Summary of Significant Accounting Policies (Polices) | 3 Months Ended |
Mar. 31, 2014 |
Summary of Significant Accounting Policies | ' |
Use of Estimates | ' |
Use of Estimates |
|
The preparation of the financial statements in accordance with GAAP requires the Company to make estimates and judgments in certain circumstances that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. In preparing these financial statements, management has made its best estimates and judgments of certain amounts included in the financial statements, giving due consideration to materiality. On an ongoing basis, the Company evaluates its estimates, including those related to revenue recognition, fair values of assets, convertible preferred stock and common stock, income taxes, pre-clinical study and clinical trial accruals and other contingencies. Management bases its estimates on historical experience or on various other assumptions that it believes to be reasonable under the circumstances. Actual results could materially differ from these estimates. |
Reverse Stock Split | ' |
Reverse Stock Split |
|
On November 1, 2013, the Company affected a 1 for 3.1 reverse stock split. All information in this report relating to the number of shares, price per share and per share amounts of stock prior to November 1, 2013 gives retroactive effect to the 1 for 3.1 reverse stock split of the Company’s stock. |
Research and Development Expenses | ' |
Research and Development Expenses |
|
Costs incurred in research and development activities are expensed as incurred, including expenses that may or may not be reimbursed under research and development collaboration agreements. Research and development costs include, but are not limited to, salaries, benefits, stock-based compensation, laboratory supplies and equipment, allocated overhead, fees for professional service providers and costs associated with product development efforts, including preclinical studies and clinical trials. |
|
The Company estimates preclinical study and clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered. |
Fair Value of Financial Instruments | ' |
Fair Value of Financial Instruments |
|
Our financial instruments primarily consist of cash, trade accounts receivable, convertible promissory notes, accounts payable and accrued expenses. The fair value of cash and cash equivalents, trade accounts receivable, convertible promissory notes, accounts payable and accrued expenses closely approximate their carrying value due to their short maturities. The carrying amounts of convertible promissory notes approximate their fair value, as the interest rates, in consideration of the conversion feature, approximate the interest rates presently available to us. |
|
We determine the fair value of the principal amount of financial and nonfinancial assets and liabilities using the fair value hierarchy, which describes three levels of inputs that may be used to measure fair value, as follows: |
|
Level 1—Quoted prices in active markets for identical assets or liabilities; |
|
Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and |
|
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
|
Level 1 assets consist of highly-liquid money market funds. There were no transfers between Level 1 and Level 2 assets during the periods presented. |
|
The assets recorded at fair value are classified within the hierarchy as follows for the periods reported (in millions): |
|
| | March 31, 2014 | | March 31, 2013 | |
| | Total | | | | Total | | | |
| | Fair Value | | Level 1 | | Fair Value | | Level 1 | |
| | | | | | | | | |
Money Market Funds | | $ | — | | $ | — | | $ | 3.3 | | $ | 3.3 | |
| | | | | | | | | | | | | |
|
For disclosure purposes at March 31, 2014 and March 31, 2013 the fair value of the principal amount of our outstanding convertible promissory notes are classified within the hierarchy as follows (in millions): |
|
| | March 31, 2014 | | March 31, 2013 | |
| | Total | | | | Total | | | |
| | Fair Value | | Level 3 | | Fair Value | | Level 3 | |
| | | | | | | | | |
Convertible Promissory Notes | | $ | — | | $ | — | | $ | 15.1 | | $ | 15.1 | |
| | | | | | | | | | | | | |
|
These convertible promissory notes were originally issued during 2009 and 2010. Considering 1) the lack of time value, 2) the absence of an established market for the convertible promissory notes, and, 3) our knowledge of the terms, rates, risk and returns provided by the convertible promissory notes as compared to financing available for privately-held biopharmaceutical companies, we determined that the carrying value of the convertible promissory notes approximates their fair value. There were no transfers between Level 3, Level 2 and, Level 1 during the periods presented. |
Net Loss Per Share of Common Stock | ' |
Net Loss Per Share of Common Stock |
|
We compute net loss per common share by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Potentially dilutive securities consisting of stock options, convertible preferred stock and convertible promissory notes are not included in the diluted net loss per common share calculation for all periods presented, because the inclusion of such shares would have had an antidilutive effect. |
|
| | Three Months Ended March 31, | | | | | | | |
| | 2014 | | 2013 | | | | | | | |
| | (in thousands, except | | | | | | | |
per share amounts) | | | | | | |
Basic and diluted numerator: | | | | | | | | | | | |
Net loss attributable to common stockholders | | $ | (3,751 | ) | $ | (4,612 | ) | | | | | | |
Denominator: | | | | | | | | | | | |
Weighted-average common shares outstanding- basic and diluted | | 31,360,879 | | 72,302 | | | | | | | |
Basic and diluted net loss per common share | | $ | (0.12 | ) | $ | (63.78 | ) | | | | | | |
|
For the three months ended March 31, 2014 and March 31, 2013, we excluded the following securities from the calculation of diluted net loss per share as the effect would have been antidilutive. |
|
| | As of | | | | | | | | | |
March 31, | | | | | | | | |
| | 2014 | | 2013 | | | | | | | | | |
| | (in thousands) | | | | | | | | | |
Convertible preferred stock | | — | | 12,189 | | | | | | | | | |
Convertible promissory notes | | — | | 2,845 | | | | | | | | | |
Employee stock purchase plan shares | | 45 | | — | | | | | | | | | |
Options to purchase common stock | | 1,213 | | 1,277 | | | | | | | | | |
| | 1,258 | | 16,311 | | | | | | | | | |
Revenue Recognition | ' |
Revenue Recognition |
|
We have, to date, earned revenue from research collaborations, which may include research and development services, licenses of our internally-developed technologies, or a combination of both. We recognize revenue when all of the following criteria are met: persuasive evidence of an arrangement exists; transfer or access of technology has been completed or services have been rendered; our price to the customer is fixed or determinable and collectability is reasonably assured. |
|
The terms of our licensing and research and development agreements include non-refundable upfront fees, licensing fees, contingent payment and contractual obligations for the achievement of pre-defined preclinical, clinical, regulatory and sales based events. The agreements also include royalties on sales of any commercialized products. |
|
Multiple-Element Revenue Arrangements. Certain of our collaboration and license agreements represent multiple-element revenue arrangements. To account for such transactions, we determine the elements, or deliverables, included in the arrangement and determine which deliverables are separate units for accounting purposes. We consider delivered items to be separate units of accounting if the delivered items have stand-alone value to the customer. If the delivered items are separate units we allocate the consideration received or due under the arrangement to the various elements based on each elements’ relative selling price. |
|
Milestone Revenue. Our collaboration and license agreements generally include contingent contractual payments related to achievement of specific research, development and regulatory milestones and sales-based milestones that are based solely upon the performance of the licensor or collaborator. Research, development and regulatory contingent contractual payments and milestone payments are typically payable under our collaborations when our collaborator selects a compound, or initiates or advances a covered product candidate in preclinical or clinical development, upon submission for marketing approval of a covered product with regulatory authorities, upon receipt of actual marketing approvals of a covered product or for additional indications, or upon the first commercial sale of a covered product. Sales-based contingent contractual payments are typically payable when annual sales of a covered product reach specific levels. |
|
We recognize any payment that is contingent upon the achievement of a substantive milestone entirely in the period in which the milestone is achieved. A milestone is defined as an event that can only be achieved based in whole or in part either on our performance, or the performance of our collaborators, or the occurrence of a specific outcome resulting from our past performance for which there is a substantive uncertainty at the date the arrangement is entered into that the event will be achieved. |
Long-Lived Assets | ' |
Long-Lived Assets |
|
Management reviews long-lived and certain identifiable intangibles for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset (or asset group) may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds the fair value of the assets. Fair value for our long-lived assets is determined using the expected cash flows discounted at a rate commensurate with the risks involved. |
Stock-Based Compensation | ' |
Stock-Based Compensation |
|
We recognize compensation expense using a fair-value-based method for costs related to all share-based payments, including stock options and stock issued under our 2013 Employee Stock Purchase Plan (ESPP). Stock-based compensation cost related to employees and directors is measured at the grant date, based on the fair-value—based measurement of the award using the Black-Scholes method, and is recognized as expense over the requisite service period on a straight-line basis. We are required to estimate forfeitures at the time of grant and revise those estimates in subsequent periods if actual forfeitures differ from those estimates. We use historical data to estimate pre-vesting option forfeitures and record stock-based compensation expense only for those awards that are expected to vest. We recorded stock-based compensation expense for stock-based awards to employees and directors of approximately $278,000 and $5,000 for the three months ended March 31, 2014 and 2013, respectively. |
|
The expected term for purchases under the ESPP was based on the purchase periods included in the offering. The expected volatility is determined using historical volatilities of similar peer companies based on stock prices over a look-back period corresponding to the expected term. The risk-free interest rate was determined using the yield available for zero-coupon U.S. government issues with a remaining term equal to the expected term. The forfeiture rate was determined to be zero as there is insufficient historical pre-vesting forfeiture rate information since the inception of the plan. The Company has never paid a dividend, and as such, the dividend yield is zero. See Note 4 for further information on the ESPP. |
|
Options granted to individual service providers that are not employees or directors are accounted for at estimated fair value using the Black-Scholes option-pricing method and are subject to periodic re-measurement over the period during which the services are rendered. |
Concnetrations of Risk | ' |
Concentrations of Risk |
|
Cash is maintained at financial institutions and, at times, balances may exceed federally insured limits. Amounts on deposit in excess of federally insured limits at March 31, 2014 approximated $72.0 million. |
|
A significant portion of our revenue was earned from four partners for the three months ended March 31, 2014 and from three partners for the three months ended March 31, 2013. The following table represents the amounts (in millions) and the percentage of all significant revenue earned in the periods indicated: |
|
| | Three Months Ended March 31, | | | |
| | 2014 | | 2013 | | | |
| | Amounts | | Percentages | | Amounts | | Percentages | | | |
Alexion | | $ | 0.3 | | 11.4 | % | $ | 0.1 | | 12.4 | % | | |
Amgen | | 0.6 | | 25.6 | % | 0.6 | | 41.5 | % | | |
CSL | | 0.7 | | 32.5 | % | 0.6 | | 43.7 | % | | |
Merck | | 0.5 | | 22.9 | % | — | | — | | | |
Other | | 0.1 | | 7.6 | % | 0.03 | | 2.4 | % | | |
| | | | | | | | | | | | | |
|
As of March 31, 2014, $0.5 million in accounts receivable was due from one partner; as of March 31, 2013, $0.5 million in accounts receivable was due from another partner. |
Patents, Licenses, and Other Intangible Assets | ' |
Patents, Licenses, and Other Intangible Assets |
|
The cost of acquiring licenses is capitalized and amortized on the straight-line basis over the shorter of the term of the license or its estimated economic life, ranging from five to 25 years. Third-party costs incurred for acquiring patents are capitalized. Capitalized costs are accumulated until the earlier of the period that a patent is issued or we abandon the patent claims. Cumulative capitalized patent costs are amortized on a straight-line basis from the date of issuance over the shorter of the patent term or the estimated useful economic life of the patent, ranging from 13 to 20 years. The carrying value of intangible assets is evaluated when indicators of impairment are identified. We review the license arrangements and the amortization period on a regular basis and adjust the carrying value or the amortization period of the licensed rights if there is evidence of a change in the carrying value or useful life of the asset. |