| Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements, in conformity with GAAP,
requires management to make estimates and assumptions that affect
the amounts reported in the financial statements and accompanying
notes. These estimates include useful lives for property and
equipment and related depreciation calculations, accruals for
clinical trial expenses, assumptions for valuing options and
warrants, and income taxes. Actual results could differ from these
estimates.
Cash and Cash Equivalents
All highly liquid investments with maturities of three months or
less at the time of purchase are classified as cash
equivalents.
Property and Equipment
The Company records property and equipment at cost and calculates
depreciation using the straight-line method over the estimated
useful lives of the respective assets. Machinery and equipment
includes external costs incurred for validation of the equipment.
The Company does not capitalize internal validation expense.
Computer equipment and software includes capitalized computer
software. All of the Company’s capitalized software is
purchased; the Company has no internally-developed computer
software. Leasehold improvements are amortized over the shorter of
the term of the lease or useful life of the improvement.
Impairment of Long-Lived Assets
The Company reviews for impairment whenever events or changes in
circumstances indicate that the carrying amount of property and
equipment may not be recoverable. Determination of recoverability
is based on an estimate of undiscounted future cash flows resulting
from the use of the asset and its eventual disposition. In the
event that such cash flows are not expected to be sufficient to
recover the carrying amount of the assets, the assets are written
down to their estimated fair values and the loss is recognized in
the consolidated statements of operations.
Accounting for Costs Associated with Exit or Disposal
Activities
The Company recognizes a liability for the cost associated with an
exit or disposal activity that is measured initially at its fair
value in the period in which the liability is incurred. The Company
accounted for the partial sublease of its headquarters building as
an exit activity and recorded the sublease loss in its Condensed
Consolidated Statement of Operations and Comprehensive Loss (see
Note 5).
Costs to terminate an operating lease or other contracts are
(a) costs to terminate the contract before the end of its term
or (b) costs that will continue to be incurred under the
contract for its remaining term without economic benefit to the
entity. In periods subsequent to initial measurement, changes to
the liability are measured using the credit-adjusted risk-free rate
that was used to measure the liability initially.
Revenue Recognition
Contract revenues consist of revenues from grants, collaboration
agreements and feasibility studies. License and collaboration
revenue is primarily generated through agreements with strategic
partners for the development and commercialization of our product
candidates. The terms of the agreement typically include
non-refundable upfront fees, funding of research and development
activities, payments based upon achievement of milestones and
royalties on net product sales. The Company recognizes revenue
under the provisions of the Securities and Exchange Commission
issued Staff Accounting Bulletin 104, Topic 13, Revenue Recognition
Revised and Updated (“SAB Topic 13”) and ASC
605-25, Revenue Recognition-Multiple Elements. Revenue for
arrangements not having multiple deliverables, as outlined in ASC
605-25, is recognized once costs are incurred and collectability is
reasonably assured.
Revenue is recognized when there is persuasive evidence that an
arrangement exists, delivery has occurred, the price is fixed and
determinable and collection is reasonably assured.
Multiple-deliverable arrangements, such as license and development
agreements, are analyzed to determine whether the deliverables can
be separated or whether they must be accounted for as a single unit
of accounting. When deliverables are separable, consideration
received is allocated to the separate units of accounting based on
the relative selling price method and the appropriate revenue
recognition principles are applied to each unit. When the Company
determines that an arrangement should be accounted for as a single
unit of accounting, it must determine the period over which the
performance obligations will be performed and revenue will be
recognized.
The Company estimates its performance period used for revenue
recognition based on the specific terms of each agreement, and
adjusts the performance periods, if appropriate, based on the
applicable facts and circumstances. Significant management judgment
may be required to determine the level of effort required under an
arrangement and the period over which the Company is expected to
complete its performance obligations under the arrangement. If the
Company cannot reasonably estimate when its performance obligations
either are completed or become inconsequential, then revenue
recognition is deferred until the Company can reasonably make such
estimates. Revenue is then recognized over the remaining estimated
period of performance using the cumulative catch-up method.
The Company adopted the provisions of Accounting Standards Update
No. 2009-13, Revenue Recognition (Topic 605);
Multiple-Deliverable Revenue Arrangements (“ASU
2009-13”) for new and materially modified arrangements
originating on or after January 1, 2010. ASU 2009-13 provides
updated guidance on how the deliverables in an arrangement should
be separated, and how consideration should be allocated, and it
changes the level of evidence of standalone selling price required
to separate deliverables by allowing a vendor to make its best
estimate of the standalone selling price of deliverables when
vendor-specific objective evidence or third-party evidence of
selling price is not available.
The Company allocates non-contingent consideration to each
stand-alone deliverable based upon the relative selling price of
each element. When applying the relative selling price method, the
Company determines the selling price for each deliverable using
vendor-specific objective evidence, or VSOE, of selling price, if
it exists, or third-party evidence, or TPE, of selling price, if it
exists. If neither VSOE nor TPE of selling price exist for a
deliverable, the Company uses best estimated selling price, or
BESP, for that deliverable.
Assuming the elements meet the revenue recognition guidelines, the
revenue recognition methodology prescribed for each unit of
accounting is summarized below:
Upfront Fees
Funded Research and Development and Grant
Revenue
Milestones
Royalties
Research and Development
Research and development expenses consist of costs incurred for
company-sponsored, collaborative and contracted research and
development activities. These costs include direct and
research-related overhead expenses. The Company expenses research
and development costs as such costs are incurred.
Stock-Based Compensation
The Company accounts for share-based payment arrangements in
accordance with ASC 718, Compensation-Stock Compensation Equity-Equity Based Payments to Non-Employees
Income Taxes
The Company makes certain estimates and judgments in determining
income tax expense for financial statement purposes. These
estimates and judgments occur in the calculation of certain tax
assets and liabilities, which arise from differences in the timing
of recognition of revenue and expense for tax and financial
statement purposes. As part of the process of preparing the
financial statements, the Company is required to estimate income
taxes in each of the jurisdictions in which it operates. This
process involves the Company estimating its current tax exposure
under the most recent tax laws and assessing temporary differences
resulting from differing treatment of items for tax and accounting
purposes. These differences result in deferred tax assets and
liabilities which are included in the Company’s consolidated
balance sheets. The Company estimated its current tax exposure to
be zero as it expects to be able to utilize its net operating loss
carryovers (NOLs) to offset the income recognized in the quarter
and year to date. The Company has updated its Section 382
analysis through December 31, 2015 and noted no additional
changes since the last change in 2010.
The Company assesses the likelihood that it will be able to recover
its deferred tax assets. The Company considers all available
evidence, both positive and negative, including the historical
levels of income and losses, expectations and risks associated with
estimates of future taxable income and ongoing prudent and feasible
tax planning strategies in assessing the need for a valuation
allowance. If the Company does not consider it more likely than not
that it will recover its deferred tax assets, the Company records a
valuation allowance against the deferred tax assets that it
estimates will not ultimately be recoverable. At March 31,
2016, and December 31, 2015 the Company believed that the
amount of its deferred income taxes would not be ultimately
recovered. Accordingly, the Company recorded a full valuation
allowance for deferred tax assets. However, should there be a
change in the Company’s ability to recover its deferred tax
assets the Company would recognize a benefit to its tax provision
in the period in which it determines that it is more likely than
not that it will recover its deferred tax assets.
Net Income/(Loss) Per Common Share
Basic net income/(loss) per common share is computed using the
weighted-average number of shares of common stock outstanding
during the period less the weighted-average number of restricted
shares of common stock subject to repurchase. Potentially dilutive
securities were not included in the net loss per common share
calculation for the three months ended March 31, 2016, and
2015 because the inclusion of such shares would have had an
anti-dilutive effect.
Recently Issued Accounting Pronouncements
There have been no recent accounting pronouncements or changes in
accounting pronouncements during the three months ended
March 31, 2016, as compared to the recent accounting
pronouncements described in the Company’s 2015 Annual Report
on Form 10-K that are of significance or potential significance to
the Company. |
