Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 03, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-38650 | |
Entity Registrant Name | Y-mAbs Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 47-4619612 | |
Entity Address, Address Line One | 230 Park Avenue | |
Entity Address, Address Line Two | Suite 3350 | |
Entity Address, City or Town | New York | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10169 | |
City Area Code | 646 | |
Local Phone Number | 885-8505 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | YMAB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 43,576 | |
Entity Central Index Key | 0001722964 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 233,587 | $ 114,634 |
Accounts receivable, net | 8,517 | |
Inventories | 3,820 | |
Other current assets | 3,445 | 7,729 |
Total current assets | 249,369 | 122,363 |
Property and equipment, net | 1,919 | 1,825 |
Operating lease right-of-use assets | 3,398 | 4,569 |
Other assets | 4,793 | 3,290 |
TOTAL ASSETS | 259,479 | 132,047 |
LIABILITIES | ||
Accounts payable | 6,803 | 9,372 |
Accrued liabilities | 12,169 | 8,197 |
Operating lease liabilities, current portion | 2,014 | 1,966 |
Total current liabilities | 20,986 | 19,535 |
Accrued milestone and royalty payments | 2,250 | 2,695 |
Operating lease liabilities, long-term portion | 988 | 2,013 |
Other liabilities | 939 | 1,968 |
TOTAL LIABILITIES | 25,163 | 26,211 |
Commitments and contingencies (Note 8) | ||
STOCKHOLDERS' EQUITY | ||
Preferred stock, $0.0001 par value, 5,500,000 shares authorized at June 30, 2021 and December 31, 2020; none issued at June 30, 2021 and December 31, 2020 | ||
Common stock, $0.0001 par value, 100,000,000 shares authorized at June 30, 2021 and December 31, 2020; 43,576,950 and 40,688,447 shares issued at June 30, 2021 and December 31, 2020, respectively | 4 | 4 |
Additional paid in capital | 509,049 | 391,558 |
Accumulated other comprehensive loss | (13) | (526) |
Accumulated deficit | (274,724) | (285,200) |
TOTAL STOCKHOLDERS' EQUITY | 234,316 | 105,836 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 259,479 | $ 132,047 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized shares | 5,500,000 | 5,500,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized shares | 100,000,000 | 100,000,000 |
Common stock, shares issued | 43,576,950 | 40,688,447 |
Consolidated Statements of Net
Consolidated Statements of Net Income/(Loss) and Comprehensive Income/(Loss) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue, net | $ 10,951 | $ 16,334 | ||
OPERATING COSTS AND EXPENSES | ||||
Cost of goods sold | 200 | 293 | ||
Royalties | 210 | 210 | ||
Research and development | 19,778 | $ 30,059 | 41,357 | $ 48,681 |
Selling, general, and administrative | 13,475 | 10,393 | 25,445 | 18,519 |
Total operating costs and expenses | 33,663 | 40,452 | 67,305 | 67,200 |
Loss from operations | (22,712) | (40,452) | (50,971) | (67,200) |
OTHER INCOME, NET | ||||
Gain from sale of priority review voucher, net | 62,010 | |||
Interest and other income / (loss) | (225) | 59 | (563) | 628 |
NET INCOME / (LOSS) | (22,937) | (40,393) | 10,476 | (66,572) |
Other comprehensive income / (loss) | ||||
Foreign currency translation | 78 | (91) | 513 | (66) |
COMPREHENSIVE INCOME / (LOSS) | $ (22,859) | $ (40,484) | $ 10,989 | $ (66,638) |
Net income/(loss) per share attributable to common stockholders, basic (in dollars per share) | $ (0.53) | $ (1.01) | $ 0.25 | $ (1.67) |
Weighted average common shares outstanding, basic (in shares) | 43,569,482 | 39,972,174 | 42,724,813 | 39,862,878 |
Net income/(loss) per share attributable to common stockholders, diluted (in dollars per share) | $ (0.53) | $ (1.01) | $ 0.23 | $ (1.67) |
Weighted average common shares outstanding, diluted (in shares) | 43,569,482 | 39,972,174 | 45,080,419 | 39,862,878 |
Product | ||||
Revenue, net | $ 8,951 | $ 0 | $ 14,334 | $ 0 |
License | ||||
Revenue, net | $ 2,000 | $ 2,000 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income/(Loss) | Accumulated Deficit | Total |
Balance at the beginning of period at Dec. 31, 2019 | $ 4 | $ 364,712 | $ 50 | $ (165,863) | $ 198,903 |
Balance at the beginning of period (in shares) at Dec. 31, 2019 | 39,728,416 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Exercise of stock options | 370 | 370 | |||
Exercise of stock options (in shares) | 25,778 | ||||
Stock-based compensation expense | 2,211 | 2,211 | |||
Stock-based compensation expense (in shares) | 3,429 | ||||
Foreign currency translation | 25 | 25 | |||
Net income (loss) | (26,179) | (26,179) | |||
Balance at the end of period at Mar. 31, 2020 | $ 4 | 367,293 | 75 | (192,042) | 175,330 |
Balance at the end of period (in shares) at Mar. 31, 2020 | 39,757,623 | ||||
Balance at the beginning of period at Dec. 31, 2019 | $ 4 | 364,712 | 50 | (165,863) | 198,903 |
Balance at the beginning of period (in shares) at Dec. 31, 2019 | 39,728,416 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net income (loss) | (66,572) | ||||
Balance at the end of period at Jun. 30, 2020 | $ 4 | 378,455 | (16) | (232,435) | 146,008 |
Balance at the end of period (in shares) at Jun. 30, 2020 | 40,014,519 | ||||
Balance at the beginning of period at Mar. 31, 2020 | $ 4 | 367,293 | 75 | (192,042) | 175,330 |
Balance at the beginning of period (in shares) at Mar. 31, 2020 | 39,757,623 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock | 8,707 | 8,707 | |||
Issuance of common stock (in shares) | 256,896 | ||||
Stock-based compensation expense | 2,455 | 2,455 | |||
Foreign currency translation | (91) | (91) | |||
Net income (loss) | (40,393) | (40,393) | |||
Balance at the end of period at Jun. 30, 2020 | $ 4 | 378,455 | (16) | (232,435) | 146,008 |
Balance at the end of period (in shares) at Jun. 30, 2020 | 40,014,519 | ||||
Balance at the beginning of period at Dec. 31, 2020 | $ 4 | 391,558 | (526) | (285,200) | 105,836 |
Balance at the beginning of period (in shares) at Dec. 31, 2020 | 40,688,447 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock to investors, net of issuance costs | 107,725 | 107,725 | |||
Issuance of common stock to investors, net of issuance costs (in shares) | 2,804,878 | ||||
Exercise of stock options | 110 | 110 | |||
Exercise of stock options (in shares) | 46,000 | ||||
Stock-based compensation expense | 4,698 | 4,698 | |||
Stock-based compensation expense (in shares) | 9,094 | ||||
Foreign currency translation | 435 | 435 | |||
Net income (loss) | 33,413 | 33,413 | |||
Balance at the end of period at Mar. 31, 2021 | $ 4 | 504,091 | (91) | (251,787) | 252,217 |
Balance at the end of period (in shares) at Mar. 31, 2021 | 43,548,419 | ||||
Balance at the beginning of period at Dec. 31, 2020 | $ 4 | 391,558 | (526) | (285,200) | $ 105,836 |
Balance at the beginning of period (in shares) at Dec. 31, 2020 | 40,688,447 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Exercise of stock options (in shares) | 74,332 | ||||
Net income (loss) | $ 10,476 | ||||
Balance at the end of period at Jun. 30, 2021 | $ 4 | 509,049 | (13) | (274,724) | 234,316 |
Balance at the end of period (in shares) at Jun. 30, 2021 | 43,576,950 | ||||
Balance at the beginning of period at Mar. 31, 2021 | $ 4 | 504,091 | (91) | (251,787) | 252,217 |
Balance at the beginning of period (in shares) at Mar. 31, 2021 | 43,548,419 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Exercise of stock options | 131 | 131 | |||
Exercise of stock options (in shares) | 28,332 | ||||
Stock-based compensation expense | 4,827 | 4,827 | |||
Stock-based compensation expense (in shares) | 199 | ||||
Foreign currency translation | 78 | 78 | |||
Net income (loss) | (22,937) | (22,937) | |||
Balance at the end of period at Jun. 30, 2021 | $ 4 | $ 509,049 | $ (13) | $ (274,724) | $ 234,316 |
Balance at the end of period (in shares) at Jun. 30, 2021 | 43,576,950 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net income / (loss) | $ 10,476 | $ (66,572) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Gain from sale of priority review voucher, net | (62,010) | |
Depreciation and amortization | 346 | 186 |
Stock-based compensation | 9,525 | 4,665 |
Non-cash expense in connection with equity issuance to MSK/MIT | 1,331 | |
Non-cash expense in connection with equity issuance to inventors | 7,376 | |
Foreign currency transactions | 513 | (66) |
Changes in assets and liabilities: | ||
Accounts receivable, net | (8,517) | |
Inventories | (3,820) | |
Other current assets | 4,284 | (442) |
Other assets | (1,503) | 13 |
Accounts payable | (2,569) | 1,305 |
Accrued liabilities and other | 2,658 | 2,813 |
NET CASH USED IN OPERATING ACTIVITIES | (50,617) | (49,391) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of property and equipment | (441) | (28) |
Net proceeds from sale of priority review voucher | 62,010 | |
NET CASH PROVIDED BY/ (USED IN) INVESTING ACTIVITIES | 61,569 | (28) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from issuance of common stock, net of issuance costs | 107,725 | |
Proceeds from exercised stock options | 241 | 370 |
NET CASH PROVIDED BY FINANCING ACTIVITIES | 107,966 | 370 |
Effect of exchange rates on cash and cash equivalents | 35 | (28) |
NET INCREASE / (DECREASE) IN CASH AND CASH EQUIVALENTS | 118,953 | (49,077) |
Cash and cash equivalents at the beginning of period | 114,634 | 207,136 |
Cash and cash equivalents at the end of period | $ 233,587 | $ 158,059 |
ORGANIZATION AND DESCRIPTION OF
ORGANIZATION AND DESCRIPTION OF BUSINESS | 6 Months Ended |
Jun. 30, 2021 | |
ORGANIZATION AND DESCRIPTION OF BUSINESS | |
ORGANIZATION AND DESCRIPTION OF BUSINESS | NOTE 1—ORGANIZATION AND DESCRIPTION OF BUSINESS Y-mAbs Therapeutics, Inc. (“we,” “us,” “our,” the “Company,” or “Y-mAbs”) is a commercial-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody based therapeutic products for the treatment of cancer. We are leveraging our proprietary antibody platforms and deep expertise in the field of antibodies to develop a broad portfolio of innovative medicines. The Company is headquartered in New York, New York and was incorporated on April 30, 2015 under the laws of the State of Delaware. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 6 Months Ended |
Jun. 30, 2021 | |
BASIS OF PRESENTATION | |
BASIS OF PRESENTATION | NOTE 2—BASIS OF PRESENTATION Except for the quarter ended March 31, 2021, the Company has incurred quarterly losses since inception. Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of drug candidate development; technological uncertainty; uncertainty regarding patents and proprietary rights; uncertainty in obtaining FDA approval in the United States and regulatory approval in other jurisdictions; marketing or sales capability or experience; uncertainty in getting adequate payer coverage and reimbursement; dependence on key personnel; compliance with government regulations and the need to obtain additional financing. The Company’s drug candidates currently under development will require significant additional research and development efforts, including extensive pre-clinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance reporting capabilities. The Company’s drug candidates are in various stages of development. DANYELZA (naxitamab-gqgk) was approved by the U.S. FDA in November 2020, but there can be no assurance that the Company’s other research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. The Company’s financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. The Company has experienced negative cash flows from operations since inception, and had an accumulated deficit of $274,724,000 as of June 30, 2021 and $285,200,000 as of December 31, 2020. Through June 30, 2021, the Company has funded its operations primarily through proceeds from sales of shares of its common stock, including its initial public offering in September 2018 and its subsequent public offerings in November 2019 and February 2021. On February 22, 2021, the Company announced the closing of its public offering of 2,804,878 shares of its common stock, at a public offering price of $41.00 per share, which included the exercise in full of the underwriters' option to purchase 365,853 additional shares of common stock. The aggregate gross proceeds to the Company, before deducting underwriting discounts and commissions and offering expenses payable by the Company, were approximately $115,000,000. As of June 30, 2021, the Company had cash and cash equivalents of $233,587,000, and as of December 31, 2020 the Company had cash and cash equivalents of $114,634,000. As of the issuance date of the financial statements for the second quarter ended June 30, 2021, the Company expects that its cash and cash equivalents at June 30, 2021 will be sufficient to fund its operating expenses and capital expenditure requirements through at least the next 12 months, irrespective of whether any additional product approvals are obtained. The Company may raise additional capital to fund future operations through the sale of its equity securities, incurring debt, entering into licensing or collaboration agreements with partners, grants or other sources of financing. Sufficient funds may not be available to the Company on attractive terms or at all when needed from equity or debt financing. If FDA approval for omburtamab does not occur or is significantly delayed, and the Company is unable to obtain additional financing from these or other sources when needed, it will likely be necessary to take other actions to enhance its liquidity position which may include significantly reducing the current rate of spending through delaying, scaling back current operations, or suspending certain research and development programs and other operational programs. The accompanying unaudited consolidated financial statements reflect the accounts of the Company and its wholly owned subsidiary and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information, Accounting Standards Codification (“ASC”) Topic 270-10 and with the instructions to Form 10-Q. Accordingly, these financial statements do not include all of the information and notes required by GAAP for complete financial statements. The unaudited interim financial statements include all adjustments (consisting only of normal recurring nature) necessary in the judgment of management for a fair statement of the results for the periods presented. All intercompany balances and transactions have been eliminated. The Company has evaluated subsequent events through the date of this filing. Operating results for the three and six-month period ended June 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021, any other interim periods, or any future year or period. The December 31, 2020 consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. You should read these unaudited interim condensed consolidated financial statements in conjunction with the consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Our significant accounting policies are detailed in our Annual Report on Form 10-K for the year ended December 31, 2020. Operating Leases The Company determines if an arrangement includes a lease at inception. Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses its estimated incremental borrowing rate based on information available at the lease commencement date. Because most of the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the estimated rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company’s leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that it will exercise any such options. None of the Company’s leases contain any residual value guarantees. Lease expense is recognized on a straight-line basis over the expected lease term. Related variable lease costs incurred are not material to the Company. The Company currently elects the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we will not recognize right-of-use assets or liabilities, and this includes not recognizing right-of-use assets or liabilities for existing short-term leases of those assets in transition. We also elect the practical expedient to not separate lease and non-lease components for all of our leases. The Company has made an accounting policy election to account for each separate lease component of a contract and its associated non-lease components as a single lease component. See the Lease Agreements section in Note 8 for the related disclosures. Cash and Cash Equivalents The Company considers all highly liquid instruments with original maturities of three months or less from date of purchase to be cash equivalents. All cash and cash equivalents are held in highly rated securities including a Treasury money market fund which is unrestricted as to withdrawal or use. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term and liquid nature. To date, the Company has not experienced any losses on its cash and cash equivalents, and we do not anticipate any losses with respect to such cash balances. While we maintain cash balances in excess of insured limits within a limited number of financial institutions, we mitigate our risk by maintaining the majority of our cash and equivalents with high quality financial institutions. Trade Accounts Receivables The Company’s trade accounts receivable balance consists of amounts due from sales of our approved product, DANYELZA. Receivables from product sales are recorded net of allowances which generally include chargebacks, doubtful accounts, rebates, returns, and discounts. The Company accrues allowances based on the estimation of each individual sales transaction. The Company has not experienced any write-offs related to our customers and has not recognized any allowance for doubtful accounts. Concentration of Credit Risk The Company product sales are made through arrangements primarily with three national speciality distributors in the United States of America. As of June 30, 2021, the receivables balances from such distributors totaled 99% of our outstanding accounts receivable. The Company has contractual payment terms with each of its customers and the Company monitors their financial performance, historical payment terms and credit worthiness to timely assess and respond to any changes in their credit profile. Inventory The Company values its inventories at the lower of cost or net realizable value on a first-in, first-out basis. The Company’s inventory costs include amounts related to materials, third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. Raw and intermediate materials that may be utilized for both commercial and clinical programs are identical and given the alternative future use such amounts are initially classified as inventory. Amounts in inventory associated with clinical development programs are charged to research and development expense when the product enters the research and development process and can no longer be used for commercial purposes and, therefore, does not have an alternative future use. The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. For DANYELZA, the Company commenced capitalization of inventory at the receipt of FDA approval. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of goods sold. The determination of whether inventory costs will be realizable requires estimates by management. No material inventory write-downs occurred in the three and six months ended June 30, 2021. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. • Level 1 — Unadjusted quoted prices for identical assets or liabilities in active markets; • Level 2 — Inputs other than quoted prices in active markets for identical assets and liabilities that are observable either directly or indirectly for substantially the full term of the asset or liability; and • Level 3 — Unobservable inputs for the asset or liability, which include management's own assumption about the assumptions market participants would use in pricing the asset or liability, including assumptions about risk. Cash equivalents held in money market funds are valued using other significant observable inputs, which represent a Level 2 measurement within the fair value hierarchy. The Company has no other cash equivalents. The following tables present the Company’s fair value hierarchy for its cash equivalents, which are measured at fair value on a recurring basis (in thousands): Fair Value Measurements at June 30, 2021 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ — $ 209,703 $ — $ 209,703 $ — $ 209,703 $ — $ 209,703 Fair Value Measurements at December 31, 2020 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ — $ 97,302 $ — $ 97,302 $ — $ 97,302 $ — $ 97,302 During the quarter ended June 30, 2021, there were no transfers Level 3 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, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, net product revenues, the accrual for research and development expenses, the accrual of milestone and royalty payments, and the valuation of stock options. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including expenses, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international markets. Revenue Recognition - Product revenue We recognize revenue from sales of DANYELZA at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt at the end-user hospital. The amount of revenue we recognize from sales of DANYELZA varies due to rebates, chargebacks and discounts provided under governmental and other programs, distribution related fees and other sales-related deductions. In order to determine those deductions, we estimate, utilizing the expected value method, the amount of revenue that we will ultimately be entitled to. This estimate is based upon contracts with customers and government agencies, statutorily-defined discounts applicable to government-funded programs, estimated payor mix, and other relevant factors. Calculating these amounts involves estimates and judgments. Revenue Recognition - License revenue In December 2020, the Company entered into a development and commercialization arrangement with SciClone International Pharmaceuticals Ltd. (“SciClone”) for certain indications of DANYELZA and omburtamab within China. As part of the agreement, we received a nonrefundable up-front fee of $20,000,000 for the transfer of the license and know-how related to the product indications. The Company may receive regulatory-based milestone payments up to $40,000,000 and sales-based milestone payments up to $60,000,000 and is entitled to royalties based upon the net sales generated by SciClone related to the product indications in the territory. We considered the license to be distinct from other promises within the arrangement based on the rights and know-how transferred, late-stage development of the underlying indications and anticipated lack of significant involvement required from the joint steering committee associated with the indications. Accordingly, the full transaction price of $20,000,000 was recognized upon transferring of the license and know-how to SciClone. The future potential regulatory milestone amounts were not included in the transaction price, as they were all determined to be fully constrained following the concepts of ASC 606. As part of our evaluation of the regulatory milestones constraint, we determined that the achievement of such milestones are contingent upon regulatory approvals which are not within our control and therefore not deemed probable. We expect that the sales-based milestone payments and royalty arrangements will be recognized when the related sales occur or the milestone is achieved. We reevaluate the transaction price each quarter and as uncertain events are resolved or other changes in circumstances occur, we assess whether this resolves the constraint and revenue will be recognized. We also considered that the manufacturing and supply terms, included within the arrangement, did not represent a material right to SciClone at inception as the terms reflected stand-alone selling price for similar goods or services. During the three and six-month period ended June 30, 2021, no revenue was recognized related to this arrangement as no sales were occurred which are subject to the arrangement and no milestones were achieved. In May 2021, the Company entered into an exclusive distribution agreement with Adium Pharma S.A. (“Adium”) to be the exclusive distributor in Latin America of the Company’s antibodies, including DANYELZA and omburtamab. As part of this agreement, we received and recognized a nonrefundable up-front fee of Segment Information The Company is engaged solely in the discovery and development of novel antibody-based therapeutic products for the treatment of cancer. Accordingly, the Company has determined that it operates in one operating segment. Recently Issued Accounting Pronouncements – Adopted In March 2020, the FASB issued Accounting Standards Update No. 2020-04 (“ASU 2020-04”), Reference rate reform (Topic 848)—Facilitation of the effects of reference rate reform on financial reporting. The amendments in this Update provide optional guidance for a limited time to ease the potential burden in accounting for (or recognizing the effects) of reference rate reform on financial reporting. The amendments in this Update provide optional expedients and exceptions for applying generally accepted accounting principles (GAAP) to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The amendments in this Update are effective for all entities as of March 12, 2020 through December 31, 2022. The adoption of this standard on January 1, 2021 did not have a material impact on our consolidated financial statements and related disclosures. In December 2019, the FASB issued Accounting Standards Update No. 2019-12 (“ASU 2019-12”), Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The amendments in this Update affect entities within the scope of Topic 740, Income Taxes, and are effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. The adoption of this standard on January 1, 2021 did not have a material impact on our consolidated financial statements and related disclosures. |
PRODUCT REVENUE
PRODUCT REVENUE | 6 Months Ended |
Jun. 30, 2021 | |
REVENUE RECOGNITION | |
REVENUE RECOGNITION | NOTE 4—PRODUCT REVENUE The Company’s product revenues were generated from sales of DANYELZA and totaled $8,951,000 and $14,334,000 for the three and six months ended June 30, 2021. There were no product sales during the three and six months ended June 30, 2020. Revenue from product sales is recorded net of applicable provisions for rebates, chargebacks, discounts, distribution-related fees and other sales-related deductions. Accruals for chargebacks and discounts are recorded as a direct reduction to accounts receivable. Accruals for rebates, distribution-related fees and other sales-related deductions are recorded within accrued liabilities. As of June 30, 2021, the company had recorded accounts receivable allowances of approximately $10,000 and accrued liabilities of $1,475,000 related to product sales. An analysis of the change in reserves for discounts and allowances is summarized as follows: Contractual Discounts Allowances Returns Total (in thousands) (in thousands) (in thousands) (in thousands) Balance, December 31, 2020 $ — $ — $ — $ — Current provisions relating to sales in current year 31 1,541 163 1,735 Payments/credits relating to sales in current year (21) (66) (163) (250) Balance, June 30, 2021 $ 10 $ 1,475 $ — $ 1,485 Substantially all of the Company’s product sales were in the United States. The Company had product sales to certain customers that accounted for more than 10% of total gross product revenue for the three and six months ended June 30, 2021. Two wholesalers accounted for 75% and 19%, respectively, of our gross product revenue for the three months ended June 30, 2021 and two wholesalers accounted for 77% and 13%, respectively, of our gross product revenue for the six months ended June 30, 2021. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 6 Months Ended |
Jun. 30, 2021 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | NOTE 5—NET LOSS PER SHARE Basic net loss per share (“EPS”) is calculated by dividing net income or loss attributable to common stockholders by the weighted average common stock outstanding. Diluted EPS is calculated by adjusting weighted average common shares outstanding for the dilutive effect of common stock options and restricted stock units. In periods in which a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be antidilutive. Securities that could potentially dilute basic EPS in the future were not included in the computation of diluted EPS because to do so would have been antidilutive. The calculations of basic and diluted net loss per share are as follows (in thousands, except per share amounts): Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 (in thousands, except per share amounts) Net income / (loss) (numerator) $ (22,937) $ (40,393) $ 10,476 $ (66,572) Weighted-average shares (denominator), basic 43,569 39,972 42,725 39,863 Basic net income / (loss) per share $ (0.53) $ (1.01) $ 0.25 $ (1.67) Weighted-average shares (denominator), diluted 43,569 39,972 45,080 39,863 Diluted net income / (loss) per share $ (0.53) $ (1.01) $ 0.23 $ (1.67) Potentially dilutive securities excluded from the computation of diluted earnings per share relate to stock options outstanding and unvested restricted stock units totaled 1,427,850 shares as of June 30, 2021 and 4,956,513 shares as of June 30, 2020. |
INVENTORY
INVENTORY | 6 Months Ended |
Jun. 30, 2021 | |
INVENTORY | |
INVENTORY | NOTE 6—INVENTORY Inventories consist of the following (in thousands): As of June 30, 2021 Raw Material Work In Progress Finished Goods Total Inventories $ — $ 3,700 $ 120 $ 3,820 There were no inventories as of June 30, 2020. |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 6 Months Ended |
Jun. 30, 2021 | |
ACCRUED LIABILITIES | |
ACCRUED LIABILITIES | NOTE 7—ACCRUED LIABILITIES Accrued short-term liabilities at June 30, 2021 and December 31, 2020 are as follows (in thousands): June 30, December 31, 2021 2020 Accrued licensing, milestone and royalty payments $ 3,010 $ 3,608 Accrued clinical costs 922 678 Accrued compensation and board fees 4,144 2,603 Accrued manufacturing costs 1,620 983 Sales reserves accruals 1,475 — Other 998 325 Total $ 12,169 $ 8,197 |
LICENSE AGREEMENTS AND COMMITME
LICENSE AGREEMENTS AND COMMITMENTS | 6 Months Ended |
Jun. 30, 2021 | |
LICENSE AGREEMENTS AND COMMITMENTS | |
LICENSE AGREEMENTS AND COMMITMENTS | NOTE 8—LICENSE AGREEMENTS AND COMMITMENTS As of June 30, 2021, the Company has entered into two license agreements and certain other agreements with Memorial Sloan Kettering Cancer Center (“MSK”). The license agreements, as previously disclosed in our annual report on Form 10-K, are the MSK License Agreement and the CD33 License Agreement. In addition, the Company entered into the SADA License Agreement with MSK and Massachusetts Institute of Technology (“MIT”) in 2020. Through a 2019 Settlement and Assumption and Assignment of the MSK License Agreement and Y-mAbs Sublicense Agreement (“SAAA”) with MabVax, Inc. (“MabVax”) and MSK, the Company has established a direct license with MSK relating to the GD2-GD3 Vaccine, which was originally sublicensed by the Company in 2018 from MabVax. These license agreements with MSK and MIT grant the Company certain patent rights and intellectual property rights, and in consideration thereof, the Company agreed to make certain payments and issue shares of the Company’s common stock to MSK and MIT. Certain of the payments are contingent milestone and royalty payments, as disclosed in the table below. Amounts disclosed in Note 7 for accrued milestone and royalty payments are inclusive of obligations under the MSK License Agreement, CD33 License Agreement and SADA License Agreement, collectively. We have the following significant license agreements and related commitments which include all obligations that have been paid or accrued as of and for the period three and six months ended June 30, 2021 (in thousands): Cash paid Cash paid Expense Expense Expense Expense Accrued liabilities Accrued liabilities Accrued liabilities Accrued liabilities Six months Six months Three months Six months Three months Six months Current as of Non-current Current as of Non-current ended June ended June ended June ended June ended June ended June June June December December Agreements 2021 2020 2021 2021 2020 2020 2021 2021 2020 2020 MSK $ 450 $ - $ 210 $ 210 $ - $ - $ 1,405 $ 1,800 $ 305 $ 1,640 CD33 100 — — — — — — 450 100 450 MabVax — — 10 10 — — — — — — SADA 1,000 1,995 — — 13,307 13,307 1,605 — 1,000 1,605 As of June 30, 2021, the Company has $1,800,000 of gross intangible assets related to the product rights for DANYELZA that were recorded under the MSK License Agreement and are included in “Other Assets” on the consolidated balance sheets. Amortization expense recorded during the period was not material. The below table represents the maximum clinical, regulatory or sales-based milestones as reflected within the agreements, certain of which have been paid in prior periods or are accrued as presented in the table above (in thousands): Maximum Maximum Maximum Agreements Clinical Milestones Regulatory Milestones Sales-based milestones MSK $ 2,450 $ 9,000 $ 20,000 CD33 550 500 7,500 MabVax 200 1,200 — SADA 4,730 18,125 23,750 Certain minimum royalties and clinical and regulatory milestones that become due based upon the passage of time under the CD33 License Agreement, the SADA Agreement and the MabVax Agreement are not recorded as a liability as the Company does not consider such obligations to be probable as of June 30, 2021. Other agreements We have also entered into various other support agreements with MSK including a sponsored research agreement to provide research services related to the intellectual property licensed under the MSK License Agreement; a master data services agreement, for services provided by approximately five full-time employees at MSK, who are engaged in transferring clinical data, databases, regulatory files and other know-how included in the MSK License Agreement to the Company; a master clinical trial agreement pursuant to which we committed to fund certain clinical trials at MSK; two separate core facility service agreements pursuant to which we committed to obtaining certain laboratory services from MSK; and in October 2020 we entered into a SADA sponsored research agreement pursuant to which we agreed to pay MSK to provide research services over a period of three years related to the intellectual property licensed under the SADA License Agreement. For three months ended June 30, 2021 and 2020, we incurred research and development expenses of $947,000 and $929,000, respectively, under these agreements. For six months ended June 30, 2021 and 2020, we incurred research and development expenses of $1,895,000 and $1,978,000, respectively, under these agreements. Lease Agreements In July 2019, the Company entered a development, manufacturing and supply agreement with SpectronRx in South Bend, Indiana, to secure access to clinical and commercial scale radiolabeling capacity for omburtamab. Under the terms of the agreement, SpectronRx has agreed to establish a manufacturing unit designated for the Company within its existing facilities, at which both clinical and commercial supply of radiolabeled omburtamab can be produced. Since the Company possesses the right to substantially all the economic benefits and directs the use of the production area, the Company accounts for the payments related to the access to the manufacturing space under ASC 842 as an operating lease. The term of the lease is two years from the commencement date of August 31, 2020. Upon the lease commencement date, we recorded $3,617,000 as right of use asset and $2,679,000 as lease liability with the difference of $938,000 resulting from certain prepayments and other costs incurred. The company pays equal monthly installments of approximately $117,000 per month in additional access fees through September 2022 resulting in total payments of $1,631,000 remaining under the agreement. There are no renewal options in this agreement. In February 2019, the Company entered into a lease agreement in connection with its 4,548 square feet laboratory in New Jersey. In December 2019, we expanded the space with an additional 235 square feet. The term of the lease is three years from the date the Company occupied the premises, with an option to extend for an additional two years which the Company expects to exercise and has included in the determination of the related lease liability. Fixed rent payable under the lease is approximately $144,000 per annum and is payable in equal monthly installments of approximately $12,000. In January 2018, the Company entered into a lease agreement in connection with its corporate headquarters in New York. The term of the lease is five years from the date the Company began to occupy the premises. Fixed rent payable under the lease is approximately $384,000 per annum and is payable in equal monthly installments of approximately $32,000, which are recognized on a straight-line basis. Additionally, the Company entered a three-year lease agreement for the lease of certain office space in Denmark in February 2018, as amended in November 2018 and February 2019. The lease is payable in monthly installments of approximately $19,000, which are recognized on a straight-line basis. Total operating lease costs were $646,000 and $173,000 for the three months ended June 30, 2021 and 2020, respectively, and $1,291,000 and $347,000 for the six months ended June 30, 2021 and 2020, respectively. For the three months ended June 30, 2021, the operating lease expenses were recorded as $587,000 in research and development expense and $59,000 in general and administrative expense. For the three months ended June 30, 2020, the expenses were recorded as $124,000 in research and development expense and $49,000 in general and administrative expense. For the six months ended June 30, 2021, the expenses were recorded as $1,174,000 in research and development expense and $117,000 in general and administrative expense. For the six months ended June 30, 2020, the expenses were recorded as $247,000 in research and development expense and $100,000 in general and administrative expense. Cash paid for amounts included in the measurement of lease liabilities for the three and six months ended June 30, 2021 was $549,000 and $1,093,000, respectively, and cash paid for amounts included in the measurement of lease liabilities for the three and six months ended June 30, 2020 was $205,000 and $393,000, respectively. These payments were included in net cash used in operating activities in the Company’s Consolidated Statements of Cash Flows. Maturities of operating lease liabilities at June 30, 2021 were as follows (in thousands): Operating Leases at June 30, 2021 Remainder of 2021 $ 1,086 Years ending December 31, 2022 1,589 2023 539 2024 64 Total lease payments 3,278 Less: Imputed interest (276) Total operating lease liabilities at June 30, 2021 $ 3,002 Maturities of operating leases at December 31, 2020 were as follows (in thousands): Operating Leases at December 31, 2020 2021 $ 2,180 2022 1,593 2023 540 2024 64 Total lease payments 4,377 Less: Imputed interest (398) Total operating lease liabilities at December 31, 2020 $ 3,979 Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company uses its estimate of its incremental borrowing rate based on the information available at the lease commencement date. As of June 30, 2021, the weighted average remaining lease term is 1.75 years and the weighted average discount rate used to determine the operating lease liability was 7.6%. As of December 31, 2020, the weighted average remaining lease term is 2.18 years and the weighted average discount rate used to determine the operating lease liability was 7.6%. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 6 Months Ended |
Jun. 30, 2021 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | NOTE 9—STOCKHOLDERS’ EQUITY Authorized Stock As of June 30, 2021 and December 31, 2020, the Company has authorized a total of 105,500,000 shares, 100,000,000 of which are common stock, par value $0.0001 per share, and 5,500,000 of which are preferred stock, par value $0.0001 per share. Common Stock Each share of common stock is entitled to one vote. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any, subject to preferential dividend rights of the preferred stock, none of which have been issued. The Company had issued 43,576,950 shares of its common stock as of June 30, 2021 and 40,688,447 shares of its common stock as of December 31, 2020. Preferred Stock Preferred stock may be issued from time to time in one or more series with such designations, preferences and relative participating, optional or other special rights and qualifications, limitations or restrictions as approved by the Company’s Board of Directors. No preferred stock has been issued as of June 30, 2021 or December 31, 2020. Stock grant agreements with non-employees In August 2015, we entered into stock grant agreements with certain non-employees of the Company. We agreed to issue a total of 2,800,000 shares to two non-employee researchers who were involved in the development of technology licensed from MSK in consideration for their prior service. The shares are released according to a vesting schedule. A total of 560,000 shares were issued in 2015, and a total of 448,000 shares issued in each of 2016 and 2017. In 2018, a total of 544,000 shares were issued to the two researchers, whereby one of the two grants was fully issued. In 2019 a total of 400,000 shares were issued to one of the physicians, and the remaining 400,000 shares were issued in August 2020, subject to certain conditions. No future shares will be issued under these awards. The total awards were expensed at its estimated fair value in 2015, as no future service was required to continue to vest in and receive the shares. In April 2020, in connection with the SADA License Agreement, we entered into certain stock grant agreements pursuant to which we agreed to issue a total of 213,996 shares to two non-employee researchers who were involved in the development of the SADA technology licensed from MSK and MIT in consideration for their prior service. All 213,996 shares were issued in April 2020 into escrow with 40% of the shares immediately vesting at the time of issuance and the remaining 60% of the shares subject to vesting ratably over the next three years on the anniversary date of the agreement. In accordance with the terms of the agreement, during the quarter ended June 30, 2021, the non-employee researchers vested in an additional In July 2020, pursuant to the stock grant agreements, we also loaned the two researchers a total of $2,610,000 related to their individual tax payments due in conjunction with the stock grants. Each of the loans are evidenced by a three year Secured Promissory Note. The outstanding principal amounts of the loans, together with all accrued interest thereon at the rate of 1% per annum, is due and payable on the maturity date of the loans. The loans are secured by Pledge and Security Agreements, pursuant to which the researchers have pledged the shares as security for repayment of the loans with interest rates that are at market. The loans are recorded at amortized cost, which approximates fair value due to the short-term nature and minimal changes in market interest rates. Issuance of common stock On February 22, 2021, we completed a third public offering of our common stock pursuant to which we issued and sold 2,804,878 shares of our common stock at a price to the public of $41.00 per share which included the exercise in full of the underwriters’ option to purchase additional shares. We received aggregate gross proceeds from our secondary public offering of $115,000,000, with aggregate net proceeds of approximately $107,725,000 after deducting underwriting discounts and commissions and offering expenses. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2021 | |
SHARE-BASED COMPENSATION | |
SHARE-BASED COMPENSATION | NOTE 10—SHARE-BASED COMPENSATION 2015 Equity Incentive Plan Our board of directors and stockholders have approved and adopted the 2015 Plan, which provided for the grant of incentive stock options, within the meaning of Section 422 of the Code (the Internal Revenue Code), to our employees and any parent and subsidiary corporations’ employees, and for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock and restricted stock units to our employees, directors and consultants and our parent and subsidiary corporations’ employees and consultants. A total of 4,500,000 shares of our common stock were reserved for issuance pursuant to the 2015 Plan. Options granted under the 2015 Plan vest according to the schedule specified in the grant agreements, which is generally a four-year period and generally become immediately exercisable upon the occurrence of a change in control, as defined. Upon the 2018 Equity Incentive Plan (the “2018 Plan’) becoming effective in September 2018, no further grants are allowed under the 2015 Plan. 2018 Equity Incentive Plan Our board of directors and stockholders approved and adopted the 2018 Plan, which became effective upon the Company’s initial public offering in September 2018 and which provides for the grant of incentive stock options, within the meaning of Section 422 of the Code (the Internal Revenue Code), to our employees and any parent and subsidiary corporations’ employees, and for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock and restricted stock units to our employees, directors and consultants and our parent and subsidiary corporations’ employees and consultants. A total of 5,500,000 shares of our common stock, inclusive of the awards previously granted under the 2015 Equity Incentive Plan, are reserved for issuance pursuant to the 2018 Plan. In addition, the number of shares available for issuance under the 2018 Plan will also include an annual increase on the first day of each fiscal year beginning in 2019, equal to 4% of the outstanding shares of common stock as of the last day of our immediately preceding fiscal year. The exercise price of options granted under the plans must at least be equal to the fair market value of our common stock on the date of grant. The term of an incentive stock option may not exceed 10 years , except that with respect to any participant who owns more than 10% of the voting power of all classes of our outstanding stock, the term must not exceed five years and the exercise price must equal at least 110% of the fair market value on the grant date. The administrator will determine the methods of payment of the exercise price of an option, which may include cash, shares or other property acceptable to the administrator, as well as other types of consideration permitted by applicable law. Options granted under the 2018 Plan vest according to the schedule specified in the grant agreements, which is generally a four-year period and generally become immediately exercisable upon the occurrence of a change in control, as defined. Stock Option Valuation For the three month periods ended June 30, 2021 and 2020, stock-based compensation for stock option grants were $4,752,000 and $2,406,000, respectively, for options granted to employees and directors. For the three months ended June 30, 2021, the expenses were recorded as $1,753,000 in research and development expense and $2,999,000 in selling, general, and administrative expense. For the three months ended June 30, 2020, the expenses were recorded as $537,000 in research and development expense and $1,871,000 in selling, general, and administrative expense. For the six month periods ended June 30, 2021 and 2020, stock-based compensation for stock option grants were $9,380,000 and $4,594,000, respectively, for options granted to employees and directors. For the six months ended June 30, 2021, the expenses were recorded as $3,444,000 in research and development expense and $5,936,000 in selling, general, and administrative expense. For the six months ended June 30, 2020, the expenses were recorded as $1,026,000 in research and development expense and $3,570,000 in selling, general, and administrative expense. The following table summarizes common stock options issued and outstanding: Weighted Weighted Aggregate average average intrinsic remaining exercise value contractual Options price (in thousands) life (years) Outstanding and expected to vest at December 31, 2020 5,674,100 $ 22.55 $ 156,726 7.51 Granted 209,000 32.44 Exercised (74,332) 3.24 Forfeited (25,000) 36.95 Outstanding and expected to vest at June 30, 2021 5,783,768 $ 23.10 $ 85,272 7.14 Exercisable at June 30, 2021 3,370,715 $ 11.83 $ 76,242 5.90 The weighted average fair value of stock options granted for the three months ended June 30, 2021 and 2020 was $32.44 and $27.65, respectively. There were 209,000 and 324,000 shares stock options granted for the three months ended June 30, 2021 and 2020, respectively. The weighted average fair value of stock options granted for the six months ended June 30, 2021 and 2020 was $32.44 and $20.32, respectively. There were 209,000 and 1,041,000 shares stock options granted for the six months ended June 30, 2021 and 2020, respectively. The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model. We estimate our expected share price volatility based on the historical volatility of a group of publicly traded peer companies and we expect to continue to do so until such time as we have adequate historical data regarding the volatility of our own traded share price. The expected term of our stock options has been determined utilizing the “simplified” method for awards issued to employees as we have limited historical data to support the expected term assumption. The risk free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The expected dividend yield is based on the fact that we have never paid cash dividends on shares of our common stock and do not expect to pay any cash dividends in the foreseeable future. As of June 30, 2021, we had $47,280,000 of unrecognized compensation expense related to employee stock options that are expected to vest over a period of 2.73 years. As of June 30, 2020, we had $32,443,000 of unrecognized compensation expense related to employee stock options that are expected to vest over a period of 2.92 years. Restricted Stock Unit Activity For the three months ended June 30, 2021 and June 30, 2020, stock-based compensation for restricted stock unit grants was $75,000 and $49,000, respectively. For the three months ended June 30, 2021, the expenses were recorded as $68,000 in research and development expense and $7,000 in selling, general, and administrative expense. For the three months ended June 30, 2020, the expenses were recorded as $44,000 in research and development expense and $5,000 in selling, general, and administrative expense. For the six months ended June 30, 2021 and June 30, 2020, stock-based compensation for restricted stock unit grants was $145,000 and $72,000, respectively. For the six months ended June 30, 2021, the expenses were recorded as $131,000 in research and development expense and $14,000 in selling, general, and administrative expense. For the six months ended June 30, 2020, the expenses were recorded as $65,000 in research and development expense and $7,000 in selling, general, and administrative expense. The following table summarizes restricted stock units issued and outstanding: Weighted Weighted average average remaining grant vesting Restricted Stock Units price life (years) Outstanding and expected to vest at December 31, 2020 30,146 $ 25.45 2.18 Granted 6,217 34.32 Vested (9,293) 21.19 Forfeited (2,751) 27.89 Outstanding and expected to vest at June 30, 2021 24,319 $ 29.07 1.99 As of June 30, 2021, we had $585,000 of unrecognized compensation related to employee restricted stock units that are expected to vest over a period of 1.99 years. As of June 30, 2020, we had $462,000 of unrecognized compensation related to employee restricted stock units that are expected to vest over a period of 2.31 years. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 6 Months Ended |
Jun. 30, 2021 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 11—RELATED PARTY TRANSACTIONS MSK is a shareholder of the Company. Under the MSK License Agreement, the SADA License Agreement, the CD33 License Agreement, and various other supporting agreements with MSK, we have expensed costs in the total amount of $1,157,000 and $5,527,000 in the three months ended June 30, 2021 and 2020, respectively, for milestones, minimum royalties, and research and development costs. We expensed costs in the total amounts of $2,105,000 and $6,576,000 in the six months ended June 30, 2021 and 2020, respectively, under these agreements with MSK. Please refer to Note 8 – License Agreements and Commitments for additional details on our agreements with MSK. As of June 30, 2021, we had a total of $594,000 recorded as accounts payable, $5,513,000 as accrued liabilities, thereby totaling $6,107,000 due to MSK. As of December 31, 2020, we had a total of $833,000 recorded as accounts payable, $7,161,000 as accrued liabilities, thereby totaling $7,994,000 due to MSK. |
INCOME TAXES
INCOME TAXES | 6 Months Ended |
Jun. 30, 2021 | |
INCOME TAXES | |
INCOME TAXES | NOTE 12—INCOME TAXES The Company provided no current and deferred income taxes on net losses of $22,937,000 and $40,393,000 for the three month periods ended June 30, 2021 and 2020, respectively, and the net income of $10,476,000 and the net loss of $66,572,000 for the six month periods ended June 30, 2021 and 2020, respectively. The Company recognizes income tax benefits for tax positions determined more likely than not to be sustained upon examination, based on the technical merits of the positions. As of June 30, 2021 and December 31, 2020, the Company has determined that there were no uncertain tax positions. The Company’s tax returns for the years 2015 to 2020 are open for tax examination by U.S. federal and state, and the Danish tax authorities. The Company maintains a full valuation allowance on its U.S. and foreign deferred tax assets. The valuation allowance related primarily to net U.S. deferred tax assets from operating losses, and research and development tax credit carryforwards. The assessment regarding whether a valuation allowance is required considers both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable. In making this assessment, significant weight is given to evidence that can be objectively verified. In its evaluation, the Company considered its cumulative losses historically and in recent years and its forecasted losses in the near term as significant negative evidence. Based upon review of available positive and negative evidence, the Company determined that the negative evidence outweighed the positive evidence and a full valuation allowance on its U.S. and foreign deferred tax assets will be maintained. The Company will continue to assess the realizability of its deferred tax assets and will adjust the valuation allowance as needed. |
OTHER BENEFITS
OTHER BENEFITS | 6 Months Ended |
Jun. 30, 2021 | |
OTHER BENEFITS | |
OTHER BENEFITS | NOTE 13—OTHER BENEFITS The Company has adopted a defined contribution 401(k) savings plan (the 401(k) plan) covering all U.S. employees of the Company. Participants may elect to defer a percentage of their pretax or after-tax compensation to the 401(k) plan, subject to defined limitations. The plan allows for a discretionary match by the Company. The Company made The Company has established a retirement program for employees of the Company’s Danish subsidiary pursuant to which all such employees can contribute an amount at their election from their base compensation and may receive contributions from our Danish subsidiary. No contributions from Danish subsidiary were made for three and six months ended June 30, 2021 and 2020. In addition, health insurance benefits for our Danish employees are fully paid for by such employees. Our Danish subsidiary does not incur any costs for these health insurance benefits. |
GAIN FROM SALE OF PRIORITY REVI
GAIN FROM SALE OF PRIORITY REVIEW VOUCHER | 6 Months Ended |
Jun. 30, 2021 | |
GAIN FROM SALE OF PRIORITY REVIEW VOUCHER | |
GAIN FROM SALE OF PRIORITY REVIEW VOUCHER | NOTE 14 —GAIN FROM SALE OF PRIORITY REVIEW VOUCHER On December 28, 2020, the Company announced that it entered into a definitive agreement to sell its DANYELZA Priority Review Voucher to United Therapeutics Corporation for $105,000,000. The PRV was granted in conjunction with the approval by the U.S. Food and Drug Administration (“FDA”) of DANYELZA, for the treatment of refractory/relapsed high-risk neuroblastoma. Under the terms of the Company’s license agreement with MSK, Y-mAbs retained 60% of the net proceeds received from the sale, and the remaining 40% was paid to MSK. The transaction closed on January 21, 2021 once the substantive closing conditions included within the agreement were resolved. The Company recognized a net gain of $62,010,000 during the six months ended June 30, 2021 related to the sale. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Operating Leases | Operating Leases The Company determines if an arrangement includes a lease at inception. Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses its estimated incremental borrowing rate based on information available at the lease commencement date. Because most of the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the estimated rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company’s leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that it will exercise any such options. None of the Company’s leases contain any residual value guarantees. Lease expense is recognized on a straight-line basis over the expected lease term. Related variable lease costs incurred are not material to the Company. The Company currently elects the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we will not recognize right-of-use assets or liabilities, and this includes not recognizing right-of-use assets or liabilities for existing short-term leases of those assets in transition. We also elect the practical expedient to not separate lease and non-lease components for all of our leases. The Company has made an accounting policy election to account for each separate lease component of a contract and its associated non-lease components as a single lease component. See the Lease Agreements section in Note 8 for the related disclosures. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid instruments with original maturities of three months or less from date of purchase to be cash equivalents. All cash and cash equivalents are held in highly rated securities including a Treasury money market fund which is unrestricted as to withdrawal or use. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term and liquid nature. To date, the Company has not experienced any losses on its cash and cash equivalents, and we do not anticipate any losses with respect to such cash balances. While we maintain cash balances in excess of insured limits within a limited number of financial institutions, we mitigate our risk by maintaining the majority of our cash and equivalents with high quality financial institutions. |
Trade Accounts Receivables | Trade Accounts Receivables The Company’s trade accounts receivable balance consists of amounts due from sales of our approved product, DANYELZA. Receivables from product sales are recorded net of allowances which generally include chargebacks, doubtful accounts, rebates, returns, and discounts. The Company accrues allowances based on the estimation of each individual sales transaction. The Company has not experienced any write-offs related to our customers and has not recognized any allowance for doubtful accounts. |
Concentration of Credit Risk | Concentration of Credit Risk The Company product sales are made through arrangements primarily with three national speciality distributors in the United States of America. As of June 30, 2021, the receivables balances from such distributors totaled 99% of our outstanding accounts receivable. The Company has contractual payment terms with each of its customers and the Company monitors their financial performance, historical payment terms and credit worthiness to timely assess and respond to any changes in their credit profile. |
Inventory | Inventory The Company values its inventories at the lower of cost or net realizable value on a first-in, first-out basis. The Company’s inventory costs include amounts related to materials, third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. Raw and intermediate materials that may be utilized for both commercial and clinical programs are identical and given the alternative future use such amounts are initially classified as inventory. Amounts in inventory associated with clinical development programs are charged to research and development expense when the product enters the research and development process and can no longer be used for commercial purposes and, therefore, does not have an alternative future use. The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. For DANYELZA, the Company commenced capitalization of inventory at the receipt of FDA approval. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of goods sold. The determination of whether inventory costs will be realizable requires estimates by management. No material inventory write-downs occurred in the three and six months ended June 30, 2021. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. • Level 1 — Unadjusted quoted prices for identical assets or liabilities in active markets; • Level 2 — Inputs other than quoted prices in active markets for identical assets and liabilities that are observable either directly or indirectly for substantially the full term of the asset or liability; and • Level 3 — Unobservable inputs for the asset or liability, which include management's own assumption about the assumptions market participants would use in pricing the asset or liability, including assumptions about risk. Cash equivalents held in money market funds are valued using other significant observable inputs, which represent a Level 2 measurement within the fair value hierarchy. The Company has no other cash equivalents. The following tables present the Company’s fair value hierarchy for its cash equivalents, which are measured at fair value on a recurring basis (in thousands): Fair Value Measurements at June 30, 2021 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ — $ 209,703 $ — $ 209,703 $ — $ 209,703 $ — $ 209,703 Fair Value Measurements at December 31, 2020 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ — $ 97,302 $ — $ 97,302 $ — $ 97,302 $ — $ 97,302 During the quarter ended June 30, 2021, there were no transfers Level 3 |
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, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, net product revenues, the accrual for research and development expenses, the accrual of milestone and royalty payments, and the valuation of stock options. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including expenses, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international markets. |
Revenue Recognition | Revenue Recognition - Product revenue We recognize revenue from sales of DANYELZA at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt at the end-user hospital. The amount of revenue we recognize from sales of DANYELZA varies due to rebates, chargebacks and discounts provided under governmental and other programs, distribution related fees and other sales-related deductions. In order to determine those deductions, we estimate, utilizing the expected value method, the amount of revenue that we will ultimately be entitled to. This estimate is based upon contracts with customers and government agencies, statutorily-defined discounts applicable to government-funded programs, estimated payor mix, and other relevant factors. Calculating these amounts involves estimates and judgments. Revenue Recognition - License revenue In December 2020, the Company entered into a development and commercialization arrangement with SciClone International Pharmaceuticals Ltd. (“SciClone”) for certain indications of DANYELZA and omburtamab within China. As part of the agreement, we received a nonrefundable up-front fee of $20,000,000 for the transfer of the license and know-how related to the product indications. The Company may receive regulatory-based milestone payments up to $40,000,000 and sales-based milestone payments up to $60,000,000 and is entitled to royalties based upon the net sales generated by SciClone related to the product indications in the territory. We considered the license to be distinct from other promises within the arrangement based on the rights and know-how transferred, late-stage development of the underlying indications and anticipated lack of significant involvement required from the joint steering committee associated with the indications. Accordingly, the full transaction price of $20,000,000 was recognized upon transferring of the license and know-how to SciClone. The future potential regulatory milestone amounts were not included in the transaction price, as they were all determined to be fully constrained following the concepts of ASC 606. As part of our evaluation of the regulatory milestones constraint, we determined that the achievement of such milestones are contingent upon regulatory approvals which are not within our control and therefore not deemed probable. We expect that the sales-based milestone payments and royalty arrangements will be recognized when the related sales occur or the milestone is achieved. We reevaluate the transaction price each quarter and as uncertain events are resolved or other changes in circumstances occur, we assess whether this resolves the constraint and revenue will be recognized. We also considered that the manufacturing and supply terms, included within the arrangement, did not represent a material right to SciClone at inception as the terms reflected stand-alone selling price for similar goods or services. During the three and six-month period ended June 30, 2021, no revenue was recognized related to this arrangement as no sales were occurred which are subject to the arrangement and no milestones were achieved. In May 2021, the Company entered into an exclusive distribution agreement with Adium Pharma S.A. (“Adium”) to be the exclusive distributor in Latin America of the Company’s antibodies, including DANYELZA and omburtamab. As part of this agreement, we received and recognized a nonrefundable up-front fee of |
Segment Information | Segment Information The Company is engaged solely in the discovery and development of novel antibody-based therapeutic products for the treatment of cancer. Accordingly, the Company has determined that it operates in one operating segment. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements – Adopted In March 2020, the FASB issued Accounting Standards Update No. 2020-04 (“ASU 2020-04”), Reference rate reform (Topic 848)—Facilitation of the effects of reference rate reform on financial reporting. The amendments in this Update provide optional guidance for a limited time to ease the potential burden in accounting for (or recognizing the effects) of reference rate reform on financial reporting. The amendments in this Update provide optional expedients and exceptions for applying generally accepted accounting principles (GAAP) to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The amendments in this Update are effective for all entities as of March 12, 2020 through December 31, 2022. The adoption of this standard on January 1, 2021 did not have a material impact on our consolidated financial statements and related disclosures. In December 2019, the FASB issued Accounting Standards Update No. 2019-12 (“ASU 2019-12”), Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The amendments in this Update affect entities within the scope of Topic 740, Income Taxes, and are effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. The adoption of this standard on January 1, 2021 did not have a material impact on our consolidated financial statements and related disclosures. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of cash equivalents measured at fair value on recurring basis | The following tables present the Company’s fair value hierarchy for its cash equivalents, which are measured at fair value on a recurring basis (in thousands): Fair Value Measurements at June 30, 2021 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ — $ 209,703 $ — $ 209,703 $ — $ 209,703 $ — $ 209,703 Fair Value Measurements at December 31, 2020 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ — $ 97,302 $ — $ 97,302 $ — $ 97,302 $ — $ 97,302 |
PRODUCT REVENUE (Tables)
PRODUCT REVENUE (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
REVENUE RECOGNITION | |
Change in reserves for discounts and allowances | Contractual Discounts Allowances Returns Total (in thousands) (in thousands) (in thousands) (in thousands) Balance, December 31, 2020 $ — $ — $ — $ — Current provisions relating to sales in current year 31 1,541 163 1,735 Payments/credits relating to sales in current year (21) (66) (163) (250) Balance, June 30, 2021 $ 10 $ 1,475 $ — $ 1,485 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
NET LOSS PER SHARE | |
Schedule of basic and diluted net loss per share | Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 (in thousands, except per share amounts) Net income / (loss) (numerator) $ (22,937) $ (40,393) $ 10,476 $ (66,572) Weighted-average shares (denominator), basic 43,569 39,972 42,725 39,863 Basic net income / (loss) per share $ (0.53) $ (1.01) $ 0.25 $ (1.67) Weighted-average shares (denominator), diluted 43,569 39,972 45,080 39,863 Diluted net income / (loss) per share $ (0.53) $ (1.01) $ 0.23 $ (1.67) |
INVENTORY (Tables)
INVENTORY (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
INVENTORY | |
Schedule of inventory | Inventories consist of the following (in thousands): As of June 30, 2021 Raw Material Work In Progress Finished Goods Total Inventories $ — $ 3,700 $ 120 $ 3,820 |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
ACCRUED LIABILITIES | |
Summary of accrued short-term liabilities | Accrued short-term liabilities at June 30, 2021 and December 31, 2020 are as follows (in thousands): June 30, December 31, 2021 2020 Accrued licensing, milestone and royalty payments $ 3,010 $ 3,608 Accrued clinical costs 922 678 Accrued compensation and board fees 4,144 2,603 Accrued manufacturing costs 1,620 983 Sales reserves accruals 1,475 — Other 998 325 Total $ 12,169 $ 8,197 |
LICENSE AGREEMENTS AND COMMIT_2
LICENSE AGREEMENTS AND COMMITMENTS (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Agreements | |
Maturities of operating lease liabilities | Maturities of operating lease liabilities at June 30, 2021 were as follows (in thousands): Operating Leases at June 30, 2021 Remainder of 2021 $ 1,086 Years ending December 31, 2022 1,589 2023 539 2024 64 Total lease payments 3,278 Less: Imputed interest (276) Total operating lease liabilities at June 30, 2021 $ 3,002 Maturities of operating leases at December 31, 2020 were as follows (in thousands): Operating Leases at December 31, 2020 2021 $ 2,180 2022 1,593 2023 540 2024 64 Total lease payments 4,377 Less: Imputed interest (398) Total operating lease liabilities at December 31, 2020 $ 3,979 |
MSK, CD33, MabVax and SADA License Agreements | |
Agreements | |
Summary of significant license agreements, related commitments and milestone information | We have the following significant license agreements and related commitments which include all obligations that have been paid or accrued as of and for the period three and six months ended June 30, 2021 (in thousands): Cash paid Cash paid Expense Expense Expense Expense Accrued liabilities Accrued liabilities Accrued liabilities Accrued liabilities Six months Six months Three months Six months Three months Six months Current as of Non-current Current as of Non-current ended June ended June ended June ended June ended June ended June June June December December Agreements 2021 2020 2021 2021 2020 2020 2021 2021 2020 2020 MSK $ 450 $ - $ 210 $ 210 $ - $ - $ 1,405 $ 1,800 $ 305 $ 1,640 CD33 100 — — — — — — 450 100 450 MabVax — — 10 10 — — — — — — SADA 1,000 1,995 — — 13,307 13,307 1,605 — 1,000 1,605 Maximum Maximum Maximum Agreements Clinical Milestones Regulatory Milestones Sales-based milestones MSK $ 2,450 $ 9,000 $ 20,000 CD33 550 500 7,500 MabVax 200 1,200 — SADA 4,730 18,125 23,750 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
SHARE-BASED COMPENSATION | |
Schedule of common stock options issued and outstanding | Weighted Weighted Aggregate average average intrinsic remaining exercise value contractual Options price (in thousands) life (years) Outstanding and expected to vest at December 31, 2020 5,674,100 $ 22.55 $ 156,726 7.51 Granted 209,000 32.44 Exercised (74,332) 3.24 Forfeited (25,000) 36.95 Outstanding and expected to vest at June 30, 2021 5,783,768 $ 23.10 $ 85,272 7.14 Exercisable at June 30, 2021 3,370,715 $ 11.83 $ 76,242 5.90 |
Schedule of restricted stock units issued and outstanding | Weighted Weighted average average remaining grant vesting Restricted Stock Units price life (years) Outstanding and expected to vest at December 31, 2020 30,146 $ 25.45 2.18 Granted 6,217 34.32 Vested (9,293) 21.19 Forfeited (2,751) 27.89 Outstanding and expected to vest at June 30, 2021 24,319 $ 29.07 1.99 |
BASIS OF PRESENTATION - Accumul
BASIS OF PRESENTATION - Accumulated deficit (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
BASIS OF PRESENTATION | ||
Accumulated deficit | $ (274,724) | $ (285,200) |
BASIS OF PRESENTATION - Seconda
BASIS OF PRESENTATION - Secondary public offering (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 22, 2021 | Mar. 31, 2021 |
Common Stock | ||
Issuance of stock | ||
Issuance of common stock, Stock offering (in shares) | 2,804,878 | |
Secondary public offering, February 22, 2021 | ||
Issuance of stock | ||
Aggregate gross proceeds | $ 115,000 | |
Secondary public offering, February 22, 2021 | Common Stock | ||
Issuance of stock | ||
Issuance of common stock, Stock offering (in shares) | 2,804,878 | |
Share price (in dollars per share) | $ 41 | |
Secondary public offering, February 22, 2021, Underwriters' option | Common Stock | ||
Issuance of stock | ||
Issuance of common stock, Stock offering (in shares) | 365,853 |
BASIS OF PRESENTATION - Cash an
BASIS OF PRESENTATION - Cash and cash equivalents (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
BASIS OF PRESENTATION | ||
Cash and cash equivalents | $ 233,587 | $ 114,634 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration of Credit Risk (Details) - Credit Concentration Risk - Accounts Receivable - Two Customers | 6 Months Ended |
Jun. 30, 2021customer | |
Concentration risk | |
Number of customers | 3 |
Concentration risk percentage (as a percent) | 99.00% |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value Measurement (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Fair value measurements | ||
Level 1 to Level 2 Transfers | $ 0 | |
Level 2 to Level 1 Transfers | 0 | |
Transfers into Level 3 | 0 | |
Transfers out of Level 3 | 0 | |
Recurring | ||
Fair value measurements | ||
Cash equivalents | 209,703 | $ 97,302 |
Recurring | Money market funds | ||
Fair value measurements | ||
Cash equivalents | 209,703 | 97,302 |
Recurring | Level 2 | ||
Fair value measurements | ||
Cash equivalents | 209,703 | 97,302 |
Recurring | Level 2 | Money market funds | ||
Fair value measurements | ||
Cash equivalents | $ 209,703 | $ 97,302 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue Recognition - License Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Dec. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2021 | Dec. 31, 2020 | May 31, 2021 | |
Agreements | |||||
Revenue | $ 10,951 | $ 16,334 | |||
License | |||||
Agreements | |||||
Revenue | 2,000 | 2,000 | |||
License | Development and commercialization arrangement | SciClone | |||||
Agreements | |||||
Revenue | 0 | 0 | $ 20,000 | ||
Amount of milestone achieved | 0 | 0 | |||
Upfront payment | $ 20,000 | ||||
Maximum regulatory milestones | 40,000 | 40,000 | |||
Maximum sales-based milestones | $ 60,000 | $ 60,000 | |||
License | Development and commercialization arrangement | Adium | |||||
Agreements | |||||
Upfront payment | $ 2,000 | $ 2,000 | |||
Maximum regulatory milestones | $ 3,500 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Segment (Details) | 6 Months Ended |
Jun. 30, 2021segment | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Number of operating segments | 1 |
PRODUCT REVENUE - Discounts and
PRODUCT REVENUE - Discounts and Allowances (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue | ||||
Revenue | $ 10,951 | $ 16,334 | ||
Change in reserves for discounts and allowances | ||||
Discounts, Current provisions relating to sales in current year | 31 | |||
Discounts, Payments/credits relating to sales in current year | (21) | |||
Discounts, Balance at end of period | 10 | 10 | ||
Contractual Allowances, Current provisions relating to sales in current year | 1,541 | |||
Contractual Allowances, Payments/credits relating to sales in current year | (66) | |||
Contractual Allowances, Balance at end of period | 1,475 | 1,475 | ||
Returns, Current provisions relating to sales in current year | 163 | |||
Returns, Payments/credits relating to sales in current year | (163) | |||
Reserves for discounts and allowances, Current provisions relating to sales in current year | 1,735 | |||
Reserves for discounts and allowances, Payments/credits relating to sales in current year | (250) | |||
Reserves for discounts and allowances, Balance at end of period | 1,485 | 1,485 | ||
Accounts receivable | ||||
Change in reserves for discounts and allowances | ||||
Reserves for discounts and allowances, Balance at end of period | 10 | 10 | ||
Accrued liabilities | ||||
Change in reserves for discounts and allowances | ||||
Reserves for discounts and allowances, Balance at end of period | 1,475 | 1,475 | ||
Product | ||||
Revenue | ||||
Revenue | 8,951 | $ 0 | 14,334 | $ 0 |
Product, DANYELZA | ||||
Revenue | ||||
Revenue | $ 8,951 | $ 14,334 |
PRODUCT REVENUE - Concentration
PRODUCT REVENUE - Concentrations (Details) - Customer Concentration Risk - Revenue - Product - customer | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Concentration Risk [Line Items] | ||
Number of wholesale customers | 2 | 2 |
Wholesaler One | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage (as a percent) | 75.00% | 77.00% |
Wholesaler Two | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage (as a percent) | 19.00% | 13.00% |
NET LOSS PER SHARE - Basic and
NET LOSS PER SHARE - Basic and diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
NET LOSS PER SHARE | ||||
Net income / (loss) (numerator), Basic (in dollars) | $ (22,937) | $ (40,393) | $ 10,476 | $ (66,572) |
Net income / (loss) (numerator), Diluted (in dollars) | $ (22,937) | $ (40,393) | $ 10,476 | $ (66,572) |
Weighted-average shares (denominator), basic (in dollars per share) | 43,569,482 | 39,972,174 | 42,724,813 | 39,862,878 |
Basic net income / (loss) per share (in dollars per share) | $ (0.53) | $ (1.01) | $ 0.25 | $ (1.67) |
Weighted-average shares (denominator), diluted (in dollars per share) | 43,569,482 | 39,972,174 | 45,080,419 | 39,862,878 |
Diluted net income / (loss) per share (in dollars per share) | $ (0.53) | $ (1.01) | $ 0.23 | $ (1.67) |
NET LOSS PER SHARE - Anti-dilut
NET LOSS PER SHARE - Anti-dilutive securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
NET LOSS PER SHARE | ||
Potentially dilutive securities outstanding | 1,427,850 | 4,956,513 |
INVENTORY (Details)
INVENTORY (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Jun. 30, 2020 |
INVENTORY | ||
Work in Process | $ 3,700 | |
Finished Goods | 120 | |
Inventory Total | $ 3,820 | $ 0 |
ACCRUED LIABILITIES (Details)
ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Accrued short-term liabilities | ||
Accrued licensing, milestone and royalty payments | $ 3,010 | $ 3,608 |
Accrued clinical costs | 922 | 678 |
Accrued compensation and board fees | 4,144 | 2,603 |
Accrued manufacturing costs | 1,620 | 983 |
Sales reserves accruals | 1,475 | |
Other | 998 | 325 |
Total | $ 12,169 | $ 8,197 |
LICENSE AGREEMENTS AND COMMIT_3
LICENSE AGREEMENTS AND COMMITMENTS - MSK, CD33 and MabVax License Agreement (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021USD ($)agreement | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)agreement | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
Financial statement information | |||||
Accrued liabilities, current | $ 12,169 | $ 12,169 | $ 8,197 | ||
Accrued liabilities, noncurrent | $ 2,250 | $ 2,250 | 2,695 | ||
MSK | |||||
Agreements | |||||
Number of license agreements | agreement | 2 | 2 | |||
MSK License Agreement | |||||
Financial statement information | |||||
Cash paid | $ 450 | ||||
Expense | $ 210 | 210 | |||
Accrued liabilities, current | 1,405 | 1,405 | 305 | ||
Accrued liabilities, noncurrent | 1,800 | 1,800 | 1,640 | ||
Milestones | |||||
Maximum Clinical Milestones | 2,450 | 2,450 | |||
Maximum Regulatory Milestones | 9,000 | 9,000 | |||
Maximums Sales-based Milestones | 20,000 | 20,000 | |||
MSK License Agreement | Other long-term assets | |||||
Financial statement information | |||||
Gross intangible assets related to Danyelza | 1,800 | 1,800 | |||
CD33 License Agreement | |||||
Financial statement information | |||||
Cash paid | 100 | ||||
Accrued liabilities, current | 100 | ||||
Accrued liabilities, noncurrent | 450 | 450 | 450 | ||
Milestones | |||||
Maximum Clinical Milestones | 550 | 550 | |||
Maximum Regulatory Milestones | 500 | 500 | |||
Maximums Sales-based Milestones | 7,500 | 7,500 | |||
MabVax Agreement | |||||
Financial statement information | |||||
Expense | 10 | 10 | |||
Milestones | |||||
Maximum Clinical Milestones | 200 | 200 | |||
Maximum Regulatory Milestones | 1,200 | 1,200 | |||
SADA License Agreement | |||||
Financial statement information | |||||
Cash paid | 1,000 | $ 1,995 | |||
Expense | $ 13,307 | 13,307 | |||
Accrued liabilities, current | 1,605 | 1,605 | 1,000 | ||
Accrued liabilities, noncurrent | $ 1,605 | ||||
Milestones | |||||
Maximum Clinical Milestones | 4,730 | 4,730 | |||
Maximum Regulatory Milestones | 18,125 | 18,125 | |||
Maximums Sales-based Milestones | $ 23,750 | $ 23,750 |
LICENSE AGREEMENTS AND COMMIT_4
LICENSE AGREEMENTS AND COMMITMENTS - Other agreements (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Oct. 31, 2020 | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)agreementemployee | Jun. 30, 2020USD ($)employeeagreement | |
Agreements | |||||
Research and development | $ 19,778 | $ 30,059 | $ 41,357 | $ 48,681 | |
Other Agreements with MSK | |||||
Agreements | |||||
Research and development | $ 947 | $ 929 | $ 1,895 | $ 1,978 | |
CFSAs | |||||
Agreements | |||||
Number of service agreements | agreement | 2 | 2 | |||
SRA | |||||
Agreements | |||||
Research service period | 3 years | ||||
Researchers, Employees of MSK | MDSA | |||||
Agreements | |||||
Number of individuals | employee | 5 | 5 |
LICENSE AGREEMENTS AND COMMIT_5
LICENSE AGREEMENTS AND COMMITMENTS - Lease agreements (Details) $ in Thousands | 1 Months Ended | ||||||
Aug. 31, 2020USD ($) | Feb. 28, 2019USD ($)ft² | Jun. 30, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019ft² | Feb. 28, 2018 | Jan. 31, 2018USD ($) | |
Leases | |||||||
Operating lease right-of-use assets | $ 3,398 | $ 4,569 | |||||
Lease liabilities | $ 3,002 | $ 3,979 | |||||
Manufacturing facility, Indiana | |||||||
Leases | |||||||
Lease term | 2 years | ||||||
Operating lease right-of-use assets | $ 3,617 | ||||||
Lease liabilities | 2,679 | ||||||
Difference between right of use asset and lease liability recognized | 938 | ||||||
Access fee monthly installment | 117 | ||||||
Amount of additional access fees to be paid in monthly installments | $ 1,631 | ||||||
Option to extend | false | ||||||
Laboratory, New Jersey | |||||||
Leases | |||||||
Leased area (in square feet) | ft² | 4,548 | ||||||
Additional leased area (in square feet) | ft² | 235 | ||||||
Lease term | 3 years | ||||||
Option to extend | true | ||||||
Option to extend, period | 2 years | ||||||
Fixed rent payable per annum | $ 144 | ||||||
Lease payable per month | 12 | ||||||
Corporate headquarters, New York | |||||||
Leases | |||||||
Lease term | 5 years | ||||||
Fixed rent payable per annum | $ 384 | ||||||
Lease payable per month | $ 32 | ||||||
Office space, Denmark | |||||||
Leases | |||||||
Lease term | 3 years | ||||||
Lease payable per month | $ 19 |
LICENSE AGREEMENTS AND COMMIT_6
LICENSE AGREEMENTS AND COMMITMENTS - Lease costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Leases | ||||
Total operating lease costs | $ 646 | $ 173 | $ 1,291 | $ 347 |
Cash paid for amounts included in the measurement of lease liabilities | 549 | 205 | 1,093 | 393 |
Research and development expense | ||||
Leases | ||||
Total operating lease costs | 587 | 124 | 1,174 | 247 |
General and administrative | ||||
Leases | ||||
Total operating lease costs | $ 59 | $ 49 | $ 117 | $ 100 |
LICENSE AGREEMENTS AND COMMIT_7
LICENSE AGREEMENTS AND COMMITMENTS - Lease maturities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Future minimum commitments under all non-cancelable operating leases | ||
Remainder of year | $ 1,086 | |
First fiscal year | 1,589 | $ 2,180 |
Second fiscal year | 539 | 1,593 |
Third fiscal year | 64 | 540 |
Fourth fiscal year | 64 | |
Total lease payments | 3,278 | 4,377 |
Less: Imputed interest | (276) | (398) |
Total operating lease liabilities at end of period | $ 3,002 | $ 3,979 |
LICENSE AGREEMENTS AND COMMIT_8
LICENSE AGREEMENTS AND COMMITMENTS - Lease term and discount rate (Details) | Jun. 30, 2021 | Dec. 31, 2020 |
LICENSE AGREEMENTS AND COMMITMENTS | ||
Weighted average remaining lease term | 1 year 9 months | 2 years 2 months 4 days |
Weighted average discount rate | 7.60% | 7.60% |
STOCKHOLDERS' EQUITY - Authoriz
STOCKHOLDERS' EQUITY - Authorized, Common and Preferred Stock (Details) | 6 Months Ended | |
Jun. 30, 2021USD ($)Vote$ / sharesshares | Dec. 31, 2020$ / sharesshares | |
STOCKHOLDERS' EQUITY | ||
Total shares authorized | 105,500,000 | 105,500,000 |
Common stock, authorized shares | 100,000,000 | 100,000,000 |
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized shares | 5,500,000 | 5,500,000 |
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
Number of votes per common share | Vote | 1 | |
Common stock dividends issued | $ | $ 0 | |
Common stock, shares issued | 43,576,950 | 40,688,447 |
Preferred stock, shares issued | 0 | 0 |
STOCKHOLDERS' EQUITY - Stock gr
STOCKHOLDERS' EQUITY - Stock grant agreements with non-employees (Details) $ in Thousands | Jun. 30, 2021individual | Aug. 31, 2020shares | Jul. 31, 2020USD ($)individual | Apr. 30, 2020USD ($)individualshares | Aug. 31, 2015individualshares | Jun. 30, 2021 | Jun. 30, 2020shares | Jun. 30, 2020USD ($) | Dec. 31, 2019individualshares | Dec. 31, 2018individualitemshares | Dec. 31, 2017shares | Dec. 31, 2016shares | Dec. 31, 2015shares | Jun. 30, 2021 |
Share-Based Compensation Awards | ||||||||||||||
Non-cash expense in connection with equity issuance to inventors | $ | $ 7,376 | |||||||||||||
Nonemployees | Researchers, Employees of MSK | ||||||||||||||
Share-Based Compensation Awards | ||||||||||||||
Number of individuals | individual | 2 | 1 | 2 | |||||||||||
Number of stock grants fully issued | item | 1 | |||||||||||||
SADA License Agreement | Researchers, Employees of MSK | ||||||||||||||
Share-Based Compensation Awards | ||||||||||||||
Number of individuals | individual | 2 | |||||||||||||
Notes receivable, noncurrent | $ | $ 2,610 | |||||||||||||
Notes receivable term | 3 years | |||||||||||||
Notes receivable interest rate (as a percent) | 1.00% | |||||||||||||
SADA License Agreement | Nonemployees | Researchers, Employees of MSK | ||||||||||||||
Share-Based Compensation Awards | ||||||||||||||
Number of individuals | individual | 2 | 2 | ||||||||||||
Vesting (as a percent) | 60.00% | |||||||||||||
SADA License Agreement | Nonemployees | Researchers, Employees of MSK | Research and development expense | ||||||||||||||
Share-Based Compensation Awards | ||||||||||||||
Non-cash expense in connection with equity issuance to inventors | $ | $ 7,376 | |||||||||||||
SADA License Agreement | Nonemployees | Researchers, Employees of MSK | Tranche one | ||||||||||||||
Share-Based Compensation Awards | ||||||||||||||
Vesting (as a percent) | 40.00% | |||||||||||||
SADA License Agreement | Nonemployees | Researchers, Employees of MSK | Tranche two | ||||||||||||||
Share-Based Compensation Awards | ||||||||||||||
Vesting (as a percent) | 20.00% | |||||||||||||
Remaining vesting percentage | 40.00% | 60.00% | 40.00% | 40.00% | ||||||||||
Vesting period | 2 years | 3 years | ||||||||||||
Common Stock | ||||||||||||||
Share-Based Compensation Awards | ||||||||||||||
Issuance of common stock to non-employees (in shares) | 256,896 | |||||||||||||
Common Stock | Nonemployees | Researchers, Employees of MSK | ||||||||||||||
Share-Based Compensation Awards | ||||||||||||||
Shares agreed to be issued | 2,800,000 | |||||||||||||
Issuance of common stock to non-employees (in shares) | 400,000 | 400,000 | 544,000 | 448,000 | 448,000 | 560,000 | ||||||||
Common Stock | SADA License Agreement | Nonemployees | Researchers, Employees of MSK | ||||||||||||||
Share-Based Compensation Awards | ||||||||||||||
Shares agreed to be issued | 213,996 | |||||||||||||
Issuance of common stock to non-employees (in shares) | 213,996 |
STOCKHOLDERS' EQUITY - Issuance
STOCKHOLDERS' EQUITY - Issuance of common stock (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 22, 2021 | Mar. 31, 2021 | Jun. 30, 2021 |
Issuance of stock | |||
Proceeds from issuance of common stock, net | $ 107,725 | ||
Issuance of common stock to investors, net of issuance costs | $ 107,725 | ||
Secondary public offering, February 22, 2021 | |||
Issuance of stock | |||
Aggregate gross proceeds | $ 115,000 | ||
Proceeds from issuance of common stock, net | $ 107,725 | ||
Common Stock | |||
Issuance of stock | |||
Issuance of common stock, Stock offering (in shares) | 2,804,878 | ||
Common Stock | Secondary public offering, February 22, 2021 | |||
Issuance of stock | |||
Issuance of common stock, Stock offering (in shares) | 2,804,878 | ||
Share price (in dollars per share) | $ 41 |
SHARE-BASED COMPENSATION - 2015
SHARE-BASED COMPENSATION - 2015 Plan (Details) - 2015 Plan - shares | 12 Months Ended | |
Dec. 31, 2015 | Sep. 30, 2018 | |
Share-Based Compensation Awards | ||
Shares reserved for issuance pursuant to the plan | 4,500,000 | |
Shares available for grant | 0 | |
Stock options | ||
Share-Based Compensation Awards | ||
Vesting period | 4 years |
SHARE-BASED COMPENSATION - 2018
SHARE-BASED COMPENSATION - 2018 Plan (Details) - 2018 Plan | 6 Months Ended |
Jun. 30, 2021shares | |
Share-Based Compensation Awards | |
Shares reserved for issuance pursuant to the plan | 5,500,000 |
Annual increase on share reserve (as a percent) | 4.00% |
Stock options | Employees and nonemployees owning less than 10% of voting power | |
Share-Based Compensation Awards | |
Term of award | 10 years |
Vesting period | 4 years |
Stock options | Participants owning more than 10% of voting power | |
Share-Based Compensation Awards | |
Term of award | 5 years |
Stock options | Participants owning more than 10% of voting power | Minimum | |
Share-Based Compensation Awards | |
Ownership (as a percent) | 10.00% |
Option price as percentage of fair market value of common stock on the date of grant | 110.00% |
SHARE-BASED COMPENSATION - Stoc
SHARE-BASED COMPENSATION - Stock option expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-Based Compensation Awards | ||||
Options granted (in shares) | 209,000 | 324,000 | 209,000 | 1,041,000 |
Stock options | Employees and directors | ||||
Share-Based Compensation Awards | ||||
Stock-based compensation expenses | $ 4,752 | $ 2,406 | $ 9,380 | $ 4,594 |
Stock options | Employees and directors | Research and development expense | ||||
Share-Based Compensation Awards | ||||
Stock-based compensation expenses | 1,753 | 537 | 3,444 | 1,026 |
Stock options | Employees and directors | General and administrative | ||||
Share-Based Compensation Awards | ||||
Stock-based compensation expenses | $ 2,999 | $ 1,871 | $ 5,936 | $ 3,570 |
SHARE-BASED COMPENSATION - St_2
SHARE-BASED COMPENSATION - Stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Options | |||||
Outstanding at beginning of period (in shares) | 5,674,100 | ||||
Granted (in shares) | 209,000 | 324,000 | 209,000 | 1,041,000 | |
Exercised (in shares) | (74,332) | ||||
Forfeited, shares (in shares) | (25,000) | ||||
Outstanding at end of period (in shares) | 5,783,768 | 5,783,768 | 5,674,100 | ||
Exercisable at end of period (in shares) | 3,370,715 | 3,370,715 | |||
Weighted average exercise price | |||||
Outstanding at beginning of period (in dollars per share) | $ 22.55 | ||||
Granted (in dollars per share) | 32.44 | ||||
Exercised (in dollars per share) | 3.24 | ||||
Forfeited (in dollars per share) | 36.95 | ||||
Outstanding at end of period (in dollars per share) | $ 23.10 | 23.10 | $ 22.55 | ||
Exercisable at end of period (in dollars per share) | $ 11.83 | $ 11.83 | |||
Aggregate intrinsic value and Weighted average remaining contractual life (years) | |||||
Outstanding (in dollars) | $ 85,272 | $ 85,272 | $ 156,726 | ||
Exercisable (in dollars) | $ 76,242 | $ 76,242 | |||
Outstanding (in years) | 7 years 1 month 20 days | 7 years 6 months 3 days | |||
Exercisable (in years) | 5 years 10 months 24 days | ||||
Weighted average grant-date fair value of stock options granted (in dollars per share) | $ 32.44 | $ 27.65 | $ 32.44 | $ 20.32 |
SHARE-BASED COMPENSATION - St_3
SHARE-BASED COMPENSATION - Stock option unrecognized compensation (Details) - Stock options - Employees - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Unrecognized compensation related to employee stock options | ||
Unrecognized compensation | $ 47,280 | $ 32,443 |
Expected vesting period | 2 years 8 months 23 days | 2 years 11 months 1 day |
SHARE-BASED COMPENSATION - Rest
SHARE-BASED COMPENSATION - Restricted Stock Unit Activity (Details) - RSUs - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Share-Based Compensation Awards | |||||
Stock-based compensation expenses | $ 75 | $ 49 | $ 145 | $ 72 | |
Restricted stock units issued and outstanding | |||||
Outstanding and expected to vest at beginning of period (in shares) | 30,146 | ||||
Granted (in shares) | 6,217 | ||||
Vested (in shares) | (9,293) | ||||
Forfeited (in shares) | (2,751) | ||||
Outstanding and expected to vest at end of period (in shares) | 24,319 | 24,319 | 30,146 | ||
Weighted average grant price | |||||
Weighted average grant price, Outstanding and expected to vest, Beginning of period (in dollars per share) | $ 25.45 | ||||
Weighted average grant price, Granted (in dollars per share) | 34.32 | ||||
Weighted average grant price, Vested (in dollars per share) | 21.19 | ||||
Weighted average grant price, Forfeited (in dollars per share) | 27.89 | ||||
Weighted average grant price, Outstanding and expected to vest, End of period (in dollars per share) | $ 29.07 | $ 29.07 | $ 25.45 | ||
Weighted average remaining vesting life | 1 year 11 months 26 days | 2 years 3 months 21 days | 2 years 2 months 4 days | ||
Unrecognized compensation | $ 585 | 462 | $ 585 | $ 462 | |
Research and development expense | |||||
Share-Based Compensation Awards | |||||
Stock-based compensation expenses | 68 | 44 | 131 | 65 | |
General and administrative | |||||
Share-Based Compensation Awards | |||||
Stock-based compensation expenses | $ 7 | $ 5 | $ 14 | $ 7 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - MSK - MSK License Agreement, CD33 License Agreement, CTA, CFAs, SRA and MDSA - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Related party transactions | |||||
Expensed costs | $ 1,157 | $ 5,527 | $ 2,105 | $ 6,576 | |
Due to related parties, Accounts payable | 594 | 594 | $ 833 | ||
Due to related parties, Accrued liabilities | 5,513 | 5,513 | 7,161 | ||
Due to related parties | $ 6,107 | $ 6,107 | $ 7,994 |
INCOME TAXES - Expense (Details
INCOME TAXES - Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income tax expense | ||||
Current income taxes | $ 0 | $ 0 | $ 0 | $ 0 |
Deferred income taxes | 0 | 0 | 0 | 0 |
Domestic and foreign loss before income taxes: | ||||
Income (loss) before income tax benefit | $ (22,937) | $ (40,393) | $ 10,476 | $ (66,572) |
INCOME TAXES - Uncertain tax po
INCOME TAXES - Uncertain tax positions (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
INCOME TAXES | ||
Uncertain tax position | $ 0 | $ 0 |
OTHER BENEFITS (Details)
OTHER BENEFITS (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
UNITED STATES | ||||
Benefit plan | ||||
Employer matching contribution to defined contribution plan (as a percent) | 0.00% | 0.00% | 0.00% | 0.00% |
DENMARK | ||||
Benefit plan | ||||
Employer matching contribution to defined contribution plan (as a percent) | 0.00% | 0.00% | 0.00% | 0.00% |
Costs for employee health insurance benefits | $ 0 | $ 0 | $ 0 | $ 0 |
GAIN FROM SALE OF PRIORITY RE_2
GAIN FROM SALE OF PRIORITY REVIEW VOUCHER (Details) - USD ($) $ in Thousands | Jan. 21, 2021 | Jun. 30, 2021 |
Disposal | ||
Net gain recognized | $ 62,010 | |
Priority Review Voucher | Disposal Group, Disposed of by Sale, Not Discontinued Operations | ||
Disposal | ||
Consideration | $ 105,000 | |
Percentage of net proceeds from monetization entitled to be retained | 60.00% | |
Percentage of net proceeds from monetization to be paid to MSK | 40.00% | |
Net gain recognized | $ 62,010 |