Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 04, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Transition Report | false | |
Entity File Number | 001-37841 | |
Entity Registrant Name | Kadmon Holdings, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 27-3576929 | |
Entity Address, Address Line One | 450 East 29th Street | |
Entity Address, City or Town | New York | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10016 | |
City Area Code | 833 | |
Local Phone Number | 900-5366 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Title of 12(b) Security | Common stock, par value $0.001 per share | |
Trading Symbol | KDMN | |
Security Exchange Name | NYSE | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 160,026,281 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001557142 | |
Current Fiscal Year End Date | --12-31 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 120,046 | $ 139,597 |
Accounts receivable, net | 1,234 | 954 |
Inventories, net | 500 | 640 |
Investment, equity securities | 28,194 | 41,997 |
Prepaid expenses and other current assets | 2,854 | 1,416 |
Total current assets | 152,828 | 184,604 |
Fixed assets, net | 2,159 | 2,444 |
Right of use lease asset | 18,782 | 19,651 |
Goodwill | 3,580 | 3,580 |
Restricted cash | 2,117 | 2,116 |
Investment, at cost | 2,300 | 2,300 |
Other noncurrent assets | 11 | 103 |
Total assets | 181,777 | 214,798 |
Current liabilities: | ||
Accounts payable | 6,751 | 9,043 |
Accrued expenses | 11,714 | 14,248 |
Lease liability - current | 4,024 | 3,966 |
Warrant liabilities | 1,329 | 1,485 |
Total current liabilities | 23,818 | 28,742 |
Lease liability - noncurrent | 18,732 | 19,759 |
Deferred tax liability | 461 | 461 |
Other long term liabilities | 101 | |
Total liabilities | 43,011 | 49,063 |
Commitments and contingencies (Note 13) | ||
Stockholders’ equity: | ||
Convertible preferred stock, $0.001 par value; 10,000,000 shares authorized at March 31, 2020 and December 31, 2019; 28,708 shares issued and outstanding at March 31, 2020 and December 31, 2019. | 42,950 | 42,433 |
Common stock, $0.001 par value; 400,000,000 shares authorized at March 31, 2020 and December 31, 2019; 159,830,774 and 159,759,996 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 160 | 160 |
Additional paid-in capital | 458,539 | 456,211 |
Accumulated deficit | (362,883) | (333,069) |
Total stockholders’ equity | 138,766 | 165,735 |
Total liabilities and stockholders’ equity | $ 181,777 | $ 214,798 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 400,000,000 | 400,000,000 |
Common stock, shares issued | 159,830,774 | 159,759,996 |
Common stock, shares outstanding | 159,830,774 | 159,759,996 |
Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 28,708 | 28,708 |
Preferred stock, shares outstanding | 28,708 | 28,708 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenues: | ||
Total revenue | $ 6,735,000 | $ 241,000 |
Cost of sales | 328,000 | 31,000 |
Write-down of inventory | 284,000 | |
Gross profit | 6,123,000 | 210,000 |
Operating expenses: | ||
Research and development | 12,874,000 | 14,991,000 |
Selling, general and administrative | 9,366,000 | 7,946,000 |
Total operating expenses | 22,240,000 | 22,937,000 |
Loss from operations | (16,117,000) | (22,727,000) |
Other (expense) income: | ||
Interest income | 466,000 | 656,000 |
Interest expense | (932,000) | |
Change in fair value of warrant liabilities | 156,000 | (224,000) |
Unrealized (loss) gain on equity securities | (13,803,000) | 26,828,000 |
Other income (expense) | 1,000 | (9,000) |
Total other (expense) income | (13,180,000) | 26,319,000 |
(Loss) income before income tax expense | (29,297,000) | 3,592,000 |
Income tax benefit | 0 | 0 |
Net (loss) income | (29,297,000) | 3,592,000 |
Deemed dividend on convertible preferred stock | 517,000 | 515,000 |
Net (loss) income attributable to common stockholders | $ (29,814,000) | $ 3,077,000 |
Basic net (loss) income per share of common stock | $ (0.19) | $ 0.02 |
Diluted net (loss) income per share of common stock | $ (0.19) | $ 0.02 |
Weighted average basic shares of common stock outstanding | 158,031,405 | 126,330,788 |
Weighted average diluted shares of common stock outstanding | 158,031,405 | 126,406,039 |
Product Sales [Member] | ||
Revenues: | ||
Total revenue | $ 589,000 | $ 67,000 |
License and Other Revenue [Member] | ||
Revenues: | ||
Total revenue | $ 6,146,000 | $ 174,000 |
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, 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 | |||
Balance at Dec. 31, 2019 | $ 42,433 | $ 160 | 456,211 | (333,069) | 165,735 |
Balance, Shares at Dec. 31, 2019 | 28,708 | 159,759,996 | |||
Share-based compensation expense | 2,037 | 2,037 | |||
Common stock issued for warrant exercises | 7 | 7 | |||
Common stock issued for warrant exercises, shares | 2,777 | ||||
Common stock issued for option exercises | 284 | 284 | |||
Common stock issued for option exercises, shares | 68,001 | ||||
Beneficial conversion feature on convertible preferred stock | $ 103 | (103) | |||
Accretion of dividends on convertible preferred stock | 414 | (414) | |||
Net income (loss) | (29,297) | (29,297) | |||
Balance at Mar. 31, 2020 | $ 42,950 | $ 160 | $ 458,539 | $ (362,883) | $ 138,766 |
Balance, Shares at Mar. 31, 2020 | 28,708 | 159,830,774 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities: | ||
Net (loss) income | $ (29,297) | $ 3,592 |
Adjustments to reconcile net (loss) income to net cash used in operating activities: | ||
Depreciation and amortization of fixed assets | 418 | 467 |
Non-cash operating lease cost | 869 | 818 |
Write-down of inventory | 284 | |
Amortization of debt discount | 95 | |
Share-based compensation | 2,037 | 2,156 |
Change in fair value of warrant liabilities | (156) | 224 |
Unrealized loss (gain) on equity securities | 13,803 | (26,828) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (280) | 189 |
Inventories, net | (144) | (11) |
Prepaid expenses and other assets | (1,346) | (388) |
Accounts payable | (2,399) | (1,311) |
Lease liability | (969) | (908) |
Accrued expenses and other liabilities | (2,635) | (2,228) |
Net cash used in operating activities | (19,815) | (24,133) |
Cash flows from investing activities: | ||
Purchases of fixed assets | (26) | (298) |
Net cash used in investing activities | (26) | (298) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net | 29,049 | |
Proceeds from exercise of options | 284 | |
Proceeds from exercise of warrants | 7 | |
Net cash provided by financing activities | 291 | 29,049 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (19,550) | 4,618 |
Cash, cash equivalents and restricted cash, beginning of period | 141,713 | 96,856 |
Cash, cash equivalents and restricted cash, end of period | 122,163 | 101,474 |
Components of cash, cash equivalents, and restricted cash | ||
Total cash, cash equivalents, and restricted cash | 122,163 | 101,474 |
Supplemental cash flow disclosures: | ||
Cash paid for interest | 836 | |
Non-cash investing and financing activities: | ||
Unpaid fixed asset additions | 107 | 81 |
Operating cash flows paid for amounts included in the measurement of lease liabilities | 1,192 | 1,150 |
Operating lease liabilities arising from obtaining right-of-use assets | 31 | |
Accounting Standards Update 2016-02 [Member] | ||
Non-cash investing and financing activities: | ||
Cumulative effect of change in accounting principle | 27,083 | |
Preferred Stock [Member] | ||
Non-cash investing and financing activities: | ||
Beneficial conversion feature on convertible preferred stock | 103 | 103 |
Accretion of dividends on convertible preferred stock | $ 414 | $ 412 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2020 | |
Organization [Abstract] | |
Organization | 1. Organization Nature of Business Kadmon Holdings, Inc. (together with its subsidiaries, “Kadmon” or “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 immune 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. Liquidity The Company maintained cash and cash equivalents of $120.0 million at March 31, 2020 . The Company had an accumulated deficit of $362.9 million and working capital of $129.0 million at March 31, 2020 . The Company expects that its cash and cash equivalents will enable it to advance its Phase 2 clinical studies of KD025, 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, including the Company’s ownership of MeiraGTx Holding plc (“MeiraGTx”) ordinary shares with a fair value of $28.2 million at March 31, 2020, 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 sold securities totaling an aggregate of $101.6 million pursuant to this registration statement as of March 31, 2020 . 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 expected to enable the Company to advance its ongoing clinical studies for KD025, advance certain of its other pipeline product candidates, including KD033 and KD045, and provide for other working capital purposes. C ash and cash equivalents will not 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. Additionally, the outlook for the spread and eventual containment of the COVID-19 pandemic remains unpredictable, as does its potential impact on the economy (domestically and globally) and the biotechnology industry in particular. The COVID-19 pandemic has had a negative near-term impact on capital markets and may impact the Comp any’s ability to access capital . 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 (which is not assured at this time), its long-term business plan may not be accomplished and the Company may be forced to curtail or cease operations. These factors individually and collectively 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 | 3 Months Ended |
Mar. 31, 2020 | |
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 months ended March 31, 2020 are not necessarily indicative of the final results that may be expected for the year ending December 31, 2020. 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, 2019. 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 (Note 10), the accrual of research and development and clinical trial expenses (Note 11), and the valuation of the Company’s investment in MeiraGTx ordinary shares (Note 8). 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, 2019. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies, other than those described below. Revenue Recognition 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 Company’s revenues have primarily been generated through product sales, collaborative research, development and commercialization license agreements, and other service agreements. The following table summarizes revenue from contracts with customers for the three months ended March 31, 2020 and 2019 (in thousands): Three Months Ended March 31, 2020 2019 Product sales $ 589 $ 67 License revenue 6,000 — Other revenue 146 174 Total revenue $ 6,735 $ 241 Product Sales The Company markets CLOVIQUE™ (Trientine Hydrochloride Capsules, USP), a room-temperature stable innovative product developed in-house at Kadmon and generic Trientine Hydrochloride Capsules USP, 250 mg (collectively, “CLOVIQUE”), for the treatment of Wilson’s Disease. These contracts typically include a single promise to deliver a fixed amount of product to the customer with payment due within 30 - 60 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. The timing of revenue recognition may differ from the timing of invoicing to customers. The Company has not recognized any assets for costs to obtain or fulfill a contract with a customer as of March 31, 2020 . License Revenue License revenue consists of a milestone payment earned pursuant to a joint venture and license agreement entered into with Meiji Seika Pharma Co., Ltd (“Meiji”) to develop KD025 in Japan (Note 9). As of December 31, 2019, the Company had one performance obligation related to a license agreement with Meiji that had not yet been satisfied and for which the upfront cash payment had not been received. The transaction price of $6.0 million was allocated to the single combined performance obligation under the contract and the performance obligation was completed during the first quarter of 2020. There are no performance obligations that have not yet been satisfied as of March 31, 2020 and there is no transaction price allocated to future performance obligations under ASC 606. Other Revenue The other revenue generated by the Company is primarily related to a sublease agreement with MeiraGTx (Note 8). The Company recognizes revenue related to sublease agreements as they are performed. Recent Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, “Income Taxes: Simplifying the Accounting for Income Taxes” , which removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. The ASU is effective for annual or interim periods beginning after December 15, 2020, with early adoption permitted. The Company does not expect the standard to have a significant impact on its consolidated financial statements. 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 Company adopted this standard on January 1, 2020, and the standard did not have a significant impact on its consolidated financial statements as the Company does not have any material agreements that are within the scope of this ASU. 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 A SC 350-40 to determine which implementation costs to capitalize. The Company adopted this standard on January 1, 2020, and the standard did not have a significant impact on its consolidated financial statements as the Company’s cloud computing contracts are 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. For smaller reporting companies, ASU 2017-04 is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2022, with early adoption permitted. 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. For smaller reporting companies, the ASU is effective for interim and annual periods beginning after December 15, 2022, 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 | 3 Months Ended |
Mar. 31, 2020 | |
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 March 31, 2020 , 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. T he Company accrued $0.4 million of dividends on the 5% convertible preferred stock during each of the three months ended March 31, 2020 and 2019 . 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 March 31, 2020 and 2019 , which is a beneficial conversion feature. The stated liquidation preference amount on the 5% convertible preferred stock totaled $33.1 million at March 31, 2020 . 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) Income per Share Att
Net (Loss) Income per Share Attributable to Common Stockholders | 3 Months Ended |
Mar. 31, 2020 | |
Net (Loss) Income per Share Attributable to Common Stockholders [Abstract] | |
Net (Loss) Income per Share Attributable to Common Stockholders | 4. Net ( Loss ) Income per Share Attributable to Common Stockholders Basic net (loss) income attributable to common stockholders per share is computed by dividing the net (loss) income 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 the three months ended March 31, 2020, diluted net loss per common share is the same as basic net loss per common share for that period. For the three months ended March 31, 2019, diluted net income per share is calculated in a manner consistent with that of basic net income per share while giving effect to all potentially dilutive common shares that were outstanding during the period. The following table summarizes the computation of basic and diluted net (loss) income per share attributable to common stockholders of the Company (in thousands, except share and per share amounts) : Three Months Ended March 31, 2020 2019 Numerator – basic and diluted: Net (loss) income available to common stockholders - basic and diluted $ (29,814) $ 3,077 Denominator – basic and diluted: Weighted average common shares outstanding used to compute basic net (loss) income per share 158,031,405 126,330,788 Effect of dilution: Options to purchase common stock — 75,251 Weighted average shares of common stock outstanding used to compute diluted net (loss) income per share 158,031,405 126,406,039 Net (loss) income per share, basic $ (0.19) $ 0.02 Net (loss) income per share, diluted $ (0.19) $ 0.02 The amounts in the table below were excluded from the calculation of diluted net (loss) income per share, due to their anti-dilutive effect: Three Months Ended March 31, 2020 2019 Options to purchase common stock 15,837,954 8,816,778 Warrants to purchase common stock 11,917,052 11,999,852 Convertible preferred stock 3,579,249 3,562,221 Total shares of common stock equivalents 31,334,255 24,378,851 |
Financial Instruments
Financial Instruments | 3 Months Ended |
Mar. 31, 2020 | |
Financial Instruments [Abstract] | |
Financial Instruments | 5. Financial Instruments Equity Issued Pursuant to Credit Agreements In connection with a credit agreement entered into in 2015, 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 March 31, 2020 , 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 $1.3 million at March 31, 2020 and approximately $1.5 million at December 31, 2019. The Company used the Black-Scholes pricing model to value the warrant liability at March 31, 2020 with the following assumptions: risk-free interest rate of 0.3% , expected term of 2.4 years, expected volatility of 79.0% and a dividend rate of 0% . The change in fair value of the 2015 W arrants was approximately $(0.2) million for the three months ended March 31, 2020 and approximately $0.2 million for the three months ended March 31, 2019 , respectively. None of these instrum ents had been exercised as of March 31, 2020 and December 31, 2019 . Fair Value Classification The Company held certain warrant liabilities that are required to be measured at fair value on a recurring basis. The table below represents the values of the Company’s warrant liabilities at March 31, 2020 and December 31, 2019 (in thousands): Fair Value Measurement Using Significant Other Observable Inputs (Level 2) March 31, December 31, Description 2020 2019 Warrants $ 1,329 $ 1,485 Total $ 1,329 $ 1,485 The table below represents a roll-forward of warrant liabilities measured using Level 2 inputs from January 1, 2019 to March 31, 2020 (in thousands): Significant Other Observable Inputs (Level 2) Balance at January 1, 2019 $ 524 Change in fair value of warrant liabilities 961 Balance at December 31, 2019 $ 1,485 Change in fair value of warrant liabilities (156) Balance at March 31, 2020 $ 1,329 The Level 2 inputs used to value the Company’s warrant liabilities 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 represents a roll-forward of warrants outstanding from January 1, 2020 to March 31, 2020 : Warrants Weighted Average Exercise Price Balance, January 1, 2020 11,921,452 $ 5.97 Exercised (4,400) — Balance, March 31, 2020 11,917,052 $ 5.97 |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2020 | |
Inventories [Abstract] | |
Inventories | 6. 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 $1.8 million and $3.0 million at March 31, 2020 and December 31, 2019 , respectively. If the amount and timing of future sales differ from management’s assumptions, adjustments to the estimated inventory reserves may be required. Inventories are comprised of the following (in thousands): March 31, December 31, 2020 2019 Raw materials $ 190 $ 371 Finished goods, net 310 269 Total inventories $ 500 $ 640 |
Fixed Assets
Fixed Assets | 3 Months Ended |
Mar. 31, 2020 | |
Fixed Assets [Abstract] | |
Fixed Assets | 7. Fixed Assets Fixed assets consisted of the following (in thousands): Useful Lives March 31, December 31, (Years) 2020 2019 Leasehold improvements 4 -8 $ 10,398 $ 10,397 Office equipment and furniture 3 -15 1,254 1,234 Machinery and laboratory equipment 3 -15 3,604 3,599 Software 1 -5 4,044 3,971 Construction-in-progress ̶̶̶̶ 79 45 19,379 19,246 Less accumulated depreciation and amortization (17,220) (16,802) Fixed assets, net $ 2,159 $ 2,444 Depreciation and amortization of fixed assets totaled $0.4 million and $0.5 million for the three months ended March 31, 2020 and 2019 , respectively. Unamortized computer software costs were $0.3 million at March 31, 2020 and December 31, 2019 . The amortization of computer software costs amounted to $0.1 million for each of the three months ended March 31, 2020 and 2019 . |
Ownership of MeiraGTx Ordinary
Ownership of MeiraGTx Ordinary Shares | 3 Months Ended |
Mar. 31, 2020 | |
Ownership of MeiraGTx Ordinary Shares [Abstract] | |
Ownership of MeiraGTx Ordinary Shares | 8. Ownership of MeiraGTx Ordinary Shares At both March 31, 2020 and December 31, 2019, the Company maintained a 5.7% ownership in the ordinary shares of MeiraGTx with a fair value of $28.2 million and $42.0 million, respectively. The Company has recorded an unrealized (loss) gain on the MeiraGTx ordinary shares of $(13.8) million and $26.8 million for the three months ended March 31, 2020 and 2019 , respectively. The Company’s ownership of MeiraGTx ordinary shares is valued using Level 1 inputs, which includes quoted prices in active markets for identical assets in accordance with the fair value hierarchy. The Company did not realize any gains related to the ordinary shares of MeiraGTx during the three months ended March 31, 2020 or 2019. The table below represents a rollforward of the Company’s ownership of MeiraGTx ordinary shares from January 1, 2019 to March 31, 2020 (in thousands): Significant Observable Inputs (Level 1) Balance as of January 1, 2019 $ 34,075 Unrealized gain on ordinary shares sold during the year 8,148 Realized gain on sale of ordinary shares (22,000) Unrealized gain on remaining ownership of ordinary shares 21,774 Balance as of December 31, 2019 $ 41,997 Unrealized loss on ownership of ordinary shares (13,803) Balance as of March 31, 2020 $ 28,194 The Company is party to a sublease agreement to provide office space to MeiraGTx, which is automatically renewed on a monthly basis unless MeiraGTx provides 30 days’ prior written notice. The Company recognized $0.1 million to other revenue related to this sublease agreement during each of the three months ended March 31, 2020 and 2019 . The Company received cash payments of $0.1 million, from MeiraGTx for each of the three months ended March 31, 2020 and 2019 . The Company had no amounts receivable from MeiraGTx at March 31, 2020 or December 31, 2019. |
License Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2020 | |
License Agreements [Abstract] | |
License Agreements | 9. 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, 2019 . Since the date of such financial statements, there have been no significant changes to the Company’s license agreements other than described below. Meiji In December 2019, the Company entered into a collaboration agreement with Meiji, a Tokyo-based wholly owned subsidiary of Meiji Holdings Co., Ltd., to form a joint venture to exclusively develop and commercialize KD025 in Japan and certain other Asian countries. The joint venture was entered into through the creation of Romeck Pharma, LLC (“Romeck”), whereby the Company entered into a royalty-bearing exclusive license agreement with Romeck and Meiji in exchange for a 50% interest in Romeck. Romeck is domiciled in Japan with shared oversight between the Company and Meiji. Under the terms of the license agreement, the Company received an upfront payment of $6.0 million in January 2020 and is eligible to receive an additional $23.0 million in development, regulatory and commercial milestone payments upon the occurrence of specified events over the term of the agreement. In addition, the Company is eligible to receive double-digit percentage royalty payments on sales of KD025 for GVHD in Japan. The Company assessed the applicability of ASC 810 to the aforementioned agreements and based on the corporate structure, voting rights and contributions of the various parties in connection with these agreements, determined that Romeck was a VIE, however consolidation was not required as the Company was not the primary beneficiary based upon the voting and managerial structure of the entity. The purpose of the VIE is to develop and commercialize KD025 in Japan and the operations of Romeck will be financed entirely by Meiji. The Company has not and is not required to provide financial support under the agreements and has no exposure to loss as a result of its involvement in the VIE. The Company’s investment in Romeck was accounted for under the equity method as the Company has the ability to exercise significant influence over Romeck. The equity method investment was recorded at immaterial cost representing the Company’s initial capital contribution for its ownership. This value was determined based upon the corporate structure which does not allocate profits or losses to the Company. An adjustment to this recorded investment will only occur upon a sales transaction or liquidation event, as defined in the agreement. The Company evaluated the arrangement under ASC 808 and determined that the license agreement and related joint venture with Romeck is not within the scope of ASC 808, and that the license agreement represents a contract with a customer under ASC 606. The Company has determined that the license agreement contains a single combined performance obligation that consists of the exclusive license to Kadmon’s intellectual property and related initial technology transfer. All other promises included in the license agreement were deemed to be immaterial in the context of the contract including clinical supply, participation in a JSC, and limited technical assistance as requested by Romeck and Meiji. The Company determined that the $6.0 million non-refundable, upfront payment under the license agreement constituted the entire consideration to be included in the transaction price at the inception of the arrangement. As such, this amount was allocated to the single performance obligation. The potential development, regulatory and commercial milestone payments and sales-based royalties that the Company is eligible to receive represent variable consideration under the license agreement. The development and regulatory milestone amounts were excluded from the transaction price and were fully constrained based on their probability of achievement and the fact that Company cannot reasonably conclude that a significant reversal of revenue related to these milestones would not occur. Any future sales-based royalties, including commercial milestone payments based on the level of sales, will be included in the transaction price and recognized as revenue when the related sales occur and the milestones are achieved. The Company will reevaluate the transaction price at the end of each reporting period as uncertain events are resolved or other changes in circumstances occur, and, if necessary, adjust its estimate of the transaction price. The single combined performance obligation represents a license of functional intellectual property. The Company had not received the upfront payment or completed the single combined performance obligation as of December 31, 2019. The Company recognized $6.0 million in license revenue in the first quarter of 2020 upon completion of the initial technology transfer. No other milestone or royalty revenues have been earned as of March 31, 2020 . |
Share-based Compensation
Share-based Compensation | 3 Months Ended |
Mar. 31, 2020 | |
Share-based Compensation [Abstract] | |
Share-based Compensation | 10. Share-based Compensation 2016 Equity Incentive Plan A total of 16,194,138 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, 2019. On January 1, 2020 , pursuant to the evergreen provision contained in the 2016 Equity Plan, the number of shares reserved for future grants was increased by 5,591,600 shares, which was three and one half percent ( 3.5% ) of the outstanding shares of commo n stock on December 31, 2019 . This reserve will 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 March 31, 2020 , there were options to purchase an aggregate of 15,837,954 shares of common stock outstanding at a weighted average price of $5.27 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 $16.7 million and $6.5 million at March 31, 2020 and December 31, 2019 , respectively. That expense is expected to be recognized over a weighted average period of 2.6 years and 2.2 years as of March 31, 2020 and December 31, 2019 , respectively. The Company recorded share-based compensation expense under the 2016 Equity Plan of $ 2.0 million and $2.2 million for the three months ended March 31, 2020 and 2019 , respectively. The following table summarizes information about stock options outstanding, not including performance stock options, from January 1, 2020 to March 31, 2020 : Options Outstanding Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Balance, January 1, 2020 11,802,601 $ 5.59 7.52 $ 9,520 Granted 4,247,000 4.34 Exercised (68,001) 4.18 53 Forfeited (143,646) 4.74 Balance, March 31, 2020 15,837,954 $ 5.27 7.91 $ 7,090 Options vested and exercisable, March 31, 2020 8,216,814 $ 6.58 6.44 $ 3,907 The aggregate intrinsic value in the table above represents the total pre ‑tax intrinsic value calculated as the difference between the fair value of the Company’s com mon stock at March 31, 2020 ( $4.19 per share) and December 31, 2019 ( $4.53 per share) and the exercise price, multiplied by the related in ‑the ‑money options that would have been received by the option holders had they exercised their options at the end of the fiscal year. This amount changes based on the fair value of the Company’s common stock. There were 68,001 options exercised during the three months ended March 31, 2020 with an aggregate intrinsic value of $0.1 million. There were no options exercised during the three months ended March 31, 2019. There were 4,247,000 stock options granted during the three months ended March 31, 2020 with a weighted-average exercise price of $4.34 . During the three months ended March 31, 2019, 529,870 stock options were granted with a weighted ‑average exercise price of $2.19 . 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: Three Months Ended Three Months Ended March 31, 2020 March 31, 2019 Weighted average fair value of grants $2.87 $1.50 Expected volatility 75.46% - 76.05% 76.32% - 77.73% Risk-free interest rate 0.82% - 1.64% 2.50% - 2.61% Expected life (years) 6.00 6.00 Expected dividend yield 0% 0% Performance Awards A total of 1,290,000 Performance Options with an exercise price of $4.06 were outstanding at March 31, 2020 with an intrinsic value of $0.2 million and at December 31, 2019 with no intrinsic value. The weighted average remaining contractual life of outstanding Performance Options at March 31, 2020 was 6.4 years. Compensation expense for Performance Awards is recognized on a straight-line basis over the awards’ requisite service period. At March 31, 2020 , there was $0.4 million of total unrecognized compensation expense related to unvested Performance Options, which is expected to be recognized over a weighted-average period of 0.9 years. At both March 31, 2020 and December 31, 2019, 853,335 Performance Options had vested and no Performance Options had been exercised. Stock Appreciation Rights A total of 835,000 stock appreciation rights (“SARs”) with an exercise price of $3.64 were outstanding at March 31, 2020 with an intrinsic value of $0.5 million and December 31, 2019 no intrinsic value. The weighted average remaining contractual life of outstanding SARs at March 31, 2020 was 6.3 years. Compensation expense for SARs is recognized on a straight-line basis over the awards’ requisite service period. At March 31, 2020 , there was $0.4 million of total unrecognized compensation cost related to unvested SARs that is expected to be recognized over a weighted-average period of 0.7 years. At March 31, 2020 and December 31, 2019 , 616,667 SARs had vested 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 March 31, 2020 and December 31, 2019 . 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 March 31, 2020 . 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, 2019 . The Board elected not to increase the shares reserved for issuance under the 2016 ESPP on January 1, 2020. No shares were issued under the 2016 ESPP during either of the three months ended March 31, 2020 and 2019 . No meaningful compensation expense was recognized for the ESPP during the three months ended March 31, 2020 and 2019 . |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2020 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | 11. Accrued Expenses Short-term accrued expenses at March 31, 2020 and December 31, 2019 include the following (in thousands): March 31, December 31, 2020 2019 Commission payable $ 2,395 $ 2,395 Compensation, benefits and severance 2,223 4,668 Research and development 5,278 4,962 Other 1,818 2,223 Total accrued expenses $ 11,714 $ 14,248 Commission payable The Company recorded $2.4 million in accrued liabilities at both March 31, 2020 and December 31, 2019 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 March 31, 2020 and December 31, 2019 , these accrued expenses totaled $2.2 million and $4.7 million, respectively. 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 March 31, 2020 and December 31, 2019 , accrued research and development expenses for which the Company has not yet been invoiced totaled $5.3 million and $5.0 million, respectively. |
Commitments And Contingencies
Commitments And Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 12. 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, 2019 . Since the date of such financial statements, there have been no material changes to the Company’s commitments or contingencies, including leases. Contingent License Agreement Milestones The Company has entered into several license agreements for products currently under development (Note 9).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 March 31, 2020 . Any payments made prior to FDA approval will be expensed as research and development. Payments made after FDA approval will be capitalized. 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. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 13. 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, 2019 . 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 8). |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2020 | |
Income Taxes [Abstract] | |
Income Taxes | 14. 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. There was no change in deferred tax liability for the three months ended March 31, 2020 or 2019 and no income tax expense was recorded for the three months ended March 31, 2020 or 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 March 31, 2020 and December 31, 2019 . At December 31, 2019 , the Company had unused federal and state NOL carryforwards of $371.1 million and $307.2 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 $79.9 million of federal NOL carryforwards that will not expire. In the United States, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) on March 27, 2020, which provides relief to taxpayers affected by COVID-19. The CARES Act includes several business provisions that may impact a company’s accounting for income taxes. In addition, the impact of COVID-19 itself on businesses draws attention to certain provisions in ASC 740. The Company analyzed the business provisions in the CARES Act and determined that the Act does not have a significant impact on its income tax provision. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. 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. Paycheck Protection Program Loan under the Coronavirus Aid, Relief, and Economic Security Act On April 15, 2020, the Company received the proceeds from a loan in t he amount of approximately $3.1 million (the “PPP Loan”) from PNC Bank, National Association , as lender, pursuant to the Paycheck Protection Program (“P PP”) of the CARES Act . The PPP Loan matures on April 15, 2022 and bears interest at a rate of 1% per annum. Commencing November 15, 2020, the Company is required to pay the lender equal monthly payments of principal and interest as required to fully amortize by April 15, 2022 the principal amount outstanding on the PPP Loan as of October 15 , 2020. The PPP Loan is evidenced by a promissory note dated April 15, 2020 (the “Note”), which contains customary events of default relating to, among other things, payment defaults and breaches of representations and warranties. The PPP Loan may be prepaid by the Company at any time prior to maturity with no prepayment penalties. The application for these funds required the Company to certify in good faith that the current economic uncertainty made the loan request necessary to support the ongoing operations of the Company. This certification further required the Company to take into account our current business activity and our ability to access other sources of liquidity sufficient to support ongoing operations in a manner that is not significantly detrimental to the business. The Company made this good faith assertion based upon the degree of uncertainty introduced to the capital markets as a result of the COVID-19 pandemic and the Company’s dependency on its ability to raise capital to fund ongoing operations. While the Company has made this assertion in good faith based upon all available guidance, management will continue to assess their continued qualification if and when updated guidance is released by the Treasury Department. All or a portion of the PPP Loan may be forgiven by the U.S. Small Business Administration (“SBA”) upon application by the Company beginning 60 days but not later than 120 days after loan approval and upon documentation of expenditures in accordance with the SBA requirements. Under the CARES Act, loan forgiveness is available for the sum of documented payroll costs, covered rent payments, covered mortgage interest and covered utilities during the eight-week period beginning on the date of loan approval. For purposes of the CARES Act, payroll costs exclude compensation of an individual employee in excess of $100,000, prorated annually. Not more than 25% of the forgiven amount may be for non-payroll costs. Forgiveness is reduced if full-time headcount declines, or if salaries and wages for employees with salaries of $100,000 or less annually are reduced by more than 25%. The ultimate forgiveness of the PPP loan is also predicated upon regulatory authorities concurring with management’s good faith assessment that the current economic uncertainty made the loan request necessary to support ongoing operations. If, despite the Company’s good-faith belief that given the circumstances the Company satisfied all eligibility requirements for the PPP Loan, the Company is later determined to have violated any applicable laws or regulations or it is otherwise determined that the Company was ineligible to receive the PPP Loan, the Company may be required to repay the PPP Loan in its entirety and/or be subject to additional penalties. In the event the PPP Loan, or any portion thereof, is forgiven pursuant to the PPP, the amount forgiven is applied to outstanding principal. The Company intends to use all proceeds from the PPP Loan to retain employees, maintain payroll and make lease, rent and utility payments. Under the terms of the loan, the Company may be eligible for full or partial loan forgiveness in the second quarter of 2020, however, no assurance is provided that the Company will apply for, or obtain forgiveness for , any portion of the Loan. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policy) | 3 Months Ended |
Mar. 31, 2020 | |
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 months ended March 31, 2020 are not necessarily indicative of the final results that may be expected for the year ending December 31, 2020. 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, 2019. |
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 (Note 10), the accrual of research and development and clinical trial expenses (Note 11), and the valuation of the Company’s investment in MeiraGTx ordinary shares (Note 8). |
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, 2019. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies, other than those described below. |
Revenue Recognition | Revenue Recognition 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 Company’s revenues have primarily been generated through product sales, collaborative research, development and commercialization license agreements, and other service agreements. The following table summarizes revenue from contracts with customers for the three months ended March 31, 2020 and 2019 (in thousands): Three Months Ended March 31, 2020 2019 Product sales $ 589 $ 67 License revenue 6,000 — Other revenue 146 174 Total revenue $ 6,735 $ 241 Product Sales The Company markets CLOVIQUE™ (Trientine Hydrochloride Capsules, USP), a room-temperature stable innovative product developed in-house at Kadmon and generic Trientine Hydrochloride Capsules USP, 250 mg (collectively, “CLOVIQUE”), for the treatment of Wilson’s Disease. These contracts typically include a single promise to deliver a fixed amount of product to the customer with payment due within 30 - 60 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. The timing of revenue recognition may differ from the timing of invoicing to customers. The Company has not recognized any assets for costs to obtain or fulfill a contract with a customer as of March 31, 2020 . License Revenue License revenue consists of a milestone payment earned pursuant to a joint venture and license agreement entered into with Meiji Seika Pharma Co., Ltd (“Meiji”) to develop KD025 in Japan (Note 9). As of December 31, 2019, the Company had one performance obligation related to a license agreement with Meiji that had not yet been satisfied and for which the upfront cash payment had not been received. The transaction price of $6.0 million was allocated to the single combined performance obligation under the contract and the performance obligation was completed during the first quarter of 2020. There are no performance obligations that have not yet been satisfied as of March 31, 2020 and there is no transaction price allocated to future performance obligations under ASC 606. Other Revenue The other revenue generated by the Company is primarily related to a sublease agreement with MeiraGTx (Note 8). The Company recognizes revenue related to sublease agreements as they are performed. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, “Income Taxes: Simplifying the Accounting for Income Taxes” , which removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. The ASU is effective for annual or interim periods beginning after December 15, 2020, with early adoption permitted. The Company does not expect the standard to have a significant impact on its consolidated financial statements. 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 Company adopted this standard on January 1, 2020, and the standard did not have a significant impact on its consolidated financial statements as the Company does not have any material agreements that are within the scope of this ASU. 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 A SC 350-40 to determine which implementation costs to capitalize. The Company adopted this standard on January 1, 2020, and the standard did not have a significant impact on its consolidated financial statements as the Company’s cloud computing contracts are 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. For smaller reporting companies, ASU 2017-04 is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2022, with early adoption permitted. 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. For smaller reporting companies, the ASU is effective for interim and annual periods beginning after December 15, 2022, 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) | 3 Months Ended |
Mar. 31, 2020 | |
Summary of Significant Accounting Policies [Abstract] | |
Disaggregation of Revenue | Three Months Ended March 31, 2020 2019 Product sales $ 589 $ 67 License revenue 6,000 — Other revenue 146 174 Total revenue $ 6,735 $ 241 |
Net (Loss) Income Per Share A_2
Net (Loss) Income Per Share Attributable To Common Stockholders (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Net (Loss) Income per Share Attributable to Common Stockholders [Abstract] | |
Computation of Basic and Diluted Net Income (Loss) per Share Attributable to Common Stockholders | Three Months Ended March 31, 2020 2019 Numerator – basic and diluted: Net (loss) income available to common stockholders - basic and diluted $ (29,814) $ 3,077 Denominator – basic and diluted: Weighted average common shares outstanding used to compute basic net (loss) income per share 158,031,405 126,330,788 Effect of dilution: Options to purchase common stock — 75,251 Weighted average shares of common stock outstanding used to compute diluted net (loss) income per share 158,031,405 126,406,039 Net (loss) income per share, basic $ (0.19) $ 0.02 Net (loss) income per share, diluted $ (0.19) $ 0.02 |
Anti-dilutive Amounts Excluded From Calculation of Diluted Net Income (Loss) per Share | Three Months Ended March 31, 2020 2019 Options to purchase common stock 15,837,954 8,816,778 Warrants to purchase common stock 11,917,052 11,999,852 Convertible preferred stock 3,579,249 3,562,221 Total shares of common stock equivalents 31,334,255 24,378,851 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Financial Instruments [Abstract] | |
Fair Values of Financial Instruments | Fair Value Measurement Using Significant Other Observable Inputs (Level 2) March 31, December 31, Description 2020 2019 Warrants $ 1,329 $ 1,485 Total $ 1,329 $ 1,485 |
Rollforward of Level 2 Investments | Significant Other Observable Inputs (Level 2) Balance at January 1, 2019 $ 524 Change in fair value of warrant liabilities 961 Balance at December 31, 2019 $ 1,485 Change in fair value of warrant liabilities (156) Balance at March 31, 2020 $ 1,329 |
Warrants Outstanding | Warrants Weighted Average Exercise Price Balance, January 1, 2020 11,921,452 $ 5.97 Exercised (4,400) — Balance, March 31, 2020 11,917,052 $ 5.97 |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Inventories [Abstract] | |
Schedule of Inventories | March 31, December 31, 2020 2019 Raw materials $ 190 $ 371 Finished goods, net 310 269 Total inventories $ 500 $ 640 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fixed Assets [Abstract] | |
Fixed Assets | Useful Lives March 31, December 31, (Years) 2020 2019 Leasehold improvements 4 -8 $ 10,398 $ 10,397 Office equipment and furniture 3 -15 1,254 1,234 Machinery and laboratory equipment 3 -15 3,604 3,599 Software 1 -5 4,044 3,971 Construction-in-progress ̶̶̶̶ 79 45 19,379 19,246 Less accumulated depreciation and amortization (17,220) (16,802) Fixed assets, net $ 2,159 $ 2,444 |
Ownership of MeiraGTx Ordinar_2
Ownership of MeiraGTx Ordinary Shares (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Ownership of MeiraGTx Ordinary Shares [Abstract] | |
Schedule Of MeiraGTx Investment | Significant Observable Inputs (Level 1) Balance as of January 1, 2019 $ 34,075 Unrealized gain on ordinary shares sold during the year 8,148 Realized gain on sale of ordinary shares (22,000) Unrealized gain on remaining ownership of ordinary shares 21,774 Balance as of December 31, 2019 $ 41,997 Unrealized loss on ownership of ordinary shares (13,803) Balance as of March 31, 2020 $ 28,194 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
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, January 1, 2020 11,802,601 $ 5.59 7.52 $ 9,520 Granted 4,247,000 4.34 Exercised (68,001) 4.18 53 Forfeited (143,646) 4.74 Balance, March 31, 2020 15,837,954 $ 5.27 7.91 $ 7,090 Options vested and exercisable, March 31, 2020 8,216,814 $ 6.58 6.44 $ 3,907 |
Weighted-average Fair Value of Stock Option Awards Granted | Three Months Ended Three Months Ended March 31, 2020 March 31, 2019 Weighted average fair value of grants $2.87 $1.50 Expected volatility 75.46% - 76.05% 76.32% - 77.73% Risk-free interest rate 0.82% - 1.64% 2.50% - 2.61% Expected life (years) 6.00 6.00 Expected dividend yield 0% 0% |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Accrued Expenses [Abstract] | |
Short-term Accrued Expenses | March 31, December 31, 2020 2019 Commission payable $ 2,395 $ 2,395 Compensation, benefits and severance 2,223 4,668 Research and development 5,278 4,962 Other 1,818 2,223 Total accrued expenses $ 11,714 $ 14,248 |
Organization (Narrative) (Detai
Organization (Narrative) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | |
Organization [Line Items] | |||||
Accumulated deficit | $ (362,883,000) | $ (362,883,000) | $ (333,069,000) | ||
Working capital | 129,000,000 | 129,000,000 | |||
Equity securities fair value | 28,194,000 | 28,194,000 | 41,997,000 | ||
Cash and cash equivalents | 120,046,000 | 120,046,000 | 139,597,000 | $ 99,358,000 | |
Gross proceeds from common stock | 101,600,000 | ||||
Registration statement, authorized amount | 200,000,000 | ||||
Common Stock [Member] | |||||
Organization [Line Items] | |||||
Registration statement, authorized amount | 50,000,000 | ||||
MeiraGTx Ltd. [Member] | |||||
Organization [Line Items] | |||||
Equity securities fair value | $ 28,194,000 | $ 28,194,000 | $ 41,997,000 | $ 34,075,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020USD ($)segmentcontract | Dec. 31, 2019contract | |
Summary Of Significant Accounting Policies [Line Items] | ||
Number of operating segments | segment | 1 | |
License Revenue [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Number of performance obligations | contract | 0 | 1 |
License revenue | $ | $ 6 | |
Minimum [Member] | Product Sales [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Payment term | 30 days | |
Maximum [Member] | Product Sales [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Payment term | 60 days |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Disaggregation of Revenue) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 6,735 | $ 241 |
Product Sales [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 589 | 67 |
License Revenue [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 6,000 | |
Other Revenue [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 146 | $ 174 |
Stockholders_ Equity (Narrative
Stockholders’ Equity (Narrative) (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Dec. 31, 2019 | Apr. 01, 2016 | |
Equity [Line Items] | |||||
Unit price | $ 4.19 | $ 4.19 | $ 4.53 | $ 12 | |
Preferred stock conversion price | $ 9.60 | $ 9.60 | |||
Common stock, shares authorized | 400,000,000 | 400,000,000 | 400,000,000 | ||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||
Gross proceeds from common stock | $ 101.6 | ||||
Convertible Preferred Stock [Member] | |||||
Equity [Line Items] | |||||
Preferred stock outstanding | 28,708 | 28,708 | 28,708 | ||
Convertible preferred stock rate | 5.00% | ||||
Liquidation preference | $ 33.1 | $ 33.1 | |||
Beneficial conversion feature, discount percentage | 20.00% | ||||
Accrued dividends on preferred stock | $ 0.4 | $ 0.4 | |||
Deemed dividends on preferred stock | $ 0.1 | $ 0.1 |
Net (Loss) Income per Share A_3
Net (Loss) Income 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 | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Net (Loss) Income per Share Attributable to Common Stockholders [Abstract] | ||
Net (loss) income available to common stockholders - basic and diluted | $ (29,814) | $ 3,077 |
Weighted average common shares outstanding used to compute basic net (loss) income per share | 158,031,405 | 126,330,788 |
Options to purchase common stock | 75,251 | |
Weighted average shares of common stock outstanding used to compute diluted net (loss) income per share | 158,031,405 | 126,406,039 |
Net (loss) income per share, basic | $ (0.19) | $ 0.02 |
Net (loss) income per share, diluted | $ (0.19) | $ 0.02 |
Net (Loss) Income per Share A_4
Net (Loss) Income per Share Attributable to Common Stockholders (Anti-dilutive Amounts Excluded From Calculation of Diluted Net Income (Loss) per Share) (Details) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares of common stock equivalents | 31,334,255 | 24,378,851 |
Options To Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares of common stock equivalents | 15,837,954 | 8,816,778 |
Warrants To Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares of common stock equivalents | 11,917,052 | 11,999,852 |
Convertible Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares of common stock equivalents | 3,579,249 | 3,562,221 |
Financial Instruments (Narrativ
Financial Instruments (Narrative) (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Aug. 31, 2016$ / sharesshares | Mar. 31, 2020USD ($)item$ / sharesshares | Mar. 31, 2019USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2019USD ($)shares | |
Financial Instruments [Line Items] | |||||
Warrants outstanding, shares | 11,917,052 | 11,921,452 | |||
Warrants To Purchase Common Stock [Member] | |||||
Financial Instruments [Line Items] | |||||
Fair value of liability | $ | $ 1.3 | $ 1.5 | |||
2015 Credit Agreement, Warrants [Member] | |||||
Financial Instruments [Line Items] | |||||
Warrants to purchase | $ | $ 6.3 | ||||
Common units converted to warrants | 617,651 | ||||
Strike price | $ / shares | $ 10.20 | $ 4.50 | |||
Warrants outstanding, shares | 88,238 | ||||
Expected term | 2 years 4 months 24 days | ||||
Change in fair value of warrant | $ | $ (0.2) | $ 0.2 | |||
Warrants exercised | 0 | 0 | |||
2015 Credit Agreement, Warrants [Member] | Expected Dividend YIeld [Member] | |||||
Financial Instruments [Line Items] | |||||
Warrants and Rights Outstanding, Measurement Input | item | 0 | ||||
2015 Credit Agreement, Warrants [Member] | Expected Volatility [Member] | |||||
Financial Instruments [Line Items] | |||||
Warrants and Rights Outstanding, Measurement Input | item | 0.790 | ||||
2015 Credit Agreement, Warrants [Member] | Risk Free Interest Rate [Member] | |||||
Financial Instruments [Line Items] | |||||
Warrants and Rights Outstanding, Measurement Input | item | 0.003 | ||||
2015 Credit Agreement, Fifth Amendment [Member] | |||||
Financial Instruments [Line Items] | |||||
Strike price | $ / shares | $ 3.30 | ||||
Warrants outstanding, shares | 529,413 |
Financial Instruments (Fair Val
Financial Instruments (Fair Values of Financial Instruments) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Financial Instruments [Line Items] | ||
Total financial instruments | $ 1,329 | $ 1,485 |
Warrants To Purchase Common Stock [Member] | ||
Financial Instruments [Line Items] | ||
Total financial instruments | 1,300 | 1,500 |
Warrants To Purchase Common Stock [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Financial Instruments [Line Items] | ||
Total financial instruments | $ 1,329 | $ 1,485 |
Financial Instruments (Rollforw
Financial Instruments (Rollforward of Level 2 Investments) (Details) - Significant Other Observable Inputs (Level 2) [Member] - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Financial Instruments [Line Items] | ||
Balance | $ 1,485 | $ 524 |
Change in fair value of warrant liabilities | (156) | 961 |
Balance | $ 1,329 | $ 1,485 |
Financial Instruments (Warrants
Financial Instruments (Warrants Outstanding) (Details) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Financial Instruments [Abstract] | |
Warrants, Balance | shares | 11,921,452 |
Warrants, Exercised | shares | (4,400) |
Warrants, Balance | shares | 11,917,052 |
Weighted Average Exercise Price, Balance | $ / shares | $ 5.97 |
Weighted Average Exercise Price, Exercised | $ / shares | |
Weighted Average Exercise Price, Balance | $ / shares | $ 5.97 |
Inventories (Narrative) (Detail
Inventories (Narrative) (Details) - USD ($) $ in Millions | Mar. 31, 2020 | Dec. 31, 2019 |
Inventories [Abstract] | ||
Reserve for expirable inventory | $ 1.8 | $ 3 |
Inventories (Schedule of Invent
Inventories (Schedule of Inventories) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Inventories [Abstract] | ||
Raw materials | $ 190 | $ 371 |
Finished goods, net | 310 | 269 |
Total inventories | $ 500 | $ 640 |
Fixed Assets (Narrative) (Detai
Fixed Assets (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Fixed Assets [Abstract] | |||
Depreciation and amortization of fixed assets | $ 418 | $ 467 | |
Unamortized computer software costs | 300 | $ 300 | |
Amortization of computer software costs | $ 100 | $ 100 |
Fixed Assets (Fixed Assets) (De
Fixed Assets (Fixed Assets) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 19,379 | $ 19,246 |
Less accumulated depreciation and amortization | (17,220) | (16,802) |
Fixed assets, net | 2,159 | 2,444 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 10,398 | 10,397 |
Office Equipment and Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 1,254 | 1,234 |
Machinery and Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 3,604 | 3,599 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 4,044 | 3,971 |
Construction-in-progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 79 | $ 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 |
Ownership of MeiraGTx Ordinar_3
Ownership of MeiraGTx Ordinary Shares (Narrative) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Investment Holdings [Line Items] | ||||
Investment, equity securities | $ 28,194,000 | $ 41,997,000 | ||
Unrealized (loss) gain on equity securities | (13,803,000) | $ 26,828,000 | ||
Accounts receivable, net | $ 1,234,000 | $ 954,000 | ||
MeiraGTx Ltd. [Member] | ||||
Investment Holdings [Line Items] | ||||
Ownership percentage | 5.70% | 5.70% | ||
Investment, equity securities | $ 28,194,000 | $ 41,997,000 | $ 34,075,000 | |
Unrealized (loss) gain on equity securities | (13,800,000) | 26,800,000 | ||
Service revenue to license | 100,000 | 100,000 | ||
Cash payments for service revenue | 100,000 | $ 100,000 | ||
Accounts receivable, net | $ 0 | $ 0 | ||
Period of notice to cancel lease | 30 days |
Ownership of MeiraGTx Ordinar_4
Ownership of MeiraGTx Ordinary Shares (Schedule Of MeiraGTx Investment) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Investment Holdings [Line Items] | ||
Balance | $ 41,997 | |
Balance | 28,194 | $ 41,997 |
MeiraGTx Ltd. [Member] | ||
Investment Holdings [Line Items] | ||
Balance | 41,997 | 34,075 |
Unrealized gain on ordinary shares sold during the year | 8,148 | |
Realized gain on sale of ordinary shares | (22,000) | |
Unrealized gain on remaining ownership of ordinary shares | 21,774 | |
Unrealized loss on ownership of ordinary shares | (13,803) | |
Balance | $ 28,194 | $ 41,997 |
License Agreements (Narrative)
License Agreements (Narrative) (Details) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020USD ($)contract | Dec. 31, 2019contract | |
License Revenue [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
License revenue | $ 6 | |
Number of performance obligations | contract | 0 | 1 |
License Agreement, Meiji Seika Pharma Co. Ltd [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Ownership percentage | 50.00% | |
Milestone payment | $ 6 | |
Potential proceeds from partnership agreement | $ 23 |
Share-based Compensation (Narra
Share-based Compensation (Narrative) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | Apr. 01, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock Price | $ 4.19 | $ 4.53 | $ 12 | |
Options Outstanding, Value, Exercised | $ 284,000 | |||
Performance Awards [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options vested | 853,335 | 853,335 | ||
Common stock issued for option exercises, shares | 0 | 0 | ||
Options To Purchase Common Stock [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation, options granted | 4,247,000 | 529,870 | ||
Weighted average exercise price of options granted during the period (per share) | $ 4.34 | $ 2.19 | ||
Share-based compensation, options outstanding, weighted average remaining contractual term (years) | 7 years 10 months 28 days | |||
Share based compensation, options outstanding, aggregate intrinsic value | $ 7,090,000 | $ 9,520,000 | ||
Options outstanding | 15,837,954 | 11,802,601 | ||
Options outstanding, Exercise price | $ 5.27 | $ 5.59 | ||
Common stock issued for option exercises, shares | 68,001 | 0 | ||
Stock options exercised, intrinsic value | $ 53,000 | |||
Expected dividend yield | 0.00% | 0.00% | ||
Expected life (years) | 6 years | 6 years | ||
Stock Appreciation Rights [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation expense | $ 400,000 | |||
Weighted average period for recognition of compensation expense | 8 months 12 days | |||
Share-based compensation, options outstanding, weighted average remaining contractual term (years) | 6 years 3 months 18 days | |||
Share based compensation, options outstanding, aggregate intrinsic value | $ 500,000 | $ 0 | ||
Options outstanding | 835,000 | 835,000 | ||
Options outstanding, Exercise price | $ 3.64 | |||
Options vested | 616,667 | 616,667 | ||
Common stock issued for option exercises, shares | 0 | 0 | ||
2016 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares authorized for issuance | 16,194,138 | |||
Additional units available for grant | 5,591,600 | |||
Increase in authorized shares as a percentage of common stock issued | 3.50% | |||
Unrecognized compensation expense | $ 16,700,000 | $ 6,500,000 | ||
Weighted average period for recognition of compensation expense | 2 years 7 months 6 days | 2 years 2 months 12 days | ||
Share based compensation, options granted | 15,837,954 | |||
Weighted average exercise price of options granted during the period (per share) | $ 5.27 | |||
Stock compensation expense | $ 2,000,000 | $ 2,200,000 | ||
2016 Equity Incentive Plan [Member] | Performance Awards [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation expense | $ 400,000 | |||
Weighted average period for recognition of compensation expense | 10 months 24 days | |||
Share-based compensation, options outstanding, weighted average remaining contractual term (years) | 6 years 4 months 24 days | |||
Share based compensation, options outstanding, aggregate intrinsic value | $ 200,000 | $ 0 | ||
Options outstanding | 1,290,000 | 1,290,000 | ||
Options outstanding, Exercise price | $ 4.06 | |||
2014 Long-Term Incentive Plan (“LTIP”) [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock issued for option exercises, shares | 0 | |||
Equity instruments granted | 9,750 | 9,750 | ||
Equity instruments base price | $ 6 | |||
Equity instrument payable, common stock value percent above grant price | 333.00% | |||
Equity instrument payable, common stock value | $ 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 | |||
Stock compensation expense | $ 0 | $ 0 | ||
Maximum [Member] | 2016 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Increase in authorized shares annual percentage | 4.00% |
Share-based Compensation (Stock
Share-based Compensation (Stock Options Outstanding) (Details) - Options To Purchase Common Stock [Member] - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options Outstanding, Units, Beginning Balance | 11,802,601 | ||
Options Outstanding, Units, Granted | 4,247,000 | 529,870 | |
Options Outstanding, Units, Exercised | (68,001) | 0 | |
Options Outstanding, Units, Forfeited | (143,646) | ||
Options Outstanding, Units, Ending Balance | 15,837,954 | 11,802,601 | |
Options Vested and Exercisable, Units | 8,216,814 | ||
Options Outstanding, Weighted Average Exercise Price, Beginning Balance | $ 5.59 | ||
Options Outstanding, Weighted Average Exercise Price, Granted | 4.34 | $ 2.19 | |
Options Outstanding, Weighted Average Exercise Price, Exercised | 4.18 | ||
Options Outstanding, Weighted Average Exercise Price, Forfeited | 4.74 | ||
Options Outstanding, Weighted Average Exercise Price, Ending Balance | 5.27 | $ 5.59 | |
Options Vested and Exercisable, Weighted Average Exercise Price | $ 6.58 | ||
Options Outstanding, Weighted Average Remaining Contractual Term (years) | 7 years 10 months 28 days | ||
Options Vested and Exercisable, Weighted Average Remaining Contractual Term (years) | 6 years 5 months 9 days | 7 years 6 months 7 days | |
Options Outstanding, Aggregate Intrinsic Value | $ 7,090 | $ 9,520 | |
Options exercised, aggregate intrinsic value | 53 | ||
Options Vested and Exercisable, Aggregate Intrinsic Value | $ 3,907 |
Share-based Compensation (Weigh
Share-based Compensation (Weighted-average Fair Value of Stock Option Awards Granted) (Details) - Options To Purchase Common Stock [Member] - $ / shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value of grants | $ 2.87 | $ 1.50 |
Expected life (years) | 6 years | 6 years |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 75.46% | 76.32% |
Risk-free interest rate | 0.82% | 2.50% |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 76.05% | 77.73% |
Risk-free interest rate | 1.64% | 2.61% |
Accrued Expenses (Narrative) (D
Accrued Expenses (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Short-Term Accrued Expenses [Line Items] | ||
Severance expense | $ 2,200 | $ 4,700 |
Research and development | 5,278 | 4,962 |
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 | $ 2,400 |
Accrued Expenses (Short-term Ac
Accrued Expenses (Short-term Accrued Expenses) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Accrued Expenses [Abstract] | ||
Commission payable | $ 2,395 | $ 2,395 |
Compensation, benefits and severance | 2,223 | 4,668 |
Research and development | 5,278 | 4,962 |
Other | 1,818 | 2,223 |
Total accrued expenses | $ 11,714 | $ 14,248 |
Commitments and Contingencies (
Commitments and Contingencies (Narrative) (Details) $ in Millions | Mar. 31, 2020USD ($) |
Commitments and Contingencies [Abstract] | |
Contingent milestone payments | $ 225.9 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Income Tax Disclosure [Line Items] | |||
Income tax benefit | $ 0 | $ 0 | |
Change in deferred tax liability | $ 0 | $ 0 | |
Federal [Member] | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 371,100,000 | ||
Operating loss carryforwards, no expiration | 79,900,000 | ||
State [Member] | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 307,200,000 |
Subsequent Events (Narrative) (
Subsequent Events (Narrative) (Details) $ in Millions | Apr. 15, 2020USD ($) |
Subsequent Event [Member] | |
Subsequent Event [Line Items] | |
Proceeds from PPP loan | $ 3.1 |
Uncategorized Items - kdmn-2020
Label | Element | Value |
Restricted Cash and Cash Equivalents | us-gaap_RestrictedCashAndCashEquivalents | $ 2,116,000 |
Restricted Cash and Cash Equivalents | us-gaap_RestrictedCashAndCashEquivalents | $ 2,117,000 |