Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 04, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | Kadmon Holdings, Inc. | |
Entity Central Index Key | 0001557142 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Common Stock, Shares Outstanding | 129,690,886 | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Small Business | true |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 66,132 | $ 94,740 |
Accounts receivable, net | 687 | 1,690 |
Inventories, net | 214 | 925 |
Investment, equity securities | 56,379 | |
Prepaid expenses and other current assets | 1,048 | 1,581 |
Total current assets | 124,460 | 98,936 |
Fixed assets, net | 2,728 | 3,654 |
Right of use lease asset | 20,510 | |
Goodwill | 3,580 | 3,580 |
Restricted cash | 2,116 | 2,116 |
Investment, equity securities | 34,075 | |
Investment, at cost | 2,300 | 2,300 |
Other noncurrent assets | 187 | |
Total assets | 155,881 | 144,661 |
Current liabilities: | ||
Accounts payable | 8,484 | 9,986 |
Accrued expenses | 13,578 | 13,508 |
Lease liability - current | 3,905 | |
Fair market value of financial instruments | 594 | 524 |
Secured term debt - current | 27,763 | |
Total current liabilities | 54,324 | 24,018 |
Lease liability - noncurrent | 20,774 | |
Deferred rent | 4,290 | |
Deferred tax liability | 415 | 415 |
Other long term liabilities | 244 | 47 |
Secured term debt – net of current portion and discount | 27,480 | |
Total liabilities | 75,757 | 56,250 |
Commitments and contingencies (Note 15) | ||
Stockholders’ equity: | ||
Convertible preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2019 and December 31, 2018; 28,708 and 30,000 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 41,915 | 42,231 |
Common stock, $0.001 par value; 400,000,000 and 200,000,000 shares authorized at September 30, 2019 and December 31, 2018, respectively; 129,634,540 and 113,130,817 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 130 | 113 |
Additional paid-in capital | 358,905 | 315,710 |
Accumulated deficit | (320,826) | (269,643) |
Total stockholders’ equity | 80,124 | 88,411 |
Total liabilities and stockholders’ equity | $ 155,881 | $ 144,661 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 28,708 | 30,000 |
Preferred stock, shares outstanding | 28,708 | 30,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 400,000,000 | 200,000,000 |
Common stock, shares issued | 129,634,540 | 113,130,817 |
Common stock, shares outstanding | 129,634,540 | 113,130,817 |
Convertible Preferred Stock [Member] | ||
Preferred stock, shares outstanding | 28,708 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenues: | ||||
Total revenue | $ 226,000 | $ 372,000 | $ 693,000 | $ 1,164,000 |
Cost of sales | 73,000 | 59,000 | 149,000 | 361,000 |
Write-down of inventory | 0 | 20,000 | 932,000 | 265,000 |
Gross profit | 153,000 | 293,000 | (388,000) | 538,000 |
Operating expenses: | ||||
Research and development | 13,227,000 | 11,918,000 | 43,326,000 | 31,876,000 |
Selling, general and administrative | 10,174,000 | 9,668,000 | 27,101,000 | 26,730,000 |
Total operating expenses | 23,401,000 | 21,586,000 | 70,427,000 | 58,606,000 |
Loss from operations | (23,248,000) | (21,293,000) | (70,815,000) | (58,068,000) |
Other (expense) income: | ||||
Interest income | 418,000 | 534,000 | 1,622,000 | 742,000 |
Interest expense | (931,000) | (877,000) | (2,799,000) | (3,680,000) |
Change in fair value of financial instruments | (126,000) | 198,000 | (70,000) | 802,000 |
Loss on equity method investment | (1,242,000) | |||
Unrealized (loss) gain on equity securities | (38,634,000) | 7,564,000 | 22,304,000 | 48,072,000 |
Other income | 126,000 | 75,000 | 115,000 | 77,000 |
Total other (expense) income | (39,147,000) | 7,494,000 | 21,172,000 | 44,771,000 |
Loss before income tax benefit | (62,395,000) | (13,799,000) | (49,643,000) | (13,297,000) |
Income tax benefit | 0 | 0 | 0 | 562,000 |
Net loss | (62,395,000) | (13,799,000) | (49,643,000) | (12,735,000) |
Deemed dividend on convertible preferred stock | 517,000 | 515,000 | 1,540,000 | 1,496,000 |
Net loss attributable to common stockholders | $ (62,912,000) | $ (14,314,000) | $ (51,183,000) | $ (14,231,000) |
Basic and diluted net loss per share of common stock | $ (0.49) | $ (0.13) | $ (0.40) | $ (0.15) |
Weighted average basic and diluted shares of common stock outstanding | 128,225,469 | 113,101,776 | 128,360,618 | 92,378,205 |
Net Sales [Member] | ||||
Revenues: | ||||
Total revenue | $ 50,000 | $ 198,000 | $ 164,000 | $ 633,000 |
Other Revenue [Member] | ||||
Revenues: | ||||
Total revenue | $ 176,000 | $ 174,000 | $ 529,000 | $ 531,000 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2017 | $ 40,220 | $ 79 | $ 198,856 | $ (237,397) | $ 1,758 |
Balance, Shares at Dec. 31, 2017 | 30,000 | 78,643,954 | |||
Share-based compensation expense | 2,572 | 2,572 | |||
Common stock issued for warrant exercises | 26 | 26 | |||
Common stock issued for warrant exercises, shares | 8,195 | ||||
Beneficial conversion feature on convertible preferred stock | $ 98 | (98) | |||
Accretion of dividends on convertible preferred stock | 392 | (392) | |||
Net income (loss) | (20,441) | (20,441) | |||
Balance at Mar. 31, 2018 | $ 40,710 | $ 79 | 201,454 | (234,311) | 7,932 |
Balance, Shares at Mar. 31, 2018 | 30,000 | 78,652,149 | |||
Balance at Dec. 31, 2017 | $ 40,220 | $ 79 | 198,856 | (237,397) | 1,758 |
Balance, Shares at Dec. 31, 2017 | 30,000 | 78,643,954 | |||
Beneficial conversion feature on convertible preferred stock | 299 | ||||
Accretion of dividends on convertible preferred stock | 1,197 | ||||
Net income (loss) | (12,735) | ||||
Balance at Sep. 30, 2018 | $ 41,716 | $ 113 | 313,664 | (227,611) | 127,882 |
Balance, Shares at Sep. 30, 2018 | 30,000 | 113,101,776 | |||
Balance at Dec. 31, 2017 | $ 40,220 | $ 79 | 198,856 | (237,397) | 1,758 |
Balance, Shares at Dec. 31, 2017 | 30,000 | 78,643,954 | |||
Balance at Dec. 31, 2018 | $ 42,231 | $ 113 | 315,710 | (269,643) | 88,411 |
Balance, Shares at Dec. 31, 2018 | 30,000 | 113,130,817 | |||
Balance at Mar. 31, 2018 | $ 40,710 | $ 79 | 201,454 | (234,311) | 7,932 |
Balance, Shares at Mar. 31, 2018 | 30,000 | 78,652,149 | |||
Share-based compensation expense | 3,023 | 3,023 | |||
Common stock issued in public offering, net | $ 34 | 105,727 | 105,761 | ||
Common stock issued in public offering, net, shares | 34,303,030 | ||||
Common stock issued for warrant exercises | 562 | 562 | |||
Common stock issued for warrant exercises, shares | 123,639 | ||||
Common stock issued under ESPP plan | 65 | 65 | |||
Common stock issued under ESPP plan, shares | 22,958 | ||||
Cumulative effect of change in accounting principle - ASC 606 adoption at Mar. 31, 2018 | 24,017 | 24,017 | |||
Beneficial conversion feature on convertible preferred stock | $ 98 | (98) | |||
Accretion of dividends on convertible preferred stock | 393 | (393) | |||
Net income (loss) | 21,505 | 21,505 | |||
Balance at Jun. 30, 2018 | $ 41,201 | $ 113 | 310,831 | (213,297) | 138,848 |
Balance, Shares at Jun. 30, 2018 | 30,000 | 113,101,776 | |||
Share-based compensation expense | 2,833 | 2,833 | |||
Beneficial conversion feature on convertible preferred stock | $ 103 | (103) | |||
Accretion of dividends on convertible preferred stock | 412 | (412) | |||
Net income (loss) | (13,799) | (13,799) | |||
Balance at Sep. 30, 2018 | $ 41,716 | $ 113 | 313,664 | (227,611) | 127,882 |
Balance, Shares at Sep. 30, 2018 | 30,000 | 113,101,776 | |||
Share-based compensation expense | 1,963 | 1,963 | |||
Common stock issued under ESPP plan | 83 | 83 | |||
Common stock issued under ESPP plan, shares | 29,041 | ||||
Beneficial conversion feature on convertible preferred stock | $ 103 | (103) | |||
Accretion of dividends on convertible preferred stock | 412 | (412) | |||
Net income (loss) | (41,517) | (41,517) | |||
Balance at Dec. 31, 2018 | $ 42,231 | $ 113 | 315,710 | (269,643) | 88,411 |
Balance, Shares at Dec. 31, 2018 | 30,000 | 113,130,817 | |||
Share-based compensation expense | 2,156 | 2,156 | |||
Common stock issued in public offering, net | $ 14 | 29,035 | 29,049 | ||
Common stock issued in public offering, net, shares | 13,778,705 | ||||
Beneficial conversion feature on convertible preferred stock | $ 103 | (103) | |||
Accretion of dividends on convertible preferred stock | 412 | (412) | |||
Net income (loss) | 3,592 | 3,592 | |||
Balance at Mar. 31, 2019 | $ 42,746 | $ 127 | 346,901 | (266,566) | 123,208 |
Balance, Shares at Mar. 31, 2019 | 30,000 | 126,909,522 | |||
Balance at Dec. 31, 2018 | $ 42,231 | $ 113 | 315,710 | (269,643) | $ 88,411 |
Balance, Shares at Dec. 31, 2018 | 30,000 | 113,130,817 | |||
Common stock issued in public offering, net, shares | 13,778,705 | ||||
Beneficial conversion feature on convertible preferred stock | $ 308 | ||||
Accretion of dividends on convertible preferred stock | 1,232 | ||||
Net income (loss) | (49,643) | ||||
Balance at Sep. 30, 2019 | $ 41,915 | $ 130 | 358,905 | (320,826) | 80,124 |
Balance, Shares at Sep. 30, 2019 | 28,708 | 129,634,540 | |||
Balance at Mar. 31, 2019 | $ 42,746 | $ 127 | 346,901 | (266,566) | 123,208 |
Balance, Shares at Mar. 31, 2019 | 30,000 | 126,909,522 | |||
Share-based compensation expense | 1,969 | 1,969 | |||
Common stock issued in public offering, net | $ 3 | 6,644 | 6,647 | ||
Common stock issued in public offering, net, shares | 2,538,100 | ||||
Common stock issued under ESPP plan | 73 | 73 | |||
Common stock issued under ESPP plan, shares | 32,273 | ||||
Beneficial conversion feature on convertible preferred stock | $ 102 | (102) | |||
Accretion of dividends on convertible preferred stock | 406 | (406) | |||
Common stock issued upon conversion of convertible preferred stock | $ (1,856) | 1,856 | |||
Common stock issued upon conversion of convertible preferred stock, shares | (1,292) | 154,645 | |||
Net income (loss) | 9,160 | 9,160 | |||
Balance at Jun. 30, 2019 | $ 41,398 | $ 130 | 357,443 | (257,914) | 141,057 |
Balance, Shares at Jun. 30, 2019 | 28,708 | 129,634,540 | |||
Share-based compensation expense | 1,462 | 1,462 | |||
Beneficial conversion feature on convertible preferred stock | $ 103 | (103) | |||
Accretion of dividends on convertible preferred stock | 414 | (414) | |||
Net income (loss) | (62,395) | (62,395) | |||
Balance at Sep. 30, 2019 | $ 41,915 | $ 130 | $ 358,905 | $ (320,826) | $ 80,124 |
Balance, Shares at Sep. 30, 2019 | 28,708 | 129,634,540 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (49,643,000) | $ (12,735,000) |
Adjustments to reconcile net income to net cash used in operating activities: | ||
Depreciation and amortization of fixed assets | 1,356,000 | 1,105,000 |
Amortization of right of use lease asset | 2,495,000 | |
Write-down of inventory | 932,000 | 265,000 |
Amortization of deferred financing costs | 228,000 | |
Amortization of debt discount | 283,000 | 1,077,000 |
Amortization of debt premium | (345,000) | |
Share-based compensation | 5,587,000 | 8,428,000 |
Change in fair value of financial instruments | 70,000 | (802,000) |
Loss on equity method investment | 1,242,000 | |
Unrealized gain on equity securities | (22,304,000) | (48,072,000) |
Deferred tax liability | (562,000) | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 1,003,000 | 207,000 |
Inventories, net | (221,000) | (1,127,000) |
Prepaid expenses and other assets | 346,000 | (1,109,000) |
Accounts payable | (1,402,000) | (1,072,000) |
Lease liability | (2,763,000) | |
Accrued expenses, other liabilities and deferred rent | 314,000 | 686,000 |
Net cash used in operating activities | (63,947,000) | (52,586,000) |
Cash flows from investing activities: | ||
Purchases of fixed assets | (430,000) | (811,000) |
Net cash used in investing activities | (430,000) | (811,000) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net | 35,696,000 | 105,761,000 |
Payments of financing costs | (596,000) | |
Principal payments on secured term debt | (6,574,000) | |
Proceeds from issuance of ESPP shares | 73,000 | 65,000 |
Proceeds from exercise of warrants | 575,000 | |
Net cash provided by financing activities | 35,769,000 | 99,231,000 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (28,608,000) | 45,834,000 |
Cash, cash equivalents and restricted cash, beginning of period | 96,856,000 | 69,633,000 |
Cash, cash equivalents and restricted cash, end of period | 68,248,000 | 115,467,000 |
Components of cash, cash equivalents, and restricted cash | ||
Total cash, cash equivalents, and restricted cash | 96,856,000 | 69,633,000 |
Supplemental cash flow disclosures: | ||
Cash paid for interest | 2,514,000 | 2,750,000 |
Non-cash investing and financing activities: | ||
Beneficial conversion feature on convertible preferred stock | 308,000 | 299,000 |
Accretion of dividends on convertible preferred stock | 1,232,000 | 1,197,000 |
Operating lease liabilities arising from obtaining right-of-use assets | 212,000 | |
Common stock issued upon conversion of convertible preferred stock | 1,856,000 | |
Accounting Standards Update 2016-02 [Member] | ||
Non-cash investing and financing activities: | ||
Cumulative effect of change in accounting principle | $ 27,083,000 | |
ASU 2014-09 [Member] | ||
Non-cash investing and financing activities: | ||
Cumulative effect of change in accounting principle | $ 24,017,000 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2019 | |
Organization [Abstract] | |
Organization | 1. Organization Nature of Business Kadmon Holdings, Inc. (together with its subsidiaries, “Kadmon” or the “Company”) is a biopharmaceutical company engaged in the discovery, development and commercialization of small molecules and biologics to address significant unmet medical needs, with a near-term clinical focus on inflammatory and fibrotic diseases as well as immuno-oncology. 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. 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 in the remainder of 2019 and in 2020. Liquidity The Company maintained cash and cash equivalents of $66.1 million at September 30, 2019 . The Company had an accumulated deficit of $320.8 million and working capital of $70.1 million at September 30, 2019 . Subsequently, in October 2019, the Company entered into a transaction pursuant to which it sold approximately 1.4 million ordinary shares of MeiraGTx Holdings plc (“MeiraGTx”) for gross proceeds of $22.0 million. Pursuant to the 2015 Credit Agreement, half of the proceeds received from the sale, or $11.0 million, were used to pay down part of the outstanding amounts owed under the 2015 Credit Agreement. After this repayment, approximately $17.0 million remained outstanding under the 2015 Credit Agreement (Note 5). The remaining $11.0 million in gross proceeds were added to the Company’s cash balances in October 2019. The Company expects that its cash and cash equivalents will enable it to advance its Phase 2 clinical studies of KD025 and advance certain of its other pipeline product candidates and provide for other working capital purposes. Management’s plans include continuing to finance operations through the issuance of additional equity securities, monetization of assets and expanding the Company’s commercial portfolio through the development of its current pipeline or through strategic collaborations. Any transactions that 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. The Company filed a shelf registration statement on Form S-3 (File No. 333-233766) on September 13, 2019, which was declared effective by the Securities Exchange Commission (“SEC”) on September 24, 2019. Under this registration statement, the Company may sell, in one or more transactions, up to $200.0 million of common stock, preferred stock, debt securities, warrants, purchase contracts and units , an amount which includes $50.0 million of shares of its common stock that may be issued in one or more “at-the-market” placements at prevailing market prices under the Company’s Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”) . The Company had not sold any securities pursuant to this registration statement as of September 30, 2019. In April 2019, the Company sold 2,538,100 shares of common stock at a price of $2.70 per share and received total gross proceeds of $6.9 million ( $6.7 million net of $0.2 million of comm issions payable by the Company) and in January 2019, the Company sold 13,778,705 shares of common stock at a weighted average price of $2.17 per share and received total gross proceeds of $29.9 million ( $29.0 million net of $0.9 million of commissions payable by the Company). These sales were effected pursuant to the Company’s registration statement on Form S-3 (File No. 333-222364), which was declared effective by the SEC on January 10, 2018. The Company completed these sales pursuant to its Sales Agreement with Cantor Fitzgerald under which the Company could sell up to $40.0 million in shares of its common stock in one or more “at-the-market” placements at prevailing market prices. Going Concern The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), 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. Since inception, the Company has experienced significant losses and incurred negative cash flows from operations. The Company expects to incur further losses over the next several years as it develops its business. The Company has spent, and expects to continue to spend, a substantial amount of funds in connection with implementing its business strategy, including its planned product development efforts, preparation for its planned clinical trials, performance of clinical trials and its research and discovery efforts. The Company’s cash and cash equivalents are not expected to be sufficient to enable the Company to meet its long-term expected plans, including commercialization of clinical pipeline products, if approved, or initiation or completion of future registrational studies. The Company has no current commitments for additional financing and may not be successful in its efforts to raise additional funds or achieve profitable operations, and there can be no assurance that additional financing will be available to the Company on commercially acceptable terms or at all. Any amounts raised will be used for further development of the Company’s product candidates, for marketing and promotion, to secure additional property and equipment and for other working capital purposes. If the Company is unable to obtain additional capital, its long-term business plan may not be accomplished and the Company may be forced to curtail or cease operations. Further, the 2015 Credit Agreement contains a minimum liquidity covenant. The Company’s violation of its minimum liquidity covenant would constitute an event of default under the 2015 Credit Agreement. Upon an event of default, the lender may terminate the commitments under the 2015 Credit Agreement and declare the loans then outstanding under the 2015 Credit Agreement to be due and payable in whole or in part, together with any applicable fees and accrued interest thereon. If an event of default arises under the 2015 Credit Agreement, the Company may need to use cash and cash equivalents on hand to fund certain repayment commitments under the 2015 Credit Agreement. These factors individually and collectively continue to 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 | 9 Months Ended |
Sep. 30, 2019 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. 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 its products and the regulatory environment in which the Company operate s. The accompanying consolidated financial statements, which include the accounts of Kadmon Holdings, Inc. and its domestic and international subsidiaries, all of which are wholly owned by Kadmon Holdings, Inc., have been prepared in accordance with GAAP for interim financial information and pursuant to the rules and regulations of the SEC. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the Company’s opinion, the financial statements include all adjustments (consisting of normal recurring adjustments) and disclosures considered necessary in order to make the financial statements not misleading. Operating results for the three and nine months ended September 30, 2019 are not necessarily indicative of the final results that may be expected for the year ending December 31, 2019. These unaudited financial statements should be read in conjunction with the audited financial statements included in Item 8 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. Use of Estimates The preparation of financial statements in accordance 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. The most significant estimates are related to share-based compensation, the accrual of research and development and clinical trial expenses, and the valuation of the Company’s investment in MeiraGTx ordinary shares (Note 11). Critical Accounting Policies The Company’s significant accounting policies are disclosed in the audited financial statements included in Item 8 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies, other than those described below. Accounting for Leases In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016 02, Leases (“ASC 842”), to enhance the transparency and comparability of financial reporting related to leasing arrangements. Under this new lease standard, most leases are required to be recognized on the balance sheet as right-of-use (“ROU”) assets and lease liabilities. Disclosure requirements have been enhanced with the objective of enabling financial statement users to assess the amount, timing and uncertainty of cash flows arising from leases. Prior to January 1, 2019, GAAP did not require lessees to recognize assets and liabilities related to operating leases on the balance sheet. The new standard establishes a ROU model that requires a lessee to recognize a ROU asset and corresponding lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations as well as the reduction of the right of use asset. The Company has adopted the standard effective January 1, 2019 and has chosen to use the effective date as our date of initial application. Consequently, financial information will not be updated and the disclosures required under the new standard will not be provided for dates and periods prior to January 1, 2019. The new standard provides a number of optional practical expedients in transition. The Company has elected to apply the ‘package of practical expedients’, which allow it to not reassess (i) whether existing or expired arrangements contain a lease, (ii) the lease classification of existing or expired leases, or (iii) whether previous initial direct costs would qualify for capitalization under the new lease standard. The Company has also elected to apply (i) the practical expedient, which allows it to not separate lease and non-lease components, for new leases entered into after adoption and (ii) the short-term lease exemption for all leases with an original term of less than 12 months, for purposes of applying the recognition and measurements requirements in the new standard. In preparation for adoption of the standard, the Company implemented internal controls to enable the preparation of financial information including the assessment of the impact of the standard. For the impact to the Company’s consolidated financial statement upon adoption of the new leasing standard, see Note 8 to the unaudited consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and the Company’s control over the use of the identified asset(s), if applicable. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company will utilize the incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. As of the ASC 842 effective date, the Company’s incremental borrowing rate ranged from approximately 4.0% - 5.6% based on the remaining lease term of the applicable leases. The Company has elected to combine lease and non-lease components as a single component. Operating leases are recognized on the balance sheet as ROU lease assets, lease liabilities current and lease liabilities non-current. Fixed rents are included in the calculation of the lease balances while variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected term on a straight-line basis. Revenue Recognition The Company adopted FASB ASC 606, Revenue from Contracts with Customers (“ASC 606”), on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption– i.e. by recognizing the cumulative effect of initially applying ASC 606 as an adjustment to the opening balance of stockholders’ equity at January 1, 2018. The Company recognizes revenue in accordance with ASC 606, the core principle of which is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to receive in exchange for those goods or services. To achieve this core principle, five basic criteria must be met before revenue can be recognized: (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to performance obligations in the contract; and (5) recognize revenue when or as the Company satisfies a performance obligation. Disaggregation of Revenue The following table summarizes revenue from contracts with customers for the three and nine months ended September 30, 2019 and 2018 : Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Product sales $ 50 $ 198 $ 164 $ 633 Other revenue 176 174 529 531 Total revenue $ 226 $ 372 $ 693 $ 1,164 Product Sales The Company markets and distributes a portfolio of products, including ribavirin and tetrabenazine. These contracts typically include a single promise to deliver a fixed amount of product to the customer with payment due within 30 days of shipment. Revenues are recognized when control of the promised goods is transferred to the customer, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods. 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. Other Revenue Other revenue generated by the Company is primarily related to a sublease agreement and an expired transition services agreement (the “TSA”) with MeiraGTx. The Company performed various professional services under the TSA that supported MeiraGTx until the expiration of the TSA in April 2018. No further services were performed or TSA revenue recognized after April 2018. The Company continues to provide office space to MeiraGTx under a sublease agreement. The Company recognizes sublease income on a straight-line basis over the term of the sublease arrangement . Contract Balances The timing of revenue recognition may differ from the timing of invoicing to customers. Accounts receivable are recorded at the invoiced amount, net of an allowance for doubtful accounts. A receivable is recognized in the period the Company delivers goods or provides services or when its right to consideration is unconditional. The Company has not recognized any assets for costs to obtain or fulfill a contract with a customer as of September 30, 2019 . Transaction Price Allocated to Future Performance Obligations ASC 606 requires that the Company disclose the aggregate amount of a transaction price that is allocated to performance obligations that have not yet been satisfied as of September 30, 2019 . The guidance provides certain practical expedients that limit this requirement and the Company has various contracts that meet the practical expedients provided by ASC 606. The Company does no t have any performance obligations that have not yet been satisfied as of September 30, 2019 and therefore there is no transaction price allocated to future performance obligations under ASC 606. Recent Accounting Pronouncements In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606, which requires transactions in collaborative arrangements to be accounted for under ASC 606 if the counterparty is a customer for a good or service (or bundle of goods and services) that is a distinct unit of account. The ASU also precludes entities from presenting consideration from transactions with a collaborator that is not a customer together with revenue recognized from contracts with customers. The ASU is effective for annual or interim periods beginning after December 15, 2019. Early adoption is permitted for entities that have adopted ASC 606. The Company is evaluating the impact of adopting this standard. In August 2018, the FASB issued ASU No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (a consensus of the FASB Emerging Issues Task Force), which requires customers in a cloud computing arrangement that is a service contract to follow the internal-use software guidance in Accounting Standards Codification 350-40 to determine which implementation costs to capitalize as assets. This ASU is effective for annual or any interim periods beginning after December 15, 2019. The Company does not expect the standard to have a significant impact on its consolidated financial statements, as the Company’s cloud computing contracts are not material. In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation, which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees, subject to specific exceptions. This ASU is effective for annual or any interim periods beginning after December 15, 2018. The Company adopted this standard on January 1, 2019, and the standard did not have a significant impact on its consolidated financial statements as the fair value of the Company’s awards to non-employees is not material. In January 2017, the FASB issued ASU No. 2017-04, Intangibles – Goodwill and Other, 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. I n June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments, to require financial assets carried at amortized cost to be presented at the net amount expected to be collected based on historical experience, current conditions and forecasts. The ASU is effective for interim and annual periods beginning after December 15, 2019, with early adoption permitted. Adoption of the ASU is on a modified retrospective basis. The Company does not expect this guidance to have a material impact on its financial statements . |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders’ Equity [Abstract] | |
Stockholders’ Equity | 3. Stockholders’ Equity 5% Convertible Preferred Stock The Company had 28,708 shares of 5% convertible preferred stock outstanding at September 30, 2019 , which shares convert into shares of the Company’s common stock at a 20% discount to the initial public offering price per share of common stock in the Company’s initial public offering (the “IPO”) of $12.00 per share, or $9.60 per share. In May 2019, a holder of 1,292 shares of 5% convertible preferred stock exercised its right to convert such shares into 154,645 shares of the Company’s common stock. T he Company accrued dividends on the 5% convertible preferred stock of $0.4 million and $1.2 million during the three and nine months ended September 30, 2019 and 2018 , respectively. T he Company calculated a deemed dividend of $0.1 million on the $0.4 million of accrued dividends during each of the three months ended September 30, 2019 and 2018 , and $0.3 million on the $1.2 million of accrued dividends during each of the nine months ended September 30, 2019 and 2018 , which is a beneficial conversion feature. The stated liquidation preference amount on the 5% convertible preferred stock totaled $33.1 million at September 30, 2019 . Common Stock The Company’s restated certificate of incorporation authorizes the issuance of up to 400,000,000 shares of the Company’s common stock, par value $0.001 per share. |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 9 Months Ended |
Sep. 30, 2019 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |
Net Loss per Share Attributable to Common Stockholders | 4. Net Loss per Share Attributable to Common Stockholders Basic net loss attributable to common stockholders per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. Shares issued during the period are weighted for the portion of the period during which they were outstanding. Because the Company has reported a net loss for all periods presented, diluted net loss per share of common stock is the same as basic net loss per share of common stock 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): Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Numerator – basic and diluted: Net loss available to common stockholders - basic and diluted $ (62,912) $ (14,314) $ (51,183) $ (14,231) Denominator – basic and diluted: Weighted average shares of common stock outstanding used to compute basic and diluted net loss per share 128,225,469 113,101,776 128,360,618 92,378,205 Net loss per share, basic and diluted $ (0.49) $ (0.13) $ (0.40) $ (0.15) The amounts in the table below were excluded from the calculation of diluted net loss per share, due to their anti-dilutive effect: Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Options to purchase common stock 11,999,752 9,713,427 11,999,752 9,713,427 Warrants to purchase common stock 11,999,852 11,999,852 11,999,852 11,999,852 Convertible preferred stock 3,493,002 3,476,385 3,493,002 3,476,385 Total shares of common stock equivalents 27,492,606 25,189,664 27,492,606 25,189,664 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2019 | |
Debt [Abstract] | |
Debt | 5. Debt The Company is a party to one credit agreement (the 2015 Credit Agreement) with outstanding indebtedness in the following amount (in thousands): September 30, December 31, 2019 2018 Secured term debt due July 1, 2020 $ 28,046 $ 28,046 Total debt before debt discount 28,046 28,046 Less: Debt discount (283) (566) Total debt payable $ 27,763 $ 27,480 Debt payable, current portion $ 27,763 $ — Debt payable, long-term $ — $ 27,480 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 (the “2015 Credit Agreement”). The interest rate on the loan is LIBOR plus 9.375% with a 1% floor. As of September 30, 2019 , there were five amendments to the 2015 Credit Agreement, which, among other things, have extended the maturity date and due date of principal payments under the 2015 Credit Agreement, repaid all amounts due to one of the lenders, revised terms of certain warrants issued in connection with the 2015 Credit Agreement (Note 6), and amended certain covenants, including certain non-financial developmental milestones that must be met by December 31, 2019. Each of these developmental milestones had been satisfied as of September 30, 2019. The 2015 Credit Agreement also contains a minimum liquidity covenant. As amended, the key terms of the loan require monthly payments of interest only through December 31, 2019, with principal payments in the amount of $750,000 payable monthly beginning on January 31, 2020. Any outstanding balance of the loan and accrued interest is required to be repaid on July 1, 2020 , the maturity date. The secured term loan is collateralized by a first priority perfected security interest in all the tangible and intangible property of the Company. The Company entered into a sixth waiver agreement to the 2015 Credit Agreement in March 2019 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 our independent registered public accounting firm, BDO USA, LLP, for the year ended December 31, 2018 contains an explanatory paragraph regarding our ability to continue as a going concern, which is an event of default under the 2015 Credit Agreement. In October 2019, the Company entered into a transaction pursuant to which it sold approximately 1.4 million ordinary shares of MeiraGTx for gross proceeds of $22.0 million (Note 11). Pursuant to the 2015 Credit Agreement, half of the proceeds received from the sale, or $11.0 million, were used to pay down part of the outstanding amounts owed under the 2015 Credit Agreement (Note 5). After this repayment, approximately $17.0 million of principal remained outstanding under the 2015 Credit Agreement. The minimum payments required on the outstanding balances of the 2015 Credit Agreement at September 30, 2019 are (in thousands): 2015 Credit Agreement 2019 $ — 2020 28,046 $ 28,046 The following table provides components of interest expense and other related financing costs (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Interest expense $ 836 $ 830 $ 2,516 $ 2,720 Amortization of deferred financing costs, debt discount and debt premium 95 47 283 960 Interest expense $ 931 $ 877 $ 2,799 $ 3,680 |
Financial Instruments
Financial Instruments | 9 Months Ended |
Sep. 30, 2019 | |
Financial Instruments [Abstract] | |
Financial Instruments | 6. Financial Instruments Equity Issued Pursuant to Credit Agreements In connection with the 2015 Credit Agreement (Note 5), as fees to the lenders thereunder, the Company issued warrants to purchase an aggregate of $6.3 million of the Company’s Class A units with an expiration date of August 2022, which 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 upon consummation of the Company’s IPO in August 2016 (the “2015 Warrants”). As of September 30, 2019 , the exercise price of a portion of the 2015 Warrants to purchase an aggregate of 529,413 shares of the Company’s common stock was $3.30 per warrant share and the exercise price of the remaining 2015 Warrants to purchase an aggregate of 88,238 shares of the Company’s common stock was $4.50 per warrant share. Since these warrants are exercisable and are redeemable at the option of the holder upon the occurrence of, and during the continuance of, an event of default, the fair value of the 2015 Warrants was recorded as a short-term liability of approximately $0.6 million at September 30, 2019 and approximately $0.5 million at December 31, 2018. The Company used the Black-Scholes pricing model to value the warrant liability at September 30, 2019 with the following assumptions: risk-free interest rate of 1.6% , expected term of 2.9 years, expected volatility of 71.0% and a dividend rate of 0% . The change in fair value of the 2015 W arrants was approximately $0.1 million for both the three and nine months ended September 30, 2019 , and approximately $(0.2) million and $(0.1) million for the three and nine months ended September 30, 2018 , respectively. None of these instrum ents had been exercised as of September 30, 2019 and December 31, 2018 . Other Warrants In connection with a sale of common stock by the Company in March 2017, warrants to purchase 2,707,138 shares of common stock were issued at an exercise price of $4.50 per share. During April 2018, warrants to purchase 119,047 shares of common stock were exercised for which the Company received proceeds of $0.5 million. The remaining 2,588,091 warrants expired in April 2018. 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 change in the fair value of these warrants was $(0.7) million for the nine months ended September 30, 2018. As these warrants expired in April 2018, no change in fair value was recorded for these warrants after April 2018. Fair Value of Long-term Debt The Company maintained a long-term secured debt balance of $27.5 million at December 31, 2018 . Because the secured debt will become due on July 1, 2020 and monthly principal payments of $750,000 will become due starting January 31, 2020, it has been recorded as long-term secured debt at December 31, 2018. At September 30, 2019 , the outstanding secured debt of $27.8 million due in the first and second quarter of 2020 was recorded as short-term secured debt. As such, the Company did not maintain a long-term secured debt balance at September 30, 2019 . The underlying agreements for these balances were negotiated with third parties on an arms-length basis, at an interest rate which is considered to be in line with overall market conditions. 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 September 30, 2019 and December 31, 2018 (in thousands): Fair Value Measurement Using Significant Other Observable Inputs (Level 2) September 30, December 31, Description 2019 2018 Warrants $ 594 $ 524 Total $ 594 $ 524 The table below represents a roll-forward of Level 2 financial instruments from January 1, 2018 to September 30, 2019 (in thousands): Significant Other Observable Inputs (Level 2) Balance at January 1, 2018 $ 1,952 Change in fair value of financial instruments (1,525) Fair value of warrants modified in the Fifth Amendment 111 Exercise of warrants recorded as liability (14) Balance at December 31, 2018 $ 524 Change in fair value of financial instruments 70 Balance at September 30, 2019 $ 594 The Level 2 inputs used to value the Company’s financial instruments were determined using prices that can be directly observed or corroborated in active markets. Although the fair value of this obligation is calculated using the observable market price of the Company’s 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. Warrants Outstanding The following table summarizes information about warrants outstanding at September 30, 2019 and December 31, 2018: Warrants Weighted Average Exercise Price Balance, December 31, 2018 11,999,852 $ 5.95 Granted — — Exercised — — Forfeited — — Balance, September 30, 2019 11,999,852 $ 5.95 |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2019 | |
Inventories [Abstract] | |
Inventories | 7. Inventories Inventories are stated at the lower of cost or net realizable value (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 dates 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 $2.9 million and $2.2 million at September 30, 2019 and December 31, 2018 , respectively. The Company expensed inventory that it believes will not be sold prior to reaching its expiration date totaling $0.9 million during the nine months ended September 30, 2019 and totaling less than $0.1 million and $0.3 million during the three and nine months ended September 30, 2018 , respectively. The Company did no t record any such expense during the three months ended September 30, 2019 . If the amount and timing of future sales differ from management’s assumptions, adjustments to the estimated inventory reserves may be required. Inventories Produced in Preparation for Product Launches The Company capitalizes inventories produced in preparation for product launches sufficient to support estimated initial market demand. Typically, capitalization of such inventory begins when positive results have been obtained for the clinical trials that the Company believes are necessary to support regulatory approval, uncertainties regarding ultimate regulatory approval have been significantly reduced and the Company has determined it is probable that these capitalized costs will provide some future economic benefit in excess of capitalized costs. The material factors considered by the Company in evaluating these uncertainties include the receipt and analysis of positive clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applicat ions and the compilation of regulatory application s . The Company closely monitors the status of each product within the regulatory approval process, including all relevant communication with regulatory authorities. If the Company is aware of any specific material risks or contingencies other than the normal regulatory review and approval process or if there are any specific issues identified relating to safety, efficacy, manufacturing, marketing or labeling, the related inventory would generally not be capitalized. For inventories that are capitalized in preparation of product launch, anticipated future sales, expected approval date and shelf lives are evaluated in assessing realizability. The shelf life of a product is determined as part of the regulatory approval process; however, in evaluating whether to capitalize pre-launch inventory production costs, the Company considers the product stability data of all of the pre-approval production to date to determine whether there is adequate expected shelf life for the capitalized pre-launch production costs. I n September 2019 , the U.S. Food and Drug Administration (“FDA”) approved the Company’s generic t rientine h yd rochloride capsules USP, 250 mg . In October 2019, the FDA approved CLOVIQUE™ ( t rientine hydrochloride capsules, USP), the Company’s room-temperature stable, branded generic product. Trientine hydrochloride is used for the treatment of Wilson's disease in patients who are intolerant of penicillamine. CLOVIQUE ™ is the first FDA-approved trientine product in a portable blister pack that offers room temperature stability for up to 30 days, potentially providing patients more convenience. Accordingly, the pre-launch costs of these products are realizable as the Company expects the inventory will be sold or used prior to expiration. The Company maintained $0.2 million and $0.9 million of trientine hydrochloride inventory at September 30, 2019 and December 31, 2018 , respectively. Inventories are comprised of the following (in thousands): September 30, December 31, 2019 2018 Raw materials $ 60 $ — Work-in-process 123 886 Finished goods, net 31 39 Total inventories $ 214 $ 925 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | 8. Leases On January 1, 2019, the Company adopted ASC 842 using the modified retrospective transition approach allowed under ASU 2018-11, Leases (Topic 842: Targeted Improvements), which releases companies from presenting comparative periods and related disclosures under ASC 842 and requires a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption (Note 2). The Company is party to six operating leases for office or laboratory space and three finance leases for office IT equipment. The Company’s finance leases are immaterial both individually and in the aggregate. The Company has elected to apply the short-term lease exception to all leases of one year or less. As of September 30, 2019 , this exception applied to two operating leases for office space, which are each for a term of one year. Further, the Company has applied the guidance in ASC 842 to its corporate office and laboratory leases and has determined that these should be classified as operating leases. Consequently, as a result of the adoption of ASC 842, the Company recognized a ROU lease asset of approximately $22.7 million with a corresponding lease liability of approximately $27.0 million based on the present value of the minimum rental payments of such leases. In accordance with ASC 842, the beginning balance of the ROU lease asset was reduced by the existing deferred rent liability at inception of approximately $4.3 million. In the consolidated balance sheets at September 30, 2019 , the Company has a ROU asset balance of $20.5 million and a current and non-current lease liability of $3.9 million and $20.8 million, respectively, relating to the ROU lease asset. The balance of both the ROU lease asset and the lease liabilities primarily consists of future payments under the Company’s office lease in New York, New York. The Company is party to an operating lease in New York, New York for office and laboratory space for its headquarters. The lease commenced in October 2010, its initial term is set to expire in February 2021, and the Company opened a secured letter of credit with a third party financial institution in lieu of providing a security deposit of $2.0 million, which letter of credit is included in restricted cash at September 30, 2019 . As of September 30, 2019 , there were six amendments to this lease agreement, which altered office and laboratory capacity and extended the lease term through October 2025, with total lease cost of $1.2 million and $3.5 million for the three and nine months ended September 30, 2019 , respectively. This office lease contains the ability to extend portions of the lease at fair market value but does not have any renewal options. The Company is party to an operating lease in Warrendale, Pennsylvania for the Company’s specialty-focused commercial operation. In March 2019, the Company entered into an amendment to this lease, which extended the lease term to September 30, 2022 with two five -year renewal options, which would extend the term to September 30, 2032, if exercised. Rental payments under the renewal period would be at market rates determined from the average rentals of similar tenants in the same industrial park. The option to renew this office lease was not considered when assessing the value of the ROU asset because the Company was not reasonably certain that it would assert its option to renew the lease. Total lease cost for this lease was $0.2 million and $0.5 million for the three and nine months ended September 30, 2019 , respectively. In August 2015, the Company entered into an operating office lease agreement in Cambridge, Massachusetts for the Company’s 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 providing a security deposit of $0.1 million, which letter of credit is included in restricted cash at September 30, 2019 . The Company is also party to an operating lease for laboratory space in Princeton, New Jersey, which expires in February 2021. Neither of these office leases contain any renewal options. Total lease cost for these leases was $0.1 million and $0.3 million for the three and nine months ended September 30, 2019 , respectively. Quantitative information regarding the Company’s leases for the three and nine months ended September 30, 2019 is as follows (in thousands): Three Months Ended Nine Months Ended Lease Cost Classification September 30, 2019 September 30, 2019 Operating lease cost (a) SG&A expenses $ 1,156 $ 3,478 Variable lease cost SG&A expenses 358 989 Sublease income (b) Other revenue (179) (529) Net Lease Cost $ 1,335 $ 3,938 Other Information Operating cash flows paid for amounts included in the measurement of lease liabilities $ 1,150 $ 3,498 Operating lease liabilities arising from obtaining ROU assets 127 212 Weighted average remaining lease term (years) 5.7 5.7 Weighted average discount rate 4.1% 4.1% (a) Includes short-term lease costs and finance lease costs, which are immaterial. (b) Includes sublease income related to MeiraGTx (Note 11). Future lease payments under noncancellable leases are as follows (in thousands) at September 30, 2019 : Year ending December 31, Operating Leases Finance Leases 2019 $ 1,205 $ 22 2020 4,833 48 2021 4,937 6 2022 4,844 — 2023 4,153 — Thereafter 7,732 — Total Lease Payments $ 27,704 $ 76 Less: Imputed Interest (3,093) (8) Total Lease Liabilities $ 24,611 $ 68 Note: As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The Company uses the incremental borrowing rate on January 1, 2019 for operating leases that commenced prior to that date. Future minimum rental payments under noncancellable leases are as follows (in thousands) at December 31, 2018: Year ending December 31, Amount 2019 $ 4,672 2020 4,204 2021 4,177 2022 4,286 2023 4,153 Thereafter 7,731 Total $ 29,223 |
Fixed Assets
Fixed Assets | 9 Months Ended |
Sep. 30, 2019 | |
Fixed Assets [Abstract] | |
Fixed Assets | 9. Fixed Assets Fixed assets consisted of the following (in thousands): Useful Lives September 30, December 31, (Years) 2019 2018 Leasehold improvements 4 -8 $ 10,397 $ 10,187 Office equipment and furniture 3 -15 1,289 1,529 Machinery and laboratory equipment 3 -15 3,455 3,247 Software 1 -5 3,971 3,831 Construction-in-progress ̶̶̶̶ 45 45 19,157 18,839 Less accumulated depreciation and amortization (16,429) (15,185) Fixed assets, net $ 2,728 $ 3,654 Depreciation and amortization of fixed assets totaled $1.4 million and $1.1 million for the nine months ended September 30, 2019 and 2018 , respectively, and $0.5 million and $0.4 million for the three months ended September 30, 2019 and 2018 , respectively. Unamortized computer software costs were $0.4 million and $0.7 million at September 30, 2019 and December 31, 2018 , respectively. The amortization of computer software costs amounted to $0.3 million and $0.1 million for the nine months ended September 30, 2019 and 2018 , respectively, and $0.1 million for each of the three months ended September 30, 2019 and 2018 . |
Goodwill
Goodwill | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill [Abstract] | |
Goodwill And Other Intangible Assets | 10. Goodwill The Company’s goodwill relates to the 2010 acquisition of Kadmon Pharmaceuticals, LLC, a Pennsylvania limited liability company that was formed in April 2000. There were no changes in the carrying amount of goodwill for the nine months ended September 30, 2019 or the year ended December 31, 2018 . |
Investment in MeiraGTx
Investment in MeiraGTx | 9 Months Ended |
Sep. 30, 2019 | |
Investment in MeiraGTx [Abstract] | |
Investment in MeiraGTx | 11. Investment in MeiraGTx On June 12, 2018, MeiraGTx completed its initial public offering (the “MeiraGTx IPO”) whereby it sold 5,000,000 ordinary shares at an initial public offering price of $15.00 per ordinary share. MeiraGTx, an exempted company under the laws of the Cayman Islands, is a clinical-stage biotechnology company developing novel gene therapy treatments for a wide range of inherited and acquired disorders for which there are no effective treatments available. The shares began trading on the Nasdaq Global Select Market on June 7, 2018 under the symbol “MGTX.” Prior to the MeiraGTx IPO, for the period beginning January 1, 2018 through June 12, 2018, the Company recorded its share of MeiraGTx’s net loss under the equity method of accounting of $1.2 million. The Company had no remaining basis in any of the investments held in MeiraGTx prior to the MeiraGTx IPO. Upon completion of the MeiraGTx IPO, the Company’s investment was diluted to a 13.0% ownership in MeiraGTx common stock and the Company no longer had the ability to exert significant influence over MeiraGTx. The Company discontinued the equity method of accounting for its investment in MeiraGTx on June 12, 2018 and determined that the remaining investment was an equity security accounted for in accordance with ASC 321, Investments – Equity Securities, at the date the investment no longer qualified for the equity method of accounting. ASC 321 requires the investment to be recorded at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer. As the Company’s investment in MeiraGTx’s ordinary shares had a readily determinable market value, the Company recorded an unrealized gain of $40.5 million for the three and nine months ended September 30, 2018 related to the fair value of its ownership of ordinary shares of MeiraGTx. As of September 30, 2019 and December 31, 2018, the Company maintained a 9.7% and 12.9% ownership, respectively, in the ordinary shares of MeiraGTx with a fair value of $56.4 million and $34.1 million, respectively. As of December 31, 2018, the investment was recorded as a noncurrent investment in equity securities since depending on certain circumstances, the Company could, at times, have been deemed to be an affiliate of MeiraGTx. During the third quarter of 2019 the affiliate restrictions on the resale of these securities were removed and, accordingly, the Company’s investment in MeiraGTx has been recorded as a current investment in equity securities as of September 30, 2019 . The Company has recorded an unrealized gain (loss) on the MeiraGTx ordinary shares investment of $(38.6) million and $22.3 million for the three and nine months ended September 30, 2019 , respectively. The investment in MeiraGTx is valued using Level 1 inputs, which includes quoted prices in active markets for identical assets in accordance with the fair value hierarchy (Note 6). The Company has not realized any gains related to the investment in ordinary shares of MeiraGTx as of September 30, 2019 . In October 2019, the Company entered into a transaction pursuant to which it sold approximately 1.4 million ordinary shares of MeiraGTx for gross proceeds of $22.0 million. After consummation of the transaction, the Company held approximately 5.7% of the outstanding ordinary shares of MeiraGTx. The Company was party to a TSA with MeiraGTx, which expired in April 2018. Upon expiration of the TSA, the Company continued to provide office space to MeiraGTx. On October 1, 2018, the Company and MeiraGTx entered into a sublease agreement, which was effective from October 1, 2018 for a period of two months and is automatically renewed on a monthly basis unless MeiraGTx provides 30 days’ prior written notice. The Company’s accounting for this sublease as a lessor was not impacted by the adoption of the new leasing standard ASC 842 (Note 2). As part of the TSA and sublease agreement with MeiraGTx, the Company recognized $0.1 million and $0.4 million to other revenue during each of the three and nine months ended September 30, 2019 and 2018 , respectively. The Company received cash payments of $0.4 million and $1.3 million, respectively, from MeiraGTx for the nine months ended September 30, 2019 and 2018 . The Company had no amounts receivable from MeiraGTx at September 30, 2019 or December 31, 2018. |
License Agreements
License Agreements | 9 Months Ended |
Sep. 30, 2019 | |
License Agreements [Abstract] | |
License Agreements | 12. License Agreements The Company has entered into several license agreements for products currently under development. The Company’s license agreements are disclosed in the audited financial statements included in Item 8 of its Annual Report on Form 10-K for the year ended December 31, 2018 . Since the date of such financial statements, there have been no significant changes to the Company’s license agreements other than described below. 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. The Company provided a notice of immediate termination of the license agreement to Jinghua on September 3, 2019. As of September 30, 2019, the Company had earned $4 million in development milestones under this agreement. Dyax Corp. (acquired by Shire Plc in January 2016, subsequently acquired by Takeda Pharmaceuticals Co., Ltd. in 2018) 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, the “Dyax Property”). The agreement expired on its terms on September 22, 2015, but the Company retained the right to a commercial license to any research target within two years of such expiration. The Company exercised its right to a commercial license of two targets in September 2017, resulting in a license fee becoming payable to Shire Plc (who acquired Dyax) of $1.5 million, which was recorded as 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 license agreement requires the Company to pay a fixed single digit royalty upon any commercial sales and also requires additional payments contingent on the achievement of certain development milestones such as receiving certain regulatory approvals and commencing certain clinical trials. None of these targets had been achieved and, as such, no assets or liabilities associated with the milestones had been recorded as of the year ended December 31, 2018. In September 2019, the Company achieved a development milestone under the license agreement, resulting in a license fee becoming payable to Takeda Pharmaceuticals Co., Ltd (which acquired Shire Plc) of $1.5 million, which was recorded as research and development expense during the three and nine months ended September 30, 2019. Contingent License Agreement Milestones 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 $225.9 million at September 30, 2019 . 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. |
Share-based Compensation
Share-based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Compensation [Abstract] | |
Share-based Compensation | 13. Share-based Compensation 2016 Equity Incentive Plan A total of 11,668,905 shares of the Company’s common stock were authorized and reserved for issuance under the Company’s Amended and Restated 2016 Equity Incentive Plan (the “2016 Equity Plan”) at December 31, 2018. This reserve automatically increased to 16,194,138 on January 1, 2019 and will automatically increase 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 Company’s board of directors (the “Board”). At September 30, 2019 , there were options to purchase an aggregate of 10,709,752 shares of common stock outstanding at a weighted average price of $5.73 per share under the 2016 Equity Plan. Total unrecognized compensation expense related to unvested options granted under the Company’s share-based compensation plan was $4.4 million and $6.8 million at September 30, 2019 and December 31, 2018 , respectively. That expense is expected to be recognized over a weighted average period of 1.3 years and 1.5 years as of September 30, 2019 and December 31, 2018 , respectively. The Company recorded share-based compensation expense under the 2016 Equity Plan of $ 5.6 million and $8.4 million for the nine months ended September 30, 2019 and 2018 , respectively, and $1.5 million and $2.8 million for the three months ended September 30, 2019 and 2018 , respectively. The following table summarizes information about stock options outstanding, not including performance stock options, at September 30, 2019 and December 31, 2018 : Options Outstanding Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Balance, December 31, 2018 9,764,539 $ 6.24 7.84 $ — Granted 1,593,973 1.48 Exercised — — Forfeited (648,760) 4.74 Balance, September 30, 2019 10,709,752 $ 5.73 7.50 $ — Options vested and exercisable, September 30, 2019 6,081,492 $ 7.99 6.35 $ — There were no options exercised during the nine months ended September 30, 2019 and 2018 . There were 1,593,973 stock options granted during the nine months ended September 30, 2019 with a weighted-average exercise price of $1.48 . During the nine months ended September 30, 2018 , 280,924 stock options were granted with a weighted ‑average exercise price of $4.62 . The fair value of each stock option award, not including performance stock options, was estimated at the date of grant using the Black-Scholes option-pricing model and the assumptions noted in the following table: Nine Months Ended Nine Months Ended September 30, 2019 September 30, 2018 Weighted average fair value of grants $1.48 $2.20 Expected volatility 76.19% - 77.73% 72.94% - 75.14% Risk-free interest rate 1.41% - 2.61% 2.44% - 2.84% Expected life (years) 5.5 - 6.0 5.5 - 6.0 Expected dividend yield 0% 0% Performance Awards On April 3, 2018, the Company granted 1,597,500 nonqualified performance-based stock options (the “Performance Options”) to certain executive officers (each, a “Grantee”) under the 2016 Equity Plan, which represent the maximum number of Performance Options that may be earned if all three performance milestones (each, a “Performance Goal”) are achieved during the three -year period following the grant date (the “Performance Period”). The Performance Options may be earned based on the achievement of three separate Performance Goals related to the Company’s operating and research and development activities during the Performance Period, subject to the Grantee’s employment through the achievement date. If no Performance Goals are achieved during the Performance Period, the Performance Options will be forfeited. Each Performance Option was granted with an exercise price of $4.06 per share and does not contain any voting rights. No other Performance Options have been granted under the 2016 Equity Plan. The weighted-average fair value of the Performance Options granted was $2.71 and was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions: risk-free interest rate of 2.67% , expected term of 6.0 years, expected volatility of 74.50% and a dividend rate of 0% . Compensation expense for the Performance Options is recognized on a straight-line basis over the awards’ requisite service period. The Performance Options vest upon the satisfaction of both a service condition and the satisfaction of one or more performance conditions. Therefore, the Company initially determined which outcomes were probable of achievement. The Company believes that the three-year service condition (explicit service period) and all three performance conditions (implicit service periods) will be satisfied. The requisite service period would be three years as that is the longest period of both the explicit service period and the implicit service periods. The first two performance conditions were satisfied during 2018 and the third performance condition was satisfied during the third quarter of 2019. During the year ended December 31, 2018, 307,500 Performance Options were forfeited. A total of 1,290,000 Performance Options were outstanding at both September 30, 2019 and December 31, 2018 with an exercise price of $4.06 per share and no intrinsic value. The weighted average remaining contractual life of outstanding Performance Options at September 30, 2019 was 6.9 years. At September 30, 2019 , there was $0.6 million of total unrecognized compensation expense related to unvested Performance Options, which is expected to be recognized over a weighted-average period of 1.4 years. No Performance Options were vested at December 31, 2018. At September 30, 2019 , 744,168 Performance Options had vested and no Performance Options had been exercised. Stock Appreciation Rights A total of 835,000 stock appreciation rights (“SARs”) were outstanding at both September 30, 2019 and December 31, 2018 , with an exercise price of $3.64 per share and no intrinsic value. The weighted average remaining contractual life of outstanding SARs at September 30, 2019 was 6.8 years. Compensation expense for SARs is recognized on a straight-line basis over the awards’ requisite service period. At September 30, 2019 , there was $0.6 million of total unrecognized compensation cost related to unvested SARs that is expected to be recognized over a weighted-average period of 1.2 years. At September 30, 2019 and December 31, 2018 , 398,33 4 and 278,335 SARs had vested, respectively, and no SARs had been exercised. 2 014 Long-term Incentive Plan (the “LTIP”) A total of 9,750 units have been granted under the LTIP as of both September 30, 2019 and December 31, 2018 . The LTIP is payable upon the fair market value of the Company’s common stock exceeding 333% of the $6.00 grant price ( or $20.00 ) per share prior to December 7, 2024. The holders of the LTIP awards have no right to demand a particular form of payment, and the Company reserves the right to make payment in the form of cash or common stock. No LTIP awards were exercisable or had been exercised at September 30, 2019 . 2016 Employee Stock Purchase Plan A total of 2,551,180 shares of the Company’s common stock were reserved for issuance under the Amended and Restated 2016 Employee Stock Purchase Plan (the “2016 ESPP”) at December 31, 2018 . The Board elected not to increase the shares reserved for issuance under the 2016 ESPP on January 1, 2019. The Company issued 32,273 and 22,958 shares to employees under the 2016 ESPP during the nine months ended September 30, 2019 and 2018 , respectively. In October 2019, the Company issued 56,346 shares to employees under the 2016 ESPP. No meaningful compensation expense was recognized for the ESPP during the nine months ended September 30, 2019 and 2018 . |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2019 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | 14. Accrued Expenses Short-term accrued expenses at September 30, 2019 and December 31, 2018 include the following (in thousands): September 30, December 31, 2019 2018 Commission payable $ 2,395 $ 2,395 Compensation, benefits and severance 3,430 3,848 Research and development 5,251 4,847 Other 2,502 2,418 Total accrued expenses $ 13,578 $ 13,508 Commission payable The Company recorded $2.4 million in accrued liabilities at both September 30, 2019 and December 31, 2018 relating to commissions to third parties for Class E redeemable convertible unit raises during 2014 and 2015. Compensation, benefits and severance Compensation, benefits and severance represent earned and unpaid employee wages and bonuses, as well as contractual severance to be paid to former employees. At September 30, 2019 and December 31, 2018 , these accrued expenses totaled $3.4 million and $3.8 million, respectively. In August 2019, the Company entered into a Separation Agreement and General Release (the “Separation Agreement”) with Steven N. Gordon, Esq., Executive Vice President, General Counsel, Chief Administrative, Compliance and Legal Officer, and Corporate Secretary of the Company. The Separation Agreement provides that Mr. Gordon will receive, among other things, $0.9 million in aggregate cash payments (including reimbursement of certain of Mr. Gordon’s expenses) over 18 months. At September 30, 2019, $0.6 million of severance payable to Mr. Gordon was recorded as accrued expenses while $0.2 million was recorded as other long-term liabilities. The full terms of Mr. Gordon’s separation are set forth as an exhibit to this Quarterly Report on Form 10-Q, and this summary is qualified by the full terms set forth in that exhibit. Separately, a separation agreement with Dr. Samuel D. Waksal, which expired on February 8, 2019, contained severance payments and certain supplement conditional payments. The Company has no t recorded any expense related to these conditional payments as of September 30, 2019 as none of the conditional payments were met as of the expiration of the agreement on February 8, 2019. Research and development The Company has contracts with third parties for the development of the Company’s product candidates. The timing of the expenses varies depending upon the timing of initiation of clinical trials and enrollment of patients in clinical trials. At September 30, 2019 and December 31, 2018 , accrued research and development expenses for which the Company has not yet been invoiced totaled $5.3 million and $4.8 million, respectively. |
Commitments And Contingencies
Commitments And Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 15. Commitments and Contingencies The Company’s commitments are disclosed in the audited financial statements included in Item 8 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 . Since the date of such financial statements, there have been no material changes to the Company’s commitments other than certain non-cancellable minimum batch commitments to purchase KD034 inventory through 2023. These commitments include $0.4 million for 2019, $0.5 million for 2020, $0.4 million for 2021 and $0.3 million for both 2022 and 2023. Further, the Company’s commitments related to lease agreements are disclosed in Note 8 . The Company has been 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 have been 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. The Company has no significant contingencies related to legal proceedings at September 30, 2019 . |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 16. Related Party Transactions The Company’s related party transactions are disclosed in the audited financial statements included in Item 8 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 . Since the date of such financial statements, there have been no changes to the Company’s related party transactions other than those related to MeiraGTx (Note 11). |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2019 | |
Income Taxes [Abstract] | |
Income Taxes | 17. Income Taxes The Company files a consolidated tax return for Kadmon Holdings, Inc. and its domestic subsidiaries and the required information returns for its international subsidiaries, all of which are wholly owned. Where permitted, the Company files combined state returns, but in some instances separate company returns for certain subsidiaries on a stand-alone basis are required. The Tax Cuts and Jobs Act (the “Tax Act”) was enacted in December 2017. The Tax 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. In accordance with the Tax Act, the Company determined it necessary to reduce the recorded deferred tax liability by $0.6 million during the nine months ended September 30, 2018 to allow naked credit deferred tax liabilities to be used as a source of taxable income in the future. This change in deferred tax liability was recognized as income tax benefit in the consolidated financial statements of operations for the nine months ended September 30, 2018. There was no change in deferred tax liability for the three and nine months ended September 30, 2019 and no income tax expense was recorded for the three and nine months ended September 30, 2019 . Deferred income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company’s deferred tax assets relate primarily to its net operating loss (“NOL”) carryforwards and other balance sheet basis differences. 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 September 30, 2019 and December 31, 2018 . At December 31, 2018, the Company had unused federal and state NOL carryforwards of $460.3 million and $404.3 million, respectively, that may be applied against future taxable income. The Company has fully reserved the deferred tax asset related to these NOL carryforwards as reflected in its consolidated financial statements. These carryforwards expire at various dates through December 31, 2037, with the exception of approximately $44.0 million of federal NOL carryforwards that will not expire. The 20-year limitation was eliminated for losses generated after January 1, 2018, giving the taxpayer the ability to carry forward losses indefinitely. However, NOL carryforwards arising after January 1, 2018, will now be limited to 80 percent of taxable income. The use of the Company’s NOL carryforwards may, however, be subject to limitations as a result of an ownership change. A corporation undergoes an “ownership change,” in general, if a greater than 50% change (by value) in its equity ownership by one or more five-percent stockholders (or certain groups of non-five-percent stockholders) over a three-year period occurs. After such an ownership change, the corporation’s use of its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income is subject to an annual limitation determined by the equity value of the corporation on the date the ownership change occurs multiplied by a rate determined monthly by the Internal Revenue Service. This rate for October 2019 equals 1.77 percent. The Company experienced ownership changes under Section 382 of the Internal Revenue Code of 1986, as amended, in 2010, 2011 and 2016, but the Company did not reduce the gross deferred tax assets related to the NOL carryforwards because the limitations do not hinder the Company’s ability to potentially utilize all of the NOL carryforwards. The Company is likely to experience another ownership change in the future, possibly in 2019, as a result of shifts in stock ownership due to any future equity offerings. A renewed ownership change will likely materially and substantially reduce the Company’s ability to fully utilize the NOL carryforwards and, consequently, will likely reduce the gross deferred tax assets related to the NOL carryforwards. If an ownership change occurred and if the Company earned net taxable income, its ability to use the pre-change NOLs to offset U.S. federal taxable income would be subject to these limitations, which could potentially result in increased future tax liability compared to the tax liability the Company would incur if the use of NOL carryforwards were not so limited. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 18. Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Joint Venture with BioNova Pharmaceuticals Ltd. In November 2019, the Company announced a strategic partnership with BioNova Pharmaceuticals Ltd. (“BioNova”) to form a joint venture to exclusively develop and commercialize KD025, the Company’s lead product candidate, for the treatment of graft-versus-host-disease (“GVHD”) in the People’s Republic of China. The joint venture, BK Pharmaceuticals Limited, is domiciled in Hong Kong with shared oversight between the Company and BioNova. Under the terms of the transaction agreements, the Company will receive an upfront payment and is eligible to receive development, regulatory and commercial milestone payments upon the occurrence of specified events. In aggregate, the upfront payment and potential milestones could total up to $45.0 million over the term of the agreements. In addition, the Company is eligible to receive double-digit percentage royalty payments on sales of KD025 for GVHD in China. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policy) | 9 Months Ended |
Sep. 30, 2019 | |
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 its products and the regulatory environment in which the Company operate s. |
Principles of Consolidation | The accompanying consolidated financial statements, which include the accounts of Kadmon Holdings, Inc. and its domestic and international subsidiaries, all of which are wholly owned by Kadmon Holdings, Inc., have been prepared in accordance with GAAP for interim financial information and pursuant to the rules and regulations of the SEC. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. |
Interim Financial Statements | In the Company’s opinion, the financial statements include all adjustments (consisting of normal recurring adjustments) and disclosures considered necessary in order to make the financial statements not misleading. Operating results for the three and nine months ended September 30, 2019 are not necessarily indicative of the final results that may be expected for the year ending December 31, 2019. These unaudited financial statements should be read in conjunction with the audited financial statements included in Item 8 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. |
Use of Estimates | Use of Estimates The preparation of financial statements in accordance 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. The most significant estimates are related to share-based compensation, the accrual of research and development and clinical trial expenses, and the valuation of the Company’s investment in MeiraGTx ordinary shares (Note 11). |
Critical Accounting Policies | Critical Accounting Policies The Company’s significant accounting policies are disclosed in the audited financial statements included in Item 8 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies, other than those described below. |
Accounting for Leases | Accounting for Leases In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016 02, Leases (“ASC 842”), to enhance the transparency and comparability of financial reporting related to leasing arrangements. Under this new lease standard, most leases are required to be recognized on the balance sheet as right-of-use (“ROU”) assets and lease liabilities. Disclosure requirements have been enhanced with the objective of enabling financial statement users to assess the amount, timing and uncertainty of cash flows arising from leases. Prior to January 1, 2019, GAAP did not require lessees to recognize assets and liabilities related to operating leases on the balance sheet. The new standard establishes a ROU model that requires a lessee to recognize a ROU asset and corresponding lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations as well as the reduction of the right of use asset. The Company has adopted the standard effective January 1, 2019 and has chosen to use the effective date as our date of initial application. Consequently, financial information will not be updated and the disclosures required under the new standard will not be provided for dates and periods prior to January 1, 2019. The new standard provides a number of optional practical expedients in transition. The Company has elected to apply the ‘package of practical expedients’, which allow it to not reassess (i) whether existing or expired arrangements contain a lease, (ii) the lease classification of existing or expired leases, or (iii) whether previous initial direct costs would qualify for capitalization under the new lease standard. The Company has also elected to apply (i) the practical expedient, which allows it to not separate lease and non-lease components, for new leases entered into after adoption and (ii) the short-term lease exemption for all leases with an original term of less than 12 months, for purposes of applying the recognition and measurements requirements in the new standard. In preparation for adoption of the standard, the Company implemented internal controls to enable the preparation of financial information including the assessment of the impact of the standard. For the impact to the Company’s consolidated financial statement upon adoption of the new leasing standard, see Note 8 to the unaudited consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and the Company’s control over the use of the identified asset(s), if applicable. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company will utilize the incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. As of the ASC 842 effective date, the Company’s incremental borrowing rate ranged from approximately 4.0% - 5.6% based on the remaining lease term of the applicable leases. The Company has elected to combine lease and non-lease components as a single component. Operating leases are recognized on the balance sheet as ROU lease assets, lease liabilities current and lease liabilities non-current. Fixed rents are included in the calculation of the lease balances while variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected term on a straight-line basis. |
Revenue Recognition | Revenue Recognition The Company adopted FASB ASC 606, Revenue from Contracts with Customers (“ASC 606”), on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption– i.e. by recognizing the cumulative effect of initially applying ASC 606 as an adjustment to the opening balance of stockholders’ equity at January 1, 2018. The Company recognizes revenue in accordance with ASC 606, the core principle of which is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to receive in exchange for those goods or services. To achieve this core principle, five basic criteria must be met before revenue can be recognized: (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to performance obligations in the contract; and (5) recognize revenue when or as the Company satisfies a performance obligation. Disaggregation of Revenue The following table summarizes revenue from contracts with customers for the three and nine months ended September 30, 2019 and 2018 : Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Product sales $ 50 $ 198 $ 164 $ 633 Other revenue 176 174 529 531 Total revenue $ 226 $ 372 $ 693 $ 1,164 Product Sales The Company markets and distributes a portfolio of products, including ribavirin and tetrabenazine. These contracts typically include a single promise to deliver a fixed amount of product to the customer with payment due within 30 days of shipment. Revenues are recognized when control of the promised goods is transferred to the customer, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods. 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. Other Revenue Other revenue generated by the Company is primarily related to a sublease agreement and an expired transition services agreement (the “TSA”) with MeiraGTx. The Company performed various professional services under the TSA that supported MeiraGTx until the expiration of the TSA in April 2018. No further services were performed or TSA revenue recognized after April 2018. The Company continues to provide office space to MeiraGTx under a sublease agreement. The Company recognizes sublease income on a straight-line basis over the term of the sublease arrangement . Contract Balances The timing of revenue recognition may differ from the timing of invoicing to customers. Accounts receivable are recorded at the invoiced amount, net of an allowance for doubtful accounts. A receivable is recognized in the period the Company delivers goods or provides services or when its right to consideration is unconditional. The Company has not recognized any assets for costs to obtain or fulfill a contract with a customer as of September 30, 2019 . Transaction Price Allocated to Future Performance Obligations ASC 606 requires that the Company disclose the aggregate amount of a transaction price that is allocated to performance obligations that have not yet been satisfied as of September 30, 2019 . The guidance provides certain practical expedients that limit this requirement and the Company has various contracts that meet the practical expedients provided by ASC 606. The Company does no t have any performance obligations that have not yet been satisfied as of September 30, 2019 and therefore there is no transaction price allocated to future performance obligations under ASC 606. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606, which requires transactions in collaborative arrangements to be accounted for under ASC 606 if the counterparty is a customer for a good or service (or bundle of goods and services) that is a distinct unit of account. The ASU also precludes entities from presenting consideration from transactions with a collaborator that is not a customer together with revenue recognized from contracts with customers. The ASU is effective for annual or interim periods beginning after December 15, 2019. Early adoption is permitted for entities that have adopted ASC 606. The Company is evaluating the impact of adopting this standard. In August 2018, the FASB issued ASU No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (a consensus of the FASB Emerging Issues Task Force), which requires customers in a cloud computing arrangement that is a service contract to follow the internal-use software guidance in Accounting Standards Codification 350-40 to determine which implementation costs to capitalize as assets. This ASU is effective for annual or any interim periods beginning after December 15, 2019. The Company does not expect the standard to have a significant impact on its consolidated financial statements, as the Company’s cloud computing contracts are not material. In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation, which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees, subject to specific exceptions. This ASU is effective for annual or any interim periods beginning after December 15, 2018. The Company adopted this standard on January 1, 2019, and the standard did not have a significant impact on its consolidated financial statements as the fair value of the Company’s awards to non-employees is not material. In January 2017, the FASB issued ASU No. 2017-04, Intangibles – Goodwill and Other, 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. I n June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments, to require financial assets carried at amortized cost to be presented at the net amount expected to be collected based on historical experience, current conditions and forecasts. The ASU is effective for interim and annual periods beginning after December 15, 2019, with early adoption permitted. Adoption of the ASU is on a modified retrospective basis. The Company does not expect this guidance to have a material impact on its financial statements . |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Summary of Significant Accounting Policies [Abstract] | |
Disaggregation of Revenue | Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Product sales $ 50 $ 198 $ 164 $ 633 Other revenue 176 174 529 531 Total revenue $ 226 $ 372 $ 693 $ 1,164 |
Net Loss Per Share Attributab_2
Net Loss Per Share Attributable To Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |
Computation of Basic and Diluted Net Income (Loss) per Share Attributable to Common Stockholders | Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Numerator – basic and diluted: Net loss available to common stockholders - basic and diluted $ (62,912) $ (14,314) $ (51,183) $ (14,231) Denominator – basic and diluted: Weighted average shares of common stock outstanding used to compute basic and diluted net loss per share 128,225,469 113,101,776 128,360,618 92,378,205 Net loss per share, basic and diluted $ (0.49) $ (0.13) $ (0.40) $ (0.15) |
Anti-dilutive Amounts Excluded From Calculation of Diluted Net Income (Loss) per Share | Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Options to purchase common stock 11,999,752 9,713,427 11,999,752 9,713,427 Warrants to purchase common stock 11,999,852 11,999,852 11,999,852 11,999,852 Convertible preferred stock 3,493,002 3,476,385 3,493,002 3,476,385 Total shares of common stock equivalents 27,492,606 25,189,664 27,492,606 25,189,664 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Debt [Abstract] | |
Debt Payable | September 30, December 31, 2019 2018 Secured term debt due July 1, 2020 $ 28,046 $ 28,046 Total debt before debt discount 28,046 28,046 Less: Debt discount (283) (566) Total debt payable $ 27,763 $ 27,480 Debt payable, current portion $ 27,763 $ — Debt payable, long-term $ — $ 27,480 |
Minimum Payments Required on Outstanding Balances | 2015 Credit Agreement 2019 $ — 2020 28,046 $ 28,046 |
Interest Expense and Other Related Financing Costs | Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Interest expense $ 836 $ 830 $ 2,516 $ 2,720 Amortization of deferred financing costs, debt discount and debt premium 95 47 283 960 Interest expense $ 931 $ 877 $ 2,799 $ 3,680 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Financial Instruments [Abstract] | |
Fair Values of Financial Instruments | Fair Value Measurement Using Significant Other Observable Inputs (Level 2) September 30, December 31, Description 2019 2018 Warrants $ 594 $ 524 Total $ 594 $ 524 |
Rollforward of Level 2 Investments | Significant Other Observable Inputs (Level 2) Balance at January 1, 2018 $ 1,952 Change in fair value of financial instruments (1,525) Fair value of warrants modified in the Fifth Amendment 111 Exercise of warrants recorded as liability (14) Balance at December 31, 2018 $ 524 Change in fair value of financial instruments 70 Balance at September 30, 2019 $ 594 |
Warrants Outstanding | Warrants Weighted Average Exercise Price Balance, December 31, 2018 11,999,852 $ 5.95 Granted — — Exercised — — Forfeited — — Balance, September 30, 2019 11,999,852 $ 5.95 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Inventories [Abstract] | |
Schedule of Inventories | September 30, December 31, 2019 2018 Raw materials $ 60 $ — Work-in-process 123 886 Finished goods, net 31 39 Total inventories $ 214 $ 925 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Quantitative Infromation Regarding Leases | Three Months Ended Nine Months Ended Lease Cost Classification September 30, 2019 September 30, 2019 Operating lease cost (a) SG&A expenses $ 1,156 $ 3,478 Variable lease cost SG&A expenses 358 989 Sublease income (b) Other revenue (179) (529) Net Lease Cost $ 1,335 $ 3,938 Other Information Operating cash flows paid for amounts included in the measurement of lease liabilities $ 1,150 $ 3,498 Operating lease liabilities arising from obtaining ROU assets 127 212 Weighted average remaining lease term (years) 5.7 5.7 Weighted average discount rate 4.1% 4.1% (a) Includes short-term lease costs and finance lease costs, which are immaterial. (b) Includes sublease income related to MeiraGTx (Note 11). |
Schedule Of Future Lease Payments | Year ending December 31, Operating Leases Finance Leases 2019 $ 1,205 $ 22 2020 4,833 48 2021 4,937 6 2022 4,844 — 2023 4,153 — Thereafter 7,732 — Total Lease Payments $ 27,704 $ 76 Less: Imputed Interest (3,093) (8) Total Lease Liabilities $ 24,611 $ 68 |
Future Minimum Rental Payments Under Noncancellable Leases | Year ending December 31, Amount 2019 $ 4,672 2020 4,204 2021 4,177 2022 4,286 2023 4,153 Thereafter 7,731 Total $ 29,223 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Fixed Assets [Abstract] | |
Fixed Assets | Useful Lives September 30, December 31, (Years) 2019 2018 Leasehold improvements 4 -8 $ 10,397 $ 10,187 Office equipment and furniture 3 -15 1,289 1,529 Machinery and laboratory equipment 3 -15 3,455 3,247 Software 1 -5 3,971 3,831 Construction-in-progress ̶̶̶̶ 45 45 19,157 18,839 Less accumulated depreciation and amortization (16,429) (15,185) Fixed assets, net $ 2,728 $ 3,654 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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, 2018 9,764,539 $ 6.24 7.84 $ — Granted 1,593,973 1.48 Exercised — — Forfeited (648,760) 4.74 Balance, September 30, 2019 10,709,752 $ 5.73 7.50 $ — Options vested and exercisable, September 30, 2019 6,081,492 $ 7.99 6.35 $ — |
Weighted-average Fair Value of Stock Option Awards Granted | Nine Months Ended Nine Months Ended September 30, 2019 September 30, 2018 Weighted average fair value of grants $1.48 $2.20 Expected volatility 76.19% - 77.73% 72.94% - 75.14% Risk-free interest rate 1.41% - 2.61% 2.44% - 2.84% Expected life (years) 5.5 - 6.0 5.5 - 6.0 Expected dividend yield 0% 0% |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Accrued Expenses [Abstract] | |
Short-term Accrued Expenses | September 30, December 31, 2019 2018 Commission payable $ 2,395 $ 2,395 Compensation, benefits and severance 3,430 3,848 Research and development 5,251 4,847 Other 2,502 2,418 Total accrued expenses $ 13,578 $ 13,508 |
Organization (Narrative) (Detai
Organization (Narrative) (Details) - USD ($) | Jun. 12, 2018 | Oct. 31, 2019 | Apr. 30, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 |
Organization [Line Items] | ||||||||||
Stock issued, shares | 13,778,705 | |||||||||
Accumulated deficit | $ (320,826,000) | $ (320,826,000) | $ (269,643,000) | |||||||
Working capital | 70,100,000 | 70,100,000 | ||||||||
Cash and cash equivalents | 66,132,000 | 66,132,000 | 94,740,000 | $ 113,351,000 | ||||||
Debt outstanding | $ 27,763,000 | $ 27,763,000 | $ 27,480,000 | |||||||
Common stock issued | 2,538,100 | 129,634,540 | 129,634,540 | 113,130,817 | ||||||
Price per share of common stock | $ 2.70 | $ 2.17 | $ 2.17 | |||||||
Private placement, amount authorized for sale | $ 40,000,000 | |||||||||
Proceeds from private placement, gross | $ 6,900,000 | 29,900,000 | ||||||||
Proceeds from private placement | 6,700,000 | 29,000,000 | ||||||||
Private placement, commisions payable | $ 200,000 | $ 900,000 | ||||||||
Registration statement, authorized amount | $ 200,000,000 | |||||||||
Common Stock [Member] | ||||||||||
Organization [Line Items] | ||||||||||
Stock issued, shares | 2,538,100 | 13,778,705 | 34,303,030 | |||||||
Registration statement, authorized amount | $ 50,000,000 | |||||||||
MeiraGTx Ltd. [Member] | ||||||||||
Organization [Line Items] | ||||||||||
Stock issued, shares | 5,000,000 | |||||||||
Price per share of common stock | $ 15 | |||||||||
Subsequent Event [Member] | MeiraGTx Ltd. [Member] | ||||||||||
Organization [Line Items] | ||||||||||
Shares sold | 1,400,000 | |||||||||
Proceeds from sale of shares | $ 22,000,000 | |||||||||
Proceeds from sale of equity method investment, added to cash balance | 11,000,000 | |||||||||
2015 Credit Agreement, Fifth Amendment [Member] | Subsequent Event [Member] | ||||||||||
Organization [Line Items] | ||||||||||
Debt repaid | 11,000,000 | |||||||||
Debt outstanding | $ 17,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) | 9 Months Ended |
Sep. 30, 2019segment | |
Summary Of Significant Accounting Policies [Line Items] | |
Number of operating segments | 1 |
Standard payment term | 30 days |
Minimum [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Incremental borrowing rate | 4.00% |
Maximum [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Incremental borrowing rate | 5.60% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Disaggregation of Revenue) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 226 | $ 372 | $ 693 | $ 1,164 |
Net Sales [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 50 | 198 | 164 | 633 |
Other Revenue [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 176 | $ 174 | $ 529 | $ 531 |
Stockholders_ Equity (Narrative
Stockholders’ Equity (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Apr. 01, 2016 | |
Equity [Line Items] | ||||||
Preferred stock outstanding | 28,708 | 28,708 | 30,000 | |||
Unit price | $ 12 | |||||
Preferred stock conversion price | $ 9.60 | $ 9.60 | ||||
Accrued dividends on preferred stock | $ 1,232 | $ 1,197 | ||||
Common stock, shares authorized | 400,000,000 | 400,000,000 | 200,000,000 | |||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | |||
Convertible Preferred Stock [Member] | ||||||
Equity [Line Items] | ||||||
Preferred stock outstanding | 28,708 | 28,708 | ||||
Convertible preferred stock rate | 5.00% | |||||
Liquidation preference | $ 33,100 | $ 33,100 | ||||
Beneficial conversion feature, discount percentage | 20.00% | |||||
Shares converted | 1,292 | |||||
Accrued dividends on preferred stock | 400 | $ 400 | $ 1,200 | 1,200 | ||
Deemed dividends on preferred stock | $ 100 | $ 400 | $ 300 | $ 1,200 | ||
Common Stock [Member] | ||||||
Equity [Line Items] | ||||||
Shares issued upon conversion | 154,645 |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Common Stockholders (Computation of Basic and Diluted Net Income (Loss) per Share Attributable to Common Stockholders) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | ||||
Net loss available to common stockholders - basic and diluted | $ (62,912) | $ (14,314) | $ (51,183) | $ (14,231) |
Weighted average shares of common stock outstanding used to compute basic and diluted net loss per share | 128,225,469 | 113,101,776 | 128,360,618 | 92,378,205 |
Net loss per share, basic and diluted | $ (0.49) | $ (0.13) | $ (0.40) | $ (0.15) |
Net Loss per Share Attributab_4
Net Loss per Share Attributable to Common Stockholders (Anti-dilutive Amounts Excluded From Calculation of Diluted Net Income (Loss) per Share) (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total shares of common stock equivalents | 27,492,606 | 25,189,664 | 27,492,606 | 25,189,664 |
Options To Purchase Common Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total shares of common stock equivalents | 11,999,752 | 9,713,427 | 11,999,752 | 9,713,427 |
Warrants To Purchase Common Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total shares of common stock equivalents | 11,999,852 | 11,999,852 | 11,999,852 | 11,999,852 |
Convertible Preferred Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total shares of common stock equivalents | 3,493,002 | 3,476,385 | 3,493,002 | 3,476,385 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) shares in Millions | 1 Months Ended | 9 Months Ended | ||
Oct. 31, 2019USD ($)shares | Aug. 31, 2015USD ($)item | Sep. 30, 2019USD ($) | Dec. 31, 2018USD ($) | |
Debt Instrument [Line Items] | ||||
Debt outstanding | $ 27,763,000 | $ 27,480,000 | ||
2015 Credit Agreement [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt outstanding | 28,046,000 | |||
2015 Credit Agreement, Fifth Amendment [Member] | ||||
Debt Instrument [Line Items] | ||||
Monthly principal payments | $ 750,000 | |||
2015 Credit Agreement, Fifth Amendment [Member] | Subsequent Event [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt repaid | $ 11,000,000 | |||
Debt outstanding | $ 17,000,000 | |||
Secured Term Debt [Member] | 2015 Credit Agreement [Member] | ||||
Debt Instrument [Line Items] | ||||
Total borrowings | $ 35,000,000 | |||
Maturity date | Jul. 1, 2020 | |||
Number of lenders | item | 2 | |||
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% | |||
MeiraGTx Ltd. [Member] | Subsequent Event [Member] | ||||
Debt Instrument [Line Items] | ||||
Shares sold | shares | 1.4 | |||
Proceeds from sale of shares | $ 22,000,000 |
Debt (Debt Payable) (Details)
Debt (Debt Payable) (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Debt Instrument [Line Items] | ||
Total debt before debt discount | $ 28,046 | $ 28,046 |
Less: Debt discount | (283) | (566) |
Total debt payable | 27,763 | 27,480 |
Debt payable, current portion | 27,763 | |
Debt payable, long-term | 27,480 | |
Secured Term Debt Due July 1, 2020 [Member] | Secured Term Debt [Member] | ||
Debt Instrument [Line Items] | ||
Total debt before debt discount | $ 28,046 | $ 28,046 |
Maturity date | Jul. 1, 2020 |
Debt (Minimum Payments Required
Debt (Minimum Payments Required on Outstanding Balances) (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Total debt payable | $ 27,763 | $ 27,480 |
2015 Credit Agreement [Member] | ||
Debt Instrument [Line Items] | ||
2019 | ||
2020 | 28,046 | |
Total debt payable | $ 28,046 |
Debt (Interest Expense and Othe
Debt (Interest Expense and Other Related Financing Costs) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Debt [Abstract] | ||||
Interest expense | $ 836 | $ 830 | $ 2,516 | $ 2,720 |
Amortization of deferred financing costs, debt discount and debt premium | 95 | 47 | 283 | 960 |
Interest expense | $ 931 | $ 877 | $ 2,799 | $ 3,680 |
Financial Instruments (Narrativ
Financial Instruments (Narrative) (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Apr. 30, 2018USD ($)shares | Mar. 31, 2017$ / sharesshares | Aug. 31, 2016$ / sharesshares | Sep. 30, 2019USD ($)item$ / sharesshares | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)item$ / sharesshares | Sep. 30, 2018USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2018USD ($)shares | |
Financial Instruments [Line Items] | |||||||||
Warrants fair value | $ | $ 600,000 | $ 600,000 | $ 500,000 | ||||||
Long-term secured term debt fair value | $ | $ 27,500,000 | ||||||||
Short term secured debt | $ | $ 27,800,000 | $ 27,800,000 | |||||||
Warrants outstanding, shares | shares | 11,999,852 | 11,999,852 | 11,999,852 | ||||||
2015 Credit Agreement [Member] | |||||||||
Financial Instruments [Line Items] | |||||||||
Strike price | $ / shares | $ 10.20 | $ 4.50 | $ 4.50 | ||||||
Common units converted to warrants | shares | 617,651 | ||||||||
Change in fair value of warrant | $ | $ 100,000 | $ (200,000) | $ 100,000 | $ (100,000) | |||||
Warrants to purchase | $ | $ 6,300,000 | ||||||||
Warrants outstanding, shares | shares | 88,238 | 88,238 | |||||||
Warrants exercised | shares | 0 | 0 | 0 | ||||||
Expected term | 2 years 10 months 24 days | 2 years 10 months 24 days | |||||||
2015 Credit Agreement [Member] | Expected Dividend YIeld [Member] | |||||||||
Financial Instruments [Line Items] | |||||||||
Warrants and Rights Outstanding, Measurement Input | item | 0 | 0 | |||||||
2015 Credit Agreement [Member] | Expected Volatility [Member] | |||||||||
Financial Instruments [Line Items] | |||||||||
Warrants and Rights Outstanding, Measurement Input | item | 71 | 71 | |||||||
2015 Credit Agreement [Member] | Risk Free Interest Rate [Member] | |||||||||
Financial Instruments [Line Items] | |||||||||
Warrants and Rights Outstanding, Measurement Input | item | 1.6 | 1.6 | |||||||
2015 Credit Agreement, Fifth Amendment [Member] | |||||||||
Financial Instruments [Line Items] | |||||||||
Strike price | $ / shares | $ 3.30 | $ 3.30 | |||||||
Monthly principal payments | $ | $ 750,000 | ||||||||
Warrants outstanding, shares | shares | 529,413 | 529,413 | |||||||
Other Warrants [Member] | |||||||||
Financial Instruments [Line Items] | |||||||||
Warrants issued | shares | 2,707,138 | ||||||||
Strike price | $ / shares | $ 4.50 | ||||||||
Change in fair value of warrant | $ | $ 0 | $ (700,000) | |||||||
Warrants exercised | shares | 119,047 | ||||||||
Proceeds from warrants exercises | $ | $ 500,000 | ||||||||
Warrants expired | shares | 2,588,091 |
Financial Instruments (Fair Val
Financial Instruments (Fair Values of Financial Instruments) (Details) - Significant Other Observable Inputs (Level 2) [Member] - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Financial Instruments [Line Items] | ||
Total financial instruments | $ 594 | $ 524 |
Warrants [Member] | ||
Financial Instruments [Line Items] | ||
Total financial instruments | $ 594 | $ 524 |
Financial Instruments (Rollforw
Financial Instruments (Rollforward of Level 2 Investments) (Details) - Significant Other Observable Inputs (Level 2) [Member] - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Financial Instruments [Line Items] | ||
Balance | $ 524 | $ 1,952 |
Change in fair value of financial instruments | 70 | (1,525) |
Fair value of warrants modified in the Fifth Amendment | 111 | |
Exercise of warrants recorded as liability | (14) | |
Balance | $ 594 | $ 524 |
Financial Instruments (Warrants
Financial Instruments (Warrants Outstanding) (Details) | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Financial Instruments [Abstract] | |
Warrants, Outstanding | shares | 11,999,852 |
Warrants, Granted | shares | |
Warrants, Exercised | shares | |
Warrants, Forfeited | shares | |
Warrants, Outstanding | shares | 11,999,852 |
Warrants, Weighted Average Exercise Price, Outstanding | $ / shares | $ 5.95 |
Warrants, Weighted Average Exercise Price, Granted | $ / shares | |
Warrant, Weighted Average Exercise Price, Exercised | $ / shares | |
Warrants, Weighted Average Exercise Price, Forfeited | $ / shares | |
Warrants, Weighted Average Exercise Price, Outstanding | $ / shares | $ 5.95 |
Inventories (Narrative) (Detail
Inventories (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Inventory [Line Items] | |||||
Reserve for expirable inventory | $ 2,900,000 | $ 2,900,000 | $ 2,200,000 | ||
Expensed inventory | 0 | $ 20,000 | 932,000 | $ 265,000 | |
Work-in-process inventory | 123,000 | 123,000 | 886,000 | ||
Maximum [Member] | |||||
Inventory [Line Items] | |||||
Expensed inventory | $ 100,000 | ||||
Trientine Hydrochloride [Member] | |||||
Inventory [Line Items] | |||||
Work-in-process inventory | $ 200,000 | $ 200,000 | $ 900,000 |
Inventories (Schedule of Invent
Inventories (Schedule of Inventories) (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Inventories [Abstract] | ||
Raw materials | $ 60 | |
Work-in-process | 123 | $ 886 |
Finished goods, net | 31 | 39 |
Total inventories | $ 214 | $ 925 |
Leases (Narrative) (Details)
Leases (Narrative) (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($)itemcontract | Dec. 31, 2018USD ($) | Mar. 31, 2018USD ($) | |
Lessee, Lease, Description [Line Items] | ||||
Number of operating leases | contract | 6 | |||
Number of finance leases | contract | 3 | |||
Number of leases utilizing short-term exception | contract | 2 | |||
Right of use assets | $ 20,510 | $ 20,510 | ||
Lease liability | 24,611 | 24,611 | ||
Cumulative effect of change in accounting principle - ASC 606 adoption | $ 24,017 | |||
Current lease liability | 3,905 | 3,905 | ||
Noncurrent lease liability | 20,774 | $ 20,774 | ||
New York Property [Member] | ||||
Lessee, Lease, Description [Line Items] | ||||
Number of lease amendments | item | 6 | |||
Operating lease cost | 1,200 | $ 3,500 | ||
New York Property [Member] | Letter of Credit [Member] | ||||
Lessee, Lease, Description [Line Items] | ||||
Secured letter of credit | $ 2,000 | $ 2,000 | ||
Warrendale, Pennsylvania Property [Member] | ||||
Lessee, Lease, Description [Line Items] | ||||
Number of renewal options | item | 2 | |||
Term of renewal option | 5 years | 5 years | ||
Operating lease cost | $ 200 | $ 500 | ||
Cambridge, Massachusetts And Princeton, New Jersey Properties [Member] | ||||
Lessee, Lease, Description [Line Items] | ||||
Operating lease cost | 100 | 300 | ||
Cambridge, Massachusetts And Princeton, New Jersey Properties [Member] | Letter of Credit [Member] | ||||
Lessee, Lease, Description [Line Items] | ||||
Secured letter of credit | $ 100 | $ 100 | ||
Accounting Standards Update 2016-02 [Member] | ||||
Lessee, Lease, Description [Line Items] | ||||
Right of use assets | $ 22,700 | |||
Lease liability | 27,000 | |||
Cumulative effect of change in accounting principle - ASC 606 adoption | $ 4,300 |
Leases (Quantitative Infromatio
Leases (Quantitative Infromation Regarding Leases) (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($) | |||
Leases [Abstract] | ||||
Operating lease cost | $ 1,156 | [1] | $ 3,478 | [1] |
Variable lease cost | 358 | 989 | ||
Sublease Income | (179) | [2] | (529) | [2] |
Net Lease Cost | 1,335 | 3,938 | ||
Operating cash flows paid for amounts included in the measurement of lease liabilities | 1,150 | 3,498 | ||
Operating lease liabilities arising from obtaining ROU assets | $ 127 | $ 212 | ||
Weighted average remaining lease term (years) | 5 years 8 months 12 days | 5 years 8 months 12 days | ||
Weighted average discount rate | 4.10% | 4.10% | ||
[1] | Includes short-term lease costs and finance lease costs, which are immaterial. | |||
[2] | Includes sublease income related to MeiraGTx (Note 11). |
Leases (Schedule Of Future Leas
Leases (Schedule Of Future Lease Payments) (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Operating Leases | ||
2019 | $ 1,205 | |
2020 | 4,833 | |
2021 | 4,937 | |
2022 | 4,844 | |
2023 | 4,153 | |
Thereafter | 7,732 | |
Total Lease Payments | 27,704 | |
Less: Imputed Interest | (3,093) | |
Total Lease Liabilities | 24,611 | |
Finance Leases | ||
2019 | 22 | |
2020 | 48 | |
2021 | 6 | |
Total Lease Payments | 76 | |
Less: Imputed Interest | (8) | |
Total Lease Liabilities | $ 68 | |
2019 | $ 4,672 | |
2020 | 4,204 | |
2021 | 4,177 | |
2022 | 4,286 | |
2023 | 4,153 | |
Thereafter | 7,731 | |
Total | $ 29,223 |
Fixed Assets (Narrative) (Detai
Fixed Assets (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Fixed Assets [Abstract] | |||||
Depreciation and amortization of fixed assets | $ 500 | $ 400 | $ 1,356 | $ 1,105 | |
Unamortized computer software costs | 400 | 400 | $ 700 | ||
Amortization of computer software costs | $ 100 | $ 100 | $ 300 | $ 100 |
Fixed Assets (Fixed Assets) (De
Fixed Assets (Fixed Assets) (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 19,157 | $ 18,839 |
Less accumulated depreciation and amortization | (16,429) | (15,185) |
Fixed assets, net | 2,728 | 3,654 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 10,397 | 10,187 |
Office Equipment and Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 1,289 | 1,529 |
Machinery and Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 3,455 | 3,247 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 3,971 | 3,831 |
Construction-in-progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 45 | $ 45 |
Minimum [Member] | Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives (Years) | 4 years | |
Minimum [Member] | Office Equipment and Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives (Years) | 3 years | |
Minimum [Member] | Machinery and Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives (Years) | 3 years | |
Minimum [Member] | Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives (Years) | 1 year | |
Maximum [Member] | Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives (Years) | 8 years | |
Maximum [Member] | Office Equipment and Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives (Years) | 15 years | |
Maximum [Member] | Machinery and Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives (Years) | 15 years | |
Maximum [Member] | Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives (Years) | 5 years |
Goodwill (Narrative) (Details)
Goodwill (Narrative) (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Goodwill [Abstract] | ||
Change in goodwill | $ 0 | $ 0 |
Investment in MeiraGTx (Narrati
Investment in MeiraGTx (Narrative) (Details) - USD ($) | Jun. 13, 2018 | Jun. 12, 2018 | Oct. 31, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Jun. 12, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Apr. 30, 2019 |
Investment Holdings [Line Items] | ||||||||||
Stock issued, shares | 13,778,705 | |||||||||
Sale of Stock, Price Per Share | $ 2.17 | $ 2.17 | $ 2.70 | |||||||
Ownership percentage | 13.00% | |||||||||
Unrealized (loss) gain on equity securities | $ (38,634,000) | $ 7,564,000 | $ 22,304,000 | $ 48,072,000 | ||||||
Accounts receivable, net | 687,000 | 687,000 | $ 1,690,000 | |||||||
License Agreement, MeiraGTx Ltd. [Member] | ||||||||||
Investment Holdings [Line Items] | ||||||||||
Equity method investment, gross profit (loss) | $ 1,200,000 | |||||||||
MeiraGTx Ltd. [Member] | ||||||||||
Investment Holdings [Line Items] | ||||||||||
Equity method investment, fair value | 56,400,000 | $ 56,400,000 | $ 34,100,000 | |||||||
Stock issued, shares | 5,000,000 | |||||||||
Sale of Stock, Price Per Share | $ 15 | $ 15 | ||||||||
Ownership percentage | 9.70% | 12.90% | ||||||||
Unrealized (loss) gain on equity securities | (38,600,000) | $ 22,300,000 | 40,500,000 | |||||||
Service revenue to license | 100,000 | $ 400,000 | 100,000 | 400,000 | ||||||
Cash payments for service revenue | 400,000 | $ 1,300,000 | ||||||||
Accounts receivable, net | $ 0 | $ 0 | $ 0 | |||||||
Lease period | 2 months | |||||||||
Period of notice to cancel lease | 30 days | |||||||||
Subsequent Event [Member] | MeiraGTx Ltd. [Member] | ||||||||||
Investment Holdings [Line Items] | ||||||||||
Ownership percentage | 5.70% | |||||||||
Shares sold | 1,400,000 | |||||||||
Proceeds from sale of shares | $ 22,000,000 |
License Agreements (Narrative)
License Agreements (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | 34 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2017 | Sep. 03, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Contingent milestone payments | $ 225,900 | $ 225,900 | ||||
Research and development expense | 13,227 | $ 11,918 | 43,326 | $ 31,876 | ||
License Agreement, Dyax Corp. [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Research and development expense | $ 1,500 | $ 1,500 | $ 1,500 | |||
License Agreement, Jinghua [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
License revenue | $ 4,000 |
Share-based Compensation (Narra
Share-based Compensation (Narrative) (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Oct. 31, 2019shares | Sep. 30, 2019USD ($)$ / sharesshares | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)item$ / sharesshares | Sep. 30, 2018USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | |
Performance Awards [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options vested | 744,168 | 0 | ||||
Options exercised | 0 | |||||
Service period | 3 years | |||||
Number of performance goals | item | 3 | |||||
Options To Purchase Common Stock [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share based compensation, options granted | 1,593,973 | 280,924 | ||||
Weighted average exercise price of options granted during the period (per share) | $ / shares | $ 1.48 | $ 4.62 | ||||
Share-based compensation, options outstanding, weighted average remaining contractual term (years) | 7 years 6 months | |||||
Share based compensation, options granted, aggregate intrinsic value | $ | ||||||
Options exercised | 0 | 0 | ||||
Expected dividend yield | 0.00% | 0.00% | ||||
Options outstanding | 10,709,752 | 10,709,752 | 9,764,539 | |||
Stock Appreciation Rights [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation expense | $ | $ 600,000 | $ 600,000 | ||||
Weighted average period for recognition of compensation expense | 1 year 2 months 12 days | |||||
Share-based compensation, options outstanding, weighted average remaining contractual term (years) | 6 years 9 months 18 days | |||||
Share based compensation, options granted, aggregate intrinsic value | $ | $ 0 | $ 0 | $ 0 | |||
Exercise price | $ / shares | $ 3.64 | $ 3.64 | $ 3.64 | |||
Options vested | 398,334 | 278,335 | ||||
Options exercised | 0 | 0 | ||||
Options outstanding | 835,000 | 835,000 | 835,000 | |||
2016 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Increase in authorized shares as a percentage of common stock issued | 4.00% | |||||
Shares authorized for issuance | 16,194,138 | 16,194,138 | 11,668,905 | |||
Unrecognized compensation expense | $ | $ 4,400,000 | $ 4,400,000 | $ 6,800,000 | |||
Weighted average period for recognition of compensation expense | 1 year 3 months 18 days | 1 year 6 months | ||||
Share based compensation, options granted | 10,709,752 | |||||
Weighted average exercise price of options granted during the period (per share) | $ / shares | $ 5.73 | |||||
Stock compensation expense | $ | 1,500,000 | $ 2,800,000 | $ 5,600,000 | $ 8,400,000 | ||
2016 Equity Incentive Plan [Member] | Performance Awards [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation expense | $ | 600,000 | $ 600,000 | ||||
Weighted average period for recognition of compensation expense | 1 year 4 months 24 days | |||||
Share based compensation, options granted | 1,597,500 | |||||
Weighted average exercise price of options granted during the period (per share) | $ / shares | $ 4.06 | |||||
Share-based compensation, options outstanding, weighted average remaining contractual term (years) | 6 years 10 months 24 days | |||||
Share based compensation, options granted, aggregate intrinsic value | $ | $ 0 | $ 0 | $ 0 | |||
Exercise price | $ / shares | $ 4.06 | $ 4.06 | ||||
Weighted average fair value of grants | $ / shares | $ 2.71 | |||||
Expected dividend yield | 0.00% | |||||
Expected life (years) | 6 years | |||||
Risk-free interest rate | 2.67% | |||||
Volatility | 74.50% | |||||
Options forfeited | 307,500 | |||||
Options outstanding | 1,290,000 | 1,290,000 | 1,290,000 | |||
Number of performance goals | item | 3 | |||||
Performance period | 3 years | |||||
2014 Long-Term Incentive Plan (“LTIP”) [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options exercised | 0 | |||||
Equity instruments granted | 9,750 | 9,750 | ||||
Equity instruments base price | $ / shares | $ 6 | |||||
Equity instrument payable, common stock value percent above grant price | 333.00% | |||||
Equity instrument payable, common stock value | $ / shares | $ 20 | |||||
2016 Employee Stock Purchase Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares authorized for issuance | 2,551,180 | |||||
Share based compensation, options granted | 32,273 | 22,958 | ||||
Stock compensation expense | $ | $ 0 | $ 0 | ||||
Minimum [Member] | Options To Purchase Common Stock [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected life (years) | 5 years 6 months | 5 years 6 months | ||||
Risk-free interest rate | 1.41% | 2.44% | ||||
Maximum [Member] | Options To Purchase Common Stock [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected life (years) | 6 years | 6 years | ||||
Risk-free interest rate | 2.61% | 2.84% | ||||
Subsequent Event [Member] | 2016 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share based compensation, options granted | 56,346 |
Share-based Compensation (Stock
Share-based Compensation (Stock Options Outstanding) (Details) - Options To Purchase Common Stock [Member] - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options Outstanding, Units, Beginning Balance | 9,764,539 | ||
Options Outstanding, Units, Granted | 1,593,973 | 280,924 | |
Options Outstanding, Units, Exercised | 0 | 0 | |
Options Outstanding, Units, Forfeited | (648,760) | ||
Options Outstanding, Units, Ending Balance | 10,709,752 | 9,764,539 | |
Options Vested and Exercisable, Units | 6,081,492 | ||
Options Outstanding, Weighted Average Exercise Price, Beginning Balance | $ 6.24 | ||
Options Outstanding, Weighted Average Exercise Price, Granted | 1.48 | $ 4.62 | |
Options Outstanding, Weighted Average Exercise Price, Exercised | |||
Options Outstanding, Weighted Average Exercise Price, Forfeited | 4.74 | ||
Options Outstanding, Weighted Average Exercise Price, Ending Balance | 5.73 | $ 6.24 | |
Options Vested and Exercisable, Weighted Average Exercise Price | $ 7.99 | ||
Options Outstanding, Weighted Average Remaining Contractual Term (years) | 7 years 6 months | ||
Options Vested and Exercisable, Weighted Average Remaining Contractual Term (years) | 6 years 4 months 6 days | 7 years 10 months 2 days | |
Options Outstanding, Aggregate Intrinsic Value |
Share-based Compensation (Weigh
Share-based Compensation (Weighted-average Fair Value of Stock Option Awards Granted) (Details) - Options To Purchase Common Stock [Member] - $ / shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value of grants | $ 1.48 | $ 2.20 |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 76.19% | 72.94% |
Risk-free interest rate | 1.41% | 2.44% |
Expected life (years) | 5 years 6 months | 5 years 6 months |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 77.73% | 75.14% |
Risk-free interest rate | 2.61% | 2.84% |
Expected life (years) | 6 years | 6 years |
Accrued Expenses (Narrative) (D
Accrued Expenses (Narrative) (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Short-Term Accrued Expenses [Line Items] | ||
Severance expense | $ 3,400,000 | $ 3,800,000 |
Research and development | 5,251,000 | 4,847,000 |
Executive Vice President [Member] | ||
Short-Term Accrued Expenses [Line Items] | ||
Severance cost | 900,000 | |
Executive Vice President [Member] | Accrued Expenses [Member] | ||
Short-Term Accrued Expenses [Line Items] | ||
Severance cost | 600,000 | |
Executive Vice President [Member] | Other Long-Term Liabilities [Member] | ||
Short-Term Accrued Expenses [Line Items] | ||
Severance cost | 200,000 | |
Third Party Investors [Member] | 2014 Stock Issuance [Member] | Class E Redeemable Convertible Units [Member] | ||
Short-Term Accrued Expenses [Line Items] | ||
Accrued liabilities current, commissions payable | 2,400,000 | $ 2,400,000 |
Dr. Samuel D. Waksal [Member] | ||
Short-Term Accrued Expenses [Line Items] | ||
Severance expense | $ 0 |
Accrued Expenses (Short-term Ac
Accrued Expenses (Short-term Accrued Expenses) (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Accrued Expenses [Abstract] | ||
Commission payable | $ 2,395 | $ 2,395 |
Compensation, benefits and severance | 3,430 | 3,848 |
Research and development | 5,251 | 4,847 |
Other | 2,502 | 2,418 |
Total accrued expenses | $ 13,578 | $ 13,508 |
Commitments and Contingencies (
Commitments and Contingencies ((Narrative) (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2019USD ($)claim | |
Commitments and Contingencies [Abstract] | |
Purchase obligation, 2019 | $ 0.4 |
Purchase obligation, 2020 | 0.5 |
Purchase obligation, 2021 | 0.4 |
Purchase obligation, 2022 | 0.3 |
Purchase obligation, 2023 | $ 0.3 |
Number of claims filed | claim | 0 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Line Items] | ||||||
Income tax benefit | $ 0 | $ 0 | $ 0 | $ (562,000) | ||
Change in deferred tax liability | $ 0 | $ 0 | ||||
U.S. federal corporate tax rate | 21.00% | 35.00% | ||||
Tax Cuts and Jobs Act of 2017, Deferred Income Tax Benefit | $ 600,000 | |||||
Federal [Member] | ||||||
Income Tax Disclosure [Line Items] | ||||||
Net operating loss carryforwards | $ 460,300,000 | |||||
Operating loss carryforwards, no expiration | 44,000,000 | |||||
State [Member] | ||||||
Income Tax Disclosure [Line Items] | ||||||
Net operating loss carryforwards | $ 404,300,000 |
Subsequent Events (Details)
Subsequent Events (Details) $ in Millions | Nov. 06, 2019USD ($) |
Maximum [Member] | Subsequent Event [Member] | |
Subsequent Event [Line Items] | |
Potential proceeds from partnership agreement | $ 45 |
Uncategorized Items - kdmn-2019
Label | Element | Value |
Restricted Cash and Cash Equivalents | us-gaap_RestrictedCashAndCashEquivalents | $ 2,116,000 |
Restricted Cash and Cash Equivalents | us-gaap_RestrictedCashAndCashEquivalents | $ 2,116,000 |