduct substantially all their transactions in U.S. dollars, or are otherwise dependent upon the U.S. parent for funding. Accordingly, these subsidiaries use the U.S. dollar as their functional currency. Unless otherwise noted, all references to “$” or “dollar” refer to the U.S. dollar. Foreign currency transaction gains and losses are included in the determination of net income. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. In the accompanying unaudited interim condensed consolidated financial statements, estimates are used for, but not limited to, stock-based compensation, allowance for doubtful accounts, accruals for chargebacks, administrative fees and rebates, Medicaid rebates, returns and other allowances, allowance for inventory obsolescence, valuation of financial instruments and intangible assets, accruals for contingent liabilities, fair value of long-lived assets, deferred taxes and valuation allowance, purchase price allocations, and the depreciable lives of long-lived assets. Because of the uncertainties inherent in such estimates, actual results may differ from those estimates. Management periodically evaluates estimates used in the preparation of the financial statements for reasonableness. Recent Accounting Pronouncements In March 2016, the Financial Accounting Standards Board (“FASB”) issued guidance simplifying the accounting for and financial statement disclosure of stock-based compensation awards. Under the guidance, all excess tax benefits and tax deficiencies related to stock-based compensation awards are to be recognized as income tax expenses or benefits in the income statement and excess tax benefits should be classified along with other income tax cash flows in the operating activities section of the statement of cash flows. Under the guidance, companies can also elect to either estimate the number of awards that are expected to vest or account for forfeitures as they occur. In addition, the guidance amends some of the other stock-based compensation awards guidance to more clearly articulate the requirements and cash flow presentation for withholding shares for tax-withholding purposes. The guidance is effective for reporting periods beginning after December 15, 2016 and early adoption is permitted, though all amendments of the guidance must be adopted in the same period. The adoption of certain amendments of the guidance must be applied prospectively, and adoption of the remaining amendments must be applied either on a modified retrospective basis or retrospectively to all periods presented. We are currently evaluating the impact that this guidance will have on our consolidated financial statements. In March 2016, the FASB issued guidance to clarify the requirements for assessing whether contingent call or put options that can accelerate the payment of principal on debt instruments are clearly and closely related to their debt hosts. The amendments of this guidance are effective for reporting periods beginning after December 15, 2016, and early adoption is permitted. Entities are required to apply the guidance to existing debt instruments using a modified retrospective transition method as of the beginning of the fiscal year of adoption. We adopted this guidance in the first quarter of 2016, effective as of January 1, 2016, on a modified retrospective basis. The adoption of this new guidance did not have a material impact on our consolidated financial statements. In February 2016, the FASB issued guidance for accounting for leases. The guidance requires lessees to recognize assets and liabilities related to long-term leases on the balance sheet and expands disclosure requirements regarding leasing arrangements. The guidance is effective for reporting periods beginning after December 15, 2018 and early adoption is permitted. The guidance must be adopted on a modified retrospective basis and provides for certain practical expedients. We are currently evaluating the impact that this guidance will have on our consolidated financial statements. In November 2015, the FASB issued guidance simplifying the balance sheet classification of deferred taxes. The new guidance requires that all deferred taxes be presented as noncurrent, rather than separated into current and noncurrent amounts. The guidance is effective for reporting periods beginning after December 15, 2016 and early adoption is permitted. In addition, the adoption of guidance can be applied either prospectively or retrospectively to all periods presented. We adopted this guidance for the year ended December 31, 2015 on a retrospective basis, and all periods are presented under this guidance. In July 2015, the FASB issued guidance for inventory. Under the guidance, an entity should measure inventory within the scope of this guidance at the lower of cost and net realizable value, except when inventory is measured using the last in first out (“LIFO”) method or the retail inventory method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. In addition, the FASB has amended some of the other inventory guidance to more clearly articulate the requirements for the measurement and disclosure of inventory. The guidance is effective for reporting periods beginning after December 15, 2016. The guidance should be applied prospectively, with earlier application permitted. We adopted this guidance in the first quarter of 2016, effective as of January 1, 2016, on a prospective basis. The adoption of this new guidance did not have a material impact on our consolidated financial statements. In April 2015, the FASB issued guidance as to whether a cloud computing arrangement (e.g., software as a service, platform as a service, infrastructure as a service, and other similar hosting arrangements) includes a software license and, based on that determination, how to account for such arrangements. If a cloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. The guidance is effective for reporting periods beginning after December 15, 2015, and can be adopted on either a prospective or retrospective basis. We adopted this guidance in the first quarter of 2016, effective as of January 1, 2016, on a prospective basis. The adoption of this new guidance did not have a material impact on our consolidated financial statements. In April 2015, the FASB issued guidance to simplify the balance sheet disclosure for debt issuance costs. Under the guidance, debt issuance costs related to a recognized debt liability are presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, in the same manner as debt discounts, rather than as an asset. In August 2015, the FASB issued guidance clarifying debt issuance costs related to line-of-credit arrangements, which guidance states that the SEC does not object to an entity deferring and presenting debt issuance costs as an asset and subsequently amortizing the deferred debt issuance costs ratably over the term of the line-of-credit arrangement, regardless of whether there are any outstanding borrowings on the line-of-credit. The guidance is effective for reporting periods beginning after December 15, 2015 and must be adopted on a retrospective basis. Early adoption is permitted. We adopted this guidance for the year ended December 31, 2015 on a retrospective basis, and all periods are presented under this guidance. In May 2014, the FASB issued guidance for revenue recognition for contracts, superseding the previous revenue recognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identify the contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. The new standard will result in enhanced disclosures regarding the nature, amount, timing, and uncertainty of revenue arising from contracts with customers. In August 2015, the FASB issued guidance approving a one-year deferral, making the standard effective for reporting periods beginning after December 15, 2017, with early adoption permitted only for reporting periods beginning after December 15, 2016. In March 2016, the FASB issued guidance to clarify the implementation guidance on principal versus agent considerations for reporting revenue gross rather than net, with the same deferred effective date. In April 2016, the FASB issued guidance to clarify the implementation guidance on identifying performance obligations and the accounting for licenses of intellectual property, with the same deferred effective date. In May 2016, the FASB issued guidance rescinding SEC paragraphs related to revenue recognition, pursuant to two SEC Staff Announcements at the March 3, 2016 Emerging Issues Task Force meeting. In May 2016, the FASB also issued guidance to clarify the implementation guidance on assessing collectability, presentation of sales tax, noncash consideration, and contracts and contract modifications at transition, with the same effective date. We are currently evaluating the impact, if any, that this guidance will have on our consolidated financial statements. We have evaluated all other issued and unadopted Accounting Standards Updates and believe the adoption of these standards will not have a material impact on our condensed consolidated statements of earnings, balance sheets, or cash flows. |
REVENUE RECOGNITION AND RELATED
REVENUE RECOGNITION AND RELATED ALLOWANCES | 6 Months Ended |
Jun. 30, 2016 | |
Revenue Recognition [Abstract] | |
REVENUE RECOGNITION AND RELATED ALLOWANCES | 2. REVENUE RECOGNITION AND RELATED ALLOWANCES Revenue Recognition Revenue is recognized for product sales and contract manufacturing product sales upon passing of risk and title to the customer, when estimates of the selling price and discounts, rebates, promotional adjustments, price adjustments, returns, chargebacks, and other potential adjustments are reasonably determinable, collection is reasonably assured, and we have no further performance obligations. Contract manufacturing arrangements are typically less than two weeks in duration, and therefore the revenue is recognized upon completion of the aforementioned factors rather than using a proportional performance method of revenue recognition. The estimates for discounts, rebates, promotional adjustments, price adjustments, returns, chargebacks, and other potential adjustments reduce gross revenues to net revenues in the accompanying unaudited interim condensed consolidated statements of earnings, and are presented as current liabilities or reductions in accounts receivable in the accompanying unaudited interim condensed consolidated balance sheets (see “Accruals for Chargebacks, Rebates, Returns, and Other Allowances”). Historically, we have not entered into revenue arrangements with multiple elements. Occasionally, we engage in contract services, which include product development services, laboratory services, and royalties on net sales of certain contract manufactured products. For these services, revenue is recognized according to the terms of the agreement with the customer, which sometimes include substantive, measurable risk-based milestones, and when we have a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the resulting receivable is reasonably assured, and we have no further performance obligations under the agreement. Accruals for Chargebacks, Rebates, Returns, and Other Allowances Our generic and branded product revenues are typically subject to agreements with customers allowing chargebacks, Medicaid rebates, product returns, administrative fees and other rebates, and prompt payment discounts. We accrue for these items at the time of sale and continually monitor and re-evaluate the accruals as additional information becomes available. We adjust the accruals at the end of each reporting period, to reflect any such updates to the relevant facts and circumstances. Accruals are relieved upon receipt of payment from the customer or upon issuance of credit to the customer. (in thousands) Accruals for Chargebacks, Rebates, Returns, and Other Allowances Administrative Prompt Medicaid Fees and Other Payment Chargebacks Rebates Returns Rebates Discounts Balance at December 31, 2014 $ 6,865 $ 2,264 $ 1,445 $ 1,487 $ 471 Accruals/Adjustments 21,644 2,177 776 2,913 1,231 Credits Taken Against Reserve (22,588) (2,550) (502) (2,960) (1,217) Balance at June 30, 2015 $ 5,921 $ 1,891 $ 1,719 $ 1,440 $ 485 Balance at December 31, 2015 $ 11,381 $ 4,631 $ 2,648 $ 1,653 $ 674 Accruals/Adjustments 43,349 5,773 3,256 5,071 2,180 Credits Taken Against Reserve (34,731) (3,895) (2,595) (4,274) (1,678) Balance at June 30, 2016 $ 19,999 $ 6,509 $ 3,309 $ 2,450 $ 1,176 Credit Concentration Our customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and pharmaceutical companies. During the three months ended June 30, 2016, three 28 21 18 three 25 24 17 74 20 18 15 20 22 19 |
INDEBTEDNESS
INDEBTEDNESS | 6 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
INDEBTEDNESS | 3. INDEBTEDNESS Convertible Senior Notes In December 2014, we issued $ 143.8 3.0 69.48 96.21 The Notes are convertible at the option of the holder under certain circumstances and upon conversion we may elect to settle such conversion in shares of our common stock, cash, or a combination thereof. As a result of our cash conversion option, we separately accounted for the value of the embedded conversion option as a debt discount (with an offset to Additional Paid in Capital (“APIC”)) of $ 33.6 (in thousands) June 30, December 31, Principal amount $ 143,750 $ 143,750 Unamortized debt discount (23,872) (27,016) Deferred financing costs (2,885) (3,307) Net carrying value $ 116,993 $ 113,427 We had accrued interest of $ 0.4 Three Months Ended Six Months Ended (in thousands) June 30, June 30, June 30, June 30, Contractual coupon $ 1,078 $ 1,078 $ 2,156 $ 2,156 Amortization of debt discount 1,582 1,501 3,144 2,981 Amortization of finance fees 211 211 422 422 Capitalized interest (54) (6) (100) (15) $ 2,817 $ 2,784 $ 5,622 $ 5,544 As of June 30, 2016, the effective interest rate on the Notes was 7.8 Line of Credit In May 2016, we entered into a credit arrangement (the “Line of Credit”) with Citizens Bank Capital, a division of Citizens Asset Finance, Inc. (the “Citizens Agreement”). The Citizens Agreement provides for a $ 30.0 10.0 May 12, 2019 LIBOR rate plus 1.25%, 1.50%, or 1.75% per annum, depending upon availability under the Citizens Agreement, or an alternative base rate plus either 0.25%, 0.50%, or 0.75% per annum 0.25 The Citizens Agreement is secured by a lien on substantially all of ANI Pharmaceutical Inc.’s and its principal domestic subsidiary’s assets and any future domestic subsidiary guarantors’ assets. The Citizens Agreement includes covenants, subject to certain exceptions, including covenants that restrict our ability to incur additional indebtedness, acquire or dispose of assets, and make and incur capital expenditures. The Citizens Agreement also imposes a financial covenant requiring compliance with a minimum fixed charge coverage ratio of 1.10 to 1.00 12.5 3.75 As of June 30, 2016, we had no outstanding balance on the Line of Credit. In the three months ended June 30, 2016, we deferred $ 0.3 0.3 16 |
EARNINGS PER SHARE
EARNINGS PER SHARE | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
EARNINGS PER SHARE | 4. EARNINGS PER SHARE Basic earnings per share is computed by dividing net income available to common shareholders by the weighted-average number of shares of common stock outstanding during the period. For periods of net income, and when the effects are not anti-dilutive, we calculate diluted earnings per share by dividing net income available to common shareholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options, unvested restricted stock awards, stock purchase warrants, and any conversion gain on our Notes (Note 3), using the treasury stock method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share. Our unvested restricted shares contain non-forfeitable rights to dividends, and therefore are considered to be participating securities; in periods of net income, the calculation of basic and diluted earnings per share excludes from the numerator net income attributable to the unvested restricted shares, and excludes the impact of those shares from the denominator. For purposes of determining diluted earnings per share, we have elected a policy to assume that the principal portion of the Notes (Note 3) is settled in cash. As such, the principal portion of the Notes has no effect on either the numerator or denominator when determining diluted earnings per share. Any conversion gain is assumed to be settled in shares and is incorporated in diluted earnings per share using the treasury method. The warrants issued in conjunction with the issuance of the Notes (Note 3) are considered to be dilutive when they are in-the-money relative to our average stock price during the period; the bond hedge purchased in conjunction with the issuance of the Notes is always considered to be anti-dilutive. Basic Diluted Basic Diluted (in thousands, except per share amounts) Three Months Ended Three Months Ended Six Months Ended Six Months Ended 2016 2015 2016 2015 2016 2015 2016 2015 Net income $ 1,125 $ 3,571 $ 1,125 $ 3,571 $ 2,471 $ 7,940 $ 2,471 $ 7,940 Net income allocated to restricted stock (8) (24) (8) (23) (17) (53) (17) (52) Net income allocated to common shares $ 1,117 $ 3,547 $ 1,117 $ 3,548 $ 2,454 $ 7,887 $ 2,454 $ 7,888 Basic Weighted-Average Shares Outstanding 11,402 11,344 11,402 11,344 11,398 11,335 11,398 11,335 Dilutive effect of stock options 139 205 116 221 Diluted Weighted-Average Shares Outstanding 11,541 11,549 11,514 11,556 Earnings Per Share $ 0.10 $ 0.31 $ 0.10 $ 0.31 $ 0.22 $ 0.70 $ 0.21 $ 0.68 The number of anti-dilutive shares, which have been excluded from the computation of diluted earnings per share, including the shares underlying the Notes, was 4.5 4.6 4.5 4.6 |
INVENTORIES
INVENTORIES | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
INVENTORIES | 5. INVENTORIES (in thousands) June 30, December 31, Raw materials $ 12,583 $ 10,192 Packaging materials 935 998 Work-in-progress 588 456 Finished goods 11,204 1,897 25,310 13,543 Reserve for excess/obsolete inventories (258) (156) Inventories, net $ 25,052 $ 13,387 Vendor Concentration We source the raw materials for our products, including active pharmaceutical ingredients (“API”), from both domestic and international suppliers. Generally, only a single source of API is qualified for use in each product due to the cost and time required to validate a second source of supply. As a result, we are dependent upon our current vendors to reliably supply the API required for ongoing product manufacturing. During the three months ended June 30, 2016, we purchased approximately 48 0.3 29 0.2 43 40 |
PROPERTY, PLANT, AND EQUIPMENT
PROPERTY, PLANT, AND EQUIPMENT | 6 Months Ended |
Jun. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT, AND EQUIPMENT | 6. PROPERTY, PLANT, AND EQUIPMENT (in thousands) June 30, December 31, Land $ 87 $ 87 Buildings 3,682 3,682 Machinery, furniture, and equipment 7,311 5,623 Construction in progress 2,725 2,189 13,805 11,581 Less: accumulated depreciation (4,894) (4,450) Property, Plant, and Equipment, net $ 8,911 $ 7,131 Depreciation expense was $ 0.2 0.4 0.3 54 6 0.1 15 Construction in progress consists of multiple projects, primarily related to new equipment to expand our manufacturing capability as our product lines continue to grow. |
GOODWILL AND INTANGIBLE ASSETS
GOODWILL AND INTANGIBLE ASSETS | 6 Months Ended |
Jun. 30, 2016 | |
GOODWILL AND INTANGIBLE ASSETS | |
GOODWILL AND INTANGIBLE ASSETS | GOODWILL AND INTANGIBLE ASSETS Goodwill As a result of our 2013 merger with BioSante Pharmaceuticals, Inc. (“BioSante”), we recorded goodwill of $ 1.8 st Definite-lived Intangible Assets Acquisition of Abbreviated New Drug Applications In July 2015, we purchased the Abbreviated New Drug Applications (“ANDAs”) for 22 previously marketed generic drug products from Teva Pharmaceuticals (“Teva”) for $ 25.0 10 In March 2015, we purchased an ANDA from Teva for Flecainide for $ 4.5 10 In the first quarter of 2014, we purchased the ANDAs to produce 31 previously marketed generic drug products from Teva for $ 12.5 10 Acquisition of New Drug Applications and Product Rights In April 2016, we purchased the rights, title, and interest in the New Drug Application (“NDA”) for Inderal LA, as well as certain documentation, trademark rights, and finished goods from Cranford Pharmaceuticals, LLC for $ 60.0 60.0 0.3 3.9 64.2 52.4 10 0.6 In September 2015, we entered into an agreement to purchase the NDAs for Corticotropin and Corticotropin-Zinc from Merck Sharp & Dohme B.V. for $75.0 million in cash and a percentage of future net sales. The transaction closed in January 2016, and we made the $ 75.0 0.3 75.3 10 As part of our 2013 merger with BioSante, we acquired a testosterone gel product that was licensed to Teva (the “Testosterone Gel NDA”). In May 2015, we acquired from Teva the approved NDA for the previously-licensed product. Pursuant to the terms of the purchase agreement, upon commercialization, we will pay Teva a royalty of up to $ 5.0 5 10.9 11 In August 2014, we entered into an agreement to purchase (the “Vancocin Purchase Agreement”) the product rights to Vancocin from Shire ViroPharma Incorporated for $ 11.0 10.5 10 In July 2014, we entered into an agreement to purchase (the “Lithobid Purchase Agreement”) the product rights to Lithobid from Noven Therapeutics, LLC for $ 11.0 1.0 12.0 10 Marketing and Distribution Rights In January 2016, we purchased from H2-Pharma, LLC the rights to market, sell, and distribute the authorized generic of Lipofen® and a generic hydrocortisone rectal cream product, along with the rights to an early-stage development project, for total consideration of $ 10.0 8.8 1.2 42 10.0 In August 2015, we entered into a distribution agreement with IDT Australia Limited (“IDT”) to market several products in the U.S. The products, all of which are approved ANDAs, require various FDA filings and approvals prior to commercialization. In general, IDT will be responsible for regulatory submissions to the Food and Drug Administration (“FDA”) and the manufacturing of certain products. We made an upfront payment to IDT of $ 1.0 1.0 seven (in thousands) June 30, 2016 December 31, 2015 Weighted Average Gross Carrying Accumulated Gross Carrying Accumulated Amortization Acquired ANDA intangible assets $ 42,076 $ (6,289) $ 42,076 $ (4,287) 10.0 years NDAs and product rights 161,150 (12,546) 33,422 (5,754) 10.1 years Marketing and distribution rights 11,042 (1,361) 1,000 (60) 4.7 years Non-compete agreement 624 (22) - - 7.0 years $ 214,892 $ (20,218) $ 76,498 $ (10,101) Definite-lived intangible assets are stated at cost, net of amortization using the straight line method over the expected useful lives of the intangible assets. Amortization expense was $ 5.7 1.2 10.1 2.4 We test for impairment of definite-lived intangible assets when events or circumstances indicate that the carrying value of the assets may not be recoverable. No such triggering events were identified during the three and six months ended June 30, 2016 and 2015 and therefore no impairment loss was recognized in the three and six months ended June 30, 2016 or 2015. (in thousands) 2016 (remainder of the year) $ 11,450 2017 22,722 2018 22,367 2019 22,367 2020 21,885 2021 and thereafter 93,883 Total $ 194,674 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
STOCK-BASED COMPENSATION | 8. STOCK-BASED COMPENSATION All equity-based service awards are granted under the ANI Pharmaceuticals, Inc. Amended and Restated 2008 Stock Incentive Plan (the “2008 Plan”). As of June 30, 2016, 0.3 (in thousands) Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Cost of sales $ 24 $ 21 $ 14 $ 37 Research and development 22 33 49 49 Selling, general, and adminstrative 2,171 975 3,259 1,511 $ 2,217 $ 1,029 $ 3,322 $ 1,597 Separation Agreement On April 26, 2016, we entered into a Separation Agreement and Release (the “Separation Agreement”) with our former Chief Financial Officer (the “Former Officer”), who resigned effective May 6, 2016. Under the Separation Agreement, 25,167 4,050 2,000 0.9 0.4 (in thousands) Options RSAs Outstanding December 31, 2014 458 63 Granted 120 28 Options Exercised/RSAs Vested (31) (10) Forfeited (33) (5) Outstanding June 30, 2015 514 76 Outstanding December 31, 2015 474 63 Granted 273 42 Options Exercised/RSAs Vested (54) (15) Forfeited (50) (12) Outstanding June 30, 2016 643 78 |
STOCKHOLDER'S EQUITY
STOCKHOLDER'S EQUITY | 6 Months Ended |
Jun. 30, 2016 | |
Stockholders Equity Note [Abstract] | |
SHAREHOLDER'S EQUITY | STOCKHOLDER’S EQUITY Stock Repurchase Program In October 2015, our Board of Directors authorized a program to repurchase up to $ 25.0 In January 2016, we purchased 65 2.5 Warrants No warrants to purchase shares of common stock were granted, exercised, or expired unexercised during the three and six month ended June 30, 2016. Warrants to purchase 0.1 |
INCOME TAXES
INCOME TAXES | 6 Months Ended |
Jun. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES We use the asset and liability method of accounting for income taxes. Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The measurement of a deferred tax asset is reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized. The utilization of our NOL carryforwards will be limited in future years as prescribed by Section 382 of the U.S. Internal Revenue Code. As of both June 30, 2016 and December 31, 2015, we had provided a valuation allowance against certain state net operating loss (“NOL”) carryforwards of approximately $ 0.1 We use a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return, as well as guidance on derecognition, classification, interest and penalties, and financial statement reporting disclosures. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. We have not identified any uncertain income tax positions that could have a material impact on the consolidated financial statements. We recognize interest and penalties accrued on any unrecognized tax exposures as a component of income tax expense; we did not have any such amounts accrued as of June 30, 2016 and December 31, 2015. We are subject to taxation in various jurisdictions and all of our income tax returns remain subject to examination by tax authorities due to the availability of NOL carryforwards. We calculate income tax benefits related to stock-based compensation arrangements using the with and without method. For interim periods, we recognize an income tax provision/(benefit) based on our estimated annual effective tax rate expected for the entire year. The interim annual estimated effective tax rate is based on the statutory tax rates then in effect, as adjusted for estimated changes in temporary and estimated permanent differences, and excludes certain discreet items whose tax effect is recognized in the interim period in which they occur. We also have elected to exclude the impacts from significant pre-tax non-recognized subsequent events from our interim estimated annual effective rate until the period in which they occur. Our estimated annual effective tax rate changes throughout the year as our on-going estimates of pre-tax income, changes in temporary differences, and permanent differences are revised, and as discreet items occur. Our estimated annual effective tax rate was 53.4 52.2 52.8 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Operating Leases We lease equipment under operating leases that expire in September 2018 and February 2021. We also lease office space under operating leases that expire in September 2018 and April 2021. Future minimum lease payments due under these leases total $ 0.4 Rent expense for each of the three months ended June 30, 2016 and 2015 totaled $ 20 40 38 Government Regulation Our products and facilities are subject to regulation by a number of federal and state governmental agencies. The FDA, in particular, maintains oversight of the formulation, manufacture, distribution, packaging, and labeling of all of our products. The Drug Enforcement Administration (“DEA”) maintains oversight over our products that are controlled substances. Unapproved Products Two of our products, Esterified Estrogen with Methyltestosterone tablets (“EEMT”) and Opium Tincture, are marketed without approved NDAs or ANDAs. During the three months ended June 30, 2016 and 2015, net revenues for these products totaled $ 9.0 11.0 18.0 21.3 The FDA's policy with respect to the continued marketing of unapproved products is stated in the FDA's September 2011 Compliance Policy Guide Sec. 440.100 titled “Marketed New Drugs without Approved NDAs or ANDAs.” Under this policy, the FDA has stated that it will follow a risk-based approach with regard to enforcement against such unapproved products. The FDA evaluates whether to initiate enforcement action on a case-by-case basis, but gives higher priority to enforcement action against products in certain categories, such as those marketed as unapproved drugs with potential safety risks or that lack evidence of effectiveness. We believe that, so long as we comply with In addition, one group of products that we manufacture on behalf of a contract customer is marketed by that customer without an approved NDA. If the FDA took enforcement action against such customer, the customer may be required to seek FDA approval for the group of products or withdraw them from the market. Our contract manufacturing revenues for these unapproved products for each of the three months ended June 30, 2016 and 2015 were $ 0.5 0.8 We receive royalties on the net sales of a group of contract-manufactured products, which are marketed by the contract customer without an approved NDA. If the FDA took enforcement action against such customer, the customer may be required to seek FDA approval for the group of products or withdraw them from the market. Our royalties on the net sales of these unapproved products for each of the three months ended June 30, 2016 and 2015 were $ 0.1 0.2 Louisiana Medicaid Lawsuit On September 11, 2013, the Attorney General of the State of Louisiana filed a lawsuit in Louisiana state court against numerous pharmaceutical companies, including us, under various state laws, alleging that each defendant caused the state’s Medicaid agency to provide reimbursement for drug products that allegedly were not approved by the FDA and therefore allegedly not reimbursable under the federal Medicaid program. The lawsuit relates to three cough and cold prescription products manufactured and sold by our former Gulfport, Mississippi operation, which was sold in September 2010. Through its lawsuit, the state seeks unspecified damages, statutory fines, penalties, attorneys’ fees, and costs. While we cannot predict the outcome of the lawsuit at this time, we could be subject to material damages, penalties, and fines. We intend to vigorously defend against all claims in the lawsuit. Other Commitments and Contingencies All manufacturers of the drug Reglan and its generic equivalent metoclopramide, including ANI, are facing allegations from plaintiffs in various states, including California, New Jersey, and Pennsylvania, claiming bodily injuries as a result of ingestion of metoclopramide or its brand name, Reglan, prior to the FDA's February 2009 Black Box warning requirement. In August 2012, we were dismissed with prejudice from all New Jersey cases. We consider our exposure to this litigation to be limited due to several factors: (1) the only generic metoclopramide that we manufactured prior to the implementation of the FDA's warning requirement was an oral solution introduced after May 28, 2008; (2) our market share for the oral solution was a very small portion of the overall metoclopramide market; and (3) once we received a request for change of labeling from the FDA, we submitted our proposed changes within 30 days, and such changes were subsequently approved by the FDA. At the present time, we are unable to assess the likely outcome of the cases in the remaining states. Our insurance company has assumed the defense of this matter. We cannot provide assurances that the outcome of these matters will not have an adverse effect on our business, financial condition, and operating results. Furthermore, like all pharmaceutical manufacturers, we may be exposed to other product liability claims in the future, which could further limit our coverage under future insurance policies or cause those policies to become more expensive, which could harm our business, financial condition, and operating results. |
FAIR VALUE DISCLOSURES
FAIR VALUE DISCLOSURES | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE DISCLOSURES | FAIR VALUE DISCLOSURES Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value. The inputs used in measuring the fair value of cash and cash equivalents are considered to be level 1 in accordance with the three-tier fair value hierarchy. The fair market values are based on period-end statements supplied by the various banks and brokers that held the majority of our funds. The fair value of short-term financial instruments (primarily accounts receivable, prepaid expenses, accounts payable, accrued expenses, borrowings under line of credit, and other current liabilities) approximate their carrying values because of their short-term nature. While our Notes are recorded on our accompanying unaudited interim condensed consolidated balance sheets at their net carrying value of $ 117.0 155.4 Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis Our contingent value rights (“CVRs”), which were granted coincident with our merger with BioSante and expire in June 2023, are considered contingent consideration and are classified as liabilities. As such, the CVRs were recorded as purchase consideration at their estimated fair value, using level 3 inputs, and are marked to market each reporting period until settlement. The fair value of CVRs is estimated using the present value of our projection of the expected payments pursuant to the terms of the CVR agreement, which is the primary unobservable input. If our projection or expected payments were to increase substantially, the value of the CVRs could increase as a result. The present value of the liability was calculated using a discount rate of 15 (in thousands) Description Fair Value at Level 1 Level 2 Level 3 Liabilities CVRs $ - $ - $ - $ - Description Fair Value at Level 1 Level 2 Level 3 Liabilities CVRs $ - $ - $ - $ - Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis We do not have any financial assets and liabilities measured at fair value on a non-recurring basis. Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis We do not have any non-financial assets and liabilities that are measured at fair value on a recurring basis. Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis We measure our long-lived assets, including property, plant, and equipment, intangible assets, and goodwill, at fair value on a non-recurring basis. These assets are recognized at fair value when they are deemed to be other-than-temporarily impaired. No such fair value impairment was recognized in the three and six months ended June 30, 2016 and 2015. Acquired Non-Financial Assets Measured at Fair Value In April 2016, we purchased the rights, title, and interest in the NDA for Inderal LA, as well as certain documentation, trademark rights, and finished goods from Cranford Pharmaceuticals, LLC for $60.0 million in cash and milestone payments based on future gross profits from sales of products under the NDA (Note 7). In addition, at closing, we transferred $ 5.0 60.0 0.3 3.9 64.2 12 52.4 10 10.9 3.9 0.6 10 0.3 In January 2016, we purchased from Merck Sharp & Dohme B.V. the NDAs for two previously marketed generic drug products for $ 75.0 0.3 10 10 In January 2016, we purchased from H2-Pharma, LLC the rights to market, sell, and distribute the authorized generic of Lipofen® and a generic hydrocortisone rectal cream product, along with the rights to an early-stage development project, for total consideration of $ 10.0 8.8 1.2 42 10 |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 6 Months Ended |
Jun. 30, 2016 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENT | 13. SUBSEQUENT EVENT In July 2016, we commenced administration of our 2016 Employee Stock Purchase Plan (the “ESPP”), which was approved by shareholders in our May 25, 2016 annual shareholder meeting. The Board of Directors and shareholders approved a maximum of 0.2 |
BUSINESS, PRESENTATION, AND R19
BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis of Presentation | Basis of Presentation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In our opinion, the accompanying unaudited interim condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations, and cash flows. The consolidated balance sheet at December 31, 2015, has been derived from audited financial statements of that date. The unaudited interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the United States Securities and Exchange Commission. We believe that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim condensed consolidated financial statements are read in conjunction with the audited financial statements and notes previously distributed in our Annual Report on Form 10-K for the year ended December 31, 2015. Certain prior period information has been reclassified to conform to the current period presentation. |
Principles of consolidation | Principles of Consolidation The unaudited interim condensed consolidated financial statements include the accounts of ANI Pharmaceuticals, Inc. and its subsidiaries. All inter-company accounts and transactions have been eliminated in consolidation. |
Foreign Currency | Foreign Currency The company has subsidiaries located outside of the U.S. All existing subsidiaries currently conduct substantially all their transactions in U.S. dollars, or are otherwise dependent upon the U.S. parent for funding. Accordingly, these subsidiaries use the U.S. dollar as their functional currency. Unless otherwise noted, all references to “$” or “dollar” refer to the U.S. dollar. Foreign currency transaction gains and losses are included in the determination of net income. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. In the accompanying unaudited interim condensed consolidated financial statements, estimates are used for, but not limited to, stock-based compensation, allowance for doubtful accounts, accruals for chargebacks, administrative fees and rebates, Medicaid rebates, returns and other allowances, allowance for inventory obsolescence, valuation of financial instruments and intangible assets, accruals for contingent liabilities, fair value of long-lived assets, deferred taxes and valuation allowance, purchase price allocations, and the depreciable lives of long-lived assets. Because of the uncertainties inherent in such estimates, actual results may differ from those estimates. Management periodically evaluates estimates used in the preparation of the financial statements for reasonableness. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In March 2016, the Financial Accounting Standards Board (“FASB”) issued guidance simplifying the accounting for and financial statement disclosure of stock-based compensation awards. Under the guidance, all excess tax benefits and tax deficiencies related to stock-based compensation awards are to be recognized as income tax expenses or benefits in the income statement and excess tax benefits should be classified along with other income tax cash flows in the operating activities section of the statement of cash flows. Under the guidance, companies can also elect to either estimate the number of awards that are expected to vest or account for forfeitures as they occur. In addition, the guidance amends some of the other stock-based compensation awards guidance to more clearly articulate the requirements and cash flow presentation for withholding shares for tax-withholding purposes. The guidance is effective for reporting periods beginning after December 15, 2016 and early adoption is permitted, though all amendments of the guidance must be adopted in the same period. The adoption of certain amendments of the guidance must be applied prospectively, and adoption of the remaining amendments must be applied either on a modified retrospective basis or retrospectively to all periods presented. We are currently evaluating the impact that this guidance will have on our consolidated financial statements. In March 2016, the FASB issued guidance to clarify the requirements for assessing whether contingent call or put options that can accelerate the payment of principal on debt instruments are clearly and closely related to their debt hosts. The amendments of this guidance are effective for reporting periods beginning after December 15, 2016, and early adoption is permitted. Entities are required to apply the guidance to existing debt instruments using a modified retrospective transition method as of the beginning of the fiscal year of adoption. We adopted this guidance in the first quarter of 2016, effective as of January 1, 2016, on a modified retrospective basis. The adoption of this new guidance did not have a material impact on our consolidated financial statements. In February 2016, the FASB issued guidance for accounting for leases. The guidance requires lessees to recognize assets and liabilities related to long-term leases on the balance sheet and expands disclosure requirements regarding leasing arrangements. The guidance is effective for reporting periods beginning after December 15, 2018 and early adoption is permitted. The guidance must be adopted on a modified retrospective basis and provides for certain practical expedients. We are currently evaluating the impact that this guidance will have on our consolidated financial statements. In November 2015, the FASB issued guidance simplifying the balance sheet classification of deferred taxes. The new guidance requires that all deferred taxes be presented as noncurrent, rather than separated into current and noncurrent amounts. The guidance is effective for reporting periods beginning after December 15, 2016 and early adoption is permitted. In addition, the adoption of guidance can be applied either prospectively or retrospectively to all periods presented. We adopted this guidance for the year ended December 31, 2015 on a retrospective basis, and all periods are presented under this guidance. In July 2015, the FASB issued guidance for inventory. Under the guidance, an entity should measure inventory within the scope of this guidance at the lower of cost and net realizable value, except when inventory is measured using the last in first out (“LIFO”) method or the retail inventory method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. In addition, the FASB has amended some of the other inventory guidance to more clearly articulate the requirements for the measurement and disclosure of inventory. The guidance is effective for reporting periods beginning after December 15, 2016. The guidance should be applied prospectively, with earlier application permitted. We adopted this guidance in the first quarter of 2016, effective as of January 1, 2016, on a prospective basis. The adoption of this new guidance did not have a material impact on our consolidated financial statements. In April 2015, the FASB issued guidance as to whether a cloud computing arrangement (e.g., software as a service, platform as a service, infrastructure as a service, and other similar hosting arrangements) includes a software license and, based on that determination, how to account for such arrangements. If a cloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. The guidance is effective for reporting periods beginning after December 15, 2015, and can be adopted on either a prospective or retrospective basis. We adopted this guidance in the first quarter of 2016, effective as of January 1, 2016, on a prospective basis. The adoption of this new guidance did not have a material impact on our consolidated financial statements. In April 2015, the FASB issued guidance to simplify the balance sheet disclosure for debt issuance costs. Under the guidance, debt issuance costs related to a recognized debt liability are presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, in the same manner as debt discounts, rather than as an asset. In August 2015, the FASB issued guidance clarifying debt issuance costs related to line-of-credit arrangements, which guidance states that the SEC does not object to an entity deferring and presenting debt issuance costs as an asset and subsequently amortizing the deferred debt issuance costs ratably over the term of the line-of-credit arrangement, regardless of whether there are any outstanding borrowings on the line-of-credit. The guidance is effective for reporting periods beginning after December 15, 2015 and must be adopted on a retrospective basis. Early adoption is permitted. We adopted this guidance for the year ended December 31, 2015 on a retrospective basis, and all periods are presented under this guidance. In May 2014, the FASB issued guidance for revenue recognition for contracts, superseding the previous revenue recognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identify the contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. The new standard will result in enhanced disclosures regarding the nature, amount, timing, and uncertainty of revenue arising from contracts with customers. In August 2015, the FASB issued guidance approving a one-year deferral, making the standard effective for reporting periods beginning after December 15, 2017, with early adoption permitted only for reporting periods beginning after December 15, 2016. In March 2016, the FASB issued guidance to clarify the implementation guidance on principal versus agent considerations for reporting revenue gross rather than net, with the same deferred effective date. In April 2016, the FASB issued guidance to clarify the implementation guidance on identifying performance obligations and the accounting for licenses of intellectual property, with the same deferred effective date. In May 2016, the FASB issued guidance rescinding SEC paragraphs related to revenue recognition, pursuant to two SEC Staff Announcements at the March 3, 2016 Emerging Issues Task Force meeting. In May 2016, the FASB also issued guidance to clarify the implementation guidance on assessing collectability, presentation of sales tax, noncash consideration, and contracts and contract modifications at transition, with the same effective date. We are currently evaluating the impact, if any, that this guidance will have on our consolidated financial statements. We have evaluated all other issued and unadopted Accounting Standards Updates and believe the adoption of these standards will not have a material impact on our condensed consolidated statements of earnings, balance sheets, or cash flows. |
REVENUE RECOGNITION AND RELAT20
REVENUE RECOGNITION AND RELATED ALLOWANCES (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Revenue Recognition [Abstract] | |
Schedule of Valuation and Qualifying Accounts Disclosure | The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the six months ended June 30, 2015 and 2016, respectively: (in thousands) Accruals for Chargebacks, Rebates, Returns, and Other Allowances Administrative Prompt Medicaid Fees and Other Payment Chargebacks Rebates Returns Rebates Discounts Balance at December 31, 2014 $ 6,865 $ 2,264 $ 1,445 $ 1,487 $ 471 Accruals/Adjustments 21,644 2,177 776 2,913 1,231 Credits Taken Against Reserve (22,588) (2,550) (502) (2,960) (1,217) Balance at June 30, 2015 $ 5,921 $ 1,891 $ 1,719 $ 1,440 $ 485 Balance at December 31, 2015 $ 11,381 $ 4,631 $ 2,648 $ 1,653 $ 674 Accruals/Adjustments 43,349 5,773 3,256 5,071 2,180 Credits Taken Against Reserve (34,731) (3,895) (2,595) (4,274) (1,678) Balance at June 30, 2016 $ 19,999 $ 6,509 $ 3,309 $ 2,450 $ 1,176 |
INDEBTEDNESS (Tables)
INDEBTEDNESS (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Convertible Debt | The carrying value of the Notes is as follows as of: (in thousands) June 30, December 31, Principal amount $ 143,750 $ 143,750 Unamortized debt discount (23,872) (27,016) Deferred financing costs (2,885) (3,307) Net carrying value $ 116,993 $ 113,427 |
Interest Income and Interest Expense Disclosure | The following table sets forth the components of total interest expense related to the Notes recognized in the accompanying unaudited interim condensed consolidated statements of earnings for the three and six months ended June 30, 2016 and 2015: Three Months Ended Six Months Ended (in thousands) June 30, June 30, June 30, June 30, Contractual coupon $ 1,078 $ 1,078 $ 2,156 $ 2,156 Amortization of debt discount 1,582 1,501 3,144 2,981 Amortization of finance fees 211 211 422 422 Capitalized interest (54) (6) (100) (15) $ 2,817 $ 2,784 $ 5,622 $ 5,544 |
EARNINGS PER SHARE (Tables)
EARNINGS PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | Earnings per share for the three and six months ended June 30, 2016 and 2015 are calculated for basic and diluted earnings per share as follows: Basic Diluted Basic Diluted (in thousands, except per share amounts) Three Months Ended Three Months Ended Six Months Ended Six Months Ended 2016 2015 2016 2015 2016 2015 2016 2015 Net income $ 1,125 $ 3,571 $ 1,125 $ 3,571 $ 2,471 $ 7,940 $ 2,471 $ 7,940 Net income allocated to restricted stock (8) (24) (8) (23) (17) (53) (17) (52) Net income allocated to common shares $ 1,117 $ 3,547 $ 1,117 $ 3,548 $ 2,454 $ 7,887 $ 2,454 $ 7,888 Basic Weighted-Average Shares Outstanding 11,402 11,344 11,402 11,344 11,398 11,335 11,398 11,335 Dilutive effect of stock options 139 205 116 221 Diluted Weighted-Average Shares Outstanding 11,541 11,549 11,514 11,556 Earnings Per Share $ 0.10 $ 0.31 $ 0.10 $ 0.31 $ 0.22 $ 0.70 $ 0.21 $ 0.68 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | (in thousands) June 30, December 31, Raw materials $ 12,583 $ 10,192 Packaging materials 935 998 Work-in-progress 588 456 Finished goods 11,204 1,897 25,310 13,543 Reserve for excess/obsolete inventories (258) (156) Inventories, net $ 25,052 $ 13,387 |
PROPERTY, PLANT, AND EQUIPMENT
PROPERTY, PLANT, AND EQUIPMENT (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant, and equipment consist of the following as of: (in thousands) June 30, December 31, Land $ 87 $ 87 Buildings 3,682 3,682 Machinery, furniture, and equipment 7,311 5,623 Construction in progress 2,725 2,189 13,805 11,581 Less: accumulated depreciation (4,894) (4,450) Property, Plant, and Equipment, net $ 8,911 $ 7,131 |
GOODWILL AND INTANGIBLE ASSETS
GOODWILL AND INTANGIBLE ASSETS (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
GOODWILL AND INTANGIBLE ASSETS | |
Schedule of Intangible Assets and Goodwill | The components of net definite-lived intangible assets are as follows: (in thousands) June 30, 2016 December 31, 2015 Weighted Average Gross Carrying Accumulated Gross Carrying Accumulated Amortization Acquired ANDA intangible assets $ 42,076 $ (6,289) $ 42,076 $ (4,287) 10.0 years NDAs and product rights 161,150 (12,546) 33,422 (5,754) 10.1 years Marketing and distribution rights 11,042 (1,361) 1,000 (60) 4.7 years Non-compete agreement 624 (22) - - 7.0 years $ 214,892 $ (20,218) $ 76,498 $ (10,101) |
Finite-lived Intangible Assets Amortization Expense | Expected future amortization expense is as follows: (in thousands) 2016 (remainder of the year) $ 11,450 2017 22,722 2018 22,367 2019 22,367 2020 21,885 2021 and thereafter 93,883 Total $ 194,674 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | The following table summarizes stock-based compensation expense, net of forfeitures, included in our accompanying unaudited interim condensed consolidated statements of earnings: (in thousands) Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Cost of sales $ 24 $ 21 $ 14 $ 37 Research and development 22 33 49 49 Selling, general, and adminstrative 2,171 975 3,259 1,511 $ 2,217 $ 1,029 $ 3,322 $ 1,597 |
Schedule of Share-based Compansation, Stock Option And Restricted Stock, Activity | A summary of stock option and restricted stock activity under the Plan during the six months ended June 30, 2016 and 2015 is presented below: (in thousands) Options RSAs Outstanding December 31, 2014 458 63 Granted 120 28 Options Exercised/RSAs Vested (31) (10) Forfeited (33) (5) Outstanding June 30, 2015 514 76 Outstanding December 31, 2015 474 63 Granted 273 42 Options Exercised/RSAs Vested (54) (15) Forfeited (50) (12) Outstanding June 30, 2016 643 78 |
FAIR VALUE DISCLOSURES (Tables)
FAIR VALUE DISCLOSURES (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | The following table presents our financial assets and liabilities accounted for at fair value on a recurring basis as of June 30, 2016 and December 31, 2015, by level within the fair value hierarchy: (in thousands) Description Fair Value at Level 1 Level 2 Level 3 Liabilities CVRs $ - $ - $ - $ - Description Fair Value at Level 1 Level 2 Level 3 Liabilities CVRs $ - $ - $ - $ - |
REVENUE RECOGNITION AND RELAT28
REVENUE RECOGNITION AND RELATED ALLOWANCES (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Valuation and Qualifying Accounts Disclosure | ||
Beginning balance | $ 13,586 | |
Ending balance | 23,406 | |
Chargebacks | ||
Valuation and Qualifying Accounts Disclosure | ||
Beginning balance | 11,381 | $ 6,865 |
Accruals/Adjustments | 43,349 | 21,644 |
Credits Taken Against Reserve | (34,731) | (22,588) |
Ending balance | 19,999 | 5,921 |
Medicaid Rebates | ||
Valuation and Qualifying Accounts Disclosure | ||
Beginning balance | 4,631 | 2,264 |
Accruals/Adjustments | 5,773 | 2,177 |
Credits Taken Against Reserve | (3,895) | (2,550) |
Ending balance | 6,509 | 1,891 |
Returns | ||
Valuation and Qualifying Accounts Disclosure | ||
Beginning balance | 2,648 | 1,445 |
Accruals/Adjustments | 3,256 | 776 |
Credits Taken Against Reserve | (2,595) | (502) |
Ending balance | 3,309 | 1,719 |
Administrative Fees and Other Rebates | ||
Valuation and Qualifying Accounts Disclosure | ||
Beginning balance | 1,653 | 1,487 |
Accruals/Adjustments | 5,071 | 2,913 |
Credits Taken Against Reserve | (4,274) | (2,960) |
Ending balance | 2,450 | 1,440 |
Prompt Payment Discounts | ||
Valuation and Qualifying Accounts Disclosure | ||
Beginning balance | 674 | 471 |
Accruals/Adjustments | 2,180 | 1,231 |
Credits Taken Against Reserve | (1,678) | (1,217) |
Ending balance | $ 1,176 | $ 485 |
REVENUE RECOGNITION AND RELAT29
REVENUE RECOGNITION AND RELATED ALLOWANCES (Details Textual) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Net Accounts Receivable [Member] | ||||
Concentration Risk, Percentage | 74.00% | |||
Customer One [Member] | Net Revenues [Member] | ||||
Concentration Risk, Percentage | 28.00% | 20.00% | 25.00% | 20.00% |
Customer Two [Member] | Net Revenues [Member] | ||||
Concentration Risk, Percentage | 21.00% | 18.00% | 24.00% | 22.00% |
Customer Three [Member] | Net Revenues [Member] | ||||
Concentration Risk, Percentage | 18.00% | 15.00% | 17.00% | 19.00% |
INDEBTEDNESS (Details)
INDEBTEDNESS (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Principal amount | $ 143,750 | $ 143,750 |
Unamortized debt discount | (23,872) | (27,016) |
Deferred financing costs | (2,885) | (3,307) |
Net carrying value | $ 116,993 | $ 113,427 |
INDEBTEDNESS (Details 1)
INDEBTEDNESS (Details 1) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Contractual coupon | $ 1,078 | $ 1,078 | $ 2,156 | $ 2,156 |
Amortization of debt discount | 1,582 | 1,501 | 3,144 | 2,981 |
Amortization of finance fees | 211 | 211 | 422 | 422 |
Capitalized interest | (54) | (6) | (100) | (15) |
Interest Expense, Debt | $ 2,817 | $ 2,784 | $ 5,622 | $ 5,544 |
INDEBTEDNESS (Details Textual)
INDEBTEDNESS (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | ||
May 31, 2016 | Jun. 30, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Long-term Debt, Gross | $ 143,750 | $ 143,750 | ||
Debt Instrument, Unamortized Discount | 23,872 | 27,016 | ||
Deferred Finance Costs, Net | 2,885 | 3,307 | ||
Line of Credit Facility, Increase, Accrued Interest | 16 | |||
Prepaid Expenses and Other Current Assets [Member] | ||||
Deferred Costs, Current | $ 300 | |||
Convertible Senior Notes [Member] | ||||
Long-term Debt, Gross | $ 143,800 | |||
Long-term Debt, Percentage Bearing Fixed Interest, Percentage Rate | 3.00% | |||
Debt Instrument, Convertible, Conversion Price | $ 69.48 | |||
Debt Instrument, Unamortized Discount | $ 33,600 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 96.21 | |||
Debt Instrument, Interest Rate, Effective Percentage | 7.80% | |||
Convertible Senior Notes [Member] | Accrued Liabilities [Member] | ||||
Interest Payable, Current | $ 400 | $ 400 | ||
Line of Credit [Member] | ||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 30,000 | |||
Debt Instrument, Maturity Date | May 12, 2019 | |||
Line of Credit Facility, Commitment Fee Percentage | 0.25% | |||
Debt Instrument, Description of Variable Rate Basis | LIBOR rate plus 1.25%, 1.50%, or 1.75% per annum, depending upon availability under the Citizens Agreement, or an alternative base rate plus either 0.25%, 0.50%, or 0.75% per annum | |||
Deferred Finance Costs, Net | $ 300 | |||
Debt Instrument, Covenant Description | 1.10 to 1.00 | |||
Required Minimum Availability Percentage To Trigger Covenants Line of Credit | 12.50% | |||
Required Minimum Availability Balance To Trigger Covenants Line of Credit | $ 3,750 | |||
Line Of Credit Facility Additional Revolving Commitment | $ 10,000 |
EARNINGS PER SHARE (Details)
EARNINGS PER SHARE (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Net income, Basic | $ 1,125 | $ 3,571 | $ 2,471 | $ 7,940 |
Net income, Diluted | 1,125 | 3,571 | 2,471 | 7,940 |
Net income allocated to common shares, Basic | 1,117 | 3,547 | 2,454 | 7,887 |
Net income allocated to common shares, Diluted | $ 1,117 | $ 3,548 | $ 2,454 | $ 7,888 |
Basic Weighted-Average Shares Outstanding, Basic | 11,402 | 11,344 | 11,398 | 11,335 |
Dilutive effect of stock options, Diluted | 139 | 205 | 116 | 221 |
Diluted Weighted-Average Shares Outstanding, Diluted | 11,541 | 11,549 | 11,514 | 11,556 |
Earnings Per Share, Basic | $ 0.10 | $ 0.31 | $ 0.22 | $ 0.7 |
Earnings Per Share, Diluted | $ 0.10 | $ 0.31 | $ 0.21 | $ 0.68 |
Restricted Stock [Member] | ||||
Net income allocated to restricted stock, Basic | $ (8) | $ (24) | $ (17) | $ (53) |
Net income allocated to restricted stock, Diluted | $ (8) | $ (23) | $ (17) | $ (52) |
EARNINGS PER SHARE (Details Tex
EARNINGS PER SHARE (Details Textual) - shares shares in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4.5 | 4.6 | 4.5 | 4.6 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Inventories | ||
Raw materials | $ 12,583 | $ 10,192 |
Packaging materials | 935 | 998 |
Work-in-progress | 588 | 456 |
Finished goods | 11,204 | 1,897 |
Inventory, Gross, Total | 25,310 | 13,543 |
Reserve for excess/obsolete inventories | (258) | (156) |
Inventories, net | $ 25,052 | $ 13,387 |
INVENTORIES (Details Textual)
INVENTORIES (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Accounts Payable, Current | $ 4,961 | $ 4,961 | $ 2,066 | ||
Two Suppliers (2015) [Member] | Sales Revenue, Net [Member] | |||||
Concentration Risk, Percentage | 43.00% | 40.00% | |||
Four Suppliers (2016) [Member] | |||||
Accounts Payable, Current | $ 300 | 300 | |||
Four Suppliers (2016) [Member] | Sales Revenue, Net [Member] | |||||
Concentration Risk, Percentage | 48.00% | ||||
Two Suppliers (2016) [Member] | |||||
Accounts Payable, Current | $ 200 | $ 200 | |||
Two Suppliers (2016) [Member] | Sales Revenue, Net [Member] | |||||
Concentration Risk, Percentage | 29.00% |
PROPERTY, PLANT, AND EQUIPMEN37
PROPERTY, PLANT, AND EQUIPMENT (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment, Gross, Total | $ 13,805 | $ 11,581 |
Less: accumulated depreciation | (4,894) | (4,450) |
Property, Plant, and Equipment, net | 8,911 | 7,131 |
Land [Member] | ||
Property, Plant and Equipment, Gross, Total | 87 | 87 |
Buildings [Member] | ||
Property, Plant and Equipment, Gross, Total | 3,682 | 3,682 |
Machinery, furniture and equipment [Member] | ||
Property, Plant and Equipment, Gross, Total | 7,311 | 5,623 |
Construction in progress [Member] | ||
Property, Plant and Equipment, Gross, Total | $ 2,725 | $ 2,189 |
PROPERTY, PLANT, AND EQUIPMEN38
PROPERTY, PLANT, AND EQUIPMENT (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Depreciation, Total | $ 200 | $ 200 | $ 400 | $ 300 |
Interest Costs Capitalized | $ 54 | $ 6 | $ 100 | $ 15 |
GOODWILL AND INTANGIBLE ASSET39
GOODWILL AND INTANGIBLE ASSETS (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Aug. 31, 2015 | Jul. 31, 2015 | Mar. 31, 2015 | Mar. 31, 2014 | Jun. 30, 2016 | Dec. 31, 2015 | |
GOODWILL AND INTANGIBLE ASSETS | ||||||
Gross Carrying Amount | $ 214,892 | $ 76,498 | ||||
Accumulated Amortization | (20,218) | (10,101) | ||||
Acquired ANDA intangible assets | ||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||
Gross Carrying Amount | 42,076 | 42,076 | ||||
Accumulated Amortization | $ (6,289) | (4,287) | ||||
Weighted Average Amortization Period | 10 years | 10 years | 10 years | 10 years | ||
NDAs and product rights | ||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||
Gross Carrying Amount | $ 161,150 | 33,422 | ||||
Accumulated Amortization | $ (12,546) | (5,754) | ||||
Weighted Average Amortization Period | 10 years 1 month 6 days | |||||
Marketing and distribution rights | ||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||
Gross Carrying Amount | $ 1,000 | $ 11,042 | 1,000 | |||
Accumulated Amortization | $ (1,361) | (60) | ||||
Weighted Average Amortization Period | 7 years | 4 years 8 months 12 days | ||||
Non Compete Agreement [Member] | ||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||
Gross Carrying Amount | $ 624 | 0 | ||||
Accumulated Amortization | $ (22) | $ 0 | ||||
Weighted Average Amortization Period | 7 years |
GOODWILL AND INTANGIBLE ASSET40
GOODWILL AND INTANGIBLE ASSETS (Details 1) $ in Thousands | Jun. 30, 2016USD ($) |
GOODWILL AND INTANGIBLE ASSETS | |
2016 (remainder of the year) | $ 11,450 |
2,017 | 22,722 |
2,018 | 22,367 |
2,019 | 22,367 |
2,020 | 21,885 |
2021 and thereafter | 93,883 |
Total | $ 194,674 |
GOODWILL AND INTANGIBLE ASSET41
GOODWILL AND INTANGIBLE ASSETS (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||||
Apr. 30, 2016 | Jan. 31, 2016 | Aug. 31, 2015 | Jul. 31, 2015 | May 31, 2015 | Aug. 31, 2014 | Jul. 31, 2014 | Jun. 30, 2016 | Jun. 30, 2015 | Mar. 31, 2015 | Mar. 31, 2014 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
GOODWILL AND INTANGIBLE ASSETS | ||||||||||||||
Amortization of Intangible Assets | $ 5,700 | $ 1,200 | $ 10,100 | $ 2,400 | ||||||||||
Payments to Acquire Intangible Assets | 144,494 | 4,500 | ||||||||||||
Goodwill | 1,838 | 1,838 | $ 1,838 | |||||||||||
Finite-Lived Intangible Assets, Gross | 214,892 | 214,892 | 76,498 | |||||||||||
Accrued Royalties Related To Asset Purchase | 3,882 | $ 0 | $ 3,882 | $ 0 | ||||||||||
Cranford Pharmaceuticals [Member] | Non Compete Agreement [Member] | ||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||||||||
Finite-Lived Intangible Asset, Useful Life | 7 years | |||||||||||||
Finite-Lived Intangible Assets, Gross | $ 600 | |||||||||||||
Acquired ANDA Intangible Assets [Member] | ||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||||||||
Payments to Acquire Intangible Assets | $ 25,000 | $ 4,500 | $ 12,500 | |||||||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | 10 years | 10 years | 10 years | ||||||||||
Finite-Lived Intangible Assets, Gross | 42,076 | $ 42,076 | 42,076 | |||||||||||
Marketing and Distribution Rights [Member] | ||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||||||||
Finite-Lived Intangible Asset, Useful Life | 7 years | 4 years 8 months 12 days | ||||||||||||
Finite-Lived Intangible Assets, Gross | $ 1,000 | 11,042 | $ 11,042 | $ 1,000 | ||||||||||
Marketing and Distribution Rights [Member] | H2 - Pharma, LLC [Member] | ||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||||||||
Payments to Acquire Intangible Assets | $ 8,800 | |||||||||||||
Finite-Lived Intangible Asset, Useful Life | 4 years | |||||||||||||
Finite-Lived Intangible Assets, Gross | $ 10,000 | |||||||||||||
Acquisition Costs Capitalized | 42 | |||||||||||||
Accrued Royalties Assumed in Asset Purchase | 1,200 | |||||||||||||
Lithobid Purchase Agreement [Member] | ||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||||||||
Payments to Acquire Intangible Assets | $ 11,000 | |||||||||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | |||||||||||||
Finite-Lived Intangible Assets, Gross | $ 12,000 | |||||||||||||
Payment To Acquire Intangible Assets If Contingency Occurs | $ 1,000 | |||||||||||||
Vancocin Purchase Agreement [Member] | ||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||||||||
Payments to Acquire Intangible Assets | $ 11,000 | |||||||||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | |||||||||||||
Finite-Lived Intangible Assets, Gross | $ 10,500 | |||||||||||||
New Drug Applications [Member] | Merck Sharp Dohme B.V [Member] | ||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||||||||
Payments to Acquire Intangible Assets | $ 75,000 | |||||||||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | |||||||||||||
Finite-Lived Intangible Assets, Gross | $ 75,300 | |||||||||||||
Acquisition Costs Capitalized | $ 300 | |||||||||||||
New Drug Applications [Member] | Cranford Pharmaceuticals [Member] | ||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||||||||
Payments to Acquire Intangible Assets | $ 60,000 | 60,000 | ||||||||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | |||||||||||||
Finite-Lived Intangible Assets, Gross | $ 52,400 | |||||||||||||
Acquisition Costs Capitalized | $ 300 | |||||||||||||
Accrued Royalties Related To Asset Purchase | 3,900 | 3,900 | ||||||||||||
Asset Acquisition Purchase Price | $ 64,200 | $ 64,200 | ||||||||||||
New Drug Applications [Member] | Testosterone Gel NDA [Member] | ||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||||||||
Finite-Lived Intangible Asset, Useful Life | 11 years | |||||||||||||
Maximum Royalties Potentially Payable | $ 5,000 | |||||||||||||
Royalty Rate | 5.00% | |||||||||||||
Finite-Lived Intangible Assets, Gross | $ 10,900 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Allocated Share-based Compensation Expense | $ 2,217 | $ 1,029 | $ 3,322 | $ 1,597 |
Cost of Sales [Member] | ||||
Allocated Share-based Compensation Expense | 24 | 21 | 14 | 37 |
Research and Development Expense [Member] | ||||
Allocated Share-based Compensation Expense | 22 | 33 | 49 | 49 |
Selling, General and Administrative Expenses [Member] | ||||
Allocated Share-based Compensation Expense | $ 2,171 | $ 975 | $ 3,259 | $ 1,511 |
STOCK-BASED COMPENSATION (Det43
STOCK-BASED COMPENSATION (Details 1) - shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Options [Member] | ||
Option Shares | ||
Outstanding at the beginning of the period (in shares) | 474 | 458 |
Granted (in shares) | 273 | 120 |
Options Exercised/RSAs Vested (in shares) | (54) | (31) |
Forfeited (in shares) | (50) | (33) |
Outstanding at the end of the period (in shares) | 643 | 514 |
RSAs [Member] | ||
Option Shares | ||
Outstanding at the beginning of the period (in shares) | 63 | 63 |
Granted (in shares) | 42 | 28 |
Options Exercised/RSAs Vested (in shares) | (15) | (10) |
Forfeited (in shares) | (12) | (5) |
Outstanding at the end of the period (in shares) | 78 | 76 |
STOCK-BASED COMPENSATION (Det44
STOCK-BASED COMPENSATION (Details Textual) - USD ($) $ in Thousands | May 06, 2016 | Apr. 26, 2016 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 300,000 | 300,000 | ||||
Allocated Share-based Compensation Expense | $ 2,217 | $ 1,029 | $ 3,322 | $ 1,597 | ||
Former Chief Financial Officer [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Total Cost For Officer Transition Non Stock Based Compensation | $ 400 | |||||
Options [Member] | Former Chief Financial Officer [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Allocated Share-based Compensation Expense | $ 900 | |||||
Stock Option Grants Vested During Period Due To Modification | 25,167 | |||||
Stock Options Modified During Period | 4,050 | |||||
Restricted Stock [Member] | Former Chief Financial Officer [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share Based Payment Awards Other Than Stock Options Modified During Period | 2,000 |
STOCKHOLDER'S EQUITY (Details T
STOCKHOLDER'S EQUITY (Details Textual) - USD ($) shares in Thousands, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | |
Jan. 31, 2016 | Jun. 30, 2015 | Jun. 30, 2015 | Oct. 31, 2015 | |
Class Of Warrant Or Right Number Of Securities Called By Warrants That Expired During Period Number | 100 | 100 | ||
Stock Repurchase Program [Member] | ||||
Stock Repurchase Program, Authorized Amount | $ 25 | |||
Stock Repurchased and Retired During Period, Shares | 65 | |||
Stock Repurchased and Retired During Period, Value | $ 2.5 |
INCOME TAXES (Details Textual)
INCOME TAXES (Details Textual) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Mar. 31, 2016 | Jun. 30, 2016 | Dec. 31, 2015 | |
Effective Income Tax Rate Reconciliation, Percent | 52.20% | 53.40% | 52.80% | |
Deferred Tax Assets, Valuation Allowance | $ 0.1 | $ 0.1 | $ 0.1 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
COMMITMENTS AND CONTINGENCIES | ||||
Operating Leases, Future Minimum Payments Due, Total | $ 400 | $ 400 | ||
Operating Leases, Rent Expense | 20 | $ 20 | 40 | $ 38 |
Unapproved Products [Member] | ||||
COMMITMENTS AND CONTINGENCIES | ||||
Revenue, Net | 9,000 | 11,000 | 18,000 | 21,300 |
Unapproved Products [Member] | Contract Customer [Member] | ||||
COMMITMENTS AND CONTINGENCIES | ||||
Revenue, Net | 500 | 500 | 800 | 800 |
Royalty Revenue, Total | $ 100 | $ 100 | $ 200 | $ 200 |
FAIR VALUE DISCLOSURES (Details
FAIR VALUE DISCLOSURES (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Liabilities | ||
CVRs | $ 0 | $ 0 |
Fair Value, Inputs, Level 1 [Member] | ||
Liabilities | ||
CVRs | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Liabilities | ||
CVRs | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Liabilities | ||
CVRs | $ 0 | $ 0 |
FAIR VALUE DISCLOSURES (Detai49
FAIR VALUE DISCLOSURES (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | ||||
Apr. 30, 2016 | Jan. 31, 2016 | Aug. 31, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Fair Value Inputs, Assets, Quantitative Information | ||||||
Fair Value Inputs, Discount Rate | 15.00% | |||||
Payments to Acquire Intangible Assets | $ 144,494 | $ 4,500 | ||||
Long-term Debt, Total | 116,993 | $ 113,427 | ||||
Finite-Lived Intangible Assets, Gross | 214,892 | 76,498 | ||||
Inventory, Finished Goods, Gross | 11,204 | 1,897 | ||||
Accrued Royalties Related To Asset Purchase | 3,882 | $ 0 | ||||
Cranford Pharmaceuticals [Member] | Non Compete Agreement [Member] | ||||||
Fair Value Inputs, Assets, Quantitative Information | ||||||
Fair Value Inputs, Discount Rate | 10.00% | |||||
Finite-Lived Intangible Assets, Gross | $ 600 | |||||
Finite-Lived Intangible Asset, Useful Life | 7 years | |||||
Cranford Pharmaceuticals [Member] | Prepaid Purchase Order [Member] | ||||||
Fair Value Inputs, Assets, Quantitative Information | ||||||
Prepaid Expense and Other Assets, Current | $ 300 | |||||
Merck Sharp Dohme B.V [Member] | ||||||
Fair Value Inputs, Assets, Quantitative Information | ||||||
Fair Value Inputs, Discount Rate | 10.00% | |||||
Finite-Lived Intangible Assets, Gross | $ 75,000 | |||||
Finite-Lived Intangible Asset, Useful Life | 10 years | |||||
Acquisition Costs Capitalized | $ 300 | |||||
Fair Value, Inputs, Level 1 [Member] | ||||||
Fair Value Inputs, Assets, Quantitative Information | ||||||
Notes Payable, Fair Value Disclosure | 155,400 | |||||
New Drug Applications [Member] | Cranford Pharmaceuticals [Member] | ||||||
Fair Value Inputs, Assets, Quantitative Information | ||||||
Fair Value Inputs, Discount Rate | 12.00% | |||||
Payments to Acquire Intangible Assets | $ 60,000 | 60,000 | ||||
Finite-Lived Intangible Assets, Gross | $ 52,400 | |||||
Finite-Lived Intangible Asset, Useful Life | 10 years | |||||
Acquisition Costs Capitalized | $ 300 | |||||
Inventory, Finished Goods, Gross | 10,900 | |||||
Funds Held In Escrow In Relation To Asset Purchase | $ 5,000 | |||||
Accrued Royalties Related To Asset Purchase | 3,900 | |||||
Asset Acquisition Purchase Price | 64,200 | |||||
Marketing and Distribution Rights [Member] | ||||||
Fair Value Inputs, Assets, Quantitative Information | ||||||
Finite-Lived Intangible Assets, Gross | $ 1,000 | $ 11,042 | $ 1,000 | |||
Finite-Lived Intangible Asset, Useful Life | 7 years | 4 years 8 months 12 days | ||||
Marketing and Distribution Rights [Member] | H2 - Pharma, LLC [Member] | ||||||
Fair Value Inputs, Assets, Quantitative Information | ||||||
Fair Value Inputs, Discount Rate | 10.00% | |||||
Payments to Acquire Intangible Assets | $ 8,800 | |||||
Finite-Lived Intangible Assets, Gross | 10,000 | |||||
Acquisition Costs Capitalized | 42 | |||||
Accrued Royalties Assumed in Asset Purchase | $ 1,200 |
SUBSEQUENT EVENT (Details Textu
SUBSEQUENT EVENT (Details Textual) shares in Millions | Jul. 31, 2016shares |
Subsequent Event [Member] | Employee Stock Purchase Plan [Member] | |
Subsequent Event [Line Items] | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 0.2 |