Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Oct. 31, 2017 | |
Document and Entity Information | ||
Entity Registrant Name | Celldex Therapeutics, Inc. | |
Entity Central Index Key | 744,218 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2017 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 135,985,329 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Current Assets: | ||
Cash and Cash Equivalents | $ 54,735 | $ 42,461 |
Marketable Securities | 85,795 | 147,315 |
Accounts and Other Receivables | 3,013 | 1,784 |
Prepaid and Other Current Assets | 3,774 | 4,009 |
Total Current Assets | 147,317 | 195,569 |
Property and Equipment, Net | 11,308 | 13,192 |
Intangible Assets, Net | 67,815 | 81,487 |
Other Assets | 2,002 | 2,134 |
Goodwill | 90,976 | 90,976 |
Total Assets | 319,418 | 383,358 |
Current Liabilities: | ||
Accounts Payable | 1,278 | 1,740 |
Accrued Expenses | 17,845 | 28,657 |
Current Portion of Long-Term Liabilities | 5,792 | 4,826 |
Total Current Liabilities | 24,915 | 35,223 |
Other Long-Term Liabilities | 75,351 | 82,704 |
Total Liabilities | 100,266 | 117,927 |
Commitments and Contingent Liabilities | ||
Stockholders' Equity: | ||
Convertible Preferred Stock, $.01 Par Value; 3,000,000 Shares Authorized; No Shares Issued and Outstanding at September 30, 2017 and December 31, 2016 | ||
Common Stock, $.001 Par Value; 297,000,000 Shares Authorized; 132,108,478 and 120,516,654 Shares Issued and Outstanding at September 30, 2017 and December 31, 2016, respectively | 132 | 121 |
Additional Paid-In Capital | 1,025,108 | 982,255 |
Accumulated Other Comprehensive Income | 2,588 | 2,541 |
Accumulated Deficit | (808,676) | (719,486) |
Total Stockholders' Equity | 219,152 | 265,431 |
Total Liabilities and Stockholders' Equity | $ 319,418 | $ 383,358 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
CONDENSED 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 | 132,108,478 | 120,516,654 |
Common Stock, Shares Outstanding | 132,108,478 | 120,516,654 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
REVENUES: | ||||
Product Development and Licensing Agreements | $ 1,238 | $ 493 | $ 2,488 | $ 1,551 |
Contracts and Grants | 2,686 | 1,727 | 6,799 | 3,362 |
Total Revenues | 3,924 | 2,220 | 9,287 | 4,913 |
OPERATING EXPENSES: | ||||
Research and Development | 21,915 | 25,009 | 72,707 | 78,168 |
General and Administrative | 5,346 | 6,950 | 19,109 | 24,049 |
In-Process Research and Development Impairment | 13,000 | 13,000 | ||
Gain on Fair Value Remeasurement of Contingent Consideration | (4,600) | (200) | ||
Amortization of Acquired Intangible Assets | 224 | 254 | 672 | 760 |
Total Operating Expenses | 35,885 | 32,213 | 105,288 | 102,977 |
Operating Loss | (31,961) | (29,993) | (96,001) | (98,064) |
Investment and Other Income, Net | 398 | 395 | 1,611 | 1,841 |
Net Loss Before Income Tax Benefit | (31,563) | (29,598) | (94,390) | (96,223) |
Income Tax Benefit | 5,200 | 5,200 | ||
Net Loss | $ (26,363) | $ (29,598) | $ (89,190) | $ (96,223) |
Basic and Diluted Net Loss Per Common Share (in dollars per share) | $ (0.20) | $ (0.29) | $ (0.71) | $ (0.97) |
Shares Used in Calculating Basic and Diluted Net Loss per Share (in shares) | 129,640 | 100,672 | 125,856 | 99,398 |
COMPREHENSIVE LOSS: | ||||
Net Loss | $ (26,363) | $ (29,598) | $ (89,190) | $ (96,223) |
Other Comprehensive Income: | ||||
Unrealized Gain (Loss) on Marketable Securities | 11 | (113) | 47 | 303 |
Comprehensive Loss | $ (26,352) | $ (29,711) | $ (89,143) | $ (95,920) |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Cash Flows from Operating Activities: | ||
Net Loss | $ (89,190) | $ (96,223) |
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities: | ||
Depreciation and Amortization | 3,392 | 2,135 |
Amortization of Intangible Assets | 672 | 760 |
Amortization and Premium of Marketable Securities, Net | (171) | 768 |
Loss on Sale or Disposal of Assets | 6 | 74 |
In-Process Research and Development Impairment | 13,000 | |
Gain on Fair Value Remeasurement of Contingent Consideration | (200) | |
Income Tax Benefit | (5,200) | |
Stock-Based Compensation Expense | 9,728 | 11,709 |
Non-Cash Expense | 1,638 | |
Changes in Operating Assets and Liabilities: | ||
Accounts and Other Receivables | (1,229) | (609) |
Prepaid and Other Current Assets | 525 | (325) |
Other Assets | 132 | |
Accounts Payable and Accrued Expenses | (10,888) | (11,560) |
Other Liabilities | (987) | (1,054) |
Net Cash Used in Operating Activities | (80,410) | (92,687) |
Cash Flows from Investing Activities: | ||
Sales and Maturities of Marketable Securities | 183,683 | 194,915 |
Purchases of Marketable Securities | (122,235) | (149,877) |
Investment in Other | (1,801) | |
Acquisition of Property and Equipment | (1,598) | (2,113) |
Net Cash Provided by Investing Activities | 59,850 | 41,124 |
Cash Flows from Financing Activities: | ||
Net Proceeds from Stock Issuances | 32,642 | 10,666 |
Proceeds from Issuance of Stock from Employee Benefit Plans | 192 | 532 |
Net Cash Provided by Financing Activities | 32,834 | 11,198 |
Net Increase (Decrease) in Cash and Cash Equivalents | 12,274 | (40,365) |
Cash and Cash Equivalents at Beginning of Period | 42,461 | 72,108 |
Cash and Cash Equivalents at End of Period | 54,735 | 31,743 |
Non-cash Investing Activities | ||
Acquisition of Property and Equipment Included in Accounts Payable and Accrued Expenses | 75 | $ 65 |
Non-cash Supplemental Disclosure | ||
Shares Issued to Former Kolltan Executive for Settlement of Severance | $ 302 |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2017 | |
Basis of Presentation | |
Basis of Presentation | (1) Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared by Celldex Therapeutics, Inc. (the “Company” or “Celldex”) in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and reflect the operations of the Company and its wholly-owned subsidiary. In June 2017, the Company liquidated its wholly-owned subsidiary, Celldex Therapeutics Europe GmbH. All intercompany balances and transactions have been eliminated in consolidation. These interim financial statements do not include all the information and footnotes required by U.S. GAAP for annual financial statements and should be read in conjunction with the audited financial statements for the year ended December 31, 2016, which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 14, 2017. In the opinion of management, the interim financial statements reflect all normal recurring adjustments necessary to fairly state the Company’s financial position and results of operations for the interim periods presented. The year-end condensed balance sheet data presented for comparative purposes was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for any future interim period or the fiscal year ending December 31, 2017. At September 30, 2017, the Company had cash, cash equivalents and marketable securities of $140.5 million. The Company has had recurring losses and incurred a loss of $89.2 million for the nine months ended September 30, 2017. Net cash used in operations for the nine months ended September 30, 2017 was $80.4 million. The Company believes that the cash, cash equivalents and marketable securities at November 7, 2017 will be sufficient to meet estimated working capital requirements and fund planned operations for at least the next twelve months from the date of issuance of these financial statements. During the next twelve months and beyond, the Company will take further steps to raise additional capital to meet its liquidity needs. These capital raising activities may include, 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. While the Company may seek capital through a number of means, 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 future 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. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2017 | |
Significant Accounting Policies | |
Significant Accounting Policies | (2) Significant Accounting Policies The significant accounting policies used in preparation of these condensed consolidated financial statements on Form 10-Q for the quarterly period ended September 30, 2017 are consistent with those discussed in Note 2 to the financial statements in our Annual Report on Form 10-K for the year ended December 31, 2016, except for the adoption of new accounting standards during the first nine months of 2017 as discussed below. Newly-Adopted Accounting Pronouncements On January 1, 2017, the Company adopted a new U.S. GAAP accounting standard which involves several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. The Company elected to continue to estimate forfeitures expected to occur to determine stock-based compensation expense. Upon adoption, the Company’s gross deferred tax assets and corresponding valuation allowance each increased by $17.7 million related to tax deductions from the exercise of stock options that previously would have been credited to additional paid-in-capital when realized. On January 1, 2017, the Company adopted a new U.S. GAAP accounting standard which simplifies how an entity is required to test goodwill for impairment. A goodwill impairment will be measured by the amount by which a reporting unit’s carrying value exceeds its fair value, with the amount of impairment not to exceed the carrying amount of goodwill. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board 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 May 2014, the FASB issued a new U.S GAAP accounting standard that updates guidance and disclosure requirements for recognizing revenue. The new revenue recognition standard provides a five-step model for recognizing revenue from contracts with customers. The core principle is that a company should recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. The new standard will be effective for the Company on January 1, 2018 and can be applied using one of two methods: retrospectively to each prior period presented or a modified retrospective application by recognizing a cumulative-effect adjustment as a component of equity as of the date of adoption. The Company expects to adopt the new revenue standard using the modified retrospective application method. During the fourth quarter of 2017, the Company plans to finalize its assessments over the impact that these standards may have on its consolidated financial statements and disclosures. As a result of adopting this standard, the Company plans to implement additional processes and controls, including additional disclosures, to comply with the new standard. In February 2016, the FASB issued 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 will be effective for the Company on January 1, 2019. The Company is currently evaluating the potential impact that this standard may have on the Company’s consolidated financial statements. In August 2016, the FASB issued new U.S. GAAP guidance which clarifies the classification of certain cash receipts and payments in the statement of cash flows. This standard is effective for the company 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. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Measurements | |
Fair Value Measurements | (3) Fair Value Measurements The following tables set forth the Company’s financial assets and liabilities subject to fair value measurements: As of Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ $ — $ $ — Marketable securities — — $ $ — $ $ — Liabilities: Kolltan acquisition contingent consideration $ $ — $ — $ $ $ — $ — $ As of Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ $ — $ $ — Marketable securities — — $ $ — $ $ — Liabilities: Kolltan acquisition contingent consideration $ $ — $ — $ $ $ — $ — $ 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 nine months ended September 30, 2017 (in thousands): Other Long-Term Balance at December 31, 2016 $ Fair value adjustments included in operating expenses ) Balance at September 30, 2017 $ The valuation technique used to measure fair value of the Company’s Level 3 liabilities, which consist of contingent consideration related to the acquisition of Kolltan in 2016 (Note 11), was primarily an income approach. The Company may be required to pay future consideration of up to $172.5 million that is contingent upon the achievement of specified development, regulatory approvals or sales-based milestone events. The significant unobservable inputs used in the fair value measurement of the contingent consideration are estimates including probability of success, discount rates and amount of time until the conditions of the milestone payments are met. During the three and nine months ended September 30, 2017, the Company recorded a $4.6 million and a $0.2 million gain on fair value remeasurement of contingent consideration, respectively, primarily due to a reduction in fair value attributed to the milestones related to the Company’s anti-KIT program and partially offset by losses related to changes in discount rates and the passage of time affecting remaining milestones. The Company’s anti-KIT program includes CDX-0158 and CDX-0159, a variant of CDX-0158. CDX-0159 is being fully developed in-house with the intention of replacing CDX-0158 in clinical development. The Company expects manufacturing and IND-enabling efforts for CDX-0159 will be completed in 2018. The Company did not have any transfers of assets or liabilities between the fair value measurement classifications during the nine months ended September 30, 2017. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2017 | |
Marketable Securities | |
Marketable Securities | (4) Marketable Securities The following is a summary of marketable securities, classified as available-for-sale: Amortized Gross Gross Fair Value (In thousands) September 30, 2017 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ $ $ ) $ Maturing after one year through three years — — — — Total U.S. government and municipal obligations $ $ $ ) $ Corporate debt securities Maturing in one year or less $ $ $ ) $ Maturing after one year through three years — — — — Total corporate debt securities $ $ $ ) $ Total marketable securities $ $ $ ) $ December 31, 2016 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ $ $ ) $ Maturing after one year through three years — Total U.S. government and municipal obligations $ $ $ ) $ Corporate debt securities Maturing in one year or less $ $ — $ ) $ Maturing after one year through three years — — — — Total corporate debt securities $ $ — $ ) $ Total marketable securities $ $ $ ) $ The Company holds investment grade marketable securities and none were considered to be other-than-temporarily impaired as of September 30, 2017. Marketable securities include $0.3 million and $0.6 million in accrued interest at September 30, 2017 and December 31, 2016, respectively. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 9 Months Ended |
Sep. 30, 2017 | |
Intangible Assets and Goodwill | |
Intangible Assets and Goodwill | (5) Intangible Assets and Goodwill Intangible Assets, Net The table below presents information for the Company’s finite-lived intangible assets that are subject to amortization and indefinite-lived intangible assets: September 30, 2017 December 31, 2016 Estimated Gross Accumulated Net Carrying Gross Accumulated Net Carrying (In thousands) Finite-lived Intangible Assets: License Rights 16 years $ $ ) $ $ $ ) $ Indefinite-lived Intangible Assets: IPR&D Indefinite — — Total Intangible Assets, Net $ $ ) $ $ $ ) $ Indefinite-lived intangible assets consist of acquired in-process research and development (“IPR&D”) related to the development of glembatumumab vedotin acquired in connection with the CuraGen acquisition and the development of the anti-KIT program, CDX-3379 and the TAM programs acquired in connection with the Kolltan acquisition. As of September 30, 2017, no IPR&D asset had reached technological feasibility nor did any have alternative future uses. The Company performs an impairment test on IPR&D assets at least annually, or more frequently if events or changes in circumstances indicate that IPR&D assets may be impaired. During the three and nine months ended September 30, 2017, the Company recorded a non-cash partial impairment charge of $13.0 million on the anti-KIT program IPR&D assets acquired from Kolltan. The Company determined that changes in projected development and regulatory timelines related to the anti-KIT program taken together constituted a triggering event that required the Company to evaluate the intangible asset for impairment. As part of this evaluation, the present value of probability adjusted estimated net future cash flows was used to determine the fair value of the program and compared to the carrying value of the program. As a result of this impairment assessment, the Company concluded that a non-cash partial impairment charge of $13.0 million on the anti-KIT program IPR&D asset acquired from Kolltan be recorded for the three and nine months ended September 30, 2017 for the amount the fair value of the anti-KIT program exceeded its carrying amount. 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 There have been no changes to the carrying amount of goodwill during the nine months ended September 30, 2017. The Company performs an annual impairment test of goodwill as of July 1 each year. The Company tested goodwill for impairment as of July 1, 2017 and concluded that goodwill was not impaired. |
Other Long-Term Liabilities
Other Long-Term Liabilities | 9 Months Ended |
Sep. 30, 2017 | |
Other Long-Term Liabilities | |
Other Long-Term Liabilities | (6) Other Long-Term Liabilities Other long-term liabilities include the following: September 30, 2017 December 31, 2016 (In thousands) Deferred Rent $ $ Net Deferred Tax Liabilities related to IPR&D Deferred Income from Sale of Tax Benefits Accrued Lease Restructuring Long-Term Severance Contingent Milestones Deferred Revenue Total Less Current Portion ) ) Long-Term Portion $ $ In November 2015, December 2014, January 2014 and January 2013, the Company received approval from the New Jersey Economic Development Authority and agreed to sell New Jersey tax benefits of $9.8 million, $1.9 million, $1.1 million and $0.8 million to an independent third party for $9.2 million, $1.8 million, $1.0 million and $0.8 million, respectively. 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. The Company recognized $0.0 million and $0.5 million in other income related to the sale of these tax benefits for the three and nine months ended September 30, 2017, respectively, and $0.0 million and $0.6 million during the three and nine months ended September 30, 2016, respectively. In December 2016, the Company decided not to occupy the 11,500 square feet of expansion space (“Needham Expansion”) at its Needham, Massachusetts facility. The Company agreed to lease the Needham Expansion in August 2015 and the term of the lease expires in July 2020. In October 2017, the Company entered into a sublease agreement for the Needham Expansion. In March 2017, the Company terminated its lease in Branford, CT and consolidated its Connecticut operations in its New Haven, CT facility. The Company recorded restructuring expense of $0.2 million to general and administrative expense related to the Branford, CT lease termination. The activity related to accrued lease restructuring for the nine months ended September 30, 2017 is presented below (in thousands): Accrued Lease Balance at December 31, 2016 $ Expense Payments ) Balance at September 30, 2017 $ |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2017 | |
Stockholders' Equity | |
Stockholders' Equity | (7) Stockholders’ Equity In May 2016, the Company and Cantor Fitzgerald & Co. (“Cantor”) entered into a controlled equity offering sales agreement (“2016 Cantor Agreement”) 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. During the nine months ended September 30, 2017, the Company issued 11,326,363 shares of its common stock under the 2016 Cantor Agreement resulting in net proceeds to the Company of $32.6 million, after deducting commission and offering expenses. At September 30, 2017, the Company had $11.7 million remaining in aggregate gross offering price available under the 2016 Cantor Agreement. In October 2017, the Company completed sales under the 2016 Cantor Agreement and issued 3,871,709 shares of its common stock resulting in net proceeds to the Company of $11.3 million. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2017 | |
Stock-Based Compensation | |
Stock-Based Compensation | (8) Stock-Based Compensation A summary of stock option activity for the nine months ended September 30, 2017 is as follows: Shares Weighted Weighted Options Outstanding at December 31, 2016 $ Granted $ Exercised — $ — Canceled ) $ Options Outstanding at September 30, 2017 $ Options Vested and Expected to Vest at September 30, 2017 $ Options Exercisable at September 30, 2017 $ Shares Available for Grant Under the 2008 Plan The weighted average grant-date fair value of stock options granted during the nine month period ended September 30, 2017 was $1.57. Stock-based compensation expense for the three and nine months ended September 30, 2017 and 2016 was recorded as follows: Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 (In thousands) Research and development $ $ $ $ General and administrative Total stock-based compensation expense $ $ $ $ The fair value of employee and director stock options granted during the three and nine month periods ended September 30, 2017 and 2016 were valued using the Black-Scholes option-pricing model with the following assumptions: Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 Expected stock price volatility % % 76 — 77 % 70 — 77 % Expected option term 6.0 years 6.0 years 6.0 years 6.0 years Risk-free interest rate % % 2.0 — 2.3 % 1.4 — 1.6 % Expected dividend yield None None None None |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 9 Months Ended |
Sep. 30, 2017 | |
Accumulated Other Comprehensive Income | |
Accumulated Other Comprehensive Income | (9) Accumulated Other Comprehensive Income The changes in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the nine months ended September 30, 2017 are summarized below: Unrealized (Loss) Foreign Total (In thousands) Balance at December 31, 2016 $ ) $ $ Other comprehensive gain — Balance at September 30, 2017 $ ) $ $ No amounts were reclassified out of accumulated other comprehensive income during the nine months ended September 30, 2017. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2017 | |
Revenue | |
Revenue | (10) Revenue Rockefeller University (Rockefeller) In 2013, the Company entered into an agreement, as amended, with Rockefeller pursuant to which the Company performs research and development services for Rockefeller. The Company bills Rockefeller quarterly for actual time and direct costs incurred and records those amounts to revenue in the quarter the services are performed. The Company recorded $0.3 million and $1.4 million in revenue related to the Rockefeller agreement during the three and nine months ended September 30, 2017, respectively, and $1.1 million and $1.8 million during the three and nine months ended September 30, 2016, respectively. Bristol-Myers Squibb Company (BMS) In 2014, the Company entered into a clinical trial collaboration with BMS to evaluate the safety, tolerability and preliminary efficacy of varlilumab and Opdivo ® , BMS’s PD-1 immune checkpoint inhibitor, in a Phase 1/2 study. Under the terms of this clinical trial collaboration, BMS made a one-time payment to the Company of $5.0 million and BMS and the Company amended the terms of the Company’s existing license agreement with Medarex, which was acquired by BMS, related to the Company’s CD27 program whereby certain future milestone payments were waived and future royalty rates were reduced that may have been due from the Company to Medarex. In return, BMS was granted a time-limited right of first negotiation if the Company wishes to out-license varlilumab. The companies also agreed to work exclusively with each other to explore anti-PD-1 antagonist antibody and anti-CD27 agonist antibody combination regimens. The clinical trial collaboration provides that the companies share development costs and that the Company will be responsible for conducting the ongoing Phase 1/2 study. The Company has determined that its performance obligations under the BMS agreement, which primarily include performing research and development, supplying varlilumab and participating in the joint development committee, should be accounted for as a single unit of accounting and estimated that its performance period under the BMS agreement would be 5 years. Accordingly, the $5.0 million up-front payment was initially recorded as deferred revenue and is being recognized as revenue on a straight-line basis over the estimated 5-year performance period using the Contingency Adjusted Performance Model (“CAPM”). The BMS agreement also provides for BMS to reimburse the Company for 50% of the external costs incurred by the Company in connection with the clinical trial. The BMS payments are recognized as revenue under the CAPM. The Company recorded $0.9 million and $2.1 million in revenue related to the BMS agreement during the three and nine months ended September 30, 2017, respectively, and $0.5 million and $1.5 million during the three and nine months ended September 30, 2016, respectively. International AIDS Vaccine Initiative (IAVI) In 2017, the Company entered into an agreement with IAVI pursuant to which the Company performs research and development and manufacturing services for IAVI outlined under subsequently negotiated task orders. Revenue is recognized as services are performed under the negotiated task orders. The Company recorded $1.7 million and $4.0 million in revenue related to the IAVI agreement during the three and nine months ended September 30, 2017, respectively. Frontier Biotechnologies, Inc. (Frontier) In 2017, the Company entered into an agreement with Frontier pursuant to which the Company performs research and development and manufacturing services for Frontier outlined under subsequently negotiated task orders. Revenue is recognized as services are performed under the negotiated task orders. The Company recorded $0.6 million in revenue related to the Frontier agreement during both the three and nine months ended September 30, 2017. |
Kolltan Acquisition
Kolltan Acquisition | 9 Months Ended |
Sep. 30, 2017 | |
Kolltan Acquisition | |
Kolltan Acquisition | (11) Kolltan Acquisition In connection with the Kolltan Acquisition, effective November 29, 2016, the Company issued 18,257,996 shares of common stock of the Company in exchange for all of the share and debt interests in Kolltan. The Company also agreed to issue an aggregate of 437,901 shares of its common stock, less tax withholdings, to certain former officers of Kolltan. During the nine months ended September 30, 2017, the Company issued 91,749 shares of its common stock and at September 30, 2017, the Company’s remaining obligation is to issue 125,123 shares of its common stock, less tax withholdings, related to this severance obligation. In addition, in the event that certain specified preclinical and clinical development milestones related to Kolltan’s development programs and/or Celldex’s development programs and certain commercial milestones related to Kolltan’s drug candidates are achieved, Celldex will be required to pay Kolltan’s stockholders milestone payments of up to $172.5 million, which milestone payments 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. The transaction was accounted for as a business combination with Celldex treated as the accounting acquirer. All of the assets acquired and liabilities assumed in the transaction are recognized at their acquisition-date fair values, while transaction costs associated with the transaction are expensed as incurred. Purchase Price The purchase price for Kolltan was based on the acquisition-date fair value of the consideration transferred, which was calculated based on the closing price of the Company’s common stock of $4.02 per share on November 29, 2016. The acquisition-date fair value of the consideration transferred consisted of the following (in thousands): Fair value of common stock issued for upfront payment $ Fair value of contingent consideration Kolltan transaction expenses paid in cash by the Company Total consideration transferred $ Allocations of Assets and Liabilities The Company has allocated the consideration transferred for Kolltan to net tangible assets, intangible assets, and goodwill. The difference between the aggregate consideration transferred and the fair value of assets acquired and liabilities assumed was allocated to goodwill. This goodwill relates to the potential synergies from the Kolltan Acquisition and deferred tax liabilities related to acquired IPR&D intangible assets. None of the goodwill is expected to be deductible for income tax purposes. The following table summarizes the fair values of the assets acquired and liabilities assumed at the acquisition date (in thousands): Cash and cash equivalents $ Other current and long-term assets Property and equipment, net In-process research and development (IPR&D) Goodwill Deferred tax liabilities, net ) Other assumed liabilities ) Total $ The purchase price allocation has been prepared on a preliminary basis and is subject to change as additional information becomes available concerning the fair value and tax basis of the acquired assets and liabilities. Any adjustments to the purchase price allocation will be made as soon as practicable but no later than one year from the acquisition date. Pro Forma Financial Information If the operations of the Company and Kolltan were combined as of January 1, 2016, the unaudited pro forma net loss for the three and nine months ended September 30, 2016 would have been $35.5 million and $120.4 million, respectively, or $(0.30) and $(1.02) per share, respectively. The unaudited pro forma combined results are not necessarily indicative of the actual results that would have occurred had the acquisition been consummated at that date or of the future operations of the combined entities. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2017 | |
Income Taxes | |
Income Taxes | (12) Income Taxes Massachusetts, New Jersey and Connecticut are the three states in which the Company primarily operates or has operated and has income tax nexus. The Company’s wholly-owned subsidiary, Celldex Australia Pty Ltd, operates in Brisbane, Australia. The Company is not currently under examination by any jurisdictions for any tax year. The Company has evaluated the positive and negative evidence bearing upon the realizability of its net deferred tax assets, which are comprised principally of net operating loss carryforwards, capitalized R&D expenditures and R&D tax credit carryforwards. The Company has determined that it is more likely than not that it will not recognize the benefits of federal and state deferred tax assets and, as a result, a full valuation allowance was maintained at September 30, 2017 and December 31, 2016 against the Company’s net deferred tax assets. As of September 30, 2017 and December 31, 2016, the Company had $22.9 million and $28.1 million of deferred tax liabilities, net recorded on the balance sheet primarily associated with temporary differences related to the Company’s IPR&D assets. The $5.2 million decrease in deferred tax liabilities, net during the three and nine months ended September 30, 2017 was due to the partial impairment of the anti-KIT program IPR&D assets. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2017 | |
Net Loss Per Share | |
Net Loss Per Share | (13) 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. 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: Nine months ended September 30, 2017 2016 Stock options Restricted stock |
Significant Accounting Polici19
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Significant Accounting Policies | |
Newly-Adopted Accounting Pronouncements | Newly-Adopted Accounting Pronouncements On January 1, 2017, the Company adopted a new U.S. GAAP accounting standard which involves several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. The Company elected to continue to estimate forfeitures expected to occur to determine stock-based compensation expense. Upon adoption, the Company’s gross deferred tax assets and corresponding valuation allowance each increased by $17.7 million related to tax deductions from the exercise of stock options that previously would have been credited to additional paid-in-capital when realized. On January 1, 2017, the Company adopted a new U.S. GAAP accounting standard which simplifies how an entity is required to test goodwill for impairment. A goodwill impairment will be measured by the amount by which a reporting unit’s carrying value exceeds its fair value, with the amount of impairment not to exceed the carrying amount of goodwill. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board 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 May 2014, the FASB issued a new U.S GAAP accounting standard that updates guidance and disclosure requirements for recognizing revenue. The new revenue recognition standard provides a five-step model for recognizing revenue from contracts with customers. The core principle is that a company should recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. The new standard will be effective for the Company on January 1, 2018 and can be applied using one of two methods: retrospectively to each prior period presented or a modified retrospective application by recognizing a cumulative-effect adjustment as a component of equity as of the date of adoption. The Company expects to adopt the new revenue standard using the modified retrospective application method. During the fourth quarter of 2017, the Company plans to finalize its assessments over the impact that these standards may have on its consolidated financial statements and disclosures. As a result of adopting this standard, the Company plans to implement additional processes and controls, including additional disclosures, to comply with the new standard. In February 2016, the FASB issued 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 will be effective for the Company on January 1, 2019. The Company is currently evaluating the potential impact that this standard may have on the Company’s consolidated financial statements. In August 2016, the FASB issued new U.S. GAAP guidance which clarifies the classification of certain cash receipts and payments in the statement of cash flows. This standard is effective for the company 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. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Measurements | |
Schedule of financial assets and liabilities subject to fair value measurements | As of Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ $ — $ $ — Marketable securities — — $ $ — $ $ — Liabilities: Kolltan acquisition contingent consideration $ $ — $ — $ $ $ — $ — $ As of Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ $ — $ $ — Marketable securities — — $ $ — $ $ — Liabilities: Kolltan acquisition contingent consideration $ $ — $ — $ $ $ — $ — $ |
Schedule of the Company's contingent consideration liabilities measured at fair value using Level 3 inputs | The following table reflects the activity for the Company’s contingent consideration liabilities measured at fair value using Level 3 inputs for the nine months ended September 30, 2017 (in thousands): Other Long-Term Balance at December 31, 2016 $ Fair value adjustments included in operating expenses ) Balance at September 30, 2017 $ |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Marketable Securities | |
Summary of marketable securities, classified as available-for-sale | Amortized Gross Gross Fair Value (In thousands) September 30, 2017 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ $ $ ) $ Maturing after one year through three years — — — — Total U.S. government and municipal obligations $ $ $ ) $ Corporate debt securities Maturing in one year or less $ $ $ ) $ Maturing after one year through three years — — — — Total corporate debt securities $ $ $ ) $ Total marketable securities $ $ $ ) $ December 31, 2016 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ $ $ ) $ Maturing after one year through three years — Total U.S. government and municipal obligations $ $ $ ) $ Corporate debt securities Maturing in one year or less $ $ — $ ) $ Maturing after one year through three years — — — — Total corporate debt securities $ $ — $ ) $ Total marketable securities $ $ $ ) $ |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Intangible Assets and Goodwill | |
Schedule of finite-lived intangible assets subject to amortization and indefinite-lived assets | September 30, 2017 December 31, 2016 Estimated Gross Accumulated Net Carrying Gross Accumulated Net Carrying (In thousands) Finite-lived Intangible Assets: License Rights 16 years $ $ ) $ $ $ ) $ Indefinite-lived Intangible Assets: IPR&D Indefinite — — Total Intangible Assets, Net $ $ ) $ $ $ ) $ |
Other Long-Term Liabilities (Ta
Other Long-Term Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Other Long-Term Liabilities | |
Schedule of other long-term liabilities | September 30, 2017 December 31, 2016 (In thousands) Deferred Rent $ $ Net Deferred Tax Liabilities related to IPR&D Deferred Income from Sale of Tax Benefits Accrued Lease Restructuring Long-Term Severance Contingent Milestones Deferred Revenue Total Less Current Portion ) ) Long-Term Portion $ $ |
Schedule of activity related to accrued lease restructuring | The activity related to accrued lease restructuring for the nine months ended September 30, 2017 is presented below (in thousands): Accrued Lease Balance at December 31, 2016 $ Expense Payments ) Balance at September 30, 2017 $ |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Stock-Based Compensation | |
Summary of stock option activity | Shares Weighted Weighted Options Outstanding at December 31, 2016 $ Granted $ Exercised — $ — Canceled ) $ Options Outstanding at September 30, 2017 $ Options Vested and Expected to Vest at September 30, 2017 $ Options Exercisable at September 30, 2017 $ Shares Available for Grant Under the 2008 Plan |
Schedule of stock-based compensation expense | Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 (In thousands) Research and development $ $ $ $ General and administrative Total stock-based compensation expense $ $ $ $ |
Schedule of assumptions used for the fair value of employee and director stock options granted | Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 Expected stock price volatility % % 76 — 77 % 70 — 77 % Expected option term 6.0 years 6.0 years 6.0 years 6.0 years Risk-free interest rate % % 2.0 — 2.3 % 1.4 — 1.6 % Expected dividend yield None None None None |
Accumulated Other Comprehensi25
Accumulated Other Comprehensive Income (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Accumulated Other Comprehensive Income | |
Summary of changes in accumulated other comprehensive income | Unrealized (Loss) Foreign Total (In thousands) Balance at December 31, 2016 $ ) $ $ Other comprehensive gain — Balance at September 30, 2017 $ ) $ $ |
Kolltan Acquisition (Tables)
Kolltan Acquisition (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Kolltan Acquisition | |
Schedule of acquisition-date fair value of the consideration transferred | The acquisition-date fair value of the consideration transferred consisted of the following (in thousands): Fair value of common stock issued for upfront payment $ Fair value of contingent consideration Kolltan transaction expenses paid in cash by the Company Total consideration transferred $ |
Summary of fair values of the assets acquired and liabilities assumed at the acquisition date | The following table summarizes the fair values of the assets acquired and liabilities assumed at the acquisition date (in thousands): Cash and cash equivalents $ Other current and long-term assets Property and equipment, net In-process research and development (IPR&D) Goodwill Deferred tax liabilities, net ) Other assumed liabilities ) Total $ |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Net Loss Per Share | |
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 | Nine months ended September 30, 2017 2016 Stock options Restricted stock |
Basis of Presentation - (Detail
Basis of Presentation - (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Basis of Presentation | ||||
Cash, cash equivalents and marketable securities | $ 140,500 | $ 140,500 | ||
Net Loss | $ (26,363) | $ (29,598) | (89,190) | $ (96,223) |
Net cash used in operations | $ 80,410 | $ 92,687 |
Significant Accounting Polici29
Significant Accounting Policies - (Details) $ in Millions | Jan. 01, 2017USD ($) |
Accounting Standards Update | Adjustments for New Accounting Principle, Early Adoption | |
Newly-Adopted Accounting Pronouncements | |
Increase in deferred tax and valuation allowance | $ 17.7 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Fair Value Measurements - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Level 2 | ||
Assets: | ||
Money market funds and cash equivalents | $ 42,032 | $ 20,445 |
Marketable securities | 85,795 | 147,315 |
Total financial assets at fair value | 127,827 | 167,760 |
Level 3 | ||
Liabilities: | ||
Kolltan acquisition contingent consideration | 44,000 | 44,200 |
Total financial liabilities at fair value | 44,000 | 44,200 |
Fair value | ||
Assets: | ||
Money market funds and cash equivalents | 42,032 | 20,445 |
Marketable securities | 85,795 | 147,315 |
Total financial assets at fair value | 127,827 | 167,760 |
Liabilities: | ||
Kolltan acquisition contingent consideration | 44,000 | 44,200 |
Total financial liabilities at fair value | $ 44,000 | $ 44,200 |
Fair Value Measurements - Conti
Fair Value Measurements - Contingent Consideration Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2017 | Sep. 30, 2017 | |
Roll-forward of acquisition-related contingent consideration | ||
Fair value adjustments included in operating expenses | $ (4,600) | $ (200) |
Fair value | Level 3 | Other Long-Term Liabilities | ||
Roll-forward of acquisition-related contingent consideration | ||
Balance at beginning of period | 44,200 | |
Fair value adjustments included in operating expenses | (200) | |
Balance at end of period | $ 44,000 | $ 44,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2017 | Nov. 29, 2016 | |
Fair value measurements | |||
Gain on Fair Value Remeasurement of Contingent Consideration | $ 4,600 | $ 200 | |
Kolltan | Specified development, regulatory approvals or sales-based milestones | |||
Fair value measurements | |||
Milestone payments | $ 172,500 | ||
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 | ||
Asset transfer into level 3 | 0 | ||
Liabilities transfers out of level 3 | 0 | ||
Liabilities transfers into level 3 | $ 0 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Amortized Cost | ||
Amortized cost | $ 85,803 | $ 147,370 |
Gross Unrealized Gains | ||
Gross Unrealized Gains | 8 | 13 |
Gross Unrealized Losses | ||
Gross Unrealized Losses | (16) | (68) |
Fair Value | ||
Fair Value | 85,795 | 147,315 |
Other-than-temporarily impairment | 0 | |
Accrued interest | 300 | 600 |
U.S government and municipal obligations | ||
Amortized Cost | ||
Maturing in one year or less | 13,725 | 52,754 |
Maturing after one year through three years | 296 | |
Amortized cost | 13,725 | 53,050 |
Gross Unrealized Gains | ||
Maturing in one year or less | 5 | 5 |
Maturing after one year through three years | 8 | |
Gross Unrealized Gains | 5 | 13 |
Gross Unrealized Losses | ||
Maturing in one year or less | (3) | (12) |
Gross Unrealized Losses | (3) | (12) |
Fair Value | ||
Maturing in one year or less | 13,727 | 52,747 |
Maturing after one year through three years | 304 | |
Fair Value | 13,727 | 53,051 |
Corporate debt securities | ||
Amortized Cost | ||
Maturing in one year or less | 72,078 | 94,320 |
Amortized cost | 72,078 | 94,320 |
Gross Unrealized Gains | ||
Maturing in one year or less | 3 | |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | ||
Maturing in one year or less | (13) | (56) |
Gross Unrealized Losses | (13) | (56) |
Fair Value | ||
Maturing in one year or less | 72,068 | 94,264 |
Fair Value | $ 72,068 | $ 94,264 |
Intangible Assets and Goodwil34
Intangible Assets and Goodwill (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2017 | Dec. 31, 2016 | |
Intangible Assets and Goodwill | |||
Changes to carrying amount of goodwill | $ 0 | ||
Finite-lived intangible asset | |||
Accumulated Amortization | $ (7,175,000) | (7,175,000) | $ (6,503,000) |
Total Intangible Assets | |||
Gross carrying amount of total intangible assets, net | 74,990,000 | 74,990,000 | 87,990,000 |
Net carrying amount of total intangible assets, net | 67,815,000 | 67,815,000 | 81,487,000 |
In-Process Research and Development Impairment | 13,000,000 | $ 13,000,000 | |
License Rights | |||
Finite-lived intangible asset | |||
Estimated Life | 16 years | ||
Gross carrying amount finite-lived | 14,500,000 | $ 14,500,000 | 14,500,000 |
Accumulated Amortization | (7,175,000) | (7,175,000) | (6,503,000) |
Net carrying amount finite-lived | 7,325,000 | 7,325,000 | 7,997,000 |
IPR&D | |||
Indefinite-lived intangible assets: | |||
Gross carrying amount of indefinite-lived | 60,490,000 | 60,490,000 | 73,490,000 |
Net carrying amount of indefinite-lived | 60,490,000 | 60,490,000 | $ 73,490,000 |
Kolltan | IPR&D | |||
Total Intangible Assets | |||
In-Process Research and Development Impairment | $ 13,000,000 | $ 13,000,000 |
Other Long-Term Liabilities (De
Other Long-Term Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Other Long-Term Liabilities | ||
Deferred Rent | $ 669 | $ 398 |
Net Deferred Tax Liabilities related to IPR&D | 22,854 | 28,054 |
Deferred Income from Sale of Tax Benefits | 8,940 | 9,436 |
Accrued Lease Restructuring | 854 | 1,154 |
Long-Term Severance | 100 | 539 |
Contingent Milestones | 44,000 | 44,200 |
Deferred Revenue | 3,726 | 3,749 |
Total | 81,143 | 87,530 |
Less Current Portion | (5,792) | (4,826) |
Long-Term Portion | $ 75,351 | $ 82,704 |
Other Long-Term Liabilities- NJ
Other Long-Term Liabilities- NJ Tax (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Nov. 30, 2015 | Dec. 31, 2014 | Jan. 31, 2014 | Jan. 31, 2013 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Investment and Other Income, Net | $ 398 | $ 395 | $ 1,611 | $ 1,841 | ||||
New Jersey Tax Benefit | ||||||||
Amount of tax benefit | $ 9,800 | $ 1,900 | $ 1,100 | $ 800 | ||||
Proceeds from sale of tax credits | $ 9,200 | $ 1,800 | $ 1,000 | $ 800 | ||||
Base of operations requirement (in years) | 5 years | |||||||
Investment and Other Income, Net | $ 0 | $ 0 | $ 500 | $ 600 |
Other Long-Term Liabilities - L
Other Long-Term Liabilities - Lease Restructure (Details) $ in Thousands | 1 Months Ended | 9 Months Ended | |
Mar. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2016ft² | |
Accrued Lease Restructuring | |||
Beginning Balance | $ 1,154 | ||
Expense | 170 | ||
Payments | (470) | ||
Ending Balance | $ 854 | ||
Needham Massachusetts, non occupancy | |||
Lease Restructuring | |||
Expansion space (in square feet) | ft² | 11,500 | ||
General and administrative | Branford, CT lease termination | |||
Accrued Lease Restructuring | |||
Expense | $ 200 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | ||
Oct. 31, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | May 31, 2016 | |
Stockholders' Equity | ||||
Net proceeds from sale of common stock | $ 32,642 | $ 10,666 | ||
Controlled Equity Offering Sales Agreement | Common Stock | ||||
Stockholders' Equity | ||||
Aggregate offering price of common stock | $ 60,000 | |||
Common stock issued (in shares) | 11,326,363 | |||
Net proceeds from sale of common stock | $ 32,600 | |||
Aggregate gross offering price available | $ 11,700 | |||
Controlled Equity Offering Sales Agreement | Common Stock | Subsequent Event | ||||
Stockholders' Equity | ||||
Common stock issued (in shares) | 3,871,709 | |||
Net proceeds from sale of common stock | $ 11,300 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Plans (Details) - Stock options - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Shares | ||
Options Outstanding at beginning of the period (in shares) | 10,218,710 | |
Granted (in shares) | 2,309,900 | |
Canceled (in shares) | (945,792) | |
Options Outstanding at the end of the period (in shares) | 11,582,818 | 10,218,710 |
Options Vested and Expected to Vest at the end of the period (in shares) | 11,460,583 | |
Options Exercisable at the end of the period (in shares) | 7,360,799 | |
Shares Available for Grant Under the 2008 Plan | 7,780,663 | |
Weighted Average Exercise Price Per Share | ||
Options Outstanding at beginning of the period (in dollars per share) | $ 11.14 | |
Granted (in dollars per share) | 2.34 | |
Canceled (in dollars per share) | 9.21 | |
Options Outstanding at the end of the period (in dollars per share) | 9.54 | $ 11.14 |
Options Vested and Expected to Vest at the end of the period (in dollars per share) | 9.59 | |
Options Exercisable at the end of the period (in dollars per share) | $ 11.05 | |
Weighted Average Remaining Contractual Term (In Years) | ||
Options Outstanding at the end of the period | 5 years 10 months 24 days | 6 years 6 months |
Options Vested and Expected to Vest at the end of the period | 5 years 9 months 18 days | |
Options Exercisable at the end of the period | 4 years 1 month 6 days | |
Weighted average grant-date fair value (in dollars per share) | $ 1.57 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Stock-based compensation expense | ||||
Total stock-based compensation expense | $ 2,739 | $ 3,796 | $ 9,728 | $ 11,709 |
Research and development | ||||
Stock-based compensation expense | ||||
Total stock-based compensation expense | 1,546 | 2,042 | 5,310 | 5,866 |
General and administrative | ||||
Stock-based compensation expense | ||||
Total stock-based compensation expense | $ 1,193 | $ 1,754 | $ 4,418 | $ 5,843 |
Stock-Based Compensation - Valu
Stock-Based Compensation - Valuation (Details) - Stock options | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Black-Scholes option with following assumptions: | ||||
Expected stock price volatility (as a percent) | 76.00% | 76.00% | ||
Expected stock price volatility, minimum (as a percent) | 76.00% | 70.00% | ||
Expected stock price volatility, maximum (as a percent) | 77.00% | 77.00% | ||
Expected option term | 6 years | 6 years | 6 years | 6 years |
Risk-free interest rate (as a percent) | 2.00% | 1.40% | ||
Risk-free interest rate, minimum (as a percent) | 2.00% | 1.40% | ||
Risk-free interest rate, maximum (as a percent) | 2.30% | 1.60% | ||
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% | 0.00% |
Accumulated Other Comprehensi42
Accumulated Other Comprehensive Income (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2017USD ($) | |
Changes in accumulated other comprehensive income | |
Amounts reclassified from other comprehensive income | $ 0 |
Balance at December 31, 2016 | 265,431 |
Balance at September 30, 2017 | 219,152 |
Unrealized (Loss) Gain on Marketable Securities | |
Changes in accumulated other comprehensive income | |
Balance at December 31, 2016 | (55) |
Other comprehensive gain | 47 |
Balance at September 30, 2017 | (8) |
Foreign Currency Items | |
Changes in accumulated other comprehensive income | |
Balance at December 31, 2016 | 2,596 |
Balance at September 30, 2017 | 2,596 |
Accumulated Other Comprehensive Income | |
Changes in accumulated other comprehensive income | |
Balance at December 31, 2016 | 2,541 |
Other comprehensive gain | 47 |
Balance at September 30, 2017 | $ 2,588 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2014 | Dec. 31, 2016 | |
Revenue | ||||||
Deferred revenue | $ 3,726 | $ 3,726 | $ 3,749 | |||
Revenues | 3,924 | $ 2,220 | 9,287 | $ 4,913 | ||
Rockefeller | ||||||
Revenue | ||||||
Revenues | 300 | 1,100 | 1,400 | 1,800 | ||
Bristol-Myers Squibb Company | ||||||
Revenue | ||||||
Estimated performance period (in years) | 5 years | |||||
Deferred revenue | $ 5,000 | |||||
Reimbursement of external costs incurred by the company (as a percent) | 50.00% | |||||
Revenues | 900 | $ 500 | 2,100 | $ 1,500 | ||
International AIDS Vaccine Initiative | ||||||
Revenue | ||||||
Revenues | 1,700 | 4,000 | ||||
Frontier Biotechnologies Inc | ||||||
Revenue | ||||||
Revenues | $ 600 | $ 600 |
Kolltan Acquisition- Purchase P
Kolltan Acquisition- Purchase Price (Details) - USD ($) $ / shares in Units, $ in Thousands | Nov. 29, 2016 | Sep. 30, 2017 | Dec. 31, 2016 |
Acquisition-date fair value of consideration transferred | |||
Fair value of contingent consideration | $ 44,000 | $ 44,200 | |
Kolltan | |||
Kolltan Acquisition | |||
Shares issued as part of consideration (in shares) | 18,257,996 | ||
Shares issuable in lieu of cash severance obligations (in shares) | 437,901 | ||
Shares issued in lieu of cash severance obligations (in shares) | 91,749 | ||
Remaining obligation (in shares) | 125,123 | ||
Closing price of common stock (in dollars per share) | $ 4.02 | ||
Acquisition-date fair value of consideration transferred | |||
Fair value of common stock issued for upfront payment | $ 73,397 | ||
Fair value of contingent consideration | 44,200 | ||
Kolltan transaction expenses paid in cash by the Company | 3,768 | ||
Total consideration transferred | 121,365 | ||
Kolltan | Specified development, regulatory approvals or sales-based milestones | |||
Kolltan Acquisition | |||
Milestone payments | $ 172,500 |
Kolltan Acquisition - Allocatio
Kolltan Acquisition - Allocations of Assets and Liabilities (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2016 | Sep. 30, 2016 | Sep. 30, 2017 | Dec. 31, 2016 | Nov. 29, 2016 | |
Summary of fair values of assets acquired and liabilities assumed | |||||
Goodwill | $ 90,976 | $ 90,976 | |||
Kolltan | |||||
Kolltan Acquisition | |||||
Goodwill expected to be deductible for income tax purposes | $ 0 | ||||
Summary of fair values of assets acquired and liabilities assumed | |||||
Cash and cash equivalents | 8,160 | ||||
Other current and long-term assets | 799 | ||||
Property and equipment, net | 2,072 | ||||
In-process research and development (IPR&D) | 61,690 | ||||
Goodwill | 82,011 | ||||
Deferred tax liabilities, net | (23,393) | ||||
Other assumed liabilities | (9,974) | ||||
Total | $ 121,365 | ||||
Pro Forma Financial Information | |||||
Net loss | $ (35,500) | $ (120,400) | |||
Basic and Diluted Net Loss Per Common Share | $ (0.3) | $ (1.02) |
Income Taxes (Details)
Income Taxes (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2017USD ($)state | Sep. 30, 2017USD ($)state | Dec. 31, 2016USD ($) | |
Income Taxes | |||
Number of states in which the entity primarily operates or has operated and has income tax nexus | state | 3 | 3 | |
Net Deferred Tax Liabilities related to In-Process Research and Development | $ 22,854 | $ 22,854 | $ 28,054 |
Decrease in deferred tax liabilities | $ (5,200) | $ (5,200) |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Anti-dilutive securities | ||
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 | 11,679,486 | 10,210,598 |
Stock options | ||
Anti-dilutive securities | ||
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 | 11,582,818 | 10,150,598 |
Restricted stock | ||
Anti-dilutive securities | ||
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 | 96,668 | 60,000 |