Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 02, 2018 | Jun. 30, 2017 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | kdmn | ||
Entity Registrant Name | Kadmon Holdings, Inc. | ||
Entity Central Index Key | 1,557,142 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Accelerated Filer | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Public Float | $ 115,222,352 | ||
Entity Common Stock, Shares Outstanding | 78,652,149 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 67,517 | $ 36,093 |
Accounts receivable, net | 325 | 655 |
Accounts receivable from affiliates | 861 | 555 |
Inventories, net | 201 | 1,950 |
Prepaid expenses and other current assets | 1,109 | 1,034 |
Total current assets | 70,013 | 40,287 |
Fixed assets, net | 4,292 | 5,427 |
Goodwill | 3,580 | 3,580 |
Restricted cash | 2,116 | 2,116 |
Investment, at cost | 3,542 | 3,542 |
Investment, equity method | 7,599 | |
Other noncurrent assets | 9 | 5 |
Total assets | 83,552 | 62,556 |
Current liabilities: | ||
Accounts payable | 8,008 | 6,296 |
Accrued expenses | 8,577 | 12,150 |
Deferred revenue | 4,400 | 4,400 |
Fair market value of financial instruments | 1,952 | |
Secured term debt - current | 33,707 | 1,900 |
Total current liabilities | 56,644 | 24,746 |
Deferred revenue | 19,617 | 24,017 |
Deferred rent | 4,347 | 4,377 |
Deferred tax liability | 939 | 1,376 |
Fair market value of financial instruments - non current | 3,305 | |
Other long term liabilities | 247 | 1,250 |
Secured term debt – net of current portion and discount | 28,677 | |
Total liabilities | 81,794 | 87,748 |
Commitments and contingencies (Note 16 and 17) | ||
Stockholders’ equity (deficit): | ||
Common Stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2017 and December 31, 2016; 78,643,954 and 45,078,666 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively | 79 | 45 |
Additional paid-in capital | 198,856 | 92,166 |
Accumulated deficit | (237,397) | (155,705) |
Total stockholders’ equity (deficit) | 1,758 | (25,192) |
Total liabilities and stockholders’ equity (deficit) | 83,552 | 62,556 |
Convertible Preferred Stock [Member] | ||
Stockholders’ equity (deficit): | ||
Convertible Preferred Stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2017 and December 31, 2016, respectively; 30,000 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively | $ 40,220 | $ 38,302 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 | Aug. 01, 2016 | Jul. 26, 2016 | Jun. 08, 2016 |
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | ||
Common stock, shares issued | 78,643,954 | 45,078,666 | |||
Common stock, shares outstanding | 78,643,954 | 45,078,666 | 45,078,666 | ||
Convertible Preferred Stock [Member] | |||||
Preferred stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |
Preferred stock, shares issued | 30,000 | 30,000 | 30,000 | ||
Preferred stock, shares outstanding | 30,000 | 30,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Revenues | |||
Net sales | $ 5,257 | $ 18,514 | $ 29,299 |
License and other revenue | 7,007 | 7,541 | 6,420 |
Total revenue | 12,264 | 26,055 | 35,719 |
Cost of sales | 1,332 | 3,485 | 3,731 |
Write-down of inventory | 1,654 | 385 | 2,274 |
Gross profit | 9,278 | 22,185 | 29,714 |
Operating expenses: | |||
Research and development | 40,777 | 35,840 | 33,558 |
Selling, general and administrative | 37,057 | 105,880 | 104,740 |
Impairment of intangible asset | 31,269 | ||
Gain on settlement of payable | (4,131) | ||
Total operating expenses | 77,834 | 137,589 | 169,567 |
Loss from operations | (68,556) | (115,404) | (139,853) |
Other expense (income) : | |||
Interest income | (132) | (38) | (10) |
Interest expense | 5,962 | 72,634 | 27,160 |
Loss on extinguishment of debt | 11,176 | 2,934 | |
Change in fair value of financial instruments | (2,096) | (4,380) | (1,494) |
Gain on deconsolidation of subsidiary | (24,000) | ||
Loss on equity method investment | 7,599 | 13,625 | 2,776 |
Other expense (income) | 6 | (8) | (134) |
Total other expense | 11,339 | 93,009 | 7,232 |
Loss before income tax expense | (79,895) | (208,413) | (147,085) |
Income tax expense (benefit) | (121) | 342 | (3) |
Net loss | (79,774) | (208,755) | (147,082) |
Deemed dividend on convertible preferred stock and Class E redeemable convertible units | 1,918 | 21,733 | |
Net loss attributable to common stockholders | $ (81,692) | $ (230,488) | $ (147,082) |
Basic and diluted net loss per share of common stock | $ (1.42) | $ (9.74) | $ (18.10) |
Weighted average basic and diluted shares of common stock outstanding | 57,405,331 | 23,674,512 | 8,127,781 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) | Class E Redeemable Convertible Units [Member] | Class A Units [Member]Additional Paid-in Capital [Member] | Class A Units [Member] | Class B Units [Member] | Class C Units[Member] | Class D Units [Member] | Convertible Preferred Stock [Member]Preferred Stock [Member] | Convertible Preferred Stock [Member] | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2014 | $ 37,052,000 | $ 341,343,000 | $ (496,763,000) | $ (155,420,000) | |||||||||
Balance, Shares at Dec. 31, 2014 | 3,438,984 | 50,882,656 | 1 | 1 | 4,373,674 | ||||||||
Issuance to settle obligation | $ 6,606,000 | $ 10,541,000 | $ 10,541,000 | ||||||||||
Issuance to settle obligation, shares | 574,392 | 1,808,334 | |||||||||||
Issuance of units to non-employee directors | $ 63,000 | ||||||||||||
Issuance of units to non-employee directors, shares | 10,435 | ||||||||||||
Accretion of units fee discount and repayment premium | (4,302,000) | (4,302,000) | |||||||||||
Accretion of units fee discount and repayment premium | $ 4,302,000 | ||||||||||||
Share-based compensation expense | 10,324,000 | 10,324,000 | |||||||||||
Issuance of units | $ 10,833,000 | 15,000,000 | $ 15,000,000 | ||||||||||
Issuance of units, shares | 945,441 | 1,250,000 | |||||||||||
Issuance of units related to option exercises | 30,000 | $ 30,000 | $ 4,800 | ||||||||||
Issuance of units related to option exercises, shares | 5,011 | 772 | |||||||||||
Net loss | (147,082,000) | $ (147,082,000) | |||||||||||
Balance at Dec. 31, 2015 | $ 58,856,000 | 372,936,000 | (643,845,000) | (270,909,000) | |||||||||
Balance, Shares at Dec. 31, 2015 | 4,969,252 | 53,946,001 | 1 | 1 | 4,373,674 | ||||||||
Issuance to settle obligation | $ 13,460,000 | 125,000 | $ 125,000 | $ 1,000 | 2,499,000 | 2,500,000 | |||||||
Issuance to settle obligation, shares | 1,170,437 | 25,000 | 208,334 | ||||||||||
Equity raised through issuance of Class E units, net | $ 5,500,000 | ||||||||||||
Equity raised through issuance of Class E units, net, shares | 478,266 | ||||||||||||
Accretion of units fee discount and repayment premium | (5,812,000) | (5,812,000) | |||||||||||
Accretion of units fee discount and repayment premium | $ 5,812,000 | ||||||||||||
Share-based compensation expense | 47,217,000 | $ 47,217,000 | |||||||||||
Issuance of units related to option exercises | $ 41,000 | $ 41,000 | |||||||||||
Issuance of units related to option exercises, shares | 7,200 | 1,109 | |||||||||||
Common stock issued in private placement, net, shares | 478,266 | ||||||||||||
Common stock and warrants issued in public offering, net | $ 6,000 | 69,744,000 | $ 69,750,000 | ||||||||||
Common stock and warrants issued in public offering, net, shares | 6,250,000 | ||||||||||||
Initial public offering costs | (3,739,000) | (3,739,000) | |||||||||||
Beneficial conversion feature on Class E units at IPO | 13,431,000 | (13,431,000) | 13,431,000 | ||||||||||
Cummulative effect of change in accounting principle - ASU 2016-09 forfeiture adjustment | 1,990,000 | (1,990,000) | |||||||||||
Corporate conversion from Kadmon Holdings, LLC to Kadmon Holdings, Inc. | (720,618,000) | 720,618,000 | |||||||||||
Corporate conversion to common stock | $ (83,628,000) | $ 19,000 | 83,607,000 | 83,626,000 | |||||||||
Corporate conversion to common stock, shares | (6,617,955) | (53,978,201) | (1) | (1) | (4,373,674) | 19,585,865 | |||||||
Conversion of convertible debt | $ 30,000,000 | $ 30,000,000 | $ 19,000 | 182,712,000 | 182,731,000 | ||||||||
Conversion of convertible debt, shares | 30,000 | 19,034,467 | |||||||||||
Beneficial conversion feature on convertible debt | 45,683,000 | 45,683,000 | |||||||||||
Beneficial conversion feature on convertible preferred stock | $ 7,660,000 | (7,660,000) | 7,660,000 | ||||||||||
Accretion of dividends on convertible preferred stock | 600,000 | 642,000 | (642,000) | 642,000 | |||||||||
Reclassification of warrants to equity | 1,716,000 | 1,716,000 | |||||||||||
Beneficial conversion feature on warrants | 634,000 | 634,000 | |||||||||||
Net loss | (208,755,000) | (208,755,000) | |||||||||||
Balance at Dec. 31, 2016 | $ 38,302,000 | $ 45,000 | 92,166,000 | (155,705,000) | (25,192,000) | ||||||||
Balance, Shares at Dec. 31, 2016 | 30,000 | 45,078,666 | |||||||||||
Share-based compensation expense | 12,354,000 | 12,354,000 | |||||||||||
Common stock issued under ESPP plan | 30,000 | 30,000 | |||||||||||
Common stock issued for warrant exercises | 37,000 | 37,000 | |||||||||||
Common stock issued for warrant exercises, shares | 11,839 | ||||||||||||
Common stock issued under ESPP plan, shares | 10,594 | ||||||||||||
Common stock issued in private placement, net | $ 7,000 | 19,209,000 | 19,216,000 | ||||||||||
Common stock issued in private placement, net, shares | 6,767,855 | ||||||||||||
Common stock and warrants issued in public offering, net | $ 27,000 | 75,060,000 | 75,087,000 | ||||||||||
Common stock and warrants issued in public offering, net, shares | 26,775,000 | ||||||||||||
Beneficial conversion feature on convertible preferred stock | $ 384,000 | (384,000) | 384,000 | ||||||||||
Accretion of dividends on convertible preferred stock | $ 1,500,000 | 1,534,000 | (1,534,000) | 1,534,000 | |||||||||
Net loss | (79,774,000) | (79,774,000) | |||||||||||
Balance at Dec. 31, 2017 | $ 40,220,000 | $ 79,000 | $ 198,856,000 | $ (237,397,000) | $ 1,758,000 | ||||||||
Balance, Shares at Dec. 31, 2017 | 30,000 | 78,643,954 |
Consolidated Statements of Sto6
Consolidated Statements of Stockholders' Equity (Deficit) (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Class E Redeemable Convertible Units [Member] | |
Issuance of units, transaction costs | $ 40 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Cash flows from operating activities: | |||
Net loss | $ (79,774) | $ (208,755) | $ (147,082) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization of fixed assets | 1,822 | 2,280 | 2,312 |
Amortization of intangible asset | 15,223 | 27,442 | |
Impairment of intangible asset | 31,269 | ||
Write-down of inventory | 1,654 | 385 | 2,274 |
Write-down of capitalized computer software development costs | 62 | ||
Gain on purchase commitment | (243) | ||
Loss on extinguishment of debt / conversion of debt | 11,176 | 2,934 | |
Write-off of deferred financing costs and debt discount | 3,820 | 2,752 | |
Amortization of deferred financing costs | 509 | 1,304 | 1,290 |
Amortization of debt discount | 2,297 | 3,118 | 3,867 |
Amortization of debt premium | (564) | ||
Accretion of repayment premium on secured term debt | (345) | ||
Share-based compensation | 12,354 | 47,217 | 10,324 |
Gain on settlement of payable | (4,131) | ||
Bad debt expense | 3 | 6 | 5 |
Gain on deconsolidation of subsidiary | (24,000) | ||
Change in fair value of financial instruments | (2,096) | (4,380) | (1,494) |
Beneficial conversion feature expense on warrants | 1,745 | ||
Beneficial conversion feature expense on convertible debt | 44,170 | ||
Fair value of units issued to consultants | 3,000 | ||
Fair value of shares / units issued in settlement of obligation | 4,360 | 13,647 | |
Accrued legal settlement | 10,350 | ||
Deferred taxes | (437) | 27 | (3) |
Paid-in-kind interest | 14,695 | 11,434 | |
Loss on equity method investment | 7,599 | 13,625 | 2,776 |
Changes in operating assets and liabilities: | |||
Restricted cash | (89) | ||
Accounts receivable, net | 21 | 937 | (1,313) |
Inventories, net | 95 | 1,133 | 1,930 |
Prepaid expenses and other assets | (134) | (479) | 597 |
Accounts payable | 1,605 | 530 | (4,413) |
Accrued expenses, other liabilities and deferred rent | (4,652) | 544 | 3,040 |
Deferred revenue | (4,400) | (4,500) | (10,300) |
Net cash used in operating activities | (64,098) | (52,950) | (60,977) |
Cash flows from investing activities: | |||
Purchases of fixed assets | (479) | (539) | (161) |
Net cash used in investing activities | (479) | (539) | (161) |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock and warrants, net | 95,954 | ||
Proceeds from issuance of ESPP shares | 30 | ||
Proceeds from warrant exercises | 37 | ||
Proceeds from issuance of common stock in IPO, net | 69,750 | ||
Payments of initial public offering costs | (3,293) | (445) | |
Payment of financing costs related to debt exchange agreements | (534) | ||
Proceeds from issuance of secured term debt | 35,000 | ||
Proceeds from issuance of convertible debt | 112,500 | ||
Payment of financing costs | (20) | (4,069) | |
Principal payments on secured term debt | (380) | (107,204) | |
Proceeds from related party loans | 2,000 | ||
Repayment of related party loans | (3,000) | (2,000) | |
Proceeds from issuance of Class A units, net | 15,000 | ||
Proceeds from issuance of Class E redeemable convertible units, net | 5,500 | 10,833 | |
Proceeds from exercise of stock options | 41 | 30 | |
Net cash provided by financing activities | 96,001 | 68,084 | 61,645 |
Net increase in cash and cash equivalents | 31,424 | 14,595 | 507 |
Cash and cash equivalents, beginning of period | 36,093 | 21,498 | 20,991 |
Cash and cash equivalents, end of period | 67,517 | 36,093 | 21,498 |
Supplemental cash flow disclosures: | |||
Cash paid for interest | 3,689 | 3,723 | 8,019 |
Cash paid for taxes | 356 | 339 | 153 |
Non-cash investing and financing activities: | |||
Settlement of related party loan | 500 | ||
Units issued in settlement of obligation | 11,725 | 9,063 | |
Capitalized lease obligations | 208 | 230 | 20 |
Unpaid financing/offering costs | 56 | 1,958 | |
Equity method investment related to deconsolidation | 24,000 | ||
Financing costs paid with convertible notes | 2,260 | ||
Fair value of warrants issued to lenders | $ 6,300 | ||
Cost Method Investment in affiliate | 1,242 | ||
Beneficial conversion feature on convertible preferred stock | 384 | 7,660 | |
Accretion of dividends on convertible preferred stock | 1,534 | 642 | |
Beneficial conversion feature on Class E units at IPO | 13,431 | ||
Conversion of Class E units into common stock | (83,626) | ||
Conversion of convertible debt into common stock | 176,615 | ||
Conversion of convertible debt into convertible preferred stock | 30,000 | ||
Reclassification of warrants from liabilty to equity | 1,716 | ||
Fair value of warrants issued in private placement | 1,651 | ||
Fair value of modification to lender warrants | $ 908 | ||
Class E Redeemable Convertible Units [Member] | |||
Cash flows from financing activities: | |||
Proceeds from issuance of Class E redeemable convertible units, net | 5,500 | ||
Non-cash investing and financing activities: | |||
Conversion of Class E units into common stock | $ 83,628 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2017 | |
Organization [Abstract] | |
Organization | 1. Organization Nature of Business Kadmon Holdings, Inc. (together with its subsidiaries, “Kadmon” or “Company”) is a fully integrated biopharmaceutical company engaged in the discovery, development and commercialization of small molecules and biologics to address disease areas of significant unmet medical needs, with a near-term clinical focus on inflammatory and fibrotic diseases . The Company leverages its multi ‑disciplinary research and clinical development team members to identify and pursue a diverse portfolio of novel product candidates, both through in-licensing products and employing its small molecule and biologics platforms. By retaining global commercial rights to its lead product candidates, the Company believes that it has the ability to develop these candidates while maintaining flexibility for commercial and licensing arrangements. The Company expects to continue to progress its clinical candidates and have further clinical trial events throughout 2018 . Corporate Conversion, Initial Public Offering and Debt Conversion On July 26, 2016, in connection with the pricing of the Company’s initial public offering (“ IPO ”) , Kadmon Holdings, LLC filed a certificate of conversion, whereby Kadmon Holdings, LLC effected a corporate conversion from a Delaware limited liability company to a Delaware corporation and changed its name to Kadmon Holdings, Inc. As a result of the corporate conversion, accumulated deficit was reduced to zero on the date of the corporate conversion, and the corresponding amount was credited to additional paid-in capital. In connection with this corporate conversion, the Company filed a certificate of incorporation and adopted bylaws, all of which were previously approved by the Company’s board of directors and stockholders. Pursuant to the Company’s certificate of incorporation, the Company is authorized to issue up to 200,000,000 shares of common stock $0.001 par value per share and 10,000,000 shares of preferred stock $0.001 par value per share. All references in the audited consolidated financial statements to the number of shares and per-share amounts of common stock have been retroactively restated to reflect this conversion. On August 1, 2016, the Company completed its IPO whereby it sold 6,250,000 shares of common stock at $12.00 per share. The aggregate net proceeds received by the Company from the offering were $66.0 million, net of underwriting discounts and commissions of $5.3 million and offering expenses of $3.7 million. Upon the closing of the IPO, 45,078,666 shares of common stock were outstanding, which includes 19,034,467 shares of common stock as a result of the conversion of the Company’s Senior Convertible Term Loan and Second Lien Convert (Note 7). The shares began trading on the New York Stock Exchange on July 27, 2016 under the symbol “KDMN.” Liquidity The Company had an accumulated deficit of $237.4 million and working capital of $13.4 million at December 31, 2017 . For the year ended December 31, 2017 , the Company earned a $2.0 million milestone payment pursuant to a license agreement entered into with Jinghua to develop products using human monoclonal antibodies . The Company also raised gross proceeds of $22.7 million in March 2017 ( $ 20.9 million net of placement agent fees and other offering costs and expenses ) and gross proceeds of $80.4 million in September 2017 ( $75.1 million net of underwriting fees, commissions and other offering costs and expenses ) of which $66.8 million of gross proceeds closed in September 2017 and the remaining $13.6 million of gross proceeds closed in October 2017 . These raises, in total, together with its existing cash, are expected to enable the Company to advance its planned Phase 2 clinical studies for KD025 and tesevatinib, advance certain of its other pipeline product candidates and provide for other working capital purposes . On March 31, 2017, the Company entered into its third amendment to the 2015 Credit Agreement (the “Third Amendment”). Pursuant to the Third Amendment, principal payments owed under the 2015 Credit Agreement, in the amount of $380,000 per month, were deferred until January 31, 2018. Additionally, the parties amended a future capital raising covenant by extending the time period by which the Company was required to raise the remaining $17.0 million of capital by six months, from June 30, 2017 to December 31, 2017, which was satisfied in September 2017. All other material terms of the 2015 Credit Agreement, including the maturity date, remain the same. The Company maintained cash and cash equivalents of $67.5 million at December 31, 2017 . Management’s plans include continuing to finance operations through the issuance of additional equity securities and increasing the commercial portfolio through the development of the current pipeline or through strategic collaborations. Any transactions which occur may contain covenants that restrict the ability of management to operate the business or may have rights, preferences or privileges senior to the Company’s common stock and may dilute current stockholders of the Company. Engaging in a transaction with a third party is contingent on negotiations among the parties; therefore, there is no certainty that the Company will enter into such an agreement should the Company so desire . |
Going Concern
Going Concern | 12 Months Ended |
Dec. 31, 2017 | |
Going Concern [Abstract] | |
Going Concern | 2. Going Concern The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, which contemplate continuation of the Company as a going concern. The Company has not established a source of revenues sufficient to cover its operating costs, and as such, has been dependent on funding operations through the issuance of debt and sale of equity securities. The Company expects to incur further losses over the next several years as it develops its business. A t December 31, 2017 , the Company had working capital of only $13.4 million. The Company’s accumulated deficit amounted to $237.4 million and $155.7 million at December 31, 2017 and 2016 , respectively. Net cash used in operating activities was $64.1 million, $53.0 million and $61.0 million for years ended December 31, 2017, 2016 and 2015 . The Company must raise additional capital to fund its continued operations and remain in compliance with its debt covenants. The Company may not be successful in its efforts to raise additional funds or achieve profitable operations. Amounts raised will be used for further development of the Company’s product candidates, to provide financing for marketing and promotion, to secure additional property and equipment, and for other working capital purposes. Even if the Company is able to raise additional funds through the sale of its equity securities, or loans from financial institutions, the Company’s cash needs could be greater than anticipated in which case it could be forced to raise additional capital. In September 2017, the Company raised $80.4 million in gross proceeds ( $75.1 million net of $5 .3 million in underwriting fees , commissions and other offering costs and expenses ) from the issuance of 26,775,000 shares of common stock and warrants to purchase 10,710,000 shares of common stock at an initial exercise price of $3.35 per share for a term of 5 years from the date of issuance at a combined price of $3.001 per share and accompanying warrant (“2017 Public Offering”). Gross proceeds of $66.8 million and the issuance of 22,275,000 shares of common stock and warrants to purchase 8,910,000 shares of common stock closed in September 2017 and the remaining $13.6 million of gross proceeds and the issuance of 4,500,000 shares of common stock and warrants to purchase 1,800,000 shares of common stock closed in October 2017. In March 2017, the Company raised $22.7 million in gross proceeds ( $2 0.9 million net of $1.8 million in placement agent fees and other offering costs and expenses ) from the issuance of 6,767,855 shares of common stock, at a price of $3.36 per share, and warrants to purchase 2,707,138 shares of common stock at an initial exercise price of $4.50 per share for a term of 13 months from the date of issuance (“2017 Private Placement”). At the present time, the Company has no commitments for any additional financing, and there can be no assurance that, if needed, additional capital will be available to the Company on commercially acceptable terms or at all. If the Company cannot obtain the needed capital, it may not be able to become profitable and may have to curtail or cease its operations. These and other factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements do not include any adjustments or classifications that may result from the possible inability of the Company to continue as a going concern . |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Basis of Presentation The Company operates in one segment considering the nature of the Company’s products and services, class of customers, methods used to distribute the products and the regulatory environment in which the Company operates. Principles of Consolidation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The consolidated financial statements include the accounts of Kadmon Holdings, Inc. and its domestic and international subsidiaries, all of which are wholly owned. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Actual results could differ from those estimates. Company Valuation To estimate certain expenses and record certain transactions, it was necessary for the Company to estimate the fair value of its membership units. Given the absence of a public trading market prior to the IPO, and in accordance with the American Institute of Certified Public Accountants’ Practice Guide, “Valuation of Privately ‑Held ‑Company Equity Securities Issued as Compensation”, the Company exercised reasonable judgment and considered numerous objective and subjective factors to determine its best estimate of the fair value of its membership units (Note 4). Revenue Recognition The Company recognizes sales when the risk of loss has been transferred to the customer. As is typical in the pharmaceutical industry, gross product sales are subject to a variety of deductions, primarily representing rebates, chargebacks, returns, and discounts to government agencies, wholesalers, and managed care organizations. These deductions represent management’s best estimates of the related reserves and, as such, judgment is required when estimating the impact of these sales deductions on gross sales for a reporting period. If estimates are not representative of the actual future settlement, results could be materially affected. The Company’s product sales were substantially derived from the sale of its ribavirin portfolio of products during the years ended December 31, 2017, 2016 and 2015 . The Company accounts for revenue arrangements that contain multiple deliverables in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), Topic 605 ‑25, “Revenue Recognition for Arrangements with Multiple Elements”, which addresses the determination of whether an arrangement involving multiple deliverables contains more than one unit of accounting. A delivered item within an arrangement is considered a separate unit of accounting only if both of the following criteria are met: · the delivered item has value to the customer on a stand ‑alone basis; and · the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in control of the vendor. In accordance with FASB ASC Topic 605 ‑25, if both of the criteria above are not met, then separate accounting for the individual deliverables is not appropriate. Revenue recognition for arrangements with multiple deliverables constituting a single unit of accounting is recognized generally over the greater of the term of the arrangement or the expected period of performance, either on a straight ‑line basis or on a modified proportional performance method. Non ‑refundable license fees are recognized as revenue when the Company has a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the receivable is reasonably assured and the Company has no future performance obligations under the license agreement. The Company may earn contingent payments from third parties based on the achievement of certain clinical and commercial milestones. The Company recognizes milestone revenue as the underlying criteria is achieved in accordance with FASB ASC Topic 605 ‑28, “Revenue Recognition Milestone Method”. The Company reassesses the period of performance over which the Company recognizes deferred upfront license fees and makes adjustments as appropriate in the period in which a change in the estimated period of performance is identified. In the event a licensee elects to discontinue development of a specific product candidate under a single target license, but retains its right to use the Company’s technology to develop an alternative product candidate to the same target or a target substitute, the Company would cease amortization of any remaining portion of the upfront fee until there is substantial pre ‑clinical activity on another product candidate and its remaining period of substantial involvement can be estimated. In the event that a single target license were to be terminated, the Company would recognize as revenue any portion of the upfront fee that had not previously been recorded as revenue, but was classified as deferred revenue, at the date of such termination or through the remaining substantial involvement in the wind down of the agreement. Foreign Revenue Foreign product sales represented approximately 26.9% , 8.6% and 10% of total product sales for the years ended December 31, 2017, 2016 and 2015 , respectively, the majority of which were to the Netherlands and Ireland. Sales Returns Reserve Revenue is recognized net of sales returns, which are estimated using the Company’s historical experience. The sales returns reserve was $0.6 million and $0.4 million at December 31, 2017 and 2016 , respectively. Sales returns expense was $0.6 million, $0.9 million and $0.7 million for the years ended December 31, 2017, 2016 and 2015 , respectively . Actual results could differ from original estimates resulting in future adjustments to revenue. Reserve for Wholesaler Chargebacks and Rebates The Company maintains a reserve for wholesaler chargebacks and rebates to properly reflect the realizable value of accounts receivable. A chargeback represents a contractual allowance provided by the Company to its wholesalers for any variances between wholesale and lower retail prices of the Company’s pharmaceutical products. The Company estimates the reserve for wholesaler chargebacks based on wholesaler inventory levels, contract prices and historical experience. Rebate reserves represent contractual allowances based on specific customer contracts. The rebate allowance is estimated as a percentage of specific customer sales. The reserve for wholesaler chargebacks and rebates was $ 0.2 million and $0.1 million at December 31, 2017 and 2016 , respectively. Wholesaler c hargebacks and r ebates expense was $0. 3 million, $0. 5 million and $ 1.0 million for the years ended December 31, 2017, 2016 and 2015 , respectively . Rebates Payable The Company issues rebates related to various government programs and buying groups. In these instances, the rebates are paid in cash to the party managing the discount buying program. The estimated rebates earned but unpaid was $0.3 million and $0.4 million at December 31, 2017 and 2016 , respectively. Such amounts have been included in accounts payable on the Company’s consolidated balance sheets. R ebates expense was $0. 7 million, $0. 8 million and $ 1.2 million for the years ended December 31, 2017, 2016 and 2015 , respectively . Shipping and Handling Costs Shipping and handling costs for raw materials and finished goods prior to their sale are classified in cost of sales. Freight charges for shipments to customers are not billed to customers and are included in selling, general and administrative expenses when incurred and were $0.1 million , $0.2 million and $0.3 million for the years ended December 31, 2017, 2016 and 2015 , respectively. Foreign Currencies The consolidated financial statements are presented in U.S. dollars, the reporting currency of the Company. Gains or losses on transactions denominated in a currency other than the Company’s functional currency, which arise as a result of changes in foreign currency exchange rates, are recorded in other income on the consolidated statements of operations. The transaction gains (loss) were ( $25,000 ), $9,000 and $124,000 for the years ended December 31, 2017, 2016 and 2015 , respectively. Share ‑based Compensation Expense The Company recognizes share ‑based compensation expense in accordance with FASB ASC Topic 718, “Stock Compensation” (“ASC 718”), for all share ‑based awards made to employees and board members based on estimated fair values. ASC 718 requires companies to measure the cost of employee services incurred in exchange for the award of equity instruments based on the estimated fair value of the share ‑based award on the grant date. The expense is recognized over the requisite service period. All share ‑based awards to non ‑employees are accounted for in accordance with FASB ASC Topic 505 ‑50, “Equity Based Payments to Non ‑Employees,” where the value of unit compensation is based on the measurement date, as determined at either a) the date at which a performance commitment is reached, or b) the date at which the necessary performance to earn the equity instruments is complete. The Company uses a Black ‑Scholes option ‑pricing model to value the Company’s option awards. Using this option ‑pricing model, the fair value of each employee and board member award is estimated on the grant date. The fair value is expensed on a straight ‑line basis over the vesting period. The option awards generally vest pro ‑rata annually. The expected volatility assumption is based on the volatility of the share price of comparable public companies. The expected life is determined using the “simplified method” permitted by Staff Accounting Bulletin Numbers 107 and 110 (the midpoint between the term of the agreement and the weighted average vesting term). The risk ‑free interest rate is based on the implied yield on a U.S. Treasury security at a constant maturity with a remaining term equal to the expected term of the option granted. The dividend yield is zero, as the Company has never declared a cash dividend. In the fourth quarter of 2016, the Company adopted ASU 2016 ‑09, “ Compensation—Stock Compensation ” . ASU 2016-09 requires that certain other amendments relevant to the Company be applied using a modified-retrospective transition method by means of a cumulative-effect adjustment to accumulated deficit as of the beginning of the period in which the guidance is adopted. As a result of adopting ASU 2016-09 during the three months ended December 31, 2016, the Company adjusted accumulated deficit for amendments related to an entity-wide accounting policy election to recognize share-based award forfeitures only as they occur rather than an estimate by applying a forfeiture rate. The Company recorded a $2.0 million charge to accumulated deficit as of January 1, 2016 and an associated credit to additional paid-in capital for previously unrecognized share-based compensation expense as a result of applying this policy election. The Company also recorded $0.8 million in additional share-based compensation expense during the fourth quarter of 2016 as a result of applying estimated forfeitures recorded during the nine m onths ended September 30, 2016. ASU 2016-09 also requires the recognition of the income tax effects of awards in the consolidated statement of operations when the awards vest or are settled, thus eliminating addition paid-in capital pools. The Company elected to adopt the amendments related to the presentation of excess tax benefits on the condensed consolidated statement of cash flows using a prospective transition method. Modification of Awards A change in any of the terms or conditions of the awards is accounted for as a modification of the award. Incremental compensation cost is measured as the excess, if any, of the fair value of the modified award over the fair value of the original award immediately before its terms are modified, measured based on the fair value of the awards and other pertinent factors at the modification date. For vested awards, the Company recognizes incremental compensation cost in the period the modification occurs. For unvested awards, if the award is probable of vesting both before and after the change, the Company recognizes the sum of the incremental compensation cost and the remaining unrecognized compensation cost for the original award on the modification date over the remaining requisite service period. If the fair value of the modified award is lower than the fair value of the original award immediately before modification, the minimum compensation cost the Company recognizes is the cost of the original award. Research and Development Innovation is critical to the success of the Company, and drug discovery and development are time ‑consuming, expensive and unpredictable. The Company has built a pipeline of therapeutic candidates in all stages of development. The focus is on serious diseases where there is a great need and opportunity for innovative medicines. Product candidates and development strategies contemplate both immediate possibilities in medicine, such as reducing toxicity or addressing certain disease resistance and mutation, and future possibilities and medical needs. Included in research and development expense are personnel related costs, expenditures for laboratory equipment and consumables, payments made pursuant to licensing and acquisition agreements, and the cost of conducting clinical trials. Expenses incurred associated with conducting clinical trials include, but are not limited to, dosing of patients with clinical drug candidates, assistance from third party consultants and other industry experts, accumulation and interpretation of data on drug safety and efficacy, and manufacturing of active pharmaceutical ingredients and placebos for use within the clinical trial. The Company has entered into agreements with third parties to acquire technologies and pharmaceutical product candidates for development (Note 12). Such agreements generally require an initial payment by the Company when the contract is executed, and additional payments upon the achievement of certain milestones. Additionally, the Company may be obligated to make future royalty payments in the event the Company commercializes the pharmaceutical product candidate and achieves a certain sales volume. In accordance with FASB ASC Topic 730 ‑10 ‑55, “Research and Development”, expenditures for research and development, including upfront licensing fees and milestone payments associated with products that have not yet been approved by the FDA, are charged to research and development expense as incurred. Future contract milestone payments will be recognized as expense when achievement of the milestone is determined to be probable. Once a product candidate receives regulatory approval, subsequent license payments are recorded as an intangible asset. Research and development expense was $40.8 million, $35.8 million and $33.6 million during the years ended December 31, 2017, 2016 and 2015 , respectively. Income Taxes The Company accounts for income taxes in accordance with the asset and liability method of accounting for income taxes prescribed by FASB ASC Topic 740, “Accounting for Income Taxes” (“ASC 740”). Under the asset and liability method of ASC 740, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to the taxable income in the years in which those temporary differences are expected to be recovered or settled. Under ASC 740, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment dates. The Company follows FASB ASC Topic 740 ‑10, “Accounting for Uncertainty in Income Taxes”, which prescribes a recognition threshold and measurement attribute for financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. At December 31, 2017 and 2016 , the Company had no material uncertain tax positions to be accounted for in the financial statements. The Company recognizes interest and penalties, if any, related to unrecognized tax benefits in interest expense. Under ASU 2016-09, all excess tax benefits and tax deficiencies (including tax benefits of dividends on share-based payment awards) should be recognized as income tax expense or benefit in the statement of operations. The tax effects of exercised or vested awards should be treated as discrete items in the reporting period in which they occur. An entity also should recognize excess tax benefits regardless of whether the benefits reduce tax payable in the current period. The Company made an early adoption on the ASU 2016-09 effect in the fourth quarter of 2016. There was no cumulative impact as the federal and state excess deductions would be offset by a corresponding change to the valuation allowance. Cash and Cash Equivalents Cash and cash equivalents are comprised of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase. At times, cash balances deposited at major financial banking institutions exceed the federally insured limit. The Company regularly monitors the financial condition of the institutions in which it has depository accounts and believes the risk of loss is minimal. Restricted Cash The Company has a lease agreement for the premises it occupies in New York. A secured letter of credit in lieu of a lease deposit totaling $2.0 million is secured by restricted cash in the same amount at December 31, 2017 and 2016 . The secured letter of credit will remain in place for the life of the related lease, expiring in October 2024 (Note 16). The Company also has a lease agreement for the premises it occupies in Massachusetts. A secured letter of credit in lieu of a lease deposit totaling $91,000 was established during the third quarter of 2015 and is secured by restricted cash in the same amount at December 31, 2017 and 2016 . The secured letter of credit will remain in place for the life of the related lease, expiring in April 2023 (Note 16). Allowance for Doubtful Accounts The Company reviews the collectability of accounts receivable based on an assessment of historical experience, current economic conditions, and other collection indicators. The Company has recorded an allowance for doubtful accounts of $0.7 million at both December 31, 2017 and 2016 . Adjustments to the allowance for doubtful accounts are recorded to selling, general and administrative expenses, and amounted to $3,000 , $6,000 , and $5,000 for the years ended December 31, 2017, 2016 and 2015 , respectively. When accounts are determined to be uncollectible they are written off against the reserve balance and the reserve is reassessed. When payments are received on reserved accounts they are applied to the customer’s account and the reserve is reassessed. Inventories Inventories are stated at the lower of cost or market (on a first ‑in, first ‑out basis) using standard costs. Standard costs include an allocation of overhead rates, which include those costs attributable to managing the supply chain and are evaluated regularly. Variances are expensed as incurred. Investments The Company follows FASB ASC Topic 323, “Investments—Equity Method and Joint Ventures” (“ASC 323”), in accounting for its investment in a joint venture. In the event the Company’s share of the joint venture’s net losses reduces the Company’s investment to zero, the Company will discontinue applying the equity method and will not provide for additional losses unless the Company has guaranteed obligations of the joint venture or is otherwise committed to provide further financial support for the joint venture. If the joint venture subsequently reports net income, the Company will resume applying the equity method only after its share of that net income equals the share of net losses not recognized during the period the equity method was suspended. The Company follows FASB ASC Topic 325, “Investments—Other” (“ASC 325”), in accounting for its investment in the stock of another company. In the event further contributions or additional shares are purchased, the Company will increase the basis in the investment. In the event distributions are made or indications exist that the fair value of the investment has decreased below the carrying amount, the Company will decrease the value of the investment as considered appropriate. The Company’s total investment balance totaled $3.5 million and $11.1 million at December 31, 2017 and 2016 , respectively. For all non ‑consolidated investments, the Company will continually assess the applicability of FASB ASC Topic 810, “Consolidation” (“ASC 810”), to determine if the investments qualify for consolidation. At December 31, 2017 and 2016 , no such investments qualified for consolidation (Note 12). Fixed Assets Fixed assets are recorded at cost and depreciated over their estimated useful lives. Leasehold improvements are amortized over the shorter of their estimated useful lives or the lease term, using the straight ‑line method. Construction ‑in ‑progress and software under development are stated at cost and not depreciated. These items are transferred to fixed assets when the assets are placed into service. Intangible Assets Intangible assets are stated at cost, less accumulated amortization. The Company accounts for the purchases of intangible assets in accordance with FASB ASC Topic 350 “Intangibles—Goodwill and Other”. Intangible assets are recognized based on their acquisition cost. The assets will be tested for impairment at least once annually, if determined to have an indefinite life, or whenever events or changes in circumstances indicate that the carrying amount may no longer be recoverable. If any of the Company’s intangible or long ‑lived assets are considered to be impaired, the amount of impairment to be recognized is the excess of the carrying amount of the assets over its fair value. Applicable long ‑lived assets, including intangible assets with definitive lives, are amortized or depreciated over the shorter of their estimated useful lives, the estimated period that the assets will generate revenue, or the statutory or contractual term in the case of patents. Estimates of useful lives and periods of expected revenue generation are reviewed periodically for appropriateness and are based upon management’s judgment. Goodwill The Company’s goodwill relates to the 2010 acquisition of Kadmon Pharmaceuticals, a Pennsylvania limited liability company that was formed in April 2000. Goodwill is not amortized, but rather is assessed for impairment annually or upon the occurrence of an event that indicates impairment may have occurred, in accordance with FASB ASC Topic 350 “Intangibles—Goodwill and Other”. No impairment to goodwill was recorded during the years ended December 31, 2017, 2016 and 2015 . Impairment of Long ‑Lived Assets Long ‑lived assets, such as intangible assets (other than goodwill) and fixed assets, are evaluated for impairment periodically, or when events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. When any such impairment exists, a charge is recorded in the statement of operations to adjust the carrying value of the related assets. The Company performed a trigger analysis over all other long ‑lived assets at the lowest identifiable level of cash flows and determined that an impairment existed during the year ended December 31, 2015 (Note 11) and no impairment triggers existed during the years ended December 31, 2017 and 2016 . An impairment of $31.3 million was recognized during the year ended December 31, 2015, while no such impairment was recognized during the years ended December 31, 2017 and 2016 (Note 11). Accounting for Leases The Company recognizes rent expense for operating leases as of the earlier of the possession date or the lease commencement date. Rental expense, inclusive of rent escalations, rent holidays, concessions and tenant allowances are recognized over the lease term on a straight ‑line basis. See Note 16 for a further discussion of operating leases. The Company has entered into capital lease agreements for information technology and laboratory equipment. Amortization expense for capital lease agreements is included in depreciation and amortization of fixed assets. As a result of these leases, the Company capitalized $208,000 , $230,000 and $20,000 as office equipment and furniture during the years ended December 31, 2017, 2016 and 2015 , respectively. The unamortized portion of capital leases totaled $270,000 and $191,000 at December 31, 2017 and 2016 , respectively. Accounting for Contingencies The Company follows the guidance of FASB ASC Topic 450, “Contingencies” (“ASC 450”), in accounting for contingencies. If some amount within a range of loss is probable and appears at the time to be a better estimate than any other amount within the range, that amount shall be expensed. If a loss is probable, and no amount within the range is a better estimate than any other amount, the estimated minimum amount in the range shall be expensed. Fair Value of Financial Instruments The Company follows the provisions of FASB ASC Topic 820, “Fair Value Measurements and Disclosures” (“ASC 820”). This pronouncement defines fair value, establishes a framework for measuring fair value under GAAP and requires expanded disclosures about fair value measurements. ASC 820 emphasizes that fair value is a market ‑based measurement, not an entity ‑specific measurement, and defines fair value as the price to sell an asset or transfer a liability in an orderly transaction between market participants at the measurement date. ASC 820 discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow) and the cost approach (cost to replace the service capacity of an asset or replacement cost). These valuation techniques are based upon observable and unobservable inputs. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect the Company’s market assumptions. ASC 820 utilizes a fair value hierarchy that prioritizes inputs to fair value measurement techniques into three broad levels. The following is a brief description of those three levels: · Level 1: Observable inputs such as quoted prices for identical assets or liabilities in active markets. · Level 2: Observable inputs other than quoted prices that are directly or indirectly observable for the asset or liability, including quoted prices for similar assets or liabilities in active markets; quoted prices for similar or identical assets or liabilities in markets that are not active; and model ‑derived valuations whose inputs are observable or whose significant value drivers are observable. · Level 3: Unobservable inputs that reflect the reporting entity’s own assumptions. The fair value of cash and cash equivalents, accounts receivable and accounts payable approximate their carrying amounts due to their short term nature ( Note 8 ). Loan Modifications and Extinguishments The Company follows the provisions of FASB ASC Subtopic 470 ‑50 “Debt Modifications and Extinguishments” (“ASC 470 ‑60”) and ASC Subtopic 470 ‑60, “Troubled Debt Restructurings by Debtors” (“ASC 470 ‑60”). Under ASC 470 ‑50, an exchange of debt instruments between or a modification of a debt instrument by a debtor and a creditor in a nontroubled debt situation is deemed to have been accomplished with debt instruments that are substantially different if the present value of the cash flows under the terms of the new debt instrument is at least 10 percent different from the present value of the remaining cash flows under the terms of the original instrument. If the terms of a debt instrument are changed or modified and the cash flow effect on a present value basis is less than 10 percent, the debt instruments are not considered to be substantially different, except in the following two circumstances: · A modification or an exchange affects the terms of an embedded conversion option, from which the change in the fair value of the embedded conversion option (calculated as the difference between the fair value of the embedded conversion option immediately before and after the modification or exchange) is at least 10 percent of the carrying amount of the original debt instrument immediately before the modification or exchange. · A modification or an exchange of debt instruments adds a substantive conversion option or eliminates a conversion option that was substantive at the date of the modification or exchange. Under ASC 470 ‑60, a restructuring of a debt constitutes a troubled debt restructuring for purposes of this Subtopic if the creditor for economic or legal reasons related to the debtor’s financial difficulties grants a concession to the debtor that it would not otherwise consider. Warrants and Derivative Liabilities The Company accounts for its derivative financial instruments in accordance with FASB ASC Topic 815, “Derivatives and Hedging” (“ASC 815”). The Company does not have derivative financial instruments that are hedges. ASC 815 establishes accounting and reporting standards requiring that derivative instruments, both freestanding and embedded in other contracts, be recorded on the balance sheet as either an asset or liability measured at its fair value each reporting period. ASC 815 also requires that changes in the fair value of derivative instruments be recognized currently in the results of operations unless specific criteria are met. For embedded features that are not clearly and closely related to the host instrument, are not carried at fair value, and are derivatives, the feature will be bifurcated and recorded as an asset or liability as noted above, unless the exceptions below are not met. Freestanding instruments that do not meet these exceptions will be accounted for in the same manner. ASC 815 provides an exception—if an embedded derivative or freestanding instrument is both indexed to the company’s own units and classified in members’ units, it can be accounted for in members’ unit. If at least one of the criteria is not met, the embedded derivative or warrant is classified as an asset or liability and recorded to fair value each reporting period through the income statement. The Company assesses classification of our warrants, other freestanding derivatives, and embedded features at each reporting date to determine whether a change in classification is required. The Company’s accounting for its embedded features, the warrants and the success fee, are explained further in Note 8. Recent Accounting Pronouncements In May 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-09, Compensation – Stock Compensation , which clarifies the guidance about which changes to the terms and conditions of a share-based payments award require an entity to apply modification accounting in Topic 718. This ASU is effective for annual or any interim periods beginning after December 15, 2017. Early adoption is permitted, including adoption in any interim period. The Company does not expect the standard to have a significant impact on its consolidated financial statements as the fair value of the Company’s modified awards is immaterial . In January 2017, the FASB issued ASU No. 2017-04, Intangibles – Goodwill and Other (“ASU 2017-04”), which simplifies the subsequent measurement of goodwill by eliminating “Step 2” from the goodwill impairment test. Instead of performing Step 2 to determine the amount of an impairment charge, the fair value of a reporting unit will be compared with its carrying amount and an impairment charge will be recognized for the value by whic |
Stockholders_ Equity (Deficit)
Stockholders’ Equity (Deficit) | 12 Months Ended |
Dec. 31, 2017 | |
Stockholders’ Equity (Deficit) [Abstract] | |
Stockholders’ Equity (Deficit) | 4. Stockholders’ Equity (Defic it ) Conversion Event The Class B, C and D units were required to automatically convert into Class A units pursuant to the Company’s Second Amended and Restated Limited Liability Company Operating Agreement, as amended (the “Operating Agreement”) upon certain defined conversion events including, but not limited to, dissolution of the Company or an underwritten IPO of the Company’s equity (each, a “Conversion Event”). The Conversion Event occurred on August 1, 2016, upon consummation of the Company’s IPO. The valuation of the Company at the Conversion Event was greater than $45.8 million, which resulted in the Class B and C units receiving $41.7 million of the proceeds of the Conversion Event in the form of equivalent Class A units. The Class D units converted into Class A units such that the holders thereof received $4.2 million of such proceeds. The proceeds in excess of $45.8 million were shared ratably by the other holders of Class A units. Class A Units Class A units represent ed the Company’s common stock equivalents. At December 31, 2016 , Kadmon I, LLC (“Kadmon I”) held approximately 12.1% of the total outstanding common stock of the Company. Kadmon I was a Delaware limited liability company that was formed in August 2009 and was an affiliate of the Company (Note 19). Kadmon I’s funds were raised through a private offering of 80% of Kadmon I’s total membership interests, the other 20% being owned by certain other members, including members of the Company’s board of directors and an executive officer at the time of such offering. Once each Kadmon I investor has received aggregate distributions equal to four times the amount of their initial investment, their collective ownership percentage in additional distributions would have decreased from 80% to 50% , and the collective ownership percentage for the members of the Company’s board of directors, an executive officer and members in Kadmon I, and certain other members who received units would have increased from 20% to 50% . The change in ownership percentages would have required the Company to evaluate whether such changes would result in additional compensation expense. Kadmon I investors had never received any distributions. Accordingly, no additional compensation expense was recognized. On January 23, 2017, Kadmon I, LLC was dissolved and liquidated. Upon dissolution and liquidation, all assets of Kadmon I, LLC which consists solely of the shares of common stock in Kadmon Holdings, Inc., were distributed to the members of Kadmon I, LLC. During the year ended December 31, 2016 , the Company issued 25,000 Class A units to settle third party obligations, for which the Company expensed $0.1 million related to these settlements during the year ended December 31, 2016 and issued 7,200 Class A units as the result of stock option exercises. The Company also recorded an expense of $3.0 million during the year ended December 31, 2016 related to the 1,500,000 Class A units issued in an advisory agreement entered into in April 2015. The Class A units converted into common stock at the Conversion Event resulting in no Class A units outstanding at December 31, 2017 . Class B Unit The Class B unit did not participate in distributions from the Company, did not have any preferences in relation to the Class A units, was non ‑voting, and was non ‑redeemable. The only right afforded to the Class B unit was the right to convert into Class A units pursuant to the Company’s Operating Agreement (see “Conversion Event”). The Class B unit converted into common stock at the Conversion Event resulting in no Class B units outstanding at December 31, 2017 . Class C Unit The Class C unit did not participate in distributions from the Company, does not have any preferences in relation to the Class A units, is non ‑voting, and is non ‑redeemable. The only right afforded to the Class C unit was the right to convert into Class A units pursuant to the Operating Agreement (see “Conversion Event”). The Class C unit converted into common stock at the Conversion Event resulting in no Class C units outstanding at December 31, 2017 . Class D Units The Class D units did not participate in distributions from the Company, did not have any preferences in relation to the Class A units, were non ‑voting, and were non ‑redeemable. The only right afforded to the Class D unit was the right to convert into Class A units pursuant to the Company’s Operating Agreement (see “Conversion Event”). The Class D units converted into common stock at the Conversion Event resulting in no Class D units outstanding at December 31, 2017 . Class E Redeemable Convertible Units One series of Class E redeemable convertible units, the Class E Series E ‑1 units (the “Class E redeemable convertible units”), was authorized. The Company was able to issue Class E redeemable convertible units with an aggregate Class E original issue price of up to $85 million, calculated in accordance with the terms of the Operating Agreement, of any series without being subject to preemptive rights. The Class E redeemable convertible units had voting rights and powers equal to the Class A units on an as ‑if converted basis, had a liquidation preference for liquidating distributions and participated in distributions from the Company on an as ‑converted basis on non ‑liquidating distributions. In the case of a qualified IPO, the Class E redeemable convertible units automatically converted into Class A units at a conversion price of the lower of 85% of the value of Class A units (or the price per share of common stock of the corporate successor to the Company) or $11.50 per unit. Prior to a qualified IPO, the Class E redeemable convertible units could be converted at $11.50 per unit. A qualified IPO was defined as an offering of the Company’s equity interests with gross proceeds to the Company of at least $75 million. At any time after December 31, 2017, Class E redeemable convertible units were redeemable for cash at the option of the holders of at least 80% of all Class E redeemable convertible units at a redemption price equal to 125% of the liquidation preference. After January 1, 2016 all Class E redeemable convertible units began to accrue a liquidation preference (payable in connection with such liquidating distribution from the Company) at a rate of 5% per annum, compounding annually, with such liquidation preference rate increasing by 100 basis points every six months to a maximum of 10% . Redemption was subject to the Company’s ability to make such payment under then ‑existing debt obligations. Based on the terms of the Class E redeemable convertible units, the fair value of the Class E redeemable convertible units issued was classified as mezzanine capital on the Company’s consolidated balance sheet. The Company accreted changes in the redemption value of the Class E redeemable convertible units to paid ‑in capital using the interest method, as the Company did not have available retained earnings, from the date of issuance to the earliest redemption date. During the year ended December 31, 2016 , the Company raised $5.5 million in gross proceeds, with no transaction costs, through the issuance of 478,266 Class E redeemable convertible units. Dr. Harlan W. Waksal, the Company’s President and Chief Executive Officer, certain entities affiliated with GoldenTree Asset Management LP, Bart M. Schwartz, Esq., the Company’s Chairman of the board of directors, and D. Dixon Boardman, a member of the Company’s board of directors subscribed for 86,957 , 43,479 , 21,740 and 21,740 Class E redeemable convertible units, respectively. The Company calculated a deemed dividend on the Class E redeemable convertible units of $13.4 million in August 2016, which equals a 15% discount to the IPO price of the Company’s common stock of $12.00 per share upon conversion to common stock at the Conversion Event, a beneficial conversion feature. The Class E redeemable convertible units converted into common stock at the Conversion Event resulting in no Class E redeemable convertible units outstanding at December 31, 2017 . 5% Convertible Preferred Stock Our certificate of incorporation permitted the Company’s board of directors to issue up to 10,000,000 shares of preferred stock from time to time in one or more classes or series. Concurrently with the closing of the Company’s IPO and pursuant to the terms of the exchange agreement entered into with the holders of the Company’s Senior Convertible Term Loan, the Company issued to such holders 30,000 shares of 5% convertible preferred stock, designated as the convertible preferred stock. Each share of convertible preferred stock was issued for an amount equal to $1,000 per share, which is referred to as the original purchase price. Shares of convertible preferred stock with an aggregate original purchase price and initial liquidation preference of $30.0 million were issued to the holders of the Senior Convertible Term Loan in exchange for an equivalent principal amount of the Senior Convertible Term Loan pursuant to the terms of an exchange agreement dated as of June 8, 2016, between the Company and those holders, which is referred to as the exchange agreement. The shares of 5% convertible preferred stock are entitled to receive dividends, when and as declared by the board of directors and to the extent of funds legally available for the payment of dividends, at an annual rate of 5% of the sum of the original purchase price per share of 5% convertible preferred stock plus any dividend arrearages. Dividends on the 5% convertible preferred stock shall, at the Company’s option, either be paid in cash or added to the stated liquidation preference amount for purposes of calculating dividends at the 5% annual rate (until such time as the Company declares and pays the missed dividend in full and in cash, at which time that dividend will no longer be part of the stated liquidation preference amount). Dividends shall be payable annually on June 30 of each year and shall be cumulative from the most recent dividend payment date on which the dividend has been paid or, if no dividend has ever been paid, from the original date of issuance of the 5% convertible preferred stock and shall accumulate from day to day whether or not declared until paid. The 5% convertible preferred stock converts into shares of the Company’s common stock at a 20% discount to the price per share of common stock in the IPO. T he Company calculated a deemed dividend on the 5% convertible preferred stock of $7.5 million in August 2016, which equals the 20% discount to the IPO price of the Company’s common stock of $12.00 per share, a beneficial conversion feature. The 5% convertible preferred stock, inclusive of accrued and unpaid dividends, is convertible into 3,351,717 and 3,191,843 shares of common stock at December 31, 2017 and 2016 , respectively. T he Company accrued dividends on the 5% convertible preferred stock of $1.5 m illion and $0.6 million for the years ended December 31, 2017 and 2016 , respectively . T he Company also calculated a deemed dividend of $0.4 million on the $1.5 million of accrued dividends for the year ended December 31, 2017 and $0.2 million on the $0.6 million of accrued dividends for the year ended December 31, 2016 , which equals the 20% discount to the IPO price of the Company’s common stock of $12.00 per share , a beneficial conversion feature . Approximately $1.4 million of accrued dividends that were payable on June 30, 2017 was added to the stated liquidation preference amount of the 5% convertible preferred stock. The stated liquidation preference amount on the 5% convertible preferred stock totaled $31.4 million at December 31, 2017 . Common Stock Prior to the IPO, there were no shares outstanding of the Company’s common stock, par value $0.001 per share, and no stockholders of record. The Company’s certificate of incorporation authorizes the issuance of up to 200,000,000 shares of the Company’s common stock. On August 1, 2016, the Company completed its IPO whereby it sold 6,250,000 shares of common stock at $12.00 per share. The aggregate net proceeds received by the Company from the offering were $66.0 million, net of underwriting discounts and commissions of $5.3 million and offering expenses of $3.7 million. At December 31, 2017 , 78,643,954 shares o f common stock were outstanding . During the year ended December 31, 2017 , the Company raised $80.4 million in gross proceeds, $75.1 million net of $ 5.3 million in underwriting fees , commissions and other offering costs and expenses , from the issuance of 26,775,000 shares of common stock and warrants to purchase 10,710,000 shares of common stock at an initial exercise price of $3.35 per share for a term of 5 years from the date of issuance at a combined price of $3.001 per share and accompanying warrant. The Company allocated $5 7.6 million to the common stock which was recorded as common stock and additional paid in capital and allocated $2 2.8 million to the warrants which was recorded to additional paid in capital. The Company also raised $22.7 million in gross proceeds, $ 20.9 million net of $1.8 million in placement agent fees and other offering costs and expenses , from the issuance of 6,767,855 shares of common stock, at a price of $3.36 per share, and warrants to purchase 2,707,138 shares of common stock at an initial exercise price of $4.50 per share for a term of 13 months from the date of issuance. In connection with the 2017 Private Placement, the Company agreed to file a registration statement to register the shares of common stock and the shares of common stock underlying the warrants for resale. Under the agreement, the registration statement had to be filed within 30 days of the closing of the financing and declared effective within the timeline provided in the agreement. If the applicable deadlines were not met, monthly liquidated damages of 2.0% of the subscription amount (with an 8.0% cap) were due to the purchaser. The registration statement was filed on April 10, 2017 and declared effective on April 21, 2017. Valuation Prior to the IPO, to estimate certain expenses and record certain transactions, it was necessary for the Company to estimate the fair value of its membership units. Given the absence of a public trading market, and in accordance with the American Institute of Certified Public Accountants’ Practice Guide, “Valuation of Privately ‑Held ‑Company Equity Securities Issued as Compensation,” the Company exercised reasonable judgment and considered numerous objective and subjective factors to determine its best estimate of the fair value of its membership units. Factors considered included: · recent equity financings and the related valuations; · the estimated present value of the Company’s future cash flows; · industry information such as market size and growth; · market capitalization of comparable companies and the estimated value of transactions such companies have engaged in; and · macroeconomic conditions. The Company updated the valuation of Class A units as of September 30, 2015 using a methodology consistent with prior valuations. At the time of the valuation, the Company had issued $92.0 million in second ‑lien convertible debt, and it was deemed appropriate to place additional weighting on this consideration, as compared to prior valuations. The Company also considered equity raised through the issuance of $15.0 million in Class A units during 2015. The Company assigned no value to the Ribasphere products to reflect changes in market conditions that have resulted in lower sales of the Ribasphere products. As a result of the revised inputs to the analysis, the estimated fair value of each Class A unit was decreased from $39.00 to $32.50 as of September 30, 2015. |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 12 Months Ended |
Dec. 31, 2017 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |
Net Loss per Share Attributable to Common Stockholders | 5. Net Loss per Share Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock outstanding for the period. Because the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods. The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company ( in thousands, except share and per share amounts): Years Ended December 31, 2017 2016 2015 Numerator – basic and diluted: Net loss attributable to common stockholders $ (81,692) $ (230,488) $ (147,082) Denominator – basic and diluted: Weighted average common stock outstanding used to compute basic and diluted net loss per share 57,405,331 23,674,512 8,127,781 Net loss per share, basic and diluted $ (1.42) $ (9.74) $ (18.10) The amounts in the table below were excluded from the calculation of diluted net loss per share, due to their anti-dilutive effect: Years Ended December 31, 2017 2016 2015 Convertible preferred stock 3,351,717 3,191,843 3,191,843 Options to purchase common stock 8,496,872 6,437,515 1,685,248 Warrants to purchase common stock 14,699,990 1,328,452 1,328,452 Total shares of common stock equivalents 26,548,579 10,957,810 6,205,543 |
Commercial Partnership
Commercial Partnership | 12 Months Ended |
Dec. 31, 2017 | |
Commercial Partnership [Abstract] | |
Commercial Partnership | 6. Commercial Partnership On June 17, 2013, the Company entered into a series of agreements with a commercial partner AbbVie Inc. (“AbbVie”), related to our ribavirin products. Pursuant to an asset purchase agreement, as amended, we sold marketing authorizations and related assets for ribavirin in certain countries outside the United States . The Company received upfront payments totaling $64.0 million, and could receive additional contingent payments totaling $51.0 million based on the achievement of certain milestones. The Company did no t ear n any such milestones during the years ended December 31, 2017, 2016 and 2015 . Of the $64.0 million upfront payment, $44.0 million was considered allocable to the domestic licensing arrangement and was recorded as deferred revenue to be recognized over the 10 year term of the agreement. The Company will recognize the upfront payment to revenue on a straight ‑line basis over the life of the agreement. The Company recognized $4.4 million of the upfront consideration as license revenue during each of the years ended December 31, 2017, 2016 and 2015 . At December 31, 2017 and 2016 , $24.0 million and $28.4 million were recorded as deferred revenue, respectively, of which $4.4 million was short ‑term. In October 2014, the Company entered into a series of amendments with AbbVie whereby the parties agreed to eliminate all potential future unearned and unpaid milestones and also agreed to a revised royalty structure for the sale of ribavirin products under the domestic license agreement. The Company received upfront payments of $6.0 million in consideration of future royalties payable resulting from the resale of certain ribavirin products by AbbVie during 2015 and 2016. At the time of receipt the balance was recorded to deferred revenue, $3.0 million of which was recorded as short ‑term as it related to prepaid royalties for 2015 and $3.0 million of which was recorded as long ‑term as it related to prepaid royalties for 2016. The Company will recognize portions of the deferred revenue to income as ribavirin is sold by AbbVie. The Company is entitled to receive additional compensation from AbbVie for any royalties earned in excess of the annual prepayment. If royalties earned do not exceed the annual prepayment, the Company is required to refund the excess to AbbVie. Since the royalties earned from the resale of ribavirin products by AbbVie under the domestic license agreement did not exceed the $3.0 million annual prepayment in 2015, the Company refunded approximately $2.1 million of the prepaid royalty to AbbVie as a credit against future purchases during the year ended December 31, 2016 . The Company had recorded this amount as an accrued expense at December 31, 2015. Furthermore, the Company was required to refund approximately $2.9 million of the prepaid royalty to AbbVie resulting from the resale of ribavirin products by AbbVie during 2016. The Company settled approximately $2.9 million and $0.7 million of the prepaid royalty refund as of December 31, 2017 and 2016 , respectively, and therefore has no refunds of prepaid royalties due to Abbvie at December 31, 2017 . The Company had recorded an accrued expense of $2.2 million at December 31, 2016 . The Company has a continuing obligation to supply ribavirin products, maintain the marketing authorizations for certain ribavirin products and maintain the intellectual property for Ribasphere and RibaPak through the term of the agreements ending December 31, 2020. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2017 | |
Debt [Abstract] | |
Debt | 7. Debt Concurrent with the closing of the IPO on August 1, 2016, the Company’s Senior Convertible Term Loan and Second Lien Convert converted into 19,034,467 shares of common stock. The Company is a party to one credit agreement in the following amount (in thousands): December 31, 2017 2016 Secured term debt due June 17, 2018 34,620 34,620 Total debt before fees and debt discount/premium 34,620 34,620 Less: Deferred financing costs (228) (737) Debt discount (1,030) (3,306) Add: Debt premium 345 — Total debt payable $ 33,707 $ 30,577 Debt payable, current portion $ 33,707 $ 1,900 Debt payable, long-term $ — $ 28,677 Secured Term Debt August 2015 Secured Term Debt In August 2015, the Company entered into a secured term loan in the amount of $35.0 million with two lenders (“2015 Credit Agreement”). The interest rate on the loan is LIBOR plus 9.375% with a 1% floor. The Company incurred and paid a $788,000 commitment fee in connection with the loan that will be amortized to interest expense over the term of the agreement. The basic terms of the loan required monthly payments of interest only through the first anniversary date of the loan and require the Company to maintain certain financial covenants requiring the Company to maintain a minimum liquidity amount and minimum revenue levels beginning after June 30, 2016 through August 1, 2016, the date the Company consummated its IPO. Beginning on the first anniversary date of the loan, the Company is required to make monthly principal payments in the amount of $380,000 . Any outstanding balance of the loan and accrued interest is to be repaid on June 17, 2018 . The secured term loan is collateralized by a first priority perfected security interest in all the tangible and intangible property of the Company. In conjunction with the 2015 Credit Agreement, warrants to purchase $6.3 million of Class A units were issued to two lenders, of which $5.4 million was recorded as a debt discount and $ 0.9 million was recorded as loss on extinguishment of debt (Note 8). The debt discount is being amortized over the life of the outstanding term loan using the effective interest method. Deferred financing costs of $1.3 million were recognized in recording the 2015 Credit Agreement and will be amortized to interest expense over the three year term of the agreement. Additionally, a fee paid to one existing lender of $113,000 was charged to loss on extinguishment of debt in accordance with ASC 470. There was also $1.5 million of debt discount and $390,000 of deferred financing cost write ‑offs charged to loss on extinguishment of debt in accordance with ASC 470 in connection with this transaction. Unamortized deferred financing costs were $0.2 million and $0.7 million at December 31, 2017 and 2016 , respectively. Approximately $0.5 million , $0.4 million and $0.4 million were charged to interest expense during the years ended December 31, 2017, 2016 and 2015 , respectively. The Company entered into a third waiver agreement to the 2015 Credit Agreement in September 2016 to negotiate the amendment and restatement of certain covenants of the Company contained in the 2015 Credit Agreement. In connection with such negotiation, the lenders under the 2015 Credit Agreement had agreed to refrain from exercising certain rights under the 2015 Credit Agreement, including the declaration of a default and to forbear from acceleration of any repayment rights with respect to existing covenants until the parties have consummated the amendment and restatement of such provisions. In addition, certain payments required to be made under the 2015 Credit Agreement had been deferred while the parties negotiated the amendment. The parties executed a second amendment to the 2015 Credit Agreement in November 2016 whereby the Company deferred further principal payments owed under the 2015 Credit Agreement in the amount of $380,000 per month until August 31, 2017. Additionally, the parties amended various clinical development milestones and added a covenant pursuant to which the Company was required to raise $40.0 million of additional equity capital by the end of the second quarter of 2017. All other material terms of the 2015 Credit Agreement, including the maturity date, remain the same. The Company entered into a fourth waiver agreement to the 2015 Credit Agreement in March 2017 under which the lenders under the 2015 Credit Agreement agreed to refrain from exercising certain rights under the 2015 Credit Agreement, including the declaration of a default and to forbear from acceleration of any repayment rights with respect to existing covenants. The report and opinion of the Company’s independent registered public accounting firm, BDO USA, LLP, contain ed an explanatory paragraph regarding the Company’s ability to continue as a going concern, which was an event of default under the 2015 Credit Agreement. On March 31, 2017, the Company entered into the Third Amendment. Pursuant to this amendment, principal payments owed under the 2015 Credit Agreement, in the amount of $380,000 per month, were deferred until January 31, 2018. Additionally, the parties amended a future capital raising covenant by extending the time period by which the Company was required to raise the remaining $17.0 million of capital by six months, from June 30, 2017 to December 31, 2017, which was satisfied in September 2017. All other material terms of the 2015 Credit Agreement, including the maturity date, remain the same. The clinical development milestone was deemed satisfied in a letter agreement entered into on December 22, 2017 with a majority of lenders under our 2015 Credit Agreement. As of the date hereof, the Company is not in default under the terms of the 2015 Credit Agreement. The Third Amendment also amended certain terms of the warrants to purchase an aggregate of 617,651 shares of the Company’s common stock issued in connection with the 2015 Credit Agreement (the “2015 Warrants”). Pursuant to the Third Amendment, the warrants may now only be exercised for cash and the exercise price was reduced from $10.20 per share to $4.50 per share. The redemption feature in the 2015 Warrants was also amended such that the warrant holder may only demand a redemption of the 2015 Warrants upon the occurrence of, and during the continuance of, an event of default. Prior to this amendment, the warrant could be redeemed by the warrant holder at any time after the 51 st month. As amended, if these warrants are exercised, the Company will receive approximately $2.8 million in proceeds in the aggregate. As a result of the Third Amendment, $0.9 million was recorded as a debt premium at March 31, 2017, inclusive of the fair value of the warrant modification utilizing a Black-Scholes calculation, and will be amortized to interest expense over the remaining term of the agreement as the amendment was deemed to be a modification in accordance with ASC 470 (Note 8). Approximately $0.6 million was recorded to interest expense during the year ended December 31, 2017 . The Company entered into a fifth waiver agreement to the 2015 Credit Agreement in March 2018 under which the lenders under the 2015 Credit Agreement agreed to refrain from exercising certain rights under the 2015 Credit Agreement, including the declaration of a default and to forbear from acceleration of any repayment rights with respect to existing covenants. The report and opinion of the Company’s independent registered public accounting firm, BDO USA, LLP, contains an explanatory paragraph regarding the Company’s ability to continue as a going concern, which is an event of default under the 2015 Credit Agreement. The minimum payments required on the outstanding balances of the 2015 Credit Agreement at December 31, 2017 are (in thousands): 2015 Credit Agreement 2018 $ 34,620 $ 34,620 The following table provides components of interest expense and other related financing costs (in thousands): Years Ended December 31, 2017 2016 2015 Interest expense and other financing costs $ 3,720 $ 3,782 $ 7,817 Interest expense - beneficial conversion feature — 45,915 — Interest paid-in kind — 14,695 11,434 Write-off of deferred financing costs and debt discount — 3,820 2,752 Amortization of deferred financing costs, debt discount and debt premium 2,242 4,422 5,157 Interest expense $ 5,962 $ 72,634 $ 27,160 |
Financial Instruments
Financial Instruments | 12 Months Ended |
Dec. 31, 2017 | |
Financial Instruments [Abstract] | |
Financial Instruments | 8. Financial Instruments Success Fee In October 2011, an executive officer and member of Kadmon Holdings, LLC issued an equity instrument for which the underlying value is based on 536,065 Class A units. The intrinsic value of the instrument is redeemable for cash upon certain defined liquidity or distribution events (“Success Fee”). Upon consummation of the Company’s IPO on August 1, 2016 with a price per share of $12.00 per share, the fair value of this equity instrument had a fair value of $0, which resulted in no Success Fee owed by the Company . As a result of marking to market this instrument, the Company recorded ($0.1) million and ($0.2) million to change in fair value of financial instruments for the years ended December 31, 2016 and 2015, respectively. As there were no quoted prices for identical or similar instruments prior to the IPO, the Company had utilized a Black ‑Scholes calculation to value this instrument at December 31, 2015, with the following assumptions: risk-free interest rate of 0.49% , expected term of 0.5 years, expected volatility of 79.2% , unit price of $32.50 . strike price of $74.17 and a dividend rate of 0% . Equity issued pursuant to Credit Agreements In connection with the incurrence of the Senior Convertible Term Loan, the Company issued three tranches of warrants as fees to the lenders that were redeemable for Class A units. The change in fair value of the warrants was ($0.2) million and ($1.3) million for the years ended December 31, 2016 and 2015 , respectively. Upon consummation of the Company’s IPO on August 1, 2016 with a price per share of common stock in the IPO of $12.00 , the warrants to purchase Class A units issued to lenders in the Senior Convertible Term Loan were exchanged for 351,992 warrants with a strike price of $10.20 per share to purchase the same number of shares of the Company’s common stock. Since the strike price was determined at IPO, the aggregate fair value of these warrants totaling $1.7 million was reclassified from liability to equity upon consummation of the Company’s IPO in August 2016 . At December 31, 2015 the Company utilized a binomial model to measure all three warrant tranches. Due to the uncertainty of the strike price of the warrants, the Company performed each calculation multiple times using a weighted number of units exercisable based on the Company’s best estimate of how many units would be issuable. The inputs used in the calculations to measure all three warrant tranches at December 31, 2015 are as follows: risk-free interest rate of 0.49% , expected term of 0.5 years, expected volatility of 79.2% , unit price of $32.50 . strike price of $61.75 and a dividend rate of 0% . In connection with the 2015 Credit Agreement, the Company issued warrants as fees to the lenders to purchase an aggregate of $6.3 million of the Company’s Class A units. The strike price of the warrants was 85% of the price per unit in an IPO or, if before an IPO, 85% of the deemed per unit equity value as defined in the 2015 Credit Agreement. The warrants were exercisable as of the earlier of an IPO or July 1, 2016. Prior to the Third Amendment, these warrants were redeemable at the option of the holder after the 51 st month from the issue date and were r e corded as a non-current liability of $3.3 million at December 31, 2016. Since these warrants are now redeemable at the option of the holder upon the occurrence of, and during the continuance of, an event of default , they are recorded as a liability of $1.2 million at December 31, 2017 . Upon entry into the agreement in August 2015, the warrants issued to an existing lender was recorded to loss on extinguishment of debt of $0.9 million and the warrants issued to the new lender was recorded as a debt discount of $5.4 million and will be amortized over the three year term (Note 7) in accordance with ASC 470. As a result of the Third Amendment, $0.9 million was recorded as a debt premium and will be amortized to interest expense over the remaining term of the agreement as the Third Amendment was deemed to be a modification in accordance with ASC 470 . The Company used the Black-Scholes pricing model to value the warrant liability at December 31, 2017 with the following assumptions: risk-free interest rate of 2.20% , expected term of 4.66 years, expected volatility of 74.9% and a dividend rate of 0% . Upon consummation of the Company’s IPO on August 1, 2016 with a price per share of common stock in the IPO of $12.00, the warrants to purchase Class A units issued to lenders under the 2015 Credit Agreement were exchanged for 617,651 warrants with a strike price of $10.20 per share to purchase the same number of shares of the Company’s common stock. The decline in fair value of the warrants was $(1.1) million and $(4.3) million for the years ended December 31, 2017 and 2016 , while there was no change in fair value of fin ancial instruments for the year ended December 31, 2015. None of these instruments have been exercised at December 31, 2017 or December 31, 2016 . At December 31, 2017 , the fair value of the warrant liability was approximately $1.2 million and is recorded as a short-term liability since the redemption feature of the warrant terminates upon the current maturity of the 2015 credit agreement on June 17, 2018. Other Warrants On April 16, 2013, the Company issued warrants with an estimated fair value of $1.4 million for the purchase of 30,000 Class A units at a strike price of $21.24 as consideration for fundraising efforts performed. Upon consummation of the Company’s IPO on August 1, 2016 and Corporate Conversion, these warrants to purchase Class A units were exchanged for 46,163 warrants to purchase the same number of shares of the Company’s common stock at a strike price of $138.06 . None of these warrants have been exercised at December 31, 2017 . In connection with the sale of common stock in March 2017, warrants to purchase 2,707,138 shares of common stock were issued at an exercise price of $4.50 per share. At December 31, 2017 , all of these warrants were outstanding. These warrants included a cash settlement option requiring the Company to record a liability for the fair value of the warrants at the time of issuance and at each reporting period with any change in the fair value reported as other income or expense. The Company used the Black-Scholes pricing model to value the warrant liability at December 31, 2017 with the following assumptions : risk-free interest rate of 1.39% , expected term of 0.27 years, expected volatility of 71.5% and a dividend rate of 0% . A t the time of issuance, approximately $1.6 million was recorded as warrant liability. The change in the fair value of these warrants was $(0.9) million for the year ended December 31, 2017 . At December 31, 2017 , the fair value of the warrant liability was approximately $0.7 million and is recorded as a short-term liability as the warrants expire in April 2018. In connection with the 2017 Public Offering, the Company issued warrants to purchase 10,710,000 shares of common stock at an initial exercise price of $3.35 per share for a term of 5 years from the date of issuance. As of December 31, 2017 , warrants to purchase 10,687,200 shares of common stock were outstanding. The Company assessed the warrants under FASB ASC 480 and determined that the warrants were outside the scope of ASC 480. The Company next assessed the warrants under FASB ASC 815. Under the related guidance, a reporting entity shall not consider a contract to be a derivative instrument if the contract is both (1) indexed to the entity’s own stock and (2) classified in stockholders’ equity. The Company determined that the warrants were indexed to the Company’s stock, as the agreements do not contain any exercise contingencies and the warrants’ settlement amount equals the difference between the fair value of the Company’s common stock price and the warrant strike price. The Company also assessed the classification in stockholders’ equity and determined the warrants met all of the criteria for classification as equity under ASC 815. Based on this analysis, the Company determined that the warrant should be classified as equity and recorded $22.8 million to additional paid in capital, which represents the allocation of the 2017 Public Offering proceeds to the fair value of the warrants at issuance date. Fair Value of Long ‑term Debt The Company had no long-term secured debt at December 31, 2017 and maintained a long ‑term secured term debt balance of $28.7 million at December 31, 2016 . Since the secured debt becomes due in June 2018, it has been recorded as short-term secured debt at December 31, 2017 . The underlying agreements for these balances were negotiated with parties that included fully independent third parties, at an interest rate which is considered to be in line with over-arching market conditions. Based on these factors management considers the carrying value of the debt to approximate fair value at December 31, 2017 . Fair Value Classification The Company held certain liabilities that are required to be measured at fair value on a recurring basis. Fair value guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: · Level 1—Quoted prices in active markets for identical assets or liabilities. · Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. · Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The table below represents the values of the Company’s financial instruments at December 31, 2017 and December 31, 2016 (in thousands): Fair Value Measurement Using: December 31, Significant Other Observable Inputs Significant Unobservable Inputs Description 2016 (Level 2) (Level 3) Warrants $ 3,305 $ 3,305 $ — Total $ 3,305 $ 3,305 $ — December 31, Significant Other Observable Inputs Significant Unobservable Inputs Description 2017 (Level 2) (Level 3) Warrants $ 1,952 $ 1,952 $ — Total $ 1,952 $ 1,952 $ — The table below represents a rollforward of the Level 2 and Level 3 financial instruments from January 1, 2015 to December 31, 2017 (in thousands). Significant Other Observable Inputs Significant Unobservable Inputs (Level 2) (Level 3) Balance as of January 1, 2016 $ — $ 8,289 Transfer of warrants from Level 3 to Level 2 6,300 (6,300) Change in fair value of financial instruments (4,107) (273) Beneficial conversion feature recognized on warrants issued in connection with 2015 credit agreement 1,112 — Reclassification of warrants to APIC in connection with IPO — (1,716) Balance as of December 31, 2016 $ 3,305 $ — Fair value of warrants modified in the Third Amendment (908) — Issuance of warrants in private placement 1,651 — Change in fair value of financial instruments (2,096) — Balance as of December 31, 2017 $ 1,952 $ — The Level 2 inputs used to value our financial instruments were determined using prices that can be directly observed or corroborated in active markets. In August 2016, the warrants issued in connection with the 2015 Credit Agreement were transferred from Level 3 to Level 2 as the Company’s securities began trading on the New York Stock Exchange. Although the fair value of this obligation is calculated using the observable market price of Kadmon Holdings Inc. common stock, an active market for this financial instrument does not exist and therefore the Company has classified the fair value of this liability as a Level 2 liability in the table above. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2017 | |
Inventories [Abstract] | |
Inventories | 9. Inventories Inventories are stated at the lower of cost or market (on a first ‑in, first ‑out basis) using standard costs. Standard costs include an allocation of overhead rates, which include those costs attributable to managing the supply chain and are evaluated regularly. Variances are expensed as incurred. The Company regularly reviews the expiration date of its inventories and maintains a reserve for inventories that are probable to expire before shipment. Inventories recorded on the Company’s consolidated balance sheets are net of a reserve for expirable inventory of $4.8 million and $4.9 million at December 31, 2017 and 2016 , respectively. The Company expensed Ribasphere inventory that it believes will not be sold prior to reaching its product expiration date totaling $1.7 million, $0.4 million and $2.3 million during the years ended December 31, 2017, 2016 and 2015 , respectively. If the amount and timing of future sales differ from management’s assumptions, adjustments to the estimated inventory reserves may be required. Inventories are comprised of the following (in thousands): December 31, December 31, 2017 2016 Raw materials $ — $ 1,153 Work-in-process 80 — Finished goods, net 121 797 Total inventories $ 201 $ 1,950 |
Fixed Assets
Fixed Assets | 12 Months Ended |
Dec. 31, 2017 | |
Fixed Assets [Abstract] | |
Fixed Assets | 10. Fixed Assets Fixed assets consisted of the following (in thousands): Useful Lives December 31, December 31, (Years) 2017 2016 Leasehold improvements 4 -8 $ 10,120 $ 10,274 Office equipment and furniture 3 -15 1,488 2,193 Machinery and laboratory equipment 3 -15 2,765 3,255 Software 1 -5 3,162 3,581 Construction-in-progress ̶̶̶̶ 408 44 17,943 19,347 Less accumulated depreciation and amortization (13,651) (13,920) Fixed assets, net $ 4,292 $ 5,427 Depreciation and amortization of fixed assets totaled $1.8 million, $2.3 million and $2.3 million in each of the years ended December 31, 2017, 2016 and 2015 , respectively. The construction ‑in ‑progress balance was related to costs of unimplemented software still under development. Unamortized computer software costs were $0.2 million and $0.8 million at December 31, 2017 and 2016 , respectively. The amortization of computer software costs amounted to $0.6 million, $0.7 million and $0.7 million during the years ended December 31, 2017, 2016 and 2015 , respectively. During the first quarter of 2017, the Company disposed of $2.1 million of fully depreciated assets. There was no consideration received for the disposal of these assets and the disposal did not have a significant impact on the consolidated financial statements of the Company. |
Goodwill and Other Intangible A
Goodwill and Other Intangible Assets | 12 Months Ended |
Dec. 31, 2017 | |
Goodwill and Other Intangible Assets [Abstract] | |
Goodwill and Other Intangible Assets | 11. Goodwill and Other Intangible Assets The changes in the carrying amount of goodwill and other amortizable intangible assets at December 31, 2017 and 2016 are as follows (in thousands): Balance as of December 31, 2015 Amortization Impairment Balance as of December 31, 2016 Remaining Useful Life as of December 31, 2016 Ribasphere product rights $ 15,223 $ (15,223) $ — $ — — Goodwill $ 3,580 $ — $ — $ 3,580 — Balance as of December 31, 2016 Amortization Impairment Balance as of December 31, 2017 Remaining Useful Life as of December 31, 2017 Ribasphere product rights $ — $ — $ — $ — — Goodwill $ 3,580 $ — $ — $ 3,580 — In September 2015, the Company reviewed the estimated useful life of the Ribasphere product rights and determined that the actual lives of the Ribasphere product rights intangible asset was shorter than the estimated useful lives used for amortization purposes in the Company’s financial statements due to the continued growth of competitor products that do not necessitate the use of Ribasphere as a complement in treating the hepatitis C infection. As a result, effective September 30, 2015, the Company changed its estimate of the useful life of its Ribasphere product rights intangible asset to 1.25 years to better reflect the estimated period during which the remaining asset will generate cash flows. The Company also determined that the carrying value of the Ribasphere product rights exceeded its fair value and recorded an impairment loss of $31.3 million in September 2015. In October 2015, the Company determined that the proportional performance method of amortization was more appropriate than straight-line amortization. The amortization of the Ribasphere product rights intangible asset based on the consumption of the economic benefit (Ribasphere gross profit), became a reliably determinable method of amortization due to the remaining asset useful life being only 1.25 years and the ability to more accurately forecast the Ribasphere market. Accordingly, Kadmon amortized the remaining book value of the intangible asset utilizing the proportional performance method starting October 1, 2015 and ending December 31, 2016. Amortization expense is included within selling, general and administrative expenses on the Company’s consolidated statements of operations. No amortization expense related to the intangible asset was recorded in the year ended December 31, 2017 , as the Ribasphere product rights intangible asset was fully amortized as of December 31, 2016. The Company recorded amortization expense rel ated to the intangible asset of $15.2 million and $27.4 million for the years ended December 31, 2016 and 2015 , respectively. The accumulated amortization of the intangible asset was $(140.7) million and at both December 31, 2017 and 2016 . |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2017 | |
License Agreements [Abstract] | |
License Agreements | 12. License Agreements Yale University On February 4, 2011, the Company entered into a license agreement with Yale University, whereby the Company obtained the worldwide exclusive license and right to make, use, sell, import and export PHY906, a development stage botanical compound, and the related technology. In April 2016, the Company entered into a mutual termination agreement with Yale University. All rights and licenses granted under the agreement were immediately terminated and reverted to the party granting such rights. Symphony Evolution, Inc. In August 2010, the Company entered into a license agreement with Symphony Evolution, Inc. (Symphony), under which Symphony granted to the Company an exclusive, worldwide, royalty ‑bearing, sublicensable license under certain Symphony patents, copyrights and technology to develop, make, use, sell, import and export XL647 and the related technology in the field of oncology and non ‑oncology. The Company is the licensee of granted patents in Australia, Canada, Europe, Japan and the United States. The patents claim tesevatinib as a composition ‑of ‑matter, as well as use of tesevatinib to treat certain cancers. A pending U.S. application supports additional composition ‑of ‑matter claims and methods of synthesis. The last to expire U.S. patent in this family has a term that ends in May 2026 based on a calculated Patent Term Adjustment (PTA) and without regard to any potential Patent Term Extension (PTE), which could further extend the term by an additional five years. The Company is the licensee of a second family of granted patents in China and Europe, as well as applications in Canada, Eurasia, Japan, Taiwan and the United States. These patents and applications disclose the use of tesevatinib to treat PKD. The last to expire U.S. patent in this family would have a term that ends in 2031, though this term could be extended by obtaining a PTA and/or PTE. The license agreement includes a series of acquisition and worldwide development milestone payments totaling up to $218.4 million, and $14.1 million of these payments and other fees have been paid as of December 31, 2017 . Additionally, the license agreement includes commercial milestone payments totaling up to $175.0 million, none of which have been paid as of December 31, 2017 , contingent upon the achievement of various sales milestones, as well as single ‑digit sales royalties. The royalty term expires with the last to expire patent. The agreement with Symphony will expire upon the expiration of the last to expire patent within the licensed patents. The Company may terminate the agreement at any time upon six months written notice to Symphony. Either party may terminate the agreement for any material breach by the other party that is not cured within a specified time period. Symphony may terminate the agreement if the Company challenges the licensed patents. Either party may terminate the agreement upon the bankruptcy or insolvency of the other party. All other contingent payments will be expensed as research and development as incurred. Valeant Pharmaceuticals North America LLC On February 25, 2014, the Company entered into an agreement with Valeant for the co ‑promotion of Syprine ® , a chelation therapy indicated in the treatment of patients with Wilson’s disease who are intolerant of penicillamine. In February 2016, the Company entered into a mutual termination agreement with Valeant. Upon termination, neither party shall have any rights or obligation including any and all past, present and future payments. Additionally, all rights and licenses granted under the agreement were immediately terminated and reverted to the party granting such rights. As a result of the termination, in February 2016 the Company recorded a gain on settlement of the $3.9 million other milestone payable to Valeant in connection with the acquisition of the drug Infergen. Princeton University On December 8, 2010, the Company entered into a license agreement with Princeton University (“Princeton”) whereby the Company obtained from Princeton a worldwide exclusive license and right to make, use and sell products identified by Princeton’s Flux technology (“Princeton License”). The Company was obligated to pay Princeton an annual license fee of $60,000 , which was recorded as a research and development expense. In addition, the Princeton License required the Company to make payments contingent on the achievement of certain development milestones totaling $31.0 million, such as receiving certain government approvals. Upon commercial sale, the Company was obligated to pay a low single digit royalty based on net sales levels. No development milestones or sales were achieved as of December 31, 2017 and 2016 . In February 2017, the Company entered into a mutual termination agreement with Princeton. All rights and licenses granted under the agreement were immediately terminated and shall revert to the party granting such rights. MeiraGTx Limited In April 2015, the Company executed several agreements which transferred its ownership of Kadmon Gene Therapy, LLC to MeiraGTx Limited (“MeiraGTx”), a then wholly ‑owned subsidiary of the Company. As part of these agreements, the Company also transferred various property rights, employees and management tied to the intellectual property and contracts identified in the agreements to MeiraGTx. At a later date, MeiraGTx ratified its shareholder agreement and accepted the pending equity subscription agreements, which provided equity ownership to various parties. The execution of these agreements resulted in a 48% ownership in MeiraGTx by the Company. After MeiraGTx was deconsolidated or derecognized, the retained ownership interest was initially recognized at fair value and a gain of $24.0 million was recorded based on the fair value of this equity investment. The Company’s investment is being accounted for under the equity method at zero cost with an estimated fair value at the time of the transaction of $24.0 million. This value was determined based upon the implied value established by the cash raised by MeiraGTx in exchange for equity interests by third parties. The Company assessed the applicability of ASC 810 to the aforementioned agreements and based on the corporate structure, voting rights and contributions of the various parties in connection with these agreements, determined that MeiraGTx is a variable interest entity, however consolidation is not required as the Company is not the primary beneficiary based upon the voting and managerial structure of the entity. MeiraGTx, a limited company organized under the laws of England and Wales, was established to focus on the development of novel gene therapy treatments for a range of inherited and acquired disorders. MeiraGTx is developing therapies for ocular diseases, including rare inherited blindness, as well as xerostomia following radiation treatment for head and neck cancer. MeiraGTx is also developing an innovative gene regulation platform that has the potential to expand the way that gene therapy can be applied, creating a new paradigm for biologic therapeutics in the biopharmaceutical industry. The summarized financial information for MeiraGTx as of and for the years ended December 31, 2017 and 2016 is as follows (amounts in thousands): 2017 2016 Balance Sheet Data: Cash $ 8,549 $ 17,477 Other current assets 2,926 1,613 Noncurrent assets 14,379 3,461 Current liabilities 21,402 6,041 Noncurrent liabilities 479 815 Mezzanine equity 51,410 33,002 Total stockholders’ deficit (47,437) (17,308) Statement of Operations Data: General and administrative expense $ 9,879 $ 6,027 Research and development expense 22,414 14,038 Net loss (32,717) (19,792) As part of a transition services agreement with MeiraGTx, the Company recognized $0.6 million of service revenue to license and other revenue during the year ended December 31, 2017 , and recognized $1.0 million of service revenue to license and other revenue during each of the years ended December 31, 2016 and 2015. During April 2016, the Company received 230,000 shares of MeiraGTx’s convertible preferred Class C shares as a settlement for $1.2 million in receivables from MeiraGTx. Under ASC 323, the Class C shares of MeiraGTx do not qualify as common stock or in-substance common stock and the $1.2 million was recorded as a cost method investment. The Company also received cash payments of $0.3 million and $0.2 million during 2017 and 2016 , respectively, related to service revenue earned . The Company assessed the recoverability of both the cost method and equity method investment in MeiraGTx at December 31, 2017 and 2016 and identified no events or changes in circumstances that may have a significant adverse impact on the fair value of this investment. For the years ended December 31, 2017, 2016 and 2015 , the Company recorded its share of MeiraGTx’s net loss of $7.6 million , $13.6 million, and $2.8 million, respectively, inclusive of adjustments related to MeiraGTx’s 2015 financial statements that resulted in the Company recording a loss on equity method investment of $3.9 million for the year ended December 31, 2016 . The Company maintains a 25.6% ownership in MeiraGTx at December 31, 2017 , inclusive of C preferred shares issued by MeiraGTx . For accounting purposes, the Company has determined that the C preferred shares issued by MeiraGTx are not in-substance common stock. Accordingly, the Company record s 38.7% of MeiraGTx’s losses, which represents what the Company ’s percentage would be if only A ordinary shares were outstanding. The Company’s maximum exposure associated with MeiraGTx is limited to its initial investment of $24.0 million , which has been written down to zero at December 31, 2017 based on t he Company’s absorption of MeiraGTx’s net losses . Nano Terra, Inc. On April 8, 2011, the Company entered into a series of transactions with Nano Terra, Inc. (“Nano Terra”), pursuant to which the Company (i) paid $2.3 million for Nano Terra’s Series B Preferred Stock, (ii) entered into a joint venture with Surface Logix, Inc. (“Surface Logix”) (Nano Terra’s wholly ‑owned subsidiary) through the formation of NT Life Sciences, LLC (“NT Life”), whereby the Company contributed $0.9 million at the date of formation in exchange for a 50% interest in NT Life and (iii) entered into a sub ‑licensing arrangement with NT Life and Surface Logix . Pursuant to the sub ‑licensing arrangement, the Company was granted a worldwide, exclusive license under certain intellectual property owned by Surface Logix to three clinical-stage product candidates , as well as rights to Surface Logix’s drug discovery platform, Pharmacomer™ Technology, each of which were licensed by Surface Logix to NT Life. In December 2014, the Company received one share of Nano Terra’s Common Stock for every 100 shares of Series B Preferred Stock held by the Company, resulting in approximately a 1% holding in Nano Terra as of December 31, 2017 and 2016 . In accordance with ASC 325, “Investments—Other”, the Company continues to account for the investment under the cost method. The primary product candidates are currently in early to mid ‑stage clinical development for a variety of diseases and target several novel pathways of disease by inhibiting the activity of specific enzymes. Nano Terra and NT Life are research and development companies, each of which independently maintains intellectual property for the purpose of pursuing medical discoveries. The Company is a minority shareholder of Nano Terra and thereby is unable to exercise significant influence with regard to the entity’s daily operations. The Company is represented on the board of m anagers of NT Life and is a party to decisions which influence the direction of the organization. Since inception, the Company has continuously assessed the applicability of ASC 810, based on the corporate structure, voting rights and contributions of the various parties in connection with these agreements, and determined that Nano Terra and NT Life are not variable interest entities and not subject to consolidation. On April 8, 2011 the Company recorded its $2.3 million investment in Nano Terra in accordance with ASC 325, and its investment of $ 0. 9 million in NT Life in accordance with ASC 323, of which was $450,000 was recorded as a loss on equity investment and $450,000 was recorded as an impairment loss in 2011. In accordance with ASC 325 ‑20 ‑35, the Company assessed the recoverability of the investment in Nano Terra as of December 31, 2017 and 2016 and identified no events or changes in circumstances that may have a significant adverse impact on the fair value of this investment. There was no activity of the joint venture during the years ended December 31, 2017, 2016 and 2015 which resulted in income or loss to the Company. The Company’s maximum exposure associated with Nano Terra and NT Life is limited to cash contributions made. Additionally, subject to certain exceptions, the Company must pay to the previous shareholders of Surface Logix from which Nano Terra acquired Surface Logix a mid-single digit percentage royalty of net sales of the applicable licensed products and a percentage that ranges between a low twenty percent and a low forty percent of all sublicensing revenue the Company receives in the event the Company further assigns or sublicenses its rights under the sub-licensing arrangement to certain third parties. In addition, the Company must pay to NT Life a ten percent royalty of any remaining net sales amount of the applicable licensed products and all of such sublicensing revenue after taking into account the royalties and sublicensing revenue paid to the previous shareholders of Surface Logix . No sublicensing revenue or sales were achieved as of December 31, 2017 and 2016 . Dyax Corp. (acquired by Shire Plc in January 2016) On July 22, 2011 the Company entered into a license agreement with Dyax Corp. (“Dyax”) for the rights to use the Dyax Antibody Libraries, Dyax Materials and Dyax Know ‑How (collectively “Dyax Property”). The agreement terminated on September 22, 2015, but the Company had a right to a commercial license of any research target within two years o f expiration of the agreement. The Company exercised its right to a commercial license of two targets in September 2017, resulting in a license fee payable to Shire Plc of $1.5 million which was recorded to research and development expense for the year ended December 31, 2017 . The agreement includes the world ‑wide, non ‑exclusive, royalty ‑free, non ‑transferable license to use the Dyax Property to be used in the research field, without the right to sublicense. Additionally, the Company has the option to obtain a sublicense for use in the commercial field if any research target is obtained. The Company was required to pay Dyax $0.6 million upon entering into the agreement and $0.3 million annually to maintain the agreement. The initial payment was deferred and recorded as prepaid expense; $0.3 million of which will be amortized over the term of the agreement, and $0.3 million of which was amortized in a manner consistent with that of the annual payments. All subsequent annual payments will be and have been recorded as prepaid expense and amortized over the applicable term of one year. On September 13, 2012 the Company entered into a separate license agreement with Dyax whereby the Company obtained from Dyax the exclusive, worldwide license to use research, develop, manufacture and commercialize DX ‑2400 in exchange for a payment of $0.5 million . All payments associated with this agreement were recorded as research and development expense at the time the agreement was executed. The DX ‑2400 license requires the Company to make additional payments contingent on the achievement of certain development milestones (such as receiving certain regulatory approvals and commencing certain clinical trials) and sales targets. None of these targets have been achieved and, as such, no assets or liabilities associated with the milestones have been recorded in the accompanying consolidated financial statements for the year ended December 31, 2017 . The DX ‑2400 license also includes royalty payments commencing on the first commercial sale of any licensed product, which had not occurred as of December 31, 2017 and 2016 . Chiromics On November 18, 2011 the Company entered into a non ‑exclusive, royalty free license agreement with Chiromics LLC (“Chiromics”) for access to two chemical compound libraries for the research, discovery and development of biological and/or pharmaceutical products. The Company was required to pay $0.2 million upon execution of the agreement and $0.2 million following the delivery of each of the chemical compounds included within the related library. The Company was additionally required to make quarterly payments of $0.2 million for the eight quarters following delivery of all compounds; such payments were expensed to research and develop ment expense in those quarters. Zydus In June 2008, the Company entered into an asset purchase agreement with Zydus Pharmaceuticals USA, Inc. (“Zydus”) and Cadila Healthcare Limited where the Company purchased all of Zydus’ rights, title and interest to high dosages of ribavirin. Under the terms of the agreement, the Company paid a one ‑time purchase price of $1.1 million. The Company was required to pay a royalty based on net sales of products in the low twenty percents, subject to specified reductions and offsets. In April 2013, the Company entered into an amendment to the asset purchase agreement with Zydus which reduced the royalty payable on net sales of products from the low twenty percents to the mid-teens percents. In June 2008, the Company also entered into a non ‑exclusive patent license agreement with Zydus, under which Zydus granted to the Company a non ‑exclusive, royalty free, fully paid up, non ‑transferable license under certain Zydus patent rights related to ribavirin. This agreement will expire upon the expiration or termination of a specific licensed patent. Either party may terminate the agreement for any material breach by the other party that is not cured within a specified time period or upon the bankruptcy or insolvency of the other party. The Company recorded royalty expense of $0.1 million, $1.2 million and $2.7 million for the years ended December 31, 2017, 2016 and 2015 , respectively. Jinghua In November 2015, the Company entered into a license agreement with Jinghua Pharmaceutical Group Co., Ltd. (“Jinghua”). Under this agreement, the Company granted to Jinghua an exclusive, royalty ‑bearing, sublicensable license under certain of its intellectual property and know ‑how to use, develop, manufacture, and commercialize certain monoclonal antibodies in China, Hong Kong, Macau and Taiwan. In partial consideration for the rights granted to Jinghua under the agreement, the Company received an upfront payment of $10.0 million in the form of an equity investment in Class E redeemable convertible units of the Company. The Company is eligible to receive from Jinghua a royalty equal to a percentage of net sales of product in the territory in the low ten percents. In addition to such payments, the Company is eligible to receive milestone payments for the achievement of certain development milestones, totaling up to $40.0 million. The Company earned a $2.0 million milestone payment in March 2016, which was recorded as license and other revenue during the year ended December 31, 2016 . The Company earned a $2.0 million milestone payment in January 2017, which was received in February 2017, and was recorded as license and other revenue during the year ended December 31, 2017 .The Company is also eligible to receive a portion of sublicensing revenue from Jinghua ranging from the low ten percents to the low thirty percents based on the development stage of a product. No such revenue was earned during the years ended December 31, 2017, 2016 and 2015 The Company’s agreement with Jinghua will continue on a product ‑by ‑product and country ‑by ‑country basis until the later of ten years after the first commercial sale of the product in such country or the date on which there is no longer a valid claim covering the licensed antibody contained in the product in such country. Either party may terminate the agreement for any material breach by the other party that is not cured within a specified time period or upon the bankruptcy or insolvency of the other party. No patents were licensed to the Company under this agreement. Camber Pharmaceuticals, Inc. In February 2016, we entered into a supply and distribution agreement with Camber Pharmaceuticals, Inc. (Camber) for the purposes of marketing, selling and distributing tetrabenazine, a medicine that is used to treat the involuntary movements (chorea) of Huntington’s disease. The initial term of the agreement was twelve months. In May 2016, we amended our agreement with Camber to include the marketing, selling and distributing of valganciclovir, a medicine that is used for the treatment of CMV retinitis, a viral inflammation of the retina of the eye, in patients with acquired immunodeficiency syndrome (AIDS) and for the prevention of CMV disease, a common viral infection complicating solid organ transplants, in kidney, heart and kidney pancreas transplant patients . In August 2016, we amended our agreement with Camber to include the marketing, selling and distributing of several other products that have not had meaningful sales to date. In February 2017, we entered into a third amendment to the supply and distribution agreement with Camber extending the initial term of the agreement by an additional twelve months. The supply and distribution agreement with Camber terminated on February 23, 2018. Under the agreement, as amended, we obtained commercial supplies of the Camber products at a contracted price and distributed them through our existing sales force and commercial network. We retained 100% of the revenue generated from the sale of the Camber products. The Company recognized revenue from the sales of tetrabenazine of $1.0 million and $0.6 million during the years ended December 31, 2017 and 2016 , respectively. No revenue was generated from sales of tetrabenazine in 2015. The Company recognized revenue from sales of valganciclovir of $0.2 million and $0.9 million during the years ended December 31, 2017 and 2016 . No revenue was generated from sales of valganciclovir in 2015. No meaningful revenue was generated from sales of the other Camber products for the years ended December 31, 2017, 2016 and 2015 . |
Share-based Compensation
Share-based Compensation | 12 Months Ended |
Dec. 31, 2017 | |
Share-based Compensation [Abstract] | |
Share-based Compensation | 13. Share ‑based Compensation 2011 Equity Incentive Plan—Options The 2011 Equity Incentive Plan was adopted in July 2011. Under this plan, the Company’s board of directors was able to grant unit ‑based awards to certain employees, officers, directors, managers, consultants and advisors. The plan was amended on November 7, 2013 to authorize the grant of a number of options to purchase Class A units equal to 7.5% of the outstanding Class A units calculated on a fully diluted basis. The Company’s board of directors had the authority, in its discretion, to determine the terms and conditions of any option grant, including the vesting schedule. Effective July 26, 2016, no award may be granted under the 2011 Equity Plan. The 2011 Equity Plan was merged with and into the 2016 Equity Incentive Plan, outstanding awards were converted into awards with respect to our common stock and any new awards will be issued under the terms of the 2016 Equity Incentive Plan. 2016 Equity Incentive Plan The Company’s 2016 Equity Incentive Plan (the “2016 Equity Plan”), was approved by the Company’s board of directors and holders of the Company’s membership units in July 2016 . The 2016 Equity Plan was Amended and Restated effective December 5, 2017. It is intended to make available incentives that will assist the Company to attract, retain and motivate employees, including officers, consultants and directors. The Company may provide these incentives through the grant of stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares and units and other cash-based or stock-based awards. A total of 6,720,000 shares of the Company’s common stock was initially authorized and reserved for issuance under the 2016 Equity Plan , which was increased to 8,523,147 on January 1, 2017 . At December 31, 2017 the number of additional shares available for grant was 8,496,872 . This 2016 Equity Plan provided for annual increase s in the number of shares available for issuance under the 2016 Equity Plan on January 1, 201 7 and each subsequent anniversary through January 1, 2025, by an amount equal to the smaller of (a) 4% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or (b) an amount determined by the board of directors. This reserve was increased to include any shares issuable upon exercise of options granted under the Company’s 2011 Equity Incentive Plan that expire or terminate without having been exercised in full. Appropriate adjustments will be made in the number of authorized shares and other numerical limits in the 2016 Equity Plan and in outstanding awards to prevent dilution or enlargement of participants’ rights in the event of a stock split or other change in the Company’s capital structure. Shares subject to awards which expire or are cancelled or forfeited will again become available for issuance under the 2016 Equity Plan. The shares available will not be reduced by awards settled in cash or by shares withheld to satisfy tax withholding obligations. Only the net number of shares issued upon the exercise of stock appreciation rights or options exercised by means of a net exercise or by tender of previously owned shares will be deducted from the shares available under the 2016 Equity Plan. The 2016 Equity Plan will be generally administered by the compensation committee of the Company’s board of directors. Subject to the provisions of the 2016 Equity Plan, the compensation committee will determine, in its discretion, the persons to whom and the times at which awards are granted, the sizes of such awards and all of their terms and conditions. However, the compensation committee may delegate to one or more of our officers the authority to grant awards to persons who are not officers or directors, subject to certain limitations contained in the 2016 Equity Plan and award guidelines established by the compensation committee. The compensation committee will have the authority to construe and interpret the terms of the 2016 Equity Plan and awards granted under it. The 2016 Equity Plan provides, subject to certain limitations, for indemnification by the Company of any director, officer or employee against all reasonable expenses, including attorneys’ fees, incurred in connection with any legal action arising from such person's action or failure to act in administering the 2016 Equity Plan. Awards may be granted under the 2016 Equity Plan to the Company’s employees, including officers, directors or consultants or those of any present or future parent or subsidiary corporation or other affiliated entity. All awards will be evidenced by a written agreement between the Company and the holder of the award and may include any of the following: · Stock options. The Company may grant nonstatutory stock options or incentive stock options as described in Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”), each of which gives its holder the right, during a specified term (not exceeding 10 years) and subject to any specified vesting or other conditions, to purchase a number of shares of our common stock at an exercise price per share determined by the administrator, which may not be less than the fair market value of a share of the Company’s common stock on the date of grant. · Stock appreciation rights. A stock appreciation right gives its holder the right, during a specified term (not exceeding 10 years) and subject to any specified vesting or other conditions, to receive the appreciation in the fair market value of the Company’s common stock between the date of grant of the award and the date of its exercise. The Company may pay the appreciation in shares of the Company’s common stock or in cash. · Restricted stock. The administrator may grant restricted stock awards either as a bonus or as a purchase right at such price as the administrator determines. Shares of restricted stock remain subject to forfeiture until vested, based on such terms and conditions as the administrator specifies. Holders of restricted stock will have the right to vote the shares and to receive any dividends paid, except that the dividends may be subject to the same vesting conditions as the related shares. · Restricted stock units. Restricted stock units represent rights to receive shares of the Company’s common stock (or their value in cash) at a future date without payment of a purchase price, subject to vesting or other conditions specified by the administrator. Holders of restricted stock units have no voting rights or rights to receive cash dividends unless and until shares of common stock are issued in settlement of such awards. However, the administrator may grant restricted stock units that entitle their holders to dividend equivalent rights. · Performance shares and performance units. Performance shares and performance units are awards that will result in a payment to their holder only if specified performance goals are achieved during a specified performance period. Performance share awards are rights whose value is based on the fair market value of shares of the Company’s common stock, while performance unit awards are rights denominated in dollars. The administrator establishes the applicable performance goals based on one or more measures of business performance enumerated in the 2016 Equity Plan, such as revenue, gross margin, net income or total stockholder return. To the extent earned, performance share and unit awards may be settled in cash or in shares of our common stock. Holders of performance shares or performance units have no voting rights or rights to receive cash dividends unless and until shares of common stock are issued in settlement of such awards. However, the administrator may grant performance shares that entitle their holders to dividend equivalent rights. · Cash-based awards and other stock-based awards. The administrator may grant cash-based awards that specify a monetary payment or range of payments or other stock-based awards that specify a number or range of shares or units that, in either case, are subject to vesting or other conditions specified by the administrator. Settlement of these awards may be in cash or shares of our common stock, as determined by the administrator. Their holder will have no voting rights or right to receive cash dividends unless and until shares of our common stock are issued pursuant to the award. The administrator may grant dividend equivalent rights with respect to other stock-based awards. The 201 6 Equity Plan contains certain change of control provisions that provide for varied acceleration of vesting of outstanding awards, a ssumption, c ontinuation or s ubstitution of outstanding awards or cash-out of outstanding awards in the event of a change of control. Any awards which are not assumed or continued in connection with a change in control or are not exercised or settled prior to the change in control will terminate effective as of the time of the change in control. The compensation committee may provide for the acceleration of vesting of any or all outstanding awards upon such terms and to such extent as it determines, except that the vesting of all awards held by members of the board of directors who are not employees will automatically be accelerated in full. The 2016 Equity Plan also authorizes the compensation committee, in its discretion and without the consent of any participant, to cancel each or any outstanding award denominated in shares upon a change in control in exchange for a payment to the participant with respect to each share subject to the cancelled award of an amount equal to the excess of the consideration to be paid per share of common stock in the change in control transaction over the exercise price per share, if any, under the award. The 2016 Equity Plan will continue in effect until it is terminated by the administrator, provided, however, that all awards will be granted, if at all, within 10 years of its effective date. The administrator may amend, suspend or terminate the 2016 Equity Plan at any time, provided that without stockholder approval, the plan cannot be amended to increase the number of shares authorized, change the class of persons eligible to receive incentive stock options, or effect any other change that would require stockholder approval under any applicable law or listing rule. Total unrecognized compensation expense related to unvested options granted under the Company’s share ‑based compensation plan was $13.3 million and $21.7 million at December 31, 2017 and 2016 , respectively. That expense is expected to be recognized over a weighted average period of 1.9 years and 1.7 years as of December 31, 2017 and 2016 , respectively. The Company recorded share ‑based option compensation expense under the 2011 Equity Incentive Plan and 2016 Equity Plan of $12.4 million, $24.6 million and $10.3 million for the years ended December 31, 2017, 2016 and 2015 , respectively. In January 2015, the compensation committee of the Company’s board of directors approved the amendments of all outstanding option awards under the 2011 Equity Incentive Plan that have an exercise price above $6.00 per unit to adjust the exercise price per unit to $6.00 per unit (Note 4), the estimated fair value of the Company’s Class A units as of October 31, 2014. The awarded options have the same vesting schedule as the original award. The amendment to the option awards resulted in a modification charge of $1.1 million, of which $668,000 was expensed immediately during the first quarter of 2015 and the remaining amount will be recognized over the vesting periods of each award. These vesting periods range from one to two years. On July 13, 2016, the compensation committee of the Company’s board of directors approved the amendment of all outstanding option awards issued under the Company’s 2011 Equity Incentive Plan whereby, effective upon pricing of the Company’s IPO, the exercise price (on a post-Corporate Conversion, post-split basis) was adjusted to equal the price per share of the Company’s common stock in the IPO. The amendment was made to the awards as the original exercise price was substantially higher than the price of the Company’s common stock in the IPO as a result of changes in the Company’s capital structure that occurred upon IPO. Options to purchase an aggregate of approximately 1.6 million shares of the Company’s Class A units were modified. Following this modification, the previously granted options will have the same vesting schedule as the original award and are modified on a one-for-one basis. The modification resulted in a $4.0 million charge, of which the incremental value of the previously vested portion of the awards totaling $1.8 million was expensed immediately during the third quarter of 2016 and the remaining $2.2 million will be recognized over the remaining vesting periods of each award. These vesting periods range from one to three years. The following table summarizes information about unit options outstanding at December 31, 2017 and 2016 : Options Outstanding Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Balance, December 31, 2015 1,685,248 $ 37.38 8.72 $ — Granted 4,858,460 7.12 Exercised (1,109) 36.63 Forfeited (105,084) 32.09 Balance, December 31, 2016 6,437,515 $ 8.32 9.28 $ 2,227,268 Granted 2,853,000 3.69 Exercised — — Forfeited (793,643) 6.23 Balance, December 31, 2017 8,496,872 $ 6.96 8.83 $ — Options vested and exercisable, December 31, 2017 3,969,407 $ 9.76 8.04 $ — The aggregate intrinsic value in the table above represents the total pre ‑tax intrinsic value calculated as the difference between the fair value of the Company’s common stock at December 31, 2017 ( $3.62 per share) and December 31, 2016 ( $5.35 per share) and the exercise price, multiplied by the related in ‑the ‑money options that would have been received by the option holders had they exercised their options at the end of the fiscal year. This amount changes based on the fair value of the Company’s common stock. There were no options exercised during the year ended December 31, 2017. There were 1,109 options exercised during the year ended December 31, 2016 that were not in ‑the ‑money. There were 772 options exercised during 2015 that were in ‑the ‑money, with an aggregate intrinsic value at time of exercise of $4,800 . During the year ended December 31, 2016 , 1,630,536 options were granted to the Company’s Chief Executive Officer and 3,227,924 options were granted to the Company’s employees and directors. The weighted ‑average fair value of the stock option awards granted to employees, officers, directors and advisors was $2.44 , $7.12 and $20.67 during the years ended December 31, 2017, 2016 and 2015 , respectively, and was estimated at the date of grant using the Black ‑Scholes option ‑pricing model and the assumptions noted in the following table: Year Ended December 31, 2017 December 31, 2016 December 31, 2015 Weighted average fair value of grants $2.44 $7.12 $20.67 Expected volatility 74.48% - 74.92% 74.98% - 79.35% 77.23% - 93.85% Risk-free interest rate 1.87% - 2.22% 1.15% - 2.20% 1.54% - 1.93% Expected life 5.5 - 6.0 years 5.0 - 6.0 years 5.2 - 6.0 years Expected dividend yield 0% 0% 0% In December 2015, the option agreement entered into with the Company’s Chief Executive Officer was replaced in its entirety by an option agreement dated December 31, 2015 so that the number of units is set to 769,231 unit options valued at $15.2 million which will be recognized as compensation expense over the vesting term. These units under this option agreement were issued outside of the 2011 Equity Incentive Plan. The Company expensed $2.9 million, $7.2 million and $5.1 million during the years ended December 31, 2017 and 2016 and the fourth quarter of 2015, respectively. The options vest 1/3 at the grant date, 1/3 in August 2016 and 1/3 in August 2017. While the awards vest over this term they are not exercisable until the occurrence of the Calculation Date. The Calculation Date is defined as the earliest to occur of 1) a sale of the Company (as defined in the Company’s second amended and restated limited liability company agreement dated as of June 27, 2014), 2) the date on which the Company consummates an IPO and 3) the date the key employee ceases to be a service provider to the Company. The Calculation Date was deemed to have occurred upon consummation of the Company’s IPO on July 26, 2016. On July 13, 2016, the compensation committee of the Company’s board of directors approved an option award for Dr. Harlan W. Waksal increasing the number of options (giving effect to the Corporate Conversion) subject to his original option grant. The number of shares subject to this option award shall equal the difference between the 769,231 options originally granted to Dr. Harlan W. Waksal and 5% of the Company’s outstanding common equity determined on a fully diluted basis on the IPO date, which amounted to 1,630,536 options. The effective date of the new option award was the IPO date of July 26, 2016. The exercise price per share of common stock subject to the new incremental options awarded was equal to the IPO price per share of common stock at the IPO date of $12.00. The option award was subject to the same vesting schedule applicable to the original option grant such that all options awarded will vest on August 4, 2017. In consideration for the new option award, Dr. Harlan W. Waksal has committed to perform an additional year of service in connection with receipt of the additional option shares. In the event Dr. Harlan W. Waksal voluntarily terminates his employment prior to completion of this additional year of service, Dr. Harlan W. Waksal shall forfeit 25% of the additional options, or 25% of the aggregate additional option gain associated with the additional option shares in the event the options are exercised, as applicable. This modification resulted in a $12.4 million charge, of which the incremental value of the previously vested portion of the awards totaling $8.3 million was expensed during the third quarter of 2016 and the remaining amount of the unvested portion totaling $4.1 million will be recognized over the additional two years of service through August 4, 2018 . Stock Appreciation Rights The Company granted 1,040,000 stock appreciation rights to three executive employees during the year ended December 31, 2017 . No stock appreciation rights were granted under the 2016 Equity Plan prior to 201 7 . The weighted-average fair value of the stock appreciation rights granted to the three executive officers was $2.42 and was estimate d at the date of grant using the Black-Scholes option-pricing model with the following assumptions : risk-free interest rate of 2.22% , expected term of 6.0 years, expected volatility of 74.92% , and a dividend rate of 0% . Compensation expense for stock appreciation rights is recognized on a straight-line basis over the a wards’ requisite service period . A t December 31, 2017 , there was $2.5 million of total unrecognized compensation cost related to stock appreciation rights. The unrecognized compensation cost is expected to be recognized over a weighted-average period of 2.9 years . No stock appreciation rights were exercised during the year ended December 31, 2017 . 2014 Long ‑term Incentive Plan (“LTIP”) The LTIP was adopted in May 2014 and amended in December 2014. Under the LTIP, the Company’s board of directors may grant up to 10% of the equity value of the Company including the following types of awards: · Equity Appreciation Rights Units (“EAR units”) whereby the holder would possess the right to a payment equal to the appreciation in value of the designated underlying equity from the grant date to the determination date. Such value is calculated as the product of the excess of the fair market value on the determination date of one EAR unit over the base price specified in the grant agreement and the number of EAR units specified by the award, or, when applicable, the portion thereof which is exercised. · Performance Awards which become payable on the attainment of one or more performance goals established by the Plan Administrator. No performance period shall end prior to an IPO or Change in Control (the “Determination Date”). The Company’s board of directors has the authority, at its discretion, to determine the terms and conditions of any LTIP grant, including vesting schedule. Certain key employees were granted a total of 1,250 EAR units and 8,500 EAR units with a base price of $6.00/unit , expiring 10 years from the grant date (the “Award”) during 2015 and 2014, respectively. Each unit entitles the holder to a payment amount equal to 0.001% of the fair market value of all of the outstanding equity in the Company on a fully diluted basis assuming the exercise of all derivative securities as of the Determination Date. The number of EAR units shall be adjusted to equal a certain percentage of the Company’s outstanding common equity securities determined on the first trading date following the Determination Date. The EAR units vest based on the earlier of (a) the expiration date if an IPO is consummated on or before that date or (b) the date of a change in control that occurs after the submission date of a Form S ‑1 registration statement to the SEC but prior to the expiration date. The EAR units also vest upon achieving certain predetermined stock price targets subject to continuing service through the date of the Form S ‑1 submission. The payment amount with respect to the holder’s EAR units will be determined using the fair market value of the common stock on the trading date immediately preceding the settlement date. Each payment under the Award will be made in a lump sum and is considered a separate payment. The Company reserves the right to make payment in the form of common stock following the consummation of an IPO or in connection with a change in control, subject to the terms of the LTIP. Any settlement in the form of common stock will be limited to a maximum share allocation. The holder has no right to demand a particular form of payment. A total of 9,750 units were granted under the LTIP at December 31, 2017 and 2016 . The compensation expense for this award was recognized upon consummation of the Company’s IPO on August 1, 2016 and was recorded as additional paid in capital . No compensation expense had been recorded prior to this date. The Company utilized a Monte-Carlo simulation to determine the fair value of the awards granted under the LTIP of $22.6 million, which was recorded as share-based compensation during the third quarter of 2016 as these awards are not forfeitable. The LTIP is payable upon the fair market value of the Company’s common stock exceeding 333% of the $6.00 grant price ( $20.00 ) per share prior to December 7, 2024. The holders of the LTIP have no right to demand a particular form of payment, and the Company reserve s the right to make payment in the form of cash or common stock. 2016 Employee Stock Purchase Plan (“2016 ESPP”) The Company’s board of directors has adopted and the Company’s stockholders have approved the 2016 ESPP. A total of 1,125,000 shares of the Company’s common stock were initially available for sale under the 2016 ESPP , which increased to 1,801,180 on January 1, 2017 . The Company issued 10,594 shares of common stock under the 2016 ESPP in October 2017. No meaningful compensation expense was recognized for the ESPP during the years ended December 31, 2017 and 2016 . In addition, the 2016 ESPP provides for annual increases in the number of shares available for issuance under the 2016 ESPP on January 1, 2017 and each subsequent anniversary through 2025, equal to the smallest of: · 750,000 shares; · 1.5% of the outstanding shares of the Company’s common stock on the immediately preceding December 31; or · such other amount as may be determined by the Company’s board of directors. Appropriate adjustments will be made in the number of authorized shares and in outstanding purchase rights to prevent dilution or enlargement of participants’ rights in the event of a stock split or other change in the Company’s capital structure. Shares subject to purchase rights which expire or are cancelled will again become available for issuance under the 2016 ESPP. The compensation committee of the Company’s board of directors will administer the 2016 ESPP and have full authority to interpret the terms of the 2016 ESPP. The 2016 ESPP provides, subject to certain limitations, for indemnification by the Company of any director, officer or employee against all reasonable expenses, including attorneys’ fees, incurred in connection with any legal action arising from such person’s action or failure to act in administering the 2016 ESPP. All of the Company’s employees, including the Company’s named executive officers, and employees of any of the Company’s subsidiaries designated by the compensation committee are eligible to participate if they are customarily employed by the Company or any participating subsidiary for at least 20 hours per week and more than five months in any calendar year, subject to any local law requirements applicable to participants in jurisdictions outside the United States. However, an employee may not be granted rights to purchase stock under the 2016 ESPP if such employee: · immediately after the grant would own stock or options to purchase stock possessing 5.0% or more of the total combined voting power or value of all classes of the Company’s capital stock; or · holds rights to purchase stock under all of the Company’s employee stock purchase plans that would accrue at a rate that exceeds $25,000 worth of the Company’s stock for each calendar year in which the right to be granted would be outstanding at any time. The 2016 ESPP is intended to qualify under Section 423 of the Code but also permits us to include our non-U.S. employees in offerings not intended to qualify under Section 423. The 2016 ESPP will typically be implemented through consecutive six-month offering periods. The offering periods generally start on the first trading day of April and October of each year. The administrator may, in its discretion, modify the terms of future offering periods, including establishing offering periods of up to 27 months and providing for multiple purchase dates. The administrator may vary certain terms and conditions of separate offerings for employees of the Company’s non-U.S. subsidiaries where required by local law or desirable to obtain intended tax or accounting treatment. The 2016 ESPP permits participants to purchase common stock through payroll deductions of up to 10.0% of their eligible compensation, which includes a participant’s regular and recurring straight time gross earnings and payments for overtime and shift premiums, but exclusive of payments for incentive compensation, bonuses and other similar compensation. Amounts deducted and accumulated from participant compensation, or otherwise funded in any participating non-U.S. jurisdiction in which payroll deductions are not permitted, are used to purchase shares of the Company’s common stock at the end of each offering period. The purchase price of the shares will be 85.0% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the last day of the offering period. Participants may end their participation at any time during an offering period and will be paid their accrued payroll deductions that have not yet been used to purchase shares of common stock. Participation ends automatically upon termination of employment with the Company. Each participant in any offering will have an option to purchase for each full month contained in the offering period a number of shares determined by dividing $2,083 by the fair market value of a share of the Company’s common stock on the first day of the offering period or 200 shares, if less, and except as limited in order to comply with Section 423 of the Code. Prior to the beginning of any offering period, the administrator may alter the maximum number of shares that may be purchased by any participant during the offering period or specify a maximum aggregate number of shares that may be purchased by all participants in the offering period. If insufficient shares remain available under the plan to permit all participants to purchase the number of shares to which they would otherwise be entitled, the administrator will make a pro rata allocation of the available shares. Any amounts withheld from participants’ compensation in excess of the amounts used to purchase shares will be refunded, without interest. A participant may not transfer rights granted under the 2016 ESPP other than by will, the laws of descent and distribution or as otherwise provided under the 2016 ESPP. In the event of a change in control, an acquiring or successor corporation may assume the Company’s rights and obligations under outstanding purchase rights or substitute substantially equivalent purchase rights. If the acquiring or successor corporation does not assume or substitute for outstanding purchase rights, then the purchase date of the offering periods then in progress will be accelerated to a date prior to the change in control. The 2016 ESPP will remain in effect until terminated by the administrator. The compensation committee has the authority to amend, suspend or terminate the 2016 ESPP at any time. Warrants The following table summarizes information about warrants outstanding at December 31, 2017 and 2016 : Warrants Weighted Average Exercise Price Balance, December 31, 2015 710,801 $ 46.64 Granted 617,651 10.20 Balance, December 31, 2016 1,328,452 $ 29.70 Granted 13,394,338 3.58 Exercised (22,800) 3.35 Forfeited — — Balance, December 31, 2017 14,699,990 $ 5.94 In conjunction with 2015 Credit Agreement, warrants to purchase $6.3 million of Class A units were issued to two lenders at 85% of the price per share of common stock in the IPO. Upon consummation of the Company’s IPO on August 1, 2016 with a price per share of common stock in the IPO of $12.00, these warrants to purchase Class A units were exchanged for 617,651 warrants at a strike price of $10.20 to purchase the same number of shares of the Company’s common stock (Note 8). |
Accrued Expenses and Other Shor
Accrued Expenses and Other Short Term Liabilities | 12 Months Ended |
Dec. 31, 2017 | |
Accrued Expenses and Other Short Term Liabilities [Abstract] | |
Accrued Expenses and Other Short Term Liabilities | 14. Accrued Expenses and Other Short Term Liabilities Short ‑term accrued expenses at December 31, 2017 and 2016 include the following (in thousands): December 31, December 31, 2017 2016 Commission payable $ 2,395 $ 2,395 Compensation and benefits 758 954 Severance 1,122 1,744 Royalty arrangements — 2,502 Other 4,302 4,555 Total Accrued Expenses $ 8,577 $ 12,150 Commission Payable During 2015, the Company raised $873,000 in gross proceeds, $833,000 net of $40,000 in transaction costs, through the issuance of 75,875 Class E redeemable convertible units. At December 31, 2017 and 2016 , $40,000 remains in accrued liabilities relating to commissions to third parties for Class E redeemable convertible raises during 2015. During 2014, the Company raised $39.5 million in gross proceeds, $36.4 million net of $3.1 million in transaction costs, through the issuance of 3,438,984 Class E redeemable convertible units. Of the $3.1 million in transaction costs, $2.4 million remains in accrued liabilities at December 31, 2017 and 2016 relating to commissions to third parties for Class E redeemable convertible raises during 2014. Severance Severance balances represent contractual compensation to be paid to former employees, a significant portion of which relates to the separation agreement with Dr. Samuel D. Waksal. Effective as of February 8, 2016, Dr. Samuel D. Waksal resigned from all positions with the Company and is no longer employed by the Company in any capacity. At December 31, 2017 , accrued severance payable to Dr. Samuel D. Waksal totaled $1.2 million, of which $1.0 million is recorded as accrued expense and $0.2 million is recorded as other long ‑term liabilities. At December 31, 2016, accrued severance payable to Dr. Samuel D. Waksal totaled $2.2 million, of which $1.0 is recorded as accrued expense and $1.2 million is recorded as other long-term liabilities. The separation agreement with Dr. Samuel D. Waksal contains certain supplement conditional payments, none of which have been met at December 31, 2017 . The Company has not recorded any expense related to these conditional payments at December 31, 2017 and will continue to evaluate the probability of these conditional payments. Separation Agreement with Dr. Samuel D. Waksal Dr. Samuel D. Waksal founded the Company in October 2010 and, until August 2014, was the chairman of the Company’s board of directors and the Company’s Chief Executive Officer. In August 2014, he stepped down as the Company’s Chief Executive Officer and became the Company’s Chief of Innovation, Science and Strategy. In connection with his resignation on February 8, 2016, the Company entered into a separation agreement with Dr. Samuel D. Waksal terminating his employment with the Company and providing that he shall perform no further paid or unpaid services for the Company whether as employee, consultant, contractor or any other service provider. The principal provisions of the separation agreement are summarized below. Severance and Other Payments The Company agreed to make a series of payments (all subject to withholding taxes) to Dr. Samuel D. Waksal, some of which are contingent, structured as follows: · a $3.0 million severance payment, of which $0.9 million and $1.0 million was paid during 2016 and 2017, with the remaining $1.1 million payable during 2018 and 2019. Severance expense totaling $3.1 million, including the cost of Company ‑paid medical benefits, was recorded during the first quarter of 2016 as these payments are probable and estimable; · supplemental conditional payments of up to $6.75 million in the aggregate that are payable in 2017 ( $2.25 million), 2018 ( $2.25 million) and 2019 ( $2.25 million) if specified benchmarks related to the valuation of the Company implied by the public offering price in the IPO, the net proceeds to the Company from the IPO and the Company’s equity market capitalization on specified dates are achieved and subject to the Company having cash and cash equivalents less payables of $50 million or more on the dates when the Company makes those payments. The supplemental conditional payments that were payable in 2017 and 2018 were not earned and will therefore not be paid. The remaining conditional payment in 2019, although estimable, is not probable at December 31, 2017 as the Company is not able to determine if or when the benchmark related to the valuation of the Company will be achieved. The Company has not recorded any expense related to these conditional payments at December 31, 2017 and will continue to evaluate the probability of these conditional payments; · an amount equal to five percent (up to a maximum of $15 million) of any cash received by the Company or guaranteed cash payments (as defined below) payable to the Company pursuant to the first three business development programs that the Company enters into on or before February 8, 2019 to research, develop, market or commercialize the Company’s ROCK2 program or the Company’s immuno ‑oncology program. For purposes of the separation agreement, ROCK2 program is defined to mean pathways involving ROCK2 or other pathways effecting inflammation , fibrosis, cancer or neurodegenerative diseases; immunooncology program is defined to mean antibodies or small molecules involved in inducing the immune system to make an anti ‑tumor response; and guaranteed cash payments is defined to mean payments to the Company of cash contractually provided for pursuant to an agreement entered into by the Company with respect to a business development program, which payments are not subject to the Company’s meeting any milestones or thresholds. If the aggregate cash and guaranteed cash payments received by the Company pursuant to any business development program exceed $800 million before the completion of the IPO, the equity market capitalization requirements that must be met for Dr. Samuel D. Waksal to earn the supplemental payments of up to $6.75 million described above shall be deemed fulfilled, regardless of the Company’s equity market capitalization at the applicable time. These conditional payments are not estimable or probable at December 31, 2017 as the Company is not able to determine if or when the Company will enter into these business development programs. The Company has not recorded any expense related to these conditional payments at December 31, 2017 and will continue to evaluate the probability of these conditional payments. LTIP EAR Unit Award In December 2014, Dr. Samuel D. Waksal received an award of EAR units under the 2014 LTIP with a base price of $6.00 per EAR unit (see description under “Executive Compensation” for the terms of our EAR units). The number of EAR units granted to Dr. Samuel D. Waksal was adjusted to equal 0.75% of our common stock determined on the first trading date following the date of the IPO. Based on the adjustments, the number of shares underlying Dr. Samuel D. Waksal’s LTIP award is 1,783,618 . The separation agreement provides that: · by virtue of his separation from the Company, Dr. Samuel D. Waksal acknowledges that he is no longer entitled to vesting at December 16, 2024 date but is eligible to vest based on a change in control or stock price increase, as described herein below; · the service component included in the vesting condition related to the occurrence of a change of control after an initial public offering but before December 16, 2024 is now satisfied; · the service component included in the vesting condition related to the occurrence of a 333% increase in the fair market value of each EAR unit from the $6.00 grant price per unit before December 16, 2024 is now satisfied; and · Dr. Samuel D. Waksal’s EAR units shall not be subject to forfeiture, termination or recapture payment for violation of the restrictive covenants contained in the 2014 LTIP. The compensation expense for this award was recognized upon consummation of the Company’s IPO on August 1, 2016 and was recorded as additional paid in capital . No compensation expense had been recorded prior to this date. The Company utilized a Monte-Carlo simulation to determine the fair value of the award granted under the LTIP of $11.6 million, which was recorded during the third quarter of 2016 as this award is not forfeitable. Lock ‑up Agreement Dr. Samuel D. Waksal has agreed to enter into a 180 ‑day lock ‑up agreement in connection with the IPO. If requested by the managing underwriters in any subsequent offering at the time of which Dr. Samuel D. Waksal owns five percent or more the Company’s common stock, he will enter into a lock ‑up agreement for a period not to exceed 90 days and in the form customarily requested by the managing underwriters for that offering (subject to mutually agreed exceptions), so long as other equityholders enter into substantially similar lock ‑up agreements. If any of our equityholders that signs a lock ‑up agreement is released from its provisions by the managing underwriters, Dr. Samuel D. Waksal will also be released from his lock ‑up agreement. Covenants The separation agreement contains customary non ‑solicitation, non ‑competition and non ‑disparagement provisions that continue in effect until February 8, 2019. In addition, Dr. Samuel D. Waksal agrees to make himself available, at the Company’s expense, to assist the Company in protecting its ownership of intellectual property and in accessing his knowledge of scientific and/or research and development efforts undertaken during his employment with the Company. Releases The separation agreement provides for mutual releases by the parties and related persons of all claims arising out of Dr. Samuel D. Waksal’s relationship with the Company as employee, founder, investor, member, owner, member or Chairman of the Board, Chief Executive Officer, or officer. Royalty Arrangements The Company has contracts with third parties, which require the Company to make royalty payments based on the sales revenue of the products specified in the contract. The Company records royalty expense as the associated sales are recognized, and classifies such amounts as selling, general and administrative expenses in the accompanying consolidated statements of operations. Royalty payable was $0.1 million and $2.5 million at December 31, 2017 and 2016 , respectively. These royalties are generally paid quarterly. Royalty expense was $0.1 million, $1.2 million and $2.7 million for the years ended December 31, 2017, 2016 and 2015 , respectively. Approximately $2.2 million of the royalty payable at December 31, 2016 is the prepaid royalty that was refunded to the Company’s commercial partner (Note 6). |
401(k) Profit-Sharing Plan
401(k) Profit-Sharing Plan | 12 Months Ended |
Dec. 31, 2017 | |
401(k) Profit-Sharing Plan [Abstract] | |
401(k) Profit-Sharing Plan | 15. 401(k) Profit ‑Sharing Plan In October 2011, the Company began sponsoring a qualified Tax Deferred Savings Plan (401(k)) for all eligible employees of the Company and its subsidiaries. Participation in the plan is voluntary. Participating employees may defer up to 75% of their compensation up to the maximum prescribed by the Internal Revenue Code. The Company has an obligation to match non ‑highly compensated employee contributions of up to 6% of deferrals and also has the option to make discretionary matching contributions and profit sharing contributions to the plan annually, as determined by the Company’s board of directors. The plan’s effective date is October 1, 2011 and incorporates funds converted from the Kadmon Pharmaceuticals Profit Sharing Plan. The Company expensed employer matching contributions of $0.2 million, $0.3 million and $0.3 million for the years ended December 31, 2017, 2016 and 2015 , respectively. The Company made disbursements of $0.3 million in each of the years e nded December 31, 2017 and 2016 . The Company typically disburses employer matching contributions during the first quarter following the plan year. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2017 | |
Commitments [Abstract] | |
Commitments | 16. Commitments Lease Commitments The Company has three primary operating locations which are occupied under long ‑term leasing arrangements. In October 2010, Kadmon Corporation, LLC entered into a corporate headquarters and laboratory lease in New York, New York, expiring in February 2021 and opened a secured letter of credit with a third party financial institution in lieu of a security deposit for $2.0 million. As of December 31, 2016, there were four amendments to this lease agreement, which altered office and laboratory capacity and extended the lease term through October 2024. On August 11, 2017, the Company entered into the fifth and sixth amendments for the corporate headquarters and laboratory lease in New York, New York. Pursuant to the terms of the amendments, the Company surrendered a portion of its laboratory space, made a surrender payment of approximately $1.1 million which equated to the Company’s deferred rent liability for the surrendered space, extended the term of the lease for an additional year through October 28, 2025, and received approximately $1.1 million in rent abatement beginning on September 1, 2017, which will be recognized straight-line over the remaining term of the lease. All other material terms of the lease remain intact. Rental expense for this lease amounted to $5.7 million, $6.4 million and $6.2 million for each of the years ended December 31, 2017, 2016 and 2015 . During future years, the base rent amount associated with these premises will increase 3.5% annually. The Company has the ability to extend portions of the lease on the same terms and conditions as the current lease, except that the base rent will be adjusted to the fair market rental rate for the building based on the rental rate for comparable space in the building at the time of extension. The Company is party to an operating lease in Warrendale, Pennsylvania (the Company’s specialty-focused commercial operation), which expires on September 30, 2019 , with a five ‑year renewal option. Rental payments under the renewal period will be at market rates determined from the average rentals of similar tenants in the same industrial park. Rental expense for this lease was $0.6 million for each of the years ended December 31, 2017, 2016 and 2015 , respectively. In August 2015, the Company entered into an office lease agreement in Cambridge, Massachusetts (the Company’s new clinical office) effective January 2016 and expiring in April 2023 . The Company opened a secured letter of credit with a third party financial institution in lieu of a security deposit for $91,000 . Rental expense for this lease was $0.3 million in each of the years ended December 31, 2017 and 2016 . No rental expense was incurred for this lease during the year ended December 31, 2015 . Future minimum rental payments under noncancellable leases are as follows (in thousands) at December 31, 2017 : Year ending December 31, Amount 2018 $ 4,579 2019 4,517 2020 4,049 2021 4,148 2022 4,286 Thereafter 11,884 Total $ 33,463 Licensing Commitments The Company has entered into several license agreements for products currently under development (Note 12). The Company may be obligated in future periods to make additional payments, which would become due and payable only upon the achievement of certain research and development, regulatory, and approval milestones. The specific timing of such milestones cannot be predicted and depends upon future discretionary clinical developments as well as regulatory agency actions which cannot be predicted with certainty (including action which may never occur). These additional contingent milestone payments aggregate to $400.4 million at December 31, 2017 . Any payments made prior to FDA approval will be expensed as research and development. Payments made after FDA approval will be capitalized. Further, under the terms of certain licensing agreements, the Company may be obligated to pay commercial milestones contingent upon the realization of sales revenues and sublicense revenues. Due to the long ‑range nature of such commercial milestones, they are neither probable at this time nor predictable, and consequently are not included in the additional contingent milestone payment amount. Employment Agreements Two former employees of the Company received $1.25 million each upon the consummation of the IPO, which the Company settled through the issuance of an aggregate of 208,334 shares of its common stock on August 1, 2016. The amount of compensation due to another former employee as a result of this event is contingent upon the valuation of the Company at the time of the transaction, which was not achieved upon consummation of the IPO on August 1, 2016. Certain employment agreements also provide for routine severance compensation. The Company has recorded a liability for such agreements of $1.2 million and $2.9 million at December 31, 2017 and 2016 , respectively , which is primarily attributable to the severance expense recognized in connection with the resi gnation of Dr. Samuel D. Waksal (Note 14). |
Contingencies
Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Contingencies [Abstract] | |
Contingencies | 17. Contingencies The Company is subject to various legal proceedings that arise from time to time in the ordinary course of its business. Although the Company believes that the various proceedings brought against it are without merit, and that it has adequate product liability and other insurance to cover any claims, litigation is subject to many factors which are difficult to predict and there can be no assurance that the Company will not incur material costs in the resolution of legal matters. Should the Company determine that any future obligations will exist, the Company will record expense equal to the amount which is deemed probable and estimable. Legal Proceedings The Glodek Litigation On July 25, 2016, Kevin Glodek filed and served a Summons with Notice against Kadmon Holdings, LLC and Kadmon Holdings, Inc. in the New York State Supreme Court, for the county of New York, for an amount of no less than $2.8 million with interest, plus costs and disbursements. Company counsel demanded a complaint and that complaint was served and filed on September 6, 2016. In the complaint, Glodek alleges fraud, misrepresentation, breach of contract, breach of the implied covenant of good faith and fair dealing, and unjust enrichment, for amounts to be determined at trial, but in no event less than $4 million with interest, plus costs and disbursements. Glodek’s claims arise out of a 2015 settlement agreement, in which he released all claims he had against Kadmon Holdings, LLC and Kadmon Holdings, Inc. On September 21, 2016, Glodek filed an Amended Summons and an Amended Complaint adding Steven N. Gordon and Mr. Poukalov as named defendants. All defendants moved (i) to dismiss the Amended Complaint and (ii) for sanctions or, in the alternative, to disqualify Glodek’s counsel. Argument on the motions was conducted on January 24, 2017 before the Honorable Anil Singh. On April 18, 2017, the complaint was dismissed in its entirety. Glodek filed a Notice of Appeal on May 18, 2017, and ha d 9 months within which to “perfect” his appeal by filing a brief and the record. Defendants filed a Notice of Cross Appeal on May 18, 2017 . Glodek has filed a motion to expand his time to perfect his appeal, which the defendants have opposed. |
Concentrations
Concentrations | 12 Months Ended |
Dec. 31, 2017 | |
Concentrations [Abstract] | |
Concentrations | 18. Concentrations Major Customers Sales to two major customers aggregate to approximately 29% , 41% and 31% of the Company’s net sales for the years ended December 31, 2017, 2016 and 2015 , respectively. Net accounts receivable from these customers totaled $0.1 at each of the years ended December 31, 2017 and 2016 . Major Suppliers Due to requirements of the U.S. Food and Drug Administration and other factors, the Company is generally unable to make immediate changes to its supplier arrangements. Manufacturing services related to each of the Company’s pharmaceutical products are primarily provided by a single source. The Company’s raw materials are also provided by a single source for each product. Management attempts to mitigate this risk through long ‑term contracts and inventory safety stock. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 19. Related Party Transactions At December 31, 2016, Kadmon I held approximately 12.1% of the total outstanding common stock of Kadmon Holdings. The sole manager of Kadmon I was an executive officer of the Company. Kadmon I has no special rights or preferences in connection with its investment into Kadmon Holdings, and had the same rights as all other holders of Kadmon Holdings Class A units. On January 23, 2017, Kadmon I, LLC was dissolved and liquidated. Upon dissolution and liquidation, all assets of Kadmon I, LLC which consists solely of the shares of common stock in Kadmon Holdings, Inc., were distributed to the members of Kadmon I, LLC. During 2014 the Chief Executive Officer and member, a family member of the Chief Executive Officer and member and an executive officer provided the Company with short ‑term, interest ‑free loans to meet operating obligations. During this time the maximum amount which was outstanding in the aggregate was $3.5 million and was recorded as a related party loan on the Company’s balance sheet. The $0.5 million related party loan with a family member of the Chief Executive Officer and member was settled in January 2015 through the issuance of 43,478 Class E redeemable convertible units. At December 31, 2015 , the $3.0 million related party loan with the Chief Executive Officer and director was still outstanding and was repaid in full during the fourth quarter of 2016. In April 2015, the Company executed several agreements which transferred the Company’s ownership of KGT to MeiraGTx, a then wholly ‑owned subsidiary of the Company. The execution of all these agreements resulted in a 48% ownership in MeiraGTx by the Company, or a $24.0 million equity investment at the time of the initial transaction (Note 12). In July and August 2015, a family member of the Chief Executive Officer and member provided the Company with interest ‑free loans totaling $2.0 million. The loans were repaid in full in August 2015. In September 2015, the Company entered into an agreement with GoldenTree Asset Management LP and certain of its affiliated entities in connection with (i) a settlement of certain claims alleging breaches of a letter agreement between the Company and such entities relating to a prior investment by such entities in the Company’s securities, which letter agreement was terminated as part of this settlement and (ii) participation by such entities in an aggregate amount of $15.0 million in the 2015 Credit Agreement, including the warrants issued in connection therewith, and the Senior Convertible Term Loan (the GoldenTree Agreement). Subject to certain terms and conditions contained therein, the GoldenTree Agreement provided GoldenTree Asset Management LP and certain of its affiliated entities with certain most favored nation rights, anti ‑dilution protections including the issuance of additional Class E redeemable convertible membership units with a conversion price equal to any down round price and a right to appoint a member of the Company’s board of directors, among other things. The aforementioned rights terminated upon the closing of the IPO on August 1, 2016. In June 2016, the Company entered into an agreement with 72 KDMN Investments, LLC whereby the Company agreed to extend certain rights to 72 KDMN Investments, LLC which shall survive closing of the IPO, including board of director designation rights and confidentiality rights, subject to standard exceptions. In addition, the Company agreed to provide 72 KDMN Investments, LLC with most favored nation rights which terminated upon the closing of the IPO on August 1, 2016. Andrew B. Cohen, a former member of our board of directors, is an affiliate of 72 KDMN. In January 2017, Mr. Cohen resigned from the Company’s board of directors and the Company received notice that 72 KDMN forfeits, relinquishes and waives any and all rights it has to designate a director to the Company’s board of directors. In June 2016, Dr. Harlan W. Waksal, the Company’s President and Chief Executive Officer, certain entities affiliated with GoldenTree Asset Management LP, Bart M. Schwartz, the chairman of the Company’s board of directors, 72 KDMN and D. Dixon Boardman, a member of the Company’s board of directors, subscribed for 86,957 , 43,479 , 21,740 , 86,957 and 21,740 of the Company’s Class E redeemable convertible units, respectively, at a value of $11.50 per unit. In June 2016, the Company entered into certain agreements with Falcon Flight LLC and one of its affiliates in connection with a settlement of certain claims alleging breaches of a letter agreement between the Company and Falcon Flight LLC relating to a prior investment by Falcon Flight LLC and its affiliate in the Company’s securities, which letter agreement was amended and restated as part of this settlement, which, together with a supplemental letter agreement, we refer to as the Falcon Flight Agreement. Subject to certain terms and conditions contained therein, the Falcon Flight Agreement provides Falcon Flight LLC and its affiliate with certain most favored nation rights, information rights, consent rights, anti ‑dilution protections including the issuance of 1,061,741 additional Class E redeemable convertible membership units with a conversion price equal to any down ‑round price, a right to designate a member of the Company’s board of then managers or observer and notice requirements with respect to any waivers by the underwriters in connection with lock ‑up agreements, among other things. The aforementioned rights terminated upon the closing of the IPO on August 1, 2016, except for indemnification of Falcon Flight LLC’s board designee or observer, which survives termination. In addition, the Company agreed to pay $0.5 million to Falcon Flight LLC within one business day following the consummation of the IPO, and $0.3 million within sixty days following the consummation of the IPO. The Company recorded an estimate for this settlement of approximately $10.4 million in September 2015 and recorded an additional expense of $2.6 million in June 2016 based on the excess of the fair value of this settlement over the $10.4 million previously expensed in 2015. Certain of the Company’s existing institutional investors, including investors affiliated with certain of the Company’s directors, purchased an aggregate of 2,708,332 shares of the Company’s common stock in its IPO at the IPO price of $12.00 per share, for an aggregate purchase price of $32.5 million, and on the same terms as the shares that were sold to the public generally. Perceptive Advisors, LLC, Third Point Partners, LLC. and GoldenTree purchased 1,458,333 shares of the Company’s common stock for $17.5 million, 1,041,666 shares of the Company’s common stock for $12.5 million and 208,333 shares of the Company’s common stock for $2.5 million, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Taxes [Abstract] | |
Income Taxes | 20. Income Taxes The Company files U.S. federal and state tax return s for Kadmon Holdings, Inc. and the required information returns for its international subsidiaries, all of which are wholly owned. The Company recorded an income tax benefit of $0.1 million for the year ended December 31, 2017 , related to a $0.4 million adjustment to the deferred tax liability, as explained below, net of $0.3 million of income tax expense related to a $2.0 million milestone payment received from Jinghua. The Company recorded income tax expense of $0.3 million for the year ended December 31, 2016 , related to a $2.0 million milestone payment received from Jinghua . The Company recorded an immaterial amount of income tax benefit for the year ended December 31, 2015. The Tax Cuts and Jobs Act (the “Act”) was enacted in December 2017. The Act reduces the U.S. federal corporate tax rate from 35 percent to 21 percent, requires companies to pay a one-time transition tax on earnings of certain foreign subsidiaries that were previously tax deferred, creates new taxes on certain foreign earnings and reduces the orphan drug tax credit. The Company recognized a deferred income tax benefit of $0.4 million for the year ended December 31, 2017 due to the write-down of a deferred tax liability related to the reduction of the corporate income tax rate per the Act . The income tax provision consists of the following components (in thousands): For the Year Ended December 31, 2017 2016 2015 Current tax expense (benefit) Foreign $ 316 $ 315 $ — Federal — — — State — — — Total current tax expense 316 315 — Deferred tax expense (benefit) Federal (485) (15) 1 State 48 42 (4) Total deferred tax benefit (437) 27 (3) Total income tax expense (benefit) $ (121) $ 342 $ (3) The income tax expense (benefit) differs from the expense (benefit) that would result from applying federal statutory rates to loss before income taxes as follows (in thousands): For the Year Ended December 31, 2017 2016 2015 Amount Rate Amount Rate Amount Rate Expected federal statutory income tax $ (27,821) -35.0% $ (72,945) -35.0% $ (51,480) -35.0% State income taxes, net of federal benefits (8,314) -10.5% (9,485) -4.6% (4,544) -3.1% Change in federal tax rate used for deferred purposes 112,611 141.7% 200 0.1% 972 0.7% Adjustment to deferred tax assets 15,210 19.1% — 0.0% (6,492) -4.4% Change in valuation allowance (91,807) -115.5% 82,572 39.6% 61,541 41.8% Income tax expense (benefit ) $ (121) -0.2% $ 342 0.1% $ (3) 0.0% Deferred income tax expense (benefit) results primarily from the timing of temporary differences between the tax and financial statement carrying amounts of goodwill. The net deferred tax asset and liability in the accompanying consolidated balance sheets consists of the following components (in thousands): For the Year Ended December 31, 2017 2016 Deferred tax assets Net operating loss carryforward $ 112,289 $ 171,074 Foreign tax credit carryforward 631 315 Capitalized research and development 66,500 78,147 Share-based compensation 18,735 22,233 Loss on equity investment 6,294 5,900 Organization costs 30 46 Depreciation 772 1,050 Intangibles 30,788 47,595 Inventory reserve and other 2,145 3,631 Total deferred tax assets 238,184 329,991 Deferred tax liability Goodwill (939) (1,376) Total deferred tax liability (939) (1,376) Total deferred tax assets, net 237,245 328,615 Valuation allowance (238,184) (329,991) Deferred tax liability $ (939) $ (1,376) At December 31, 2017 , the Company has unused federal and state net operating loss carry-forwards of $419.2 million and $362.0 million, respectively, that may be applied against future taxable income. These carry-forwards expire at various dates through December 31, 203 7 . The Company experienced ownership changes under Internal Revenue Code Section 382 in 2010, 2011 and 2016, which limits the Company’s ability to utilize net operating loss carry-forwards. The Company did not reduce the gross deferred tax assets related to the net operating loss carry-forwards, however, because the limitations do not hinder the Company’s ability to potentially utilize all of the net operating loss carry-forwards. In accordance with ASC 740, “Income Taxes,” the Company recorded a valuation allowance to fully offset the gross deferred tax asset, because it is more likely than not that the Company will not realize future benefits associated with these deferred tax assets at December 31, 2017 and 2016 . The change in deferred tax liability has been recognized as an income tax benefit in the consolidated statements of operations for the years ended December 31, 2017 and 2015 and as income tax expense for the year ended December 31, 201 6 . The federal income tax return for the period of September 16, 2010 through December 31, 2010 was audited by the Internal Revenue Service during 2012 and early 2013. As a result of the audit, the Company’s operating loss carry-forwards were reduced by $1.4 million, which is reflected in the table above. The Company follows guidance on accounting for uncertainty in income taxes which prescribes a minimum threshold a tax position is required to meet before being recognized in the financial statements. The Company does not have any liabilities as of December 31, 201 7 and 201 6 to account for potential income tax exposure. The Company is obligated to file income tax returns in the U.S. federal jurisdiction and several U.S. States. Since the Company had losses in the past, all prior years that generated net operating loss carry-forwards are open and subject to audit examination in relation to the net operating loss generated from those years. |
Quarterly Financial Data
Quarterly Financial Data | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Data [Abstract] | |
Quarterly Financial Data | 2 1 . Quarterly Financial Data (unaudited) The following table presents our unaudited quarterly financial data. Our quarterly results of operations for these periods are not necessarily indicative of our future results of operations. Three Months Ended Three Months Ended Three Months Ended Three Months Ended (in thousands, December 31, September 30, June 30, March 31, except per share data) 2017 2016 2017 2016 2017 2016 2017 2016 Net sales $ 187 $ 3,010 $ 1,036 $ 4,345 $ 1,698 $ 4,967 $ 2,336 $ 6,192 License and other revenue 1,277 1,267 1,241 1,350 1,259 1,453 3,230 3,471 Total revenue 1,464 4,277 2,277 5,695 2,957 6,420 5,566 9,663 Cost of sales 222 640 277 880 266 880 567 1,085 Write-down of inventory (22) 119 933 129 373 2 370 135 Gross profit 1,264 3,518 1,067 4,686 2,318 5,538 4,629 8,443 Operating expenses: Research and development 10,499 8,539 11,775 9,631 10,056 8,587 8,447 9,083 Selling, general and administrative 7,916 14,620 9,121 48,426 9,902 19,148 10,118 23,686 Gain on settlement of payable — — — (256) — — — (3,875) Total operating expenses 18,415 23,159 20,896 57,801 19,958 27,735 18,565 28,894 Loss from operations (17,151) (19,641) (19,829) (53,115) (17,640) (22,197) (13,936) (20,451) Total other expense 1,476 1,716 1,874 64,049 4,674 14,837 3,315 12,407 Income tax expense (benefit) (437) 27 — — — — 316 315 Net loss (18,190) (21,384) (21,703) (117,164) (22,314) (37,034) (17,567) (33,173) Deemed dividend on convertible preferred stock and Class E redeemable convertible units 490 469 490 21,264 469 — 469 — Net loss attributable to common stockholders (18,680) (21,853) (22,193) (138,428) (1) (22,783) (37,034) (18,036) (33,173) Basic and diluted net loss per share of common stock $ (0.24) $ (0.48) $ (0.42) $ (4.24) $ (0.44) $ (4.46) $ (0.39) $ (4.00) Weighted average basic and diluted shares of common stock outstanding 78,397,156 45,078,666 52,572,880 32,678,259 (2) 51,846,521 8,304,334 46,507,435 8,302,635 (1) Net loss attributable to common stockholders for the three months ended September 30, 2016 includes the beneficial conversion feature of the Company’s debt upon conversion into shares of the Company’s common stock on August 1, 2016 of $44.2 million, the beneficial conversion feature of certain outstanding warrants which became exercisable into shares of the Company’s common stock on August 1, 2016 of $1.7 million, the deemed dividends on the Company’s convertible preferred stock and Class E redeemable convertible units of $20.9 million and share-based compensation expense related to the Company’s LTIP of $22.6 million. (2) Weighted average basic and diluted shares of common stock outstanding for the three months ended September 30, 2016 includes shares issued as a result of the Corporate Conversion (Note 1). |
Summary of Significant Accoun29
Summary of Significant Accounting Policies (Policy) | 12 Months Ended |
Dec. 31, 2017 | |
Summary of Significant Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company operates in one segment considering the nature of the Company’s products and services, class of customers, methods used to distribute the products and the regulatory environment in which the Company operates. |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The consolidated financial statements include the accounts of Kadmon Holdings, Inc. and its domestic and international subsidiaries, all of which are wholly owned. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Actual results could differ from those estimates. |
Company Valuation | Company Valuation To estimate certain expenses and record certain transactions, it was necessary for the Company to estimate the fair value of its membership units. Given the absence of a public trading market prior to the IPO, and in accordance with the American Institute of Certified Public Accountants’ Practice Guide, “Valuation of Privately ‑Held ‑Company Equity Securities Issued as Compensation”, the Company exercised reasonable judgment and considered numerous objective and subjective factors to determine its best estimate of the fair value of its membership units (Note 4). |
Revenue Recognition | Revenue Recognition The Company recognizes sales when the risk of loss has been transferred to the customer. As is typical in the pharmaceutical industry, gross product sales are subject to a variety of deductions, primarily representing rebates, chargebacks, returns, and discounts to government agencies, wholesalers, and managed care organizations. These deductions represent management’s best estimates of the related reserves and, as such, judgment is required when estimating the impact of these sales deductions on gross sales for a reporting period. If estimates are not representative of the actual future settlement, results could be materially affected. The Company’s product sales were substantially derived from the sale of its ribavirin portfolio of products during the years ended December 31, 2017, 2016 and 2015 . The Company accounts for revenue arrangements that contain multiple deliverables in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), Topic 605 ‑25, “Revenue Recognition for Arrangements with Multiple Elements”, which addresses the determination of whether an arrangement involving multiple deliverables contains more than one unit of accounting. A delivered item within an arrangement is considered a separate unit of accounting only if both of the following criteria are met: · the delivered item has value to the customer on a stand ‑alone basis; and · the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in control of the vendor. In accordance with FASB ASC Topic 605 ‑25, if both of the criteria above are not met, then separate accounting for the individual deliverables is not appropriate. Revenue recognition for arrangements with multiple deliverables constituting a single unit of accounting is recognized generally over the greater of the term of the arrangement or the expected period of performance, either on a straight ‑line basis or on a modified proportional performance method. Non ‑refundable license fees are recognized as revenue when the Company has a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the receivable is reasonably assured and the Company has no future performance obligations under the license agreement. The Company may earn contingent payments from third parties based on the achievement of certain clinical and commercial milestones. The Company recognizes milestone revenue as the underlying criteria is achieved in accordance with FASB ASC Topic 605 ‑28, “Revenue Recognition Milestone Method”. The Company reassesses the period of performance over which the Company recognizes deferred upfront license fees and makes adjustments as appropriate in the period in which a change in the estimated period of performance is identified. In the event a licensee elects to discontinue development of a specific product candidate under a single target license, but retains its right to use the Company’s technology to develop an alternative product candidate to the same target or a target substitute, the Company would cease amortization of any remaining portion of the upfront fee until there is substantial pre ‑clinical activity on another product candidate and its remaining period of substantial involvement can be estimated. In the event that a single target license were to be terminated, the Company would recognize as revenue any portion of the upfront fee that had not previously been recorded as revenue, but was classified as deferred revenue, at the date of such termination or through the remaining substantial involvement in the wind down of the agreement. |
Foreign Revenue | Foreign Revenue Foreign product sales represented approximately 26.9% , 8.6% and 10% of total product sales for the years ended December 31, 2017, 2016 and 2015 , respectively, the majority of which were to the Netherlands and Ireland. |
Sales Returns Reserve | Sales Returns Reserve Revenue is recognized net of sales returns, which are estimated using the Company’s historical experience. The sales returns reserve was $0.6 million and $0.4 million at December 31, 2017 and 2016 , respectively. Sales returns expense was $0.6 million, $0.9 million and $0.7 million for the years ended December 31, 2017, 2016 and 2015 , respectively . Actual results could differ from original estimates resulting in future adjustments to revenue. |
Reserve for Wholesaler Chargebacks and Rebates | Reserve for Wholesaler Chargebacks and Rebates The Company maintains a reserve for wholesaler chargebacks and rebates to properly reflect the realizable value of accounts receivable. A chargeback represents a contractual allowance provided by the Company to its wholesalers for any variances between wholesale and lower retail prices of the Company’s pharmaceutical products. The Company estimates the reserve for wholesaler chargebacks based on wholesaler inventory levels, contract prices and historical experience. Rebate reserves represent contractual allowances based on specific customer contracts. The rebate allowance is estimated as a percentage of specific customer sales. The reserve for wholesaler chargebacks and rebates was $ 0.2 million and $0.1 million at December 31, 2017 and 2016 , respectively. Wholesaler c hargebacks and r ebates expense was $0. 3 million, $0. 5 million and $ 1.0 million for the years ended December 31, 2017, 2016 and 2015 , respectively . |
Rebates Payable | Rebates Payable The Company issues rebates related to various government programs and buying groups. In these instances, the rebates are paid in cash to the party managing the discount buying program. The estimated rebates earned but unpaid was $0.3 million and $0.4 million at December 31, 2017 and 2016 , respectively. Such amounts have been included in accounts payable on the Company’s consolidated balance sheets. R ebates expense was $0. 7 million, $0. 8 million and $ 1.2 million for the years ended December 31, 2017, 2016 and 2015 , respectively . |
Shipping and Handling Costs | Shipping and Handling Costs Shipping and handling costs for raw materials and finished goods prior to their sale are classified in cost of sales. Freight charges for shipments to customers are not billed to customers and are included in selling, general and administrative expenses when incurred and were $0.1 million , $0.2 million and $0.3 million for the years ended December 31, 2017, 2016 and 2015 , respectively. |
Foreign Currencies | Foreign Currencies The consolidated financial statements are presented in U.S. dollars, the reporting currency of the Company. Gains or losses on transactions denominated in a currency other than the Company’s functional currency, which arise as a result of changes in foreign currency exchange rates, are recorded in other income on the consolidated statements of operations. The transaction gains (loss) were ( $25,000 ), $9,000 and $124,000 for the years ended December 31, 2017, 2016 and 2015 , respectively. |
Share-based Compensation Expense | Share ‑based Compensation Expense The Company recognizes share ‑based compensation expense in accordance with FASB ASC Topic 718, “Stock Compensation” (“ASC 718”), for all share ‑based awards made to employees and board members based on estimated fair values. ASC 718 requires companies to measure the cost of employee services incurred in exchange for the award of equity instruments based on the estimated fair value of the share ‑based award on the grant date. The expense is recognized over the requisite service period. All share ‑based awards to non ‑employees are accounted for in accordance with FASB ASC Topic 505 ‑50, “Equity Based Payments to Non ‑Employees,” where the value of unit compensation is based on the measurement date, as determined at either a) the date at which a performance commitment is reached, or b) the date at which the necessary performance to earn the equity instruments is complete. The Company uses a Black ‑Scholes option ‑pricing model to value the Company’s option awards. Using this option ‑pricing model, the fair value of each employee and board member award is estimated on the grant date. The fair value is expensed on a straight ‑line basis over the vesting period. The option awards generally vest pro ‑rata annually. The expected volatility assumption is based on the volatility of the share price of comparable public companies. The expected life is determined using the “simplified method” permitted by Staff Accounting Bulletin Numbers 107 and 110 (the midpoint between the term of the agreement and the weighted average vesting term). The risk ‑free interest rate is based on the implied yield on a U.S. Treasury security at a constant maturity with a remaining term equal to the expected term of the option granted. The dividend yield is zero, as the Company has never declared a cash dividend. In the fourth quarter of 2016, the Company adopted ASU 2016 ‑09, “ Compensation—Stock Compensation ” . ASU 2016-09 requires that certain other amendments relevant to the Company be applied using a modified-retrospective transition method by means of a cumulative-effect adjustment to accumulated deficit as of the beginning of the period in which the guidance is adopted. As a result of adopting ASU 2016-09 during the three months ended December 31, 2016, the Company adjusted accumulated deficit for amendments related to an entity-wide accounting policy election to recognize share-based award forfeitures only as they occur rather than an estimate by applying a forfeiture rate. The Company recorded a $2.0 million charge to accumulated deficit as of January 1, 2016 and an associated credit to additional paid-in capital for previously unrecognized share-based compensation expense as a result of applying this policy election. The Company also recorded $0.8 million in additional share-based compensation expense during the fourth quarter of 2016 as a result of applying estimated forfeitures recorded during the nine m onths ended September 30, 2016. ASU 2016-09 also requires the recognition of the income tax effects of awards in the consolidated statement of operations when the awards vest or are settled, thus eliminating addition paid-in capital pools. The Company elected to adopt the amendments related to the presentation of excess tax benefits on the condensed consolidated statement of cash flows using a prospective transition method. Modification of Awards A change in any of the terms or conditions of the awards is accounted for as a modification of the award. Incremental compensation cost is measured as the excess, if any, of the fair value of the modified award over the fair value of the original award immediately before its terms are modified, measured based on the fair value of the awards and other pertinent factors at the modification date. For vested awards, the Company recognizes incremental compensation cost in the period the modification occurs. For unvested awards, if the award is probable of vesting both before and after the change, the Company recognizes the sum of the incremental compensation cost and the remaining unrecognized compensation cost for the original award on the modification date over the remaining requisite service period. If the fair value of the modified award is lower than the fair value of the original award immediately before modification, the minimum compensation cost the Company recognizes is the cost of the original award. |
Research and Development | Research and Development Innovation is critical to the success of the Company, and drug discovery and development are time ‑consuming, expensive and unpredictable. The Company has built a pipeline of therapeutic candidates in all stages of development. The focus is on serious diseases where there is a great need and opportunity for innovative medicines. Product candidates and development strategies contemplate both immediate possibilities in medicine, such as reducing toxicity or addressing certain disease resistance and mutation, and future possibilities and medical needs. Included in research and development expense are personnel related costs, expenditures for laboratory equipment and consumables, payments made pursuant to licensing and acquisition agreements, and the cost of conducting clinical trials. Expenses incurred associated with conducting clinical trials include, but are not limited to, dosing of patients with clinical drug candidates, assistance from third party consultants and other industry experts, accumulation and interpretation of data on drug safety and efficacy, and manufacturing of active pharmaceutical ingredients and placebos for use within the clinical trial. The Company has entered into agreements with third parties to acquire technologies and pharmaceutical product candidates for development (Note 12). Such agreements generally require an initial payment by the Company when the contract is executed, and additional payments upon the achievement of certain milestones. Additionally, the Company may be obligated to make future royalty payments in the event the Company commercializes the pharmaceutical product candidate and achieves a certain sales volume. In accordance with FASB ASC Topic 730 ‑10 ‑55, “Research and Development”, expenditures for research and development, including upfront licensing fees and milestone payments associated with products that have not yet been approved by the FDA, are charged to research and development expense as incurred. Future contract milestone payments will be recognized as expense when achievement of the milestone is determined to be probable. Once a product candidate receives regulatory approval, subsequent license payments are recorded as an intangible asset. Research and development expense was $40.8 million, $35.8 million and $33.6 million during the years ended December 31, 2017, 2016 and 2015 , respectively. |
Income Taxes | Income Taxes The Company accounts for income taxes in accordance with the asset and liability method of accounting for income taxes prescribed by FASB ASC Topic 740, “Accounting for Income Taxes” (“ASC 740”). Under the asset and liability method of ASC 740, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to the taxable income in the years in which those temporary differences are expected to be recovered or settled. Under ASC 740, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment dates. The Company follows FASB ASC Topic 740 ‑10, “Accounting for Uncertainty in Income Taxes”, which prescribes a recognition threshold and measurement attribute for financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. At December 31, 2017 and 2016 , the Company had no material uncertain tax positions to be accounted for in the financial statements. The Company recognizes interest and penalties, if any, related to unrecognized tax benefits in interest expense. Under ASU 2016-09, all excess tax benefits and tax deficiencies (including tax benefits of dividends on share-based payment awards) should be recognized as income tax expense or benefit in the statement of operations. The tax effects of exercised or vested awards should be treated as discrete items in the reporting period in which they occur. An entity also should recognize excess tax benefits regardless of whether the benefits reduce tax payable in the current period. The Company made an early adoption on the ASU 2016-09 effect in the fourth quarter of 2016. There was no cumulative impact as the federal and state excess deductions would be offset by a corresponding change to the valuation allowance. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents are comprised of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase. At times, cash balances deposited at major financial banking institutions exceed the federally insured limit. The Company regularly monitors the financial condition of the institutions in which it has depository accounts and believes the risk of loss is minimal. |
Restricted Cash | Restricted Cash The Company has a lease agreement for the premises it occupies in New York. A secured letter of credit in lieu of a lease deposit totaling $2.0 million is secured by restricted cash in the same amount at December 31, 2017 and 2016 . The secured letter of credit will remain in place for the life of the related lease, expiring in October 2024 (Note 16). The Company also has a lease agreement for the premises it occupies in Massachusetts. A secured letter of credit in lieu of a lease deposit totaling $91,000 was established during the third quarter of 2015 and is secured by restricted cash in the same amount at December 31, 2017 and 2016 . The secured letter of credit will remain in place for the life of the related lease, expiring in April 2023 (Note 16). |
Allowance for Doubtful Accounts | Allowance for Doubtful Accounts The Company reviews the collectability of accounts receivable based on an assessment of historical experience, current economic conditions, and other collection indicators. The Company has recorded an allowance for doubtful accounts of $0.7 million at both December 31, 2017 and 2016 . Adjustments to the allowance for doubtful accounts are recorded to selling, general and administrative expenses, and amounted to $3,000 , $6,000 , and $5,000 for the years ended December 31, 2017, 2016 and 2015 , respectively. When accounts are determined to be uncollectible they are written off against the reserve balance and the reserve is reassessed. When payments are received on reserved accounts they are applied to the customer’s account and the reserve is reassessed. |
Inventories | Inventories Inventories are stated at the lower of cost or market (on a first ‑in, first ‑out basis) using standard costs. Standard costs include an allocation of overhead rates, which include those costs attributable to managing the supply chain and are evaluated regularly. Variances are expensed as incurred. |
Investments | Investments The Company follows FASB ASC Topic 323, “Investments—Equity Method and Joint Ventures” (“ASC 323”), in accounting for its investment in a joint venture. In the event the Company’s share of the joint venture’s net losses reduces the Company’s investment to zero, the Company will discontinue applying the equity method and will not provide for additional losses unless the Company has guaranteed obligations of the joint venture or is otherwise committed to provide further financial support for the joint venture. If the joint venture subsequently reports net income, the Company will resume applying the equity method only after its share of that net income equals the share of net losses not recognized during the period the equity method was suspended. The Company follows FASB ASC Topic 325, “Investments—Other” (“ASC 325”), in accounting for its investment in the stock of another company. In the event further contributions or additional shares are purchased, the Company will increase the basis in the investment. In the event distributions are made or indications exist that the fair value of the investment has decreased below the carrying amount, the Company will decrease the value of the investment as considered appropriate. The Company’s total investment balance totaled $3.5 million and $11.1 million at December 31, 2017 and 2016 , respectively. For all non ‑consolidated investments, the Company will continually assess the applicability of FASB ASC Topic 810, “Consolidation” (“ASC 810”), to determine if the investments qualify for consolidation. At December 31, 2017 and 2016 , no such investments qualified for consolidation (Note 12). |
Fixed Assets | Fixed Assets Fixed assets are recorded at cost and depreciated over their estimated useful lives. Leasehold improvements are amortized over the shorter of their estimated useful lives or the lease term, using the straight ‑line method. Construction ‑in ‑progress and software under development are stated at cost and not depreciated. These items are transferred to fixed assets when the assets are placed into service. |
Intangible Assets | Intangible Assets Intangible assets are stated at cost, less accumulated amortization. The Company accounts for the purchases of intangible assets in accordance with FASB ASC Topic 350 “Intangibles—Goodwill and Other”. Intangible assets are recognized based on their acquisition cost. The assets will be tested for impairment at least once annually, if determined to have an indefinite life, or whenever events or changes in circumstances indicate that the carrying amount may no longer be recoverable. If any of the Company’s intangible or long ‑lived assets are considered to be impaired, the amount of impairment to be recognized is the excess of the carrying amount of the assets over its fair value. Applicable long ‑lived assets, including intangible assets with definitive lives, are amortized or depreciated over the shorter of their estimated useful lives, the estimated period that the assets will generate revenue, or the statutory or contractual term in the case of patents. Estimates of useful lives and periods of expected revenue generation are reviewed periodically for appropriateness and are based upon management’s judgment. |
Goodwill | Goodwill The Company’s goodwill relates to the 2010 acquisition of Kadmon Pharmaceuticals, a Pennsylvania limited liability company that was formed in April 2000. Goodwill is not amortized, but rather is assessed for impairment annually or upon the occurrence of an event that indicates impairment may have occurred, in accordance with FASB ASC Topic 350 “Intangibles—Goodwill and Other”. No impairment to goodwill was recorded during the years ended December 31, 2017, 2016 and 2015 . |
Impairment of Long Lived Assets | Impairment of Long ‑Lived Assets Long ‑lived assets, such as intangible assets (other than goodwill) and fixed assets, are evaluated for impairment periodically, or when events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. When any such impairment exists, a charge is recorded in the statement of operations to adjust the carrying value of the related assets. The Company performed a trigger analysis over all other long ‑lived assets at the lowest identifiable level of cash flows and determined that an impairment existed during the year ended December 31, 2015 (Note 11) and no impairment triggers existed during the years ended December 31, 2017 and 2016 . An impairment of $31.3 million was recognized during the year ended December 31, 2015, while no such impairment was recognized during the years ended December 31, 2017 and 2016 (Note 11). |
Accounting for Leases | Accounting for Leases The Company recognizes rent expense for operating leases as of the earlier of the possession date or the lease commencement date. Rental expense, inclusive of rent escalations, rent holidays, concessions and tenant allowances are recognized over the lease term on a straight ‑line basis. See Note 16 for a further discussion of operating leases. The Company has entered into capital lease agreements for information technology and laboratory equipment. Amortization expense for capital lease agreements is included in depreciation and amortization of fixed assets. As a result of these leases, the Company capitalized $208,000 , $230,000 and $20,000 as office equipment and furniture during the years ended December 31, 2017, 2016 and 2015 , respectively. The unamortized portion of capital leases totaled $270,000 and $191,000 at December 31, 2017 and 2016 , respectively. |
Accounting for Contingencies | Accounting for Contingencies The Company follows the guidance of FASB ASC Topic 450, “Contingencies” (“ASC 450”), in accounting for contingencies. If some amount within a range of loss is probable and appears at the time to be a better estimate than any other amount within the range, that amount shall be expensed. If a loss is probable, and no amount within the range is a better estimate than any other amount, the estimated minimum amount in the range shall be expensed. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company follows the provisions of FASB ASC Topic 820, “Fair Value Measurements and Disclosures” (“ASC 820”). This pronouncement defines fair value, establishes a framework for measuring fair value under GAAP and requires expanded disclosures about fair value measurements. ASC 820 emphasizes that fair value is a market ‑based measurement, not an entity ‑specific measurement, and defines fair value as the price to sell an asset or transfer a liability in an orderly transaction between market participants at the measurement date. ASC 820 discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow) and the cost approach (cost to replace the service capacity of an asset or replacement cost). These valuation techniques are based upon observable and unobservable inputs. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect the Company’s market assumptions. ASC 820 utilizes a fair value hierarchy that prioritizes inputs to fair value measurement techniques into three broad levels. The following is a brief description of those three levels: · Level 1: Observable inputs such as quoted prices for identical assets or liabilities in active markets. · Level 2: Observable inputs other than quoted prices that are directly or indirectly observable for the asset or liability, including quoted prices for similar assets or liabilities in active markets; quoted prices for similar or identical assets or liabilities in markets that are not active; and model ‑derived valuations whose inputs are observable or whose significant value drivers are observable. · Level 3: Unobservable inputs that reflect the reporting entity’s own assumptions. The fair value of cash and cash equivalents, accounts receivable and accounts payable approximate their carrying amounts due to their short term nature ( Note 8 ). |
Loan Modifications and Extinguishments | Loan Modifications and Extinguishments The Company follows the provisions of FASB ASC Subtopic 470 ‑50 “Debt Modifications and Extinguishments” (“ASC 470 ‑60”) and ASC Subtopic 470 ‑60, “Troubled Debt Restructurings by Debtors” (“ASC 470 ‑60”). Under ASC 470 ‑50, an exchange of debt instruments between or a modification of a debt instrument by a debtor and a creditor in a nontroubled debt situation is deemed to have been accomplished with debt instruments that are substantially different if the present value of the cash flows under the terms of the new debt instrument is at least 10 percent different from the present value of the remaining cash flows under the terms of the original instrument. If the terms of a debt instrument are changed or modified and the cash flow effect on a present value basis is less than 10 percent, the debt instruments are not considered to be substantially different, except in the following two circumstances: · A modification or an exchange affects the terms of an embedded conversion option, from which the change in the fair value of the embedded conversion option (calculated as the difference between the fair value of the embedded conversion option immediately before and after the modification or exchange) is at least 10 percent of the carrying amount of the original debt instrument immediately before the modification or exchange. · A modification or an exchange of debt instruments adds a substantive conversion option or eliminates a conversion option that was substantive at the date of the modification or exchange. Under ASC 470 ‑60, a restructuring of a debt constitutes a troubled debt restructuring for purposes of this Subtopic if the creditor for economic or legal reasons related to the debtor’s financial difficulties grants a concession to the debtor that it would not otherwise consider. |
Warrants and Derivative Liabilities | Warrants and Derivative Liabilities The Company accounts for its derivative financial instruments in accordance with FASB ASC Topic 815, “Derivatives and Hedging” (“ASC 815”). The Company does not have derivative financial instruments that are hedges. ASC 815 establishes accounting and reporting standards requiring that derivative instruments, both freestanding and embedded in other contracts, be recorded on the balance sheet as either an asset or liability measured at its fair value each reporting period. ASC 815 also requires that changes in the fair value of derivative instruments be recognized currently in the results of operations unless specific criteria are met. For embedded features that are not clearly and closely related to the host instrument, are not carried at fair value, and are derivatives, the feature will be bifurcated and recorded as an asset or liability as noted above, unless the exceptions below are not met. Freestanding instruments that do not meet these exceptions will be accounted for in the same manner. ASC 815 provides an exception—if an embedded derivative or freestanding instrument is both indexed to the company’s own units and classified in members’ units, it can be accounted for in members’ unit. If at least one of the criteria is not met, the embedded derivative or warrant is classified as an asset or liability and recorded to fair value each reporting period through the income statement. The Company assesses classification of our warrants, other freestanding derivatives, and embedded features at each reporting date to determine whether a change in classification is required. The Company’s accounting for its embedded features, the warrants and the success fee, are explained further in Note 8. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-09, Compensation – Stock Compensation , which clarifies the guidance about which changes to the terms and conditions of a share-based payments award require an entity to apply modification accounting in Topic 718. This ASU is effective for annual or any interim periods beginning after December 15, 2017. Early adoption is permitted, including adoption in any interim period. The Company does not expect the standard to have a significant impact on its consolidated financial statements as the fair value of the Company’s modified awards is immaterial . In January 2017, the FASB issued ASU No. 2017-04, Intangibles – Goodwill and Other (“ASU 2017-04”), which simplifies the subsequent measurement of goodwill by eliminating “Step 2” from the goodwill impairment test. Instead of performing Step 2 to determine the amount of an impairment charge, the fair value of a reporting unit will be compared with its carrying amount and an impairment charge will be recognized for the value by which the carrying amount exceeds the reporting unit’s fair value. ASU 2017-04 is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company does not expect the standard to have a significant impact on its consolidated financial statements as the Company’s goodwill balance is immaterial . In November 2016, the FASB issued ASU No. 2016-18, “ Statement of Cash Flows (Topic 230): Restricted Cash ”. This ASU requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Entities will also be required to reconcile such total amounts on the balance sheet and disclose the nature of the restrictions. The Company will adopt this standard on January 1, 2018 and it is not expected to have a significant impact on its consolidated financial statements as the Company’s restricted cash balances are immaterial. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes all existing revenue recognition requirements, including most industry-specific guidance . The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to re ceive for those goods or services. The FASB has continued to issue accounting standards updates to clarify and provide implementation guidance related to Revenue from Contracts with Customers, including ASU 2016-08, Revenue from Contract with Customers: Principal versus Agent Considerations, ASU 2016-10, Revenue from Contracts with Customers: Identifying Performance Obligations and Licensing, and ASU 2016-12, Revenue from Contracts with Customers: Narrow-Scope Improvements and Practical Expedients. These amendments address a number of areas, including the entity’s identification of its performance obligations in a contract, collectability, non-cash consideration, presentation of sales tax and an entity’s evaluation of the nature of its promise to grant a license of intellectual property and whether or not that revenue is recognized over time or at a point in time. The Company has adopted the standard effective January 1, 2018 using the modified retrospective method applied to all contracts applying the practical expedient for contract modifications, which allows a company to aggregate the impact of all modifications entered into prior to the earliest period presented. In preparation for adoption of the standard, the Company has implemented internal controls to enable the preparation of financial information including the assessment of the impact of the standard. Adoption of the standard is expected to result in a de crease to deferred revenues of approximately $24.0 million along with a cumulative adjustment to the Company's accumulated deficit of $24.0 million as of January 1, 2018. In March 2016, the FASB issued ASU No. 2016 ‑06, “ Derivatives and Hedging ”. This ASU clarifies the requirements for assessing whether contingent call (put) options that can accelerate the payment of principal on debt instruments are clearly and closely related to their debt hosts. This guidance is effective for annual and interim reporting periods of public entities beginning after December 15, 2016, with early adoption permitted. An entity should apply the amendments in this ASU on a modified retrospective basis to existing debt instruments as of the beginning of the fiscal year for which the amendments are effective. The Company adopted this standard on January 1, 2017, which did not impact the consolidated financial statements of the Company . In February 2016, the FASB issued ASU No. 2016 ‑02, “ Leases ”. This ASU amends the existing accounting standards for lease accounting, including requiring lessees to recognize most leases on their balance sheets. This guidance is effective for annual and interim reporting periods of public entities beginning after December 15, 2018, with early adoption permitted. The Company evaluated the impact of adopting the standard on its consolidated financial statements and determined that upon adoption it will have to record a right of use asset and offsetting liability on the Company’s balance sheet. In July 2015, the FASB issued ASU No. 2015 ‑11, “ Inventory (Topic 330) ” which simplifies the subsequent measurement of inventory. It replaces the current lower of cost or market test with a lower of cost or net realizable value test. The standard is effective for public entities for annual reporting periods beginning after December 15, 2016, and interim periods therein. Early adoption is permitted. The new guidance must be applied prospectively. The Company adopted this standard on January 1, 2017, which did not impact the consolidated financial statements of the Company. |
Net Loss per Share Attributab30
Net Loss per Share Attributable to Common Stockholders (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |
Computation of Basic and Diluted Net Loss per Share Attributable to Common Stockholders | Years Ended December 31, 2017 2016 2015 Numerator – basic and diluted: Net loss attributable to common stockholders $ (81,692) $ (230,488) $ (147,082) Denominator – basic and diluted: Weighted average common stock outstanding used to compute basic and diluted net loss per share 57,405,331 23,674,512 8,127,781 Net loss per share, basic and diluted $ (1.42) $ (9.74) $ (18.10) |
Anti-dilutive Amounts Excluded From Calculation of Diluted Net Loss per Share | Years Ended December 31, 2017 2016 2015 Convertible preferred stock 3,351,717 3,191,843 3,191,843 Options to purchase common stock 8,496,872 6,437,515 1,685,248 Warrants to purchase common stock 14,699,990 1,328,452 1,328,452 Total shares of common stock equivalents 26,548,579 10,957,810 6,205,543 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Debt [Abstract] | |
Debt Payable | December 31, 2017 2016 Secured term debt due June 17, 2018 34,620 34,620 Total debt before fees and debt discount/premium 34,620 34,620 Less: Deferred financing costs (228) (737) Debt discount (1,030) (3,306) Add: Debt premium 345 — Total debt payable $ 33,707 $ 30,577 Debt payable, current portion $ 33,707 $ 1,900 Debt payable, long-term $ — $ 28,677 |
Minimum Payments Required on Outstanding Balances | 2015 Credit Agreement 2018 $ 34,620 $ 34,620 |
Interest Expense and Other Related Financing Costs | Years Ended December 31, 2017 2016 2015 Interest expense and other financing costs $ 3,720 $ 3,782 $ 7,817 Interest expense - beneficial conversion feature — 45,915 — Interest paid-in kind — 14,695 11,434 Write-off of deferred financing costs and debt discount — 3,820 2,752 Amortization of deferred financing costs, debt discount and debt premium 2,242 4,422 5,157 Interest expense $ 5,962 $ 72,634 $ 27,160 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Financial Instruments [Abstract] | |
Fair Values of Financial Instruments | Fair Value Measurement Using: December 31, Significant Other Observable Inputs Significant Unobservable Inputs Description 2016 (Level 2) (Level 3) Warrants $ 3,305 $ 3,305 $ — Total $ 3,305 $ 3,305 $ — December 31, Significant Other Observable Inputs Significant Unobservable Inputs Description 2017 (Level 2) (Level 3) Warrants $ 1,952 $ 1,952 $ — Total $ 1,952 $ 1,952 $ — |
Rollforward of Level 2 and Level 3 Investments | Significant Other Observable Inputs Significant Unobservable Inputs (Level 2) (Level 3) Balance as of January 1, 2016 $ — $ 8,289 Transfer of warrants from Level 3 to Level 2 6,300 (6,300) Change in fair value of financial instruments (4,107) (273) Beneficial conversion feature recognized on warrants issued in connection with 2015 credit agreement 1,112 — Reclassification of warrants to APIC in connection with IPO — (1,716) Balance as of December 31, 2016 $ 3,305 $ — Fair value of warrants modified in the Third Amendment (908) — Issuance of warrants in private placement 1,651 — Change in fair value of financial instruments (2,096) — Balance as of December 31, 2017 $ 1,952 $ — |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Inventories [Abstract] | |
Schedule of Inventories | December 31, December 31, 2017 2016 Raw materials $ — $ 1,153 Work-in-process 80 — Finished goods, net 121 797 Total inventories $ 201 $ 1,950 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Fixed Assets [Abstract] | |
Fixed Assets | Useful Lives December 31, December 31, (Years) 2017 2016 Leasehold improvements 4 -8 $ 10,120 $ 10,274 Office equipment and furniture 3 -15 1,488 2,193 Machinery and laboratory equipment 3 -15 2,765 3,255 Software 1 -5 3,162 3,581 Construction-in-progress ̶̶̶̶ 408 44 17,943 19,347 Less accumulated depreciation and amortization (13,651) (13,920) Fixed assets, net $ 4,292 $ 5,427 |
Goodwill and Other Intangible35
Goodwill and Other Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Goodwill and Other Intangible Assets [Abstract] | |
Carrying Amount of Goodwill and Other Amortizable Intangible Assets | Balance as of December 31, 2015 Amortization Impairment Balance as of December 31, 2016 Remaining Useful Life as of December 31, 2016 Ribasphere product rights $ 15,223 $ (15,223) $ — $ — — Goodwill $ 3,580 $ — $ — $ 3,580 — Balance as of December 31, 2016 Amortization Impairment Balance as of December 31, 2017 Remaining Useful Life as of December 31, 2017 Ribasphere product rights $ — $ — $ — $ — — Goodwill $ 3,580 $ — $ — $ 3,580 — |
License Agreements (Tables)
License Agreements (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
License Agreements [Abstract] | |
Summarized Financial Information for MeiraGTx | 2017 2016 Balance Sheet Data: Cash $ 8,549 $ 17,477 Other current assets 2,926 1,613 Noncurrent assets 14,379 3,461 Current liabilities 21,402 6,041 Noncurrent liabilities 479 815 Mezzanine equity 51,410 33,002 Total stockholders’ deficit (47,437) (17,308) Statement of Operations Data: General and administrative expense $ 9,879 $ 6,027 Research and development expense 22,414 14,038 Net loss (32,717) (19,792) |
Share-based Compensation (Table
Share-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Share-based Compensation [Abstract] | |
Stock Options Outstanding | Options Outstanding Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Balance, December 31, 2015 1,685,248 $ 37.38 8.72 $ — Granted 4,858,460 7.12 Exercised (1,109) 36.63 Forfeited (105,084) 32.09 Balance, December 31, 2016 6,437,515 $ 8.32 9.28 $ 2,227,268 Granted 2,853,000 3.69 Exercised — — Forfeited (793,643) 6.23 Balance, December 31, 2017 8,496,872 $ 6.96 8.83 $ — Options vested and exercisable, December 31, 2017 3,969,407 $ 9.76 8.04 $ — |
Weighted-average Fair Value of Stock Option Awards Granted | Year Ended December 31, 2017 December 31, 2016 December 31, 2015 Weighted average fair value of grants $2.44 $7.12 $20.67 Expected volatility 74.48% - 74.92% 74.98% - 79.35% 77.23% - 93.85% Risk-free interest rate 1.87% - 2.22% 1.15% - 2.20% 1.54% - 1.93% Expected life 5.5 - 6.0 years 5.0 - 6.0 years 5.2 - 6.0 years Expected dividend yield 0% 0% 0% |
Warrants Outstanding | Warrants Weighted Average Exercise Price Balance, December 31, 2015 710,801 $ 46.64 Granted 617,651 10.20 Balance, December 31, 2016 1,328,452 $ 29.70 Granted 13,394,338 3.58 Exercised (22,800) 3.35 Forfeited — — Balance, December 31, 2017 14,699,990 $ 5.94 |
Accrued Expenses and Other Sh38
Accrued Expenses and Other Short Term Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accrued Expenses and Other Short Term Liabilities [Abstract] | |
Short-term Accrued Expenses | December 31, December 31, 2017 2016 Commission payable $ 2,395 $ 2,395 Compensation and benefits 758 954 Severance 1,122 1,744 Royalty arrangements — 2,502 Other 4,302 4,555 Total Accrued Expenses $ 8,577 $ 12,150 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments [Abstract] | |
Future Minimum Rental Payments Under Noncancellable Leases | Year ending December 31, Amount 2018 $ 4,579 2019 4,517 2020 4,049 2021 4,148 2022 4,286 Thereafter 11,884 Total $ 33,463 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Taxes [Abstract] | |
Income Tax Provision | For the Year Ended December 31, 2017 2016 2015 Current tax expense (benefit) Foreign $ 316 $ 315 $ — Federal — — — State — — — Total current tax expense 316 315 — Deferred tax expense (benefit) Federal (485) (15) 1 State 48 42 (4) Total deferred tax benefit (437) 27 (3) Total income tax expense (benefit) $ (121) $ 342 $ (3) |
Effective Income Tax Rate Reconciliation | For the Year Ended December 31, 2017 2016 2015 Amount Rate Amount Rate Amount Rate Expected federal statutory income tax $ (27,821) -35.0% $ (72,945) -35.0% $ (51,480) -35.0% State income taxes, net of federal benefits (8,314) -10.5% (9,485) -4.6% (4,544) -3.1% Change in federal tax rate used for deferred purposes 112,611 141.7% 200 0.1% 972 0.7% Adjustment to deferred tax assets 15,210 19.1% — 0.0% (6,492) -4.4% Change in valuation allowance (91,807) -115.5% 82,572 39.6% 61,541 41.8% Income tax expense (benefit ) $ (121) -0.2% $ 342 0.1% $ (3) 0.0% |
Net Deferred Tax Assets and Liabilities | For the Year Ended December 31, 2017 2016 Deferred tax assets Net operating loss carryforward $ 112,289 $ 171,074 Foreign tax credit carryforward 631 315 Capitalized research and development 66,500 78,147 Share-based compensation 18,735 22,233 Loss on equity investment 6,294 5,900 Organization costs 30 46 Depreciation 772 1,050 Intangibles 30,788 47,595 Inventory reserve and other 2,145 3,631 Total deferred tax assets 238,184 329,991 Deferred tax liability Goodwill (939) (1,376) Total deferred tax liability (939) (1,376) Total deferred tax assets, net 237,245 328,615 Valuation allowance (238,184) (329,991) Deferred tax liability $ (939) $ (1,376) |
Quarterly Financial Data (Table
Quarterly Financial Data (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Data [Abstract] | |
Schedule of Quarterly Financial Data | Three Months Ended Three Months Ended Three Months Ended Three Months Ended (in thousands, December 31, September 30, June 30, March 31, except per share data) 2017 2016 2017 2016 2017 2016 2017 2016 Net sales $ 187 $ 3,010 $ 1,036 $ 4,345 $ 1,698 $ 4,967 $ 2,336 $ 6,192 License and other revenue 1,277 1,267 1,241 1,350 1,259 1,453 3,230 3,471 Total revenue 1,464 4,277 2,277 5,695 2,957 6,420 5,566 9,663 Cost of sales 222 640 277 880 266 880 567 1,085 Write-down of inventory (22) 119 933 129 373 2 370 135 Gross profit 1,264 3,518 1,067 4,686 2,318 5,538 4,629 8,443 Operating expenses: Research and development 10,499 8,539 11,775 9,631 10,056 8,587 8,447 9,083 Selling, general and administrative 7,916 14,620 9,121 48,426 9,902 19,148 10,118 23,686 Gain on settlement of payable — — — (256) — — — (3,875) Total operating expenses 18,415 23,159 20,896 57,801 19,958 27,735 18,565 28,894 Loss from operations (17,151) (19,641) (19,829) (53,115) (17,640) (22,197) (13,936) (20,451) Total other expense 1,476 1,716 1,874 64,049 4,674 14,837 3,315 12,407 Income tax expense (benefit) (437) 27 — — — — 316 315 Net loss (18,190) (21,384) (21,703) (117,164) (22,314) (37,034) (17,567) (33,173) Deemed dividend on convertible preferred stock and Class E redeemable convertible units 490 469 490 21,264 469 — 469 — Net loss attributable to common stockholders (18,680) (21,853) (22,193) (138,428) (1) (22,783) (37,034) (18,036) (33,173) Basic and diluted net loss per share of common stock $ (0.24) $ (0.48) $ (0.42) $ (4.24) $ (0.44) $ (4.46) $ (0.39) $ (4.00) Weighted average basic and diluted shares of common stock outstanding 78,397,156 45,078,666 52,572,880 32,678,259 (2) 51,846,521 8,304,334 46,507,435 8,302,635 (1) Net loss attributable to common stockholders for the three months ended September 30, 2016 includes the beneficial conversion feature of the Company’s debt upon conversion into shares of the Company’s common stock on August 1, 2016 of $44.2 million, the beneficial conversion feature of certain outstanding warrants which became exercisable into shares of the Company’s common stock on August 1, 2016 of $1.7 million, the deemed dividends on the Company’s convertible preferred stock and Class E redeemable convertible units of $20.9 million and share-based compensation expense related to the Company’s LTIP of $22.6 million. Weighted average basic and diluted shares of common stock outstanding for the three months ended September 30, 2016 includes shares issued as a result of the Corporate Conversion (Note 1). |
Organization (Details)
Organization (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 01, 2016 | Oct. 31, 2017 | Sep. 30, 2017 | Mar. 31, 2017 | Jan. 31, 2017 | Nov. 30, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Nov. 30, 2016 | Jul. 26, 2016 | Jun. 08, 2016 | Dec. 31, 2014 |
Stock issued, shares | 6,250,000 | ||||||||||||
Stock issued, price per share | $ 12 | ||||||||||||
Proceeds from IPO, net | $ 66,000 | $ 69,750 | |||||||||||
Offering expenses | 3,700 | ||||||||||||
Underwriting discounts and commissions | $ 5,300 | ||||||||||||
Transaction costs | $ 3,293 | $ 445 | |||||||||||
Gross proceeds from common stock | $ 95,954 | ||||||||||||
Shares outstanding | 45,078,666 | 78,643,954 | 45,078,666 | ||||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | ||||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||
Accumulated deficit | $ (237,397) | $ (155,705) | |||||||||||
Working capital | 13,400 | ||||||||||||
Proceeds from issuance of redeemable convertible units | 5,500 | 10,833 | |||||||||||
Cash and cash equivalents | $ 67,517 | $ 36,093 | $ 21,498 | $ 20,991 | |||||||||
Class E Redeemable Convertible Units [Member] | |||||||||||||
Stock issued, shares | 478,266 | ||||||||||||
Proceeds from issuance of redeemable convertible units | $ 5,500 | ||||||||||||
Convertible Preferred Stock [Member] | |||||||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |||||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||
License Agreement, Jinghua [Member] | |||||||||||||
Milestone payment | $ 2,000 | $ 2,000 | $ 2,000 | ||||||||||
Proceeds from issuance of redeemable convertible units | $ 10,000 | ||||||||||||
2015 Second-Lien Convertible Debt [Member] | |||||||||||||
Shares converted | 19,034,467 | ||||||||||||
2015 Credit Agreement [Member] | |||||||||||||
Deferred Principal Payments | $ 380 | $ 380 | |||||||||||
Additional equity capital to be raised | $ 17,000 | $ 40,000 | |||||||||||
2017 Public Offering [Member] | |||||||||||||
Stock issued, shares | 4,500,000 | 22,275,000 | 26,775,000 | ||||||||||
Transaction costs | $ 5,300 | ||||||||||||
Gross proceeds from common stock | $ 13,600 | $ 66,800 | 80,400 | ||||||||||
Net proceeds from common stock | $ 75,100 | ||||||||||||
2017 Private Placement [Member] | |||||||||||||
Stock issued, shares | 6,767,855 | 6,767,855 | |||||||||||
Transaction costs | $ 1,800 | $ 1,800 | |||||||||||
Gross proceeds from common stock | 22,700 | 22,700 | |||||||||||
Net proceeds from common stock | $ 20,900 | $ 20,900 |
Going Concern (Details)
Going Concern (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 01, 2016 | Oct. 31, 2017 | Sep. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Going Concern [Line Items] | |||||||
Working capital (deficit) | $ 13,400 | ||||||
Accumulated deficit | (237,397) | $ (155,705) | |||||
Net cash used in operating activities | (64,098) | (52,950) | $ (60,977) | ||||
Gross proceeds from common stock | 95,954 | ||||||
Transaction costs | $ 3,293 | $ 445 | |||||
Stock issued, shares | 6,250,000 | ||||||
Price per share of common stock | $ 12 | ||||||
2017 Public Offering [Member] | |||||||
Going Concern [Line Items] | |||||||
Gross proceeds from common stock | $ 13,600 | $ 66,800 | 80,400 | ||||
Net proceeds from common stock | 75,100 | ||||||
Transaction costs | $ 5,300 | ||||||
Stock issued, shares | 4,500,000 | 22,275,000 | 26,775,000 | ||||
Price per share of common stock | $ 3.001 | ||||||
Warrants issued | 1,800,000 | 8,910,000 | 10,710,000 | ||||
Warrants exercise price | $ 3.35 | ||||||
Warrant exercise price term | 5 years | ||||||
2017 Private Placement [Member] | |||||||
Going Concern [Line Items] | |||||||
Gross proceeds from common stock | $ 22,700 | $ 22,700 | |||||
Net proceeds from common stock | 20,900 | 20,900 | |||||
Transaction costs | $ 1,800 | $ 1,800 | |||||
Stock issued, shares | 6,767,855 | 6,767,855 | |||||
Price per share of common stock | $ 3.36 | $ 3.36 | |||||
Warrants issued | 2,707,138 | 2,707,138 | |||||
Warrants exercise price | $ 4.50 | $ 4.50 | |||||
Warrant exercise price term | 13 months | 13 months |
Summary of Significant Accoun44
Summary of Significant Accounting Policies (Details) $ in Thousands | Aug. 01, 2016shares | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Sep. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2017USD ($)segment | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Jan. 01, 2018USD ($) |
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Number of operating segments | segment | 1 | ||||||||||||
Sales returns reserve | $ 600 | $ 400 | $ 600 | $ 400 | |||||||||
Sales returns expense | 600 | 900 | $ 700 | ||||||||||
Reserve for wholesaler chargebacks and rebates | 200 | 100 | 200 | 100 | |||||||||
Wholesaler chargebacks and rebates expense | 300 | 500 | 1,000 | ||||||||||
Estimated rebates earned but unpaid | 300 | 400 | 300 | 400 | |||||||||
Rebates expense | 700 | 800 | 1,200 | ||||||||||
Freight charges | 100 | 200 | 300 | ||||||||||
Transaction gains (loss) | (25) | 9 | 124 | ||||||||||
Research and development expense | 10,499 | $ 11,775 | $ 10,056 | $ 8,447 | 8,539 | $ 9,631 | $ 8,587 | $ 9,083 | 40,777 | 35,840 | 33,558 | ||
Allowance for doubtful accounts | 700 | 700 | 700 | 700 | |||||||||
Adjustments to allowance for doubtful accounts | 3 | 6 | 5 | ||||||||||
Total investment balance | 3,500 | 11,100 | 3,500 | 11,100 | |||||||||
Impairment of intangible assets | 31,300 | ||||||||||||
Impairment to goodwill | 0 | 0 | 0 | ||||||||||
Capitalized lease obligations | 208 | 230 | $ 20 | ||||||||||
Unamortized portion of capital leases | 270 | 191 | 270 | 191 | |||||||||
Accumulated deficit | 237,397 | 155,705 | $ 237,397 | 155,705 | |||||||||
ASU 2016-09 [Member] | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Stock compensation expense | 800 | $ 2,000 | |||||||||||
Options [Member] | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Dividend yield | 0.00% | 0.00% | 0.00% | ||||||||||
Foreign [Member] | Geographic Concentration Risk [Member] | Net Sales [Member] | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Revenue percentage | 26.90% | 8.60% | 10.00% | ||||||||||
New York [Member] | Secured Letter of Credit [Member] | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Secured letter of credit | 2,000 | $ 2,000 | $ 2,000 | $ 2,000 | |||||||||
Massachusetts [Member] | Secured Letter of Credit [Member] | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Secured letter of credit | $ 91 | $ 91 | |||||||||||
2015 Second-Lien Convertible Debt [Member] | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Shares converted | shares | 19,034,467 | ||||||||||||
Subsequent Event [Member] | ASU 2014-09 [Member] | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Deferred Revenue | $ 24,000 | ||||||||||||
Accumulated deficit | $ 24,000 |
Stockholders_ Equity (Deficit)
Stockholders’ Equity (Deficit) (Details) - USD ($) | Aug. 01, 2016 | Jun. 08, 2016 | Oct. 31, 2017 | Sep. 30, 2017 | Mar. 31, 2017 | Aug. 31, 2016 | Jun. 30, 2016 | Nov. 30, 2015 | Sep. 30, 2016 | Jun. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Jul. 26, 2016 | Sep. 30, 2015 | Jan. 31, 2015 | Oct. 31, 2014 |
Proceeds from issuance of redeemable convertible units | $ 5,500,000 | $ 10,833,000 | |||||||||||||||
Transaction costs | 3,293,000 | $ 445,000 | |||||||||||||||
Stock issued, shares | 6,250,000 | ||||||||||||||||
Prepaid expenses | $ 1,109,000 | $ 1,034,000 | |||||||||||||||
Issuance of units related to option exercises, shares | 1,109 | 772 | |||||||||||||||
Beneficial conversion feature on convertible preferred stock | 384,000 | $ 7,660,000 | |||||||||||||||
Accrued dividends on preferred stock | $ 1,534,000 | $ 642,000 | |||||||||||||||
Deemed dividends on preferred stock | $ 20,900,000 | ||||||||||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | ||||||||||||||
Price per share of common stock | $ 12 | ||||||||||||||||
Underwriting discounts and commissions | $ 5,300,000 | ||||||||||||||||
Offering expenses | 3,700,000 | ||||||||||||||||
Proceeds from IPO, net | $ 66,000,000 | $ 69,750,000 | |||||||||||||||
Shares outstanding | 45,078,666 | 78,643,954 | 45,078,666 | ||||||||||||||
Gross proceeds from common stock | $ 95,954,000 | ||||||||||||||||
Common stock issued | 78,643,954 | 45,078,666 | |||||||||||||||
Common stock and warrants issued in public offering, net | $ 75,087,000 | $ 69,750,000 | |||||||||||||||
Third Party Investors [Member] | |||||||||||||||||
Transaction costs | 40,000 | $ 3,100,000 | |||||||||||||||
GoldenTree Asset Management LP [Member] | |||||||||||||||||
Stock issued, shares | 208,333 | ||||||||||||||||
Kadmon I, LLC [Member] | |||||||||||||||||
Ownership percentage | 12.10% | ||||||||||||||||
Kadmon I, LLC [Member] | Investment Funds [Member] | |||||||||||||||||
Ownership percentage | 80.00% | ||||||||||||||||
Ownership percentage after distribution | 50.00% | ||||||||||||||||
Kadmon I, LLC [Member] | Certain Parties [Member] | |||||||||||||||||
Ownership percentage | 20.00% | ||||||||||||||||
Ownership percentage after distribution | 50.00% | ||||||||||||||||
Class A Units [Member] | |||||||||||||||||
Advisory agreement expense | $ 3,000,000 | ||||||||||||||||
Issuance of units related to option exercises, shares | 7,200 | 5,011 | |||||||||||||||
Shares issued for settlements | 25,000 | ||||||||||||||||
Third party obligations settlement expense | $ 100,000 | ||||||||||||||||
Unit price | $ 32.50 | $ 39 | |||||||||||||||
Class B Units [Member] | |||||||||||||||||
Common units outstanding | 0 | ||||||||||||||||
Class C Units[Member] | |||||||||||||||||
Common units outstanding | 0 | ||||||||||||||||
Class D Units [Member] | |||||||||||||||||
Common units outstanding | 0 | ||||||||||||||||
Class D Units [Member] | Conversion Event Threshold Three [Member] | |||||||||||||||||
Proceeds from conversion event | $ 4,200,000 | ||||||||||||||||
Class E Redeemable Convertible Units [Member] | |||||||||||||||||
Proceeds from issuance of redeemable convertible units | $ 5,500,000 | ||||||||||||||||
Stock issued, shares | 478,266 | ||||||||||||||||
Preferred stock issued | 43,478 | ||||||||||||||||
Redemption value | $ 85,000,000 | ||||||||||||||||
Liquidation preference | 125.00% | ||||||||||||||||
Liquidation preference rate increase | 1.00% | ||||||||||||||||
Unit price | $ 11.50 | ||||||||||||||||
Beneficial conversion feature, discount percentage | 15.00% | ||||||||||||||||
Deemed dividends on preferred stock | $ 13,400,000 | ||||||||||||||||
Class E Redeemable Convertible Units [Member] | Chief Executive Officer [Member] | |||||||||||||||||
Stock issued, shares | 86,957 | 86,957 | |||||||||||||||
Class E Redeemable Convertible Units [Member] | Board of Directors Chairman [Member] | |||||||||||||||||
Stock issued, shares | 21,740 | 21,740 | |||||||||||||||
Class E Redeemable Convertible Units [Member] | Directors [Member] | |||||||||||||||||
Stock issued, shares | 21,740 | 21,740 | |||||||||||||||
Class E Redeemable Convertible Units [Member] | Third Party Investors [Member] | |||||||||||||||||
Stock issued, shares | 75,875 | 3,438,984 | |||||||||||||||
Class E Redeemable Convertible Units [Member] | GoldenTree Asset Management LP [Member] | |||||||||||||||||
Stock issued, shares | 43,479 | 43,479 | |||||||||||||||
Convertible Preferred Stock [Member] | |||||||||||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |||||||||||||
Preferred stock issued | 30,000 | 30,000 | 30,000 | ||||||||||||||
Preferred stock outstanding | 30,000 | 30,000 | |||||||||||||||
Issuance per share | $ 1,000 | ||||||||||||||||
Accrued dividends added to liquidation preference | $ 1,400,000 | ||||||||||||||||
Liquidation preference | $ 30,000,000 | $ 31,400,000 | |||||||||||||||
Beneficial conversion feature, discount percentage | 20.00% | ||||||||||||||||
Shares issued for conversion | 3,351,717 | 3,191,843 | |||||||||||||||
Accrued dividends on preferred stock | $ 1,500,000 | $ 600,000 | |||||||||||||||
Deemed dividends on preferred stock | $ 7,500,000 | 400,000 | 200,000 | ||||||||||||||
Series B And C Preferred Stock [Member] | Conversion Event Threshold Three [Member] | |||||||||||||||||
Proceeds from conversion event | 41,700,000 | ||||||||||||||||
License Agreement, Jinghua [Member] | |||||||||||||||||
Proceeds from issuance of redeemable convertible units | $ 10,000,000 | ||||||||||||||||
Minimum [Member] | Conversion Event Threshold Three [Member] | |||||||||||||||||
Company valuation | $ 45,800,000 | ||||||||||||||||
Minimum [Member] | Class E Redeemable Convertible Units [Member] | |||||||||||||||||
Percent of value for conversion | 80.00% | ||||||||||||||||
Qualified IPO threshold | $ 75,000,000 | ||||||||||||||||
Liquidation preference | 5.00% | ||||||||||||||||
Maximum [Member] | Class E Redeemable Convertible Units [Member] | |||||||||||||||||
Liquidation preference | 10.00% | ||||||||||||||||
Pre-IPO [Member] | Class E Redeemable Convertible Units [Member] | |||||||||||||||||
Conversion price | $ 11.50 | ||||||||||||||||
Post-IPO [Member] | Class A Units [Member] | |||||||||||||||||
Percent of value for conversion | 85.00% | ||||||||||||||||
Post-IPO [Member] | Class E Redeemable Convertible Units [Member] | |||||||||||||||||
Conversion price | $ 11.50 | ||||||||||||||||
2015 Second-Lien Convertible Debt [Member] | |||||||||||||||||
Borrowings, face amount | $ 15,000,000 | $ 92,000,000 | |||||||||||||||
2017 Public Offering [Member] | |||||||||||||||||
Transaction costs | $ 5,300,000 | ||||||||||||||||
Stock issued, shares | 4,500,000 | 22,275,000 | 26,775,000 | ||||||||||||||
Price per share of common stock | $ 3.001 | ||||||||||||||||
Gross proceeds from common stock | $ 13,600,000 | $ 66,800,000 | $ 80,400,000 | ||||||||||||||
Net proceeds from common stock | $ 75,100,000 | ||||||||||||||||
Warrants issued | 1,800,000 | 8,910,000 | 10,710,000 | ||||||||||||||
Warrants exercise price | $ 3.35 | ||||||||||||||||
Warrant exercise price term | 5 years | ||||||||||||||||
Proceeds from common stock issued in public offering | $ 57,600,000 | ||||||||||||||||
Proceeds from warrants issued in public offering | 22,800,000 | ||||||||||||||||
2017 Private Placement [Member] | |||||||||||||||||
Transaction costs | $ 1,800,000 | $ 1,800,000 | |||||||||||||||
Stock issued, shares | 6,767,855 | 6,767,855 | |||||||||||||||
Price per share of common stock | $ 3.36 | $ 3.36 | |||||||||||||||
Gross proceeds from common stock | $ 22,700,000 | $ 22,700,000 | |||||||||||||||
Net proceeds from common stock | $ 20,900,000 | $ 20,900,000 | |||||||||||||||
Warrants issued | 2,707,138 | 2,707,138 | |||||||||||||||
Warrants exercise price | $ 4.50 | $ 4.50 | |||||||||||||||
Warrant exercise price term | 13 months | 13 months | |||||||||||||||
Liquidation damages, as percentage of subscription amount | 2.00% | ||||||||||||||||
2017 Private Placement [Member] | Maximum [Member] | |||||||||||||||||
Liquidation damages, as percentage of subscription amount | 8.00% |
Net Loss per Share Attributab46
Net Loss per Share Attributable to Common Stockholders (Computation of Basic and Diluted Net Loss per Share Attributable to Common Stockholders) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | ||
Net Loss per Share Attributable to Common Stockholders [Abstract] | ||||||||||||
Net loss available to common stockholders | $ (18,680) | $ (22,193) | $ (22,783) | $ (18,036) | $ (21,853) | $ (138,428) | [1] | $ (37,034) | $ (33,173) | $ (81,692) | $ (230,488) | $ (147,082) |
Weighted average common shares outstanding used to compute basic and diluted net loss per share | 78,397,156 | 52,572,880 | 51,846,521 | 46,507,435 | 45,078,666 | 32,678,259 | [2] | 8,304,334 | 8,302,635 | 57,405,331 | 23,674,512 | 8,127,781 |
Net loss per share, basic and diluted | $ (0.24) | $ (0.42) | $ (0.44) | $ (0.39) | $ (0.48) | $ (4.24) | $ (4.46) | $ (4) | $ (1.42) | $ (9.74) | $ (18.10) | |
[1] | Net loss attributable to common stockholders for the three months ended September 30, 2016 includes the beneficial conversion feature of the Company's debt upon conversion into shares of the Company's common stock on August 1, 2016 of $44.2 million, the beneficial conversion feature of certain outstanding warrants which became exercisable into shares of the Company's common stock on August 1, 2016 of $1.7 million, the deemed dividends on the Company's convertible preferred stock and Class E redeemable convertible units of $20.9 million and share-based compensation expense related to the Company's LTIP of $22.6 million. | |||||||||||
[2] | Weighted average basic and diluted shares of common stock outstanding for the three months ended September 30, 2016 includes shares issued as a result of the Corporate Conversion (Note 1). |
Net Loss per Share Attributab47
Net Loss per Share Attributable to Common Stockholders (Anti-dilutive Amounts Excluded From Calculation of Diluted Net Loss per Share) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |||
Convertible preferred stock | $ 3,351,717 | $ 3,191,843 | $ 3,191,843 |
Options to purchase common stock | 8,496,872 | 6,437,515 | 1,685,248 |
Warrants to purchase common stock | 14,699,990 | 1,328,452 | 1,328,452 |
Total shares of common stock equivalents | $ 26,548,579 | $ 10,957,810 | $ 6,205,543 |
Commercial Partnership (Details
Commercial Partnership (Details) - USD ($) $ in Thousands | Jun. 17, 2013 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Oct. 31, 2014 |
License revenue | $ 1,277 | $ 1,241 | $ 1,259 | $ 3,230 | $ 1,267 | $ 1,350 | $ 1,453 | $ 3,471 | $ 7,007 | $ 7,541 | $ 6,420 | ||
Deferred revenue, short term | 4,400 | 4,400 | 4,400 | 4,400 | |||||||||
Deferred revenue, long term | 19,617 | 24,017 | 19,617 | 24,017 | |||||||||
Accrued expenses | 8,577 | 12,150 | 8,577 | 12,150 | |||||||||
Other long term liability | 247 | 1,250 | 247 | 1,250 | |||||||||
AbbVie, Inc. [Member] | |||||||||||||
Upfront Payment | $ 64,000 | ||||||||||||
Contingent milestone payments | 51,000 | $ 0 | 0 | 0 | |||||||||
License agreement, term | 10 years | ||||||||||||
License revenue | $ 4,400 | 4,400 | 4,400 | ||||||||||
Deferred revenue | $ 44,000 | 24,000 | 28,400 | 24,000 | 28,400 | $ 6,000 | |||||||
Deferred revenue, short term | 4,400 | 4,400 | $ 3,000 | 3,000 | |||||||||
Deferred revenue, long term | $ 3,000 | ||||||||||||
Royalties refunded | 2,100 | ||||||||||||
Royalties from resales refunded | 2,900 | ||||||||||||
Accrued expenses | 2,200 | 2,200 | |||||||||||
Other long term liability | $ 2,900 | $ 700 | $ 2,900 | $ 700 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) | Aug. 01, 2016$ / sharesshares | Aug. 31, 2015USD ($)item | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Mar. 31, 2017USD ($) | Nov. 30, 2016USD ($) | Sep. 30, 2015USD ($) |
Debt Instrument [Line Items] | ||||||||
Debt discount | $ 1,030,000 | $ 3,306,000 | ||||||
Debt Instrument, Unamortized Premium | 345,000 | |||||||
Loss on extinguishment of debt | (11,176,000) | $ (2,934,000) | ||||||
Deferred financing costs | $ 228,000 | 737,000 | ||||||
2015 Second-Lien Convertible Debt [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Shares converted | shares | 19,034,467 | |||||||
Total borrowings | 15,000,000 | $ 92,000,000 | ||||||
2015 Credit Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Deferred principal payments | $ 380,000 | $ 380,000 | ||||||
Additional equity capital to be raised | 17,000,000 | $ 40,000,000 | ||||||
Warrants exercise price | $ / shares | $ 10.20 | $ 10.20 | ||||||
Secured Term Debt [Member] | 2015 Credit Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Total borrowings | $ 35,000,000 | |||||||
Fees | $ 788,000 | |||||||
Monthly principal payments | $ 380,000 | |||||||
Maturity date | Jun. 17, 2018 | |||||||
Number of lenders | item | 2 | |||||||
Debt discount | $ 1,500,000 | |||||||
Deferred financing cost write-offs | 390,000 | |||||||
Deferred financing costs | 1,300,000 | |||||||
Unamortized deferred financing costs | $ 200,000 | 700,000 | ||||||
Debt term | 3 years | |||||||
Interest expense | $ 500,000 | $ 400,000 | $ 400,000 | |||||
Warrants exercise price | $ / shares | $ 10.20 | |||||||
Secured Term Debt [Member] | 2015 Credit Agreement [Member] | Class A Warrants [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants to purchase | $ 6,300,000 | $ 6,300,000 | ||||||
Debt discount | 5,400,000 | 5,400,000 | ||||||
Loss on extinguishment of debt | $ 900,000 | |||||||
Secured Term Debt [Member] | 2015 Credit Agreement [Member] | One Exsisting Lender [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Loss on extinguishment of debt | 113,000 | |||||||
Secured Term Debt [Member] | 2015 Credit Agreement, Third Amendment [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt Instrument, Unamortized Premium | $ 900,000 | |||||||
Interest expense | $ 600,000 | |||||||
Warrants issued | shares | 617,651 | |||||||
Warrants exercise price | $ / shares | $ 4.50 | |||||||
Expected proceeds if warrants are exercised | $ 2,800,000 | |||||||
Secured Term Debt [Member] | London Interbank Offered Rate (LIBOR) [Member] | 2015 Credit Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument spread | 9.375% | |||||||
Secured Term Debt [Member] | London Interbank Offered Rate (LIBOR) [Member] | Minimum [Member] | 2015 Credit Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument spread | 1.00% |
Debt (Debt Payable) (Details)
Debt (Debt Payable) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Debt Instrument [Line Items] | ||
Total debt before fees, interest and debt discount/premium | $ 34,620 | $ 34,620 |
Less: Deferred financing costs | (228) | (737) |
Debt discount | (1,030) | (3,306) |
Add: Debt premium | 345 | |
Total debt payable | 33,707 | 30,577 |
Debt payable, current portion | 33,707 | 1,900 |
Debt payable, long-term | 28,677 | |
Secured Term Debt Due June 17, 2018 [Member] | Secured Term Debt [Member] | ||
Debt Instrument [Line Items] | ||
Total debt before fees, interest and debt discount/premium | $ 34,620 | $ 34,620 |
Maturity date | Jun. 17, 2018 |
Debt (Minimum Payments Required
Debt (Minimum Payments Required on Outstanding Balances) (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Debt Instrument [Line Items] | ||
Total debt payable | $ 33,707 | $ 30,577 |
Credit Agreement [Member] | ||
Debt Instrument [Line Items] | ||
2,018 | 34,620 | |
Total debt payable | $ 34,620 |
Debt (Interest Expense and Othe
Debt (Interest Expense and Other Related Financing Costs) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Debt [Abstract] | |||
Interest expense and other financing costs | $ 3,720 | $ 3,782 | $ 7,817 |
Interest expense - beneficial conversion feature | 45,915 | ||
Interest paid-in kind | 14,695 | 11,434 | |
Write-off of deferred financing costs and debt discount | 3,820 | 2,752 | |
Amortization of deferred financing costs, debt discount and debt premium | 2,242 | 4,422 | 5,157 |
Interest expense | $ 5,962 | $ 72,634 | $ 27,160 |
Financial Instruments (Narrativ
Financial Instruments (Narrative) (Details) | Aug. 01, 2016USD ($)$ / sharesshares | Oct. 31, 2017shares | Sep. 30, 2017shares | Mar. 31, 2017USD ($)$ / sharesshares | Aug. 31, 2015USD ($) | Oct. 31, 2011shares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)item | Dec. 31, 2015USD ($)$ / shares | Jun. 30, 2016$ / shares | Sep. 30, 2015$ / shares | Oct. 31, 2014$ / shares | Apr. 16, 2013USD ($)$ / sharesshares |
Fair value of liability | $ 1,952,000 | $ 3,305,000 | |||||||||||
Warrants reclassified from liabilities to equity | 1,700,000 | ||||||||||||
Change in fair value of warrant | (200,000) | $ (1,300,000) | |||||||||||
Price per share of common stock at IPO date | $ / shares | $ 12 | ||||||||||||
Long-term secured term debt fair value | 28,700,000 | ||||||||||||
Loss on extinguishment of debt | (11,176,000) | (2,934,000) | |||||||||||
Debt discount | 1,030,000 | $ 3,306,000 | |||||||||||
Number of tranches | item | 3 | ||||||||||||
Warrants [Member] | |||||||||||||
Fair value of liability | $ 1,952,000 | $ 3,305,000 | |||||||||||
Risk-free interest rate | 2.20% | ||||||||||||
Expected life | 4 years 7 months 28 days | ||||||||||||
Volatility | 74.90% | ||||||||||||
Expected dividend yield | 0.00% | ||||||||||||
Success Fee [Member] | |||||||||||||
Fair value of liability | $ 0 | ||||||||||||
Change in fair value of liability | (100,000) | $ (200,000) | |||||||||||
Risk-free interest rate | 0.49% | ||||||||||||
Expected life | 6 months | ||||||||||||
Volatility | 79.20% | ||||||||||||
Unit price | $ / shares | $ 32.50 | ||||||||||||
Strike price | $ / shares | $ 74.17 | ||||||||||||
Expected dividend yield | 0.00% | ||||||||||||
Equity Issued from Credit Agreement [Member] | |||||||||||||
Fair value of liability | $ 1,200,000 | 3,300,000 | |||||||||||
Risk-free interest rate | 0.49% | ||||||||||||
Expected life | 6 months | ||||||||||||
Volatility | 79.20% | ||||||||||||
Unit price | $ / shares | $ 32.50 | ||||||||||||
Strike price | $ / shares | $ 61.75 | ||||||||||||
Expected dividend yield | 0.00% | ||||||||||||
Class E Redeemable Convertible Units [Member] | |||||||||||||
Unit price | $ / shares | $ 11.50 | ||||||||||||
Class A Units [Member] | |||||||||||||
Shares used for underlying value of equity instrument | shares | 536,065 | ||||||||||||
Unit price | $ / shares | $ 32.50 | $ 39 | |||||||||||
2015 Credit Agreement [Member] | |||||||||||||
Fair value of liability | $ 1,200,000 | ||||||||||||
Strike price | $ / shares | $ 10.20 | $ 10.20 | |||||||||||
Common units converted to warrants | shares | 617,651 | ||||||||||||
Change in fair value of warrant | $ (1,100,000) | $ (4,300,000) | |||||||||||
Third Amended and Restated Convertible Credit Agreement [Member] | |||||||||||||
Strike price | $ / shares | $ 10.20 | ||||||||||||
Common units converted to warrants | shares | 351,992 | ||||||||||||
Other Warrants [Member] | |||||||||||||
Fair value of liability | $ 1,600,000 | 700,000 | |||||||||||
Change in fair value of liability | (900,000) | ||||||||||||
Strike price | $ / shares | $ 138.06 | $ 4.50 | $ 21.24 | ||||||||||
Warrants reclassified from liabilities to equity | $ 22,800,000 | ||||||||||||
Common units converted to warrants | shares | 46,163 | ||||||||||||
Warrants to purchase | $ 2,707,138 | ||||||||||||
Warrants issued | $ 1,400,000 | ||||||||||||
Number of units for purchase | shares | 30,000 | ||||||||||||
Risk-free interest rate | 1.39% | ||||||||||||
Expected life | 3 months 7 days | ||||||||||||
Volatility | 71.50% | ||||||||||||
Expected dividend yield | 0.00% | ||||||||||||
Secured Term Debt [Member] | 2015 Credit Agreement [Member] | |||||||||||||
Strike price | $ / shares | $ 10.20 | ||||||||||||
Debt discount | $ 1,500,000 | ||||||||||||
Secured Term Debt [Member] | Class A Warrants [Member] | 2015 Credit Agreement [Member] | |||||||||||||
Warrants to purchase | $ 6,300,000 | 6,300,000 | |||||||||||
Strike price, percent for calculation | 85.00% | ||||||||||||
Loss on extinguishment of debt | $ 900,000 | ||||||||||||
Debt discount | $ 5,400,000 | $ 5,400,000 | |||||||||||
2017 Public Offering [Member] | |||||||||||||
Warrants issued | shares | 1,800,000 | 8,910,000 | 10,710,000 | ||||||||||
Strike price | $ / shares | $ 3.35 | ||||||||||||
Warrant exercise price term | 5 years | ||||||||||||
Price per share of common stock at IPO date | $ / shares | $ 3.001 | ||||||||||||
Warrants to purchase | $ 10,687,200 | ||||||||||||
2017 Private Placement [Member] | |||||||||||||
Warrants issued | shares | 2,707,138 | 2,707,138 | |||||||||||
Strike price | $ / shares | $ 4.50 | $ 4.50 | |||||||||||
Warrant exercise price term | 13 months | 13 months | |||||||||||
Price per share of common stock at IPO date | $ / shares | $ 3.36 | $ 3.36 |
Financial Instruments (Fair Val
Financial Instruments (Fair Values of Financial Instruments) (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 | Aug. 01, 2016 |
Total financial instruments | $ 1,952 | $ 3,305 | |
Significant Other Observable Inputs (Level 2) [Member] | |||
Total financial instruments | 1,952 | 3,305 | |
Warrants [Member] | |||
Total financial instruments | 1,952 | 3,305 | |
Warrants [Member] | Significant Other Observable Inputs (Level 2) [Member] | |||
Total financial instruments | $ 1,952 | $ 3,305 | |
Success Fee [Member] | |||
Total financial instruments | $ 0 |
Financial Instruments (Rollforw
Financial Instruments (Rollforward of Level 2 and Level 3 Investments) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Significant Other Observable Inputs (Level 2) [Member] | ||
Balance | $ 3,305 | |
Transfer of warrants from Level 3 to Level 2 | $ 6,300 | |
Fair value of warrants modified in the Third Amendment | (908) | |
Issuance of warrants in private placement | 1,651 | |
Change in fair value of financial instruments | (2,096) | (4,107) |
Beneficial conversion feature recognized on warrants issued in connection with 2015 credit agreement | 1,112 | |
Balance | $ 1,952 | 3,305 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Balance | 8,289 | |
Transfer of warrants from Level 3 to Level 2 | (6,300) | |
Change in fair value of financial instruments | (273) | |
Reclassification of warrants to APIC in connection with IPO | $ (1,716) |
Inventories (Narrative) (Detail
Inventories (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Inventories [Abstract] | |||||||||||
Reserve for expirable inventory | $ 4,800 | $ 4,900 | $ 4,800 | $ 4,900 | |||||||
Expensed inventory | $ (22) | $ 933 | $ 373 | $ 370 | $ 119 | $ 129 | $ 2 | $ 135 | $ 1,654 | $ 385 | $ 2,274 |
Inventories (Schedule of Invent
Inventories (Schedule of Inventories) (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Inventories [Abstract] | ||
Raw materials | $ 1,153 | |
Work-in-process | $ 80 | |
Finished goods, net | 121 | 797 |
Total inventories | $ 201 | $ 1,950 |
Fixed Assets (Narrative) (Detai
Fixed Assets (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Fixed Assets [Abstract] | ||||
Depreciation and amortization of fixed assets | $ 1,822 | $ 2,280 | $ 2,312 | |
Unamortized computer software costs | 200 | 800 | ||
Amortization of computer software costs | $ 600 | $ 700 | $ 700 | |
Fully depreciated assets disposed of | $ 2,100 |
Fixed Assets (Fixed Assets) (De
Fixed Assets (Fixed Assets) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 17,943 | $ 19,347 |
Less accumulated depreciation and amortization | (13,651) | (13,920) |
Fixed assets, net | 4,292 | 5,427 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 10,120 | 10,274 |
Office Equipment and Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 1,488 | 2,193 |
Machinery and Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 2,765 | 3,255 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 3,162 | 3,581 |
Construction-in-progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 408 | $ 44 |
Minimum [Member] | Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Life (Years) | 4 years | |
Minimum [Member] | Office Equipment and Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Life (Years) | 3 years | |
Minimum [Member] | Machinery and Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Life (Years) | 3 years | |
Minimum [Member] | Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Life (Years) | 1 year | |
Maximum [Member] | Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Life (Years) | 8 years | |
Maximum [Member] | Office Equipment and Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Life (Years) | 15 years | |
Maximum [Member] | Machinery and Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Life (Years) | 15 years | |
Maximum [Member] | Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Life (Years) | 5 years |
Goodwill and Other Intangible60
Goodwill and Other Intangible Assets (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Goodwill and Other Intangible Assets [Abstract] | |||
Ribasphere product rights, Remaining Useful Life | 1 year 3 months | ||
Ribasphere product rights, Impairment | $ 31,300 | ||
Amortization expense | 15,223 | $ 27,442 | |
Accumulated amortization | $ (140,700) | $ (140,700) |
Goodwill and Other Intangible61
Goodwill and Other Intangible Assets (Carrying Amount of Goodwill and Other Amortizable Intangible Assets) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Goodwill and Other Intangible Assets [Abstract] | |||
Ribasphere product rights, Beginning Balance | $ 15,223 | ||
Ribasphere product rights, Amortization | (15,223) | $ (27,442) | |
Ribasphere product rights, Impairment | (31,300) | ||
Ribasphere product rights, Ending Balance | $ 15,223 | ||
Ribasphere product rights, Remaining Useful Life | 1 year 3 months | ||
Goodwill, Beginning Balance | 3,580 | 3,580 | |
Goodwill, Impairment | 0 | 0 | $ 0 |
Goodwill, Ending Balance | $ 3,580 | $ 3,580 | $ 3,580 |
License Agreements (Narrative)
License Agreements (Narrative) (Details) | Sep. 13, 2012USD ($) | Nov. 18, 2011USD ($)item | Jul. 22, 2011USD ($) | Apr. 08, 2011USD ($) | Jan. 31, 2017USD ($) | Apr. 30, 2016shares | Feb. 29, 2016USD ($) | Nov. 30, 2015USD ($) | Apr. 30, 2015USD ($) | Dec. 31, 2014shares | Jun. 30, 2008USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Sep. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2017USD ($)item | Dec. 31, 2016USD ($)item | Dec. 31, 2015USD ($) | Dec. 31, 2011USD ($) | Dec. 31, 2016USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Revenue | $ 187,000 | $ 1,036,000 | $ 1,698,000 | $ 2,336,000 | $ 3,010,000 | $ 4,345,000 | $ 4,967,000 | $ 6,192,000 | $ 5,257,000 | $ 18,514,000 | $ 29,299,000 | |||||||||||||
Accounts receivable, net | 325,000 | 655,000 | 325,000 | 655,000 | $ 655,000 | |||||||||||||||||||
Proceeds from issuance of redeemable convertible units | 5,500,000 | 10,833,000 | ||||||||||||||||||||||
Research and development | 10,499,000 | $ 11,775,000 | $ 10,056,000 | $ 8,447,000 | $ 8,539,000 | 9,631,000 | $ 8,587,000 | 9,083,000 | 40,777,000 | 35,840,000 | 33,558,000 | |||||||||||||
Gain on settlement of payable | $ 256,000 | $ 3,875,000 | 4,131,000 | |||||||||||||||||||||
Loss on equity method investment | (7,599,000) | $ (13,625,000) | (2,776,000) | |||||||||||||||||||||
License Agreement, Symphony Evolution, Inc. [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Acquisition and worldwide development milestone payment | 14,100,000 | |||||||||||||||||||||||
Commercial milestone payment | 0 | |||||||||||||||||||||||
License Agreement, Symphony Evolution, Inc. [Member] | Maximum [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Acquisition and worldwide development milestone payment | 218,400,000 | |||||||||||||||||||||||
Commercial milestone payment | 175,000,000 | |||||||||||||||||||||||
License Agreement, Valeant Pharmaceuticals North America LLC, Syprine [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Gain on settlement of payable | $ 3,900,000 | |||||||||||||||||||||||
License Agreement, Princeton University [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
License maintenance fees | 60,000 | |||||||||||||||||||||||
Contingent milestone payments | $ 31,000,000 | $ 31,000,000 | ||||||||||||||||||||||
Number of milestones met | item | 0 | 0 | ||||||||||||||||||||||
License agreement sales | $ 0 | $ 0 | ||||||||||||||||||||||
License Agreement, MeiraGTx Ltd. [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Service revenue to license | 600,000 | 1,000,000 | 1,000,000 | |||||||||||||||||||||
Shares received for settlement | shares | 230,000 | |||||||||||||||||||||||
Settled receivables | 1,200,000 | |||||||||||||||||||||||
Cash payments for service revenue | $ 300,000 | 200,000 | ||||||||||||||||||||||
Equity method investment, ownership percentage | 48.00% | 25.60% | 25.60% | |||||||||||||||||||||
Equity method investment, cost | $ 0 | |||||||||||||||||||||||
Equity method investment, fair value | 24,000,000 | $ 0 | $ 0 | |||||||||||||||||||||
Equity method investment, gain based on the fair value | $ 24,000,000 | |||||||||||||||||||||||
Equity method investment, gross profit (loss) | (7,600,000) | $ (13,600,000) | (2,800,000) | |||||||||||||||||||||
Loss on equity method investment | $ (3,900,000) | |||||||||||||||||||||||
License Agreement, MeiraGTx Ltd. [Member] | Class A [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Equity method investment, ownership percentage | 38.70% | 38.70% | ||||||||||||||||||||||
License Agreement, Nano Terra, Inc. [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Ownership percentage | 1.00% | 1.00% | ||||||||||||||||||||||
Shares converted | shares | 100 | |||||||||||||||||||||||
License Agreement, Nano Terra, Inc. [Member] | Class B Units [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Purchase of shares | $ 2,300,000 | |||||||||||||||||||||||
NT Life Sciences, LLC (“NT Life”) [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Equity method investment, gross profit (loss) | $ (450,000) | |||||||||||||||||||||||
Purchase of shares | $ 900,000 | |||||||||||||||||||||||
Ownership percentage | 50.00% | |||||||||||||||||||||||
Equity method investment, impairment | $ 450,000 | |||||||||||||||||||||||
License Agreement, Dyax Corp. [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
License agreement, upfront fee / payment | $ 500,000 | $ 600,000 | ||||||||||||||||||||||
License maintenance fees | 300,000 | |||||||||||||||||||||||
License agreement, obligation amortized over agreement term | 300,000 | |||||||||||||||||||||||
License agreement, obligation amortized over one year | $ 300,000 | |||||||||||||||||||||||
License Agreement, Shire Plc. [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Research and development | $ 1,500,000 | |||||||||||||||||||||||
License Agreement, Chiromics [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
License agreement, upfront fee / payment | $ 200,000 | |||||||||||||||||||||||
Number of chemical compounds | item | 2 | |||||||||||||||||||||||
License agreement, fee for chemical compound | $ 200,000 | |||||||||||||||||||||||
License agreement, quarterly fee for chemical compounds | $ 200,000 | |||||||||||||||||||||||
Number of quarters, quarterly fee for chemical compounds | item | 8 | |||||||||||||||||||||||
License Agreement, Zydus [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
One time purchase price of rights, title and interest to high dosages of ribavirin | $ 1,100,000 | |||||||||||||||||||||||
Estimated percentage of royalty based on net sales of products | 20.00% | |||||||||||||||||||||||
Royalty expense | 100,000 | $ 1,200,000 | 2,700,000 | |||||||||||||||||||||
License Agreement, Jinghua [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Sublicensing revenue | $ 0 | 0 | 0 | |||||||||||||||||||||
Proceeds from issuance of redeemable convertible units | $ 10,000,000 | |||||||||||||||||||||||
License agreement, term | 10 years | |||||||||||||||||||||||
Revenue recognition, milestone method, revenue recognized | $ 2,000,000 | $ 2,000,000 | 2,000,000 | |||||||||||||||||||||
Estimated percentage of sublicensing revenue | 10.00% | |||||||||||||||||||||||
Number of patents licensed | item | 0 | |||||||||||||||||||||||
License Agreement, Jinghua [Member] | Maximum [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Contingent milestone payments | $ 40,000,000 | |||||||||||||||||||||||
Estimated percentage of sublicensing revenue | 30.00% | |||||||||||||||||||||||
License Agreement, Jinghua [Member] | Minimum [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Estimated percentage of sublicensing revenue | 10.00% | |||||||||||||||||||||||
License Agreement, Camber Pharmaceuticals, Inc., Tetrabenazine [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Revenue | $ 1,000,000 | 600,000 | 0 | |||||||||||||||||||||
License Agreement, Camber Pharmaceuticals, Inc., Valganciclovir [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
License agreement sales | $ 0 | |||||||||||||||||||||||
Revenue | 200,000 | 900,000 | ||||||||||||||||||||||
License Agreement, Camber Pharmaceuticals, Inc., Abacavir, Entecavir, Lamivudine, Lamivudine (HBV) and Lamivudine and Zidovudine [Member] | ||||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||
Revenue | $ 0 | $ 0 | $ 0 |
License Agreements (Summarized
License Agreements (Summarized Financial Information for MeiraGTx) (Details) - MeiraGTx Ltd. [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Schedule of Equity Method Investments [Line Items] | ||
Cash | $ 8,549 | $ 17,477 |
Other current assets | 2,926 | 1,613 |
Noncurrent assets | 14,379 | 3,461 |
Current liabilities | 21,402 | 6,041 |
Noncurrent liabilities | 479 | 815 |
Mezzanine equity | 51,410 | 33,002 |
Total stockholders’ equity | (47,437) | (17,308) |
General and administrative expense | 9,879 | 6,027 |
Research and development expense | 22,414 | 14,038 |
Net loss attributable to non‑controlling interest in subsidiary and other | $ (32,717) | $ (19,792) |
Share-based Compensation (Narra
Share-based Compensation (Narrative) (Details) | Jul. 13, 2016USD ($)shares | Oct. 31, 2017shares | Sep. 30, 2017shares | Mar. 31, 2017$ / sharesshares | Dec. 31, 2015USD ($) | May 31, 2014 | Jul. 31, 2011 | Sep. 30, 2016USD ($) | Dec. 31, 2015USD ($) | Mar. 31, 2015USD ($) | Jul. 31, 2016USD ($)shares | Sep. 30, 2016USD ($) | Dec. 31, 2017USD ($)item$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares | Aug. 01, 2016$ / shares | Jul. 26, 2016shares | Jan. 31, 2015$ / shares | Apr. 16, 2013$ / shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Share based compensation, options granted | 2,853,000 | 4,858,460 | |||||||||||||||||
Weighted average exercise price of options granted during the period (per share) | $ / shares | $ 3.69 | $ 7.12 | |||||||||||||||||
Options Outstanding, Units, Exercised | 1,109 | 772 | |||||||||||||||||
Options Outstanding, Value, Exercised | $ | $ 4,800 | ||||||||||||||||||
Weighted average grant date fair value of options granted during the period (per share) | $ / shares | 2.44 | $ 7.12 | $ 20.67 | ||||||||||||||||
Equity instruments number of shares authorized as a percentage of equity value | 10.00% | ||||||||||||||||||
Options [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Weighted average grant date fair value of options granted during the period (per share) | $ / shares | $ 2.44 | $ 7.12 | $ 20.67 | ||||||||||||||||
Stock Appreciation Rights [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Unrecognized compensation expense | $ | $ 2,500,000 | ||||||||||||||||||
Weighted average period for recognition of compensation expense | 2 years 10 months 24 days | ||||||||||||||||||
Share based compensation, options granted | 1,040,000 | ||||||||||||||||||
Weighted average exercise price of options granted during the period (per share) | $ / shares | $ 2.42 | ||||||||||||||||||
Options Outstanding, Units, Exercised | 0 | ||||||||||||||||||
Number of executives | item | 3 | ||||||||||||||||||
Expected dividend yield | 0.00% | ||||||||||||||||||
Expected life | 6 years | ||||||||||||||||||
Risk-free interest rate | 2.22% | ||||||||||||||||||
Volatility | 74.92% | ||||||||||||||||||
Chief Executive Officer [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Share based compensation, options granted | 1,630,536 | ||||||||||||||||||
Employees and Director [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Share based compensation, options granted | 3,227,924 | ||||||||||||||||||
Option Agreement, December 31, 2015 [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Stock compensation expense | $ | $ 5,100,000 | $ 2,900,000 | $ 7,200,000 | ||||||||||||||||
Option Agreement, December 31, 2015 [Member] | Chief Executive Officer [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Share based compensation, options granted | 769,231 | ||||||||||||||||||
Share based compensation, options granted, value | $ | $ 15,200,000 | ||||||||||||||||||
Option Agreement, December 31, 2015 [Member] | Tranche One [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Vesting percentage | 33.30% | ||||||||||||||||||
Option Agreement, December 31, 2015 [Member] | Tranche Two [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Vesting percentage | 33.30% | ||||||||||||||||||
Option Agreement, December 31, 2015 [Member] | Tranche Three [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Vesting percentage | 33.30% | ||||||||||||||||||
Option Agreement, July 13, 2016 [Member] | Chief Executive Officer [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Share based compensation, options granted | 1,630,536 | ||||||||||||||||||
Modification charge | $ | $ 12,400,000 | ||||||||||||||||||
Incremental modification charge | $ | $ 8,300,000 | ||||||||||||||||||
Company's outstanding common equity at IPO date, percentage | 5.00% | ||||||||||||||||||
Percentage of options forfeited | 25.00% | ||||||||||||||||||
Additional year of service | 2 years | ||||||||||||||||||
Option Agreement, July 13, 2016 [Member] | Tranche One [Member] | Chief Executive Officer [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Incremental modification charge | $ | $ 4,100,000 | ||||||||||||||||||
2011 Equity Incentive Plan [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Shares authorized for issuance | 0 | ||||||||||||||||||
2016 Equity Incentive Plan [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Additional units available for grant | 8,496,872 | ||||||||||||||||||
Increase in authorized shares as a percentage of common stock issued | 4.00% | ||||||||||||||||||
Incentive plan termination period | 10 years | ||||||||||||||||||
Shares authorized for issuance | 6,720,000 | 8,523,147 | |||||||||||||||||
Unrecognized compensation expense | $ | $ 13,300,000 | $ 21,700,000 | |||||||||||||||||
Weighted average period for recognition of compensation expense | 1 year 10 months 24 days | 1 year 8 months 12 days | |||||||||||||||||
Stock compensation expense | $ | $ 12,400,000 | $ 24,600,000 | $ 10,300,000 | ||||||||||||||||
2016 Equity Incentive Plan [Member] | January 2015 Modification [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Incremental modification charge | $ | $ 1,100,000 | ||||||||||||||||||
Stock compensation expense | $ | $ 668,000 | ||||||||||||||||||
2016 Equity Incentive Plan [Member] | July 2016 Modification [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Incremental modification charge | $ | 4,000,000 | ||||||||||||||||||
Stock compensation expense | $ | $ 1,800,000 | ||||||||||||||||||
Remaining stock compensation | $ | $ 2,200,000 | ||||||||||||||||||
Number of shares affected by modification | 1,600,000 | ||||||||||||||||||
2016 Equity Incentive Plan [Member] | Tranche One [Member] | January 2015 Modification [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Vesting period | 1 year | ||||||||||||||||||
2016 Equity Incentive Plan [Member] | Tranche Two [Member] | January 2015 Modification [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Vesting period | 2 years | ||||||||||||||||||
2014 Long-Term Incentive Plan (“LTIP”) [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Stock compensation expense | $ | $ 22,600,000 | $ 0 | |||||||||||||||||
Equity instruments granted | 9,750 | 9,750 | |||||||||||||||||
Equity instrument payable, common stock value percent above grant price | 333.00% | ||||||||||||||||||
Equity instrument payable, common stock value | $ / shares | $ 20 | ||||||||||||||||||
2014 Long-Term Incentive Plan (“LTIP”) [Member] | Equity Appreciation Rights Units [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Equity instruments granted | 1,250 | 8,500 | |||||||||||||||||
Equity instruments base price | $ / shares | $ 6 | $ 6 | |||||||||||||||||
Equity instruments expiration period | 10 years | 10 years | |||||||||||||||||
Equity instruments payment as a percentage of fair market value of outstanding equity | 0.001% | 0.001% | |||||||||||||||||
2016 Employee Stock Purchase Plan [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Additional units available for grant | 750,000 | ||||||||||||||||||
Increase in authorized shares as a percentage of common stock issued | 1.50% | ||||||||||||||||||
Shares authorized for issuance | 1,801,180 | 1,125,000 | |||||||||||||||||
Share based compensation, options granted | 10,594 | ||||||||||||||||||
Stock compensation expense | $ | $ 0 | $ 0 | |||||||||||||||||
Maximum payroll deduction | 10.00% | ||||||||||||||||||
Offering period | 27 months | ||||||||||||||||||
Amount divided by market price to determine number of shares | $ | $ 2,083 | ||||||||||||||||||
Percentage of fair market value of common stock | 85.00% | ||||||||||||||||||
Class A [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Unit price | $ / shares | $ 3.62 | $ 5.35 | |||||||||||||||||
Class A [Member] | 2011 Equity Incentive Plan [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Percent available to grant out of outstanding units | 7.50% | ||||||||||||||||||
Class A [Member] | 2016 Equity Incentive Plan [Member] | January 2015 Modification [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Exercise price | $ / shares | $ 6 | ||||||||||||||||||
Other Warrants [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Warrants exercise price | $ / shares | $ 4.50 | $ 138.06 | $ 21.24 | ||||||||||||||||
Expected dividend yield | 0.00% | ||||||||||||||||||
Expected life | 3 months 7 days | ||||||||||||||||||
Risk-free interest rate | 1.39% | ||||||||||||||||||
Volatility | 71.50% | ||||||||||||||||||
2015 Credit Agreement [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Class of Warrant or Right, Outstanding | 617,651 | ||||||||||||||||||
Warrants exercise price | $ / shares | $ 10.20 | $ 10.20 | |||||||||||||||||
2015 Credit Agreement [Member] | Secured Term Debt [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Warrants exercise price | $ / shares | $ 10.20 | ||||||||||||||||||
Minimum [Member] | 2016 Equity Incentive Plan [Member] | July 2016 Modification [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Vesting period | 1 year | ||||||||||||||||||
Minimum [Member] | 2016 Employee Stock Purchase Plan [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Number of hours per week for eligibility | 20 hours | ||||||||||||||||||
Number of months employed for eligibility | 5 months | ||||||||||||||||||
Percentage of ownership of stock or options | 5.00% | ||||||||||||||||||
Rate of yearly ownership value | $ | $ 25,000 | ||||||||||||||||||
Number of shares for ESPP for offering period | 200 | ||||||||||||||||||
Maximum [Member] | 2016 Equity Incentive Plan [Member] | July 2016 Modification [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Vesting period | 3 years | ||||||||||||||||||
2017 Public Offering [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Warrants issued | 1,800,000 | 8,910,000 | 10,710,000 | ||||||||||||||||
Warrants exercise price | $ / shares | $ 3.35 | ||||||||||||||||||
Warrant exercise price term | 5 years | ||||||||||||||||||
2017 Private Placement [Member] | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||
Warrants issued | 2,707,138 | 2,707,138 | |||||||||||||||||
Warrants exercise price | $ / shares | $ 4.50 | $ 4.50 | |||||||||||||||||
Warrant exercise price term | 13 months | 13 months |
Share-based Compensation (Stock
Share-based Compensation (Stock Options Outstanding) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation [Abstract] | |||
Options Outstanding, Units, Beginning Balance | 6,437,515 | 1,685,248 | |
Options Outstanding, Units, Granted | 2,853,000 | 4,858,460 | |
Options Outstanding, Units, Exercised | (1,109) | (772) | |
Options Outstanding, Units, Forfeited | (793,643) | (105,084) | |
Options Outstanding, Units, Ending Balance | 8,496,872 | 6,437,515 | 1,685,248 |
Options Vested and Exercisable, Units | 3,969,407 | ||
Options Outstanding, Weighted Average Exercise Price, Beginning Balance | $ 8.32 | $ 37.38 | |
Options Outstanding, Weighted Average Exercise Price, Granted | 3.69 | 7.12 | |
Options Outstanding, Weighted Average Exercise Price, Exercised | 36.63 | ||
Options Outstanding, Weighted Average Exercise Price, Forfeited | 6.23 | 32.09 | |
Options Outstanding, Weighted Average Exercise Price, Ending Balance | 6.96 | $ 8.32 | $ 37.38 |
Options Vested and Exercisable, Weighted Average Exercise Price | $ 9.76 | ||
Options Outstanding, Weighted Average Remaining Contractual Term (years) | 8 years 9 months 29 days | 9 years 3 months 11 days | 8 years 8 months 19 days |
Options Vested and Exercisable, Weighted Average Remaining Contractual Term (years) | 8 years 15 days | ||
Options Outstanding, Aggregate Intrinsic Value | $ 2,227,268 |
Share-based Compensation (Weigh
Share-based Compensation (Weighted-average Fair Value of Stock Option Awards Granted) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average fair value of grants | $ 2.44 | $ 7.12 | $ 20.67 |
Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average fair value of grants | $ 2.44 | $ 7.12 | $ 20.67 |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Options [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 74.48% | 74.98% | 77.23% |
Risk-free interest rate | 1.87% | 1.15% | 1.54% |
Expected life | 5 years 6 months | 5 years | 5 years 2 months 12 days |
Options [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 74.92% | 79.35% | 93.85% |
Risk-free interest rate | 2.22% | 2.20% | 1.93% |
Expected life | 6 years | 6 years | 6 years |
Share-based Compensation (Warra
Share-based Compensation (Warrants Outstanding) (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation [Abstract] | ||
Warrants, beginning balance | 1,328,452 | 710,801 |
Warrants, granted | 13,394,338 | 617,651 |
Warrants, exercised | (22,800) | |
Warrants, forfeited | ||
Warrants, ending balance | 14,699,990 | 1,328,452 |
Weighted average exercise price, beginning balance | $ 29.70 | $ 46.64 |
Weighted average exercise price, granted | 3.58 | 10.20 |
Weighted average exercise price, exercised | 3.35 | |
Weighted average exercise price, forfeited | ||
Weighted average exercise price, ending balance | $ 5.94 | $ 29.70 |
Accrued Expenses and Other Sh68
Accrued Expenses and Other Short Term Liabilities (Narrative) (Details) | Aug. 01, 2016shares | Mar. 31, 2017USD ($)shares | Jun. 30, 2016$ / sharesshares | Sep. 30, 2016USD ($) | Jul. 31, 2016USD ($) | Dec. 31, 2017USD ($)$ / sharesitemshares | Dec. 31, 2016USD ($)shares | Dec. 31, 2015USD ($)shares | Sep. 30, 2015USD ($)$ / shares | Oct. 31, 2014$ / shares |
Short-Term Accrued Expenses [Line Items] | ||||||||||
Payments of initial public offering costs | $ 3,293,000 | $ 445,000 | ||||||||
Stock issued, shares | shares | 6,250,000 | |||||||||
Severance expense | $ 2,900,000 | 2,900,000 | ||||||||
Severance cost | 1,122,000 | 1,744,000 | ||||||||
Accrued expenses | 8,577,000 | 12,150,000 | ||||||||
Other long term liabilities | $ 247,000 | $ 1,250,000 | ||||||||
Units granted | shares | 13,394,338 | 617,651 | ||||||||
Term of lock-up agreement related to IPO | 180 days | |||||||||
Percentage ownership triggering reduced lock-up term | 5.00% | |||||||||
Term of maximum lock-up agreement in event of 5% ownership and subsequent offering (90 days) | 90 days | |||||||||
Royalty arrangements | $ 2,502,000 | |||||||||
Deferred revenue, short term | $ 4,400,000 | 4,400,000 | ||||||||
Royalty Arrangement [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Royalty expense | 100,000 | 1,200,000 | $ 2,700,000 | |||||||
Deferred revenue, short term | 2,200,000 | |||||||||
Board of Directors Chairman [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Severance expense | 1,200,000 | 2,200,000 | ||||||||
Severance cost | 3,000,000 | |||||||||
Severance costs, due in year one | 1,000,000 | 900,000 | ||||||||
Severance costs, due in year two | 1,100,000 | |||||||||
Severance costs including medical benefits | 3,100,000 | |||||||||
Accrued expenses | 1,000,000 | 1,000,000 | ||||||||
Other long term liabilities | $ 200,000 | $ 1,200,000 | ||||||||
Percent of cash received or receivable from business development programs to be used for research and development | 5.00% | |||||||||
Cap on cash received or receivable from business development programs to be used for research and development | $ 15,000,000 | |||||||||
Number of business development programs qualifying for contributions to research and development | item | 3 | |||||||||
Cash received or receivable from business development program before IPO to trigger fulfillment of conditional severance payments | $ 800,000,000 | |||||||||
Board of Directors Chairman [Member] | Supplemental Conditional Payments [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Aggregate payments | 6,750,000 | |||||||||
Payments, 2017 | 2,250,000 | |||||||||
Payments, 2018 | 2,250,000 | |||||||||
Payments, 2019 | 2,250,000 | |||||||||
Minimum payables to trigger supplemental conditional payments | 50,000,000 | |||||||||
Class A Units [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Shares issued for advisory agreement | shares | 25,000 | 1,808,334 | ||||||||
Unit price | $ / shares | $ 32.50 | $ 39 | ||||||||
Class E Redeemable Convertible Units [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Shares issued for advisory agreement | shares | 1,170,437 | 574,392 | ||||||||
Stock issued, shares | shares | 478,266 | |||||||||
Unit price | $ / shares | $ 11.50 | |||||||||
Class E Redeemable Convertible Units [Member] | Board of Directors Chairman [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Stock issued, shares | shares | 21,740 | 21,740 | ||||||||
2015 Stock Issuance [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Accrued liabilities current, commissions payable | 40,000 | $ 40,000 | ||||||||
2014 Stock Issuance [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Accrued liabilities current, commissions payable | 2,400,000 | 2,400,000 | ||||||||
2017 Private Placement [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Payments of initial public offering costs | $ 1,800,000 | $ 1,800,000 | ||||||||
Stock issued, shares | shares | 6,767,855 | 6,767,855 | ||||||||
2015 Second-Lien Convertible Debt [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Borrowings, face amount | 15,000,000 | $ 92,000,000 | ||||||||
Equity Appreciation Rights Units [Member] | Board of Directors Chairman [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Price of units granted | $ / shares | $ 6 | |||||||||
2014 Long-Term Incentive Plan (“LTIP”) [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Stock compensation expense | $ 22,600,000 | $ 0 | ||||||||
2014 Long-Term Incentive Plan (“LTIP”) [Member] | Board of Directors Chairman [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Stock compensation expense | $ 11,600,000 | |||||||||
2014 Long-Term Incentive Plan (“LTIP”) [Member] | Equity Appreciation Rights Units [Member] | Board of Directors Chairman [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Vesting condition, Percent increase in fair market value per unit | 333.00% | |||||||||
Award adjustment percentage | 0.75% | |||||||||
Shares authorized for issuance | shares | 1,783,618 | |||||||||
Third Party Investors [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Gross proceeds from issuance of redeemable convertible units | 873,000 | $ 39,500,000 | ||||||||
Net proceeds from issuance of redeemable convertible units | 833,000 | 36,400,000 | ||||||||
Payments of initial public offering costs | $ 40,000 | $ 3,100,000 | ||||||||
Third Party Investors [Member] | Class E Redeemable Convertible Units [Member] | ||||||||||
Short-Term Accrued Expenses [Line Items] | ||||||||||
Stock issued, shares | shares | 75,875 | 3,438,984 |
Accrued Expenses and Other Sh69
Accrued Expenses and Other Short Term Liabilities (Short-term Accrued Expenses) (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Accrued Expenses and Other Short Term Liabilities [Abstract] | ||
Commission payable | $ 2,395 | $ 2,395 |
Compensation and benefits | 758 | 954 |
Severance | 1,122 | 1,744 |
Royalty arrangements | 2,502 | |
Other | 4,302 | 4,555 |
Total accrued expenses | $ 8,577 | $ 12,150 |
401(k) Profit-Sharing Plan (Det
401(k) Profit-Sharing Plan (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2011 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
401(k) Profit-Sharing Plan [Abstract] | ||||
Participating employees maximum compensation deferral percentage | 75.00% | |||
Employee contributions matching percentage | 6.00% | |||
Expensed employer matching contributions | $ 0.2 | $ 0.3 | $ 0.3 | |
Employer matching contributions disbursements | $ 0.3 | $ 0.3 |
Commitments (Narrative) (Detail
Commitments (Narrative) (Details) | Aug. 11, 2017USD ($) | Dec. 31, 2017USD ($)stateitemshares | Dec. 31, 2016USD ($)shares | Dec. 31, 2015USD ($) | Aug. 01, 2016shares |
Commitments [Line Items] | |||||
Number of primary operating locations | state | 3 | ||||
Payment of surrender cost | $ 1,100,000 | ||||
Proceeds from rent abatement | $ 1,100,000 | ||||
Number of former employees | item | 2 | ||||
Amount payable upon consummation of IPO | $ 1,250,000 | ||||
Common stock issued | shares | 78,643,954 | 45,078,666 | |||
Employment agrrement liability | $ 1,200,000 | $ 1,200,000 | |||
Severance expense | 2,900,000 | 2,900,000 | |||
Future Discretionary Clinical Developments and Regulatory Agency Actions [Member] | |||||
Commitments [Line Items] | |||||
Additional contingent milestone payments | 400,400,000 | ||||
New York [Member] | |||||
Commitments [Line Items] | |||||
Rental expense | $ 5,700,000 | 6,400,000 | $ 6,200,000 | ||
Base rent annual percentage increase | 3.50% | ||||
Pennsylvania [Member] | |||||
Commitments [Line Items] | |||||
Expiration date | Sep. 30, 2019 | ||||
Renewal option | 5 years | ||||
Rental expense | $ 600,000 | 600,000 | 600,000 | ||
Massachusetts [Member] | |||||
Commitments [Line Items] | |||||
Expiration date | Apr. 1, 2023 | ||||
Rental expense | $ 300,000 | 300,000 | $ 0 | ||
Secured Letter of Credit [Member] | New York [Member] | |||||
Commitments [Line Items] | |||||
Secured letter of credit | 2,000,000 | $ 2,000,000 | |||
Secured Letter of Credit [Member] | Massachusetts [Member] | |||||
Commitments [Line Items] | |||||
Secured letter of credit | $ 91,000 | ||||
Former Employees [Member] | |||||
Commitments [Line Items] | |||||
Common stock issued | shares | 208,334 |
Commitments (Future Minimum Ren
Commitments (Future Minimum Rental Payments Under Noncancellable Leases) (Details) $ in Thousands | Dec. 31, 2017USD ($) |
Commitments [Abstract] | |
2,018 | $ 4,579 |
2,019 | 4,517 |
2,020 | 4,049 |
2,021 | 4,148 |
2,022 | 4,286 |
Thereafter | 11,884 |
Total | $ 33,463 |
Contingencies (Details)
Contingencies (Details) - USD ($) $ in Millions | Sep. 06, 2016 | Jul. 25, 2016 |
The Glodek Litigation [Member] | ||
Loss Contingencies [Line Items] | ||
Claim amount | $ 4 | $ 2.8 |
Concentrations (Details)
Concentrations (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017USD ($)customer | Dec. 31, 2016USD ($)customer | Dec. 31, 2015 | |
Concentration Risk [Line Items] | |||
Net accounts receivable | $ 325 | $ 655 | |
Customer Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Net accounts receivable | $ 100 | $ 100 | |
Net Sales [Member] | Customer Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Number of major customers | customer | 2 | 2 | |
Revenue percentage | 29.00% | 41.00% | 31.00% |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 01, 2016 | Jun. 30, 2016 | Sep. 30, 2015 | Jan. 31, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Aug. 31, 2015 | Apr. 30, 2015 |
Related Party Transaction [Line Items] | |||||||||
Derivative liability | $ 1,952 | ||||||||
Related party loans outstanding | $ 3,000 | $ 3,500 | |||||||
Settlement of related party loan | $ 500 | $ 500 | |||||||
Equity investment | $ 7,599 | ||||||||
Interest free loans | $ 2,000 | ||||||||
Price per share of common stock at IPO date | $ 12 | ||||||||
Stock issued, shares | 6,250,000 | ||||||||
Stock issued | $ 19,216 | ||||||||
GoldenTree Asset Management LP [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Settlement of related party loan | $ 15,000 | ||||||||
Stock issued, shares | 208,333 | ||||||||
Stock issued | $ 2,500 | ||||||||
Falcon Flight LLC [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Settlement due within One Day of IPO | $ 500 | ||||||||
Settlement due within 60 Days of IPO | 300 | ||||||||
Settlement expense | $ 2,600 | $ 10,400 | |||||||
Institutional Investors [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock issued, shares | 2,708,332 | ||||||||
Stock issued | $ 32,500 | ||||||||
Perceptive Advisors, LLC [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock issued, shares | 1,458,333 | ||||||||
Stock issued | $ 17,500 | ||||||||
Third Point Partners, LLC [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock issued, shares | 1,041,666 | ||||||||
Stock issued | $ 12,500 | ||||||||
Class A [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Unit price | $ 3.62 | $ 5.35 | |||||||
Class E Redeemable Convertible Units [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Preferred stock issued | 43,478 | ||||||||
Stock issued, shares | 478,266 | ||||||||
Unit price | $ 11.50 | ||||||||
Class E Redeemable Convertible Units [Member] | GoldenTree Asset Management LP [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock issued, shares | 43,479 | 43,479 | |||||||
Class E Redeemable Convertible Units [Member] | 72 KDMN Investments, LLC [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock issued, shares | 86,957 | ||||||||
Class E Redeemable Convertible Units [Member] | Falcon Flight LLC [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Common units issued | 1,061,741 | ||||||||
Kadmon I [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Ownership percentage | 12.10% | ||||||||
MeiraGTx [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Ownership percentage | 48.00% | ||||||||
Equity investment | $ 24,000 | ||||||||
Chief Executive Officer [Member] | Class E Redeemable Convertible Units [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock issued, shares | 86,957 | 86,957 | |||||||
Board of Directors Chairman [Member] | Class E Redeemable Convertible Units [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock issued, shares | 21,740 | 21,740 | |||||||
Directors [Member] | Class E Redeemable Convertible Units [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock issued, shares | 21,740 | 21,740 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Jan. 31, 2017 | Dec. 31, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Mar. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Line Items] | |||||||||
Income tax expense (benefit) | $ (437) | $ 316 | $ 27 | $ 315 | $ (121) | $ 342 | $ (3) | ||
U.S. federal corporate tax rate | 35.00% | 35.00% | 35.00% | ||||||
Tax Cuts and Jobs Act of 2017, Deferred Income Tax Benefit | $ 400 | ||||||||
Reduction of operating loss carryforwards | $ 1,400 | ||||||||
Scenario, Plan [Member] | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
U.S. federal corporate tax rate | 21.00% | ||||||||
Federal [Member] | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Net operating loss carryforwards | 419,200 | 419,200 | |||||||
State [Member] | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Net operating loss carryforwards | $ 362,000 | 362,000 | |||||||
License Agreement, Jinghua [Member] | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Change in deferred tax liability | 400 | ||||||||
Income tax expense (benefit) | 100 | 300 | |||||||
Milestone payment | $ 2,000 | $ 2,000 | $ 2,000 |
Income Taxes (Income Tax Provis
Income Taxes (Income Tax Provision) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
Dec. 31, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Taxes [Abstract] | |||||||
Current tax expense (benefit) - Foreign | $ 316 | $ 315 | |||||
Total current tax expense | 316 | 315 | |||||
Deferred tax expense (benefit) - Federal | (485) | (15) | $ 1 | ||||
Deferred tax expense (benefit) - State | 48 | 42 | (4) | ||||
Total deferred tax benefit | (437) | 27 | (3) | ||||
Income tax expense (benefit) | $ (437) | $ 316 | $ 27 | $ 315 | $ (121) | $ 342 | $ (3) |
Income Taxes (Effective Income
Income Taxes (Effective Income Tax Rate Reconciliation) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
Dec. 31, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Taxes [Abstract] | |||||||
Expected federal statutory income tax | $ (27,821) | $ (72,945) | $ (51,480) | ||||
State income taxes, net of federal benefits | (8,314) | (9,485) | (4,544) | ||||
Change in federal tax rate used for deferred purposes | 112,611 | 200 | 972 | ||||
Adjustment to deferred tax assets | 15,210 | (6,492) | |||||
Change in valuation allowance | (91,807) | 82,572 | 61,541 | ||||
Income tax expense (benefit) | $ (437) | $ 316 | $ 27 | $ 315 | $ (121) | $ 342 | $ (3) |
Expected federal statutory income tax, Percent | (35.00%) | (35.00%) | (35.00%) | ||||
State income taxes, net of federal benefits, Percent | (10.50%) | (4.60%) | (3.10%) | ||||
Change in federal tax rate used for deferred purposes, Percent | 141.70% | 0.10% | 0.70% | ||||
Adjustment to deferred tax assets, Percent | 19.10% | 0.00% | (4.40%) | ||||
Change in valuation allowance, Percent | (115.50%) | 39.60% | 41.80% | ||||
Income tax expense (benefit) , Percent | (0.20%) | 0.10% | 0.00% |
Income Taxes (Net Deferred Tax
Income Taxes (Net Deferred Tax Assets and Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Income Taxes [Abstract] | ||
Net operating loss carryforward | $ 112,289 | $ 171,074 |
Foreign tax credit carryforward (LT) | 631 | 315 |
Capitalized research and development | 66,500 | 78,147 |
Share-based compensation | 18,735 | 22,233 |
Loss on equity investment | 6,294 | 5,900 |
Organization costs | 30 | 46 |
Depreciation | 772 | 1,050 |
Intangibles | 30,788 | 47,595 |
Inventory reserve and other | 2,145 | 3,631 |
Total deferred tax assets | 238,184 | 329,991 |
Goodwill | (939) | (1,376) |
Total deferred tax liability | (939) | (1,376) |
Total deferred tax assets, net | 237,245 | 328,615 |
Valuation allowance | (238,184) | (329,991) |
Deferred tax liability | $ (939) | $ (1,376) |
Quarterly Financial Data (Detai
Quarterly Financial Data (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 7 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Jul. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | ||
Net sales | $ 187 | $ 1,036 | $ 1,698 | $ 2,336 | $ 3,010 | $ 4,345 | $ 4,967 | $ 6,192 | $ 5,257 | $ 18,514 | $ 29,299 | ||
License and other revenue | 1,277 | 1,241 | 1,259 | 3,230 | 1,267 | 1,350 | 1,453 | 3,471 | 7,007 | 7,541 | 6,420 | ||
Total revenue | 1,464 | 2,277 | 2,957 | 5,566 | 4,277 | 5,695 | 6,420 | 9,663 | 12,264 | 26,055 | 35,719 | ||
Cost of sales | 222 | 277 | 266 | 567 | 640 | 880 | 880 | 1,085 | 1,332 | 3,485 | 3,731 | ||
Write-down of inventory | (22) | 933 | 373 | 370 | 119 | 129 | 2 | 135 | 1,654 | 385 | 2,274 | ||
Gross profit | 1,264 | 1,067 | 2,318 | 4,629 | 3,518 | 4,686 | 5,538 | 8,443 | 9,278 | 22,185 | 29,714 | ||
Research and development | 10,499 | 11,775 | 10,056 | 8,447 | 8,539 | 9,631 | 8,587 | 9,083 | 40,777 | 35,840 | 33,558 | ||
Selling, general and administrative | 7,916 | 9,121 | 9,902 | 10,118 | 14,620 | 48,426 | 19,148 | 23,686 | 37,057 | 105,880 | 104,740 | ||
Impairment of intangible asset | 31,269 | ||||||||||||
Gain on settlement of payable | (256) | (3,875) | (4,131) | ||||||||||
Total operating expenses | 18,415 | 20,896 | 19,958 | 18,565 | 23,159 | 57,801 | 27,735 | 28,894 | 77,834 | 137,589 | 169,567 | ||
Loss from operations | (17,151) | (19,829) | (17,640) | (13,936) | (19,641) | (53,115) | (22,197) | (20,451) | (68,556) | (115,404) | (139,853) | ||
Total other expense | 1,476 | 1,874 | 4,674 | 3,315 | 1,716 | 64,049 | 14,837 | 12,407 | 11,339 | 93,009 | 7,232 | ||
Income tax expense (benefit) | (437) | 316 | 27 | 315 | (121) | 342 | (3) | ||||||
Net loss | (18,190) | (21,703) | (22,314) | (17,567) | (21,384) | (117,164) | (37,034) | (33,173) | (79,774) | (208,755) | (147,082) | ||
Deemed dividend on convertible preferred stock and Class E redeemable convertible units | 490 | 490 | 469 | 469 | 469 | 21,264 | 1,918 | 21,733 | |||||
Net loss attributable to common stockholders | $ (18,680) | $ (22,193) | $ (22,783) | $ (18,036) | $ (21,853) | $ (138,428) | [1] | $ (37,034) | $ (33,173) | $ (81,692) | $ (230,488) | $ (147,082) | |
Basic and diluted net loss per share of common stock | $ (0.24) | $ (0.42) | $ (0.44) | $ (0.39) | $ (0.48) | $ (4.24) | $ (4.46) | $ (4) | $ (1.42) | $ (9.74) | $ (18.10) | ||
Weighted average basic and diluted shares of common stock outstanding | 78,397,156 | 52,572,880 | 51,846,521 | 46,507,435 | 45,078,666 | 32,678,259 | [2] | 8,304,334 | 8,302,635 | 57,405,331 | 23,674,512 | 8,127,781 | |
Beneficial conversion feature expense on convertible debt | $ 44,200 | $ 44,170 | |||||||||||
Deemed dividends on preferred stock | 20,900 | ||||||||||||
Beneficial conversion feature expense on warrants | 1,700 | $ 1,745 | |||||||||||
2014 Long-Term Incentive Plan (“LTIP”) [Member] | |||||||||||||
Allocated Share-based Compensation Expense | $ 22,600 | $ 0 | |||||||||||
[1] | Net loss attributable to common stockholders for the three months ended September 30, 2016 includes the beneficial conversion feature of the Company's debt upon conversion into shares of the Company's common stock on August 1, 2016 of $44.2 million, the beneficial conversion feature of certain outstanding warrants which became exercisable into shares of the Company's common stock on August 1, 2016 of $1.7 million, the deemed dividends on the Company's convertible preferred stock and Class E redeemable convertible units of $20.9 million and share-based compensation expense related to the Company's LTIP of $22.6 million. | ||||||||||||
[2] | Weighted average basic and diluted shares of common stock outstanding for the three months ended September 30, 2016 includes shares issued as a result of the Corporate Conversion (Note 1). |