Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Oct. 31, 2016 | |
Document and Entity Information | ||
Entity Registrant Name | VIVUS INC | |
Entity Central Index Key | 881,524 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 104,843,301 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 154,137 | $ 95,395 |
Available-for-sale securities | 129,449 | 146,168 |
Accounts receivable, net | 10,295 | 8,997 |
Inventories | 11,259 | 13,602 |
Prepaid expenses and other assets | 5,552 | 9,430 |
Total current assets | 310,692 | 273,592 |
Property and equipment, net | 715 | 994 |
Non-current assets | 1,744 | 2,616 |
Total assets | 313,151 | 277,202 |
Current liabilities: | ||
Accounts payable | 6,440 | 7,060 |
Accrued and other liabilities | 9,944 | 15,891 |
Deferred revenue | 89,128 | 22,142 |
Current portion of long-term debt | 9,015 | 14,356 |
Total current liabilities | 114,527 | 59,449 |
Long-term debt, net of current portion | 229,876 | 217,034 |
Deferred revenue, net of current portion | 6,845 | 6,508 |
Non-current accrued and other liabilities | 16 | 1,296 |
Total liabilities | 351,264 | 284,287 |
Commitments and contingencies | ||
Stockholders' deficit | ||
Preferred stock; $1.00 par value; 5,000 shares authorized; no shares issued and outstanding at September 30, 2016 and December 31, 2015 | ||
Common stock; $.001 par value; 200,000 shares authorized; 104,819 and 104,055 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | 105 | 104 |
Additional paid-in capital | 831,192 | 829,428 |
Accumulated other comprehensive income (loss) | 207 | (261) |
Accumulated deficit | (869,617) | (836,356) |
Total stockholders' deficit | (38,113) | (7,085) |
Total liabilities and stockholders' deficit | $ 313,151 | $ 277,202 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 1 | $ 1 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 104,819,000 | 104,055,000 |
Common stock, shares outstanding | 104,819,000 | 104,055,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Revenue: | ||||
Net product revenue | $ 12,294 | $ 14,011 | $ 37,455 | $ 40,652 |
License and milestone revenue | 11,574 | |||
Supply revenue | 10,056 | 1,526 | 26,651 | |
Royalty revenue | 1,059 | 869 | 3,472 | 1,210 |
Total revenue | 13,353 | 24,936 | 42,453 | 80,087 |
Operating expenses: | ||||
Cost of goods sold | 2,065 | 11,765 | 8,416 | 31,531 |
Selling, general and administrative | 10,440 | 17,129 | 39,254 | 65,730 |
Research and development | 1,696 | 1,532 | 3,821 | 6,825 |
Inventory impairment and other non-recurring charges | 2,539 | 32,061 | ||
Total operating expenses | 14,201 | 32,965 | 51,491 | 136,147 |
Loss from operations | (848) | (8,029) | (9,038) | (56,060) |
Interest expense and other expense, net | 8,313 | 8,076 | 24,209 | 24,851 |
Loss before income taxes | (9,161) | (16,105) | (33,247) | (80,911) |
(Benefit) Provision for income taxes | (9) | 1 | 14 | 13 |
Net loss | $ (9,152) | $ (16,106) | $ (33,261) | $ (80,924) |
Basic and diluted net loss per share: | ||||
Basic and diluted net loss per share (in dollars per share) | $ (0.09) | $ (0.15) | $ (0.32) | $ (0.78) |
Shares used in per share computation: | ||||
Basic and diluted (in shares) | 104,484 | 104,014 | 104,228 | 103,950 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net loss | $ (9,152) | $ (16,106) | $ (33,261) | $ (80,924) |
Other comprehensive loss: | ||||
Unrealized (loss) gain on securities, net of taxes | (158) | 51 | 469 | 124 |
Comprehensive loss | $ (9,310) | $ (16,055) | $ (32,792) | $ (80,800) |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (33,261) | $ (80,924) |
Adjustments to reconcile net loss to net cash used for operating activities: | ||
Depreciation and amortization | 823 | 1,079 |
Amortization of debt issuance costs and discounts | 13,860 | 12,761 |
Amortization of discount or premium on available-for-sale securities | 700 | 1,940 |
Share-based compensation expense | 1,740 | 3,032 |
Inventory impairment charge | 29,522 | |
Changes in assets and liabilities: | ||
Accounts receivable | (1,298) | (3,299) |
Inventories | 2,343 | (4,113) |
Prepaid expenses and other assets | 4,206 | 3,611 |
Accounts payable | (620) | (2,908) |
Accrued and other liabilities | (7,227) | (2,563) |
Deferred revenue | 67,323 | 781 |
Net cash provided by (used for) operating activities | 48,589 | (41,081) |
Cash flows from investing activities: | ||
Property and equipment purchases | (310) | |
Purchases of available-for-sale securities | (50,523) | (176,510) |
Proceeds from maturity of available-for-sale securities | 60,050 | 219,500 |
Proceeds from sale of Available-for-sale Securities | 6,960 | |
Net cash provided by investing activities | 16,487 | 42,680 |
Cash flows from financing activities: | ||
Repayments of note payable | (6,359) | (5,402) |
Sale of common stock through employee stock purchase plan | 25 | 125 |
Net cash used for financing activities | (6,334) | (5,277) |
Net increase (decrease) in cash and cash equivalents | 58,742 | (3,678) |
Cash and cash equivalents: | ||
Beginning of period | 95,395 | 83,174 |
End of period | $ 154,137 | $ 79,496 |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2016 | |
BASIS OF PRESENTATION | |
BASIS OF PRESENTATION | 1. BASIS OF PRESENTATION The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended September 30, 2016, are not necessarily indicative of the results that may be expected for the year ending December 31, 2016. Management has evaluated all events and transactions that occurred after September 30, 2016, through the date these unaudited condensed consolidated financial statements were filed. There were no events or transactions during this period that require recognition or disclosure in these unaudited condensed consolidated financial statements. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. The unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 as filed on March 9, 2016 with the Securities and Exchange Commission, or SEC, and as amended by the Form 10-K/A filed on April 22, 2016 with the SEC. The unaudited condensed consolidated financial statements include the accounts of VIVUS, Inc. and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated. When reference is made to the “Company” or “VIVUS” in these footnotes, it refers to the Delaware corporation, or VIVUS, Inc., and its California predecessor, as well as all of its consolidated subsidiaries. Implementation of ASU 2015-03 In April 2015, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs . The standard requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The Company adopted this standard as required beginning in the first quarter of 2016 and retrospectively applied this standard to the balance sheet as of December 31, 2015. The amounts impacted by the adoption of this standard are as follows: As Reported December 31, 2015 Adjustment to reflect ASU 2015-03 As Adjusted December 31, 2015 Prepaid expenses and other assets $ $ $ Total current assets $ $ $ Non-current assets $ $ $ Total assets $ $ $ Long-term debt, current portion $ $ $ Total current liabilities $ $ $ Long-term debt, net of current portion $ $ $ Total liabilities $ $ $ Total liabilities and stockholders’ equity $ $ $ Use of Estimates The preparation of these unaudited condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. On an ongoing basis, the Company evaluates its estimates, including critical accounting policies or estimates related to available-for-sale securities, debt instruments, research and development expenses, income taxes, inventories, revenues, contingencies and litigation and share-based compensation. The Company bases its estimates on historical experience, information received from third parties and on various market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ significantly from those estimates under different assumptions or conditions. Significant Accounting Policies Other than the implementation of ASU 2015-03 discussed above, there have been no changes to the Company’s significant accounting policies since the Company’s Annual Report on Form 10-K for the year ended December 31, 2015. Recent Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases (Topic 842), which modifies the accounting by lessees for all leases with a term greater than 12 months. The standard will require lessees to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. For public companies, the standard is effective for annual and interim periods beginning on or after December 15, 2018 and must be applied retrospectively. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements. In March 2016, the FASB issued Accounting Standards Update 2016-09, Improvements to Employee Share-Based Payment Accounting , which is designed to simplify several aspects of accounting for share-based payment award transactions, including income tax consequences, classification of awards as either equity or liabilities, classification on the statement of cash flows and forfeiture rate calculations. For public companies, the standard is effective for annual and interim periods beginning on or after December 15, 2016. Early adoption is permitted. The Company is currently evaluating the impact of this guidance on its consolidated financial statements. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2016 | |
SHARE-BASED COMPENSATION | |
SHARE-BASED COMPENSATION | 2. SHARE-BASED COMPENSATION Total share-based compensation expense for all of the Company’s share-based awards was as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2016 2015 2016 2015 Cost of goods sold $ $ $ $ Selling, general and administrative Research and development Non-recurring charges — — Total share-based compensation expense $ $ $ $ Share-based compensation costs capitalized as part of the cost of inventory were $19,000 and $26,000 for the three and nine months ended September 30, 2016, respectively, and $11,000 and $35,000 for the three and nine months ended September 30, 2015, respectively. |
CASH, CASH EQUIVALENTS, AND AVA
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES | 9 Months Ended |
Sep. 30, 2016 | |
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES | |
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES | 3. CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES The fair value and the amortized cost of cash, cash equivalents, and available-for-sale securities by major security type at September 30, 2016 and December 31, 2015, are presented in the tables that follow (in thousands). As of September 30, 2016 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents and available-for-sale securities Cost Gains Losses Fair Value Cash and money market funds $ $ — $ — $ U.S. Treasury securities Corporate debt securities Total Less amounts classified as cash and cash equivalents — — Total available-for-sale securities $ $ $ $ As of December 31, 2015 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents and available-for-sale securities Cost Gains Losses Fair Value Cash and money market funds $ $ — $ — $ U.S. Treasury securities — Corporate debt securities Total Less amounts classified as cash and cash equivalents — — Total available-for-sale securities $ $ $ $ As of September 30, 2016, the Company’s available-for-sale securities had original contractual maturities up to 57 months. However, in response to changes in the availability of and the yield on alternative investments as well as liquidity requirements, the Company may sell these securities prior to their stated maturities. As these securities are readily marketable and are viewed by the Company as available to support current operations, securities with maturities beyond 12 months are classified as current assets. Due to their short-term maturities, the Company believes that the fair value of its bank deposits, accounts payable and accrued expenses approximate their carrying value. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Three levels of inputs, of which the first two are considered observable and the last unobservable, may be used to measure fair value. The three levels are: · Level 1 — Quoted prices in active markets for identical assets or liabilities. · Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. · Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following table represents the fair value hierarchy for our cash equivalents and available-for-sale securities by major security type as of September 30, 2016 and December 31, 2015 (in thousands): As of September 30, 2016 Level 1 Level 2 Level 3 Total Cash and money market funds $ $ — $ — $ U.S. Treasury securities — — Corporate debt securities — — Total $ $ $ — $ As of December 31, 2015 Level 1 Level 2 Level 3 Total Cash and money market funds $ $ — $ — $ U.S. Treasury securities — — Corporate debt securities — — Total $ $ $ — $ |
ACCOUNTS RECEIVABLE
ACCOUNTS RECEIVABLE | 9 Months Ended |
Sep. 30, 2016 | |
ACCOUNTS RECEIVABLE | |
ACCOUNTS RECEIVABLE | 4. ACCOUNTS RECEIVABLE Accounts receivable consist of the following (in thousands): Balance as of September 30, December 31, 2016 2015 Qsymia $ $ STENDRA/SPEDRA Qsymia allowance for cash discounts Net $ $ |
INVENTORIES
INVENTORIES | 9 Months Ended |
Sep. 30, 2016 | |
INVENTORIES | |
INVENTORIES | 5. INVENTORIES Inventories consist of the following (in thousands): Balance as of September 30, December 31, 2016 2015 Raw materials $ $ Work-in-process Finished goods Deferred costs Inventories $ $ Raw materials inventories consist primarily of the active pharmaceutical ingredients, or API, for Qsymia and STENDRA/SPEDRA. Deferred costs inventories consist primarily of Qsymia and represent Qsymia product shipped to the Company’s wholesalers and certified retail pharmacies, but not yet dispensed to patients through prescriptions, net of prompt payment discounts, and for which recognition of revenue has been deferred. Inventories are stated at the lower of cost or market. Cost is determined using the first in, first out method for all inventories, which are valued using a weighted-average cost method calculated for each production batch. The Company periodically evaluates the carrying value of inventory on hand for potential excess amounts over demand using the same lower of cost or market approach as that used to value the inventory. In the second quarter of 2015, the Company recorded inventory impairment charges of $29.5 million primarily for Qsymia API inventory in excess of expected demand. |
PREPAID EXPENSES AND OTHER ASSE
PREPAID EXPENSES AND OTHER ASSETS | 9 Months Ended |
Sep. 30, 2016 | |
PREPAID EXPENSES AND OTHER ASSETS | |
PREPAID EXPENSES AND OTHER ASSETS | 6. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consist of the following (in thousands): Balance as of September 30, December 31, 2016 2015 Prepaid sales and marketing expenses $ $ Prepaid insurance Other prepaid expenses and assets Total $ $ The amounts included in prepaid expenses and other current assets consist primarily of prepayments for future services, a receivable from a supplier and interest income receivable. These costs have been deferred as prepaid expenses and other current assets on the consolidated balance sheets and will be either (i) charged to expense accordingly when the related prepaid services are rendered to the Company, or (ii) converted to cash when the receivable is collected by the Company. |
NON-CURRENT ASSETS
NON-CURRENT ASSETS | 9 Months Ended |
Sep. 30, 2016 | |
NON-CURRENT ASSETS | |
NON-CURRENT ASSETS | 7. NON-CURRENT ASSETS Non-current assets consist primarily of patent acquisition and assignment costs. |
ACCRUED AND OTHER LIABILITIES
ACCRUED AND OTHER LIABILITIES | 9 Months Ended |
Sep. 30, 2016 | |
ACCRUED AND OTHER LIABILITIES | |
ACCRUED AND OTHER LIABILITIES | 8. ACCRUED AND OTHER LIABILITIES Accrued and other liabilities consist of the following (in thousands): Balance as of September 30, December 31, 2016 2015 Accrued employee compensation and benefits $ $ Accrued non-recurring charges (see Note 10) Accrued interest on debt (see Note 13) Accrued manufacturing costs Other accrued liabilities Total $ $ The amounts included in other accrued liabilities consist of obligations primarily related to sales, marketing, research, clinical development, corporate activities and royalties. |
NON-CURRENT ACCRUED AND OTHER L
NON-CURRENT ACCRUED AND OTHER LIABILITIES | 9 Months Ended |
Sep. 30, 2016 | |
NON-CURRENT ACCRUED AND OTHER LIABILITIES | |
NON-CURRENT ACCRUED AND OTHER LIABILITIES | 9. NON-CURRENT ACCRUED AND OTHER LIABILITIES Non-current accrued and other liabilities at December 31, 2015 primarily consisted of costs associated with the exit of certain operating leases and security deposits relating to the sublease agreements. |
INVENTORY IMPAIRMENT AND OTHER
INVENTORY IMPAIRMENT AND OTHER NON-RECURRING CHARGES | 9 Months Ended |
Sep. 30, 2016 | |
INVENTORY IMPAIRMENT AND OTHER NON-RECURRING CHARGES | |
INVENTORY IMPAIRMENT AND OTHER NON-RECURRING CHARGES | 10. INVENTORY IMPAIRMENT AND OTHER NON-RECURRING CHARGES For the nine months ended September 30, 2015, the Company recognized impairment charges of $29.5 million, primarily for Qsymia API inventory in excess of demand and, to a lesser extent, certain STENDRA raw materials. Additionally, non-recurring charges for the three and nine months ended September 30, 2015 included employee severance and related costs of $2.5 million and share-based compensation of $36,000 related to the July 2015 corporate restructuring plan, which reduced the Company’s workforce by approximately 60 job positions. There were no non-recurring charges in the three and nine months ended September 30, 2016. Accruals for severance at September 30, 2016 and December 31, 2015 relate to the Company’s 2015 corporate restructuring plan and its 2013 cost reduction plan. The following table sets forth activities for the Company’s cost reduction plan obligations (in thousands): Facilities- Severance related obligations obligations Total Balance of accrued costs at December 31, 2015 $ $ $ Charges — — — Payments Balance of accrued costs at March 31, 2016 Charges — — — Payments Balance of accrued costs at June 30, 2016 Charges — — — Reclassifications Payments Balance of accrued costs at September 30, 2016 $ $ — $ Total accrued employee severance in the Company’s unaudited condensed consolidated balance sheet at September 30, 2016 is included under current liabilities in “Accrued and other liabilities.” The balance of the accrued employee severance and facilities-related costs at September 30, 2016 is anticipated to be paid out as follows (in thousands): 2016 (remaining three months) $ 2017 $ |
DEFERRED REVENUE
DEFERRED REVENUE | 9 Months Ended |
Sep. 30, 2016 | |
DEFERRED REVENUE | |
DEFERRED REVENUE | 11. DEFERRED REVENUE Deferred revenue consists of the following (in thousands): Balance as of September 30, December 31, 2016 2015 Qsymia deferred revenue - current $ $ STENDRA deferred revenue - current Deferred revenue - current $ $ STENDRA deferred revenue - non-current $ $ Qsymia deferred revenue consists of product shipped to the Company’s wholesalers, certified retail pharmacies and certified home delivery pharmacy services networks, but not yet dispensed to patients through prescriptions, net of prompt payment discounts. SPEDRA deferred revenue primarily relates to a prepayment of $70 million in licensing fees from Metuchen Pharmaceuticals LLC, or Metuchen, (see Note 12) and a prepayment for future royalties on sales of SPEDRA. |
LICENSE, COMMERCIALIZATION AND
LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENTS | 9 Months Ended |
Sep. 30, 2016 | |
LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENTS | |
LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENTS | 12. LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENTS During 2013, the Company entered into separate license and commercialization agreements and separate commercial supply agreements with each of the Menarini Group, through its subsidiary Berlin Chemie AG, or Menarini, Auxilium Pharmaceuticals, Inc, or Auxilium, and Sanofi and its affiliate, or Sanofi, to commercialize and promote avanafil (STENDRA or SPEDRA) in their respective territories. Menarini’s territory is comprised of over 40 European countries, including the European Union, or EU, plus Australia and New Zealand. Sanofi’s territory is comprised of Africa, the Middle East, Turkey and Eurasia. Auxilium’s territory was comprised of the United States and Canada and their respective territories. In January 2015, Auxilium was acquired by Endo. Auxilium terminated the supply agreement effective June 30, 2016, and the license agreement effective September 30, 2016. On September 30, 2016, the Company entered into a license and commercialization agreement, or the license agreement, and a commercial supply agreement, or the supply agreement, with Metuchen. Under the terms of the license agreement, Metuchen received an exclusive license to develop, commercialize and promote STENDRA in the United States, Canada, South America and India, or the Territory, effective October 1, 2016. The Company and Metuchen have agreed not to develop, commercialize, or in-license any other product that operates as a PDE-5 inhibitor in the Territory for a limited time period, subject to certain exceptions. The license agreement will terminate upon the expiration of the last-to-expire payment obligations under the license agreement; upon expiration of the term of the license agreement, the exclusive license granted under the license agreement shall become fully paid-up, royalty-free, perpetual and irrevocable as to the Company but not certain trademark royalties due to MTPC. Metuchen will obtain STENDRA exclusively from us for a mutually agreed term pursuant to the supply agreement. Metuchen may elect to transfer the control of the supply chain for STENDRA for the Territory to itself or its designee by assigning to Metuchen the Company’s agreements with the contract manufacturer For 2016 and each subsequent calendar year during the term of the supply agreement, if Metuchen fails to purchase an agreed minimum purchase amount of STENDRA from the Company, it will reimburse the Company for the shortfall as it relates to the Company’s out of pocket costs to acquire certain raw materials needed to manufacture STENDRA. Upon the termination of the supply agreement (other than by Metuchen for the Company’s uncured material breach or upon completion of the transfer of the control of the supply chain), Metuchen’s agreed minimum purchase amount of STENDRA from the Company shall accelerate for the entire then current initial term or renewal term, as applicable. The initial term under the Supply Agreement will be for a period of five years, with automatic renewal for successive two year periods unless either party provides a termination notice to the other party at least two years in advance of the expiration of the then current term. On September 30, 2016, the Company received $70 million from Metuchen under the license agreement. This amount was recorded as deferred revenue on the consolidated balance sheet at September 30, 2016 and will be recognized as license revenue as we complete our obligations under the license agreement. Metuchen will also reimburse the Company for payments made to cover royalty and milestone obligations to Mitsubishi Tanabe Pharmaceutical Corporation, or MTPC, during the term of the license agreement. |
LONG-TERM DEBT AND COMMITMENTS
LONG-TERM DEBT AND COMMITMENTS | 9 Months Ended |
Sep. 30, 2016 | |
LONG-TERM DEBT AND COMMITMENTS | |
LONG-TERM DEBT AND COMMITMENTS | 13. LONG-TERM DEBT AND COMMITMENTS Convertible Senior Notes Due 2020 In May 2013, the Company closed an offering of $220.0 million in 4.5% Convertible Senior Notes due May 2020, or the Convertible Notes. The Convertible Notes are governed by an indenture, dated May 2013 between the Company and Deutsche Bank National Trust Company, as trustee. In May 2013, the Company closed on an additional $30.0 million of Convertible Notes upon exercise of an option by the initial purchasers of the Convertible Notes at a conversion rate of approximately $14.86 per share. Total net proceeds from the Convertible Notes were approximately $241.8 million. The Convertible Notes are convertible at the option of the holders under certain conditions at any time prior to the close of business on the business day immediately preceding November 1, 2019. On or after November 1, 2019, holders may convert all or any portion of their Convertible Notes at any time at their option at the conversion rate then in effect, regardless of these conditions. Subject to certain limitations, the Company will settle conversions of the Convertible Notes by paying or delivering, as the case may be, cash, shares of its common stock or a combination of cash and shares of our common stock, at the Company’s election. Interest payments are made quarterly. For the three and nine months ended September 30, 2016, total interest expense related to the Convertible Notes was $7.5 million and $22.1 million, respectively, including amortization of $4.4 million and $13.0 million, respectively, of the debt discount and amortization of $235,000 and $689,000, respectively, of deferred financing costs. For the three and nine months ended September 30, 2015, total interest expense related to the Convertible Notes was $6.9 million and $20.2 million, respectively, including amortization of $4.0 million and $11.9. million, respectively, of the debt discount and amortization of $215,000 and $630,000, respectively, of deferred financing costs. Senior Secured Notes Due 2018 In March 2013, the Company entered into the Purchase and Sale Agreement between the Company and BioPharma Secured Investments III Holdings Cayman LP, or Biopharma, a Cayman Islands exempted limited partnership, providing for the purchase of a debt like instrument, or the Senior Secured Notes. Under the agreement, the Company received $50 million, less $500,000 in funding and facility payments, at the initial closing in April 2013. The scheduled quarterly payments on the Senior Secured Notes are subject to the net sales of (i) Qsymia and (ii) any other obesity agent developed or marketed by us or our affiliates or licensees. The scheduled quarterly payments, other than the payment(s) scheduled to be made in the second quarter of 2018, are capped at the lower of the scheduled payment amounts or 25% of the net sales of (i) and (ii) above. Accordingly, if 25% of the net sales is less than the scheduled quarterly payment, then 25% of the net sales is due for that quarter, with the exception of the payment(s) scheduled to be made in the second quarter of 2018, when any unpaid scheduled quarterly payments plus any accrued and unpaid make whole premiums must be paid. Any quarterly payment less than the scheduled quarterly payment amount will be subject to a make whole premium equal to the applicable scheduled quarterly payment of the preceding quarter less the actual payment made to BioPharma for the preceding quarter multiplied by 1.03. The Company may elect to pay full scheduled quarterly payments if it chooses. For the three and nine months ended September 30, 2016, the interest expense related to the Senior Secured Notes was $1.3 million and $3.6 million, respectively, including amortization of deferred financing costs of $46,000 and $189,000, respectively. For the three and nine months ended September 30, 2015, the interest expense related to the Senior Secured Notes was $1.5 million and $4.9 million, respectively, including amortization of deferred financing costs of $94,000 and $306,000, respectively. Debt is as follows (in thousands): September 30, 2016 Principal amount of Convertible Senior Notes due 2020 $ Principal amount of Senior Secured Notes due 2018 Less: Debt issuance costs Less: Discount on convertible senior notes Less: Current portion Long-term debt, net of current portion $ Future estimated payments on the Senior Secured Notes as of September 30, 2016 are as follows: 2016 (remaining three months) $ 2017 2018 Total Less: Interest portion Senior Secured Notes $ As a condition of the FDA granting approval to commercialize Qsymia in the U.S., the Company agreed to complete certain post-marketing requirements. One requirement was to perform a cardiovascular outcomes trial, or CVOT, on Qsymia. The cost of a CVOT is estimated to be between $180 million and $220 million incurred over a period of approximately five years. The Company is working with the FDA to determine a pathway to provide the FDA with information to support the safety of Qsymia in a more cost effective manner. To date, the Company has not incurred expenses related to the CVOT. |
NET INCOME (LOSS) PER SHARE
NET INCOME (LOSS) PER SHARE | 9 Months Ended |
Sep. 30, 2016 | |
NET INCOME (LOSS) PER SHARE | |
NET INCOME (LOSS) PER SHARE | 14. NET INCOME (LOSS) PER SHARE The Company computes basic net income (loss) per share applicable to common stockholders based on the weighted average number of common shares outstanding during the applicable period. Diluted net income per share is based on the weighted average number of common and common equivalent shares, which represent shares that may be issued in the future upon the exercise of outstanding stock options or upon a net share settlement of the Company’s Convertible Notes. Common share equivalents are excluded from the computation in periods in which they have an anti-dilutive effect. Stock options for which the price exceeds the average market price over the period have an anti-dilutive effect on net income per share and, accordingly, are excluded from the calculation. The triggering conversion conditions that allow holders of the Convertible Notes to convert have not been met. If such conditions are met and the note holders opt to convert, the Company may choose to pay in cash, common stock, or a combination thereof; however, if this occurs, the Company has the intent and ability to net share settle this debt security; thus the Company uses the treasury stock method for earnings per share purposes. Due to the effect of the capped call instrument purchased in relation to the Convertible Notes, there would be no net shares issued until the market value of the Company’s stock exceeds $20 per share, and thus no impact on diluted net income per share. Further, when there is a net loss, potentially dilutive common equivalent shares are not included in the calculation of net loss per share since their inclusion would be anti-dilutive. As the Company recognized a net loss for each of the three and nine month periods ended September 30, 2016 and 2015, all potential common equivalent shares were excluded for these periods as they were anti-dilutive. Awards and options which were not included in the computation of diluted net loss per share because the effect would be anti-dilutive for the three and nine months ended September 30, 2016 were 10,261,000 and 10,520,000, respectively, and for the three and nine months ended September 30, 2015 were 6,958,000 and 7,582,000, respectively. |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2016 | |
INCOME TAXES | |
INCOME TAXES | 15. INCOME TAXES For the three and nine months ended September 30, 2016, the Company recorded a benefit of $9,000 and a provision for taxes of $14,000, respectively. For the three and nine months ended September 30, 2015, the Company recorded a provision for taxes of $1,000 and $13,000, respectively. The benefit and provision for income taxes for each of the periods ended September 30, 2016 and 2015 was primarily comprised of state taxes during the period. The Company periodically evaluates the realizability of its net deferred tax assets based on all available evidence, both positive and negative. The realization of net deferred tax assets is dependent on the Company's ability to generate sufficient future taxable income during periods prior to the expiration of tax attributes to fully utilize these assets. The Company weighed both positive and negative evidence and determined that there is a continued need for a full valuation allowance on its deferred tax assets in the United States as of September 30, 2016. Should the Company determine that it would be able to realize its remaining deferred tax assets in the foreseeable future, an adjustment to its remaining deferred tax assets would cause a material increase to income in the period such determination is made. As of September 30, 2016, the Company’s only unrecognized tax benefit is related to California research and development activities in the amount of $66,000. We do not expect to have any other significant changes to unrecognized tax benefits through the end of the fiscal year. Because of our history of tax losses, certain tax years remain open to tax audit. The Company’s policy is to recognize interest and penalties related to uncertain tax positions (if any) as a component of the income tax provision. |
LEGAL MATTERS
LEGAL MATTERS | 9 Months Ended |
Sep. 30, 2016 | |
LEGAL MATTERS | |
LEGAL MATTERS | 16. LEGAL MATTERS Shareholder Lawsuit On March 27, 2014, Mary Jane and Thomas Jasin, who purport to be purchasers of VIVUS common stock, filed an Amended Complaint in Santa Clara County Superior Court alleging securities fraud against the Company and three of its former officers and directors. In that complaint, captioned Jasin v. VIVUS, Inc ., Case No. 114-cv-261427, plaintiffs asserted claims under California’s securities and consumer protection securities statutes. Plaintiffs alleged generally that defendants misrepresented the prospects for the Company’s success, including with respect to the launch of Qsymia, while purportedly selling VIVUS stock for personal profit. Plaintiffs alleged losses of “at least” $2.8 million, and sought damages and other relief. On June 5, 2014, the Company and the other defendants filed a demurrer to the Amended Complaint seeking its dismissal. With the demurrer pending, on July 18, 2014, the same plaintiffs filed a complaint in the United States District Court for the Northern District of California, captioned Jasin v. VIVUS, Inc ., Case No. 5:14-cv-03263. The Jasins’ federal complaint alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, based on facts substantially similar to those alleged in their state court action. On September 15, 2014, pursuant to an agreement between the parties, plaintiffs moved to voluntarily dismiss, with prejudice, the state court action. In the federal action, defendants filed a motion to dismiss on November 12, 2014. On December 3, 2014, plaintiffs filed a First Amended Complaint in the federal action. On January 21, 2015, defendants filed a motion to dismiss the First Amended Complaint. The court ruled on that motion on June 18, 2015, dismissing the seven California claims with prejudice and dismissing the two federal claims with leave to amend. Plaintiffs filed a Second Amended Complaint on August 17, 2015. Defendants moved to dismiss that complaint on October 2, 2015. On September 10, 2015, plaintiffs moved for entry of judgment on their state claims. Briefing on both defendants’ motion to dismiss and plaintiffs’ motion for entry of judgment was completed on December 15, 2015. On April 19, 2016, the court issued a ruling granting defendants’ motion to dismiss without leave to amend and denying as moot plaintiffs’ motion for entry of judgment. On May 18, 2016, the plaintiffs filed a notice of appeal, and on September 23, 2016, plaintiffs filed their opening appellate brief. Defendants’ response is due on November 23, 2016. The Company maintains directors’ and officers’ liability insurance that it believes affords coverage for much of the anticipated cost of the remaining Jasin action, subject to the use of the Company’s financial resources to pay for its self-insured retention and the policies’ terms and conditions. The Company and the defendant former officers and directors cannot predict the outcome of the lawsuit, but they believe the lawsuit is without merit and intend to continue vigorously defending against the claims. Qsymia ANDA Litigation On May 7, 2014, the Company received a Paragraph IV certification notice from Actavis Laboratories FL indicating that it filed an abbreviated new drug application, or ANDA, with the U.S. Food and Drug Administration, or FDA, requesting approval to market a generic version of Qsymia and contending that the patents listed for Qsymia in the FDA Orange Book at the time the notice was received (U.S. Patents 7,056,890, 7,553,818, 7,659,256, 7,674,776, 8,580,298, and 8,580,299 (collectively “patents-in-suit”)) are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale of a generic form of Qsymia as described in their ANDA. On June 12, 2014, the Company filed a lawsuit in the U.S. District Court for the District of New Jersey against Actavis Laboratories FL, Inc., Actavis, Inc., and Actavis PLC, collectively referred to as Actavis. The lawsuit (Case No. 14-3786 (SRC)(CLW)) was filed on the basis that Actavis’ submission of their ANDA to obtain approval to manufacture, use, sell or offer for sale generic versions of Qsymia prior to the expiration of the patents-in-suit constitutes infringement of one or more claims of those patents. In accordance with the Hatch-Waxman Act, as a result of having filed a timely lawsuit against Actavis, FDA approval of Actavis’ ANDA will be stayed until the earlier of (i) up to 30 months from the Company’s May 7, 2014 receipt of Actavis’ Paragraph IV certification notice (i.e. November 7, 2016) or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed. On January 21, 2015, the Company received a second Paragraph IV certification notice from Actavis contending that two additional patents listed in the Orange Book for Qsymia (U.S. Patents 8,895,057 and 8,895,058) are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale, or offer for sale of a generic form of Qsymia. On March 4, 2015, the Company filed a second lawsuit in the U.S. District Court for the District of New Jersey against Actavis (Case No. 15-1636 (SRC)(CLW)) in response to the second Paragraph IV certification notice on the basis that Actavis’ submission of their ANDA constitutes infringement of one or more claims of the patents-in-suit. On July 7, 2015, the Company received a third Paragraph IV certification notice from Actavis contending that two additional patents listed in the Orange Book for Qsymia (U.S. Patents 9,011,905 and 9,011,906) are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale, or offer for sale of a generic form of Qsymia. On August 17, 2015, the Company filed a third lawsuit in the U.S. District Court for the District of New Jersey against Actavis (Case No. 15-6256 (SRC)(CLW)) in response to the third Paragraph IV certification notice on the basis that Actavis’ submission of their ANDA constitutes infringement of one or more claims of the patents-in-suit. The three lawsuits against Actavis have been consolidated into a single suit (Case No. 14-3786 (SRC)(CLW)). On July 20, 2016, the U.S. District Court for the District of New Jersey issued a claim construction (Markman) ruling governing the suit. The Court adopted the Company’s proposed constructions for all but one of the disputed claim terms and adopted a compromise construction that was acceptable to the Company for the final claim term. Expert discovery is ongoing and no trial date has been scheduled. On March 5, 2015, the Company received a Paragraph IV certification notice from Teva Pharmaceuticals USA, Inc. indicating that it filed an ANDA with the FDA, requesting approval to market a generic version of Qsymia and contending that eight patents listed for Qsymia in the Orange Book at the time of the notice (U.S. Patents 7,056,890, 7,553,818, 7,659,256, 7,674,776, 8,580,298, 8,580,299, 8,895,057 and 8,895,058) (collectively “patents-in-suit”) are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of a generic form of Qsymia as described in their ANDA. On April 15, 2015, the Company filed a lawsuit in the U.S. District Court for the District of New Jersey against Teva Pharmaceutical USA, Inc. and Teva Pharmaceutical Industries, Ltd., collectively referred to as Teva. The lawsuit (Case No. 15-2693 (SRC)(CLW)) was filed on the basis that Teva’s submission of their ANDA to obtain approval to manufacture, use, sell, or offer for sale generic versions of Qsymia prior to the expiration of the patents-in-suit constitutes infringement of one or more claims of those patents. In accordance with the Hatch-Waxman Act, as a result of having filed a timely lawsuit against Teva, FDA approval of Teva’s ANDA will be stayed until the earlier of (i) up to 30 months from our March 5, 2015 receipt of Teva’s Paragraph IV certification notice (i.e. September 5, 2017) or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed. On August 5, 2015, the Company received a second Paragraph IV certification notice from Teva contending that two additional patents listed in the Orange Book for Qsymia (U.S. Patents 9,011,905 and 9,011,906) are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale, or offer for sale of a generic form of Qsymia. On September 18, 2015, the Company filed a second lawsuit in the U.S. District Court for the District of New Jersey against Teva (Case No. 15-6957(SRC)(CLW)) in response to the second Paragraph IV certification notice on the basis that Teva’s submission of their ANDA constitutes infringement of one or more claims of the patents-in-suit. The two lawsuits against Teva have been consolidated into a single suit (Case No. 15-2693 (SRC)(CLW)). On July 20, 2016, the U.S. District Court for the District of New Jersey issued a claim construction (Markman) ruling governing the suit. The Court adopted the Company’s proposed constructions for all but one of the disputed claim terms and adopted a compromise construction that was acceptable to the Company for the final claim term. On September 27, 2016, Dr. Reddy’s Laboratories, S.A. and Dr. Reddy’s Laboratories, Inc., collectively referred to as DRL, were substituted for Teva as defendants in the lawsuit as a result of Teva’s transfer to DRL of ownership and all rights in the ANDA that is the subject of the lawsuit. Fact discovery is ongoing and no trial date has been scheduled. STENDRA ANDA Litigation On June 20, 2016, the Company received a Paragraph IV certification notice from Hetero USA, Inc. indicating that it filed an ANDA with the FDA, requesting approval to market a generic version of STENDRA and contending that patents listed for STENDRA in the Orange Book at the time of the notice (U.S. Patents 6,656,935, and 7,501,409) (collectively “patents-in-suit”) are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of a generic form of STENDRA as described in their ANDA. On July 27, 2016, the Company filed a lawsuit in the U.S. District Court for the District of New Jersey against Hetero USA, Inc. and Hetero Labs Limited, collectively referred to as Hetero. The lawsuit (Case No. 16-4560 (KSH)(CLW)) was filed on the basis that Hetero’s submission of their ANDA to obtain approval to manufacture, use, sell, or offer for sale generic versions of STENDRA prior to the expiration of the patents-in-suit constitutes infringement of one or more claims of those patents. In accordance with the Hatch-Waxman Act, as a result of having filed a timely lawsuit against Hetero, FDA approval of Hetero’s ANDA will be stayed until the earlier of (i) up to 30 months from the expiration of STENDRA’s New Chemical Entity, or NCE, exclusivity period (i.e. October 27, 2019) or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed. The Company intends to vigorously enforce its intellectual property rights relating to Qsymia and STENDRA, but the Company cannot predict the outcome of these matters. The Company is not aware of any other asserted or unasserted claims against it where it believes that an unfavorable resolution would have an adverse material impact on the operations or financial position of the Company. |
SEGMENT INFORMATION
SEGMENT INFORMATION | 9 Months Ended |
Sep. 30, 2016 | |
SEGMENT INFORMATION | |
SEGMENT INFORMATION | 17. SEGMENT INFORMATION The Company operates in one reportable segment—the development and commercialization of novel therapeutic products. The Company has identified its Chief Executive Officer as the Chief Operating Decision Maker, or CODM, who manages the Company’s operations on a consolidated basis for purposes of allocating resources. When evaluating financial performance, the CODM reviews individual customer and product information, while other financial information is reviewed on a consolidated basis. Therefore, results of operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. Disclosures about revenues by product and by geographic area are presented below. Geographic Information Outside the United States, or ROW, the Company sells avanafil (STENDRA/SPEDRA) through a commercialization licensee principally in the EU. The geographic classification of product sales was based on the location of the customer. The geographic classification of supply, license and milestone revenue was based on the domicile of the entity from which the revenue was earned. Net product revenue by geographic region was as follows (in thousands): Three Months Ended September 30, 2016 2015 U.S. ROW Total U.S. ROW Total Qsymia—Net product revenue $ $ — $ $ $ — $ STENDRA/SPEDRA—License and milestone revenue — — — — — — STENDRA/SPEDRA—Supply revenue — — — STENDRA/SPEDRA —Royalty revenue Total revenue $ $ (1) $ $ $ (2) $ Nine Months Ended September 30, 2016 2015 U.S. ROW Total U.S. ROW Total Qsymia—Net product revenue $ $ — $ $ $ — $ STENDRA/SPEDRA—License and milestone revenue — — — — STENDRA/SPEDRA—Supply revenue — STENDRA/SPEDRA —Royalty revenue Total revenue $ $ (3) $ $ $ (4) $ (1) $0.6 million of which was attributable to Germany. (2) $5.6 million of which was attributable to Germany. (3) $3.3 million of which was attributable to Germany. (4) $23.1 million of which was attributable to Germany. |
BASIS OF PRESENTATION (Policies
BASIS OF PRESENTATION (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
BASIS OF PRESENTATION | |
Retrospective Application | Implementation of ASU 2015-03 In April 2015, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs . The standard requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The Company adopted this standard as required beginning in the first quarter of 2016 and retrospectively applied this standard to the balance sheet as of December 31, 2015. The amounts impacted by the adoption of this standard are as follows: As Reported December 31, 2015 Adjustment to reflect ASU 2015-03 As Adjusted December 31, 2015 Prepaid expenses and other assets $ $ $ Total current assets $ $ $ Non-current assets $ $ $ Total assets $ $ $ Long-term debt, current portion $ $ $ Total current liabilities $ $ $ Long-term debt, net of current portion $ $ $ Total liabilities $ $ $ Total liabilities and stockholders’ equity $ $ $ |
Use of Estimates | Use of Estimates The preparation of these unaudited condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. On an ongoing basis, the Company evaluates its estimates, including critical accounting policies or estimates related to available-for-sale securities, debt instruments, research and development expenses, income taxes, inventories, revenues, contingencies and litigation and share-based compensation. The Company bases its estimates on historical experience, information received from third parties and on various market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ significantly from those estimates under different assumptions or conditions. |
Significant Accounting Policies | Significant Accounting Policies Other than the implementation of ASU 2015-03 discussed above, there have been no changes to the Company’s significant accounting policies since the Company’s Annual Report on Form 10-K for the year ended December 31, 2015. |
Available-for-Sale Securities | As of September 30, 2016, the Company’s available-for-sale securities had original contractual maturities up to 57 months. However, in response to changes in the availability of and the yield on alternative investments as well as liquidity requirements, the Company may sell these securities prior to their stated maturities. As these securities are readily marketable and are viewed by the Company as available to support current operations, securities with maturities beyond 12 months are classified as current assets. Due to their short-term maturities, the Company believes that the fair value of its bank deposits, accounts payable and accrued expenses approximate their carrying value. |
Inventories | Inventories are stated at the lower of cost or market. Cost is determined using the first in, first out method for all inventories, which are valued using a weighted-average cost method calculated for each production batch. The Company periodically evaluates the carrying value of inventory on hand for potential excess amounts over demand using the same lower of cost or market approach as that used to value the inventory |
Income Taxes | The Company’s policy is to recognize interest and penalties related to uncertain tax positions (if any) as a component of the income tax provision. |
Net Loss Per Share | The Company computes basic net income (loss) per share applicable to common stockholders based on the weighted average number of common shares outstanding during the applicable period. Diluted net income per share is based on the weighted average number of common and common equivalent shares, which represent shares that may be issued in the future upon the exercise of outstanding stock options or upon a net share settlement of the Company’s Convertible Notes. Common share equivalents are excluded from the computation in periods in which they have an anti-dilutive effect. Stock options for which the price exceeds the average market price over the period have an anti-dilutive effect on net income per share and, accordingly, are excluded from the calculation. The triggering conversion conditions that allow holders of the Convertible Notes to convert have not been met. If such conditions are met and the note holders opt to convert, the Company may choose to pay in cash, common stock, or a combination thereof; however, if this occurs, the Company has the intent and ability to net share settle this debt security; thus the Company uses the treasury stock method for earnings per share purposes. Due to the effect of the capped call instrument purchased in relation to the Convertible Notes, there would be no net shares issued until the market value of the Company’s stock exceeds $20 per share, and thus no impact on diluted net income per share. Further, when there is a net loss, potentially dilutive common equivalent shares are not included in the calculation of net loss per share since their inclusion would be anti-dilutive. As the Company recognized a net loss for each of the three and nine month periods ended September 30, 2016 and 2015, all potential common equivalent shares were excluded for these periods as they were anti-dilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases (Topic 842), which modifies the accounting by lessees for all leases with a term greater than 12 months. The standard will require lessees to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. For public companies, the standard is effective for annual and interim periods beginning on or after December 15, 2018 and must be applied retrospectively. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements. In March 2016, the FASB issued Accounting Standards Update 2016-09, Improvements to Employee Share-Based Payment Accounting , which is designed to simplify several aspects of accounting for share-based payment award transactions, including income tax consequences, classification of awards as either equity or liabilities, classification on the statement of cash flows and forfeiture rate calculations. For public companies, the standard is effective for annual and interim periods beginning on or after December 15, 2016. Early adoption is permitted. The Company is currently evaluating the impact of this guidance on its consolidated financial statements. |
BASIS OF PRESENTATION (Tables)
BASIS OF PRESENTATION (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
BASIS OF PRESENTATION | |
Summary of Amounts impacted by the Adoption of New Accounting Standard | As Reported December 31, 2015 Adjustment to reflect ASU 2015-03 As Adjusted December 31, 2015 Prepaid expenses and other assets $ $ $ Total current assets $ $ $ Non-current assets $ $ $ Total assets $ $ $ Long-term debt, current portion $ $ $ Total current liabilities $ $ $ Long-term debt, net of current portion $ $ $ Total liabilities $ $ $ Total liabilities and stockholders’ equity $ $ $ |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
SHARE-BASED COMPENSATION. | |
Schedule of share-based compensation expense | Total share-based compensation expense for all of the Company’s share-based awards was as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2016 2015 2016 2015 Cost of goods sold $ $ $ $ Selling, general and administrative Research and development Non-recurring charges — — Total share-based compensation expense $ $ $ $ |
CASH, CASH EQUIVALENTS, AND A27
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES | |
Schedule of fair value and amortized cost of cash, cash equivalents, and available-for-sale securities by major security type | As of September 30, 2016 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents and available-for-sale securities Cost Gains Losses Fair Value Cash and money market funds $ $ — $ — $ U.S. Treasury securities Corporate debt securities Total Less amounts classified as cash and cash equivalents — — Total available-for-sale securities $ $ $ $ As of December 31, 2015 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents and available-for-sale securities Cost Gains Losses Fair Value Cash and money market funds $ $ — $ — $ U.S. Treasury securities — Corporate debt securities Total Less amounts classified as cash and cash equivalents — — Total available-for-sale securities $ $ $ $ |
Schedule of Fair Value of Separate Accounts by Major Category of Investment | The following table represents the fair value hierarchy for our cash equivalents and available-for-sale securities by major security type as of September 30, 2016 and December 31, 2015 (in thousands): As of September 30, 2016 Level 1 Level 2 Level 3 Total Cash and money market funds $ $ — $ — $ U.S. Treasury securities — — Corporate debt securities — — Total $ $ $ — $ As of December 31, 2015 Level 1 Level 2 Level 3 Total Cash and money market funds $ $ — $ — $ U.S. Treasury securities — — Corporate debt securities — — Total $ $ $ — $ |
ACCOUNTS RECEIVABLE (Tables)
ACCOUNTS RECEIVABLE (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
ACCOUNTS RECEIVABLE | |
Schedule of accounts receivable | Accounts receivable consist of the following (in thousands): Balance as of September 30, December 31, 2016 2015 Qsymia $ $ STENDRA/SPEDRA Qsymia allowance for cash discounts Net $ $ |
INVENTORIES (Tables)
INVENTORIES (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
INVENTORIES | |
Schedule of inventories | Inventories consist of the following (in thousands): Balance as of September 30, December 31, 2016 2015 Raw materials $ $ Work-in-process Finished goods Deferred costs Inventories $ $ |
PREPAID EXPENSES AND OTHER AS30
PREPAID EXPENSES AND OTHER ASSETS (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
PREPAID EXPENSES AND OTHER ASSETS | |
Schedule of prepaid expenses and other assets | Prepaid expenses and other current assets consist of the following (in thousands): Balance as of September 30, December 31, 2016 2015 Prepaid sales and marketing expenses $ $ Prepaid insurance Other prepaid expenses and assets Total $ $ |
ACCRUED AND OTHER LIABILITIES (
ACCRUED AND OTHER LIABILITIES (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
ACCRUED AND OTHER LIABILITIES | |
Schedule of accrued and other liabilities | Accrued and other liabilities consist of the following (in thousands): Balance as of September 30, December 31, 2016 2015 Accrued employee compensation and benefits $ $ Accrued non-recurring charges (see Note 10) Accrued interest on debt (see Note 13) Accrued manufacturing costs Other accrued liabilities Total $ $ |
INVENTORY IMPAIRMENT AND OTHE32
INVENTORY IMPAIRMENT AND OTHER NON-RECURRING CHARGES (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
INVENTORY IMPAIRMENT AND OTHER NON-RECURRING CHARGES | |
Schedule of activity for the cost reduction plan (the restructuring accrual) | The following table sets forth activities for the Company’s cost reduction plan obligations (in thousands): Facilities- Severance related obligations obligations Total Balance of accrued costs at December 31, 2015 $ $ $ Charges — — — Payments Balance of accrued costs at March 31, 2016 Charges — — — Payments Balance of accrued costs at June 30, 2016 Charges — — — Reclassifications Payments Balance of accrued costs at September 30, 2016 $ $ — $ |
Schedule of balance of the accrued employee severance and facilities-related costs anticipated to be paid out | The balance of the accrued employee severance and facilities-related costs at September 30, 2016 is anticipated to be paid out as follows (in thousands): 2016 (remaining three months) $ 2017 $ |
LONG-TERM DEBT AND COMMITTMENTS
LONG-TERM DEBT AND COMMITTMENTS (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
LONG-TERM DEBT AND COMMITMENTS | |
Schedule of debt | Debt is as follows (in thousands): September 30, 2016 Principal amount of Convertible Senior Notes due 2020 $ Principal amount of Senior Secured Notes due 2018 Less: Debt issuance costs Less: Discount on convertible senior notes Less: Current portion Long-term debt, net of current portion $ Future estimated payments on the Senior Secured Notes as of September 30, 2016 are as follows: 2016 (remaining three months) $ 2017 2018 Total Less: Interest portion Senior Secured Notes $ |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
SEGMENT INFORMATION | |
Schedule of net product revenue by geographic region | Net product revenue by geographic region was as follows (in thousands): Three Months Ended September 30, 2016 2015 U.S. ROW Total U.S. ROW Total Qsymia—Net product revenue $ $ — $ $ $ — $ STENDRA/SPEDRA—License and milestone revenue — — — — — — STENDRA/SPEDRA—Supply revenue — — — STENDRA/SPEDRA —Royalty revenue Total revenue $ $ (1) $ $ $ (2) $ Nine Months Ended September 30, 2016 2015 U.S. ROW Total U.S. ROW Total Qsymia—Net product revenue $ $ — $ $ $ — $ STENDRA/SPEDRA—License and milestone revenue — — — — STENDRA/SPEDRA—Supply revenue — STENDRA/SPEDRA —Royalty revenue Total revenue $ $ (3) $ $ $ (4) $ (1) $0.6 million of which was attributable to Germany. (2) $5.6 million of which was attributable to Germany. (3) $3.3 million of which was attributable to Germany. (4) $23.1 million of which was attributable to Germany. |
BASIS OF PRESENTATION (Details)
BASIS OF PRESENTATION (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Prepaid Expense and Other Assets, Current | $ 5,552 | $ 9,430 |
Assets, Current | 310,692 | 273,592 |
Assets Noncurrent Excluding Property Plant And Equipment | 1,744 | 2,616 |
Assets | 313,151 | 277,202 |
Long-term Debt, Current Maturities | 9,015 | 14,356 |
Liabilities, Current | 114,527 | 59,449 |
Long-term Debt, Excluding Current Maturities | 229,876 | 217,034 |
Liabilities | 351,264 | 284,287 |
Liabilities and Equity | $ 313,151 | 277,202 |
Accounting Standards Update 2015-03 [Member] | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Prepaid Expense and Other Assets, Current | (1,194) | |
Assets, Current | (1,194) | |
Assets Noncurrent Excluding Property Plant And Equipment | (2,185) | |
Assets | (3,379) | |
Long-term Debt, Current Maturities | (1,194) | |
Liabilities, Current | (1,194) | |
Long-term Debt, Excluding Current Maturities | (2,185) | |
Liabilities | (3,379) | |
Liabilities and Equity | (3,379) | |
Scenario, Previously Reported [Member] | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Prepaid Expense and Other Assets, Current | 10,624 | |
Assets, Current | 274,786 | |
Assets Noncurrent Excluding Property Plant And Equipment | 4,801 | |
Assets | 280,581 | |
Long-term Debt, Current Maturities | 15,550 | |
Liabilities, Current | 60,643 | |
Long-term Debt, Excluding Current Maturities | 219,219 | |
Liabilities | 287,666 | |
Liabilities and Equity | $ 280,581 |
SHARE-BASED COMPENSATION (Detai
SHARE-BASED COMPENSATION (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-Based Compensation Expense | ||||
Share-based compensation | $ 641,000 | $ 256,000 | $ 1,740,000 | $ 3,032,000 |
Cost of goods sold | ||||
Share-Based Compensation Expense | ||||
Share-based compensation | 40,000 | 34,000 | 115,000 | 86,000 |
Selling, general and administrative | ||||
Share-Based Compensation Expense | ||||
Share-based compensation | 413,000 | 207,000 | 1,299,000 | 2,550,000 |
Research and development | ||||
Share-Based Compensation Expense | ||||
Share-based compensation | 188,000 | (49,000) | 326,000 | 332,000 |
Inventory | ||||
Share-Based Compensation Expense | ||||
Total share-based compensation cost capitalized as part of cost of inventory | $ 19,000 | 11,000 | $ 26,000 | 35,000 |
Non-recurring charges | ||||
Share-Based Compensation Expense | ||||
Share-based compensation | $ 64,000 | $ 64,000 |
CASH, CASH EQUIVALENTS, AND A37
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES (Fair Value of Cash, Cash Equivalents, and Available-For-Sale Securities) (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Sep. 30, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Dec. 31, 2014 | |
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||||
Cash and Cash Equivalents, at Carrying Value | $ 154,137 | $ 95,395 | $ 79,496 | $ 83,174 |
Available-for-sale Debt Securities, Amortized Cost Basis, Total | 129,241 | 146,430 | ||
Available-for-sale securities including cash and cash equivalents, Amortized Cost | 283,378 | 241,825 | ||
Less amounts classified as cash equivalents, Amortized Cost | (154,137) | (95,395) | (79,496) | (83,174) |
Available-for-sale securities, Gross Unrealized Gains | 249 | 20 | ||
Available-for-sale securities, Gross Unrealized Losses | (41) | (282) | ||
Available-for-sale Securities, Debt Securities, Current | 129,449 | 146,168 | ||
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||||
Cash and Cash Equivalents, Fair Value Disclosure | 154,137 | 95,395 | ||
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 283,586 | 241,563 | ||
Less amounts classified as cash equivalents, Estimated Fair Value | (154,137) | (95,395) | ||
Available-for-sale Securities, Debt Securities, Current | $ 129,449 | 146,168 | ||
Maximum original contractual maturities of available for sale securities | 57 months | |||
Cash and money market funds | $ 154,137 | 95,395 | $ 79,496 | $ 83,174 |
Cash and Cash Equivalents, Fair Value Disclosure | 154,137 | 95,395 | ||
U.S. Treasury securities | ||||
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||||
Available-for-sale Debt Securities, Amortized Cost Basis, Total | 28,223 | 84,734 | ||
Available-for-sale securities, Gross Unrealized Gains | 13 | 0 | ||
Available-for-sale securities, Gross Unrealized Losses | (1) | (107) | ||
Available-for-sale Securities, Debt Securities, Current | 28,235 | 84,627 | ||
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||||
Available-for-sale Securities, Debt Securities, Current | 28,235 | 84,627 | ||
Corporate Debt Securities [Member] | ||||
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||||
Available-for-sale Debt Securities, Amortized Cost Basis, Total | 101,018 | 61,696 | ||
Available-for-sale securities, Gross Unrealized Gains | 236 | 20 | ||
Available-for-sale securities, Gross Unrealized Losses | (40) | (175) | ||
Available-for-sale Securities, Debt Securities, Current | 101,214 | 61,541 | ||
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||||
Available-for-sale Securities, Debt Securities, Current | 101,214 | 61,541 | ||
Cash and money market funds | ||||
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||||
Cash and Cash Equivalents, at Carrying Value | 154,137 | 95,395 | ||
Less amounts classified as cash equivalents, Amortized Cost | (154,137) | (95,395) | ||
Available-for-sale securities, Gross Unrealized Losses | 0 | |||
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||||
Cash and Cash Equivalents, Fair Value Disclosure | 154,137 | 95,395 | ||
Less amounts classified as cash equivalents, Estimated Fair Value | (154,137) | (95,395) | ||
Cash and money market funds | 154,137 | 95,395 | ||
Cash and Cash Equivalents, Fair Value Disclosure | $ 154,137 | $ 95,395 |
CASH, CASH EQUIVALENTS, AND A38
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES (Fair Value Hierarchy for Cash Equivalents and Available-For-Sale Securities) (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Fair value measurements | ||
Cash and Cash Equivalents, Fair Value Disclosure | $ 154,137 | $ 95,395 |
Available-for-sale Securities, Debt Securities, Current | 129,449 | 146,168 |
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 283,586 | 241,563 |
U.S. Treasury securities | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 28,235 | 84,627 |
Corporate Debt Securities [Member] | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 101,214 | 61,541 |
Level 1 | ||
Fair value measurements | ||
Cash and Cash Equivalents, Fair Value Disclosure | 154,137 | 95,395 |
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 182,372 | 180,022 |
Level 1 | U.S. Treasury securities | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 28,235 | 84,627 |
Level 1 | Corporate Debt Securities [Member] | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 0 | 0 |
Level 2 | ||
Fair value measurements | ||
Cash and Cash Equivalents, Fair Value Disclosure | 0 | 0 |
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 101,214 | 61,541 |
Level 2 | U.S. Treasury securities | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 0 | 0 |
Level 2 | Corporate Debt Securities [Member] | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 101,214 | 61,541 |
Level 3 | ||
Fair value measurements | ||
Cash and Cash Equivalents, Fair Value Disclosure | 0 | 0 |
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 0 | 0 |
Level 3 | U.S. Treasury securities | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | 0 | 0 |
Level 3 | Corporate Debt Securities [Member] | ||
Fair value measurements | ||
Available-for-sale Securities, Debt Securities, Current | $ 0 | $ 0 |
ACCOUNTS RECEIVABLE (Details)
ACCOUNTS RECEIVABLE (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2015 | |
Accounts Receivable, Gross, Current | $ 10,461 | $ 9,160 |
Qsymia allowance for cash discounts | (166) | (163) |
Accounts Receivable, Net, Current | 10,295 | 8,997 |
Qsymia | ||
Accounts Receivable, Gross, Current | 9,216 | 8,508 |
STENDRA/SPEDRA | ||
Accounts Receivable, Gross, Current | $ 1,245 | $ 652 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Jun. 30, 2015 | Sep. 30, 2016 | Dec. 31, 2015 | |
Inventory balances | |||
Raw materials | $ 7,587 | $ 8,645 | |
Work in process | 1,112 | 247 | |
Finished goods | 2,013 | 4,282 | |
Deferred costs | 547 | 428 | |
Total | $ 11,259 | $ 13,602 | |
Qsymia | |||
Inventory balances | |||
Total charge for inventories on hand in excess of demand | $ 29,500 |
PREPAID EXPENSES AND OTHER AS41
PREPAID EXPENSES AND OTHER ASSETS (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
PREPAID EXPENSES AND OTHER ASSETS | ||
Prepaid sales and marketing expenses | $ 2,576 | $ 3,434 |
Prepaid insurance | 179 | 1,124 |
Other prepaid expenses and assets | 2,797 | 4,872 |
Total | $ 5,552 | $ 9,430 |
ACCRUED AND OTHER LIABILITIES42
ACCRUED AND OTHER LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
ACCRUED AND OTHER LIABILITIES | ||
Accrued employee compensation and benefits | $ 2,576 | $ 3,621 |
Accrued non-recurring charges (see Note 10) | 12 | 503 |
Accrued interest on debt (see Note 13) | 1,917 | 1,293 |
Accrued manufacturing costs | 686 | 5,408 |
Other accrued liabilities | 4,753 | 5,066 |
Total | $ 9,944 | $ 15,891 |
INVENTORY IMPAIRMENT AND OTHE43
INVENTORY IMPAIRMENT AND OTHER NON-RECURRING CHARGES (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Sep. 30, 2015USD ($)employee | Jun. 30, 2015USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($)employee | Sep. 30, 2016USD ($) | Dec. 31, 2015USD ($) | |
Non-Recurring Charges | |||||||||
Restructuring, Settlement and Impairment Provisions | $ 2,539 | $ 32,061 | |||||||
Total inventory impairment and other non-recurring expense | 2,539 | 32,061 | |||||||
Non-recurring charges | $ 0 | $ 0 | |||||||
Activity for the Company's cost reduction plan obligations | |||||||||
Balance of accrued costs at the end of the period | 706 | $ 739 | $ 881 | 881 | |||||
Charges | 0 | ||||||||
Payments | (24) | (33) | (142) | ||||||
Reclassifications | (670) | ||||||||
Balance of accrued costs at the end of the period | 12 | 706 | 739 | 12 | |||||
Additional disclosures | |||||||||
Accrued severance and facilities-related costs, Current | $ 12 | $ 503 | |||||||
Restructuring accrual anticipated to be paid out | |||||||||
2016 (remaining three months) | 7 | ||||||||
2,019 | 5 | ||||||||
Total | 706 | 739 | 881 | 881 | 12 | 881 | |||
July 2015 Restructuring Plan member | |||||||||
Non-Recurring Charges | |||||||||
Employee severance and related costs | 2,500 | 2,500 | |||||||
Share-based compensation (see Note 15) | $ 36 | $ 36 | |||||||
Number of employees reduced | employee | 60 | 60 | |||||||
Employee severance costs | |||||||||
Activity for the Company's cost reduction plan obligations | |||||||||
Balance of accrued costs at the end of the period | 287 | 294 | 410 | 410 | |||||
Charges | 0 | ||||||||
Payments | (7) | (7) | (116) | ||||||
Reclassifications | (268) | ||||||||
Balance of accrued costs at the end of the period | 12 | 287 | 294 | 12 | |||||
Restructuring accrual anticipated to be paid out | |||||||||
Total | 287 | 294 | 410 | 410 | $ 12 | 410 | |||
Facilities-related costs | |||||||||
Activity for the Company's cost reduction plan obligations | |||||||||
Balance of accrued costs at the end of the period | 419 | 445 | 471 | 471 | |||||
Charges | 0 | ||||||||
Payments | (17) | (26) | (26) | ||||||
Reclassifications | (402) | ||||||||
Balance of accrued costs at the end of the period | 419 | 445 | |||||||
Restructuring accrual anticipated to be paid out | |||||||||
Total | $ 419 | $ 445 | $ 471 | $ 471 | $ 471 | ||||
Qsymia | |||||||||
Non-Recurring Charges | |||||||||
Inventory impairment (see Note 4) | $ 29,500 | ||||||||
Nonrecurring transaction | Qsymia | |||||||||
Non-Recurring Charges | |||||||||
Restructuring, Settlement and Impairment Provisions | $ 29,500 | ||||||||
Total inventory impairment and other non-recurring expense | $ 29,500 |
DEFERRED REVENUE (Details)
DEFERRED REVENUE (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
DEFERRED REVENUE | ||
Current deferred revenue | $ 89,128 | $ 22,142 |
Non-Current deferred revenue | 6,845 | 6,508 |
Qsymia | ||
DEFERRED REVENUE | ||
Current deferred revenue | 17,566 | 19,275 |
STENDRA/SPEDRA | ||
DEFERRED REVENUE | ||
Current deferred revenue | 71,562 | 2,867 |
Non-Current deferred revenue | $ 6,845 | $ 6,508 |
LICENSE, COMMERCIALIZATION AN45
LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENTS (Details) $ in Millions | Sep. 30, 2016 | Jul. 05, 2013item | Sep. 30, 2016USD ($) |
STENDRA/SPEDRA | Metuchen | |||
License, Commercialization, and Development Agreements with Third Parties | |||
Prepayment received for future royalties | $ | $ 70 | ||
License and commercialization agreement | SPEDRA | Menarini Group | Minimum | |||
License, Commercialization, and Development Agreements with Third Parties | |||
Number of European countries covered under the license agreement | item | 40 | ||
Supply agreement | STENDRA/SPEDRA | Metuchen | |||
License, Commercialization, and Development Agreements with Third Parties | |||
Initial term | 5 years | ||
Additional period of auto-renewal | 2 years | ||
Supply agreement | STENDRA/SPEDRA | Metuchen | Minimum | |||
License, Commercialization, and Development Agreements with Third Parties | |||
Termination notice of license and supply agreement | 2 years |
LONG-TERM DEBT AND COMMITMENTS
LONG-TERM DEBT AND COMMITMENTS (Narrative) (Details) - USD ($) | May 29, 2013 | Apr. 09, 2013 | Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | May 21, 2013 |
FDA Approval Qsymia (PMR and CVOT) Member | |||||||
Long-term debt | |||||||
Contractual Obligation Term | 5 years | ||||||
Minimum | FDA Approval Qsymia (PMR and CVOT) Member | |||||||
Long-term debt | |||||||
Contractual Obligation | $ 180,000,000 | $ 180,000,000 | |||||
Maximum | FDA Approval Qsymia (PMR and CVOT) Member | |||||||
Long-term debt | |||||||
Contractual Obligation | 220,000,000 | 220,000,000 | |||||
Convertible Senior Notes Due 2020 | |||||||
Long-term debt | |||||||
Offering amount | $ 220,000,000 | ||||||
Interest rate (as a percent) | 4.50% | ||||||
Increase in debt instrument face amount | $ 30,000,000 | ||||||
Conversion price per share (in dollars per share) | $ 14.86 | ||||||
Net proceeds from offering | $ 241,800,000 | ||||||
Total interest expense recognized | 7,500,000 | $ 6,900,000 | 22,100,000 | $ 20,200,000 | |||
Amortization of debt discount | 4,400,000 | 4,000,000 | 13,000,000 | 11,900,000 | |||
Amortization of deferred financing costs | 235,000 | 215,000 | 689,000 | 630,000 | |||
Senior Secured Notes Due 2018 | |||||||
Long-term debt | |||||||
Total interest expense recognized | 1,300,000 | 1,500,000 | 3,600,000 | 4,900,000 | |||
Amortization of deferred financing costs | $ 46,000 | $ 94,000 | $ 189,000 | $ 306,000 | |||
Amount received | $ 50,000,000 | ||||||
Amount received in funding and facility payments | $ 500,000 | ||||||
Amount due as a percentage of net sales, if scheduled quarterly payments are less than 25% of the net sales | 25.00% | 25.00% | |||||
Make-whole premium ratio | 1.03 | 1.03 |
LONG-TERM DEBT AND COMMITMENT47
LONG-TERM DEBT AND COMMITMENTS (Schedule of Debt) (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Dec. 31, 2015 | |
Long-term debt | ||
Senior Secured Notes | $ 284,643 | |
Less: Debt issuance costs | (2,501) | |
Less: Discount on convertible senior notes | (43,251) | |
Net carrying value | 238,891 | |
Less: Current Portion | (9,015) | $ (14,356) |
Long-term debt, net of current portion | 229,876 | $ 217,034 |
Convertible Senior Notes Due 2020 | ||
Long-term debt | ||
Senior Secured Notes | 250,000 | |
Senior Secured Notes Due 2018 | ||
Long-term debt | ||
Senior Secured Notes | 34,643 | |
2016 (remaining three months) | 8,875 | |
2,017 | 23,750 | |
2,018 | 38,376 | |
Total | 71,001 | |
Less: Interest portion | $ (36,358) |
NET INCOME (LOSS) PER SHARE (De
NET INCOME (LOSS) PER SHARE (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Net income (loss) per share. | ||||
Equivalent shares of options excluded from computation of diluted net income (loss) per share because anti-dilutive effect | 10,261,000 | 6,958,000 | 10,520,000 | 7,582,000 |
Convertible Senior Notes Due 2020 | ||||
Net income (loss) per share. | ||||
Net shares issued | 0 | |||
Minimum stock price to trigger conversion of debt (in dollars per share) | $ 20 | |||
Convertible Senior Notes Due 2020 | Convertible Common Stock | ||||
Net income (loss) per share. | ||||
Dilutive Securities impact on diluted net income (in dollars per share) | $ 0 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
INCOME TAXES | ||||
Income Tax Expense (Benefit) | $ (9,000) | $ 1,000 | $ 14,000 | $ 13,000 |
Unrecognized Tax Benefits | $ 66,000 | $ 66,000 |
LEGAL MATTERS (Details)
LEGAL MATTERS (Details) $ in Millions | Jul. 27, 2016 | Aug. 05, 2015item | Jul. 07, 2015item | Jun. 18, 2015item | Mar. 25, 2015 | Mar. 05, 2015item | Jan. 21, 2015item | May 07, 2014 | Mar. 27, 2014USD ($)item |
Hetero USA Inc | |||||||||
LEGAL MATTERS | |||||||||
Period from receipt of certification notice until which FDA approval of ANDA will be stayed | 30 months | ||||||||
Period of stay of FDA approval of ANDA from receipt of certification notice | 30 months | ||||||||
Third Paragraph IV Certification Notice from Actavis Member | |||||||||
LEGAL MATTERS | |||||||||
Number of patents-in-suit | 2 | ||||||||
Gain Contingency, Patents Allegedly Infringed upon, Number | 2 | ||||||||
Second Paragraph IV Certification Notice from Actavis Member | |||||||||
LEGAL MATTERS | |||||||||
Number of patents-in-suit | 2 | ||||||||
Gain Contingency, Patents Allegedly Infringed upon, Number | 2 | ||||||||
Paragraph IV Certification Notice from Teva Pharmaceuticals Member | |||||||||
LEGAL MATTERS | |||||||||
Number of patents-in-suit | 8 | ||||||||
Gain Contingency, Patents Allegedly Infringed upon, Number | 8 | ||||||||
Actavis | |||||||||
LEGAL MATTERS | |||||||||
Period from receipt of certification notice until which FDA approval of ANDA will be stayed | 30 months | ||||||||
Period of stay of FDA approval of ANDA from receipt of certification notice | 30 months | ||||||||
Teva | |||||||||
LEGAL MATTERS | |||||||||
Number of patents-in-suit | 2 | ||||||||
Period from receipt of certification notice until which FDA approval of ANDA will be stayed | 30 months | ||||||||
Period of stay of FDA approval of ANDA from receipt of certification notice | 30 months | ||||||||
Gain Contingency, Patents Allegedly Infringed upon, Number | 2 | ||||||||
Securities fraud lawsuit | |||||||||
LEGAL MATTERS | |||||||||
Loss contingency, number of officers, defendants in lawsuit | 3 | ||||||||
Securities fraud lawsuit | Federal Leave To Amend Claims Member | |||||||||
LEGAL MATTERS | |||||||||
Loss Contingency, Claims Dismissed, Number | 2 | ||||||||
Securities fraud lawsuit | California Prejudice Claims Member | |||||||||
LEGAL MATTERS | |||||||||
Loss Contingency, Claims Dismissed, Number | 7 | ||||||||
Securities fraud lawsuit | Minimum | |||||||||
LEGAL MATTERS | |||||||||
Amount of damages sought | $ | $ 2.8 |
SEGMENT INFORMATION (Details)
SEGMENT INFORMATION (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($)segment | Sep. 30, 2015USD ($) | |
Geographic Information | ||||
Net product revenue | $ 12,294 | $ 14,011 | $ 37,455 | $ 40,652 |
License and milestone revenue | 11,574 | |||
Supply revenue | 10,056 | 1,526 | 26,651 | |
Royalty revenue | 1,059 | 869 | 3,472 | 1,210 |
Total revenue | 13,353 | 24,936 | $ 42,453 | 80,087 |
Number of Operating Segments | segment | 1 | |||
U.S. | ||||
Geographic Information | ||||
Total revenue | 12,719 | 19,338 | $ 39,104 | 56,906 |
ROW | ||||
Geographic Information | ||||
Total revenue | 634 | 5,598 | 3,349 | 23,181 |
Germany | ||||
Geographic Information | ||||
Total revenue | 600 | 5,600 | 3,300 | 23,100 |
Qsymia | ||||
Geographic Information | ||||
Net product revenue | 12,294 | 14,011 | 37,455 | 40,652 |
Qsymia | U.S. | ||||
Geographic Information | ||||
Net product revenue | 12,294 | 14,011 | 37,455 | 40,652 |
STENDRA/SPEDRA | ||||
Geographic Information | ||||
License and milestone revenue | 11,574 | |||
Supply revenue | 10,056 | 1,526 | 26,651 | |
Royalty revenue | 1,059 | 869 | 3,472 | 1,210 |
STENDRA/SPEDRA | U.S. | ||||
Geographic Information | ||||
Supply revenue | 5,020 | 16,602 | ||
Royalty revenue | 425 | 307 | 1,649 | (348) |
STENDRA/SPEDRA | ROW | ||||
Geographic Information | ||||
License and milestone revenue | 11,574 | |||
Supply revenue | 5,036 | 1,526 | 10,049 | |
Royalty revenue | $ 634 | $ 562 | $ 1,823 | $ 1,558 |