SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2014 |
Summary of Significant Accounting Policies | ' |
Use of Estimates | ' |
|
Use of Estimates |
|
|
|
The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and related disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Critical estimates include product returns reserve percentages and inputs used to determine stock-based compensation expense and the fair value of financial instruments and other liabilities measured at fair value. Cyclacel reviews its estimates on an ongoing basis. The estimates are based on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances. Actual results may differ from these estimates. Cyclacel believes the judgments and estimates required by the following accounting policies to be significant in the preparation of the Company’s consolidated financial statements. |
Reclassification | ' |
|
Reclassification |
|
|
|
Certain amounts in prior period financial statements have been reclassified to conform to current period financial statement presentation. On the consolidated balance sheet as of December 31, 2013, certain amounts have been reclassified from “Accrued and other current liabilities” to “Other liabilities.” |
Risks and Uncertainties | ' |
|
Risks and Uncertainties |
|
|
|
Drug candidates developed by the Company typically will require approvals or clearances from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s drug candidates will receive any of the required approvals or clearances. If the Company was denied approval or clearance or such approval was delayed, or is unable to obtain the necessary financing to complete development and approval, there will be a material adverse impact on the Company’s financial condition and results of operations. |
Cash and Cash Equivalents | ' |
|
Cash and Cash Equivalents |
|
|
|
Cash equivalents are stated at cost, which is substantially the same as fair value. The Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to be cash equivalents and categorizes such investments as held to maturity. The objectives of the Company’s cash management policy are to safeguard and preserve funds, to maintain liquidity sufficient to meet Cyclacel’s cash flow requirements and to attain a market rate of return. |
Fair Value of Financial Instruments | ' |
|
Fair Value of Financial Instruments |
|
|
|
Financial instruments consist of cash and cash equivalents, accounts payable, accrued liabilities, common stock warrants, financial instruments associated with stock purchase agreements, and other arrangements. The carrying amounts of cash and cash equivalents, accounts payable and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities. The financial instruments associated with stock purchase agreements and certain other liabilities are measured at fair value using applicable inputs as described in Note 3 - Fair Value. |
Revenue Recognition | ' |
|
Revenue Recognition |
|
|
|
Grant revenues from government agencies and private research foundations are recognized as the related qualified research and development costs are incurred, up to the limit of the prior approval funding amounts. Grant revenues are not refundable. |
Clinical Trial Accounting | ' |
|
Clinical Trial Accounting |
|
|
|
Data management and monitoring of the Company’s clinical trials are performed with the assistance of contract research organizations (“CROs”) or clinical research associates (“CRAs”) in accordance with the Company’s standard operating procedures. Typically, CROs and some CRAs bill monthly for services performed, and others bill based upon milestones achieved. For outstanding amounts, the Company accrues unbilled clinical trial expenses based on estimates of the level of services performed each period. Costs of setting up clinical trial sites for participation in the trials are expensed immediately as research and development expenses. Clinical trial costs related to patient enrollment are accrued as patients are entered into and progress through the trial. Any initial payment made to a clinical trial site is recognized upon execution of the clinical trial agreement and expensed as research and development expense. |
Research and Development Expenditures | ' |
|
Research and Development Expenditures |
|
|
|
Research and development expenses consist primarily of costs associated with the Company’s product candidates, upfront fees, milestones, compensation and other expenses for research and development personnel, supplies and development materials, costs for consultants and related contract research, facility costs and depreciation. Expenditures relating to research and development are expensed as incurred. |
Foreign Currency and Currency Translation | ' |
|
Foreign Currency and Currency Translation |
|
|
|
Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange gains (losses) in the statement of operations. |
|
|
|
The assets and liabilities of the Company’s international subsidiary are translated from its functional currency into United States dollars at exchange rates prevailing at the balance sheet date. Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions. |
|
|
|
Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive income. |
Income Taxes | ' |
|
Income Taxes |
|
|
|
The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. |
|
|
|
The Company applies the accounting guidance codified in ASC 740 “Income taxes” (“ASC 740”) related to accounting for uncertainty in income taxes. ASC 740 specifies the accounting for uncertainty in income taxes recognized in a company’s financial statements by prescribing a minimum probability threshold a tax position is required to meet before being recognized in the financial statements. |
|
|
|
Credit is taken in the accounting period for research and development tax credits, which will be claimed from H.M. Revenue & Customs (“HMRC”), the United Kingdom’s taxation and customs authority, in respect of qualifying research and development costs incurred in the same accounting period. |
|
|
|
Tax years 2011, 2012 and 2013 remain open to examination by major taxing jurisdictions to which the Company is subject, which are primarily in the United States and the United Kingdom, as carryforward attributes generated in years past may still be adjusted upon examination by the Internal Revenue Service (“IRS”), the HMRC or state tax authorities if they have or will be used in a future period. The Company is currently not under examination by the IRS or any other jurisdictions for any tax years. |
|
|
|
Income tax benefit, net from continuing operations, on the consolidated statements of operations of $1.4 million for the six months ended June 30, 2014 consists of research and development tax credits from the HMRC. |
Stock-based compensation | ' |
|
Stock-based Compensation |
|
|
|
The Company grants stock options, restricted stock units and restricted stock to officers, employees and directors under the Amended and Restated Equity Incentive Plan (“2006 Plan”), which was approved on March 16, 2006, as amended on May 21, 2007, subsequently amended and restated on April 14, 2008, and further amended on May 23, 2012. Under the 2006 Plan, the Company has granted various types of awards, which are described more fully in Note 6 - Stock-Based Compensation Arrangements. The Company accounts for these awards under ASC 718 “Compensation — Stock Compensation” (“ASC 718”). |
|
|
|
ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on date of grant and recognition of compensation over the requisite service period for awards expected to vest. The fair value of restricted stock and restricted stock units is determined based on the number of shares granted and the quoted price of the Company’s common stock on the date of grant. The determination of grant-date fair value for stock option awards is estimated using the Black-Scholes model, which includes variables such as the expected volatility of the Company’s share price, the anticipated exercise behavior of employees, interest rates, and dividend yields. These variables are projected based on historical data, experience, and other factors. Changes in any of these variables could result in material adjustments to the expense recognized for share-based payments. Such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line attribution method. The estimation of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from current estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised. The Company considers many factors when estimating expected forfeitures, including type of awards granted, employee class, and historical experience. Actual results and future estimates may differ substantially from current estimates. |
Segments | ' |
|
Segments |
|
|
|
After considering its business activities and geographic reach, the Company has concluded that it operates in just one operating segment being the discovery, development and commercialization of novel, mechanism-targeted drugs to treat cancer and other serious disorders, with development operations in two geographic areas, namely the United States and the United Kingdom. |
Net Loss Per Common Share | ' |
|
Net Income (Loss) Per Common Share |
|
|
|
The Company calculates net income (loss) per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic net income (loss) per common share was determined by dividing net income (loss) applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted net income (loss) per common share was determined by dividing net income (loss) applicable to common shareholders by the weighted average number of shares of common stock outstanding during the period, adjusted for the dilutive effect of all potential dilutive shares outstanding during the year, which includes outstanding common stock options, restricted stock, restricted stock units, convertible preferred stock and common stock warrants. |
|
|
|
The computation of basic earnings per share and diluted earnings per share for ‘‘Income (loss) from continuing operations’’ for the three and six months ended June 30, 2013 and 2014 is as follows (in $000s, except share and per share amounts): |
|
|
|
| | Three Months Ended | | | Six Months Ended | |
June 30, | June 30, |
| | 2013 | | | 2014 | | | 2013 | | | 2014 | |
Net income (loss) from continuing operations | | $ | 1,478 | | | $ | (4,819 | ) | | $ | (1,620 | ) | | $ | (9,696 | ) |
Deemed dividend on convertible exchangeable preferred shares | | | — | | | | — | | | | (8,366 | ) | | | — | |
Dividend on convertible exchangeable preferred shares | | | (63 | ) | | | (50 | ) | | | (185 | ) | | $ | (100 | ) |
Numerator for earnings per share for Income (loss) from continuing operations – Basic and Diluted | | $ | 1,415 | | | $ | (4,869 | ) | | $ | (10,171 | ) | | $ | (9,796 | ) |
| | | | | | | | | | | | | | | | |
Weighted average shares of common stock outstanding – Basic | | | 13,885,442 | | | | 22,582,283 | | | | 11,849,270 | | | | 21,064,739 | |
Dilutive effect of stock options | | | 41,929 | | | | — | | | | — | | | | — | |
Weighted average shares of common stock outstanding - Diluted | | | 13,927,371 | | | | 22,582,283 | | | | 11,849,270 | | | | 21,064,739 | |
| | | | | | | | | | | | | | | | |
Net income (loss) from continuing operations – Basic | | $ | 0.1 | | | $ | (0.22 | ) | | $ | (0.86 | ) | | $ | (0.47 | ) |
Net income (loss) from continuing operations – Diluted | | $ | 0.1 | | | $ | (0.22 | ) | | $ | (0.86 | ) | | $ | (0.47 | ) |
|
|
|
The following potentially dilutive shares of common stock have not been included in the computation of diluted net loss per share for the three and six month periods ended June 30, 2013 and 2014 as the result would be anti-dilutive: |
|
|
|
| | Three Months Ended | | | Six Months Ended | |
June 30, | June 30, |
| | 2013 | | | 2014 | | | 2013 | | | 2014 | |
Stock options | | | 334,996 | | | | 1,001,298 | | | | 487,719 | | | | 1,001,298 | |
Restricted Stock and Restricted Stock Units | | | 123,143 | | | | 119,015 | | | | 123,143 | | | | 119,015 | |
Convertible preferred stock | | | 25,573 | | | | 20,381 | | | | 25,573 | | | | 20,381 | |
Common stock warrants | | | 1,591,795 | | | | 1,440,022 | | | | 1,591,795 | | | | 1,440,022 | |
Total shares excluded from calculation | | | 2,075,507 | | | | 2,580,716 | | | | 2,228,230 | | | | 2,580,716 | |
|
|
Comprehensive Income (Loss) | ' |
|
Comprehensive Income (Loss) |
|
|
|
In accordance with ASC 220 “Comprehensive Income” (“ASC 220”), all components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss), including foreign currency translation adjustments, are reported, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income. |
Recent Events | ' |
|
Recent Events |
|
|
|
On May 22, 2014, the Board of Directors (the “Board”) of the Company declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s 6% Convertible Exchangeable Preferred Stock (“Preferred Stock”). The cash dividend was paid on August 1, 2014 to the holders of record of the Preferred Stock as of the close of business on July 1, 2014. |
Accounting Standards Adopted in the Period | ' |
|
Accounting Standards Adopted in the Period |
|
|
|
On January 1, 2014 the Company adopted guidance issued by the Financial Accounting Standards Board (“FASB”) relating to the presentation of an unrecognized tax benefit when a net operating loss carryforward (“NOL”), a similar tax loss, or a tax credit carryforward exists. The guidance states that an unrecognized tax benefit, or a portion of an unrecognized tax benefit, should be presented in the financial statements as a reduction to a deferred tax asset for a NOL, a similar tax loss, or a tax credit carryforward, except to the extent it is not available at the reporting date under the tax law of the applicable jurisdiction to settle any additional income taxes that would result from the disallowance of a tax position or the tax law of the applicable jurisdiction does not require the entity to use, and the entity does not intend to use, the deferred tax asset for such purpose, the unrecognized tax benefit should be presented in the financial statements as a liability and should not be combined with deferred tax assets. The adoption of this guidance has not had a material impact on our consolidated financial statements. |
|
|
|
On January 1, 2014 the Company adopted guidance issued by the FASB relating to certain foreign currency matters. This guidance clarifies the parent company’s accounting for the cumulative translation adjustment when a reporting entity ceases to have a controlling financial interest in a subsidiary or group of assets that is a nonprofit activity or a business within a foreign entity or of an investment in a foreign entity. The adoption of this guidance has not had a material impact on our consolidated financial statements. |
|
|
|
On January 1, 2014 the Company adopted guidance issued by the FASB relating to obligations resulting from joint and several liability arrangements for which the total amount of the obligation is fixed at the reporting date. This provides guidance for the |
|
|
|
recognition, measurement, and disclosure of obligations resulting from joint and several liability arrangements for which the total amount of the obligation is fixed at the reporting date, except for obligations addressed within existing guidance in GAAP. The guidance should be applied retrospectively to all prior periods presented for those obligations resulting from joint and several liability arrangements that exist at the beginning of an entity’s fiscal year of adoption. The adoption of this guidance has not had a material impact on our consolidated financial statements. |
|
|
|
On June 10, 2014 the Company adopted guidance issued by the FASB relating to financial reporting for development stage entities. The guidance eliminates certain financial reporting requirements for development stage entities, including the presentation of inception-to-date information about income statement line items, cash flows, and equity transactions, and also eliminates an exception provided to development stage entities for determining whether an entity is a variable interest entity on the basis of the amount of equity that is at risk. The adoption of this guidance has resulted in the elimination of inception-to-date information. |
|
|
|
Recent Accounting Pronouncements Not Yet Effective |
|
|
|
In June 2014, the FASB issued guidance on accounting for share based payments when the terms of an award provide that a performance target could be achieved after the requisite service period. The guidance requires that a performance target that affects vesting and that could be achieved after the requisite service period should be treated as a performance condition. This guidance is effective for annual periods, and interim periods within those annual periods, after January 1, 2016. We are currently evaluating the impact of the guidance on our consolidated financial statements. |
|
|
|
In May 2014, the FASB issued new guidance on accounting for revenue from contracts with customers. This new guidance will replace existing revenue guidelines with a new model, in which revenue is recognized upon transfer of control over goods or services to a customer. The new standard will be effective for the Company on January 1, 2017, for both interim and annual periods. The guidance can be adopted using either a full retrospective (with certain practical expedients) or a modified retrospective method of transition. Under the modified retrospective approach, financial statements will be prepared for the year of adoption using the new standard, but prior periods will not be adjusted. Instead, companies will recognize a cumulative catch-up adjustment to the opening balance of retained earnings at the effective date for contracts that still require performance by the company, and disclose all line items in the year of adoption as if they were prepared under current revenue requirements. At this time, the Company has not decided on which method it will use to adopt the new standard, nor has it determined the effects of the new guidelines on its results of operations and financial position. For the foreseeable future, the Company’s revenues will be limited to grants received from government agencies or nonprofit organizations, and the Company is evaluating the effects of the new standard on these types of revenue streams. |