Document_and_Entity_Informatio
Document and Entity Information | 6 Months Ended | |
Jun. 30, 2014 | Aug. 11, 2014 | |
Document and Entity Information [Abstract] | ' | ' |
Entity Registrant Name | 'Cyclacel Pharmaceuticals, Inc. | ' |
Entity Central Index Key | '0001130166 | ' |
Trading Symbol | 'cycc | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Smaller Reporting Company | ' |
Entity Common Stock, Shares Outstanding | ' | 22,676,475 |
Document Type | '10-Q | ' |
Document Period End Date | 30-Jun-14 | ' |
Amendment Flag | 'false | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q2 | ' |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $33,456 | $31,146 |
Prepaid expenses and other current assets | 3,422 | 3,388 |
Current assets of discontinued operations | 403 | 639 |
Total current assets | 37,281 | 35,173 |
Property and equipment (net) | 305 | 275 |
Long-term assets of discontinued operations | 24 | 72 |
Total assets | 37,610 | 35,520 |
Current liabilities: | ' | ' |
Accounts payable | 4,543 | 2,545 |
Accrued and other current liabilities | 3,095 | 4,431 |
Other liabilities measured at fair value | ' | 20 |
Current liabilities of discontinued operations | 145 | 260 |
Total current liabilities | 7,783 | 7,256 |
Other liabilities | 238 | 241 |
Total liabilities | 8,021 | 7,497 |
Commitments and contingencies | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2013 and June 30, 2014; 335,273 shares issued and outstanding at December 31, 2013 and June 30, 2014. Aggregate preference in liquidation of $3,989,749 at December 31, 2013 and June 30, 2014. | ' | ' |
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2013 and June 30, 2014; 19,369,332 and 22,676,475 shares issued and outstanding at December 31, 2013 and June 30, 2014, respectively. | 23 | 19 |
Additional paid-in capital | 328,774 | 317,543 |
Accumulated other comprehensive income (loss) | -97 | -109 |
Accumulated deficit | -299,111 | -289,430 |
Total stockholders' equity | 29,589 | 28,023 |
Total liabilities and stockholders' equity | $37,610 | $35,520 |
CONDENSED_CONSOLIDATED_BALANCE1
CONDENSED CONSOLIDATED BALANCE SHEETS (Parentheticals) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, except Share data, unless otherwise specified | ||
CONSOLIDATED BALANCE SHEETS | ' | ' |
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 335,273 | 335,273 |
Preferred stock, shares outstanding | 335,273 | 335,273 |
Preferred stock, liquidation preference value (in dollars) | $3,989,749 | $3,989,749 |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 22,676,475 | 19,369,332 |
Common stock, shares outstanding | 22,676,475 | 19,369,332 |
CONDENSED_CONSOLIDATED_STATEME
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Revenues: | ' | ' | ' | ' |
Grant revenue | $356 | $264 | $752 | $476 |
Total revenues | 356 | 264 | 752 | 476 |
Operating expenses: | ' | ' | ' | ' |
Research and development | 4,545 | 2,631 | 8,889 | 4,211 |
General and administrative | 1,386 | 1,787 | 2,848 | 4,470 |
Total operating expenses | 5,931 | 4,418 | 11,737 | 8,681 |
Operating loss | -5,575 | -4,154 | -10,985 | -8,205 |
Other income (expense): | ' | ' | ' | ' |
Change in valuation of financial instruments associated with stock purchase agreement | -64 | ' | -111 | ' |
Change in valuation of Economic Rights | ' | ' | ' | 570 |
Change in valuation of liabilities measured at fair value | 20 | ' | 20 | ' |
Foreign exchange gains (losses) | -43 | -101 | -33 | 19 |
Interest income | 1 | 3 | 2 | 4 |
Other income, net | 26 | 5,500 | 26 | 5,504 |
Total other income (expense) | -60 | 5,402 | -96 | 6,097 |
Income (loss) from continuing operations before taxes | -5,635 | 1,248 | -11,081 | -2,108 |
Income tax benefit | 816 | 230 | 1,385 | 488 |
Net income (loss) from continuing operations | -4,819 | 1,478 | -9,696 | -1,620 |
Discontinued operations: | ' | ' | ' | ' |
Income from discontinued operations | 10 | 24 | 23 | 50 |
Income tax on discontinued operations | -3 | -10 | -8 | -20 |
Net income from discontinued operations | 7 | 14 | 15 | 30 |
Net income (loss) | -4,812 | 1,492 | -9,681 | -1,590 |
Deemed dividend on convertible exchangeable preferred shares | ' | ' | ' | -8,366 |
Dividend on convertible exchangeable preferred shares | -50 | -63 | -100 | -185 |
Net income (loss) applicable to common shareholders | ($4,862) | $1,429 | ($9,781) | ($10,141) |
Basic earnings per common share: | ' | ' | ' | ' |
Net income (loss) per share, continuing operations (in dollars per share) | ($0.22) | $0.10 | ($0.47) | ($0.86) |
Net income (loss) per share, discontinued operations (in dollars per share) | $0 | $0 | $0 | $0 |
Net income (loss) per share applicable to common shareholders (in dollars per share) | ($0.22) | $0.10 | ($0.46) | ($0.86) |
Diluted earnings per common share: | ' | ' | ' | ' |
Net income (loss) per share, continuing operations - Diluted | ($0.22) | $0.10 | ($0.47) | ($0.86) |
Net income (loss) per share, discontinued operations (in dollars per share) | $0 | $0 | $0 | $0 |
Net income (loss) per share applicable to common shareholders (in dollars per share) | ($0.22) | $0.10 | ($0.46) | ($0.86) |
Weighted average shares of common stock outstanding: | ' | ' | ' | ' |
Basic (in shares) | 22,582,283 | 13,885,442 | 21,064,739 | 11,849,270 |
Diluted (in shares) | 22,582,283 | 13,927,371 | 21,064,739 | 11,849,270 |
CONDENSED_CONSOLIDATED_STATEME1
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ' | ' | ' | ' |
Net income (loss) from continuing operations | ($4,819) | $1,478 | ($9,696) | ($1,620) |
Net income from discontinued operations | 7 | 14 | 15 | 30 |
Net income (loss) | -4,812 | 1,492 | -9,681 | -1,590 |
Translation adjustment | -3,121 | -14 | -4,080 | 6,638 |
Unrealized foreign exchange gain (loss) on intercompany loans | 3,125 | 202 | 4,092 | -6,691 |
Comprehensive income (loss) | ($4,808) | $1,680 | ($9,669) | ($1,643) |
CONDENSED_CONSOLIDATED_STATEME2
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (Unaudited) (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Operating activities: | ' | ' |
Net loss | ($9,681) | ($1,590) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Change in valuation of liabilities measured at fair value | -20 | -1,120 |
Change in valuation of financial instruments associated with stock purchase agreement | 111 | ' |
Depreciation | 46 | 36 |
Gain on sale of patents | ' | -5,500 |
Stock-based compensation | 370 | 146 |
Changes in operating assets and liabilities: | ' | ' |
Prepaid expenses and other assets | 34 | -1,124 |
Accounts payable and other current liabilities | 313 | -1,530 |
Net cash used in operating activities | -8,827 | -10,682 |
Investing activities: | ' | ' |
Purchase of property, plant and equipment | -65 | -92 |
Minimum royalty payments received from termination of ALIGN license agreement | 192 | 264 |
Proceeds from sale of patents | ' | 5,500 |
Net cash provided by investing activities | 127 | 5,672 |
Financing activities: | ' | ' |
Proceeds from issuance of common stock, net of issuance costs | 10,965 | 22,495 |
Payment of preferred stock dividend | -100 | -192 |
Net cash provided by financing activities | 10,865 | 22,303 |
Effect of exchange rate changes on cash and cash equivalents | 145 | -37 |
Net increase in cash and cash equivalents | 2,310 | 17,256 |
Cash and cash equivalents, beginning of period | 31,146 | 16,412 |
Cash and cash equivalents, end of period | 33,456 | 33,668 |
Cash received during the period for: | ' | ' |
Interest | 3 | 5 |
Taxes | 1,811 | ' |
Schedule of non-cash transactions: | ' | ' |
Issuance of Ordinary shares in lieu of cash bonus | ' | $181 |
NATURE_OF_OPERATIONS_AND_BASIS
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | 6 Months Ended | ||
Jun. 30, 2014 | |||
Organization of the Company | ' | ||
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | ' | ||
1 | NATURE OF OPERATIONS AND BASIS OF PRESENTATION | ||
Nature of Operations | |||
Cyclacel Pharmaceuticals, Inc. (“Cyclacel” or “the Company”), a development-stage biopharmaceutical company, is a pioneer in the field of cell cycle biology with a vision to improve patient healthcare with orally available innovative medicines. Cyclacel’s goal is to develop and commercialize small molecule drugs that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, particularly those of high unmet medical need. | |||
Cyclacel’s clinical development priorities are focused on sapacitabine, an orally available, cell cycle modulating nucleoside analogue. | |||
Sapacitabine is being evaluated in the SEAMLESS Phase 3 study being conducted under a Special Protocol Assessment (“SPA”) agreement with the US Food and Drug Administration (“FDA”) for the front-line treatment of acute myeloid leukemia (“AML”) in the elderly and in Phase 2 studies for AML, myelodysplastic syndromes (“MDS”), non-small cell lung cancer (“NSCLC”) and chronic lymphocytic leukemia. Sapacitabine is also being evaluated in a Phase 1 study in combination with seliciclib, our second clinical candidate, in patients with solid tumors, in particular those carrying gBRCA mutations. The FDA and the European Medicines Agency (“EMA”), have designated sapacitabine as an orphan drug for the treatment of both AML and MDS. | |||
In our second development program we are evaluating cyclin dependent kinase, or CDK, inhibitors. CDKs are involved in cancer cell growth, metastatic spread and DNA damage repair. Seliciclib, our most advanced CDK inhibitor, is an oral, highly selective inhibitor of CDK enzymes. To date, seliciclib has been evaluated in several Phase 1 and 2 studies in various cancers, including NSCLC and nasopharyngeal cancer (“NPC”), and has shown signs of anti-cancer activity. Seliciclib will also be evaluated in an investigator-initiated clinical study to treat rheumatoid arthritis (“RA”) supported by an approximately $1.5 million grant from the United Kingdom's Medical Research Council. | |||
Our second generation CDK inhibitor, CYC065, is an oral, highly selective inhibitor of CDK enzymes. CYC065 has been shown to have increased anti-proliferative potency and improved pharmaceutical properties compared to seliciclib. Investigational new drug (“IND”) enabling studies with CYC065 are in progress supported by a $1.9 million grant from the Biomedical Catalyst of the United Kingdom government. | |||
In addition to these development programs, in our polo-like kinase (“PLK”) inhibitor program, we have discovered CYC140 and other potent and selective small molecule inhibitors of PLK1, a kinase active during cell division, targeting the mitotic phase of the cell cycle. PLK was discovered by Professor David Glover, our Chief Scientist. We have received a grant award of approximately $3.7 million from the Biomedical Catalyst of the United Kingdom government to complete IND-directed preclinical development of CYC140. | |||
We currently retain virtually all marketing rights worldwide to the compounds associated with our drug programs. | |||
As a development stage enterprise, substantially all efforts of the Company to date have been devoted to performing research and development, conducting clinical trials, developing and acquiring intellectual property, raising capital and recruiting and training personnel. | |||
Capital Resources | |||
The Company’s existing capital resources are expected to be sufficient to take the Company beyond the completion of the SEAMLESS Phase 3 trial but not sufficient to complete development of other indications or product candidates or to commercialize any of the Company’s product candidates. | |||
Basis of Presentation | |||
The condensed consolidated balance sheet as of June 30, 2014, the condensed consolidated statements of operations, comprehensive income (loss), and cash flows for the three and six months ended June 30, 2013 and 2014 and all related disclosures contained in the accompanying notes are unaudited. The condensed consolidated balance sheet as of December 31, 2013 is derived from the audited consolidated financial statements included in the 2013 Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”). The condensed consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the condensed consolidated balance sheet as of June 30, 2014, and the results of operations, comprehensive loss and cash flows for the three and six months ended June 30, 2014, have been made. The interim results for the three and six months ended June 30, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014 or for any other year. The condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2013, included in the Company’s Annual Report on Form 10-K filed with the SEC. |
SUMMARY_OF_SIGNIFICANT_ACCOUNT
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Summary of Significant Accounting Policies | ' | ||||||||||||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ||||||||||||||||
2 | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||||||||||||||
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 | |||||||||||||||||
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 | |||||||||||||||||
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 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 | |||||||||||||||||
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 | |||||||||||||||||
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 | |||||||||||||||||
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 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 | |||||||||||||||||
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 | |||||||||||||||||
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 | |||||||||||||||||
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 | |||||||||||||||||
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 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) | |||||||||||||||||
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 | |||||||||||||||||
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 | |||||||||||||||||
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. |
FAIR_VALUE
FAIR VALUE | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Fair Value | ' | ||||||||||||||||
FAIR VALUE | ' | ||||||||||||||||
3 | FAIR VALUE | ||||||||||||||||
As defined in ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”), fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, ASC 820 establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: | |||||||||||||||||
· | Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. | ||||||||||||||||
· | Level 2: Inputs other than quoted prices within Level 1 that are observable for the asset or liability, either directly or indirectly. | ||||||||||||||||
· | Level 3: Unobservable inputs that are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. | ||||||||||||||||
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considering counterparty credit risk in its measurement of fair value. | |||||||||||||||||
The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of December 31, 2013 (in $000s): | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
ASSETS | |||||||||||||||||
Cash equivalents | $ | 26,476 | $ | — | $ | — | $ | 26,476 | |||||||||
Financial instrument associated with stock Purchase Agreement | — | 397 | — | 397 | |||||||||||||
Total assets | $ | 26,476 | $ | 397 | $ | — | $ | 26,873 | |||||||||
LIABILITIES | |||||||||||||||||
Other liabilities measured at fair value: | |||||||||||||||||
Scottish Enterprise agreement | — | — | 20 | 20 | |||||||||||||
Other liabilities measured at fair value | — | — | 20 | 20 | |||||||||||||
Total liabilities | $ | — | $ | — | $ | 20 | $ | 20 | |||||||||
The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of June 30, 2014 (in $000s): | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
ASSETS | |||||||||||||||||
Cash equivalents | $ | 22,677 | $ | — | $ | — | $ | 22,677 | |||||||||
Financial instrument associated with stock purchase agreement | — | 286 | — | 286 | |||||||||||||
Total assets | $ | 22,677 | $ | 286 | $ | — | $ | 22,963 | |||||||||
The following table reconciles the beginning and ending balances of Level 3 inputs for the six months ended June 30, 2014 (in $000s): | |||||||||||||||||
Level 3 | |||||||||||||||||
Balance as of December 31, 2013 | 20 | ||||||||||||||||
Change in valuation of Scottish Enterprise agreement | (20 | ) | |||||||||||||||
Balance as of June 30, 2014 | — | ||||||||||||||||
Financial Instrument Associated with Stock Purchase Agreement | |||||||||||||||||
On November 14, 2013, the Company entered into a common stock purchase agreement with Aspire Capital Fund, LLC (“Aspire”) (the “Purchase Agreement”) under which Aspire purchased 511,509 shares of common stock for an aggregate purchase price of $2.0 million and committed to purchase up to an additional 3,042,038 shares from time to time as directed by the Company over the next two years at prices derived from the market prices on or near the date of each sale (see Note 8 – Stockholders’ Equity). | |||||||||||||||||
The Company has accounted for the right to sell additional shares under the Purchase Agreement based on the guidance of ASC 815 “Derivative Financial Instruments” (“ASC 815”), which requires the instrument to be measured at fair value with changes in fair value reported in earnings. The instrument had a fair value of $0.5 million at the date of the transaction and a fair value of $0.4 million and $0.3 million as of December 31, 2013 and June 30, 2014, respectively. The $0.1 million decrease in the fair value of the Purchase Agreement during the six months ended June 30, 2014 was recognized as a loss in the consolidated statements of operations. The primary inputs used to determine fair value are the price of the Company’s common stock, the remaining term, and aggregate share purchases on the measurement date. The fair value of the Purchase Agreement is remeasured each reporting period and gains or losses will continue to be reported until the agreement is exhausted or expired. | |||||||||||||||||
Liabilities Measured at Fair Value | |||||||||||||||||
Scottish Enterprise Agreement | |||||||||||||||||
On June 22, 2009, the Company amended the agreement with Scottish Enterprise (“SE”) (the “Amendment”), in order to allow the Company to implement a reduction of the Company’s research operations located in Scotland in exchange for the parties’ agreement to modify the payment terms of the agreement in the principal amount of £5 million (approximately $8.0 million at December 31, 2009), which SE had previously entered into with the Company. The agreement provided for repayment of up to £5 million in the event the Company significantly reduced its Scottish research operations. Pursuant to the terms of the Amendment, in association with Cyclacel’s material reduction in staff at its Scottish research facility, the parties agreed to a modified payment of £1 million (approximately $1.7 million at June 22, 2009) payable in two equal tranches. On July 1, 2009, the first installment of £0.5 million (approximately $0.8 million) was paid and the remaining amount of £0.5 million (approximately $0.8 million) was paid on January 6, 2010. | |||||||||||||||||
In addition, should a further reduction below current minimum staff levels be effectuated before July 1, 2014 without SE’s prior consent, the Company would have been obligated to pay up to £4 million to SE, which will be calculated as a maximum of £4 million (approximately $6.5 million at December 31, 2013 and $6.8 million at June 30, 2014) less the market value of the shares held by SE at the time staffing levels in Scotland fall below the prescribed minimum levels. If the Company were to have reduced staffing levels below the prescribed levels, the amount potentially payable to SE would have been approximately £3.8 million (approximately $6.3 million) and approximately £3.9 million (approximately $6.6 million) at December 31, 2013 and June 30, 2014, respectively. | |||||||||||||||||
This arrangement is accounted for as a liability under ASC Topic 480 “Distinguishing Liabilities from Equity” (“ASC 480”), and is measured at fair value. Changes in fair value are recognized in earnings. Due to the nature of the associated contingency and the likelihood of occurrence, the Company concluded the fair value of this liability was approximately $20,000 and $0 at December 31, 2013 and June 30, 2014, respectively. The most significant inputs in estimating the fair value of this liability are the probabilities that staffing levels fall below the prescribed minimum and that the Company is unable or unwilling to replace such employees within the prescribed time period. At December 31, 2013, the Company used a scenario analysis model to arrive at the fair value of the Scottish Enterprise Agreement and assumed a 30% probability of falling below a minimum staffing level and a 1% probability that the occurrence of such an event would not be cured within the prescribed time period. At June 30, 2014, the Company determined that the probability of falling below a minimum staffing level was 0% given the proximity to the expiration of the agreement on July 1, 2014 and staffing levels had not fallen below the minimum level as of that date. Changes in the value of this liability have been recorded in the consolidated statement of operations. |
PREPAID_EXPENSES_AND_OTHER_CUR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Prepaid Expenses And Other Current Assets [Abstract] | ' | ||||||||
PREPAID EXPENSES AND OTHER CURRENT ASSETS | ' | ||||||||
4 | PREPAID EXPENSES AND OTHER CURRENT ASSETS | ||||||||
The following is a summary of prepaid expenses and other current assets at December 31, 2013 and June 30, 2014 (in $000s): | |||||||||
December 31, | June 30, | ||||||||
2013 | 2014 | ||||||||
Research and development tax credit receivable | $ | 1,744 | $ | 1,374 | |||||
Prepayments | 427 | 1,015 | |||||||
Grant receivable | 357 | 202 | |||||||
Sales tax receivable | 209 | 378 | |||||||
Deposits | 132 | 128 | |||||||
Other current assets | 519 | 325 | |||||||
$ | 3,388 | $ | 3,422 |
ACCRUED_AND_OTHER_CURRENT_LIAB
ACCRUED AND OTHER CURRENT LIABILITIES | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Accrued and Other Current Liabilities | ' | ||||||||
ACCRUED AND OTHER CURRENT LIABILITIES | ' | ||||||||
5 | ACCRUED AND OTHER CURRENT LIABILITIES | ||||||||
Accrued and other current liabilities consisted of the following (in $000s): | |||||||||
December 31, | June 30, | ||||||||
2013 | 2014 | ||||||||
Accrued research and development | $ | 3,435 | $ | 2,761 | |||||
Accrued legal and professional fees | 265 | 183 | |||||||
Other current liabilities | 731 | 151 | |||||||
$ | 4,431 | $ | 3,095 | ||||||
STOCK_BASED_COMPENSATION
STOCK BASED COMPENSATION | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Stock-Based Compensation Arrangements | ' | ||||||||||||||||
STOCK BASED COMPENSATION | ' | ||||||||||||||||
6 | STOCK BASED COMPENSATION | ||||||||||||||||
ASC 718 requires compensation expense associated with share-based awards to be recognized over the requisite service period, which for the Company is the period between the grant date and the date the award vests or becomes exercisable. Most of the awards granted by the Company (and still outstanding), vest ratably over three to four years. Certain awards made to executive officers vest over three to five years, depending on the terms of their employment with the Company. | |||||||||||||||||
The Company recognizes all share-based awards under the straight-line attribution method. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company evaluates its forfeiture assumptions quarterly and the expected forfeiture rate is adjusted when necessary. Ultimately, the actual expense recognized over the vesting period is based on only those shares that vest. | |||||||||||||||||
Stock based compensation has been reported within expense line items on the consolidated statement of operations for the three and six months ended June 30, 2013 and 2014 as shown in the following table (in $000s): | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2013 | 2014 | 2013 | 2014 | ||||||||||||||
General and administrative | $ | 60 | $ | 126 | $ | 117 | $ | 255 | |||||||||
Research and development | 14 | 57 | 29 | 115 | |||||||||||||
Stock-based compensation costs before income taxes | $ | 74 | $ | 183 | $ | 146 | $ | 370 | |||||||||
2006 Plan | |||||||||||||||||
On March 16, 2006, the 2006 Plan was adopted, under which Cyclacel may make equity incentive grants to its officers, employees, directors and consultants. The Company has reserved 1,428,571 shares of the Company’s common stock under the 2006 Plan. Stock option awards granted under the 2006 Plan have a maximum life of 10 years and generally vest over a four-year period from the date of grant. | |||||||||||||||||
There were 32,697 and 54,000 options granted during the six months ended June 30, 2013 and 2014, respectively. | |||||||||||||||||
There were no stock options exercised during the three and six months ended June 30, 2013 and 2014. The Company does not expect to be able to benefit for the deduction for stock option exercises that may occur during the year ended December 31, 2014 because the company has tax loss carryforwards from prior periods that would be expected to offset any potential taxable income for the year ended December 31, 2014. | |||||||||||||||||
Outstanding Options | |||||||||||||||||
A summary of the share option activity and related information is as follows: | |||||||||||||||||
Number of | Weighted | Weighted | Aggregate | ||||||||||||||
Options | Average | Average | Intrinsic | ||||||||||||||
Outstanding | Exercise | Remaining | Value ($000) | ||||||||||||||
Price Per Share | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Options outstanding at December 31, 2013 | 949,685 | $ | 15.02 | 7.38 | $ | 152 | |||||||||||
Granted | 54,000 | $ | 3.09 | ||||||||||||||
Exercised | — | $ | — | ||||||||||||||
Cancelled/forfeited | (2,387 | ) | $ | 31.08 | |||||||||||||
Options outstanding at June 30, 2014 | 1,001,298 | $ | 14.34 | 7.05 | $ | 8 | |||||||||||
Unvested at June 30, 2014 | 487,253 | $ | 4.23 | 9.37 | $ | — | |||||||||||
Vested and exercisable at June 30, 2014 | 514,045 | $ | 23.92 | 4.85 | $ | 6 | |||||||||||
The fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718. | |||||||||||||||||
The expected term assumption is estimated using past history of early exercise behavior and expectations about future behaviors. | |||||||||||||||||
Estimates of pre-vesting option forfeitures are based on the Company’s experience. Currently the Company uses a forfeiture rate of 0 - 30% depending on when and to whom the options are granted. The Company adjusts its estimate of forfeitures over the requisite service period based on the extent to which actual forfeitures differ, or are expected to differ, from such estimates. Changes in estimated forfeitures are recognized through a cumulative adjustment in the period of change and may impact the amount of compensation expense to be recognized in future periods. | |||||||||||||||||
The Company considers many factors when estimating expected forfeitures, including types of awards, employee class, and historical experience. | |||||||||||||||||
The weighted average risk-free interest rate represents interest rate for treasury constant maturities published by the Federal Reserve Board. If the term of available treasury constant maturity instruments is not equal to the expected term of an employee option, Cyclacel uses the weighted average of the two Federal Reserve securities closest to the expected term of the employee option. | |||||||||||||||||
Restricted Stock Units | |||||||||||||||||
Summarized information for restricted stock unit activity for the six months ended June 30, 2014 is as follows: | |||||||||||||||||
Restricted Stock | Weighted Average | ||||||||||||||||
Units (1) | Grant | ||||||||||||||||
Date Value Per Share | |||||||||||||||||
Non-vested at December 31, 2013 | 119,248 | $ | 5.62 | ||||||||||||||
Granted | — | $ | — | ||||||||||||||
Forfeited | (233 | ) | $ | 5.39 | |||||||||||||
Non-vested at June 30, 2014 | 119,015 | $ | 5.62 | ||||||||||||||
-1 | Includes 85,097 restricted stock units issued that will vest upon the fulfillment of certain clinical and financial conditions. | ||||||||||||||||
The Company issued 85,097 restricted stock units to employees during the three months ended June 30, 2013 that will vest upon the fulfillment of certain clinical and financial conditions and will terminate if they have not vested by December 31, 2014. The Company determined that the satisfaction of the vesting criteria was not probable as of June 30, 2014 and, as a result, did not record any expense related to these awards for the three and six months ended June 30, 2014. The Company did not issue any restricted stock units during the six months ended June 30, 2014. |
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended | |
Jun. 30, 2014 | ||
Commitments and Contingencies | ' | |
COMMITMENTS AND CONTINGENCIES | ' | |
7 | COMMITMENTS AND CONTINGENCIES | |
Distribution, Licensing and Research Agreements | ||
The Company has entered into licensing agreements with academic and research organizations. Under the terms of these agreements, the Company has received licenses to technology and patent applications. The Company is required to pay royalties on future sales of products employing the technology or falling under claims of patent applications. | ||
Pursuant to the Daiichi Sankyo license under which the Company licenses certain patent rights for sapacitabine, its lead drug candidate, the Company is under an obligation to use reasonable endeavors to develop a product and obtain regulatory approval to sell a product and has agreed to pay Daiichi Sankyo an up-front fee, reimbursement for Daiichi Sankyo’s enumerated expenses, milestone payments and royalties on a country-by-country basis. The up-front fee, Phase 3 entry milestone, and certain past reimbursements have been paid. A further $10.0 million in aggregate milestone payments could be payable subject to achievement of all the specific contractual milestones and the Company’s decision to continue with these projects. Royalties are payable in each country for the term of patent protection in the country or for ten years following the first commercial sale of licensed products in the country, whichever is later. Royalties are payable on net sales. Net sales are defined as the gross amount invoiced by the Company or its affiliates or licensees, less discounts, credits, taxes, shipping and bad debt losses. The agreement extends from its commencement date to the date on which no further amounts are owed under it. If the Company wishes to appoint a third party to develop or commercialize a sapacitabine-based product in Japan, within certain limitations, Daiichi Sankyo must be notified and given a right of first refusal, with the right of first refusal ending sixty days after notification, to develop and/or commercialize in Japan. In general, the license may be terminated by the Company for technical, scientific, efficacy, safety, or commercial reasons on nine months’ notice, or twelve months’ notice, if after a launch of a sapacitabine-based product, or by either party for material default. |
STOCKHOLDERS_EQUITY
STOCKHOLDERS' EQUITY | 6 Months Ended | ||||||||||||
Jun. 30, 2014 | |||||||||||||
Stockholders' Equity | ' | ||||||||||||
STOCKHOLDERS' EQUITY | ' | ||||||||||||
8 | STOCKHOLDERS’ EQUITY | ||||||||||||
Preferred Stock | |||||||||||||
As of June 30, 2014, there were 335,273 shares of the Company’s 6% Convertible Exchangeable Preferred Stock (“Preferred Stock”) issued and outstanding at an issue price of $10.00 per share. Dividends on the Preferred Stock are cumulative from the date of original issuance at the annual rate of 6% of the liquidation preference of the Preferred Stock, payable quarterly on the first day of February, May, August and November, commencing February 1, 2005. Any dividends must be declared by the Company’s Board and must come from funds that are legally available for dividend payments. The Preferred Stock has a liquidation preference of $10.00 per share, plus accrued and unpaid dividends. | |||||||||||||
The Preferred Stock is convertible at the option of the holder at any time into the Company’s shares of common stock at a conversion rate of approximately 0.06079 shares of common stock for each share of Preferred Stock based on a price of $164.50. The Company has reserved 20,381 shares of common stock for issuance upon conversion of the remaining shares of Preferred Stock outstanding at June 30, 2014. The shares of previously-converted Preferred Stock have been retired, cancelled and restored to the status of authorized but unissued shares of preferred stock, subject to reissuance by the Board as shares of Preferred Stock of one or more series. | |||||||||||||
The Company may automatically convert the Preferred Stock into common stock if the closing price of the Company’s common stock has exceeded $246.75, which is 150% of the conversion price of the Preferred Stock, for at least 20 trading days during any 30-day trading period, ending within five trading days prior to notice of automatic conversion. | |||||||||||||
The Certificate of Designations governing the Preferred Stock provides that if the Company fails to pay dividends on its Preferred Stock for six quarterly periods, holders of Preferred Stock are entitled to nominate and elect two directors to the Board. This right accrued to the holders of Preferred Stock as of August 2, 2010 and two directors were nominated and elected at the annual meeting held on May 24, 2011. | |||||||||||||
The Preferred Stock has no maturity date and no voting rights prior to conversion into common stock, except under limited circumstances. | |||||||||||||
The Company may, at its option, redeem the Preferred Stock in whole or in part, out of funds legally available at the redemption prices per share stated below, plus an amount equal to accrued and unpaid dividends up to the date of redemption: | |||||||||||||
Year from November 1, 2013 to October 31, 2014 | $ | 10.06 | |||||||||||
November 1, 2014 and thereafter | $ | 10 | |||||||||||
The Preferred Stock is exchangeable, in whole but not in part, at the option of the Company on any dividend payment date beginning on November 1, 2005 (the “Exchange Date”) for the Company’s 6% Convertible Subordinated Debentures (“Debentures”) at the rate of $10.00 principal amount of Debentures for each share of Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have terms substantially similar to those of the Preferred Stock. No such exchanges have taken place to date. | |||||||||||||
Conversion of Convertible Preferred Stock | |||||||||||||
During the six months ended June 30, 2013, the Company converted an aggregate of 792,460 shares of Preferred Stock into an aggregate of 1,513,653 shares of the Company’s common stock. There were no conversions of the Company’s Preferred Stock into shares of common stock during the six months ended June 30, 2014. Since the Company’s transaction with Xcyte Therapies, Inc. in 2006, holders have exchanged 1,711,540 shares of Preferred Stock into common stock as a result of arms-length negotiations between the Company and the other parties. | |||||||||||||
The table below provides details of the aggregate activities during the six months ended June 30, 2013: | |||||||||||||
Six | |||||||||||||
Months Ended | |||||||||||||
June 30, | |||||||||||||
2013 | |||||||||||||
Preferred shares exchanged | 792,460 | ||||||||||||
Shares of common stock issued: | |||||||||||||
At stated conversion terms | 48,174 | ||||||||||||
Incremental shares issued under the exchange transaction | 1,465,479 | ||||||||||||
Total shares of common stock issued | 1,513,653 | ||||||||||||
As the Preferred stockholders received additional shares of common stock issued to them upon conversion as compared to what they would have been entitled to receive under the stated rate of exchange, the Company recorded the excess of (1) the fair value of all securities and other consideration transferred to the holders of the Preferred Stock and (2) the fair value of securities issuable pursuant to the original conversion terms as a deemed dividend resulting in an increase in the net loss attributable to common shareholders. Specifically, the Company recorded deemed dividends related to the additional shares issued under the exchange transactions of $8.4 million for the six months ended June 30, 2013. | |||||||||||||
Common Stock | |||||||||||||
April 2014 Underwriting Agreement | |||||||||||||
On April 3, 2014, the Company entered into an underwriting agreement relating to the public offering and sale of 2,857,143 shares of the Company’s common stock, par value $0.001, at a price to the public of $3.50 per share, for proceeds, net of certain fees and expenses, of approximately $9.3 million. | |||||||||||||
November 2013 Stock Purchase Agreement | |||||||||||||
On November 14, 2013, the Company entered into a common stock Purchase Agreement with Aspire. Upon execution of the Purchase Agreement, Aspire purchased 511,509 shares of common stock for an aggregate purchase price of $2.0 million. Under the terms of the Purchase Agreement, Aspire has committed to purchase up to an additional 3,042,038 shares from time to time as directed by the Company or, in certain instances, as agreed to by both parties, over the next two years at prices derived from the market prices on or near the date of each sale. However, such commitment is limited to an additional $18.0 million of share purchases. In consideration for entering into the Purchase Agreement, concurrent with the execution of the Purchase Agreement, the Company issued 166,105 shares of the Company’s common stock to Aspire in lieu of a commitment fee. The fair value of these shares has been recorded as a component of other assets and will continue to be remeasured each reporting period, until the agreement is exhausted or expired, with gains or losses reported in the consolidated statements of operations. During the six months ended June 30, 2014, the Company sold 450,000 shares to Aspire under the Purchase Agreement for proceeds of $1.7 million. | |||||||||||||
May 2013 Underwriting Agreement | |||||||||||||
On May 16, 2013, the Company entered into an underwriting agreement relating to the public offering and sale of up to 6,666,667 shares of the Company’s common stock, par value $0.001, at a price to the public of $3.00 per share. On May 21, 2013, the Company closed the public offering and completed the sale of 6,833,334 shares of its common stock, which includes 166,667 shares that were subject to the underwriters’ over-allotment option, at a price to the public of $3.00 per share, for proceeds, net of certain fees and expenses, of approximately $19.0 million. | |||||||||||||
Common Stock Bonus | |||||||||||||
During the six months ended June 30, 2013, the Company issued 31,643 shares of common stock with a fair value of approximately $0.2 million to employees in lieu of cash in connection with bonuses recorded for the year ended December 31, 2012. There were no such stock issuances during the six months ended June 30, 2014. | |||||||||||||
December 2012 Stock Purchase Agreement | |||||||||||||
On December 14, 2012, the Company entered into a common stock purchase agreement with Aspire. Upon execution of the purchase agreement, Aspire purchased 158,982 shares of common stock for an aggregate purchase price of $1.0 million based on the closing price of the Company’s common stock on December 13, 2012, the date upon which the business terms were agreed. Under the terms of the purchase agreement, Aspire committed to purchase up to an additional 1,455,787 shares from time to time as directed by the Company over the next two years at prices derived from the market prices on or near the date of each sale. However, such commitment was limited to an additional $19.0 million of share purchases. In consideration for entering into the Purchase Agreement, concurrent with the execution of the Purchase Agreement, the Company issued 74,548 shares of the Company’s common stock to Aspire in lieu of a commitment fee. The fair value of the 74,548 shares of common stock along with the direct costs incurred in the connection with the Aspire transaction have been allocated to the shares sold at inception of this agreement and the right to sell additional shares in the future based on the ratio of shares sold at inception to the listed shares subject to this agreement. The agreement terminated on November 14, 2013 and no rights or obligations remain under the agreement. | |||||||||||||
March 2012 Sale of Common Stock and Economic Rights | |||||||||||||
On March 22, 2012, the Company entered into a purchase agreement with certain existing institutional stockholders, raising approximately $2.9 million of proceeds, net of certain fees and expenses. The proceeds from the financing were used to fund ongoing litigation-related expenses on certain intellectual property and for general corporate purposes. Under the terms of the purchase agreement, the investors purchased 669,726 shares of the Company’s common stock at a price of $4.53, which is equal to the 10-day average closing price of the Company’s common stock for the period ending on March 21, 2012. The shares issued at closing were subject to a lock-up period of one year from the date of issuance. | |||||||||||||
In addition to the common stock, investors received contractual rights to receive cash equal to 10% of any future litigation settlement related to the specified intellectual property, subject to a cap. In April 2013, the Economic Rights were settled for payment of $0.6 million. | |||||||||||||
Common Stock Warrants | |||||||||||||
The following table summarizes information about warrants outstanding at June 30, 2014: | |||||||||||||
Issued in Connection With | Expiration | Common | Weighted | ||||||||||
Date | Shares | Average | |||||||||||
Issuable | Exercise | ||||||||||||
Price | |||||||||||||
July 2009 Series II stock issuance | 2014 | 98,893 | $ | 7 | |||||||||
January 2010 stock issuance | 2015 | 101,785 | $ | 22.82 | |||||||||
January 2010 stock issuance | 2015 | 100,714 | $ | 19.95 | |||||||||
October 2010 stock issuance | 2015 | 594,513 | $ | 13.44 | |||||||||
July 2011 stock issuance | 2016 | 544,117 | $ | 9.52 | |||||||||
Total | 1,440,022 | $ | 12.63 | ||||||||||
There were no exercises of warrants during the six months ended June 30, 2013 and 2014. Warrants for 151,773 shares of common stock, issued in connection with the February 2007 stock issuance, expired during the six months ended June 30, 2014. |
DISCONTINUED_OPERATIONS
DISCONTINUED OPERATIONS | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Discontinued Operations | ' | ||||||||||||||||
DISCONTINUED OPERATIONS | ' | ||||||||||||||||
9 | DISCONTINUED OPERATIONS | ||||||||||||||||
On August 10, 2012, the Company entered into an agreement with Sinclair Pharmaceuticals Limited (“Sinclair”) to terminate, effective September 30, 2012, the distribution agreements relating to the promotion and sale of Xclair®, Numoisyn® Lozenges and Numoisyn® Liquid (collectively, the “ALIGN products”). | |||||||||||||||||
Product revenue, cost of goods sold and selling, general and administrative costs related to the promotion and sale of the ALIGN products have been reclassified from operating results from continuing operations to income from discontinued operations in the consolidated statement of operations for all periods presented as follows (in $000s): | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2013 | 2014 | 2013 | 2014 | ||||||||||||||
Interest income | $ | 24 | $ | 10 | $ | 50 | $ | 23 | |||||||||
Income tax on discontinued operations | (10 | ) | (3 | ) | (20 | ) | (8 | ) | |||||||||
Net income from discontinued operations | $ | 14 | $ | 7 | $ | 30 | $ | 15 | |||||||||
The assets and liabilities associated with product promotion and sales have been classified within assets and liabilities of discontinued operations in the accompanying consolidated balance sheets (in $000s): | |||||||||||||||||
December 31, | June 30, | ||||||||||||||||
2013 | 2014 | ||||||||||||||||
Current assets of discontinued operations: | |||||||||||||||||
Short term portion of minimum royalty arrangement receivable, net | $ | 379 | $ | 258 | |||||||||||||
Returns indemnification receivable | 260 | 145 | |||||||||||||||
Total current assets of discontinued operations | 639 | 403 | |||||||||||||||
Long-term assets of discontinued operations: | |||||||||||||||||
Long-term portion of minimum royalty arrangement receivable, net | 72 | 24 | |||||||||||||||
Total assets of discontinued operations | $ | 711 | $ | 427 | |||||||||||||
Current liabilities of discontinued operations: | |||||||||||||||||
Returns provision | $ | 260 | $ | 145 | |||||||||||||
Total current liabilities of discontinued operations | $ | 260 | $ | 145 |
SUMMARY_OF_SIGNIFICANT_ACCOUNT1
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. |
SUMMARY_OF_SIGNIFICANT_ACCOUNT2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Summary of Significant Accounting Policies | ' | ||||||||||||||||
Schedule of basic earnings per share and diluted earnings per share | ' | ||||||||||||||||
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 | ) | ||||||
Schedule of antidilutive shares excluded from computation of diluted net loss per share | ' | ||||||||||||||||
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 |
FAIR_VALUE_Tables
FAIR VALUE (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Fair Value | ' | ||||||||||||||||
Schedule of financial assets and liabilities measured on a recurring basis | ' | ||||||||||||||||
The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of December 31, 2013 (in $000s): | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
ASSETS | |||||||||||||||||
Cash equivalents | $ | 26,476 | $ | — | $ | — | $ | 26,476 | |||||||||
Financial instrument associated with stock Purchase Agreement | — | 397 | — | 397 | |||||||||||||
Total assets | $ | 26,476 | $ | 397 | $ | — | $ | 26,873 | |||||||||
LIABILITIES | |||||||||||||||||
Other liabilities measured at fair value: | |||||||||||||||||
Scottish Enterprise agreement | — | — | 20 | 20 | |||||||||||||
Other liabilities measured at fair value | — | — | 20 | 20 | |||||||||||||
Total liabilities | $ | — | $ | — | $ | 20 | $ | 20 | |||||||||
The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of June 30, 2014 (in $000s): | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
ASSETS | |||||||||||||||||
Cash equivalents | $ | 22,677 | $ | — | $ | — | $ | 22,677 | |||||||||
Financial instrument associated with stock purchase agreement | — | 286 | — | 286 | |||||||||||||
Total assets | $ | 22,677 | $ | 286 | $ | — | $ | 22,963 | |||||||||
Schedule of of Level 3 inputs | ' | ||||||||||||||||
Level 3 | |||||||||||||||||
Balance as of December 31, 2013 | 20 | ||||||||||||||||
Change in valuation of Scottish Enterprise agreement | (20 | ) | |||||||||||||||
Balance as of June 30, 2014 | — |
PREPAID_EXPENSES_AND_OTHER_CUR1
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Prepaid Expenses And Other Current Assets [Abstract] | ' | ||||||||
Schedule of prepaid expenses and other current assets | ' | ||||||||
December 31, | June 30, | ||||||||
2013 | 2014 | ||||||||
Research and development tax credit receivable | $ | 1,744 | $ | 1,374 | |||||
Prepayments | 427 | 1,015 | |||||||
Grant receivable | 357 | 202 | |||||||
Sales tax receivable | 209 | 378 | |||||||
Deposits | 132 | 128 | |||||||
Other current assets | 519 | 325 | |||||||
$ | 3,388 | $ | 3,422 |
ACCRUED_AND_OTHER_CURRENT_LIAB1
ACCRUED AND OTHER CURRENT LIABILITIES (Tables) | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Accrued and Other Current Liabilities | ' | ||||||||
Schedule of accrued and other current liabilities | ' | ||||||||
December 31, | June 30, | ||||||||
2013 | 2014 | ||||||||
Accrued research and development | $ | 3,435 | $ | 2,761 | |||||
Accrued legal and professional fees | 265 | 183 | |||||||
Other current liabilities | 731 | 151 | |||||||
$ | 4,431 | $ | 3,095 | ||||||
STOCK_BASED_COMPENSATION_Table
STOCK BASED COMPENSATION (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Stock-Based Compensation Arrangements | ' | ||||||||||||||||
Schedule of stock based compensation expense | ' | ||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2013 | 2014 | 2013 | 2014 | ||||||||||||||
General and administrative | $ | 60 | $ | 126 | $ | 117 | $ | 255 | |||||||||
Research and development | 14 | 57 | 29 | 115 | |||||||||||||
Stock-based compensation costs before income taxes | $ | 74 | $ | 183 | $ | 146 | $ | 370 | |||||||||
Schedule of stock option activity | ' | ||||||||||||||||
Number of | Weighted | Weighted | Aggregate | ||||||||||||||
Options | Average | Average | Intrinsic | ||||||||||||||
Outstanding | Exercise | Remaining | Value ($000) | ||||||||||||||
Price Per Share | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Options outstanding at December 31, 2013 | 949,685 | $ | 15.02 | 7.38 | $ | 152 | |||||||||||
Granted | 54,000 | $ | 3.09 | ||||||||||||||
Exercised | — | $ | — | ||||||||||||||
Cancelled/forfeited | (2,387 | ) | $ | 31.08 | |||||||||||||
Options outstanding at June 30, 2014 | 1,001,298 | $ | 14.34 | 7.05 | $ | 8 | |||||||||||
Unvested at June 30, 2014 | 487,253 | $ | 4.23 | 9.37 | $ | — | |||||||||||
Vested and exercisable at June 30, 2014 | 514,045 | $ | 23.92 | 4.85 | $ | 6 | |||||||||||
Schedule of restricted stock units activity | ' | ||||||||||||||||
Restricted Stock | Weighted Average | ||||||||||||||||
Units (1) | Grant | ||||||||||||||||
Date Value Per Share | |||||||||||||||||
Non-vested at December 31, 2013 | 119,248 | $ | 5.62 | ||||||||||||||
Granted | — | $ | — | ||||||||||||||
Forfeited | (233 | ) | $ | 5.39 | |||||||||||||
Non-vested at June 30, 2014 | 119,015 | $ | 5.62 | ||||||||||||||
-1 | Includes 85,097 restricted stock units issued that will vest upon the fulfillment of certain clinical and financial conditions. |
STOCKHOLDERS_EQUITY_Tables
STOCKHOLDERS' EQUITY (Tables) | 6 Months Ended | ||||||||||
Jun. 30, 2014 | |||||||||||
Stockholders' Equity | ' | ||||||||||
Schedule of redemption prices per share | ' | ||||||||||
Year from November 1, 2013 to October 31, 2014 | $ | 10.06 | |||||||||
November 1, 2014 and thereafter | $ | 10 | |||||||||
Schedule of conversion of convertible preferred stock | ' | ||||||||||
Six | |||||||||||
Months Ended | |||||||||||
June 30, | |||||||||||
2013 | |||||||||||
Preferred shares exchanged | 792,460 | ||||||||||
Shares of common stock issued: | |||||||||||
At stated conversion terms | 48,174 | ||||||||||
Incremental shares issued under the exchange transaction | 1,465,479 | ||||||||||
Total shares of common stock issued | 1,513,653 | ||||||||||
Schedule of warrants outstanding | ' | ||||||||||
Issued in Connection With | Expiration | Common | Weighted | ||||||||
Date | Shares | Average | |||||||||
Issuable | Exercise | ||||||||||
Price | |||||||||||
July 2009 Series II stock issuance | 2014 | 98,893 | $ | 7 | |||||||
January 2010 stock issuance | 2015 | 101,785 | $ | 22.82 | |||||||
January 2010 stock issuance | 2015 | 100,714 | $ | 19.95 | |||||||
October 2010 stock issuance | 2015 | 594,513 | $ | 13.44 | |||||||
July 2011 stock issuance | 2016 | 544,117 | $ | 9.52 | |||||||
Total | 1,440,022 | $ | 12.63 |
DISCONTINUED_OPERATIONS_Tables
DISCONTINUED OPERATIONS (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Discontinued Operations | ' | ||||||||||||||||
Schedule of assets and liabilities, and product revenue, cost of goods sold and selling, general and administrative costs of discontinued operations | ' | ||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2013 | 2014 | 2013 | 2014 | ||||||||||||||
Interest income | $ | 24 | $ | 10 | $ | 50 | $ | 23 | |||||||||
Income tax on discontinued operations | (10 | ) | (3 | ) | (20 | ) | (8 | ) | |||||||||
Net income from discontinued operations | $ | 14 | $ | 7 | $ | 30 | $ | 15 | |||||||||
December 31, | June 30, | ||||||||||||||||
2013 | 2014 | ||||||||||||||||
Current assets of discontinued operations: | |||||||||||||||||
Short term portion of minimum royalty arrangement receivable, net | $ | 379 | $ | 258 | |||||||||||||
Returns indemnification receivable | 260 | 145 | |||||||||||||||
Total current assets of discontinued operations | 639 | 403 | |||||||||||||||
Long-term assets of discontinued operations: | |||||||||||||||||
Long-term portion of minimum royalty arrangement receivable, net | 72 | 24 | |||||||||||||||
Total assets of discontinued operations | $ | 711 | $ | 427 | |||||||||||||
Current liabilities of discontinued operations: | |||||||||||||||||
Returns provision | $ | 260 | $ | 145 | |||||||||||||
Total current liabilities of discontinued operations | $ | 260 | $ | 145 |
NATURE_OF_OPERATIONS_AND_BASIS1
NATURE OF OPERATIONS AND BASIS OF PRESENTATION (Details) (USD $) | 6 Months Ended |
In Millions, unless otherwise specified | Jun. 30, 2014 |
Nature of Operations | ' |
Grants awarded from United Kingdom' s Medical Research Council | $1.50 |
Grant awarded from UK Government's Biomedical Catalyst | 1.9 |
Grant received | $3.70 |
SUMMARY_OF_SIGNIFICANT_ACCOUNT3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Summary of Significant Accounting Policies | ' | ' | ' | ' |
Net income (loss) from continuing operations | ($4,819) | $1,478 | ($9,696) | ($1,620) |
Deemed dividend on convertible exchangeable preferred shares | ' | ' | ' | -8,366 |
Dividend on convertible exchangeable preferred shares | -50 | -63 | -100 | -185 |
Numerator for earnings per share for Income (loss) from continuing operations - Basic and Diluted | ($4,869) | $1,415 | ($9,796) | ($10,171) |
Weighted average shares of common stock outstanding - Basic | 22,582,283 | 13,885,442 | 21,064,739 | 11,849,270 |
Dilutive effect of stock options | ' | 41,929 | ' | ' |
Weighted average shares of common stock outstanding - Diluted | 22,582,283 | 13,927,371 | 21,064,739 | 11,849,270 |
Net income (loss) from continuing operations - Basic | ($0.22) | $0.10 | ($0.47) | ($0.86) |
Net income (loss) from continuing operations - Diluted | ($0.22) | $0.10 | ($0.47) | ($0.86) |
SUMMARY_OF_SIGNIFICANT_ACCOUNT4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Net loss per common share | ' | ' | ' | ' |
Total shares excluded from calculation | 2,580,716 | 2,075,507 | 2,580,716 | 2,228,230 |
Stock options | ' | ' | ' | ' |
Net loss per common share | ' | ' | ' | ' |
Total shares excluded from calculation | 1,001,298 | 334,996 | 1,001,298 | 487,719 |
Restricted Stock and Restricted Stock Units | ' | ' | ' | ' |
Net loss per common share | ' | ' | ' | ' |
Total shares excluded from calculation | 119,015 | 123,143 | 119,015 | 123,143 |
Convertible preferred stock | ' | ' | ' | ' |
Net loss per common share | ' | ' | ' | ' |
Total shares excluded from calculation | 20,381 | 25,573 | 20,381 | 25,573 |
Common stock warrants | ' | ' | ' | ' |
Net loss per common share | ' | ' | ' | ' |
Total shares excluded from calculation | 1,440,022 | 1,591,795 | 1,440,022 | 1,591,795 |
SUMMARY_OF_SIGNIFICANT_ACCOUNT5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 2) (USD $) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | 22-May-14 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Country | Segment | ||||
Country | |||||
Summary of Significant Accounting Policies | ' | ' | ' | ' | ' |
Income tax benefit | ' | $816 | $230 | $1,385 | $488 |
Segments | ' | ' | ' | ' | ' |
Number of operating segments | ' | ' | ' | 1 | ' |
Number of geographic areas for development operations | ' | 2 | ' | 2 | ' |
Cash dividend declared per share (in dollars per share) | $0.15 | ' | ' | ' | ' |
Dividend rate (in percent) | 6.00% | ' | ' | ' | ' |
FAIR_VALUE_Details
FAIR VALUE (Details) (Recurring basis, USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
Level 1 | ' | ' |
ASSETS | ' | ' |
Cash equivalents | $22,677,000 | $26,476,000 |
Financial instrument associated with stock purchase agreement | ' | ' |
Total assets | 22,677,000 | 26,476,000 |
Other liabilities measured at fair value: | ' | ' |
Scottish Enterprise agreement | ' | ' |
Other liabilities measured at fair value | ' | ' |
Total liabilities | ' | ' |
Level 2 | ' | ' |
ASSETS | ' | ' |
Cash equivalents | ' | ' |
Financial instrument associated with stock purchase agreement | 286,000 | 397,000 |
Total assets | 286,000 | 397,000 |
Other liabilities measured at fair value: | ' | ' |
Scottish Enterprise agreement | ' | ' |
Other liabilities measured at fair value | ' | ' |
Total liabilities | ' | ' |
Level 3 | ' | ' |
ASSETS | ' | ' |
Cash equivalents | ' | ' |
Financial instrument associated with stock purchase agreement | ' | ' |
Total assets | ' | ' |
Other liabilities measured at fair value: | ' | ' |
Scottish Enterprise agreement | ' | 20,000 |
Other liabilities measured at fair value | ' | 20,000 |
Total liabilities | ' | 20,000 |
Total | ' | ' |
ASSETS | ' | ' |
Cash equivalents | 22,677,000 | 26,476,000 |
Financial instrument associated with stock purchase agreement | 286,000 | 397,000 |
Total assets | 22,963,000 | 26,873,000 |
Other liabilities measured at fair value: | ' | ' |
Scottish Enterprise agreement | ' | 20,000 |
Other liabilities measured at fair value | ' | 20,000 |
Total liabilities | ' | $20,000 |
FAIR_VALUE_Details_1
FAIR VALUE (Details 1) (Guarantees, USD $) | 6 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 |
Guarantees | ' |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ' |
Balance as of December 31, 2013 | $20 |
Change in valuation of Scottish Enterprise agreement | -20 |
Balance as of June 30, 2014 | ' |
FAIR_VALUE_Details_2
FAIR VALUE (Details 2) (Purchase Agreement, Aspire Capital Fund, LLC, USD $) | 0 Months Ended | 6 Months Ended | |
In Millions, except Share data, unless otherwise specified | Nov. 14, 2013 | Jun. 30, 2014 | Dec. 31, 2013 |
Purchase Agreement | Aspire Capital Fund, LLC | ' | ' | ' |
Fair value measurements | ' | ' | ' |
Number of shares issued under purchase agreement | 511,509 | ' | ' |
Purchase price for shares issued under purchase agreement | $2 | ' | ' |
Shares committed to purchase | 3,042,038 | ' | ' |
Period of common stock purchase agreement | '2 years | ' | ' |
Fair value of financial instrument | 0.5 | 0.3 | 0.4 |
Decrease in the fair value of the Purchase Agreement | ' | $0.10 | ' |
FAIR_VALUE_Details_3
FAIR VALUE (Details 3) (Scottish Enterprise Agreement) | 6 Months Ended | ||||||||||
Jun. 30, 2014 | Jun. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2013 | Jan. 06, 2010 | Jan. 06, 2010 | Dec. 31, 2009 | Jul. 01, 2009 | Jul. 01, 2009 | Jun. 22, 2009 | Jun. 22, 2009 | |
USD ($) | GBP (£) | USD ($) | GBP (£) | USD ($) | GBP (£) | USD ($) | USD ($) | GBP (£) | USD ($) | GBP (£) | |
Scottish Enterprise Agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Maximum guaranteed amount potentially due to SE | $6,800,000 | ' | $6,500,000 | £ 4,000,000 | ' | ' | $8,000,000 | ' | ' | ' | £ 5,000,000 |
Modified payment for which parties agreed | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,700,000 | 1,000,000 |
Amount paid | ' | ' | ' | ' | 800,000 | 500,000 | ' | 800,000 | 500,000 | ' | ' |
Potential amount to be paid if staffing levels reduced below the prescribed levels | 6,600,000 | 3,900,000 | 6,300,000 | 3,800,000 | ' | ' | ' | ' | ' | ' | ' |
Fair value of the liability | $0 | ' | $20,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Expected volatility (as a percent) | 30.00% | 30.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Probability of falling below a minimum staffing level within prescribed time period (as a percent) | 1.00% | 1.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' |
PREPAID_EXPENSES_AND_OTHER_CUR2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Prepaid Expense and Other Assets, Current [Abstract] | ' | ' |
Research and development tax credit receivable | $1,374 | $1,744 |
Prepayments | 1,015 | 427 |
Grant receivable | 202 | 357 |
Sales tax receivable | 378 | 209 |
Deposits | 128 | 132 |
Other current assets | 325 | 519 |
Prepaid expenses and other current assets | $3,422 | $3,388 |
ACCRUED_AND_OTHER_CURRENT_LIAB2
ACCRUED AND OTHER CURRENT LIABILITIES (Details) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Accrued and Other Current Liabilities | ' | ' |
Accrued research and development | $2,761 | $3,435 |
Accrued legal and professional fees | 183 | 265 |
Other current liabilities | 151 | 731 |
Total | $3,095 | $4,431 |
STOCK_BASED_COMPENSATION_Detai
STOCK BASED COMPENSATION (Details) | 6 Months Ended |
Jun. 30, 2014 | |
Minimum | ' |
Stock-based compensation | ' |
Vesting period | '3 years |
Maximum | ' |
Stock-based compensation | ' |
Vesting period | '4 years |
Executive officers | Minimum | ' |
Stock-based compensation | ' |
Vesting period | '3 years |
Executive officers | Maximum | ' |
Stock-based compensation | ' |
Vesting period | '5 years |
STOCK_BASED_COMPENSATION_Detai1
STOCK BASED COMPENSATION (Details 1) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Stock-based compensation | ' | ' | ' | ' |
Stock-based compensation costs before income taxes | $183 | $74 | $370 | $146 |
General and administrative | ' | ' | ' | ' |
Stock-based compensation | ' | ' | ' | ' |
Stock-based compensation costs before income taxes | 126 | 60 | 255 | 117 |
Research and development | ' | ' | ' | ' |
Stock-based compensation | ' | ' | ' | ' |
Stock-based compensation costs before income taxes | $57 | $14 | $115 | $29 |
STOCK_BASED_COMPENSATION_Detai2
STOCK BASED COMPENSATION (Details 2) (Stock options, USD $) | 6 Months Ended | 12 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Dec. 31, 2013 |
Stock options | ' | ' | ' |
Number of Options Outstanding | ' | ' | ' |
Options outstanding at December 31, 2013 (in shares) | 949,685 | ' | ' |
Granted (in shares) | 54,000 | 32,697 | ' |
Exercised (in shares) | ' | ' | ' |
Cancelled / forfeited (in shares) | -2,087 | ' | ' |
Options outstanding at June 30, 2014 (in shares) | 1,001,298 | ' | 949,685 |
Unvested at June 30, 2014 | 487,253 | ' | ' |
Vested and exercisable at June 30, 2014 | 514,045 | ' | ' |
Weighted Average Exercise Price Per Share | ' | ' | ' |
Options outstanding at December 31, 2013 (in dollars per share) | $15.02 | ' | ' |
Granted (in dollars per share) | $3.09 | ' | ' |
Exercised (in dollars per share) | ' | ' | ' |
Cancelled / forfeited (in dollars per share) | $31.08 | ' | ' |
Options outstanding at June 30, 2014 (in dollars per share) | $14.34 | ' | $15.02 |
Unvested at June 30, 2014 (in dollars per share) | $4.23 | ' | ' |
Vested and exercisable at June 30, 2014 (in dollars per share) | $23.92 | ' | ' |
Weighted Average Remaining Contractual Term (Years) | ' | ' | ' |
Options outstanding | '7 years 18 days | ' | '7 years 4 months 17 days |
Unvested at the end of the period | '9 years 4 months 13 days | ' | ' |
Vested and exercisable at the end of the period | '4 years 10 months 6 days | ' | ' |
Aggregate Intrinsic Value | ' | ' | ' |
Options outstanding | $8 | ' | $152 |
Unvested at the end of the period | ' | ' | ' |
Vested and exercisable at the end of the period | $6 | ' | ' |
STOCK_BASED_COMPENSATION_Detai3
STOCK BASED COMPENSATION (Details 3) | 6 Months Ended | |
Jun. 30, 2014 | Jun. 30, 2013 | |
Stock-based compensation | ' | ' |
Number of shares reserved for issuance | 1,428,571 | ' |
Stock options | ' | ' |
Stock-based compensation | ' | ' |
Expiration period | '10 years | ' |
Vesting period | '4 years | ' |
Options granted (in shares) | 54,000 | 32,697 |
STOCK_BASED_COMPENSATION_Detai4
STOCK BASED COMPENSATION (Details 4) (Restricted Stock Units, USD $) | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | ||
Restricted Stock Units | ' | ' | |
Nonvested activity | ' | ' | |
Non-vested at December 31, 2013 (in shares) | 119,248 | [1] | ' |
Granted (in shares) | ' | [1] | 85,097 |
Forfeited (in shares) | -233 | [1] | ' |
Non-vested at June 30, 2014 (in shares) | 119,015 | [1] | ' |
Weighted Average Grant Date Value Per Share | ' | ' | |
Non-vested at December 31, 2013 (in dollars per share) | $5.62 | ' | |
Granted (in dollars per share) | ' | ' | |
Forfeited (in dollars per share) | $5.39 | ' | |
Non-vested at June 30, 2014 (in dollars per share) | $5.62 | ' | |
[1] | Includes 85,097 restricted stock units issued that will vest upon the fulfillment of certain clinical and financial conditions. |
STOCK_BASED_COMPENSATION_Detai5
STOCK BASED COMPENSATION (Details 5) | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | ||
Minimum | ' | ' | |
Stock based compensation, additional disclosures | ' | ' | |
Forfeiture rate (as a percent) | 0.00% | ' | |
Maximum | ' | ' | |
Stock based compensation, additional disclosures | ' | ' | |
Forfeiture rate (as a percent) | 30.00% | ' | |
Stock options | ' | ' | |
Stock based compensation, additional disclosures | ' | ' | |
Number of Federal Reserve securities whose weighted average is used for calculation of weighted average risk-free interest rate | 2 | ' | |
Restricted Stock Units | ' | ' | |
Stock based compensation, additional disclosures | ' | ' | |
Granted (in shares) | ' | [1] | 85,097 |
[1] | Includes 85,097 restricted stock units issued that will vest upon the fulfillment of certain clinical and financial conditions. |
COMMITMENTS_AND_CONTINGENCIES_
COMMITMENTS AND CONTINGENCIES (Details) (USD $) | Jun. 30, 2014 |
In Millions, unless otherwise specified | |
Commitments and Contingencies | ' |
Future milestone payments payable | $10 |
STOCKHOLDERS_EQUITY_Details
STOCKHOLDERS' EQUITY (Details) (USD $) | Jun. 30, 2014 |
Year from November 1, 2013 to October 31, 2014 | ' |
Stockholders' equity | ' |
Redemption price per share (in dollars per share) | $10.06 |
November 1, 2014 and thereafter | ' |
Stockholders' equity | ' |
Redemption price per share (in dollars per share) | $10 |
STOCKHOLDERS_EQUITY_Details_2
STOCKHOLDERS' EQUITY (Details 2) (USD $) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 0 Months Ended | 6 Months Ended | 102 Months Ended | 6 Months Ended | ||||
In Thousands, except Share data, unless otherwise specified | 22-May-14 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Dec. 31, 2013 | Aug. 02, 2010 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2013 |
Preferred stock | Preferred stock | Preferred stock | Preferred stock | Common stock | |||||||
Director | Director | Quarter | Minimum | ||||||||
Conversion_rate | Series | ||||||||||
Quarter | |||||||||||
Stockholders' equity | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Preferred stock, shares issued | ' | 335,273 | ' | 335,273 | ' | 335,273 | ' | 335,273 | 335,273 | ' | ' |
Preferred stock, shares outstanding | ' | 335,273 | ' | 335,273 | ' | 335,273 | ' | 335,273 | 335,273 | ' | ' |
Preferred stock, par value (in dollars per share) | ' | $0.00 | ' | $0.00 | ' | $0.00 | ' | $10 | $10 | ' | ' |
Dividend rate on convertible exchangeable preferred stock (in percent) | 6.00% | ' | ' | ' | ' | ' | ' | 6.00% | ' | ' | ' |
Liquidation preference (in dollars per share) | ' | ' | ' | ' | ' | ' | ' | $10 | $10 | ' | ' |
Number of shares to be issued for each preferred stock upon conversion | ' | ' | ' | ' | ' | ' | ' | 0.06079 | ' | ' | ' |
Conversion price (in dollars per share) | ' | ' | ' | ' | ' | ' | ' | $164.50 | ' | ' | ' |
Shares reserved for future issuance upon conversion | ' | ' | ' | ' | ' | ' | ' | 20,381 | 20,381 | ' | ' |
Number of series of Preferred Stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1 | ' |
Closing price of stock (in dollars per share) | ' | ' | ' | ' | ' | ' | ' | ' | ' | $246.75 | ' |
Percentage of the closing sales price of the entity's common stock that the conversion price must exceed in order for the preferred stock to be convertible | ' | ' | ' | ' | ' | ' | ' | 150.00% | ' | ' | ' |
Number of trading days within 30 trading days in which the closing price of the entity's common stock must exceed the conversion price for the preferred stock to be convertible | ' | ' | ' | ' | ' | ' | ' | ' | ' | '20 days | ' |
Number of trading days during which the closing price of the entity's common stock must exceed the conversion price for at least 20 days in order for the preferred stock to be convertible | ' | ' | ' | ' | ' | ' | ' | '30 days | ' | ' | ' |
Number of trading days prior to notice of automatic conversion | ' | ' | ' | ' | ' | ' | ' | '5 days | ' | ' | ' |
Number of quarters in which no preferred stock dividends have been paid | ' | ' | ' | ' | ' | ' | ' | 6 | 6 | ' | ' |
Number of Board of Directors to be elected by Preferred Stock holders if entity fails to pay dividends on Preferred Stock | ' | ' | ' | ' | ' | ' | ' | 2 | ' | ' | ' |
Number of Board of Directors elected by the Preferred Stock holders when the entity failed to pay dividends on Preferred Stock | ' | ' | ' | ' | ' | ' | 2 | ' | ' | ' | ' |
Interest rate (as a percent) | ' | ' | ' | ' | ' | ' | ' | 6.00% | 6.00% | ' | ' |
Debt principal amount per share, basis for exchange (in dollars per share) | ' | ' | ' | ' | ' | ' | ' | $10 | ' | ' | ' |
Debt instrument, term | ' | ' | ' | ' | ' | ' | ' | '25 years | ' | ' | ' |
Preferred shares exchanged (in shares) | ' | ' | ' | ' | ' | ' | ' | ' | 1,711,540 | ' | 792,460 |
Number of shares issued upon conversion | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,513,653 |
Deemed dividends recorded | ' | ' | ' | ' | $8,366 | ' | ' | ' | ' | ' | ' |
STOCKHOLDERS_EQUITY_Details_3
STOCKHOLDERS' EQUITY (Details 3) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2013 | Apr. 03, 2014 |
In Millions, except Share data, unless otherwise specified | Common stock | Common stock | ||
April 2014 Issuance | ||||
Equity Offering [Line Items] | ' | ' | ' | ' |
Number of common shares sold into underwriting agreement (in shares) | ' | ' | 31,643 | 2,857,143 |
Common stock, par value (in dollars per share) | $0.00 | $0.00 | ' | $0.00 |
Share price per share | ' | ' | ' | $3.50 |
Proceed from public offering | ' | ' | ' | $9.30 |
STOCKHOLDERS_EQUITY_Details_4
STOCKHOLDERS' EQUITY (Details 4) | 102 Months Ended | 6 Months Ended |
Jun. 30, 2014 | Jun. 30, 2013 | |
Preferred stock | Common stock | |
Conversion of Convertible Preferred Stock | ' | ' |
Preferred shares exchanged | 1,711,540 | 792,460 |
Shares of common stock issued: | ' | ' |
At stated conversion terms | ' | 48,174 |
Incremental shares issued under the exchange transaction | ' | 1,465,479 |
Total shares of common stock issued | ' | 1,513,653 |
STOCKHOLDERS_EQUITY_Details_5
STOCKHOLDERS' EQUITY (Details 5) (USD $) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 6 Months Ended | 0 Months Ended | 6 Months Ended | 0 Months Ended | 0 Months Ended | 1 Months Ended | ||||||
Apr. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Dec. 31, 2013 | Jun. 30, 2013 | Nov. 14, 2013 | Jun. 30, 2014 | Nov. 14, 2013 | Dec. 14, 2012 | Dec. 14, 2012 | 16-May-13 | 21-May-13 | Mar. 22, 2012 | |
Common stock | November 2013 stock issuance | November 2013 stock issuance | November 2013 stock issuance | December 2012 stock issuance | December 2012 stock issuance | May 2013 sale of common stock | May 2013 sale of common stock | March 2012 Sale of Common Stock and Economic Rights | |||||||
Common stock | Common stock | Common stock | Common stock | Common stock | |||||||||||
Aspire Capital Fund, LLC | Aspire Capital Fund, LLC | Maximum | Aspire Capital Fund, LLC | Maximum | |||||||||||
Aspire Capital Fund, LLC | Aspire Capital Fund, LLC | ||||||||||||||
Common Stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of shares issued under purchase agreement | ' | ' | ' | ' | ' | ' | ' | 511,509 | 450,000 | ' | 158,982 | ' | ' | ' | ' |
Purchase price for shares issued under purchase agreement | ' | ' | ' | ' | ' | ' | ' | $2,000,000 | $1,700,000 | ' | $1,000,000 | ' | ' | ' | ' |
Shares committed to purchase | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,042,038 | ' | 1,455,787 | ' | ' | ' |
Period of common stock purchase agreement | ' | ' | ' | ' | ' | ' | ' | '2 years | ' | ' | '2 years | ' | ' | ' | ' |
Common stock purchase agreement, purchase commitment | ' | ' | ' | ' | ' | ' | ' | ' | ' | 18,000,000 | ' | 19,000,000 | ' | ' | ' |
Stock issued for non-cash consideration | ' | ' | ' | ' | ' | ' | ' | 166,105 | ' | ' | 74,548 | ' | ' | ' | ' |
Shares committed for sale under agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6,666,667 | ' | ' |
Common stock, par value (in dollars per share) | ' | $0.00 | ' | $0.00 | ' | $0.00 | ' | ' | ' | ' | ' | ' | $0.00 | ' | ' |
Offering price (in dollars per share) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $3 | $3 | $4.53 |
Shares sold (in shares) | ' | ' | ' | ' | ' | ' | 31,643 | ' | ' | ' | ' | ' | ' | 6,833,334 | 669,726 |
Number of share sold that were subject to the underwriters' over-allotment option | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 166,667 | ' |
Proceeds from sale of common stock, net of certain fees and expenses | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 19,000,000 | ' |
Fair value of common stock issued | ' | ' | ' | ' | ' | ' | 200,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Change in valuation of financial instruments associated with stock purchase agreement | ' | 64,000 | ' | 111,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net proceeds | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2,900,000 |
Number of days used to calculate average closing price | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '10 days |
Amount to be paid as percentage of future litigation settlement amount received | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 10.00% |
Lock-up period from the date of issuance | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '1 year |
Economic Rights settled for payments | $600,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
STOCKHOLDERS_EQUITY_Details_6
STOCKHOLDERS' EQUITY (Details 6) (USD $) | Jun. 30, 2014 |
Warrants outstanding | ' |
Common Shares Issuable | 1,440,022 |
Weighted Average Exercise Price (in dollars per share) | $12.63 |
Number of shares of common stock issued in connection with warrants | 151,773 |
July 2009 Series II stock issuance | ' |
Warrants outstanding | ' |
Common Shares Issuable | 98,893 |
Weighted Average Exercise Price (in dollars per share) | $7 |
January 2010 stock issuance, one | ' |
Warrants outstanding | ' |
Common Shares Issuable | 100,714 |
Weighted Average Exercise Price (in dollars per share) | $19.95 |
January 2010 stock issuance, two | ' |
Warrants outstanding | ' |
Common Shares Issuable | 101,785 |
Weighted Average Exercise Price (in dollars per share) | $22.82 |
October 2010 stock issuance | ' |
Warrants outstanding | ' |
Common Shares Issuable | 594,513 |
Weighted Average Exercise Price (in dollars per share) | $13.44 |
July 2011 stock issuance | ' |
Warrants outstanding | ' |
Common Shares Issuable | 544,117 |
Weighted Average Exercise Price (in dollars per share) | $9.52 |
DISCONTINUED_OPERATIONS_Detail
DISCONTINUED OPERATIONS (Details) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Reclassification of operating results from continuing operations to loss from discontinued operations | ' | ' | ' | ' |
Income tax on discontinued operations | ($3) | ($10) | ($8) | ($20) |
Net income from discontinued operations | 7 | 14 | 15 | 30 |
ALIGN products | ' | ' | ' | ' |
Reclassification of operating results from continuing operations to loss from discontinued operations | ' | ' | ' | ' |
Interest income | 10 | 24 | 23 | 50 |
Income tax on discontinued operations | -3 | -10 | -8 | -20 |
Net income from discontinued operations | $7 | $14 | $15 | $30 |
DISCONTINUED_OPERATIONS_Detail1
DISCONTINUED OPERATIONS (Details 2) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets of discontinued operations: | ' | ' |
Total current assets of discontinued operations | $403 | $639 |
Current liabilities of discontinued operations: | ' | ' |
Total current liabilities of discontinued operations | 145 | 260 |
ALIGN products | ' | ' |
Current assets of discontinued operations: | ' | ' |
Short-term portion of minimum royalty arrangement receivable, net | 258 | 379 |
Returns indemnification receivable | 145 | 260 |
Total current assets of discontinued operations | 403 | 639 |
Long-term assets of discontinued operations: | ' | ' |
Long-term portion of minimum royalty arrangement receivable, net | 24 | 72 |
Total assets of discontinued operations | 427 | 711 |
Current liabilities of discontinued operations: | ' | ' |
Returns provision | 145 | 260 |
Total current liabilities of discontinued operations | $145 | $260 |