Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2020 | May 04, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-36296 | |
Entity Registrant Name | Sesen Bio, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-2025616 | |
Entity Address, Address Line One | 245 First Street | |
Entity Address, Address Line Two | Suite 1800 | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02142 | |
City Area Code | 617 | |
Local Phone Number | 444-8550 | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Trading Symbol | SESN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Filer Category | Accelerated Filer | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 110,416,298 | |
Entity Central Index Key | 0001485003 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 42,463 | $ 48,121 |
Prepaid expenses and other current assets | 2,420 | 6,326 |
Total current assets | 44,883 | 54,447 |
Restricted cash | 20 | 20 |
Property and equipment, net of accumulated depreciation of $789 and $758, respectively | 207 | 238 |
Intangible assets | 46,400 | 46,400 |
Goodwill | 13,064 | 13,064 |
Other assets | 91 | 196 |
Total Assets | 104,665 | 114,365 |
Current liabilities: | ||
Accounts payable | 2,068 | 1,902 |
Accrued expenses | 4,893 | 6,169 |
Other current liabilities | 405 | 446 |
Total current liabilities | 7,366 | 8,517 |
Deferred tax liability | 12,528 | 12,528 |
Total Liabilities | 86,214 | 141,065 |
Commitments and contingencies | ||
Stockholders’ Equity (Deficit): | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized at March 31, 2020 and December 31, 2019; no shares issued and outstanding at March 31, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.001 par value per share; 200,000,000 shares authorized at March 31, 2020 and December 31, 2019; 109,991,553 and 106,801,409 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 110 | 107 |
Additional paid-in capital | 270,301 | 266,717 |
Accumulated deficit | (251,960) | (293,524) |
Total Stockholders’ Equity (Deficit) | 18,451 | (26,700) |
Total Liabilities and Stockholders’ Equity (Deficit) | $ 104,665 | $ 114,365 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Property and equipment, accumulated depreciation | $ 789 | $ 758 |
Preferred stock, par value ((in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 109,991,553 | 106,801,409 |
Common stock, shares outstanding (in shares) | 109,991,553 | 106,801,409 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating expenses: | ||
Research and development | $ 8,867 | $ 4,686 |
General and administrative | 3,448 | 3,055 |
Change in fair value of contingent consideration | (53,700) | (1,000) |
Total operating expenses | (41,385) | 6,741 |
Income (Loss) from Operations | 41,385 | (6,741) |
Other income (expense): | ||
Other income, net | 179 | 261 |
Net Income (Loss) and Comprehensive Income (Loss) | 41,564 | (6,480) |
Net income (loss) attributable to common stockholders - basic | 34,407 | (6,480) |
Net Income (Loss) Available to Common Stockholders, Diluted | $ 34,408 | $ (6,480) |
Net income (loss) per common share - basic (in dollars per share) | $ 0.31 | $ (0.08) |
Weighted-average common shares outstanding - basic (in shares) | 109,808 | 77,458 |
Net income (loss) per common share - diluted (in dollars per share) | $ 0.31 | $ (0.08) |
Weighted-average common shares outstanding - diluted (in shares) | 109,823 | 77,458 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Beginning balance (in shares) | 77,456,180 | |||
Beginning balance (in shares) | 77,464,781 | |||
Beginning balance at Dec. 31, 2018 | $ 44,207 | $ 77 | $ 230,154 | $ (186,024) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net income | (6,480) | (6,480) | ||
Share-based compensation | 326 | 326 | ||
Sales of common stock under 2014 ESPP (in shares) | 8,601 | |||
Sales of common stock under 2014 ESPP | 7 | 7 | ||
Ending balance (in shares) at Mar. 31, 2019 | 77,464,781 | |||
Ending balance at Mar. 31, 2019 | 38,060 | $ 77 | 230,487 | (192,504) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Beginning balance (in shares) | 77,464,781 | |||
Beginning balance (in shares) | 106,801,409 | |||
Beginning balance (in shares) | 109,991,553 | |||
Beginning balance at Dec. 31, 2019 | (26,700) | $ 107 | 266,717 | (293,524) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net income | 41,564 | 41,564 | ||
Share-based compensation | 407 | 407 | ||
Sales of common stock under 2014 ESPP (in shares) | 2,785 | |||
Sales of common stock under 2014 ESPP | 1 | 1 | ||
Issuance of common stock under ATM offering, net of issuance costs of $xxx (in shares) | 3,187,359 | |||
Issuance of common stock under ATM Offering, net of issuance costs of $98 | 3,179 | $ 3 | 3,176 | |
Ending balance (in shares) at Mar. 31, 2020 | 109,991,553 | |||
Ending balance at Mar. 31, 2020 | $ 18,451 | $ 110 | $ 270,301 | $ (251,960) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Beginning balance (in shares) | 109,991,553 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Issuance of common stock, issuance costs | $ 98 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Cash Flows from Operating Activities: | |||
Net income (loss) | $ 41,564 | $ (6,480) | |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | |||
Depreciation | 31 | 49 | |
Share-based compensation | 407 | 326 | |
Change in fair value of contingent consideration | (53,700) | (1,000) | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other assets | 4,011 | (1,912) | |
Accounts payable | 166 | 316 | |
Accrued expenses and other liabilities | (1,317) | 709 | |
Net Cash Used in Operating Activities | (8,838) | (7,992) | $ (37,500) |
Cash Flows from Investing Activities: | |||
Net Cash Used in Investing Activities | 0 | 0 | |
Cash Flows from Financing Activities: | |||
Proceeds from issuance of common stock under ATM Offering, net of issuance costs | 3,179 | 0 | |
Proceeds from sales of common stock under 2014 ESPP | 1 | 7 | |
Net Cash Provided by Financing Activities | 3,180 | 7 | |
Net Decrease in Cash, Cash Equivalents and Restricted Cash | (5,658) | (7,985) | |
Cash, Cash Equivalents and Restricted Cash - Beginning of Period | 48,141 | 50,442 | 50,442 |
Cash, Cash Equivalents and Restricted Cash - End of Period | 42,483 | 42,457 | $ 48,141 |
Supplemental disclosure of non-cash operating activities: | |||
Right-of-use assets related to the adoption of ASC 842 | 0 | 236 | |
Cash paid for amounts included in the measurement of lease liabilities | $ 38 | $ 38 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 3 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | DESCRIPTION OF BUSINESS Sesen Bio, Inc. ("Sesen" or the “Company”), a Delaware corporation formed in February 2008, is a late-stage clinical company developing targeted fusion protein therapeutics ("TFPTs") for the treatment of patients with cancer. The Company’s most advanced product candidate, Vicinium ® , also known as VB4-845, is a locally-administered targeted fusion protein composed of an anti-epithelial cell adhesion molecule ("EpCAM") antibody fragment tethered to a truncated form of Pseudomonas exotoxin A . The Company has an ongoing single-arm, multi-center, open-label Phase 3 clinical trial of Vicinium as a monotherapy in patients with high-risk, bacillus Calmette-Guérin ("BCG")-unresponsive non-muscle invasive bladder cancer ("NMIBC") (the "VISTA Trial"). The VISTA Trial completed enrollment in April 2018 with a total of 133 patients, and in December 2019, the Company initiated submission of the Biologics License Application ("BLA") for Vicinium to the United States Food and Drug Administration ("FDA") under Rolling Review, which enables individual modules to be submitted and reviewed on an ongoing basis, rather than waiting for all sections to be completed before submission. The Company operates in one segment under the direction of its Chief Executive Officer (chief operating decision maker). Viventia Acquisition In September 2016, the Company entered into a Share Purchase Agreement with Viventia Bio, Inc., a corporation incorporated under the laws of the Province of Ontario, Canada ("Viventia"), the shareholders of Viventia named therein (the “Selling Shareholders”) and, solely in its capacity as seller representative, Clairmark Investments Ltd., a corporation incorporated under the laws of the Province of Ontario, Canada (“Clairmark”) (the “Share Purchase Agreement”), pursuant to which the Company agreed to and simultaneously completed the acquisition of all of the outstanding capital stock of Viventia from the Selling Shareholders (the “Viventia Acquisition”). In connection with the closing of the Viventia Acquisition, the Company issued 4.0 million shares of its common stock to the Selling Shareholders, which at that time represented approximately 19.9% of the voting power of the Company as of immediately prior to the issuance of such shares. Clairmark is an affiliate of Leslie L. Dan, a director of the Company until his retirement in July 2019. In addition, under the Share Purchase Agreement, the Company is obligated to pay to the Selling Shareholders certain post-closing contingent cash payments upon the achievement of specified milestones and based upon net sales, in each case subject to the terms and conditions set forth in the Share Purchase Agreement, including: (i) a one-time milestone payment of $12.5 million payable upon the first sale of Vicinium (the “Purchased Product”), in the United States; (ii) a one-time milestone payment of $7.0 million payable upon the first sale of the Purchased Product in any one of certain specified European countries; (iii) a one-time milestone payment of $3.0 million payable upon the first sale of the Purchased Product in Japan; and (iv) quarterly earn-out payments equal to 2% of net sales of the Purchased Product during specified earn-out periods. Such earn-out payments are payable with respect to net sales in a country beginning on the date of the first sale in such country and ending on the earlier of (i) December 31, 2033 and (ii) fifteen seven Liquidity and Going Concern As of March 31, 2020, the Company had cash and cash equivalents of $42.5 million , net working capital of $37.5 million and an accumulated deficit of $252.0 million. The Company incurred negative cash flows from operating activities of $37.5 million for the year ended December 31, 2019 and $8.8 million for the three months ended March 31, 2020. Since its inception, the Company has received no revenue from sales of its products, and management anticipates that operating losses will continue for the foreseeable future as the Company continues its ongoing Phase 3 VISTA Trial for Vicinium for the treatment of high-risk NMIBC and seeks marketing approval from the FDA. The Company has financed its operations to date primarily through private placements of its common stock, preferred stock, common stock warrants and convertible bridge notes, venture debt borrowings, its initial public offering ("IPO"), follow-on public offerings, sales effected in "at-the-market" ("ATM") offerings, a License Agreement with F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. (collectively, "Roche") (the "License Agreement with Roche") and, to a lesser extent, from a collaboration. See “Note 9. Stockholders’ Equity” below for information regarding the Company’s recently completed equity financings. Under Accounting Standards Codification ("ASC") Topic 205-40, Presentation of Financial Statements - Going Concern , management is required at each reporting period to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about an entity's ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management's plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt about the Company's ability to continue as a going concern. The mitigating effect of management's plans, however, is only considered if both (i) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (ii) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity's ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans must have been approved by the Company's board of directors before the date that the financial statements are issued. The Company's future success is dependent on its ability to develop its product candidates, including Vicinium for the treatment of high-risk NMIBC, and ultimately upon its ability to attain profitable operations. In order to commercialize its product candidates, including Vicinium for the treatment of high-risk NMIBC, the Company needs to complete clinical development and comply with comprehensive regulatory requirements. The Company is subject to a number of risks similar to other late-stage clinical companies, including, but not limited to, successful discovery and development of its product candidates, raising additional capital, development and commercialization by its competitors of new technological innovations, protection of proprietary technology and market acceptance of its products. The successful discovery and development of product candidates, including Vicinium for the treatment of high-risk NMIBC, requires substantial working capital, and management expects to seek additional funds through equity or debt financings or through additional collaboration, licensing transactions or other sources. The Company may be unable to obtain equity or debt financings or enter into additional collaboration or licensing transactions at favorable terms, or at all. To the extent that the Company raises additional capital through the sale of equity or convertible debt securities, the ownership interests of existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of existing stockholders. Debt financing, if available, may involve agreements that include liens or other restrictive covenants limiting the Company's ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If the Company raises additional funds through government or other third-party funding, strategic collaborations and alliances or licensing arrangements, it may have to relinquish valuable rights to its technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable. If the Company is unable to raise additional funds when needed, it may be required to implement cost reduction strategies and delay, limit, reduce or terminate its product development or future commercialization efforts or grant rights to develop and market products or product candidates that management would otherwise prefer to develop and market. The Company's management does not believe that its cash and cash equivalents of $42.5 million as of March 31, 2020 is sufficient to fund the Company's current operating plan for at least twelve months after the issuance of these condensed consolidated financial statements. Given the history of significant losses, negative cash flows from operations, limited cash resources currently on hand, the ongoing COVID-19 pandemic and dependence by the Company on its ability - about which there can be no certainty - to obtain additional financing to fund its operations after the current cash resources are exhausted, substantial doubt exists about the Company's ability to continue as a going concern. These condensed consolidated financial statements were prepared under the assumption that the Company will continue as a going concern and do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION | BASIS OF PRESENTATION The accompanying financial statements have been prepared in accordance with United States generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the ASC and Accounting Standards Updates (“ASUs”), promulgated by the Financial Accounting Standards Board (“FASB”). Interim Financial Statements The accompanying unaudited interim condensed consolidated financial statements have been prepared from the books and records of the Company in accordance with GAAP for interim financial information and Rule 10-01 of Regulation S-X promulgated by the United States Securities and Exchange Commission (“SEC”), which permit reduced disclosures for interim periods. All adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the accompanying condensed consolidated balance sheets and statements of income (operations) and comprehensive income (loss), stockholders’ equity and cash flows have been made. Although these interim financial statements do not include all of the information and footnotes required for complete annual financial statements, management believes the disclosures are adequate to make the information presented not misleading. These unaudited interim results of operations and cash flows for the three months ended March 31, 2020 are not necessarily indicative of the results that may be expected for the full year. These unaudited interim condensed consolidated financial statements and footnotes should be read in conjunction with the Company’s audited annual consolidated financial statements and footnotes included in its Annual Report on Form 10-K, as filed with the SEC on March 16, 2020, wherein a more complete discussion of significant accounting policies and certain other information can be found. Use of Estimates The preparation of financial statements in accordance with GAAP and the rules and regulations of the SEC requires the use of estimates and assumptions, based on judgments considered reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience, known trends and events and various other factors that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Although management believes its estimates and assumptions are reasonable when made, they are based upon information available at the time they are made. Management evaluates the estimates and assumptions on an ongoing basis and, if necessary, makes adjustments. Due to the risks and uncertainties involved in the Company’s business and evolving market conditions, and given the subjective element of the estimates and assumptions made, actual results may differ from estimated results. The most significant estimates and judgments impact the fair value of intangible assets, goodwill and contingent consideration; income taxes (including the valuation allowance for deferred tax assets); research and development expenses; and going concern considerations. Principles of Consolidation The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiary Viventia and its indirect subsidiaries, Viventia Bio USA Inc. and Viventia Biotech (EU) Limited. All intercompany transactions and balances have been eliminated in consolidation. Foreign Currency Translation The functional currency of the Company and each of its subsidiaries is the U.S. dollar. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIESThe Company's complete summary of significant accounting policies can be found in "Item 15. Exhibits and Financial Statement Schedules - Note 3. Summary of Significant Accounting Policies" in the audited annual consolidated financial statements included in its Annual Report on Form 10-K for the year ended December 31, 2019. |
RECENT ACCOUNTING PRONOUNCEMENT
RECENT ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 2020 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | RECENT ACCOUNTING PRONOUNCEMENTS Adopted in 2020 In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"). ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets held. The amendments in ASU 2016-13 eliminate the probable threshold for initial recognition of a credit loss in current GAAP and reflect an entity’s current estimate of all expected credit losses. ASU 2016-13 is effective for annual and interim periods beginning January 1, 2020 and is to be applied using a modified retrospective transition method. The Company adopted this guidance effective January 1, 2020, and it did not have a material impact on the Company’s financial position, results of operations or cash flows. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurements ("ASU 2018-13"). ASU 2018-13 modifies fair value measurement disclosure requirements. ASU 2018-13 is effective for annual and interim periods beginning after December 15, 2019. The Company adopted this guidance effective January 1, 2020, and although it resulted in some additional footnote disclosures, it did not have a material impact on the Company’s disclosures. For the new disclosures regarding our Level 3 instruments, please read Note 5, Fair Value Measurements and Financial Instruments, to these condensed consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-15, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract ("ASU 2018-15") . ASU 2018-15 requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance to determine which implementation costs to defer and recognize as an asset. The effective date for ASU 2018-15 is for annual and interim periods beginning after December 15, 2019. The amendments in this ASU should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The Company adopted this guidance effective January 1, 2020, and it did not have a material impact on the Company’s financial position, results of operations or cash flows. Pending Adoption In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ("ASU 2019-12"). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The amendments in ASU 2019-12 also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted. The method with which the amendments in this ASU are to be applied varies depending on the nature of the tax item impacted by amendment. Because the Company generates losses and pays no income taxes, it does not expect the adoption of ASU 2019-12 to have a material impact on the Company's financial position, results of operations or cash flows. |
FAIR VALUE MEASUREMENT AND FINA
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS | FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS The carrying values of cash and cash equivalents, restricted cash, prepaid expenses and other current assets, and accounts payable on the Company’s consolidated balance sheets approximated their fair values as of March 31, 2020 and December 31, 2019 due to their short-term nature. Certain of the Company’s financial instruments are measured at fair value using a three-level hierarchy that prioritizes the inputs used to measure fair value. This fair value hierarchy prioritizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: Level 1 : Inputs are quoted prices for identical instruments in active markets. Level 2 : Inputs are quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; or model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 : Inputs are unobservable and reflect the Company’s own assumptions, based on the best information available, including the Company’s own data. The following tables set forth the carrying amounts and fair values of the Company's financial instruments measured at fair value on a recurring basis as of March 31, 2020 and December 31, 2019 (in thousands): March 31, 2020 Fair Value Measurement Based on Carrying Amount Fair Value Quoted Prices in Active Significant other Observable Significant Unobservable Assets: Money market funds $ 31,276 $ 31,276 $ 31,276 $ — $ — Liabilities: Contingent consideration $ 66,320 $ 66,320 $ — $ — $ 66,320 December 31, 2019 Fair Value Measurement Based on Carrying Amount Fair Value Quoted Prices in Active Significant other Observable Significant Unobservable Assets: Money market funds $ 31,146 $ 31,146 $ 31,146 $ — $ — Liabilities: Contingent consideration $ 120,020 $ 120,020 $ — $ — $ 120,020 The Company evaluates transfers between fair value levels at the end of each reporting period. There were no transfers of assets or liabilities between fair value levels during the three months ended March 31, 2020. Contingent Consideration On September 20, 2016, the Company acquired Viventia through the issuance of common stock plus contingent consideration, pursuant to the terms of a Share Purchase Agreement. The Company recorded the acquired assets and liabilities based on their estimated fair values as of the acquisition date and finalized its purchase accounting for the Viventia Acquisition during the third quarter of 2017. The contingent consideration relates to amounts potentially payable to the former shareholders of Viventia under the Share Purchase Agreement. Contingent consideration is measured at its estimated fair value at each reporting period, with fluctuations in value resulting in a non-cash charge to earnings (or loss) during the period. The estimated fair value measurement is based on significant inputs, including internally developed financial forecasts, probabilities of success, and the timing of certain milestone events and achievements, which are not observable in the market, representing a Level 3 measurement within the fair value hierarchy. The valuation of contingent consideration requires the use of significant assumptions and judgments, which management believes are consistent with those that would be made by a market participant. Management reviews its assumptions and judgments on an ongoing basis as additional market and other data is obtained, and any future changes in the assumptions and judgments utilized by management may cause the estimated fair value of contingent consideration to fluctuate materially, resulting in earnings volatility. The following table sets forth a summary of the change in the fair value of the Company's contingent consideration liability, measured on a recurring basis at each reporting period, for the three months ended March 31, 2020 (in thousands): Balance at December 31, 2019 $ 120,020 Change in fair value of contingent consideration (53,700) Balance at March 31, 2020 $ 66,320 The fair value of the Company’s contingent consideration was determined using probabilities of successful achievement of regulatory milestones and commercial sales, the period in which these milestones and sales are expected to be achieved ranging from 2021 to 2033, and the level of commercial sales of Vicinium forecasted for the United States, Europe, Japan and other potential markets. There have been no changes to the valuation methods utilized during the three months ended March 31, 2020. Because of the business environment uncertainty created by the ongoing COVID-19 pandemic, management carefully reviewed as of March 31, 2020 all of the Company’s financial forecast assumptions related to probability, timing and anticipated level of commercial sales, which were used to determine the estimated fair value of contingent consideration as of December 31, 2019, and determined that no financial forecast changes were currently required. Given the evolving and uncertain nature of the COVID-19 pandemic, management will continue to closely monitor developments in order to timely determine if any financial forecast changes may be required. Changes to probabilities of success, timing of certain milestones and achievements, and level of commercial sales could materially affect the valuation of contingent consideration. However, the estimated fair value of contingent consideration is also determined by applying appropriate discount rates to future cash outflows related to the contingent payment obligations, and these discount rates have increased significantly as a result of the extreme volatility of financial markets as global economies shut down in order to contain the spread of COVID-19. The milestone payments constitute debt-like obligations, and the high-yield debt index rate applied to the milestones in order to determine the estimated fair value increased from 11.8% as of December 31, 2019 to 17.9% as of March 31, 2020. The discount rate applied to the 2% royalty due on forecasted Vicinium revenues is derived from the Company’s estimated weighted-average cost of capital (“WACC”), and this WACC-derived discount rate increased from 5.6% as of December 31, 2019 to 14.7% as of March 31, 2020. These significant increases in the applicable discount rates resulted in a $53.7 million decrease in the estimated |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL | 3 Months Ended |
Mar. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS AND GOODWILL | INTANGIBLE ASSETS AND GOODWILL Intangible Assets Intangible assets on the Company's consolidated balance sheet are the result of the Viventia Acquisition in September 2016. The following table sets forth the composition of intangible assets as of March 31, 2020 and December 31, 2019 (in thousands): March 31, 2020 December 31, 2019 IPR&D intangible assets: Vicinium United States rights $ 31,700 $ 31,700 Vicinium European Union rights 14,700 14,700 Total Intangibles $ 46,400 $ 46,400 Goodwill Goodwill on the Company's consolidated balance sheet is the result of the Viventia Acquisition in September 2016. Goodwill had a carrying value of $13.1 million as of March 31, 2020 and December 31, 2019. Quantitative Impairment Testing Because of the business environment uncertainly created by the ongoing COVID-19 pandemic, which resulted in the application of higher discount rates to the Company's financial forecasts as discussed above, management performed an interim quantitative impairment test as of March 31, 2020. Based on this quantitative testing, management concluded that the carrying values of the Company's intangible assets and goodwill were not impaired as of March 31, 2020. |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
LEASES | LEASES On January 1, 2019, the Company adopted ASC 842 using the optional transition method. The Company’s lease portfolio includes: 1. An operating lease for its 31,100 square foot facility in Winnipeg, Manitoba which consists of manufacturing, laboratory, warehouse and office space, under a five five 2. Short-term property leases for modular office space for 1) its current corporate headquarters in Cambridge, MA and 2) office space in Philadelphia, PA. The short-term leases renew every four six The asset component of the Company’s operating leases is recorded as operating lease right-of-use assets and reported within other assets on the Company's consolidated balance sheet. The short-term liability is recorded in other current liabilities on the Company’s consolidated balance sheet. Operating lease cost is recognized on a straight-line basis over the lease term. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 3 Months Ended |
Mar. 31, 2020 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | ACCRUED EXPENSESThe following table sets forth the composition of accrued expenses as of March 31, 2020 and December 31, 2019 (in thousands): March 31, December 31, 2019 Research and development $ 3,517 $ 3,688 Payroll-related expenses 627 1,638 Severance to former Executives and other employees 155 378 Professional fees 544 378 Other 50 87 Total Accrued Expenses $ 4,893 $ 6,169 Management Changes On August 26, 2019, Richard Fitzgerald departed as the Company's Chief Financial Officer. In connection with his separation from the Company, Mr. Fitzgerald and the Company entered into a Separation Agreement and General Release dated as of September 9, 2019 (the “Fitzgerald Separation Agreement”), pursuant to which the Company provided Mr. Fitzgerald with twelve months of separation payments and benefits. The Company recorded $0.3 million of expense, which will be paid through the normal payroll cycle through August 2020. On August 2, 2019, Dennis Kim, M.D., MPH departed as the Company's Chief Medical Officer. In connection with his separation from the Company, Dr. Kim and the Company entered into a Separation Agreement and General Release dated as of August 2, 2019 (the “Kim Separation Agreement”), pursuant to which the Company provided Dr. Kim with six months of separation payments in the amount of $0.2 million. In addition, Dr. Kim and the Company entered into a Consulting Agreement dated as of August 3, 2019 (the "Kim Consulting Agreement"), pursuant to which the Company agreed to pay Dr. Kim $0.1 million in consulting fees and transition expenses over the following three months ended November 2, 2019. The Company recorded $0.3 million of expenses related to these agreements in 2019. The Kim Consulting Agreement payments were made in a lump sum when the agreement concluded in November 2019. The separation payments were paid through the normal payroll cycle through January 2020, when the Company concluded its obligations under the Kim Separation Agreement. |
STOCKHOLDERS' EQUITY (DEFICIT)
STOCKHOLDERS' EQUITY (DEFICIT) | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
STOCKHOLDERS' EQUITY (DEFICIT) | STOCKHOLDERS' EQUITY (DEFICIT) Equity Financings ATM Offering In November 2019, the Company entered into an Open Market Sale Agreement SM (the "Sales Agreement") with Jefferies LLC ("Jefferies"), under which the Company may issue and sell shares of its common stock from time to time for an aggregate sales price of up to $35.0 million through Jefferies (the "ATM Offering"). Sales of common stock under the Sales Agreement are made by any method that is deemed to be an ATM offering as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended, including but not limited to sales made directly on or through the Nasdaq Global Market or any other existing trading market for the common stock. The Company has no obligation to sell any of its common stock and may at any time suspend offers under the Sales Agreement or terminate the Sales Agreement. Subject to the terms and conditions of the Sales Agreement, Jefferies will use its commercially reasonable efforts to sell common stock from time to time, as the sales agent, based upon the Company’s instructions, which include a prohibition on sales below a minimum price set by the Company from time to time. The Company has provided Jefferies with customary indemnification rights, and Jefferies is entitled to a commission at a fixed rate equal to 3.0% of the gross proceeds for each sale of common stock. The Company incurred $0.2 million in legal, accounting and printing costs related to the commencement of the ATM Offering. From its inception in November 2019 through March 31, 2020, the Company raised $5.1 million of net proceeds from the sale of 5.2 million shares of common stock at a weighted-average price of $1.06 per share under the ATM Offering, including $3.2 million of net proceeds from the sale of 3.2 million shares of common stock at a weighted-average price of $1.02 per share during the three months ended March 31, 2020. Share issue costs, including sales agent commissions, related to the ATM Offering totaled $0.1 million during the three months ended March 31, 2020. June 2019 Financing In June 2019, the Company raised $27.8 million of net proceeds from the sale of 20.4 million shares of common stock and accompanying warrants to purchase an additional 20.4 million shares of common stock in an underwritten public offering (the "June 2019 Financing"). The combined purchase price for each share of common stock and accompanying warrant was $1.47. Subject to certain ownership limitations, the warrants issued in the June 2019 Financing were exercisable immediately upon issuance at an exercise price of $1.47 per share, subject to adjustments as provided under the terms of such warrants, and have a one Preferred Stock Pursuant to its Amended and Restated Certificate of Incorporation (the "Certificate of Incorporation"), the Company is authorized to issue 5.0 million shares of "blank check" preferred stock, $0.001 par value per share, which enables its board of directors, from time to time, to create one or more series of preferred stock. Each series of preferred stock issued shall have the rights, preferences, privileges and restrictions as designated by the board of directors. The issuance of any series of preferred stock could affect, among other things, the dividend, voting and liquidation rights of the Company's common stock. The Company had no preferred stock issued and outstanding as of March 31, 2020 and December 31, 2019. Common Stock Pursuant to its Certificate of Incorporation, the Company is authorized to issue 200.0 million shares of common stock, $0.001 par value per share, of which 110.0 million and 106.8 million shares were issued and outstanding as of March 31, 2020 and December 31, 2019, respectively. In addition, the Company had reserved for issuance the following amounts of shares of its common stock for the purposes described below as of March 31, 2020 and December 31, 2019 (in thousands): March 31, 2020 December 31, 2019 Shares of common stock issued 109,992 106,801 Shares of common stock reserved for issuance for: Warrants 22,895 22,895 Stock options 9,704 6,236 Shares available for grant under 2014 Stock Incentive Plan 5,370 8,753 Shares available for sale under 2014 Employee Stock Purchase Plan 25 28 Total shares of common stock issued and reserved for issuance 147,986 144,713 The voting, dividend and liquidation rights of holders of shares of common stock are subject to and qualified by the rights, powers and preferences of holders of shares of preferred stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company's stockholders; provided, however, that, except as otherwise required by law, holders of common stock shall not be entitled to vote on any amendment to the Company’s Certificate of Incorporation that relates solely to the terms of one or more outstanding series of preferred stock if the holders of such affected series are entitled, either separately or together as a class with the holders of one or more such series, to vote thereon. There shall be no cumulative voting. Dividends may be declared and paid on the common stock from funds lawfully available thereof as and when determined by the board of directors and subject to any preferential dividend or other rights of any then-outstanding preferred stock. The Company has never declared or paid, and for the foreseeable future does not expect to declare or pay, dividends on its common stock. Upon the dissolution or liquidation of the Company, whether voluntary or involuntary, holders of common stock will be entitled to receive all assets of the Company available for distribution to its stockholders, subject to any preferential or other rights of any then-outstanding preferred stock. Warrants All of the Company’s outstanding warrants are non-tradeable and permanently classified as equity because they meet the derivative scope exception under ASC Topic 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity ("ASC 815-40") . The following table sets forth the Company's warrant activity for the three months ended March 31, 2020 (in thousands): Year-to-Date Warrant Activity Issued Exercise Price (1) Expiration December 31, 2019 Issued (Exercised) March 31, 2020 Jun-2019 $1.47 Jun-2020 20,410 — — 20,410 Mar-2018 $0.95* Mar-2023 1,943 — — 1,943 Nov-2017 $0.55* Nov-2022 487 — — 487 May-2015 $11.83 Nov-2024 28 — — 28 Nov-2014 $11.04 Nov-2024 27 — — 27 22,895 — — 22,895 (1) As of March 31, 2020. |
EARNINGS (LOSS) PER SHARE
EARNINGS (LOSS) PER SHARE | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
EARNINGS (LOSS) PER SHARE | EARNINGS (LOSS) PER SHARE A net loss cannot be diluted. Therefore, when the Company is in a net loss position, basic and diluted loss per common share are the same. If the Company achieves profitability, the denominator of a diluted earnings per common share calculation includes both the weighted-average number of shares outstanding and the number of common stock equivalents, if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock awards and units using the treasury stock method, along with the effect, if any, from outstanding convertible securities. The majority of the Company’s outstanding warrants to purchase common stock have participation rights to any dividends that may be declared in the future and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of loss, no loss is allocated to the participating securities since the holders have no contractual obligation to share in the losses of the Company. For periods with net income, diluted net earnings per share is calculated by either (i) adjusting the weighted-average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period as determined using the treasury stock method or (ii) the two-class method considering common stock equivalents, whichever is more dilutive. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common stockholders. Accordingly, the Company applied the two-class method to calculate basic and diluted net earnings per share of common stock for the three months ended March 31, 2020. The two-class method was not applied for the three months ended March 31, 2019 as the Company’s participating securities do not have any obligation to absorb net losses. For purposes of the diluted net loss per share calculation, common stock equivalents are excluded from the calculation if their effect would be anti-dilutive. The following table illustrates the determination of earnings (loss) per share for each period presented: March 31, 2020 2019 (in thousands, except per share amounts) Basic Earnings (Loss) Per Share: Numerator: Net income (loss) $ 41,564 $ (6,480) Income attributable to participating securities - basic $ 7,157 $ — Net income (loss) attributable to common stockholders - basic $ 34,407 $ (6,480) Denominator: Weighted average common shares outstanding - basic 109,808 77,458 Net income (loss) per share applicable to common stockholders - basic $ 0.31 $ (0.08) Dilutive Earnings (Loss) Per Share: Numerator: Net income (loss) $ 41,564 $ (6,480) Income attributable to participating securities - diluted $ 7,156 $ — Net income (loss) attributable to common stockholders - diluted $ 34,408 $ (6,480) Denominator: Weighted average shares outstanding 109,808 77,458 Dilutive impact from: Stock options and employee stock purchase plan 15 — Weighted average common shares outstanding for diluted 109,823 77,458 Net income (loss) per share applicable to common stockholders - diluted $ 0.31 $ (0.08) The following potentially dilutive securities outstanding as of March 31, 2020 and 2019 have been excluded from the denominator of the diluted loss per share of common stock outstanding calculation as their effect is anti-dilutive (in thousands): March 31, 2020 2019 Warrants 55 9,258 Stock options 9,703 5,689 9,758 14,947 |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
SHARE-BASED COMPENSATION | SHARE-BASED COMPENSATION The following table sets forth the amount of share-based compensation expense recognized by the Company by line item on its consolidated statements of income (operations) for the three months ended March 31, 2020 and 2019 (in thousands): Three Months ended 2020 2019 Research and development $ 79 $ 52 General and administrative 328 274 $ 407 $ 326 2014 Stock Incentive Plan The Company's 2014 Stock Incentive Plan, as amended ("2014 Plan"), was adopted by its board of directors in December 2013 and subsequently approved by its stockholders in January 2014. The 2014 Plan became effective immediately prior to the closing of the Company's IPO in February 2014 and provides for the grant of incentive and non-qualified stock options, restricted stock awards and units, stock appreciation rights and other stock-based awards, with amounts and terms of grants determined by the Company's board of directors at the time of grant, to the Company's employees, officers, directors, consultants and advisors. Currently there are only stock options outstanding under the 2014 Plan, which generally vest over a four ten 2009 Stock Incentive Plan The Company maintains a 2009 Stock Incentive Plan, as amended and restated ("2009 Plan"), which provided for the grant of incentive and non-qualified stock options and restricted stock awards and units, with amounts and terms of grants determined by the Company's board of directors at the time of grant, to its employees, officers, directors, consultants and advisors. Upon the closing of its IPO in February 2014, the Company ceased granting awards under the 2009 Plan and all shares (i) available for issuance under the 2009 Plan at such time and (ii) subject to outstanding awards under the 2009 Plan that expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased without having been fully exercised or resulting in any common stock being issued were carried over to the 2014 Plan. Stock options granted under the 2009 Plan are exercisable for a period of ten years from the date of grant. There were 0.1 million fully vested stock options outstanding under the 2009 Plan as of March 31, 2020. Out-of-Plan Inducement Grants From time to time, the Company has granted equity awards to its newly hired executives in accordance with the Nasdaq Stock Market LLC ("Nasdaq") employment inducement grant exemption (Nasdaq Listing Rule 5635(c)(4)). Such grants are made outside of the 2014 Plan and act as an inducement material to the executive's acceptance of employment with the Company. T here were 2.2 million stock options outstanding which were granted as employment inducement awards outside of the 2014 Plan as of March 31, 2020. Stock Options The following table sets forth a summary of the Company’s total stock option activity, including awards granted under the 2014 Plan and 2009 Plan and inducement grants made outside of stockholder approved plans, for the three months ended March 31, 2020: Number of Shares under Option Weighted-average Exercise Price per Option Weighted-average Remaining Contractual Life Aggregate Intrinsic Value Outstanding at December 31, 2019 6,236 $1.52 8.8 $ 358 Granted 3,468 $0.89 Exercised — $0.00 Canceled or forfeited — $0.00 Outstanding at March 31, 2020 9,704 $1.29 9.0 $ — Exercisable at March 31, 2020 2,284 $2.11 8.0 $ — The Company recognized share-based compensation expense related to stock options of $0.4 million and $0.3 million for the three months ended March 31, 2020 and 2019, respectively. As of March 31, 2020, there was $2.9 million of total unrecognized compensation cost related to non-vested stock options which the Company expects to recognize over a weighted-average period of 2.7 years. The weighted-average grant-date fair value of stock options granted during the three months ended March 31, 2020 was $0.56 per option. The total intrinsic value of stock options exercised during the three months ended March 31, 2020 was de minimus. For the three months ended March 31, 2020, the grant-date fair value of stock options was determined using the following weighted-average inputs and assumptions in the Black-Scholes option pricing model: Fair value of common stock $0.56 Exercise price $0.89 Expected term (in years) 5.98 Risk-free interest rate 1.5 Expected volatility 71.1 Dividend yield —% |
EMPLOYEE BENEFIT PLANS
EMPLOYEE BENEFIT PLANS | 3 Months Ended |
Mar. 31, 2020 | |
Retirement Benefits [Abstract] | |
EMPLOYEE BENEFIT PLANS | EMPLOYEE BENEFIT PLANS 2014 Employee Stock Purchase Plan The Company's 2014 Employee Stock Purchase Plan ("2014 ESPP") was adopted by its board of directors in December 2013 and subsequently approved by its stockholders in January 2014. The 2014 ESPP became effective immediately prior to the closing of the Company's IPO in February 2014 and established an initial reserve of 0.2 million shares of the Company's common stock for issuance to participating employees. The purpose of the 2014 ESPP is to enhance employee interest in the success and progress of the Company by encouraging employee ownership of common stock of the Company. The 2014 ESPP provides employees with the opportunity to purchase shares of the Company’s common stock at a 15% discount to the market price through payroll deductions or lump sum cash investments. The Company estimates the number of shares to be issued at the end of an offering period and recognizes expense over the requisite service period. Shares of the Company's common stock issued and sold pursuant to the 2014 ESPP are shown on the consolidated statements of changes in stockholders' equity. As of March 31, 2020, there were approximately 25,000 shares of the Company's common stock available for sale under the 2014 ESPP. Defined Contribution Plans United States - 401(k) Plan The Company maintains a 401(k) defined contribution retirement plan which covers all of its U.S. employees. Employees are eligible to participate on the first of the month following their date of hire. Under the 401(k) plan, participating employees may defer up to 100% of their pre-tax salary, subject to certain statutory limitations. Employee contributions vest immediately. The plan allows for a discretionary match per participating employee up to a maximum $4,000 per year. The expenses incurred for the periods presented were de minimis. Canada - Defined Contribution Plan The Company maintains a defined contribution plan for its Canadian employees. Participants may contribute a percentage of their annual compensation to this plan, subject to statutory limitations. The Company contributes up to the first 4% of eligible compensation for its Canadian-based employees to the retirement plan. The expenses incurred for the periods presented were de minimis. |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 3 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LICENSE AGREEMENTS | LICENSE AGREEMENTS Vicinium License Agreements License Agreement with Zurich The Company has a License Agreement with the University of Zurich ("Zurich") which grants the Company exclusive license rights, with the right to sublicense, to make, have made, use and sell under certain patents primarily directed to the Company's targeting agent, including an EpCAM chimera and related immunoconjugates and methods of use and manufacture of the same. These patents cover some key aspects of Vicinium. The Company may be obligated to pay $0.75 million in milestone payments for the first product candidate that achieves applicable clinical development milestones. Based on current status, the Company anticipates that these milestones may be triggered by Vicinium's clinical development pathway. As part of the consideration, the Company is also obligated to pay up to a 4% royalty on the net product sales for products covered by or manufactured using a method covered by a valid claim in the Zurich patent rights. Royalties owed to Zurich will be reduced if the total royalty rate owed by the Company to Zurich and any other third party is 10% or greater, provided that the royalty rate to Zurich may not be less than 2% of net sales. The obligation to pay royalties in a particular country expires upon the expiration or termination of the last of the Zurich patent rights that covers the manufacture, use or sale of a product. There is no obligation to pay royalties in a country if there is no valid claim that covers the product or a method of manufacturing the product. License Agreement with Micromet The Company has a License Agreement with Micromet AG ("Micromet"), now part of Amgen, Inc., which grants it nonexclusive rights, with certain sublicense rights, for know-how and patents allowing exploitation of certain single chain antibody products. These patents cover some key aspects of Vicinium. Under the terms of the License Agreement with Micromet, the Company may be obligated to pay up to €3.6 million in milestone payments for the first product candidate that achieves applicable clinical development milestones. Based on current clinical status, the Company anticipates that certain of these milestones may be triggered by Vicinium’s clinical development pathway. The Company is also required to pay up to a 3.5% royalty on the net sales for products covered by the agreement, which includes Vicinium. The royalty rate owed to Micromet in a particular country will be reduced to 1.5% if there are no valid claims covering the product in that country. The obligation to pay royalties in a particular country expires upon the later of the expiration date of the last valid claim covering the product and the tenth anniversary of the first commercial sale of the product in such country. Finally, the Company is required to pay to Micromet an annual license maintenance fee of €50,000, which can be credited towards any royalty payment the Company owes to Micromet. License Agreement with XOMA The Company has a License Agreement with XOMA Ireland Limited ("XOMA") which grants it non-exclusive rights to certain XOMA patent rights and know-how related to certain expression technology, including plasmids, expression strains, plasmid maps and production systems. These patents and related know-how cover some key aspects of Vicinium. Under the terms of the License Agreement with XOMA, the Company is required to pay up to $0.25 million in milestone payments for a product candidate that incorporates know-how under the license and achieves applicable clinical development milestones. Based on current clinical status, the Company anticipates that these milestones may be triggered by Vicinium’s clinical development pathway. The Company is also required to pay a 2.5% royalty on the net sales for products incorporating XOMA’s technology, which includes Vicinium. The Company has the right to reduce the amount of royalties owed to XOMA on a country-by-country basis by the amount of royalties paid to other third parties, provided that the royalty rate to XOMA may not be less than 1.75% of net sales. In addition, the foregoing royalty rates are reduced by 50% with respect to products that are not covered by a valid patent claim in the country of sale. The obligation to pay royalties in a particular country expires upon the later of the expiration date of the last valid claim covering the product and the tenth anniversary of the first commercial sale of the product in such country. Other License Agreements License Agreement with Roche In June 2016, the Company entered into the License Agreement with Roche, pursuant to which the Company granted Roche an exclusive, worldwide license, including the right to sublicense, to its patent rights and know-how related to the Company’s monoclonal antibody EBI-031 and all other IL-6 anti-IL-6 antagonist monoclonal antibody technology owned by the Company (collectively, the "Licensed Intellectual Property"). Under the License Agreement with Roche, Roche is required to continue developing, at its cost, EBI-031 and any other product made from the Licensed Intellectual Property that contains an IL-6 antagonist anti-IL monoclonal antibody (“Licensed Product”) and pursue ongoing patent prosecution, at its cost. Financial Terms The Company received from Roche an upfront license fee of $7.5 million in August 2016 upon the effectiveness of the License Agreement with Roche following approval by the Company's stockholders, and Roche agreed to pay up to an additional $262.5 million upon the achievement of specified regulatory, development and commercialization milestones with respect to up to two unrelated indications. Specifically, an aggregate amount of up to $197.5 million is payable to the Company for the achievement of specified milestones with respect to the first indication, consisting of $72.5 million in development milestones, $50.0 million in regulatory milestones and $75.0 million in commercialization milestones. In September 2016, Roche paid the Company the first development milestone of $22.5 million as a result of the Investigational New Drug application for EBI-031 becoming effective on or before September 15, 2016. Additional amounts of up to $65.0 million are payable upon the achievement of specified development and regulatory milestones in a second indication. In addition, the Company is entitled to receive royalty payments in accordance with a tiered royalty rate scale, with rates ranging from 7.5% to 15% of net sales of potential future products containing EBI-031 and up to 50% of these rates for net sales of potential future products containing other IL-6 compounds, with each of the royalties subject to reduction under certain circumstances and to the buy-out options of Roche. Buy-Out Options The License Agreement with Roche provides for two “option periods” during which Roche may elect to make a one-time payment to the Company and, in turn, terminate its diligence, milestone and royalty payment obligations under the License Agreement with Roche. Specifically, (i) Roche may exercise a buy-out option following the first dosing (“Initiation”) in the first Phase 2 study for a Licensed Product until the day before Initiation of the first Phase 3 study for a Licensed Product, in which case Roche is required to pay the Company $135.0 million within 30 days after Roche's exercise of such buy-out option and receipt of an invoice from the Company, or (ii) Roche may exercise a buy-out option following the day after Initiation of the first Phase 3 study for a Licensed Product until the day before the acceptance for review by the FDA or other regulatory authority of a BLA or similar application for marketing approval for a Licensed Product in either the United States or in the E.U., in which case Roche is required to pay the Company, within 30 days after Roche’s exercise of such buy-out option and receipt of an invoice from the Company, $265.0 million, which amount would be reduced to $220.0 million if none of the Company’s patent rights containing a composition of matter claim covering any compound or Licensed Product has issued in the E.U. Termination Either the Company or Roche may each terminate the License Agreement with Roche if the other party breaches any of its material obligations under the agreement and does not cure such breach within a specified cure period. Roche may terminate the License Agreement with Roche following effectiveness by providing advance written notice to the Company or by providing written notice if the Company is debarred, disqualified, suspended, excluded, or otherwise declared ineligible from certain federal or state agencies or programs. The Company may terminate the License Agreement with Roche if, prior to the first filing of a BLA for a Licensed Product, there is a period of 12 months where Roche is not conducting sufficient development activities with respect to the products made from the Licensed Intellectual Property. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 3 Months Ended |
Mar. 31, 2020 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | RELATED PARTY TRANSACTIONS The Company leases its facility in Winnipeg, Manitoba from an affiliate of Leslie L. Dan, a director of the Company until his retirement in July 2019. For each of the three months ended March 31, 2020 and 2019, the Company paid $0.1 million of rent, which includes the related operating expenses. The Company pays fees under an intellectual property license agreement to Protoden Technologies Inc. (“Protoden”), a company owned by Clairmark, an affiliate of Mr. Dan. Pursuant to the agreement, the Company has an exclusive, perpetual, irrevocable and non-royalty bearing license, with the right to sublicense, to certain patents and technology to make, use and sell products that utilize such patents and technology. The annual fee is $0.1 million. Upon expiration of the term on December 31, 2024, the licenses granted to the Company will require no further payments to Protoden. For each of the three months ended March 31, 2020 and 2019, the Company paid $0.1 million under this agreement. |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 3 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENT | SUBSEQUENT EVENTS On March 2, 2020, the Company received written notice (the “Notice”) from The Nasdaq Stock Market, LLC (“Nasdaq”) indicating that the Company is not in compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(a)(1). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company had a period of 180 calendar days, or until August 31, 2020, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-day period. On April 17, 2020, the Company received written notice from Nasdaq that the 180-day grace period to regain compliance with the $1.00 minimum bid price requirement has been extended in response to the COVID-19 pandemic and related extraordinary market conditions. As a result of this extension, the Company now has until November 12, 2020, to regain compliance with the minimum bid price requirement. If the Company is not in compliance by November 12, 2020, the Company may be afforded a second 180 calendar day period to regain compliance. To qualify, the Company would be required to apply to have its common stock listed on the Nasdaq Capital Market and meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except for the minimum bid price requirement, and will need to provide written notice to Nasdaq of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company does not qualify for the second compliance period or fails to regain compliance during the second 180-day period, then Nasdaq will notify the Company of its determination to delist the common stock, at which point the Company would have an opportunity to appeal the delisting determination to a Nasdaq hearings panel. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Interim Financial Statements | Interim Financial Statements The accompanying unaudited interim condensed consolidated financial statements have been prepared from the books and records of the Company in accordance with GAAP for interim financial information and Rule 10-01 of Regulation S-X promulgated by the United States Securities and Exchange Commission (“SEC”), which permit reduced disclosures for interim periods. All adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the accompanying condensed consolidated balance sheets and statements of income (operations) and comprehensive income (loss), stockholders’ equity and cash flows have been made. Although these interim financial statements do not include all of the information and footnotes required for complete annual financial statements, management believes the disclosures are adequate |
Use of Estimates | Use of Estimates The preparation of financial statements in accordance with GAAP and the rules and regulations of the SEC requires the use of estimates and assumptions, based on judgments considered reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience, known trends and events and various other factors that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Although management believes its estimates and assumptions are reasonable when made, they are based upon information available at the time they are made. Management evaluates the estimates and assumptions on an ongoing basis and, if necessary, makes adjustments. Due to the risks and uncertainties involved in the Company’s business and evolving market conditions, and given the subjective element of the estimates and assumptions made, actual results may differ from estimated results. The most significant estimates and judgments impact the fair value of intangible assets, goodwill and contingent consideration; income taxes (including the valuation allowance for deferred tax assets); research and development expenses; and going concern considerations. |
Principles of Consolidation | Principles of ConsolidationThe Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiary Viventia and its indirect subsidiaries, Viventia Bio USA Inc. and Viventia Biotech (EU) Limited. All intercompany transactions and balances have been eliminated in consolidation. |
Foreign Currency Translation | Foreign Currency Translation The functional currency of the Company and each of its subsidiaries is the U.S. dollar. |
Recent Accounting Pronouncements | Adopted in 2020 In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"). ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets held. The amendments in ASU 2016-13 eliminate the probable threshold for initial recognition of a credit loss in current GAAP and reflect an entity’s current estimate of all expected credit losses. ASU 2016-13 is effective for annual and interim periods beginning January 1, 2020 and is to be applied using a modified retrospective transition method. The Company adopted this guidance effective January 1, 2020, and it did not have a material impact on the Company’s financial position, results of operations or cash flows. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurements ("ASU 2018-13"). ASU 2018-13 modifies fair value measurement disclosure requirements. ASU 2018-13 is effective for annual and interim periods beginning after December 15, 2019. The Company adopted this guidance effective January 1, 2020, and although it resulted in some additional footnote disclosures, it did not have a material impact on the Company’s disclosures. For the new disclosures regarding our Level 3 instruments, please read Note 5, Fair Value Measurements and Financial Instruments, to these condensed consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-15, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract ("ASU 2018-15") . ASU 2018-15 requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance to determine which implementation costs to defer and recognize as an asset. The effective date for ASU 2018-15 is for annual and interim periods beginning after December 15, 2019. The amendments in this ASU should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The Company adopted this guidance effective January 1, 2020, and it did not have a material impact on the Company’s financial position, results of operations or cash flows. Pending Adoption In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ("ASU 2019-12"). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The amendments in ASU 2019-12 also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted. The method with which the amendments in this ASU are to be applied varies depending on the nature of the tax item impacted by amendment. Because the Company generates losses and pays no income taxes, it does not expect the adoption of ASU 2019-12 to have a material impact on the Company's financial position, results of operations or cash flows. |
FAIR VALUE MEASUREMENT AND FI_2
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Summary of Carrying Amounts and Fair Values of Financial Instruments Measured | The following tables set forth the carrying amounts and fair values of the Company's financial instruments measured at fair value on a recurring basis as of March 31, 2020 and December 31, 2019 (in thousands): March 31, 2020 Fair Value Measurement Based on Carrying Amount Fair Value Quoted Prices in Active Significant other Observable Significant Unobservable Assets: Money market funds $ 31,276 $ 31,276 $ 31,276 $ — $ — Liabilities: Contingent consideration $ 66,320 $ 66,320 $ — $ — $ 66,320 December 31, 2019 Fair Value Measurement Based on Carrying Amount Fair Value Quoted Prices in Active Significant other Observable Significant Unobservable Assets: Money market funds $ 31,146 $ 31,146 $ 31,146 $ — $ — Liabilities: Contingent consideration $ 120,020 $ 120,020 $ — $ — $ 120,020 |
Summary of Contingent Consideration Liability | The following table sets forth a summary of the change in the fair value of the Company's contingent consideration liability, measured on a recurring basis at each reporting period, for the three months ended March 31, 2020 (in thousands): Balance at December 31, 2019 $ 120,020 Change in fair value of contingent consideration (53,700) Balance at March 31, 2020 $ 66,320 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | The following table sets forth the composition of intangible assets as of March 31, 2020 and December 31, 2019 (in thousands): March 31, 2020 December 31, 2019 IPR&D intangible assets: Vicinium United States rights $ 31,700 $ 31,700 Vicinium European Union rights 14,700 14,700 Total Intangibles $ 46,400 $ 46,400 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | The following table sets forth the composition of accrued expenses as of March 31, 2020 and December 31, 2019 (in thousands): March 31, December 31, 2019 Research and development $ 3,517 $ 3,688 Payroll-related expenses 627 1,638 Severance to former Executives and other employees 155 378 Professional fees 544 378 Other 50 87 Total Accrued Expenses $ 4,893 $ 6,169 |
STOCKHOLDERS' EQUITY (DEFICIT)
STOCKHOLDERS' EQUITY (DEFICIT) (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Summary of Common Stock | In addition, the Company had reserved for issuance the following amounts of shares of its common stock for the purposes described below as of March 31, 2020 and December 31, 2019 (in thousands): March 31, 2020 December 31, 2019 Shares of common stock issued 109,992 106,801 Shares of common stock reserved for issuance for: Warrants 22,895 22,895 Stock options 9,704 6,236 Shares available for grant under 2014 Stock Incentive Plan 5,370 8,753 Shares available for sale under 2014 Employee Stock Purchase Plan 25 28 Total shares of common stock issued and reserved for issuance 147,986 144,713 |
Summary of Warrants Outstanding and Warrant Activity | The following table sets forth the Company's warrant activity for the three months ended March 31, 2020 (in thousands): Year-to-Date Warrant Activity Issued Exercise Price (1) Expiration December 31, 2019 Issued (Exercised) March 31, 2020 Jun-2019 $1.47 Jun-2020 20,410 — — 20,410 Mar-2018 $0.95* Mar-2023 1,943 — — 1,943 Nov-2017 $0.55* Nov-2022 487 — — 487 May-2015 $11.83 Nov-2024 28 — — 28 Nov-2014 $11.04 Nov-2024 27 — — 27 22,895 — — 22,895 (1) As of March 31, 2020. |
EARNINGS (LOSS) PER SHARE (Tabl
EARNINGS (LOSS) PER SHARE (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings (Loss) Per Share | The following table illustrates the determination of earnings (loss) per share for each period presented: March 31, 2020 2019 (in thousands, except per share amounts) Basic Earnings (Loss) Per Share: Numerator: Net income (loss) $ 41,564 $ (6,480) Income attributable to participating securities - basic $ 7,157 $ — Net income (loss) attributable to common stockholders - basic $ 34,407 $ (6,480) Denominator: Weighted average common shares outstanding - basic 109,808 77,458 Net income (loss) per share applicable to common stockholders - basic $ 0.31 $ (0.08) Dilutive Earnings (Loss) Per Share: Numerator: Net income (loss) $ 41,564 $ (6,480) Income attributable to participating securities - diluted $ 7,156 $ — Net income (loss) attributable to common stockholders - diluted $ 34,408 $ (6,480) Denominator: Weighted average shares outstanding 109,808 77,458 Dilutive impact from: Stock options and employee stock purchase plan 15 — Weighted average common shares outstanding for diluted 109,823 77,458 Net income (loss) per share applicable to common stockholders - diluted $ 0.31 $ (0.08) |
Schedule of Potentially Dilutive Securities Excluded from Diluted Loss Calculation | The following potentially dilutive securities outstanding as of March 31, 2020 and 2019 have been excluded from the denominator of the diluted loss per share of common stock outstanding calculation as their effect is anti-dilutive (in thousands): March 31, 2020 2019 Warrants 55 9,258 Stock options 9,703 5,689 9,758 14,947 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Share-Based Compensation Expense | The following table sets forth the amount of share-based compensation expense recognized by the Company by line item on its consolidated statements of income (operations) for the three months ended March 31, 2020 and 2019 (in thousands): Three Months ended 2020 2019 Research and development $ 79 $ 52 General and administrative 328 274 $ 407 $ 326 |
Schedule of Stock Option Activity | The following table sets forth a summary of the Company’s total stock option activity, including awards granted under the 2014 Plan and 2009 Plan and inducement grants made outside of stockholder approved plans, for the three months ended March 31, 2020: Number of Shares under Option Weighted-average Exercise Price per Option Weighted-average Remaining Contractual Life Aggregate Intrinsic Value Outstanding at December 31, 2019 6,236 $1.52 8.8 $ 358 Granted 3,468 $0.89 Exercised — $0.00 Canceled or forfeited — $0.00 Outstanding at March 31, 2020 9,704 $1.29 9.0 $ — Exercisable at March 31, 2020 2,284 $2.11 8.0 $ — |
Schedule of Weighted-Average Inputs and Assumptions in Black-Scholes Option | For the three months ended March 31, 2020, the grant-date fair value of stock options was determined using the following weighted-average inputs and assumptions in the Black-Scholes option pricing model: Fair value of common stock $0.56 Exercise price $0.89 Expected term (in years) 5.98 Risk-free interest rate 1.5 Expected volatility 71.1 Dividend yield —% |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Apr. 30, 2018patient | Sep. 30, 2016USD ($)shares | Mar. 31, 2020USD ($)segment | Mar. 31, 2019USD ($) | Dec. 31, 2019USD ($) | |
Variable Interest Entity [Line Items] | |||||
Number of patients | patient | 133 | ||||
Number of Operating Segments | segment | 1 | ||||
Cash and cash equivalents | $ 42,463 | $ 48,121 | |||
Net working capital | 37,500 | ||||
Accumulated deficit | 251,960 | 293,524 | |||
Negative cash flows from operating activities incurred | $ 8,838 | $ 7,992 | $ 37,500 | ||
Viventia Bio, Inc. | |||||
Variable Interest Entity [Line Items] | |||||
Shares of common stock issued to the selling shareholders (in shares) | shares | 4,000,000 | ||||
Percentage of voting interests acquired (as a percent) | 19.90% | ||||
One-time milestone payment upon first sale of product | $ 12,500 | ||||
Period during which quarterly earn-outs are payable after date of net sales | 15 years | ||||
Period in which acquiree is to use commercially reasonable efforts to achieve marketing authorizations | 7 years | ||||
Viventia Bio, Inc. | Vicinium | Collaborative Arrangement, Revenue based on Specified Milestone | |||||
Variable Interest Entity [Line Items] | |||||
Percentage of net sales of quarterly earn-out payments during earn-out periods | 2.00% | ||||
Viventia Bio, Inc. | Vicinium | Europe | Collaborative Arrangement, Revenue based on Specified Milestone | |||||
Variable Interest Entity [Line Items] | |||||
One-time milestone payment upon first sale of product | $ 7,000 | ||||
Viventia Bio, Inc. | Vicinium | Japan | Collaborative Arrangement, Revenue based on Specified Milestone | |||||
Variable Interest Entity [Line Items] | |||||
One-time milestone payment upon first sale of product | $ 3,000 |
FAIR VALUE MEASUREMENT AND FI_3
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS - Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Significant Unobservable Inputs (Level 3) | ||
Liabilities: | ||
Contingent consideration | $ 66,320 | $ 120,020 |
Carrying Amount | ||
Assets: | ||
Money market funds (cash equivalents) | 31,276 | 31,146 |
Liabilities: | ||
Contingent consideration | 66,320 | 120,020 |
Fair Value | Recurring | ||
Assets: | ||
Money market funds (cash equivalents) | 31,276 | 31,146 |
Liabilities: | ||
Contingent consideration | 66,320 | 120,020 |
Fair Value | Recurring | Quoted Prices in Active Markets (Level 1) | ||
Assets: | ||
Money market funds (cash equivalents) | 31,276 | 31,146 |
Liabilities: | ||
Contingent consideration | 0 | 0 |
Fair Value | Recurring | Significant other Observable Inputs (Level 2) | ||
Assets: | ||
Money market funds (cash equivalents) | 0 | 0 |
Liabilities: | ||
Contingent consideration | 0 | 0 |
Fair Value | Recurring | Significant Unobservable Inputs (Level 3) | ||
Assets: | ||
Money market funds (cash equivalents) | 0 | 0 |
Liabilities: | ||
Contingent consideration | $ 66,320 | $ 120,020 |
FAIR VALUE MEASUREMENT AND FI_4
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS - Summary of Changes in Fair Value of Contingent Consideration (Details) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019USD ($) | Mar. 31, 2020 | Dec. 31, 2019 | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |||
Contingent consideration liability measurements used (in percentage) | 0.179 | 0.118 | |
Royalty rate | 2.00% | ||
Unobservable Inputs (Level 3) | |||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |||
Change in fair value of contingent consideration | $ (53,700) | ||
Discount Rate | |||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |||
Weighted-average cost of capital | 14.70% | 5.60% |
INTANGIBLE ASSETS AND GOODWIL_2
INTANGIBLE ASSETS AND GOODWILL (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Finite-Lived Intangible Assets [Line Items] | ||
Goodwill | $ 13,064 | $ 13,064 |
Vicinium | IPR&D intangible assets | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets | 46,400 | 46,400 |
Vicinium | IPR&D intangible assets | United States | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets | 31,700 | 31,700 |
Vicinium | IPR&D intangible assets | Europe | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets | $ 14,700 | $ 14,700 |
LEASES - Narrative (Details)
LEASES - Narrative (Details) | 3 Months Ended | |
Mar. 31, 2020USD ($)ft²term | Mar. 31, 2019USD ($) | |
Lessee, Lease, Description [Line Items] | ||
Monthly rent | $ 21,400 | |
Rent expense | $ 66,000 | $ 76,000 |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Lease term | 4 months | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Lease term | 6 months | |
Canada | ||
Lessee, Lease, Description [Line Items] | ||
Office space, square foot | ft² | 31,100 | |
Lease term | 5 years | |
Renewal option | term | 1 | |
Renewal term | 5 years | |
Monthly rent | $ 12,800 | |
Related operating expenses (per month) | 12,500 | |
Operating lease cost (including related operating costs) | $ 76,000 | $ 75,000 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Research and development | $ 3,517 | $ 3,688 |
Payroll-related expenses | 627 | 1,638 |
Severance to former Executives and other employees | 155 | 378 |
Professional fees | 544 | 378 |
Other | 50 | 87 |
Total Accrued Expenses | $ 4,893 | $ 6,169 |
ACCRUED EXPENSES - Narrative (D
ACCRUED EXPENSES - Narrative (Details) - USD ($) $ in Thousands | Sep. 09, 2019 | Aug. 02, 2019 | Mar. 31, 2020 | Dec. 31, 2019 | Aug. 03, 2019 |
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | |||||
Severance to former Executives and other employees | $ 155 | $ 378 | |||
Former Chief Financial Officer | |||||
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | |||||
Separation Agreement, period of separation payments and benefits agreed to | 12 months | ||||
Severance to former Executives and other employees | $ 300 | ||||
Former Chief Medical Officer | |||||
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | |||||
Separation Agreement, period of separation payments and benefits agreed to | 6 months | ||||
Severance to former Executives and other employees | $ 300 | ||||
Separation payments | $ 200 | ||||
Consulting fees and transition expenses | $ 100 |
STOCKHOLDERS' EQUITY (DEFICIT_2
STOCKHOLDERS' EQUITY (DEFICIT) - Equity Financing (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | 1 Months Ended | 3 Months Ended | 5 Months Ended | ||
Nov. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2020 | Mar. 31, 2020 | Mar. 30, 2020 | |
Class of Stock [Line Items] | |||||
Proceeds from sale of stock | $ 27,800 | ||||
Sale of stock, shares issued (in shares) | 20.4 | ||||
Stock price per share (in dollars per share) | $ 1.47 | ||||
Issuance of common stock, issuance costs | $ 98 | ||||
Number of warrants issued (in shares) | 20.4 | ||||
Exercise price per warrant (in dollars per share) | $ 1.47 | ||||
Warrants exercise period | 1 year | ||||
ATM Facility | |||||
Class of Stock [Line Items] | |||||
Aggregate sales price | $ 35,000 | ||||
Commission fixed rate | 3.00% | ||||
Legal, accounting and printing costs | $ 200 | ||||
Proceeds from sale of stock | $ 3,200 | $ 5,100 | |||
Sale of stock, shares issued (in shares) | 3.2 | 5.2 | |||
Stock price per share (in dollars per share) | $ 1.06 | $ 1.06 | $ 1.02 |
STOCKHOLDERS' EQUITY (DEFICIT_3
STOCKHOLDERS' EQUITY (DEFICIT) - Preferred Stock (Details) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Equity [Abstract] | ||
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
STOCKHOLDERS' EQUITY (DEFICIT_4
STOCKHOLDERS' EQUITY (DEFICIT) - Common Stock (Details) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Equity [Abstract] | ||
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares issued (in shares) | 109,991,553 | 106,801,409 |
Common stock, shares outstanding (in shares) | 109,991,553 | 106,801,409 |
STOCKHOLDERS' EQUITY (DEFICIT_5
STOCKHOLDERS' EQUITY (DEFICIT) - Summary of Common Stock Issued and Reserved for Issuance (Details) - shares | Mar. 31, 2020 | Dec. 31, 2019 |
Class of Warrant or Right [Line Items] | ||
Common stock, shares issued (in shares) | 109,991,553 | 106,801,409 |
Shares of common stock reserved for issuance for: | ||
Total shares of common stock issued and reserved for issuance (in shares) | 147,986,000 | 144,713,000 |
Warrants | ||
Shares of common stock reserved for issuance for: | ||
Shares of common stock available for issuance (in shares) | 22,895,000 | 22,895,000 |
Stock options | ||
Shares of common stock reserved for issuance for: | ||
Shares of common stock available for issuance (in shares) | 9,704,000 | 6,236,000 |
Shares available for grant under 2014 Stock Incentive Plan | ||
Shares of common stock reserved for issuance for: | ||
Shares of common stock available for issuance (in shares) | 5,370,000 | 8,753,000 |
Shares available for sale under 2014 Employee Stock Purchase Plan | ||
Shares of common stock reserved for issuance for: | ||
Shares of common stock available for issuance (in shares) | 25,000 | 28,000 |
STOCKHOLDERS' EQUITY (DEFICIT_6
STOCKHOLDERS' EQUITY (DEFICIT) - Warrants (Details) - $ / shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Jun. 30, 2019 | |
Class of Warrant or Right [Line Items] | ||
Exercise price per warrant (in dollars per share) | $ 1.47 | |
Warrant Or Right Outstanding [Roll Forward] | ||
Warrants outstanding, beginning balance (in shares) | 22,895 | |
Warrants Issued (in shares) | 0 | |
Warrants Exercised (in shares) | 0 | |
Warrants outstanding, ending balance (in shares) | 22,895 | |
Warrants, Expiring June 2020 | ||
Class of Warrant or Right [Line Items] | ||
Exercise price per warrant (in dollars per share) | $ 1.47 | |
Warrant Or Right Outstanding [Roll Forward] | ||
Warrants outstanding, beginning balance (in shares) | 20,410 | |
Warrants Issued (in shares) | 0 | |
Warrants Exercised (in shares) | 0 | |
Warrants outstanding, ending balance (in shares) | 20,410 | |
Warrants, Expiring March 2023 | ||
Class of Warrant or Right [Line Items] | ||
Exercise price per warrant (in dollars per share) | $ 0.95 | |
Warrant Or Right Outstanding [Roll Forward] | ||
Warrants outstanding, beginning balance (in shares) | 1,943 | |
Warrants Issued (in shares) | 0 | |
Warrants Exercised (in shares) | 0 | |
Warrants outstanding, ending balance (in shares) | 1,943 | |
Warrants, Expiring November 2022 | ||
Class of Warrant or Right [Line Items] | ||
Exercise price per warrant (in dollars per share) | $ 0.55 | |
Warrant Or Right Outstanding [Roll Forward] | ||
Warrants outstanding, beginning balance (in shares) | 487 | |
Warrants Issued (in shares) | 0 | |
Warrants Exercised (in shares) | 0 | |
Warrants outstanding, ending balance (in shares) | 487 | |
Warrants, Expiring November 2024, Issued May 2015 | ||
Class of Warrant or Right [Line Items] | ||
Exercise price per warrant (in dollars per share) | $ 11.83 | |
Warrant Or Right Outstanding [Roll Forward] | ||
Warrants outstanding, beginning balance (in shares) | 28 | |
Warrants Issued (in shares) | 0 | |
Warrants Exercised (in shares) | 0 | |
Warrants outstanding, ending balance (in shares) | 28 | |
Warrants, Expiring November 2024, Issued November 2014 | ||
Class of Warrant or Right [Line Items] | ||
Exercise price per warrant (in dollars per share) | $ 11.04 | |
Warrant Or Right Outstanding [Roll Forward] | ||
Warrants outstanding, beginning balance (in shares) | 27 | |
Warrants Issued (in shares) | 0 | |
Warrants Exercised (in shares) | 0 | |
Warrants outstanding, ending balance (in shares) | 27 |
STOCKHOLDERS' EQUITY (DEFICIT_7
STOCKHOLDERS' EQUITY (DEFICIT) - Stock Options and Employee Stock Purchase Plan (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Equity [Abstract] | ||
Compensation expense related to vested awards | $ 407 | $ 326 |
EARNINGS (LOSS) PER SHARE (Deta
EARNINGS (LOSS) PER SHARE (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] | ||
Net income (loss) | $ 41,564 | $ (6,480) |
Income attributable to participating securities - basic | 7,157 | 0 |
Net income (loss) attributable to common stockholders - basic | $ 34,407 | $ (6,480) |
Weighted-average common shares outstanding - basic (in shares) | 109,808 | 77,458 |
Net income (loss) per share applicable to common stockholders - basic (in dollars per share) | $ 0.31 | $ (0.08) |
Income attributable to participating securities - diluted | $ 7,156 | $ 0 |
Net income (loss) attributable to common stockholders - diluted | $ 34,408 | $ (6,480) |
Incremental Common Shares Attributable to Dilutive Effect of Share-based Payment Arrangements | 15 | 0 |
Weighted-average common shares outstanding - diluted (in shares) | 109,823 | 77,458 |
Net income (loss) per share applicable to common stockholders - diluted (in dollars per share) | $ 0.31 | $ (0.08) |
EARNINGS (LOSS) PER SHARE - Ant
EARNINGS (LOSS) PER SHARE - Antidilutive (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from calculation of diluted net (loss) income per share (in shares) | 9,758 | 14,947 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from calculation of diluted net (loss) income per share (in shares) | 55 | 9,258 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from calculation of diluted net (loss) income per share (in shares) | 9,703 | 5,689 |
SHARE-BASED COMPENSATION - Shar
SHARE-BASED COMPENSATION - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 407 | $ 326 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | 79 | 52 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 328 | $ 274 |
SHARE-BASED COMPENSATION - Narr
SHARE-BASED COMPENSATION - Narrative (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options outstanding (in shares) | 9,704 | 6,236 | |
Share-based compensation expense | $ 407 | $ 326 | |
Unrecognized compensation cost, non-vested stock options | $ 2,900 | ||
Weighted-average period to recognize non-vested stock options | 2 years 8 months 12 days | ||
Weighted-average grant-date fair value of stock options granted (in dollars per share) | $ 0.56 | ||
Employee | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options outstanding (in shares) | 2,200 | ||
Stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares of common stock available for issuance (in shares) | 9,704 | 6,236 | |
2014 Stock Incentive Plan | Stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Award vesting period | 4 years | ||
Period exercisable from date of grant | 10 years | ||
Stock options outstanding (in shares) | 9,600 | ||
Shares of common stock available for issuance (in shares) | 5,400 | ||
2014 Stock Incentive Plan | Vesting on the First Anniversary of Date of Grant | Stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation, vesting rate | 25.00% | ||
2014 Stock Incentive Plan | Vesting at End of Each Successive Three-Month Period Thereafter | Stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation, vesting rate | 6.25% | ||
2009 Stock Incentive Plan | Stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Period exercisable from date of grant | 10 years | ||
Vested stock options outstanding (in shares) | 100 |
SHARE-BASED COMPENSATION - Stoc
SHARE-BASED COMPENSATION - Stock Options (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Number of Shares under Option (in thousands) | ||
Outstanding at beginning of period (in shares) | 6,236 | |
Granted (in shares) | 3,468 | |
Exercised (in shares) | 0 | |
Canceled or forfeited (in shares) | 0 | |
Outstanding at end of period (in shares) | 9,704 | 6,236 |
Exercisable at end of period (in shares) | 2,284 | |
Weighted-average Exercise Price per Option | ||
Outstanding at beginning of period (in dollars per share) | $ 1.52 | |
Granted (in dollars per share) | 0.89 | |
Exercised (in dollars per share) | 0 | |
Canceled or forfeited (in dollars per share) | 0 | |
Outstanding at end of period (in dollars per share) | 1.29 | $ 1.52 |
Exercisable (in dollars per share) | $ 2.11 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||
Weighted-average Remaining Contractual Life (in years), Outstanding | 9 years | 8 years 9 months 18 days |
Weighted-average Remaining Contractual Life (in years), Exercisable | 8 years | |
Aggregate Intrinsic Value, Outstanding | $ 0 | $ 358 |
Aggregate Intrinsic Value, Exercisable | $ 0 |
SHARE-BASED COMPENSATION - Weig
SHARE-BASED COMPENSATION - Weighted-Average Inputs and Assumptions (Details) | 3 Months Ended |
Mar. 31, 2020$ / shares | |
Share-based Payment Arrangement [Abstract] | |
Fair value of common stock (in dollars per share) | $ 0.56 |
Exercise price (in dollars per share) | $ 0.89 |
Expected term (in years) | 5 years 11 months 23 days |
Risk-free interest rate | 1.50% |
Expected volatility | 71.10% |
Dividend yield | 0.00% |
EMPLOYEE BENEFIT PLANS (Details
EMPLOYEE BENEFIT PLANS (Details) - USD ($) shares in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Feb. 28, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Defined contribution retirement plan, maximum employee contribution deferred | 100.00% | |
Discretionary match per participating employee, maximum | $ 4,000 | |
Employer matching contribution, percent of employees' eligible compensation | 4.00% | |
2014 Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of common stock available for issuance (in shares) | 200 | |
Common stock purchase price, discount rate | 15.00% | |
Common stock available for sale (in shares) | 25 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) € in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Sep. 30, 2016USD ($) | Aug. 31, 2016USD ($) | Jun. 30, 2016USD ($)option | Mar. 31, 2020USD ($) | Mar. 31, 2020EUR (€) | |
Organization And Basis Of Presentation [Line Items] | |||||
Royalty rate | 2.00% | 2.00% | |||
University of Zurich | |||||
Organization And Basis Of Presentation [Line Items] | |||||
License agreement, royalty on net product sales, percentage | 4.00% | 4.00% | |||
License agreement, rate requiring reduction in the amount of royalties owed | 10.00% | 10.00% | |||
License agreement, royalty on net product sales, minimum | 2.00% | 2.00% | |||
University of Zurich | Collaborative Arrangement, Revenue Based on Clinical Development Milestone | |||||
Organization And Basis Of Presentation [Line Items] | |||||
License agreement, amount payable upon achievement of specified milestone | $ 750 | ||||
Micromet AG | |||||
Organization And Basis Of Presentation [Line Items] | |||||
License agreement, royalty on net product sales, percentage | 3.50% | 3.50% | |||
Potential milestone payments | € | € 3,600 | ||||
License Agreement, royalty payment, reduction, conditions not met | 1.50% | 1.50% | |||
License maintenance fees | € | € 50 | ||||
XOMA Ireland Limited | |||||
Organization And Basis Of Presentation [Line Items] | |||||
License agreement, amount payable upon achievement of specified milestone | $ 250 | ||||
License agreement, royalty on net product sales, percentage | 2.50% | 2.50% | |||
License agreement, rate requiring reduction in the amount of royalties owed | 50.00% | 50.00% | |||
License agreement, royalty on net product sales, minimum | 1.75% | 1.75% | |||
Roche | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Up-front license fee | $ 7,500 | ||||
Additional up-front fee | 262,500 | ||||
License agreement, option periods | option | 2 | ||||
License agreement, buyout amount under first option period | $ 135,000 | ||||
License agreement, period to pay buyout option once exercised | 30 days | ||||
License agreement, buyout amount under second option period | $ 265,000 | ||||
License agreement, buyout amount under second option period, upon non-issuance of patent rights or licensed product | $ 220,000 | ||||
License agreement, period for termination where sufficient development activities are not performed | 12 months | ||||
Roche | First Indication | |||||
Organization And Basis Of Presentation [Line Items] | |||||
License agreement, amount payable upon achievement of specified milestone | 197,500 | ||||
Roche | Collaborative Arrangement, Revenue Based on Development Milestone | |||||
Organization And Basis Of Presentation [Line Items] | |||||
License agreement, amount payable upon achievement of specified milestone | 72,500 | ||||
Roche | Collaborative Arrangement, Revenue Based on Regulatory Milestone | |||||
Organization And Basis Of Presentation [Line Items] | |||||
License agreement, amount payable upon achievement of specified milestone | 50,000 | ||||
Roche | Collaborative Arrangement, Revenue Based on Commercialization Milestone | |||||
Organization And Basis Of Presentation [Line Items] | |||||
License agreement, amount payable upon achievement of specified milestone | $ 75,000 | ||||
Roche | Second Indication | |||||
Organization And Basis Of Presentation [Line Items] | |||||
License agreement, amount payable upon achievement of specified milestone | $ 65,000 | ||||
Roche | EBI-031 | Minimum | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Royalty rate | 7.50% | 7.50% | |||
Roche | EBI-031 | Maximum | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Royalty rate | 15.00% | 15.00% | |||
Roche | EBI-031 | Collaborative Arrangement, Revenue Based on Development Milestone | |||||
Organization And Basis Of Presentation [Line Items] | |||||
License agreement, amount payable upon achievement of specified milestone | $ 22,500 | ||||
Roche | IL-6 | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Royalty rate | 50.00% | 50.00% |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Majority shareholder | Lease Facility In Winnipeg, Manitoba | ||
Related Party Transaction [Line Items] | ||
Amount of related party transaction | $ 0.1 | |
Protoden | Protoden Intellectual Property | ||
Related Party Transaction [Line Items] | ||
Amount of related party transaction | 0.1 | $ 0.1 |
Annual fee under license agreement | $ 0.1 |