Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Oct. 27, 2015 | |
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, 2015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 98,645,692 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Current Assets: | ||
Cash and Cash Equivalents | $ 66,791 | $ 28,020 |
Marketable Securities | 237,819 | 173,023 |
Accounts and Other Receivables | 527 | 427 |
Prepaid and Other Current Assets | 4,119 | 3,515 |
Total Current Assets | 309,256 | 204,985 |
Property and Equipment, Net | 11,864 | 10,535 |
Intangible Assets, Net | 21,047 | 21,807 |
Other Assets | 1,500 | 1,722 |
Goodwill | 8,965 | 8,965 |
Total Assets | 352,632 | 248,014 |
Current Liabilities: | ||
Accounts Payable | 1,217 | 2,603 |
Accrued Expenses | 19,623 | 19,296 |
Current Portion of Long-Term Liabilities | 2,795 | 2,592 |
Total Current Liabilities | 23,635 | 24,491 |
Other Long-Term Liabilities | 10,370 | 11,863 |
Total Liabilities | $ 34,005 | $ 36,354 |
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, 2015 and December 31, 2014 | ||
Common Stock, $.001 Par Value; 297,000,000 Shares Authorized; 98,645,692 and 89,592,779 Shares Issued and Outstanding at September 30, 2015 and December 31, 2014, respectively | $ 99 | $ 90 |
Additional Paid-In Capital | 874,240 | 672,739 |
Accumulated Other Comprehensive Income | 2,560 | 2,590 |
Accumulated Deficit | (558,272) | (463,759) |
Total Stockholders' Equity | 318,627 | 211,660 |
Total Liabilities and Stockholders' Equity | $ 352,632 | $ 248,014 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2015 | Dec. 31, 2014 |
CONDENSED BALANCE SHEETS (Parenthetical) | ||
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 | 98,645,692 | 89,592,779 |
Common Stock, Shares Outstanding | 98,645,692 | 89,592,779 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
REVENUE: | ||||
Product Development and Licensing Agreements | $ 377 | $ 284 | $ 1,053 | $ 518 |
Contracts and Grants | 649 | 817 | 2,636 | 1,591 |
Total Revenue | 1,026 | 1,101 | 3,689 | 2,109 |
OPERATING EXPENSE: | ||||
Research and Development | 24,656 | 26,185 | 76,271 | 77,355 |
General and Administrative | 8,487 | 5,004 | 22,761 | 14,373 |
Amortization of Acquired Intangible Assets | 254 | 254 | 760 | 760 |
Total Operating Expense | 33,397 | 31,443 | 99,792 | 92,488 |
Operating Loss | (32,371) | (30,342) | (96,103) | (90,379) |
Investment and Other Income, Net | 391 | 2,260 | 1,590 | 4,121 |
Net Loss | $ (31,980) | $ (28,082) | $ (94,513) | $ (86,258) |
Basic and Diluted Net Loss Per Common Share (Note 3) (in dollars per share) | $ (0.32) | $ (0.31) | $ (0.98) | $ (0.97) |
Shares Used in Calculating Basic and Diluted Net Loss per Share (Note 3) (in shares) | 98,568 | 89,404 | 96,518 | 89,346 |
COMPREHENSIVE LOSS: | ||||
Net Loss | $ (31,980) | $ (28,082) | $ (94,513) | $ (86,258) |
Other Comprehensive (Loss) Income: | ||||
Foreign Currency Translation Adjustments | (3) | 15 | (4) | |
Unrealized Gain (Loss) on Marketable Securities | 124 | (121) | (45) | (40) |
Comprehensive Loss | $ (31,856) | $ (28,206) | $ (94,543) | $ (86,302) |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Cash Flows from Operating Activities: | ||
Net Loss | $ (94,513) | $ (86,258) |
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities: | ||
Depreciation and Amortization | 2,151 | 1,764 |
Amortization of Intangible Assets | 760 | 760 |
Amortization and Premium of Marketable Securities, Net | (501) | (754) |
Realized Gain on Sales and Maturities of Marketable Securities | (11) | |
Stock-Based Compensation Expense | 8,677 | 4,719 |
Non-Cash Expense | 216 | |
Changes in Operating Assets and Liabilities: | ||
Accounts and Other Receivables | (100) | (2,416) |
Prepaid and Other Current Assets | (478) | (1,428) |
Other Assets | 6 | 49 |
Accounts Payable and Accrued Expenses | (70) | (740) |
Other Liabilities | (1,290) | 4,992 |
Net Cash Used in Operating Activities | (85,142) | (79,323) |
Cash Flows from Investing Activities: | ||
Sales and Maturities of Marketable Securities | 129,349 | 89,215 |
Purchases of Marketable Securities | (193,815) | (146,159) |
Acquisition of Property and Equipment | (4,469) | (1,766) |
Net Cash Used in Investing Activities | (68,935) | (58,710) |
Cash Flows from Financing Activities: | ||
Net Proceeds from Stock Issuances | 188,840 | |
Proceeds from Issuance of Stock from Employee Benefit Plans | 3,993 | 1,160 |
Net Cash Provided by Financing Activities | 192,833 | 1,160 |
Effect of Exchange Rate Changes on Cash and Cash Equivalents | 15 | (4) |
Net Increase (Decrease) in Cash and Cash Equivalents | 38,771 | (136,877) |
Cash and Cash Equivalents at Beginning of Period | 28,020 | 169,402 |
Cash and Cash Equivalents at End of Period | 66,791 | $ 32,525 |
Non-cash Investing Activities | ||
Acquisition of Property and Equipment included in Accounts Payable and Accrued Expenses | $ 38 |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2015 | |
Basis of Presentation | |
Basis of Presentation | (1) Basis of Presentation The accompanying unaudited condensed 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”). On December 31, 2014, the Company’s wholly-owned subsidiary, Celldex Research Corporation, merged into Celldex Therapeutics, Inc. The unaudited condensed statement of operations and comprehensive loss and the statement of cash flows for the three and nine months ended September 30, 2014 reflect the operations of the Company and its former wholly-owned subsidiary. All intercompany 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, 2014, which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 24, 2015. 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, 2015. At September 30, 2015, the Company had cash, cash equivalents and marketable securities of $304.6 million. The Company incurred a loss of $94.5 million for the nine months ended September 30, 2015. Net cash used in operations for the nine months ended September 30, 2015 was $85.1 million. The Company believes that the cash, cash equivalents and marketable securities at September 30, 2015 will be sufficient to meet estimated working capital requirements and fund planned operations for at least the next twelve months. During the next twelve months, the Company may take further steps to raise additional capital to meet its long-term liquidity needs. These capital raising activities may include, but may not be limited to, one or more of the following: the licensing of technology programs 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 financing 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. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
Significant Accounting Policies | |
Significant Accounting Policies | (2) Significant Accounting Policies The significant accounting policies used in preparation of these condensed financial statements for the nine months ended September 30, 2015 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, 2014, except for the adoption of new accounting standards during the first nine months of 2015 as discussed below. 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 financial position or results of operations upon adoption. In May 2014, the FASB issued a new U.S. GAAP accounting standard that creates modifications to various other revenue accounting standards for specialized transactions and industries. The new U.S. GAAP accounting standard is intended to conform revenue accounting principles with a concurrently issued new standard under International Financial Reporting Standards, as well as, to enhance disclosures related to disaggregated revenue information. In July 2015, the FASB voted to defer the amendments in this update apply public business entities for the annual period ending after December 15, 2017. The amendment allows for two methods of adoption, a full retrospective method or a modified retrospective approach with the cumulative effect recognized at the date of initial application. The Company will further study the implications of this standard in order to evaluate the expected impact on the financial statements. In April 2015, the FASB issued amendments that provide guidance to customers about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. The new guidance does not change the accounting for a customer’s accounting for service contracts. The standard update is effective for fiscal years beginning after December 15, 2015 and interim periods within those years. Early adoption is permitted. The standard allows for adoption retrospectively or prospectively to all arrangements entered into or materially modified after the effective date. The amendment is not expected to have a material impact on our financial statements. In August 2014, the FASB issued a new U.S. GAAP accounting standard that provides guidance about management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. The new accounting standard requires management to assess an entity’s ability to continue as a going concern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. The new accounting standard is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The Company does not expect the adoption of this standard to have a material impact on the financial statements. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2015 | |
Net Loss Per Share | |
Net Loss Per Share | (3) 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, 2015 2014 Stock options Restricted stock |
Comprehensive Loss
Comprehensive Loss | 9 Months Ended |
Sep. 30, 2015 | |
Comprehensive Loss | |
Comprehensive Loss | (4) Comprehensive Loss The changes in Accumulated Other Comprehensive Income by component for the three and nine months ended September 30, 2015 are summarized below. No amounts were reclassified out of accumulated other comprehensive income during the three or nine months ended September 30, 2015. Unrealized Gain (Loss) on Marketable Securities, net of tax Foreign Currency Items Total (In thousands) Balance at June 30, 2015 $ ) $ $ Other comprehensive income before reclassifications — Amounts reclassified from other comprehensive income — — — Net current-period other comprehensive income — Balance at September 30, 2015 $ ) $ $ Balance at December 31, 2014 $ $ $ Other comprehensive (loss) income before reclassifications ) ) Amounts reclassified from other comprehensive income — — — Net current-period other comprehensive income ) ) Balance at September 30, 2015 $ ) $ $ |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Measurements. | |
Fair Value Measurements | (5) Fair Value Measurements The following tables set forth the Company’s financial assets subject to fair value measurements: As of September 30, 2015 Level 1 Level 2 Level 3 (In thousands) Money market funds and cash equivalents $ $ — $ $ — Marketable securities — — $ $ — $ $ — As of December 31, 2014 Level 1 Level 2 Level 3 (In thousands) Money market funds and cash equivalents $ $ — $ $ — Marketable securities — — $ $ — $ $ — There have been no transfers of assets or liabilities between the fair value measurement classifications. The Company’s financial instruments consist mainly of cash and cash equivalents, marketable securities, short-term accounts receivable and accounts payable. 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. Short-term accounts receivable and accounts payable are reflected in the accompanying financial statements at cost, which approximates fair value due to the short-term nature of these instruments. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2015 | |
Marketable Securities | |
Marketable Securities | (6) Marketable Securities A summary of marketable securities is shown below: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value (In thousands) September 30, 2015 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, 2014 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 marketable securities held by the Company were high investment grade and there were no marketable securities that the Company considered to be other-than-temporarily impaired as of September 30, 2015. Marketable securities include $1.2 million and $1.4 million in accrued interest at September 30, 2015 and December 31, 2014, respectively. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 9 Months Ended |
Sep. 30, 2015 | |
Intangible Assets and Goodwill | |
Intangible Assets and Goodwill | (7) Intangible Assets and Goodwill Intangible assets, net of accumulated amortization, and goodwill are as follows: September 30, 2015 December 31, 2014 Estimated Life Cost Accumulated Amortization Net Cost Accumulated Amortization Net (In thousands) Intangible Assets: IPR&D Indefinite $ — $ $ — $ Amgen Amendment 16 years $ ) $ ) Core Technology 11 years ) ) Total Intangible Assets $ $ ) $ $ $ ) $ Goodwill Indefinite $ — $ $ — $ The IPR&D intangible asset was recorded in connection with the acquisition of CuraGen and relates to the development of glembatumumab vedotin. At the date of acquisition and at September 30, 2015, glembatumumab vedotin had not yet reached technological feasibility nor did it have any alternative future use. Glembatumumab vedotin is in a randomized, Phase 2b study for the treatment of triple negative breast cancer and a Phase 2 study for the treatment of metastatic melanoma. The Company performed an annual impairment test of the IPR&D and goodwill assets as of July 1, 2015 and concluded that the IPR&D and goodwill assets were not impaired. |
Other Long-Term Liabilities
Other Long-Term Liabilities | 9 Months Ended |
Sep. 30, 2015 | |
Other Long-Term Liabilities | |
Other Long-Term Liabilities | (8) Other Long-Term Liabilities Other long-term liabilities include the following: September 30, 2015 December 31, 2014 (In thousands) Deferred Rent $ $ Net Deferred Tax Liability related to IPR&D Deferred Income from Sale of Tax Benefits Deferred Revenue Total Less Current Portion ) ) Long-Term Portion $ $ In December 2014, January 2014, January 2013, January 2012 and January 2011, the Company received approval from the New Jersey Economic Development Authority and agreed to sell New Jersey tax benefits worth $1.9 million, $1.1 million, $0.8 million, $0.8 million and $0.6 million to an independent third party for $1.8 million, $1.0 million, $0.8 million, $0.7 million and $0.5 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. During the nine months ended September 30, 2015 and 2014, the Company recorded $0.6 million and $0.4 million to other income related to the sale of these tax benefits, respectively. In September 2013, the Company entered into an agreement with Rockefeller University pursuant to which the Company performs research and development services for Rockefeller. The agreement included an upfront payment of $1.3 million which is being recognized as revenue over the term of the agreement. The Company bills Rockefeller quarterly for actual time and direct costs incurred and recorded $0.5 million and $2.1 million in revenue related to the Rockefeller agreement during the three and nine months ended September 30, 2015 and $0.8 million and $1.5 million during the three and nine months ended September 30, 2014, respectively. In May 2014, the Company entered into a clinical trial collaboration with Bristol-Myers Squibb Company (“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 (a subsidiary of 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 will 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. These BMS payments will be recognized as revenue under the CAPM. The Company recorded $0.3 million and $1.0 million in revenue related to the BMS agreement during the three and nine months ended September 30, 2015, respectively, and $0.3 million and $0.4 million during the three and nine months ended September 30, 2014, respectively. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2015 | |
Stockholders' Equity | |
Stockholders' Equity | (9) Stockholders’ Equity In March 2015, the Company issued 8,337,500 shares of its common stock in an underwritten public offering resulting in net proceeds to the Company of $188.8 million, after deducting underwriting fees and offering expenses. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2015 | |
Stock-Based Compensation | |
Stock-Based Compensation | (10) Stock-Based Compensation A summary of stock option activity for the nine months ended September 30, 2015 is as follows: Shares Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (In Years) Options Outstanding at December 31, 2014 $ Granted $ Exercised ) $ Canceled ) $ Options Outstanding at September 30, 2015 $ Options Vested and Expected to Vest at September 30, 2015 $ Options Exercisable at September 30, 2015 $ Shares Available for Grant under the 2008 Plan The weighted average grant-date fair value of stock options granted during the nine months ended September 30, 2015 was $15.41 per share. Stock-based compensation expense for the three and nine months ended September 30, 2015 and 2014 was recorded as follows: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 (In thousands) Research and development $ $ $ $ General and administrative Total stock-based compensation expense $ $ $ $ The fair values of employee and director stock options granted during the three and nine months ended September 30, 2015 and 2014 were valued using the Black-Scholes option-pricing model with the following assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Expected stock price volatility % % 67 - 69 % 71 - 72 % Expected option term 6.0 years 6.0 years 6.0 years 6.0 years Risk-free interest rate % 2.1 - 2.2 % 1.8 - 2.2 % 2.1 - 2.2 % Expected dividend yield None None None None |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2015 | |
Income Taxes | |
Income Taxes | (11) 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 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, 2015 and December 31, 2014 against the Company’s net deferred tax assets. |
Significant Accounting Polici17
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Significant Accounting Policies | |
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 financial position or results of operations upon adoption. In May 2014, the FASB issued a new U.S. GAAP accounting standard that creates modifications to various other revenue accounting standards for specialized transactions and industries. The new U.S. GAAP accounting standard is intended to conform revenue accounting principles with a concurrently issued new standard under International Financial Reporting Standards, as well as, to enhance disclosures related to disaggregated revenue information. In July 2015, the FASB voted to defer the amendments in this update apply public business entities for the annual period ending after December 15, 2017. The amendment allows for two methods of adoption, a full retrospective method or a modified retrospective approach with the cumulative effect recognized at the date of initial application. The Company will further study the implications of this standard in order to evaluate the expected impact on the financial statements. In April 2015, the FASB issued amendments that provide guidance to customers about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. The new guidance does not change the accounting for a customer’s accounting for service contracts. The standard update is effective for fiscal years beginning after December 15, 2015 and interim periods within those years. Early adoption is permitted. The standard allows for adoption retrospectively or prospectively to all arrangements entered into or materially modified after the effective date. The amendment is not expected to have a material impact on our financial statements. In August 2014, the FASB issued a new U.S. GAAP accounting standard that provides guidance about management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. The new accounting standard requires management to assess an entity’s ability to continue as a going concern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. The new accounting standard is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The Company does not expect the adoption of this standard to have a material impact on the financial statements. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
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, 2015 2014 Stock options Restricted stock |
Comprehensive Loss (Tables)
Comprehensive Loss (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Comprehensive Loss | |
Summary of changes in accumulated other comprehensive income (loss) by component | Unrealized Gain (Loss) on Marketable Securities, net of tax Foreign Currency Items Total (In thousands) Balance at June 30, 2015 $ ) $ $ Other comprehensive income before reclassifications — Amounts reclassified from other comprehensive income — — — Net current-period other comprehensive income — Balance at September 30, 2015 $ ) $ $ Balance at December 31, 2014 $ $ $ Other comprehensive (loss) income before reclassifications ) ) Amounts reclassified from other comprehensive income — — — Net current-period other comprehensive income ) ) Balance at September 30, 2015 $ ) $ $ |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Measurements. | |
Schedule of financial assets subject to fair value measurements | As of September 30, 2015 Level 1 Level 2 Level 3 (In thousands) Money market funds and cash equivalents $ $ — $ $ — Marketable securities — — $ $ — $ $ — As of December 31, 2014 Level 1 Level 2 Level 3 (In thousands) Money market funds and cash equivalents $ $ — $ $ — Marketable securities — — $ $ — $ $ — |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Marketable Securities | |
Summary of marketable securities | Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value (In thousands) September 30, 2015 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, 2014 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, 2015 | |
Intangible Assets and Goodwill | |
Schedule of intangible assets, net of accumulated amortization, and goodwill | September 30, 2015 December 31, 2014 Estimated Life Cost Accumulated Amortization Net Cost Accumulated Amortization Net (In thousands) Intangible Assets: IPR&D Indefinite $ — $ $ — $ Amgen Amendment 16 years $ ) $ ) Core Technology 11 years ) ) Total Intangible Assets $ $ ) $ $ $ ) $ Goodwill Indefinite $ — $ $ — $ |
Other Long-Term Liabilities (Ta
Other Long-Term Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Other Long-Term Liabilities | |
Schedule of Other long-term liabilities | September 30, 2015 December 31, 2014 (In thousands) Deferred Rent $ $ Net Deferred Tax Liability related to IPR&D Deferred Income from Sale of Tax Benefits Deferred Revenue Total Less Current Portion ) ) Long-Term Portion $ $ |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Stock-Based Compensation | |
Summary of stock option activity | Shares Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (In Years) Options Outstanding at December 31, 2014 $ Granted $ Exercised ) $ Canceled ) $ Options Outstanding at September 30, 2015 $ Options Vested and Expected to Vest at September 30, 2015 $ Options Exercisable at September 30, 2015 $ Shares Available for Grant under the 2008 Plan |
Schedule of stock-based compensation expense | Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 (In thousands) Research and development $ $ $ $ General and administrative Total stock-based compensation expense $ $ $ $ |
Schedule of assumptions used for the fair values of employee stock options granted | Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Expected stock price volatility % % 67 - 69 % 71 - 72 % Expected option term 6.0 years 6.0 years 6.0 years 6.0 years Risk-free interest rate % 2.1 - 2.2 % 1.8 - 2.2 % 2.1 - 2.2 % Expected dividend yield None None None None |
Basis of Presentation (Details)
Basis of Presentation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Basis of Presentation | ||||
Cash, cash equivalents and marketable securities | $ 304,600 | $ 304,600 | ||
Net Loss | $ (31,980) | $ (28,082) | (94,513) | $ (86,258) |
Net cash used in operations | $ (85,142) | $ (79,323) |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
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 | 8,127,878 | 7,008,421 |
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 | 8,098,128 | 6,999,421 |
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 | 29,750 | 9,000 |
Comprehensive Loss (Details)
Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2015 | Sep. 30, 2015 | |
Changes in accumulated other comprehensive income (loss) by component | ||
Balance at the beginning of the period | $ 2,436 | $ 2,590 |
Other comprehensive (loss) income before reclassifications | 124 | (30) |
Net current-period other comprehensive income | 124 | (30) |
Balance at the end of the period | 2,560 | 2,560 |
Unrealized Gain (Loss) on Marketable Securities, net of tax | ||
Changes in accumulated other comprehensive income (loss) by component | ||
Balance at the beginning of the period | (160) | 9 |
Other comprehensive (loss) income before reclassifications | 124 | (45) |
Net current-period other comprehensive income | 124 | (45) |
Balance at the end of the period | (36) | (36) |
Foreign Currency Items | ||
Changes in accumulated other comprehensive income (loss) by component | ||
Balance at the beginning of the period | 2,596 | 2,581 |
Other comprehensive (loss) income before reclassifications | 15 | |
Net current-period other comprehensive income | 15 | |
Balance at the end of the period | $ 2,596 | $ 2,596 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Fair value measurements | ||
Assets transferred between the fair value measurement classifications | $ 0 | |
Liabilities transferred between the fair value measurement classifications | 0 | |
Fair Value Measurements | Level 2 | ||
Fair value measurements | ||
Money market funds and cash equivalents | 54,692 | $ 18,677 |
Marketable securities | 237,819 | 173,023 |
Total financial assets at fair value | 292,511 | 191,700 |
Fair Value Measurements | Fair value | ||
Fair value measurements | ||
Money market funds and cash equivalents | 54,692 | 18,677 |
Marketable securities | 237,819 | 173,023 |
Total financial assets at fair value | $ 292,511 | $ 191,700 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Amortized Cost | ||
Amortized cost | $ 237,855 | $ 173,014 |
Gross Unrealized Gains | ||
Gross Unrealized Gains | 120 | 88 |
Gross Unrealized Losses | ||
Gross Unrealized Losses | (156) | (79) |
Fair Value | ||
Fair Value | 237,819 | 173,023 |
Marketable securities considered to be other-than-temporarily impaired | 0 | |
Accrued interest included in marketable securities | 1,200 | 1,400 |
U.S. government and municipal obligations | ||
Amortized Cost | ||
Maturing in one year or less | 43,379 | 44,580 |
Maturing after one year through three years | 22,921 | 16,108 |
Amortized cost | 66,300 | 60,688 |
Gross Unrealized Gains | ||
Maturing in one year or less | 21 | 30 |
Maturing after one year through three years | 54 | 49 |
Gross Unrealized Gains | 75 | 79 |
Gross Unrealized Losses | ||
Maturing in one year or less | (2) | (6) |
Maturing after one year through three years | (45) | (1) |
Gross Unrealized Losses | (47) | (7) |
Fair Value | ||
Maturing in one year or less | 43,398 | 44,604 |
Maturing after one year through three years | 22,930 | 16,156 |
Fair Value | 66,328 | 60,760 |
Corporate debt securities | ||
Amortized Cost | ||
Maturing in one year or less | 135,613 | 89,636 |
Maturing after one year through three years | 35,942 | 22,690 |
Amortized cost | 171,555 | 112,326 |
Gross Unrealized Gains | ||
Maturing in one year or less | 24 | 6 |
Maturing after one year through three years | 21 | 3 |
Gross Unrealized Gains | 45 | 9 |
Gross Unrealized Losses | ||
Maturing in one year or less | (89) | (37) |
Maturing after one year through three years | (20) | (35) |
Gross Unrealized Losses | (109) | (72) |
Fair Value | ||
Maturing in one year or less | 135,548 | 89,605 |
Maturing after one year through three years | 35,943 | 22,658 |
Fair Value | $ 171,491 | $ 112,263 |
Intangible Assets and Goodwil30
Intangible Assets and Goodwill (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Dec. 31, 2014 | |
Intangible Assets and Goodwill | ||
Goodwill | $ 8,965 | $ 8,965 |
Finite-lived intangible asset | ||
Accumulated Amortization | (6,549) | (5,789) |
Total Intangible Assets | ||
Cost of total intangible assets | 27,596 | 27,596 |
Intangible Assets, Net (Excluding Goodwill) | $ 21,047 | 21,807 |
Amgen Amendment | ||
Finite-lived intangible asset | ||
Estimated Life | 16 years | |
Cost | $ 14,500 | 14,500 |
Accumulated Amortization | (5,381) | (4,708) |
Net | $ 9,119 | 9,792 |
Core Technology | ||
Finite-lived intangible asset | ||
Estimated Life | 11 years | |
Cost | $ 1,296 | 1,296 |
Accumulated Amortization | (1,168) | (1,081) |
Net | 128 | 215 |
IPR&D | ||
Indefinite-lived intangible assets: | ||
Indefinite-lived intangible assets | $ 11,800 | $ 11,800 |
Other Long-Term Liabilities (De
Other Long-Term Liabilities (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jan. 31, 2014 | Jan. 31, 2013 | Jan. 31, 2012 | Jan. 31, 2011 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
Other Long-Term Liabilities | |||||||
Deferred Rent | $ 399 | $ 482 | |||||
Net Deferred Tax Liability related to IPR&D | 4,661 | 4,661 | |||||
Deferred Income from Sale of Tax Benefits | 3,417 | 4,015 | |||||
Deferred Revenue | 4,688 | 5,297 | |||||
Total | 13,165 | 14,455 | |||||
Less Current Portion | (2,795) | (2,592) | |||||
Long-Term Portion | $ 10,370 | 11,863 | |||||
Amount at which New Jersey tax benefit agreed to be sold | $ 1,100 | $ 800 | $ 800 | $ 600 | 1,900 | ||
Amount of sale of New Jersey tax benefit | $ 1,000 | $ 800 | $ 700 | $ 500 | $ 1,800 | ||
Period for which base of operations must be maintained | 5 years | ||||||
Other income related to sale of tax benefits | $ 600 | $ 400 |
Other Long-Term Liablilities (D
Other Long-Term Liablilities (Details 2) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
May. 31, 2014 | Sep. 30, 2013 | Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
REVENUE | ||||||
Contracts and Grants | $ 649 | $ 817 | $ 2,636 | $ 1,591 | ||
Rockefeller Development Services Agreement | ||||||
REVENUE | ||||||
Upfront payment recognized as revenue over the term of the agreement | $ 1,300 | |||||
Contracts and Grants | 500 | 800 | 2,100 | 1,500 | ||
Bristol Meyers Collaborative Arrangement | ||||||
REVENUE | ||||||
Term of the agreement | 5 years | |||||
Upfront payment recognized as revenue over the term of the agreement | $ 5,000 | |||||
Contracts and Grants | $ 300 | $ 300 | $ 1,000 | $ 400 | ||
Reimbursement of external costs incurred by the company (as a percent) | 50.00% |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Underwritten Public Offering $ in Millions | 1 Months Ended |
Mar. 31, 2015USD ($)shares | |
Stockholders' Equity | |
Common stock issued (in shares) | shares | 8,337,500 |
Net proceeds from sale of stock in an underwritten public offering | $ 188.8 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - Stock options - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2015 | Dec. 31, 2014 | |
Shares | ||
Options Outstanding at beginning of the period (in shares) | 7,015,350 | |
Granted (in shares) | 1,806,650 | |
Exercised (in shares) | (660,658) | |
Canceled (in shares) | (63,214) | |
Options Outstanding at the end of the period (in shares) | 8,098,128 | 7,015,350 |
Options Vested and Expected to Vest at the end of the period (in shares) | 8,045,278 | |
Options Exercisable at the end of the period (in shares) | 4,480,232 | |
Shares Available for Grant under the 2008 Plan (in shares) | 5,842,723 | |
Weighted Average Exercise Price Per Share | ||
Options Outstanding at beginning of the period (in dollars per share) | $ 9.34 | |
Granted (in dollars per share) | 25.05 | |
Exercised (in dollars per share) | 5.68 | |
Canceled (in dollars per share) | 15.32 | |
Options Outstanding at the end of the period (in dollars per share) | 13.10 | $ 9.34 |
Options Vested and Expected to Vest at the end of the period (in dollars per share) | 13.04 | |
Options Exercisable at the end of the period (in dollars per share) | $ 8.25 | |
Weighted Average Remaining Contractual Term | ||
Options Outstanding at the beginning of the period | 6 years 10 months 24 days | 6 years 7 months 6 days |
Options Outstanding at the end of the period | 6 years 10 months 24 days | 6 years 7 months 6 days |
Options Vested and Expected to Vest at the end of the period | 6 years 10 months 24 days | |
Options Exercisable at the end of the period | 5 years 3 months 18 days | |
Additional information | ||
Weighted average grant-date fair value (in dollars per share) | $ 15.41 |
Stock-Based Compensation (Det35
Stock-Based Compensation (Details 2) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Valuation and Expenses Information | ||||
Total stock-based compensation expense (in dollars) | $ 3,868 | $ 1,958 | $ 8,677 | $ 4,719 |
Stock options | ||||
Assumptions used for fair values of employee and director stock options granted | ||||
Expected stock price volatility (as a percent) | 67.00% | 72.00% | ||
Expected stock price volatility, minimum (as a percent) | 67.00% | 71.00% | ||
Expected stock price volatility, maximum (as a percent) | 69.00% | 72.00% | ||
Expected option term | 6 years | 6 years | 6 years | 6 years |
Risk-free interest rate (as a percent) | 1.90% | |||
Risk-free interest rate, minimum (as a percent) | 2.10% | 1.80% | 2.10% | |
Risk-free interest rate, maximum (as a percent) | 2.20% | 2.20% | 2.20% | |
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% | 0.00% |
Research and development | ||||
Valuation and Expenses Information | ||||
Total stock-based compensation expense (in dollars) | $ 1,715 | $ 977 | $ 4,228 | $ 2,315 |
General and administrative | ||||
Valuation and Expenses Information | ||||
Total stock-based compensation expense (in dollars) | $ 2,153 | $ 981 | $ 4,449 | $ 2,404 |
Income Taxes (Details)
Income Taxes (Details) | Sep. 30, 2015item |
Income Taxes | |
Number of states in which the entity primarily operates or has operated and has income tax nexus | 3 |