Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Feb. 21, 2017 | Jun. 30, 2016 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | ANI PHARMACEUTICALS INC | ||
Entity Central Index Key | 1,023,024 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 475.9 | ||
Trading Symbol | ANIP | ||
Class C Special Stock [Member] | |||
Document Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 10,864 | ||
Common Stock [Member] | |||
Document Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 11,589,686 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Current Assets | ||
Cash and cash equivalents | $ 27,365 | $ 154,684 |
Accounts receivable, net of $31,535 and $13,586 of adjustments for chargebacks and other allowances at December 31, 2016 and 2015, respectively | 45,895 | 21,932 |
Inventories, net | 26,183 | 13,387 |
Prepaid income taxes | 0 | 1,127 |
Prepaid expenses and other current assets | 3,564 | 1,453 |
Total Current Assets | 103,007 | 192,583 |
Property and equipment, net | 10,998 | 7,131 |
Restricted cash | 5,002 | 0 |
Deferred tax asset, net of valuation allowance | 26,227 | 17,316 |
Intangible assets, net | 175,792 | 66,397 |
Goodwill | 1,838 | 1,838 |
Total Assets | 322,864 | 285,265 |
Current Liabilities | ||
Accounts payable | 3,389 | 2,066 |
Accrued expenses and other | 927 | 617 |
Accrued royalties | 11,956 | 606 |
Accrued compensation and related expenses | 1,631 | 1,188 |
Current income taxes payable | 2,398 | 0 |
Accrued government rebates | 5,891 | 4,631 |
Returned goods reserve | 5,756 | 2,648 |
Total Current Liabilities | 31,948 | 11,756 |
Long-term Liabilities | ||
Long-term royalties | 625 | 0 |
Convertible notes, net of discount and deferred financing costs | 120,643 | 113,427 |
Total Liabilities | 153,216 | 125,183 |
Commitments and Contingencies (Note 11) | ||
Stockholders' Equity | ||
Common Stock, $0.0001 par value, 33,333,334 shares authorized; 11,588,701 shares issued and outstanding at December 31, 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 December 31, 2016 and 2015, respectively | 0 | 0 |
Preferred Stock, $0.0001 par value, 1,666,667 shares authorized; 0 shares issued and outstanding at December 31, 2016 and 2015, respectively | 0 | 0 |
Additional paid-in capital | 172,563 | 164,431 |
Accumulated deficit | (2,916) | (4,350) |
Total Stockholders' Equity | 169,648 | 160,082 |
Total Liabilities and Stockholders' Equity | $ 322,864 | $ 285,265 |
Consolidated Balance Sheets _Pa
Consolidated Balance Sheets [Parenthetical] - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Adjustments for chargebacks and other allowances | $ 31,535 | $ 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 [Member] | ||
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 | 11,588,701 | 11,498,228 |
Common Stock, Outstanding Shares | 11,588,701 | 11,498,228 |
Class C Special Stock [Member] | ||
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 |
Consolidated Statements of Earn
Consolidated Statements of Earnings - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Net Revenues | $ 128,622 | $ 76,322 | $ 55,970 |
Operating Expenses | |||
Cost of sales (excluding depreciation and amortization) | 48,780 | 12,692 | 11,473 |
Research and development | 2,906 | 2,874 | 2,678 |
Selling, general, and administrative | 27,829 | 21,156 | 17,935 |
Depreciation and amortization | 22,343 | 6,900 | 3,878 |
Intangible asset impairment charge | 6,685 | 0 | 0 |
Total Operating Expenses | 108,543 | 43,622 | 35,964 |
Operating Income | 20,079 | 32,700 | 20,006 |
Other Expense, net | |||
Interest expense, net | (11,327) | (11,008) | (787) |
Other (expense)/income, net | (74) | 41 | 160 |
Income Before (Provision)/Benefit for Income Taxes | 8,678 | 21,733 | 19,379 |
(Provision)/benefit for income taxes | (4,744) | (6,358) | 9,368 |
Net Income | $ 3,934 | $ 15,375 | $ 28,747 |
Basic and Diluted Earnings Per Share: | |||
Basic Earnings Per Share (in dollars per share) | $ 0.34 | $ 1.34 | $ 2.61 |
Diluted Earnings Per Share (in dollars per share) | $ 0.34 | $ 1.32 | $ 2.59 |
Basic Weighted-Average Shares Outstanding (in shares) | 11,445 | 11,370 | 10,941 |
Diluted Weighted-Average Shares Outstanding (in shares) | 11,573 | 11,557 | 11,053 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Class C Special Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2013 | $ 40,962 | $ 1 | $ 0 | $ 89,501 | $ (68) | $ (48,472) |
Balance (in shares) at Dec. 31, 2013 | 9,629 | 9 | ||||
Stock-based Compensation Expense | 3,423 | $ 0 | 0 | 3,423 | $ 0 | 0 |
Issuance of Common Stock in Equity Offering | 46,680 | $ 0 | 0 | 46,680 | $ 0 | 0 |
Issuance of Common Stock in Equity Offering (in shares) | 1,613 | 0 | ||||
Allocation of proceeds from sale of Convertible Notes to Embedded Conversion Option | 20,195 | $ 0 | 0 | 20,195 | $ 0 | 0 |
Cost of Bond-hedge, Net of Proceeds from Sale of Warrant | (2,575) | 0 | 0 | (2,575) | 0 | 0 |
Issuance of Common Stock upon Warrant Exercise | 750 | $ 0 | 0 | 750 | $ 0 | 0 |
Issuance of Common Stock upon Warrant Exercise (in shares) | 83 | 0 | ||||
Issuance of Common Shares upon Stock Option Exercise | 819 | $ 0 | 0 | 819 | $ 0 | 0 |
Issuance of Common Shares upon Stock Option Exercise (in Shares) | 43 | 0 | ||||
Issuance of Restricted Stock Awards | 0 | $ 0 | 0 | (68) | $ 68 | 0 |
Issuance of Restricted Stock Awards (in Shares) | 20 | (9) | ||||
Excess Tax Benefit from Stock-based Compensation Awards | 784 | $ 0 | 0 | 784 | $ 0 | 0 |
Net Income | 28,747 | 0 | 0 | 0 | 0 | 28,747 |
Balance at Dec. 31, 2014 | 139,785 | $ 1 | 0 | 159,509 | $ 0 | (19,725) |
Balance (in shares) at Dec. 31, 2014 | 11,388 | 0 | ||||
Stock-based Compensation Expense | 3,856 | $ 0 | 0 | 3,856 | $ 0 | 0 |
Issuance of Common Shares upon Stock Option Exercise | 819 | $ 0 | 0 | 706 | $ 113 | 0 |
Issuance of Common Shares upon Stock Option Exercise (in Shares) | 84 | (5) | ||||
Changes in Treasury Stock Related to Stock-based Compensation Arrangements | (113) | $ 0 | 0 | 0 | $ (113) | 0 |
Changes in Treasury Stock Related to Stock-based Compensation Arrangements (in shares) | 0 | 7 | ||||
Issuance of Restricted Stock Awards | 0 | $ 0 | 0 | 0 | $ 0 | 0 |
Issuance of Restricted Stock Awards (in Shares) | 26 | (2) | ||||
Excess Tax Benefit from Stock-based Compensation Awards | 360 | $ 0 | 0 | 360 | $ 0 | 0 |
Net Income | 15,375 | 0 | 0 | 0 | 0 | 15,375 |
Balance at Dec. 31, 2015 | 160,082 | $ 1 | 0 | 164,431 | $ 0 | (4,350) |
Balance (in shares) at Dec. 31, 2015 | 11,498 | 0 | ||||
Stock-based Compensation Expense | 6,067 | $ 0 | 0 | 6,067 | $ 0 | 0 |
Changes in Treasury Stock Related to Stock-based Compensation Arrangements | (122) | $ 0 | 0 | 0 | $ (122) | 0 |
Changes in Treasury Stock Related to Stock-based Compensation Arrangements (in shares) | 0 | 10 | ||||
Issuance of Common Shares upon Stock Option and ESPP Exercise | 1,570 | $ 0 | 0 | 1,448 | $ 122 | 0 |
Issuance of Common Shares upon Stock Option and ESPP Exercise (in shares) | 119 | (10) | ||||
Repurchase of Common Stock under Stock Repurchase Program | (2,500) | $ 0 | 0 | 0 | $ 0 | (2,500) |
Repurchase of Common Stock under Stock Repurchase Program (in shares) | (65) | 0 | ||||
Issuance of Restricted Stock Awards | 0 | $ 0 | 0 | 0 | $ 0 | 0 |
Issuance of Restricted Stock Awards (in Shares) | 37 | 0 | ||||
Excess Tax Benefit from Stock-based Compensation Awards | 617 | $ 0 | 0 | 617 | $ 0 | 0 |
Net Income | 3,934 | 0 | 0 | 0 | 0 | 3,934 |
Balance at Dec. 31, 2016 | $ 169,648 | $ 1 | $ 0 | $ 172,563 | $ 0 | $ (2,916) |
Balance (in shares) at Dec. 31, 2016 | 11,589 | 0 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash Flows From Operating Activities | |||
Net income | $ 3,934 | $ 15,375 | $ 28,747 |
Adjustments to reconcile net loss to net cash and cash equivalents provided by operating activities: | |||
Stock-based compensation | 6,067 | 3,856 | 3,423 |
Deferred taxes | (8,911) | (1,877) | (14,459) |
Depreciation and amortization | 22,343 | 6,900 | 3,878 |
Non-cash interest relating to convertible notes and loan cost amortization | 7,281 | 6,831 | 559 |
Intangible asset impairment charge | 6,685 | 0 | 0 |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (23,963) | (4,635) | (4,784) |
Inventories, net | (1,938) | (5,869) | (3,468) |
Prepaid expenses and other current assets | (647) | (314) | (558) |
Accounts payable | 1,076 | (1,027) | 225 |
Accrued royalties | 6,269 | (96) | 702 |
Accrued compensation and related expenses | 443 | (160) | 575 |
Current income taxes, net | 3,525 | (5,380) | 4,233 |
Accrued government rebates | 1,260 | 2,367 | 2,011 |
Returned goods reserve | 3,108 | 1,203 | 709 |
Accrued expenses and other | 940 | 90 | 240 |
Net Cash and Cash Equivalents Provided by Operating Activities | 27,472 | 17,264 | 22,033 |
Cash Flows From Investing Activities | |||
Changes in restricted cash | (5,002) | 0 | 0 |
Acquisition of product rights and other related assets | (144,494) | (30,500) | (34,634) |
Acquisition of property and equipment | (4,566) | (2,183) | (1,120) |
Net Cash and Cash Equivalents Used in Investing Activities | (154,062) | (32,683) | (35,754) |
Cash Flows From Financing Activities | |||
Net proceeds from equity offering | 0 | 0 | 46,680 |
Net proceeds from convertible debt offering | 0 | 0 | 138,243 |
Purchase of call option overlay, net | 0 | 0 | (15,623) |
Payment of debt issuance costs | (294) | 0 | 0 |
Proceeds from stock option exercises | 1,570 | 819 | 819 |
Proceeds from warrant exercise | 0 | 0 | 750 |
Excess tax benefit from share-based compensation awards | 617 | 360 | 784 |
Repurchase of common stock under the stock repurchase program | (2,500) | 0 | 0 |
Treasury stock purchases for restricted stock vestings and forfeitures | (122) | (113) | 0 |
Net Cash and Cash Equivalents (Used in)/Provided by Financing Activities | (729) | 1,066 | 171,653 |
Change in Cash and Cash Equivalents | (127,319) | (14,353) | 157,932 |
Cash and cash equivalents, beginning of period | 154,684 | 169,037 | 11,105 |
Cash and cash equivalents, end of period | 27,365 | 154,684 | 169,037 |
Supplemental disclosure for cash flow information: | |||
Cash paid for interest, net of amounts capitalized | 4,078 | 4,149 | 0 |
Cash paid for income taxes, net | 9,537 | 13,255 | 147 |
Supplemental non-cash investing and financing activities: | |||
Accrued royalties related to asset purchase | 3,882 | 0 | 0 |
Property and equipment purchased and included in accounts payable | $ 247 | $ 439 | $ 0 |
DESCRIPTION OF BUSINESS AND SUM
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2016 | |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 1. DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES ANI Pharmaceuticals, Inc. and its consolidated subsidiaries (together, “ANI,” the “Company,” “we,” “us,” or “our”) is an integrated specialty pharmaceutical company focused on delivering value to our customers by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals. ANI was organized as a Delaware corporation in April 2001. At our two facilities located in Baudette, Minnesota, we manufacture oral solid dose products, as well as liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment. We also perform contract manufacturing for other pharmaceutical companies. On June 19, 2013, BioSante Pharmaceuticals, Inc. (“BioSante”) acquired ANIP Acquisition Company (“ANIP”) in an all-stock, tax-free reorganization (the “Merger”), in which ANIP became a wholly-owned subsidiary of BioSante. BioSante was renamed ANI Pharmaceuticals, Inc. The Merger was accounted for as a reverse acquisition pursuant to which ANIP was considered the acquiring entity for accounting purposes. As such, ANIP's historical results of operations replace BioSante's historical results of operations for all periods prior to the Merger. The results of operations of both companies are included in our consolidated financial statements for all periods after completion of the Merger. Our operations are subject to certain risks and uncertainties including, among others, current and potential competitors with greater resources, dependence on significant customers, lack of operating history and uncertainty of future profitability, and possible fluctuations in financial results. The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business. The propriety of using the going-concern basis is dependent upon, among other things, the achievement of future profitable operations, the ability to generate sufficient cash from operations, and potential other funding sources, including cash on hand, to meet our obligations as they become due. We believe the going-concern basis is appropriate for the accompanying consolidated financial statements based on our current operating plan and business strategy for the 12 months following the issuance of this report. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Certain prior period information has been reclassified to conform to the current period presentation. The consolidated financial statements include the accounts of ANI Pharmaceuticals, Inc. and its subsidiaries. All intercompany accounts and transactions are eliminated in consolidation. 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. 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 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, government 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 could differ from those estimates. We have no components of other comprehensive income and accordingly, no statement of comprehensive income is included in the accompanying consolidated financial statements. Our customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and other pharmaceutical companies. During the year ended December 31, 2016, three customers represented approximately 28 22 18 83 26 20 18 30 25 14 We source the raw materials for 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 costs and time required to validate a second source of supply. As a result, we are dependent upon our current vendors to supply reliably the API required for ongoing product manufacturing. During the year ended December 31, 2016, we purchased approximately 25 33 42 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 consolidated statements of earnings, and are presented as current liabilities or reductions in accounts receivable in the accompanying consolidated balance sheets (see “Accruals for Chargebacks, Rebates, Returns, and Other Allowances”). Historically, we have not entered into revenue arrangements with multiple elements. We record revenue related to marketing and distribution agreements with third parties in which we sell products under Abbreviated New Drug Applications (“ANDAs”) or New Drug Applications (“NDAs”) owned or licensed by these third parties. We have assessed and determined that we are the principal for sales under each of these marketing and distribution agreements and recognize the revenue on a gross basis when risk and title are passed 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. Under these agreements, we pay these third parties a specified percentage of the gross profit earned on sales of the products. These profit-sharing percentages are recognized in cost of sales in our consolidated statements of earnings and are accrued in accrued royalties in our consolidated balance sheets until payment has occurred. 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. We consider all highly liquid instruments with maturities of three months or less when purchased to be cash equivalents. All interest bearing and non-interest bearing accounts are guaranteed by the Federal Deposit Insurance Corporation (“FDIC”) up to $ 250 We extend credit to customers on an unsecured basis. We use the allowance method to provide for doubtful accounts based on our evaluation of the collectability of accounts receivable, whereby we provide an allowance for doubtful accounts equal to the estimated uncollectible amounts. Our estimate is based on historical collection experience and a review of the current status of trade accounts receivable. We determine trade receivables to be delinquent when greater than 30 days past due. Receivables are written off when it is determined that amounts are uncollectible. We determined that no allowance for doubtful accounts was necessary as of December 31, 2016 and 2015. Our generic and branded product revenues are typically subject to agreements with customers allowing chargebacks, government rebates, product returns, administrative fees and other rebates, and prompt payment discounts. We accrue for these items at the time of sale based on the estimates and methodologies described below. In the aggregate, these accruals exceed 50 We continually monitor and re-evaluate the accruals as additional information becomes available, which includes, among other things, trade inventory levels, customer product mix, products returned by customers, and trends in government rebates experience. 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 or upon issuance of credit to the customer. Chargebacks Chargebacks, primarily from wholesalers, result from arrangements we have with indirect customers establishing prices for products which the indirect customer purchases through a wholesaler. Alternatively, we may pre-authorize wholesalers to offer specified contract pricing to other indirect customers. Under either arrangement, we provide a chargeback credit to the wholesaler for any difference between the contracted price with the indirect customer and the wholesaler's invoice price, typically Wholesale Acquisition Cost ("WAC"). Chargeback credits are calculated as follows: Prior period chargebacks claimed by wholesalers are analyzed to determine the actual average selling price ("ASP") for each product. This calculation is performed by product by wholesaler. ASPs can be affected by several factors such as: · A change in customer mix · A change in negotiated terms with customers · A change in the volume of off-contract purchases · Changes in WAC As necessary, we adjust ASPs based on anticipated changes in the factors above. The difference between ASP and WAC is recorded as a reduction in both gross revenues in the consolidated statements of earnings and accounts receivable in the consolidated balance sheets, at the time we recognize revenue from the product sale. To evaluate the adequacy of our chargeback accruals, we obtain on-hand inventory counts from the wholesalers. This inventory is multiplied by the chargeback amount, the difference between ASP and WAC, to arrive at total expected future chargebacks, which is then compared to the chargeback accruals. We continually monitor chargeback activity and adjust ASPs when we believe that actual selling prices will differ from current ASPs. Government Rebates Our government rebates reserve consists of estimated payments due to governmental agencies for purchases made by third parties under various governmental programs. The two largest government programs that impact our net revenue and our government rebates reserve are federal and state Medicaid rebate programs and Medicare. We participate in certain qualifying federal and state Medicaid rebate programs whereby discounts and rebates are provided to participating programs after the final dispensing of the product by a pharmacy to a Medicaid plan participant. Medicaid rebates are typically billed up to 120 days after the product is shipped. Medicaid rebate amounts per product unit are established by law, based on the Average Manufacturer Price (“AMP”), which is reported on a monthly and quarterly basis, and, in the case of branded products, best price, which is reported on a quarterly basis. Our Medicaid reserves are based on expected claims from state Medicaid programs. Estimates for expected claims are driven by patient usage, sales mix, calculated AMP or best price, as well as inventory in the distribution channel that will be subject to a Medicaid rebate. As a result of the delay between selling the products and rebate billing, our Medicaid rebate reserve includes both an estimate of outstanding claims for end-customer sales that have occurred but for which the related claim has not been billed, as well as an estimate for future claims that will be made when inventory in the distribution channel is sold through to plan participants. Many of our products are also covered under Medicare. We, like all pharmaceutical companies, must provide a discount for any products sold under NDAs to Medicare Part D participants. This applies to all products sold under NDAs, regardless of whether the products are marketed as branded or generic. Our estimates for these discounts are based on historical experience with Medicare rebates for our products. While such experience has allowed for reasonable estimations in the past, history may not always be an accurate indicator of future rebates. Medicare rebates are typically billed up to 120 days after the product is shipped. As a result of the delay between selling the products and rebate billing, our Medicare rebate reserve includes both an estimate of outstanding claims for end-customer sales that have occurred but for which the related claim has not been billed, as well as an estimate for future claims that will be made when inventory in the distribution channel is sold through to Medicare Part D participants. To evaluate the adequacy of our government rebate reserves, we review the reserves on a quarterly basis against actual claims data to ensure the liability is fairly stated. We continually monitor our government rebate reserve and adjust our estimates if we believe that actual government rebates may differ from our established accruals. Accruals for government rebates are recorded as a reduction to gross revenues in the consolidated statements of earnings and as an increase to accrued government rebates in the consolidated balance sheets. Returns We maintain a return policy that allows customers to return product within a specified period prior to and subsequent to the expiration date. Generally, product may be returned for a period beginning six months prior to its expiration date to up to one year after its expiration date. Our product returns are settled through the issuance of a credit to the customer. Our estimate for returns is based upon historical experience with actual returns. While such experience has allowed for reasonable estimation in the past, history may not always be an accurate indicator of future returns. We continually monitor our estimates for returns and make adjustments when we believe that actual product returns may differ from the established accruals. Accruals for returns are recorded as a reduction to gross revenues in the consolidated statements of earnings and as an increase to the return goods reserve in the consolidated balance sheets. Administrative Fees and Other Rebates Administrative fees or rebates are offered to wholesalers, group purchasing organizations and indirect customers. We accrue for fees and rebates, by product by wholesaler, at the time of sale based on contracted rates and ASPs. To evaluate the adequacy of our administrative fee accruals, we obtain on-hand inventory counts from the wholesalers. This inventory is multiplied by the ASPs to arrive at total expected future sales, which is then multiplied by contracted rates. The result is then compared to the administrative fee accruals. We continually monitor administrative fee activity and adjust our accruals when we believe that actual administrative fees will differ from the accruals. Accruals for administrative fees and other rebates are recorded as a reduction in both gross revenues in the consolidated statements of earnings and accounts receivable in the consolidated balance sheets. Prompt Payment Discounts We often grant sales discounts for prompt payment. The reserve for prompt payment discounts is based on invoices outstanding. We assume, based on past experience, that all available discounts will be taken. Accruals for prompt payment discounts are recorded as a reduction in both gross revenues in the consolidated statements of earnings and accounts receivable in the consolidated balance sheets. (in thousands) Accruals for Chargebacks, Returns, and Other Allowances Administrative Prompt Government Fees and Other Payment Chargebacks Rebates Returns Rebates Discounts Balance at December 31, 2013 $ 4,076 $ 253 $ 736 $ 735 $ 332 Accruals/Adjustments 35,740 2,692 1,493 5,212 1,820 Credits Taken Against Reserve (32,951) (681) (784) (4,460) (1,681) Balance at December 31, 2014 $ 6,865 $ 2,264 $ 1,445 $ 1,487 $ 471 Accruals/Adjustments 51,933 6,719 2,808 6,136 2,744 Credits Taken Against Reserve (47,417) (4,352) (1,605) (5,970) (2,541) Balance at December 31, 2015 $ 11,381 $ 4,631 $ 2,648 $ 1,653 $ 674 Accruals/Adjustments 114,433 9,671 10,271 12,747 5,517 Credits Taken Against Reserve (99,029) (8,411) (7,163) (10,850) (4,637) Balance at December 31, 2016 $ 26,785 $ 5,891 $ 5,756 $ 3,550 $ 1,554 Inventories consist of raw materials, packaging materials, work-in-progress, and finished goods. Inventories are stated at the lower of standard cost or net realizable value. We periodically review and adjust standard costs, which generally approximate weighted average cost. Property and Equipment Property and equipment are recorded at cost. Expenditures for repairs and maintenance are charged to expense as incurred. Depreciation is recorded on a straight-line basis over estimated useful lives as follows: Buildings and improvements 20 40 Machinery, furniture, and equipment 3 10 Construction in progress consists of multiple projects, primarily related to new equipment to expand our manufacturing capability as our product lines continue to grow. Construction in progress includes the cost of construction and other direct costs attributable to the construction, along with capitalized interest. Depreciation is not recorded on construction in progress until such time as the assets are placed in service. We review property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. No impairment loss related to property and equipment was recognized during the years ended December 31, 2016, 2015, and 2014. Assets held for disposal are reportable at the lower of the carrying amount or fair value, less costs to sell. No assets were held for disposal as of December 31, 2016 and 2015. Intangible assets were acquired as part of the Merger and several asset purchase transactions. These assets include ANDAs for a total of 54 previously marketed generic products we acquired in 2014 and 2015, NDAs and product rights for our branded products Lithobid, Vancocin, Inderal LA, and Corticotropin, an NDA for male testosterone gel, acquired marketing and distribution rights, a non-compete agreement, and The ANDAs, NDAs and product rights, marketing and distribution rights, and non-compete agreement are amortized over their remaining estimated useful lives, ranging from two to 10 We recognized an impairment charge of $ 6.7 The testosterone gel NDA asset was classified as held for sale as of December 31, 2016. Goodwill relates to the Merger and represents the excess of the total purchase consideration over the fair value of acquired assets and assumed liabilities, using the purchase method of accounting. Goodwill is not amortized, but is subject to periodic review for impairment. Goodwill is reviewed annually, as of October 31, and whenever events or changes in circumstances indicate that the carrying amount of the goodwill might not be recoverable. We perform our review of goodwill on our one reporting unit. Before employing detailed impairment testing methodologies, we first evaluate the likelihood of impairment by considering qualitative factors relevant to our reporting unit. When performing the qualitative assessment, we evaluate events and circumstances that would affect the significant inputs used to determine the fair value of the goodwill. Events and circumstances evaluated include: macroeconomic conditions that could affect us, industry and market considerations for the generic pharmaceutical industry that could affect us, cost factors that could affect our performance, our financial performance (including share price), and consideration of any company-specific events that could negatively affect us, our business, or the fair value of our business. If we determine that it is more likely than not that goodwill is impaired, we will then apply detailed testing methodologies. Otherwise, we will conclude that no impairment has occurred. Detailed impairment testing involves comparing the fair value of our one reporting unit to its carrying value, including goodwill. Fair value reflects the price a market participant would be willing to pay in a potential sale of ANI. If the fair value exceeds carrying value, then it is concluded that no goodwill impairment has occurred. If the carrying value of the reporting unit exceeds its fair value, a second step is required to measure possible goodwill impairment loss. The second step includes hypothetically valuing the tangible and intangible assets and liabilities of our one reporting unit as if it had been acquired in a business combination. Then, the implied fair value of our one reporting unit's goodwill is compared to the carrying value of that goodwill. If the carrying value of our one reporting unit's goodwill exceeds the implied fair value of the goodwill, we recognize an impairment loss in an amount equal to the excess, not to exceed the carrying value. No impairment loss related to goodwill was recognized in the years ended December 31, 2016, 2015, and 2014. At times, we have entered into arrangements with various commercial partners to further business opportunities. In collaborative arrangements such as these, when we are actively involved and exposed to the risks and rewards of the activities and are determined to be the principal participant in the collaboration, we classify third party costs incurred and revenues in the consolidated statements of earnings on a gross basis. Otherwise, third party revenues and costs generated by collaborative arrangements are presented on a net basis. Payments between us and the other participants are recorded and classified based on the nature of the payments. We have entered profit-sharing arrangements with third parties in which we sell products under ANDAs or NDAs owned or licensed by these third parties. Under these agreements, we pay these third parties a specified percentage of the gross profit earned on sales of the products. These profit-sharing percentages are recorded in cost of sales in our consolidated statements of earnings when the associated revenue is recognized and are recorded in accrued royalties in our consolidated balance sheets when the associated revenue is recognized and until payment has occurred. Research and development costs are expensed as incurred and primarily consist of expenses relating to product development. Research and development costs totaled $ 2.9 2.9 2.7 We have a stock-based compensation plan that includes stock options and restricted stock, which are awarded in exchange for employee and non-employee director services. Stock-based compensation cost for stock options is determined at the grant date using an option pricing model and stock-based compensation cost for restricted stock is based on the closing market price of the stock at the grant date. The value of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the employee's requisite service period. In addition, in July 2016, we commenced administration of our Employee Stock Purchase Plan (“ESPP”). We recognize the estimated fair value of stock-based compensation awards and classify the expense where the underlying salaries are classified. We incurred $ 6.1 3.9 3.4 25 Valuation of stock awards requires us to make assumptions and to apply judgment to determine the fair value of the awards. These assumptions and judgments include estimating the future volatility of our stock price, dividend yields, and future employee stock option exercise behaviors. Changes in these assumptions can affect the fair value estimate. 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. We calculate income tax benefits related to stock-based compensation arrangements using the with and without method. 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. 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 to the consolidated financial statements. We are subject to taxation in various jurisdictions in the U.S. and remain subject to examination by taxing jurisdictions for the years 1998 and all subsequent periods due to the availability of net operating loss carryforwards. 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 December 31, 2016, 2015, and 2014. We consider potential tax effects resulting from discontinued operations and record intra-period tax allocations, when those effects are deemed material. 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, shares to be purchased under our ESPP, unvested restricted stock awards, stock purchase warrants, and any conversion gain on the Notes, 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 and certain of our outstanding warrants 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 (but not net loss) attributable to the unvested restricted shares and to the participating warrants, 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 our 3.0 The numerator for earnings per share for the years ended December 31, 2016, 2015, and 2014 are calculated for basic and diluted earnings per share as follows: Basic Diluted (in thousands, except per share amounts) Year Ended December 31, Year Ended December 31, 2016 2015 2014 2016 2015 2014 Net income $ 3,934 $ 15,375 $ 28,747 $ 3,934 $ 15,375 $ 28,747 Net income allocated to restricted stock (21) (85) (159) (21) (84) (158) Net income allocated to common shares $ 3,913 $ 15,290 $ 28,588 $ 3,913 $ 15,291 $ 28,589 Basic Weighted-Average Shares Outstanding 11,445 11,370 10,941 11,445 11,370 10,941 Dilutive effect of stock options and ESPP 128 187 71 Dilutive effect of warrants - - 41 Diluted Weighted-Average Shares Outstanding 11,573 11,557 11,053 Earnings per share $ 0.34 $ 1.34 $ 2.61 $ 0.34 $ 1.32 $ 2.59 The number of anti-dilutive shares, which have been excluded from the computation of diluted earnings per share, including the shares underlying the Notes, were 4.5 4.5 4.7 Our consolidated balance sheets include various financial instruments (primarily cash and cash equivalents, prepaid expenses, accounts receivable, accounts payable, accrued expenses, and other current liabilities) that are carried at cost and that approximate fair value. The fair value of our long-term indebtedness is estimated based on the quoted prices for the same or similar issues, or on the current rates we have been offered for debt of the same remaining maturities. 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 which prioritizes and ranks the level of observability of inputs used in measuring fair value. These tiers include: ⋅ Level 1Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. ⋅ Level 2Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities. ⋅ Level 3Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. See Note 6 for additional information regarding fair value. We currently operate in a single reportable segment. Recent Accounting Pronouncements Not Yet Adopted In January 2017, the Financial Accounting Standards Board (“FASB”) issued guidance to simplify the measurement of goodwill. The guidance eliminates Step 2 from the goodwill impairment test. Instead, under the amendments in this guidance, an entity should perform its annual or interim goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss. The guidance also eliminates the requirements for any reporting unit with a zero or negative carrying amount to perform a qualitative assessment and, if it fails that qualitative test, to perform Step 2 of the goodwill impairment test. An entity is required to disclose the amount of goodwill allocated to each reporting unit with a zero or negative carrying amount of net assets. The guidance is effective for public business entities for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, and early adoption is permitted for interim or annual goodwill impai |
INDEBTEDNESS
INDEBTEDNESS | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
INDEBTEDNESS | 2. INDEBTEDNESS Convertible Senior Notes In December 2014, we issued $ 143.8 122.6 3.0 2,068,792 69.48 The Notes are convertible at the option of the holder (i) during any calendar quarter beginning after March 31, 2015, if the last reported sale price of the common stock for at least 20 30 130 1,000 Upon conversion by the holders, 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 Offering costs of $ 5.5 4.2 1.3 A portion of the offering proceeds was used to simultaneously enter into “bond hedge” (or purchased call) and “warrant” (or written call) transactions with an affiliate of one of the offering underwriters (collectively, the “Call Option Overlay”). We entered into the Call Option Overlay to synthetically raise the initial conversion price of the Notes to $ 96.21 69.48 2,068,792 96.21 2,068,792 15.6 (in thousands) 2016 2015 Principal amount $ 143,750 $ 143,750 Unamortized debt discount (20,644) (27,016) Deferred financing costs (2,463) (3,307) Net Carrying value $ 120,643 $ 113,427 (in thousands) 2016 2015 Contractual coupon $ 4,312 $ 4,312 Amortization of debt discount 6,372 6,043 Amortization of finance fees 844 844 Capitalized interest (234) (56) $ 11,294 $ 11,143 The effective interest rate on the Notes as of December 31, 2016 and 2015 was 7.9 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 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 12.5 3.75 As of December 31, 2016, we had no outstanding balance on the Line of Credit. In February 2017, we drew down $ 30.0 40.0 In the second quarter of 2016, we deferred $ 0.3 0.3 65 |
INVENTORIES
INVENTORIES | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
INVENTORIES | 3. INVENTORIES (in thousands) 2016 2015 Raw materials $ 14,138 $ 10,192 Packaging materials 930 998 Work-in-progress 477 456 Finished goods 10,812 1,897 26,357 13,543 Reserve for excess/obsolete inventories (174) (156) Inventories, net $ 26,183 $ 13,387 |
PROPERTY, PLANT, AND EQUIPMENT
PROPERTY, PLANT, AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT, AND EQUIPMENT | 4. PROPERTY, PLANT, AND EQUIPMENT Property, Plant, and Equipment consist of the following as of December 31: (in thousands) 2016 2015 Land $ 160 $ 87 Buildings 3,756 3,682 Machinery, furniture, and equipment 8,176 5,623 Construction in progress 4,293 2,189 16,385 11,581 Less: accumulated depreciation (5,387) (4,450) Property, Plant, and Equipment, net $ 10,998 $ 7,131 Depreciation expense for the years ended December 31, 2016, 2015, and 2014 totaled $ 0.9 0.7 0.6 0.2 56 |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2016 | |
GOODWILL AND INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | 5. INTANGIBLE ASSETS Goodwill As a result of the Merger we recorded goodwill of $ 1.8 For the goodwill impairment analyses performed at October 31, 2016, 2015, and 2014, we performed qualitative assessments to determine whether it was more likely than not that our goodwill asset was impaired in order to determine the necessity of performing a quantitative impairment test, under which management would calculate the asset’s fair value. When performing the qualitative assessments, we evaluated events and circumstances that would affect the significant inputs used to determine the fair value of the goodwill. Events and circumstances evaluated include: macroeconomic conditions that could affect us, industry and market considerations for the generic pharmaceutical industry that could affect us, cost factors that could affect our performance, our financial performance (including share price), and consideration of any company-specific events that could negatively affect us, our business, or our fair value. Based on our assessments of the aforementioned factors, it was determined that it was more likely than not that the fair value of our one reporting unit is greater than its carrying amount as of October 31, 2016, 2015, and 2014, and therefore no quantitative testing for impairment was required. In addition to the qualitative impairment analysis performed at October 31, 2016, there were no events or changes in circumstances that could have reduced the fair value of our reporting unit below its carrying value from October 31, 2016 to December 31, 2016. No impairment loss was recognized during the years ended December 31, 2016, 2015, and 2014, and the balance of goodwill was $1.8 million as of both December 31, 2016 and 2015. Definite-lived Intangible Assets Acquisition of Abbreviated New Drug Applications In July 2015, we purchased 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 On December 26, 2013, we entered into an agreement to purchase ANDAs to produce 31 previously marketed generic drug products from Teva for $ 12.5 8.5 4.0 10 Acquisition of New Drug Applications and Product Rights 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 0.3 3.9 64.2 52.4 10 0.6 seven 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 0.3 75.3 10 In conjunction with our merger with BioSante (the “Merger”), we acquired a testosterone gel product that was licensed to Teva (the “Testosterone Gel NDA”) and this product was assigned an intangible asset value of $ 10.9 Teva transferred the rights of the product back to ANI. In exchange, we will pay Teva a royalty of 5.0 5 We assessed the value of the Testosterone Gel NDA under the new arrangement and determined that the net asset value was recoverable as of the May 2015 transfer date and subsequent balance sheet dates. We began the commercialization process for the product during the second half of 2015 and it continued throughout 2016. In late 2016, we determined that the development and manufacturing costs required to commercialize the product had increased and would pose a significant barrier to commercializing the product ourselves. Generic competition in the testosterone replacement market had increased substantially by the end of 2016, leading to significant decreases in pricing for the product. In the fourth quarter, management began putting forth efforts to sell the Testosterone Gel NDA rather than commercialize it ourselves. As a result of all these factors, in the fourth quarter of 2016, we determined that the facts and circumstances indicated that the asset could be impaired. We performed an impairment assessment, which indicated that the fair value of the asset was lower than the carrying value. We determined the fair value of the Testosterone Gel NDA by using a discounted cash flows model. As a result of this assessment, we recorded an intangible asset 6.7 We also determined in the fourth quarter of 2016 that the asset met the criteria for being held for sale The Testosterone Gel NDA is now recorded as a short-term asset held for sale in the prepaid expenses and other assets caption in the accompanying consolidated balance sheets at $ 0.9 In August 2014, we entered into an agreement to purchase (the “Vancocin Purchase Agreement”) the product rights to Vancocin from Shire ViroPharma Incorporated (“Shire”) 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 (“Noven”) 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 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 FDA and the manufacturing of certain products. We made an upfront payment to IDT of $ 1.0 seven The components of net definite-lived intangible assets are as follows: (in thousands) December 31, 2016 December 31, 2015 Weighted Average Gross Carrying Accumulated Gross Carrying Accumulated Amortization Amount Amortization Amount Amortization Period Acquired ANDA intangible assets $ 42,076 $ (8,390) $ 42,076 $ (4,287) 10.0 years NDAs and product rights 150,250 (17,081) 33,422 (5,754) 10.0 years Marketing and distribution rights 11,042 (2,662) 1,000 (60) 4.7 years Non-compete agreement 624 (67) - - 7.0 years $ 203,992 $ (28,200) $ 76,498 $ (10,101) Definite-lived intangible assets are stated at cost, net of accumulated amortization using the straight line method over the expected useful lives of the intangible assets. 21.4 6.2 3.3 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. We recorded an intangible asset impairment of $6.7 million in the year ended December 31, 2016 in relation to the Testosterone Gel NDA. The testosterone gel NDA asset was classified as held for sale as of December 31, 2016. (in thousands) 2017 $ 21,731 2018 21,376 2019 21,376 2020 20,894 2021 19,448 2022 and thereafter 70,967 Total $ 175,792 |
FAIR VALUE DISCLOSURES
FAIR VALUE DISCLOSURES | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE DISCLOSURES | 6. 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 which prioritizes and ranks the level of observability of inputs used in measuring fair value. Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis 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, and other current liabilities) approximate their carrying values because of their short-term nature. While our Notes are recorded on our consolidated balance sheets at their net carrying value of $ 120.6 166.4 Our contingent value rights (“CVRs”), which were granted coincident with our merger with BioSante and expire in June 2023, are considered to be 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 management’s 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) Fair Value at Description December 31, 2016 Level 1 Level 2 Level 3 Liabilities CVRs $ - $ - $ - $ - Fair Value at Description December 31, 2015 Level 1 Level 2 Level 3 Liabilities CVRs $ - $ - $ - $ - Financial Liabilities Measured at Fair Value on a Non-Recurring Basis In December 2014, we issued $ 143.8 9 A portion of the offering proceeds was used to simultaneously enter into “bond hedge” (or purchased call) and “warrant” (or written call) transactions with an affiliate of one of the offering underwriters (Note 2). The exercise price of the bond hedge is $ 69.48 2,068,792 96.21 2,068,792 15.6 Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis We have no 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 years ended December 31, 2015 and 2014. In the fourth quarter of 2016, the facts and circumstances surrounding our testosterone gel NDA indicated that the asset could be impaired. Our testosterone gel NDA intangible asset was initially acquired as part of the Merger, when we acquired a testosterone gel product that was licensed to Teva. This product was assigned an intangible asset value of $ 10.9 5.0 5 30 our valuation. As a result of this assessment, we recorded an intangible asset impairment of $6.7 million in the year ended December 31, 2016. We also determined in the fourth quarter of 2016 that the asset met the criteria for being held for sale. The Testosterone Gel NDA is now recorded as a short-term asset held for sale in the prepaid expenses and other assets caption in the accompanying consolidated balance sheets at $ 0.9 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 5.0 60.0 0.3 3.9 64.2 12 52.4 10 10.9 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 In July 2015, we purchased from Teva the ANDAs for 22 previously marketed generic drug products for $ 25.0 25.0 10 10 In March 2015, we purchased from Teva the ANDA for Flecainide for $ 4.5 4.5 10 10 In August 2014, we acquired from Shire the U.S. product rights associated with Vancocin, certain equipment, and inventory, for total consideration of $ 11.0 0.1 10 10.5 10 0.2 10 0.4 In July 2014, we acquired from Noven the product rights associated with Lithobid, as well as a small amount of raw material inventory, for total consideration of $ 12.0 45 10 10 86 In the first quarter of 2014, we purchased from Teva the ANDAs for 31 previously marketed generic drug products for $ 12.5 10 10 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2016 | |
Stockholders Equity Note [Abstract] | |
SHAREHOLDER'S EQUITY | 7. STOCKHOLDERS’ EQUITY Authorized shares We are authorized to issue up to 33.3 0.0001 0.0001 1.7 0.0001 There were 11.6 11.5 There were 11 thousand shares of class C special stock issued and outstanding as of December 31, 2016 and 2015. Each share of class C special stock entitles its holder to one vote per share. Each share of class C special stock is exchangeable, at the option of the holder, for one share of our common stock, at an exchange price of $ 90.00 There were no shares of undesignated preferred stock outstanding as of December 31, 2016 and 2015. Equity Offering On March 10, 2014, we completed a follow-on public offering of 1.6 31.00 50.0 46.7 3.3 0.2 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 2.1 Number of Underlying Shares of Common Stock Per Share Issue Date (in thousands) Exercise Price Expiration Date December 4, 2014 1,799 $ 96.21 March 1, 2020 December 5, 2014 270 $ 96.21 March 1, 2020 All outstanding warrants are classified as equity. No warrants were granted, exercised, or expired unexercised during the year ended December 31, 2016. No warrants were issued or exercised during the year ended December 31, 2015. Warrants to purchase 405 In December 2014, we issued 2.1 20 9.00 63 9.00 198 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
STOCK-BASED COMPENSATION | 8. STOCK-BASED COMPENSATION In July 2016, we commenced administration of the ANI Pharmaceuticals, Inc. 2016 Employee Stock Purchase Plan, 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 15 2 23 All equity-based service awards are granted under the ANI Pharmaceuticals, Inc. Amended and Restated 2008 Stock Incentive Plan (the “2008 Plan”). As of December 31, 2016, 0.2 We measure the cost of equity-based service awards based on the grant-date fair value of the award. The cost is recognized over the period during which an employee is required to provide service in exchange for the award or the requisite service period. We recognize stock-based compensation expense ratably over the vesting periods of the awards, adjusted for estimated forfeitures. (in thousands) Years Ended December 31, 2016 2015 2014 Cost of sales $ 60 $ 82 $ 104 Research and development $ 112 $ 109 $ 69 Selling, general, and administrative $ 5,870 $ 3,665 $ 3,250 We recognized income tax benefits of $ 1.0 0.4 0.6 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 Stock Options Outstanding stock options granted to employees generally vest over a period of four years and have 10 10 Years Ended December 31, 2016 2015 2014 Expected option life (years) 5.50 - 6.25 5.50 - 6.25 5.39 - 6.25 Risk-free interest rate 1.14% - 1.55% 1.31% - 1.82% 1.55% - 2.03% Expected stock price volatility 49.4% - 51.7% 47.9% - 50.5% 50.6% - 55.1% Dividend yield We use the simplified method to estimate the life of options. In 2014, 0.3 5.39 On April 7, 2016, the Board of Directors approved grants of options to purchase 63 13 On April 16, 2015, the Board of Directors approved grants of options to purchase 47 9 3 On April 1, 2014, the Board of Directors approved grants of options to purchase 59 16 25 Weighted Weighted Average Weighted Average Remaining (in thousands, except per share and Option Average Grant-date Term Aggregate remaining term data) Shares Exercise Price Fair Value (years) Intrinsic Value Outstanding December 31, 2013 120 $ 50.35 2.4 $ 81 Granted 120 31.59 $ 16.84 Options previously granted, approved by shareholders 325 6.39 Exercised (43) 19.45 638 Forfeited (4) 6.36 Expired (60) 73.96 Outstanding December 31, 2014 458 $ 14.44 8.7 $ 19,472 Granted 138 62.07 $ 30.08 Exercised (89) 9.24 3,937 Forfeited (33) 11.81 Expired - - Outstanding December 31, 2015 474 $ 29.40 8.2 $ 10,136 Granted 265 45.60 $ 22.45 Exercised (127) 11.79 5,837 Forfeited (32) 47.84 Expired (2) 139.32 Outstanding December 31, 2016 578 $ 39.28 8.2 $ 12,928 Exercisable at December 31, 2016 128 $ 30.87 7.1 $ 4,033 Vested or expected to vest at December 31, 2016 567 $ 39.11 8.2 $ 12,776 As of December 31, 2016, there was $ 7.6 2.7 1.6 0.7 0.8 0.3 0.8 0.1 Restricted Stock Awards Restricted stock awards (“RSAs”) granted to employees generally vest over a period of four years. RSAs granted to non-officer directors generally vest over a period of one to three years. On April 7, 2016, the Board of Directors approved grants of 31 6 On April 16, 2015, the Board of Directors approved grants of 24 On April 1, 2014, the Board of Directors approved grants of 30 Shares of our common stock delivered to employees and directors will be unrestricted upon vesting. During the vesting period, the recipient of the restricted stock has full voting rights as a stockholder and would receive dividends, if declared, even though the restricted stock remains subject to transfer restrictions and will generally be forfeited upon termination of the officer prior to vesting. The fair value of each RSA is based on the market value of our stock on the date of grant. Weighted Average Grant Weighted Average (in thousands, except per share and Date Fair Remaining Term remaining term data) Shares Value (years) Unvested at December 31, 2013 50 $ 10.20 2.8 Granted 30 29.61 Vested (17) 10.20 Forfeited - - Unvested at December 31, 2014 63 $ 19.34 2.6 Granted 28 67.26 Vested (23) 15.82 Forfeited (5) 19.41 Unvested at December 31, 2015 63 $ 42.72 2.2 Granted 38 40.59 Vested (30) 33.89 Forfeited (8) 46.05 Unvested at December 31, 2016 63 $ 45.72 2.2 As of December 31, 2016, there was $ 2.0 2.2 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 9. INCOME TAXES (in thousands) 2016 2015 2014 Current income tax provision: Federal $ 11,717 $ 7,264 $ 4,034 State 1,321 611 273 Total 13,038 7,875 4,307 Deferred income tax (benefit)/provision: Federal (8,387) (1,468) 2,113 State (658) (409) 154 Total (9,045) (1,877) 2,267 Change in valuation allowance 134 - (16,726) Excess tax benefit from stock-based compensation awards 617 360 784 Total provision/(benefit) for income taxes $ 4,744 $ 6,358 $ (9,368) As of December 31, 2016 2015 2014 US Federal statutory rate 35.0 % 35.0 % 35.0 % State taxes, net of Federal benefit 2.1 % 2.1 % 1.0 % International tax structure impacts 23.3 % - % - % Domestic production activities deduction (14.4) % (5.3) % - % Change in valuation allowance 1.6 % - % (86.5) % Stock-based compensation no windfall tax benefit 5.7 % 1.1 % 4.7 % Stock-based compensation windfall tax benefits - % (0.1) % (1.2) % Change in tax rates and other 1.4 % (3.5) % (1.4) % Total income tax provision/(benefit) 54.7 % 29.3 % (48.4) % (in thousands) As of December 31, 2016 2015 Deferred tax assets: Accruals and advances $ 3,002 $ 2,153 Bond hedge 10,921 12,243 Accruals for chargebacks and returns 7,137 2,945 Inventory 1,255 1,271 Intangible asset 6,302 3,631 Net operating loss carryforward 5,095 7,938 Other 1,680 1,149 Total deferred tax assets $ 35,392 $ 31,330 Deferred tax liabilities: Depreciation $ (857) $ (700) Debt discount (7,664) (10,029) Intangible assets (353) (3,127) Other (16) (16) Total deferred tax liabilities $ (8,890) $ (13,872) Valuation allowance (275) (142) Total deferred tax asset, net $ 26,227 $ 17,316 As of December 31, 2016, we had Federal net operating loss carryforwards of approximately $ 13.7 approximately $0.8 million per year. We are required to establish a valuation allowance for deferred tax assets if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. We consider the projected future taxable income and tax planning strategies in making this assessment. As of December 31, 2016 and 2015, we have provided a valuation allowance against certain state net operating loss carryforwards of $ 0.3 0.1 We are subject to income taxes in numerous jurisdictions in the U.S. Significant judgment is required in evaluating our tax positions and determining our provision for income taxes. We establish liabilities for tax-related uncertainties based on estimates of whether, and the extent to which, additional taxes will be due. These liabilities are established when we believe that certain positions might be challenged despite our belief that our tax return positions are fully supportable. We adjust these liabilities in light of changing facts and circumstances, such as the outcome of a tax audit. The provision for income taxes includes the impact of changes to the liability that is considered appropriate. We identified no material uncertain tax positions as of December 31, 2016 and 2015. We are subject to income tax audits in all jurisdictions for which we file tax returns. Tax audits by their nature are often complex and can require several years to complete. Neither ANI Pharmaceuticals, Inc. nor any of its subsidiaries is currently under audit in any jurisdiction. All of our income tax returns remain subject to examination by tax authorities due to the availability of net operating loss carryforwards. |
COLLABORATIVE ARRANGEMENTS
COLLABORATIVE ARRANGEMENTS | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATIVE ARRANGEMENTS | 10. COLLABORATIVE ARRANGEMENTS RiconPharma LLC In July 2011, we entered into a collaborative arrangement with RiconPharma LLC (“RiconPharma”). Under the parties' master product development and collaboration agreement (the “RiconPharma Agreement”), we and RiconPharma agreed to collaborate in a cost, asset and profit sharing arrangement for the development, manufacturing, regulatory approval, and marketing of pharmaceutical products in the United States. In July 2016, we launched our Nilutamide product under the agreement. In general, RiconPharma is responsible for developing the products and we are responsible for manufacturing, sales, marketing, and distribution of the products. The parties are jointly responsible for directing any bioequivalence studies. We are responsible for obtaining and maintaining all necessary regulatory approvals, including the preparation of all ANDAs. Under the RiconPharma Agreement and unless otherwise specified in an amendment, the parties will own equally all the rights, title, and interest in the products. To the extent permitted by applicable law, we will be identified on the product packaging as the manufacturer and distributor of the product. During the term, both parties are prohibited from developing, manufacturing, selling, or distributing any products that are identical or bioequivalent to products covered under the agreement. The agreement may be terminated or amended under certain specified circumstances. In August 2016, we and Ricon agreed to a partial termination of the agreement, with only the Nilutamide product remaining under the agreement. We recognize the costs incurred with respect to this agreement as expense and classify the expenses based on the nature of the costs. In the year ended December 31, 2016 , we incurred $ 2.0 23 31 0.4 Sofgen Pharmaceuticals August 2013 Sofgen Agreement In August 2013, we entered into an agreement with Sofgen Pharmaceuticals (“Sofgen”) to develop Nimodipine (the “August 2013 Sofgen Agreement”). In general, Sofgen was responsible for the development, manufacturing, and regulatory submission of the product, and we made payments based on the completion of certain milestones. In December 2015, we launched Nimodipine under our label. Sofgen manufactures the drug and we market and distribute the product under our label in the United States, remitting a percentage of profits from sales of the drug to Sofgen. Under the August 2013 Sofgen Agreement, Sofgen owns all the rights, title, and interest in Nimodipine. During the term, both parties are prohibited from developing, manufacturing, selling, or distributing any product in the United States that is identical or bioequivalent to the product covered under the agreement. The agreement may be terminated or amended under certain specified circumstances. We recognize the costs incurred with respect to the August 2013 Sofgen Agreement as expense and classify the expenses based on the nature of the costs. In the year ended December 31, 2016, we incurred $ 0.6 August 2013 Sofgen Agreement. year ended December 31, 2015, we incurred an immaterial amount of cost of sales related to the August 2013 Sofgen Agreement. In the year we incurred an immaterial amount of research and development expense related to the August 2013 Sofgen Agreement. In the years ended December 31, 0.4 0.2 April 2014 Sofgen Agreement In April 2014, we entered into a second collaboration agreement with Sofgen to develop an oral soft gel prescription product (the “April 2014 Sofgen Agreement”). The product will be subject to an ANDA filing once developed. In general, Sofgen will be responsible for the development, manufacturing, and regulatory submission of the product, including preparation of the ANDA, and we will make payments based on the completion of certain milestones. Upon approval, Sofgen will manufacture the drug and we will market and distribute the product under our label in the United States, remitting a percentage of profits from sales of the drug to Sofgen. Under the April 2014 Sofgen Agreement, Sofgen will own all the rights, title, and interest in the product. During the term, both parties are prohibited from developing, selling, or distributing any product in the United States that is identical or bioequivalent to the product covered under the agreement. The agreement can be terminated or amended under certain specified circumstances. The agreement’s initial term is ten years from the launch of the product, which term will automatically renew for two year terms until either party terminates the agreement. We recognize the costs incurred with respect to the April 2014 Sofgen Agreement as expense and classify the expenses based on the nature of the costs. In the year ended December 31, 2016, we did not incur any research and development expenses related to this agreement. In the years ended December 31, 2015 and 2014, we incurred $ 37 0.1 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 11. 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. (in thousands) Minimum Annual Rental Year Payments 2017 $ 99 2018 97 2019 66 2020 68 2021 19 Thereafter - Total $ 349 Rent expense for the years ended December 31, 2016, 2015, and 2014 totaled $ 81 74 70 Vendor Purchase Minimums We have supply agreements with four vendors that include purchase minimums. Pursuant to these agreements, we will be required to purchase a total of $ 9.0 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 considered controlled substances. Unapproved Products Two of our products, Esterified Estrogen with Methyltestosterone (“EEMT”) and Opium Tincture, are marketed without approved NDAs or ANDAs. During the years ended December 31, 2016, 2015, and 2014, net revenues for these products totaled $ 34.3 44.3 29.8 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 applicable manufacturing standards, the FDA will not take action against us under the current enforcement policy. There can be no assurance, however, that the FDA will continue this policy or not take a contrary position with any individual product or group of products. If the FDA were to take a contrary position, we may be required to seek FDA approval for these products or withdraw such products from the market. If we decide to withdraw the products from the market, our net revenues for generic pharmaceutical products would decline materially, and if we decide to seek FDA approval, we would face increased expenses and might need to suspend sales of the products until such approval was obtained, and there are no assurances that we would receive such approval. 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 the group of unapproved products for the years ended December 31, 2016, 2015, and 2014 were $ 1.5 1.6 1.2 We received 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 were less than 1% of total revenues for the three years ended December 31, 2016, 2015, and 2014. 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, have faced 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. In August 2016, we settled the outstanding California cases. 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 and paid all losses in settlement of the California cases. We launched Erythromycin Ethylsuccinate (“EES”) on September 27, 2016 under a previously approved ANDA. In August, we filed with the FDA to reintroduce this product under a Changes Being Effected in 30 Days submission (a “CBE-30 submission”). Under a CBE-30 submission, certain defined changes to an ANDA can be made if the FDA does not object in writing within 30 days. The FDA’s regulations, guidance documents, and historic actions support the filing of a CBE-30 for the types of changes that we proposed for our EES ANDA. We received no formal written letter from the FDA within 30 days of the CBE-30 submission date, and as such, launched the product in accordance with FDA regulations. On December 16, 2016, and nearly four months after our CBE-30 submission, the FDA sent us a formal written notice that a Prior Approval Supplement (“PAS”) was required for this ANDA. Under a PAS, proposed changes to an ANDA cannot be implemented without prior review and approval by the FDA. Because we did not receive this notice in the timeframe prescribed by the FDA’s regulations, we believe that our supplemental ANDA is valid, and as such continue to market the product. In addition, we filed a PAS which was accepted by the FDA and has an assigned action date of June 2017. We reserve all of our legal options in this matter. |
QUARTERLY FINANCIAL DATA
QUARTERLY FINANCIAL DATA | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Data [Abstract] | |
QUARTERLY FINANCIAL DATA | 12. QUARTERLY FINANCIAL DATA (unaudited) The following table presents unaudited quarterly consolidated operating results for each of our last eight fiscal quarters. 2016 Quarters (unaudited) (in thousands, except per share data) First Second Third Fourth Net revenues $ 20,555 $ 31,337 $ 38,525 $ 38,205 Total operating expenses 14,889 26,143 30,604 36,907 Operating income 5,666 5,194 7,921 1,298 Net income/(loss) $ 1,346 $ 1,125 $ 2,543 $ (1,080) Basic and diluted earnings/(loss) per share: Basic earnings/(loss) per share $ 0.12 $ 0.10 $ 0.22 $ (0.09) Diluted earnings/(loss) per share $ 0.12 $ 0.10 $ 0.22 $ (0.09) 2015 Quarters (unaudited) (in thousands, except per share data) First Second Third Fourth Net revenues $ 18,799 $ 19,516 $ 19,972 $ 18,035 Total operating expenses 9,232 11,102 11,521 11,767 Operating income 9,567 8,414 8,451 6,268 Net income $ 4,369 $ 3,571 $ 4,559 $ 2,876 Basic and diluted earnings per share: Basic earnings per share $ 0.38 $ 0.31 $ 0.40 $ 0.25 Diluted earnings per share $ 0.38 $ 0.31 $ 0.39 $ 0.25 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2016 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 13. SUBSEQUENT EVENTS In February 2017, we entered into an agreement with Cranford Pharmaceuticals, LLC to purchase a distribution license, trademark and certain finished goods inventory for Inderal® XL for $20.2 million in cash. The transaction closed in February 2017, and we made the $ 20.2 In February 2017, we entered into an agreement with Holmdel Pharmaceuticals, LP to purchase the NDA, trademark and certain finished goods inventory for InnoPran XL®, including a license to an Orange Book listed patent, for $ 30.6 30.0 0.6 |
DESCRIPTION OF BUSINESS AND S20
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Organization and Business | Organization and Business ANI Pharmaceuticals, Inc. and its consolidated subsidiaries (together, “ANI,” the “Company,” “we,” “us,” or “our”) is an integrated specialty pharmaceutical company focused on delivering value to our customers by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals. ANI was organized as a Delaware corporation in April 2001. At our two facilities located in Baudette, Minnesota, we manufacture oral solid dose products, as well as liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment. We also perform contract manufacturing for other pharmaceutical companies. On June 19, 2013, BioSante Pharmaceuticals, Inc. (“BioSante”) acquired ANIP Acquisition Company (“ANIP”) in an all-stock, tax-free reorganization (the “Merger”), in which ANIP became a wholly-owned subsidiary of BioSante. BioSante was renamed ANI Pharmaceuticals, Inc. The Merger was accounted for as a reverse acquisition pursuant to which ANIP was considered the acquiring entity for accounting purposes. As such, ANIP's historical results of operations replace BioSante's historical results of operations for all periods prior to the Merger. The results of operations of both companies are included in our consolidated financial statements for all periods after completion of the Merger. Our operations are subject to certain risks and uncertainties including, among others, current and potential competitors with greater resources, dependence on significant customers, lack of operating history and uncertainty of future profitability, and possible fluctuations in financial results. The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business. The propriety of using the going-concern basis is dependent upon, among other things, the achievement of future profitable operations, the ability to generate sufficient cash from operations, and potential other funding sources, including cash on hand, to meet our obligations as they become due. We believe the going-concern basis is appropriate for the accompanying consolidated financial statements based on our current operating plan and business strategy for the 12 months following the issuance of this report. |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Certain prior period information has been reclassified to conform to the current period presentation. |
Principles of consolidation | Principles of Consolidation The consolidated financial statements include the accounts of ANI Pharmaceuticals, Inc. and its subsidiaries. All intercompany accounts and transactions are 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 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, government 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 could differ from those estimates. |
Comprehensive Income | Comprehensive Income We have no components of other comprehensive income and accordingly, no statement of comprehensive income is included in the accompanying consolidated financial statements. |
Credit Concentration | Credit Concentration Our customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and other pharmaceutical companies. During the year ended December 31, 2016, three customers represented approximately 28 22 18 83 26 20 18 30 25 14 |
Vendor Concentration | Vendor Concentration We source the raw materials for 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 costs and time required to validate a second source of supply. As a result, we are dependent upon our current vendors to supply reliably the API required for ongoing product manufacturing. During the year ended December 31, 2016, we purchased approximately 25 33 42 |
Revenue Recognition | 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 consolidated statements of earnings, and are presented as current liabilities or reductions in accounts receivable in the accompanying consolidated balance sheets (see “Accruals for Chargebacks, Rebates, Returns, and Other Allowances”). Historically, we have not entered into revenue arrangements with multiple elements. We record revenue related to marketing and distribution agreements with third parties in which we sell products under Abbreviated New Drug Applications (“ANDAs”) or New Drug Applications (“NDAs”) owned or licensed by these third parties. We have assessed and determined that we are the principal for sales under each of these marketing and distribution agreements and recognize the revenue on a gross basis when risk and title are passed 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. Under these agreements, we pay these third parties a specified percentage of the gross profit earned on sales of the products. These profit-sharing percentages are recognized in cost of sales in our consolidated statements of earnings and are accrued in accrued royalties in our consolidated balance sheets until payment has occurred. 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. |
Cash and Cash Equivalents | Cash and Cash Equivalents We consider all highly liquid instruments with maturities of three months or less when purchased to be cash equivalents. All interest bearing and non-interest bearing accounts are guaranteed by the Federal Deposit Insurance Corporation (“FDIC”) up to $ 250 |
Accounts Receivable | Accounts Receivable We extend credit to customers on an unsecured basis. We use the allowance method to provide for doubtful accounts based on our evaluation of the collectability of accounts receivable, whereby we provide an allowance for doubtful accounts equal to the estimated uncollectible amounts. Our estimate is based on historical collection experience and a review of the current status of trade accounts receivable. We determine trade receivables to be delinquent when greater than 30 days past due. Receivables are written off when it is determined that amounts are uncollectible. We determined that no allowance for doubtful accounts was necessary as of December 31, 2016 and 2015. |
Accruals for Chargebacks, Rebates, Returns and Other Allowances | Our generic and branded product revenues are typically subject to agreements with customers allowing chargebacks, government rebates, product returns, administrative fees and other rebates, and prompt payment discounts. We accrue for these items at the time of sale based on the estimates and methodologies described below. In the aggregate, these accruals exceed 50 We continually monitor and re-evaluate the accruals as additional information becomes available, which includes, among other things, trade inventory levels, customer product mix, products returned by customers, and trends in government rebates experience. 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 or upon issuance of credit to the customer. Chargebacks Chargebacks, primarily from wholesalers, result from arrangements we have with indirect customers establishing prices for products which the indirect customer purchases through a wholesaler. Alternatively, we may pre-authorize wholesalers to offer specified contract pricing to other indirect customers. Under either arrangement, we provide a chargeback credit to the wholesaler for any difference between the contracted price with the indirect customer and the wholesaler's invoice price, typically Wholesale Acquisition Cost ("WAC"). Chargeback credits are calculated as follows: Prior period chargebacks claimed by wholesalers are analyzed to determine the actual average selling price ("ASP") for each product. This calculation is performed by product by wholesaler. ASPs can be affected by several factors such as: · A change in customer mix · A change in negotiated terms with customers · A change in the volume of off-contract purchases · Changes in WAC As necessary, we adjust ASPs based on anticipated changes in the factors above. The difference between ASP and WAC is recorded as a reduction in both gross revenues in the consolidated statements of earnings and accounts receivable in the consolidated balance sheets, at the time we recognize revenue from the product sale. To evaluate the adequacy of our chargeback accruals, we obtain on-hand inventory counts from the wholesalers. This inventory is multiplied by the chargeback amount, the difference between ASP and WAC, to arrive at total expected future chargebacks, which is then compared to the chargeback accruals. We continually monitor chargeback activity and adjust ASPs when we believe that actual selling prices will differ from current ASPs. Government Rebates Our government rebates reserve consists of estimated payments due to governmental agencies for purchases made by third parties under various governmental programs. The two largest government programs that impact our net revenue and our government rebates reserve are federal and state Medicaid rebate programs and Medicare. We participate in certain qualifying federal and state Medicaid rebate programs whereby discounts and rebates are provided to participating programs after the final dispensing of the product by a pharmacy to a Medicaid plan participant. Medicaid rebates are typically billed up to 120 days after the product is shipped. Medicaid rebate amounts per product unit are established by law, based on the Average Manufacturer Price (“AMP”), which is reported on a monthly and quarterly basis, and, in the case of branded products, best price, which is reported on a quarterly basis. Our Medicaid reserves are based on expected claims from state Medicaid programs. Estimates for expected claims are driven by patient usage, sales mix, calculated AMP or best price, as well as inventory in the distribution channel that will be subject to a Medicaid rebate. As a result of the delay between selling the products and rebate billing, our Medicaid rebate reserve includes both an estimate of outstanding claims for end-customer sales that have occurred but for which the related claim has not been billed, as well as an estimate for future claims that will be made when inventory in the distribution channel is sold through to plan participants. Many of our products are also covered under Medicare. We, like all pharmaceutical companies, must provide a discount for any products sold under NDAs to Medicare Part D participants. This applies to all products sold under NDAs, regardless of whether the products are marketed as branded or generic. Our estimates for these discounts are based on historical experience with Medicare rebates for our products. While such experience has allowed for reasonable estimations in the past, history may not always be an accurate indicator of future rebates. Medicare rebates are typically billed up to 120 days after the product is shipped. As a result of the delay between selling the products and rebate billing, our Medicare rebate reserve includes both an estimate of outstanding claims for end-customer sales that have occurred but for which the related claim has not been billed, as well as an estimate for future claims that will be made when inventory in the distribution channel is sold through to Medicare Part D participants. To evaluate the adequacy of our government rebate reserves, we review the reserves on a quarterly basis against actual claims data to ensure the liability is fairly stated. We continually monitor our government rebate reserve and adjust our estimates if we believe that actual government rebates may differ from our established accruals. Accruals for government rebates are recorded as a reduction to gross revenues in the consolidated statements of earnings and as an increase to accrued government rebates in the consolidated balance sheets. Returns We maintain a return policy that allows customers to return product within a specified period prior to and subsequent to the expiration date. Generally, product may be returned for a period beginning six months prior to its expiration date to up to one year after its expiration date. Our product returns are settled through the issuance of a credit to the customer. Our estimate for returns is based upon historical experience with actual returns. While such experience has allowed for reasonable estimation in the past, history may not always be an accurate indicator of future returns. We continually monitor our estimates for returns and make adjustments when we believe that actual product returns may differ from the established accruals. Accruals for returns are recorded as a reduction to gross revenues in the consolidated statements of earnings and as an increase to the return goods reserve in the consolidated balance sheets. Administrative Fees and Other Rebates Administrative fees or rebates are offered to wholesalers, group purchasing organizations and indirect customers. We accrue for fees and rebates, by product by wholesaler, at the time of sale based on contracted rates and ASPs. To evaluate the adequacy of our administrative fee accruals, we obtain on-hand inventory counts from the wholesalers. This inventory is multiplied by the ASPs to arrive at total expected future sales, which is then multiplied by contracted rates. The result is then compared to the administrative fee accruals. We continually monitor administrative fee activity and adjust our accruals when we believe that actual administrative fees will differ from the accruals. Accruals for administrative fees and other rebates are recorded as a reduction in both gross revenues in the consolidated statements of earnings and accounts receivable in the consolidated balance sheets. Prompt Payment Discounts We often grant sales discounts for prompt payment. The reserve for prompt payment discounts is based on invoices outstanding. We assume, based on past experience, that all available discounts will be taken. Accruals for prompt payment discounts are recorded as a reduction in both gross revenues in the consolidated statements of earnings and accounts receivable in the consolidated balance sheets. (in thousands) Accruals for Chargebacks, Returns, and Other Allowances Administrative Prompt Government Fees and Other Payment Chargebacks Rebates Returns Rebates Discounts Balance at December 31, 2013 $ 4,076 $ 253 $ 736 $ 735 $ 332 Accruals/Adjustments 35,740 2,692 1,493 5,212 1,820 Credits Taken Against Reserve (32,951) (681) (784) (4,460) (1,681) Balance at December 31, 2014 $ 6,865 $ 2,264 $ 1,445 $ 1,487 $ 471 Accruals/Adjustments 51,933 6,719 2,808 6,136 2,744 Credits Taken Against Reserve (47,417) (4,352) (1,605) (5,970) (2,541) Balance at December 31, 2015 $ 11,381 $ 4,631 $ 2,648 $ 1,653 $ 674 Accruals/Adjustments 114,433 9,671 10,271 12,747 5,517 Credits Taken Against Reserve (99,029) (8,411) (7,163) (10,850) (4,637) Balance at December 31, 2016 $ 26,785 $ 5,891 $ 5,756 $ 3,550 $ 1,554 |
Inventories | Inventories Inventories consist of raw materials, packaging materials, work-in-progress, and finished goods. Inventories are stated at the lower of standard cost or net realizable value. We periodically review and adjust standard costs, which generally approximate weighted average cost. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost. Expenditures for repairs and maintenance are charged to expense as incurred. Depreciation is recorded on a straight-line basis over estimated useful lives as follows: Buildings and improvements 20 40 Machinery, furniture, and equipment 3 10 Construction in progress consists of multiple projects, primarily related to new equipment to expand our manufacturing capability as our product lines continue to grow. Construction in progress includes the cost of construction and other direct costs attributable to the construction, along with capitalized interest. Depreciation is not recorded on construction in progress until such time as the assets are placed in service. We review property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. No impairment loss related to property and equipment was recognized during the years ended December 31, 2016, 2015, and 2014. Assets held for disposal are reportable at the lower of the carrying amount or fair value, less costs to sell. No assets were held for disposal as of December 31, 2016 and 2015. |
Intangible Assets | Intangible Assets Intangible assets were acquired as part of the Merger and several asset purchase transactions. These assets include ANDAs for a total of 54 previously marketed generic products we acquired in 2014 and 2015, NDAs and product rights for our branded products Lithobid, Vancocin, Inderal LA, and Corticotropin, an NDA for male testosterone gel, acquired marketing and distribution rights, a non-compete agreement, and The ANDAs, NDAs and product rights, marketing and distribution rights, and non-compete agreement are amortized over their remaining estimated useful lives, ranging from two to 10 We recognized an impairment charge of $ 6.7 The testosterone gel NDA asset was classified as held for sale as of December 31, 2016. |
Goodwill | Goodwill Goodwill relates to the Merger and represents the excess of the total purchase consideration over the fair value of acquired assets and assumed liabilities, using the purchase method of accounting. Goodwill is not amortized, but is subject to periodic review for impairment. Goodwill is reviewed annually, as of October 31, and whenever events or changes in circumstances indicate that the carrying amount of the goodwill might not be recoverable. We perform our review of goodwill on our one reporting unit. Before employing detailed impairment testing methodologies, we first evaluate the likelihood of impairment by considering qualitative factors relevant to our reporting unit. When performing the qualitative assessment, we evaluate events and circumstances that would affect the significant inputs used to determine the fair value of the goodwill. Events and circumstances evaluated include: macroeconomic conditions that could affect us, industry and market considerations for the generic pharmaceutical industry that could affect us, cost factors that could affect our performance, our financial performance (including share price), and consideration of any company-specific events that could negatively affect us, our business, or the fair value of our business. If we determine that it is more likely than not that goodwill is impaired, we will then apply detailed testing methodologies. Otherwise, we will conclude that no impairment has occurred. Detailed impairment testing involves comparing the fair value of our one reporting unit to its carrying value, including goodwill. Fair value reflects the price a market participant would be willing to pay in a potential sale of ANI. If the fair value exceeds carrying value, then it is concluded that no goodwill impairment has occurred. If the carrying value of the reporting unit exceeds its fair value, a second step is required to measure possible goodwill impairment loss. The second step includes hypothetically valuing the tangible and intangible assets and liabilities of our one reporting unit as if it had been acquired in a business combination. Then, the implied fair value of our one reporting unit's goodwill is compared to the carrying value of that goodwill. If the carrying value of our one reporting unit's goodwill exceeds the implied fair value of the goodwill, we recognize an impairment loss in an amount equal to the excess, not to exceed the carrying value. No impairment loss related to goodwill was recognized in the years ended December 31, 2016, 2015, and 2014. |
Collaborative Arrangements | Collaborative Arrangements At times, we have entered into arrangements with various commercial partners to further business opportunities. In collaborative arrangements such as these, when we are actively involved and exposed to the risks and rewards of the activities and are determined to be the principal participant in the collaboration, we classify third party costs incurred and revenues in the consolidated statements of earnings on a gross basis. Otherwise, third party revenues and costs generated by collaborative arrangements are presented on a net basis. Payments between us and the other participants are recorded and classified based on the nature of the payments. |
Royalties | Royalties We have entered profit-sharing arrangements with third parties in which we sell products under ANDAs or NDAs owned or licensed by these third parties. Under these agreements, we pay these third parties a specified percentage of the gross profit earned on sales of the products. These profit-sharing percentages are recorded in cost of sales in our consolidated statements of earnings when the associated revenue is recognized and are recorded in accrued royalties in our consolidated balance sheets when the associated revenue is recognized and until payment has occurred. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred and primarily consist of expenses relating to product development. Research and development costs totaled $ 2.9 2.9 2.7 |
Stock-Based Compensation | Stock-Based Compensation We have a stock-based compensation plan that includes stock options and restricted stock, which are awarded in exchange for employee and non-employee director services. Stock-based compensation cost for stock options is determined at the grant date using an option pricing model and stock-based compensation cost for restricted stock is based on the closing market price of the stock at the grant date. The value of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the employee's requisite service period. In addition, in July 2016, we commenced administration of our Employee Stock Purchase Plan (“ESPP”). We recognize the estimated fair value of stock-based compensation awards and classify the expense where the underlying salaries are classified. We incurred $ 6.1 3.9 3.4 25 Valuation of stock awards requires us to make assumptions and to apply judgment to determine the fair value of the awards. These assumptions and judgments include estimating the future volatility of our stock price, dividend yields, and future employee stock option exercise behaviors. Changes in these assumptions can affect the fair value estimate. |
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. We calculate income tax benefits related to stock-based compensation arrangements using the with and without method. 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. 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 to the consolidated financial statements. We are subject to taxation in various jurisdictions in the U.S. and remain subject to examination by taxing jurisdictions for the years 1998 and all subsequent periods due to the availability of net operating loss carryforwards. 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 December 31, 2016, 2015, and 2014. We consider potential tax effects resulting from discontinued operations and record intra-period tax allocations, when those effects are deemed material. |
Earnings per Share | 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, shares to be purchased under our ESPP, unvested restricted stock awards, stock purchase warrants, and any conversion gain on the Notes, 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 and certain of our outstanding warrants 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 (but not net loss) attributable to the unvested restricted shares and to the participating warrants, 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 our 3.0 The numerator for earnings per share for the years ended December 31, 2016, 2015, and 2014 are calculated for basic and diluted earnings per share as follows: Basic Diluted (in thousands, except per share amounts) Year Ended December 31, Year Ended December 31, 2016 2015 2014 2016 2015 2014 Net income $ 3,934 $ 15,375 $ 28,747 $ 3,934 $ 15,375 $ 28,747 Net income allocated to restricted stock (21) (85) (159) (21) (84) (158) Net income allocated to common shares $ 3,913 $ 15,290 $ 28,588 $ 3,913 $ 15,291 $ 28,589 Basic Weighted-Average Shares Outstanding 11,445 11,370 10,941 11,445 11,370 10,941 Dilutive effect of stock options and ESPP 128 187 71 Dilutive effect of warrants - - 41 Diluted Weighted-Average Shares Outstanding 11,573 11,557 11,053 Earnings per share $ 0.34 $ 1.34 $ 2.61 $ 0.34 $ 1.32 $ 2.59 The number of anti-dilutive shares, which have been excluded from the computation of diluted earnings per share, including the shares underlying the Notes, were 4.5 4.5 4.7 |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Our consolidated balance sheets include various financial instruments (primarily cash and cash equivalents, prepaid expenses, accounts receivable, accounts payable, accrued expenses, and other current liabilities) that are carried at cost and that approximate fair value. The fair value of our long-term indebtedness is estimated based on the quoted prices for the same or similar issues, or on the current rates we have been offered for debt of the same remaining maturities. 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 which prioritizes and ranks the level of observability of inputs used in measuring fair value. These tiers include: ⋅ Level 1Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. ⋅ Level 2Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities. ⋅ Level 3Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. See Note 6 for additional information regarding fair value. |
Segment Information | Segment Information We currently operate in a single reportable segment. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recent Accounting Pronouncements Not Yet Adopted In January 2017, the Financial Accounting Standards Board (“FASB”) issued guidance to simplify the measurement of goodwill. The guidance eliminates Step 2 from the goodwill impairment test. Instead, under the amendments in this guidance, an entity should perform its annual or interim goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss. The guidance also eliminates the requirements for any reporting unit with a zero or negative carrying amount to perform a qualitative assessment and, if it fails that qualitative test, to perform Step 2 of the goodwill impairment test. An entity is required to disclose the amount of goodwill allocated to each reporting unit with a zero or negative carrying amount of net assets. The guidance is effective for public business entities for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, and early adoption is permitted for interim or annual goodwill impairment tests performed for testing dates after January 1, 2017. The guidance must be adopted on a prospective basis. We are currently evaluating the impact, if any, that the adoption of this guidance will have on our consolidated financial statements. In January 2017, the FASB issued guidance clarifying the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions or disposals of assets or businesses. The guidance provides a screen to determine when an integrated set of assets and activities is not a business, provides a framework to assist entities in evaluating whether both an input and substantive process are present, and narrows the definition of the term output. The guidance is effective for public business entities for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, and early adoption is permitted. The guidance must be adopted on a prospective basis. We are currently evaluating the impact, if any, that the adoption of this guidance will have on our consolidated financial statements. In November 2016, the FASB issued guidance to reduce diversity in practice that exists in the classification and presentation of changes in restricted cash on the statement of cash flows. The revised guidance requires that amounts generally described as restricted cash and restricted cash equivalents be included in with cash and cash equivalents when reconciling the beginning of period and end of period total amounts shown on the statement of cash flows. The guidance is effective for the fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. If an entity adopts the guidance in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. The guidance must be adopted on a retrospective basis. We will adopt this guidance as of January 1, 2017, on a retrospective basis, and all periods will be presented under this guidance. The adoption of this new guidance will result in the inclusion of our $ 5.0 In August 2016, the FASB issued guidance on the classification of certain cash receipts and cash payments in the statement of cash flows, including those related to debt prepayment or debt extinguishment costs, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance, and distributions received from equity method investees. The guidance is effective for public business entities for fiscal years beginning after December 15, 2017, and for interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. If an entity adopts the guidance in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. The guidance must be adopted on a retrospective basis and must be applied to all periods presented, but may be applied prospectively if retrospective application would be impracticable. We are currently evaluating the impact, if any, that the adoption of this guidance will have on our consolidated statements of cash flows. In June 2016, the FASB issued guidance with respect to measuring credit losses on financial instruments, including trade receivables. The guidance eliminates the probable initial recognition threshold that was previously required prior to recognizing a credit loss on financial instruments. The credit loss estimate can now reflect an entity's current estimate of all future expected credit losses. Under the previous guidance, an entity only considered past events and current conditions. The guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The adoption of certain amendments of this guidance must be applied on a modified retrospective basis and the adoption of the remaining amendments must be applied on a prospective basis. We currently expect that the adoption of this guidance will likely change the way we assess the collectability of our receivables and recoverability of other financial instruments. We have not yet begun to evaluate the specific impacts of this guidance nor have we determined the manner in which we will adopt this guidance. In March 2016, the FASB issued guidance simplifying the accounting for and financial statement disclosure of stock-based compensation awards, consisting of changes in the accounting for excess tax benefits and tax deficiencies, and changes in the accounting for forfeitures associated with share-based awards, among other things. We will adopt this guidance as of January 1, 2017. Pursuant to the adoption requirements for excess tax benefits and tax deficiencies, we will no longer recognize excess tax benefits or tax deficiencies in APIC; rather, we will recognize them prospectively as a component of our current period income tax expense. We will not reverse our current APIC pool, which was $ 3.1 14 increasing our accumulated deficit 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 the adoption of this guidance will have on our consolidated financial statements. We currently expect that the adoption of this guidance will likely change the way we account for our operating leases and will likely result in recording the future benefits of those leases and the related minimum lease payments on our consolidated balance sheets. We have not yet begun to evaluate the specific impacts of 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 do not intend to adopt the guidance early. We expect that the adoption of this guidance will likely change the way we recognize revenue generated under customer contracts. However, we are currently reviewing our contracts with customers to determine if the accounting for these contracts will be impacted by the adoption of this guidance and, if so, if that impact will be material to our consolidated financial statements. We have not yet determined the manner in which we will adopt this guidance. Recently Adopted Accounting Pronouncements 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 were effective for reporting periods beginning after December 15, 2016, and early adoption was permitted. Entities were 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 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 was effective for reporting periods beginning after December 15, 2016. The guidance was required to 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 was effective for reporting periods beginning after December 15, 2015, and could 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 August 2014, the FASB 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 consolidated statements of earnings, balance sheets, or cash flows. |
DESCRIPTION OF BUSINESS AND S21
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of Valuation and Qualifying Accounts Disclosure | The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the years ended December 31, 2016, 2015, and 2014: (in thousands) Accruals for Chargebacks, Returns, and Other Allowances Administrative Prompt Government Fees and Other Payment Chargebacks Rebates Returns Rebates Discounts Balance at December 31, 2013 $ 4,076 $ 253 $ 736 $ 735 $ 332 Accruals/Adjustments 35,740 2,692 1,493 5,212 1,820 Credits Taken Against Reserve (32,951) (681) (784) (4,460) (1,681) Balance at December 31, 2014 $ 6,865 $ 2,264 $ 1,445 $ 1,487 $ 471 Accruals/Adjustments 51,933 6,719 2,808 6,136 2,744 Credits Taken Against Reserve (47,417) (4,352) (1,605) (5,970) (2,541) Balance at December 31, 2015 $ 11,381 $ 4,631 $ 2,648 $ 1,653 $ 674 Accruals/Adjustments 114,433 9,671 10,271 12,747 5,517 Credits Taken Against Reserve (99,029) (8,411) (7,163) (10,850) (4,637) Balance at December 31, 2016 $ 26,785 $ 5,891 $ 5,756 $ 3,550 $ 1,554 |
Schedule of Earnings Per Share, Basic and Diluted | The numerator for earnings per share for the years ended December 31, 2016, 2015, and 2014 are calculated for basic and diluted earnings per share as follows: Basic Diluted (in thousands, except per share amounts) Year Ended December 31, Year Ended December 31, 2016 2015 2014 2016 2015 2014 Net income $ 3,934 $ 15,375 $ 28,747 $ 3,934 $ 15,375 $ 28,747 Net income allocated to restricted stock (21) (85) (159) (21) (84) (158) Net income allocated to common shares $ 3,913 $ 15,290 $ 28,588 $ 3,913 $ 15,291 $ 28,589 Basic Weighted-Average Shares Outstanding 11,445 11,370 10,941 11,445 11,370 10,941 Dilutive effect of stock options and ESPP 128 187 71 Dilutive effect of warrants - - 41 Diluted Weighted-Average Shares Outstanding 11,573 11,557 11,053 Earnings per share $ 0.34 $ 1.34 $ 2.61 $ 0.34 $ 1.32 $ 2.59 |
INDEBTEDNESS (Tables)
INDEBTEDNESS (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Convertible Debt | The carrying value of the Notes is as follows as of December 31: (in thousands) 2016 2015 Principal amount $ 143,750 $ 143,750 Unamortized debt discount (20,644) (27,016) Deferred financing costs (2,463) (3,307) Net Carrying value $ 120,643 $ 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 consolidated statements of earnings for the year ended December 31: (in thousands) 2016 2015 Contractual coupon $ 4,312 $ 4,312 Amortization of debt discount 6,372 6,043 Amortization of finance fees 844 844 Capitalized interest (234) (56) $ 11,294 $ 11,143 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventories consist of the following as of December 31: (in thousands) 2016 2015 Raw materials $ 14,138 $ 10,192 Packaging materials 930 998 Work-in-progress 477 456 Finished goods 10,812 1,897 26,357 13,543 Reserve for excess/obsolete inventories (174) (156) Inventories, net $ 26,183 $ 13,387 |
PROPERTY, PLANT, AND EQUIPMENT
PROPERTY, PLANT, AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, Plant, and Equipment consist of the following as of December 31: (in thousands) 2016 2015 Land $ 160 $ 87 Buildings 3,756 3,682 Machinery, furniture, and equipment 8,176 5,623 Construction in progress 4,293 2,189 16,385 11,581 Less: accumulated depreciation (5,387) (4,450) Property, Plant, and Equipment, net $ 10,998 $ 7,131 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
GOODWILL AND INTANGIBLE ASSETS | |
Schedule of Intangible Assets and Goodwill | The components of net definite-lived intangible assets are as follows: (in thousands) December 31, 2016 December 31, 2015 Weighted Average Gross Carrying Accumulated Gross Carrying Accumulated Amortization Amount Amortization Amount Amortization Period Acquired ANDA intangible assets $ 42,076 $ (8,390) $ 42,076 $ (4,287) 10.0 years NDAs and product rights 150,250 (17,081) 33,422 (5,754) 10.0 years Marketing and distribution rights 11,042 (2,662) 1,000 (60) 4.7 years Non-compete agreement 624 (67) - - 7.0 years $ 203,992 $ (28,200) $ 76,498 $ (10,101) |
Finite-lived Intangible Assets Amortization Expense | Expected future amortization expense is as follows for the years ending December 31: (in thousands) 2017 $ 21,731 2018 21,376 2019 21,376 2020 20,894 2021 19,448 2022 and thereafter 70,967 Total $ 175,792 |
FAIR VALUE DISCLOSURES (Tables)
FAIR VALUE DISCLOSURES (Tables) | 12 Months Ended |
Dec. 31, 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 that were accounted for at fair value on a recurring basis as of December 31, 2016 and 2015, by level within the fair value hierarchy: (in thousands) Fair Value at Description December 31, 2016 Level 1 Level 2 Level 3 Liabilities CVRs $ - $ - $ - $ - Fair Value at Description December 31, 2015 Level 1 Level 2 Level 3 Liabilities CVRs $ - $ - $ - $ - |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Stockholders Equity Note [Abstract] | |
Schedule of Stockholders' Equity Note, Warrants or Rights | Warrants to purchase an aggregate of 2.1 Number of Underlying Shares of Common Stock Per Share Issue Date (in thousands) Exercise Price Expiration Date December 4, 2014 1,799 $ 96.21 March 1, 2020 December 5, 2014 270 $ 96.21 March 1, 2020 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 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 incurred under the 2008 Plan and included in our consolidated statements of earnings: (in thousands) Years Ended December 31, 2016 2015 2014 Cost of sales $ 60 $ 82 $ 104 Research and development $ 112 $ 109 $ 69 Selling, general, and administrative $ 5,870 $ 3,665 $ 3,250 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | For 2016, 2015, and 2014, the fair value of each option grant was estimated on the date of grant using the Black-Scholes option-pricing model, using the following weighted average assumptions: Years Ended December 31, 2016 2015 2014 Expected option life (years) 5.50 - 6.25 5.50 - 6.25 5.39 - 6.25 Risk-free interest rate 1.14% - 1.55% 1.31% - 1.82% 1.55% - 2.03% Expected stock price volatility 49.4% - 51.7% 47.9% - 50.5% 50.6% - 55.1% Dividend yield |
Schedule of Share-based Compansation, Stock Option And Restricted Stock, Activity | A summary of stock option activity under the Plan during the years ended December 31, 2016, 2015, and 2014 is presented below: Weighted Weighted Average Weighted Average Remaining (in thousands, except per share and Option Average Grant-date Term Aggregate remaining term data) Shares Exercise Price Fair Value (years) Intrinsic Value Outstanding December 31, 2013 120 $ 50.35 2.4 $ 81 Granted 120 31.59 $ 16.84 Options previously granted, approved by shareholders 325 6.39 Exercised (43) 19.45 638 Forfeited (4) 6.36 Expired (60) 73.96 Outstanding December 31, 2014 458 $ 14.44 8.7 $ 19,472 Granted 138 62.07 $ 30.08 Exercised (89) 9.24 3,937 Forfeited (33) 11.81 Expired - - Outstanding December 31, 2015 474 $ 29.40 8.2 $ 10,136 Granted 265 45.60 $ 22.45 Exercised (127) 11.79 5,837 Forfeited (32) 47.84 Expired (2) 139.32 Outstanding December 31, 2016 578 $ 39.28 8.2 $ 12,928 Exercisable at December 31, 2016 128 $ 30.87 7.1 $ 4,033 Vested or expected to vest at December 31, 2016 567 $ 39.11 8.2 $ 12,776 |
Nonvested Restricted Stock Shares Activity | A summary of RSA activity under the Plan during the years ended December 31, 2016, 2015, and 2014 is presented below: Weighted Average Grant Weighted Average (in thousands, except per share and Date Fair Remaining Term remaining term data) Shares Value (years) Unvested at December 31, 2013 50 $ 10.20 2.8 Granted 30 29.61 Vested (17) 10.20 Forfeited - - Unvested at December 31, 2014 63 $ 19.34 2.6 Granted 28 67.26 Vested (23) 15.82 Forfeited (5) 19.41 Unvested at December 31, 2015 63 $ 42.72 2.2 Granted 38 40.59 Vested (30) 33.89 Forfeited (8) 46.05 Unvested at December 31, 2016 63 $ 45.72 2.2 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | Our total provision/(benefit) from income taxes consists of the following for the years ended December 31, 2016, 2015, and 2014: (in thousands) 2016 2015 2014 Current income tax provision: Federal $ 11,717 $ 7,264 $ 4,034 State 1,321 611 273 Total 13,038 7,875 4,307 Deferred income tax (benefit)/provision: Federal (8,387) (1,468) 2,113 State (658) (409) 154 Total (9,045) (1,877) 2,267 Change in valuation allowance 134 - (16,726) Excess tax benefit from stock-based compensation awards 617 360 784 Total provision/(benefit) for income taxes $ 4,744 $ 6,358 $ (9,368) |
Schedule of Effective Income Tax Rate Reconciliation | The difference between our expected income tax provision/(benefit) from applying federal statutory tax rates to the pre-tax income/(loss) and actual income tax provision/(benefit) relates primarily to the effect of the following: As of December 31, 2016 2015 2014 US Federal statutory rate 35.0 % 35.0 % 35.0 % State taxes, net of Federal benefit 2.1 % 2.1 % 1.0 % International tax structure impacts 23.3 % - % - % Domestic production activities deduction (14.4) % (5.3) % - % Change in valuation allowance 1.6 % - % (86.5) % Stock-based compensation no windfall tax benefit 5.7 % 1.1 % 4.7 % Stock-based compensation windfall tax benefits - % (0.1) % (1.2) % Change in tax rates and other 1.4 % (3.5) % (1.4) % Total income tax provision/(benefit) 54.7 % 29.3 % (48.4) % |
Schedule of Deferred Tax Assets and Liabilities | Deferred income taxes reflect the net tax effects of differences between the bases of assets and liabilities for financial reporting and income tax purposes. Our deferred income tax assets and liabilities consisted of the following: (in thousands) As of December 31, 2016 2015 Deferred tax assets: Accruals and advances $ 3,002 $ 2,153 Bond hedge 10,921 12,243 Accruals for chargebacks and returns 7,137 2,945 Inventory 1,255 1,271 Intangible asset 6,302 3,631 Net operating loss carryforward 5,095 7,938 Other 1,680 1,149 Total deferred tax assets $ 35,392 $ 31,330 Deferred tax liabilities: Depreciation $ (857) $ (700) Debt discount (7,664) (10,029) Intangible assets (353) (3,127) Other (16) (16) Total deferred tax liabilities $ (8,890) $ (13,872) Valuation allowance (275) (142) Total deferred tax asset, net $ 26,227 $ 17,316 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating Leases of Lessee Disclosure | For the annual periods after December 31, 2016, approximate minimum annual rental payments under non-cancelable leases are presented below: (in thousands) Minimum Annual Rental Year Payments 2017 $ 99 2018 97 2019 66 2020 68 2021 19 Thereafter - Total $ 349 |
QUARTERLY FINANCIAL DATA (Table
QUARTERLY FINANCIAL DATA (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | The information below has been prepared on a basis consistent with our audited consolidated financial statements. 2016 Quarters (unaudited) (in thousands, except per share data) First Second Third Fourth Net revenues $ 20,555 $ 31,337 $ 38,525 $ 38,205 Total operating expenses 14,889 26,143 30,604 36,907 Operating income 5,666 5,194 7,921 1,298 Net income/(loss) $ 1,346 $ 1,125 $ 2,543 $ (1,080) Basic and diluted earnings/(loss) per share: Basic earnings/(loss) per share $ 0.12 $ 0.10 $ 0.22 $ (0.09) Diluted earnings/(loss) per share $ 0.12 $ 0.10 $ 0.22 $ (0.09) 2015 Quarters (unaudited) (in thousands, except per share data) First Second Third Fourth Net revenues $ 18,799 $ 19,516 $ 19,972 $ 18,035 Total operating expenses 9,232 11,102 11,521 11,767 Operating income 9,567 8,414 8,451 6,268 Net income $ 4,369 $ 3,571 $ 4,559 $ 2,876 Basic and diluted earnings per share: Basic earnings per share $ 0.38 $ 0.31 $ 0.40 $ 0.25 Diluted earnings per share $ 0.38 $ 0.31 $ 0.39 $ 0.25 |
DESCRIPTION OF BUSINESS AND S32
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Beginning balance | $ 13,586 | ||
Ending balance | 31,535 | $ 13,586 | |
Chargebacks [Member] | |||
Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Beginning balance | 11,381 | 6,865 | $ 4,076 |
Accruals/Adjustments | 114,433 | 51,933 | 35,740 |
Credits Taken Against Reserve | (99,029) | (47,417) | (32,951) |
Ending balance | 26,785 | 11,381 | 6,865 |
Government Rebates [Member] | |||
Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Beginning balance | 4,631 | 2,264 | 253 |
Accruals/Adjustments | 9,671 | 6,719 | 2,692 |
Credits Taken Against Reserve | (8,411) | (4,352) | (681) |
Ending balance | 5,891 | 4,631 | 2,264 |
Allowance for Sales Returns [Member] | |||
Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Beginning balance | 2,648 | 1,445 | 736 |
Accruals/Adjustments | 10,271 | 2,808 | 1,493 |
Credits Taken Against Reserve | (7,163) | (1,605) | (784) |
Ending balance | 5,756 | 2,648 | 1,445 |
Administrative Fees And Other Rebates [Member] | |||
Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Beginning balance | 1,653 | 1,487 | 735 |
Accruals/Adjustments | 12,747 | 6,136 | 5,212 |
Credits Taken Against Reserve | (10,850) | (5,970) | (4,460) |
Ending balance | 3,550 | 1,653 | 1,487 |
Prompt Payment Discounts [Member] | |||
Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Beginning balance | 674 | 471 | 332 |
Accruals/Adjustments | 5,517 | 2,744 | 1,820 |
Credits Taken Against Reserve | (4,637) | (2,541) | (1,681) |
Ending balance | $ 1,554 | $ 674 | $ 471 |
DESCRIPTION OF BUSINESS AND S33
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Net income, Basic | $ (1,080) | $ 2,543 | $ 1,125 | $ 1,346 | $ 2,876 | $ 4,559 | $ 3,571 | $ 4,369 | $ 3,934 | $ 15,375 | $ 28,747 |
Net income allocated to common shares, Basic | $ 3,913 | $ 15,290 | $ 28,588 | ||||||||
Basic Weighted-Average Shares Outstanding | 11,445 | 11,370 | 10,941 | ||||||||
Earnings per share | $ (0.09) | $ 0.22 | $ 0.10 | $ 0.12 | $ 0.25 | $ 0.40 | $ 0.31 | $ 0.38 | $ 0.34 | $ 1.34 | $ 2.61 |
Net income, Diluted | $ (1,080) | $ 2,543 | $ 1,125 | $ 1,346 | $ 2,876 | $ 4,559 | $ 3,571 | $ 4,369 | $ 3,934 | $ 15,375 | $ 28,747 |
Net income allocated to common shares, Diluted | $ 3,913 | $ 15,291 | $ 28,589 | ||||||||
Diluted Weighted-Average Shares Outstanding (in shares) | 11,573 | 11,557 | 11,053 | ||||||||
Earnings per share, Diluted | $ (0.09) | $ 0.22 | $ 0.10 | $ 0.12 | $ 0.25 | $ 0.39 | $ 0.31 | $ 0.38 | $ 0.34 | $ 1.32 | $ 2.59 |
Equity Option [Member] | |||||||||||
Dilutive effect | 128 | 187 | 71 | ||||||||
Warrant [Member] | |||||||||||
Dilutive effect | 0 | 0 | 41 | ||||||||
Restricted Stock [Member] | |||||||||||
Net income allocated to restricted stock, Basic | $ (21) | $ (85) | $ (159) | ||||||||
Net income allocated to restricted stock, Diluted | $ (21) | $ (84) | $ (158) |
DESCRIPTION OF BUSINESS AND S34
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) - USD ($) $ in Thousands, shares in Millions | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Jan. 31, 2017 | |
Fdic Guaranteed Amount | $ 250 | |||
Chargebacks And Other Accruals As Percent Of Gross Revenue | 50.00% | |||
Impairment of Intangible Assets, Finite-lived | $ 6,685 | $ 0 | $ 0 | |
Research and Development Expense, Total | 2,906 | 2,874 | 2,678 | |
Allocated Share-based Compensation Expense | $ 6,100 | $ 3,900 | $ 3,400 | |
Long-term Debt, Percentage Bearing Fixed Interest, Percentage Rate | 3.00% | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4.5 | 4.5 | 4.7 | |
Restricted Cash and Cash Equivalents, Noncurrent | $ 5,002 | $ 0 | ||
Testosterone Gel NDA [Member] | New Drug Applications [Member] | ||||
Impairment of Intangible Assets, Finite-lived | 6,700 | |||
Adjustments for New Accounting Pronouncement [Member] | Subsequent Event [Member] | ||||
New Accounting Pronouncement or Change in Accounting Principle, Cumulative Effect of Change on Equity or Net Assets | $ 14 | |||
Adjustments for New Accounting Pronouncement [Member] | Additional Paid-in Capital [Member] | ||||
APIC Pool Not Tax Effected | 3,100 | |||
Employee Stock Purchase Plan [Member] | ||||
Allocated Share-based Compensation Expense | $ 25 | |||
Minimum [Member] | Finite-Lived Intangible Assets [Member] | ||||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 2 years | |||
Maximum [Member] | Finite-Lived Intangible Assets [Member] | ||||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 10 years | |||
Building and Building Improvements [Member] | Minimum [Member] | ||||
Property, Plant and Equipment, Useful Life | 20 years | |||
Building and Building Improvements [Member] | Maximum [Member] | ||||
Property, Plant and Equipment, Useful Life | 40 years | |||
Machinery and Equipment [Member] | Minimum [Member] | ||||
Property, Plant and Equipment, Useful Life | 3 years | |||
Machinery and Equipment [Member] | Maximum [Member] | ||||
Property, Plant and Equipment, Useful Life | 10 years | |||
Customer One [Member] | ||||
Concentration Risk, Percentage | 28.00% | 26.00% | 30.00% | |
Customer Two [Member] | ||||
Concentration Risk, Percentage | 22.00% | 20.00% | 25.00% | |
Customer Three [Member] | ||||
Concentration Risk, Percentage | 18.00% | 18.00% | 14.00% | |
Customer One Two And Three [Member] | ||||
Concentration Risk, Percentage | 83.00% | |||
Two Suppliers 2014 [Member] | ||||
Concentration Risk, Percentage | 42.00% | |||
One Suppliers 2016 [Member] | ||||
Concentration Risk, Percentage | 25.00% | |||
Two Suppliers 2015 [Member] | ||||
Concentration Risk, Percentage | 33.00% |
INDEBTEDNESS (Details)
INDEBTEDNESS (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Principal amount | $ 143,750 | $ 143,750 |
Unamortized debt discount | (20,644) | (27,016) |
Deferred financing costs | (2,463) | (3,307) |
Net carrying value | $ 120,643 | $ 113,427 |
INDEBTEDNESS (Details 1)
INDEBTEDNESS (Details 1) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Contractual coupon | $ 4,312 | $ 4,312 |
Amortization of debt discount | 6,372 | 6,043 |
Amortization of finance fees | 844 | 844 |
Capitalized interest | (234) | (56) |
Interest Expense, Debt | $ 11,294 | $ 11,143 |
INDEBTEDNESS (Details Textual)
INDEBTEDNESS (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
May 31, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Feb. 28, 2017 | Jun. 30, 2016 | |
Long-term Debt, Gross | $ 143,750 | $ 143,750 | ||||
Long-term Debt, Percentage Bearing Fixed Interest, Percentage Rate | 3.00% | |||||
Debt Instrument, Unamortized Discount | $ 20,644 | $ 27,016 | ||||
Debt Instrument, Interest Rate, Effective Percentage | 7.90% | 7.80% | ||||
Amortization of Financing Costs | $ 844 | $ 844 | ||||
Deferred Finance Costs, Net | 2,463 | 3,307 | ||||
Interest Income (Expense), Nonoperating, Net | (11,327) | $ (11,008) | $ (787) | |||
Subsequent Event [Member] | ||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 40,000 | |||||
Long-term Line of Credit | $ 30,000 | |||||
Prepaid Expenses and Other Current Assets [Member] | ||||||
Deferred Costs, Current | 300 | |||||
Convertible Senior Notes [Member] | ||||||
Long-term Debt, Gross | 143,800 | |||||
Proceeds from Issuance of Debt | $ 122,600 | |||||
Long-term Debt, Percentage Bearing Fixed Interest, Percentage Rate | 3.00% | |||||
Underlying Shares Of Common Stock Convertible Debt | 2,068,792 | |||||
Debt Instrument, Convertible, Conversion Price | $ 69.48 | |||||
Debt Instrument, Convertible, Threshold Trading Days | 20 | |||||
Debt Instrument Percent Of Conversion Price | 130.00% | |||||
Per Note Principal | $ 1,000 | |||||
Debt Instrument, Unamortized Discount | $ 33,600 | |||||
Deferred Offering Costs | $ 5,500 | |||||
Exercise Price Of Bond Hedge | $ 69.48 | |||||
Underlying Shares Of Common Stock Bond Hedge | 2,068,792 | 2,068,792 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 96.21 | $ 96.21 | ||||
Net Adjustments To Additional Paid In Capital Bond Hedge Acquired Warrant Issued Net | $ 15,600 | |||||
Debt Instrument, Convertible, Threshold Consecutive Trading Days | 30 days | |||||
Amortization of Financing Costs | $ 4,200 | |||||
Payments of Stock Issuance Costs | $ 1,300 | |||||
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 | |||||
Interest Income (Expense), Nonoperating, Net | $ 65 | |||||
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 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Inventories | ||
Raw materials | $ 14,138 | $ 10,192 |
Packaging materials | 930 | 998 |
Work-in-progress | 477 | 456 |
Finished goods | 10,812 | 1,897 |
Inventory, Gross, Total | 26,357 | 13,543 |
Reserve for excess/obsolete inventories | (174) | (156) |
Inventories, net | $ 26,183 | $ 13,387 |
PROPERTY, PLANT, AND EQUIPMEN39
PROPERTY, PLANT, AND EQUIPMENT (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment, Gross, Total | $ 16,385 | $ 11,581 |
Less: accumulated depreciation | (5,387) | (4,450) |
Property, Plant, and Equipment, net | 10,998 | 7,131 |
Land [Member] | ||
Property, Plant and Equipment, Gross, Total | 160 | 87 |
Buildings [Member] | ||
Property, Plant and Equipment, Gross, Total | 3,756 | 3,682 |
Machinery, furniture and equipment [Member] | ||
Property, Plant and Equipment, Gross, Total | 8,176 | 5,623 |
Construction in progress [Member] | ||
Property, Plant and Equipment, Gross, Total | $ 4,293 | $ 2,189 |
PROPERTY, PLANT, AND EQUIPMEN40
PROPERTY, PLANT, AND EQUIPMENT (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Depreciation, Total | $ 900 | $ 700 | $ 600 |
Interest Costs Capitalized | $ 200 | $ 56 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Aug. 31, 2015 | Jul. 31, 2015 | Mar. 31, 2015 | Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
GOODWILL AND INTANGIBLE ASSETS | ||||||||
Gross Carrying Amount | $ 203,992 | $ 76,498 | ||||||
Accumulated Amortization | (28,200) | (10,101) | ||||||
Acquired ANDA intangible assets | ||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||
Gross Carrying Amount | $ 25,000 | $ 4,500 | $ 4,500 | 42,076 | 42,076 | |||
Accumulated Amortization | $ (8,390) | $ (4,287) | ||||||
Weighted Average Amortization Period | 10 years | 10 years | 10 years | 10 years | 10 years | 10 years | 10 years | |
NDAs and product rights | ||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||
Gross Carrying Amount | $ 150,250 | $ 33,422 | ||||||
Accumulated Amortization | $ (17,081) | (5,754) | ||||||
Weighted Average Amortization Period | 10 years | |||||||
Marketing and distribution rights | ||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||
Gross Carrying Amount | $ 1,000 | $ 11,042 | 1,000 | |||||
Accumulated Amortization | $ (2,662) | (60) | ||||||
Weighted Average Amortization Period | 7 years | 4 years 8 months 12 days | ||||||
Non-compete agreement | ||||||||
GOODWILL AND INTANGIBLE ASSETS | ||||||||
Gross Carrying Amount | $ 624 | 0 | ||||||
Accumulated Amortization | $ (67) | $ 0 | ||||||
Weighted Average Amortization Period | 7 years |
INTANGIBLE ASSETS (Details 1)
INTANGIBLE ASSETS (Details 1) $ in Thousands | Dec. 31, 2016USD ($) |
GOODWILL AND INTANGIBLE ASSETS | |
2,017 | $ 21,731 |
2,018 | 21,376 |
2,019 | 21,376 |
2,020 | 20,894 |
2,021 | 19,448 |
2022 and thereafter | 70,967 |
Total | $ 175,792 |
INTANGIBLE ASSETS (Details Text
INTANGIBLE ASSETS (Details Textual) - USD ($) $ in Thousands | Mar. 06, 2014 | Jan. 02, 2014 | Apr. 30, 2016 | Jan. 31, 2016 | Aug. 31, 2015 | Jul. 31, 2015 | May 31, 2015 | Mar. 31, 2015 | Aug. 31, 2014 | Jul. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
GOODWILL AND INTANGIBLE ASSETS | |||||||||||||||
Amortization of Intangible Assets | $ 21,400 | $ 6,200 | $ 3,300 | ||||||||||||
Payments to Acquire Intangible Assets | 144,494 | 30,500 | 34,634 | ||||||||||||
Goodwill | 1,838 | 1,838 | |||||||||||||
Finite-Lived Intangible Assets, Gross | 203,992 | 76,498 | |||||||||||||
Accrued Royalties Related To Asset Purchase | 3,882 | 0 | 0 | ||||||||||||
Impairment of Intangible Assets, Finite-lived | $ 6,685 | $ 0 | $ 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 | $ 4,500 | $ 12,500 | |||||||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | 10 years | 10 years | 10 years | 10 years | 10 years | 10 years | ||||||||
Finite-Lived Intangible Assets, Gross | $ 25,000 | $ 4,500 | $ 4,500 | $ 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 | $ 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 | ||||||||||||||
Testosterone Gel NDA [Member] | Prepaid Expenses and Other Current Assets [Member] | |||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | |||||||||||||||
Assets Held-for-sale, Not Part of Disposal Group, Current | 900 | ||||||||||||||
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 | ||||||||||||||
Acquisition Costs Capitalized | $ 45 | ||||||||||||||
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 | ||||||||||||||
Acquisition Costs Capitalized | $ 100 | ||||||||||||||
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 | ||||||||||||||
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 | ||||||||||||||
Asset Acquisition Purchase Price | $ 64,200 | ||||||||||||||
New Drug Applications [Member] | Testosterone Gel NDA [Member] | |||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | |||||||||||||||
Maximum Royalties Potentially Payable | $ 5,000 | ||||||||||||||
Royalty Rate | 5.00% | ||||||||||||||
Finite-Lived Intangible Assets, Gross | 10,900 | ||||||||||||||
Impairment of Intangible Assets, Finite-lived | $ 6,700 | ||||||||||||||
Teva Pharmaceuticals [Member] | |||||||||||||||
GOODWILL AND INTANGIBLE ASSETS | |||||||||||||||
Intangible Asset Purchase Agreement Payment | $ 4,000 | $ 8,500 |
FAIR VALUE DISCLOSURES (Details
FAIR VALUE DISCLOSURES (Details) - USD ($) $ in Thousands | Dec. 31, 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 (Detai45
FAIR VALUE DISCLOSURES (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Apr. 30, 2016 | Jan. 31, 2016 | Aug. 31, 2015 | Jul. 31, 2015 | May 31, 2015 | Mar. 31, 2015 | Aug. 31, 2014 | Jul. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Fair Value Inputs, Assets, Quantitative Information | |||||||||||||
Fair Value Inputs, Discount Rate | 15.00% | ||||||||||||
Payments to Acquire Intangible Assets | $ 144,494 | $ 30,500 | $ 34,634 | ||||||||||
Long-term Debt, Gross | 143,750 | 143,750 | |||||||||||
Long-term Debt, Total | 120,643 | 113,427 | |||||||||||
Finite-Lived Intangible Assets, Gross | 203,992 | 76,498 | |||||||||||
Property, Plant and Equipment, Net, Total | 10,998 | 7,131 | |||||||||||
Inventory, Net, Total | 26,183 | 13,387 | |||||||||||
Inventory, Finished Goods, Gross | 10,812 | 1,897 | |||||||||||
Accrued Royalties Related To Asset Purchase | 3,882 | $ 0 | $ 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 3 [Member] | |||||||||||||
Fair Value Inputs, Assets, Quantitative Information | |||||||||||||
Theoretical Interest Rate For Debt Without Embedded Conversion Option | 9.00% | ||||||||||||
Fair Value, Inputs, Level 1 [Member] | |||||||||||||
Fair Value Inputs, Assets, Quantitative Information | |||||||||||||
Notes Payable, Fair Value Disclosure | 166,400 | ||||||||||||
Convertible Senior Notes [Member] | |||||||||||||
Fair Value Inputs, Assets, Quantitative Information | |||||||||||||
Long-term Debt, Gross | $ 143,800 | ||||||||||||
Exercise Price Of Bond Hedge | $ 69.48 | ||||||||||||
Underlying Shares Of Common Stock Bond Hedge | 2,068,792 | 2,068,792 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 96.21 | $ 96.21 | |||||||||||
Net Adjustments To Additional Paid In Capital Bond Hedge Acquired Warrant Issued Net | $ 15,600 | ||||||||||||
Lithobid Purchase Agreement [Member] | |||||||||||||
Fair Value Inputs, Assets, Quantitative Information | |||||||||||||
Fair Value Inputs, Discount Rate | 10.00% | ||||||||||||
Payments to Acquire Intangible Assets | $ 11,000 | ||||||||||||
Finite-Lived Intangible Assets, Gross | $ 12,000 | ||||||||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | ||||||||||||
Acquisition Costs Capitalized | $ 45 | ||||||||||||
Inventory, Net, Total | $ 86 | ||||||||||||
Vancocin Purchase Agreement [Member] | |||||||||||||
Fair Value Inputs, Assets, Quantitative Information | |||||||||||||
Fair Value Inputs, Discount Rate | 10.00% | ||||||||||||
Payments to Acquire Intangible Assets | $ 11,000 | ||||||||||||
Finite-Lived Intangible Assets, Gross | $ 10,500 | ||||||||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | ||||||||||||
Acquisition Costs Capitalized | $ 100 | ||||||||||||
Property, Plant and Equipment, Net, Total | $ 200 | ||||||||||||
Property, Plant and Equipment, Useful Life | 10 years | ||||||||||||
Inventory, Net, Total | $ 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 | ||||||||||||
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 | ||||||||||||
Acquired ANDA Intangible Assets [Member] | |||||||||||||
Fair Value Inputs, Assets, Quantitative Information | |||||||||||||
Fair Value Inputs, Discount Rate | 10.00% | 10.00% | 10.00% | ||||||||||
Payments to Acquire Intangible Assets | $ 25,000 | $ 4,500 | $ 4,500 | $ 12,500 | |||||||||
Finite-Lived Intangible Assets, Gross | $ 25,000 | $ 4,500 | $ 4,500 | $ 42,076 | $ 42,076 | ||||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | 10 years | 10 years | 10 years | 10 years | 10 years | 10 years | ||||||
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 | ||||||||||||
Testosterone Gel NDA [Member] | Prepaid Expenses and Other Current Assets [Member] | |||||||||||||
Fair Value Inputs, Assets, Quantitative Information | |||||||||||||
Assets Held-for-sale, Not Part of Disposal Group, Current | $ 900 | ||||||||||||
Testosterone Gel NDA [Member] | New Drug Applications [Member] | |||||||||||||
Fair Value Inputs, Assets, Quantitative Information | |||||||||||||
Fair Value Inputs, Discount Rate | 30.00% | ||||||||||||
Finite-Lived Intangible Assets, Gross | $ 10,900 | ||||||||||||
Royalty Rate | 5.00% | ||||||||||||
Maximum Royalties Potentially Payable | $ 5,000 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) shares in Thousands | Dec. 31, 2016$ / sharesshares |
Class of Warrant, Issued On December 4, 2014 - Expires March 1, 2020 [Member] | |
Number of Underlying Shares Of Common Stock | shares | 1,799 |
Per Share Exercise Price | $ / shares | $ 96.21 |
Class of Warrant, Issued On December 5, 2014 - Expires March 1, 2020 [Member] | |
Number of Underlying Shares Of Common Stock | shares | 270 |
Per Share Exercise Price | $ / shares | $ 96.21 |
STOCKHOLDERS' EQUITY (Details T
STOCKHOLDERS' EQUITY (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Mar. 10, 2014 | Jan. 31, 2016 | Jan. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Oct. 31, 2015 |
Proceeds from Issuance of Common Stock, Net | $ 0 | $ 0 | $ 46,680 | ||||
Preferred Stock, Shares Authorized | 1,666,667 | 1,666,667 | |||||
Preferred Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 | |||||
Stock Repurchase Program [Member] | |||||||
Stock Repurchase Program, Authorized Amount | $ 25,000 | ||||||
Stock Repurchased and Retired During Period, Shares | 65,000 | ||||||
Stock Repurchased and Retired During Period, Value | $ 2,500 | ||||||
Warrant [Member] | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 9 | $ 9 | |||||
Stock Issued During Period Due To Warrant Exercise Number | 20,000 | 63,000 | |||||
Class Of Warrant Or Right Number Of Securities Called By Warrants That Expired During Period Number | 405,000 | 198,000 | |||||
Class of Warrant or Right, Outstanding | 2,100,000 | ||||||
Class Of Warrant Or Right Issued During Period Number | 2,100,000 | ||||||
Common Stock [Member] | |||||||
Stock Issued During Period, Shares, New Issues | 1,600,000 | 1,613 | |||||
Shares Issued, Price Per Share | $ 31 | ||||||
Proceeds from Issuance of Common Stock | $ 50,000 | ||||||
Proceeds from Issuance of Common Stock, Net | 46,700 | ||||||
Payments of Stock Issuance Costs | $ 3,300 | ||||||
Stock Issued During Period Shares New Issues Due to Exercise of Option to Purchase Additional Shares | 200,000 | ||||||
Common Stock, Shares Authorized | 33,300,000 | ||||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | ||||||
Common Stock, Shares, Issued | 11,600,000 | 11,500,000 | |||||
Common Stock, Shares, Outstanding | 11,600,000 | 11,500,000 | |||||
Class C Special Stock [Member] | |||||||
Common Stock, Shares Authorized | 781,281 | 781,281 | |||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 | |||||
Common Stock Conversion Price | $ 90 | $ 90 | |||||
Common Stock, Shares, Issued | 10,864 | 10,864 | |||||
Common Stock, Shares, Outstanding | 10,864 | 10,864 | |||||
Undesignated Preferred Stock [Member] | |||||||
Preferred Stock, Shares Authorized | 1,700,000 | ||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.0001 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Allocated Share-based Compensation Expense | $ 6,100 | $ 3,900 | $ 3,400 |
Cost of Sales [Member] | 2008 Plan [Member] | |||
Allocated Share-based Compensation Expense | 60 | 82 | 104 |
Research and Development Expense [Member] | 2008 Plan [Member] | |||
Allocated Share-based Compensation Expense | 112 | 109 | 69 |
Selling, General and Administrative Expenses [Member] | 2008 Plan [Member] | |||
Allocated Share-based Compensation Expense | $ 5,870 | $ 3,665 | $ 3,250 |
STOCK-BASED COMPENSATION (Det49
STOCK-BASED COMPENSATION (Details 1) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum [Member] | |||
Expected option life (years) | 5 years 6 months | 5 years 6 months | 5 years 4 months 20 days |
Risk-free interest rate | 1.14% | 1.31% | 1.55% |
Expected stock price volatility | 49.40% | 47.90% | 50.60% |
Maximum [Member] | |||
Expected option life (years) | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Risk-free interest rate | 1.55% | 1.82% | 2.03% |
Expected stock price volatility | 51.70% | 50.50% | 55.10% |
STOCK-BASED COMPENSATION (Det50
STOCK-BASED COMPENSATION (Details 2) - Options [Member] - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Option Shares | ||||
Outstanding at the beginning of the period (in shares) | 474 | 458 | 120 | |
Granted (in shares) | 265 | 138 | 120 | |
Options previously granted, approved by shareholders | 325 | |||
Exercised (in shares) | (127) | (89) | (43) | |
Forfeited (in shares) | (32) | (33) | (4) | |
Expired (in shares) | (2) | 0 | (60) | |
Outstanding at the end of the period (in shares) | 578 | 474 | 458 | 120 |
Exercisable at the end of the period (in shares) | 128 | |||
Vested or expected to vest at the end of the period (in shares) | 567 | |||
Weighted Average Exercise Price | ||||
Outstanding at the beginning of the period (in dollars per share) | $ 29.40 | $ 14.44 | $ 50.35 | |
Granted (in dollars per share) | 45.60 | 62.07 | 31.59 | |
Options previously granted, approved by shareholders (in dollars per share) | 6.39 | |||
Exercised (in dollars per share) | 11.79 | 9.24 | 19.45 | |
Forfeited (in dollars per share) | 47.84 | 11.81 | 6.36 | |
Expired (in dollars per share) | 139.32 | 0 | 73.96 | |
Outstanding at the end of the period (in dollars per share) | 39.28 | 29.40 | 14.44 | $ 50.35 |
Exercisable at the end of the period (in dollars per share) | 30.87 | |||
Vested or expected to vest at the end of the period (in dollars per share) | 39.11 | |||
Weighted Average Grant-date Fair Value | ||||
Granted (in dollars per share) | $ 22.45 | $ 30.08 | $ 16.84 | |
Weighted Average Remaining Term (Years) | ||||
Outstanding at the end of the period weighted average remaining term | 8 years 2 months 12 days | 8 years 2 months 12 days | 8 years 8 months 12 days | 2 years 4 months 24 days |
Exercisable at the end of the period weighted average remaining term | 7 years 1 month 6 days | |||
Vested or expected to vest at the end of the period weighted average remaining term | 8 years 2 months 12 days | |||
Aggregate Intrinsic Value | ||||
Outstanding at the beginning of the period intrinsic value (in dollars) | $ 10,136 | $ 19,472 | $ 81 | |
Exercised at the end of the period intrinsic value (in dollars) | 5,837 | 3,937 | 638 | |
Outstanding at the end of the period intrinsic value (in dollars) | 12,928 | $ 10,136 | $ 19,472 | $ 81 |
Exercisable at the end of the period intrinsic value (in dollars) | 4,033 | |||
Vested or expected to vest at the end of the period intrinsic value (in dollars) | $ 12,776 |
STOCK-BASED COMPENSATION (Det51
STOCK-BASED COMPENSATION (Details 3) - Restricted Stock Awards [Member] - $ / shares shares in Thousands | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Unvested, Shares, Outstanding, Beginning of period | 63 | 63 | 50 | |
Unvested Shares, Granted | 38 | 28 | 30 | |
Unvested Shares, Vested | (30) | (23) | (17) | |
Unvested Shares, Forfeited | (8) | (5) | 0 | |
Unvested Shares, Outstanding, End of period | 63 | 63 | 63 | 50 |
Weighted Average Grant Date Fair Value, Outstanding, Beginning of period | $ 42.72 | $ 19.34 | $ 10.20 | |
Weighted Average Grant Date Fair Value, Granted | 40.59 | 67.26 | 29.61 | |
Weighted Average Grant Date Fair Value, Vested | 33.89 | 15.82 | 10.20 | |
Weighted Average Grant Date Fair Value, Forfeited | 46.05 | 19.41 | 0 | |
Weighted Average Grant Date Fair Value, Outstanding, End of period | $ 45.72 | $ 42.72 | $ 19.34 | $ 10.20 |
Weighted Average Remaining Term (in years) | 2 years 2 months 12 days | 2 years 2 months 12 days | 2 years 7 months 6 days | 2 years 9 months 18 days |
STOCK-BASED COMPENSATION (Det52
STOCK-BASED COMPENSATION (Details Textual) - USD ($) $ in Thousands | May 06, 2016 | Apr. 07, 2016 | Oct. 12, 2015 | Apr. 26, 2016 | Apr. 16, 2015 | Aug. 20, 2014 | Apr. 01, 2014 | Jun. 30, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
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 | 200,000 | ||||||||||
Allocated Share-based Compensation Expense | $ 6,100 | $ 3,900 | $ 3,400 | ||||||||
Employee Service Share-based Compensation, Tax Benefit from Compensation Expense | $ 1,000 | $ 400 | $ 600 | ||||||||
Maximum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 6 years 3 months | 6 years 3 months | 6 years 3 months | ||||||||
Minimum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 5 years 6 months | 5 years 6 months | 5 years 4 months 20 days | ||||||||
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] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Options Previously Granted Approved By Share holders | 300,000 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 7,600 | ||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 8 months 12 days | ||||||||||
Employee Service Share-based Compensation, Cash Received from Exercise of Stock Options | $ 1,600 | $ 800 | $ 800 | ||||||||
Employee Service Share-based Compensation, Tax Benefit Realized from Exercise of Stock Options | $ 700 | $ 300 | $ 100 | ||||||||
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 | 2,000 | ||||||||||
Options [Member] | Officer [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 63,000 | 47,000 | 25,000 | 59,000 | |||||||
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 | 4,050 | ||||||||||
Non-Employee Director Stock Option [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 13,000 | 3,000 | 9,000 | 16,000 | |||||||
Options Previously Granted Approved By Shareholders [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 5 years 4 months 20 days | ||||||||||
Employees Restricted Stock [Member] | Cost of Sales [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Allocated Share-based Compensation Expense | $ 2 | ||||||||||
Employees Restricted Stock [Member] | Selling, General and Administrative Expenses [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Allocated Share-based Compensation Expense | $ 23 | ||||||||||
2008 Plan [Member] | Restricted Stock [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 2 months 12 days | ||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options | $ 2,000 | ||||||||||
2008 Plan [Member] | Non-employee Director Restricted Stock [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 6,000 | 4,000 | |||||||||
2008 Plan [Member] | Non-employee Director Restricted Stock [Member] | Maximum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 3 years | ||||||||||
2008 Plan [Member] | Non-employee Director Restricted Stock [Member] | Minimum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 1 year | ||||||||||
2008 Plan [Member] | Employees Restricted Stock [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 4 years | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 31,000 | 24,000 | 30,000 | ||||||||
Employee Stock Purchase Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Allocated Share-based Compensation Expense | $ 25 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 200,000 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Discount from Market Price, Purchase Date | 15.00% |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Current income tax provision: | |||
Federal | $ 11,717 | $ 7,264 | $ 4,034 |
State | 1,321 | 611 | 273 |
Total | 13,038 | 7,875 | 4,307 |
Deferred income tax (benefit)/provision: | |||
Federal | (8,387) | (1,468) | 2,113 |
State | (658) | (409) | 154 |
Total | (9,045) | (1,877) | 2,267 |
Change in valuation allowance | 134 | 0 | (16,726) |
Excess tax benefit from stock-based compensation awards | 617 | 360 | 784 |
Total provision/(benefit) for income taxes | $ 4,744 | $ 6,358 | $ (9,368) |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
US Federal statutory rate | 35.00% | 35.00% | 35.00% |
State taxes, net of Federal benefit | 2.10% | 2.10% | 1.00% |
International tax structure impacts | 23.30% | 0.00% | 0.00% |
Domestic production activities deduction | (14.40%) | (5.30%) | 0.00% |
Change in valuation allowance | 1.60% | 0.00% | (86.50%) |
Stock-based compensation - no windfall tax benefit | 5.70% | 1.10% | 4.70% |
Stock-based compensation - windfall tax benefits | 0.00% | (0.10%) | (1.20%) |
Change in tax rates and other | 1.40% | (3.50%) | (1.40%) |
Total income tax provision/(benefit) | 54.70% | 29.30% | (48.40%) |
INCOME TAXES (Details 2)
INCOME TAXES (Details 2) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred tax assets: | ||
Accruals and advances | $ 3,002 | $ 2,153 |
Bond hedge | 10,921 | 12,243 |
Accruals for chargebacks and returns | 7,137 | 2,945 |
Inventory | 1,255 | 1,271 |
Intangible asset | 6,302 | 3,631 |
Net operating loss carryforward | 5,095 | 7,938 |
Other | 1,680 | 1,149 |
Total deferred tax assets | 35,392 | 31,330 |
Deferred tax liabilities: | ||
Depreciation | (857) | (700) |
Debt discount | (7,664) | (10,029) |
Intangible assets | (353) | (3,127) |
Other | (16) | (16) |
Total deferred tax liabilities | (8,890) | (13,872) |
Valuation allowance | (275) | (142) |
Total deferred tax asset, net | $ 26,227 | $ 17,316 |
INCOME TAXES (Details Textual)
INCOME TAXES (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Deferred Tax Assets, Valuation Allowance | $ 275 | $ 142 |
Operating Loss Carryforwards | $ 13,700 | |
Operating Loss Carryforwards, Limitations on Use | approximately $0.8 million per year. |
COLLABORATIVE ARRANGEMENTS (Det
COLLABORATIVE ARRANGEMENTS (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cost of Revenue, Total | $ 48,780,000 | $ 12,692,000 | $ 11,473,000 |
Research and Development Expense, Total | 2,906,000 | 2,874,000 | 2,678,000 |
Riconpharma LLC [Member] | |||
Cost of Revenue, Total | 2,000,000 | ||
Research and Development Expense, Total | 23,000 | 31,000 | 400,000 |
Sofgen Pharmaceuticals [Member] | April 2014 Sofgen Agreement [Member] | |||
Research and Development Expense, Total | 37,000 | 100,000 | |
Sofgen Pharmaceuticals [Member] | August 2013 Sofgen Agreement [Member] | |||
Cost of Revenue, Total | $ 600,000 | ||
Research and Development Expense, Total | $ 400 | $ 200,000 |
COMMITMENTS AND CONTINGENCIES58
COMMITMENTS AND CONTINGENCIES (Details) $ in Thousands | Dec. 31, 2016USD ($) |
2,017 | $ 99 |
2,018 | 97 |
2,019 | 66 |
2,020 | 68 |
2,021 | 19 |
Thereafter | 0 |
Total | $ 349 |
COMMITMENTS AND CONTINGENCIES59
COMMITMENTS AND CONTINGENCIES (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
COMMITMENTS AND CONTINGENCIES | ||||
Operating Leases, Rent Expense | $ 81 | $ 74 | $ 70 | |
Four Vendors [Member] | Scenario, Forecast [Member] | ||||
COMMITMENTS AND CONTINGENCIES | ||||
Long-term Purchase Commitment, Amount | $ 9,000 | |||
Unapproved Products [Member] | ||||
COMMITMENTS AND CONTINGENCIES | ||||
Revenue, Net | 34,300 | 44,300 | 29,800 | |
Unapproved Products [Member] | Contract Customer [Member] | ||||
COMMITMENTS AND CONTINGENCIES | ||||
Revenue, Net | $ 1,500 | $ 1,600 | $ 1,200 |
QUARTERLY FINANCIAL DATA (Detai
QUARTERLY FINANCIAL DATA (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Net revenues | $ 38,205 | $ 38,525 | $ 31,337 | $ 20,555 | $ 18,035 | $ 19,972 | $ 19,516 | $ 18,799 | $ 128,622 | $ 76,322 | $ 55,970 |
Total operating expenses | 36,907 | 30,604 | 26,143 | 14,889 | 11,767 | 11,521 | 11,102 | 9,232 | 108,543 | 43,622 | 35,964 |
Operating income | 1,298 | 7,921 | 5,194 | 5,666 | 6,268 | 8,451 | 8,414 | 9,567 | 20,079 | 32,700 | 20,006 |
Net income/(loss) | $ (1,080) | $ 2,543 | $ 1,125 | $ 1,346 | $ 2,876 | $ 4,559 | $ 3,571 | $ 4,369 | $ 3,934 | $ 15,375 | $ 28,747 |
Basic and diluted earnings/(loss) per share: | |||||||||||
Basic earnings/(loss) per share (in dollars per share) | $ (0.09) | $ 0.22 | $ 0.10 | $ 0.12 | $ 0.25 | $ 0.40 | $ 0.31 | $ 0.38 | $ 0.34 | $ 1.34 | $ 2.61 |
Diluted earnings/(loss) per share (in dollars per share) | $ (0.09) | $ 0.22 | $ 0.10 | $ 0.12 | $ 0.25 | $ 0.39 | $ 0.31 | $ 0.38 | $ 0.34 | $ 1.32 | $ 2.59 |
SUBSEQUENT EVENTS (Details Text
SUBSEQUENT EVENTS (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Feb. 28, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Subsequent Event [Line Items] | ||||
Payments to Acquire Intangible Assets | $ 144,494 | $ 30,500 | $ 34,634 | |
Inderal XL [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Payments to Acquire Intangible Assets | $ 20,200 | |||
InnoPran XL [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Payments to Acquire Intangible Assets | 30,600 | |||
InnoPran XL [Member] | Subsequent Event [Member] | Cash [Member] | ||||
Subsequent Event [Line Items] | ||||
Payments to Acquire Intangible Assets | 600 | |||
InnoPran XL [Member] | Subsequent Event [Member] | Line of Credit [Member] | ||||
Subsequent Event [Line Items] | ||||
Payments to Acquire Intangible Assets | $ 30,000 |