Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 01, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Current Fiscal Year End Date | --12-31 | ||
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 | ||
Title of 12(b) Security | Common stock, par value $0.001 per share | ||
Trading Symbol | KDMN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 495,163,071 | ||
Entity Common Stock, Shares Outstanding | 171,816,945 | ||
Documents Incorporated by Reference [Text Block] | DOCUMENTS INCORPORATED BY REFERENCE Portions of Kadmon Holdings, Inc.’s definitive proxy statement for the 2021 Annual Meeting of Shareholders are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent stated herein. | ||
Entity Central Index Key | 0001557142 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 74,423 | $ 139,597 |
Marketable debt securities, available-for-sale | 49,435 | |
Accounts receivable, net | 695 | 954 |
Inventories, net | 102 | 640 |
Prepaid expenses and other current assets | 2,082 | 1,416 |
Investment, equity securities | 10,564 | 41,997 |
Total current assets | 137,301 | 184,604 |
Fixed assets, net | 1,287 | 2,444 |
Right of use lease asset | 16,112 | 19,651 |
Goodwill | 3,580 | 3,580 |
Restricted cash | 2,117 | 2,116 |
Investment, at cost | 2,300 | 2,300 |
Other noncurrent assets | 13 | 103 |
Total assets | 162,710 | 214,798 |
Current liabilities: | ||
Accounts payable | 10,933 | 9,043 |
Accrued expenses | 11,534 | 14,248 |
Term debt - current | 1,699 | |
Lease liability - current | 4,223 | 3,966 |
Warrant liabilities | 1,082 | 1,485 |
Total current liabilities | 29,471 | 28,742 |
Lease liability - noncurrent | 15,579 | 19,759 |
Deferred tax liability | 278 | 461 |
Term debt - noncurrent | 1,359 | |
Other long term liabilities | 101 | |
Total liabilities | 46,687 | 49,063 |
Commitments and contingencies (Note 15) | ||
Stockholders’ equity: | ||
Convertible preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2020 and December 31, 2019; 28,708 shares issued and outstanding at December 31, 2020 and December 31, 2019. | 44,555 | 42,433 |
Common stock, $0.001 par value; 400,000,000 shares authorized at December 31, 2020 and December 31, 2019; 171,530,045 and 159,759,996 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively | 171 | 160 |
Additional paid-in capital | 515,429 | 456,211 |
Accumulated deficit | (444,104) | (333,069) |
Accumulated other comprehensive loss | (28) | |
Total stockholders’ equity | 116,023 | 165,735 |
Total liabilities and stockholders’ equity | $ 162,710 | $ 214,798 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 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 | 171,530,045 | 159,759,996 |
Common stock, shares outstanding | 171,530,045 | 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 And Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Total revenue | $ 8,288 | $ 5,095 |
Cost of sales | 1,150 | 377 |
Write-down of inventory | 851 | 912 |
Gross profit | 6,287 | 3,806 |
Operating expenses: | ||
Research and development | 65,392 | 56,461 |
Selling, general and administrative | 43,176 | 36,425 |
Total operating expenses | 108,568 | 92,886 |
Loss from operations | (102,281) | (89,080) |
Other (expense) income: | ||
Interest income | 1,191 | 2,067 |
Interest expense | (21) | (3,381) |
Change in fair value of warrant liabilities | 403 | (961) |
Realized gain on equity securities | 19,784 | 22,000 |
Unrealized (loss) gain on equity securities | (31,433) | 7,922 |
Gain on extinguishment of obligation | 3,684 | |
Other (expense) income | (422) | 111 |
Total other (expense) income | (6,814) | 27,758 |
Loss before income tax (benefit) expense | (109,095) | (61,322) |
Income tax (benefit) expense | (182) | 46 |
Net loss | (108,913) | (61,368) |
Deemed dividend on convertible preferred stock | 2,122 | 2,058 |
Net loss attributable to common stockholders | $ (111,035) | $ (63,426) |
Basic and diluted net loss per share of common stock | $ (0.67) | $ (0.48) |
Weighted average basic and diluted shares of common stock outstanding | 166,240,356 | 132,308,548 |
Other comprehensive loss: | ||
Net unrealized loss on available-for-sale securities | $ 28 | |
Other comprehensive loss | 28 | |
Comprehensive loss attributable to common shareholders | (111,063) | $ (63,426) |
Net Sales [Member] | ||
Total revenue | 1,665 | 420 |
License and Other Revenue [Member] | ||
Total revenue | $ 6,623 | $ 4,675 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [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 | 7,208 | 7,208 | ||||
Common stock issued in public offering, net | $ 46 | 130,722 | $ 130,768 | |||
Common stock issued in public offering, net, shares | 46,216,805 | 46,216,805 | ||||
Common stock issued under ESPP plan | $ 1 | 194 | $ 195 | |||
Common stock issued under ESPP plan, shares | 88,619 | |||||
Common stock issued for warrant exercises | 256 | 256 | ||||
Common stock issued for warrant exercises, shares | 76,776 | |||||
Common stock issued for stock option exercises | 265 | 265 | ||||
Common stock issued for stock option exercises, shares | 92,334 | |||||
Beneficial conversion feature on convertible preferred stock | $ 412 | (412) | 412 | |||
Accretion of dividends on convertible preferred stock | 1,646 | (1,646) | 1,646 | |||
Common stock issued upon conversion of convertible preferred stock | $ (1,856) | 1,856 | ||||
Common stock issued upon conversion of convertible preferred stock, shares | (1,292) | 154,645 | ||||
Net loss | (61,368) | (61,368) | ||||
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 | 9,363 | 9,363 | ||||
Common stock issued in public offering, net | $ 11 | 48,430 | $ 48,441 | |||
Common stock issued in public offering, net, shares | 11,060,786 | 11,060,786 | ||||
Common stock issued under ESPP plan | 436 | $ 436 | ||||
Common stock issued under ESPP plan, shares | 164,614 | |||||
Common stock issued for warrant exercises | 12 | 12 | ||||
Common stock issued for warrant exercises, shares | 229,356 | |||||
Common stock issued for stock option exercises | 977 | 977 | ||||
Common stock issued for stock option exercises, shares | 315,293 | |||||
Beneficial conversion feature on convertible preferred stock | $ 424 | (424) | 424 | |||
Accretion of dividends on convertible preferred stock | 1,698 | (1,698) | 1,698 | |||
Other comprehensive loss | $ (28) | (28) | ||||
Net loss | (108,913) | (108,913) | ||||
Balance at Dec. 31, 2020 | $ 44,555 | $ 171 | $ 515,429 | $ (28) | $ (444,104) | $ 116,023 |
Balance, Shares at Dec. 31, 2020 | 28,708 | 171,530,045 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (108,913) | $ (61,368) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization of premiums and discounts on available-for-sale securities | 445 | |
Depreciation and amortization of fixed assets | 1,643 | 1,784 |
Non-cash operating lease cost | 3,539 | 3,354 |
Write-down of inventory | 851 | 912 |
Amortization of debt discount | 565 | |
Share-based compensation | 9,363 | 7,208 |
Change in fair value of warrant liabilities | (403) | 961 |
Net unrealized loss (gain) on equity securities | 11,649 | (29,922) |
Gain on extinguishment of obligations | (3,522) | |
Deferred taxes | (182) | 46 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 259 | 736 |
Inventories, net | (313) | (627) |
Prepaid expenses and other assets | (576) | 62 |
Accounts payable | 1,890 | (902) |
Lease liability | (3,966) | (3,717) |
Accrued expenses and other liabilities | 707 | 841 |
Net cash used in operating activities | (87,529) | (80,067) |
Cash flows from investing activities: | ||
Purchases of investment debt securities | (52,530) | |
Sales and maturities of investment debt securities | 2,622 | |
Purchases of fixed assets | (443) | (515) |
Sale of equity securities | 19,784 | 22,000 |
Net cash provided by (used in) investing activities | (30,567) | 21,485 |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net | 48,441 | 130,768 |
Proceeds from issuance of term debt | 3,057 | |
Principal payments on secured term debt | (28,045) | |
Proceeds from exercise of options | 977 | 265 |
Proceeds from issuance of ESPP shares | 436 | 195 |
Proceeds from exercise of warrants | 12 | 256 |
Net cash provided by financing activities | 52,923 | 103,439 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (65,173) | 44,857 |
Cash, cash equivalents and restricted cash, beginning of period | 141,713 | 96,856 |
Cash, cash equivalents and restricted cash, end of period | 76,540 | 141,713 |
Components of cash, cash equivalents, and restricted cash | ||
Total cash, cash equivalents, and restricted cash | 141,713 | 141,713 |
Supplemental cash flow disclosures: | ||
Cash paid for interest | 2,841 | |
Non-cash investing and financing activities: | ||
Beneficial conversion feature on convertible preferred stock | 424 | 412 |
Accretion of dividends on convertible preferred stock | 1,698 | 1,646 |
Operating cash flows paid for amounts included in the measurement of lease liabilities | 4,833 | 4,679 |
Operating lease liabilities arising from obtaining right-of-use assets | 212 | |
Unpaid fixed asset additions | 59 | |
Common stock issued upon conversion of convertible preferred stock | 1,856 | |
Cumulative effect of change in accounting principle | 27,083 | |
Accounting Standards Update 2016-02 [Member] | ||
Non-cash investing and financing activities: | ||
Capitalized lease obligations | $ 43 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2020 | |
Organization [Abstract] | |
Organization | 1. Organization Nature of Business Kadmon Holdings, Inc. (together with its subsidiaries, “Kadmon” or “Company”) is a clinical-stage biopharmaceutical company engaged in the discovery, development and delivery of transformative therapies 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. The Company’s most advanced product candidate, belumosudil (KD025) is an orally administered, selective small molecule inhibitor of Rho-associated coiled-coil kinase 2 (“ROCK2”), a signaling pathway that modulates inflammatory response. A pivotal study of belumosudil is ongoing in patients with chronic graft-versus-host disease (“cGVHD”), a complication that can occur following hematopoietic cell transplantation (“HCT”) and results in multi-organ inflammation and fibrosis. In November 2020, the U.S. Food and Drug Administration (“FDA”) accepted the New Drug Application (NDA) for belumosudil for the treatment of patients with cGVHD. The FDA granted Priority Review for the NDA for belumosudil and assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of May 30, 2021. The NDA is being reviewed under the FDA's Real-Time Oncology Review (“RTOR”) and Project Orbis pilot programs. The FDA has granted Breakthrough Therapy Designation to belumosudil for the treatment of patients with cGVHD after failure of two or more lines of systemic therapy as well as Orphan Drug Designation to belumosudil for the treatment of cGVHD. In addition to cGVHD, the Company is developing belumosudil in for the treatment of systemic sclerosis (“SSc”), an autoimmune disease characterized by chronic inflammation, fibrosis and vascular damage. The FDA has granted Orphan Drug Designation to belumosudil for the treatment of SSc. A double-blind, placebo-controlled, 60-patient Phase 2 clinical trial of belumosudil in diffuse cutaneous SSc (KD025-209) is ongoing. Further, the Company has a biologics research platform focused on the development of immuno-oncology therapeutics, specifically, IL-15-containing fusion proteins for the treatment of cancer. KD033 is an anti-PD-L1/IL-15 fusion protein and is the most advanced product candidate from the Company’s IL-15 platform. The Company initiated a Phase 1 clinical trial of KD033 in adults with metastatic or locally advanced solid tumors in 2020. Liquidity The Company had an accumulated deficit of $ 444.1 million, working capital of $ 107.8 million, and cash, cash equivalents and marketable debt securities of $ 123.9 million at December 31, 2020. Net cash used in operating activities was $ 87.5 million and $ 80.1 million for the years ended December 31, 2020 and 2019, respectively. On February 16, 2021, we issued $ 240.0 million aggregate principal amount of 3.625 % convertible senior notes due 2027 (the "Notes"), pursuant to an Indenture dated February 16, 2021 (the “Indenture”), between us and U.S. Bank National Association, as trustee, in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The Notes issued in the offering include $ 40.0 million in aggregate principal amount of Notes sold to the initial purchasers (the “Initial Purchasers”) resulting from the exercise in full of their option to purchase additional Notes. We received net proceeds from the offering of approximately $ 232.8 million, after deducting the Initial Purchasers’ discount. On February 10, 2021, concurrently with the pricing of the Notes, the Company entered into privately negotiated capped call transactions (the “Capped Call Transactions”) with certain financial institutions. The Company used approximately $ 33.0 million of the net proceeds from the Note Offering to pay for the cost of the Capped Call Transactions (Note 17). The Company entered into a Sales Agreement with Cantor Fitzgerald & Co. (“Cantor”) in August 2017 under which the Company could sell up to $ 50.0 million in shares of its common stock in one or more placements at prevailing market prices for its common stock (the “ATM Program”). Any such sales would be effected pursuant to the Company’s registration statement on Form S-3 (File No. 333-233766), which was declared effective by the Securities Exchange Commission (“SEC”) on September 24, 2019. In May 2020, the Company sold 11,060,786 shares of common stock at a weighted average price of $ 4.52 per share through the ATM Program and received total net proceeds of $ 48.4 million (net of $ 1.6 million of commission payable by the Company to Cantor). Under this registration statement, the Company registered to sell, in one or more transactions, up to $ 200.0 million of common stock, preferred stock, debt securities, warrants, purchase contracts and units. The Company had sold securities totaling an aggregate of $ 151.5 million pursuant to this registration statement as of December 31, 2020. In May 2020, the Company entered into a single transaction pursuant to which it sold approximately 1.1 million ordinary shares of MeiraGTx Holdings plc (“MeiraGTx”) for gross proceeds of $ 15.5 million. In July 2020, the Company entered into an additional single transaction pursuant to which it sold approximately 0.3 million ordinary shares of MeiraGTx for gross proceeds of $ 4.2 million. The Company expects that its cash, cash equivalents and marketable debt securities will enable it to advance its planned commercial launch efforts for belumosudil, if approved, advance certain of its other pipeline product candidates, including KD033, and provide for other working capital purposes. The Company also filed a shelf registration statement on Form S-3 (File No. 333-238969) on June 5, 2020, which was declared effective by the SEC on June 16, 2020. Under this registration statement, the Company may sell, in one or more transactions, up to $ 300.0 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 the ATM Program under the Sales Agreement with Cantor. The Company had not sold any securities pursuant to this registration statement as of December 31, 2020. Management’s plans include continuing to finance operations through the issuance of additional equity and debt securities, monetization of assets and expanding the Company’s commercial portfolio through the development of its current pipeline or through strategic collaborations. Any transactions that occur may contain covenants that restrict the ability of management to operate the business or may have rights, preferences or privileges senior to the Company’s common stock and may dilute current stockholders of the Company. The Company has not established a source of revenues sufficient to cover operating costs, and as such, has been dependent on funding operations through the issuance of debt and sale of equity securities. The Company’s cash, cash equivalents and marketable debt securities available at December 31, 2020 was $ 123.9 million and in February 2021, we raised $ 232.8 million of net proceeds through the issuance of the Notes. Although cash, cash equivalents and marketable debt securities, inclusive of net proceeds received from the issuance of the Notes, is expected to enable the Company to advance planned commercial launch efforts for belumosudil, if approved, advance certain of the Company’s other pipeline product candidates, including KD033, and provide for other working capital purposes, it may 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. The Company has no commitments for any additional financing and may not be successful in efforts to raise additional funds or achieve profitable operations. Any amounts raised will be used for further development of product candidates, to provide financing for marketing and promotion, to secure additional property and equipment, and for other working capital purposes. The Company expressed substantial doubt about its ability to continue as a going concern in the Company’s 2019 Annual Report on Form 10-K filed with the SEC on March 5, 2020, based upon our recurring and continuing losses from operations and our need for additional funding to continue operations. The substantial doubt about the Company’s ability to continue as a going concern remained in the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 5, 2020. Based on the Company’s cash, cash equivalents and marketable debt securities after the closing of the February 2021 issuance of the Notes, the Company believes the substantial doubt about its ability to continue as a going concern is alleviated as of the date of the issuance of this report. COVID-19 The global COVID-19 pandemic may materially affect the Company’s results of operations and financial position. While the economic impact of the COVID-19 pandemic may be difficult to assess or predict, this widespread pandemic has resulted in a significant disruption of global financial markets, which may reduce the Company’s ability to access capital. If the disruption to the financial markets is protracted, the Company’s liquidity could be negatively affected in the future. In addition, a recession or market correction resulting from the COVID-19 pandemic could materially affect the Company’s business and the value of its common stock. During these uncertain times, the Company’s top priorities are to ensure the health and welfare of its employees, maintain product safety and continue to advance its clinical studies. However, the Company’s clinical trials have been impacted, and the Company may experience delays in anticipated timelines and milestones. For instance, due to interruptions at clinical sites, enrollment has been delayed in the Company’s ongoing Phase 2 clinical trial of belumosudil in systemic sclerosis and enrollment was also delayed in the Company’s ongoing Phase 1 clinical trial of KD033 in patients with metastatic or locally advanced solid tumors. In addition, the Company may experience disruptions in its supply chain, including its supply of product candidates, which may adversely affect the conduct of its clinical trials. The Company relies on contract research organizations (“CROs”) to conduct its clinical trials. CROs may be unable to conduct clinical trials for product candidates as a result of the COVID-19 pandemic. The COVID-19 pandemic could impact healthcare systems and clinical trial sites’ ability to conduct trials to varied degrees and times. COVID-19 creates risk of interrupting availability of necessary clinical supplies as well as local regulatory reviews, hospital ethics committee reviews and site monitors. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 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 the products and the regulatory environment in which the Company operates. 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 conformity with accounting principles generally accepted in the United States of America (“GAAP”), and pursuant to the rules and regulations of the SEC. 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. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Actual results could differ from those estimates. Revenue Recognition The Company recognizes revenue in accordance with FASB ASC 606, Revenue from Contracts with Customers (“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. The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s balance sheet. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. 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 year ended December 31, 2020 (in thousands): Years Ended December 31, 2020 2019 Product sales $ 1,665 420 License revenue 6,000 4,000 Other revenue 623 675 Total revenue $ 8,288 5,095 Product Sales These contracts typically include a single promise to deliver a fixed amount of product to the customer with payment due within 30 days of shipment. Revenues are recognized when control of the promised goods is transferred to the customer, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods. 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 December 31, 2020. Sales Returns Reserve, Reserve for Wholesaler Chargebacks and Rebates, and Rebates Payable As is typical in the pharmaceutical industry, gross product sales are subject to a variety of deductions, primarily representing rebates, chargebacks, returns, and discounts to government agencies, wholesalers, and managed care organizations. These deductions represent management’s best estimates of the related reserves and, as such, judgment is required when estimating the impact of these sales deductions on gross sales for a reporting period. If estimates are not representative of the actual future settlement, results could be materially affected. The Company did no t have any significant expense related to these sales deductions during 2020 or 2019. License Revenue The terms of these license agreements typically may include payment to the Company of one or more of the following: nonrefundable, up-front license fees, research, development and commercial milestone payments; and other contingent payments due based on the activities of the counterparty or the reimbursement by licensees of costs associated with patent maintenance. Each of these types of revenue are recorded as license revenues in the Company’s statement of operations. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each arrangement, the Company performs the following steps: i. identify the promised goods and services in the contract; ii. determine whether the promised goods or services are performance obligations, including whether they are distinct within the context of the contract; iii. measure the transaction price, including the constraint on variable consideration; iv. allocate the transaction price to the performance obligations; and v. recognize revenue when (or as) performance obligations are satisfied. See Note 11, “License Agreements” for additional details regarding the Company’s license arrangements. As part of the accounting for these arrangements, the Company allocates the transaction price to each performance obligation on a relative stand-alone selling price basis. The stand-alone selling price may be, but is not presumed to be, the contract price. In determining the allocation, the Company maximizes the use of observable inputs. When the stand-alone selling price of a good or service is not directly observable, the Company estimates the stand-alone selling price for each performance obligation using assumptions that require judgment. Acceptable estimation methods include, but are not limited to: (i) the adjusted market assessment approach, (ii) the expected cost plus margin approach, and (iii) the residual approach (when the stand-alone selling price is not directly observable and is either highly variable or uncertain). In order for the residual approach to be used, the Company must demonstrate that (a) there are observable stand-alone selling prices for one or more of the performance obligations and (b) one of the two criteria in ASC 606-10- 32-34(c)(1) and (2) is met. The residual approach cannot be used if it would result in a stand-alone selling price of zero for a performance obligation as a performance obligation, by definition, has value on a stand-alone basis. An option in a contract to acquire additional goods or services gives rise to a performance obligation only if the option provides a material right to the customer that it would not receive without entering into that contract. Factors that the Company considers in evaluating whether an option represents a material right include, but are not limited to: (i) the overall objective of the arrangement, (ii) the benefit the collaborator might obtain from the arrangement without exercising the option, (iii) the cost to exercise the option (e.g. priced at a significant and incremental discount) and (iv) the likelihood that the option will be exercised. With respect to options determined to be performance obligations, the Company recognizes revenue when those future goods or services are transferred or when the options expire. The Company’s revenue arrangements may include the following: Up-front License Fees: If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of an agreement that includes research and development milestone payments, the Company evaluates whether each milestone is considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjust the Company’s estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license revenues and earnings in the period of adjustment. Research and Development Activities: If the Company is entitled to reimbursement from its collaborators for specified research and development activities or the reimbursement of costs associated with patent maintenance, the Company determines whether such funding would result in license revenues or an offset to research and development expenses. Royalties: If the Company is entitled to receive sales-based royalties from its collaborators, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, provided the reported sales are reliably measurable, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its collaboration and license arrangements. Supply Services: Arrangements that include a promise for future supply of drug substance or drug product or research services at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the licensee exercises these options, any additional payments are recorded in license revenues when the licensee obtains control of the goods, which is upon delivery, or as the services are performed. The Company receives payments from its licensees based on schedules established in each contract. Upfront payments and fees are recorded as deferred revenue upon receipt, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. Transaction Price Allocated to Future Performance Obligations ASC 606 requires that the Company disclose the aggregate amount of transaction price that is allocated to performance obligations that have not yet been satisfied as of December 31, 2020. The guidance provides certain practical expedients that limit this requirement. The Company has various contracts that meet the following practical expedients provided by ASC 606: 1. The performance obligation is part of a contract that has an original expected duration of one year or less. 2. Revenue is recognized from the satisfaction of the performance obligations in the amount billable to the customer. 3. The variable consideration is allocated entirely to a wholly unsatisfied performance obligation or to a wholly unsatisfied promise to transfer a distinct good or service that forms part of a single performance obligation. As of December 31, 2020, the Company had no performance obligations that had not yet been satisfied and therefore 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 10). The Company recognizes revenue related to sublease agreements as they are performed. Share-based Compensation Expense The Company’s accounting policy for share-based compensation is disclosed in Note 12 “Share-based Compensation”. Research and Development Expenses Costs incurred for research and development are expensed as incurred. Included in research and development expense are personnel related costs including stock-based compensation, expenditures for laboratory equipment and consumables, payments made pursuant to licensing and acquisition agreements, and the cost of conducting clinical trials. Expenses incurred associated with conducting clinical trials include, but are not limited to, drug development trials and studies, drug manufacturing, laboratory supplies, external research and overhead. The Company has entered into agreements with third parties to acquire technologies and pharmaceutical product candidates for development (Note 11). Such agreements generally require an initial payment by the Company when the contract is executed, and additional payments upon the achievement of certain milestones. Additionally, the Company may be obligated to make future royalty payments in the event the Company commercializes the pharmaceutical product candidate and achieves a certain sales volume. In accordance with FASB ASC Topic 730 - 10 - 55, Research and Development, expenditures for research and development, including upfront licensing fees and milestone payments associated with products that have not yet been approved by the FDA, are charged to research and development expense as incurred. Future contract milestone payments will be recognized as expense when achievement of the milestone is determined to be probable. Once a product candidate receives regulatory approval, subsequent license payments are recorded as an intangible asset. Research and development expense was $ 65.4 million and $ 56.5 million during the years ended December 31, 2020 and 2019, respectively. Accruals for Research and Development Expenses and Clinical Trials As part of the process of preparing its financial statements, the Company is required to recognize its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials . This process involves reviewing open contracts and purchase orders, communicating with the applicable personnel to identify services that have been performed on behalf of the Company and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual cost. These estimates are periodically confirmed and reconciled with the third parties providing the service. The majority of service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known to the Company at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2020 and 2019, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. Income Taxes The Company’s accounting policy for income taxes is disclosed in Note 16 “Income Taxes”. Cash, Cash Equivalents and Marketable Debt Securities The Company considers all highly liquid securities with an original or remaining maturity of three months or less at the time of acquisition to be cash equivalents. Marketable debt securities are considered to be available-for-sale and are carried at fair market value. The estimated fair value of the available-for-sale marketable debt securities is determined based on quoted market prices or rates for similar instruments. Unrealized gains and losses, if any, are reported in accumulated other comprehensive income (loss). The cost of marketable debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in other (expense) income. Realized gains and losses, and declines in value judged to be other-than-temporary, if any, are also included in other (expense) income. Interest and dividends on available-for-sale securities are included in other income. The Company determines the appropriate classification of its investments in debt securities at the time of purchase. All of the Company’s debt securities are classified as available-for-sale and are reported as short-term or long-term based on maturity dates and whether such assets are reasonably expected to be realized in cash or sold or consumed during the normal cycle of business. The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations if the Company experienced a credit loss and have the intent to sell the investment or if it is more likely than not that the Company will be required to sell the investment before recovery of the amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company’s investment policy, the severity and the duration of the impairment and changes in value subsequent to the end of the period. The following tables summarize the Company’s cash, cash equivalents and marketable debt securities as of December 31, 2020 and 2019: December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash and money market funds $ 71,382 $ — $ — 71,382 Corporate debt securities 3,041 — — 3,041 Total cash and cash equivalents 74,423 — — 74,423 Marketable debt securities: Corporate debt securities 49,463 4 ( 32 ) 49,435 Total marketable debt securities 49,463 4 ( 32 ) 49,435 Total cash, cash equivalents and marketable debt securities $ 123,886 $ 4 $ ( 32 ) $ 123,858 December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash and money market funds $ 139,597 $ — $ — 139,597 Total cash and cash equivalents 139,597 — — 139,597 Marketable debt securities: Corporate debt securities — — — — Total marketable debt securities — — — — Total cash, cash equivalents and marketable debt securities $ 139,597 $ — $ — $ 139,597 At December 31, 2020, the Company had invested in 18 available-for-sale marketable debt securities that were in an unrealized loss position for less than one year and no securities were in an unrealized loss position for more than 12 months. The aggregate fair value of debt securities in an unrealized loss position at December 31, 2020 was $ 35.7 million. The unrealized losses of less than $ 0.1 million related to these corporate debt securities were included in accumulated other comprehensive loss as of December 31, 2020. Unrealized losses on corporate debt securities have not been recognized into income because the issuers’ bonds are of high credit quality (rated A3/A- or higher), it is likely that management will not be required to sell the securities prior to their anticipated recovery, and the decline in fair value is largely due to market conditions and/or changes in interest rates. The issuers continue to make timely interest payments on the bonds. The fair value is expected to recover as the bonds approach maturity and the Company does not believe any unrealized losses represent other-than-temporary impairments. Accrued interest receivable on available-for-sale marketable debt securities totaled $ 0.4 million at December 31, 2020 and is included in prepaid expenses and other current assets. Restricted Cash The Company has a lease agreement for the premises it occupies in New York. A secured letter of credit in lieu of a lease deposit totaling $ 2.0 million is secured by restricted cash in the same amount at December 31, 2020 and 2019. The secured letter of credit will remain in place for the life of the related lease, expiring in October 2025 (Note 8). The Company also has a lease agreement for the premises it occupies in Massachusetts. A secured letter of credit in lieu of a lease deposit totaling approximately $ 0.1 million is secured by restricted cash in the same amount at December 31, 2020 and 2019. The secured letter of credit will remain in place for the life of the related lease, expiring in April 2023 (Note 8). Concentration of Credit Risk The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company regularly monitors the financial condition of the institutions in which it has depository accounts and believes the risk of loss is minimal as these banks are large financial institutions. The Company has no off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount, net of an allowance for doubtful accounts. A receivable is recognized in the period the Company deliver goods or provide services or when the Company’s right to consideration is unconditional. The Company reviews the collectability of accounts receivable based on an assessment of historical experience, current economic conditions, and other collection indicators. The Company had no significant allowance for doubtful accounts at December 31, 2020 or December 31, 2019. When accounts are determined to be uncollectible they are written off against the reserve balance and the reserve is reassessed. When payments are received on reserved accounts they are applied to the customer’s account and the reserve is reassessed. Inventories The Company’s accounting policy for inventories is disclosed in Note 7 “Inventories”. Investment in Equity Securities Equity securities consist of investments in common stock of companies traded on public markets (Note 10). These shares are carried on the Company’s balance sheet at fair value based on the closing price of the shares owned on the last trading day before the balance sheet of this report. Fluctuations in the underlying bid price of the shares result in unrealized gains or losses. In accordance with FASB ASC 321, Investments – Equity Securities (“ASC 321”), the Company recognizes these fluctuations in value as other expense (income). For investments sold, the Company recognizes the gains and losses attributable to these investments as realized gains or losses in other expense (income). The Company’s total investment balance in equity securities totaled $ 10.6 million and $ 42.0 million at December 31, 2020 and 2019, respectively. Investments The Company follows FASB ASC Topic 323, “Investments—Equity Method and Joint Ventures” (“ASC 323”), in accounting for its investments in a joint venture. In the event the Company’s share of the joint venture’s net losses reduces the Company’s investment to zero, the Company will discontinue applying the equity method and will not provide for additional losses unless the Company has guaranteed obligations of the joint venture or is otherwise committed to provide further financial support for the joint venture. If the joint venture subsequently reports net income, the Company will resume applying the equity method only after its share of that net income equals the share of net losses not recognized during the period the equity method was suspended. The Company follows FASB ASC Topic 325, “Investments—Other” (“ASC 325”), in accounting for its investment in the stock of another company accounted for as cost method investments. The Company currently only has one such investment, which is measured in accordance with the “practicability election” allowable for investments without a readily determinable fair value that do not qualify for the NAV practical expedient under ASC 820, “Fair Value Measurement”. This requires investments to be measured at cost minus impairment, plus or minus changes resulting from observable price changes in orderly transactions for an identical or similar investment of the same issuer. In the event further contributions or additional shares are purchased, the Company will increase the basis in the investment. In the event distributions are made or indications exist that the fair value of the investment has decreased below the carrying amount, the Company will decrease the value of the investment as considered appropriate. The Company’s cost method investment balance totaled $ 2.3 million at both December 31, 2020 and 2019, respectively. For all non - consolidated investments, the Company will continually assess the applicability of FASB ASC Topic 810, “Consolidation” (“ASC 810”), to determine if the investments qualify for consolidation. At December 31, 2020 and 2019, no such investments qualified for consolidation. Fixed Assets The Company’s accounting policy for fixed assets is disclosed in Note 9 “Fixed Assets”. Goodwill The Company’s goodwill relates to the 2010 acquisition of Kadmon Pharmaceuticals, a Pennsylvania limited liability company that was formed in April 2000. Goodwill is not amortized, but rather is assessed for impairment annually or upon the occurrence of an event that indicates impairment may have occurred, in accordance with FASB ASC Topic 350 “Intangibles—Goodwill and Other”. The Company maintains a goodwill balance of $ 3.6 million at both December 31, 2020 and 2019. There were no changes in the carrying amount of goodwill and no impairment to goodwill was recorded for the years ended December 31, 2020 and 2019. Impairment of Long-Lived Assets Long - lived assets, including fixed assets and definite-lived intangible assets, are evaluated for impairment periodically, or when events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. When any such impairment exists, a charge is recorded in the statement of operations to adjust the carrying value of the related assets. The Company performed a trigger analysis over all other long - lived assets at the lowest identifiable level of cash flows and determined that no impairment triggers existed during the years ended December 31, 2020 and 2019. Accounting for Leases The Company’s accounting policy for leases is disclosed in Note 8 “Leases”. Accounting for Contingencies The Company follows the guidance of FASB ASC Topic 450, “Contingencies” (“ASC 450”), in accounting for contingencies. If some amount within a range of loss is probable and appears at the time to be a better estimate than any other amount within the range, that amount shall be recognized. If a loss is probable, and no amount within the range is a better estimate than any other amount, the estimated minimum amount in the range shall be recognized. Fair Value of Financial Instruments The Company follows the provisions of FASB ASC Topic 820, “Fair Value Measurements and Disclosures” (“ASC 820”). This pronouncement defines fair value, establishes a framework for measuring fair value under GAAP and requires expanded disclosures about fair value measurements. ASC 820 emphasizes that fair value is a market - based measurement, not an entity - specific measurement, and defines fair value as the price to sell an asset or transfer a liability in an orderly transaction between market participants at the measurement date. ASC 820 discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow) and the cost approach (cost to replace the service capacity of an asset or replacement cost). These valuation techniques are based upon observable and unobservable inputs. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect the Company’s market assumptions. ASC 820 utilizes a fair value hierarchy that prioritizes inputs to fair value measurement techniques into three broad levels. The following is a brief description of those three levels: Level 1: Observable inputs such as quoted prices for identical assets or liabilities in active markets. Level 2: Observable inputs other than quoted prices that are directly or indirectly observable for the asset or liability, including quoted prices for similar assets or liabilities in active markets; quoted prices for similar or identical assets or liabilities in markets that are not active; and model - derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3: Unobservable inputs that reflect the reporting entity’s own assumptions. The carrying amounts reported in the consolidated balance sheet for cash and cash equivalents, receivables, accounts payable and accrued expenses approximate their fair value based on the short-term nature of these instruments. The carrying amount reported in the consolidated balance sheet for investment in equity securities approximates fair value as the asset has a readily determinable market value (Note 10). Warrants and Derivative Liabilities The Company accounts for its derivative financial instruments in accordance with FASB ASC Topic 815, Derivatives and Hedging (“ASC 815”). The Company does not have derivative financial instruments that are hedges. ASC 815 establishes accounting and reporting standards requiring that derivative instruments, both freestanding and embedded in other contracts, be recorded on the balance sheet as either an asset or liability measured at its fair value each reporting period. ASC 815 also requires that changes in the fair value of derivative instruments be recognized currently in the results of operations unless specific criteria are met. For embedded features that are not clearly and closely related to the host instrument, are not carried at fa |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders’ Equity [Abstract] | |
Stockholders’ Equity | 3. Stockholders’ Equity 5% Convertible Preferred Stock The Company’s certificate of incorporation permitted the Company’s board of directors to issue up to 10,000,000 shares of preferred stock from time to time in one or more classes or series. Concurrently with the closing of the Company’s initial public offering (the “IPO”) in 2016 and pursuant to the terms of the exchange agreement entered into with the holders of the Company’s Senior Convertible Term Loan, the Company issued to such holders 30,000 shares of 5 % convertible preferred stock, designated as the convertible preferred stock. Each share of convertible preferred stock was issued for an amount equal to $ 1,000 per share, which is referred to as the original purchase price. Shares of convertible preferred stock with an aggregate original purchase price and initial liquidation preference of $ 30.0 million were issued to the holders of the Senior Convertible Term Loan in exchange for an equivalent principal amount of the Senior Convertible Term Loan pursuant to the terms of an exchange agreement dated as of June 8, 2016, between the Company and those holders, which is referred to as the exchange agreement. The shares of 5 % convertible preferred stock are entitled to receive dividends, when and as declared by the board of directors and to the extent of funds legally available for the payment of dividends, at an annual rate of 5 % of the sum of the original purchase price per share of 5 % convertible preferred stock plus any dividend arrearages. Dividends on the 5 % convertible preferred stock shall, at the Company’s option, either be paid in cash or added to the stated liquidation preference amount for purposes of calculating dividends at the 5 % annual rate (until such time as the Company declares and pays the missed dividend in full and in cash, at which time that dividend will no longer be part of the stated liquidation preference amount). Dividends shall be payable annually on June 30 of each year and shall be cumulative from the most recent dividend payment date on which the dividend has been paid or, if no dividend has ever been paid, from the original date of issuance of the 5 % convertible preferred stock and shall accumulate from day to day whether or not declared until paid. The Company had 28,708 shares of 5 % convertible preferred stock outstanding at December 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 IPO of $ 12.00 per share, or $ 9.60 per share. In May 2019, a holder of 1,292 shares of 5 % convertible preferred stock exercised its right to convert such shares into 154,645 shares of the Company’s common stock. The 5 % convertible preferred stock, inclusive of accrued and unpaid dividends, is convertible into 3,712,931 and 3,536,125 shares of common stock at December 31, 2020 and 2019, respectively. Approximately $ 1.7 million and $ 1.6 million of accrued dividends that were payable on both June 30, 2020 and June 30, 2019, respectively, were added to the stated liquidation preference amount of the 5 % convertible preferred stock on those respective dates. The stated liquidation preference amount on the 5 % convertible preferred stock totaled $ 34.8 million and $ 33.1 million at December 31, 2020 and December 31, 2019, respectively. 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. For the year ended December 31, 2020, the Company raised an aggregate of $ 50.0 million, $ 48.4 million net of $ 1.6 million of commissions payable by the Company, from the issuance of 11,060,786 shares of common stock at a weighted average issuance price of $ 4.52 per share. For the year ended December 31, 2019, the Company raised an aggregate of $ 138.5 million, $ 130.8 million net of $ 7.7 million of underwriting discounts and other offering costs and expenses, from the issuance of 46,216,805 shares of common stock at a weighted average issuance price of $ 3.00 per share. |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 12 Months Ended |
Dec. 31, 2020 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |
Net Loss per Share Attributable to Common Stockholders | 4. Net Loss per Share Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock outstanding for the period. Because the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods. The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company ( in thousands, except share and per share amounts): Years Ended December 31, 2020 2019 Numerator – basic and diluted: Net loss attributable to common stockholders $ ( 111,035 ) $ ( 63,426 ) Denominator – basic and diluted: Weighted average common stock outstanding used to compute basic and diluted net loss per share 166,240,356 132,308,548 Net loss per share, basic and diluted $ ( 0.67 ) $ ( 0.48 ) The amounts in the table below were excluded from the calculation of diluted net loss per share, due to their anti-dilutive effect: Years Ended December 31, 2020 2019 Options to purchase common stock 17,290,685 13,092,601 Warrants to purchase common stock 10,582,119 11,921,452 Convertible preferred stock 3,712,931 3,536,125 Total shares of common stock equivalents 31,585,735 28,550,178 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2020 | |
Debt [Abstract] | |
Debt | 5. Debt August 2015 Secured Term Debt In August 2015, the Company entered into a secured term loan in the amount of $ 35.0 million with two lenders (“2015 Credit Agreement”). The interest rate on the loan was LIBOR plus 9.375 % with a 1 % floor. At December 31, 2018, the Company maintained an outstanding principal balance of $ 28.0 million under the 2015 Credit Agreement. In October 2019, the Company entered into a transaction pursuant to which it sold approximately 1.4 million ordinary shares of MeiraGTx for gross proceeds of $ 22.0 million (Note 10). Pursuant to the 2015 Credit Agreement, half of the proceeds received from the sale, or $ 11.0 million, were used to pay down part of the outstanding amounts owed under the 2015 Credit Agreement. After this repayment, approximately $ 17.0 million of principal remained outstanding under the 2015 Credit Agreement. In November 2019, the Company repaid the remaining $ 17.0 million of principal outstanding under the credit agreement with Perceptive Credit Opportunities Fund, L.P., as amended. As such, the Company has no further payment obligations under the 2015 Credit Agreement at December 31, 2019. The Company recognized $ 3.4 million of interest expense in 2019 related to the 2015 Credit Agreement. Paycheck Protection Program of the Coronavirus Aid, Relief, and Economic Security Act On April 15, 2020, the Company received the proceeds from a loan in the amount of approximately $ 3.1 million (the “Loan”) from PNC Bank, National Association, as lender, pursuant to the Paycheck Protection Program (“PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). The Loan matures on April 15, 2022 and bears interest at a rate of 1 % per annum. On August 20, 2020, the loan was amended so that, commencing August 15, 2021, 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 Loan as of October 15, 2020. The 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 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 then 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 its current business activity and its 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 various factors, including 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. All or a portion of the Loan may be forgiven by the U.S. Small Business Administration (“SBA”) upon application by the Company upon documentation of expenditures in accordance with the SBA requirements. Under the CARES Act, loan forgiveness is available for the sum of eligible and documented payroll costs, covered rent payments, covered mortgage interest and covered utilities during the eight-week period beginning on the date of loan approval. If, despite the Company’s good-faith belief that given the circumstances the Company satisfied all eligibility requirements for the 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 Loan, the Company may be required to repay the Loan in its entirety and/or be subject to additional penalties. In the event the Loan, or any portion thereof, is forgiven pursuant to the PPP, the amount forgiven is applied to outstanding principal. The Company used all proceeds from the 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. The Company has applied for forgiveness, however, no assurance is provided that the Company will obtain forgiveness for any portion of the Loan. The Company has accounted for the Loan as a debt instrument in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 470, Debt. At December 31, 2020, $ 1.7 million of principal payments due in 2021 have been recorded as short-term debt and the remaining balance of $ 1.4 million is recorded as long-term debt. The Company does not expect to incur any material interest expense under the Loan. |
Financial Instruments
Financial Instruments | 12 Months Ended |
Dec. 31, 2020 | |
Financial Instruments [Abstract] | |
Financial Instruments | 6. Financial Instruments The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy defines three levels and prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. Items classified as Level 1 within the valuation hierarchy consist of the Company’s cash equivalents held in money market funds and its ownership of MeiraGTx (Note 10). The Company measures these investments at fair value determined based on Level 1 observable quoted price market inputs. Items classified as Level 2 within the valuation hierarchy consist of the Company’s marketable debt securities and warrant liabilities. The Company estimates the fair values of the marketable debt securities by taking into consideration valuations obtained from third-party pricing sources. These pricing sources utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include market pricing based on real-time trade data for the same or similar securities, issuer credit spreads, benchmark yields, and other observable inputs. 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. The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value at December 31, 2020 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): Fair Value Measurements Using Description Total Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents: Money market funds $ 67,467 $ 67,467 $ — $ — Corporate debt securities 3,041 — 3,041 — Short-term investments: Corporate debt securities 49,435 — 49,435 — Ownership of MeiraGTx 10,564 10,564 — — $ 130,507 $ 78,031 $ 52,476 $ — Financial liabilities Warrant liabilities $ 1,082 $ — $ 1,082 $ — The following table presents information about the Company’s financial assets and liabilities that have been measured at fair value at December 31, 2019 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): Fair Value Measurements Using Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Description Total Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents: Money market funds $ 136,058 $ 136,058 $ — $ — Short-term investments: Ownership of MeiraGTx 41,997 41,997 — — $ 178,055 $ 136,058 $ — $ — Financial liabilities Warrant liabilities $ 1,485 $ — $ 1,485 $ — The Company has not recognized any material gross realized gains or losses on sales of available-for-sale marketable debt securities. Warrant Liabilities In connection with the 2015 Credit Agreement (Note 5), as fees to the lenders thereunder, the Company issued warrants to purchase an aggregate of $ 6.3 million of the Company’s Class A units with an expiration date of August 2022, which were exchanged for 617,651 warrants with a strike price of $ 10.20 per share to purchase the same number of shares of the Company’s common stock upon consummation of the Company’s IPO in August 2016 (the “2015 Warrants”). As of December 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 under the warrant agreement, the fair value of the 2015 Warrants was recorded as a short-term liability of approximately $ 1.1 million at December 31, 2020 and approximately $ 1.5 million at December 31, 2019. The Company used the Black-Scholes pricing model to value the liability related to the 2015 Warrants at December 31, 2020 and 2019 with the following assumptions: December 31, December 31, 2020 2019 Stock Price $ 4.15 $ 4.53 Strike price $ 3.30 - $ 4.50 $ 3.30 - $ 4.50 Expected Volatility 72.92 % 72.20 % Risk-free interest rate 0.12 % 1.62 % Expected term 1.7 years 2.7 years Expected dividend yield 0 % 0 % The change in fair value of the 2015 Warrants was $( 0.4 ) million and $ 1.0 million for the years ended December 31, 2020 and 2019, respectively. No ne of these instruments have been exercised at December 31, 2020 or December 31, 2019. The table below represents a rollforward of the Level 2 financial instruments from January 1, 2018 to December 31, 2020 (in thousands): Significant Other Observable Inputs (Level 2) Balance as of January 1, 2019 $ 524 Change in fair value of warrant liabilities 961 Balance as of December 31, 2019 $ 1,485 Change in fair value of warrant liabilities ( 403 ) Balance as of December 31, 2020 $ 1,082 Other Warrants In connection with the incurrence of the Senior Convertible Term Loan in 2015, the Company issued three tranches of warrants as fees to the lenders that were redeemable for Class A units. Upon consummation of the Company’s IPO in 2016, the warrants to purchase Class A units issued to lenders in the Senior Convertible Term Loan were exchanged for 351,992 warrants with a strike price of $ 10.20 per share to purchase the same number of shares of the Company’s common stock. Since the strike price was determined at IPO, the aggregate fair value of these warrants was reclassified from liability to equity upon consummation of the Company’s IPO in August 2016. No ne of these warrants have been exercised at December 31, 2020. On April 16, 2013, the Company issued warrants with an estimated fair value of $ 1.4 million for the purchase of 30,000 Class A units at a strike price of $ 21.24 as consideration for fundraising efforts performed. Upon consummation of the Company’s IPO in 2016, these warrants to purchase Class A units were exchanged for 46,163 warrants to purchase the same number of shares of the Company’s common stock at a strike price of $ 138.06 . None of these warrants have been exercised at December 31, 2020. In connection with the 2017 Public Offering, the Company issued warrants to purchase 10,710,000 shares of common stock at an initial exercise price of $ 3.35 per share for a term of 5 years from the date of issuance. The Company assessed the warrants under FASB ASC 480 and ASC 815. The Company determined that the warrants were indexed to the Company’s stock and met all of the criteria for classification as equity under ASC 815. Based on this analysis, the Company recorded the fair value of the warrants to equity at issuance date. As of December 31, 2020, warrants to purchase 9,253,667 shares of common stock were outstanding. During 2020, the Company received proceeds of less than $ 0.1 million related to exercises of these warrants. Warrants Outstanding The following table summarizes information about warrants outstanding at December 31, 2020 and 2019: Warrants Weighted Average Exercise Price Balance, January 1, 2019 11,999,852 $ 5.95 Exercised ( 78,400 ) 3.35 Balance, December 31, 2019 11,921,452 $ 5.97 Exercised ( 1,339,333 ) 3.35 Balance, December 31, 2020 10,582,119 $ 6.30 |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2020 | |
Inventories [Abstract] | |
Inventories | 7. Inventories Inventories are stated at the lower of cost or net realizable value (on a first - in, first - out basis) using standard costs. Standard costs include an allocation of overhead rates, which include those costs attributable to managing the supply chain and are evaluated regularly. Variances are expensed as incurred. The Company capitalizes inventory costs associated with the Company’s products after regulatory approval, if ever, when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development. The Company regularly reviews the expiration date of its inventories and maintains a reserve for inventories that are probable to expire before shipment. Inventories recorded on the Company’s consolidated balance sheets are net of a reserve for expirable inventory of $ 2.1 million and $ 3.0 million at December 31, 2020 and 2019, respectively. The Company expensed inventory that it believes will not be sold prior to reaching its product expiration date totaling $ 0.9 million and $ 0.9 million during the years ended December 31, 2020 and 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): December 31, 2020 2019 Raw materials $ — $ 371 Finished goods, net 102 269 Total inventories $ 102 $ 640 During the year ended December 31, 2020, the Company recorded a loss to cost of goods sold for $ 0.3 million related to minimum batch commitments to purchase CLOVIQUE inventory in 2020. Additionally, in December 2020 the company terminated a supply agreement which included certain minimum batch purchase commitments related to CLOVIQUE through 2023. In connection with the termination, the Company recorded $ 0.4 million of contract termination cost expense to selling, general and administrative expense in December 2020. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | 8. Leases The Company has adopted FASB ASU No. 2016 02, Leases (“ASC 842”) effective January 1, 2019 using the modified retrospective transition approach allowed under ASU 2018-11, Leases (Topic 842: Targeted Improvements). The Company has also elected to apply (i) the practical expedient, which allows it to not separate lease and non-lease components, for new leases entered into after adoption and (ii) the short-term lease exemption for all leases with an original term of 12 months or less, for purposes of applying the recognition and measurements requirements in ASC 842. As of December 31, 2020, the short-term lease exemption applied to two operating leases for office space which are for a term of one year. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and the Company’s control over the use of the identified asset(s), if applicable. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company will utilize the incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. As of the ASC 842 effective date, the Company’s incremental borrowing rate ranged from approximately 4.0 %- 5.6 % based on the remaining lease term of the applicable leases. Operating leases are recognized on the balance sheet as ROU lease assets, lease liabilities current and lease liabilities non-current. Fixed rents are included in the calculation of the lease balances while variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected term on a straight-line basis. The Company is party to six operating leases for office or laboratory space and two finance leases for office IT equipment. The Company’s finance leases are immaterial both individually and in the aggregate. In the consolidated balance sheets at December 31, 2020, the Company has a ROU lease asset balance of $ 16.1 million and a current and non-current lease liability of $ 4.2 million and $ 15.6 million, respectively. The balance of both the ROU lease asset and the lease liabilities primarily consists of future payments under the Company’s office lease in New York, New York. The Company is party to an operating lease in New York, New York for office and laboratory space for its headquarters. The lease commenced in October 2010, its initial term is set to expire in February 2021, and the Company opened a secured letter of credit with a third party financial institution in lieu of providing a security deposit of $ 2.0 million, which letter of credit is included in restricted cash at December 31, 2020. As of December 31, 2020, there were six amendments to this lease agreement, which altered office and laboratory capacity and extended the lease term through October 2025, with total lease cost of $ 4.8 million for the year ended December 31, 2020. This office lease contains the ability to extend portions of the lease at fair market value but does not have any renewal options. The Company is party to an operating lease in Warrendale, Pennsylvania for the Company’s specialty-focused commercial operation. In March 2019, the Company entered into an amendment to this lease, which extended the lease term to September 30, 2022 with two five year renewal options, which would extend the term to September 30, 2032, if exercised. Rental payments under the renewal period would be at market rates determined from the average rentals of similar tenants in the same industrial park. The option to renew this office lease was not considered when assessing the value of the ROU asset because the Company was not reasonably certain that it would assert its option to renew the lease. Total lease cost for this lease was $ 0.7 million for the year ended December 31, 2020. In August 2015, the Company entered into an operating office lease agreement in Cambridge, Massachusetts for the Company’s clinical office effective January 2016 and expiring in April 2023. The Company opened a secured letter of credit with a third party financial institution in lieu of providing a security deposit of $ 0.1 million, which letter of credit is included in restricted cash at 2019. The Company is also party to an operating lease for laboratory space in Monmouth Junction, New Jersey, which expires in February 2022. Neither of these office leases contain any renewal options. Total lease cost for these leases was $ 0.4 million for the year ended December 31, 2020. Quantitative information regarding the Company’s leases for the year ended December 31, 2020 and 2019 is as follows (in thousands): Year Ended Year Ended Lease Cost Classification December 31, 2020 December 31, 2019 Operating lease cost (a) SG&A expenses $ 4,592 $ 4,632 Variable lease cost SG&A expenses 1,487 1,346 Sublease income (b) Other revenue ( 623 ) ( 674 ) Net Lease Cost $ 5,456 $ 5,304 Other Information Weighted average remaining lease term (years) 4.5 5.5 Weighted average discount rate 4.1 % 4.1 % (a) Includes short-term lease costs and finance leases costs, which are immaterial. (b) Includes sublease income related to MeiraGTx (Note 10). Future lease payments under noncancellable leases are as follows (in thousands) at December 31, 2020: Year ending December 31, Operating Leases Finance Leases 2021 $ 4,937 $ 25 2022 4,868 19 2023 4,174 14 2024 4,158 — 2025 3,573 — Thereafter — — Total Lease Payments $ 21,710 $ 58 Less: Imputed Interest ( 1,956 ) ( 10 ) Total Lease Liabilities $ 19,754 $ 48 Note: As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. |
Fixed Assets
Fixed Assets | 12 Months Ended |
Dec. 31, 2020 | |
Fixed Assets [Abstract] | |
Fixed Assets | 9. Fixed Assets Fixed assets are carried at cost less accumulated depreciation and amortization. Depreciation and amortization of fixed assets is calculated using the straight-line method over their estimated useful lives. Leasehold improvements are amortized over the shorter of their estimated useful lives or the lease term, using the straight - line method. Construction - in - progress and software under development are stated at cost and not depreciated. These items are transferred to fixed assets when the assets are placed into service. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. Expenditures for repairs and maintenance, which do not improve or extend the life of the assets, are expensed as incurred. Fixed assets consisted of the following (in thousands): Useful Lives December 31, December 31, (Years) 2020 2019 Leasehold improvements 4 - 8 $ 10,398 $ 10,397 Office equipment and furniture 3 - 15 1,363 1,234 Machinery and laboratory equipment 3 - 15 3,835 3,599 Software 1 - 5 4,136 3,971 Construction-in-progress ̶̶̶̶ — 45 19,732 19,246 Less accumulated depreciation and amortization ( 18,445 ) ( 16,802 ) Fixed assets, net $ 1,287 $ 2,444 Depreciation and amortization of fixed assets totaled $ 1.6 million and $ 1.8 million in the years ended December 31, 2020 and 2019, respectively. |
Ownership of MeiraGTx Ordinary
Ownership of MeiraGTx Ordinary Shares | 12 Months Ended |
Dec. 31, 2020 | |
Ownership of MeiraGTx Ordinary Shares [Abstract] | |
Ownership of MeiraGTx Ordinary Shares | 10. Ownership of MeiraGTx Ordinary Shares In April 2015, the Company executed several agreements which transferred its ownership of Kadmon Gene Therapy, LLC to MeiraGTx. As part of these agreements, the Company also transferred various property rights, employees and management tied to the intellectual property and contracts identified in the agreements to MeiraGTx. At a later date, MeiraGTx ratified its shareholder agreement and accepted the pending equity subscription agreements, which provided equity ownership to various parties. The execution of these agreements resulted in a 48 % ownership in MeiraGTx by the Company. On June 12, 2018, MeiraGTx completed its initial public offering (the “MeiraGTx IPO”) whereby it sold 5,000,000 ordinary shares at $ 15.00 per share. The shares began trading on the Nasdaq Global Select Market on June 7 , 2018 under the symbol “MGTX.” In October 2019, the Company entered into a transaction pursuant to which it sold approximately 1.4 million ordinary shares of MeiraGTx for gross proceeds of $ 22.0 million, which was recorded as a realized gain on equity securities. The Company entered into transactions in May 2020 and July 2020 pursuant to which it sold an aggregate of approximately 1.4 million ordinary shares of MeiraGTx for gross proceeds of $ 19.8 million, which was recorded as a realized gain on equity securities. The realized gain represents the total gain on the sale of ordinary shares since the MeiraGTx IPO in June 2018. The Company has recorded a net unrealized (loss) gain on its MeiraGTx ordinary share investment of $( 31.4 ) million and $ 7.9 million for the years ended December 31, 2020 and 2019, respectively. The unrealized gains on equity securities consists of two components: (i) the reversal of the gain or loss recognized in previous periods on equity securities sold and (ii) the change in unrealized gain or loss resulting from mark-to-market adjustments on equity securities still held. The table below represents a rollforward of the MeiraGTx investment from January 1, 2019 to December 31, 2020 (in thousands). Significant Observable Inputs (Level 1) Balance as of January 1, 2019 $ 34,075 Unrealized gain on ordinary shares sold during 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 ordinary shares sold during the year ( 8,244 ) Realized gain on sale of ordinary shares ( 19,784 ) Unrealized loss on remaining ownership of ordinary shares ( 3,405 ) Balance as of December 31, 2020 $ 10,564 As of December 31, 2020 and 2019, the Company maintained a 1.6 % and 5.7 % ownership in the ordinary shares of MeiraGTx with a fair value of $ 10.6 million and $ 42.0 million, respectively. During the third quarter of 2019 the affiliate restrictions on the resale of these securities were removed and, accordingly, the Company’s investment in MeiraGTx has been recorded as a current investment in equity securities at both December 31, 2020 and 2019. The investment in MeiraGTx is valued using Level 1 inputs which includes quoted prices in active markets for identical assets in accordance with the fair value hierarchy (Note 2). As part of the agreements executed with MeiraGTx in April 2015, the Company entered into a transition services agreement (“TSA”) with MeiraGTx which expired in April 2018. Upon expiration of the TSA, the Company continued to provide office space to MeiraGTx. On October 1, 2018, the Company and MeiraGTx entered into a sublease agreement which is effective from October 1, 2018 for a period of two months and will automatically be renewed on a monthly basis unless MeiraGTx provides 30 days prior written notice. The monthly sublease amount is approximately $ 50 thousand. As part of the TSA and sublease agreement with MeiraGTx, the Company recognized $ 0.6 million and $ 0.6 million to license and other revenue during the years ended December 31, 2020 and 2019, respectively. The Company received cash payments of $ 0.6 million from MeiraGTx during both 2020 and 2019 and the Company has no amounts receivable from MeiraGTx at either December 31, 2020 or 2019. |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2020 | |
License Agreements [Abstract] | |
License Agreements | 11. License Agreements Nano Terra, Inc. On April 8, 2011, the Company entered into a series of transactions with Nano Terra, Inc. (“Nano Terra”), pursuant to which the Company (i) paid $ 2.3 million for Nano Terra’s Series B Preferred Stock, (ii) entered into a joint venture with Surface Logix, Inc. (“Surface Logix”) (Nano Terra’s wholly - owned subsidiary) through the formation of NT Life Sciences, LLC (“NT Life”), whereby the Company contributed $ 0.9 million at the date of formation in exchange for a 50 % interest in NT Life and (iii) entered into a sub - licensing arrangement with NT Life and Surface Logix. Pursuant to the sub - licensing arrangement, the Company was granted a worldwide, exclusive license under certain intellectual property owned by Surface Logix to three clinical-stage product candidates, including belumosudil, each of which were licensed by Surface Logix to NT Life. In December 2014, the Company received one share of Nano Terra’s Common Stock for every 100 shares of Series B Preferred Stock held by the Company, resulting in approximately a 1 % holding in Nano Terra as of December 31, 2020 and 2019. In accordance with ASC 325, “Investments—Other”, the Company continues to account for the investment under the cost method (Note 2). Nano Terra and NT Life are research and development companies, each of which independently maintains intellectual property for the purpose of pursuing medical discoveries. The Company is a minority shareholder of Nano Terra and thereby is unable to exercise significant influence with regard to the entity’s daily operations. The Company is represented on the board of managers of NT Life and is a party to decisions which influence the direction of the organization. Since inception, the Company has continuously assessed the applicability of ASC 810, based on the corporate structure, voting rights and contributions of the various parties in connection with these agreements, and determined that Nano Terra and NT Life are not variable interest entities (“VIE”) and not subject to consolidation. On April 8, 2011 the Company recorded its $ 2.3 million investment in Nano Terra in accordance with ASC 325 and the Company has assessed the recoverability of the investment in Nano Terra as of December 31, 2020 and 2019 and identified no events or changes in circumstances that may have a significant adverse impact on the fair value of this investment. No impairment or changes resulting from observable price changes occurred during the year ended December 31, 2020. There was no activity of the joint venture during the years ended December 31, 2020 and 2019 which resulted in income or loss to the Company. The Company’s maximum exposure associated with Nano Terra and NT Life is limited to cash contributions made. Additionally, subject to certain exceptions, the Company must pay a percentage that ranges between a low twenty percent and a low forty percent of all sublicensing revenue the Company receives in the event the Company further assigns or sublicenses its rights under the sub-licensing arrangement to certain third parties. In addition, the Company must pay to the previous shareholders of Surface Logix from which Nano Terra acquired Surface Logix and NT Life royalties on net sales in the amount of 5 % and 10 %, respectively. As the Company owns 50 % of NT Life, the cumulative results of these obligations is that the Company will owe an aggregate royalty a 9.75 % on net sales of licensed products. No sublicensing revenue or sales were achieved as of December 31, 2020 and 2019. Dyax Corp. (acquired by Shire Plc in January 2016, acquired by Takeda Pharmaceuticals Co., Ltd. in 2018) On July 22, 2011 the Company entered into a license agreement with Dyax Corp. (“Dyax”) for the rights to use the Dyax Antibody Libraries, Dyax Materials and Dyax Know - How (collectively “Dyax Property”). The agreement terminated on September 22, 2015, but the Company had a right to a commercial license of any research target within two years of expiration of the agreement. The Company exercised its right to a commercial license of two targets in September 2017, one of which is KD033. Under the terms of the agreement, the Company recorded $ 1.5 million in development milestone expense during each of the fourth quarter of 2019 and second quarter of 2020 related to development milestones reached by the Company. BioNova Pharmaceuticals Ltd. In November 2019, the Company entered into a strategic partnership with BioNova Pharmaceuticals Ltd. (“BioNova”) to form a joint venture to exclusively develop and commercialize belumosudil (KD025), the Company’s lead product candidate, for the treatment of graft-versus-host-disease (“GVHD”) in the People’s Republic of China. The joint venture was entered into through the creation of BK Pharmaceuticals Limited (“BK Pharma”), whereby the Company entered into a royalty-bearing exclusive license agreement with BK Pharma and BioNova in exchange for a 20 % interest in BK Pharma. BK Pharma is domiciled in Hong Kong with shared oversight between the Company and BioNova. Under the terms of the license agreement, the Company received an upfront payment of $ 4.0 million in December 2019 and is eligible to receive an additional $ 41.0 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 belumosudil for GVHD in China. 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 BK Pharma 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 belumosudil in China and the operations of BK Pharma will be financed and guaranteed entirely by BioNova. 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 BK Pharma was accounted for under the equity method as the Company has the ability to exercise significant influence over BK Pharma. 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, Collaborative Arrangements (“ASC 808”), and determined that the license agreement and related joint venture with BioNova 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 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 joint steering committee (“JSC”), and limited technical assistance as requested by BK Pharma and BioNova. The Company determined that the $ 4.0 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 performance obligation represents a license of functional intellectual property and the associated revenue was recognized upon completion of the initial technology transfer in December 2019. The Company recognized $ 4.0 million in license revenue for the year ended December 31, 2019. No other milestone or royalty revenues have been earned as of December 31, 2020. Meiji Seika Pharma Co., Ltd In December 2019, the Company entered into a collaboration agreement with Meiji Seika Pharma Co., Ltd (“Meiji”), a Tokyo-based wholly owned subsidiary of Meiji Holdings Co., Ltd., to form a joint venture to exclusively develop and commercialize belumosudil 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 belumosudil 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 belumosudil 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 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 performance obligation represents a license of functional intellectual property and the associated revenue was recognized upon completion of the initial technology transfer in the first quarter of 2020. The Company had not received the upfront payment or completed the single combined performance obligation as of December 31, 2019. As such, the Company recognized $ 6.0 million in license revenue in the first quarter of 2020 upon completion of the single combined performance obligation. No other milestone or royalty revenues have been earned as of December 31, 2020. |
Share-based Compensation
Share-based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Compensation [Abstract] | |
Share-based Compensation | 12. Share - based Compensation Accounting for Share-based Compensation The Company recognizes share - based compensation expense in accordance with FASB ASC Topic 718, “Stock Compensation” (“ASC 718”), for all share - based awards made to employees, non-employees and board members based on estimated fair values. ASC 718 requires companies to measure the cost of employee services incurred in exchange for the award of equity instruments based on the estimated fair value of the share - based award on the grant date. The expense is recognized over the requisite service period. The Company recognizes share-based award forfeitures as they occur. The Company uses a Black - Scholes option - pricing model to value the Company’s option awards. Using this option - pricing model, the fair value of each employee and board member award is estimated on the grant date. The fair value is expensed on a straight - line basis over the vesting period. The option awards generally vest pro - rata annually. The expected volatility assumption is based on the volatility of the share price of comparable public companies. The expected life is determined using the “simplified method” permitted by Staff Accounting Bulletin Numbers 107 and 110 (the midpoint between the term of the agreement and the weighted average vesting term). The risk - free interest rate is based on the implied yield on a U.S. Treasury security at a constant maturity with a remaining term equal to the expected term of the option granted. The dividend yield is zero, as the Company has never declared a cash dividend. As of December 31, 2020, the only equity compensation plans from which the Company may currently issue new awards are the Company’s 2016 Equity Incentive Plan (as amended and restated to date, the “2016 Equity Plan”) and 2016 Employee Stock Purchase Plan (as amended and restated to date, the “2016 ESPP”), each as more fully described below. 2016 Equity Incentive Plan Pursuant to the 2016 Equity Plan, the Company’s Board of Directors may grant incentive and nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares and units and other cash-based or stock-based awards. A total of 21,785,738 shares of the Company’s common stock were authorized and reserved for issuance under the 2016 Equity Plan at December 31, 2020 and there were 3,973,996 shares available for future grants. The 2016 Equity Plan provides for annual increases in the number of shares available for issuance under the 2016 Equity Plan on January 1 of each year by an amount equal to the smaller of (a) 4 % of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or (b) an amount determined by the board of directors. In accordance with the terms of the 2016 Equity Plan, effective as of January 1, 2020, the number of shares of common stock available for issuance under the 2016 Equity Plan increased by 5,591,600 shares, which was less than four percent ( 4 %) of the outstanding shares of common stock on December 31, 2019. On January 1, 2021, the number of shares of common stock available for issuance under the 2016 Equity Plan increased by 6,861,201 shares, which was four percent ( 4 %) of the outstanding shares of common stock on December 31, 2020. Options issued under the 2016 Equity Plan generally vest over 3 years from the date of grant in equal annual tranches and are exercisable for up to 10 years from the date of issuance. Upon exercise of stock options granted under the 2016 Equity Plan, the Company issues new shares from the shares reserved for issuance. S hares subject to awards which expire or are cancelled or forfeited will again become available for issuance under the 2016 Equity Plan. The shares available will not be reduced by awards settled in cash or by shares withheld to satisfy tax withholding obligations. Only the net number of shares issued upon the exercise of stock appreciation rights or options exercised by means of a net exercise or by tender of previously owned shares will be deducted from the shares available under the 2016 Equity Plan. The Company recorded share - based option compensation expense under the 2016 Equity Plan for all outstanding stock options, performance stock options and stock appreciation rights of $ 9.4 million and $ 7.2 million for the years ended December 31, 2020 and 2019, respectively. Total unrecognized compensation expense related to unvested stock options granted under the Company’s share - based compensation plan was $ 11.9 million and $ 6.5 million at December 31, 2020 and 2019, respectively. That expense is expected to be recognized over a weighted average period of 1.9 years and 2.2 years as of December 31, 2020 and 2019, respectively. The following table summarizes information about stock options outstanding, not including performance stock options, at December 31, 2020 and 2019: Options Outstanding Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Balance, January 1, 2019 9,764,539 $ 6.24 7.84 $ — Granted 2,943,973 3.11 Exercised ( 92,334 ) 2.87 166 Forfeited ( 813,577 ) 4.63 Balance, December 31, 2019 11,802,601 $ 5.59 7.52 $ 9,520 Granted 5,027,540 4.35 Exercised ( 321,769 ) 3.11 438 Forfeited ( 507,687 ) 4.51 Balance, December 31, 2020 16,000,685 $ 5.29 7.11 $ 7,365 Options vested and exercisable, December 31, 2020 9,749,998 $ 6.04 5.97 $ 5,951 The aggregate intrinsic value in the table above represents the total pre - tax intrinsic value calculated as the difference between the fair value of the Company’s common stock at December 31, 2020 ($ 4.15 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 321,769 options exercised during the year ended December 31, 2020 with an aggregate intrinsic value of $ 0.4 million. There were 92,334 options exercised during the year ended December 31, 2019 with an aggregate intrinsic value of $ 0.2 million. The weighted - average fair value of the stock option awards, not including performance stock options, granted to employees, officers, directors and advisors was $ 2.86 and $ 2.07 during the years ended December 31, 2020 and 2019, respectively, and was estimated at the date of grant using the Black - Scholes option - pricing model and the assumptions noted in the following table: Years Ended December 31, 2020 December 31, 2019 Weighted average fair value of grants $ 2.86 $ 2.07 Expected volatility 75.46 % - 87.48 % 75.96 % - 77.73 % Risk-free interest rate 0.29 % - 1.64 % 1.41 % - 2.61 % Expected life 2.0 - 6.0 years 5.5 - 6.0 years Expected dividend yield 0 % 0 % Performance Options The Company granted 1,597,000 nonqualified performance-based stock options under the 2016 Equity Plan to three executive employees during the year ended December 31, 2018. No other performance-based stock options have been granted under the 2016 Equity Plan. Compensation expense for the Performance Options is recognized on a straight-line basis over the awards’ requisite service period. The Performance Options vest upon the satisfaction of both a service condition and the satisfaction of one or more performance conditions. The Company initially determined which outcomes are probable of achievement. The requisite service period would be three years as that is the longest period of both the explicit service period and the implicit service periods. The first two performance conditions were satisfied during 2018 and the third performance condition was satisfied in 2019. A total of 1,290,000 Performance Options with an exercise price of $ 4.06 were outstanding at both December 31, 2020 and 2019 with an intrinsic value of $ 0.3 million and $ 0.6 million, respectively. The weighted average remaining contractual life of outstanding Performance Options at December 31, 2020 was 5.7 years. At December 31, 2020, there was $ 0.1 million of total unrecognized compensation expense related to unvested Performance Options, which is expected to be recognized over a weighted-average period of 0.3 years. At December 31, 2020 and December 31, 2019, 962,502 and 853,335 Performance Options had vested, respectively, and no Performance Options had been exercised. Stock Appreciation Rights The Company granted 1,040,000 stock appreciation rights (“SARs”) under the 2016 Equity Plan to three executive employees during the year ended December 31, 2017. No other SARs have been granted under the 2016 Equity Plan. A total of 835,000 SARs with an exercise price of $ 3.64 were outstanding at both December 31, 2020 and 2019 with an intrinsic value of $ 0.5 million and $ 0.7 million, respectively. The weighted average remaining contractual life of outstanding SARs at December 31, 2020 was 5.6 years. Compensation expense for SARs is recognized on a straight-line basis over the awards’ requisite service period. At December 31, 2020, there was no unrecognized compensation cost related to SARs. At December 31, 2020 and December 31, 2019, 835,000 and 616,667 SARs had vested and no SARs had been exercised. 2014 Long - term Incentive Plan (“LTIP”) The LTIP was adopted in May 2014 and amended in December 2014. Under the LTIP, the Company’s board of directors may grant up to 10 % of the equity value of the Company in Equity Appreciation Rights Units (“EAR units”) or Performance Awards. In 2015 and 2014, certain employees were granted a total of 9,750 EAR units with a base price of $ 6.00 per unit, expiring 10 years from the grant date. No other awards have been granted under the LTIP and no future awards are available to be granted under the LTIP. The EAR units vested in 2016 and are payable upon the fair market value of the Company’s common stock exceeding 333 % of the $ 6.00 grant price ($ 20.00 ) per share prior to December 7, 2024. The EAR units are also payable upon a change in control where the acquisition price of the Company’s common stock exceeds $ 6.00 per share. The payment amount with respect to the holder’s EAR units will be determined using the fair market value of the common stock on the trading date immediately preceding the settlement date. Each payment under the Award will be made in a lump sum and is considered a separate payment. The holders of the LTIP 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. Any settlement in the form of common stock will be limited to a maximum share allocation, which is 3,478,057 shares of the Company’s common stock. A total of 9,750 units were outstanding under the LTIP at December 31, 2020 and 2019. The compensation expense for this award was recognized upon consummation of the Company’s IPO in 2016 and was recorded as additional paid in capital. 2016 Employee Stock Purchase Plan In July 2016, the Company adopted the 2016 ESPP. The 2016 ESPP provides for annual increases in the number of shares available for sale under the 2016 ESPP on January 1 of each year by an amount equal to the smaller of (a) 750,000 shares, (b) one-and-a-half percent ( 1.5 %) of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or (c) an amount determined by the board of directors. On January 1, 2020 and January 1, 2021, the number of shares reserved for sale was not increased by the Company’s board of directors. As of December 31, 2020, there was a total of 2,551,180 shares reserved for sale under the 2016 ESPP and there were 2,235,354 shares available for future sales. The Company issued 164,614 shares and 88,619 shares of common stock under the 2016 ESPP during the years ended December 31, 2020 and 2019, respectively. No significant compensation expense was recognized for the ESPP during the years ended December 31, 2020 and 2019. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | 13. Accrued Expenses Short - term accrued expenses at December 31, 2020 and 2019 include the following (in thousands): December 31, December 31, 2020 2019 Commission payable $ — $ 2,395 Compensation, benefits and severance 5,585 4,668 Research and development 4,183 4,962 Other 1,766 2,223 Total Accrued Expenses $ 11,534 $ 14,248 Commission payable Commission payable represents commissions to third parties for Class E redeemable convertible unit raises during 2014 and 2015. During the year ended December 31, 2020, the Company recorded $ 2.4 million as a non-cash gain on extinguishment of obligation due to the expiration of the Company’s obligation related to this portion of the commission. 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. 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. Accrued research and development expenses represent incurred expenses for which the Company has not yet been invoiced. Other During the year ended December 31, 2020, the Company recorded $ 1.0 million as a non-cash gain on extinguishment of obligation due to the expiration of the Company’s obligation relating to a terminated license agreement. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2020 | |
Employee Benefit Plan [Abstract] | |
Employee Benefit Plan | 14. Employee Benefit Plan In October 2011, the Company began sponsoring a qualified Tax Deferred Savings Plan (401(k)) for all eligible employees of the Company. Participation in the plan is voluntary. Participating employees may defer up to 75 % of their compensation up to the maximum prescribed by the Internal Revenue Code. The Company has an obligation to match non - highly compensated employee contributions of up to 6 % of deferrals and also has the option to make discretionary matching contributions and profit sharing contributions to the plan annually, as determined by the Company’s board of directors. The Company expensed employer matching contributions of $ 0.2 million and $ 0.3 million for the years ended December 31, 2020 and 2019, respectively. The Company made disbursements of $ 0.3 million and $ 0.2 million for the years ended December 31, 2020 and 2019, respectively. The Company typically disburses employer matching contributions during the first quarter following the plan year. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 15. Commitments and Contingencies Lease Commitments The Company’s commitments related to lease agreements are disclosed in Note 8 . Contingent License Agreement Milestones The Company has entered into several license agreements for products currently under development (Note 11). 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 $ 229.1 million at December 31, 2020. Any payments made prior to FDA approval will be expensed as research and development. Payments made after FDA approval will be capitalized. Further, under the terms of certain licensing agreements, the Company may be obligated to pay commercial milestones contingent upon the realization of sales revenues and sublicense revenues. Due to the long - range nature of such commercial milestones, they are neither probable at this time nor predictable, and consequently are not included in the additional contingent milestone payment amount. Legal Contingencies The Company has been subject to various legal proceedings that arise from time to time in the ordinary course of its business. Although the Company believes that the various proceedings brought against it have been without merit, and that it has adequate product liability and other insurance to cover any claims, litigation is subject to many factors which are difficult to predict and there can be no assurance that the Company will not incur material costs in the resolution of legal matters. Should the Company determine that any future obligations exist, the Company will record an expense equal to the amount which is deemed probable and estimable. The Company has no significant contingencies related to legal proceedings at December 31, 2020. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes [Abstract] | |
Income Taxes | 16. Income Taxes The Company accounts for income taxes in accordance with the asset and liability method of accounting for income taxes prescribed by FASB ASC Topic 740, “Accounting for Income Taxes” (“ASC 740”). Under the asset and liability method of ASC 740, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to the taxable income in the years in which those temporary differences are expected to be recovered or settled. Under ASC 740, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment dates. The Company follows FASB ASC Topic 740 - 10, “Accounting for Uncertainty in Income Taxes”, which prescribes a recognition threshold and measurement attribute for financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. At December 31, 2020 and 2019, the Company had no material uncertain tax positions to be accounted for in the financial statements. The Company recognizes interest and penalties, if any, related to unrecognized tax benefits in interest expense. The Company is obligated to file income tax returns in the U.S. federal jurisdiction and several U.S. states. Since the Company had losses in the past, all prior years that generated net operating loss carryforwards are open and subject to audit examination in relation to the net operating loss generated from those years. The Company recorded an income tax (benefit) expense of approximately $( 0.2 ) million and less than $ 0.1 million for the years ended December 31, 2020 and 2019, respectively, related to adjustments to the deferred tax liability. The deferred tax liability was initially recorded to account for the book vs. tax basis difference related to the goodwill intangible asset, also known as a “naked credit”. The deferred tax liability was excluded from sources of future taxable income, as the timing of its reversal cannot be predicted due to the indefinite life of the goodwill. In accordance with the Tax Cuts and Jobs Act of 2017, losses generated beginning with the 2018 tax year may be carried forward indefinitely for U.S. federal tax purposes, however losses were initially limited to offset 80% of taxable income in future years. Thus, 80% of the U.S. federal deferred tax liability related to goodwill was able to be used to offset the valuation allowance as of December 31, 2019. In accordance with the Coronavirus Aid, Relief, and Economic Security Act of 2020, however, losses generated in 2018 through 2020 may now offset 100% of taxable income in future years. Since the Company’s losses generated in 2018 through 2020 are greater than the book vs. tax basis difference related to goodwill, all of the U.S. federal deferred tax liability related to goodwill may be used to offset the valuation allowance as of December 31, 2020. This resulted in a reduction of the deferred tax liability of approximately $ 0.2 million during the year ended December 31, 2020. The Company files income tax returns in various states including New York, Massachusetts, and Pennsylvania, which provide for a 20-year loss carryforward before expiration. Thus, none of the U.S. state deferred tax liability related to goodwill may be used to offset the valuation allowance. As such, approximately $ 0.3 million of the deferred tax liability cannot be used to offset the valuation allowance for U.S. state income tax purposes. Other than the $ 0.2 million deferred tax benefit mentioned above, no provision or benefit for federal or state income taxes has been recorded during the year ended December 31, 2020, as the Company has incurred a net loss for all of the periods presented, and the Company has provided a full valuation allowance against its deferred tax assets. The income tax (benefit) expense differs from the (benefit) expense that would result from applying federal statutory rates to loss before income taxes as follows (in thousands): For the Years Ended December 31, 2020 2019 Amount Rate Amount Rate Expected federal statutory income tax $ ( 22,862 ) 21.0 % $ ( 12,897 ) 21.0 % State income taxes, net of federal benefits ( 9,733 ) 8.9 % 1,700 - 2.8 % Adjustment to deferred tax assets related to ownership change — 0.0 % 26,287 - 42.8 % Adjustment to deferred tax assets 1,013 - 0.9 % 469 - 0.8 % Change in valuation allowance 31,400 - 28.8 % ( 15,513 ) 25.3 % Income tax (benefit) expense $ ( 182 ) 0.2 % $ 46 - 0.1 % Deferred income tax (benefit) expense results primarily from the timing of temporary differences between the tax and financial statement carrying amounts of goodwill. The net deferred tax asset and liability in the accompanying consolidated balance sheets consists of the following components (in thousands): For the Years Ended December 31, 2020 2019 Deferred tax assets Net operating loss carryforward $ 106,848 $ 96,924 Foreign tax credit carryforward 631 631 Capitalized research and development 104,876 92,265 Share-based compensation 24,908 22,846 Depreciation 1,198 1,039 Intangibles 22,073 24,647 Right of use lease liability 5,684 6,677 Other 788 250 Total deferred tax assets 267,006 245,279 Deferred tax liabilities Goodwill ( 972 ) ( 461 ) Right of use lease asset ( 4,636 ) ( 5,531 ) Unrealized gain on MeiraGTx equity securities investment ( 1,677 ) ( 7,604 ) Change in fair value of warrant liabilities — ( 3,536 ) Total deferred tax liabilities ( 7,285 ) ( 17,132 ) Total deferred tax assets, net 259,721 228,147 Valuation allowance ( 259,999 ) ( 228,608 ) Deferred tax liability $ ( 278 ) $ ( 461 ) At December 31, 2020, the Company has unused federal and state net operating loss (“NOL”) carryforwards of $ 408.4 million and $ 349.6 million, respectively, that may be applied against future taxable income. Approximately $ 291.1 million of the federal NOL carryforwards expire at various dates through December 31, 2037, and approximately $ 117.3 million of federal net operating loss carryforwards will not expire. Approximately all of the $ 349.6 million state NOL carryforwards expire at various dates through December 31, 2040. The 20-year limitation was eliminated for federal losses generated after January 1, 2018, giving the taxpayer the ability to carry forward federal losses indefinitely. However, federal NOL carryforwards arising after January 1, 2021, are limited to 80 percent of taxable income. The use of the Company’s NOL carryforwards may, however, be subject to limitations as a result of an ownership change. A corporation undergoes an “ownership change,” in general, if a greater than 50% change (by value) in its equity ownership by one or more five - percent stockholders (or certain groups of non - five - percent stockholders) over a three - year period occurs. After such an ownership change, the corporation’s use of its pre - change NOL carryforwards and other pre - change tax attributes to offset its post - change income is subject to an annual limitation determined by the equity value of the corporation on the date the ownership change occurs multiplied by a rate determined monthly by the Internal Revenue Service. The Company experienced ownership changes under Section 382 of the Code in 2010, 2011 and 2016, but the Company did not reduce the gross deferred tax assets related to the NOL carryforwards because the limitations do not hinder the Company’s ability to potentially utilize all of the NOL carryforwards. The Company also experienced an ownership change under Section 382 of the Code in 2019, as a result of equity offerings. This ownership change reduced the Company’s ability to potentially utilize all of the NOL carryforwards and, consequently, resulted in a reduction to the Company’s gross deferred tax assets and related valuation allowance of $ 125.2 million during November 2019. If an additional ownership change occurred in the future and if the Company earned net taxable income, the Company’s ability to use its pre - change NOLs to offset U.S. federal taxable income would be subject to these limitations, which could potentially result in increased future tax liability compared to the tax liability the Company would incur if its use of NOL carryforwards were not so limited. In addition, for state income, franchise and similar tax purposes, there may be periods during which the use of NOL carryforwards is suspended or otherwise limited, which could accelerate or permanently increase the Company’s state income, franchise or similar taxes. In accordance with ASC 740, “Income Taxes,” the Company recorded a valuation allowance to fully offset the gross deferred tax asset, because it is more likely than not that the Company will not realize future benefits associated with these deferred tax assets at December 31, 2020 and 2019. The change in deferred tax liability has been recognized as an income tax expense and benefit in the consolidated statements of operations for the years ended December 31, 2020 and 2019, respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | 17. Subsequent Events CLOVIQUE ANDA Sale The Company currently 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”). Trientine hydrochloride is used for the treatment of Wilson’s disease in patients who are intolerant of penicillamine. In February 2021, the Company entered into an agreement to divest the CLOVIQUE ANDA’s and associated US-based patents and trademarks for $ 0.1 million, with the opportunity to earn up to $ 1.0 million more per year, for 3 years post-relaunch, in the form of backend sales-related payment. The Company does not expect this to have a significant impact on the consolidated financial statements as the revenues derived from CLOVIQUE in 2020 and 2019 were $ 1.6 million and $ 0.4 million, respectively, and Kadmon will have the right to reference, and to continue to market and sell, under the CLOVIQUE ANDAs until such time as it has exhausted its existing inventory. Convertible Senior Notes On February 16, 2021, the Company issued $ 240.0 million aggregate principal amount of 3.625 % convertible senior notes due 2027 (the "Notes"), pursuant to an Indenture dated February 16, 2021 (the “Indenture”), between Kadmon and U.S. Bank National Association, as trustee (the “Trustee”), in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. The Notes issued in the Note Offering include $ 40.0 million in aggregate principal amount of Notes sold to the initial purchasers (the “Initial Purchasers”) resulting from the exercise in full of their option to purchase additional Notes. Kadmon received net proceeds from the Note Offering of approximately $ 232.8 million, after deducting the Initial Purchasers’ discount. This transaction will be recorded in the first quarter of 2021 and the accounting for the transaction is not yet finalized. The Notes are senior, unsecured obligations of Kadmon and will accrue interest payable semiannually in arrears on February 15 and August 15 of each year, beginning on August 15, 2021, at a rate of 3.625 % per year. The Notes will mature on February 15, 2027, unless earlier converted or repurchased. Upon maturity, the Notes are convertible into cash, shares of Kadmon’s common stock or a combination of cash and shares of Kadmon’s common stock, at Kadmon’s election. The conversion rate will initially be 143.7815 shares of Kadmon’s common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $ 6.96 per share of Kadmon’s common stock, for a total of approximately 34,507,560 shares). Capped Call Transactions with Respect to the Notes On February 10, 2021, concurrently with the pricing of the Notes, the Company entered into privately negotiated capped call transactions (the “Capped Call Transactions”) with certain financial institutions (the “Capped Call Counterparties”). The Company used approximately $ 33.0 million of the net proceeds from the Note Offering to pay for the cost of the Capped Call Transactions. The Capped Call Transactions are expected generally to reduce the potential dilution to Kadmon’s common stock upon any conversion of Notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted Notes, as the case may be, with such reduction and/or offset subject to a cap initially equal to $ 10.70 (which represents a premium of 100 % over the last reported sale price of Kadmon’s common stock on February 10, 2021) and is subject to certain adjustments under the terms of the Capped Call Transactions. The Capped Calls cover 34,507,560 shares of our common stock (subject to anti-dilution and certain other adjustments), which is the same number of shares of common stock that initially underlie the Notes. The Capped Calls have an initial strike price of approximately $ 6.96 per share, which corresponds to the initial conversion price of the Notes. The Capped Call Transactions are separate transactions, entered into by us with the Capped Call Counterparties, and are not part of the terms of the Notes. The accounting for these Capped Call instruments is not finalized. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policy) | 12 Months Ended |
Dec. 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 the products and the regulatory environment in which the Company operates. |
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 conformity with accounting principles generally accepted in the United States of America (“GAAP”), and pursuant to the rules and regulations of the SEC. 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. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Actual results could differ from those estimates. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with FASB ASC 606, Revenue from Contracts with Customers (“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. The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s balance sheet. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. 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 year ended December 31, 2020 (in thousands): Years Ended December 31, 2020 2019 Product sales $ 1,665 420 License revenue 6,000 4,000 Other revenue 623 675 Total revenue $ 8,288 5,095 Product Sales These contracts typically include a single promise to deliver a fixed amount of product to the customer with payment due within 30 days of shipment. Revenues are recognized when control of the promised goods is transferred to the customer, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods. 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 December 31, 2020. Sales Returns Reserve, Reserve for Wholesaler Chargebacks and Rebates, and Rebates Payable As is typical in the pharmaceutical industry, gross product sales are subject to a variety of deductions, primarily representing rebates, chargebacks, returns, and discounts to government agencies, wholesalers, and managed care organizations. These deductions represent management’s best estimates of the related reserves and, as such, judgment is required when estimating the impact of these sales deductions on gross sales for a reporting period. If estimates are not representative of the actual future settlement, results could be materially affected. The Company did no t have any significant expense related to these sales deductions during 2020 or 2019. License Revenue The terms of these license agreements typically may include payment to the Company of one or more of the following: nonrefundable, up-front license fees, research, development and commercial milestone payments; and other contingent payments due based on the activities of the counterparty or the reimbursement by licensees of costs associated with patent maintenance. Each of these types of revenue are recorded as license revenues in the Company’s statement of operations. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each arrangement, the Company performs the following steps: i. identify the promised goods and services in the contract; ii. determine whether the promised goods or services are performance obligations, including whether they are distinct within the context of the contract; iii. measure the transaction price, including the constraint on variable consideration; iv. allocate the transaction price to the performance obligations; and v. recognize revenue when (or as) performance obligations are satisfied. See Note 11, “License Agreements” for additional details regarding the Company’s license arrangements. As part of the accounting for these arrangements, the Company allocates the transaction price to each performance obligation on a relative stand-alone selling price basis. The stand-alone selling price may be, but is not presumed to be, the contract price. In determining the allocation, the Company maximizes the use of observable inputs. When the stand-alone selling price of a good or service is not directly observable, the Company estimates the stand-alone selling price for each performance obligation using assumptions that require judgment. Acceptable estimation methods include, but are not limited to: (i) the adjusted market assessment approach, (ii) the expected cost plus margin approach, and (iii) the residual approach (when the stand-alone selling price is not directly observable and is either highly variable or uncertain). In order for the residual approach to be used, the Company must demonstrate that (a) there are observable stand-alone selling prices for one or more of the performance obligations and (b) one of the two criteria in ASC 606-10- 32-34(c)(1) and (2) is met. The residual approach cannot be used if it would result in a stand-alone selling price of zero for a performance obligation as a performance obligation, by definition, has value on a stand-alone basis. An option in a contract to acquire additional goods or services gives rise to a performance obligation only if the option provides a material right to the customer that it would not receive without entering into that contract. Factors that the Company considers in evaluating whether an option represents a material right include, but are not limited to: (i) the overall objective of the arrangement, (ii) the benefit the collaborator might obtain from the arrangement without exercising the option, (iii) the cost to exercise the option (e.g. priced at a significant and incremental discount) and (iv) the likelihood that the option will be exercised. With respect to options determined to be performance obligations, the Company recognizes revenue when those future goods or services are transferred or when the options expire. The Company’s revenue arrangements may include the following: Up-front License Fees: If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of an agreement that includes research and development milestone payments, the Company evaluates whether each milestone is considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjust the Company’s estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license revenues and earnings in the period of adjustment. Research and Development Activities: If the Company is entitled to reimbursement from its collaborators for specified research and development activities or the reimbursement of costs associated with patent maintenance, the Company determines whether such funding would result in license revenues or an offset to research and development expenses. Royalties: If the Company is entitled to receive sales-based royalties from its collaborators, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, provided the reported sales are reliably measurable, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its collaboration and license arrangements. Supply Services: Arrangements that include a promise for future supply of drug substance or drug product or research services at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the licensee exercises these options, any additional payments are recorded in license revenues when the licensee obtains control of the goods, which is upon delivery, or as the services are performed. The Company receives payments from its licensees based on schedules established in each contract. Upfront payments and fees are recorded as deferred revenue upon receipt, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. Transaction Price Allocated to Future Performance Obligations ASC 606 requires that the Company disclose the aggregate amount of transaction price that is allocated to performance obligations that have not yet been satisfied as of December 31, 2020. The guidance provides certain practical expedients that limit this requirement. The Company has various contracts that meet the following practical expedients provided by ASC 606: 1. The performance obligation is part of a contract that has an original expected duration of one year or less. 2. Revenue is recognized from the satisfaction of the performance obligations in the amount billable to the customer. 3. The variable consideration is allocated entirely to a wholly unsatisfied performance obligation or to a wholly unsatisfied promise to transfer a distinct good or service that forms part of a single performance obligation. As of December 31, 2020, the Company had no performance obligations that had not yet been satisfied and therefore 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 10). The Company recognizes revenue related to sublease agreements as they are performed. |
Share-based Compensation Expense | Share-based Compensation Expense The Company’s accounting policy for share-based compensation is disclosed in Note 12 “Share-based Compensation”. |
Research and Development | Research and Development Expenses Costs incurred for research and development are expensed as incurred. Included in research and development expense are personnel related costs including stock-based compensation, expenditures for laboratory equipment and consumables, payments made pursuant to licensing and acquisition agreements, and the cost of conducting clinical trials. Expenses incurred associated with conducting clinical trials include, but are not limited to, drug development trials and studies, drug manufacturing, laboratory supplies, external research and overhead. The Company has entered into agreements with third parties to acquire technologies and pharmaceutical product candidates for development (Note 11). Such agreements generally require an initial payment by the Company when the contract is executed, and additional payments upon the achievement of certain milestones. Additionally, the Company may be obligated to make future royalty payments in the event the Company commercializes the pharmaceutical product candidate and achieves a certain sales volume. In accordance with FASB ASC Topic 730 - 10 - 55, Research and Development, expenditures for research and development, including upfront licensing fees and milestone payments associated with products that have not yet been approved by the FDA, are charged to research and development expense as incurred. Future contract milestone payments will be recognized as expense when achievement of the milestone is determined to be probable. Once a product candidate receives regulatory approval, subsequent license payments are recorded as an intangible asset. Research and development expense was $ 65.4 million and $ 56.5 million during the years ended December 31, 2020 and 2019, respectively. Accruals for Research and Development Expenses and Clinical Trials As part of the process of preparing its financial statements, the Company is required to recognize its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials . This process involves reviewing open contracts and purchase orders, communicating with the applicable personnel to identify services that have been performed on behalf of the Company and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual cost. These estimates are periodically confirmed and reconciled with the third parties providing the service. The majority of service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known to the Company at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2020 and 2019, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. |
Income Taxes | Income Taxes The Company’s accounting policy for income taxes is disclosed in Note 16 “Income Taxes”. |
Cash, Cash Equivalents And Marketable Debt Securities | Cash, Cash Equivalents and Marketable Debt Securities The Company considers all highly liquid securities with an original or remaining maturity of three months or less at the time of acquisition to be cash equivalents. Marketable debt securities are considered to be available-for-sale and are carried at fair market value. The estimated fair value of the available-for-sale marketable debt securities is determined based on quoted market prices or rates for similar instruments. Unrealized gains and losses, if any, are reported in accumulated other comprehensive income (loss). The cost of marketable debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in other (expense) income. Realized gains and losses, and declines in value judged to be other-than-temporary, if any, are also included in other (expense) income. Interest and dividends on available-for-sale securities are included in other income. The Company determines the appropriate classification of its investments in debt securities at the time of purchase. All of the Company’s debt securities are classified as available-for-sale and are reported as short-term or long-term based on maturity dates and whether such assets are reasonably expected to be realized in cash or sold or consumed during the normal cycle of business. The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations if the Company experienced a credit loss and have the intent to sell the investment or if it is more likely than not that the Company will be required to sell the investment before recovery of the amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company’s investment policy, the severity and the duration of the impairment and changes in value subsequent to the end of the period. The following tables summarize the Company’s cash, cash equivalents and marketable debt securities as of December 31, 2020 and 2019: December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash and money market funds $ 71,382 $ — $ — 71,382 Corporate debt securities 3,041 — — 3,041 Total cash and cash equivalents 74,423 — — 74,423 Marketable debt securities: Corporate debt securities 49,463 4 ( 32 ) 49,435 Total marketable debt securities 49,463 4 ( 32 ) 49,435 Total cash, cash equivalents and marketable debt securities $ 123,886 $ 4 $ ( 32 ) $ 123,858 December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash and money market funds $ 139,597 $ — $ — 139,597 Total cash and cash equivalents 139,597 — — 139,597 Marketable debt securities: Corporate debt securities — — — — Total marketable debt securities — — — — Total cash, cash equivalents and marketable debt securities $ 139,597 $ — $ — $ 139,597 At December 31, 2020, the Company had invested in 18 available-for-sale marketable debt securities that were in an unrealized loss position for less than one year and no securities were in an unrealized loss position for more than 12 months. The aggregate fair value of debt securities in an unrealized loss position at December 31, 2020 was $ 35.7 million. The unrealized losses of less than $ 0.1 million related to these corporate debt securities were included in accumulated other comprehensive loss as of December 31, 2020. Unrealized losses on corporate debt securities have not been recognized into income because the issuers’ bonds are of high credit quality (rated A3/A- or higher), it is likely that management will not be required to sell the securities prior to their anticipated recovery, and the decline in fair value is largely due to market conditions and/or changes in interest rates. The issuers continue to make timely interest payments on the bonds. The fair value is expected to recover as the bonds approach maturity and the Company does not believe any unrealized losses represent other-than-temporary impairments. Accrued interest receivable on available-for-sale marketable debt securities totaled $ 0.4 million at December 31, 2020 and is included in prepaid expenses and other current assets. |
Restricted Cash | Restricted Cash The Company has a lease agreement for the premises it occupies in New York. A secured letter of credit in lieu of a lease deposit totaling $ 2.0 million is secured by restricted cash in the same amount at December 31, 2020 and 2019. The secured letter of credit will remain in place for the life of the related lease, expiring in October 2025 (Note 8). The Company also has a lease agreement for the premises it occupies in Massachusetts. A secured letter of credit in lieu of a lease deposit totaling approximately $ 0.1 million is secured by restricted cash in the same amount at December 31, 2020 and 2019. The secured letter of credit will remain in place for the life of the related lease, expiring in April 2023 (Note 8). |
Concentration Of Credit Risk | Concentration of Credit Risk The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company regularly monitors the financial condition of the institutions in which it has depository accounts and believes the risk of loss is minimal as these banks are large financial institutions. The Company has no off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. |
Accounts Receivable And Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount, net of an allowance for doubtful accounts. A receivable is recognized in the period the Company deliver goods or provide services or when the Company’s right to consideration is unconditional. The Company reviews the collectability of accounts receivable based on an assessment of historical experience, current economic conditions, and other collection indicators. The Company had no significant allowance for doubtful accounts at December 31, 2020 or December 31, 2019. When accounts are determined to be uncollectible they are written off against the reserve balance and the reserve is reassessed. When payments are received on reserved accounts they are applied to the customer’s account and the reserve is reassessed. |
Inventories | Inventories The Company’s accounting policy for inventories is disclosed in Note 7 “Inventories”. |
Investment In Equity Securities | Investment in Equity Securities Equity securities consist of investments in common stock of companies traded on public markets (Note 10). These shares are carried on the Company’s balance sheet at fair value based on the closing price of the shares owned on the last trading day before the balance sheet of this report. Fluctuations in the underlying bid price of the shares result in unrealized gains or losses. In accordance with FASB ASC 321, Investments – Equity Securities (“ASC 321”), the Company recognizes these fluctuations in value as other expense (income). For investments sold, the Company recognizes the gains and losses attributable to these investments as realized gains or losses in other expense (income). The Company’s total investment balance in equity securities totaled $ 10.6 million and $ 42.0 million at December 31, 2020 and 2019, respectively. |
Investments | Investments The Company follows FASB ASC Topic 323, “Investments—Equity Method and Joint Ventures” (“ASC 323”), in accounting for its investments in a joint venture. In the event the Company’s share of the joint venture’s net losses reduces the Company’s investment to zero, the Company will discontinue applying the equity method and will not provide for additional losses unless the Company has guaranteed obligations of the joint venture or is otherwise committed to provide further financial support for the joint venture. If the joint venture subsequently reports net income, the Company will resume applying the equity method only after its share of that net income equals the share of net losses not recognized during the period the equity method was suspended. The Company follows FASB ASC Topic 325, “Investments—Other” (“ASC 325”), in accounting for its investment in the stock of another company accounted for as cost method investments. The Company currently only has one such investment, which is measured in accordance with the “practicability election” allowable for investments without a readily determinable fair value that do not qualify for the NAV practical expedient under ASC 820, “Fair Value Measurement”. This requires investments to be measured at cost minus impairment, plus or minus changes resulting from observable price changes in orderly transactions for an identical or similar investment of the same issuer. In the event further contributions or additional shares are purchased, the Company will increase the basis in the investment. In the event distributions are made or indications exist that the fair value of the investment has decreased below the carrying amount, the Company will decrease the value of the investment as considered appropriate. The Company’s cost method investment balance totaled $ 2.3 million at both December 31, 2020 and 2019, respectively. For all non - consolidated investments, the Company will continually assess the applicability of FASB ASC Topic 810, “Consolidation” (“ASC 810”), to determine if the investments qualify for consolidation. At December 31, 2020 and 2019, no such investments qualified for consolidation. |
Fixed Assets | Fixed Assets The Company’s accounting policy for fixed assets is disclosed in Note 9 “Fixed Assets”. |
Goodwill | Goodwill The Company’s goodwill relates to the 2010 acquisition of Kadmon Pharmaceuticals, a Pennsylvania limited liability company that was formed in April 2000. Goodwill is not amortized, but rather is assessed for impairment annually or upon the occurrence of an event that indicates impairment may have occurred, in accordance with FASB ASC Topic 350 “Intangibles—Goodwill and Other”. The Company maintains a goodwill balance of $ 3.6 million at both December 31, 2020 and 2019. There were no changes in the carrying amount of goodwill and no impairment to goodwill was recorded for the years ended December 31, 2020 and 2019. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long - lived assets, including fixed assets and definite-lived intangible assets, are evaluated for impairment periodically, or when events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. When any such impairment exists, a charge is recorded in the statement of operations to adjust the carrying value of the related assets. The Company performed a trigger analysis over all other long - lived assets at the lowest identifiable level of cash flows and determined that no impairment triggers existed during the years ended December 31, 2020 and 2019. |
Accounting for Leases | Accounting for Leases The Company’s accounting policy for leases is disclosed in Note 8 “Leases”. |
Accounting for Contingencies | Accounting for Contingencies The Company follows the guidance of FASB ASC Topic 450, “Contingencies” (“ASC 450”), in accounting for contingencies. If some amount within a range of loss is probable and appears at the time to be a better estimate than any other amount within the range, that amount shall be recognized. If a loss is probable, and no amount within the range is a better estimate than any other amount, the estimated minimum amount in the range shall be recognized. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company follows the provisions of FASB ASC Topic 820, “Fair Value Measurements and Disclosures” (“ASC 820”). This pronouncement defines fair value, establishes a framework for measuring fair value under GAAP and requires expanded disclosures about fair value measurements. ASC 820 emphasizes that fair value is a market - based measurement, not an entity - specific measurement, and defines fair value as the price to sell an asset or transfer a liability in an orderly transaction between market participants at the measurement date. ASC 820 discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow) and the cost approach (cost to replace the service capacity of an asset or replacement cost). These valuation techniques are based upon observable and unobservable inputs. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect the Company’s market assumptions. ASC 820 utilizes a fair value hierarchy that prioritizes inputs to fair value measurement techniques into three broad levels. The following is a brief description of those three levels: Level 1: Observable inputs such as quoted prices for identical assets or liabilities in active markets. Level 2: Observable inputs other than quoted prices that are directly or indirectly observable for the asset or liability, including quoted prices for similar assets or liabilities in active markets; quoted prices for similar or identical assets or liabilities in markets that are not active; and model - derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3: Unobservable inputs that reflect the reporting entity’s own assumptions. The carrying amounts reported in the consolidated balance sheet for cash and cash equivalents, receivables, accounts payable and accrued expenses approximate their fair value based on the short-term nature of these instruments. The carrying amount reported in the consolidated balance sheet for investment in equity securities approximates fair value as the asset has a readily determinable market value (Note 10). |
Warrants and Derivative Liabilities | Warrants and Derivative Liabilities The Company accounts for its derivative financial instruments in accordance with FASB ASC Topic 815, Derivatives and Hedging (“ASC 815”). The Company does not have derivative financial instruments that are hedges. ASC 815 establishes accounting and reporting standards requiring that derivative instruments, both freestanding and embedded in other contracts, be recorded on the balance sheet as either an asset or liability measured at its fair value each reporting period. ASC 815 also requires that changes in the fair value of derivative instruments be recognized currently in the results of operations unless specific criteria are met. For embedded features that are not clearly and closely related to the host instrument, are not carried at fair value, and are derivatives, the feature will be bifurcated and recorded as an asset or liability as noted above, unless the exceptions below are met. Freestanding instruments that do not meet these exceptions will be accounted for in the same manner. ASC 815 provides an exception—if an embedded derivative or freestanding instrument is both indexed to the company’s own stock and classified in stockholders’ equity, it can be accounted for in stockholders’ equity. If at least one of the criteria is not met, the embedded derivative or warrant is classified as an asset or liability and recorded to fair value each reporting period through the income statement. The Company has historically issued warrants in connection with debt and equity issuances. The Company assesses classification of its warrants and embedded features at each reporting date to determine whether a change in classification is required. The Company’s accounting for its embedded warrants are explained further in Note 6. |
Related Party Transactions | Related Party Transactions Certain of the Company’s existing institutional investors purchased an aggregate of 10,444,117 shares of the Company’s common stock in the public offering that closed in November 2019. Consonance Capital Management LP purchased 4,900,000 shares of the Company’s common stock for $ 16.7 million, Perceptive Advisors LLC purchased 1,470,588 shares of the Company’s common stock for $ 5.0 million, Vivo Capital VIII LLC purchased 1,323,529 shares of the Company’s common stock for $ 4.5 million, Acuta Capital Partners LLC purchased 1,250,000 shares of the Company’s common stock for $ 4.3 million and Millenium Management LLC purchased 1,500,000 shares of the Company’s common stock for $ 5.1 million. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2020-06, “ Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity” (“ASU 2020-06”),which simplifies the guidance on an issuer’s accounting for convertible instruments and contracts in its own equity. The provisions of ASU 2020-06 are applicable for fiscal years beginning after December 15, 2021, with early adoption permitted no earlier than fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its financial statements. In December 2019, the FASB issued 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 also adds guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. 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 amendments also preclude 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 Accounting Standards Codification 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. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company does not expect the standard to have a significant impact on its consolidated financial statements . In 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) | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Significant Accounting Policies [Abstract] | |
Disaggregation of Revenue | Years Ended December 31, 2020 2019 Product sales $ 1,665 420 License revenue 6,000 4,000 Other revenue 623 675 Total revenue $ 8,288 5,095 |
Summary of Cash, Cash Equivalents and Marketable Debt Securities | December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash and money market funds $ 71,382 $ — $ — 71,382 Corporate debt securities 3,041 — — 3,041 Total cash and cash equivalents 74,423 — — 74,423 Marketable debt securities: Corporate debt securities 49,463 4 ( 32 ) 49,435 Total marketable debt securities 49,463 4 ( 32 ) 49,435 Total cash, cash equivalents and marketable debt securities $ 123,886 $ 4 $ ( 32 ) $ 123,858 December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash and money market funds $ 139,597 $ — $ — 139,597 Total cash and cash equivalents 139,597 — — 139,597 Marketable debt securities: Corporate debt securities — — — — Total marketable debt securities — — — — Total cash, cash equivalents and marketable debt securities $ 139,597 $ — $ — $ 139,597 |
Net Loss Per Share Attributab_2
Net Loss Per Share Attributable To Common Stockholders (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |
Computation of Basic and Diluted Net Income (Loss) per Share Attributable to Common Stockholders | Years Ended December 31, 2020 2019 Numerator – basic and diluted: Net loss attributable to common stockholders $ ( 111,035 ) $ ( 63,426 ) Denominator – basic and diluted: Weighted average common stock outstanding used to compute basic and diluted net loss per share 166,240,356 132,308,548 Net loss per share, basic and diluted $ ( 0.67 ) $ ( 0.48 ) |
Anti-dilutive Amounts Excluded From Calculation of Diluted Net Income (Loss) per Share | Years Ended December 31, 2020 2019 Options to purchase common stock 17,290,685 13,092,601 Warrants to purchase common stock 10,582,119 11,921,452 Convertible preferred stock 3,712,931 3,536,125 Total shares of common stock equivalents 31,585,735 28,550,178 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Financial Instruments [Abstract] | |
Fair Values of Financial Instruments | Fair Value Measurements Using Description Total Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents: Money market funds $ 67,467 $ 67,467 $ — $ — Corporate debt securities 3,041 — 3,041 — Short-term investments: Corporate debt securities 49,435 — 49,435 — Ownership of MeiraGTx 10,564 10,564 — — $ 130,507 $ 78,031 $ 52,476 $ — Financial liabilities Warrant liabilities $ 1,082 $ — $ 1,082 $ — The following table presents information about the Company’s financial assets and liabilities that have been measured at fair value at December 31, 2019 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): Fair Value Measurements Using Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Description Total Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash equivalents: Money market funds $ 136,058 $ 136,058 $ — $ — Short-term investments: Ownership of MeiraGTx 41,997 41,997 — — $ 178,055 $ 136,058 $ — $ — Financial liabilities Warrant liabilities $ 1,485 $ — $ 1,485 $ — |
Fair Value Assumptions | December 31, December 31, 2020 2019 Stock Price $ 4.15 $ 4.53 Strike price $ 3.30 - $ 4.50 $ 3.30 - $ 4.50 Expected Volatility 72.92 % 72.20 % Risk-free interest rate 0.12 % 1.62 % Expected term 1.7 years 2.7 years Expected dividend yield 0 % 0 % |
Rollforward of Level 2 Investments | Significant Other Observable Inputs (Level 2) Balance as of January 1, 2019 $ 524 Change in fair value of warrant liabilities 961 Balance as of December 31, 2019 $ 1,485 Change in fair value of warrant liabilities ( 403 ) Balance as of December 31, 2020 $ 1,082 |
Warrants Outstanding | Warrants Weighted Average Exercise Price Balance, January 1, 2019 11,999,852 $ 5.95 Exercised ( 78,400 ) 3.35 Balance, December 31, 2019 11,921,452 $ 5.97 Exercised ( 1,339,333 ) 3.35 Balance, December 31, 2020 10,582,119 $ 6.30 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventories [Abstract] | |
Schedule of Inventories | December 31, 2020 2019 Raw materials $ — $ 371 Finished goods, net 102 269 Total inventories $ 102 $ 640 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Quantitative Infromation Regarding Leases | Year Ended Year Ended Lease Cost Classification December 31, 2020 December 31, 2019 Operating lease cost (a) SG&A expenses $ 4,592 $ 4,632 Variable lease cost SG&A expenses 1,487 1,346 Sublease income (b) Other revenue ( 623 ) ( 674 ) Net Lease Cost $ 5,456 $ 5,304 Other Information Weighted average remaining lease term (years) 4.5 5.5 Weighted average discount rate 4.1 % 4.1 % (a) Includes short-term lease costs and finance leases costs, which are immaterial. (b) Includes sublease income related to MeiraGTx (Note 10). |
Schedule Of Future Lease Payments | Year ending December 31, Operating Leases Finance Leases 2021 $ 4,937 $ 25 2022 4,868 19 2023 4,174 14 2024 4,158 — 2025 3,573 — Thereafter — — Total Lease Payments $ 21,710 $ 58 Less: Imputed Interest ( 1,956 ) ( 10 ) Total Lease Liabilities $ 19,754 $ 48 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fixed Assets [Abstract] | |
Fixed Assets | Useful Lives December 31, December 31, (Years) 2020 2019 Leasehold improvements 4 - 8 $ 10,398 $ 10,397 Office equipment and furniture 3 - 15 1,363 1,234 Machinery and laboratory equipment 3 - 15 3,835 3,599 Software 1 - 5 4,136 3,971 Construction-in-progress ̶̶̶̶ — 45 19,732 19,246 Less accumulated depreciation and amortization ( 18,445 ) ( 16,802 ) Fixed assets, net $ 1,287 $ 2,444 |
Ownership of MeiraGTx Ordinar_2
Ownership of MeiraGTx Ordinary Shares (Tables) | 12 Months Ended |
Dec. 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 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 ordinary shares sold during the year ( 8,244 ) Realized gain on sale of ordinary shares ( 19,784 ) Unrealized loss on remaining ownership of ordinary shares ( 3,405 ) Balance as of December 31, 2020 $ 10,564 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 12 Months Ended |
Dec. 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, 2019 9,764,539 $ 6.24 7.84 $ — Granted 2,943,973 3.11 Exercised ( 92,334 ) 2.87 166 Forfeited ( 813,577 ) 4.63 Balance, December 31, 2019 11,802,601 $ 5.59 7.52 $ 9,520 Granted 5,027,540 4.35 Exercised ( 321,769 ) 3.11 438 Forfeited ( 507,687 ) 4.51 Balance, December 31, 2020 16,000,685 $ 5.29 7.11 $ 7,365 Options vested and exercisable, December 31, 2020 9,749,998 $ 6.04 5.97 $ 5,951 |
Weighted-average Fair Value of Stock Option Awards Granted | Years Ended December 31, 2020 December 31, 2019 Weighted average fair value of grants $ 2.86 $ 2.07 Expected volatility 75.46 % - 87.48 % 75.96 % - 77.73 % Risk-free interest rate 0.29 % - 1.64 % 1.41 % - 2.61 % Expected life 2.0 - 6.0 years 5.5 - 6.0 years Expected dividend yield 0 % 0 % |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accrued Expenses [Abstract] | |
Short-term Accrued Expenses | December 31, December 31, 2020 2019 Commission payable $ — $ 2,395 Compensation, benefits and severance 5,585 4,668 Research and development 4,183 4,962 Other 1,766 2,223 Total Accrued Expenses $ 11,534 $ 14,248 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes [Abstract] | |
Effective Income Tax Rate Reconciliation | For the Years Ended December 31, 2020 2019 Amount Rate Amount Rate Expected federal statutory income tax $ ( 22,862 ) 21.0 % $ ( 12,897 ) 21.0 % State income taxes, net of federal benefits ( 9,733 ) 8.9 % 1,700 - 2.8 % Adjustment to deferred tax assets related to ownership change — 0.0 % 26,287 - 42.8 % Adjustment to deferred tax assets 1,013 - 0.9 % 469 - 0.8 % Change in valuation allowance 31,400 - 28.8 % ( 15,513 ) 25.3 % Income tax (benefit) expense $ ( 182 ) 0.2 % $ 46 - 0.1 % |
Net Deferred Tax Assets and Liabilities | For the Years Ended December 31, 2020 2019 Deferred tax assets Net operating loss carryforward $ 106,848 $ 96,924 Foreign tax credit carryforward 631 631 Capitalized research and development 104,876 92,265 Share-based compensation 24,908 22,846 Depreciation 1,198 1,039 Intangibles 22,073 24,647 Right of use lease liability 5,684 6,677 Other 788 250 Total deferred tax assets 267,006 245,279 Deferred tax liabilities Goodwill ( 972 ) ( 461 ) Right of use lease asset ( 4,636 ) ( 5,531 ) Unrealized gain on MeiraGTx equity securities investment ( 1,677 ) ( 7,604 ) Change in fair value of warrant liabilities — ( 3,536 ) Total deferred tax liabilities ( 7,285 ) ( 17,132 ) Total deferred tax assets, net 259,721 228,147 Valuation allowance ( 259,999 ) ( 228,608 ) Deferred tax liability $ ( 278 ) $ ( 461 ) |
Organization (Narrative) (Detai
Organization (Narrative) (Details) - USD ($) | Feb. 16, 2021 | Feb. 10, 2021 | Jun. 12, 2018 | Jul. 31, 2020 | May 31, 2020 | Oct. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
Organization [Line Items] | ||||||||
Stock issued, shares | 11,060,786 | 46,216,805 | ||||||
Accumulated deficit | $ (444,104,000) | $ (333,069,000) | ||||||
Working capital | 107,800,000 | |||||||
Net cash used in operating activities | 87,529,000 | 80,067,000 | ||||||
Gross proceeds from common stock | 50,000,000 | $ 138,500,000 | ||||||
Cash, cash equivalents, and marketable securities | $ 123,900,000 | |||||||
Common Stock [Member] | ||||||||
Organization [Line Items] | ||||||||
Stock issued, shares | 11,060,786 | 46,216,805 | ||||||
MeiraGTx Ltd. [Member] | ||||||||
Organization [Line Items] | ||||||||
Stock issued, shares | 5,000,000 | 300,000 | 1,100,000 | 1,400,000 | ||||
Shares sold | 1,400,000 | |||||||
Proceeds from sale of shares | $ 22,000,000 | |||||||
Gross proceeds from common stock | $ 4,200,000 | $ 15,500,000 | ||||||
Proceeds from private placement, gross | $ 19,800,000 | |||||||
Subsequent Event [Member] | ||||||||
Organization [Line Items] | ||||||||
Cost of capped call | $ 33,000,000 | |||||||
Senior Notes Due 2027 [Member] | Subsequent Event [Member] | ||||||||
Organization [Line Items] | ||||||||
Borrowings, face amount | $ 240,000,000 | |||||||
Interest rate | 3.625% | |||||||
Proceeds from issuance of debt | $ 232,800,000 | |||||||
Initial Purchasers [Member] | Subsequent Event [Member] | ||||||||
Organization [Line Items] | ||||||||
Borrowings, face amount | $ 40,000,000 | |||||||
At Market Program [Member] | ||||||||
Organization [Line Items] | ||||||||
Stock issued, shares | 11,060,786 | |||||||
Stock issued, price per share | $ 4.52 | |||||||
Proceeds from private placement, gross | $ 48,400,000 | |||||||
Private placement, commisions payable | 1,600,000 | |||||||
At Market Program [Member] | Common Stock [Member] | ||||||||
Organization [Line Items] | ||||||||
Registration statement, authorized amount | 50,000,000 | |||||||
Registration Statement 2019 [Member] | ||||||||
Organization [Line Items] | ||||||||
Registration statement, authorized amount | 200,000,000 | |||||||
Registration statement, aggregate value of securities sold | 151,500,000 | |||||||
Registration Statement 2020 [Member] | ||||||||
Organization [Line Items] | ||||||||
Registration statement, authorized amount | 300,000,000 | |||||||
Registration Statement 2020 [Member] | Common Stock [Member] | ||||||||
Organization [Line Items] | ||||||||
Registration statement, authorized amount | $ 50,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2019USD ($)shares | Dec. 31, 2020USD ($)securitysegmentshares | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Number of operating segments | segment | 1 | |||
Sales returns expense | $ 0 | $ 0 | ||
Number of securities in unrealized loss position, less than a year | security | 18 | |||
Number of securities in unrealized loss position, more than 12 months | security | 0 | |||
Fair value of debt securities in unrealized loss positions | $ 35,700,000 | |||
Gross unrealized losses | 32,000 | |||
Accrued interest receivable | 400,000 | |||
Allowance for doubtful accounts | 0 | 0 | ||
Total investment balance | 2,300,000 | 2,300,000 | ||
Impairment of intangible assets | 0 | 0 | $ 0 | |
Goodwill | 3,580,000 | 3,580,000 | ||
Impairment to goodwill | 0 | 0 | ||
Research and development expense | 65,392,000 | 56,461,000 | ||
Investment, equity securities | $ 10,564,000 | $ 41,997,000 | ||
Stock issued, shares | shares | 11,060,786 | 46,216,805 | ||
Stock issued, value | $ 48,441,000 | $ 130,768,000 | ||
Net Sales [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Payment term | 30 days | |||
Maximum [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Gross unrealized losses | $ 100,000 | |||
Common Stock [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Stock issued, shares | shares | 11,060,786 | 46,216,805 | ||
Stock issued, value | $ 11,000 | $ 46,000 | ||
Institutional Investors [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Stock issued, shares | shares | 10,444,117 | |||
Consonance Capital Management LP [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Stock issued, shares | shares | 4,900,000 | |||
Stock issued, value | $ 16,700,000 | |||
Perceptive Advisors, LLC [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Stock issued, shares | shares | 1,470,588 | |||
Stock issued, value | $ 5,000,000 | |||
Vivo Capital VIII LLC [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Stock issued, shares | shares | 1,323,529 | |||
Stock issued, value | $ 4,500,000 | |||
Acuta Capital Partners LLC [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Stock issued, shares | shares | 1,250,000 | |||
Stock issued, value | $ 4,300,000 | |||
Millenium Management LLC [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Stock issued, shares | shares | 1,500,000 | |||
Stock issued, value | $ 5,100,000 | |||
Letter of Credit [Member] | New York [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Secured letter of credit | 2,000,000 | 2,000,000 | ||
Letter of Credit [Member] | Massachusetts [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Secured letter of credit | $ 100,000 | $ 100,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Disaggregation of Revenue) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 8,288 | $ 5,095 |
Net Sales [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 1,665 | 420 |
License Revenue [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 6,000 | 4,000 |
Other Revenue [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 623 | $ 675 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Summary of Cash, Cash Equivalents and Marketable Debt Securities) (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 123,886 | $ 139,597 |
Gross Unrealized Gains | 4 | |
Gross Unrealized Losses | (32) | |
Fair Value | 123,858 | 139,597 |
Corporate Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 49,435 | |
Cash and Cash Equivalents [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 74,423 | 139,597 |
Fair Value | 74,423 | 139,597 |
Cash and Cash Equivalents [Member] | Cash and Money Market Funds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 71,382 | 139,597 |
Fair Value | 71,382 | $ 139,597 |
Cash and Cash Equivalents [Member] | Corporate Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 3,041 | |
Fair Value | 3,041 | |
Marketable Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 49,463 | |
Gross Unrealized Gains | 4 | |
Gross Unrealized Losses | (32) | |
Fair Value | 49,435 | |
Marketable Debt Securities [Member] | Corporate Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 49,463 | |
Gross Unrealized Gains | 4 | |
Gross Unrealized Losses | (32) | |
Fair Value | $ 49,435 |
Stockholders_ Equity (Narrative
Stockholders’ Equity (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 08, 2016 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
Equity [Line Items] | |||||
Accrued dividends on preferred stock | $ 1,698 | $ 1,646 | |||
IPO price per share | $ 12 | ||||
Common stock, shares authorized | 400,000,000 | 400,000,000 | |||
Common stock, par value | $ 0.001 | $ 0.001 | |||
Gross proceeds from common stock | $ 50,000 | $ 138,500 | |||
Underwriting discounts and commissions | 1,600 | 7,700 | |||
Stock issued, value | $ 48,441 | $ 130,768 | |||
Stock issued, shares | 11,060,786 | 46,216,805 | |||
Price per share of common stock | $ 4.52 | $ 3 | |||
Convertible Preferred Stock [Member] | |||||
Equity [Line Items] | |||||
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||
Preferred Stock, Shares Issued | 30,000 | 28,708 | 28,708 | ||
Preferred stock outstanding | 28,708 | 28,708 | |||
Convertible preferred stock rate | 5.00% | ||||
Issuance per share | $ 1,000 | ||||
Liquidation preference | $ 30,000 | $ 34,800 | $ 33,100 | ||
Preferred stock conversion price | $ 9.60 | ||||
Beneficial conversion feature, discount percentage | 20.00% | ||||
Shares converted | 1,292 | ||||
Shares issued upon conversion | 154,645 | ||||
Shares issued for conversion | 3,712,931 | 3,536,125 | |||
Accrued dividends on preferred stock | $ 1,700 | $ 1,600 |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Common Stockholders (Computation of Basic and Diluted Net Income (Loss) per Share Attributable to Common Stockholders) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | ||
Net loss available to common stockholders - basic and diluted | $ (111,035) | $ (63,426) |
Weighted average common stock outstanding used to compute basic and diluted net loss per share | 166,240,356 | 132,308,548 |
Net loss per share, basic and diluted | $ (0.67) | $ (0.48) |
Net Loss per Share Attributab_4
Net Loss per Share Attributable to Common Stockholders (Anti-dilutive Amounts Excluded From Calculation of Diluted Net Income (Loss) per Share) (Details) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares of common stock equivalents | 31,585,735 | 28,550,178 |
Options To Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares of common stock equivalents | 17,290,685 | 13,092,601 |
Warrants Liabilities [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares of common stock equivalents | 10,582,119 | 11,921,452 |
Convertible Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares of common stock equivalents | 3,712,931 | 3,536,125 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) shares in Millions | 1 Months Ended | 12 Months Ended | ||||
Nov. 30, 2019USD ($) | Oct. 31, 2019USD ($)shares | Aug. 31, 2015USD ($)item | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of term debt | $ 3,057,000 | |||||
Term debt - current | 1,699,000 | |||||
Term debt - noncurrent | 1,359,000 | |||||
2015 Credit Agreement [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Interest expense | $ 3,400,000 | |||||
Debt repaid | $ 17,000,000 | $ 11,000,000 | ||||
Debt outstanding | $ 17,000,000 | 0 | $ 28,000,000 | |||
Cares Act Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of term debt | $ 3,100,000 | |||||
Interest rate | 1.00% | |||||
Term debt - current | $ 1,700,000 | |||||
Term debt - noncurrent | $ 1,400,000 | |||||
Secured Term Debt [Member] | 2015 Credit Agreement [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Total borrowings | $ 35,000,000 | |||||
Number of lenders | item | 2 | |||||
Secured Term Debt [Member] | London Interbank Offered Rate (LIBOR) [Member] | 2015 Credit Agreement [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument spread | 9.375% | |||||
Secured Term Debt [Member] | London Interbank Offered Rate (LIBOR) [Member] | Minimum [Member] | 2015 Credit Agreement [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument spread | 1.00% | |||||
MeiraGTx Ltd. [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Shares sold | shares | 1.4 | |||||
Proceeds from sale of shares | $ 22,000,000 |
Financial Instruments (Narrativ
Financial Instruments (Narrative) (Details) - USD ($) | Aug. 01, 2016 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2017 | Dec. 31, 2015 | Dec. 31, 2018 | Apr. 16, 2013 |
Financial Instruments [Line Items] | |||||||
Warrants fair value | $ 1,100,000 | $ 1,500,000 | |||||
Warrants outstanding, shares | 10,582,119 | 11,921,452 | 11,999,852 | ||||
Warrants Liabilities [Member] | |||||||
Financial Instruments [Line Items] | |||||||
Fair value of liability | $ 1,082,000 | $ 1,485,000 | |||||
2015 Credit Agreement [Member] | |||||||
Financial Instruments [Line Items] | |||||||
Additional unit warrants issued | 617,651 | ||||||
Strike price | $ 4.50 | $ 10.20 | |||||
Change in fair value of warrant | $ (400,000) | $ 1,000,000 | |||||
Warrants to purchase | $ 6,300,000 | ||||||
Warrants outstanding | $ 88,238 | ||||||
Warrants exercised | 0 | 0 | |||||
Third Amended and Restated Convertible Credit Agreement [Member] | |||||||
Financial Instruments [Line Items] | |||||||
Additional unit warrants issued | 351,992 | ||||||
Strike price | $ 10.20 | ||||||
Warrants exercised | 0 | ||||||
2015 Credit Agreement, Fifth Amendment [Member] | |||||||
Financial Instruments [Line Items] | |||||||
Strike price | $ 3.30 | ||||||
Warrants outstanding, shares | 529,413 | ||||||
Other Warrants [Member] | |||||||
Financial Instruments [Line Items] | |||||||
Strike price | $ 138.06 | $ 21.24 | |||||
Common units converted to warrants | 46,163 | ||||||
Warrants outstanding | $ 1,400,000 | ||||||
Warrants exercised | 0 | ||||||
Number of units for purchase | 30,000 | ||||||
2017 Public Offering [Member] | |||||||
Financial Instruments [Line Items] | |||||||
Warrants issued | 10,710,000 | ||||||
Strike price | $ 3.35 | ||||||
Warrant exercise price term | 5 years | ||||||
Warrants outstanding | $ 9,253,667 | ||||||
Proceeds from warrants exercises | $ 100,000 |
Financial Instruments (Fair Val
Financial Instruments (Fair Values of Financial Instruments) (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Financial Instruments [Line Items] | ||
Fair Value | $ 123,858 | $ 139,597 |
Equity securities fair value | 10,564 | 41,997 |
Financial assets | 130,507 | 178,055 |
Quoted Prices in Active Markets for Identical Items (Level 1) [Member] | ||
Financial Instruments [Line Items] | ||
Equity securities fair value | 10,564 | 41,997 |
Financial assets | 78,031 | 136,058 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Financial Instruments [Line Items] | ||
Financial assets | 52,476 | |
Money Market Funds [Member] | ||
Financial Instruments [Line Items] | ||
Cash equivalents | 67,467 | 136,058 |
Money Market Funds [Member] | Quoted Prices in Active Markets for Identical Items (Level 1) [Member] | ||
Financial Instruments [Line Items] | ||
Cash equivalents | 67,467 | 136,058 |
Corporate Debt Securities [Member] | ||
Financial Instruments [Line Items] | ||
Cash equivalents | 3,041 | |
Fair Value | 49,435 | |
Corporate Debt Securities [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Financial Instruments [Line Items] | ||
Cash equivalents | 3,041 | |
Fair Value | 49,435 | |
Warrants Liabilities [Member] | ||
Financial Instruments [Line Items] | ||
Financial liabilities | 1,082 | 1,485 |
Warrants Liabilities [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Financial Instruments [Line Items] | ||
Financial liabilities | $ 1,082 | $ 1,485 |
Financial Instruments (Fair V_2
Financial Instruments (Fair Value Assumptions) (Details) - item | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Expected term | 1 year 8 months 12 days | 2 years 8 months 12 days |
Stock Price [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants input | 4.15 | 4.53 |
Strike Price [Member] | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants input | 3.30 | 3.30 |
Strike Price [Member] | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants input | 4.50 | 4.50 |
Expected Volatility [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants input | 0.7292 | 0.7220 |
Risk Free Interest Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants input | 0.0012 | 0.0162 |
Expected Dividend YIeld [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants input | 0 | 0 |
Financial Instruments (Rollforw
Financial Instruments (Rollforward of Level 2 Investments) (Details) - Significant Other Observable Inputs (Level 2) [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Financial Instruments [Line Items] | ||
Balance | $ 1,485 | $ 524 |
Change in fair value of warrant liabilities | (403) | 961 |
Balance | $ 1,082 | $ 1,485 |
Financial Instruments (Warrants
Financial Instruments (Warrants Outstanding) (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Financial Instruments [Abstract] | ||
Warrants, Outstanding | 11,921,452 | 11,999,852 |
Warrants, Exercised | (1,339,333) | (78,400) |
Warrants, Outstanding | 10,582,119 | 11,921,452 |
Warrants, Weighted Average Exercise Price, Outstanding | $ 5.97 | $ 5.95 |
Warrant, Weighted Average Exercise Price, Exercised | 3.35 | 3.35 |
Warrants, Weighted Average Exercise Price, Outstanding | $ 6.30 | $ 5.97 |
Inventories (Narrative) (Detail
Inventories (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Inventories [Abstract] | ||
Reserve for expirable inventory | $ 2,100 | $ 3,000 |
Expensed inventory | 851 | $ 912 |
Loss on inventory purchase commitment | 300 | |
Loss on contract termination | $ 400 |
Inventories (Schedule of Invent
Inventories (Schedule of Inventories) (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventories [Abstract] | ||
Raw materials | $ 371 | |
Finished goods, net | 102 | 269 |
Total inventories | $ 102 | $ 640 |
Leases (Narrative) (Details)
Leases (Narrative) (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020USD ($)contract | Dec. 31, 2019USD ($) | |
Lessee, Lease, Description [Line Items] | ||
Number of operating leases | contract | 6 | |
Number of finance leases | contract | 2 | |
Number of leases utilizing short-term exception | contract | 2 | |
Right of use assets | $ 16,112 | $ 19,651 |
Current lease liability | 4,223 | 3,966 |
Noncurrent lease liability | $ 15,579 | 19,759 |
Minimum [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Incremental borrowing rate | 4.00% | |
Maximum [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Incremental borrowing rate | 5.60% | |
Letter of Credit [Member] | New York [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Secured letter of credit | $ 2,000 | $ 2,000 |
New York Property [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Number of lease amendments | contract | 6 | |
Operating lease cost | $ 4,800 | |
New York Property [Member] | Letter of Credit [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Secured letter of credit | $ 2,000 | |
Warrendale, Pennsylvania Property [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Number of renewal options | contract | 2 | |
Term of renewal option | 5 years | |
Operating lease cost | $ 700 | |
Cambridge, Massachusetts And Princeton, New Jersey Properties [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Secured letter of credit | 100 | |
Operating lease cost | $ 400 |
Leases (Quantitative Infromatio
Leases (Quantitative Infromation Regarding Leases) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | ||
Leases [Abstract] | |||
Operating lease cost | [1] | $ 4,592 | $ 4,632 |
Variable lease cost | 1,487 | 1,346 | |
Sublease Income | [2] | (623) | (674) |
Net Lease Cost | $ 5,456 | $ 5,304 | |
Weighted average remaining lease term (years) | 4 years 6 months | 5 years 6 months | |
Weighted average discount rate | 4.10% | 4.10% | |
[1] | Includes short-term lease costs and finance leases costs, which are immaterial. | ||
[2] | Includes sublease income related to MeiraGTx (Note 10). |
Leases (Schedule Of Future Leas
Leases (Schedule Of Future Lease Payments) (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Operating Leases | |
2021 | $ 4,937 |
2022 | 4,868 |
2023 | 4,174 |
2024 | 4,158 |
2025 | 3,573 |
Total Lease Payments | 21,710 |
Less: Imputed Interest | (1,956) |
Total Lease Liabilities | 19,754 |
Finance Leases | |
2021 | 25 |
2022 | 19 |
2023 | 14 |
Total Lease Payments | 58 |
Less: Imputed Interest | (10) |
Total Lease Liabilities | $ 48 |
Fixed Assets (Narrative) (Detai
Fixed Assets (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Fixed Assets [Abstract] | ||
Depreciation and amortization, fixed assets | $ 1,643 | $ 1,784 |
Fixed Assets (Fixed Assets) (De
Fixed Assets (Fixed Assets) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 19,732 | $ 19,246 |
Less accumulated depreciation and amortization | (18,445) | (16,802) |
Fixed assets, net | 1,287 | 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 | 1,363 | 1,234 |
Machinery and Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 3,835 | 3,599 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 4,136 | 3,971 |
Construction-in-progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 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 ($) | Jun. 12, 2018 | Jul. 31, 2020 | May 31, 2020 | Oct. 31, 2019 | Oct. 31, 2018 | Dec. 31, 2020 | Dec. 31, 2019 | Apr. 30, 2015 |
Investment Holdings [Line Items] | ||||||||
Investment, equity securities | $ 10,564,000 | $ 41,997,000 | ||||||
Stock issued, shares | 11,060,786 | 46,216,805 | ||||||
Sale of Stock, Price Per Share | $ 4.52 | $ 3 | ||||||
Unrealized (loss) gain on equity securities | $ (31,433,000) | $ 7,922,000 | ||||||
Accounts receivable, net | $ 695,000 | 954,000 | ||||||
MeiraGTx Ltd. [Member] | ||||||||
Investment Holdings [Line Items] | ||||||||
Ownership percentage | 1.60% | |||||||
License Agreement, MeiraGTx Ltd. [Member] | ||||||||
Investment Holdings [Line Items] | ||||||||
Service revenue to license | $ 600,000 | 600,000 | ||||||
Cash payments for service revenue | 600,000 | 600,000 | ||||||
Accounts receivable, net | 0 | 0 | ||||||
MeiraGTx Ltd. [Member] | ||||||||
Investment Holdings [Line Items] | ||||||||
Equity method investment, ownership percentage | 48.00% | |||||||
Investment, equity securities | $ 10,600,000 | |||||||
Equity securities fair value | $ 42,000,000 | |||||||
Stock issued, shares | 5,000,000 | 300,000 | 1,100,000 | 1,400,000 | ||||
Proceeds from private placement, gross | $ 19,800,000 | |||||||
Sale of Stock, Price Per Share | $ 15 | |||||||
Ownership percentage | 5.70% | |||||||
Unrealized (loss) gain on equity securities | $ (31,400,000) | $ 7,900,000 | ||||||
Shares sold | 1,400,000 | |||||||
Proceeds from sale of shares | $ 22,000,000 | |||||||
Monthly sublease rental | $ 50,000 |
Ownership of MeiraGTx Ordinar_4
Ownership of MeiraGTx Ordinary Shares (Schedule Of MeiraGTx Investment) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Ownership of MeiraGTx Ordinary Shares [Abstract] | ||
Balance | $ 41,997 | $ 34,075 |
Unrealized gain on investment sold during year | 8,244 | 8,148 |
Realized gain on sale of investment | (19,784) | (22,000) |
Unrealized gain on remaining ownership of ordinary shares | 21,774 | |
Unrealized loss on remaining ownership of ordinary shares | (3,405) | |
Balance | $ 10,564 | $ 41,997 |
License Agreements (Narrative)
License Agreements (Narrative) (Details) | Apr. 08, 2011USD ($) | Dec. 31, 2014shares | Jun. 30, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2020USD ($)item | Dec. 31, 2019USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Research and development expense | $ 65,392,000 | $ 56,461,000 | ||||
License Agreement, Nano Terra, Inc. [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
License revenue | $ 0 | $ 0 | ||||
Purchase of shares | $ 2,300,000 | |||||
Ownership percentage | 1.00% | 1.00% | ||||
Shares converted | shares | 100 | |||||
Equity method investment, impairment | $ 0 | |||||
License Agreement, Nano Terra, Inc. [Member] | Class B Units [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Purchase of shares | 2,300,000 | |||||
License Agreement, Nano Terra, Inc. [Member] | Minimum [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Estimated percentage of sublicensing revenue | 20.00% | |||||
License Agreement, Nano Terra, Inc. [Member] | Maximum [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Estimated percentage of sublicensing revenue | 40.00% | |||||
NT Life Sciences, LLC (“NT Life”) [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Purchase of shares | $ 900,000 | |||||
Ownership percentage | 50.00% | 50.00% | ||||
Estimated percentage of royalty based on net sales of products | 9.75% | |||||
Estimated percentage of sublicensing revenue | 5.00% | |||||
NT Life Sciences, LLC (“NT Life”) [Member] | Maximum [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Estimated percentage of sublicensing revenue | 10.00% | |||||
License Agreement, Dyax Corp. [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
License agreement, term | 2 years | |||||
Number of targets | item | 2 | |||||
Research and development expense | $ 1,500,000 | $ 1,500,000 | ||||
License Agreement, BioNova Pharmaceuticals Ltd [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential proceeds from partnership agreement | $ 41,000,000 | |||||
Milestone payment | $ 4,000,000 | |||||
Equity method investment, ownership percentage | 20.00% | 20.00% | ||||
License Agreement, Meiji Seika Pharma Co., Ltd [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential proceeds from partnership agreement | 23,000,000 | |||||
Milestone payment | $ 6,000,000 | |||||
Ownership percentage | 50.00% |
Share-based Compensation (Narra
Share-based Compensation (Narrative) (Details) | 1 Months Ended | 12 Months Ended | 24 Months Ended | |||
May 31, 2014 | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018employeeshares | Dec. 31, 2017itemshares | Dec. 31, 2015$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted average grant date fair value of options granted during the period (per share) | $ / shares | $ 2.86 | $ 2.07 | ||||
Performance Awards [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation expense | $ | $ 100,000 | |||||
Weighted average period for recognition of compensation expense | 3 months 18 days | |||||
Share based compensation, options granted | 0 | 0 | 1,597,000 | |||
Weighted average exercise price of options granted during the period (per share) | $ / shares | $ 4.06 | $ 4.06 | ||||
Share-based compensation, options outstanding, weighted average remaining contractual term (years) | 5 years 8 months 12 days | |||||
Share based compensation, options granted, aggregate intrinsic value | $ | $ 300,000 | $ 600,000 | ||||
Options vested | 962,502 | 853,335 | ||||
Common stock issued for stock option exercises, shares | 0 | 0 | ||||
Number of executives | employee | 3 | |||||
Options outstanding | 1,290,000 | 1,290,000 | ||||
Service period | 3 years | |||||
Options To Purchase Common Stock [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted average grant date fair value of options granted during the period (per share) | $ / shares | $ 2.86 | $ 2.07 | ||||
Share based compensation, options granted | 5,027,540 | 2,943,973 | ||||
Weighted average exercise price of options granted during the period (per share) | $ / shares | $ 4.35 | $ 3.11 | ||||
Share-based compensation, options outstanding, weighted average remaining contractual term (years) | 7 years 1 month 9 days | 7 years 6 months 7 days | 7 years 10 months 2 days | |||
Share based compensation, options granted, aggregate intrinsic value | $ | $ 7,365,000 | $ 9,520,000 | ||||
Common stock issued for stock option exercises, shares | 321,769 | 92,334 | ||||
Intrinsic value of options exercised | $ | $ 438,000 | $ 166,000 | ||||
Expected dividend yield | 0.00% | 0.00% | ||||
Options outstanding | 16,000,685 | 11,802,601 | 9,764,539 | |||
Stock Appreciation Rights [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation expense | $ | $ 0 | |||||
Share based compensation, options granted | 0 | 0 | 1,040,000 | |||
Weighted average exercise price of options granted during the period (per share) | $ / shares | $ 3.64 | $ 3.64 | ||||
Share-based compensation, options outstanding, weighted average remaining contractual term (years) | 5 years 7 months 6 days | |||||
Share based compensation, options granted, aggregate intrinsic value | $ | $ 500,000 | $ 700,000 | ||||
Options vested | 835,000 | 616,667 | ||||
Common stock issued for stock option exercises, shares | 0 | 0 | ||||
Number of executives | item | 3 | |||||
Options outstanding | 835,000 | 835,000 | ||||
2016 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Additional units available for grant | 6,861,201 | 5,591,600 | ||||
Increase in authorized shares as a percentage of common stock issued | 4.00% | |||||
Shares authorized for issuance | 21,785,738 | |||||
Shares available for grant | 3,973,996 | |||||
Unrecognized compensation expense | $ | $ 11,900,000 | $ 6,500,000 | ||||
Weighted average period for recognition of compensation expense | 1 year 10 months 24 days | 2 years 2 months 12 days | ||||
Stock compensation expense | $ | $ 9,400,000 | $ 7,200,000 | ||||
Vesting period | 3 years | |||||
Exercise period | 10 years | |||||
2014 Long-Term Incentive Plan (“LTIP”) [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares issuable, settlement in stock | 3,478,057 | |||||
Equity instruments granted | 9,750 | 9,750 | ||||
Equity instrument payable, common stock value percent above grant price | 333.00% | |||||
Equity instrument payable, common stock value | $ / shares | $ 20 | |||||
2014 Long-Term Incentive Plan (“LTIP”) [Member] | Equity Appreciation Rights Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for grant | 0 | |||||
Share based compensation, options granted | 0 | 9,750 | ||||
Weighted average exercise price of options granted during the period (per share) | $ / shares | $ 6 | |||||
Exercise price | $ / shares | $ 6 | |||||
Exercise period | 10 years | |||||
Equity instruments number of shares authorized as a percentage of equity value | 10.00% | |||||
2016 Employee Stock Purchase Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Additional units available for grant | 750,000 | |||||
Increase in authorized shares as a percentage of common stock issued | 1.50% | |||||
Shares authorized for issuance | 2,551,180 | |||||
Shares available for grant | 2,235,354 | |||||
Share based compensation, options granted | 164,614 | 88,619 | ||||
Stock compensation expense | $ | $ 0 | $ 0 | ||||
Class A [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock, price per share | $ / shares | $ 4.15 | $ 4.53 | ||||
Maximum [Member] | 2016 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Increase in authorized shares as a percentage of common stock issued | 4.00% |
Share-based Compensation (Stock
Share-based Compensation (Stock Options Outstanding) (Details) - Options To Purchase Common Stock [Member] - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options Outstanding, Units, Beginning Balance | 11,802,601 | 9,764,539 | |
Options Outstanding, Units, Granted | 5,027,540 | 2,943,973 | |
Options Outstanding, Units, Exercised | (321,769) | (92,334) | |
Options Outstanding, Units, Forfeited | (507,687) | (813,577) | |
Options Outstanding, Units, Ending Balance | 16,000,685 | 11,802,601 | 9,764,539 |
Options Vested and Exercisable, Units | 9,749,998 | ||
Options Outstanding, Weighted Average Exercise Price, Beginning Balance | $ 5.59 | $ 6.24 | |
Options Outstanding, Weighted Average Exercise Price, Granted | 4.35 | 3.11 | |
Options Outstanding, Weighted Average Exercise Price, Exercised | 3.11 | 2.87 | |
Options Outstanding, Weighted Average Exercise Price, Forfeited | 4.51 | 4.63 | |
Options Outstanding, Weighted Average Exercise Price, Ending Balance | 5.29 | $ 5.59 | $ 6.24 |
Options Vested and Exercisable, Weighted Average Exercise Price | $ 6.04 | ||
Options Outstanding, Weighted Average Remaining Contractual Term (years) | 7 years 1 month 9 days | 7 years 6 months 7 days | 7 years 10 months 2 days |
Options Vested and Exercisable, Weighted Average Remaining Contractual Term (years) | 5 years 11 months 19 days | ||
Options Outstanding, Aggregate Intrinsic Value | $ 7,365 | $ 9,520 | |
Options exercised, Aggregate Intrinsic Value | 438 | $ 166 | |
Options Vested and Exercisable, Aggregate Intrinsic Value | $ 5,951 |
Share-based Compensation (Weigh
Share-based Compensation (Weighted-average Fair Value of Stock Option Awards Granted) (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value of grants | $ 2.86 | $ 2.07 |
Options To Purchase Common Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value of grants | $ 2.86 | $ 2.07 |
Expected dividend yield | 0.00% | 0.00% |
Options To Purchase Common Stock [Member] | Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 75.46% | 75.96% |
Risk-free interest rate | 0.29% | 1.41% |
Expected life (years) | 2 years | 5 years 6 months |
Options To Purchase Common Stock [Member] | Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 87.48% | 77.73% |
Risk-free interest rate | 1.64% | 2.61% |
Expected life (years) | 6 years | 6 years |
Accrued Expenses (Narrative) (D
Accrued Expenses (Narrative) (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Commission Payable [Member] | |
Short-Term Accrued Expenses [Line Items] | |
Non-cash gain on settlement of obligation | $ 2.4 |
Terminated License Agreement [Member] | |
Short-Term Accrued Expenses [Line Items] | |
Non-cash gain on settlement of obligation | $ 1 |
Accrued Expenses (Short-term Ac
Accrued Expenses (Short-term Accrued Expenses) (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accrued Expenses [Abstract] | ||
Commission payable | $ 2,395 | |
Compensation, benefits and severance | $ 5,585 | 4,668 |
Research and development | 4,183 | 4,962 |
Other | 1,766 | 2,223 |
Total Accrued Expenses | $ 11,534 | $ 14,248 |
Employee Benefit Plan (Narrativ
Employee Benefit Plan (Narrative) (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Employee Benefit Plan [Abstract] | ||
Participating employees maximum compensation deferral percentage | 75.00% | |
Employee contributions matching percentage | 6.00% | |
Expensed employer matching contributions | $ 0.2 | $ 0.3 |
Employer matching contributions disbursements | $ 0.3 | $ 0.2 |
Commitments and Contingencies (
Commitments and Contingencies (Narrative) (Details) | Dec. 31, 2020USD ($) |
Commitments and Contingencies [Abstract] | |
Additional contingent milestone payments | $ 229,100,000 |
Accrual for potential loss | $ 0 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Line Items] | ||
Income tax (benefit) expense | $ (182) | $ 46 |
Deferred tax liability | 278 | 461 |
Tax Cuts and Jobs Act of 2017, Deferred Income Tax Benefit | 200 | |
Operating loss carryforwards, no expiration | 117,300 | |
Reduction of operating loss carryforwards | 125,200 | |
Maximum [Member] | ||
Income Tax Disclosure [Line Items] | ||
Income tax (benefit) expense | $ 100 | |
Federal [Member] | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | 408,400 | |
Operating loss carryforwards, no expiration | 291,100 | |
State [Member] | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | $ 349,600 |
Income Taxes (Effective Income
Income Taxes (Effective Income Tax Rate Reconciliation) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes [Abstract] | ||
Expected federal statutory income tax | $ (22,862) | $ (12,897) |
State income taxes, net of federal benefits | (9,733) | 1,700 |
Adjustment to deferred tax assets related to ownership change | 26,287 | |
Adjustment to deferred tax assets | 1,013 | 469 |
Change in valuation allowance | 31,400 | (15,513) |
Income tax expense (benefit) | $ (182) | $ 46 |
Expected federal statutory income tax, Percent | 21.00% | 21.00% |
State income taxes, net of federal benefits, Percent | 8.90% | (2.80%) |
Adjustment to deferred tax assets related to ownership change, Percent | 0.00% | (42.80%) |
Adjustment to deferred tax assets, Percent | (0.90%) | (0.80%) |
Change in valuation allowance, Percent | (28.80%) | 25.30% |
Income tax expense (benefit) , Percent | 0.20% | (0.10%) |
Income Taxes (Net Deferred Tax
Income Taxes (Net Deferred Tax Assets and Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets | ||
Net operating loss carryforward | $ 106,848 | $ 96,924 |
Foreign tax credit carryforward | 631 | 631 |
Capitalized research and development | 104,876 | 92,265 |
Share-based compensation | 24,908 | 22,846 |
Depreciation | 1,198 | 1,039 |
Intangibles | 22,073 | 24,647 |
Right of use lease liability | 5,684 | 6,677 |
Other | 788 | 250 |
Total deferred tax assets | 267,006 | 245,279 |
Deferred tax liabilities | ||
Goodwill | (972) | (461) |
Right of use lease asset | (4,636) | (5,531) |
Unrealized gain on MeiraGTx equity securities investment | (1,677) | (7,604) |
Change in fair value of warrant liabilities | (3,536) | |
Total deferred tax liabilities | (7,285) | (17,132) |
Total deferred tax assets, net | 259,721 | 228,147 |
Valuation allowance | (259,999) | (228,608) |
Deferred tax liability | $ (278) | $ (461) |
Subsequent Events (Narrative) (
Subsequent Events (Narrative) (Details) | Feb. 16, 2021USD ($)item$ / shares | Feb. 10, 2021USD ($)$ / sharesshares | Feb. 28, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Subsequent Event [Line Items] | |||||
Revenues | $ 8,288,000 | $ 5,095,000 | |||
Subsequent Event [Member] | |||||
Subsequent Event [Line Items] | |||||
Cost of capped call | $ 33,000,000 | ||||
Cap stock price | $ / shares | $ 10.70 | ||||
Coverage as a percent of share price | 100.00% | ||||
Shares covered by call | shares | 34,507,560 | ||||
Subsequent Event [Member] | Senior Notes Due 2027 [Member] | |||||
Subsequent Event [Line Items] | |||||
Borrowings, face amount | $ 240,000,000 | ||||
Interest rate | 3.625% | ||||
Proceeds from issuance of debt | $ 232,800,000 | ||||
Debt conversion ratio | 0.1437815 | ||||
Conversion price | $ / shares | $ 6.96 | ||||
Convertible debt, equity issuable | item | 34,507,560 | ||||
Subsequent Event [Member] | Initial Purchasers [Member] | |||||
Subsequent Event [Line Items] | |||||
Borrowings, face amount | $ 40,000,000 | ||||
CLOVIQUE [Member] | |||||
Subsequent Event [Line Items] | |||||
Revenues | $ 1,600,000 | $ 400,000 | |||
CLOVIQUE [Member] | Subsequent Event [Member] | |||||
Subsequent Event [Line Items] | |||||
Proceeds from sale of product line | $ 100,000 | ||||
Annual potential sales-related earnings | $ 1,000,000 | ||||
Period of potential post sale related earnings | 3 years |
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 |