Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Mar. 16, 2017 | Jun. 30, 2016 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | NVLN | ||
Entity Registrant Name | NOVELION THERAPEUTICS INC. | ||
Entity Central Index Key | 827,809 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 18,558,072 | ||
Entity Public Float | $ 46,106,522 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 | |
Current assets | |||
Cash and cash equivalents (Note 14) | $ 108,927 | $ 141,824 | |
Restricted cash (Note 14) | 390 | 0 | |
Accounts receivable, net (Note 2) | 9,339 | 287 | |
Inventories - current (Note 6) | 15,718 | 0 | |
Insurance proceeds receivable (Note 16) | 22,000 | 0 | |
Prepaid expenses and other current assets | 9,762 | 625 | |
Total current assets | 166,136 | 142,736 | |
Inventories - non-current (Note 6) | 59,003 | 0 | |
Property and equipment, net (Note 7) | 4,159 | 430 | |
Accounts receivable - non-current (Note 16) | 0 | 2,000 | |
Intangible assets, net (Note 8) | 250,324 | 0 | |
Other assets | 1,160 | 0 | |
Total assets | 480,782 | 145,166 | |
Current liabilities | |||
Accounts payable | 17,609 | 1,656 | |
Accrued liabilities (Note 9) | 37,180 | 1,827 | |
Provision for legal settlement (Note 16) | 64,010 | 0 | |
Total current liabilities | 118,799 | 3,483 | |
Long-term liabilities: | |||
Convertible notes, net (Note 10) | 225,584 | 0 | |
Uncertain tax position liabilities, net (Note 13) | 381 | 342 | |
Other liabilities | 231 | 0 | |
Total liabilities | 344,995 | 3,825 | |
Contingencies, Commitments and Guarantees (Note 16) | |||
Share capital (Note 11) | |||
Common shares, without par value, 100,000,000 shares authorized at December 31, 2016 and 2015; 18,530,323 and 10,565,879(1) shares issued at December 31, 2016 and 2015, respectively. | [1] | 551,259 | 475,333 |
Additional paid-in-capital | 69,149 | 97,377 | |
Accumulated deficit | (587,208) | (534,338) | |
Accumulated other comprehensive items | 102,587 | 102,969 | |
Total shareholders’ equity | 135,787 | 141,341 | |
Total liabilities and shareholders’ equity | $ 480,782 | $ 145,166 | |
[1] | Amounts have been retroactively restated for all prior periods presented to reflect the one-for-five share consolidation of the Company’s common stock effected on December 16, 2016. |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) | Dec. 16, 2016shares | Dec. 31, 2016shares | Dec. 15, 2016shares | Dec. 31, 2015shares | |||
Statement of Financial Position [Abstract] | |||||||
Common stock, shares authorized (in shares) | [1] | 100,000,000 | 100,000,000 | ||||
Common stock, shares issued (in shares) | 18,530,323 | 18,530,323 | [1] | 92,653,562 | 10,565,489 | [1] | |
Stock consolidation ratio | 0.20 | ||||||
[1] | Amounts have been retroactively restated for all prior periods presented to reflect the one-for-five share consolidation of the Company’s common stock effected on December 16, 2016. |
Consolidated Statements of Oper
Consolidated Statements of Operations shares in Thousands, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)$ / sharesshares | ||
Income Statement [Abstract] | ||||
Net product sales | $ 13,574 | $ 0 | $ 0 | |
Cost of product sales | 5,971 | 0 | 0 | |
Operating expenses | ||||
Selling, general and administrative | 29,525 | 16,222 | 17,682 | |
Research and development | 14,784 | 9,790 | 13,803 | |
Restructuring charges | 0 | 0 | 744 | |
Termination Fee (Note 3) | 0 | (2,667) | (28,400) | |
Total operating expenses | 44,309 | 23,345 | 3,829 | |
Loss from operations | (36,706) | (23,345) | (3,829) | |
Interest (expense) income, net | (2,960) | 277 | 113 | |
Fair value loss on investment (Note 4) | (10,740) | 0 | 0 | |
Other income (expense), net | (1,999) | 81 | (481) | |
Loss from continuing operations before income taxes | (52,405) | (22,987) | (4,197) | |
Provision for Income tax (expense) recovery (Note 13) | (465) | (22) | 192 | |
Loss from continuing operations | (52,870) | (23,009) | (4,005) | |
Loss from discontinued operations, net of income taxes | 0 | 0 | (66) | |
Net loss | $ (52,870) | $ (23,009) | $ (4,071) | |
Basic and diluted net loss per common share | ||||
Continuing operations (in dollars per share) | $ / shares | [1] | $ (4.69) | $ (2.20) | $ (0.40) |
Discontinued operation (in dollars per share) | $ / shares | [1],[2] | 0 | 0 | 0 |
Net loss per common share (in dollars per share) | $ / shares | [1] | $ (4.69) | $ (2.20) | $ (0.40) |
Weighted-average shares outstanding—basic and diluted (thousands) | ||||
Basic and diluted (in shares) | shares | [1] | 11,284 | 10,434 | 10,225 |
[1] | Amounts have been retroactively restated for all prior periods presented to reflect the one-for-five share consolidation of the Company’s common stock effected on December 16, 2016 | |||
[2] | Rounded to zero. |
Consolidated Statement of Compr
Consolidated Statement of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (52,870) | $ (23,009) | $ (4,071) |
Other comprehensive loss, net of tax: | |||
Foreign currency translation | (382) | 0 | 0 |
Other comprehensive loss | (382) | 0 | 0 |
Comprehensive loss | $ (53,252) | $ (23,009) | $ (4,071) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity $ in Thousands | USD ($)shares | CAD / shares | Common SharesUSD ($)shares | Additional Paid-In CapitalUSD ($) | Accumulated DeficitUSD ($) | Accumulated Other Comprehensive IncomeUSD ($) | |
Beginning Balance (in shares) at Dec. 31, 2013 | shares | [1] | 10,215,985 | |||||
Beginning Balance at Dec. 31, 2013 | $ 157,784 | $ 466,229 | $ 95,844 | $ (507,258) | $ 102,969 | ||
Exercise of stock options, for cash (in shares) | shares | [1] | 20,809 | |||||
Exercise of stock options, for cash | 509 | $ 750 | (241) | ||||
Shares issued in connection with RSUs vested (in shares) | shares | [1] | 2,800 | |||||
Shares issued in connection with RSUs vested (Note 12) | 0 | $ 55 | (55) | ||||
Uncertain tax position liability recovery (Note 13) | 837 | 837 | |||||
Stock-based compensation expense (Note 12) | 1,453 | 1,453 | |||||
Foreign currency translation adjustment | 0 | ||||||
Net loss | (4,071) | (4,071) | |||||
Ending Balance (in shares) at Dec. 31, 2014 | shares | [1] | 10,239,594 | |||||
Ending Balance at Dec. 31, 2014 | 156,512 | $ 467,034 | 97,838 | (511,329) | 102,969 | ||
Exercise of stock options, for cash, lower range limit price (in cad per share) | CAD / shares | CAD 22.7 | ||||||
Exercise of stock options, for cash, upper range limit price (in cad per share) | CAD / shares | 26.9 | ||||||
Exercise of stock options, for cash (in shares) | shares | [1] | 313,095 | |||||
Exercise of stock options, for cash | 5,508 | $ 8,077 | (2,569) | ||||
Shares issued in connection with RSUs vested (in shares) | shares | [1] | 12,800 | |||||
Shares issued in connection with RSUs vested (Note 12) | 0 | $ 222 | (222) | ||||
Stock-based compensation expense (Note 12) | 2,330 | 2,330 | |||||
Foreign currency translation adjustment | 0 | ||||||
Net loss | (23,009) | (23,009) | |||||
Ending Balance (in shares) at Dec. 31, 2015 | shares | [1] | 10,565,489 | |||||
Ending Balance at Dec. 31, 2015 | $ 141,341 | $ 475,333 | 97,377 | (534,338) | 102,969 | ||
Exercise of stock options, for cash, lower range limit price (in cad per share) | CAD / shares | 20.4 | ||||||
Exercise of stock options, for cash, upper range limit price (in cad per share) | CAD / shares | CAD 22.7 | ||||||
Exercise of stock options, for cash (in shares) | shares | 0 | ||||||
Uncertain tax position liability recovery (Note 13) | $ 335 | 335 | |||||
Stock-based compensation expense (Note 12) | 797 | 797 | |||||
Shares issued in connection with the Acquisition of Aegerion (Note 5) (in shares) | shares | [1] | 6,060,288 | |||||
Shares issued in connection with the Acquisition of Aegerion (Note 5) | 59,381 | $ 59,381 | |||||
Shares issued in a private placement net of share issuance cost (Note 11) (in shares) | shares | [1] | 1,904,546 | |||||
Shares issued in a private placement net of share issuance cost (Note 11) | 21,481 | $ 16,545 | 4,936 | ||||
Cash distribution to shareholders (Note 4) | (15,000) | (15,000) | |||||
Aralez shares distributed to shareholders (Note 4) | (19,296) | (19,296) | |||||
Foreign currency translation adjustment | (382) | (382) | |||||
Net loss | (52,870) | (52,870) | |||||
Ending Balance (in shares) at Dec. 31, 2016 | shares | [1] | 18,530,323 | |||||
Ending Balance at Dec. 31, 2016 | $ 135,787 | $ 551,259 | $ 69,149 | $ (587,208) | $ 102,587 | ||
[1] | Amounts have been retroactively restated for all prior periods presented to reflect the one-for-five share consolidation of the Company’s common stock effected on December 16, 2016. |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash (used in) provided by operating activities | |||
Net loss | $ (52,870,000) | $ (23,009,000) | $ (4,071,000) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | |||
Depreciation | 264,000 | 576,000 | 891,000 |
Amortization of intangible assets | 2,134,000 | 0 | 0 |
Stock-based compensation | 797,000 | 2,330,000 | 1,453,000 |
Noncash interest expense | 2,676,000 | 0 | 0 |
Fair value change in contingent consideration (Notes 14, 16) | 2,042,000 | 0 | 2,000,000 |
Unrealized foreign exchange gain (losses) | 118,000 | (120,000) | 75,000 |
Loss (gain) on sale of long-lived assets | 50,000 | (36,000) | 0 |
Fair value loss on investment (Note 4) | 10,704,000 | 0 | 0 |
Deferred income taxes | (214,000) | 18,000 | (177,000) |
Impairment of long-lived assets | 0 | 11,000 | 0 |
Changes in assets and liabilities, excluding the effect of acquisition: | |||
Accounts receivable | (893,000) | 10,000 | 73,000 |
Inventories | 2,079,000 | 0 | 0 |
Prepaid and other assets | 705,000 | 442,000 | 810,000 |
Accounts payable | 4,441,000 | (184,000) | (607,000) |
Accrued liabilities | (6,389,000) | 570,000 | 108,000 |
Accrued restructuring | 0 | 0 | (130,000) |
Income taxes receivable/payable | 0 | 33,000 | 30,000 |
Net cash (used in) provided by operating activities | (34,356,000) | (19,359,000) | 455,000 |
Cash provided by investing activities | |||
Cash acquired through acquisition (Note 5) | 28,290,000 | 0 | 0 |
Cash consideration for acquisition - loan to Aegerion (Note 5) | (3,000,000) | 0 | 0 |
Proceeds from sale of long-lived assets | 192,000 | 43,000 | 115,000 |
Purchases of property and equipment | (155,000) | (9,000) | (25,000) |
Proceeds from contingent consideration (Notes 16) | 0 | 0 | 36,582,000 |
Net cash provided by investing activities | 25,327,000 | 34,000 | 36,672,000 |
Cash (used in) provided by financing activities | |||
Issuance of common shares | 21,481,000 | 5,508,000 | 509,000 |
Cash distribution paid to common shareholders | (15,000,000) | 0 | 0 |
Settlement of Backstop Agreement (Note 4) | 15,000,000 | 0 | 0 |
Aralez investment | (45,000,000) | 0 | 0 |
Net cash (used in) provided by financing activities | (23,519,000) | 5,508,000 | 509,000 |
Exchange rate effect on cash | (349,000) | (267,000) | (249,000) |
Net (decrease) increase in cash and cash equivalents | (32,897,000) | (14,084,000) | 37,387,000 |
Cash and cash equivalents, beginning of period | 141,824,000 | 155,908,000 | 118,521,000 |
Cash and cash equivalents, end of period | 108,927,000 | 141,824,000 | 155,908,000 |
Supplemental cash flow information | |||
Cash paid for interest | 33,000 | 0 | 0 |
Cash paid for taxes | 105,000 | 0 | 0 |
Non-cash financing activities | |||
Shares issued in the acquisition (Note 5) | 59,088,000 | 0 | 0 |
Convertible notes of Aegerion, at fair value (Note 10) | 222,900,000 | 0 | 0 |
Non-cash investment activities | |||
Purchases of property and equipment included in accounts payable | $ 61,000 | $ 0 | $ 0 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business. Novelion Therapeutics Inc. (Novelion or the Company) (formerly QLT, Inc.) is a biopharmaceutical company dedicated to developing new standards of care for individuals living with rare diseases. On June 14, 2016, the Company entered into an Agreement and Plan of Merger (as amended, the Merger Agreement) with Aegerion Pharmaceuticals, Inc. (Aegerion), pursuant to which on November 29, 2016, Novelion completed the acquisition (the Merger) of Aegerion. Aegerion is a rare disease biopharmaceutical company with two commercial products and global operations, through which the Company assumed certain assets and liabilities of the acquired entity, including $28.7 million in cash, cash equivalents and restricted cash and two revenue streams which will serve as further funding for Novelion's operations. Upon closing the acquisition, QLT Inc. changed its name to Novelion Therapeutics Inc. As further detailed in Note 5, the acquisition has been accounted for as a business combination in which Novelion was considered the accounting acquirer of Aegerion. As such, the Consolidated Financial Statements of Novelion include the results of Aegerion from November 29, 2016. Novelion has two commercial products, metreleptin and lomitapide from the acquisition of Aegerion and one orphan drug-designated product candidate, zuretinol acetate (zuretinol). Metreleptin, a recombinant analog of human leptin, is currently marketed in the U.S. under the brand name MYALEPT for injection. MYALEPT is approved in the U.S. as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL). Lomitapide, which is marketed in the U.S. under the brand name JUXTAPID capsules, is approved in the U.S. as an adjunct to a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with homozygous familial hypercholesterolemia (HoFH). Lomitapide is also approved in the European Union (EU), under the brand name LOJUXTA hard capsules for the treatment of adult patients with HoFH, as well as in Japan, Canada, and a small number of other countries. Zuretinol is an oral synthetic retinoid that is in late stage development for the treatment of inherited retinal disease (IRD) caused by underlying mutations in RPE65 and LRAT genes, comprising LCA and RP. Under the Merger Agreement, the Company issued certain warrants to the pre-closing shareholders of Novelion. These warrants (the Merger Agreement Warrants) may be exercised for up to an aggregate of 11,301,791 Novelion common shares at an exercise price of $0.05 per share if (i) the previously disclosed DOJ and SEC investigations are settled for amounts in excess of $40 million and/or (ii) the putative class action lawsuit alleging certain misstatements and omissions related to the marketing of JUXTAPID and the Company’s financial performance in violation of the federal securities laws is settled for an amount that exceeds the amounts, if any, available under Aegerion’s director and officer coverage in respect of that matter (together, the negotiated thresholds). The number of common shares for which the Merger Agreement Warrants may be exercised, if any, will vary based on the extent to which the settlements of the matters described above exceed the negotiated thresholds. The Merger Agreement Warrants will not be exercisable for any shares to the extent any excess in respect of such matters is equal to or less than $1.0 million in the aggregate. Also on June 14, 2016, the Company entered into a unit subscription agreement (the Unit Subscription Agreement) with the investors’ party thereto (the Investors). Pursuant to the Unit Subscription Agreement, immediately prior to the Merger, the Investors acquired units, for $8.80 per unit, consisting of (i) 1,904,546 Novelion common shares and 531,208 fully paid-up warrants (the Paid-Up Warrants), which may be exercised for up to 568,181 Novelion common shares, and (ii) 2,472,727 warrants (the Unit Subscription Agreement Warrants) exercisable for up to an aggregate of 2,644,952 Novelion common shares at an exercise price of $0.05 per share. The Unit Subscription Agreement Warrants were issued on the same terms and conditions as the Merger Agreement Warrants and are referred to collectively with the Merger Agreement Warrants as the “Contingent Warrants” in the Notes to the Consolidated Financial Statements. Refer to Note 11- Share Capital and Note 16 - Contingencies, Commitments and Guarantees for further information. On December 16, 2016, the Company completed a one-for-five (1:5) consolidation of all of its issued and outstanding common shares (the Consolidation), resulting in a reduction in the issued and outstanding common shares from approximately 92,653,562 to approximately 18,530,323 . Shares reserved under the Company’s equity and incentive plans were adjusted to reflect the Consolidation. All share and per-share data presented in the Company's Consolidated Financial Statements and notes have been retrospectively restated to reflect the Consolidation unless otherwise noted. Since the par value of the common shares is zero , neither the recorded value for common shares nor the paid-in capital has been retrospectively restated to reflect the Consolidation. As noted above, all references in the notes to the Consolidated Financial Statements to the “Company” refer to Novelion and its consolidated subsidiaries. For periods before the closing of the Merger, where the specific entities are referred to within the Consolidated Financial Statements, unless otherwise stated, “QLT” refers to QLT Inc. and its wholly-owned subsidiaries and “Aegerion” refers to Aegerion Pharmaceuticals, Inc. and its wholly-owned subsidiaries. Following the Merger, Novelion continues to conduct research and development related to zuretinol and Aegerion continues to develop and commercialize lomitapide and metreleptin, and each maintains its respective ownership of or licenses covering intellectual property related to such products and remains as party to the regulatory filings and approvals for such products. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Significant Accounting Policies. Basis of Presentation and Principles of Consolidation The accompanying Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP). All amounts herein are expressed in U.S. dollars (USD) unless otherwise noted. The accompanying Consolidated Financial Statements include operations of Novelion Therapeutics Inc. and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated. In management’s opinion, the Consolidated Financial Statements reflect all adjustments (including reclassifications of normal recurring adjustments) necessary to present fairly the financial position of Novelion as of December 31, 2016 and 2015 and the result of operations and cash flows for all periods presented. Use of Estimates The preparation of Consolidated Financial Statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the Consolidated Financial Statements, and the reported amounts of expenses during the reporting periods presented. Significant estimates and assumptions are required when determining the fair value of contingent assets and liabilities, the valuation of the convertible notes, and the valuation of the assets and liabilities acquired in a business combination including inventory and intangible assets. Significant estimates and assumptions are also required in determination of stock-based compensation and income tax. Our estimates often are based on complex judgments, probabilities and assumptions that we believe to be reasonable but that are inherently uncertain and unpredictable. For any given individual estimate or assumption made by us, there may also be other estimates or assumptions that are reasonable. Actual results may differ from estimates made by management. Changes in estimates are reflected in reported results in the period in which they become known. Reporting and Functional Currency Novelion’s reporting currency is the USD and the Company's operations utilize the USD or local currency as the functional currency, where applicable. Transactions in other currencies are recorded in the functional currency at the rate of exchange prevailing when the transactions occur. Monetary assets and liabilities denominated in other currencies are re-measured into the functional currency at rate of exchange in effect at the balance sheet date. Exchange gains and losses arising from re-measurement of foreign currency-denominated monetary assets and liabilities are included in income in the period in which they occur. For foreign entities where the local currency is the functional currency, assets and liabilities denominated in local currencies are translated into USD at end-of-period exchange rates and the resultant translation adjustments are reported, net of their related tax effects, as a component of accumulated other comprehensive items in equity. Discontinued Operations The results of operations, including the gain on disposal for businesses that have been sold or are classified as held for sale, are excluded from continuing operations and reported as discontinued operations for all periods presented. The Company sold its Visudyne business in 2012 and sold its punctal plug drug delivery system technology (PPDS Technology) in 2013. The Company has not had any continued involvement with the Visudyne business or the PPDS Technology following their sale. Amounts billed in connection with the provision of these transition services are included within discontinued operations. Cash and Cash Equivalents Cash and cash equivalents consist of highly liquid instruments purchased with an original maturity of three months or less at the date of purchase. As of December 31, 2016 and December 31, 2015 , the Company held $108.9 million and $141.8 million in cash and cash equivalents, respectively, consisting of cash and money market funds. Restricted Cash Restricted cash represents amounts deposited with Silicon Valley Bank (SVB) to collateralize the Company’s corporate credit card program and a letter of credit for the Company’s facility lease in Cambridge, Massachusetts. As of December 31, 2016, $0.4 million was held at SVB as security and hence is presented as restricted cash on the Consolidated Balance Sheet. Accounts Receivable The majority of the Company's accounts receivable arise from product sales and primarily represent amounts due from distributors, named patients, and other entities. The Company monitors the financial performance and creditworthiness of large customers to properly assess and respond to changes in their credit profile. The Company provides reserves against account receivables for estimated losses that may result from a customer’s inability to pay. Amounts determined to be uncollectible are charged or written-off against the reserve. To date, the Company's historical reserves and write-offs of accounts receivable have not been significant. Inventories and Cost of Product Sales Inventories are stated at the lower of cost or market price with cost determined on a first-in, first-out basis. Inventories acquired in a business combination are required to be fair valued at initial recognition. See " Business Combinations" section below for details. Inventory is maintained on the Company’s Consolidated Balance Sheets until the inventory is sold, donated as part of the Company’s compassionate use program, or used for clinical development. Inventory that is sold is recognized as cost of product sales in the Consolidated Statements of Operations, inventory that is donated as part of the Company’s compassionate use program is recognized as a selling, general and administrative expense in the Consolidated Statements of Operations, expired inventory is disposed of and the related costs are recognized as cost of product sales in the Consolidated Statements of Operations, and inventory used for clinical development is recognized as research and development expense in the Consolidated Statements of Operations. Inventories are reviewed periodically to identify slow-moving inventory based on sales activity, both projected and historical, as well as product shelf-life. The portion of the slow-moving inventory not expected to be sold within one year is classified as long-term inventory in the Company's accompanying Consolidated Balance Sheets. If the asset becomes impaired or is abandoned, the carrying value is written down to its fair value, and an impairment charge is recorded in the period in which the impairment occurs. In evaluating the recoverability of inventories produced, the Company considers the probability that revenue will be obtained from the future sale of the related inventory. Cost of product sales includes the cost of inventory sold, manufacturing and supply chain costs, product shipping and handling costs, charges for excess and obsolete inventory, amortization of acquired intangibles, as well as royalties payable to The Trustees of the University of Pennsylvania (UPenn) related to the sale of lomitapide and royalties payable to Amgen Inc. (Amgen), Rockefeller University and Bristol-Myers Squibb (BMS) related to the sale of metreleptin. Contingent Consideration The contingent consideration is initially recognized and measured at fair value, and are subsequently revalued at the end of each reporting period. Resulting changes in fair value are reported in continuing operations on the Consolidated Statements of Operations and comprehensive loss. See Note 16 - Contingencies, Commitments and Guarantees and Note 14 - Fair Value of Financial Instruments for more information on the Company’s historic contingent consideration asset balance. Prepaid Manufacturing Costs Cash advances paid by the Company prior to receipt of the inventory are recorded as prepaid manufacturing costs and included in prepaid expenses and other current assets. The cash advances are subject to forfeiture if the Company terminates the scheduled production. The Company expects the carrying value of the prepaid manufacturing costs to be fully realized. As of December 31, 2016, $1.4 million was recorded as prepaid manufacturing costs and hence was reported under prepaid expenses and other current assets on the Consolidated Balance Sheet. As of December 31, 2015, the Company did no t record any prepaid manufacturing costs. Property and Equipment Property and equipment are stated at cost and depreciated using the straight-line method based on estimated economic lives of 3 to 5 years for computer software and hardware, and 5 years for office furniture, fixtures, research equipment and other equipment. Leasehold improvements are amortized over the lesser of the estimated useful lives of the improvements or the remaining lease term, which include lease extensions when reasonably assured. Repair and maintenance costs are expensed as incurred. Intangible Assets Intangible assets with definite useful lives are amortized to their estimated residual values over their estimated useful lives and reviewed for impairment if certain events occur. Impairment of Long-lived Assets Impairment testing and assessments of remaining useful lives are performed when a triggering event occurs that could indicate a potential impairment. Such test first entails comparison of the carrying value of the long-lived asset to the undiscounted cash flows expected from that asset. If impairment is indicated by this test, the long-lived assets are written down by the amount, if any, by which the discounted cash flows expected from the long-lived asset exceeds its carrying value. Business Combinations The Company evaluates acquisitions of assets and other similar transactions to assess whether or not each such transaction should be accounted for as a business combination by assessing whether or not the Company has acquired inputs and processes that have the ability to create outputs. If the Company determines that an acquisition qualifies as a business, the Company applies the acquisition method of accounting which requires that the purchase price be allocated to the net assets acquired at their respective fair values. Goodwill is calculated as the excess of the consideration transferred over the net assets recognized and represents the future economic benefits arising from other assets acquired that could not be individually identified and separately recognized. Goodwill is not amortized and is not deductible for tax purposes. The Company reports provisional amounts when measurements are incomplete as of the end of the reporting period. We complete our purchase price allocation within a measurement period and which does not extend beyond one year after the acquisition date. Contingent consideration in a business combination is included as part of the acquisition cost and is recognized at fair value as of the acquisition date. Fair value is generally estimated by using a probability-weighted discounted cash flow approach. Any liability resulting from contingent consideration is re-measured to fair value at each reporting date until the contingency is resolved. These changes in fair value are recognized in earnings in other income (expense), net. The present-value models used to estimate the fair values of acquired inventory and intangibles incorporate significant assumptions, including, but not limited to: assumptions regarding the probability of obtaining marketing approval; estimated selling price, estimates of the timing and amount of future cash flows from potential product sales and related expenses; and the appropriate discount rate selected to measure the risks inherent in the future cash flows, the assessment of the asset’s life cycle and the competitive trends impacting the assets, including consideration of any technical, legal, regulatory or economic barrier. Transaction costs associated with business combinations are expensed as incurred. The Company's Consolidated Financial Statements include the results from operations of an acquired business after transaction date. Contingencies The Company records a liability in the Consolidated Financial Statements for litigation related matters when a loss is considered probable and the amount can be reasonably estimated. If the loss is not probable or a range cannot reasonably be estimated, no liability is recorded in the Consolidated Financial Statements. Convertible Notes The accounting guidance for convertible notes requires the Company to separately account for the liability and equity components of the Convertible Notes by allocating the proceeds between the liability component and the embedded conversion option. The carrying amount of the liability component is initially valued at the fair value of a similar liability that does not have an associated convertible feature. The equity component of the Convertible Notes was determined by deducting the fair value of the liability component from the fair value of the Convertible Notes as a whole on the date of acquisition. The excess of the principal amount of the liability component over its carrying amount, or debt discount, is amortized to interest expense using the effective interest method over the life of the Convertible Notes. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. Contingent Warrants The Company accounted for the Contingent Warrants in accordance with the guidance regarding the accounting for derivative financial instruments indexed to, and potentially settled in, a company’s own stock. The Contingent Warrants met the requirements to be accounted for as derivative instruments as the Contingent Warrants are variable and indexed to an event other than the fair value of the Company’s shares. See Note 11 (e) - Share Capital - Cash, Share and Warrant Distributions and Note 11 (d) - Share Capital - Private Placement for more information. Paid-Up Warrants The Company accounted for the Paid-Up Warrants issued in the Private Placement in accordance with the guidance regarding the accounting for derivative financial instruments indexed to, and potentially settled in, a company’s own stock. The Paid-Up Warrants met the requirements to be accounted for as equity instruments. The proceeds related to the sale of the Paid-Up Warrants are included in additional paid-in capital in the Consolidated Balance Sheets. See Note 11(d) - Share Capital - Private Placement for more information. Revenue Recognition The Company applies the revenue recognition guidance in accordance with Financial Accounting Standards Board Accounting Standards Codification (ASC) Subtopic No. 605-15, Revenue Recognition—Products. The Company recognizes revenue from product sales when there is persuasive evidence that an arrangement exists, title to product and associated risk of loss has passed to the customer, the price is fixed or determinable, collectability is reasonably assured and the Company has no further performance obligations. Lomitapide In the U.S., JUXTAPID® is only available for distribution through a specialty pharmacy, and is shipped directly to the patient. JUXTAPID is not available in retail pharmacies. Prior authorization and confirmation of coverage level by a patient’s private insurance plan or government payer are currently prerequisites to the shipment of product to the patient in the U.S. Revenue from sales in the U.S. covered by the patient’s private insurance plan or government payer is recognized once the product has been received by the patient. For uninsured amounts billed directly to the patient, revenue is recognized at the time of cash receipt as collectability is not reasonably assured at the time the product is received by the patient. To the extent amounts are billed in advance of delivery to the patient, the Company defers revenue until the product has been received by the patient. The Company also records revenue on sales in countries where lomitapide is available on a named patient basis, and typically paid for by a government authority or institution. In many cases, these sales are facilitated through a third-party distributor that takes title to the product upon acceptance. Because of factors such as the pricing of lomitapide, the limited number of patients, the short period from product sale to delivery to the end-customer and the limited contractual return rights, these distributors typically only hold inventory to supply specific orders for the product. The Company recognizes revenue for sales under these named patient programs upon product acceptance by either the named patient or the third-party distributor. In the event the payer’s creditworthiness has not been established, the Company recognizes revenue on a cash basis if all other revenue recognition criteria have been met. The Company records distribution and other fees paid to its distributors as a reduction of revenue, unless the Company receives an identifiable and separate benefit for the consideration and the Company can reasonably estimate the fair value of the benefit received. If both conditions are met, the Company records the consideration paid to the distributor as an operating expense. At this time, neither condition has been met and therefore, the fees paid to the Company’s distributors are recorded as a reduction of revenue. The Company records revenue net of estimated discounts and rebates, including those provided to Medicare, Medicaid, Tricare and other government programs in the U.S. and other countries. Allowances are recorded as a reduction of revenue at the time revenues from product sales are recognized. Allowances for government rebates and discounts are established based on the actual payer information, which is reasonably estimated at the time of delivery. These allowances are adjusted to reflect known changes in the factors that may impact such allowances in the quarter those changes are known. From time to time, the Company provides financial support to patient assistance programs operated by independent charitable 501(c)(3) organizations which assist patients in the U.S. in accessing treatment for HoFH. These patient assistance programs assist HoFH patients according to eligibility criteria defined independently by the charitable organization. The Company records donations made to these patient assistance programs as selling, general and administrative expense. Any payments received from these patient assistance programs on behalf of a patient who is taking lomitapide for the treatment of HoFH are recorded as a reduction of selling, general and administrative expense rather than as revenue. Beginning in 2015, the Company also offers a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are on JUXTAPID therapy. The branded co-pay assistance program assists commercially insured patients who have coverage for JUXTAPID, and is intended to reduce each participating patient’s portion of the financial responsibility for JUXTAPID’s purchase price up to a specified dollar amount of assistance. The Company records revenue net of amounts paid under the branded specific co-pay assistance program for each patient. Metreleptin In the U.S., MYALEPT is only available through an exclusive third-party distributor that takes title to the product upon shipment. MYALEPT is not available in retail pharmacies. The distributor may contractually hold inventory for no more than 21 business days. The Company recognizes revenue for these sales once the product is received by the patient as it is currently unable to reasonably estimate the rebates owed to certain government payers at the time of receipt by the distributor. Prior authorization and confirmation of coverage level by a patient’s private insurance plan or government payer are currently prerequisites to the shipment of product to a patient in the U.S. Revenue from sales in the U.S. covered by the patient’s private insurance plan or government payer is recognized once the product has been received by the patient. The Company records distribution and other fees paid to its distributor as a reduction of revenue, unless the Company receives an identifiable and separate benefit for the consideration and the Company can reasonably estimate the fair value of the benefit received. If both conditions are met, the Company records the consideration paid to the distributor as an operating expense. At this time, neither condition has been met and therefore, these fees paid to the distributor are recorded as a reduction of revenue. The Company records revenue from sales of MYALEPT net of estimated discounts and rebates, including those provided to Medicare and Medicaid in the U.S. Allowances for government rebates and discounts are established based on the actual payer information, which is reasonably estimable at the time of delivery, and the government-mandated discounts applicable to government-funded programs. These allowances are adjusted to reflect known changes in the factors that may impact such allowances in the quarter those changes are known. To date, such adjustments have not been significant. From time to time, the Company provides financial support to patient assistance programs operated by independent charitable 501(c)(3) organizations which assist eligible patients in the U.S. in accessing treatment for GL. These patient assistance programs assists GL patients according to eligibility criteria defined independently by the organization. The Company records donations made to these patient assistance programs as selling, general and administrative expense. Beginning in 2015, the Company also offers a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are on MYALEPT therapy. The branded co-pay assistance program assists commercially insured patients who have coverage for MYALEPT, and is intended to reduce each participating patient’s portion of the financial responsibility for MYALEPT’s purchase price up to a specified dollar amount of assistance. The Company records revenue net of amounts paid under the branded specific co-pay assistance program for each patient. Research and Development Expenses Research and development expenses are charged to expense as incurred. Research and development expenses comprise costs incurred in performing research and development activities, including personnel-related costs, stock-based compensation, facilities-related overhead, clinical trial costs, costs to support certain medical affairs activities, manufacturing costs for clinical and pre-clinical materials as well as other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made in accordance with the provisions of ASC No. 730 - Research and Development . Income Taxes Income taxes are reported using the asset and liability method, whereby deferred tax assets and liabilities are recognized for the future tax consequences attributable to: (i) differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and (ii) operating loss and tax credit carryforwards using applicable enacted tax rates. An increase or decrease in these tax rates will increase or decrease the carrying value of future net tax assets resulting in an increase or decrease to net income. Income tax credits, such as investment tax credits, are included as part of the provision for income taxes. Current income taxes are provided for in accordance with the laws of the relevant taxing authorities. Significant estimates are required in determining the Company’s provision for income taxes and uncertain tax positions. Some of these estimates are based on interpretations of existing tax laws or regulations. Various internal and external factors may have favorable or unfavorable effects on the Company’s future effective tax rate. These factors include, but are not limited to, changes in tax laws, regulations and/or rates, changing interpretations of existing tax laws or regulations, changes in estimates of prior years’ items, results of tax audits by tax authorities, future levels of research and development spending, changes in estimates related to repatriation of undistributed earnings of foreign subsidiaries, and changes in overall levels of pre-tax earnings. The realization of the Company’s deferred tax assets is primarily dependent on whether the Company is able to generate sufficient capital gains and taxable income prior to expiration of any loss carry forward balance. A valuation allowance is provided when it is more likely than not that a deferred tax asset will not be realized. The assessment of whether or not a valuation allowance is required often requires significant judgment including the long-range forecast of future taxable income and the evaluation of tax planning initiatives. Adjustments to the deferred tax valuation allowances are made to earnings in the period when such assessments are made. The Company records tax benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available at the reporting date. There is inherent uncertainty in quantifying income tax positions. The Company has recorded tax benefits for those tax positions where it is more likely than not that a tax benefit will result upon ultimate settlement with a tax authority that has all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will result, no tax benefit has been recognized in the Consolidated Financial Statements. See Note 13 - Income Taxes for additional information. Stock-Based Compensation The Company accounts for its stock-based compensation to employees in accordance with ASC No. 718 - Compensation - Stock Compensation and to non-employees in accordance with ASC No. 505-50 - Equity-Based Payments to Non-Employees. For service-based awards, compensation expense is recognized using the ratable method over the requisite service period, which is typically the vesting period. For awards that vest or begin vesting upon achievement of a performance condition, the Company recognizes compensation expense when achievement of the performance condition is deemed probable using a straight-line model over the implicit service period. Certain of the Company’s awards that contain performance conditions also require the Company to estimate the number of awards that will vest, which the Company estimates when the performance condition is deemed probable of achievement. For awards that vest upon the achievement of a market condition, the Company recognizes compensation expense over the derived service period. For equity awards that have previously been modified, any incremental increase in the fair value over the original award has been recorded as compensation expense on the date of the modification for vested awards or over the remaining service period for unvested awards. See Note 12 - Stock-Based Payments for further information about the Company’s equity incentive plans. The Company has a Directors’ Deferred Share Unit Plan ("DDSU Plan") for the Company’s directors. Given that vested Deferred Share Units ("DSUs") are convertible to cash only, the Company recognizes compensation expense for DSUs based on the market price of the Company’s shares. The Company also records an accrued liability to recognize the expected financial obligation related to the future settlement of these DSUs as they vest. Each reporting period, the expected obligation is revalued for changes in the market value of Novelion’s common shares. The Company issues restricted stock units ("RSUs") to its employees and directors as consideration for their provision of future services. Restricted stock-based compensation expense is measured based on the fair value market price of Novelion’s common shares on the grant date and is recognized over the requisite service period, which coincides with the vesting period. RSUs can only be exchanged and settled for Novelion’s common shares, on a one-to-one basis, upon vesting. Comprehensive Loss Comprehensive loss combines net loss and other comprehensive items. Other comprehensive items represent certain amounts that are reported as components of shareholders’ equity in the accompanying Consolidated Balance Sheets, including currency translation adjustments. Net Loss Per Common Share Basic net loss per common share is computed using the weighted average number of common shares outstanding during the period. Diluted net income per common share is computed in accordance with the treasury-shares and if-converted methods, which uses the weighted average number of common shares outstanding during the period and also includes the dilutive effect of common shares potentially issuable from outstanding stock-based awards. Recent Accounting Pronouncements- Not Yet Adopted In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards update (ASU) No. 2014-09, “Revenue from Contracts with Customers” (ASU 2014-09). ASU 2014-09 represents a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled in exchange for those goods or services. This ASU sets forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and is intended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed. In August 2015, the FASB issued ASU No. 2015-14, “ Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date,” which defers the effective date of ASU 2014-09 by one year, but permits companies to adopt one year earlier if they choose (i.e. the original effective date). As such, ASU 2014-09 will be effective for annual and interim reporting periods beginning after December 15, 2017. In March and April 2016, the FASB issued ASU No. 2016-08 “Revenue from Contracts with Customers (Topic 606): Principal versus Agent Consideration (Reporting Revenue Gross versus Net)” and ASU No. 2016-10 “Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing,” respectively, which clarify the guidance on reporting revenue as a principal versus agent, identifying performance obligations and accounting for intellectual property licenses. In addition, in May 2016, the FASB issued ASU No. 2016-12 “Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients,” which amends certain narrow aspects of Topic 606, and in December 2016, the FASB issued ASU No. 2016-20 “Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers,” which amends certain narrow aspects of Topic 606. The new standard may be adopted using either the full retrospective method, in which case the standard would be applied to each prior reporting period presented, or the modified retrospective method, in which case the cumulative effect of applying the standard would be recognized at the date of initial application. In the fourth quarter of 2016, the Company engaged an external accounting firm to assist with the new standard adoption and has made significant progress in the assessment. Based on the progress, the Company expects to complete its assessment by the second quarter of 2017. In July 2015, the FASB issued ASU No. 2015-11, “ Simplifying the Measurement of Inventory” (ASU 2015-11). ASU 2015-11 states that an entity should measure inventory at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. For public entities, ASU 2015-11 is effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The amendments in this update should be applied prospectively and early application is permitted. The Company does not expect the adoption of ASU 2015-11 to impact the Company’s consolidated resu |
Terminated Merger Transactions
Terminated Merger Transactions | 12 Months Ended |
Dec. 31, 2016 | |
Business Combinations [Abstract] | |
Terminated Merger Transactions | Terminated Merger Transactions. On June 8, 2015, QLT entered into an Agreement and Plan of Merger (as amended and restated on each of July 16, 2015 and August 26, 2015) (the InSite Merger Agreement) with InSite Vision Incorporated, a Delaware corporation (InSite). On September 15, 2015, the InSite Merger Agreement was terminated by InSite's board of directors. As a result, InSite paid QLT a termination fee of $2.7 million . In addition, in conjunction with the entry into the InSite Merger Agreement, on June 8, 2015 QLT granted InSite a secured line of credit (the Secured Note) for up to $9.9 million to fund continuing operations through to the completion of the proposed InSite merger. Upon termination of the InSite Merger Agreement, InSite’s repayment obligations under the Secured Note were accelerated and InSite paid QLT $5.8 million on September 15, 2015, which consisted of $5.7 million of principal drawn from the Secured Note and $0.1 million of accrued interest. On June 25, 2014, the Company entered into an Agreement and Plan of Merger (the Auxilium Merger Agreement) with Auxilium Pharmaceuticals, Inc., a Delaware corporation (Auxilium). On October 8, 2014, the Auxilium Merger Agreement was terminated by Auxilium's board of directors. In connection with the termination of the Auxilium Merger Agreement, on October 9, 2014, Auxilium paid QLT a termination fee of $28.4 million . On October 22, 2014, pursuant to the terms of QLT's financial advisory services agreement with Credit Suisse Securities (USA) LLC (Credit Suisse), QLT paid Credit Suisse a portion of the breakup fee equal to $5.7 million . QLT’s financial advisory services agreement with Credit Suisse was subsequently terminated. During the year ended December 31, 2015 and 2014, QLT incurred $10.2 million and $9.4 million of consulting and transaction fees in connection with QLT’s pursuit of the Auxilium and InSite Mergers, respectively. These $19.6 million of consulting and transaction fees, which is net of the $5.7 million portion of the breakup fee paid to Credit Suisse, has been reflected as part of Selling, General and Administrative expenses on the Consolidated Statements of Operations. Acquisition. Aegerion Pharmaceuticals, Inc. On November 29, 2016, Novelion completed its acquisition of Aegerion and each share of Aegerion’s common stock was exchanged for 1.0256 Novelion (pre-Consolidation) common shares (the Exchange Ratio). Immediately after the Merger, the Company had approximately 18,530,323 common shares outstanding; former shareholders of Novelion held approximately 68% of the Company, and former stockholders of Aegerion held approximately 32% of the Company. The Merger has been accounted for as a business combination under the acquisition method, with Novelion as the accounting acquirer and Aegerion as the “acquired” company. The operating results of Aegerion from November 29, 2016 are included in the accompanying Consolidated Statements of Operations for the year ended December 31, 2016. The Consolidated Balance Sheet as of December 31, 2016 reflect the acquisition of Aegerion, effective November 29, 2016. The acquisition consideration in connection with the Merger was approximately $62.4 million and consisted of the following (in thousands, except for share and per share information): Number of Novelion common shares issued in connection with the acquisition of Aegerion 6,060,288 Novelion share price on November 29, 2016 $ 9.75 Fair value of Novelion common shares issued to Aegerion stockholders $ 59,088 Liability assumed (2)(3) 3,000 Stock compensation assumed (1) 293 Total acquisition consideration $ 62,381 (1) The fair value of Aegerion in-the-money options and RSUs attributed to pre-combination services that were outstanding on November 29, 2016 and settled in connection with the Merger. (2) Represents a term loan facility provided by QLT to Aegerion on June 14, 2016, concurrently with the execution of the Merger Agreement. Aegerion borrowed $3 million against the term loan and the loan remained outstanding as of November 29, 2016. (3) Includes 10,565,879 Merger Agreement Warrants to purchase up to 11,301,791 common shares issued pursuant to the Merger Agreement, which were recognized as a liability with a fair value of zero as of November 29, 2016. Refer to Note 11 - Share Capital and Note 16 - Contingencies, Commitments and Guarantees for further details. The estimated fair value of the assets acquired and liabilities assumed are provisional as of December 31, 2016 and are based on information that is currently available to the Company. Additional information is being gathered to finalize these provisional measurements, particularly with respect to intangible assets, inventory, and deferred income taxes. Accordingly, the measurement of the assets acquired and liabilities assumed may change significantly upon finalization of the Company’s valuations and completion of the purchase price allocation, both of which are expected to occur no later than one year from the acquisition date. The following table summarizes the provisional fair values of the assets acquired and liabilities assumed at the Merger date (in thousands): November 29, 2016 Cash and cash equivalents $ 28,290 Restricted cash 390 Accounts receivable (1) 8,182 Inventories 76,800 Prepaid expenses and other current assets 9,839 Insurance proceeds receivable 22,000 Property and equipment, net 4,020 Intangible assets 252,458 Other Assets 1,352 Accounts payable (11,459 ) Accrued liabilities (41,883 ) Provision for legal settlement (63,968 ) Long-term debt (222,908 ) Other liabilities (732 ) Net assets acquired $ 62,381 (1) As of the Merger date, the fair value of accounts receivable approximated the book value acquired. The amount not expected to be collected was insignificant. • Legal Matters - Aegerion has been the subject of certain ongoing investigations and other legal proceedings. See Note 16 - Contingencies, Commitments and Guarantees for further information regarding these and other legal proceedings. • Tax Matters - Net liabilities for income taxes payable approximated $0.1 million and unrecognized tax benefits approximated $0.9 million as of the acquisition date. A net deferred tax asset related to Aegerion’s foreign subsidiaries approximated $1.1 million as of the acquisition date. The valuation of the intangible assets acquired and related amortization periods are as follows: Valuation in thousands ) Amortization period Developed Technology: JUXTAPID $ 42,300 10.75 MYALEPT 210,158 9.25 Total $ 252,458 The preliminary fair values of the intangibles were estimated using a multi-period excess earnings approach. Under this method, an intangible assets fair value is equal to the present value of the after-tax cash flows attributable solely to the intangible asset over its remaining useful life. To calculate fair value, the Company used cash flows discounted at 11% . The fair values of the purchased inventories were also estimated using a discounted present value income approach. To calculate fair value, the Company used cash flows discounted at 11% . There was no goodwill recorded as part of the acquisition of Aegerion on the acquisition date. Novelion recognized acquisition-related transaction costs associated with the Merger during the year ended December 31, 2016 totaling approximately $4.0 million . These costs, which related primarily to bank fees, legal and accounting services, and fees for other professional services, were expensed as incurred, and reported as the selling, general and administrative expenses (SG&A) in the accompanying Consolidated Statements of Operations. Actual and Pro Forma Impact of Acquisition The following table presents the amount of Aegerion net product sales and net loss included in the Company's Consolidated Statement of Operations from November 29, 2016 through December 31, 2016: (in millions, except for per share information) November 29, 2016 - December 31, 2016 Net product sales $ 13.6 Net loss (6.3 ) Basic and diluted net loss per share $ (0.34 ) The following supplemental unaudited pro forma information presents the financial results as if the Merger had occurred on January 1, 2015 for the years ended December 31, 2016 and 2015. Unaudited Supplemental Pro Forma Consolidated Results Year ended December 31, (in millions, except for per share information) 2016 2015 Net product sales $ 153.2 $ 239.9 Net loss (207.8 ) (96.3 ) Basic and diluted loss per share $ (18.41 ) $ (9.23 ) This supplemental pro forma information has been prepared for comparative purposes and does not purport to reflect what the Company’s results of operations would have been had the acquisition occurred on January 1, 2015, nor does it project the future results of operations of the Company or reflect the expected realization of any cost savings associated with the acquisition. The actual results of operations of the Company may differ significantly from the pro forma adjustments reflected here due to many factors. The unaudited supplemental pro forma financial information includes various assumptions, including those related to the provisional purchase price allocation of the assets acquired and the liabilities assumed from Aegerion. |
Strategic Transactions
Strategic Transactions | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Strategic Transactions | Strategic Transactions. Aralez Investment and Distribution On December 7, 2015, QLT entered into an Amended and Restated Share Subscription Agreement (the Amended and Restated Subscription Agreement) with Tribute Pharmaceuticals Canada Inc. (Tribute), POZEN Inc. (POZEN), Aralez Pharmaceuticals plc, (formally known as Aguono Limited) (Aralez Ireland) and certain other investors for the purpose of returning capital to QLT's shareholders in either Aralez Shares (approximately 0.13629 of an Aralez Share for each common share of the Company) or cash, subject to pro-ration (the Aralez Distribution), up to a maximum of $15.0 million funded pursuant to the terms of the Backstop Agreement (as described below). In connection with the Aralez Distribution, on June 8, 2015, QLT entered into a share purchase agreement (as amended, the Backstop Agreement) with Broadfin Healthcare Master Fund, Ltd. (Broadfin) and the JW Partners, LP, JW Opportunities Fund, LLC and JW Opportunities Master Fund, Ltd. (together the JW Parties), pursuant to which Broadfin and the JW Parties agreed to purchase up to $15.0 million of the Aralez Shares from the QLT at $6.25 per share. This arrangement provided QLT’s shareholders with the opportunity to elect to receive, in lieu of Aralez Shares, up to an aggregate of $15.0 million in cash, subject to proration among the shareholders. On February 5, 2016, QLT purchased 7,200,000 Aralez Shares (representing 10.1% of the issued and outstanding Aralez Shares), for an aggregate price of $45.0 million . On April 5, 2016 (the Distribution Date), QLT distributed 4,799,619 Aralez Shares with a fair value of $19.3 million , and $15.0 million of cash to shareholders of record on February 16, 2016. QLT held the Aralez Shares from February 5, 2016 to the Distribution Date and the Aralez Shares were marked-to-market. As a result, QLT recognized a $10.7 million loss during the year ended December 31, 2016, to reflect the change in value from the acquisition date to the Distribution Date. Pursuant to QLT’s financial advisory services agreement with Greenhill dated December 4, 2014 (as amended, the Greenhill Agreement), QLT paid Greenhill a $4.0 million advisory fee in connection with the completion of QLT’s $45.0 million investment in Aralez and exploration of other strategic initiatives described under Note 3 - T erminated Merger Transactions. Private Placement related to Aralez On June 8, 2015, QLT entered into a Share Purchase and Registration Rights Agreement (as amended, the Share Purchase and Registration Rights Agreement) with Broadfin, JW Partners, LP, JW Opportunities Fund, LLC, EcoR1 Capital Fund Qualified, L.P. and EcoR1 Capital Fund, LP (the QLT Investors). The Share Purchase and Registration Rights Agreement provided that QLT would, following the completion of the Aralez Distribution, issue and sell to the QLT Investors a certain number of QLT common shares for an aggregate purchase price of $20.0 million , reflecting a per share purchase price of $1.87 . In light of the termination of the InSite Merger Agreement and the board’s determination that QLT’s cash requirements at that time did not justify the dilution that would be caused by this private placement, on April 28, 2016, QLT and the QLT Investors mutually agreed to terminate the Share Purchase and Registration Rights Agreement. |
Acquisition
Acquisition | 12 Months Ended |
Dec. 31, 2016 | |
Business Combinations [Abstract] | |
Acquisition | Terminated Merger Transactions. On June 8, 2015, QLT entered into an Agreement and Plan of Merger (as amended and restated on each of July 16, 2015 and August 26, 2015) (the InSite Merger Agreement) with InSite Vision Incorporated, a Delaware corporation (InSite). On September 15, 2015, the InSite Merger Agreement was terminated by InSite's board of directors. As a result, InSite paid QLT a termination fee of $2.7 million . In addition, in conjunction with the entry into the InSite Merger Agreement, on June 8, 2015 QLT granted InSite a secured line of credit (the Secured Note) for up to $9.9 million to fund continuing operations through to the completion of the proposed InSite merger. Upon termination of the InSite Merger Agreement, InSite’s repayment obligations under the Secured Note were accelerated and InSite paid QLT $5.8 million on September 15, 2015, which consisted of $5.7 million of principal drawn from the Secured Note and $0.1 million of accrued interest. On June 25, 2014, the Company entered into an Agreement and Plan of Merger (the Auxilium Merger Agreement) with Auxilium Pharmaceuticals, Inc., a Delaware corporation (Auxilium). On October 8, 2014, the Auxilium Merger Agreement was terminated by Auxilium's board of directors. In connection with the termination of the Auxilium Merger Agreement, on October 9, 2014, Auxilium paid QLT a termination fee of $28.4 million . On October 22, 2014, pursuant to the terms of QLT's financial advisory services agreement with Credit Suisse Securities (USA) LLC (Credit Suisse), QLT paid Credit Suisse a portion of the breakup fee equal to $5.7 million . QLT’s financial advisory services agreement with Credit Suisse was subsequently terminated. During the year ended December 31, 2015 and 2014, QLT incurred $10.2 million and $9.4 million of consulting and transaction fees in connection with QLT’s pursuit of the Auxilium and InSite Mergers, respectively. These $19.6 million of consulting and transaction fees, which is net of the $5.7 million portion of the breakup fee paid to Credit Suisse, has been reflected as part of Selling, General and Administrative expenses on the Consolidated Statements of Operations. Acquisition. Aegerion Pharmaceuticals, Inc. On November 29, 2016, Novelion completed its acquisition of Aegerion and each share of Aegerion’s common stock was exchanged for 1.0256 Novelion (pre-Consolidation) common shares (the Exchange Ratio). Immediately after the Merger, the Company had approximately 18,530,323 common shares outstanding; former shareholders of Novelion held approximately 68% of the Company, and former stockholders of Aegerion held approximately 32% of the Company. The Merger has been accounted for as a business combination under the acquisition method, with Novelion as the accounting acquirer and Aegerion as the “acquired” company. The operating results of Aegerion from November 29, 2016 are included in the accompanying Consolidated Statements of Operations for the year ended December 31, 2016. The Consolidated Balance Sheet as of December 31, 2016 reflect the acquisition of Aegerion, effective November 29, 2016. The acquisition consideration in connection with the Merger was approximately $62.4 million and consisted of the following (in thousands, except for share and per share information): Number of Novelion common shares issued in connection with the acquisition of Aegerion 6,060,288 Novelion share price on November 29, 2016 $ 9.75 Fair value of Novelion common shares issued to Aegerion stockholders $ 59,088 Liability assumed (2)(3) 3,000 Stock compensation assumed (1) 293 Total acquisition consideration $ 62,381 (1) The fair value of Aegerion in-the-money options and RSUs attributed to pre-combination services that were outstanding on November 29, 2016 and settled in connection with the Merger. (2) Represents a term loan facility provided by QLT to Aegerion on June 14, 2016, concurrently with the execution of the Merger Agreement. Aegerion borrowed $3 million against the term loan and the loan remained outstanding as of November 29, 2016. (3) Includes 10,565,879 Merger Agreement Warrants to purchase up to 11,301,791 common shares issued pursuant to the Merger Agreement, which were recognized as a liability with a fair value of zero as of November 29, 2016. Refer to Note 11 - Share Capital and Note 16 - Contingencies, Commitments and Guarantees for further details. The estimated fair value of the assets acquired and liabilities assumed are provisional as of December 31, 2016 and are based on information that is currently available to the Company. Additional information is being gathered to finalize these provisional measurements, particularly with respect to intangible assets, inventory, and deferred income taxes. Accordingly, the measurement of the assets acquired and liabilities assumed may change significantly upon finalization of the Company’s valuations and completion of the purchase price allocation, both of which are expected to occur no later than one year from the acquisition date. The following table summarizes the provisional fair values of the assets acquired and liabilities assumed at the Merger date (in thousands): November 29, 2016 Cash and cash equivalents $ 28,290 Restricted cash 390 Accounts receivable (1) 8,182 Inventories 76,800 Prepaid expenses and other current assets 9,839 Insurance proceeds receivable 22,000 Property and equipment, net 4,020 Intangible assets 252,458 Other Assets 1,352 Accounts payable (11,459 ) Accrued liabilities (41,883 ) Provision for legal settlement (63,968 ) Long-term debt (222,908 ) Other liabilities (732 ) Net assets acquired $ 62,381 (1) As of the Merger date, the fair value of accounts receivable approximated the book value acquired. The amount not expected to be collected was insignificant. • Legal Matters - Aegerion has been the subject of certain ongoing investigations and other legal proceedings. See Note 16 - Contingencies, Commitments and Guarantees for further information regarding these and other legal proceedings. • Tax Matters - Net liabilities for income taxes payable approximated $0.1 million and unrecognized tax benefits approximated $0.9 million as of the acquisition date. A net deferred tax asset related to Aegerion’s foreign subsidiaries approximated $1.1 million as of the acquisition date. The valuation of the intangible assets acquired and related amortization periods are as follows: Valuation in thousands ) Amortization period Developed Technology: JUXTAPID $ 42,300 10.75 MYALEPT 210,158 9.25 Total $ 252,458 The preliminary fair values of the intangibles were estimated using a multi-period excess earnings approach. Under this method, an intangible assets fair value is equal to the present value of the after-tax cash flows attributable solely to the intangible asset over its remaining useful life. To calculate fair value, the Company used cash flows discounted at 11% . The fair values of the purchased inventories were also estimated using a discounted present value income approach. To calculate fair value, the Company used cash flows discounted at 11% . There was no goodwill recorded as part of the acquisition of Aegerion on the acquisition date. Novelion recognized acquisition-related transaction costs associated with the Merger during the year ended December 31, 2016 totaling approximately $4.0 million . These costs, which related primarily to bank fees, legal and accounting services, and fees for other professional services, were expensed as incurred, and reported as the selling, general and administrative expenses (SG&A) in the accompanying Consolidated Statements of Operations. Actual and Pro Forma Impact of Acquisition The following table presents the amount of Aegerion net product sales and net loss included in the Company's Consolidated Statement of Operations from November 29, 2016 through December 31, 2016: (in millions, except for per share information) November 29, 2016 - December 31, 2016 Net product sales $ 13.6 Net loss (6.3 ) Basic and diluted net loss per share $ (0.34 ) The following supplemental unaudited pro forma information presents the financial results as if the Merger had occurred on January 1, 2015 for the years ended December 31, 2016 and 2015. Unaudited Supplemental Pro Forma Consolidated Results Year ended December 31, (in millions, except for per share information) 2016 2015 Net product sales $ 153.2 $ 239.9 Net loss (207.8 ) (96.3 ) Basic and diluted loss per share $ (18.41 ) $ (9.23 ) This supplemental pro forma information has been prepared for comparative purposes and does not purport to reflect what the Company’s results of operations would have been had the acquisition occurred on January 1, 2015, nor does it project the future results of operations of the Company or reflect the expected realization of any cost savings associated with the acquisition. The actual results of operations of the Company may differ significantly from the pro forma adjustments reflected here due to many factors. The unaudited supplemental pro forma financial information includes various assumptions, including those related to the provisional purchase price allocation of the assets acquired and the liabilities assumed from Aegerion. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories. The components of inventory are as follows: December 31, 2016 2015 ( in thousands ) Work-in-process $ 20,219 $ — Finished goods 54,502 — Total $ 74,721 $ — As part of the Merger, the Company acquired $76.8 million of inventory. During the years ended December 31, 2016, 2015 and 2014, the Company did no t record any expense related to the excess or obsolete inventory in the Consolidated Statements of Operations. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment. Property and equipment consists of the following: December 31, 2016 ( in thousands ) Cost Accumulated Net Leasehold improvements $ 1,869 $ 263 $ 1,606 Office furniture and equipment 539 20 519 Research equipment 1,962 1,810 152 Computer and office equipment 10,236 8,693 1,543 Construction in progress 339 $ — 339 $ 14,945 $ 10,786 $ 4,159 December 31, 2015 ( in thousands ) Cost Accumulated Net Leasehold improvements $ 207 $ 207 $ — Office furniture and equipment 258 246 12 Research equipment 3,471 3,092 379 Computer and office equipment 9,844 9,805 39 $ 13,780 $ 13,350 $ 430 Depreciation expense was $0.3 million , $0.6 million and $0.9 million for the years ended December 31, 2016 , 2015 and 2014 , respectively. As part of the Merger, the Company acquired $4.0 million of property and equipment. In connection with the downsizing of the Company’s lease space in 2015 (see Note 16 - Contingencies, Commitments and Guarantees for more information), the Company retired the use of certain property, plant and equipment with zero or minimal net book values. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2016 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets. The following is a summary of intangible assets held by the Company at December 31, 2016 and 2015 (in thousands): Cost basis: Balance as of December 31, 2015 2016 Acquisitions Balance as of December 31, 2016 Definite-lived intangibles: Developed Technology - Juxtapid (weighted average life of 10.75 years) $ — $ 42,300 $ 42,300 Developed Technology - Myalept (weighted average life of 9.25 years) — 210,158 210,158 Total definite-lived intangibles (weighted average life of 9.50 years) $ — $ 252,458 $ 252,458 Accumulated amortization: Balance as of December 31, 2015 2016 Amortization Balance as of December 31, 2016 Definite-lived intangibles: Developed Technology - Juxtapid $ — $ (328 ) $ (328 ) Developed Technology - Myalept — (1,806 ) (1,806 ) Total definite-lived intangibles $ — $ (2,134 ) $ (2,134 ) Net intangible assets $ — $ 250,324 As part of the Merger, the Company acquired $252.5 million of intangible assets. Amortization expense for the year ended December 31, 2016 totaled $2.1 million , and zero for the years ended December 31, 2015 and 2014 , respectively. Estimated amortization of intangible assets for the five fiscal years subsequent to December 31, 2016 is as followings (in thousands): Years Ending December 31, Estimated Amortization of Intangible Assets 2017 $ 25,614 2018 25,614 2019 25,614 2020 25,614 2021 $ 25,614 Novelion will test definite-lived intangible assets for impairment when events and changes in circumstances indicate that the carrying amount of these definite-lived intangible assets may not be recoverable. Impairment loss is recognized if the carrying value of definite-lived intangible is not recoverable and its carrying value exceeds its fair value. Any impairment charges resulting from intangible asset impairment assessments are recorded to asset impairments charges on the Company’s Consolidated Statements of Operations. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2016 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities. Accrued liabilities consist of the following: December 31 (in thousands) 2016 2015 Accrued employee compensation and related costs $ 7,920 $ 1,460 Accrued sales allowances 7,849 — Other accrued liabilities 21,411 367 Total $ 37,180 $ 1,827 |
Convertible Notes, Net
Convertible Notes, Net | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Convertible Notes, Net | Convertible Notes, Net. In August 2014, Aegerion issued Convertible Notes with an aggregate principal amount of $325.0 million . The Convertible Notes are governed by the terms of an indenture and a supplemental indenture between Aegerion and The Bank of New York Mellon Trust Company, N.A., as the Trustee. The following are the key terms of the Convertible Notes: • The Convertible Notes are senior unsecured obligations of Aegerion and bear interest at a rate of 2.0% per year, payable semi-annually in arrears on February 15 and August 15 of each year, beginning on February 15, 2015. The Convertible Notes will mature on August 15, 2019, unless earlier repurchased or converted. • After the Merger, the Convertible Notes are convertible into the Company’s common shares at a conversion rate of 4.9817 common shares per $1,000 principal amount of the Convertible Notes, as adjusted for the Exchange Ratio and the Consolidation. Aegerion can, at its election, settle the conversion of the Convertible Notes through payment or delivery of cash, common shares, or a combination of cash and common shares. • On or after February 15, 2019 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their Convertible Notes, in multiples of $1,000 principal amount, at the option of the holder. • The indenture does not contain any financial covenants or restrict the Company’s ability to repurchase the Company’s securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Company’s level of indebtedness. • The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving Aegerion) occurs and is continuing, the Trustee by notice to Aegerion, or the holders of at least 25% in principal amount of the outstanding Convertible Notes by written notice to Aegerion and the Trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all of the Convertible Notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Aegerion, 100% of the principal and accrued and unpaid interest, if any, on the Convertible Notes will become due and payable automatically. Notwithstanding the foregoing, the indenture provides that, upon Aegerion’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures by Aegerion to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the Convertible Notes. On November 29, 2016, the Company completed its acquisition of Aegerion. The acquisition method of accounting requires an accounting acquirer to measure liabilities assumed at fair value on the acquisition date, as such, both the liability and equity component of the Convertible Notes were re-measured at fair value at the Merger date. The fair value of the Convertible Notes as of the Merger date was approximately $222.9 million , which was determined by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize pricing model incorporating variables such as coupon, maturity, delta, conversion ratio, parity, corporate actions and equity market closing prices to calculate conversion premiums and sensitivity values and to generate the fair value of the Convertible Notes. As of the Merger date, management attributed the fair value entirely to the liability component of the Convertible Notes for the following reasons: 1) as of the Merger date, the conversion price ( $200.74 ) was significantly higher than the price of Novelion common shares ( $9.75 ), and 2) management did not expect the price of Novelion common shares to raise above the conversion price before the Convertible Notes expire in August 2019. Novelion recorded $222.9 million as the opening balance for the liability component of the Convertible Notes and reported zero balance for the equity component of the Convertible Notes post-Merger on its Consolidated Financial Statements. The Company’s outstanding Convertible Notes balances as of December 31, 2016 consisted of the following (in thousands): Liability component: Principal $ 324,998 Less: debt discount (99,414 ) Net carrying amount $ 225,584 Equity component $ — (1) Represents interest payable within one year after December 31, 2016. The Company determined that the expected life of the debt was equal to the five year term on the Convertible Notes. The effective interest rate on the liability component was 16.42% for the period from the acquisition date through December 31, 2016 . The following table sets forth total interest expense recognized related to the Convertible Notes during the year ended December 31, 2016 (in thousands): Years Ending December 31, 2016 Contractual interest expense $ 577 Amortization of debt discount 2,676 Total $ 3,253 Future minimum payments under the Company’s Convertible Notes are as follows (in thousands): Years Ending December 31, 2017 $ 6,500 2018 6,500 2019 329,060 342,060 Less amounts representing interest (17,062 ) Less amortization of debt discount, net (99,414 ) Net carrying amount of convertible notes $ 225,584 |
Share Capital
Share Capital | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Share Capital | Share Capital. (a) Authorized Shares At December 31, 2016 and 2015, the Company was authorized to issue 100 million shares without par value. Dividends on the common shares will be paid when, and if, declared by the Board of Directors. Each holder of common shares is entitled to vote on all matters and is entitled to one vote for each share held. The Company will, at all times, reserve and keep available, out of its authorized but unissued common share, sufficient shares to affect the conversion of shares for stock options, restricted stock units, convertible notes and warrants. (b) Share Consolidation On December 16, 2016 , the Company effected a one-for-five consolidation of all of its issued and outstanding common shares without par value. As noted above, all share and per-share data presented in the Company’s Consolidated Financial Statements and notes have been retrospectively restated to reflect the Consolidation unless otherwise noted. Shares reserved and outstanding under the Company’s equity and incentive plans were adjusted to reflect the Consolidation . (c) Merger Consideration On November 29, 2016, an indirect wholly-owned subsidiary of Novelion acquired Aegerion for total consideration of $62.4 million . The consideration included 6,060,288 Novelion common shares valued at $59.1 million and 10,565,879 Merger Agreement Warrants exercisable for up to an aggregate of 11,301,791 common shares at an exercise price of $0.05 per share that were valued at zero on November 29, 2016 on the Company’s Consolidated Balance Sheet. Refer to Note 5 - Acquisition for additional information. (d) Private Placement Also on June 14, 2016, the Company entered into the Unit Subscription Agreement with the Investors. Pursuant to the Unit Subscription Agreement, immediately prior to the Merger, the Investors acquired units, for $8.80 per unit, consisting of (i) 2,472,727 Novelion common shares, which includes up to 568,181 Novelion common shares issuable upon exercise of the 531,208 Paid-Up Warrants, and (ii) 2,472,727 Unit Subscription Agreement Warrants exercisable for a maximum of 2,644,952 Novelion common shares at an exercise price of $0.05 per common share. The net consideration received from the private placement was $21.5 million ( $21.8 million gross consideration net of $0.3 million share issuance cost), which was recorded as equity and allocated based on the relative fair values of the common shares and the Paid-Up Warrants at the time of issuance. The Unit Subscription Agreement Warrants were issued on the same terms and conditions as the Merger Agreement Warrants. As of December 31, 2016 , the Unit Subscription Agreement Warrants were recognized as a liability on the Company's Consolidated Balance Sheet with a fair value of zero . (e) Cash, Share and Warrant Distributions On April 5, 2016, based on the shareholder election, Novelion distributed $15 million of cash and 4,799,619 Aralez Shares, with a fair value of $19.3 million , to its shareholders of record on February 16, 2016 according to the Amended and Restated Subscription Agreement. On November 23, 2016, the Company issued 10,565,879 Merger Agreement Warrants to its shareholders of record on November 17, 2016. As of December 31, 2016 , the Merger Agreement Warrants were recognized as a liability on the Company's Consolidated Balance Sheet with a fair value of zero . |
Stock-Based Payments
Stock-Based Payments | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Payments | Stock-Based Payments. The Company currently maintains one equity incentive plan, the Novelion 2016 Equity Incentive Plan (the NVLN Plan), formerly known as QLT 2000 Incentive Stock Plan, under which it may grant non-qualified stock options, incentive stock options, and restricted stock units (“RSUs”) to employees, directors and consultants of Novelion and its affiliates. Common shares of Novelion will be issued upon exercise of stock options and the vesting of RSUs. The Company issues stock options and RSUs with service conditions, which are generally the vesting periods of the awards. The Company has also issued RSUs that vest upon the satisfaction of certain performance conditions or the satisfaction of certain market conditions. No financial assistance is provided by Novelion to the participants under the NVLN Plan. Under the terms of the NVLN Plan, Novelion is entitled to grant awards in respect of its unissued common shares up to a maximum of 4,760,000 shares. In connection with the Merger, Novelion assumed the Aegerion 2010 Stock Option and Incentive Plan (Aegerion’s 2010 Option Plan) from Aegerion. On the closing of the Merger, on November 29, 2016, all the outstanding out-of-the-money Aegerion stock options were cancelled. All the outstanding and unexercised in-the-money Aegerion stock options were exchanged for adjusted options of Novelion and all the outstanding Aegerion RSUs held by Aegerion RSU holders were exchanged for adjusted RSUs of Novelion, in each case appropriately adjusted to reflect the Exchange Ratio. Aegerion’s 2010 Option Plan was approved by Aegerion’s stockholders in October 2010 . Aegerion’s 2010 Option Plan allowed Aegerion to make grants of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock units, unrestricted stock awards, cash-based awards, performance share awards and dividend equivalent rights. All full-time and part-time officers, employees, non-employee directors and other key persons, including consultants and prospective employees, of Aegerion were eligible to participate in Aegerion’s 2010 Option Plan. The Company does not plan to issue additional awards under Aegerion’s 2010 Option Plan. There are 10,561 options and 133,351 RSUs outstanding under Aegerion’s 2010 Stock Option Plan as of December 31, 2016. Determining the Fair Value of Stock Awards (a) Stock Options The fair value of stock options is measured with service-based and performance-based vesting criteria to employees, consultants and directors on the date of grant using the Black-Scholes option pricing model. The Black-Scholes option pricing model was developed for use in estimating the value of traded options that have no vesting restrictions and are fully transferable. In addition, option pricing models require the input of highly subjective assumptions, including the expected stock price volatility. The expected volatility and expected life of the Company’s stock options is projected based upon historical and other economic data trended into future years. The risk-free interest rate assumption is based upon observed interest rates appropriate for the expected life of the Company’s stock options. The risk-free interest rate is determined by reference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant. Forfeitures are estimated based on the Company’s historical analysis of both options and awards that forfeited prior to vesting. The weighted-average grant date fair values of stock options granted during the years ended December 31, 2016 , 2015 and 2014 , were USD $7.12 , CAD $10.60 , and CAD $9.35 , respectively. The following weighted-average assumptions were used to value stock options granted in each of the following years: Years Ended December 31, 2016 2015 2014 Expected share price volatility 38.23 % 41.30 % 42.40 % Risk-free interest rate 1.93 % 1.40 % 1.60 % Expected life of options (years) 6.19 6.80 6.80 Expected dividend yield — — — As of December 31, 2016, 205,030 options were outstanding under the NVLN Plan, which are exercisable at prices ranging between $7.15 and $35.51 per common share. The number of options issued and outstanding under the NVLN Plan represents 9.1% (2015 - 0.8% , 2014 - 4.1% ) of the Company’s issued and outstanding common shares. The Company’s stock option activity for the year ended December 31, 2016 is as follows: Weighted Weighted- Average Average Remaining Aggregate Number of Exercise Price Contractual Intrinsic Value (2) stock options (2) Per Share (2) Life (years) (in thousands) Outstanding at December 31, 2015 (3) 85,630 C$ 25.35 8.26 C$ — Granted (1) 1,629,563 $ 8.27 Exercised — $ — $ — Forfeited/cancelled (600) $ 25.35 Outstanding at December 31, 2016 1,714,593 $ 9.01 9.65 $ 528 Vested and expected to vest at December 31, 2016 1,231,203 $ 9.24 9.58 $ 437 Exercisable at December 31, 2016 205,030 $ 13.86 8.49 $ 140 (1) The Aegerion stock options assumed by the Company in connection with the Merger are included in grants made during the year ended December 31, 2016 in the above table. The total number of assumed Aegerion stock options was 10,561 with a weighted-average exercise price of $7.70 per share. (2) Shares and per share amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation. (3) Intrinsic value and exercise price of the stock options granted before 2016 were based on the underlying Novelion common shares listed on the Toronto Stock Exchange (TSX), and thus in Canadian dollars. Stock options granted in 2016 and after are and will be based on the underlying Novelion common shares listed on NASDAQ and thus in USD. In connection with the strategic transactions announced on June 8, 2015 as described under Note 3 - Terminated Merger Transactions and Note 4 - Strategic Transactions, on June 7, 2015 the Board of Directors accelerated the vesting provisions applicable to 217,294 options outstanding and unvested at that date. The impact of the accelerated vesting of these stock options on stock-based compensation expense for the year ended December 31, 2015 was $1.5 million . 1,509,563 stock options were outstanding and unvested at December 31, 2016 (2015 - zero , 2014 - 256,796 ) and the total estimated unrecognized compensation cost related to unvested stock options is $4,922,028 (2015 - zero , 2014 - $ 2,021,000 )and the weighted-average period over which such costs are expected to be recognized is 2.83 years (December 31, 2015 - 0 years, December 31, 2014 - 2.20 years). The aggregate intrinsic values of options outstanding and exercisable as of December 31, 2016, 2015, and 2014 are as follows: (In thousands) 2016 2015 2014 Aggregate intrinsic value of options outstanding (1) $ 528 C$ — C$ 2,435 Aggregate intrinsic value of options exercisable (1) 140 — 240 (1) Intrinsic value of the stock options granted before 2016 were based on the underlying Novelion common shares listed on the Toronto Stock Exchange (TSX), and thus in Canadian dollars. Stock options granted in 2016 and after are and will be based on the underlying Novelion common shares listed on NASDAQ and thus in USD. New common shares are issued upon exercise of stock options. The intrinsic value of stock options exercised and the related cash from exercise of stock options during the years ended December 31, 2016, 2015 and 2014 are as follows: (In thousands) 2016 2015 2014 $ — $ 4,930 $ 230 Cash from exercise of stock options — 5,508 509 (b) Deferred Share Units Under the DDSU Plan, at the discretion of the Board of Directors, directors can receive all or a percentage of their equity-based compensation in the form of DSUs. DSUs vest in thirty-six ( 36 ) successive and equal monthly installments beginning on the first day of the first month after the grant date. A vested DSU can only be settled by conversion to cash ( no share is issued), and is automatically converted after the director ceases to be a member of the Board unless the director is removed from the Board for just cause. Prior to conversion, the value of each DSU, at any point in time, is equivalent to the latest closing price of Novelion’s common shares on TSX on that trading day. When converted to cash, the value of a vested DSU is equivalent to the closing price of a Novelion’s common share on the trading day immediately prior to the conversion date. DSU activity is presented below: Number (1) Outstanding at December 31, 2015 30,800 Granted 8,960 Redeemed (11,360 ) Cancelled — Outstanding at December 31, 2016 28,400 Vested at December 31, 2016 28,400 (1) Shares and per share amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation. The obligation to settle DSUs in cash is recorded as a liability in the Company’s Consolidated Financial Statements and is marked-to-market at the end of each reporting period. See Note 9 - Accrued Liabilities. Cash payments under the DDSU Plan during the years ended December 31, 2016, 2015, and 2014 were as follows: (in thousands) 2016 2015 2014 Cash payments under the DDSU plan $ 105 $ — $ — The cash payments in 2016 related to two former members of the Novelion board of directors who departed from the board after the acquisition closed on November 29, 2016. The Company’s obligation to settle the remaining vested and unsettled 28,400 common shares underlying DSUs held by former directors was $0.2 million as of December 31, 2016. In connection with the Merger, the vesting provisions applicable to all of the outstanding and unvested DSUs were accelerated on November 29, 2016. The acceleration of the vesting provisions of all the outstanding and unvested DSUs during the year ended December 31, 2016 resulted in an additional $62,251 DSU compensation expense recognized on the Company's accompanying Consolidated Statements of Operations. (c) Restricted Stock Units The Company has outstanding time-vested, market-based and performance-based RSUs. Time-vested RSUs are awarded to eligible employees and entitle the grantee to receive common shares at the end of a vesting period, subject solely to the employee’s continuing employment. The majority of time-vested RSUs vest in two equal annual installments beginning a year from the grant date. Aegerion’s market-based RSUs were awarded to employees of Aegerion on July 29, 2014 and were replaced by Novelion’s market-based RSUs at the time of the acquisition. All the market-based RSUs vest when the price the day the stock price closes on the value at or above the value of the original new hire strike price and expire on July 29, 2019. Because the current stock price of the Company is significantly lower than the original new hire strike price, we expect all the market-based RSUs will expire without being vested. The performance-based RSUs are awarded to eligible employees and entitle the grantee to receive shares of common stock if specified performance goals are achieved during the performance period and the grantee remains employed during the subsequent vesting period. The majority of performance-based RSUs vest in three equal annual installments beginning upon goal achievement. Upon vesting, each RSU represents the right to receive one common share of the Company. RSU transactions for the years ended December 31, 2016 are as following: Number of RSUs (3) Outstanding at December 31, 2015 — Granted (1) (2) 1,036,735 Redeemed — Cancelled (7,854 ) Outstanding at December 31, 2016 1,028,881 (1) The weighted-average grant date fair value of the RSUs granted during the year ended December 31, 2016 was $8.82 (December 31, 2015 - zero , December 31, 2014 - CAD $20.4 ). (2) The assumed Aegerion RSUs from the Merger are included in grants made during the fiscal year ended December 31, 2016 in the above table. The total number of assumed Aegerion RSUs was 140,605 with a weighted-average merger date valuation of $9.53 per share. (3) Shares and per share amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation. RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. The Company expenses the cost of the RSUs with service-based vesting conditions, which is determined to be the fair value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. The fair value of RSUs with market-based vesting conditions is determined using a Monte Carlo simulation and the Company recognizes compensation expense over the derived service period. In connection with the strategic transactions announced on June 8, 2015 (see Note 3 - Terminated Merger Transactions and Note 4 - Strategic Transactions), the Board of Directors accelerated the vesting provisions applicable to 12,800 RSUs that were outstanding and unvested on June 7, 2015. The impact of the accelerated vesting of these RSUs during the year ended December 31, 2015 was an additional $0.2 million RSU compensation expenses recognized in the Company's 2015 results of operations. 1,028,881 RSUs were outstanding and unvested as of December 31, 2016 (December 31, 2015 - zero , December 31, 2014 - 12,800 ). In addition, the total estimated unrecognized compensation cost related to RSUs as of December 31, 2016 is $9.0 million (December 31, 2015 - zero , December 31, 2014 - $0.2 million ) and the weighted-average period over which such costs are expected to be recognized is 1.77 years (December 31, 2015 - zero years , December 31, 2014 - 2.34 years). The impact on the Company’s results of operations of stock-based compensation expense for the years ended December 31, 2016, 2015, and 2014 is as follows: (in thousands) 2016 2015 2014 Research and development $ 155 $ 1,267 $ 911 Selling, general and administrative 683 1,108 702 Total stock-based compensation expense $ 838 $ 2,375 $ 1,613 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes. Loss before provision for income taxes, classified by source of (loss)/income, is as follows: (in thousands) December 31, 2016 December 31, 2015 December 31, 2014 Canada $ (46,733 ) $ (22,987 ) $ (4,197 ) U.S. (9,521 ) — — Other Foreign 3,849 — — Loss before provision for income taxes $ (52,405 ) $ (22,987 ) $ (4,197 ) Provision for income taxes for the years ended December 31, 2016 , 2015 and 2014 are as follows: (in thousands) 2016 2015 2014 Current: Canada $ 105 $ — $ — U.S. state, net of federal income tax benefit (2 ) — — Other Foreign (517 ) — — $ (414 ) $ — $ — Deferred: Canada $ — $ (22 ) $ 192 Other Foreign (51 ) — — (51 ) (22 ) 192 (Provision for) recovery of income taxes $ (465 ) $ (22 ) $ 192 Differences between the Company’s statutory income tax rates and its effective income tax rates, as applied to the loss from continuing operations before income taxes, are reconciled as follows: (in thousands) 2016 2015 2014 Loss from continuing operations before income taxes $ (52,405 ) $ (22,987 ) $ (4,197 ) Canadian statutory tax rates 26.00 % 26.00 % 26.00 % Expected income tax recovery 13,625 5,977 1,091 Net decrease (increase) in valuation allowance (13,684 ) (2,486 ) 731 Non-taxable portion of capital gains — — 230 Investment tax credits 868 (222 ) 1,628 Stock-based compensation (133 ) (606 ) (377 ) Foreign rate differential 532 — — Non-taxable (deductible) expenditures — 76 1,752 Changes in uncertain tax positions — (1,784 ) (4,793 ) Adjustments to capital losses for settlement of uncertain tax positions — (560 ) — Other (1,673 ) (417 ) (70 ) (Provision for) recovery of income taxes $ (465 ) $ (22 ) $ 192 Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The primary components of the Company’s deferred tax assets and liabilities comprised of the following: (in thousands) 2016 2015 Deferred tax assets: Net operating loss carryforwards $ 51,808 $ 45,365 Research and development credits 14,028 14,164 Stock-based compensation 108 — Capitalized research expenses 2,124 — Capital loss carryforwards 37,452 36,207 Depreciable and amortizable assets 13,597 1,645 Other temporary differences 13,736 197 Total gross deferred tax assets 132,853 97,578 Valuation allowance (131,858 ) (97,578 ) Net deferred tax assets $ 995 $ — As of December 31, 2016, the Company has a $1.0 million net deferred tax asset attributable to its profitable foreign subsidiaries. Additionally, as of December 31, 2016 , the Company has $131.9 million of valuation allowance recorded against its Canadian, U.S. and Switzerland deferred tax assets. The valuation allowance increase of $34.3 million is primarily the result of the acquisition of Aegerion. If the Company is subsequently able to utilize all or a portion of the deferred tax assets for which the remaining valuation allowance has been established, then the Company may be required to recognize these deferred tax assets through the reduction of the valuation allowance which could result in a material benefit to results of operations in the period in which the benefit is determined. The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets and concluded that based on the Company’s history of operating losses that it is more likely than not that the benefit of its deferred tax assets will not be realized. At December 31, 2016 , the Company had approximately $166.9 million of foreign and federal net operating loss carryforwards, of which $152.6 million relate to Canada and $14.3 million relate to the Company’s U.S. subsidiaries. The loss carryforwards expire at various dates through 2036. As of December 31, 2016, the Company also had approximately $11.8 million of state net operating loss carryforwards that expire at various dates through 2036. As of December 31, 2016 , the Company also had approximately $13.5 million of Canadian national and provincial research and development credits available for carryforward. The research and development credit carryforwards expire at various dates through 2036. As of December 31, 2016 , the Company's Canadian Scientific, Research and Experimental Development pool was $13.4 million . Furthermore, as of December 31, 2016 , the Company had approximately $289.5 million of Canadian capital loss carryforwards, which carryforward indefinitely. The deferred tax benefit of these loss carryforwards and research and development credits is ultimately subject to final determination by the respective taxation authorities. Upon acquiring a company that has U.S. federal and state net operating loss carryforwards and federal and state tax credits, the Company prepared an assessment to determine if it has a legal right to use the acquired net operating losses and tax credits. In performing this assessment the Company followed the regulations within the Internal Revenue Code Sections 382 and 383. The Company determined that the U.S. net operating losses and tax credits acquired in the Aegerion acquisition will be subject to limitations under Internal Revenue Code Sections 382 and 383. Due to the ownership changes, the Company has determined that its U.S. subsidiaries, including Aegerion, will only be able to utilize approximately $14.3 million of its NOLs before expiration as a result of the annual Section 382 limitation. For Aegerion, $166.6 million of federal net operating losses and $30.2 million of federal general business credits will expire before becoming available under the Section 382 limitation. Additionally, $96.9 million of state net operating losses and $0.2 million of state credits will expire before becoming available under the Section 382 limitation. The U.S. subsidiaries may also experience ownership changes in the future as a result of subsequent shifts in share ownership that could further limit the use of the available net operating losses and credits. Additionally, Aegerion determined that at the date of the ownership change, it had a net unrealized built-in loss (“NUBIL”). The NUBIL is determined based on the difference between the fair market value of the Company’s assets and their tax basis at the ownership change. In accordance with ASC 740, the Company recorded a reserve for uncertain tax positions of approximately $7.7 million offset by $7.3 million of the Company's deferred tax assets at December 31, 2016, for a net of $0.4 million for unrecognized tax benefits as of December 31, 2016 . The following table summarizes the activity related to the Company’s unrecognized tax benefits: (in thousands) 2016 2015 2014 Total uncertain tax position liabilities as of January 1, $ 7,278 $ 5,557 $ 1,846 Current year acquisitions 911 — — Increases related to current year tax positions — 347 5,169 Changes in tax positions of a prior period — 1,934 11 Lapse due to statute of limitations (342 ) — (1,469 ) Settlements with taxing authorities (187 ) (560 ) — Total uncertain tax position liabilities as of December 31, $ 7,660 $ 7,278 $ 5,557 Of this amount of unrecognized tax benefits, approximately $7.3 million , $6.9 million and $5.2 million would be fully offset by the Company's deferred tax asset at December 31, 2016, 2015 and 2014. The Company recognizes interest and penalties as a component of income tax expense. At December 31, 2016 , 2015 and 2014 the Company had no t accrued interest or penalties as a result of the deferred assets available to offset its unrecognized tax benefits. The increase in unrecognized tax benefits during the year was the result of transfer pricing adjustments made at the Company’s Swiss subsidiary as a result of its acquisition of Aegerion. During 2016, the Company settled a dispute with the Canadian Revenue Authority surrounding its capital loss carryover as a result of its divestiture of its Eligard contingent consideration which resulted in a decrease of the unrecognized tax benefits. Additionally during 2016, the period in which the 2008 Canadian income tax return was subject to reassessment expired, which resulted in a reduction of the unrecognized tax benefits surrounding its share by buyback costs that arose during that tax year. Given that the potential net 2016 liability increase of $0.4 million , the potential 2015 liability increase of $1.7 million and the potential net 2014 liability increase of $3.7 million are fully or partially sheltered by the Company’s existing deferred tax assets, the Company has offset a portion of the total liability on the Company’s Consolidated Balance Sheets in accordance with ASU No. 2013-11 - Income Taxes (Topic 740): Presentation of Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists . ASU No. 2013-11 was adopted on a prospective basis effective January 1, 2014. The Company and its subsidiaries file income tax returns in Canada, the U.S., and various U.S. states and in foreign jurisdictions. The Canadian income tax returns are generally subject to tax examination for the tax years ended December 31, 2010 through December 31, 2016. The U.S., U.S. state and foreign income tax returns are generally subject to tax examinations for the tax years ended December 31, 2013 through December 31, 2016. To the extent the Company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by the tax authorities. The Company monitors the undistributed earnings of its foreign subsidiaries and, as necessary, provides for income taxes on those earnings that are not deemed permanently invested. As of December 31, 2016 the Company has approximately $1.5 million of undistributed earnings at its foreign subsidiaries. These earning are deemed permanently invested by the Company. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | Fair Value of Financial Instruments. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. ASC No. 820 - Fair Value Measurements and Disclosures established a fair value hierarchy for those instruments measured at fair value that distinguishes between fair value measurements based on market data (observable inputs) and those based on the Company’s own assumptions (unobservable inputs). This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: • Level 1 —Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. The Company’s Level 1 assets consist of cash, money market investments, and restricted cash. • Level 2 —Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly. The Company’s Level 2 liabilities consist of convertible notes. • Level 3 —Inputs that are unobservable for the asset or liability. The Company does not have any Level 3 assets and liabilities as of December 31, 2016. The fair value measurements of the Company’s financial instruments at December 31, 2016 and 2015 are summarized in the tables below: December 31, 2016 Significant Quoted Prices in Other Significant Active Markets for Observable Unobservable Balance at Identical Assets Inputs Inputs December 31, (in thousands) (Level 1) (Level 2) (Level 3) 2016 Assets: Cash $ 40,693 $ — $ — $ 40,693 Money market funds 68,234 — — 68,234 Restricted cash 390 — — 390 Total assets $ 109,317 $ — $ — $ 109,317 Liabilities: Convertible notes, net - long-term — 225,584 — 225,584 Total liabilities $ — $ 225,584 $ — $ 225,584 December 31, 2015 Significant Quoted Prices in Other Significant Active Markets for Observable Unobservable Balance at Identical Assets Inputs Inputs December 31, (in thousands) (Level 1) (Level 2) (Level 3) 2015 Assets: Cash $ 141,824 $ — $ — $ 141,824 Accounts receivable - Laser Earn-Out Payment (1) — — 2,000 2,000 Total assets $ 141,824 $ — $ 2,000 $ 143,824 (1) Represents the estimated fair value of the Laser Earn-Out Payment as described in Note 16 - Contingencies, Commitments and Guarantees. The fair value of the Laser Earn-Out Payment was estimated using a probability weighted approach to examine various possible outcomes with respect to the timing and amount that may be collected. The fair value of the Convertible Notes, which differs from their carrying values, is influenced by interest rates, the Company’s share price and share price volatility and is determined by prices for the Convertible Notes observed in market trading which are Level 2 inputs. The estimated fair value of the Convertible Notes at December 31, 2016 was $240.4 million . See Note 10 - Convertible Notes, Net for further information. The Company’s financial instruments that are exposed to credit risks consist primarily of cash, cash equivalents, restricted cash and accounts receivable. To limit the Company’s credit exposure, cash and cash equivalents are deposited with high-quality financial institutions in accordance with its treasury policy goal to preserve capital and maintain liquidity. The Company’s treasury policy limits investments to certain money market securities issued by governments, financial institutions and corporations with investment-grade credit ratings, and places restrictions on maturities and concentration by issuer. The Company maintains its cash, cash equivalents and restricted cash in bank accounts, which, at times, exceed federally insured limits. The Company has not experienced any credit losses in these accounts and does not believe it is exposed to any significant credit risk on these funds. The Company is subject to credit risk from its accounts receivable related to its product sales of lomitapide and metreleptin. The majority of the Company’s accounts receivable arise from product sales in the U.S. For accounts receivable that have arisen from named patient sales outside of the U.S., the payment terms are predetermined and the Company evaluates the creditworthiness of each customer or distributor on a regular basis. The Company periodically assesses the financial strength of the holders of its accounts receivable to establish allowances for anticipated losses, if necessary. The Company does not recognize revenue for uninsured amounts billed directly to a patient until the time of cash receipt as collectability is not reasonably assured at the time the product is received. To date, the Company has not incurred any credit losses. |
Basic and Diluted Net Loss per
Basic and Diluted Net Loss per Common Share | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common Share. Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per common share is computed by dividing the net loss by the weighted-average number of unrestricted common shares and dilutive common share equivalents outstanding for the period, determined using the treasury-shares and if-converted methods. Since the Company has had net losses for all periods presented, all potentially dilutive securities are anti-dilutive. Accordingly, basic and diluted net loss per common share are equal. The following table sets out the computation of basic and diluted net loss per common share: (in thousands, except per share data) 2016 2015 2014 Numerator: Loss from continuing operations $ (52,870 ) $ (23,009 ) $ (4,005 ) Loss from discontinued operations, net of income taxes — — (66 ) Net loss $ (52,870 ) $ (23,009 ) $ (4,071 ) Denominator: (thousands) weighted-average common shares outstanding 11,284 10,434 10,225 Basic and diluted net loss per common share Continuing operations $ (4.69 ) $ (2.20 ) $ (0.40 ) Discontinued operations (1) — — — Net loss per common share $ (4.69 ) $ (2.20 ) $ (0.40 ) (1) Rounded to zero. The following table sets forth potential common shares issuable upon the exercise of outstanding options, warrants, the vesting of RSUs and the conversion of the Convertible Notes (prior to consideration of the treasury shares and if-converted methods) (see Note 12 - Stock-Based Payments for details), which were excluded from the computation of diluted net loss per share because such instruments were anti-dilutive (in thousands): December 31, December 31, December 31, Stock options 1,715 86 418 Unvested restricted stock units 1,029 — 13 Warrants 14,515 568 — Convertible notes 1,619 — — Total 18,878 654 431 |
Contingencies, Commitments and
Contingencies, Commitments and Guarantees | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments, Contingencies and Guarantees | Contingencies, Commitments and Guarantees. Lease Obligations The Company leased certain office facilities and office equipment under operating leases. The future estimated operating lease payments for office space and office equipment over the next five years are summarized as follows (in thousands): Year Ending December 31: Lease Commitments 2017 $ 3,083 2018 2,400 2019 884 2020 128 Thereafter 13 Total $ 6,508 Rent expense under operating leases was approximately $0.5 million , $0.4 million , and $0.5 million for the years ended December 31, 2016 , 2015 and 2014 , respectively. During 2015, the Company entered into a sublease agreement (as amended, the Lease Agreement) to downsize its existing space in Vancouver, British Columbia, where its headquarters is located. The Company currently leases approximately 8,475 square feet of space under the terms of the Lease Agreement. The lease term applicable to this space expires on August 31, 2017. The Company's U.S. operational office, which is located at One Main Street in Cambridge, Massachusetts, consists of approximately 31,571 square feet of office space under a lease that expires in April 2019. The Company also leases office spaces in Japan, the UK, Switzerland, Germany, France, Italy, Canada, Brazil, and Turkey, with approximately 8,414 square feet of office space in the aggregate. The Company's international lease agreements expire at various dates through the year 2021. In addition to the locations listed above, the Company holds inventory at various locations, including international locations, managed by third parties. Other Commitments Amgen Licensing Agreements Metreleptin. In connection with Aegerion's acquisition of MYALEPT in January 2015, Aegerion acquired a license agreement between Amgen Inc. (Amgen) and Amylin Pharmaceuticals, Inc., dated February 7, 2006 (the Amgen License) pursuant to which an exclusive worldwide license was obtained from Amgen to certain know-how and patents and patent applications covering the composition of matter and methods of use of metreleptin to develop, manufacture and commercialize a preparation containing metreleptin (the Amgen Licensed Products). As part of the Amgen License, an exclusive sublicense of Amgen’s exclusive rights to certain metreleptin-related patents and patent applications owned by the Rockefeller University and exclusively licensed to Amgen under a license agreement dated April 14, 1995, as amended (the Rockefeller License) and an exclusive sublicense of Amgen’s non-exclusive rights to certain metreleptin-related patents and patent applications owned by The Regents of the University of California and non-exclusively licensed to Amgen under a license agreement dated July 13, 2005 (the UCSF License) were obtained. Amgen retains rights to conduct research, development, manufacturing and commercialization activities with respect to products other than the Amgen Licensed Products. Sublicenses under the licenses are permitted and are subject to certain limitations, including Amgen’s right of first offer for any out-license, partnership, co-development, commercialization, co-promotion or similar agreement related to metreleptin or the Amgen Licensed Products, which expires in February 2021. Under this license agreement, Amgen must notify us of any potential third-party partnership regarding any intellectual property rights controlled by Amgen in the neurology field and the Company will have a right of first negotiation for any license, partnership, co-development, commercialization, co-promotion or similar agreement, which expires in February 2021. Aegerion is required to make royalty payments to Amgen, Rockefeller University and BMS on net sales of each Amgen Licensed Product on a country-by-country basis (i) at a royalty rate in the low double digits where the Amgen Licensed Product has patent protection or market exclusivity granted by a regulatory authority at the time of regulatory approval in the applicable country during the applicable royalty term, which runs on a country-by-country basis until the later of (a) the expiration of the last-to-expire valid claim covering an Amgen Licensed Product in the applicable country, (b) expiration of any market exclusivity granted by a regulatory authority, and (c) 10 years from the date on which an Amgen Licensed Product is first sold to a third-party in a country after regulatory approval for the Amgen Licensed Product has been granted in such country (Amgen Royalty Term) or (ii) at a royalty rate in the mid-single digits to low double digits where the Amgen Licensed Product receives patent protection or market exclusivity following the time of regulatory approval in the applicable country, in either case subject to a variety of customary reductions. Under the Amgen License, Aegerion is also required to directly meet certain payment obligations under the Rockefeller License and UCSF License. Aegerion is required to make royalty payments to Rockefeller University on net sales of each product with patent rights or know-how in the field of obesity genes, obesity gene products, and molecules that modulate or mediate their action and/or regulation on a country-by-country basis at a range of royalty rates in the low single digits depending on whether the product has an orphan product designation or not until the later to occur of expiration of (i) patent protection, (ii) any market exclusivity period granted in the applicable country, or (iii) any data exclusivity period in the applicable country (with certain limitations related to the number of units sold). Aegerion is required to pay to Rockefeller University a percentage in the low double digits of any upfront license fees or one-time fees it receives in consideration for a sublicense of the licensed rights. There are no material payment obligations outstanding under the UCSF License. The Amgen License will terminate upon the expiration of the last Amgen Royalty Term for any Amgen Licensed Product. Aegerion has the right to terminate the Amgen License for convenience upon 90 days prior written notice to Amgen or for Amgen’s uncured material breach of the Amgen License, or becoming subject to specified bankruptcy or liquidation events. Amgen may terminate the Amgen License for the Aegerion’s uncured failure to make payments to Amgen or if the Company is the subject of specified bankruptcy or liquidation events. During the period from November 30, 2016 to December 31, 2016, there were no royalty payments made by the Company related to sales of MYALEPT. As of December 31, 2016 , $1.2 million remained as an accrual balance in royalties payable to Amgen. Shionogi & Co., Ltd. Metreleptin. In connection with Aegerion's acquisition of MYALEPT in January 2015, Aegerion acquired a license agreement between Shionogi and Amylin Pharmaceuticals, Inc., dated July 8, 2009 pursuant to which Shionogi was granted an exclusive sublicense to the patent rights licensed under the Amgen License and the Rockefeller License to develop and commercialize the Amgen Licensed Products and know-how for use in the treatment of lipodystrophy in humans in Japan, South Korea and Taiwan (the Shionogi Territory). This license agreement does not provide Shionogi with manufacturing rights. Shionogi may grant further sublicenses under the license, subject to certain limitations. The license agreement requires that Shionogi use commercially reasonable efforts to develop, obtain regulatory approvals for, and commercialize the Amgen Licensed Products in the Shionogi Territory. Shionogi is required to make royalty payments to Aegerion on net sales of each Amgen Licensed Product at a range of royalty rates in the mid-to high-single digits dependent on the amount of net sales. During the period from November 30, 2016 to December 31, 2016, Aegerion did not receive any royalty payments from Shionogi. Shionogi will be required to make milestone payments to Aegerion of up to an aggregate of approximately $25.0 million if and when Shionogi achieves certain commercialization milestones. Such milestone payments are payable only once. Under the license agreement, Shionogi has also agreed to directly comply with the payment obligations under the Rockefeller License and Amgen License, as set forth under those agreements, relating to its activities under this license agreement. The license agreement with Shionogi will terminate upon the expiration of the last Amgen Royalty Term for any Amgen Licensed Product with respect to which Shionogi has a license under this license agreement. Aegerion has the right to terminate this license agreement for Shionogi’s uncured material breach of the license agreement, failure to make any payment due to Aegerion, a procedural default, or becoming subject to specified bankruptcy or liquidation events. Shionogi may terminate this license agreement for Aegerion’s uncured material breach of this license agreement, failure to make payments due to Shionogi, or if Aegerion is the subject of specified bankruptcy or liquidation events, or if Shionogi determines it is not feasible to develop, launch or sell the Amgen Licensed Products due to scientific, technical, regulatory or commercial reasons. Aegerion may also terminate this license agreement at any time without cause by exercising its buy-back option for a one-time fee to Shionogi equal to (i) a number in the low single digits times the amount of expenses and fees incurred by Shionogi in developing the Amgen Licensed Products plus (ii) an amount no more than a number in the mid-double digits times monthly net sales of the Amgen Licensed Products by Shionogi in the month the option is exercised. University of Pennsylvania Licensing Agreement Lomitapide. In May 2006, Aegerion entered into license agreement with The Trustees of the University of Pennsylvania, (UPenn) pursuant to which it obtained an exclusive, worldwide license from UPenn to certain know-how and a range of patent rights applicable to lomitapide. In particular, Aegerion obtained a license to certain patent and patent applications owned by UPenn relating to the dosing of microsomal triglyceride transfer protein inhibitors, including lomitapide, and certain patents and patent applications and know-how covering the composition of matter of lomitapide that were assigned to UPenn by BMS in the field of monotherapy or in combination with other dyslipidemic therapies, which are therapies for the treatment of patients, with abnormally high or low levels of plasma cholesterol or triglycerides. Aegerion is obligated under this license agreement to use commercially reasonable efforts to develop, commercialize, market and sell at least one product covered by the licensed patent rights, such as lomitapide. Aegerion will be required to make specified royalty payments on net sales of products, at a range of royalty rates in the high single digits on net sales of lomitapide in countries where lomitapide has patent protection, and of any other products covered by the license (subject to a variety of customary reductions), and share with UPenn specified percentages of sublicensing royalties and certain other consideration that the Company receives under any sublicenses that Aegerion may grant. During the period from November 30, 2016 to December 31, 2016, there were no royalty payments made to UPenn. As of December 31, 2016 , $1.3 million remained as an accrual balance in royalty payable UPenn. This license agreement will remain in effect on a country-by-country basis until the expiration of the last-to-expire licensed patent right in the applicable country. Aegerion has the right to terminate this license agreement for UPenn’s uncured material breach of the license agreement or for convenience upon 60 days ’ prior written notice to UPenn, subject to certain specific conditions and consequences. UPenn may terminate this license agreement for Aegerion’s uncured material breach of the license agreement, its uncured failure to make payments to UPenn or if Aegerion is the subject of specified bankruptcy or liquidation events. Retinagenix LLC Zuretinol. Under the terms of the April 2006 co-development agreement (as amended, the Retinagenix Agreement) QLT entered into with Retinagenix LLC (Retinagenix), it obtained an exclusive, worldwide license and sub-license to certain intellectual property rights owned or controlled by Retinagenix related to the synthetic retinoid compound under development. Under the terms of this agreement, QLT is responsible for using commercially reasonable and diligent efforts to develop and commercialize in certain major markets and other markets as it reasonably determines, one or more products covered by the licensed rights or developed using such licensed rights for use in diagnosing, treating or preventing certain human diseases and conditions. QLT is also responsible for committing certain annual funding to support research and development of such products. Under the license agreement between Retinagenix and the University of Washington (the UW Agreement), Retinagenix has similar obligations, and is required to meet specific development milestones within certain timeframes, one of which was required to be achieved by December 31, 2016. However, the UW Agreement contains provision for extensions of those dates in certain circumstances. Based on the terms of the Retinagenix Agreement and the UW Agreement, and the Company’s significant development clinical spend on the zuretinol program, management believes that the Company is entitled to an extension of that milestone date until December 31, 2017, and that the Company may be entitled to certain additional extensions to December 31, 2019, along with a potential additional extension of up to 12 months should enrollment in a planned trial be delayed, provided that the Company continues to comply with the relevant provisions of the license agreements and expend certain minimum amounts on the development of zuretinol. However, it is possible that the Company may not be able to achieve the specified development milestone by December 31, 2019. As a result, management of the Company and Retinagenix have begun discussing a renegotiation of that milestone with the University of Washington. The Company is currently conducting a review of the zuretinol development program, the results of which will assist the Company in determining when the remaining development milestone can be expected to be achieved. Pursuant to the Retinagenix Agreement, Retinagenix is eligible to receive the following milestone payments: (i) $1.0 million upon initiation of the first pivotal trial for the first target indication which uses such products, (ii) $1.5 million upon completion of a filing seeking EU approval or Japan approval for the use of such products in the first indication and (iii) up to a total of an additional $10.0 million upon the achievement of other specified development or regulatory milestones and, for each of up to two additional indications, up to a total of $9.0 million upon achievement of specified development or regulatory milestones. If the Company commercializes such products, it will also pay Retinagenix royalties of between 4% and 6% of net sales, subject to reduction under certain specified circumstances. Retinagenix is also eligible to receive up to a total of $15.0 million upon achievement of specified cumulative sales milestones for such products. The term of the Retinagenix Agreement expires on the later of the expiration of 10 years after first commercial sale of licensed products, or the expiration, lapse or abandonment of all licensed patents. Retinagenix can terminate the agreement earlier if the Company fails in any material respect to meet its diligence requirements, and the Company may terminate the agreement for convenience. Each party may terminate the agreement for uncured material breach by the other party. Financial Advisory Services Milestone Obligation On February 5, 2016, pursuant to the Greenhill Agreement, QLT paid Greenhill a $4.0 million advisory fee in connection with the completion of QLT’s $45.0 million investment in Aralez and exploration of other strategic initiatives described under Note 3 - Terminated Merger Transactions and Note 4 - Strategic Transactions. The recognition and payment of the advisory fee was both contingent upon the satisfaction of various terms and conditions, which were met on February 5, 2016, and subject to the outcome of certain external factors and uncertainties, which were settled by February 5, 2016 but were beyond the Company’s control. Indemnities In connection with the sale of assets, the Company provided indemnities with respect to certain matters, including product liability, patent infringement, contractual breaches and misrepresentations, and the Company provides other indemnities to third parties under the clinical trial, license, service, supply and other agreements that it enters into in the normal course of its business. If the indemnified party were to make a successful claim pursuant to the terms of the indemnity, the Company would be required to reimburse the loss. These indemnities are generally subject to threshold amounts, specified claims periods and other restrictions and limitations. As of December 31, 2016, no amounts have been accrued in connection with such indemnities. Development and Post Marketing Regulatory Commitments Novelion and Aegerion have engaged Contract Research Organizations (CROs) to provide research, safety and project management services (the Services) in connection with the execution of their potential clinical trials and existing registries. Services would only give rise to liabilities to the extent that services are provided to Novelion or Aegerion, as applicable, and pass through expenses are incurred. As of December 31, 2016 , the Services have not yet been performed and the Company has potential commitments of approximately $42.1 million under these agreements. The amount reflected is based on the existing contracts and does not reflect any inflation, future modification to, or termination of, the existing contract or anticipated or potential new contracts. Contingencies Upon the acquisition of Aegerion, the Company assumed the assets and liabilities related to the following contingencies (in thousands): Insurance Proceeds Receivable Class action lawsuit insurance proceeds $ 22,000 Provision for Legal Settlement Class action lawsuit settlement $ (22,250 ) DOJ and SEC settlement (40,635 ) Relator legal settlement (620 ) Relators legal fees (405 ) Other litigation settlement (100 ) Total provision for legal settlement $ (64,010 ) DOJ/SEC Investigations In late 2013, Aegerion received a subpoena from the DOJ, represented by the U.S. Attorney’s Office in Boston, requesting documents regarding Aegerion’s marketing and sale of JUXTAPID in the U.S., as well as related disclosures. Aegerion believes the DOJ is seeking to determine whether it, or any of its current or former employees, violated civil and/or criminal laws, including but not limited to, the securities laws, the Federal False Claims Act, the Food and Drug Cosmetic Act, the Anti-Kickback Statute, and the Foreign Corrupt Practices Act of 1977 (FCPA). The investigation is ongoing. In late 2014, Aegerion received a subpoena from the SEC requesting certain information related to its sales activities and disclosures related to JUXTAPID. The SEC also has requested documents and information on a number of other topics, including documents related to the investigations by government authorities in Brazil into whether Aegerion’s activities in Brazil violated Brazilian anti-corruption laws, and whether Aegerion’s activities in Brazil violated the U.S. Foreign Corrupt Practices Act. Aegerion believes the SEC is seeking to determine whether Aegerion, or any of its current or former employees, violated securities laws. The investigation is ongoing. In May 2016, Aegerion reached preliminary agreements in principle with the DOJ and the SEC to resolve their investigations into the marketing and sales activities and disclosures relating to JUXTAPID. Under the terms of the preliminary agreement in principle with the DOJ, Aegerion would plead guilty to two misdemeanor misbranding violations of the Food, Drug and Cosmetic Act. One count would be based on its alleged marketing of JUXTAPID with inadequate directions for use (21 U.S.C. §§ 352(f)), and the second count would involve an alleged failure to comply with a requirement of the JUXTAPID Risk Evaluation and Mitigation Strategies (REMS) program (21 U.S.C. §§ 352(y)). Aegerion would separately enter into a five -year deferred prosecution agreement with regard to a charge that Aegerion violated the Health Insurance Portability and Accountability Act. As part of the resolution of the DOJ investigation, Aegerion is expected to enter into a civil settlement agreement with the DOJ to resolve alleged violations of the False Claims Act and, a non-monetary consent decree with the FDA. Aegerion also expects to negotiate a corporate integrity agreement with the Department of Health and Human Services. Under the terms of the preliminary agreement in principle with the SEC staff, the SEC’s Division of Enforcement will recommend that the SEC accept a settlement offer from Aegerion on a neither-admit-nor-deny basis that contains alleged negligent violations of Sections 17(a)(2) and (3) of the Securities Act of 1933, as amended, related to certain statements Aegerion made in 2013 regarding the conversion rate of patients receiving JUXTAPID prescriptions, with remedies that include censure, an order prohibiting future violations of the securities laws and payment of a civil penalty. The preliminary agreements in principle provide for a consolidated monetary package that covers payments due to both the DOJ and the SEC. The consolidated monetary package includes payments to the DOJ and the SEC by Aegerion totaling approximately $40 million in the aggregate, to be payable over three years, which is updated from the originally proposed five -year payment schedule contemplated when the preliminary agreement in principle was reached in May 2016. Certain outstanding amounts would accrue interest at a rate of 1.75% per annum. Such payments are subject to acceleration in the event of certain change of control transactions or the sale of JUXTAPID or MYALEPT. Upon completion of the Merger, the Company fair valued the contingent liability related to the DOJ and the SEC investigations as $40.6 million , which is consistent with the amounts to be provided to the DOJ and the SEC under the consolidated monetary package, and an aggregate of $1.0 million for any relator attorney fees and settlement. In March 2017, the final relator agreements were signed and we paid out the attorney fees and settlement payments. The terms of the preliminary agreements in principle described above may change following further negotiations and other terms of the final settlement remain subject to further negotiation. The preliminary agreement in principle with the DOJ is subject to approval of supervisory personnel within the DOJ and relevant federal and state agencies, and approval by a U.S. District Court judge of the criminal plea and sentence and the civil settlement agreement. The preliminary agreement in principle with the SEC is subject to review by other groups in the SEC and approval by the Commissioners of the SEC. The preliminary agreements in principle do not cover the DOJ and the SEC’s inquiries concerning Aegerion’s operations in Brazil, any potential claims by relators for attorneys’ fees, or any employment claims that may been brought by relators. DOJ inquiries into patient assistance programs Aegerion continues to cooperate with the DOJ and the SEC with respect to their investigations. As part of this cooperation, the DOJ has requested documents and information related to donations Aegerion made in the years ended December 31, 2015 and 2016 to patient assistance programs operated by independent charitable 501(c)(3) organizations. As part of this inquiry, the DOJ may pursue theories that will not be covered by the preliminary agreement in principle with the DOJ. Other pharmaceutical and biotechnology companies have disclosed similar inquiries regarding donations to patient assistance programs operated by independent charitable 501(c)(3) organizations. Investigations in Brazil In addition, federal and state authorities in Brazil are each conducting investigations to determine whether there have been violations of Brazilian laws related to the promotion of JUXTAPID in Brazil. In July 2016, the Ethics Council of the national pharmaceutical industry association, Interfarma, fined Aegerion approximately $0.5 million for violations of the industry association’s Code of Conduct, to which Aegerion is bound due to its affiliation with Interfarma. Also, the Board of Directors of Interfarma imposed an additional penalty of suspension of Aegerion’s membership, without suspension of Aegerion’s membership contribution, for a period of 180 days for Aegerion to demonstrate the implementation of effective measures to cease alleged irregular conduct, or exclusion of its membership in Interfarma if such measures are not implemented. Aegerion paid approximately $0.5 million related to this fine during the third quarter of 2016. On March 27, 2017, after the suspension period ended, Interfarma’s Board of Directors decided to reintegrate Aegerion, enabling it to participate regularly in Interfarma activities, subject to meeting certain obligations. Also, in July 2016, Aegerion received an inquiry from a Public Prosecutor Office of the Brazilian State of Paraná asking it to respond to questions related to recent media coverage regarding JUXTAPID and its relationship with a patient association to which Aegerion made donations for patient support. At this time, Aegerion does not know whether the Public Prosecutor’s inquiry will result in the commencement of any formal proceeding against Aegerion, but if Aegerion’s activities in Brazil are found to violate any laws or governmental regulations, Aegerion may be subject to significant civil lawsuits to be filed by the Public Prosecution office, and administrative penalties imposed by Brazilian regulatory authorities and additional damages and fines. Under certain circumstances, Aegerion could be barred from further sales to federal and/or state governments in Brazil, including sales of JUXTAPID and/or MYALEPT, due to penalties imposed by Brazilian regulatory authorities or through civil actions initiated by federal or state public prosecutors. As of December 31, 2016, Aegerion cannot determine if a loss is probable as a result of the investigations and inquiry in Brazil and whether the outcome will have a material adverse effect on its business and, as a result, no amounts have been recorded for a loss contingency. Shareholder Class Action Lawsuit In January 2014, a putative class action lawsuit was filed against Aegerion and certain of its former executive officers in the U.S. District Court for the District of Massachusetts (the Court) alleging certain misstatements and omissions related to the marketing of JUXTAPID and Aegerion’s financial performance in violation of the federal securities laws. The case is captioned KBC Asset Management NV et al. v. Aegerion Pharmaceuticals, Inc. et al. , No. 14-cv-10105-MLW. Through mediation, the co-lead plaintiffs and defendants reached an agreement in principle to settle the litigation on November 29, 2016. On January 17, 2017, the co-lead plaintiffs filed a stipulation of settlement with the Court that contained the settlement terms as agreed upon by the parties, including that Aegerion and its insurance carriers would contribute $22.25 million to a settlement fund for the putative class. The insurance carriers have agreed to cover $22.0 million of this amount, with Aegerion responsible for the remainder of $0.25 million . The proposed settlement is subject to a number of procedural steps and is subject to approval by the Court. Accordingly, management of the Company cannot predict the outcome of this action or when it will be resolved. Upon the completion of the Merger, the Company estimated the fair value of the amounts and recorded a loss contingency of $22.25 million and $22 million to reflect the insurance proceeds it expects to receive. Contingent Consideration Related to the Sale of Visudyne ® On September 24, 2012, the Company completed the sale of its Visudyne business to Valeant Pharmaceuticals International, Inc. (Valeant). Subject to the achievement of certain future milestones, the Company is eligible to receive the following additional consideration: (i) a milestone payment of $5.0 million if receipt of the registration required for commercial sale of the Qcellus ™ laser in the U.S. (the Laser Registration) is obtained by December 31, 2013, $2.5 million if the Laser Registration is obtained after December 31, 2013 but before January 1, 2015, and $0 if the Laser Registration is obtained thereafter (the Laser Earn-Out Payment); (ii) up to $5.0 million in each calendar year commencing January 1, 2013 (up to a maximum of $15.0 million in the aggregate) for annual net royalties exceeding $8.5 million pursuant to the Amended and Restated PDT Product Development, Manufacturing and Distribution Agreement with Novartis Pharma AG (the Novartis Agreement) or from other third-party sales of Visudyne outside of the U.S.; and (iii) a royalty on net sales attributable to new indications for Visudyne, if any should be approved by the U.S. Food and Drug Administration (FDA). On September 26, 2013, the FDA approved the premarket approval application (PMA) supplement for the Qcellus laser and on October 10, 2013, the Company invoiced Valeant for the $5.0 million Laser Earn-Out Payment. Valeant subsequently disputed payment on the basis that it believes the Laser Earn-Out Payment remains contingent upon receipt of additional governmental authorizations with regard to the Qcellus laser. As a result, on September 22, 2015 the Company commenced an action in the Supreme Court of British Columbia against Valeant for breach of contract. See "Legal Proceedings" section of this Annual Report for further details. While management of the Company believes that the $5.0 million Laser Earn-Out Payment has been triggered and is currently due and payable by Valeant, the outcome of such a dispute and litigation is uncertain and there may be difficulty in recovering damages and collecting the Laser Earn-Out Payment in full. As of December 31, 2015, Laser Earn-Out Payment was recorded as a long-term accounts receivable on the Company’s Consolidated Balance Sheet at its estimated fair value of $2.0 million . As of December 31, 2016, the fair value for the Laser Earn-Out Payment was reduced to zero . The fair value estimate of the Laser Earn-Out Payment was derived using a probability weighted approach to examine various possible outcomes with respect to the timing and amount that may be collected. In addition, it also reflects management’s assessment of collection risk, the impact of the passage of time and potential collection costs associated with the Valeant litigation. The remaining estimated fair value of the contingent consideration, which relates to estimated future net royalties pursuant to the Novartis Agreement, is currently valued at zero . For the years ended December 31, 2016 and 2015, the Company received no proceeds related to the collection of the contingent consideration for the Company’s previous sale of Visudyne. Related to the Sale of the PPDS Technology On April 3, 2013, Novelion completed the sale of its punctal plug drug delivery system technology for approximately $1.3 million (the PPDS Technology) to Mati Therapeutics Inc. (Mati) pursuant to the terms of Novelion’s asset purchase agreement with Mati (the Mati Agreement). Under the terms of the Mati Agreement, Novelion is eligible to receive future potential payments upon completion of certain product development and commercialization milestones that could reach $19.5 million (or exceed that amount if more than two products are commercialized), a low single digit royalty on worldwide net sales of all products using or developed from the PPDS Technology and a fee on payments received by Mati in respect of the PPDS Technology other than net sales revenues. For the years ended December 31, 2016 and 2015, the Company received no proceeds related to the collection of this contingent consideration. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2016 | |
Compensation and Retirement Disclosure [Abstract] | |
Employee Benefit Plan | Employee Benefit Plan. The Company maintains a defined contribution 401(k) plan (the Plan) in which substantially all of its or its subsidiaries’ permanent U.S. employees are eligible to participate. Employee contributions are voluntary and are determined on an individual basis, limited by the maximum amounts allowable under U.S. federal tax regulations. The Company makes matching contributions of 50% of the first 6% of its U.S. employees’ contributions to the Plan. Additionally, for certain employees outside of the U.S., the Company contributes amounts for retirement benefits required by applicable local laws. The Company recorded employer contribution expense of $27,331 during the year ended December 31, 2016 and recorded employer contribution expense of zero during the years ended 2015, and 2014. The Company assumed the Plan upon the completion of the Merger. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions. The Company did not enter into any transactions with related parties, other than compensation arrangements, expense allowances and other similar items in the ordinary course of business in the years ended December 31, 2016 , 2015 and 2014 . |
Segmentation Information
Segmentation Information | 12 Months Ended |
Dec. 31, 2016 | |
Segment Reporting [Abstract] | |
Segmentation information | Segmentation information. The Company currently operates in one business segment, pharmaceuticals, which is focusing on the development and commercialization of its lead products. The Company's CEO is the Company's chief operating decision maker (CODM). The Company does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Company does not accumulate discrete financial information with respect to separate service lines and does not have separately reportable segments. Enterprise-wide disclosures about product revenues and long-lived assets by geographic area and information relating to major customers are presented below. Net Product Sales The following table summarizes total net product sales from external customers by product and by geographic region. Net product sales represent sale of MYALEPT and JUXTAPID through Aegerion subsequent to the acquisition, from November 29, 2016 to December 31, 2016 and are attributed to countries based on the location of the customer. For the Year Ended December 31, 2016 (in thousands) U.S. Italy Other Foreign Countries Total MYALEPT $ 4,685 $ — $ 268 $ 4,953 JUXTAPID 6,134 1,209 1,278 8,621 Total $ 10,819 $ 1,209 $ 1,546 $ 13,574 Net product sales generated from customers outside of the U.S. were primarily derived from named patient sales in Argentina, Colombia and Italy. The total net product sales from customers in Canada subsequent to the Merger, from November 29, 2016 to December 31, 2016 was approximately $0.1 million , which related to the sales of JUXTAPID. Significant Customers For the year ended December 31, 2016 , one customer accounted for 34.5% of the Company’s net product sales, and such customer accounted for 28.5% of the Company’s accounts receivable balance. Long-lived Assets The Company’s long-lived assets primarily comprised intangible assets, inventories, and properties and equipment. As of December 31, 2016, 100% of the Company's intangible assets were held by Aegerion. 65.5% of the intangible assets were attributable to Aegerion's U.S. business and the remaining 34.5% were attributable to Aegerion's Bermuda business. Approximately 92.7% of the Company’s properties and equipment were located in the U.S., 5.1% were located in Canada, and the remaining 2.2% were located in other foreign countries. For the Company's long-term inventory, approximately 52.0% was located in the U.S. and 48.0% was located in countries outside of the U.S. |
Significant Accounting Polici27
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The accompanying Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP). All amounts herein are expressed in U.S. dollars (USD) unless otherwise noted. The accompanying Consolidated Financial Statements include operations of Novelion Therapeutics Inc. and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated. |
Reclassification | In management’s opinion, the Consolidated Financial Statements reflect all adjustments (including reclassifications of normal recurring adjustments) necessary to present fairly the financial position of Novelion as of December 31, 2016 and 2015 and the result of operations and cash flows for all periods presented. |
Use of Estimates | Use of Estimates The preparation of Consolidated Financial Statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the Consolidated Financial Statements, and the reported amounts of expenses during the reporting periods presented. Significant estimates and assumptions are required when determining the fair value of contingent assets and liabilities, the valuation of the convertible notes, and the valuation of the assets and liabilities acquired in a business combination including inventory and intangible assets. Significant estimates and assumptions are also required in determination of stock-based compensation and income tax. Our estimates often are based on complex judgments, probabilities and assumptions that we believe to be reasonable but that are inherently uncertain and unpredictable. For any given individual estimate or assumption made by us, there may also be other estimates or assumptions that are reasonable. Actual results may differ from estimates made by management. Changes in estimates are reflected in reported results in the period in which they become known. |
Reporting and Functional Currency | Reporting and Functional Currency Novelion’s reporting currency is the USD and the Company's operations utilize the USD or local currency as the functional currency, where applicable. Transactions in other currencies are recorded in the functional currency at the rate of exchange prevailing when the transactions occur. Monetary assets and liabilities denominated in other currencies are re-measured into the functional currency at rate of exchange in effect at the balance sheet date. Exchange gains and losses arising from re-measurement of foreign currency-denominated monetary assets and liabilities are included in income in the period in which they occur. For foreign entities where the local currency is the functional currency, assets and liabilities denominated in local currencies are translated into USD at end-of-period exchange rates and the resultant translation adjustments are reported, net of their related tax effects, as a component of accumulated other comprehensive items in equity. |
Discontinued Operations | Discontinued Operations The results of operations, including the gain on disposal for businesses that have been sold or are classified as held for sale, are excluded from continuing operations and reported as discontinued operations for all periods presented. The Company sold its Visudyne business in 2012 and sold its punctal plug drug delivery system technology (PPDS Technology) in 2013. The Company has not had any continued involvement with the Visudyne business or the PPDS Technology following their sale. Amounts billed in connection with the provision of these transition services are included within discontinued operations. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of highly liquid instruments purchased with an original maturity of three months or less at the date of purchase. |
Restricted Cash | Restricted Cash Restricted cash represents amounts deposited with Silicon Valley Bank (SVB) to collateralize the Company’s corporate credit card program and a letter of credit for the Company’s facility lease in Cambridge, Massachusetts. |
Accounts Receivable | Accounts Receivable The majority of the Company's accounts receivable arise from product sales and primarily represent amounts due from distributors, named patients, and other entities. The Company monitors the financial performance and creditworthiness of large customers to properly assess and respond to changes in their credit profile. The Company provides reserves against account receivables for estimated losses that may result from a customer’s inability to pay. Amounts determined to be uncollectible are charged or written-off against the reserve. To date, the Company's historical reserves and write-offs of accounts receivable have not been significant. |
Inventories and Cost of Product Sales | nventories and Cost of Product Sales Inventories are stated at the lower of cost or market price with cost determined on a first-in, first-out basis. Inventories acquired in a business combination are required to be fair valued at initial recognition. See " Business Combinations" section below for details. Inventory is maintained on the Company’s Consolidated Balance Sheets until the inventory is sold, donated as part of the Company’s compassionate use program, or used for clinical development. Inventory that is sold is recognized as cost of product sales in the Consolidated Statements of Operations, inventory that is donated as part of the Company’s compassionate use program is recognized as a selling, general and administrative expense in the Consolidated Statements of Operations, expired inventory is disposed of and the related costs are recognized as cost of product sales in the Consolidated Statements of Operations, and inventory used for clinical development is recognized as research and development expense in the Consolidated Statements of Operations. Inventories are reviewed periodically to identify slow-moving inventory based on sales activity, both projected and historical, as well as product shelf-life. The portion of the slow-moving inventory not expected to be sold within one year is classified as long-term inventory in the Company's accompanying Consolidated Balance Sheets. If the asset becomes impaired or is abandoned, the carrying value is written down to its fair value, and an impairment charge is recorded in the period in which the impairment occurs. In evaluating the recoverability of inventories produced, the Company considers the probability that revenue will be obtained from the future sale of the related inventory. Cost of product sales includes the cost of inventory sold, manufacturing and supply chain costs, product shipping and handling costs, charges for excess and obsolete inventory, amortization of acquired intangibles, as well as royalties payable to The Trustees of the University of Pennsylvania (UPenn) related to the sale of lomitapide and royalties payable to Amgen Inc. (Amgen), Rockefeller University and Bristol-Myers Squibb (BMS) related to the sale of metreleptin. |
Contingent Consideration and Contingencies | Contingent Consideration The contingent consideration is initially recognized and measured at fair value, and are subsequently revalued at the end of each reporting period. Resulting changes in fair value are reported in continuing operations on the Consolidated Statements of Operations and comprehensive loss. Contingencies The Company records a liability in the Consolidated Financial Statements for litigation related matters when a loss is considered probable and the amount can be reasonably estimated. If the loss is not probable or a range cannot reasonably be estimated, no liability is recorded in the Consolidated Financial Statements. |
Prepaid Manufacturing Costs | Prepaid Manufacturing Costs Cash advances paid by the Company prior to receipt of the inventory are recorded as prepaid manufacturing costs and included in prepaid expenses and other current assets. The cash advances are subject to forfeiture if the Company terminates the scheduled production. The Company expects the carrying value of the prepaid manufacturing costs to be fully realized. |
Intangible Assets | Intangible Assets Intangible assets with definite useful lives are amortized to their estimated residual values over their estimated useful lives and reviewed for impairment if certain events occur. |
Impairment or Long-Lived Assets | Impairment of Long-lived Assets Impairment testing and assessments of remaining useful lives are performed when a triggering event occurs that could indicate a potential impairment. Such test first entails comparison of the carrying value of the long-lived asset to the undiscounted cash flows expected from that asset. If impairment is indicated by this test, the long-lived assets are written down by the amount, if any, by which the discounted cash flows expected from the long-lived asset exceeds its carrying value. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost and depreciated using the straight-line method based on estimated economic lives of 3 to 5 years for computer software and hardware, and 5 years for office furniture, fixtures, research equipment and other equipment. Leasehold improvements are amortized over the lesser of the estimated useful lives of the improvements or the remaining lease term, which include lease extensions when reasonably assured. Repair and maintenance costs are expensed as incurred. |
Business Combinations | Business Combinations The Company evaluates acquisitions of assets and other similar transactions to assess whether or not each such transaction should be accounted for as a business combination by assessing whether or not the Company has acquired inputs and processes that have the ability to create outputs. If the Company determines that an acquisition qualifies as a business, the Company applies the acquisition method of accounting which requires that the purchase price be allocated to the net assets acquired at their respective fair values. Goodwill is calculated as the excess of the consideration transferred over the net assets recognized and represents the future economic benefits arising from other assets acquired that could not be individually identified and separately recognized. Goodwill is not amortized and is not deductible for tax purposes. The Company reports provisional amounts when measurements are incomplete as of the end of the reporting period. We complete our purchase price allocation within a measurement period and which does not extend beyond one year after the acquisition date. Contingent consideration in a business combination is included as part of the acquisition cost and is recognized at fair value as of the acquisition date. Fair value is generally estimated by using a probability-weighted discounted cash flow approach. Any liability resulting from contingent consideration is re-measured to fair value at each reporting date until the contingency is resolved. These changes in fair value are recognized in earnings in other income (expense), net. The present-value models used to estimate the fair values of acquired inventory and intangibles incorporate significant assumptions, including, but not limited to: assumptions regarding the probability of obtaining marketing approval; estimated selling price, estimates of the timing and amount of future cash flows from potential product sales and related expenses; and the appropriate discount rate selected to measure the risks inherent in the future cash flows, the assessment of the asset’s life cycle and the competitive trends impacting the assets, including consideration of any technical, legal, regulatory or economic barrier. Transaction costs associated with business combinations are expensed as incurred. The Company's Consolidated Financial Statements include the results from operations of an acquired business after transaction date. |
Convertible Notes | Convertible Notes The accounting guidance for convertible notes requires the Company to separately account for the liability and equity components of the Convertible Notes by allocating the proceeds between the liability component and the embedded conversion option. The carrying amount of the liability component is initially valued at the fair value of a similar liability that does not have an associated convertible feature. The equity component of the Convertible Notes was determined by deducting the fair value of the liability component from the fair value of the Convertible Notes as a whole on the date of acquisition. The excess of the principal amount of the liability component over its carrying amount, or debt discount, is amortized to interest expense using the effective interest method over the life of the Convertible Notes. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. |
Revenue Recognition | Revenue Recognition The Company applies the revenue recognition guidance in accordance with Financial Accounting Standards Board Accounting Standards Codification (ASC) Subtopic No. 605-15, Revenue Recognition—Products. The Company recognizes revenue from product sales when there is persuasive evidence that an arrangement exists, title to product and associated risk of loss has passed to the customer, the price is fixed or determinable, collectability is reasonably assured and the Company has no further performance obligations. Lomitapide In the U.S., JUXTAPID® is only available for distribution through a specialty pharmacy, and is shipped directly to the patient. JUXTAPID is not available in retail pharmacies. Prior authorization and confirmation of coverage level by a patient’s private insurance plan or government payer are currently prerequisites to the shipment of product to the patient in the U.S. Revenue from sales in the U.S. covered by the patient’s private insurance plan or government payer is recognized once the product has been received by the patient. For uninsured amounts billed directly to the patient, revenue is recognized at the time of cash receipt as collectability is not reasonably assured at the time the product is received by the patient. To the extent amounts are billed in advance of delivery to the patient, the Company defers revenue until the product has been received by the patient. The Company also records revenue on sales in countries where lomitapide is available on a named patient basis, and typically paid for by a government authority or institution. In many cases, these sales are facilitated through a third-party distributor that takes title to the product upon acceptance. Because of factors such as the pricing of lomitapide, the limited number of patients, the short period from product sale to delivery to the end-customer and the limited contractual return rights, these distributors typically only hold inventory to supply specific orders for the product. The Company recognizes revenue for sales under these named patient programs upon product acceptance by either the named patient or the third-party distributor. In the event the payer’s creditworthiness has not been established, the Company recognizes revenue on a cash basis if all other revenue recognition criteria have been met. The Company records distribution and other fees paid to its distributors as a reduction of revenue, unless the Company receives an identifiable and separate benefit for the consideration and the Company can reasonably estimate the fair value of the benefit received. If both conditions are met, the Company records the consideration paid to the distributor as an operating expense. At this time, neither condition has been met and therefore, the fees paid to the Company’s distributors are recorded as a reduction of revenue. The Company records revenue net of estimated discounts and rebates, including those provided to Medicare, Medicaid, Tricare and other government programs in the U.S. and other countries. Allowances are recorded as a reduction of revenue at the time revenues from product sales are recognized. Allowances for government rebates and discounts are established based on the actual payer information, which is reasonably estimated at the time of delivery. These allowances are adjusted to reflect known changes in the factors that may impact such allowances in the quarter those changes are known. From time to time, the Company provides financial support to patient assistance programs operated by independent charitable 501(c)(3) organizations which assist patients in the U.S. in accessing treatment for HoFH. These patient assistance programs assist HoFH patients according to eligibility criteria defined independently by the charitable organization. The Company records donations made to these patient assistance programs as selling, general and administrative expense. Any payments received from these patient assistance programs on behalf of a patient who is taking lomitapide for the treatment of HoFH are recorded as a reduction of selling, general and administrative expense rather than as revenue. Beginning in 2015, the Company also offers a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are on JUXTAPID therapy. The branded co-pay assistance program assists commercially insured patients who have coverage for JUXTAPID, and is intended to reduce each participating patient’s portion of the financial responsibility for JUXTAPID’s purchase price up to a specified dollar amount of assistance. The Company records revenue net of amounts paid under the branded specific co-pay assistance program for each patient. Metreleptin In the U.S., MYALEPT is only available through an exclusive third-party distributor that takes title to the product upon shipment. MYALEPT is not available in retail pharmacies. The distributor may contractually hold inventory for no more than 21 business days. The Company recognizes revenue for these sales once the product is received by the patient as it is currently unable to reasonably estimate the rebates owed to certain government payers at the time of receipt by the distributor. Prior authorization and confirmation of coverage level by a patient’s private insurance plan or government payer are currently prerequisites to the shipment of product to a patient in the U.S. Revenue from sales in the U.S. covered by the patient’s private insurance plan or government payer is recognized once the product has been received by the patient. The Company records distribution and other fees paid to its distributor as a reduction of revenue, unless the Company receives an identifiable and separate benefit for the consideration and the Company can reasonably estimate the fair value of the benefit received. If both conditions are met, the Company records the consideration paid to the distributor as an operating expense. At this time, neither condition has been met and therefore, these fees paid to the distributor are recorded as a reduction of revenue. The Company records revenue from sales of MYALEPT net of estimated discounts and rebates, including those provided to Medicare and Medicaid in the U.S. Allowances for government rebates and discounts are established based on the actual payer information, which is reasonably estimable at the time of delivery, and the government-mandated discounts applicable to government-funded programs. These allowances are adjusted to reflect known changes in the factors that may impact such allowances in the quarter those changes are known. To date, such adjustments have not been significant. From time to time, the Company provides financial support to patient assistance programs operated by independent charitable 501(c)(3) organizations which assist eligible patients in the U.S. in accessing treatment for GL. These patient assistance programs assists GL patients according to eligibility criteria defined independently by the organization. The Company records donations made to these patient assistance programs as selling, general and administrative expense. Beginning in 2015, the Company also offers a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are on MYALEPT therapy. The branded co-pay assistance program assists commercially insured patients who have coverage for MYALEPT, and is intended to reduce each participating patient’s portion of the financial responsibility for MYALEPT’s purchase price up to a specified dollar amount of assistance. The Company records revenue net of amounts paid under the branded specific co-pay assistance program for each patient. |
Research and Development Expenses | Research and Development Expenses Research and development expenses are charged to expense as incurred. Research and development expenses comprise costs incurred in performing research and development activities, including personnel-related costs, stock-based compensation, facilities-related overhead, clinical trial costs, costs to support certain medical affairs activities, manufacturing costs for clinical and pre-clinical materials as well as other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made in accordance with the provisions of ASC No. 730 - Research and Development . |
Income Taxes | Income Taxes Income taxes are reported using the asset and liability method, whereby deferred tax assets and liabilities are recognized for the future tax consequences attributable to: (i) differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and (ii) operating loss and tax credit carryforwards using applicable enacted tax rates. An increase or decrease in these tax rates will increase or decrease the carrying value of future net tax assets resulting in an increase or decrease to net income. Income tax credits, such as investment tax credits, are included as part of the provision for income taxes. Current income taxes are provided for in accordance with the laws of the relevant taxing authorities. Significant estimates are required in determining the Company’s provision for income taxes and uncertain tax positions. Some of these estimates are based on interpretations of existing tax laws or regulations. Various internal and external factors may have favorable or unfavorable effects on the Company’s future effective tax rate. These factors include, but are not limited to, changes in tax laws, regulations and/or rates, changing interpretations of existing tax laws or regulations, changes in estimates of prior years’ items, results of tax audits by tax authorities, future levels of research and development spending, changes in estimates related to repatriation of undistributed earnings of foreign subsidiaries, and changes in overall levels of pre-tax earnings. The realization of the Company’s deferred tax assets is primarily dependent on whether the Company is able to generate sufficient capital gains and taxable income prior to expiration of any loss carry forward balance. A valuation allowance is provided when it is more likely than not that a deferred tax asset will not be realized. The assessment of whether or not a valuation allowance is required often requires significant judgment including the long-range forecast of future taxable income and the evaluation of tax planning initiatives. Adjustments to the deferred tax valuation allowances are made to earnings in the period when such assessments are made. The Company records tax benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available at the reporting date. There is inherent uncertainty in quantifying income tax positions. The Company has recorded tax benefits for those tax positions where it is more likely than not that a tax benefit will result upon ultimate settlement with a tax authority that has all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will result, no tax benefit has been recognized in the Consolidated Financial Statements. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for its stock-based compensation to employees in accordance with ASC No. 718 - Compensation - Stock Compensation and to non-employees in accordance with ASC No. 505-50 - Equity-Based Payments to Non-Employees. For service-based awards, compensation expense is recognized using the ratable method over the requisite service period, which is typically the vesting period. For awards that vest or begin vesting upon achievement of a performance condition, the Company recognizes compensation expense when achievement of the performance condition is deemed probable using a straight-line model over the implicit service period. Certain of the Company’s awards that contain performance conditions also require the Company to estimate the number of awards that will vest, which the Company estimates when the performance condition is deemed probable of achievement. For awards that vest upon the achievement of a market condition, the Company recognizes compensation expense over the derived service period. For equity awards that have previously been modified, any incremental increase in the fair value over the original award has been recorded as compensation expense on the date of the modification for vested awards or over the remaining service period for unvested awards. See Note 12 - Stock-Based Payments for further information about the Company’s equity incentive plans. The Company has a Directors’ Deferred Share Unit Plan ("DDSU Plan") for the Company’s directors. Given that vested Deferred Share Units ("DSUs") are convertible to cash only, the Company recognizes compensation expense for DSUs based on the market price of the Company’s shares. The Company also records an accrued liability to recognize the expected financial obligation related to the future settlement of these DSUs as they vest. Each reporting period, the expected obligation is revalued for changes in the market value of Novelion’s common shares. The Company issues restricted stock units ("RSUs") to its employees and directors as consideration for their provision of future services. Restricted stock-based compensation expense is measured based on the fair value market price of Novelion’s common shares on the grant date and is recognized over the requisite service period, which coincides with the vesting period. RSUs can only be exchanged and settled for Novelion’s common shares, on a one-to-one basis, upon vesting. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss combines net loss and other comprehensive items. Other comprehensive items represent certain amounts that are reported as components of shareholders’ equity in the accompanying Consolidated Balance Sheets, including currency translation adjustments. |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per common share is computed using the weighted average number of common shares outstanding during the period. Diluted net income per common share is computed in accordance with the treasury-shares and if-converted methods, which uses the weighted average number of common shares outstanding during the period and also includes the dilutive effect of common shares potentially issuable from outstanding stock-based awards. |
Recent Accounting Pronouncements - Not Yet Adopted and Recently Adopted Accounting Pronouncements | Recent Accounting Pronouncements- Not Yet Adopted In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards update (ASU) No. 2014-09, “Revenue from Contracts with Customers” (ASU 2014-09). ASU 2014-09 represents a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled in exchange for those goods or services. This ASU sets forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and is intended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed. In August 2015, the FASB issued ASU No. 2015-14, “ Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date,” which defers the effective date of ASU 2014-09 by one year, but permits companies to adopt one year earlier if they choose (i.e. the original effective date). As such, ASU 2014-09 will be effective for annual and interim reporting periods beginning after December 15, 2017. In March and April 2016, the FASB issued ASU No. 2016-08 “Revenue from Contracts with Customers (Topic 606): Principal versus Agent Consideration (Reporting Revenue Gross versus Net)” and ASU No. 2016-10 “Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing,” respectively, which clarify the guidance on reporting revenue as a principal versus agent, identifying performance obligations and accounting for intellectual property licenses. In addition, in May 2016, the FASB issued ASU No. 2016-12 “Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients,” which amends certain narrow aspects of Topic 606, and in December 2016, the FASB issued ASU No. 2016-20 “Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers,” which amends certain narrow aspects of Topic 606. The new standard may be adopted using either the full retrospective method, in which case the standard would be applied to each prior reporting period presented, or the modified retrospective method, in which case the cumulative effect of applying the standard would be recognized at the date of initial application. In the fourth quarter of 2016, the Company engaged an external accounting firm to assist with the new standard adoption and has made significant progress in the assessment. Based on the progress, the Company expects to complete its assessment by the second quarter of 2017. In July 2015, the FASB issued ASU No. 2015-11, “ Simplifying the Measurement of Inventory” (ASU 2015-11). ASU 2015-11 states that an entity should measure inventory at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. For public entities, ASU 2015-11 is effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The amendments in this update should be applied prospectively and early application is permitted. The Company does not expect the adoption of ASU 2015-11 to impact the Company’s consolidated results of operations and financial position. On February 25, 2016, the FASB issued ASU No. 2016-02 - Leases , its new standard on accounting for leases. The new guidance will require organizations that lease assets (referred to as lessees) for terms of more than 12 months, to recognize on the balance sheet the assets and liabilities associated with the rights and obligations created by those leases. Consistent with current guidance, the recognition, measurement, and presentation of the expenses and cash flows associated with a particular lease will depend on its classification as a capital or operating lease. However, unlike current GAAP, which only requires capital leases to be reflected on the balance sheet, ASU No. 2016- 02 will require both types of leases to be recognized on the balance sheet. ASU No. 2016-02 also aligns many of the underlying principles of the new lessor model with those in ASC No. 606 - Revenue from Contracts with Customers, and will require lessors to increase the transparency of their exposure to changes in value of their residual assets and how they manage the associated exposure. ASU No. 2016-02 will be effective for annual periods beginning after December 15, 2018, and interim periods within those annual reporting periods. Management is currently assessing the impact ASU No. 2016-02 will have on the Company’s Consolidated Financial Statements. On March 30, 2016, the FASB issued ASU No. 2016-09 - Improvements to Employee Stock-Based Payment Accounting, ASU 2016-09 changes how companies account for certain aspects of share-based payments to employees including: (a) requiring all income tax effects of awards to be recognized in the income statement, rather than in additional paid in capital, when the awards vest or are settled, (b) eliminating the requirement that excess tax benefits be realized before companies can recognize them, (c) requiring companies to present excess tax benefits as an operating activity on the statement of cash flows rather than as a financing activity, (d) increasing the amount an employer can withhold to cover income taxes on awards and still qualify for the exception to liability classification for shares used to satisfy the employer’s statutory income tax withholding obligation, (e) requiring an employer to classify the cash paid to a tax authority when shares are withheld to satisfy its statutory income tax withholding obligation as a financing activity on its statement of cash flows and (f) electing whether to account for forfeitures of share-based payments by (1) recognizing forfeitures of awards as they occur or (2) estimating the number of awards expected to be forfeited and adjusting the estimate when it is likely to change, as is currently required. ASU 2016-09 is effective for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. The Company has adopted the new guidance on January 1, 2017. Upon adoption the Company will account for forfeitures when they occur, instead of estimating the number of awards that are expected to vest under current GAAP. The Company will retrospectively adopt the provision of this guidance related to forfeitures by utilizing the modified retrospective transition method. The adoption of ASU No. 2016-09 will not materially impact the Company’s Consolidated Financial Statements. On August 26, 2016, the FASB issued ASU No. 2016-15 - Classification of Certain Cash Receipts and Cash Payments, which amends the guidance in ASC No. 230 on the classification of certain items in the statement of cash flows. The primary purpose of ASU No. 2016-15 is to reduce the diversity in practice by making amendments that add or clarify the guidance on eight specific cash flow issues. ASU No. 2016-15 is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. ASU No. 2016-15 must be applied retrospectively to all periods presented, but may be applied prospectively from the earliest date practicable if retrospective application would be impracticable. Management is currently assessing the impact ASU No. 2016-15 will have on the Company’s Consolidated Financial Statements. On October 24, 2016, the FASB issued ASU No. 2016-16 - Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other than Inventory , which improves the accounting for the income tax consequences of intra-entity transfers of assets other than inventory and eliminates the exception for an intra-entity transfer of an asset other than inventory. ASU No. 2016-16 is effective for annual reporting periods beginning after December 15, 2017, including interim reporting periods within those annual reporting periods. ASU No. 2016-16 should be applied on a modified retrospective basis through a cumulative-effect adjustment directly to retained earnings as of the beginning of the period of adoption. Upon adoption, prior periods will be retrospectively adjusted. Management does not expect the adoption of ASU No. 2016-16 will materially impact the Company’s Consolidated Financial Statements. On November 17, 2016, the FASB issued ASU No. 2016-18 “ Statement of Cash Flows (Topic 230) - Restricted Cash ” (ASU 2016-18). ASU 2016-18 states that a statement of cash flows should explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period, and all updates should be applied using a retrospective transition method. The Company is currently evaluating the impact ASU 2016-18 will have on the Company’s Consolidated Statement of Cash Flows. On January 5, 2017, the FASB issued ASU No. 2017-01 Business Combinations (Topic 805): Clarifying the Definition of a Business , which provides a more robust framework to use in determining when a set of assets and activities is a business. It also provides more consistency in applying the guidance, reduces the costs of application and makes the definition of a business more operable. ASU No. 2017-01 is effective for annual periods beginning after December 15, 2017, including interim periods within those periods. Management is currently assessing the impact ASU No. 2017-01 will have on the Company’s Consolidated Financial Statements. Recently Adopted Accounting Pronouncements On September 25, 2015, the FASB issued Accounting Standards Update (ASU) No. 2015-16 - Business Combinations (Topic 805) Simplifying the Accounting for Measurement-Period Adjustments. Under the guidance, an acquirer must recognize adjustments to provisional amounts that are identified during the measurement period in the reporting period in which the adjustment amounts are determined. ASU No. 2015-16 also requires acquirers to present separately on the face of the income statement, or disclose in the notes, the portion of the amount recorded in current-period earnings by line item that would have been recorded in previous reporting periods if the adjustment to the provisional amounts had been recognized as of the acquisition date. ASU No. 2015-16 was effective for annual periods, and interim periods, beginning after December 15, 2015 and did not impact the Company’s financial position or results of operations. |
Fair Value Measurements and Disclosures | Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. ASC No. 820 - Fair Value Measurements and Disclosures established a fair value hierarchy for those instruments measured at fair value that distinguishes between fair value measurements based on market data (observable inputs) and those based on the Company’s own assumptions (unobservable inputs). This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: • Level 1 —Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. The Company’s Level 1 assets consist of cash, money market investments, and restricted cash. • Level 2 —Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly. The Company’s Level 2 liabilities consist of convertible notes. • Level 3 —Inputs that are unobservable for the asset or liability. |
Acquisition (Tables)
Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Business Combinations [Abstract] | |
Summary of Estimated Fair Values of Net Assets Acquired | The following table summarizes the provisional fair values of the assets acquired and liabilities assumed at the Merger date (in thousands): November 29, 2016 Cash and cash equivalents $ 28,290 Restricted cash 390 Accounts receivable (1) 8,182 Inventories 76,800 Prepaid expenses and other current assets 9,839 Insurance proceeds receivable 22,000 Property and equipment, net 4,020 Intangible assets 252,458 Other Assets 1,352 Accounts payable (11,459 ) Accrued liabilities (41,883 ) Provision for legal settlement (63,968 ) Long-term debt (222,908 ) Other liabilities (732 ) Net assets acquired $ 62,381 (1) As of the Merger date, the fair value of accounts receivable approximated the book value acquired. The amount not expected to be collected was insignificant. The acquisition consideration in connection with the Merger was approximately $62.4 million and consisted of the following (in thousands, except for share and per share information): Number of Novelion common shares issued in connection with the acquisition of Aegerion 6,060,288 Novelion share price on November 29, 2016 $ 9.75 Fair value of Novelion common shares issued to Aegerion stockholders $ 59,088 Liability assumed (2)(3) 3,000 Stock compensation assumed (1) 293 Total acquisition consideration $ 62,381 (1) The fair value of Aegerion in-the-money options and RSUs attributed to pre-combination services that were outstanding on November 29, 2016 and settled in connection with the Merger. (2) Represents a term loan facility provided by QLT to Aegerion on June 14, 2016, concurrently with the execution of the Merger Agreement. Aegerion borrowed $3 million against the term loan and the loan remained outstanding as of November 29, 2016. (3) Includes 10,565,879 Merger Agreement Warrants to purchase up to 11,301,791 common shares issued pursuant to the Merger Agreement, which were recognized as a liability with a fair value of zero as of November 29, 2016. Refer to Note 11 - Share Capital and Note 16 - Contingencies, Commitments and Guarantees for further details. Upon the acquisition of Aegerion, the Company assumed the assets and liabilities related to the following contingencies (in thousands): Insurance Proceeds Receivable Class action lawsuit insurance proceeds $ 22,000 Provision for Legal Settlement Class action lawsuit settlement $ (22,250 ) DOJ and SEC settlement (40,635 ) Relator legal settlement (620 ) Relators legal fees (405 ) Other litigation settlement (100 ) Total provision for legal settlement $ (64,010 ) |
Schedule of Finite-Lived Intangible Assets Acquired as Part of Business Combination | The valuation of the intangible assets acquired and related amortization periods are as follows: Valuation in thousands ) Amortization period Developed Technology: JUXTAPID $ 42,300 10.75 MYALEPT 210,158 9.25 Total $ 252,458 |
Pro Forma Impact of Acquisition | Actual and Pro Forma Impact of Acquisition The following table presents the amount of Aegerion net product sales and net loss included in the Company's Consolidated Statement of Operations from November 29, 2016 through December 31, 2016: (in millions, except for per share information) November 29, 2016 - December 31, 2016 Net product sales $ 13.6 Net loss (6.3 ) Basic and diluted net loss per share $ (0.34 ) The following supplemental unaudited pro forma information presents the financial results as if the Merger had occurred on January 1, 2015 for the years ended December 31, 2016 and 2015. Unaudited Supplemental Pro Forma Consolidated Results Year ended December 31, (in millions, except for per share information) 2016 2015 Net product sales $ 153.2 $ 239.9 Net loss (207.8 ) (96.3 ) Basic and diluted loss per share $ (18.41 ) $ (9.23 ) |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | The components of inventory are as follows: December 31, 2016 2015 ( in thousands ) Work-in-process $ 20,219 $ — Finished goods 54,502 — Total $ 74,721 $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment consists of the following: December 31, 2016 ( in thousands ) Cost Accumulated Net Leasehold improvements $ 1,869 $ 263 $ 1,606 Office furniture and equipment 539 20 519 Research equipment 1,962 1,810 152 Computer and office equipment 10,236 8,693 1,543 Construction in progress 339 $ — 339 $ 14,945 $ 10,786 $ 4,159 December 31, 2015 ( in thousands ) Cost Accumulated Net Leasehold improvements $ 207 $ 207 $ — Office furniture and equipment 258 246 12 Research equipment 3,471 3,092 379 Computer and office equipment 9,844 9,805 39 $ 13,780 $ 13,350 $ 430 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets and Goodwill | The following is a summary of intangible assets held by the Company at December 31, 2016 and 2015 (in thousands): Cost basis: Balance as of December 31, 2015 2016 Acquisitions Balance as of December 31, 2016 Definite-lived intangibles: Developed Technology - Juxtapid (weighted average life of 10.75 years) $ — $ 42,300 $ 42,300 Developed Technology - Myalept (weighted average life of 9.25 years) — 210,158 210,158 Total definite-lived intangibles (weighted average life of 9.50 years) $ — $ 252,458 $ 252,458 Accumulated amortization: Balance as of December 31, 2015 2016 Amortization Balance as of December 31, 2016 Definite-lived intangibles: Developed Technology - Juxtapid $ — $ (328 ) $ (328 ) Developed Technology - Myalept — (1,806 ) (1,806 ) Total definite-lived intangibles $ — $ (2,134 ) $ (2,134 ) Net intangible assets $ — $ 250,324 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | Estimated amortization of intangible assets for the five fiscal years subsequent to December 31, 2016 is as followings (in thousands): Years Ending December 31, Estimated Amortization of Intangible Assets 2017 $ 25,614 2018 25,614 2019 25,614 2020 25,614 2021 $ 25,614 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Payables and Accruals [Abstract] | |
Components of Accrued Liabilities | Accrued liabilities consist of the following: December 31 (in thousands) 2016 2015 Accrued employee compensation and related costs $ 7,920 $ 1,460 Accrued sales allowances 7,849 — Other accrued liabilities 21,411 367 Total $ 37,180 $ 1,827 |
Convertible Notes, Net (Tables)
Convertible Notes, Net (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Schedule of Outstanding Convertible Note Balances | The Company’s outstanding Convertible Notes balances as of December 31, 2016 consisted of the following (in thousands): Liability component: Principal $ 324,998 Less: debt discount (99,414 ) Net carrying amount $ 225,584 Equity component $ — (1) Represents interest payable within one year after December 31, 2016. |
Schedule of Total Interest Expense Recognized Related to Convertible Notes | The following table sets forth total interest expense recognized related to the Convertible Notes during the year ended December 31, 2016 (in thousands): Years Ending December 31, 2016 Contractual interest expense $ 577 Amortization of debt discount 2,676 Total $ 3,253 |
Summary of Future Minimum Payments under Term Loan Agreements | Future minimum payments under the Company’s Convertible Notes are as follows (in thousands): Years Ending December 31, 2017 $ 6,500 2018 6,500 2019 329,060 342,060 Less amounts representing interest (17,062 ) Less amortization of debt discount, net (99,414 ) Net carrying amount of convertible notes $ 225,584 |
Stock-Based Payments (Tables)
Stock-Based Payments (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Weighted-Average Assumptions to Estimate Fair Value | The following weighted-average assumptions were used to value stock options granted in each of the following years: Years Ended December 31, 2016 2015 2014 Expected share price volatility 38.23 % 41.30 % 42.40 % Risk-free interest rate 1.93 % 1.40 % 1.60 % Expected life of options (years) 6.19 6.80 6.80 Expected dividend yield — — — |
Summary of Stock Option Activity | The aggregate intrinsic values of options outstanding and exercisable as of December 31, 2016, 2015, and 2014 are as follows: (In thousands) 2016 2015 2014 Aggregate intrinsic value of options outstanding (1) $ 528 C$ — C$ 2,435 Aggregate intrinsic value of options exercisable (1) 140 — 240 (1) Intrinsic value of the stock options granted before 2016 were based on the underlying Novelion common shares listed on the Toronto Stock Exchange (TSX), and thus in Canadian dollars. Stock options granted in 2016 and after are and will be based on the underlying Novelion common shares listed on NASDAQ and thus in USD. New common shares are issued upon exercise of stock options. The intrinsic value of stock options exercised and the related cash from exercise of stock options during the years ended December 31, 2016, 2015 and 2014 are as follows: (In thousands) 2016 2015 2014 $ — $ 4,930 $ 230 Cash from exercise of stock options — 5,508 509 (b) Deferred Share Units The Company’s stock option activity for the year ended December 31, 2016 is as follows: Weighted Weighted- Average Average Remaining Aggregate Number of Exercise Price Contractual Intrinsic Value (2) stock options (2) Per Share (2) Life (years) (in thousands) Outstanding at December 31, 2015 (3) 85,630 C$ 25.35 8.26 C$ — Granted (1) 1,629,563 $ 8.27 Exercised — $ — $ — Forfeited/cancelled (600) $ 25.35 Outstanding at December 31, 2016 1,714,593 $ 9.01 9.65 $ 528 Vested and expected to vest at December 31, 2016 1,231,203 $ 9.24 9.58 $ 437 Exercisable at December 31, 2016 205,030 $ 13.86 8.49 $ 140 (1) The Aegerion stock options assumed by the Company in connection with the Merger are included in grants made during the year ended December 31, 2016 in the above table. The total number of assumed Aegerion stock options was 10,561 with a weighted-average exercise price of $7.70 per share. (2) Shares and per share amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation. (3) Intrinsic value and exercise price of the stock options granted before 2016 were based on the underlying Novelion common shares listed on the Toronto Stock Exchange (TSX), and thus in Canadian dollars. Stock options granted in 2016 and after are and will be based on the underlying Novelion common shares listed on NASDAQ and thus in USD. |
Allocation of Stock-Based Compensation Expense to Statements of Operations | The impact on the Company’s results of operations of stock-based compensation expense for the years ended December 31, 2016, 2015, and 2014 is as follows: (in thousands) 2016 2015 2014 Research and development $ 155 $ 1,267 $ 911 Selling, general and administrative 683 1,108 702 Total stock-based compensation expense $ 838 $ 2,375 $ 1,613 |
Summary of Deferred Shares Units Activity | DSU activity is presented below: Number (1) Outstanding at December 31, 2015 30,800 Granted 8,960 Redeemed (11,360 ) Cancelled — Outstanding at December 31, 2016 28,400 Vested at December 31, 2016 28,400 (1) Shares and per share amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation. RSU transactions for the years ended December 31, 2016 are as following: Number of RSUs (3) Outstanding at December 31, 2015 — Granted (1) (2) 1,036,735 Redeemed — Cancelled (7,854 ) Outstanding at December 31, 2016 1,028,881 (1) The weighted-average grant date fair value of the RSUs granted during the year ended December 31, 2016 was $8.82 (December 31, 2015 - zero , December 31, 2014 - CAD $20.4 ). (2) The assumed Aegerion RSUs from the Merger are included in grants made during the fiscal year ended December 31, 2016 in the above table. The total number of assumed Aegerion RSUs was 140,605 with a weighted-average merger date valuation of $9.53 per share. (3) Shares and per share amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation. Cash payments under the DDSU Plan during the years ended December 31, 2016, 2015, and 2014 were as follows: (in thousands) 2016 2015 2014 Cash payments under the DDSU plan $ 105 $ — $ — |
Summary of Restricted Stock Units Activity | DSU activity is presented below: Number (1) Outstanding at December 31, 2015 30,800 Granted 8,960 Redeemed (11,360 ) Cancelled — Outstanding at December 31, 2016 28,400 Vested at December 31, 2016 28,400 (1) Shares and per share amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation. RSU transactions for the years ended December 31, 2016 are as following: Number of RSUs (3) Outstanding at December 31, 2015 — Granted (1) (2) 1,036,735 Redeemed — Cancelled (7,854 ) Outstanding at December 31, 2016 1,028,881 (1) The weighted-average grant date fair value of the RSUs granted during the year ended December 31, 2016 was $8.82 (December 31, 2015 - zero , December 31, 2014 - CAD $20.4 ). (2) The assumed Aegerion RSUs from the Merger are included in grants made during the fiscal year ended December 31, 2016 in the above table. The total number of assumed Aegerion RSUs was 140,605 with a weighted-average merger date valuation of $9.53 per share. (3) Shares and per share amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation. Cash payments under the DDSU Plan during the years ended December 31, 2016, 2015, and 2014 were as follows: (in thousands) 2016 2015 2014 Cash payments under the DDSU plan $ 105 $ — $ — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Domestic and Foreign (Loss)/Income Before Provision for Income Taxes | before provision for income taxes, classified by source of (loss)/income, is as follows: (in thousands) December 31, 2016 December 31, 2015 December 31, 2014 Canada $ (46,733 ) $ (22,987 ) $ (4,197 ) U.S. (9,521 ) — — Other Foreign 3,849 — — Loss before provision for income taxes $ (52,405 ) $ (22,987 ) $ (4,197 ) |
Provision for Income Taxes | Provision for income taxes for the years ended December 31, 2016 , 2015 and 2014 are as follows: (in thousands) 2016 2015 2014 Current: Canada $ 105 $ — $ — U.S. state, net of federal income tax benefit (2 ) — — Other Foreign (517 ) — — $ (414 ) $ — $ — Deferred: Canada $ — $ (22 ) $ 192 Other Foreign (51 ) — — (51 ) (22 ) 192 (Provision for) recovery of income taxes $ (465 ) $ (22 ) $ 192 |
Summary of Statutory Tax Rates and Effective Tax Rates | Differences between the Company’s statutory income tax rates and its effective income tax rates, as applied to the loss from continuing operations before income taxes, are reconciled as follows: (in thousands) 2016 2015 2014 Loss from continuing operations before income taxes $ (52,405 ) $ (22,987 ) $ (4,197 ) Canadian statutory tax rates 26.00 % 26.00 % 26.00 % Expected income tax recovery 13,625 5,977 1,091 Net decrease (increase) in valuation allowance (13,684 ) (2,486 ) 731 Non-taxable portion of capital gains — — 230 Investment tax credits 868 (222 ) 1,628 Stock-based compensation (133 ) (606 ) (377 ) Foreign rate differential 532 — — Non-taxable (deductible) expenditures — 76 1,752 Changes in uncertain tax positions — (1,784 ) (4,793 ) Adjustments to capital losses for settlement of uncertain tax positions — (560 ) — Other (1,673 ) (417 ) (70 ) (Provision for) recovery of income taxes $ (465 ) $ (22 ) $ 192 |
Components of Deferred Tax Assets and Deferred Tax Liabilities | The primary components of the Company’s deferred tax assets and liabilities comprised of the following: (in thousands) 2016 2015 Deferred tax assets: Net operating loss carryforwards $ 51,808 $ 45,365 Research and development credits 14,028 14,164 Stock-based compensation 108 — Capitalized research expenses 2,124 — Capital loss carryforwards 37,452 36,207 Depreciable and amortizable assets 13,597 1,645 Other temporary differences 13,736 197 Total gross deferred tax assets 132,853 97,578 Valuation allowance (131,858 ) (97,578 ) Net deferred tax assets $ 995 $ — |
Summary of Income Tax Contingencies | The following table summarizes the activity related to the Company’s unrecognized tax benefits: (in thousands) 2016 2015 2014 Total uncertain tax position liabilities as of January 1, $ 7,278 $ 5,557 $ 1,846 Current year acquisitions 911 — — Increases related to current year tax positions — 347 5,169 Changes in tax positions of a prior period — 1,934 11 Lapse due to statute of limitations (342 ) — (1,469 ) Settlements with taxing authorities (187 ) (560 ) — Total uncertain tax position liabilities as of December 31, $ 7,660 $ 7,278 $ 5,557 |
Fair Value of Financial Instr36
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements of Financial Instruments | The fair value measurements of the Company’s financial instruments at December 31, 2016 and 2015 are summarized in the tables below: December 31, 2016 Significant Quoted Prices in Other Significant Active Markets for Observable Unobservable Balance at Identical Assets Inputs Inputs December 31, (in thousands) (Level 1) (Level 2) (Level 3) 2016 Assets: Cash $ 40,693 $ — $ — $ 40,693 Money market funds 68,234 — — 68,234 Restricted cash 390 — — 390 Total assets $ 109,317 $ — $ — $ 109,317 Liabilities: Convertible notes, net - long-term — 225,584 — 225,584 Total liabilities $ — $ 225,584 $ — $ 225,584 December 31, 2015 Significant Quoted Prices in Other Significant Active Markets for Observable Unobservable Balance at Identical Assets Inputs Inputs December 31, (in thousands) (Level 1) (Level 2) (Level 3) 2015 Assets: Cash $ 141,824 $ — $ — $ 141,824 Accounts receivable - Laser Earn-Out Payment (1) — — 2,000 2,000 Total assets $ 141,824 $ — $ 2,000 $ 143,824 (1) Represents the estimated fair value of the Laser Earn-Out Payment as described in Note 16 - Contingencies, Commitments and Guarantees. The fair value of the Laser Earn-Out Payment was estimated using a probability weighted approach to examine various possible outcomes with respect to the timing and amount that may be collected. |
Basic and Diluted Net Loss pe37
Basic and Diluted Net Loss per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net Loss Per Common Share | The following table sets out the computation of basic and diluted net loss per common share: (in thousands, except per share data) 2016 2015 2014 Numerator: Loss from continuing operations $ (52,870 ) $ (23,009 ) $ (4,005 ) Loss from discontinued operations, net of income taxes — — (66 ) Net loss $ (52,870 ) $ (23,009 ) $ (4,071 ) Denominator: (thousands) weighted-average common shares outstanding 11,284 10,434 10,225 Basic and diluted net loss per common share Continuing operations $ (4.69 ) $ (2.20 ) $ (0.40 ) Discontinued operations (1) — — — Net loss per common share $ (4.69 ) $ (2.20 ) $ (0.40 ) (1) Rounded to zero. |
Anti-Dilutive Securities Excluded from Computation of Earnings Per Share | The following table sets forth potential common shares issuable upon the exercise of outstanding options, warrants, the vesting of RSUs and the conversion of the Convertible Notes (prior to consideration of the treasury shares and if-converted methods) (see Note 12 - Stock-Based Payments for details), which were excluded from the computation of diluted net loss per share because such instruments were anti-dilutive (in thousands): December 31, December 31, December 31, Stock options 1,715 86 418 Unvested restricted stock units 1,029 — 13 Warrants 14,515 568 — Convertible notes 1,619 — — Total 18,878 654 431 |
Contingencies, Commitments an38
Contingencies, Commitments and Guarantees (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases | The future estimated operating lease payments for office space and office equipment over the next five years are summarized as follows (in thousands): Year Ending December 31: Lease Commitments 2017 $ 3,083 2018 2,400 2019 884 2020 128 Thereafter 13 Total $ 6,508 |
Schedule of Recognized Contingent Assets and Liabilities Acquired | The following table summarizes the provisional fair values of the assets acquired and liabilities assumed at the Merger date (in thousands): November 29, 2016 Cash and cash equivalents $ 28,290 Restricted cash 390 Accounts receivable (1) 8,182 Inventories 76,800 Prepaid expenses and other current assets 9,839 Insurance proceeds receivable 22,000 Property and equipment, net 4,020 Intangible assets 252,458 Other Assets 1,352 Accounts payable (11,459 ) Accrued liabilities (41,883 ) Provision for legal settlement (63,968 ) Long-term debt (222,908 ) Other liabilities (732 ) Net assets acquired $ 62,381 (1) As of the Merger date, the fair value of accounts receivable approximated the book value acquired. The amount not expected to be collected was insignificant. The acquisition consideration in connection with the Merger was approximately $62.4 million and consisted of the following (in thousands, except for share and per share information): Number of Novelion common shares issued in connection with the acquisition of Aegerion 6,060,288 Novelion share price on November 29, 2016 $ 9.75 Fair value of Novelion common shares issued to Aegerion stockholders $ 59,088 Liability assumed (2)(3) 3,000 Stock compensation assumed (1) 293 Total acquisition consideration $ 62,381 (1) The fair value of Aegerion in-the-money options and RSUs attributed to pre-combination services that were outstanding on November 29, 2016 and settled in connection with the Merger. (2) Represents a term loan facility provided by QLT to Aegerion on June 14, 2016, concurrently with the execution of the Merger Agreement. Aegerion borrowed $3 million against the term loan and the loan remained outstanding as of November 29, 2016. (3) Includes 10,565,879 Merger Agreement Warrants to purchase up to 11,301,791 common shares issued pursuant to the Merger Agreement, which were recognized as a liability with a fair value of zero as of November 29, 2016. Refer to Note 11 - Share Capital and Note 16 - Contingencies, Commitments and Guarantees for further details. Upon the acquisition of Aegerion, the Company assumed the assets and liabilities related to the following contingencies (in thousands): Insurance Proceeds Receivable Class action lawsuit insurance proceeds $ 22,000 Provision for Legal Settlement Class action lawsuit settlement $ (22,250 ) DOJ and SEC settlement (40,635 ) Relator legal settlement (620 ) Relators legal fees (405 ) Other litigation settlement (100 ) Total provision for legal settlement $ (64,010 ) |
Segmentation Information (Table
Segmentation Information (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Segment Reporting [Abstract] | |
Schedule of Net Product Sales from External Customers | The following table summarizes total net product sales from external customers by product and by geographic region. Net product sales represent sale of MYALEPT and JUXTAPID through Aegerion subsequent to the acquisition, from November 29, 2016 to December 31, 2016 and are attributed to countries based on the location of the customer. For the Year Ended December 31, 2016 (in thousands) U.S. Italy Other Foreign Countries Total MYALEPT $ 4,685 $ — $ 268 $ 4,953 JUXTAPID 6,134 1,209 1,278 8,621 Total $ 10,819 $ 1,209 $ 1,546 $ 13,574 |
Description of Business (Detail
Description of Business (Details) $ / shares in Units, $ in Thousands | Dec. 16, 2016$ / sharesshares | Nov. 29, 2016USD ($)revenue_streamdrugproduct$ / sharesshares | Nov. 28, 2016shares | May 31, 2016USD ($) | Dec. 31, 2016USD ($)shares | Dec. 15, 2016shares | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |||
Business Acquisition [Line Items] | ||||||||||||
Cash and cash equivalents | $ | $ 108,927 | $ 141,824 | $ 155,908 | $ 118,521 | ||||||||
Number of revenue streams | revenue_stream | 2 | |||||||||||
Stock consolidation ratio | 0.20 | |||||||||||
Accrued liabilities | $ | $ 37,180 | $ 1,827 | ||||||||||
Common stock, shares issued (in shares) | 18,530,323 | 18,530,323 | [1] | 92,653,562 | 10,565,489 | [1] | ||||||
Common stock, shares outstanding (in shares) | 18,530,323 | 92,653,562 | ||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0 | |||||||||||
JUXTAPID | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Accrued liabilities | $ | $ 1,000 | |||||||||||
Litigation settlement amount | $ | $ 40,000 | $ 40,000 | ||||||||||
Private Placement | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Maximum number of warrants exercisable (in shares) | 2,644,952 | |||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.05 | |||||||||||
Shares issued, price per share (in usd per share) | $ / shares | $ 8.80 | |||||||||||
Shares issued (in shares) | 2,472,727 | |||||||||||
Number of fully paid up warrants | 531,208 | |||||||||||
Shares issuable under warrant transaction (in shares) | 568,181 | 568,181 | ||||||||||
Common Stock | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Shares issued (in shares) | [2] | 1,904,546 | ||||||||||
Aegerion | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Cash and cash equivalents | $ | $ 28,700 | |||||||||||
Number of orphan drug-designated product | drug | 1 | |||||||||||
Maximum number of warrants exercisable (in shares) | 11,301,791 | |||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.05 | |||||||||||
Shares issued (in shares) | 6,060,288 | |||||||||||
Number of warrants issued (in shares) | 10,565,879 | 10,565,879 | ||||||||||
Aegerion | JUXTAPID | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Number of commercial products | product | 2 | |||||||||||
Aegerion | MYALEPT | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Number of commercial products | product | 2 | |||||||||||
Aegerion | Private Placement | ||||||||||||
Business Acquisition [Line Items] | ||||||||||||
Number of warrants issued (in shares) | 2,472,727 | |||||||||||
[1] | Amounts have been retroactively restated for all prior periods presented to reflect the one-for-five share consolidation of the Company’s common stock effected on December 16, 2016. | |||||||||||
[2] | Amounts have been retroactively restated for all prior periods presented to reflect the one-for-five share consolidation of the Company’s common stock effected on December 16, 2016. |
Significant Accounting Polici41
Significant Accounting Policies (Details) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2016USD ($)segment | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Number of operating business segments | segment | 1 | |||
Cash and cash equivalents | $ 108,927 | $ 141,824 | $ 155,908 | $ 118,521 |
Restricted cash collateral for corporate credit card program and letters of credit | 390 | 0 | ||
Prepaid manufacturing costs | 1,400 | 0 | ||
Undistributed earnings in foreign subsidiaries | $ 1,500 | |||
Maximum days MYALEPT can be held as inventory | 21 days | |||
Unrecognized tax benefits | $ 7,660 | $ 7,278 | $ 5,557 | $ 1,846 |
Computer Software and Hardware | Minimum | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Property and equipment, estimated useful lives | 3 years | |||
Computer Software and Hardware | Maximum | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Property and equipment, estimated useful lives | 5 years | |||
Office Furniture, Fixtures, Research and Other Equipment | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Property and equipment, estimated useful lives | 5 years | |||
Silicon Valley Bank | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Restricted cash collateral for corporate credit card program and letters of credit | $ 400 |
Terminated Merger Transactions
Terminated Merger Transactions (Details) - USD ($) $ in Millions | Sep. 15, 2015 | Oct. 22, 2014 | Oct. 09, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2015 | Jun. 08, 2015 |
Credit Suisse | |||||||
Business Acquisition [Line Items] | |||||||
Breakup fees paid in connection with termination of merger agreement | $ 19.6 | ||||||
The InSite Merger | |||||||
Business Acquisition [Line Items] | |||||||
Fee received in connection with termination of merger agreement | $ 2.7 | ||||||
The InSite Merger | Selling, general and administrative | |||||||
Business Acquisition [Line Items] | |||||||
Breakup fees paid in connection with termination of merger agreement | $ 9.4 | ||||||
The InSite Merger | QLT, Inc. | Secured Line of Credit | |||||||
Business Acquisition [Line Items] | |||||||
Credit facility, maximum borrowing capacity | $ 9.9 | ||||||
Contingent consideration paid | 5.8 | ||||||
Contingent consideration, principal paid | 5.7 | ||||||
Contingent consideration, accrued interest paid | $ 0.1 | ||||||
The Auxilium Merger | |||||||
Business Acquisition [Line Items] | |||||||
Fee received in connection with termination of merger agreement | $ 28.4 | ||||||
The Auxilium Merger | Credit Suisse | |||||||
Business Acquisition [Line Items] | |||||||
Breakup fees paid in connection with termination of merger agreement | $ 5.7 | $ 10.2 | |||||
The Auxilium Merger | Credit Suisse | Selling, general and administrative | |||||||
Business Acquisition [Line Items] | |||||||
Breakup fees paid in connection with termination of merger agreement | $ 5.7 |
Strategic Transactions (Details
Strategic Transactions (Details) - USD ($) | Feb. 05, 2016 | Apr. 05, 2016 | Jun. 08, 2015 |
Aralez | |||
Class of Stock [Line Items] | |||
Return of capital cash component, maximum | $ 15,000,000 | ||
Price per share (in usd per share) | $ 6.25 | ||
Business combinations, shares acquired (in shares) | 7,200,000 | ||
Percentage of voting interest acquired in business combination | 10.10% | ||
Total consideration transferred | $ 45,000,000 | ||
Special election distribution paid to common shareholders, shares (in shares) | 4,799,619 | ||
Special election distribution paid to common shareholders, fair value | $ 19,300,000 | ||
Special election distribution payable to common shareholders, cash paid | $ 15,000,000 | ||
Business combination, separately recognized transactions, net gains and losses | 10,700,000 | ||
Investment advisory fees | $ 4,000,000 | ||
Private Placement | Common Stock | |||
Class of Stock [Line Items] | |||
Return of capital cash component, maximum | $ 15,000,000 | ||
Price per share (in usd per share) | $ 1.87 | ||
Common stock, value, subscriptions | $ 20,000,000 | ||
Private Placement | Aralez | Common Stock | |||
Class of Stock [Line Items] | |||
Special election distribution payable to common shareholders (in dollars per share) | $ 0.13629 |
Acquisition - Additional Inform
Acquisition - Additional Information (Details) | Nov. 30, 2016shares | Nov. 29, 2016USD ($)$ / sharesshares | Nov. 28, 2016shares | Dec. 31, 2016USD ($) |
Common Stock | ||||
Business Acquisition [Line Items] | ||||
Common shares outstanding (in shares) | shares | 18,530,323 | |||
Foreign Tax Authority | ||||
Business Acquisition [Line Items] | ||||
Net deferred tax assets | $ 1,000,000 | |||
Private Placement | ||||
Business Acquisition [Line Items] | ||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.05 | |||
Intangible Assets | ||||
Business Acquisition [Line Items] | ||||
Fair value assumptions, intangible assets, cash flows discount, percent | 11.00% | |||
Inventories | ||||
Business Acquisition [Line Items] | ||||
Fair value assumptions, intangible assets, cash flows discount, percent | 11.00% | |||
Aegerion | ||||
Business Acquisition [Line Items] | ||||
Exchange ratio upon consummation of merger | 1.0256 | |||
Percentage of combined company stock owned by legacy shareholders | 68.00% | |||
Percentage of combined company stock owned by acquiree shareholders | 32.00% | |||
Total consideration transferred | $ 62,381,000 | |||
Liability assumed | $ 3,000,000 | |||
Number of warrants issued (in shares) | shares | 10,565,879 | 10,565,879 | ||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.05 | |||
Business combination, net tax liabilities | $ 100,000 | |||
Business combination, unrecognized tax benefits | $ 900,000 | |||
Goodwill acquired during period | $ 0 | |||
Business acquisition transaction costs charged to selling, general and administrative expenses | 4,000,000 | |||
Aegerion | Foreign Tax Authority | Subsidiaries | ||||
Business Acquisition [Line Items] | ||||
Net deferred tax assets | $ 1,100,000 | |||
Aegerion | Private Placement | ||||
Business Acquisition [Line Items] | ||||
Number of warrants issued (in shares) | shares | 2,472,727 |
Acquisition - Fair Value of Con
Acquisition - Fair Value of Consideration Paid (Details) - USD ($) | Nov. 29, 2016 | Nov. 28, 2016 | Dec. 31, 2016 |
Private Placement | |||
Business Acquisition [Line Items] | |||
Maximum number of warrants exercisable (in shares) | 2,644,952 | ||
Exercise price of warrants (in dollars per share) | $ 0.05 | ||
Aegerion | |||
Business Acquisition [Line Items] | |||
Liability assumed | $ 3,000,000 | ||
Stock compensation assumed | 293,000 | ||
Total acquisition consideration | $ 62,381,000 | ||
Number of warrants issued (in shares) | 10,565,879 | 10,565,879 | |
Maximum number of warrants exercisable (in shares) | 11,301,791 | ||
Exercise price of warrants (in dollars per share) | $ 0.05 | ||
Warrants liability fair value | $ 0 | $ 0 | |
Aegerion | Private Placement | |||
Business Acquisition [Line Items] | |||
Number of warrants issued (in shares) | 2,472,727 | ||
Aegerion | Common Stock | |||
Business Acquisition [Line Items] | |||
Number of Novelion common shares issued in connection with the acquisition of Aegerion (in shares) | 6,060,288 | ||
Novelion share price on November 29, 2016 (in dollars per share) | $ 9.75 | ||
Fair value of Novelion common shares issued to Aegerion stockholders | $ 59,088,000 |
Acquisition - Summary of Estima
Acquisition - Summary of Estimated Fair Values of Net Assets Acquired (Details) - Aegerion $ in Thousands | Nov. 29, 2016USD ($) |
Business Acquisition [Line Items] | |
Cash and cash equivalents | $ 28,290 |
Restricted cash | 390 |
Accounts receivable | 8,182 |
Inventories | 76,800 |
Prepaid expenses and other current assets | 9,839 |
Insurance proceeds receivable | 22,000 |
Property and equipment, net | 4,020 |
Intangible assets | 252,458 |
Other Assets | 1,352 |
Accounts payable | (11,459) |
Accrued liabilities | (41,883) |
Provision for legal settlement | (63,968) |
Long-term debt | (222,908) |
Other liabilities | (732) |
Net assets acquired | $ 62,381 |
Acquisition - Schedule of Finit
Acquisition - Schedule of Finite-Lived Intangible Assets Acquired (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Business Acquisition [Line Items] | |
Amortization period (in years) | 9 years 6 months |
Developed Technology [Member] | |
Business Acquisition [Line Items] | |
Developed Technology | $ 252,458 |
Developed Technology [Member] | JUXTAPID | |
Business Acquisition [Line Items] | |
Developed Technology | $ 42,300 |
Amortization period (in years) | 10 years 9 months |
Developed Technology [Member] | MYALEPT | |
Business Acquisition [Line Items] | |
Developed Technology | $ 210,158 |
Amortization period (in years) | 9 years 3 months |
Acquisition - Pro Forma Impact
Acquisition - Pro Forma Impact of Acquisition (Details) - Aegerion - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | |
Business Acquisition, Pro Forma Information [Abstract] | |||
Net product sales | $ 13.6 | ||
Net loss | $ (6.3) | ||
Basic loss per share (in dollars per share) | $ (0.34) | $ (18.41) | $ (9.23) |
Diluted loss per share (in dollars per share) | $ (0.34) | $ (18.41) | $ (9.23) |
Net product sales | $ 153.2 | $ 239.9 | |
Net loss | $ (207.8) | $ (96.3) |
Inventories - Components of Inv
Inventories - Components of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Inventory Disclosure [Abstract] | ||
Work-in-process | $ 20,219 | $ 0 |
Finished goods | 54,502 | 0 |
Total | $ 74,721 | $ 0 |
Inventories - Additional Inform
Inventories - Additional Information (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Nov. 29, 2016 | |
Inventory [Line Items] | ||||
Expense related to obsolete inventory | $ 0 | $ 0 | $ 0 | |
Aegerion | ||||
Inventory [Line Items] | ||||
Inventory acquired as part of the merger | $ 76,800,000 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Nov. 29, 2016 | |
Property, Plant and Equipment [Line Items] | ||||
Cost | $ 14,945,000 | $ 13,780,000 | ||
Accumulated Depreciation | 10,786,000 | 13,350,000 | ||
Net Book Value | 4,159,000 | 430,000 | ||
Depreciation expense | 264,000 | 576,000 | $ 891,000 | |
Book value of property and equipment retired | 0 | |||
Aegerion | ||||
Property, Plant and Equipment [Line Items] | ||||
Property and equipment, net | $ 4,020,000 | |||
Leasehold improvements | ||||
Property, Plant and Equipment [Line Items] | ||||
Cost | 1,869,000 | 207,000 | ||
Accumulated Depreciation | 263,000 | 207,000 | ||
Net Book Value | 1,606,000 | 0 | ||
Office furniture and equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Cost | 539,000 | 258,000 | ||
Accumulated Depreciation | 20,000 | 246,000 | ||
Net Book Value | 519,000 | 12,000 | ||
Research equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Cost | 1,962,000 | 3,471,000 | ||
Accumulated Depreciation | 1,810,000 | 3,092,000 | ||
Net Book Value | 152,000 | 379,000 | ||
Computer and office equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Cost | 10,236,000 | 9,844,000 | ||
Accumulated Depreciation | 8,693,000 | 9,805,000 | ||
Net Book Value | 1,543,000 | $ 39,000 | ||
Construction in progress | ||||
Property, Plant and Equipment [Line Items] | ||||
Cost | 339,000 | |||
Accumulated Depreciation | 0 | |||
Net Book Value | $ 339,000 |
Intangible Assets - Summary of
Intangible Assets - Summary of Intangible Assets (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Finite-Lived Intangible Assets [Line Items] | |||
Acquired finite-lived intangible, weighted average useful life | 9 years 6 months | ||
Cost basis: | |||
Balance as of December 31, 2015 | $ 0 | ||
2016 Acquisitions | 252,458,000 | ||
Balance as of December 31, 2016 | 252,458,000 | $ 0 | |
Accumulated amortization: | |||
Balance as of December 31, 2015 | 0 | ||
2016 Amortization | (2,134,000) | 0 | $ 0 |
Balance as of December 31, 2016 | (2,134,000) | 0 | |
Net intangible assets | |||
Balance as of December 31, 2015 | 0 | ||
Balance as of December 31, 2016 | $ 250,324,000 | 0 | |
Developed Technology Rights | JUXTAPID | |||
Finite-Lived Intangible Assets [Line Items] | |||
Acquired finite-lived intangible, weighted average useful life | 10 years 9 months | ||
Cost basis: | |||
Balance as of December 31, 2015 | $ 0 | ||
2016 Acquisitions | 42,300,000 | ||
Balance as of December 31, 2016 | 42,300,000 | 0 | |
Accumulated amortization: | |||
Balance as of December 31, 2015 | 0 | ||
2016 Amortization | (328,000) | ||
Balance as of December 31, 2016 | $ (328,000) | 0 | |
Developed Technology Rights | MYALEPT | |||
Finite-Lived Intangible Assets [Line Items] | |||
Acquired finite-lived intangible, weighted average useful life | 9 years 3 months | ||
Cost basis: | |||
Balance as of December 31, 2015 | $ 0 | ||
2016 Acquisitions | 210,158,000 | ||
Balance as of December 31, 2016 | 210,158,000 | 0 | |
Accumulated amortization: | |||
Balance as of December 31, 2015 | 0 | ||
2016 Amortization | (1,806,000) | ||
Balance as of December 31, 2016 | $ (1,806,000) | $ 0 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Nov. 29, 2016 | |
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization of intangible assets | $ 2,134,000 | $ 0 | $ 0 | |
Aegerion | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Intangible assets acquired as part of the merger | $ 252,458,000 | |||
Amortization of intangible assets | $ 2,134,000 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Future Amortization of Intangibles (Details) $ in Thousands | Dec. 31, 2016USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2,017 | $ 25,614 |
2,018 | 25,614 |
2,019 | 25,614 |
2,020 | 25,614 |
2,021 | $ 25,614 |
Accrued Liabilities - Component
Accrued Liabilities - Components of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Payables and Accruals [Abstract] | ||
Accrued employee compensation and related costs | $ 7,920 | $ 1,460 |
Accrued sales allowances | 7,849 | 0 |
Other accrued liabilities | 21,411 | 367 |
Total | $ 37,180 | $ 1,827 |
Convertible Notes, Net - Additi
Convertible Notes, Net - Additional Information (Details) | Nov. 29, 2016USD ($)$ / shares | Aug. 31, 2014USD ($)$ / shares | Aug. 31, 2014USD ($)$ / shares | Dec. 31, 2016 |
Aegerion | ||||
Convertible 2% Senior Notes | ||||
Long-term debt | $ 222,908,000 | |||
Convertible 2.0% Senior Notes | ||||
Convertible 2% Senior Notes | ||||
Aggregate principal amount of convertible notes issued | $ 325,000,000 | $ 325,000,000 | ||
Convertible senior notes interest rate | 2.00% | 2.00% | ||
Debt instrument conversion ratio | 4.9817 | |||
Conversion amount of the convertible notes (in dollars per share) | $ / shares | $ 1,000 | $ 1,000 | ||
Minimum percentage of principal amount of outstanding convertible note to declare redemption | 25.00% | 25.00% | ||
Repurchase price of principal amount of the convertible notes | 100.00% | |||
Debt instrument consent payment as percentage of principal and interest | 100.00% | 100.00% | ||
Period to resolve default | 180 days | |||
Share price (in dollars per share) | $ / shares | $ 9.75 | |||
Expected life of the debt | 5 years | |||
Debt instrument, effective interest rate | 16.42% | |||
Convertible 2.0% Senior Notes | Aegerion | ||||
Convertible 2% Senior Notes | ||||
Debt instrument conversion ratio | 200.74 | |||
Long-term debt | $ 222,900,000 | |||
Convertible debt recognized in acquisition, liability component | 222,900,000 | |||
Convertible debt recognized in acquisition, equity component | $ 0 |
Convertible Notes, Net - Outsta
Convertible Notes, Net - Outstanding Convertible Note Balances (Details) - Convertible 2.0% Senior Notes $ in Thousands | Dec. 31, 2016USD ($) |
Liability component: | |
Principal | $ 324,998 |
Less: debt discount | (99,414) |
Net carrying amount | 225,584 |
Equity component | $ 0 |
Convertible Notes, Net - Intere
Convertible Notes, Net - Interest Expense Recognized Related to Convertible Notes (Details) - Convertible 2.0% Senior Notes $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Debt Instrument [Line Items] | |
Contractual interest expense | $ 577 |
Amortization of debt discount | 2,676 |
Total | $ 3,253 |
Convertible Notes, Net - Future
Convertible Notes, Net - Future Minimum Payments under Convertible Notes (Details) - Convertible 2.0% Senior Notes $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Debt Instrument [Line Items] | |
2,017 | $ 6,500 |
2,018 | 6,500 |
2,019 | 329,060 |
Total | 342,060 |
Less amounts representing interest | (17,062) |
Less amortization of debt discount, net | (99,414) |
Net carrying amount of convertible notes | $ 225,584 |
Share Capital (Details)
Share Capital (Details) | Dec. 16, 2016 | Nov. 29, 2016USD ($)$ / sharesshares | Nov. 28, 2016shares | Apr. 06, 2016USD ($) | Feb. 05, 2016USD ($) | Dec. 31, 2016USD ($)voteshares | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($) | Apr. 05, 2016USD ($)shares | |
Class of Stock [Line Items] | ||||||||||
Common stock, shares authorized (in shares) | shares | [1] | 100,000,000 | 100,000,000 | |||||||
Number of votes per common share | vote | 1 | |||||||||
Stock consolidation ratio | 0.20 | |||||||||
Cash distribution paid to common shareholders | $ 15,000,000 | $ 15,000,000 | $ 0 | $ 0 | ||||||
Private Placement | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued (in shares) | shares | 2,472,727 | |||||||||
Maximum number of warrants exercisable (in shares) | shares | 2,644,952 | |||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.05 | |||||||||
Shares issued, price per share (in usd per share) | $ / shares | $ 8.80 | |||||||||
Number of fully paid up warrants | shares | 531,208 | |||||||||
Shares issuable under warrant transaction (in shares) | shares | 568,181 | 568,181 | ||||||||
Proceeds from issuance of private placement, net | $ 21,500,000 | |||||||||
Proceeds from issuance of private placement, gross | 21,800,000 | |||||||||
Share issuance costs from private placement | 300,000 | |||||||||
Fair value of liability for warrants not settleable in cash | 0 | |||||||||
JUXTAPID | ||||||||||
Class of Stock [Line Items] | ||||||||||
Warrants liability fair value | 0 | |||||||||
Aralez | ||||||||||
Class of Stock [Line Items] | ||||||||||
Total consideration transferred | $ 45,000,000 | |||||||||
Special election distribution paid to common shareholders, shares (in shares) | shares | 4,799,619 | |||||||||
Special election distribution paid to common shareholders, fair value | $ 19,300,000 | |||||||||
Aegerion | ||||||||||
Class of Stock [Line Items] | ||||||||||
Total consideration transferred | $ 62,381,000 | |||||||||
Shares issued (in shares) | shares | 6,060,288 | |||||||||
Number of warrants issued (in shares) | shares | 10,565,879 | 10,565,879 | ||||||||
Maximum number of warrants exercisable (in shares) | shares | 11,301,791 | |||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.05 | |||||||||
Warrants liability fair value | $ 0 | $ 0 | ||||||||
Aegerion | Private Placement | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of warrants issued (in shares) | shares | 2,472,727 | |||||||||
Common Stock | Aegerion | ||||||||||
Class of Stock [Line Items] | ||||||||||
Fair value of Novelion common shares issued to Aegerion stockholders | $ 59,088,000 | |||||||||
[1] | Amounts have been retroactively restated for all prior periods presented to reflect the one-for-five share consolidation of the Company’s common stock effected on December 16, 2016. |
Stock-Based Payments - Addition
Stock-Based Payments - Additional Information (Details) | Nov. 29, 2016USD ($) | Jun. 08, 2015shares | Jun. 07, 2015shares | Dec. 31, 2016USD ($)directorplan$ / sharesshares | Dec. 31, 2015USD ($)shares | Dec. 31, 2015USD ($)CAD / sharesshares | Dec. 31, 2014USD ($)CAD / sharesshares | Dec. 31, 2015CAD / shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of incentive plans | plan | 1 | |||||||
Options outstanding (in shares) | 1,714,593 | 85,630 | 85,630 | |||||
Weighted average grant date, fair values stock options (in dollars per share) | (per share) | $ 7.12 | CAD 10.60 | CAD 9.35 | |||||
Exercise price of options outstanding (in dollars/cad per share) | (per share) | $ 9.01 | CAD 25.35 | ||||||
Options granted during period (in shares) | 1,629,563 | |||||||
Exercised price of options (in dollars per share) | $ / shares | $ 0 | |||||||
Outstanding unvested stock options (in shares) | 1,509,563 | |||||||
Number of directors who departed from the board after the acquisition | director | 2 | |||||||
Stock Options | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Accelerated vesting awards (in shares) | 217,294 | |||||||
Accelerated compensation costs of awards | $ | $ 1,500,000 | |||||||
Outstanding unvested stock options (in shares) | 0 | 0 | 256,796 | |||||
Unrecognized compensation expense stock options | $ | $ 4,922,028 | $ 0 | CAD 0 | CAD 2,021,000 | ||||
Unrecognized compensation costs, nonvested awards, weighted average period for recognition | 2 years 9 months 29 days | 0 years | 2 years 2 months 12 days | |||||
DSUs | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Restricted stock units outstanding (in shares) | 28,400 | 30,800 | 30,800 | |||||
Vested at December 31, 2016 (in shares) | 28,400 | |||||||
Compensation liability | $ | $ 200,000 | |||||||
DSUs | The InSite Merger | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Accelerated compensation costs of awards | $ | $ 62,251 | |||||||
RSUs | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares of common stock to received by each award vested (in shares) | 1 | |||||||
Restricted stock units outstanding (in shares) | 1,028,881 | 0 | 0 | 12,800 | ||||
Unrecognized compensation costs, nonvested awards, weighted average period for recognition | 1 year 9 months 7 days | 0 years | 2 years 4 months 2 days | |||||
Unrecognized compensation costs, nonvested awards | $ | $ 9,000,000 | $ 0 | CAD 0 | CAD 200,000 | ||||
RSUs | The InSite Merger | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Accelerated vesting awards (in shares) | 12,800 | |||||||
Accelerated compensation costs of awards | $ | $ 200,000 | |||||||
Time-vested RSUs | Vesting Installment 1 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Awards vesting rights percentage | 50.00% | |||||||
Time-vested RSUs | Vesting Installment 2 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Awards vesting rights percentage | 50.00% | |||||||
Performance-based RSUs | Vesting Installment 1 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Awards vesting rights percentage | 33.33% | |||||||
Performance-based RSUs | Vesting Installment 2 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Awards vesting rights percentage | 33.33% | |||||||
Performance-based RSUs | Vesting Installment 3 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Awards vesting rights percentage | 33.33% | |||||||
NVLN Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Options outstanding (in shares) | 205,030 | |||||||
Number of options issued and outstanding to number of shares issued and outstanding, percentage | 9.10% | 0.80% | 0.80% | 4.10% | ||||
NVLN Plan | Minimum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Exercise price of options outstanding (in dollars/cad per share) | $ / shares | $ 7.15 | |||||||
NVLN Plan | Maximum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Exercise price of options outstanding (in dollars/cad per share) | $ / shares | $ 35.51 | |||||||
NVLN Plan | Common Stock | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares authorized for grant (in shares) | 4,760,000 | |||||||
Aegerion 2010 Option Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Options outstanding (in shares) | 10,561 | |||||||
Aegerion 2010 Option Plan | RSUs | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Restricted stock units outstanding (in shares) | 133,351 | |||||||
DDSU Plan | DSUs | Chief Financial Officer | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Award vesting period | 36 months | |||||||
Number of shares issued under deferred compensation arrangement (in shares) | 0 |
Stock-Based Payments - Weighted
Stock-Based Payments - Weighted-Average Assumptions to Estimate Fair Value (Details) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Expected stock price volatility | 38.23% | 41.30% | 42.40% |
Risk-free interest rate | 1.93% | 1.40% | 1.60% |
Expected life of options (years) | 6 years 2 months 9 days | 6 years 9 months 18 days | 6 years 9 months 18 days |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Stock-Based Payments - Stock Op
Stock-Based Payments - Stock Option Activity (Details) CAD / shares in Units, $ / shares in Units, CAD in Thousands, $ in Thousands | Dec. 16, 2016 | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesCAD / sharesshares | Dec. 31, 2015USD ($)shares | Dec. 31, 2015CADCAD / shares | Dec. 31, 2014USD ($) | Dec. 31, 2014CAD |
Number of Stock Options | |||||||
Outstanding, Beginning Balance (in shares) | 85,630 | ||||||
Granted (in shares) | 1,629,563 | ||||||
Exercised (in shares) | 0 | ||||||
Forfeited/cancelled (in shares) | (600) | ||||||
Outstanding, Ending Balance (in shares) | 1,714,593 | 85,630 | |||||
Weighted Average Excercise Price Per Share | |||||||
Outstanding, Beginning Balance (in cad per share) | CAD / shares | CAD 25.35 | ||||||
Granted (in dollars per share) | $ / shares | $ 8.27 | ||||||
Exercised (in dollars per share) | $ / shares | 0 | ||||||
Forfeited/cancelled (in dollars per share) | $ / shares | 25.35 | ||||||
Outstanding, Ending Balance (in dollars per share) | (per share) | $ 9.01 | CAD 25.35 | |||||
Outstanding, Weighted average remaining contractual life (years) | 9 years 7 months 24 days | 8 years 3 months 4 days | |||||
Outstanding, Aggregate intrinsic value | $ 528 | CAD 528 | CAD 0 | CAD 2,435 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercised in Period, Aggregate Intrinsic Value | $ | 0 | CAD 0 | |||||
Outstanding, Exercised, Aggregate intrinsic value | $ | $ 0 | $ 4,930 | $ 230 | ||||
Options Vested or Expected to Vest | |||||||
Vested and expected to vest at December 31, 2016, Number of options (in shares) | 1,231,203 | 1,231,203 | |||||
Exercisable at December 31, 2016, Number of options (in shares) | 205,030 | 205,030 | |||||
Vested and expected to vest at December 31, 2016, Weighted average exercise price per share (in dollars per share) | $ / shares | $ 9.24 | CAD 9.24 | |||||
Exercisable at December 31, 2016, Weighted average exercise price per share (in dollars per share) | $ / shares | $ 13.86 | CAD 13.86 | |||||
Vested and expected to vest at December 31, 2016, Weighted average remaining contractual life (years) | 9 years 6 months 29 days | ||||||
Exercisable at December 31, 2016, Weighted average remaining contractual life (years) | 8 years 5 months 27 days | ||||||
Vested and expected to vest at December 31, 2016, Aggregate intrinsic value | $ | $ 437 | CAD 437 | |||||
Exercisable at December 31, 2016, Aggregate intrinsic value | 140 | CAD 140 | CAD 0 | CAD 240 | |||
Cash from exercise of stock options | $ | $ 0 | $ 5,508 | $ 509 | ||||
Stock consolidation ratio | 0.20 | ||||||
Aegerion | |||||||
Number of Stock Options | |||||||
Granted (in shares) | 10,561 | ||||||
Weighted Average Excercise Price Per Share | |||||||
Granted (in dollars per share) | $ / shares | $ 7.70 |
Stock-Based Payments - Deferred
Stock-Based Payments - Deferred Share Units Activity (Details) $ in Thousands | Dec. 16, 2016 | Dec. 31, 2016USD ($)shares | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($) |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock consolidation ratio | 0.20 | |||
DSUs | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Outstanding, Beginning Balance (in shares) | 30,800 | |||
Granted (in shares) | 8,960 | |||
Redeemed (in shares) | (11,360) | |||
Cancelled (in shares) | 0 | |||
Outstanding, Ending Balance (in shares) | 28,400 | 30,800 | ||
Vested at December 31, 2016 (in shares) | 28,400 | |||
Cash payments under the DDSU plan | $ | $ 105 | $ 0 | $ 0 |
Stock-Based Payments - Restrict
Stock-Based Payments - Restricted Stock Units Activity (Details) | Dec. 16, 2016 | Dec. 31, 2016$ / sharesshares | Dec. 31, 2015$ / sharesshares | Dec. 31, 2014$ / sharesshares |
Number of RSUs | ||||
Stock consolidation ratio | 0.20 | |||
RSUs | ||||
Number of RSUs | ||||
Outstanding, Beginning Balance (in shares) | 0 | 12,800 | ||
Granted (in shares) | 1,036,735 | |||
Redeemed (in shares) | 0 | |||
Cancelled (in shares) | (7,854) | |||
Outstanding, Ending Balance (in shares) | 1,028,881 | 0 | 12,800 | |
Weighted average grant date fair value restricted stock granted (in dollars per share) | $ / shares | $ 8.82 | $ 0 | $ 20.4 | |
RSUs | Aegerion | ||||
Number of RSUs | ||||
Granted (in shares) | 140,605 | |||
Weighted average grant date fair value restricted stock granted (in dollars per share) | $ / shares | $ 9.53 |
Stock-Based Payments - Allocati
Stock-Based Payments - Allocation of Stock-Based Compensation Expense to Statements of Operations (Details) - USD ($) | Nov. 29, 2016 | Jun. 07, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Stock Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Accelerated vesting stock options (in shares) | 217,294 | ||||
Accelerated compensation costs of options | $ 1,500,000 | ||||
RSU | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Total stock-based compensation expense included in costs and expenses | $ 838,000 | 2,375,000 | $ 1,613,000 | ||
Research and development | RSU | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Total stock-based compensation expense included in costs and expenses | 155,000 | 1,267,000 | 911,000 | ||
Selling, general and administrative | RSU | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Total stock-based compensation expense included in costs and expenses | $ 683,000 | $ 1,108,000 | $ 702,000 | ||
The InSite Merger | DSUs | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Accelerated compensation costs of options | $ 62,251 |
Income Taxes - Income_(Loss) Be
Income Taxes - Income/(Loss) Before Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Examination [Line Items] | |||
Loss before provision for income taxes | $ (52,405) | $ (22,987) | $ (4,197) |
Domestic Tax Authority | Canada | |||
Income Tax Examination [Line Items] | |||
Loss before provision for income taxes-domestic | (46,733) | (22,987) | (4,197) |
Foreign Tax Authority | U.S. | |||
Income Tax Examination [Line Items] | |||
Loss before provision for income taxes-foreign | (9,521) | 0 | 0 |
Foreign Tax Authority | Other Foreign | |||
Income Tax Examination [Line Items] | |||
Loss before provision for income taxes-foreign | $ 3,849 | $ 0 | $ 0 |
Income Taxes - Provision for In
Income Taxes - Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Current: | |||
Current Income Tax Expense (Benefit) | $ (414) | $ 0 | $ 0 |
Deferred: | |||
Deferred Income Tax Expense (Benefit) | (51) | (22) | 192 |
(Provision for) recovery of income taxes | (465) | (22) | 192 |
Domestic Tax Authority | Canada | |||
Current: | |||
Canada | 105 | 0 | 0 |
Deferred: | |||
Canada | 0 | (22) | 192 |
State | U.S. | |||
Current: | |||
U.S. state, net of federal income tax benefit | (2) | 0 | 0 |
Foreign Tax Authority | Other Foreign | |||
Current: | |||
Other Foreign | (517) | 0 | 0 |
Deferred: | |||
Other Foreign | $ (51) | $ 0 | $ 0 |
Income Taxes - Statutory Income
Income Taxes - Statutory Income Tax Rates and Effective Tax Rates Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
Loss from continuing operations before income taxes | $ (52,405) | $ (22,987) | $ (4,197) |
Canadian statutory tax rates | 26.00% | 26.00% | 26.00% |
Expected income tax recovery | $ 13,625 | $ 5,977 | $ 1,091 |
Net decrease (increase) in valuation allowance | (13,684) | (2,486) | 731 |
Non-taxable portion of capital gains | 0 | 0 | 230 |
Investment tax credits | 868 | (222) | 1,628 |
Stock-based compensation | (133) | (606) | (377) |
Foreign rate differential | 532 | 0 | 0 |
Non-taxable (deductible) expenditures | 0 | 76 | 1,752 |
Changes in uncertain tax positions | 0 | (1,784) | (4,793) |
Adjustments to capital losses for settlement of uncertain tax positions | 0 | (560) | 0 |
Other | (1,673) | (417) | (70) |
(Provision for) recovery of income taxes | $ (465) | $ (22) | $ 192 |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Research and development credits | ||
Net operating loss carryforwards | $ 51,808 | $ 45,365 |
Research and development credits | 14,028 | 14,164 |
Stock-based compensation | 108 | 0 |
Capitalized research expenses | 2,124 | 0 |
Capital loss carryforwards | 37,452 | 36,207 |
Depreciable and amortizable assets | 13,597 | 1,645 |
Other temporary differences | 13,736 | 197 |
Total gross deferred tax assets | 132,853 | 97,578 |
Valuation allowance | (131,858) | (97,578) |
Net deferred tax assets | $ 995 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Tax Credit Carryforward [Line Items] | ||||
Valuation allowance, deferred tax assets | $ 131,858,000 | $ 97,578,000 | ||
Net operating loss carryforwards | 166,900,000 | |||
Unrecognized tax benefits | 7,660,000 | 7,278,000 | $ 5,557,000 | $ 1,846,000 |
Unrecognized tax benefits, net period increase | 400,000 | 1,700,000 | 3,700,000 | |
Deferred tax assets available to offset uncertain tax position liabilities | 7,300,000 | 6,900,000 | $ 5,200,000 | |
Accrued interest or tax penalties recorded | 0 | $ 0 | ||
Undistributed earnings in foreign subsidiaries | 1,500,000 | |||
General Business Tax Credit Carryforward | Aegerion | ||||
Tax Credit Carryforward [Line Items] | ||||
Tax credits carryforwards, amount subject to expiration | 30,200,000 | |||
Subsidiaries | ||||
Tax Credit Carryforward [Line Items] | ||||
Operating loss carryforwards, amount subject to expiration | 14,300,000 | |||
Subsidiaries | Aegerion | ||||
Tax Credit Carryforward [Line Items] | ||||
Operating loss carryforwards, amount subject to expiration | 166,600,000 | |||
Canada , United States and Switzerland | ||||
Tax Credit Carryforward [Line Items] | ||||
Valuation allowance, deferred tax assets | 131,900,000 | |||
Canada , United States and Switzerland | Net Operating Loss and Research Tax Credit Carryforward | ||||
Tax Credit Carryforward [Line Items] | ||||
Increase in deferred tax asset valuation allowance | 34,300,000 | |||
Domestic Tax Authority | Canada | ||||
Tax Credit Carryforward [Line Items] | ||||
Net operating loss carryforwards | 152,600,000 | |||
Capital loss carry forwards amount | 289,500,000 | |||
Domestic Tax Authority | Canada | Research and Development | ||||
Tax Credit Carryforward [Line Items] | ||||
Net operating loss carryforwards | 13,500,000 | |||
Scientific, research and experimental development pool | 13,400,000 | |||
Foreign Tax Authority | ||||
Tax Credit Carryforward [Line Items] | ||||
Net deferred tax assets | 1,000,000 | |||
Foreign Tax Authority | Subsidiaries | Aegerion | ||||
Tax Credit Carryforward [Line Items] | ||||
Net deferred tax assets | 1,100,000 | |||
Foreign Tax Authority | U.S. | ||||
Tax Credit Carryforward [Line Items] | ||||
Net operating loss carryforwards | 14,300,000 | |||
State | ||||
Tax Credit Carryforward [Line Items] | ||||
Net operating loss carryforwards | 11,800,000 | |||
State | Aegerion | ||||
Tax Credit Carryforward [Line Items] | ||||
Operating loss carryforwards, amount subject to expiration | 96,900,000 | |||
Tax credit carryforwards | $ 200,000 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefis (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Total uncertain tax position liabilities as of January 1, | $ 7,278 | $ 5,557 | $ 1,846 |
Current year acquisitions | 911 | 0 | 0 |
Increases related to current year tax positions | 0 | 347 | 5,169 |
Changes in tax positions of a prior period | 0 | 1,934 | 11 |
Lapse of statute of limitations | (342) | 0 | (1,469) |
Settlements with taxing authorities | (187) | (560) | 0 |
Total uncertain tax position liabilities as of December 31, | $ 7,660 | $ 7,278 | $ 5,557 |
Fair Value of Financial Instr73
Fair Value of Financial Instruments - Fair Value Measurements of Financial Instruments (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Assets: | ||
Cash | $ 40,693 | $ 141,824 |
Receivables, Fair Value Disclosure | 2,000 | |
Money market funds | 68,234 | |
Restricted cash | 390 | |
Total assets | 109,317 | 143,824 |
Liabilities: | ||
Convertible notes, net - long-term | 225,584 | |
Total liabilities | 225,584 | |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Cash | 40,693 | 141,824 |
Receivables, Fair Value Disclosure | 0 | |
Money market funds | 68,234 | |
Restricted cash | 390 | |
Total assets | 109,317 | 141,824 |
Liabilities: | ||
Convertible notes, net - long-term | 0 | |
Total liabilities | 0 | |
Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Cash | 0 | 0 |
Receivables, Fair Value Disclosure | 0 | |
Money market funds | 0 | |
Restricted cash | 0 | |
Total assets | 0 | 0 |
Liabilities: | ||
Convertible notes, net - long-term | 225,584 | |
Total liabilities | 225,584 | |
Significant Unobservable Inputs (Level 3) | ||
Assets: | ||
Cash | 0 | 0 |
Receivables, Fair Value Disclosure | 2,000 | |
Money market funds | 0 | |
Restricted cash | 0 | |
Total assets | 0 | $ 2,000 |
Liabilities: | ||
Convertible notes, net - long-term | 0 | |
Total liabilities | $ 0 |
Fair Value of Financial Instr74
Fair Value of Financial Instruments - Additional Information (Details) $ in Millions | Dec. 31, 2016USD ($) |
Significant Other Observable Inputs (Level 2) | Convertible 2.0% Senior Notes | |
Cash | |
Estimated fair value of convertible notes | $ 240.4 |
Basic and Diluted Net Loss pe75
Basic and Diluted Net Loss per Common Share - Computation of Basic and Diluted Earnings Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | ||
Earnings Per Share [Abstract] | ||||
Loss from continuing operations | $ (52,870) | $ (23,009) | $ (4,005) | |
Loss from discontinued operations, net of income taxes | 0 | 0 | (66) | |
Net loss | $ (52,870) | $ (23,009) | $ (4,071) | |
Denominator: (thousands) | ||||
Weighted-average common shares outstanding - basic and diluted (in shares) | [1] | 11,284 | 10,434 | 10,225 |
Basic and diluted net loss per common share | ||||
Continuing operations (in dollars per share) | [1] | $ (4.69) | $ (2.20) | $ (0.40) |
Discontinued operations (in dollars per share) | 0 | 0 | 0 | |
Net loss per common share (in dollars per share) | [1] | $ (4.69) | $ (2.20) | $ (0.40) |
[1] | Amounts have been retroactively restated for all prior periods presented to reflect the one-for-five share consolidation of the Company’s common stock effected on December 16, 2016 |
Basic and Diluted Net Loss pe76
Basic and Diluted Net Loss per Common Share - Anti-Dilutive Securities Excluded from Computation (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common share equivalents outstanding (in shares) | 18,878 | 654 | 431 |
Stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common share equivalents outstanding (in shares) | 1,715 | 86 | 418 |
Unvested restricted stock units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common share equivalents outstanding (in shares) | 1,029 | 0 | 13 |
Warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common share equivalents outstanding (in shares) | 14,515 | 568 | 0 |
Convertible notes | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive common share equivalents outstanding (in shares) | 1,619 | 0 | 0 |
Contingencies, Commitments an77
Contingencies, Commitments and Guarantees - Future Minimum Rental Payments for Operating Leases (Details) $ in Thousands | Dec. 31, 2016USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,017 | $ 3,083 |
2,018 | 2,400 |
2,019 | 884 |
2,020 | 128 |
Thereafter | 13 |
Total, Lease Commitments | $ 6,508 |
Contingencies, Commitments an78
Contingencies, Commitments and Guarantees - Additional Information (Details) | Jan. 17, 2017USD ($) | Nov. 29, 2016USD ($) | Feb. 05, 2016USD ($) | Mar. 29, 2017USD ($) | Dec. 31, 2016USD ($) | Jul. 31, 2016USD ($) | May 31, 2016USD ($)violation | Jan. 31, 2015 | Apr. 30, 2006USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($)ft² | Dec. 31, 2014USD ($) |
Other Commitments [Line Items] | |||||||||||||
Rent expense under operating leases | $ 500,000 | $ 400,000 | $ 500,000 | ||||||||||
Indemnification accruals | $ 0 | 0 | |||||||||||
Prosecution agreement, term | 5 years | ||||||||||||
Contingent litigation accrual | $ 40,600,000 | 64,010,000 | 64,010,000 | 0 | |||||||||
Accrued liabilities | 37,180,000 | $ 37,180,000 | $ 1,827,000 | ||||||||||
Aegerion | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Total consideration transferred | 62,381,000 | ||||||||||||
Aralez | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Investment advisory fees | $ 4,000,000 | ||||||||||||
Total consideration transferred | $ 45,000,000 | ||||||||||||
MYALEPT | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Royalty payments | 0 | ||||||||||||
UPenn | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
License agreement written notice period | 60 days | ||||||||||||
Royalty payments | $ 0 | ||||||||||||
Accrued additional royalties | 1,300,000 | 1,300,000 | |||||||||||
Amgen Inc. | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Maximum royalty payment period | 10 years | ||||||||||||
License agreement written notice period | 90 days | ||||||||||||
Rockefeller University | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Accrued additional royalties | 1,200,000 | 1,200,000 | |||||||||||
Shionogi | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
License agreements, milestone payment receivable | 25,000,000 | 25,000,000 | |||||||||||
Commercial Commitments | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Long-term contract amount | 42,100,000 | 42,100,000 | |||||||||||
Retinagenix | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
License agreements, milestone payment receivable | 15,000,000 | $ 15,000,000 | |||||||||||
License agreements, milestone payment maximum extension period | 12 months | ||||||||||||
Agreement expiration term | 10 years | ||||||||||||
Patent - Approval Stage One | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Development milestone payments | $ 1,000,000 | ||||||||||||
Patent - Approval Stage Two | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Development milestone payments | 1,500,000 | ||||||||||||
Patent - Approval Stage Three | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Development milestone payments | 10,000,000 | ||||||||||||
Maximum | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Development milestone payments | $ 9,000,000 | ||||||||||||
Maximum | Retinagenix | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Licensing agreements royalties as a percentage of sales | 6.00% | ||||||||||||
Minimum | Retinagenix | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Licensing agreements royalties as a percentage of sales | 4.00% | ||||||||||||
British Columbia | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Rental leased area | ft² | 8,475 | ||||||||||||
Massachusetts | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Rental leased area | ft² | 31,571 | ||||||||||||
Various International Locations | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Rental leased area | ft² | 8,414 | ||||||||||||
Class action lawsuit | Subsequent Event | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Settlement liabilities, current | $ 22,250,000 | ||||||||||||
Insurance-related assessment liability, insured amount | 22,000,000 | ||||||||||||
Discounted amount of insurance-related assessment liability | $ 250,000 | ||||||||||||
Class action lawsuit | Aegerion | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Loss contingency recognized in period | 22,250,000 | ||||||||||||
Gain contingency recognized period | 22,000,000 | ||||||||||||
JUXTAPID | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Number of guilty pleas for misdemeanor and misbranding violations | violation | 2 | ||||||||||||
Litigation settlement amount | 40,000,000 | $ 40,000,000 | |||||||||||
Litigation settlement, payable period | 3 years | ||||||||||||
Litigation settlement, original payment period scheduled | 5 years | ||||||||||||
Litigation settlement, interest rate on outstanding amounts | 1.75% | ||||||||||||
Accrued liabilities | $ 1,000,000 | ||||||||||||
JUXTAPID | Attorney Fees | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Accrued liabilities | $ 1,000,000 | $ 1,000,000 | |||||||||||
JUXTAPID | Attorney Fees | Subsequent Event | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Contingency accrual payment | $ 1,000,000 | ||||||||||||
JUXTAPID | Illegal Promotion and Violation of Code of Conduct [Member] | BRAZIL | Aegerion | |||||||||||||
Other Commitments [Line Items] | |||||||||||||
Litigation settlement amount | $ 500,000 | ||||||||||||
Loss contingency recognized in period | $ 0 | ||||||||||||
Suspension of Membership Period | 180 days | ||||||||||||
Litigation Settlement, Expense | $ 500,000 |
Contingencies, Commitments an79
Contingencies, Commitments and Guarantees - Contingent Assets and Liabilities Assumed (Details) - Aegerion $ in Thousands | Nov. 29, 2016USD ($) |
Insurance Proceeds Receivable | |
Class action lawsuit insurance proceeds | $ 22,000 |
Provision for Legal Settlement | |
Class action lawsuit settlement | (22,250) |
DOJ and SEC settlement | (40,635) |
Relator legal settlement | (620) |
Relators legal fees | (405) |
Other litigation settlement | (100) |
Total provision for legal settlement | $ (64,010) |
Contingencies, Commitments an80
Contingencies, Commitments and Guarantees - Contingent Consideration (Details) | Apr. 13, 2013USD ($)product | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Sep. 24, 2012USD ($) |
Valeant | ||||
Loss Contingencies [Line Items] | ||||
Discontinued operations, target royalties to be achieved for earn-out payment | $ 8,500,000 | |||
Discontinued operations, consideration, fair value | $ 0 | $ 2,000,000 | ||
Novartis Agreement | ||||
Loss Contingencies [Line Items] | ||||
Discontinued operations, consideration, fair value | 0 | |||
Visudyne | ||||
Loss Contingencies [Line Items] | ||||
Discontinued operations, contingent consideration proceeds | 0 | 0 | ||
Mati | ||||
Loss Contingencies [Line Items] | ||||
Proceeds from divestiture of businesses | $ 1,300,000 | |||
PPDS Technology | ||||
Loss Contingencies [Line Items] | ||||
Discontinued operations, contingent consideration proceeds | $ 0 | $ 0 | ||
Milestone one | Valeant | ||||
Loss Contingencies [Line Items] | ||||
Discontinued operations, consideration | 5,000,000 | |||
Milestone two | Valeant | ||||
Loss Contingencies [Line Items] | ||||
Discontinued operations, consideration | 2,500,000 | |||
Milestone three | Valeant | ||||
Loss Contingencies [Line Items] | ||||
Discontinued operations, consideration | 0 | |||
Earn-out | Valeant | ||||
Loss Contingencies [Line Items] | ||||
Discontinued operations, consideration | 15,000,000 | |||
Discontinued operations, annual earn-out | $ 5,000,000 | |||
Earn-out | Mati | ||||
Loss Contingencies [Line Items] | ||||
Discontinued operations, consideration | $ 19,500,000 | |||
Disposal Group, number of products required to be commercialized for milestone payments | product | 2 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Compensation and Retirement Disclosure [Abstract] | |||
Percentage of employer matching contribution | 50.00% | ||
Percentage of employees matching contribution | 6.00% | ||
Employer contribution expense | $ 27,331 | $ 0 | $ 0 |
Segmentation Information - Addi
Segmentation Information - Additional Information (Details) $ in Millions | 1 Months Ended | 12 Months Ended |
Dec. 31, 2016USD ($)customer | Dec. 31, 2016customersegment | |
Segment Reporting Information [Line Items] | ||
Number of operating business segments | segment | 1 | |
Customer Concentration Risk | Sales Revenue, Net | ||
Segment Reporting Information [Line Items] | ||
Number of major customers | 1 | 1 |
Customer concentration risk, percentage | 34.50% | |
Customer Concentration Risk | Accounts Receivable | ||
Segment Reporting Information [Line Items] | ||
Number of major customers | 1 | 1 |
Customer concentration risk, percentage | 28.50% | |
Geographic Concentration Risk | Intangible Assets | ||
Segment Reporting Information [Line Items] | ||
Customer concentration risk, percentage | 100.00% | |
Geographic Concentration Risk | Intangible Assets | U.S. | ||
Segment Reporting Information [Line Items] | ||
Customer concentration risk, percentage | 65.50% | |
Geographic Concentration Risk | Intangible Assets | Bermuda | ||
Segment Reporting Information [Line Items] | ||
Customer concentration risk, percentage | 34.50% | |
Geographic Concentration Risk | Property, Plant and Equipment | U.S. | ||
Segment Reporting Information [Line Items] | ||
Customer concentration risk, percentage | 92.70% | |
Geographic Concentration Risk | Property, Plant and Equipment | Canada | ||
Segment Reporting Information [Line Items] | ||
Customer concentration risk, percentage | 5.10% | |
Geographic Concentration Risk | Property, Plant and Equipment | Other Foreign Countries | ||
Segment Reporting Information [Line Items] | ||
Customer concentration risk, percentage | 2.20% | |
Geographic Concentration Risk | Inventory, Noncurrent | U.S. | ||
Segment Reporting Information [Line Items] | ||
Customer concentration risk, percentage | 52.00% | |
Geographic Concentration Risk | Inventory, Noncurrent | Other Foreign Countries | ||
Segment Reporting Information [Line Items] | ||
Customer concentration risk, percentage | 48.00% | |
JUXTAPID | Canada | ||
Segment Reporting Information [Line Items] | ||
Net product sales | $ | $ 0.1 |
Segmentation Information - Summ
Segmentation Information - Summary of Total Net Product Sale Revenues (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Segment Reporting Information [Line Items] | |||
Net product sales | $ 13,574 | $ 0 | $ 0 |
U.S. | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 10,819 | ||
Italy | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 1,209 | ||
Other Foreign Countries | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 1,546 | ||
MYALEPT | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 4,953 | ||
MYALEPT | U.S. | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 4,685 | ||
MYALEPT | Italy | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 0 | ||
MYALEPT | Other Foreign Countries | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 268 | ||
JUXTAPID | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 8,621 | ||
JUXTAPID | U.S. | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 6,134 | ||
JUXTAPID | Italy | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 1,209 | ||
JUXTAPID | Other Foreign Countries | |||
Segment Reporting Information [Line Items] | |||
Net product sales | $ 1,278 |