Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Nov. 06, 2017 | |
Document And Entity Information | ||
Entity Registrant Name | Retrophin, Inc. | |
Entity Central Index Key | 1,438,533 | |
Trading Symbol | rtrx | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 39,306,699 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2017 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 98,991,000 | $ 41,002,000 |
Marketable securities | 204,882,000 | 214,871,000 |
Accounts receivable, net | 14,543,000 | 18,510,000 |
Inventory, net | 4,318,000 | 2,826,000 |
Prepaid expenses and other current assets | 2,605,000 | 4,831,000 |
Prepaid taxes | 0 | 3,463,000 |
Note receivable, current | 0 | 46,849,000 |
Total current assets | 325,339,000 | 332,352,000 |
Property and equipment, net | 2,717,000 | 2,587,000 |
Other assets | 7,101,000 | 7,364,000 |
Intangible assets, net | 179,569,000 | 182,043,000 |
Goodwill | 936,000 | 936,000 |
Long term deferred tax asset | 4,848,000 | 0 |
Total assets | 520,510,000 | 525,282,000 |
Current liabilities: | ||
Accounts payable | 7,370,000 | 7,522,000 |
Accrued expenses | 32,253,000 | 33,308,000 |
Guaranteed minimum royalty | 2,000,000 | 2,000,000 |
Other current liabilities | 4,048,000 | 1,842,000 |
Business combination-related contingent consideration | 16,941,000 | 16,150,000 |
Tax payable | 1,152,000 | 0 |
Derivative financial instruments, warrants | 20,140,000 | 22,440,000 |
Total current liabilities | 83,904,000 | 83,262,000 |
Convertible debt | 44,911,000 | 44,422,000 |
Other non-current liabilities | 3,808,000 | 4,010,000 |
Guaranteed minimum royalty, less current portion | 7,393,000 | 8,068,000 |
Business combination-related contingent consideration, less current portion | 75,974,000 | 71,328,000 |
Deferred income tax liability, net | 0 | 6,425,000 |
Total liabilities | 215,990,000 | 217,515,000 |
Stockholders' Equity: | ||
Preferred stock $0.001 par value; 20,000,000 shares authorized; 0 issued and outstanding as of September 30, 2017 and December 31, 2016 | 0 | 0 |
Common stock $0.0001 par value; 100,000,000 shares authorized; 39,280,702 and 37,906,669 issued and outstanding as of September 30, 2017 and December 31, 2016, respectively | 4,000 | 4,000 |
Additional paid-in capital | 465,148,000 | 421,309,000 |
Accumulated deficit | (160,037,000) | (113,056,000) |
Accumulated other comprehensive loss | (595,000) | (490,000) |
Total stockholders' equity | 304,520,000 | 307,767,000 |
Total liabilities and stockholders' equity | $ 520,510,000 | $ 525,282,000 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock shares issued (in shares) | 39,280,702 | 37,906,669 |
Common stock shares outstanding (in shares) | 39,280,702 | 37,906,669 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Statement [Abstract] | ||||
Net product sales | $ 40,340 | $ 33,945 | $ 112,760 | $ 96,265 |
Operating expenses: | ||||
Cost of goods sold | 925 | 1,573 | 2,431 | 3,351 |
Research and development | 19,610 | 18,414 | 58,592 | 50,758 |
Selling, general and administrative | 24,852 | 23,466 | 74,683 | 65,714 |
Legal fee settlement | 0 | 5,212 | 2,000 | 5,212 |
Change in fair value of contingent consideration | 4,429 | 5,256 | 11,057 | 10,741 |
Restructuring | 1,132 | 396 | 2,611 | 481 |
Total operating expenses | 50,948 | 54,317 | 151,374 | 136,257 |
Operating loss | (10,608) | (20,372) | (38,614) | (39,992) |
Other income (expenses), net: | ||||
Other income, net | 557 | 151 | 1,065 | 156 |
Interest expense, net | (65) | (299) | (855) | (609) |
Change in fair value of derivative instruments | (8,901) | (10,126) | (8,921) | (4,849) |
Total other expense, net | (8,409) | (10,274) | (8,711) | (5,302) |
Loss before provision for income taxes | (19,017) | (30,646) | (47,325) | (45,294) |
Income tax benefit (expense) | 1,223 | (6,467) | 5,212 | 5,994 |
Net loss | $ (17,794) | $ (37,113) | $ (42,113) | $ (39,300) |
Net earnings (loss) per common share, basic (in dollars per share) | $ (0.46) | $ (1) | $ (1.10) | $ (1.07) |
Net earnings (loss) per common share, diluted (in dollars per share) | $ (0.46) | $ (1) | $ (1.10) | $ (1.07) |
Weighted average common shares outstanding, basic (in shares) | 38,654,086 | 36,980,356 | 38,301,893 | 36,728,911 |
Weighted average common shares outstanding, diluted (in shares) | 38,654,086 | 36,980,356 | 38,301,893 | 36,728,911 |
Comprehensive loss: | ||||
Net loss | $ (17,794) | $ (37,113) | $ (42,113) | $ (39,300) |
Foreign currency translation | (102) | 17 | (361) | 19 |
Unrealized gain (loss) on marketable securities | 83 | 308 | 256 | (397) |
Comprehensive loss | $ (17,813) | $ (36,788) | $ (42,218) | $ (39,678) |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (42,113) | $ (39,300) |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation and amortization | 13,336 | 11,953 |
Deferred income tax benefit | (7,811) | (10,999) |
Interest income from notes receivable | (651) | (1,605) |
Legal fee settlement | 0 | 5,212 |
Non-cash interest expense | 1,353 | 1,551 |
Amortization of premiums on marketable securities | 972 | 853 |
Amortization of debt discount and deferred financing costs | 460 | 491 |
Legal accrual reversal | 0 | (2,967) |
Share based compensation | 21,292 | 22,034 |
Change in fair value of liability classified warrants | 8,921 | 4,849 |
Change in fair value of contingent consideration | 11,057 | 10,741 |
Payments related to change in fair value of contingent consideration | (885) | (772) |
Provision for doubtful accounts | 321 | 58 |
Unrealized foreign currency transaction gain | (1,074) | 0 |
Other | 95 | (11) |
Changes in operating assets and liabilities, net of business acquisitions: | ||
Accounts receivable | 4,064 | (2,544) |
Inventory | (319) | (712) |
Other current and non-current operating assets | (3,747) | (937) |
Accounts payable and accrued expenses | 425 | 3,278 |
Other current and non-current operating liabilities | 2,561 | 3,879 |
Net cash provided by operating activities | 8,257 | 5,052 |
Cash Flows From Investing Activities: | ||
Purchase of fixed assets | (1,437) | (61) |
Cash paid for intangible assets | (9,632) | (7,632) |
Proceeds from the sale/maturity of marketable securities | 76,826 | 92,609 |
Purchase of marketable securities | (67,552) | (152,016) |
Proceeds from maturity of note receivable | 47,500 | 47,500 |
Cash paid upon acquisition, net of cash acquired | 0 | (500) |
Net cash provided by (used in) investing activities | 45,705 | (20,100) |
Cash Flows From Financing Activities: | ||
Payment of acquisition-related contingent consideration | (5,006) | (4,339) |
Payment of guaranteed minimum royalty | (1,500) | (1,500) |
Payment of other liability | (750) | (750) |
Proceeds from exercise of warrants | 3,645 | 5,998 |
Proceeds from exercise of stock options | 7,695 | 2,225 |
Other | 0 | (439) |
Net cash provided by financing activities | 4,084 | 1,195 |
Effect of exchange rate changes on cash | (57) | (57) |
Net change in cash | 57,989 | (13,910) |
Cash, beginning of year | 41,002 | 37,805 |
Cash, end of period | $ 98,991 | $ 23,895 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | DESCRIPTION OF BUSINESS Organization and Description of Business In this Quarterly Report on Form 10-Q, unless the context requires otherwise, the terms “we”, “our”, “us”, “Retrophin” and the “Company” refer to Retrophin, Inc., a Delaware corporation, as well as our direct and indirect subsidiaries. Retrophin is a fully integrated biopharmaceutical company headquartered in San Diego, California focused on the development, acquisition and commercialization of therapies for the treatment of serious or rare diseases. We regularly evaluate and, where appropriate, act on opportunities to expand our product pipeline through licenses and acquisitions of products in areas that will serve patients with serious or rare diseases and that we believe offer attractive growth characteristics. Research and Development Programs: Fosmetpantotenate, also known as RE-024, a novel small molecule, is being developed as a potential treatment for pantothenate kinase-associated neurodegeneration (“PKAN”). PKAN is a genetic neurodegenerative disorder that is typically diagnosed in the first decade of life. Consequences of PKAN include parkinsonism, dystonia, and other severe systemic manifestations. Fosmetpantotenate (RE-024) is a phosphopantothenate replacement therapy that aims to restore levels of this key substrate in PKAN patients. Certain international health regulators have approved the initiation of dosing fosmetpantotenate (RE-024) in PKAN patients under physician-initiated studies in accordance with local regulations in their respective countries. The Company filed a U.S. Investigational New Drug ("IND") for fosmetpantotenate (RE-024) with the FDA in the first quarter of 2015 to support the commencement of a Company-sponsored Phase 1 study, which was successfully completed during 2015. The FDA granted fosmetpantotenate (RE-024) orphan drug designation in May 2015 and fast track designation in June 2015. In February 2016, the Company announced fosmetpantotenate (RE-024) was granted orphan drug designation by the European Commission. In November 2016, the Company announced that it had reached an agreement with the FDA under the Special Protocol Assessment (SPA) process for a Phase 3 clinical trial evaluating fosmetpantotenate (RE-024) for PKAN. The Company has reviewed the study design with the European Medicines Agency ("EMA") and we expect it to support registration in Europe. In July 2017, we announced that the first patient had been dosed in the FORT (FOsmetpantotenate Replacement Therapy) Study. Sparsentan, also known as RE-021, is an investigational therapeutic agent which acts as both a potent angiotensin receptor blocker (“ARB”), as well as a selective endothelin receptor antagonist (“ERA”), with in vitro selectivity toward endothelin receptor type A. The Company has secured a license to sparsentan from Ligand Pharmaceuticals, Inc. and Bristol-Myers Squibb Company (who referred to it as DARA). The Company is developing sparsentan as a treatment for focal segmental glomerulosclerosis ("FSGS"), which is a leading cause of end-stage renal disease and nephrotic syndrome (“NS”). Sparsentan was granted orphan drug designation in the United States and the European Union in January 2015 and November 2015, respectively. In the third quarter of 2016, the Company announced positive top-line data from the Phase 2 DUET study of sparsentan for the treatment of FSGS. In early 2017, we had an End of Phase 2 meeting with the U.S. Food and Drug Administration (the "FDA") regarding the regulatory pathway for sparsentan as a treatment for FSGS. Following the meeting and our receipt of confirmatory meeting minutes, we announced our plans to initiate a single Phase 3 clinical trial to serve as the basis of a New Drug Application ("NDA") filing for sparsentan for the treatment of FSGS. During the third quarter of 2017, we submitted the Phase 3 protocol for review to the FDA, and on November 6, 2017, we received feedback from the FDA requesting additional quantitative analyses to support the trial design’s eligibility for the Subpart H accelerated approval pathway. Study start-up activities continue and we anticipate initiating the pivotal trial in 2018. N-glycanase deficiency, or NGLY1 deficiency, is an extremely rare genetic disorder believed to be caused by a deficiency in an enzyme called N-glycanase-1, which is encoded by the gene NGLY1. The condition has been characterized by symptoms such as developmental delays, seizures, complex hyperkinetic movement disorders, diminished reflexes and an inability to produce tears. There are no approved therapeutic options for NGLY1 deficiency, and current therapeutic strategies are limited to symptom management. In September 2017, we announced that we entered a three-way Cooperative Research and Development Agreement ("CRADA") with the National Institutes of Health’s National Center for Advancing Translational Sciences (NCATS) and patient advocacy foundation NGLY1.org to collaborate on research efforts aimed at the identification of potential small molecule therapeutics for NGLY1 deficiency. Liquid ursodeoxycholic acid ("L-UDCA") is a liquid formulation of ursodeoxycholic acid being developed for the treatment of a rare liver disease called primary biliary cholangitis ("PBC"). We obtained rights to L-UDCA during 2016 with the intention of making L-UDCA commercially available to the subset of PBC patients who have difficulty swallowing. Products on the Market: • Chenodal ® (chenodiol) is approved in the United States for the treatment of patients suffering from gallstones in whom surgery poses an unacceptable health risk due to disease or advanced age. Chenodal has been the standard of care for cerebrotendinous xanthomatosis ("CTX") patients for more than three decades and the Company is currently pursuing adding this indication to the label. • Cholbam ® (cholic acid) is approved in the United States for the treatment of bile acid synthesis disorders due to single enzyme defects and is further indicated for adjunctive treatment of patients with peroxisomal disorders. • Thiola ® (tiopronin) is approved in the United States for the prevention of cystine (kidney) stone formation in patients with severe homozygous cystinuria. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BASIS OF PRESENTATION | BASIS OF PRESENTATION The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the 2016 10-K filed with the SEC on March 1, 2017. The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information, the instructions for Form 10-Q and the rules and regulations of the SEC. Accordingly, since they are interim statements, the accompanying condensed consolidated financial statements do not include all of the information and notes required by GAAP for annual financial statements, but reflect all adjustments consisting of normal, recurring adjustments, that are necessary for a fair presentation of the financial position, results of operations and cash flows for the interim periods presented. Interim results are not necessarily indicative of the results that may be expected for any future periods. The December 31, 2016 balance sheet information was derived from the audited financial statements as of that date. Certain reclassifications have been made to the prior period consolidated financial statements to conform to the current period presentation. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES A summary of the significant accounting policies applied in the preparation of the accompanying condensed consolidated financial statements follows: Principles of Consolidation The unaudited condensed consolidated financial statements represent the consolidation of the accounts of the Company and its subsidiaries in conformity with GAAP. All intercompany accounts and transactions have been eliminated in consolidation. Adoption of New Accounting Standards In October 2016, the Financial Accounting Standard Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory. The new guidance changes the accounting for income tax effects of intra-entity transfers of assets other than inventory. Under the new guidance, the selling (transferring) entity is required to recognize a current tax expense or benefit upon transfer of the asset. Similarly, the purchasing (receiving) entity is required to recognize a deferred tax asset or deferred tax liability, as well as the related deferred tax benefit or expense, upon receipt of the asset. The new guidance will be effective for the Company starting in fiscal year 2018 on a modified retrospective basis. The Company has elected to early adopt this guidance as of January 1, 2017, and has reversed the recorded prepaid tax asset of $4.9 million related to an intra-entity transfer as a charge to accumulated deficit. In April 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. Specifically, the ASU requires all excess tax benefits and tax deficiencies (including tax benefits of dividends on share-based payment awards) to be recognized as income tax expense or benefit in the income statement. The tax effects of exercised or vested awards should be treated as discrete items in the reporting period in which they occur. An entity also should recognize excess tax benefits, and assess the need for a valuation allowance, regardless of whether the benefit reduces taxes payable in the current period. That is, off balance sheet accounting for net operating losses stemming from excess tax benefits would no longer be required and instead such net operating losses would be recognized when they arise. Existing net operating losses that were tracked off balance sheet would be recognized, net of a valuation allowance if required, through an adjustment to opening retained earnings in the period of adoption. Entities no longer need to maintain and track an “APIC pool.” The ASU also requires excess tax benefits to be classified along with other income tax cash flows as an operating activity in the statement of cash flows. In addition, the ASU elevates the statutory tax withholding threshold to qualify for equity classification up to the maximum statutory tax rates in the applicable jurisdiction(s). The ASU also clarifies that cash paid by an employer when directly withholding shares for tax withholding purposes should be classified as a financing activity. The ASU provides an optional accounting policy election (with limited exceptions), to be applied on an entity-wide basis, to either estimate the number of awards that are expected to vest (consistent with GAAP) or account for forfeitures when they occur. The Company adopted this guidance as of January 1, 2017, and as a result the tax effects related to share-based payments at settlement (or expiration) will be recorded through the statement of operations. For the three and nine months ended September 30, 2017, the Company recorded tax expense of $0.1 million and $0.5 million , respectively, net of valuation allowance released, related to the stock compensation short falls . In addition, the Company adopted accounting for forfeitures at actual rates in the period they occur. Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). Under the new standard, revenue is recognized at the time a good or service is transferred to a customer for the amount of consideration for which the entity expects to be entitled for that specific good or service. Entities may use a full retrospective approach or report the cumulative effect as of the date of adoption. On July 9, 2015, the FASB voted to defer the effective date by one year to December 15, 2017 for interim and annual reporting periods beginning after that date. Early adoption of Topic 606 is permitted but not before the original effective date (annual periods beginning after December 15, 2016). Based on the Company’s evaluation of the guidance performed to date, the Company has identified revenue sources and determined no variable consideration exists. Further the Company does not expect the new standard to change the timing of its recognition of revenue from product sales, but is continuing its review of the standard and any potential effects on disclosures. The Company will adopt the standard on January 1, 2018 and expects to do a full retrospective adoption. In February 2016, the FASB issued ASU No. 2016-02, Leases. The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is in the process of evaluating the impact of this guidance on its consolidated financial statements and related disclosures; however, based on the Company's current operating leases, it is expected to have a material impact to the consolidated balance sheet by increasing assets and liabilities. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. Topic 326 amends guidance on reporting credit losses for assets held at amortized cost basis and available for sale debt securities. For assets held at amortized cost basis, Topic 326 eliminates the probable initial recognition threshold in current GAAP and, instead, requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. For available for sale debt securities, credit losses should be measured in a manner similar to current GAAP, however Topic 326 will require that credit losses be presented as an allowance rather than as a write-down. This ASU affects entities holding financial assets and net investment in leases that are not accounted for at fair value through net income. The amendments affect loans, debt securities, trade receivables, net investments in leases, off balance sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash. This ASU is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. As of September 30, 2017 , the Company held $204.9 million in available for sale debt securities that are affected by this ASU. If adopted as of September 30, 2017 , Topic 326 would not have a material impact on the Company's consolidated financial statements. In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business . The new guidance dictates that, when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, it should be treated as an acquisition or disposal of an asset. The guidance will be effective for the fiscal year beginning on January 1, 2018, including interim periods within that year (early adoption is permitted). The Company is currently evaluating the potential effect of the guidance on its consolidated financial statements. In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception. These amendments simplify the accounting for certain financial instruments with down round features.The amendments require companies to disregard the down round feature when assessing whether the instrument is indexed to its own stock, for purposes of determining liability or equity classification. Companies that provide earnings per share (EPS) data will adjust their basic EPS calculation for the effect of the feature when triggered (i.e., when the exercise price of the related equity-linked financial instrument is adjusted downward because of the down round feature) and will also recognize the effect of the trigger within equity. The Company anticipates that it will adopt this guidance as of January 1, 2018, which may have impact on the derivative liability associated with warrants issued by the Company. |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES The following table summarizes our effective tax rate and income tax benefit for the three and nine months ended September 30, 2017 and 2016 ( dollars in millions ): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Effective tax rate 6.4 % (21.1 )% 11.0 % 13.2 % Income tax benefit (expense) $ 1.2 $ (6.5 ) $ 5.2 $ 6.0 For the three and nine months ended September 30, 2017, we recognized an income tax benefit of $1.2 million and $5.2 million , respectively, representing an effective tax rate of 6.4% and 11.0% , respectively. Under GAAP, quarterly effective tax rates may vary significantly depending on the actual operating results in the various tax jurisdictions, and significant transactions, as well as changes in the valuation allowance related to the expected recovery of deferred tax assets. The difference between the expected statutory federal tax benefit of 35% and the effective tax benefit for three and nine months ended September 30, 2017, was primarily attributable to the increase in valuation allowance against our deferred tax assets in the third quarter . For the three months ended September 30, 2017, when compared to the same period in 2016, the change in the tax benefit and increase in the effective income tax rate was primarily attributable to the increase of the U.S. federal valuation allowance in 2017. For the nine months ended September 30, 2017, when compared to the same period in 2016, there is no material change in the tax benefit nor effective tax rate. At September 30, 2017 and December 31, 2016, we had gross unrecognized tax benefits of $1.5 million . If recognized, none of the unrecognized tax benefits would affect the Company’s effective tax rate. We did not recognize any interest or penalties related to unrecognized tax benefits during the three months ended September 30, 2017. |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 9 Months Ended |
Sep. 30, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | MARKETABLE SECURITIES The Company's marketable securities as of September 30, 2017 and December 31, 2016 were comprised of available-for-sale marketable securities which are carried at fair value, with the unrealized gains and losses reported in accumulated other comprehensive income. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income or expense. Interest and dividends on securities classified as available-for-sale are included in interest income. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income. During the nine months ended September 30, 2017 , investment activity for the Company included $76.8 million in maturities, all relating to debt based marketable securities. Marketable securities consisted of the following ( in thousands ): September 30, 2017 December 31, 2016 Marketable other than equity securities: Commercial paper $ 5,497 $ 30,303 Corporate debt securities 159,170 134,570 Securities of government sponsored entities 40,215 49,998 Total marketable securities: $ 204,882 $ 214,871 The following is a summary of short-term marketable securities classified as available-for-sale as of September 30, 2017 ( in thousands ): Remaining Contractual Maturity Amortized Cost Unrealized Gains Unrealized Losses Aggregate Estimated Fair Value Marketable other than equity securities: Commercial paper Less than 1 $ 5,497 $ — $ — $ 5,497 Corporate debt securities Less than 1 92,029 — (127 ) 91,902 Securities of government-sponsored entities Less than 1 36,821 10 (49 ) 36,782 Total maturity less than 1 year 134,347 10 (176 ) 134,181 Corporate debt securities 1 to 2 67,397 — (129 ) 67,268 Securities of government-sponsored entities 1 to 2 3,424 9 — 3,433 Total maturity 1 to 2 years 70,821 9 (129 ) 70,701 Total available-for-sale securities $ 205,168 $ 19 $ (305 ) $ 204,882 The following is a summary of short-term marketable securities classified as available-for-sale as of December 31, 2016 ( in thousands ): Remaining Contractual Maturity (in years) Amortized Cost Unrealized Gains Unrealized Losses Aggregate Estimated Fair Value Marketable Other than Equity Securities: Commercial paper Less than 1 $ 30,330 $ — $ (27 ) $ 30,303 Corporate debt securities Less than 1 64,794 7 (91 ) 64,710 Securities of government-sponsored entities Less than 1 19,500 — (10 ) 19,490 Total maturity less than 1 year 114,624 7 (128 ) 114,503 Corporate debt securities 1 to 2 70,207 — (347 ) 69,860 Securities of government-sponsored entities 1 to 2 30,583 — (75 ) 30,508 Total maturity 1 to 2 years 100,790 — (422 ) 100,368 Total available-for-sale securities $ 215,414 $ 7 $ (550 ) $ 214,871 The primary objective of the Company’s investment portfolio is to enhance overall returns while preserving capital and liquidity. The Company’s investment policy limits interest-bearing security investments to certain types of instruments issued by institutions with primarily investment grade credit ratings and places restrictions on maturities and concentration by asset class and issuer. The Company reviews the available-for-sale investments for other-than-temporary declines in fair value below cost basis each quarter and whenever events or changes in circumstances indicate that the cost basis of an asset may not be recoverable. This evaluation is based on a number of factors, including the length of time and the extent to which the fair value has been below the cost basis and adverse conditions related specifically to the security, including any changes to the credit rating of the security, and the intent to sell, or whether the Company will more likely than not be required to sell the security before recovery of its amortized cost basis. The assessment of whether a security is other-than-temporarily impaired could change in the future due to new developments or changes in assumptions related to any particular security. As of September 30, 2017 and December 31, 2016 , the Company believed the cost basis for available-for-sale investments was recoverable in all material respects. |
DERIVATIVE FINANCIAL INSTRUMENT
DERIVATIVE FINANCIAL INSTRUMENTS | 9 Months Ended |
Sep. 30, 2017 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
DERIVATIVE FINANCIAL INSTRUMENTS | DERIVATIVE FINANCIAL INSTRUMENTS Since 2013, the Company has issued five tranches of common stock purchase warrants to secure financing, remediate covenant violations and provide consideration for amendments with respect to a credit facility extinguished in 2015. The Company accounts for derivative financial instruments in accordance with FASB ASC 815-40, Derivative and Hedging – Contracts in Entity’s Own Equity , pursuant to which instruments which do not have fixed settlement provisions are deemed to be derivative instruments. The Company’s warrants are classified as liability instruments due to an anti-dilution provision that provides for a reduction to the exercise price of the warrants if the Company issues additional equity or equity linked instruments in the future at an effective price per share less than the exercise price then in effect. The warrants are re-measured at each balance sheet date based on estimated fair value. Changes in estimated fair value are recorded as non-cash adjustments within other income (expenses), net, in the Company’s accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss. The Company recorded a loss on the change in the estimated fair value of warrants of $8.9 million for each of the three and nine months ended September 30, 2017 , and a loss on the change in the estimated fair value of warrants of $10.1 million and $4.8 million for the three and nine months ended September 30, 2016, respectively. The Company calculated the fair value of the warrants using the Black-Scholes Model as of September 30, 2017 and the Monte Carlo Simulation as of December 31, 2016 , using the following assumptions: September 30, 2017 December 31, 2016 Fair value of common stock $ 24.89 $ 18.93 Remaining life of the warrants (in years) 0.4 - 2.3 years 1.2 - 3.0 years Risk-free interest rate 1.1 - 1.6% .89 - 1.48% Expected volatility 32 - 50% 55 - 75% Dividend yield — % — % Expected volatility is based on an analysis of the Company’s volatility. The risk-free interest rate is based on the U.S. Treasury security rates for the remaining term of the warrants at the measu |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS Financial Instruments and Fair Value The Company accounts for financial instruments in accordance with ASC 820, Fair Value Measurements and Disclosures (“ASC 820”). ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described below: Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; Level 2 – Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly; and Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable. The valuation techniques used to measure the fair value of the Company’s marketable securities and all other financial instruments, all of which have counter-parties with high credit ratings, were valued based on quoted market prices or model driven valuations using significant inputs derived from or corroborated by observable market data. Based on the fair value hierarchy, the Company classified marketable securities within Level 2. In estimating the fair value of the Company’s derivative liabilities, the Company used the Black Scholes Model as of September 30, 2017 and the Monte Carlo Simulation as of December 31, 2016 . Based on the fair value hierarchy, the Company classified the derivative liability within Level 3. In estimating the fair value of the Company’s contingent consideration, the Company used the comparable uncontrolled transaction (“CUT”) method for royalty payments based on projected revenues. Based on the fair value hierarchy, the Company classified contingent consideration within Level 3 because valuation inputs are based on projected revenues discounted to a present value. Financial instruments with carrying values approximating fair value include cash and cash equivalents, accounts receivable, notes receivable, and accounts payable, due to their short term nature. As of September 30, 2017, the estimated fair value of convertible debt was $71.7 million , considering factors such as market conditions, prepayment and make-whole provisions, variability in pricing from multiple lenders and the term of the debt. The following table presents the Company’s assets and liabilities, measured and recognized at fair value on a recurring basis, classified under the appropriate level of the fair value hierarchy as of September 30, 2017 ( in thousands ): As of September 30, 2017 Total carrying and estimated fair value Quoted prices in active markets Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Marketable securities, available-for-sale $ 204,882 $ — $ 204,882 $ — Total $ 204,882 $ — $ 204,882 $ — Liabilities: Derivative liability related to warrants $ 20,140 $ — $ — $ 20,140 Business combination-related contingent consideration 92,915 — — 92,915 Total $ 113,055 $ — $ — $ 113,055 The following table presents the Company’s assets and liabilities, measured and recognized at fair value on a recurring basis, classified under the appropriate level of the fair value hierarchy as of December 31, 2016 ( in thousands ): As of December 31, 2016 Total carrying and estimated fair value Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Marketable securities, available-for-sale 214,871 — 214,871 — Total $ 214,871 $ — $ 214,871 $ — Liabilities: Derivative liability related to warrants $ 22,440 $ — $ — $ 22,440 Business combination-related contingent consideration 87,478 — — 87,478 Total $ 109,918 $ — $ — $ 109,918 The following table sets forth a summary of changes in the estimated fair value of the Company’s derivative financial instrument-warrants liability for the nine months ended September 30, 2017 ( in thousands ): Fair Value Measurements of Common Stock Warrants Using Significant Unobservable Inputs (Level 3) Balance at January 1, 2017 $ 22,440 Reclassification of derivative liability to equity upon exercise of warrants (11,221 ) Change in estimated fair value of liability classified warrants 8,921 Balance at September 30, 2017 $ 20,140 A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, the Company performs a detailed analysis of the assets and liabilities that are subject to ASC 820. See Note 6 for further discussion of derivative financial instruments relating to warrants. The following table sets forth a summary of changes in the estimated fair value of the Company's business combination-related contingent consideration for the nine months ended September 30, 2017 ( in thousands ): Fair Value Measurements of Acquisition-Related Contingent Consideration Balance at January 1, 2017 $ 87,478 Increase from revaluation of contingent consideration 11,057 Contractual payments included in accrued liabilities at September 30, 2017 (1,993 ) Contractual payments (3,782 ) Foreign currency impact 155 Balance at September 30, 2017 $ 92,915 The fair value of contingent consideration liabilities was determined by applying a form of the income approach (a level 3 input), based upon the probability-weighted projected payment amounts discounted to present value at a rate appropriate for the risk of achieving the performance targets. The key assumptions included in the calculations were the earn-out period payment probabilities, projected revenues, discount rate and the timing of payments. The present value of the expected payments considers the time at which the obligations are expected to be settled and a discount rate that reflects the risk associated with the performance payments. During the three and nine months ended September 30, 2017 , the Company incurred charges of $4.4 million and $11.1 million , respectively, in operating expenses on the Condensed Consolidated Statements of Operations and Comprehensive Loss for the revaluation of the contingent consideration liabilities. For the nine months ended September 30, 2017, $5.0 million , $3.8 million and $2.3 million of the charges were related to the increase in contingent consideration liabilities for the products Chenodal and Cholbam and product candidate L-UDCA, respectively. In each case, the value increased due to changes in the estimated timing of payments. During the three and nine months ended September 30, 2016 , the Company incurred charges of $5.3 million and $10.7 million , respectively, in operating expenses on the Condensed Consolidated Statement of Operations and Comprehensive Loss for the revaluation of the contingent consideration liabilities. For the nine months ended September 30, 2016, $4.4 million , $4.4 million , and $1.9 million of the charges were related to the increase in contingent consideration liabilities for the products Chenodal and Cholbam and product candidate L-UDCA, respectively. In each case, the value increased due to changes in the estimated timing of payments. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 9 Months Ended |
Sep. 30, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS | INTANGIBLE ASSETS As of September 30, 2017 , the net book value of amortizable intangible assets was approximately $179.6 million . The following table sets forth amortizable intangible assets as of September 30, 2017 and December 31, 2016 ( in thousands ): September 30, 2017 December 31, 2016 Finite-lived intangible assets $ 226,249 $ 215,540 Less: accumulated amortization (46,680 ) (33,497 ) Net carrying value $ 179,569 $ 182,043 The following table summarizes amortization expense for the three and nine months ended September 30, 2017 and 2016 ( in thousands ): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Research and development $ 82 $ 82 $ 244 $ 245 Selling, general and administrative 4,424 3,987 12,752 11,619 Total amortization expense $ 4,506 $ 4,069 $ 12,996 $ 11,864 |
CONVERTIBLE NOTES PAYABLE
CONVERTIBLE NOTES PAYABLE | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
CONVERTIBLE NOTES PAYABLE | CONVERTIBLE NOTES PAYABLE On May 29, 2014, the Company entered into a Note Purchase Agreement relating to a private placement by the Company of $46.0 million aggregate principal senior convertible notes due in 2019 (the “Notes”) which are convertible into shares of the Company’s common stock at an initial conversion price of $17.41 per share. The conversion price is subject to customary anti-dilution protection. The Notes bear interest at a rate of 4.5% per annum, payable semiannually in arrears on May 15 and November 15 of each year. The Notes mature on May 30, 2019 unless earlier converted or repurchased in accordance with their terms, and there are no contractual payments due prior to that date. At September 30, 2017 and December 31, 2016 , the aggregate carrying value of the Notes was $44.9 million and $44.4 million , respectively. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 9 Months Ended |
Sep. 30, 2017 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | ACCRUED EXPENSES Accrued expenses at September 30, 2017 and December 31, 2016 consisted of the following ( in thousands ): September 30, 2017 December 31, 2016 Government rebates payable $ 5,614 $ 6,967 Compensation related costs 6,885 7,441 Accrued royalties and contingent consideration 6,144 5,766 Research and development 7,218 7,311 Selling, general and administrative 1,933 3,333 Restructuring expenses 2,551 893 Miscellaneous accrued 1,908 1,597 Total accrued expenses $ 32,253 $ 33,308 |
LOSS PER COMMON SHARE
LOSS PER COMMON SHARE | 9 Months Ended |
Sep. 30, 2017 | |
Earnings Per Share [Abstract] | |
LOSS PER COMMON SHARE | LOSS PER COMMON SHARE Basic and diluted net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. The Company’s potentially dilutive shares, which include outstanding stock options, restricted stock units, warrants, and shares issuable upon conversion of the Notes, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. Basic and diluted net loss per share is calculated as follows (net loss amounts are stated in thousands) : Three Months Ended September 30, 2017 2016 Shares Net Loss EPS Shares Net Loss EPS Basic loss per share 38,654,086 $ (17,794 ) $ (0.46 ) 36,980,356 $ (37,113 ) $ (1.00 ) Dilutive loss per share 38,654,086 $ (17,794 ) $ (0.46 ) 36,980,356 $ (37,113 ) $ (1.00 ) Nine Months Ended September 30, 2017 2016 Shares Net Loss EPS Shares Net Loss EPS Basic loss per share 38,301,893 $ (42,113 ) $ (1.10 ) 36,728,911 $ (39,300 ) $ (1.07 ) Dilutive loss per share 38,301,893 $ (42,113 ) $ (1.10 ) 36,728,911 $ (39,300 ) $ (1.07 ) The following shares were excluded because they were anti-dilutive ( in thousands ): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Restricted stock units 145 281 175 310 Convertible debt 2,642 2,642 2,642 2,642 Options 7,515 6,720 6,960 6,149 Warrants 1,159 1,768 1,159 1,768 Total anti-dilutive shares 11,461 11,411 10,936 10,869 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Leases and Sublease Agreements Facilities Annual Base Rent Lease Expiration Comments Occupied Locations Corporate Headquarters San Diego CA $2.2 million July 2024 Cambridge MA January 2018 Subleased space for less than one year Vacated Locations San Diego CA $0.5 million December 2017 Available for sublease New York NY $0.5 million November 2018 Sublet through expiration Research Collaboration and Licensing Agreements As part of the Company's research and development efforts, the Company enters into research collaboration and licensing agreements with unrelated companies, scientific collaborators, universities, and consultants. These agreements contain varying terms and provisions which include fees and milestones to be paid by the Company, services to be provided, and ownership rights to certain proprietary technology developed under the agreements. Some of these agreements contain provisions which require the Company to pay royalties, in the event the Company sells or licenses any proprietary products developed under the respective agreements. Contractual Commitments The following table summarizes our principal contractual commitments, excluding open orders that support normal operations, as of September 30, 2017 ( in thousands ): Total Less than 1 year 1-3 years 3-5 years More than 5 years Operating leases $ 17,015 $ 2,326 $ 4,817 $ 5,010 $ 4,862 Guaranteed minimum royalty 13,500 2,000 4,000 4,000 3,500 Convertible note payable, including contractual interest 49,968 2,070 47,898 — — Sales support services 2,741 416 833 833 659 Product supply contracts 1,846 1,429 417 — — Purchase order commitments 387 350 37 — — $ 85,457 $ 8,591 $ 58,002 $ 9,843 $ 9,021 Legal Proceedings In January 2015, the Company received a subpoena relating to a criminal investigation by the U.S. Attorney for the Eastern District of New York. The subpoena requested information regarding, among other things, the Company’s relationship with Martin Shkreli, the Company’s former Chief Executive Officer, and individuals or entities that had been investors in investment funds previously managed by Mr. Shkreli. The Company was informed that it is not a target of the U.S. Attorney’s investigation, and cooperated with the investigation. On December 17, 2015, an indictment against Mr. Shkreli and the Company’s former outside counsel, Evan Greebel, was unsealed in the United States District Court for the Eastern District of New York. A superseding indictment reflecting additional charges was filed on June 3, 2016. The Company also cooperated with a parallel investigation by the U.S. Securities and Exchange Commission (the “SEC”). On December 17, 2015, the SEC filed a civil complaint against Mr. Shkreli, Mr. Greebel, MSMB Capital Management LLC, and MSMB Healthcare Management LLC in the United States District Court for the Eastern District of New York. In connection with these proceedings, Mr. Shkreli, as well as a number of other current and former directors, officers, and employees, sought advancement of their legal fees from the Company. Mr. Shkreli, in particular, claimed that the Company owed him in excess of $5 million in legal fees that he incurred defending these actions. The Company disputed its obligation to pay the amount in full. In November 2016, the Company and Mr. Shkreli entered into a binding term sheet with respect to a settlement under which the Company advanced $2.8 million in legal fees to Mr. Shkreli’s counsel, representing a portion of the existing legal fees related to these proceedings that Mr. Shkreli claimed should be advanced. The Company also advanced an additional $2 million in legal fees once the matter proceeded to trial. In June 2017, Mr. Shkreli’s trial commenced in the United States District Court for the Eastern District of New York. In August 2017, the trial was concluded with a conviction on several counts. Mr. Shkreli may appeal his conviction and has requested further advancement of legal fees in the event of an appeal. The Company has been reimbursed by its directors’ and officers’ insurance carriers for $3.3 million of the legal fees the Company has advanced to date. Pending the outcome of an appeal, if any, the insurance carriers have reserved their rights to assert that certain of the advanced funds pertain to claims excluded from coverage under the relevant insurance policy and are therefore recoverable by the carriers. As a result, the final amount of the reimbursement from the insurance carriers is not currently estimable. In addition, a portion of the legal fees the Company has advanced to Mr. Shkreli will be subject to reimbursement by Mr. Shkreli under Delaware law in the event it is ultimately determined that Mr. Shkreli is not entitled to be indemnified by the Company in these proceedings. On August 17, 2015, the Company filed a lawsuit in federal district court for the Southern District of New York against Mr. Shkreli, asserting that he breached his fiduciary duty of loyalty during his tenure as the Company’s Chief Executive Officer and a member of its Board of Directors (Retrophin, Inc. v. Shkreli, 15-CV-06451(NRB)). On August 19, 2015, Mr. Shkreli served a demand for JAMS arbitration on Retrophin, claiming that Retrophin had breached his December 2013 employment agreement. In response to Mr. Shkreli’s arbitration demand, the Company asserted counterclaims in the arbitration that are substantially similar to the claims it previously asserted in the federal lawsuit against Mr. Shkreli. The parties have selected an arbitration panel. On Mr. Shkreli’s application, and with the Company’s consent, the federal Court granted a stay of the federal lawsuit pending a determination by the arbitration panel whether the Company’s counterclaims would be litigated in the arbitration, as the Company is seeking. On April 22, 2016, the arbitration panel granted the parties’ request for a stay of the proceedings pending settlement discussions. In connection with these proceedings, Mr. Shkreli sought advancement of his legal fees from the Company relating to his defense of the Company’s claims against him. Mr. Shkreli claimed that he has to date incurred in excess of $2.8 million in fees, including fees incurred in negotiating with the Company over advancement. The Company disputed its obligation to pay the amount in full. In November 2016, the Company and Mr. Shkreli entered into a binding term sheet with respect to a settlement under which the significant majority of the existing legal fees related to these proceedings that Mr. Shkreli claimed should be advanced would be offset and satisfied by the $2.025 million judgment against Mr. Shkreli in the Donoghue v. Retrophin, Inc. case. The Company would also advance $0.4 million in legal fees to Mr. Shkreli’s counsel, a portion of which represented additional legal fees related to these proceedings that Mr. Shkreli claims should be advanced. In accordance with the Term Sheet, the Donoghue settlement was offset, and the Company paid the $0.4 million to Mr. Shkreli's counsel. The legal fees the Company has advanced will be subject to reimbursement by Mr. Shkreli under Delaware law in the event it is ultimately determined that Mr. Shkreli is not entitled to be indemnified by the Company in these proceedings. The Company will also be subject to additional obligations when the litigation resumes, as well as advancement obligations in the interim. For the year ended December 31, 2016, the Company recorded $5.2 million in expenses and paid $2.3 million under the settlement. For the three and nine months ended September 30, 2017, the Company recorded zero and $2.0 million , respectively, in expenses, and paid zero and $3.0 million , respectively, under the settlement. The Company received $0.7 million in reimbursement from its directors’ and officers’ insurance carriers during the year ended December 31, 2016, which is recorded as a gain in selling, general and administrative expenses within the Consolidated Statement of Operations and Comprehensive Income (Loss). Additionally, during the three and nine months ended September 30, 2017, the Company received $2.6 million in reimbursement from its directors’ and officers’ insurance carriers which is recorded as a liability on the Consolidated Balance Sheet pending the outcome of an appeal, if any. From time to time the Company is involved in legal proceedings arising in the ordinary course of business. The Company believes there is no litigation pending that could have, individually or in the aggregate, a material adverse effect on its results of operations or financial condition. |
SHARE BASED COMPENSATION
SHARE BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
SHARE BASED COMPENSATION | SHARE BASED COMPENSATION Restricted Shares Service and Performance Based Restricted Stock Units The following table summarizes the Company’s restricted stock activity during the nine months ended September 30, 2017 : Number of Restricted Stock Units Weighted Average Grant Date Fair Value Unvested December 31, 2016 407,746 $ 19.88 Granted 157,750 18.32 Vested (167,584 ) 17.97 Forfeited/canceled (6,500 ) 23.28 Unvested September 30, 2017 391,412 $ 20.01 At September 30, 2017 , unamortized stock compensation for restricted stock units was $3.4 million , with a weighted-average recognition period of 1.0 year. Performance Based Restricted Stock Units The Company did not grant any performance based restricted stock units during the three months ended September 30, 2017. During the nine months ended September 30, 2017 , the Company granted 108,500 performance based restricted stock units, which are included in the restricted stock activity table above. Stock Options The following table summarizes stock option activity during the nine months ended September 30, 2017 : Shares Underlying Options Weighted Average Exercise Price Weighted Average Remaining Contractual Life (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2016 6,430,570 $ 16.91 7.64 30,088 Granted 2,035,300 18.35 Exercised (598,968 ) 12.85 Forfeited/canceled (394,166 ) 25.05 Outstanding at September 30, 2017 7,472,736 $ 17.20 7.71 $ 63,956 At September 30, 2017 , unamortized stock compensation for stock options was $35.8 million , with a weighted-average recognition period of 2.7 years . At September 30, 2017 , outstanding options to purchase 4.3 million shares of common stock were exercisable with a weighted-average exercise price per share of $15.64 . Share Based Compensation The following table sets forth total non-cash stock-based compensation by operating statement classification for the three and nine months ended September 30, 2017 and 2016 ( in thousands ): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Research and development $ 1,998 $ 2,934 $ 7,113 $ 8,061 Selling, general & administrative 4,962 4,814 14,179 13,973 Total $ 6,960 $ 7,748 $ 21,292 $ 22,034 Exercise of Warrants During the three and nine months ended September 30, 2017, the Company issued 607,481 shares of common stock upon the exercise of outstanding warrants for cash received by the Company in the amount of $3.6 million . The Company reclassified $11.2 million of derivative liability to equity for the value of these warrants on the date of exercise. The warrants were revalued immediately prior to their exercise and the change in fair value of $3.0 million was recorded as other expense in the consolidated financial statements of the Company. At September 30, 2017 and December 31, 2016 , warrants to purchase 1,159,424 and 1,766,905 shares of common stock, respectively, were outstanding. |
INVENTORY
INVENTORY | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory, net of reserves, consisted of the following at September 30, 2017 and December 31, 2016 ( in thousands ): September 30, 2017 December 31, 2016 Raw materials $ 2,766 $ 1,336 Finished goods 1,552 1,490 Total inventory $ 4,318 $ 2,826 The inventory reserve was $0.5 million and $0.6 million at September 30, 2017 and December 31, 2016 , respectively. |
RECEIVABLES
RECEIVABLES | 9 Months Ended |
Sep. 30, 2017 | |
Receivables [Abstract] | |
RECEIVABLES | RECEIVABLES Accounts Receivables Accounts receivable, net of reserves for prompt pay discounts and doubtful accounts, was $14.5 million and $18.5 million at September 30, 2017 and December 31, 2016 , respectively. The total reserves for both periods were immaterial. Notes Receivables The notes receivable arose from the Company's sale of a Pediatric Priority Review Voucher in July 2015 to Sanofi for $245.0 million . $150.0 million was received upon closing, and $47.5 million was due on each of the first and second anniversaries of the closing. In accordance with GAAP, the Company recorded the future short term and long term notes receivable at their present value of $46.2 million and $44.9 million , respectively, at the date of the sale using a discount rate of 2.8% . The accretion on the notes receivable totaled $0.6 million for the nine months ended September 30, 2017 , and is recorded in interest expense, net, in the Consolidated Statements of Operations and Comprehensive Loss. The first anniversary payment was received on July 2, 2016. The second anniversary payment was received on June 30, 2017. The note receivable balances as of September 30, 2017 and December 31, 2016 were zero and $46.8 million , respectively. |
RESTRUCTURING
RESTRUCTURING | 9 Months Ended |
Sep. 30, 2017 | |
Restructuring and Related Activities [Abstract] | |
Restructuring | RESTRUCTURING On March 7, 2017, the Company initiated a plan to consolidate its operations to its corporate headquarters in San Diego, CA. As part of this plan, select employees will relocate from Cambridge, Massachusetts to the San Diego, California headquarters by the end of 2017. The Company estimates it could incur up to $4.0 million in employee related separation and transitional cash charges as a result of this consolidation. We expect to pay the accrued amounts related to this restructuring by the end of the first quarter of 2018. The following presents restructuring expense by quarter for 2017 ( in thousands ): Restructuring expense March 31, 2017* $ 498 June 30, 2017* 981 September 30, 2017 1,132 Nine months ended September 30, 2017 $ 2,611 *Restructuring expense for the first and second quarter of 2017 were not separately presented on the Consolidated Statements of Operations and Comprehensive Loss. We currently estimate incurring additional restructuring expenses of approximately $1.4 million in 2017. The following table presents a reconciliation of the restructuring liability recorded within accrued expenses on the Company's Condensed Consolidated Balance Sheets for the three and nine months ended September 30, 2017 ( in thousands ): Three Months Ended September 30, 2017 Nine Months Ended September 30, 2017 Liability, beginning of period $ 1,420 $ 893 Restructuring expenses 1,131 2,611 Cash settlements — (898 ) Adjustments to previous estimates — (55 ) Liability, end of period $ 2,551 $ 2,551 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS On November 3, 2017, the Company and Mission Pharmacal Company entered into Amendment Two to the Third Amendment to Trademark License and Supply Agreement, pursuant to which the Company and Mission agreed to amend the License Agreement to, among other things, include an updated budget for the development project of a new formulation of tiopronin tablets and extend the term of the License Agreement by an additional five years. |
SUMMARY OF SIGNIFICANT ACCOUN23
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The unaudited condensed consolidated financial statements represent the consolidation of the accounts of the Company and its subsidiaries in conformity with GAAP. All intercompany accounts and transactions have been eliminated in consolidation. |
Adoption of New Accounting Standards/Recently Issued Accounting Pronouncements | Adoption of New Accounting Standards In October 2016, the Financial Accounting Standard Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory. The new guidance changes the accounting for income tax effects of intra-entity transfers of assets other than inventory. Under the new guidance, the selling (transferring) entity is required to recognize a current tax expense or benefit upon transfer of the asset. Similarly, the purchasing (receiving) entity is required to recognize a deferred tax asset or deferred tax liability, as well as the related deferred tax benefit or expense, upon receipt of the asset. The new guidance will be effective for the Company starting in fiscal year 2018 on a modified retrospective basis. The Company has elected to early adopt this guidance as of January 1, 2017, and has reversed the recorded prepaid tax asset of $4.9 million related to an intra-entity transfer as a charge to accumulated deficit. In April 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. Specifically, the ASU requires all excess tax benefits and tax deficiencies (including tax benefits of dividends on share-based payment awards) to be recognized as income tax expense or benefit in the income statement. The tax effects of exercised or vested awards should be treated as discrete items in the reporting period in which they occur. An entity also should recognize excess tax benefits, and assess the need for a valuation allowance, regardless of whether the benefit reduces taxes payable in the current period. That is, off balance sheet accounting for net operating losses stemming from excess tax benefits would no longer be required and instead such net operating losses would be recognized when they arise. Existing net operating losses that were tracked off balance sheet would be recognized, net of a valuation allowance if required, through an adjustment to opening retained earnings in the period of adoption. Entities no longer need to maintain and track an “APIC pool.” The ASU also requires excess tax benefits to be classified along with other income tax cash flows as an operating activity in the statement of cash flows. In addition, the ASU elevates the statutory tax withholding threshold to qualify for equity classification up to the maximum statutory tax rates in the applicable jurisdiction(s). The ASU also clarifies that cash paid by an employer when directly withholding shares for tax withholding purposes should be classified as a financing activity. The ASU provides an optional accounting policy election (with limited exceptions), to be applied on an entity-wide basis, to either estimate the number of awards that are expected to vest (consistent with GAAP) or account for forfeitures when they occur. The Company adopted this guidance as of January 1, 2017, and as a result the tax effects related to share-based payments at settlement (or expiration) will be recorded through the statement of operations. For the three and nine months ended September 30, 2017, the Company recorded tax expense of $0.1 million and $0.5 million , respectively, net of valuation allowance released, related to the stock compensation short falls . In addition, the Company adopted accounting for forfeitures at actual rates in the period they occur. Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). Under the new standard, revenue is recognized at the time a good or service is transferred to a customer for the amount of consideration for which the entity expects to be entitled for that specific good or service. Entities may use a full retrospective approach or report the cumulative effect as of the date of adoption. On July 9, 2015, the FASB voted to defer the effective date by one year to December 15, 2017 for interim and annual reporting periods beginning after that date. Early adoption of Topic 606 is permitted but not before the original effective date (annual periods beginning after December 15, 2016). Based on the Company’s evaluation of the guidance performed to date, the Company has identified revenue sources and determined no variable consideration exists. Further the Company does not expect the new standard to change the timing of its recognition of revenue from product sales, but is continuing its review of the standard and any potential effects on disclosures. The Company will adopt the standard on January 1, 2018 and expects to do a full retrospective adoption. In February 2016, the FASB issued ASU No. 2016-02, Leases. The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is in the process of evaluating the impact of this guidance on its consolidated financial statements and related disclosures; however, based on the Company's current operating leases, it is expected to have a material impact to the consolidated balance sheet by increasing assets and liabilities. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. Topic 326 amends guidance on reporting credit losses for assets held at amortized cost basis and available for sale debt securities. For assets held at amortized cost basis, Topic 326 eliminates the probable initial recognition threshold in current GAAP and, instead, requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. For available for sale debt securities, credit losses should be measured in a manner similar to current GAAP, however Topic 326 will require that credit losses be presented as an allowance rather than as a write-down. This ASU affects entities holding financial assets and net investment in leases that are not accounted for at fair value through net income. The amendments affect loans, debt securities, trade receivables, net investments in leases, off balance sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash. This ASU is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. As of September 30, 2017 , the Company held $204.9 million in available for sale debt securities that are affected by this ASU. If adopted as of September 30, 2017 , Topic 326 would not have a material impact on the Company's consolidated financial statements. In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business . The new guidance dictates that, when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, it should be treated as an acquisition or disposal of an asset. The guidance will be effective for the fiscal year beginning on January 1, 2018, including interim periods within that year (early adoption is permitted). The Company is currently evaluating the potential effect of the guidance on its consolidated financial statements. In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception. These amendments simplify the accounting for certain financial instruments with down round features.The amendments require companies to disregard the down round feature when assessing whether the instrument is indexed to its own stock, for purposes of determining liability or equity classification. Companies that provide earnings per share (EPS) data will adjust their basic EPS calculation for the effect of the feature when triggered (i.e., when the exercise price of the related equity-linked financial instrument is adjusted downward because of the down round feature) and will also recognize the effect of the trigger within equity. The Company anticipates that it will adopt this guidance as of January 1, 2018, which may have impact on the derivative liability associated with warrants issued by the Company. |
Marketable Securities | The primary objective of the Company’s investment portfolio is to enhance overall returns while preserving capital and liquidity. The Company’s investment policy limits interest-bearing security investments to certain types of instruments issued by institutions with primarily investment grade credit ratings and places restrictions on maturities and concentration by asset class and issuer. The Company reviews the available-for-sale investments for other-than-temporary declines in fair value below cost basis each quarter and whenever events or changes in circumstances indicate that the cost basis of an asset may not be recoverable. This evaluation is based on a number of factors, including the length of time and the extent to which the fair value has been below the cost basis and adverse conditions related specifically to the security, including any changes to the credit rating of the security, and the intent to sell, or whether the Company will more likely than not be required to sell the security before recovery of its amortized cost basis. The assessment of whether a security is other-than-temporarily impaired could change in the future due to new developments or changes in assumptions related to any particular security. |
Derivatives | The Company accounts for derivative financial instruments in accordance with FASB ASC 815-40, Derivative and Hedging – Contracts in Entity’s Own Equity , pursuant to which instruments which do not have fixed settlement provisions are deemed to be derivative instruments. The Company’s warrants are classified as liability instruments due to an anti-dilution provision that provides for a reduction to the exercise price of the warrants if the Company issues additional equity or equity linked instruments in the future at an effective price per share less than the exercise price then in effect. The warrants are re-measured at each balance sheet date based on estimated fair value. Changes in estimated fair value are recorded as non-cash adjustments within other income (expenses), net, in the Company’s accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss. |
Financial Instruments and Fair Value | Financial Instruments and Fair Value The Company accounts for financial instruments in accordance with ASC 820, Fair Value Measurements and Disclosures (“ASC 820”). ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described below: Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; Level 2 – Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly; and Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable. The valuation techniques used to measure the fair value of the Company’s marketable securities and all other financial instruments, all of which have counter-parties with high credit ratings, were valued based on quoted market prices or model driven valuations using significant inputs derived from or corroborated by observable market data. Based on the fair value hierarchy, the Company classified marketable securities within Level 2. In estimating the fair value of the Company’s derivative liabilities, the Company used the Black Scholes Model as of September 30, 2017 and the Monte Carlo Simulation as of December 31, 2016 . Based on the fair value hierarchy, the Company classified the derivative liability within Level 3. In estimating the fair value of the Company’s contingent consideration, the Company used the comparable uncontrolled transaction (“CUT”) method for royalty payments based on projected revenues. Based on the fair value hierarchy, the Company classified contingent consideration within Level 3 because valuation inputs are based on projected revenues discounted to a present value. Financial instruments with carrying values approximating fair value include cash and cash equivalents, accounts receivable, notes receivable, and accounts payable, due to their short term nature. |
Loss Per Common Share | Basic and diluted net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. The Company’s potentially dilutive shares, which include outstanding stock options, restricted stock units, warrants, and shares issuable upon conversion of the Notes, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax (Expense) Benefit | The following table summarizes our effective tax rate and income tax benefit for the three and nine months ended September 30, 2017 and 2016 ( dollars in millions ): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Effective tax rate 6.4 % (21.1 )% 11.0 % 13.2 % Income tax benefit (expense) $ 1.2 $ (6.5 ) $ 5.2 $ 6.0 |
MARKETABLE SECURITIES (Tables)
MARKETABLE SECURITIES (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of marketable securities | Marketable securities consisted of the following ( in thousands ): September 30, 2017 December 31, 2016 Marketable other than equity securities: Commercial paper $ 5,497 $ 30,303 Corporate debt securities 159,170 134,570 Securities of government sponsored entities 40,215 49,998 Total marketable securities: $ 204,882 $ 214,871 |
Schedule of available for sale securities | The following is a summary of short-term marketable securities classified as available-for-sale as of September 30, 2017 ( in thousands ): Remaining Contractual Maturity Amortized Cost Unrealized Gains Unrealized Losses Aggregate Estimated Fair Value Marketable other than equity securities: Commercial paper Less than 1 $ 5,497 $ — $ — $ 5,497 Corporate debt securities Less than 1 92,029 — (127 ) 91,902 Securities of government-sponsored entities Less than 1 36,821 10 (49 ) 36,782 Total maturity less than 1 year 134,347 10 (176 ) 134,181 Corporate debt securities 1 to 2 67,397 — (129 ) 67,268 Securities of government-sponsored entities 1 to 2 3,424 9 — 3,433 Total maturity 1 to 2 years 70,821 9 (129 ) 70,701 Total available-for-sale securities $ 205,168 $ 19 $ (305 ) $ 204,882 The following is a summary of short-term marketable securities classified as available-for-sale as of December 31, 2016 ( in thousands ): Remaining Contractual Maturity (in years) Amortized Cost Unrealized Gains Unrealized Losses Aggregate Estimated Fair Value Marketable Other than Equity Securities: Commercial paper Less than 1 $ 30,330 $ — $ (27 ) $ 30,303 Corporate debt securities Less than 1 64,794 7 (91 ) 64,710 Securities of government-sponsored entities Less than 1 19,500 — (10 ) 19,490 Total maturity less than 1 year 114,624 7 (128 ) 114,503 Corporate debt securities 1 to 2 70,207 — (347 ) 69,860 Securities of government-sponsored entities 1 to 2 30,583 — (75 ) 30,508 Total maturity 1 to 2 years 100,790 — (422 ) 100,368 Total available-for-sale securities $ 215,414 $ 7 $ (550 ) $ 214,871 |
DERIVATIVE FINANCIAL INSTRUME26
DERIVATIVE FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Schedule of assumptions for valuation of warrants | The Company calculated the fair value of the warrants using the Black-Scholes Model as of September 30, 2017 and the Monte Carlo Simulation as of December 31, 2016 , using the following assumptions: September 30, 2017 December 31, 2016 Fair value of common stock $ 24.89 $ 18.93 Remaining life of the warrants (in years) 0.4 - 2.3 years 1.2 - 3.0 years Risk-free interest rate 1.1 - 1.6% .89 - 1.48% Expected volatility 32 - 50% 55 - 75% Dividend yield — % — % |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value on a recurring basis | The following table presents the Company’s assets and liabilities, measured and recognized at fair value on a recurring basis, classified under the appropriate level of the fair value hierarchy as of September 30, 2017 ( in thousands ): As of September 30, 2017 Total carrying and estimated fair value Quoted prices in active markets Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Marketable securities, available-for-sale $ 204,882 $ — $ 204,882 $ — Total $ 204,882 $ — $ 204,882 $ — Liabilities: Derivative liability related to warrants $ 20,140 $ — $ — $ 20,140 Business combination-related contingent consideration 92,915 — — 92,915 Total $ 113,055 $ — $ — $ 113,055 The following table presents the Company’s assets and liabilities, measured and recognized at fair value on a recurring basis, classified under the appropriate level of the fair value hierarchy as of December 31, 2016 ( in thousands ): As of December 31, 2016 Total carrying and estimated fair value Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Marketable securities, available-for-sale 214,871 — 214,871 — Total $ 214,871 $ — $ 214,871 $ — Liabilities: Derivative liability related to warrants $ 22,440 $ — $ — $ 22,440 Business combination-related contingent consideration 87,478 — — 87,478 Total $ 109,918 $ — $ — $ 109,918 |
Schedule of estimated fair value of the derivative financial instruments,warrants liability | The following table sets forth a summary of changes in the estimated fair value of the Company’s derivative financial instrument-warrants liability for the nine months ended September 30, 2017 ( in thousands ): Fair Value Measurements of Common Stock Warrants Using Significant Unobservable Inputs (Level 3) Balance at January 1, 2017 $ 22,440 Reclassification of derivative liability to equity upon exercise of warrants (11,221 ) Change in estimated fair value of liability classified warrants 8,921 Balance at September 30, 2017 $ 20,140 |
Schedule of summary of changes in estimated acquisition related contingent consideration | The following table sets forth a summary of changes in the estimated fair value of the Company's business combination-related contingent consideration for the nine months ended September 30, 2017 ( in thousands ): Fair Value Measurements of Acquisition-Related Contingent Consideration Balance at January 1, 2017 $ 87,478 Increase from revaluation of contingent consideration 11,057 Contractual payments included in accrued liabilities at September 30, 2017 (1,993 ) Contractual payments (3,782 ) Foreign currency impact 155 Balance at September 30, 2017 $ 92,915 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite-Lived amortizable intangible assets | The following table sets forth amortizable intangible assets as of September 30, 2017 and December 31, 2016 ( in thousands ): September 30, 2017 December 31, 2016 Finite-lived intangible assets $ 226,249 $ 215,540 Less: accumulated amortization (46,680 ) (33,497 ) Net carrying value $ 179,569 $ 182,043 |
Schedule of amortization expense | The following table summarizes amortization expense for the three and nine months ended September 30, 2017 and 2016 ( in thousands ): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Research and development $ 82 $ 82 $ 244 $ 245 Selling, general and administrative 4,424 3,987 12,752 11,619 Total amortization expense $ 4,506 $ 4,069 $ 12,996 $ 11,864 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses at September 30, 2017 and December 31, 2016 consisted of the following ( in thousands ): September 30, 2017 December 31, 2016 Government rebates payable $ 5,614 $ 6,967 Compensation related costs 6,885 7,441 Accrued royalties and contingent consideration 6,144 5,766 Research and development 7,218 7,311 Selling, general and administrative 1,933 3,333 Restructuring expenses 2,551 893 Miscellaneous accrued 1,908 1,597 Total accrued expenses $ 32,253 $ 33,308 |
LOSS PER COMMON SHARE (Tables)
LOSS PER COMMON SHARE (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Earnings Per Share [Abstract] | |
Schedule of basic and diluted net income (loss) per share | Basic and diluted net loss per share is calculated as follows (net loss amounts are stated in thousands) : Three Months Ended September 30, 2017 2016 Shares Net Loss EPS Shares Net Loss EPS Basic loss per share 38,654,086 $ (17,794 ) $ (0.46 ) 36,980,356 $ (37,113 ) $ (1.00 ) Dilutive loss per share 38,654,086 $ (17,794 ) $ (0.46 ) 36,980,356 $ (37,113 ) $ (1.00 ) Nine Months Ended September 30, 2017 2016 Shares Net Loss EPS Shares Net Loss EPS Basic loss per share 38,301,893 $ (42,113 ) $ (1.10 ) 36,728,911 $ (39,300 ) $ (1.07 ) Dilutive loss per share 38,301,893 $ (42,113 ) $ (1.10 ) 36,728,911 $ (39,300 ) $ (1.07 ) |
Schedule of common stock options, convertible debt and restricted stock units anti-dilutive | The following shares were excluded because they were anti-dilutive ( in thousands ): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Restricted stock units 145 281 175 310 Convertible debt 2,642 2,642 2,642 2,642 Options 7,515 6,720 6,960 6,149 Warrants 1,159 1,768 1,159 1,768 Total anti-dilutive shares 11,461 11,411 10,936 10,869 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of property subject to or available for operating lease | Leases and Sublease Agreements Facilities Annual Base Rent Lease Expiration Comments Occupied Locations Corporate Headquarters San Diego CA $2.2 million July 2024 Cambridge MA January 2018 Subleased space for less than one year Vacated Locations San Diego CA $0.5 million December 2017 Available for sublease New York NY $0.5 million November 2018 Sublet through expiration |
Schedule of principal contractual commitments | The following table summarizes our principal contractual commitments, excluding open orders that support normal operations, as of September 30, 2017 ( in thousands ): Total Less than 1 year 1-3 years 3-5 years More than 5 years Operating leases $ 17,015 $ 2,326 $ 4,817 $ 5,010 $ 4,862 Guaranteed minimum royalty 13,500 2,000 4,000 4,000 3,500 Convertible note payable, including contractual interest 49,968 2,070 47,898 — — Sales support services 2,741 416 833 833 659 Product supply contracts 1,846 1,429 417 — — Purchase order commitments 387 350 37 — — $ 85,457 $ 8,591 $ 58,002 $ 9,843 $ 9,021 |
SHARE BASED COMPENSATION (Table
SHARE BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Schedule of restricted stock activity | The following table summarizes the Company’s restricted stock activity during the nine months ended September 30, 2017 : Number of Restricted Stock Units Weighted Average Grant Date Fair Value Unvested December 31, 2016 407,746 $ 19.88 Granted 157,750 18.32 Vested (167,584 ) 17.97 Forfeited/canceled (6,500 ) 23.28 Unvested September 30, 2017 391,412 $ 20.01 |
Schedule of stock option issuances and balances outstanding | The following table summarizes stock option activity during the nine months ended September 30, 2017 : Shares Underlying Options Weighted Average Exercise Price Weighted Average Remaining Contractual Life (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2016 6,430,570 $ 16.91 7.64 30,088 Granted 2,035,300 18.35 Exercised (598,968 ) 12.85 Forfeited/canceled (394,166 ) 25.05 Outstanding at September 30, 2017 7,472,736 $ 17.20 7.71 $ 63,956 |
Schedule of Share based compensation expenses | The following table sets forth total non-cash stock-based compensation by operating statement classification for the three and nine months ended September 30, 2017 and 2016 ( in thousands ): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Research and development $ 1,998 $ 2,934 $ 7,113 $ 8,061 Selling, general & administrative 4,962 4,814 14,179 13,973 Total $ 6,960 $ 7,748 $ 21,292 $ 22,034 |
INVENTORY (Tables)
INVENTORY (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory, net of reserves, consisted of the following at September 30, 2017 and December 31, 2016 ( in thousands ): September 30, 2017 December 31, 2016 Raw materials $ 2,766 $ 1,336 Finished goods 1,552 1,490 Total inventory $ 4,318 $ 2,826 |
RESTRUCTURING (Tables)
RESTRUCTURING (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Costs | The following presents restructuring expense by quarter for 2017 ( in thousands ): Restructuring expense March 31, 2017* $ 498 June 30, 2017* 981 September 30, 2017 1,132 Nine months ended September 30, 2017 $ 2,611 *Restructuring expense for the first and second quarter of 2017 were not separately presented on the Consolidated Statements of Operations and Comprehensive Loss. The following table presents a reconciliation of the restructuring liability recorded within accrued expenses on the Company's Condensed Consolidated Balance Sheets for the three and nine months ended September 30, 2017 ( in thousands ): Three Months Ended September 30, 2017 Nine Months Ended September 30, 2017 Liability, beginning of period $ 1,420 $ 893 Restructuring expenses 1,131 2,611 Cash settlements — (898 ) Adjustments to previous estimates — (55 ) Liability, end of period $ 2,551 $ 2,551 |
SUMMARY OF SIGNIFICANT ACCOUN35
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Debt Instrument [Line Items] | |||||
Income tax expense (benefit) | $ (1,223) | $ 6,467 | $ (5,212) | $ (5,994) | |
Marketable securities | 204,882 | 204,882 | $ 214,871 | ||
Accounting Standards Update 2016-09 | |||||
Debt Instrument [Line Items] | |||||
Income tax expense (benefit) | $ 100 | $ 500 | |||
New Accounting Pronouncement, Early Adoption, Effect | |||||
Debt Instrument [Line Items] | |||||
Reversal of prepaid tax asset related to intra-entity transfer | 4,900 | ||||
New Accounting Pronouncement, Early Adoption, Effect | Retained Earnings | |||||
Debt Instrument [Line Items] | |||||
Cumulative effect of new accounting principle in period of adoption | $ 4,900 |
INCOME TAXES Summary of Effecti
INCOME TAXES Summary of Effective Tax Rate and Income Tax Benefit (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | ||||
Income tax benefit (expense) | $ 1,223 | $ (6,467) | $ 5,212 | $ 5,994 |
Effective tax rate | 6.40% | (21.10%) | 11.00% | 13.20% |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35.00% | 35.00% |
INCOME TAXES Additional Informa
INCOME TAXES Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||||
Income tax benefit (expense) | $ 1,223,000 | $ (6,467,000) | $ 5,212,000 | $ 5,994,000 | |
Unrecognized tax benefits | 1,500,000 | $ 1,500,000 | $ 1,500,000 | ||
Unrecognized tax benefits, income tax penalties and interest expense | $ 0 | ||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35.00% | 35.00% |
MARKETABLE SECURITIES - Additio
MARKETABLE SECURITIES - Additional Information (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Investments, Debt and Equity Securities [Abstract] | ||
Proceeds from the sale/maturity of marketable securities | $ 76,826 | $ 92,609 |
MARKETABLE SECURITIES - Marketa
MARKETABLE SECURITIES - Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Schedule of Available-for-sale Securities [Line Items] | ||
Marketable securities | $ 204,882 | $ 214,871 |
Commercial paper | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Marketable securities | 5,497 | 30,303 |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Marketable securities | 159,170 | 134,570 |
Securities of government sponsored entities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Marketable securities | $ 40,215 | $ 49,998 |
MARKETABLE SECURITIES - Availab
MARKETABLE SECURITIES - Available for Sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 205,168 | $ 215,414 |
Unrealized Gains | 19 | 7 |
Unrealized Losses | (305) | (550) |
Aggregate Estimated Fair Value | 204,882 | 214,871 |
Less than 1 year | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 134,347 | 114,624 |
Unrealized Gains | 10 | 7 |
Unrealized Losses | (176) | (128) |
Aggregate Estimated Fair Value | 134,181 | 114,503 |
1 to 2 years | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 70,821 | 100,790 |
Unrealized Gains | 9 | 0 |
Unrealized Losses | (129) | (422) |
Aggregate Estimated Fair Value | 70,701 | 100,368 |
Commercial paper | Less than 1 year | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 5,497 | 30,330 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | (27) |
Aggregate Estimated Fair Value | 5,497 | 30,303 |
Corporate debt securities | Less than 1 year | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 92,029 | 64,794 |
Unrealized Gains | 0 | 7 |
Unrealized Losses | (127) | (91) |
Aggregate Estimated Fair Value | 91,902 | 64,710 |
Corporate debt securities | 1 to 2 years | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 67,397 | 70,207 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (129) | (347) |
Aggregate Estimated Fair Value | 67,268 | 69,860 |
Securities of government sponsored entities | Less than 1 year | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 36,821 | 19,500 |
Unrealized Gains | 10 | 0 |
Unrealized Losses | (49) | (10) |
Aggregate Estimated Fair Value | 36,782 | 19,490 |
Securities of government sponsored entities | 1 to 2 years | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 3,424 | 30,583 |
Unrealized Gains | 9 | 0 |
Unrealized Losses | 0 | (75) |
Aggregate Estimated Fair Value | $ 3,433 | $ 30,508 |
DERIVATIVE FINANCIAL INSTRUME41
DERIVATIVE FINANCIAL INSTRUMENTS (Details) - Warrants $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($)tranche | Sep. 30, 2016USD ($) | |
Derivative [Line Items] | ||||
Number of tranches | tranche | 5 | |||
Loss on derivative instruments, pretax | $ | $ 8.9 | $ 10.1 | $ 8.9 | $ 4.8 |
DERIVATIVE FINANCIAL INSTRUME42
DERIVATIVE FINANCIAL INSTRUMENTS - Valuation Assumptions (Details) - Warrants - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Derivative [Line Items] | ||
Fair value of common stock (in dollars per share) | $ 24.89 | $ 18.93 |
Dividend yield | 0.00% | 0.00% |
Minimum | ||
Derivative [Line Items] | ||
Remaining life of the warrants (in years) | 4 months 24 days | 1 year 2 months 12 days |
Risk-free interest rate | 1.10% | 0.89% |
Expected volatility | 32.00% | 55.00% |
Maximum | ||
Derivative [Line Items] | ||
Remaining life of the warrants (in years) | 2 years 3 months 18 days | 3 years |
Risk-free interest rate | 1.60% | 1.48% |
Expected volatility | 50.00% | 75.00% |
FAIR VALUE MEASUREMENTS - Addit
FAIR VALUE MEASUREMENTS - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Business Acquisition [Line Items] | ||||
Fair value of convertible debt | $ 71,700 | $ 71,700 | ||
Change in fair value of contingent consideration | $ 4,429 | $ 5,256 | 11,057 | $ 10,741 |
Increase from revaluation of contingent consideration | (885) | (772) | ||
Product Rights Chenodal | ||||
Business Acquisition [Line Items] | ||||
Increase from revaluation of contingent consideration | 5,000 | 4,400 | ||
Acquired Product Rights Cholbam | ||||
Business Acquisition [Line Items] | ||||
Increase from revaluation of contingent consideration | 3,800 | 4,400 | ||
Acquired Product Rights L-UDCA | ||||
Business Acquisition [Line Items] | ||||
Increase from revaluation of contingent consideration | $ 2,300 | $ 1,900 |
FAIR VALUE MEASUREMENTS - Asset
FAIR VALUE MEASUREMENTS - Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Assets: | ||
Marketable securities, available-for-sale | $ 204,882 | $ 214,871 |
Derivative liability related to warrants | ||
Derivative liability related to warrants | 20,140 | 22,440 |
Recurring basis | ||
Assets: | ||
Marketable securities, available-for-sale | 204,882 | 214,871 |
Total | 204,882 | 214,871 |
Derivative liability related to warrants | ||
Derivative liability related to warrants | 20,140 | 22,440 |
Business combination-related contingent consideration | 92,915 | 87,478 |
Total | 113,055 | 109,918 |
Recurring basis | Quoted prices in active markets (Level 1) | ||
Assets: | ||
Marketable securities, available-for-sale | 0 | 0 |
Total | 0 | 0 |
Derivative liability related to warrants | ||
Derivative liability related to warrants | 0 | 0 |
Business combination-related contingent consideration | 0 | 0 |
Total | 0 | 0 |
Recurring basis | Significant other observable inputs (Level 2) | ||
Assets: | ||
Marketable securities, available-for-sale | 204,882 | 214,871 |
Total | 204,882 | 214,871 |
Derivative liability related to warrants | ||
Derivative liability related to warrants | 0 | 0 |
Business combination-related contingent consideration | 0 | 0 |
Total | 0 | 0 |
Recurring basis | Significant unobservable inputs (Level 3) | ||
Assets: | ||
Marketable securities, available-for-sale | 0 | 0 |
Total | 0 | 0 |
Derivative liability related to warrants | ||
Derivative liability related to warrants | 20,140 | 22,440 |
Business combination-related contingent consideration | 92,915 | 87,478 |
Total | $ 113,055 | $ 109,918 |
FAIR VALUE MEASUREMENTS - Warra
FAIR VALUE MEASUREMENTS - Warrants Liability (Details) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2017 | Sep. 30, 2017 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Reclassification of derivative liability to equity upon exercise of warrants | $ 0 | |
Warrants liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance at January 1, 2017 | $ 22,440,000 | |
Reclassification of derivative liability to equity upon exercise of warrants | (11,221,000) | |
Change in estimated fair value of liability classified warrants | 8,921,000 | |
Balance at September 30, 2017 | $ 20,140,000 | $ 20,140,000 |
FAIR VALUE MEASUREMENTS - Acqui
FAIR VALUE MEASUREMENTS - Acquisition-related Contingent Consideration (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Increase from revaluation of contingent consideration | $ (885) | $ (772) |
Recurring basis | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Balance at January 1, 2017 | 87,478 | |
Increase from revaluation of contingent consideration | 11,057 | |
Contractual payments included in accrued liabilities at September 30, 2017 | (1,993) | |
Contractual payments | (3,782) | |
Foreign currency impact | 155 | |
Balance at September 30, 2017 | $ 92,915 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Net book value of amortizable intangible assets | $ 179,569 | $ 182,043 |
INTANGIBLE ASSETS - Amortizable
INTANGIBLE ASSETS - Amortizable Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Finite-lived intangible assets | $ 226,249 | $ 215,540 |
Less: accumulated amortization | (46,680) | (33,497) |
Net carrying value | $ 179,569 | $ 182,043 |
INTANGIBLE ASSETS - Amortizatio
INTANGIBLE ASSETS - Amortization (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Finite-Lived Intangible Assets [Line Items] | ||||
Total amortization expense | $ 4,506 | $ 4,069 | $ 12,996 | $ 11,864 |
Research and development | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Total amortization expense | 82 | 82 | 244 | 245 |
Selling, general and administrative | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Total amortization expense | $ 4,424 | $ 3,987 | $ 12,752 | $ 11,619 |
CONVERTIBLE NOTES PAYABLE (Deta
CONVERTIBLE NOTES PAYABLE (Details) - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 | May 29, 2014 |
Debt Instrument [Line Items] | |||
Convertible debt | $ 44,911,000 | $ 44,422,000 | |
Note Purchase Agreement | Senior convertible notes due 2019 | |||
Debt Instrument [Line Items] | |||
Credit agreement amount | $ 46,000,000 | ||
Initial conversion price (in dollars per share) | $ 17.41 | ||
Interest rate percentage | 4.50% |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Jun. 30, 2017 | Dec. 31, 2016 |
Payables and Accruals [Abstract] | |||
Government rebates payable | $ 5,614 | $ 6,967 | |
Compensation related costs | 6,885 | 7,441 | |
Accrued royalties and contingent consideration | 6,144 | 5,766 | |
Research and development | 7,218 | 7,311 | |
Selling, general and administrative | 1,933 | 3,333 | |
Restructuring expenses | 2,551 | $ 1,420 | 893 |
Miscellaneous accrued | 1,908 | 1,597 | |
Total accrued expenses | $ 32,253 | $ 33,308 |
LOSS PER COMMON SHARE - EPS Rec
LOSS PER COMMON SHARE - EPS Reconciliation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Shares | ||||
Basic net loss per share (in shares) | 38,654,086 | 36,980,356 | 38,301,893 | 36,728,911 |
Weighted average common shares outstanding, diluted (in shares) | 38,654,086 | 36,980,356 | 38,301,893 | 36,728,911 |
Net Loss | ||||
Net loss | $ (17,794) | $ (37,113) | $ (42,113) | $ (39,300) |
Dilutive net earnings (loss) per share | $ (17,794) | $ (37,113) | $ (42,113) | $ (39,300) |
Net earnings (loss) per common share, basic (in dollars per share) | $ (0.46) | $ (1) | $ (1.10) | $ (1.07) |
Net earnings (loss) per common share, diluted (in dollars per share) | $ (0.46) | $ (1) | $ (1.10) | $ (1.07) |
LOSS PER COMMON SHARE - Antidil
LOSS PER COMMON SHARE - Antidilutive Shares (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from the calculation | 11,461 | 11,411 | 10,936 | 10,869 |
Restricted stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from the calculation | 145 | 281 | 175 | 310 |
Convertible debt | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from the calculation | 2,642 | 2,642 | 2,642 | 2,642 |
Options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from the calculation | 7,515 | 6,720 | 6,960 | 6,149 |
Warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from the calculation | 1,159 | 1,768 | 1,159 | 1,768 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Leases and Subleases Commitment (Details) - Lease Agreement | 9 Months Ended |
Sep. 30, 2017USD ($) | |
San Diego CA- Corporate | |
Other Commitments [Line Items] | |
Annual Base Rent | $ 2,200,000 |
CALIFORNIA | |
Other Commitments [Line Items] | |
Annual Base Rent | 500,000 |
NEW YORK | |
Other Commitments [Line Items] | |
Annual Base Rent | $ 500,000 |
COMMITMENTS AND CONTINGENCIES55
COMMITMENTS AND CONTINGENCIES - Contractual Commitments (Details) $ in Thousands | Sep. 30, 2017USD ($) |
Operating leases | |
Total | $ 17,015 |
Less than 1 year | 2,326 |
1-3 years | 4,817 |
3-5 years | 5,010 |
More than 5 years | 4,862 |
Guaranteed Minimum Royalty [Abstract] | |
Total | 13,500 |
Less than 1 year | 2,000 |
1-3 years | 4,000 |
3-5 years | 4,000 |
More than 5 years | 3,500 |
Purchase order commitments | |
Total | 387 |
Less than 1 year | 350 |
1-3 years | 37 |
3-5 years | 0 |
More than 5 years | 0 |
Total | |
Total | 85,457 |
Less than 1 year | 8,591 |
1-3 years | 58,002 |
3-5 years | 9,843 |
More than 5 years | 9,021 |
Convertible note payable, including contractual interest | |
Other commitments | |
Total | 49,968 |
Less than 1 year | 2,070 |
1-3 years | 47,898 |
3-5 years | 0 |
More than 5 years | 0 |
Sales support services | |
Other commitments | |
Total | 2,741 |
Less than 1 year | 416 |
1-3 years | 833 |
3-5 years | 833 |
More than 5 years | 659 |
Product supply contracts | |
Other commitments | |
Total | 1,846 |
Less than 1 year | 1,429 |
1-3 years | 417 |
3-5 years | 0 |
More than 5 years | $ 0 |
COMMITMENTS AND CONTINGENCIES56
COMMITMENTS AND CONTINGENCIES - Additional Information (Details) - Martin Shkreli - USD ($) $ in Thousands | Apr. 22, 2016 | Dec. 17, 2015 | Sep. 19, 2014 | Nov. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2017 | Sep. 30, 2017 | Dec. 31, 2016 | Dec. 31, 2016 |
Commitment And Contingency [Line Items] | |||||||||
Loss contingency, damages sought, value | $ 5,000 | ||||||||
Legal fees paid in advance | $ 2,800 | ||||||||
Contingent future legal fee advance payment | $ 2,000 | ||||||||
Legal fees reimbursed from director and officer insurance carriers | $ 3,300 | $ 2,600 | $ 2,600 | $ 700 | |||||
Legal fees | 0 | 2,000 | 5,200 | ||||||
Payments for legal settlements | $ 0 | $ 3,000 | $ 2,300 | ||||||
Retrophin, Inc. v. Shkreli | |||||||||
Commitment And Contingency [Line Items] | |||||||||
Legal fees paid in advance | $ 400 | $ 2,800 | |||||||
Litigation settlement, amount awarded from other party | $ 2,025 |
SHARE BASED COMPENSATION - Rest
SHARE BASED COMPENSATION - Restricted Stock Activity (Details) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2017USD ($)$ / sharesshares | Sep. 30, 2017USD ($)$ / sharesshares | |
Restricted stock units | ||
Number of Restricted Stock Units | ||
Beginning Balance (in shares) | 407,746,000 | |
Granted (in shares) | 157,750,000 | |
Vested (in shares) | (167,584,000) | |
Forfeited/canceled (in shares) | (6,500,000) | |
Ending Balance (in share) | 391,412,000 | 391,412,000 |
Weighted Average Grant Date Fair Value | ||
Beginning balance (in dollars per share) | $ / shares | $ 19.88 | |
Granted (in dollars per share) | $ / shares | 18.32 | |
Vested (in dollars per share) | $ / shares | 17.97 | |
Forfeited/canceled (in dollars per share) | $ / shares | 23.28 | |
Ending balance (in dollars per share) | $ / shares | $ 20.01 | $ 20.01 |
Unamortized stock compensation expense | $ | $ 3.4 | $ 3.4 |
Weighted-average recognition period (in years) | 1 year | |
Performance Based Restricted Stock Awards | ||
Number of Restricted Stock Units | ||
Granted (in shares) | 0 | 108,500 |
SHARE BASED COMPENSATION - Stoc
SHARE BASED COMPENSATION - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Weighted Average Exercise Price | ||
Number of shares exercisable (in shares) | 4,300,000 | |
Weighted average exercise price (in dollars per share) | $ 15.64 | |
Stock Options | ||
Shares Underlying Options | ||
Beginning Balance (in shares) | 6,430,570 | |
Granted (in shares) | 2,035,300 | |
Exercised (in shares) | (598,968) | |
Forfeited/canceled (in shares) | (394,166) | |
Ending Balance (in shares) | 7,472,736 | 6,430,570 |
Weighted Average Exercise Price | ||
Beginning balance (in dollars per share) | $ 16.91 | |
Granted (in dollars per share) | 18.35 | |
Exercised (in dollars per share) | 12.85 | |
Forfeited/canceled (in dollars per share) | 25.05 | |
Ending balance (in dollars per share) | $ 17.20 | $ 16.91 |
Weighted Average Remaining Contractual Life (years) | 7 years 8 months 16 days | 7 years 7 months 21 days |
Aggregate Intrinsic Value (in thousands) | $ 63,956 | $ 30,088 |
Unamortized stock compensation expense | $ 35,800 | |
Weighted-average recognition period (in years) | 2 years 8 months 12 days |
SHARE BASED COMPENSATION - St59
SHARE BASED COMPENSATION - Stock based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 6,960 | $ 7,748 | $ 21,292 | $ 22,034 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 1,998 | 2,934 | 7,113 | 8,061 |
Selling, general & administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 4,962 | $ 4,814 | $ 14,179 | $ 13,973 |
SHARE BASED COMPENSATION - Exer
SHARE BASED COMPENSATION - Exercise of Warrants (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Class of Stock [Line Items] | |||||
Warrants exercised (in shares) | 607,481 | 607,481 | |||
Proceeds from warrant exercises | $ 3,600,000 | $ 3,600,000 | |||
Reclassification of derivative liability to equity upon exercise of warrants | 0 | ||||
Changes in fair value | $ 8,901,000 | $ 10,126,000 | $ 8,921,000 | $ 4,849,000 | |
Warrants outstanding (in shares) | 1,159,424 | 1,159,424 | 1,766,905 | ||
Warrants | |||||
Class of Stock [Line Items] | |||||
Reclassification of derivative liability to equity upon exercise of warrants | $ 11,200,000 | ||||
Warrants | Other Expense | |||||
Class of Stock [Line Items] | |||||
Changes in fair value | $ 3,000,000 |
INVENTORY (Details)
INVENTORY (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,766 | $ 1,336 |
Finished goods | 1,552 | 1,490 |
Total inventory | 4,318 | 2,826 |
Inventory reserve | $ 500 | $ 600 |
RECEIVABLES (Details)
RECEIVABLES (Details) - USD ($) | 1 Months Ended | 9 Months Ended | ||
Jul. 31, 2015 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Accounts receivable, net of reserves | $ 14,543,000 | $ 18,510,000 | ||
Proceeds from maturity of note receivable | 47,500,000 | $ 47,500,000 | ||
Notes receivable | 0 | $ 46,849,000 | ||
Asklepion Pharmaceuticals, LLC | Asset Purchase Agreement | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Proceeds from maturity of note receivable | $ 245,000,000 | |||
Discount rate of future payments to be received | 2.80% | |||
At Time Of Closing | Asset Purchase Agreement | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Present value of future payments to be received | $ 46,200,000 | |||
At Time Of Closing | Asklepion Pharmaceuticals, LLC | Asset Purchase Agreement | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Proceeds from maturity of note receivable | 150,000,000 | |||
Due On First And Second Anniversaries Of Closing | Asset Purchase Agreement | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Present value of future payments to be received | 44,900,000 | |||
Due On First And Second Anniversaries Of Closing | Asklepion Pharmaceuticals, LLC | Asset Purchase Agreement | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Proceeds from maturity of note receivable | $ 47,500,000 | |||
Interest expense | Asklepion Pharmaceuticals, LLC | Asset Purchase Agreement | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Accretion on notes receivable | $ 600,000 |
RESTRUCTURING - Narrative (Deta
RESTRUCTURING - Narrative (Details) $ in Millions | Sep. 30, 2017USD ($) |
Restructuring Cost and Reserve [Line Items] | |
Restructuring costs, remaining costs expected to be incurred | $ 1.4 |
Employee Severance | |
Restructuring Cost and Reserve [Line Items] | |
Restructure costs expected to be incurred | $ 4 |
RESTRUCTURING - Schedule Of Res
RESTRUCTURING - Schedule Of Restructuring And Related Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Restructuring and Related Activities [Abstract] | ||||||
Restructuring | $ 1,132 | $ 981 | $ 498 | $ 396 | $ 2,611 | $ 481 |
RESTRUCTURING - Reconciliation
RESTRUCTURING - Reconciliation of Restructuring Liability (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2017 | Sep. 30, 2017 | |
Restructuring Reserve [Roll Forward] | ||
Liability, beginning of period | $ 1,420 | $ 893 |
Restructuring expenses | 1,131 | 2,611 |
Cash settlements | 0 | (898) |
Adjustments to previous estimates | 0 | (55) |
Liability, end of period | $ 2,551 | $ 2,551 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) | Nov. 03, 2017 |
License Agreement Terms | Subsequent Event | |
Subsequent Event [Line Items] | |
Extended term of the license agreement | 5 years |