Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2014 |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation |
The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries located in Europe. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates |
The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents |
The Company considers all highly liquid investments with an initial maturity date at the date of purchase of three months or less to be cash equivalents. |
Investment Securities | Investment Securities |
The Company has classified all of its investment securities as available-for-sale and, accordingly, carries these investments at fair value. Unrealized gains and losses, if any, are reported as a separate component of stockholders’ equity. The cost of investment securities classified as available-for-sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses, if any, are also included in interest income. The cost of securities sold is based on the specific identification method. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments |
The carrying values of the Company’s financial instruments, consisting of cash and cash equivalents, interest and other receivables, and accounts payable and accrued expenses, approximate fair value due to the relative short-term nature of these instruments. |
As disclosed in Note 4, the Company classifies its cash equivalents and available-for-sale investment securities within the fair value hierarchy as defined by authoritative guidance: |
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Level 1 Inputs | | | — | | | Quoted prices for identical instruments in active markets. | | | | | | |
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Level 2 Inputs | | | — | | | Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable. | | | | | | |
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Level 3 Inputs | | | — | | | Valuation derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. | | | | | | |
Property and Equipment | Property and Equipment |
Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight line method. Leasehold improvements are amortized over the shorter of their estimated useful lives or the term of the lease by use of the straight line method. Construction-in-process reflects amounts incurred for property, equipment or improvements that have not been placed in service. Maintenance and repair costs are expensed as incurred. When assets are retired or sold, the assets and accumulated depreciation are removed from the respective accounts and any gain or loss is recognized. |
Estimated useful lives by major asset category are as follows: |
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| | Useful Lives | | | | | | | | | |
Machinery and equipment | | | 5 to 7 years | | | | | | | | | |
Computers and software | | | 3 years | | | | | | | | | |
Furniture and fixtures | | | 10 years | | | | | | | | | |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets |
The Company reviews its long lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. No such impairment losses have been recorded by the Company. |
Revenues | Revenues |
The Company recognizes revenues in accordance with authoritative guidance established by GAAP. The Company’s revenues are primarily related to its collaboration agreements, which may provide for various types of payments, including upfront payments, funding of research and development, milestone payments, and licensing fees. The Company’s collaboration agreements also include potential payments for product royalties; however, the Company has not received any product royalties to date. |
The Company considers a variety of factors in determining the appropriate method of accounting under its collaboration agreements, including whether the various elements can be separated and accounted for individually as separate units of accounting. Where there are multiple deliverables identified within a collaboration agreement that are combined into a single unit of accounting, revenues are deferred and recognized over the expected period of performance. The specific methodology for the recognition of the revenue is determined on a case-by-case basis according to the facts and circumstances of the applicable agreement. |
Upfront, non-refundable payments that do not have stand-alone value are recorded as deferred revenue once received and recognized as revenues over the expected period of performance. Revenues from non-refundable license fees are recognized upon receipt of the payment if the license has stand-alone value, the Company does not have ongoing involvement or obligations, and the Company can determine the best estimate of the selling price for any undelivered items. When non-refundable license fees do not meet all of these criteria, the license revenues are recognized over the expected period of performance. Non-refundable payments for research funding are generally recognized as revenues over the period the related research activities are performed. Payments for reimbursement of external development costs are generally recognized as revenues using a contingency-adjusted performance model over the expected period of performance. Payments received from grants are recognized as revenues as the related research and development is performed and when collectability has been reasonably assured. |
The Company evaluates milestone payments on an individual basis and recognizes revenues from non-refundable milestone payments when the earnings process is complete and collectability is reasonably assured. Non-refundable milestone payments related to arrangements under which the Company has continuing performance obligations are recognized as revenues upon achievement of the associated milestone, provided that (i) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement and (ii) the amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with the milestone event. Where separate milestone payments do not meet these criteria, the Company recognizes revenue using a contingency-adjusted performance model over the expected period of performance. |
Research and Development Expenses | Research and Development Expenses |
Research and development expenses are charged to operations as incurred. Research and development expenses include, among other things, costs associated with services provided by contract organizations for preclinical development, manufacturing of product candidates, and clinical trials. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or services provided and the invoices received from its external service providers. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. Other indirect costs are generally recognized on a straight-line basis over the estimated period of the study. As actual costs become known, the Company adjusts its accruals. Certain research and development programs are funded under agreements with collaboration partners, and the Company’s costs related to these activities are included in research and development expenses. |
Concentrations of Risk | Concentrations of Risk |
Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash, cash equivalents, and investment securities. The Company currently invests its excess cash primarily in a money market fund, U.S. Treasury notes, and high quality, marketable debt instruments of corporations, financial institutions and government sponsored enterprises in accordance with the Company’s investment policy. The Company’s investment policy defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. All investment securities have a credit rating of at least A3/A- or better, or P-1/A-1 or better, as determined by Moody’s Investors Service or Standard & Poor’s. |
During the years ended December 31, 2014, 2013 and 2012, revenues from the Company’s agreements with certain collaborative partners exceeded 10 percent of its total revenues. During the year ended December 31, 2014, revenues from Fast Forward, LLC and Allergan, Inc. comprised 59 percent and 33 percent of total revenues, respectively. During the year ended December 31, 2013, revenues from Allergan, the National Institutes of Health, and The Michael J. Fox Foundation comprised 50 percent, 19 percent, and 15 percent of total revenues, respectively. During the year ended December 31, 2012, revenues from Allergan and Meiji Seika Pharma Co., Ltd. comprised 23 percent and 66 percent of total revenues, respectively. |
The Company does not currently have any of its own manufacturing facilities, and therefore relies on third-party manufacturers to produce its product candidates for clinical trials. Although there are potential sources of supply other than the Company’s existing suppliers, any new supplier would be required to qualify under applicable regulatory requirements. |
Stock-Based Compensation | Stock-Based Compensation |
The fair value of each employee stock option and each employee stock purchase right granted is estimated on the grant date under the fair value method using the Black-Scholes valuation model. The estimated fair value of each stock option and purchase right, including the effect of estimated forfeitures, is then expensed over the requisite service period, which is generally the vesting period. The following assumptions were used during these periods: |
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| | Years Ended December 31, | |
| | 2014 | | | 2013 | | | 2012 | |
Stock Options: | | | | | | | | | | | | |
Expected volatility | | | 93 | % | | | 94 | % | | | 98-99 | % |
Risk-free interest rate | | | 2-Jan | % | | | 2-Jan | % | | | 1 | % |
Expected dividend yield | | | 0 | % | | | 0 | % | | | 0 | % |
Expected life of options in years | | | 5.7 | | | | 6 | | | | 5.8-6.0 | |
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| | Years Ended December 31, | |
| | 2014 | | | 2013 | | | 2012 | |
Employee Stock Purchase Plan: | | | | | | | | | | | | |
Expected volatility | | | 44-95 | % | | | 69-118 | % | | | 69-137 | % |
Risk-free interest rate | | | 0.1-0.5 | % | | | 0.1-0.3 | % | | | 0.1-0.3 | % |
Expected dividend yield | | | 0 | % | | | 0 | % | | | 0 | % |
Expected life of options in years | | | 0.5-2.0 | | | | 0.5-2.0 | | | | 0.5-2.0 | |
Expected Volatility. The Company considers its historical volatility and implied volatility when determining the expected volatility. |
Risk-Free Interest Rate. The Company determines its risk-free interest rate assumption based on the U.S. Treasury yield for obligations with contractual terms similar to the expected term of the stock option or purchase right being valued. |
Expected Dividend Yield. The Company has never paid any dividends and currently has no plans to do so. |
Expected Life of Options. The Company considers, among other factors, its historical exercise experience to date as well as the mean time remaining to full vesting of all outstanding options and the mean time remaining to the end of the contractual term of all outstanding options. |
Income Taxes | Income Taxes |
Current income tax expense or benefit represents the amount of income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is computed for the expected future impact of differences between the financial reporting and income tax bases of assets and liabilities and for the expected future tax benefit to be derived from tax credits and loss carryforwards. Deferred income tax expense or benefit represents the net change during the year in the deferred income tax asset or liability. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. |
Net Loss Per Share | Net Loss Per Share |
Net loss per share is presented as basic and diluted net loss per share. Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options and warrants are considered to be common stock equivalents but are not included in the calculations of diluted net loss per share for the periods presented as their effect would be antidilutive. |
Shares used in calculating basic and diluted net loss per common share exclude the following potential common shares as their effect is antidilutive (in thousands): |
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| | Years Ended December 31, | |
| | 2014 | | | 2013 | | | 2012 | |
Antidilutive options to purchase common stock | | | 7,773 | | | | 7,245 | | | | 6,868 | |
Antidilutive warrants to purchase common stock | | | 1,966 | | | | 3,116 | | | | 4,388 | |
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| | | 9,739 | | | | 10,361 | | | | 11,256 | |
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Segment Reporting | Segment Reporting |
Management has determined that the Company operates in one business segment. All revenues for the years ended December 31, 2014, 2013 and 2012 were generated in the United States. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards |
In May 2014, the Financial Accounting Standards Board issued authoritative accounting guidance related to revenue from contracts with customers. This guidance is a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services. This guidance is effective for annual reporting periods beginning after December 15, 2016 and early adoption is not permitted. The Company will adopt this guidance on January 1, 2017. Companies may use either a full retrospective or a modified retrospective approach to adopt this guidance. The Company is evaluating which transition approach to use and its impact, if any, on its consolidated financial statements. |
In August 2014, the FASB issued authoritative accounting guidance related to an entity’s ability to continue as a going concern. This guidance will explicitly require management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures in certain circumstances. The new standard is effective for annual reporting periods ending after December 15, 2016 and early adoption is permitted. The Company intends to adopt this guidance at the beginning of its first quarter of fiscal year 2016 and does not expect it to have a material impact on its consolidated financial statements and related disclosures. |