Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 13, 2020 | Jun. 30, 2019 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Entity Registrant Name | Celldex Therapeutics, Inc. | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 40 | ||
Entity Common Stock, Shares Outstanding | 17,574,679 | ||
Entity Central Index Key | 0000744218 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current Assets: | ||
Cash and Cash Equivalents | $ 11,232 | $ 24,310 |
Marketable Securities | 53,151 | 69,712 |
Accounts and Other Receivables | 1,015 | 3,162 |
Prepaid and Other Current Assets | 1,300 | 1,895 |
Total Current Assets | 66,698 | 99,079 |
Property and Equipment, Net | 4,031 | 6,111 |
Operating Lease Right-of-Use Assets, Net | 3,473 | |
Intangible Assets, Net | 48,690 | 48,690 |
Other Assets | 41 | 1,929 |
Total Assets | 122,933 | 155,809 |
Current Liabilities: | ||
Accounts Payable | 1,174 | 1,069 |
Accrued Expenses | 6,499 | 7,007 |
Current Portion of Operating Lease Liabilities | 1,944 | |
Current Portion of Long-Term Liabilities | 2,026 | 4,526 |
Total Current Liabilities | 11,643 | 12,602 |
Long-Term Portion of Operating Lease Liabilities | 1,713 | |
Other Long-Term Liabilities | 15,551 | 19,147 |
Total Liabilities | 28,907 | 31,749 |
Commitments and Contingent Liabilities (Note 14) | ||
Stockholders' Equity: | ||
Convertible Preferred Stock, $.01 Par Value; 3,000,000 Shares Authorized; No Shares Issued and Outstanding at December 31, 2019 and 2018 | ||
Common Stock, $.001 Par Value; 297,000,000 Shares Authorized; 16,972,077 and 11,957,635 Shares Issued and Outstanding at December 31, 2019 and 2018, Respectively | 17 | 12 |
Additional Paid-In Capital | 1,104,706 | 1,083,903 |
Accumulated Other Comprehensive Income | 2,619 | 2,583 |
Accumulated Deficit | (1,013,316) | (962,438) |
Total Stockholders' Equity | 94,026 | 124,060 |
Total Liabilities and Stockholders' Equity | $ 122,933 | $ 155,809 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
CONSOLIDATED BALANCE SHEETS | ||
Convertible Preferred Stock, Par Value (in dollars per share) | $ 0.01 | $ 0.01 |
Convertible Preferred Stock, Shares Authorized | 3,000,000 | 3,000,000 |
Convertible Preferred Stock, Shares Issued | 0 | 0 |
Convertible Preferred Stock, Shares Outstanding | 0 | 0 |
Common Stock, Par Value (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 297,000,000 | 297,000,000 |
Common Stock, Shares Issued | 16,972,077 | 11,957,635 |
Common Stock, Shares Outstanding | 16,972,077 | 11,957,635 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
REVENUES: | |||
Total Revenues | $ 3,573 | $ 9,538 | $ 12,743 |
OPERATING EXPENSES: | |||
Research and Development | 42,672 | 66,449 | 96,171 |
General and Administrative | 15,426 | 19,269 | 25,003 |
Goodwill Impairment | 90,976 | ||
Intangible Asset Impairment | 18,677 | 13,000 | |
Other Asset Impairment | 1,800 | ||
Gain on Fair Value Remeasurement of Contingent Consideration | (1,294) | (29,621) | (800) |
Amortization of Acquired Intangible Assets | 224 | 896 | |
Total Operating Expenses | 58,604 | 165,974 | 134,270 |
Operating Loss | (55,031) | (156,436) | (121,527) |
Investment and Other Income, Net | 4,153 | 4,487 | 4,214 |
Net Loss Before Income Tax Benefit | (50,878) | (151,949) | (117,313) |
Income Tax Benefit | 765 | 24,282 | |
Net Loss | $ (50,878) | $ (151,184) | $ (93,031) |
Basic and Diluted Net Loss Per Common Share | $ (3.51) | $ (14.48) | $ (10.86) |
Shares Used in Calculating Basic and Diluted Net Loss per Share | 14,507 | 10,442 | 8,570 |
COMPREHENSIVE LOSS: | |||
Net Loss | $ (50,878) | $ (151,184) | $ (93,031) |
Other Comprehensive Income (Loss): | |||
Unrealized Gain on Marketable Securities | 36 | 19 | 23 |
Comprehensive Loss | (50,842) | (151,165) | (93,008) |
Product Development and Licensing Agreements | |||
REVENUES: | |||
Total Revenues | 473 | 3,341 | 3,153 |
Contracts and Grants | |||
REVENUES: | |||
Total Revenues | $ 3,100 | $ 6,197 | $ 9,590 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income. | Accumulated Deficit | Total |
Period Start Balance at Dec. 31, 2016 | $ 8 | $ 982,368 | $ 2,541 | $ (719,486) | $ 265,431 |
Balance (in shares) at Dec. 31, 2016 | 8,034,443 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Shares Issued under Stock Option and Employee Stock Purchase Plans | 265 | 265 | |||
Shares Issued under Stock Option and Employee Stock Purchase Plans (in shares) | 11,581 | ||||
Shares Issued in Connection with Cantor Agreement | $ 1 | 51,024 | 51,025 | ||
Shares Issued in Connection with Cantor Agreement (in shares) | 1,181,524 | ||||
Shares Issued in Connection with Kolltan Severance | 344 | 344 | |||
Shares Issued in Connection with Kolltan Severance (in shares) | 7,145 | ||||
Share-Based Compensation | 12,312 | 12,312 | |||
Unrealized Gains on Marketable Securities | 23 | 23 | |||
Net Loss | (93,031) | (93,031) | |||
Period End Balance at Dec. 31, 2017 | $ 9 | 1,046,313 | 2,564 | (812,517) | 236,369 |
Balance (in shares) at Dec. 31, 2017 | 9,234,693 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Shares Issued under Stock Option and Employee Stock Purchase Plans | 419 | 419 | |||
Shares Issued under Stock Option and Employee Stock Purchase Plans (in shares) | 16,047 | ||||
Shares Issued in Connection with Cantor Agreement | $ 3 | 29,019 | 29,022 | ||
Shares Issued in Connection with Cantor Agreement (in shares) | 2,702,660 | ||||
Shares Issued in Connection with Kolltan Severance | 71 | 71 | |||
Shares Issued in Connection with Kolltan Severance (in shares) | 4,235 | ||||
Share-Based Compensation | 8,081 | 8,081 | |||
Unrealized Gains on Marketable Securities | 19 | 19 | |||
Adoption of ASC 606 | 1,263 | 1,263 | |||
Net Loss | (151,184) | (151,184) | |||
Period End Balance at Dec. 31, 2018 | $ 12 | 1,083,903 | 2,583 | (962,438) | $ 124,060 |
Balance (in shares) at Dec. 31, 2018 | 11,957,635 | 11,957,635 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Shares Issued under Stock Option and Employee Stock Purchase Plans | 9 | $ 9 | |||
Shares Issued under Stock Option and Employee Stock Purchase Plans (in shares) | 3,285 | ||||
Shares Issued in Connection with Cantor Agreement | $ 5 | 16,243 | 16,248 | ||
Shares Issued in Connection with Cantor Agreement (in shares) | 5,011,157 | ||||
Share-Based Compensation | 4,551 | 4,551 | |||
Unrealized Gains on Marketable Securities | 36 | 36 | |||
Net Loss | (50,878) | (50,878) | |||
Period End Balance at Dec. 31, 2019 | $ 17 | $ 1,104,706 | $ 2,619 | $ (1,013,316) | $ 94,026 |
Balance (in shares) at Dec. 31, 2019 | 16,972,077 | 16,972,077 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash Flows From Operating Activities: | |||
Net Loss | $ (50,878) | $ (151,184) | $ (93,031) |
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities: | |||
Depreciation and Amortization | 4,858 | 3,577 | 4,414 |
Amortization of Intangible Assets | 224 | 896 | |
Amortization and Premium of Marketable Securities, Net | (1,140) | (1,048) | (290) |
Loss on Sale or Disposal of Assets | 11 | 1,220 | 55 |
Goodwill Impairment | 90,976 | ||
Intangible Asset Impairment | 18,677 | 13,000 | |
Other Asset Impairment | 1,800 | ||
Gain on Fair Value Remeasurement of Contingent Consideration | (1,294) | (29,621) | (800) |
Non-Cash Income Tax Benefit | (765) | (24,282) | |
Stock-Based Compensation Expense | 4,551 | 8,081 | 12,312 |
Changes in Operating Assets and Liabilities: | |||
Accounts and Other Receivables | 2,274 | (777) | (96) |
Prepaid and Other Current Assets | 362 | 1,783 | 793 |
Other Assets | (39) | 205 | |
Accounts Payable and Accrued Expenses | (321) | (13,110) | (8,744) |
Other Liabilities | (6,599) | (3,268) | (4,363) |
Net Cash Used in Operating Activities | (46,415) | (75,235) | (99,931) |
Cash Flows From Investing Activities: | |||
Sales and Maturities of Marketable Securities | 113,173 | 201,469 | 219,236 |
Purchases of Marketable Securities | (95,382) | (171,182) | (170,980) |
Acquisition of Property and Equipment | (731) | (813) | (1,788) |
Proceeds from Sale or Disposal of Assets | 20 | 342 | |
Net Cash Provided by Investing Activities | 17,080 | 29,816 | 46,468 |
Cash Flows From Financing Activities: | |||
Net Proceeds from Stock Issuances | 16,248 | 29,022 | 51,025 |
Proceeds from Issuance of Stock from Employee Benefit Plans | 9 | 419 | 265 |
Net Cash Provided by Financing Activities | 16,257 | 29,441 | 51,290 |
Net Decrease in Cash and Cash Equivalents | (13,078) | (15,978) | (2,173) |
Cash and Cash Equivalents at Beginning of Period | 24,310 | 40,288 | 42,461 |
Cash and Cash Equivalents at End of Period | 11,232 | 24,310 | 40,288 |
Non-cash Investing Activities | |||
Accrued construction in progress | $ 25 | 107 | 20 |
Non-cash Supplemental Disclosure | |||
Shares issued to former Kolltan executive for settlement of severance | $ 71 | $ 344 |
Nature of Business and Overview
Nature of Business and Overview | 12 Months Ended |
Dec. 31, 2019 | |
Nature of Business and Overview | |
Nature of Business and Overview | (1) Nature of Business and Overview Celldex Therapeutics, Inc. (the “Company” or “Celldex”) is a biopharmaceutical company focused on the development and commercialization of several immunotherapy technologies and other cancer-targeting biologics. The Company is primarily focusing its efforts and resources on the continued research and development of CDX-1140, CDX-3379, CDX-0159 and CDX-527. The Board of Directors of the Company approved a one for fifteen reverse stock split of the Company’s outstanding common stock, which was effected on February 8, 2019. All share and per share amounts in the financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split, including reclassifying an amount equal to the reduction in par value to additional paid-in capital. Under U.S. GAAP, the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date that the financial statements are issued. This evaluation shall initially not take into consideration the potential mitigating effects of plans that have not been fully implemented as of the date the financial statements are issued. The Company’s financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. At December 31, 2019, the Company had cash, cash equivalents and marketable securities of $64.4 million. The Company has had recurring losses and incurred a loss of $50.9 million for the year ended December 31, 2019. Net cash used in operations for the year ended December 31, 2019 was $46.4 million. As of March 26, 2020, the date of issuance of the consolidated financial statements, the Company expects that its cash, cash equivalents and marketable securities of $64.4 million as of December 31, 2019 will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of 2021. The future viability of the Company beyond that point is dependent on the Company’s ability to raise additional capital to finance its operations. The Company has generated no product revenue to date and cannot predict when and if it will generate product revenue. The Company has had recurring losses and anticipate operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of product candidates, conducting preclinical studies and clinical trials, facilities and general and administrative expenses. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date that the financial statements are issued. During the next twelve months and beyond, the Company will take further steps to raise additional capital to meet its liquidity needs including, but may not be limited to, one or more of the following: the licensing of drug candidates with existing or new collaborative partners, possible business combinations, issuance of debt, or the issuance of common stock or other securities via private placements or public offerings. Although the Company has been successful in raising capital in the past, there can be no assurance that additional financing will be available on acceptable terms, if at all, and the Company’s negotiating position in capital-raising efforts may worsen as existing resources are used. There is also no assurance that the Company will be able to enter into further collaborative relationships. Additional equity financings may be dilutive to the Company’s stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict the Company’s ability to operate as a business; and licensing or strategic collaborations may result in royalties or other terms which reduce the Company’s economic potential from products under development. The Company’s ability to continue funding its planned operations into and beyond twelve months from the issuance date is also dependent on the timing and manner of payment of contingent milestones from the Kolltan acquisition, in the event that the Company achieves the drug candidate milestones related to those payments. The Company, at its option, may decide to pay those milestone payments in cash, shares of its common stock or a combination thereof. If the Company is unable to raise the funds necessary to meet its liquidity needs, it may have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, license out programs earlier than expected, raise funds at a significant discount or on other unfavorable terms, if at all, or sell all or a part of the Company. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. In December 2019, a novel strain of coronavirus, now referred to as COVID-19, surfaced in Wuhan, China. The virus continues to spread globally, has been declared a pandemic by the World Health Organization and has spread to over 100 countries, including the United States. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as business and capital markets around the world. In an effort to halt the outbreak of COVID-19, the United States has placed significant restrictions on travel and many businesses have announced extended closures which could adversely impact our operations. Potential impactions to our business include delays in planned and ongoing preclinical and clinical trials including enrollment of patients, disruptions in time and resources provided by independent clinical investigators, contract research organizations, other third-party service providers, temporary closures of our facilities, disruptions or restrictions on our employees’ ability to travel, and delays in manufacturing and/or shipments to and from third party supplies and contract manufacturer for APIs and drug product. Any prolonged negative impacts to our business could materially impact our operating results and could lead to impairments of our Intangible (IPR&D) assets which amounted to $48.7 million at December 31, 2019. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies Basis of Presentation The balance sheets and statements of operations and comprehensive loss, stockholders’ equity, and cash flows, are consolidated for the years ended December 31, 2019 and 2018. These consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries. The Company's wholly-owned subsidiary, Celldex Australia PTY LTD was liquidated in the third quarter of 2019. All intercompany balances and transactions have been eliminated in consolidation. The Company operates in one segment, which is the business of development, manufacturing and commercialization of novel therapeutics for human health care. Use of Estimates The preparation of the financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) requires management to make estimates and use assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with a maturity date of 90 days or less at the date of purchase to be cash equivalents. Cash equivalents consist principally of money market funds and debt securities. Marketable Securities The Company invests its excess cash balances in marketable securities, including municipal bond securities, U.S. government agency securities, and highly rated corporate bonds. The Company classifies all of its marketable securities as current assets on the balance sheets because they are available-for-sale and available to fund current operations. Marketable securities are stated at fair value with unrealized gains and losses included as a component of accumulated other comprehensive income (loss), which is a separate component of stockholders’ equity, until such gains and losses are realized. If a decline in the fair value is considered other-than-temporary, based on available evidence, the unrealized loss is reclassified from accumulated other comprehensive income (loss) to the statements of operations. Realized gains and losses are determined on the specific identification method and are included in investment and other income, net. Concentration of Credit Risk and of Significant Customers and Suppliers Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash, cash equivalents, marketable securities and accounts receivable. The Company invests its cash, cash equivalents and marketable securities in debt instruments and interest-bearing accounts at major financial institutions in excess of insured limits. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity and have a high credit quality. The Company has not historically experienced credit losses from its accounts receivable and therefore has not established an allowance for doubtful accounts. Combined revenue from Rockefeller University and Duke University represented 74% of total Company revenue for the year ended December 31, 2019. Combined revenue from BMS, Rockefeller University and International AIDS Vaccine Initiative represented 86% of total Company revenue for the year ended December 31, 2018 and 77% of total Company revenue for the year ended December 31, 2017. The Company relies on contract manufacturing organizations (CMO) to manufacture drug substance and drug product as well as for future commercial supplies. The Company also relies on CMOs for supply of raw materials as well as filling, packaging, storing and shipping our drug products. The Company relies on third‑party collaborators to develop companion diagnostic tests. Fair Value Measurements The Company has certain assets and liabilities that are measured at fair value in the financial statements. The Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities) when measuring the fair value of its assets and liabilities. These assets and liabilities are classified into one of three levels of the following fair value hierarchy as defined by U.S. GAAP: Level 1: Observable inputs such as quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2: Observable inputs other than Level 1 prices, such as quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. Level 3: Unobservable inputs based on the Company’s assessment of the assumptions that market participants would use in pricing the asset or liability. Property and Equipment Property and equipment is stated at cost and depreciated over the estimated useful lives of the related assets using the straight‑line method. Laboratory equipment and office furniture and equipment are depreciated over five years, and computer equipment is depreciated over three years. Manufacturing equipment is amortized over seven to ten years. Leasehold improvements are amortized over the shorter of the estimated useful life or the non‑cancelable term of the related lease, including any renewals that are reasonably assured of occurring. Property and equipment under construction is classified as construction in progress and is depreciated or amortized only after the asset is placed in service. Expenditures for maintenance and repairs are charged to expense whereas the costs of significant improvements which extend the life of the underlying asset are capitalized. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are eliminated and any resulting gain or loss is reflected in the Company’s statements of operations and comprehensive loss. The treatment of costs to construct property and equipment depends on the nature of the costs and the stage of construction. Costs incurred in the project planning, design, construction and installation phases are capitalized as part of the cost of the asset. The Company stops capitalizing these costs when the asset is substantially complete and ready for its intended use. For manufacturing property and equipment, the Company also capitalizes the cost of validating these assets for the underlying manufacturing process. The Company completes the capitalization of validation costs when the asset is substantially complete and ready for its intended use. Costs capitalized include incremental labor and fringe benefits, and direct consultancy services. Leases The Company has operating leases of office, manufacturing and laboratory space, which have remaining lease terms of one to six years and may include one or more options to renew or terminate early. The Company determines if an arrangement contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Certain adjustments to the right-of-use asset may be required for items such as prepaid or accrued lease payments, initial direct costs paid or incentives received. The Company's leases do not contain an implicit rate, and therefore the Company uses an estimated incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. Options to extend or terminate the lease are reflected in the calculation when it is reasonably certain that the option will be exercised. The Company has elected to account for lease and non-lease components as a single lease component, however non-lease components that are variable, such as common area maintenance and utilities, are generally paid separately from rent based on actual costs incurred and therefore are not included in the right-of-use asset and operating lease liability and are reflected as an expense in the period incurred. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Other Assets Other assets included a $1.8 million non-controlling investment in a privately-held company that was accounted for under the cost method of accounting as of December 31, 2018. Based on information received in April 2019, it was determined that there was a deterioration of the private company’s financial condition due to a working capital deficiency and an inability to secure additional funding. Therefore, the Company concluded that the investment was impaired, and a non-cash impairment charge of $1.8 million was recorded during the first quarter of 2019. Contingent Consideration The Company records contingent consideration resulting from a business combination at its fair value on the acquisition date. The Company determines the fair value of the contingent consideration based primarily on the (i) timing and probability of success of clinical events or regulatory approvals; (ii) timing and probability of success of meeting clinical and commercial milestones; and (iii) discount rates. The Company’s contingent consideration liabilities arose in connection with its acquisition of Kolltan. On a quarterly basis, the Company revalues these obligations and records increases or decreases in their fair value as an adjustment to operating earnings. Changes to contingent consideration obligations can result from adjustments to discount rates, accretion of the discount rates due to the passage of time, changes in the Company’s estimates of the likelihood or timing of achieving development or commercial milestones, changes in the probability of certain clinical events or changes in the assumed probability associated with regulatory approval. The assumptions related to determining the value of contingent consideration include a significant amount of judgment, and any changes in the underlying estimates could have a material impact on the amount of contingent consideration expense recorded in any given period. Intangible Assets IPR&D assets acquired in a business combination initially are recorded at fair value and accounted for as indefinite‑lived intangible assets. These assets are capitalized on the Company’s balance sheets until either the project underlying them is completed or the assets become impaired. If a project is completed, the carrying value of the related intangible asset is amortized over the remaining estimated life of the asset beginning in the period in which the project is completed. If a project becomes impaired or is abandoned, the carrying value of the related intangible asset is written down to its fair value and an impairment charge is taken in the period in which the impairment occurs. Each IPR&D asset is assessed for impairment at least annually or when impairment indicators are present. As a result of the discontinuation of the Glemba program, the Company concluded that the Glemba IPR&D asset was fully impaired, and a non-cash impairment charge of $11.8 million was recorded in the first quarter of 2018. The remaining IPR&D assets were assessed for impairment during 2018 and 2019 and were determined not to be impaired. During the year ended December 31, 2017, the Company recorded a partial impairment charge of $13.0 million related to changes in projected development and regulatory timelines regarding the anti-KIT program. Intangible assets acquired in a business combination with a finite life are recorded at fair value and amortized over the greater of economic consumption or on a straight‑line basis over their estimated useful life. As a result of the discontinuation of the Glemba program, it was concluded that the Company’s finite-lived intangible asset was fully impaired and a non-cash impairment charge of $6.9 million was recorded in the first quarter of 2018. Goodwill The difference between the purchase price and the fair value of assets acquired and liabilities assumed in a business combination is allocated to goodwill. Goodwill is evaluated for impairment on an annual basis or when impairment indicators are present. The Company has the option to assess qualitative factors to determine if it is more likely than not that goodwill might be impaired and whether it is necessary to perform a quantitative single-step goodwill impairment test required under U.S. GAAP. As a result of the discontinuation of the Glemba program, the Company evaluated goodwill for potential impairment in the first quarter of 2018. It was determined that the goodwill asset was fully impaired and an impairment charge of $91.0 million was recorded. Impairment of Intangible and Long‑Lived Assets The Company evaluates the recoverability of its long‑lived assets, including property and equipment, right-of-use assets, and intangible assets when circumstances indicate that an event of impairment may have occurred. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written‑down to their estimated fair values. Revenue Recognition Revenues are recognized when performance obligations under agreements or contracts are satisfied, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services. The Company determines revenue recognition through the following steps: · Identification of the contract, or contracts, with a customer; · Identification of the performance obligations in the contract; · Determination of the transaction price; · Allocation of the transaction price to the performance obligations in the contract; and · Recognition of revenue when, or as, the Company satisfies a performance obligation. Revenue for the Company has historically been derived from biopharmaceutical product development agreements with collaborative partners for the research and development of therapeutic drug candidates. The terms of the agreements may include nonrefundable signing and licensing fees, funding for research, development and manufacturing, milestone payments and royalties on any product sales derived from collaborations. The Company assesses the multiple obligations typically within product development contracts to determine the distinct performance obligations and how to allocate the arrangement consideration to each distinct performance obligation. Under product development agreements, revenue is generally recognized using a cost-to-cost measure of progress. Revenue is recognized based on the costs incurred to date as a percentage of the total estimated costs to fulfill the contract. Incurred cost represents work performed, which corresponds with, and thereby best depicts, the transfer of control to the customer. Due to the nature of the work performed in these arrangements, the estimation of cost at completion is complex, subject to many variables, such as expected clinical trial costs, and requires significant judgements. Circumstances can arise that change original estimates of costs or progress toward completion. Any revisions to estimates are reflected in revenue on a cumulative catch-up basis in the period in which the change in circumstances became known. Revenue for the Company is also derived from manufacturing and research and development arrangements. The Company owns and operates a cGMP manufacturing facility in Fall River, Massachusetts, to produce drug substance for its current and planned early-stage clinical trials. In order to utilize excess capacity, the Company has, from time to time, entered into contract manufacturing and research and development arrangements in which services are provided on a time-and-material basis or at a negotiated fixed-price. Revenue from time-and-material contracts is generally recognized on an output basis as labor hours and/or direct expenses are incurred. Under fixed-price contracts, revenue is generally recognized on an output basis as progress is made toward completion of the performance obligations using surveys of performance completed to date. Contract Assets and Liabilities The Company classifies the right to consideration in exchange for products or services transferred to a client as either a receivable or a contract asset. A receivable is a right to consideration that is unconditional as compared to a contract asset which is a right to consideration that is conditional upon factors other than the passage of time. The Company’s contract liabilities result from arrangements where the Company has received payment in advance of performance under the contract. These amounts are included as deferred revenue within current portion of long-term liabilities on the condensed consolidated balance sheets. Research and Development Expenses Research and development costs, including internal and contract research costs, are expensed as incurred. Research and development expenses consist mainly of clinical trial costs, manufacturing of clinical material, toxicology and other preclinical studies, personnel costs, depreciation, license fees and funding of outside contracted research. Clinical trial expenses include expenses associated with clinical research organization, or CRO, services. Contract manufacturing expenses include expenses associated with contract manufacturing organization, or CMO, services. The invoicing from CROs and CMOs for services rendered can lag several months. The Company accrues the cost of services rendered in connection with CRO and CMO activities based on our estimate of costs incurred. The Company maintains regular communication with our CROs and CMOs to assess the reasonableness of its estimates. Differences between actual expenses and estimated expenses recorded have not been material and are adjusted for in the period in which they become known. Patent Costs Patent costs are expensed to general and administrative expense as incurred. Certain patent costs are reimbursed by the Company’s product development and licensing partners. Any reimbursed patent costs are recorded as product development and licensing agreement revenues in the Company’s financial statements. Stock‑Based Compensation The Company records stock-based compensation expense for all stock-based awards made to employees, directors and non-employees based on the estimated fair values of the stock-based awards expected to vest at the grant date and adjust, if necessary, to reflect actual forfeitures. Compensation expense for all stock-based awards is recognized using the straight-line method over the term of vesting or performance. Foreign Currency Translation Net unrealized gains and losses resulting from foreign currency translation are included in accumulated other comprehensive income. At December 31, 2019 and 2018, accumulated other comprehensive income includes a net unrealized gain related to foreign currency translation of $2.6 million. Income Taxes The Company uses the asset and liability method to account for income taxes, including the recognition of deferred tax assets and deferred tax liabilities for the anticipated future tax consequences attributable to differences between financial statement amounts and their respective tax basis. Quarterly, the Company reviews its deferred tax assets for recovery. A valuation allowance is established when the Company believes that it is more likely than not that its deferred tax assets will not be realized. Changes in valuation allowances from period to period are included in the Company’s tax provision in the period of change. The Company records uncertain tax positions in the financial statements only if it is more likely than not that the uncertain tax position will be sustained upon examination by the taxing authorities. The Company records interest and penalties related to uncertain tax positions in income tax expense. Comprehensive Loss Comprehensive loss is comprised of net loss and certain changes in stockholders’ equity that are excluded from net loss. The Company includes foreign currency translation adjustments and unrealized gains and losses on marketable securities in other comprehensive loss. The statements of operations and comprehensive loss reflect total comprehensive loss for the years ended December 31, 2019, 2018 and 2017. Net Loss Per Share Basic net loss per common share is based upon the weighted‑average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested. Diluted net loss per common share is based upon the weighted‑average number of common shares outstanding during the period plus additional weighted-average potentially dilutive common shares outstanding during the period when the effect is dilutive. In periods in which the Company reports a net loss, there is no difference between basic and diluted net loss per share because dilutive shares of common stock are not assumed to have been issued as their effect is anti-dilutive. The potentially dilutive common shares that have not been included in the net loss per common share calculations because the effect would have been anti-dilutive are as follows: Year Ended December 31, 2019 2018 2017 Stock options 1,699,202 866,132 723,747 Restricted stock 1,110 3,552 6,445 1,700,312 869,684 730,192 Newly-Adopted Accounting Pronouncements On January 1, 2019, the Company adopted a new U.S. GAAP accounting standard which requires that all lessees recognize the assets and liabilities that arise from leases on the balance sheet and disclose qualitative and quantitative information about its leasing arrangements. The new standard was adopted using the modified retrospective transition method, which requires the Company to apply the standard as of the effective date and does not require restatement of prior periods. The Company elected to apply the package of practical expedients, which allowed the Company to not reassess: (i) whether expired or existing contracts contain leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. Adoption of this standard did not have a material impact on the Company’s Consolidated Statement of Operations and Comprehensive Loss or Statement of Cash Flow, however, upon adoption, the Company recorded right-of-use assets of $3.8 million and lease liabilities of $4.7 million on its Consolidated Balance Sheet related to the Company’s operating leases. The difference between the right-of-use assets and lease liabilities recorded upon adoption is due to certain adjustments required to the right-of-use assets for prepaid rent and accrued termination expenses. Refer to Note 7 “Leases” for additional details on this adoption and the Company’s updated disclosures. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption. In August 2018, the FASB issued amendments that modify certain disclosure requirements for fair value measurements. The amendments become effective, including interim periods, beginning January 1, 2020. The adoption of this new guidance is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures. In November 2018, the FASB issued guidance to clarify the interaction between the accounting guidance for collaborative arrangements and revenue from contracts with customers. The amendments become effective, including interim periods, beginning January 1, 2020. This guidance is required to be applied retrospectively as of the date of our adoption of the new revenue standard on January 1, 2018. The adoption of this new guidance is not expected to have a material impact on the Company's consolidated financial statements and related disclosures. In June 2016, the FASB issued guidance on the Measurement of Credit Losses on Financial Instruments. The guidance requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, the standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. This standard will be effective for the Company on January 1, 2023. We are currently evaluating the potential impact that this standard may have on the Company's consolidated financial statements and related disclosures. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 12 Months Ended |
Dec. 31, 2019 | |
Accumulated Other Comprehensive Income | |
Accumulated Other Comprehensive Income | (3) Accumulated Other Comprehensive Income The changes in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the year ended December 31, 2019 are summarized below: Unrealized Gain (Loss) on Marketable Foreign Securities Currency Items Total (In thousands) Balance at December 31, 2018 $ (13) $ 2,596 $ 2,583 Other comprehensive gain 36 — 36 Balance at December 31, 2019 $ 23 $ 2,596 $ 2,619 No amounts were reclassified out of accumulated other comprehensive income during the years ended December 31, 2019, 2018 and 2017. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Measurements | |
Fair Value Measurements | (4) Fair Value Measurements The following tables set forth the Company’s financial assets and liabilities subject to fair value measurements: As of December 31, 2019 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 4,024 — $ 4,024 — Marketable securities 53,151 — 53,151 — $ 57,175 — $ 57,175 — Liabilities: Kolltan acquisition contingent consideration $ 12,485 — — $ 12,485 $ 12,485 — — $ 12,485 As of December 31, 2018 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 15,755 — $ 15,755 — Marketable securities 69,712 — 69,712 — $ 85,467 — $ 85,467 — Liabilities: Kolltan acquisition contingent consideration $ 13,779 — — $ 13,779 $ 13,779 — — $ 13,779 The Company’s financial assets consist mainly of cash and cash equivalents and marketable securities and are classified as Level 2 within the valuation hierarchy. The Company values its marketable securities utilizing independent pricing services which normally derive security prices from recently reported trades for identical or similar securities, making adjustments based on significant observable transactions. At each balance sheet date, observable market inputs may include trade information, broker or dealer quotes, bids, offers or a combination of these data sources. The following table reflects the activity for the Company’s contingent consideration liabilities measured at fair value using Level 3 inputs for the year ended December 31, 2019 (in thousands): Other Liabilities: Contingent Consideration Balance at December 31, 2018 $ 13,779 Fair value adjustments included in operating expenses (1,294) Balance at December 31, 2019 $ 12,485 The valuation technique During the year ended December 31, 2019, the Company recorded a $1.3 million gain on fair value remeasurement of contingent consideration, primarily due to changes in discount rates, the passage of time and updated assumptions for the varlilumab program. The Company did not have any transfers of assets or liabilities between the fair value measurement classifications during the years ended December 31, 2019 and 2018. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2019 | |
Marketable Securities | |
Marketable Securities | (5) Marketable Securities The following is a summary of marketable debt securities, classified as available-for-sale: Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value (In thousands) December 31, 2019 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 18,509 $ 13 $ — $ 18,522 Maturing after one year through three years — — — — Total U.S. government and municipal obligations $ 18,509 $ 13 $ — $ 18,522 Corporate debt securities Maturing in one year or less $ 34,619 $ 13 $ (3) $ 34,629 Maturing after one year through three years — — — — Total corporate debt securities $ 34,619 $ 13 $ (3) $ 34,629 Total marketable securities $ 53,128 $ 26 $ (3) $ 53,151 December 31, 2018 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 27,355 $ — $ (4) $ 27,351 Maturing after one year through three years — — — — Total U.S. government and municipal obligations $ 27,355 $ — $ (4) $ 27,351 Corporate debt securities Maturing in one year or less $ 42,370 $ — $ (9) $ 42,361 Maturing after one year through three years — — — — Total corporate debt securities $ 42,370 $ — $ (9) $ 42,361 Total marketable securities $ 69,725 $ — $ (13) $ 69,712 The Company holds investment grade marketable securities, and none were considered to be other‑than‑temporarily impaired as of December 31, 2019. Marketable securities include $0.2 million and $0.1 million in accrued interest at December 31, 2019 and December 31, 2018, respectively. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment, Net | |
Property and Equipment, Net | (6) Property and Equipment, Net Property and Equipment, Net includes the following: December 31, December 31, 2019 2018 (In thousands) Laboratory Equipment $ 8,622 $ 8,272 Manufacturing Equipment 2,510 2,497 Office Furniture and Equipment 3,873 3,791 Leasehold Improvements 17,238 17,408 Construction in Progress 191 327 Total Property and Equipment 32,434 32,295 Less: Accumulated Depreciation and Amortization (28,403) (26,184) Property and Equipment, Net $ 4,031 $ 6,111 Depreciation and amortization expense related to property and equipment was $2.7 million, $3.6 million and $4.4 million for the years ended December 31, 2019, 2018 and 2017, respectively. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases | |
Leases | (7) Leases The Company has operating leases of office, manufacturing and laboratory space, which have remaining lease terms of one to six years and may include one or more options to renew or terminate early. During the first quarter of 2019, the Company amended its Hampton, New Jersey lease to eliminate 16,200 square feet of space and extend the remaining 33,400 square feet of space for an additional five-year term with an early termination option after three years. The Company recorded an additional right-of-use asset and lease liability of $1.4 million during the first quarter of 2019 for the initial 3 years related to the amendment. Operating lease expense and variable lease expense was $2.5 million and $1.5 million for year ended December 31, 2019, respectively. Under the prior lease accounting guidance, the Company recorded total operating lease expense and variable lease expense of $4.0 million and $4.1 million for the years ended December 31, 2018 and 2017, respectively. Cash paid for amounts included in the measurement of operating lease liabilities during the year ended December 31, 2019 was $3.3 million. As of December 31, 2019, the weighted-average remaining lease term was 2 years and the weighted-average discount rate was 11.0%. Future minimum lease payments under non-cancellable leases as of December 31, 2019 were as follows: 2020 $ 2,218 2021 875 2022 747 2023 311 Total lease payments 4,151 Less imputed interest (494) Present value of operating lease liabilities $ 3,657 Under the prior lease accounting guidance, operating lease obligations, including estimated variable lease obligations, as of December 31, 2018 were as follows: 2019 $ 4,648 2020 3,140 Thereafter — Total lease payments $ 7,788 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 12 Months Ended |
Dec. 31, 2019 | |
Intangible Assets and Goodwill | |
Intangible Assets and Goodwill | (8) Intangible Assets and Goodwill Intangible Assets, Net The Company’s finite-lived intangible assets consisted solely of license rights amended under a 2009 agreement with Amgen Fremont related to developing and commercializing Glemba. As a result of the discontinuation of the Glemba program, the Company concluded that the finite-lived intangible asset was fully impaired and a non-cash impairment charge of $6.9 million was recorded in the first quarter of 2018. Amortization expense for finite intangible assets was $0.0 million, $0.2 million and $0.9 million for the years ended December 31, 2019, 2018 and 2017. At December 31, 2019 and 2018, the Company recorded indefinite-lived intangible assets of $48.7 million. At December 31, 2019, indefinite-lived intangible assets consist of acquired in-process research and development (“IPR&D”) related to the development of CDX-3379, the anti-KIT program and the TAM program. CDX-3379 is in Phase 2 development, the anti-KIT program is in Phase 1 development and the TAM program is in preclinical development. As of December 31, 2019, no IPR&D asset had reached technological feasibility nor did any have alternative future uses. Each IPR&D asset is assessed for impairment at least annually, or more frequently if events or changes in circumstances indicate that IPR&D assets may be impaired. The Company performed its annual impairment test of the IPR&D assets during the fourth quarter of 2019 and concluded that the IPR&D assets were not impaired. In the first quarter of 2018, as a result of the discontinuation of the Glemba program, the Company concluded that the Glemba IPR&D asset was fully impaired and a non-cash impairment charge of $11.8 million was recorded. Due to the nature of IPR&D projects, the Company may experience future delays or failures to obtain regulatory approvals to conduct clinical trials, failures of such clinical trials or other failures to achieve a commercially viable product, and as a result, may recognize further impairment losses in the future. Goodwill In the first quarter of 2018, the Company’s goodwill was evaluated for potential impairment due to the discontinuation of the Glemba program. The carrying amount of the Company was compared to the Company’s fair value. The Company’s fair value assessment reflected a number of significant management assumptions and estimates including the Company’s probability forecasts for pipeline assets, income taxes, capital expenditures, market premium and changes in working capital requirements. Changes in these assumptions and/or discount rates could materially impact the Company’s conclusions. Through this assessment, it was determined that the carrying amount of the Company exceeded its fair value by over $91.0 million. As such, the full goodwill asset was considered impaired and a charge of $91.0 million was recorded during the first quarter of 2018. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Expenses | |
Accrued Expenses | (9) Accrued Expenses Accrued expenses include the following: December 31, December 31, 2019 2018 (In thousands) Accrued Payroll and Employee Benefits $ 4,575 $ 4,400 Accrued Research and Development Contract Costs 1,186 1,766 Accrued Professional Fees 400 620 Other Accrued Expenses 338 221 $ 6,499 $ 7,007 |
Other Long-Term Liabilities
Other Long-Term Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Other Long-Term Liabilities | |
Other Long-Term Liabilities | (10) Other Long‑Term Liabilities Other long‑term liabilities include the following: December 31, December 31, 2019 2018 (In thousands) Net Deferred Tax Liabilities Related to IPR&D (Note 15) $ 3,007 $ 3,007 Deferred Income From Sale of Tax Benefits 1,831 4,218 Other — 1,083 Contingent Milestones (Note 4) 12,485 13,779 Deferred Revenue 254 1,586 Total 17,577 23,673 Less Current Portion (2,026) (4,526) Long-Term Portion $ 15,551 $ 19,147 In November 2015, the Company received approval from the New Jersey Economic Development Authority and agreed to sell New Jersey tax benefits of $9.8 million to an independent third party for $9.2 million. Under the agreement, the Company must maintain a base of operations in New Jersey for five years or the tax benefits must be paid back on a pro‑rata basis based on the number of years completed. During the years ended December 31, 2019, 2018 and 2017, the Company recorded $2.4 million, $2.5 million and $2.7 million to other income related to the sale of these tax benefits, respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity | |
Stockholders' Equity | (11) Stockholders’ Equity Common Stock In December 2016, the Company filed a new shelf registration statement with the Securities and Exchange Commission to register for sale any combination of the types of securities described in the shelf registration statement up to a maximum aggregate offering price of $250 million. Such registration statement was declared effective on February 13, 2017. In December 2019, the Company filed a new shelf registration statement with the Securities and Exchange Commission to register for sale any combination of the types of securities described in the shelf registration statement up to a maximum aggregate offering price of $150.0 million. In May 2016, the Company entered into an agreement with Cantor Fitzgerald & Co. (“Cantor”) to allow the Company to issue and sell shares of its common stock having an aggregate offering price of up to $60.0 million from time to time through Cantor, acting as agent. In November 2017, the Company filed a prospectus supplement registering the offer and sale of shares of common stock of up to an additional $75.0 million under the agreement with Cantor. During the years ended December 31, 2019, 2018 and 2017, the Company issued 5.0 million, 2.7 million and 1.2 million shares of its common stock, respectively, under this controlled equity offering sales agreement with Cantor resulting in net proceeds to the Company of $16.2 million, $29.0 million and $51.0 million, respectively, after deducting commission and offering expenses. At December 31, 2019, the Company had $20.7 million remaining in aggregate gross offering price available under the Cantor agreement. From January 1, 2020 through February 29 2020, the Company issued 520,606 shares of its common stock resulting in net proceeds to the Company of $1.2 million. Convertible Preferred Stock At December 31, 2019, the Company had authorized 3,000,000 shares of preferred stock all of which have been designated Class C Preferred Stock including 350,000 shares which have been designated Series C‑1 Junior Participating Cumulative Preferred Stock (the “Series C‑1 Preferred Stock”). No shares of Series C-1 Preferred Stock were outstanding at December 31, 2019 or 2018. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Stock-Based Compensation | |
Stock-Based Compensation | (12) Stock‑Based Compensation The Company has the following stock-based compensation plans: the 2004 Employee Stock Purchase Plan (the “2004 ESPP Plan”) and the 2008 Stock Option and Incentive Plan (the “2008 Plan”). Employee Stock Purchase Plan At December 31, 2019, a total of 276,666 shares of common stock are reserved for issuance under the 2004 ESPP Plan. Under the 2004 ESPP Plan, each participating employee may purchase shares of common stock through payroll deductions at a purchase price equal to 85% of the lower of the fair market value of the common stock at either the beginning of the offering period or the applicable exercise date. During the years ended December 31, 2019, 2018 and 2017, the Company issued 3,507, 9,524 and 5,359 shares under the 2004 ESPP Plan, respectively. At December 31, 2019, 250,159 shares were available for issuance under the 2004 ESPP Plan. Employee Stock Option and Incentive Plan The 2008 Plan permits the granting of incentive stock options (intended to qualify as such under Section 422A of the Internal Revenue Code of 1986, as amended), non‑qualified stock options, stock appreciation rights, performance share units, restricted stock and other awards of restricted stock in lieu of cash bonuses to employees, consultants and non‑employee directors. At December 31, 2019, the 2008 Plan allowed for a maximum of 2,233,333 shares of common stock to be issued for grants of new awards until June 9, 2025 and grants of incentive stock options until April 16, 2025. The Company’s Board of Directors determines the term of each option, option price, and number of shares for which each option is granted and the rate at which each option vests. Options generally vest over a period not to exceed four years. The term of each option cannot exceed ten years (five years for options granted to holders of more than 10% of the voting stock of the Company), and the exercise price of stock options cannot be less than the fair market value of the common stock at the date of grant (110% of fair market value for incentive stock options granted to holders of more than 10% of the voting stock of the Company). Vesting of all employee and non‑employee director stock option awards may accelerate upon a change in control as defined in the 2008 Plan. A summary of stock option activity for the year ended December 31, 2019 is as follows: Weighted Weighted Average Average Exercise Remaining Price Contractual Shares Per Share Term (In Years) Options Outstanding at December 31, 2018 866,132 $ 93.70 7.1 Granted 940,040 $ 2.77 Exercised — $ — Canceled (106,970) $ 70.22 Options Outstanding at December 31, 2019 1,699,202 $ 44.87 8.0 Options Vested and Expected to Vest at December 31, 2019 1,580,780 $ 47.90 7.9 Options Exercisable at December 31, 2019 573,996 $ 121.76 5.5 Shares Available for Grant Under the 2008 Plan 424,263 The total intrinsic value of stock options exercised during the years ended December 31, 2019, 2018 and 2017 was $0.0 million. The weighted average grant‑date fair value of stock options granted during the years ended December 31, 2019, 2018 and 2017 was $2.08, $6.60 and $23.70, respectively. The total fair value of stock options vested during the years ended December 31, 2019, 2018 and 2017 was $4.9 million, $8.0 million and $13.4 million, respectively. The aggregate intrinsic value of stock options outstanding at December 31, 2019 was $0.0 million. The aggregate intrinsic value of stock options vested and expected to vest at December 31, 2019 was $0.0 million. As of December 31, 2019, total compensation cost related to non‑vested employee and non‑employee director stock options not yet recognized was approximately $3.8 million, net of estimated forfeitures, which is expected to be recognized as expense over a weighted average period of 3.0 years. Restricted Stock A summary of restricted stock activity under the 2008 Plan for the year ended December 31, 2019 is as follows: Weighted Average Grant Date Fair Value Shares (per share) Outstanding and unvested at December 31, 2018 3,552 $ 43.84 Granted — $ — Vested (2,220) $ 49.25 Canceled (222) $ 34.83 Outstanding and unvested at December 31, 2019 1,110 $ 34.83 Valuation and Expenses Information Stock‑based compensation expense for the years ended December 31, 2019, 2018 and 2017 was recorded as follows: 2019 2018 2017 (In thousands) Research and development $ 2,053 $ 3,874 $ 6,693 General and administrative 2,498 4,207 5,619 Total stock-based compensation expense $ 4,551 $ 8,081 $ 12,312 The fair values of employee and director stock options granted during the years ended December 31, 2019, 2018 and 2017 were valued using the Black‑Scholes option pricing model with the following assumptions: 2019 2018 2017 Expected stock price volatility 90 - 91% 73 - 85% 75 - 77% Expected option term 6.0 Years 6.0 Years 6.0 Years Risk-free interest rate 1.6 - 2.5% 2.8 - 3.1% 2.0 - 2.3% Expected dividend yield None None None The Company estimates expected term based on historical exercise patterns. The Company uses its historical stock price volatility consistent with the expected term of grant as the basis for its expected volatility assumption. The risk‑free interest rate is based upon the yield of U.S. Treasury securities consistent with the expected term of the option. The dividend yield assumption is based on the Company’s history of zero dividend payouts and expectation that no dividends will be paid in the foreseeable future. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2019 | |
Revenue | |
Revenue | (13) Revenue On January 1, 2018, the Company adopted a new revenue accounting standard, “ Revenue from Contracts with Customers” (ASC 606) . Upon adoption using the modified retrospective application, the Company recognized a $1.3 million decrease to accumulated deficit, a $0.8 million decrease in deferred revenue and $0.5 million increase in accounts receivable due to the cumulative impact of adopting ASC 606 . This impact was driven by the acceleration of revenue using a percentage-of-completion method of accounting under ASC 606 for an open contract that had previously been accounted for using the Contingency Adjusted Performance Model (“CAPM”) under previous guidance. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606 while prior period amounts were not adjusted and continue to be reported in accordance with historic accounting under previous guidance. There was not a material impact to revenues as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significant changes to the Company’s business processes, systems or internal controls as a result of adopting the new standard. Revenue recognition remained largely unchanged under the new standard. Contract Assets and Liabilities At December 31, 2019 and 2018, the Company's right to consideration under all contracts was considered unconditional, and as such, there were no recorded contract assets. At December 31, 2019 and 2018, the Company had $0.3 million and $1.6 million in contract liabilities recorded, respectively. Revenue recognized from contract liabilities as of December 31, 2018 during the year ended December 31, 2019 was $1.4 million. Product Development and Licensing Revenue The Company entered into a clinical collaboration agreement with BMS in 2014 to evaluate the safety, tolerability and preliminary efficacy of varlilumab and Opdivo(R), BMS's PD-1 immune checkpoint inhibitor, in a Phase 1/2 study. Under this agreement, BMS made an upfront payment to Celldex of $5.0 million and provides funding for 50% of the external costs incurred by the Company in connection with the clinical trial. The performance obligations under the collaboration agreement consist of intellectual property licenses and the performance of research and development services. The Company determined that the performance obligations were not separately identifiable and were not distinct (and did not have standalone value) due to the specialized nature of the services to be provided, the dependent relationship between the performance obligations and the Company's proprietary technology that makes them uniquely qualified to perform the R&D services. Therefore, the Company concluded that the collaboration agreement has a single identified or combined performance obligation. As of December 31, 2019, deferred revenue related to the Company's remaining performance obligation under this arrangement was $0.0 million. The Company recorded $0.2 million, $3.3 million and $2.8 million in revenue related to this agreement during the years ended December 31, 2019, 2018 and 2017, respectively. Contract and Grants Revenue The Company has entered into agreements with Rockefeller University and Duke University pursuant to which the Company performs manufacturing and research and development services on a time-and-materials basis. The Company recognized $2.6 million, $3.2 million and $2.2 million in revenue for labor hours and direct costs incurred under these agreements during the years ended December 31, 2019, 2018 and 2017, respectively. The Company has entered into fixed-fee manufacturing and research and development arrangements with both the International AIDS Vaccine Initiative (IAVI) and Frontier Biotechnologies, Inc (Frontier). The Company recognized $0.3 million, $3.0 million and $6.6 million in revenue under these agreements during the years ended December 31, 2019, 2018 and 2017, respectively. |
Collaboration Agreements
Collaboration Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Collaboration Agreements | |
Collaboration Agreements | (14) Collaboration Agreements The Company has entered into license agreements whereby the Company has received licenses or options to license technology, specified patents or patent applications. The Company’s licensing and development collaboration agreements generally provide for royalty payments equal to specified percentages of product sales, annual license maintenance fees, continuing patent prosecution costs and potential future milestone payments to third parties upon the achievement of certain developmental, regulatory and/or commercial milestones. Nonrefundable license fee expense of $0.1 million, $0.7 million and $0.7 million was recorded to research and development expense for the years ended December 31, 2019, 2018 and 2017, respectively. University of Southampton, UK (Southampton) Under a license agreement with Southampton, the Company acquired the rights to develop human antibodies towards CD27, a potentially important target for immunotherapy of various cancers. The Company may be required to pay Southampton milestones of up to approximately $1.0 million upon obtaining first approval for commercial sale in a first indication and royalty payments in the low‑single digits on any net product sales with respect to development and commercialization of CDX-527. Amgen Inc. (Amgen) Under a license agreement with Amgen, the Company acquired the exclusive rights to CDX-301 and CD40 ligand, or CD40L. CDX-301 and CD40L are immune modulating molecules that increase the numbers and activity of immune cells that control immune responses. The Company may be required to pay Amgen milestones of up to $0.9 million upon obtaining first approval for commercial sale in a first indication and royalty payments in the low‑single digits on any net product sales with respect to development and commercialization of the technology licensed from Amgen, including CDX‑301. Yale University (Yale) Under a license agreement with Yale, the Company may be required to make a one-time payment to Yale of $3.0 million with respect to each therapeutic or prophylactic RTK royalty-bearing product, including CDX-3379, that achieves a specified commercial milestone. In addition, the Company may be required to pay a low single-digit royalty on annual worldwide net sales of each RTK royalty-bearing product, including CDX-3379. Unless earlier terminated by us or Yale, the Yale license agreement is due to expire no later than May 2038 but may expire earlier on a country by country basis under specified circumstances. MedImmune, LLC (MedImmune) Under a license agreement with MedImmune, the Company acquired exclusive rights to specified patent rights and know-how that are controlled by MedImmune and relate to the research, development, manufacture and commercialization of CDX-3379. The Company may be required to pay Medimmune up to $45.0 million upon obtaining specified regulatory and development milestones in the first indication of CDX-3379. In addition, the Company may be required to pay MedImmune one-time milestone payments of up to $125.0 million if specified annual net sale thresholds are met related to the first indication of CDX-3379. The Company may also be required to pay MedImmune a tiered royalty on annual net sales of CDX-3379 at rates ranging from high single-digit to low teens percentages. These royalties may be reduced in specified circumstances and are payable on a product by product and country by country basis until the later to occur of ten years after the first commercial sale of the product in that country and the expiration of MedImmune's patent rights that cover the sale of the product in that country. The Company may also be required to pay specified royalties on annual net sales of CDX-3379 at a rate in the low single digits to certain other third parties from whom MedImmune licensed certain intellectual property. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Income Taxes | (15) Income Taxes The components of income tax benefit (provision) are as follows: Year Ended December 31, 2019 2018 2017 (In thousands) Income Tax Benefit (Provision): Federal $ 13,869 $ 22,255 $ 57,547 State 2,170 6,406 (2,479) Foreign — 913 2,448 Expiration of NOLs and R&D Credit (18,966) — — Income Tax Rate Change — — (99,528) (2,927) 29,574 (42,012) Deferred Tax Valuation Allowance 2,927 (28,809) 66,294 $ — $ 765 $ 24,282 A reconciliation between the amount of reported income tax and the amount computed using the U.S. Statutory rate is as follows: 2019 2018 2017 (In thousands) Pre-Tax Loss $ (50,878) $ (151,949) $ (117,313) Loss at Statutory Rates (10,684) (31,909) (39,887) Difference in Foreign Tax Rates — — 326 Research and Development Credits (1,902) (2,056) (2,847) State Taxes (2,170) (6,406) (6,283) Income Tax Rate Change — — 99,528 Other (1,011) (1,175) (321) Change in Fair Value Remeasurement of Contingent Consideration (272) (6,220) — Intangible Impairment — 19,105 — Recognition of APIC NOLs — — (5,729) Impact of Pass-through Entities — (913) (2,775) Expiration of NOLs and R&D Credit 18,966 — — Change in Valuation Allowance (2,927) 28,809 (66,294) Income Tax (Benefit) Provision $ — $ (765) $ (24,282) Deferred tax assets and liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using future expected enacted rates. The principal components of the deferred tax assets and liabilities at December 31, 2019 and 2018, respectively, are as follows: December 31, December 31, 2019 2018 (In thousands) Gross Deferred Tax Assets Net Operating Loss Carryforwards $ 172,745 $ 168,239 Foreign Net Operating Loss Carryforwards — 4,485 Tax Credit Carryforwards 42,642 39,761 Deferred Research and Development Expenses 70,042 76,555 Stock-based Compensation 12,651 11,977 Fixed Assets 1,759 1,761 Accrued Expenses and Other 328 316 300,167 303,094 Gross Deferred Tax Liabilities IPR&D Intangibles (12,748) (12,748) Total Deferred Tax Assets and Liabilities 287,419 290,346 Valuation Allowance (290,426) (293,353) Net Deferred Tax Liability $ (3,007) $ (3,007) The Company has evaluated the positive and negative evidence bearing upon the realizability of its net deferred tax assets and considered its history of losses, ultimately concluding that it is “more likely than not” that the Company will not recognize the benefits of federal, state and foreign deferred tax assets and, as such, has maintained a full valuation allowance on its deferred tax assets. During year ended December 31, 2017, the Company’s gross deferred tax assets and corresponding valuation allowance each increased by $17.7 million. This was a one-time increase due to the adoption of a new accounting standard removing the requirement to recognize excess tax benefits from the exercise of stock options in additional paid-in-capital when realized. On December 22, 2017, the Tax Cuts and Jobs Act (“TCJA”) was enacted, leading to significant changes to U.S. tax law. Among other provisions, the TCJA lowered the U.S. federal corporate income tax rate from 35% to 21%, limited the deduction for net operating losses to 80% of taxable income while providing that net operating loss carryovers for years after 2017 will not expire, imposed a mandatory one-time transition tax on previously deferred foreign earnings and eliminated or reduced certain income tax deductions. As a result of the TCJA, the Company revalued its deferred tax liabilities at the new federal rate of 21%, resulting in a $6.9 million decrease and a corresponding income tax benefit. The Company also scheduled out reversals of its deferred tax assets and liabilities, determining that their reversal would create future indefinite‑lived net operating losses under the TCJA. As such, the valuation allowance was reduced relating to the remaining indefinite‑lived federal deferred tax liabilities balance, leading to an additional income tax benefit of $12.2 million. The net deferred tax liability of $3.0 million at December 31, 2019 and 2018 relates to the temporary differences associated with the IPR&D intangible assets acquired in previous business combinations and are not deductible for tax purposes. The Company recorded an income tax benefit of $0.8 million during the year ended December 31, 2018 due to a decrease in deferred tax liabilities resulting from the partial impairment of the anti-KIT program. As of December 31, 2019, the Company had federal and state net operating loss carryforwards of $638.9 million and $595.1 million, respectively, which may be available to offset certain future income tax liabilities and begin to expire in 2019 and 2028, respectively. Of the federal net operating loss carryforwards of $638.9 million, approximately $146.0 million are from 2018 and 2019 and have no expiration date. As of December 31, 2019, the Company also had federal and state research and development tax credit carryforwards of $33.4 million and $11.7 million, respectively, which may be available to offset future income tax liabilities and begin to expire in 2019 and 2018, respectively. Utilization of the net operating loss carryforwards and research and credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986, or Section 382, due to ownership changes that occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three‑year period. The Company has estimated the amounts of net operating loss and research and development tax credit carryforwards which will expire unutilized as a result of its estimated annual limitations under Section 382 and has excluded those amounts from the carryforward amounts disclosed above and in the deferred tax assets and liabilities table included in this footnote. The Company has concluded Section 382 studies through 2015 for Celldex generated NOLs. The Company incurred a foreign pre-tax loss of $0.0 million and $3.0 million during the years ended December 31, 2019 and 2018, respectively. Beginning with the 2016 tax returns, the Company elected to classify the Australian entity as a disregarded entity for income tax purposes. The foreign pre-tax losses have been included with the Federal net operating loss carryforwards. In 2019 the Australian Subsidiary was liquidated and $14.9 million of Foreign Net Operating Loss Carryovers related to the foreign subsidiary were written off. As of December 31, 2019 and 2018, the Company did not have any unrecognized tax benefits. Massachusetts, New Jersey, New York and Connecticut are the jurisdictions in which the Company primarily operates or has operated and has income tax nexus. The Company is not currently under examination by these or any other jurisdictions for any tax year. Generally, in U.S. federal and state taxing jurisdictions, all years which generated net operating losses and/or tax credit carryforwards remain subject to examination to the extent those carryforwards are utilized in a subsequent period. |
Retirement Savings Plan
Retirement Savings Plan | 12 Months Ended |
Dec. 31, 2019 | |
Retirement Savings Plan | |
Retirement Savings Plan | (16) Retirement Savings Plan The Company maintains a 401(k) Plan which is available to substantially all employees. Under the terms of the 401(k) Plan, participants may elect to contribute up to 60% of their compensation or the statutory prescribed limits. The Company may make 50% matching contributions on up to 4% of a participant’s annual salary. Benefit expense for the 401(k) Plan was $0.3 million, $0.4 million and $0.5 million for the years ended December 31, 2019, 2018 and 2017, respectively. |
Kolltan Acquisition
Kolltan Acquisition | 12 Months Ended |
Dec. 31, 2019 | |
Kolltan Acquisition | |
Kolltan Acquisition | (17) Kolltan Acquisition On November 29, 2016, the Company acquired all of the share and debt interests of Kolltan Pharmaceuticals, Inc. (“Kolltan”), a clinical-stage biopharmaceutical company, in exchange for 1,217,200 shares of the Company’s common stock plus contingent consideration in the form of development, regulatory approval and sales-based milestones ("Kolltan Milestones") of up to $172.5 million. The Kolltan Milestone payments, if any, may be made, at Celldex's sole election, in cash, in shares of Celldex's common stock or a combination of both, subject to provisions of the Merger Agreement. Certain Kolltan Milestones have been abandoned consistent with the provisions of the Merger Agreement and, because of this, as of December 31, 2019, the Company believes that the adjusted amount we may be required to pay for future consideration is up to $127.5 million contingent upon the achievement of the Kolltan Milestones. In October 2019, the Company received a letter from the representative of Kolltan’s former stockholders notifying the Company that it objected to the Company’s abandonment of certain Kolltan Milestones relating to development, regulatory approval and sales-based milestones. The Company disagrees with their objection and believes their objection to be without merit. The Company is discussing with the representative of Kolltan’s former stockholders potential amendments to the Merger Agreement with respect to the Kolltan Milestones. There can be no assurances that an amendment to the Merger Agreement will be completed on terms acceptable to the Company or at all. At this time, the Company is unable to reasonably assess the ultimate outcome of the Company’s disagreement with the representative of Kolltan’s former stockholders over its objection to the Company’s abandonment of certain Kolltan Milestones or determine an estimate of potential losses, if any. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Selected Quarterly Financial Data (Unaudited) | |
Selected Quarterly Financial Data (Unaudited) | (18) Selected Quarterly Financial Data (Unaudited) 2019 Q1 2019 Q2 2019 Q3 2019 Q4 2019 (In thousands, except per share amounts) Total revenue $ 1,425 $ 715 $ 546 $ 887 Net loss (17,239) (11,779) (11,413) (10,447) Basic and diluted net loss per common share (1.40) (0.84) (0.75) (0.64) 2018 Q1 2018 Q2 2018 Q3 2018 Q4 2018 (In thousands, except per share amounts) Total revenue $ 4,068 $ 2,763 $ 941 $ 1,764 Net loss (118,132) (16,407) (7,243) (9,402) Basic and diluted net loss per common share (12.61) (1.67) (0.66) (0.81) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The balance sheets and statements of operations and comprehensive loss, stockholders’ equity, and cash flows, are consolidated for the years ended December 31, 2019 and 2018. These consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries. The Company's wholly-owned subsidiary, Celldex Australia PTY LTD was liquidated in the third quarter of 2019. All intercompany balances and transactions have been eliminated in consolidation. The Company operates in one segment, which is the business of development, manufacturing and commercialization of novel therapeutics for human health care. |
Use of Estimates | Use of Estimates The preparation of the financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) requires management to make estimates and use assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments purchased with a maturity date of 90 days or less at the date of purchase to be cash equivalents. Cash equivalents consist principally of money market funds and debt securities. |
Marketable Securities | Marketable Securities The Company invests its excess cash balances in marketable securities, including municipal bond securities, U.S. government agency securities, and highly rated corporate bonds. The Company classifies all of its marketable securities as current assets on the balance sheets because they are available-for-sale and available to fund current operations. Marketable securities are stated at fair value with unrealized gains and losses included as a component of accumulated other comprehensive income (loss), which is a separate component of stockholders’ equity, until such gains and losses are realized. If a decline in the fair value is considered other-than-temporary, based on available evidence, the unrealized loss is reclassified from accumulated other comprehensive income (loss) to the statements of operations. Realized gains and losses are determined on the specific identification method and are included in investment and other income, net. |
Concentration of Credit Risk and of Significant Customers and Suppliers | Concentration of Credit Risk and of Significant Customers and Suppliers Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash, cash equivalents, marketable securities and accounts receivable. The Company invests its cash, cash equivalents and marketable securities in debt instruments and interest-bearing accounts at major financial institutions in excess of insured limits. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity and have a high credit quality. The Company has not historically experienced credit losses from its accounts receivable and therefore has not established an allowance for doubtful accounts. Combined revenue from Rockefeller University and Duke University represented 74% of total Company revenue for the year ended December 31, 2019. Combined revenue from BMS, Rockefeller University and International AIDS Vaccine Initiative represented 86% of total Company revenue for the year ended December 31, 2018 and 77% of total Company revenue for the year ended December 31, 2017. The Company relies on contract manufacturing organizations (CMO) to manufacture drug substance and drug product as well as for future commercial supplies. The Company also relies on CMOs for supply of raw materials as well as filling, packaging, storing and shipping our drug products. The Company relies on third‑party collaborators to develop companion diagnostic tests. |
Fair Value Measurements | Fair Value Measurements The Company has certain assets and liabilities that are measured at fair value in the financial statements. The Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities) when measuring the fair value of its assets and liabilities. These assets and liabilities are classified into one of three levels of the following fair value hierarchy as defined by U.S. GAAP: Level 1: Observable inputs such as quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2: Observable inputs other than Level 1 prices, such as quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. Level 3: Unobservable inputs based on the Company’s assessment of the assumptions that market participants would use in pricing the asset or liability. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost and depreciated over the estimated useful lives of the related assets using the straight‑line method. Laboratory equipment and office furniture and equipment are depreciated over five years, and computer equipment is depreciated over three years. Manufacturing equipment is amortized over seven to ten years. Leasehold improvements are amortized over the shorter of the estimated useful life or the non‑cancelable term of the related lease, including any renewals that are reasonably assured of occurring. Property and equipment under construction is classified as construction in progress and is depreciated or amortized only after the asset is placed in service. Expenditures for maintenance and repairs are charged to expense whereas the costs of significant improvements which extend the life of the underlying asset are capitalized. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are eliminated and any resulting gain or loss is reflected in the Company’s statements of operations and comprehensive loss. The treatment of costs to construct property and equipment depends on the nature of the costs and the stage of construction. Costs incurred in the project planning, design, construction and installation phases are capitalized as part of the cost of the asset. The Company stops capitalizing these costs when the asset is substantially complete and ready for its intended use. For manufacturing property and equipment, the Company also capitalizes the cost of validating these assets for the underlying manufacturing process. The Company completes the capitalization of validation costs when the asset is substantially complete and ready for its intended use. Costs capitalized include incremental labor and fringe benefits, and direct consultancy services. |
Leases | Leases The Company has operating leases of office, manufacturing and laboratory space, which have remaining lease terms of one to six years and may include one or more options to renew or terminate early. The Company determines if an arrangement contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Certain adjustments to the right-of-use asset may be required for items such as prepaid or accrued lease payments, initial direct costs paid or incentives received. The Company's leases do not contain an implicit rate, and therefore the Company uses an estimated incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. Options to extend or terminate the lease are reflected in the calculation when it is reasonably certain that the option will be exercised. The Company has elected to account for lease and non-lease components as a single lease component, however non-lease components that are variable, such as common area maintenance and utilities, are generally paid separately from rent based on actual costs incurred and therefore are not included in the right-of-use asset and operating lease liability and are reflected as an expense in the period incurred. Leases with an initial term of 12 months or less are not recorded on the balance sheet. |
Other Assets | Other Assets Other assets included a $1.8 million non-controlling investment in a privately-held company that was accounted for under the cost method of accounting as of December 31, 2018. Based on information received in April 2019, it was determined that there was a deterioration of the private company’s financial condition due to a working capital deficiency and an inability to secure additional funding. Therefore, the Company concluded that the investment was impaired, and a non-cash impairment charge of $1.8 million was recorded during the first quarter of 2019. |
Contingent Consideration | Contingent Consideration The Company records contingent consideration resulting from a business combination at its fair value on the acquisition date. The Company determines the fair value of the contingent consideration based primarily on the (i) timing and probability of success of clinical events or regulatory approvals; (ii) timing and probability of success of meeting clinical and commercial milestones; and (iii) discount rates. The Company’s contingent consideration liabilities arose in connection with its acquisition of Kolltan. On a quarterly basis, the Company revalues these obligations and records increases or decreases in their fair value as an adjustment to operating earnings. Changes to contingent consideration obligations can result from adjustments to discount rates, accretion of the discount rates due to the passage of time, changes in the Company’s estimates of the likelihood or timing of achieving development or commercial milestones, changes in the probability of certain clinical events or changes in the assumed probability associated with regulatory approval. The assumptions related to determining the value of contingent consideration include a significant amount of judgment, and any changes in the underlying estimates could have a material impact on the amount of contingent consideration expense recorded in any given period. |
Intangible Assets | Intangible Assets IPR&D assets acquired in a business combination initially are recorded at fair value and accounted for as indefinite‑lived intangible assets. These assets are capitalized on the Company’s balance sheets until either the project underlying them is completed or the assets become impaired. If a project is completed, the carrying value of the related intangible asset is amortized over the remaining estimated life of the asset beginning in the period in which the project is completed. If a project becomes impaired or is abandoned, the carrying value of the related intangible asset is written down to its fair value and an impairment charge is taken in the period in which the impairment occurs. Each IPR&D asset is assessed for impairment at least annually or when impairment indicators are present. As a result of the discontinuation of the Glemba program, the Company concluded that the Glemba IPR&D asset was fully impaired, and a non-cash impairment charge of $11.8 million was recorded in the first quarter of 2018. The remaining IPR&D assets were assessed for impairment during 2018 and 2019 and were determined not to be impaired. During the year ended December 31, 2017, the Company recorded a partial impairment charge of $13.0 million related to changes in projected development and regulatory timelines regarding the anti-KIT program. Intangible assets acquired in a business combination with a finite life are recorded at fair value and amortized over the greater of economic consumption or on a straight‑line basis over their estimated useful life. As a result of the discontinuation of the Glemba program, it was concluded that the Company’s finite-lived intangible asset was fully impaired and a non-cash impairment charge of $6.9 million was recorded in the first quarter of 2018. |
Goodwill | Goodwill The difference between the purchase price and the fair value of assets acquired and liabilities assumed in a business combination is allocated to goodwill. Goodwill is evaluated for impairment on an annual basis or when impairment indicators are present. The Company has the option to assess qualitative factors to determine if it is more likely than not that goodwill might be impaired and whether it is necessary to perform a quantitative single-step goodwill impairment test required under U.S. GAAP. As a result of the discontinuation of the Glemba program, the Company evaluated goodwill for potential impairment in the first quarter of 2018. It was determined that the goodwill asset was fully impaired and an impairment charge of $91.0 million was recorded. |
Impairment of Intangible and Long-Lived Assets | Impairment of Intangible and Long‑Lived Assets The Company evaluates the recoverability of its long‑lived assets, including property and equipment, right-of-use assets, and intangible assets when circumstances indicate that an event of impairment may have occurred. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written‑down to their estimated fair values. |
Revenue Recognition | Revenue Recognition Revenues are recognized when performance obligations under agreements or contracts are satisfied, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services. The Company determines revenue recognition through the following steps: · Identification of the contract, or contracts, with a customer; · Identification of the performance obligations in the contract; · Determination of the transaction price; · Allocation of the transaction price to the performance obligations in the contract; and · Recognition of revenue when, or as, the Company satisfies a performance obligation. Revenue for the Company has historically been derived from biopharmaceutical product development agreements with collaborative partners for the research and development of therapeutic drug candidates. The terms of the agreements may include nonrefundable signing and licensing fees, funding for research, development and manufacturing, milestone payments and royalties on any product sales derived from collaborations. The Company assesses the multiple obligations typically within product development contracts to determine the distinct performance obligations and how to allocate the arrangement consideration to each distinct performance obligation. Under product development agreements, revenue is generally recognized using a cost-to-cost measure of progress. Revenue is recognized based on the costs incurred to date as a percentage of the total estimated costs to fulfill the contract. Incurred cost represents work performed, which corresponds with, and thereby best depicts, the transfer of control to the customer. Due to the nature of the work performed in these arrangements, the estimation of cost at completion is complex, subject to many variables, such as expected clinical trial costs, and requires significant judgements. Circumstances can arise that change original estimates of costs or progress toward completion. Any revisions to estimates are reflected in revenue on a cumulative catch-up basis in the period in which the change in circumstances became known. Revenue for the Company is also derived from manufacturing and research and development arrangements. The Company owns and operates a cGMP manufacturing facility in Fall River, Massachusetts, to produce drug substance for its current and planned early-stage clinical trials. In order to utilize excess capacity, the Company has, from time to time, entered into contract manufacturing and research and development arrangements in which services are provided on a time-and-material basis or at a negotiated fixed-price. Revenue from time-and-material contracts is generally recognized on an output basis as labor hours and/or direct expenses are incurred. Under fixed-price contracts, revenue is generally recognized on an output basis as progress is made toward completion of the performance obligations using surveys of performance completed to date. |
Contract Assets and Liabilities | Contract Assets and Liabilities The Company classifies the right to consideration in exchange for products or services transferred to a client as either a receivable or a contract asset. A receivable is a right to consideration that is unconditional as compared to a contract asset which is a right to consideration that is conditional upon factors other than the passage of time. The Company’s contract liabilities result from arrangements where the Company has received payment in advance of performance under the contract. These amounts are included as deferred revenue within current portion of long-term liabilities on the condensed consolidated balance sheets. |
Research and Development Expenses | Research and Development Expenses Research and development costs, including internal and contract research costs, are expensed as incurred. Research and development expenses consist mainly of clinical trial costs, manufacturing of clinical material, toxicology and other preclinical studies, personnel costs, depreciation, license fees and funding of outside contracted research. Clinical trial expenses include expenses associated with clinical research organization, or CRO, services. Contract manufacturing expenses include expenses associated with contract manufacturing organization, or CMO, services. The invoicing from CROs and CMOs for services rendered can lag several months. The Company accrues the cost of services rendered in connection with CRO and CMO activities based on our estimate of costs incurred. The Company maintains regular communication with our CROs and CMOs to assess the reasonableness of its estimates. Differences between actual expenses and estimated expenses recorded have not been material and are adjusted for in the period in which they become known. |
Patent Costs | Patent Costs Patent costs are expensed to general and administrative expense as incurred. Certain patent costs are reimbursed by the Company’s product development and licensing partners. Any reimbursed patent costs are recorded as product development and licensing agreement revenues in the Company’s financial statements. |
Stock-Based Compensation | Stock‑Based Compensation The Company records stock-based compensation expense for all stock-based awards made to employees, directors and non-employees based on the estimated fair values of the stock-based awards expected to vest at the grant date and adjust, if necessary, to reflect actual forfeitures. Compensation expense for all stock-based awards is recognized using the straight-line method over the term of vesting or performance. |
Foreign Currency Translation | Foreign Currency Translation Net unrealized gains and losses resulting from foreign currency translation are included in accumulated other comprehensive income. At December 31, 2019 and 2018, accumulated other comprehensive income includes a net unrealized gain related to foreign currency translation of $2.6 million. |
Income Taxes | Income Taxes The Company uses the asset and liability method to account for income taxes, including the recognition of deferred tax assets and deferred tax liabilities for the anticipated future tax consequences attributable to differences between financial statement amounts and their respective tax basis. Quarterly, the Company reviews its deferred tax assets for recovery. A valuation allowance is established when the Company believes that it is more likely than not that its deferred tax assets will not be realized. Changes in valuation allowances from period to period are included in the Company’s tax provision in the period of change. The Company records uncertain tax positions in the financial statements only if it is more likely than not that the uncertain tax position will be sustained upon examination by the taxing authorities. The Company records interest and penalties related to uncertain tax positions in income tax expense. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is comprised of net loss and certain changes in stockholders’ equity that are excluded from net loss. The Company includes foreign currency translation adjustments and unrealized gains and losses on marketable securities in other comprehensive loss. The statements of operations and comprehensive loss reflect total comprehensive loss for the years ended December 31, 2019, 2018 and 2017. |
Net Loss Per Share | Net Loss Per Share Basic net loss per common share is based upon the weighted‑average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested. Diluted net loss per common share is based upon the weighted‑average number of common shares outstanding during the period plus additional weighted-average potentially dilutive common shares outstanding during the period when the effect is dilutive. In periods in which the Company reports a net loss, there is no difference between basic and diluted net loss per share because dilutive shares of common stock are not assumed to have been issued as their effect is anti-dilutive. The potentially dilutive common shares that have not been included in the net loss per common share calculations because the effect would have been anti-dilutive are as follows: Year Ended December 31, 2019 2018 2017 Stock options 1,699,202 866,132 723,747 Restricted stock 1,110 3,552 6,445 1,700,312 869,684 730,192 |
Newly-Adopted Accounting Pronouncements | Newly-Adopted Accounting Pronouncements On January 1, 2019, the Company adopted a new U.S. GAAP accounting standard which requires that all lessees recognize the assets and liabilities that arise from leases on the balance sheet and disclose qualitative and quantitative information about its leasing arrangements. The new standard was adopted using the modified retrospective transition method, which requires the Company to apply the standard as of the effective date and does not require restatement of prior periods. The Company elected to apply the package of practical expedients, which allowed the Company to not reassess: (i) whether expired or existing contracts contain leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. Adoption of this standard did not have a material impact on the Company’s Consolidated Statement of Operations and Comprehensive Loss or Statement of Cash Flow, however, upon adoption, the Company recorded right-of-use assets of $3.8 million and lease liabilities of $4.7 million on its Consolidated Balance Sheet related to the Company’s operating leases. The difference between the right-of-use assets and lease liabilities recorded upon adoption is due to certain adjustments required to the right-of-use assets for prepaid rent and accrued termination expenses. Refer to Note 7 “Leases” for additional details on this adoption and the Company’s updated disclosures. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption. In August 2018, the FASB issued amendments that modify certain disclosure requirements for fair value measurements. The amendments become effective, including interim periods, beginning January 1, 2020. The adoption of this new guidance is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures. In November 2018, the FASB issued guidance to clarify the interaction between the accounting guidance for collaborative arrangements and revenue from contracts with customers. The amendments become effective, including interim periods, beginning January 1, 2020. This guidance is required to be applied retrospectively as of the date of our adoption of the new revenue standard on January 1, 2018. The adoption of this new guidance is not expected to have a material impact on the Company's consolidated financial statements and related disclosures. In June 2016, the FASB issued guidance on the Measurement of Credit Losses on Financial Instruments. The guidance requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, the standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. This standard will be effective for the Company on January 1, 2023. We are currently evaluating the potential impact that this standard may have on the Company's consolidated financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Schedule of potentially dilutive common shares that have not been included in the net loss per common share calculations because the effect would have been anti-dilutive | Year Ended December 31, 2019 2018 2017 Stock options 1,699,202 866,132 723,747 Restricted stock 1,110 3,552 6,445 1,700,312 869,684 730,192 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accumulated Other Comprehensive Income | |
Summary of changes in accumulated other comprehensive income | Unrealized Gain (Loss) on Marketable Foreign Securities Currency Items Total (In thousands) Balance at December 31, 2018 $ (13) $ 2,596 $ 2,583 Other comprehensive gain 36 — 36 Balance at December 31, 2019 $ 23 $ 2,596 $ 2,619 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Measurements | |
Schedule of financial assets and liabilities subject to fair value measurements | As of December 31, 2019 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 4,024 — $ 4,024 — Marketable securities 53,151 — 53,151 — $ 57,175 — $ 57,175 — Liabilities: Kolltan acquisition contingent consideration $ 12,485 — — $ 12,485 $ 12,485 — — $ 12,485 As of December 31, 2018 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 15,755 — $ 15,755 — Marketable securities 69,712 — 69,712 — $ 85,467 — $ 85,467 — Liabilities: Kolltan acquisition contingent consideration $ 13,779 — — $ 13,779 $ 13,779 — — $ 13,779 |
Schedule of the contingent consideration liabilities measured at fair value using Level 3 inputs | Other Liabilities: Contingent Consideration Balance at December 31, 2018 $ 13,779 Fair value adjustments included in operating expenses (1,294) Balance at December 31, 2019 $ 12,485 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Marketable Securities | |
Summary of marketable debt securities, classified as available-for-sale | Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value (In thousands) December 31, 2019 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 18,509 $ 13 $ — $ 18,522 Maturing after one year through three years — — — — Total U.S. government and municipal obligations $ 18,509 $ 13 $ — $ 18,522 Corporate debt securities Maturing in one year or less $ 34,619 $ 13 $ (3) $ 34,629 Maturing after one year through three years — — — — Total corporate debt securities $ 34,619 $ 13 $ (3) $ 34,629 Total marketable securities $ 53,128 $ 26 $ (3) $ 53,151 December 31, 2018 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 27,355 $ — $ (4) $ 27,351 Maturing after one year through three years — — — — Total U.S. government and municipal obligations $ 27,355 $ — $ (4) $ 27,351 Corporate debt securities Maturing in one year or less $ 42,370 $ — $ (9) $ 42,361 Maturing after one year through three years — — — — Total corporate debt securities $ 42,370 $ — $ (9) $ 42,361 Total marketable securities $ 69,725 $ — $ (13) $ 69,712 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment, Net | |
Schedule of property and equipment | December 31, December 31, 2019 2018 (In thousands) Laboratory Equipment $ 8,622 $ 8,272 Manufacturing Equipment 2,510 2,497 Office Furniture and Equipment 3,873 3,791 Leasehold Improvements 17,238 17,408 Construction in Progress 191 327 Total Property and Equipment 32,434 32,295 Less: Accumulated Depreciation and Amortization (28,403) (26,184) Property and Equipment, Net $ 4,031 $ 6,111 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases | |
Schedule of future minimum lease payments under non-cancellable leases | Future minimum lease payments under non-cancellable leases as of December 31, 2019 were as follows: 2020 $ 2,218 2021 875 2022 747 2023 311 Total lease payments 4,151 Less imputed interest (494) Present value of operating lease liabilities $ 3,657 |
Schedule of operating lease obligations, including estimated variable lease obligations as per prior lease accounting guidance as of December 31, 2018 | Under the prior lease accounting guidance, operating lease obligations, including estimated variable lease obligations, as of December 31, 2018 were as follows: 2019 $ 4,648 2020 3,140 Thereafter — Total lease payments $ 7,788 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Expenses | |
Schedule of accrued expenses | December 31, December 31, 2019 2018 (In thousands) Accrued Payroll and Employee Benefits $ 4,575 $ 4,400 Accrued Research and Development Contract Costs 1,186 1,766 Accrued Professional Fees 400 620 Other Accrued Expenses 338 221 $ 6,499 $ 7,007 |
Other Long-Term Liabilities (Ta
Other Long-Term Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Other Long-Term Liabilities | |
Schedule of other long-term liabilities | December 31, December 31, 2019 2018 (In thousands) Net Deferred Tax Liabilities Related to IPR&D (Note 15) $ 3,007 $ 3,007 Deferred Income From Sale of Tax Benefits 1,831 4,218 Other — 1,083 Contingent Milestones (Note 4) 12,485 13,779 Deferred Revenue 254 1,586 Total 17,577 23,673 Less Current Portion (2,026) (4,526) Long-Term Portion $ 15,551 $ 19,147 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Stock-Based Compensation | |
Summary of stock option activity | Weighted Weighted Average Average Exercise Remaining Price Contractual Shares Per Share Term (In Years) Options Outstanding at December 31, 2018 866,132 $ 93.70 7.1 Granted 940,040 $ 2.77 Exercised — $ — Canceled (106,970) $ 70.22 Options Outstanding at December 31, 2019 1,699,202 $ 44.87 8.0 Options Vested and Expected to Vest at December 31, 2019 1,580,780 $ 47.90 7.9 Options Exercisable at December 31, 2019 573,996 $ 121.76 5.5 Shares Available for Grant Under the 2008 Plan 424,263 |
Summary of restricted stock activity | Weighted Average Grant Date Fair Value Shares (per share) Outstanding and unvested at December 31, 2018 3,552 $ 43.84 Granted — $ — Vested (2,220) $ 49.25 Canceled (222) $ 34.83 Outstanding and unvested at December 31, 2019 1,110 $ 34.83 |
Schedule of stock-based compensation expense | 2019 2018 2017 (In thousands) Research and development $ 2,053 $ 3,874 $ 6,693 General and administrative 2,498 4,207 5,619 Total stock-based compensation expense $ 4,551 $ 8,081 $ 12,312 |
Schedule of assumptions used for the fair value of employee stock options granted | 2019 2018 2017 Expected stock price volatility 90 - 91% 73 - 85% 75 - 77% Expected option term 6.0 Years 6.0 Years 6.0 Years Risk-free interest rate 1.6 - 2.5% 2.8 - 3.1% 2.0 - 2.3% Expected dividend yield None None None |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Schedule of components of income tax benefit (provision) | Year Ended December 31, 2019 2018 2017 (In thousands) Income Tax Benefit (Provision): Federal $ 13,869 $ 22,255 $ 57,547 State 2,170 6,406 (2,479) Foreign — 913 2,448 Expiration of NOLs and R&D Credit (18,966) — — Income Tax Rate Change — — (99,528) (2,927) 29,574 (42,012) Deferred Tax Valuation Allowance 2,927 (28,809) 66,294 $ — $ 765 $ 24,282 |
Schedule of reconciliation between the amount of reported income tax and the amount computed using the U.S. Statutory rate | 2019 2018 2017 (In thousands) Pre-Tax Loss $ (50,878) $ (151,949) $ (117,313) Loss at Statutory Rates (10,684) (31,909) (39,887) Difference in Foreign Tax Rates — — 326 Research and Development Credits (1,902) (2,056) (2,847) State Taxes (2,170) (6,406) (6,283) Income Tax Rate Change — — 99,528 Other (1,011) (1,175) (321) Change in Fair Value Remeasurement of Contingent Consideration (272) (6,220) — Intangible Impairment — 19,105 — Recognition of APIC NOLs — — (5,729) Impact of Pass-through Entities — (913) (2,775) Expiration of NOLs and R&D Credit 18,966 — — Change in Valuation Allowance (2,927) 28,809 (66,294) Income Tax (Benefit) Provision $ — $ (765) $ (24,282) |
Schedule of principal components of the deferred tax assets and liabilities | December 31, December 31, 2019 2018 (In thousands) Gross Deferred Tax Assets Net Operating Loss Carryforwards $ 172,745 $ 168,239 Foreign Net Operating Loss Carryforwards — 4,485 Tax Credit Carryforwards 42,642 39,761 Deferred Research and Development Expenses 70,042 76,555 Stock-based Compensation 12,651 11,977 Fixed Assets 1,759 1,761 Accrued Expenses and Other 328 316 300,167 303,094 Gross Deferred Tax Liabilities IPR&D Intangibles (12,748) (12,748) Total Deferred Tax Assets and Liabilities 287,419 290,346 Valuation Allowance (290,426) (293,353) Net Deferred Tax Liability $ (3,007) $ (3,007) |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Selected Quarterly Financial Data (Unaudited) | |
Schedule of selected quarterly financial data (unaudited) | 2019 Q1 2019 Q2 2019 Q3 2019 Q4 2019 (In thousands, except per share amounts) Total revenue $ 1,425 $ 715 $ 546 $ 887 Net loss (17,239) (11,779) (11,413) (10,447) Basic and diluted net loss per common share (1.40) (0.84) (0.75) (0.64) 2018 Q1 2018 Q2 2018 Q3 2018 Q4 2018 (In thousands, except per share amounts) Total revenue $ 4,068 $ 2,763 $ 941 $ 1,764 Net loss (118,132) (16,407) (7,243) (9,402) Basic and diluted net loss per common share (12.61) (1.67) (0.66) (0.81) |
Nature of Business and Overvi_2
Nature of Business and Overview (Details) $ in Thousands | Feb. 08, 2019 | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Nature of Business and Overview | ||||||||||||
Reverse stock split | 0.067 | |||||||||||
Cash, cash equivalents and marketable securities | $ 64,400 | $ 64,400 | ||||||||||
Net Loss | (10,447) | $ (11,413) | $ (11,779) | $ (17,239) | $ (9,402) | $ (7,243) | $ (16,407) | $ (118,132) | (50,878) | $ (151,184) | $ (93,031) | |
Net cash used in operations | 46,415 | 75,235 | $ 99,931 | |||||||||
Indefinite-lived intangible assets | $ 48,700 | $ 48,700 | $ 48,700 | $ 48,700 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Basis of Presentation (Details) | 12 Months Ended |
Dec. 31, 2019segment | |
Summary of Significant Accounting Policies | |
Operating segments (in segments) | 1 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Concentration of Credit Risk and Significant Customers and Suppliers (Details) - Revenue - Customer concentration | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Combined Rockefeller and Duke University | |||
Concentration risk | |||
Concentration risk (as a percent) | 74.00% | ||
Combined BMS, Rockefeller and International AIDS Vaccine Initiative | |||
Concentration risk | |||
Concentration risk (as a percent) | 86.00% | 77.00% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Laboratory equipment | |
Property and Equipment | |
Useful lives (in years) | 5 years |
Office furniture and equipment | |
Property and Equipment | |
Useful lives (in years) | 5 years |
Computer equipment | |
Property and Equipment | |
Useful lives (in years) | 3 years |
Manufacturing equipment | Minimum | |
Property and Equipment | |
Useful lives (in years) | 7 years |
Manufacturing equipment | Maximum | |
Property and Equipment | |
Useful lives (in years) | 10 years |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Lease (Details) | Dec. 31, 2019 |
Minimum | |
Term of lease (in years) | 1 year |
Maximum | |
Term of lease (in years) | 6 years |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Other Assets (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
Summary of Significant Accounting Policies | ||
Non-controlling investment | $ 1.8 | |
Non-cash impairment charge on investments | $ 1.8 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Intangible assets | |||
Non-cash impairment charge, indefinite-lived | $ 18,677 | $ 13,000 | |
IPR&D | |||
Intangible assets | |||
Non-cash impairment charge, indefinite-lived | $ 11,800 | ||
License Rights | |||
Intangible assets | |||
Non-cash impairment charge, finite lived | $ 6,900 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Goodwill (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2018 | Dec. 31, 2018 | |
Goodwill | ||
Goodwill asset impaired | $ 90,976 | |
Glemba | ||
Goodwill | ||
Goodwill asset impaired | $ 91,000 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Foreign Currency Translation (Details) - USD ($) $ in Millions | Dec. 31, 2019 | Dec. 31, 2018 |
Summary of Significant Accounting Policies | ||
Unrealized gain related to foreign currency translation included in AOCI | $ 2.6 | $ 2.6 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Net loss per share | |||
Potentially dilutive common shares not been included in net loss per common share calculations because the effect would have been anti-dilutive | 1,700,312 | 869,684 | 730,192 |
Stock options | |||
Net loss per share | |||
Potentially dilutive common shares not been included in net loss per common share calculations because the effect would have been anti-dilutive | 1,699,202 | 866,132 | 723,747 |
Restricted Stock | |||
Net loss per share | |||
Potentially dilutive common shares not been included in net loss per common share calculations because the effect would have been anti-dilutive | 1,110 | 3,552 | 6,445 |
Summary Significant Accounting
Summary Significant Accounting Policies - Newly-Adopted Accounting Pronouncements (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 31, 2019 | Jan. 01, 2019 | |
Newly-Adopted Accounting Pronouncements | |||
Lease, Practical Expedients, Package [true false] | true | ||
Right-of-use assets | $ 3,473 | ||
Lease liabilities | $ 3,657 | ||
ASC 842 | |||
Newly-Adopted Accounting Pronouncements | |||
Right-of-use assets | $ 1,400 | $ 3,800 | |
Lease liabilities | $ 1,400 | $ 4,700 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Accumulated Other Comprehensive Income | |||
Period Start Balance | $ 124,060 | $ 236,369 | $ 265,431 |
Period End Balance | 94,026 | 124,060 | 236,369 |
Amounts reclassified from AOCI | 0 | 0 | 0 |
Unrealized Gain/(Loss) on Marketable Securities | |||
Accumulated Other Comprehensive Income | |||
Period Start Balance | (13) | ||
Other comprehensive gain | 36 | ||
Period End Balance | 23 | (13) | |
Foreign Currency Items | |||
Accumulated Other Comprehensive Income | |||
Period Start Balance | 2,596 | ||
Period End Balance | 2,596 | 2,596 | |
Accumulated Other Comprehensive Income. | |||
Accumulated Other Comprehensive Income | |||
Period Start Balance | 2,583 | 2,564 | 2,541 |
Other comprehensive gain | 36 | ||
Period End Balance | $ 2,619 | $ 2,583 | $ 2,564 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Liabilities: | ||
Kolltan acquisition contingent consideration | $ 12,485 | $ 13,779 |
Fair value | Level 3 | ||
Liabilities: | ||
Kolltan acquisition contingent consideration | 12,485 | 13,779 |
Fair Value Measurements. | Level 2 | ||
Assets: | ||
Money market funds and cash equivalents | 4,024 | 15,755 |
Marketable securities | 53,151 | 69,712 |
Total financial assets at fair value | 57,175 | 85,467 |
Fair Value Measurements. | Level 3 | ||
Liabilities: | ||
Kolltan acquisition contingent consideration | 12,485 | 13,779 |
Total financial liabilities at fair value | 12,485 | 13,779 |
Fair Value Measurements. | Fair value | ||
Assets: | ||
Money market funds and cash equivalents | 4,024 | 15,755 |
Marketable securities | 53,151 | 69,712 |
Total financial assets at fair value | 57,175 | 85,467 |
Liabilities: | ||
Kolltan acquisition contingent consideration | 12,485 | 13,779 |
Total financial liabilities at fair value | $ 12,485 | $ 13,779 |
Fair Value Measurements - Conti
Fair Value Measurements - Contingent Consideration Liabilities (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Contingent consideration liabilities measured at fair value | |
Balance at beginning of period | $ 13,779 |
Balance at end of period | 12,485 |
Fair value | Level 3 | |
Contingent consideration liabilities measured at fair value | |
Balance at beginning of period | 13,779 |
Fair value adjustments included in operating expenses | (1,294) |
Balance at end of period | $ 12,485 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Fair value measurements | |||
Gain on Fair Value Remeasurement of Contingent Consideration | $ (1,294) | $ (29,621) | $ (800) |
Fair value | |||
Fair value measurements | |||
Assets level 1 to level 2 transfers | 0 | 0 | |
Assets level 2 to level 1 transfers | 0 | 0 | |
Liabilities level 1 to level 2 transfers | 0 | 0 | |
Liabilities level 2 to level 1 transfers | 0 | 0 | |
Asset transfer out of level 3 | 0 | 0 | |
Asset transfer into level 3 | 0 | 0 | |
Liabilities transfers out of level 3 | 0 | 0 | |
Liabilities transfers into level 3 | $ 0 | $ 0 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Amortized Cost | ||
Amortized Cost | $ 53,128 | $ 69,725 |
Gross Unrealized Gains | ||
Gross Unrealized Gains | 26 | |
Gross Unrealized Losses | ||
Gross Unrealized Losses | (3) | (13) |
Fair Value | ||
Fair Value | 53,151 | 69,712 |
U.S. government and municipal obligations | ||
Amortized Cost | ||
Maturing in one year or less | 18,509 | 27,355 |
Amortized Cost | 18,509 | 27,355 |
Gross Unrealized Gains | ||
Maturing in one year or less | 13 | |
Gross Unrealized Gains | 13 | |
Gross Unrealized Losses | ||
Maturing in one year or less | (4) | |
Gross Unrealized Losses | (4) | |
Fair Value | ||
Maturing in one year or less | 18,522 | 27,351 |
Fair Value | 18,522 | 27,351 |
Corporate debt securities | ||
Amortized Cost | ||
Maturing in one year or less | 34,619 | 42,370 |
Amortized Cost | 34,619 | 42,370 |
Gross Unrealized Gains | ||
Maturing in one year or less | 13 | |
Gross Unrealized Gains | 13 | |
Gross Unrealized Losses | ||
Maturing in one year or less | (3) | (9) |
Gross Unrealized Losses | (3) | (9) |
Fair Value | ||
Maturing in one year or less | 34,629 | 42,361 |
Fair Value | $ 34,629 | $ 42,361 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Marketable Securities | ||
Number of investment-grade securities in unrealized loss position over 12 months | $ 0 | |
Accrued interest | $ 200 | $ 100 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property and Equipment | |||
Total Property and Equipment | $ 32,434 | $ 32,295 | |
Less: Accumulated Depreciation and Amortization | (28,403) | (26,184) | |
Property and Equipment, Net | 4,031 | 6,111 | |
Depreciation and amortization expense | 4,858 | 3,577 | $ 4,414 |
Laboratory equipment | |||
Property and Equipment | |||
Total Property and Equipment | 8,622 | 8,272 | |
Manufacturing equipment | |||
Property and Equipment | |||
Total Property and Equipment | 2,510 | 2,497 | |
Office furniture and equipment | |||
Property and Equipment | |||
Total Property and Equipment | 3,873 | 3,791 | |
Leasehold Improvements | |||
Property and Equipment | |||
Total Property and Equipment | 17,238 | 17,408 | |
Construction in Progress | |||
Property and Equipment | |||
Total Property and Equipment | 191 | 327 | |
Property Plant and Equipment | |||
Property and Equipment | |||
Depreciation and amortization expense | $ 2,700 | $ 3,600 | $ 4,400 |
Leases (Details)
Leases (Details) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Mar. 31, 2019USD ($)ft² | Jan. 01, 2019USD ($) | |
Leases | |||||
Lease to eliminate square feet | ft² | 16,200 | ||||
Renewal term (in years) | 5 years | ||||
Lease, remaining square feet | ft² | 33,400 | ||||
Lease liabilities | $ 3,657 | ||||
Right-of-use assets | 3,473 | ||||
Operating lease expense | 2,500 | $ 4,000 | $ 4,100 | ||
Variable lease expense | 1,500 | $ 4,000 | $ 4,100 | ||
Operating lease payments | $ 3,300 | ||||
Weighted-average remaining lease term | 2 years | ||||
Weighted-average discount rate | 11.00% | ||||
Minimum | |||||
Leases | |||||
Term of lease (in years) | 1 year | ||||
Maximum | |||||
Leases | |||||
Term of lease (in years) | 6 years | ||||
ASC 842 | |||||
Leases | |||||
Term of lease (in years) | 3 years | ||||
Lease liabilities | $ 1,400 | $ 4,700 | |||
Right-of-use assets | $ 1,400 | $ 3,800 |
Leases - Future minimum lease p
Leases - Future minimum lease payments under non-cancellable leases (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Operating lease liabilities, payments due | |
2020 | $ 2,218 |
2021 | 875 |
2022 | 747 |
2023 | 311 |
Total lease payments | 4,151 |
Less imputed interest | (494) |
Present value of operating lease liabilities | $ 3,657 |
Leases - Operating lease obliga
Leases - Operating lease obligations under prior lease accounting guidance (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Operating lease obligations under prior lease accounting guidance | |
2019 | $ 4,648 |
2020 | 3,140 |
Total lease payments | $ 7,788 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill - Intangible Assets, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2019 | |
Intangible assets | ||||
Amortization of Acquired Intangible Assets | $ 224 | $ 896 | ||
Indefinite-lived intangible assets | 48,700 | $ 48,700 | ||
Non-cash impairment charge, indefinite-lived | $ 18,677 | $ 13,000 | ||
IPR&D | ||||
Intangible assets | ||||
Non-cash impairment charge, indefinite-lived | $ 11,800 | |||
License Rights | ||||
Intangible assets | ||||
Non-cash impairment charge, finite lived | $ 6,900 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill - Goodwill (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2018 | Dec. 31, 2018 | |
Goodwill | ||
Goodwill asset impaired | $ 90,976 | |
Glemba | ||
Goodwill | ||
Amount of carrying amount in excess of fair value amount | $ 91,000 | |
Goodwill asset impaired | $ 91,000 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accrued Expenses | ||
Accrued Payroll and Employee Benefits | $ 4,575 | $ 4,400 |
Accrued Research and Development Contract Costs | 1,186 | 1,766 |
Accrued Professional Fees | 400 | 620 |
Other Accrued Expenses | 338 | 221 |
Accrued Expenses | $ 6,499 | $ 7,007 |
Other Long-Term Liabilities (De
Other Long-Term Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Other Long-Term Liabilities | ||
Net Deferred Tax Liabilities Related to IPR&D (Note 15) | $ 3,007 | $ 3,007 |
Deferred Income From Sale of Tax Benefits | 1,831 | 4,218 |
Other | 1,083 | |
Contingent Milestones (Note 4) | 12,485 | 13,779 |
Deferred Revenue | 254 | 1,586 |
Total | 17,577 | 23,673 |
Less Current Portion | (2,026) | (4,526) |
Long-Term Portion | $ 15,551 | $ 19,147 |
Other Long-Term Liabilities- Ne
Other Long-Term Liabilities- New Jersey tax benefits (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2015 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Investment and other income | $ 4,153 | $ 4,487 | $ 4,214 | |
New Jersey tax benefits | ||||
Amount of tax benefit | $ 9,800 | |||
Proceeds from sale of tax credits | $ 9,200 | |||
Base of operations requirement (in years) | 5 years | |||
Investment and other income | $ 2,400 | $ 2,500 | $ 2,700 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ in Thousands | 1 Months Ended | 2 Months Ended | 12 Months Ended | ||||
Nov. 30, 2017 | May 31, 2016 | Feb. 29, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Common Stock | |||||||
Maximum aggregate offering price of securities available for sale | $ 150,000 | $ 250,000 | |||||
Aggregate offering price stock sale | $ 60,000 | ||||||
Additional offering price stock sale authorized | $ 75,000 | ||||||
Net proceeds from sale of common stock | $ 16,248 | $ 29,022 | $ 51,025 | ||||
Common Stock | |||||||
Common Stock | |||||||
Shares Issued in Connection with Cantor Agreement (in shares) | 5,011,157 | 2,702,660 | 1,181,524 | ||||
Aggregate gross offering price available | $ 20,700 | ||||||
Common Stock | Subsequent Event | |||||||
Common Stock | |||||||
Common stock issued (in shares) | 520,606 | ||||||
Net proceeds from sale of common stock | $ 1,200 |
Stockholders' Equity - Converti
Stockholders' Equity - Convertible Preferred Stock (Details) - shares | Dec. 31, 2019 | Dec. 31, 2018 |
Preferred stock, shares authorized | 3,000,000 | 3,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Series C-1 Preferred Stock | ||
Preferred stock, shares authorized | 350,000 | |
Preferred stock, shares outstanding | 0 | 0 |
Stock-Based Compensation - Empl
Stock-Based Compensation - Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock-Based Compensation | |||
Common stock reserved for issuance (in shares) | 276,666 | ||
Purchase price of fair value of common stock (in percent) | 85.00% | ||
Issued (in shares) | 3,507 | 9,524 | 5,359 |
Available for issuance (in shares) | 250,159 |
Stock-Based Compensation - Em_2
Stock-Based Compensation - Employee Stock Option and Incentive Plan (Details) - Stock options | 12 Months Ended |
Dec. 31, 2019shares | |
Stock-Based Compensation | |
Common stock authorized grants (in shares) | 2,233,333 |
Vesting period (in years) | 4 years |
Expiration period (in years) | 10 years |
Principal Owner | |
Stock-Based Compensation | |
Expiration period (in years) | 5 years |
Exercise price as a percentage of fair market value | 110.00% |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Details) - Stock options - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Shares | ||
Options Outstanding at beginning of the period (in shares) | 866,132 | |
Granted (in shares) | 940,040 | |
Canceled (in shares) | (106,970) | |
Options Outstanding at the end of the period (in shares) | 1,699,202 | 866,132 |
Options Vested and Expected to Vest at the end of the period (in shares) | 1,580,780 | |
Options Exercisable at the end of the period (in shares) | 573,996 | |
Shares Available for Grant Under the 2008 Plan | 424,263 | |
Weighted Average Exercise Price Per Share | ||
Options Outstanding at beginning of the period (in dollars per share) | $ 93.70 | |
Granted (in dollars per share) | 2.77 | |
Canceled (in dollars per share) | 70.22 | |
Options Outstanding at the end of the period (in dollars per share) | 44.87 | $ 93.70 |
Options Vested and Expected to Vest at the end of the period (in dollars per share) | 47.90 | |
Options Exercisable at the end of the period (in dollars per share) | $ 121.76 | |
Weighted Average Remaining Contractual Term (In Years) | ||
Options Outstanding at the end of the period | 8 years | 7 years 1 month 6 days |
Options Vested and Expected to Vest at the end of the period | 7 years 10 months 24 days | |
Options Exercisable at the end of the period | 5 years 6 months |
Stock-Based Compensation - Em_3
Stock-Based Compensation - Employee Stock Option and Incentive Plan Activity Additional Information (Details) - Stock options - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Additional information | |||
Intrinsic value of options exercised | $ 0 | $ 0 | $ 0 |
Weighted average grant-date fair value (in dollars per share) | $ 2.08 | $ 6.60 | $ 23.70 |
Fair value of options vested | $ 4.9 | $ 8 | $ 13.4 |
Intrinsic value of options outstanding | 0 | ||
Intrinsic value of options vested and expected to vest | 0 | ||
Compensation cost not yet recognized | $ 3.8 | ||
Weighted average period compensation cost is expected to be recognized (in years) | 3 years |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock (Details) - Restricted Stock | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Shares | |
Outstanding and unvested at the beginning of the period (in shares) | shares | 3,552 |
Vested (in shares) | shares | (2,220) |
Canceled (in shares) | shares | (222) |
Outstanding and unvested at the end of the period (in shares) | shares | 1,110 |
Weighted Average Grant Date Fair Value (per share) | |
Outstanding and unvested at the beginning of the period (in dollars per share) | $ / shares | $ 43.84 |
Vested (in dollars per share) | $ / shares | 49.25 |
Canceled (in dollars per share) | $ / shares | 34.83 |
Outstanding and unvested at the end of the period (in dollars per share) | $ / shares | $ 34.83 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock-based compensation expense | |||
Stock-based compensation expense | $ 4,551 | $ 8,081 | $ 12,312 |
Research and development | |||
Stock-based compensation expense | |||
Stock-based compensation expense | 2,053 | 3,874 | 6,693 |
General and administrative | |||
Stock-based compensation expense | |||
Stock-based compensation expense | $ 2,498 | $ 4,207 | $ 5,619 |
Stock-Based Compensation - Valu
Stock-Based Compensation - Valuation (Details) - Stock options | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Black-Scholes option with following assumptions: | |||
Expected stock price volatility, minimum (as a percent) | 90.00% | 73.00% | 75.00% |
Expected stock price volatility, maximum (as a percent) | 91.00% | 85.00% | 77.00% |
Expected option term | 6 years | 6 years | 6 years |
Risk-free interest rate, minimum (as a percent) | 1.60% | 2.80% | 2.00% |
Risk-free interest rate, maximum (as a percent) | 2.50% | 3.10% | 2.30% |
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2014 | Jan. 01, 2018 | |
Revenue | |||||||||||||
Accumulated Deficit | $ (1,013,316) | $ (962,438) | $ (1,013,316) | $ (962,438) | |||||||||
Accounts receivable | 1,015 | 3,162 | 1,015 | 3,162 | |||||||||
Contract assets | 0 | 0 | 0 | 0 | |||||||||
Contract liability | 254 | 1,586 | 254 | 1,586 | |||||||||
Revenue, contract liabilities | 1,400 | ||||||||||||
Revenues | 887 | $ 546 | $ 715 | $ 1,425 | $ 1,764 | $ 941 | $ 2,763 | $ 4,068 | 3,573 | 9,538 | $ 12,743 | ||
ASC 606 | |||||||||||||
Revenue | |||||||||||||
Accumulated Deficit | $ (1,300) | ||||||||||||
Deferred Revenue | (800) | ||||||||||||
Accounts receivable | $ 500 | ||||||||||||
Product Development and Licensing Agreements | |||||||||||||
Revenue | |||||||||||||
Revenues | 473 | 3,341 | 3,153 | ||||||||||
Contracts and Grants | |||||||||||||
Revenue | |||||||||||||
Revenues | 3,100 | 6,197 | 9,590 | ||||||||||
Bristol-Myers Squibb Company | Product Development and Licensing Agreements | |||||||||||||
Revenue | |||||||||||||
Deferred Revenue | $ 0 | 0 | $ 5,000 | ||||||||||
Reimbursement of external costs (as percent) | 50.00% | ||||||||||||
Revenues | 200 | 3,300 | 2,800 | ||||||||||
IAVI & Frontier | Contracts and Grants | |||||||||||||
Revenue | |||||||||||||
Revenues | 300 | 3,000 | 6,600 | ||||||||||
Rockefeller | Contracts and Grants | |||||||||||||
Revenue | |||||||||||||
Revenues | $ 2,600 | $ 3,200 | $ 2,200 |
Collaboration Agreements (Detai
Collaboration Agreements (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Collaborative Agreements | |||
License fee expense | $ 0.1 | $ 0.7 | $ 0.7 |
Type of cost of goods sold line item | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Southampton | |||
Collaborative Agreements | |||
Potential milestone payment | $ 1 | ||
Amgen | |||
Collaborative Agreements | |||
Potential milestone payment | 0.9 | ||
Yale | |||
Collaborative Agreements | |||
Potential milestone payment | $ 3 | ||
MedImmune | |||
Collaborative Agreements | |||
Period from the first commercial sale of licensed product for royalty payment | 10 years | ||
MedImmune | Obtaining specified regulatory and development | |||
Collaborative Agreements | |||
Potential milestone payment | $ 45 | ||
MedImmune | Specified annual net sales thresholds are met | |||
Collaborative Agreements | |||
Potential milestone payment | $ 125 |
Income Taxes - Benefit (Provisi
Income Taxes - Benefit (Provision) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Benefit (Provision): | |||
Federal | $ 13,869 | $ 22,255 | $ 57,547 |
State | 2,170 | 6,406 | (2,479) |
Foreign | 913 | 2,448 | |
Expiration of NOLs and R&D Credit | (18,966) | ||
Income Tax Rate Change | (99,528) | ||
Income tax benefit (provision) before valuation allowance | (2,927) | 29,574 | (42,012) |
Deferred Tax Valuation Allowance | $ 2,927 | (28,809) | 66,294 |
Income Tax Benefit (Provision) | $ 765 | $ 24,282 |
Income Taxes - Reconciliation (
Income Taxes - Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation between the amount of reported income tax and the amount computed using U.S. Statutory rate | |||
Pre-Tax Loss | $ (50,878) | $ (151,949) | $ (117,313) |
Loss at Statutory Rates | (10,684) | (31,909) | (39,887) |
Difference in Foreign Tax Rates | 326 | ||
Research and Development Credits | (1,902) | (2,056) | (2,847) |
State Taxes | (2,170) | (6,406) | (6,283) |
Income Tax Rate Change | 99,528 | ||
Other | (1,011) | (1,175) | (321) |
Change in Fair Value Remeasurement of Contingent Consideration | (272) | (6,220) | |
Intangible Impairment | 19,105 | ||
Recognition of APIC NOLs | (5,729) | ||
Impact of Pass-through Entities | (913) | (2,775) | |
Expiration of NOLs and R&D Credit | 18,966 | ||
Change in Valuation Allowance | $ (2,927) | 28,809 | (66,294) |
Income Tax (Benefit) Provision | $ (765) | $ (24,282) |
Income Taxes - Summary of Defer
Income Taxes - Summary of Deferred tax assets and liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Gross Deferred Tax Assets | |||
Net Operating Loss Carryforwards | $ 172,745 | $ 168,239 | |
Foreign Net Operating Loss Carryforwards | 4,485 | ||
Tax Credit Carryforwards | 42,642 | 39,761 | |
Deferred Research and Development Expenses | 70,042 | 76,555 | |
Stock-based Compensation | 12,651 | 11,977 | |
Fixed Assets | 1,759 | 1,761 | |
Accrued Expenses and Other | 328 | 316 | |
Deferred Tax Assets, Gross | 300,167 | 303,094 | |
Gross Deferred Tax Liabilities | |||
IPR&D Intangibles | (12,748) | (12,748) | |
Total Deferred Tax Assets and Liabilities | 287,419 | 290,346 | |
Valuation Allowance | (290,426) | (293,353) | |
Net Deferred Tax Liability | $ 3,007 | $ 3,007 | |
Principal components of the deferred tax assets and liabilities | |||
Increase in deferred tax and valuation allowance | $ 17,700 | ||
U.S. federal corporate income tax rate (as a percent) | 21.00% | 21.00% | 35.00% |
U.S. federal corporate income tax net operating losses (as a percent) | 80.00% | ||
Change in tax rate, deferred tax liability benefit | $ 6,900 | ||
Additional income tax benefit leading to tax liabilities | 12,200 | ||
Revaluation of deferred tax asset | 99,500 | ||
Income tax expense (benefit) | $ (765) | $ (24,282) |
Income Taxes - Carryforwards (D
Income Taxes - Carryforwards (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating Loss Carryforwards | ||
Foreign pre-tax loss | $ 0 | $ 3 |
Federal | ||
Operating Loss Carryforwards | ||
Net operating loss carryforwards | 638.9 | |
Net operating loss carryforwards with no expiration date | 146 | |
Federal | R&D credit | ||
Operating Loss Carryforwards | ||
Tax credit carryforwards | 33.4 | |
State | ||
Operating Loss Carryforwards | ||
Net operating loss carryforwards | 595.1 | |
State | R&D credit | ||
Operating Loss Carryforwards | ||
Tax credit carryforwards | 11.7 | |
Australian Subsidiary | ||
Operating Loss Carryforwards | ||
Foreign Net Operating Loss written off | $ 14.9 |
Retirement Savings Plan (Detail
Retirement Savings Plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Retirement Savings Plan | |||
Maximum contribution by participants (as a percent) | 60.00% | ||
Employer matching contributions (as a percent) | 50.00% | ||
Maximum percentage of employees' gross pay subject to employer matching contributions | 4.00% | ||
Benefit expense for the 401(k) Plan | $ 0.3 | $ 0.4 | $ 0.5 |
Kolltan Acquisition (Details)
Kolltan Acquisition (Details) - Kolltan - USD ($) $ in Millions | Nov. 29, 2016 | Dec. 31, 2019 |
Kolltan Acquisition | ||
Shares issued as part of consideration (in shares) | 1,217,200 | |
Specified development, regulatory approvals or sales-based milestones | ||
Kolltan Acquisition | ||
Potential milestone payments | $ 172.5 | $ 127.5 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Selected Quarterly Financial Data (Unaudited) | |||||||||||
Revenues | $ 887 | $ 546 | $ 715 | $ 1,425 | $ 1,764 | $ 941 | $ 2,763 | $ 4,068 | $ 3,573 | $ 9,538 | $ 12,743 |
Net loss | $ (10,447) | $ (11,413) | $ (11,779) | $ (17,239) | $ (9,402) | $ (7,243) | $ (16,407) | $ (118,132) | $ (50,878) | $ (151,184) | $ (93,031) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.64) | $ (0.75) | $ (0.84) | $ (1.40) | $ (0.81) | $ (0.66) | $ (1.67) | $ (12.61) | $ (3.51) | $ (14.48) | $ (10.86) |