Document_And_Entity_Informatio
Document And Entity Information (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Feb. 27, 2015 | Jun. 30, 2014 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | FALSE | ||
Document Period End Date | 31-Dec-14 | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | REPROS THERAPEUTICS INC. | ||
Entity Central Index Key | 897075 | ||
Current Fiscal Year End Date | -19 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $304,915,821 | ||
Trading Symbol | RPRX | ||
Entity Common Stock, Shares Outstanding | 24,276,173 |
CONSOLIDATED_BALANCE_SHEETS
CONSOLIDATED BALANCE SHEETS (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current Assets | ||
Cash and cash equivalents | $46,620 | $75,807 |
Prepaid expenses and other current assets | 289 | 189 |
Total current assets | 46,909 | 75,996 |
Fixed assets, net | 32 | 75 |
Total assets | 46,941 | 76,071 |
Current Liabilities | ||
Accounts payable | 2,090 | 2,966 |
Accrued expenses | 834 | 586 |
Total current liabilities | 2,924 | 3,552 |
Commitments and Contingencies (note 11) | ||
Stockholders' Equity | ||
Undesignated Preferred Stock, $.001 par value, 5,000,000 shares authorized, none issued and outstanding | 0 | 0 |
Common Stock, $.001 par value, 75,000,000 shares authorized, 24,113,784 and 23,125,565 shares issued, respectively and 24,001,434 and 23,013,215 shares outstanding, respectively | 24 | 23 |
Additional paid-in capital | 318,437 | 314,405 |
Cost of treasury stock, 112,350 shares | -1,380 | -1,380 |
Accumulated deficit | -273,064 | -240,529 |
Total stockholders' equity | 44,017 | 72,519 |
Total liabilities and stockholders' equity | $46,941 | $76,071 |
CONSOLIDATED_BALANCE_SHEETS_Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Preferred Stock, par value | $0.00 | $0.00 |
Preferred Stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred Stock, issued | 0 | 0 |
Preferred Stock, outstanding | 0 | 0 |
Common Stock, par value | $0.00 | $0.00 |
Common Stock, shares authorized | 75,000,000 | 75,000,000 |
Common Stock, shares issued | 24,388,523 | 23,125,565 |
Common Stock, shares outstanding | 24,276,173 | 23,013,215 |
Treasury stock, shares | 112,350 | 112,350 |
CONSOLIDATED_STATEMENTS_OF_OPE
CONSOLIDATED STATEMENTS OF OPERATIONS (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Revenues and other income | |||||||||||
Interest Income | $3 | $2 | $2 | $2 | $4 | $3 | $1 | $1 | $9 | $9 | $3 |
Total revenues and other income | 3 | 2 | 2 | 2 | 4 | 3 | 1 | 1 | 9 | 9 | 3 |
Expenses | |||||||||||
Research and development | 5,771 | 6,276 | 7,491 | 7,569 | 5,953 | 4,975 | 6,262 | 6,467 | 27,107 | 23,657 | 14,120 |
General and administrative | 1,678 | 1,277 | 1,256 | 1,226 | 1,365 | 1,215 | 1,171 | 1,067 | 5,437 | 4,818 | 4,827 |
Total expenses | 7,449 | 7,553 | 8,747 | 8,795 | 7,318 | 6,190 | 7,433 | 7,534 | 32,544 | 28,475 | 18,947 |
Net loss | ($7,446) | ($7,551) | ($8,745) | ($8,793) | ($7,314) | ($6,187) | ($7,432) | ($7,533) | ($32,535) | ($28,466) | ($18,944) |
Loss per share - basic and diluted | ($0.31) | ($0.32) | ($0.38) | ($0.38) | ($0.32) | ($0.27) | ($0.39) | ($0.41) | ($1.39) | ($1.37) | ($1.23) |
Shares used in loss per share calculation: | |||||||||||
Basic | 23,432 | 20,808 | 15,346 | ||||||||
Diluted | 23,432 | 20,808 | 15,346 |
CONSOLIDATED_STATEMENTS_OF_STO
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (USD $) | Total | Common Stock | Additional Paid-in Capital | Treasury Stock | Accumulated Deficit |
In Thousands, except Share data | |||||
Beginning Balance at Dec. 31, 2011 | $3,282 | $12 | $197,769 | ($1,380) | ($193,119) |
Beginning Balance (in shares) at Dec. 31, 2011 | 12,470,694 | 112,350 | |||
Stock based option compensation | 2,785 | 0 | 2,785 | 0 | 0 |
Issuance of 2,463,537 shares of common stock at a share price of $4.50, net of offering costs of $777 | 10,310 | 3 | 10,307 | 0 | 0 |
Issuance of 2,463,537 shares of common stock at a share price of $4.50, net of offering costs of $777 (in shares) | 2,463,537 | 0 | |||
Exercise of Series B Warrants to purchase common stock for cash | 301 | 0 | 301 | 0 | 0 |
Exercise of Series B Warrants to purchase common stock for cash (in shares) | 121,079 | 0 | |||
Issuance of common stock | 0 | 0 | 0 | 0 | 0 |
Issuance of common stock (in shares) | 100 | ||||
Issuance common stock for the cashless exercise of stock options | 0 | 0 | 0 | 0 | 0 |
Issuance common stock for the cashless exercise of stock options (in shares) | 54,971 | 0 | |||
Exercise of stock options to purchase common stock for cash | 121 | 0 | 121 | 0 | 0 |
Exercise of stock options to purchase common stock for cash (in shares) | 16,488 | 0 | |||
Issuance of 2,145,636 shares of common stock at a share price of $11.00, net of offering costs of $586 | 23,018 | 2 | 23,016 | 0 | 0 |
Issuance of 2,145,636 shares of common stock at a share price of $11.00, net of offering costs of $586 (in Shares) | 2,145,636 | 0 | |||
Net loss | -18,944 | 0 | 0 | 0 | -18,944 |
Ending Balance at Dec. 31, 2012 | 20,873 | 17 | 234,299 | -1,380 | -212,063 |
Ending Balance (in shares) at Dec. 31, 2012 | 17,272,505 | 112,350 | |||
Stock based option compensation | 3,158 | 0 | 3,158 | 0 | 0 |
Issuance shares of common stock for the cashless exercise of Series A Warrants | 0 | 1 | -1 | 0 | 0 |
Issuance shares of common stock for the cashless exercise of Series A Warrants (in shares) | 871,634 | 0 | |||
Issuance shares of common stock for the cashless exercise of Series B Warrants | 0 | 1 | -1 | 0 | 0 |
Issuance shares of common stock for the cashless exercise of Series B Warrants (in shares) | 614,837 | 0 | |||
Exercise of Series B Warrants to purchase common stock for cash | 107 | 0 | 107 | 0 | 0 |
Exercise of Series B Warrants to purchase common stock for cash (in shares) | 42,849 | 0 | |||
Issuance of common stock | 76,764 | 4 | 76,760 | 0 | 0 |
Issuance of common stock (in shares) | 4,312,500 | 0 | |||
Issuance common stock for the cashless exercise of stock options | 0 | 0 | 0 | 0 | 0 |
Issuance common stock for the cashless exercise of stock options (in shares) | 5,407 | 0 | |||
Exercise of stock options to purchase common stock for cash | 83 | 0 | 83 | 0 | 0 |
Exercise of stock options to purchase common stock for cash (in shares) | 5,833 | 0 | |||
Net loss | -28,466 | 0 | 0 | 0 | -28,466 |
Ending Balance at Dec. 31, 2013 | 72,519 | 23 | 314,405 | -1,380 | -240,529 |
Ending Balance (in shares) at Dec. 31, 2013 | 23,125,565 | 112,350 | |||
Stock based option compensation | 3,784 | 0 | 3,784 | 0 | 0 |
Issuance shares of common stock for the cashless exercise of Series A Warrants | 0 | 1 | -1 | 0 | 0 |
Issuance shares of common stock for the cashless exercise of Series A Warrants (in shares) | 836,961 | 0 | |||
Issuance shares of common stock for the cashless exercise of Series B Warrants | 0 | 0 | 0 | 0 | 0 |
Issuance shares of common stock for the cashless exercise of Series B Warrants (in shares) | 329,753 | 0 | |||
Issuance common stock for the cashless exercise of stock options | 0 | 0 | 0 | 0 | 0 |
Issuance common stock for the cashless exercise of stock options (in shares) | 72,910 | 0 | |||
Exercise of stock options to purchase common stock for cash | 147 | 0 | 147 | 0 | 0 |
Exercise of stock options to purchase common stock for cash (in shares) | 23,334 | 0 | |||
Proceeds from a shareholder transaction | 102 | 0 | 102 | 0 | |
Net loss | -32,535 | 0 | 0 | 0 | -32,535 |
Ending Balance at Dec. 31, 2014 | $44,017 | $24 | $318,437 | ($1,380) | ($273,064) |
Ending Balance (in shares) at Dec. 31, 2014 | 24,388,523 | 112,350 |
CONSOLIDATED_STATEMENTS_OF_STO1
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Issuance of shares of common stock for the cashless exercise of Series A Warrants stock options | 837,542 | 872,133 | |
Issuance of shares of common stock for the cashless exercise of Series B Warrants stock options | 380,101 | 716,767 | |
Issuance of shares of common stock for the cashless exercise of stock options | 98,329 | 8,332 | 95,416 |
Issuance of shares of common stock, offering costs | $5,200 | ||
Common Stock Price Per Share | $19 | $5.07 | |
Series B [Member] | |||
Common Stock Price Per Share | $2.49 | $2.49 | |
Maximum [Member] | |||
Exercise of stock option to purchase common stock for cash, share price | 9.6 | $18.74 | $10.88 |
Minimum [Member] | |||
Exercise of stock option to purchase common stock for cash, share price | 1.56 | $10.98 | $1.33 |
Issuance During Period 1st [Member] | |||
Issuance of shares of common stock, offering costs | 777 | ||
Common Stock Price Per Share | $4.50 | ||
Issuance During Period 2nd [Member] | |||
Issuance of shares of common stock, offering costs | $586 | ||
Common Stock Price Per Share | $11 |
CONSOLIDATED_STATEMENTS_OF_CAS
CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Cash Flows from Operating Activities | |||
Net loss | ($32,535) | ($28,466) | ($18,944) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 43 | 40 | 16 |
Noncash stock-based compensation | 3,784 | 3,158 | 2,785 |
Changes in operating assets and liabilities: | |||
(Increase) decrease in prepaid expenses and other current assets | 3 | 216 | -307 |
Increase (decrease) in accounts payable and accrued expenses | -629 | -244 | 2,377 |
Net cash used in operating activities | -29,334 | -25,296 | -14,073 |
Cash Flows from Investing Activities | |||
Capital expenditures | 0 | -63 | -30 |
Net cash used in investing activities | 0 | -63 | -30 |
Cash Flows from Financing Activities | |||
Proceeds from issuance of common stock and warrants, net of offering costs | 0 | 76,764 | 33,328 |
Exercise of stock options & warrants | 147 | 190 | 422 |
Net cash provided by financing activities | 147 | 76,954 | 33,750 |
Net increase (decrease) in cash and cash equivalents | -29,187 | 51,595 | 19,647 |
Cash and cash equivalents at beginning of period | 75,807 | 24,212 | 4,565 |
Cash and cash equivalents at end of period | $46,620 | $75,807 | $24,212 |
ORGANIZATION_AND_OPERATIONS
ORGANIZATION AND OPERATIONS | 12 Months Ended |
Dec. 31, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Operations | 1. ORGANIZATION AND OPERATIONS: |
Repros Therapeutics Inc. (the “Company”, “Repros,” or “we,” “us” or “our”) was organized on August 20, 1987. We are a biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive system disorders. | |
Our primary product candidate, Androxal®, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We are developing Androxal® for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with secondary hypogonadism exhibit low testosterone levels due to under stimulated testes but they are generally fertile. Androxal® is designed to treat the underlying mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary hypogonadism. Secondary hypogonadism due to being overweight or obese is the single greatest cause of hypogonadism in general. On February 2, 2015, we announced that we electronically submitted our New Drug Application (“NDA”) to the Food and Drug Administration (“FDA”) for Androxal®. | |
Proellex®, our product candidate for female reproductive health, is a new chemical entity that acts as a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. On December 29, 2014, we announced that we have initiated two Phase 2B studies for low dose Proellex® in the treatment of uterine fibroids and are currently conducting a Phase 2 study in the treatment of endometriosis. | |
VASOMAX® has been on partial clinical hold in the U.S. since 1998, and no further development activities are planned. | |
As of December 31, 2014, we had accumulated losses of $273.1 million, approximately $46.6 million in cash and cash equivalents, and accounts payable and accrued expenses of approximately $2.9 million, in the aggregate. We anticipate that our current liquidity will be sufficient to continue the development of our product candidates into the second half of 2016. We continue to explore potential corporate partnering opportunities for assistance in the clinical development funding and commercialization of our products, as appropriate; however, there can be no assurance that an acceptable corporate partnering opportunity will be successfully completed or that our current liquidity will be sufficient to fund all of our product development needs. | |
REVISION_OF_PRIOR_YEARS_FINANC
REVISION OF PRIOR YEARS' FINANCIAL STATEMENTS | 12 Months Ended | |||||||||||||||||||
Dec. 31, 2014 | ||||||||||||||||||||
Quantifying Prior Year Misstatements Corrected in Current Year Financial Statements [Abstract] | ||||||||||||||||||||
Revision Of Prior Yearsb Financial Statements | 2. REVISION OF PRIOR YEARS’ FINANCIAL STATEMENTS: | |||||||||||||||||||
While preparing its financial statements for the year ended December 31, 2014, the Company identified a prior period error related to the accounting for patent costs. As disclosed in its prior filings, historically the Company had capitalized patent related costs associated with its drug candidates, Androxal® and Proellex®. However, the Company has now concluded that these costs should have been expensed as research and development costs since the related products were, at the time the costs were incurred, in the development phase and had not been approved by the FDA. The Company concluded this error was not material individually or in the aggregate to any of the prior reporting periods, and therefore, no restatements of previously issued financial statements were necessary. However, if the entire correction was recorded in the current period, the cumulative impact would have been material to the current period, and would have impacted the comparability to prior periods. As such, revisions for the prior periods are reflected in the financial statements herein, and will be reflected in future filings containing such information. | ||||||||||||||||||||
The effect of the error corrections on the consolidated balance sheet as of December 31, 2013 are as follows (in thousands): | ||||||||||||||||||||
As previously | Correction | As revised | ||||||||||||||||||
reported | ||||||||||||||||||||
Other assets, net | $ | 2,906 | $ | -2,906 | $ | 0 | ||||||||||||||
Total assets | 78,977 | -2,906 | 76,071 | |||||||||||||||||
Accumulated deficit | -237,623 | -2,906 | -240,529 | |||||||||||||||||
Total stockholders’ equity | 75,425 | -2,906 | 72,519 | |||||||||||||||||
At December 31, 2012, accumulated deficit and shareholders’ equity were reported as ($209,902) and $23,034, respectively, and were revised to ($212,063) and $20,873, respectively. | ||||||||||||||||||||
At December 31, 2011, accumulated deficit and shareholders’ equity were reported as ($191,735) and $4,666, respectively, and were revised to ($193,119) and $3,282, respectively. | ||||||||||||||||||||
The effects of the error correction on the consolidated statements of operations for the years ended December 31, 2013 and 2012 are as follows (in thousands): | ||||||||||||||||||||
Year Ended December 31, 2013 | Year Ended December 31, 2012 | |||||||||||||||||||
As previously | Correction | As | As previously | Correction | As | |||||||||||||||
reported | revised | reported | revised | |||||||||||||||||
Research and development | $ | 22,912 | $ | 745 | $ | 23,657 | $ | 13,343 | $ | 777 | $ | 14,120 | ||||||||
Total expenses | 27,730 | 745 | 28,475 | 18,170 | 777 | 18,947 | ||||||||||||||
Net loss | -27,721 | -745 | -28,466 | -18,167 | -777 | -18,944 | ||||||||||||||
Loss per share – basic and diluted | -1.33 | -0.04 | -1.37 | -1.18 | -0.05 | -1.23 | ||||||||||||||
The effects of the error correction on the consolidated statements of cash flows for the years ended December 31, 2013 and 2012 are as follows (in thousands): | ||||||||||||||||||||
Year Ended December 31, 2013 | Year Ended December 31, 2012 | |||||||||||||||||||
As previously | Correction | As | As previously | Correction | As | |||||||||||||||
reported | revised | reported | revised | |||||||||||||||||
Net cash used in operating activities | $ | -24,448 | $ | -848 | $ | -25,296 | $ | -13,495 | $ | -578 | $ | -14,073 | ||||||||
Net cash used in investing activities | -911 | 848 | -63 | -608 | 578 | -30 | ||||||||||||||
SUMMARY_OF_SIGNIFICANT_ACCOUNT
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2014 | |
Accounting Policies [Abstract] | |
Summary Of Significant Accounting Policies | 3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: |
USE OF ESTIMATES | |
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. | |
CERTAIN RISKS AND UNCERTAINTIES | |
Our product candidates under development require approval from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance our product candidates will receive the necessary clearance. If we are denied clearance or clearance is delayed, it may have a material adverse impact on us. | |
Our product candidates are concentrated in rapidly changing, highly competitive markets, which are characterized by rapid technological advances, evolving regulatory requirements and industry standards. Any failure by us to anticipate or to respond adequately to technological developments in our industry, changes in regulatory requirements or industry standards, or any significant delays in the development or introduction of products or services, could have a material adverse effect on our business, operating results and future cash flows. We have no assurance of the successful development and FDA approval or the successful commercialization of our product candidates. | |
CASH AND CASH EQUIVALENTS | |
The Company considers all cash accounts and highly liquid investments having original maturities of three months or less to be cash and cash equivalents. | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |
Prepaid expenses and other current assets primarily consist of prepaid insurance, prepaid operating expenses and other miscellaneous assets, interest and other receivables. | |
FIXED ASSETS | |
Fixed assets include lab equipment, furniture and leasehold improvements and are recorded at cost, less accumulated depreciation and amortization. Depreciation is computed on the straight-line method over an estimated useful life of three to five years or, in the case of leasehold improvements, amortized over the shorter of the useful life or the remaining term of the lease. Maintenance and repairs that do not improve or extend the life of assets are expensed as incurred. When assets are sold or retired, the cost and accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income during the period in which the transaction occurred. | |
RESEARCH AND DEVELOPMENT EXPENSE | |
Research and development (“R&D”) expenses include salaries and related employee expenses, contracted regulatory affairs activities, insurance coverage for clinical trials and prior product sales, contracted research and consulting fees, fees associated with our patent portfolio, facility costs, and internal research and development supplies. We expense R&D costs in the period they are incurred. These costs consist of direct and indirect costs associated with specific projects as well as fees paid to various entities that perform research on our behalf. | |
We estimate accrued expenses as part of our process of preparing financial statements. Examples of areas in which subjective judgments may be required include costs associated with services provided by contract organizations for clinical trials, preclinical development and manufacturing of clinical materials. We accrue for costs incurred as the services are being provided by monitoring the status of the trials or services provided and the invoices received from our external service providers. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in our trials, and we recognize this cost over the estimated term of the study based on the number of patients enrolled in the trial on an ongoing basis, beginning with patient enrollment. As actual costs become known to us, we adjust our accruals. To date, our estimates have not differed significantly from the actual costs incurred. However, subsequent changes in estimates may result in a material change in our accruals, which could also materially affect our balance sheet and results of operations. | |
LOSS PER SHARE | |
Basic loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the year. Diluted loss per share is computed using the average share price for the period and applying the treasury stock method to potentially dilutive outstanding options. In applicable years all potential common stock equivalents were antidilutive and accordingly were not included in the computation. | |
SHARE-BASED COMPENSATION | |
We had one stock-based compensation plan at December 31, 2014, the 2011 Equity Incentive Plan. Accounting for stock based compensation generally requires the recognition of the cost of employee services for share-based compensation based on the grant date fair value of the equity or liability instruments issued. We use the Black-Scholes option pricing model to estimate the fair value of our stock options. Expected volatility is determined using historical volatilities based on historical stock prices for a period equal to the expected term. The expected volatility assumption is adjusted if future volatility is expected to vary from historical experience. The expected term of options represents the period of time that options granted are expected to be outstanding and falls between the options' vesting and contractual expiration dates. The risk-free interest rate is based on the yield at the date of grant of a zero-coupon U.S. Treasury bond whose maturity period equals the option's expected term. | |
INCOME TAXES | |
Our net operating losses from inception to date have resulted principally from costs incurred in conducting clinical trials and in research and development activities related to efforts to develop our products and from the associated administrative costs required to support those efforts. We have recorded a deferred tax asset for our net operating losses (“NOL”); however, as the Company has incurred net operating losses since inception, and since there is no certainty of future profits, a valuation allowance has been provided in full on our deferred tax assets in the accompanying consolidated financial statements. Additionally, during 2013, the Company completed an analysis of its section 382 limit. Based on this analysis, the Company concluded that the amount of NOL carryforwards and the credits available to offset taxable income is limited under section 382. Accordingly, if the Company generates taxable income in any year in excess of its then annual limitation, the Company may be required to pay federal income taxes even though it has unexpired NOL carryforwards. Additionally, because U.S. tax laws limit the time during which NOLs and tax credit carryforwards may be applied against future taxable income and tax liabilities, the Company may not be able to take full advantage of its NOLs and tax credit carryforwards for federal income tax purposes. Future public and private stock placements may create additional limitations on the Company’s NOLs, credits and other tax attributes. | |
Recent Accounting Pronouncements | |
In August 2014, the FASB issued Accounting Standards Update No. 2014-15, “Presentation of Financial Statements - Going Concern.” The new standard requires management to evaluate whether there are conditions or events that raise substantial doubt about an entity's ability to continue as a going concern for both annual and interim reporting periods. This guidance is effective for us for the fiscal year beginning January 1, 2016 and interim periods thereafter. The guidance is not expected to have a material impact on our consolidated financial statements. | |
In June 2014, the FASB issued Accounting Standards Update 2014-10, “Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation.” The guidance eliminates the definition of a development stage entity thereby removing the incremental financial reporting requirements from U.S. Generally Accepted Accounting Principles for development stage entities, primarily presentation of inception to date financial information. The provisions of the amendment is effective for annual reporting periods beginning after December 15, 2015. We have elected to adopt ASU 2014-10 early and as an early adopter, we are no longer providing inception-to-date financial information in our consolidated financial statements. | |
In May 2014, the FASB issued Accounting Standards Update 2014-09, “Revenue from Contracts with Customers” (“ASU 2014-09”). ASU 2014-09 is a comprehensive new revenue recognition model requiring a company to recognize revenue to depict the transfer of goods or services to a customer at an amount reflecting the consideration it expects to receive in exchange for those goods or services. In adopting ASU 2014-09, companies may use either a full retrospective or a modified retrospective approach. Additionally, this guidance requires improved disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. ASU 2014-09 is effective for the first interim period within annual reporting periods beginning after December 15, 2016, and early adoption is not permitted. The Company is currently assessing the impact of the new standard on our consolidated financial statements. | |
FIXED_ASSETS
FIXED ASSETS | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Property, Plant and Equipment [Abstract] | ||||||||
Fixed Assets | 4. FIXED ASSETS: | |||||||
Fixed assets are as follows (in thousands): | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Laboratory equipment | $ | 20 | $ | 20 | ||||
Office equipment | 101 | 101 | ||||||
Furniture and fixtures | 18 | 18 | ||||||
Leasehold improvements | 77 | 77 | ||||||
Total fixed assets | 216 | 216 | ||||||
Less — Accumulated depreciation and amortization | 184 | 141 | ||||||
Net Fixed Assets | $ | 32 | $ | 75 | ||||
Depreciation was $43,000, $40,000 and $17,000 for the years ended December 31, 2014, 2013 and 2012, respectively. | ||||||||
OPERATING_LEASES
OPERATING LEASES | 12 Months Ended |
Dec. 31, 2014 | |
Leases, Operating [Abstract] | |
Operating Leases | 5. OPERATING LEASES: |
The Company leases laboratory and office space, pursuant to leases accounted for as operating leases. The lease for the Company’s laboratory and office space expires in June 2015. Rental expense for the years ended December 31, 2014, 2013 and 2012, was approximately $74,000, $79,000 and $76,000, respectively. Future minimum lease payments under non-cancelable leases with original terms in excess of one year as of December 31, 2014, is approximately $27,000 for 2015. | |
ACCRUED_EXPENSES
ACCRUED EXPENSES | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Accrued Expenses [Abstract] | ||||||||
Accrued Expenses | 6. ACCRUED EXPENSES: | |||||||
Accrued expenses consist of the following (in thousands): | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Personnel related costs | $ | 458 | $ | 196 | ||||
Research and development costs | 284 | 277 | ||||||
Other | 92 | 113 | ||||||
Total | $ | 834 | $ | 586 | ||||
FEDERAL_INCOME_TAXES
FEDERAL INCOME TAXES | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Income Tax Disclosure [Abstract] | ||||||||
Federal Income Taxes | 7. FEDERAL INCOME TAXES: | |||||||
The Company has had net operating losses since inception and, therefore, has not been subject to federal income taxes. As of December 31, 2014, the Company has accumulated approximately $1.4 million of research and development tax credits. As of December 31, 2014, the Company had approximately $210.2 million of NOL carryforwards for federal income tax purposes. Additionally, approximately $12.2 million of NOLs and approximately $838,000 of research and development tax credits will expire in 2018. The NOL’s will expire from 2018 through 2034. The research and development credits will expire from 2018 through 2022. | ||||||||
The Tax Reform Act of 1986 provided for a limitation on the use of NOL and tax credit carryforwards following certain ownership changes that could limit the Company’s ability to utilize these NOLs and tax credits. The limitation is generally referred to as the “section 382 limit” after the IRC section. The issuance of stock, together with changes in stock ownership, resulted in multiple ownership changes for federal income tax purposes. During 2013, the Company completed an analysis of its section 382 limit. Based on this analysis, the Company concluded that the amount of NOL carryforwards and the credits available to offset taxable income is limited under section 382. Accordingly, if the Company generates taxable income in any year in excess of its then annual limitation, the Company may be required to pay federal income taxes even though it has unexpired NOL carryforwards. Additionally, because U.S. tax laws limit the time during which NOLs and tax credit carryforwards may be applied against future taxable income and tax liabilities, the Company may not be able to take full advantage of its NOLs and tax credit carryforwards for federal income tax purposes. Future public and private stock placements may create additional limitations on the Company’s NOLs, credits and other tax attributes. | ||||||||
The Company’s net operating losses from inception to date have resulted principally from costs incurred in conducting clinical trials and in research and development activities related to efforts to develop products and from the associated administrative costs required to support those efforts. The Company has recorded a deferred tax asset for its net operating losses; however, as the Company has incurred operating losses since inception, and since there is no certainty of future profits, a valuation allowance has been provided in full on the deferred tax assets in the accompanying consolidated financial statements. | ||||||||
The tax effects of temporary differences that give rise to significant portions of the deferred tax assets are as follows (in thousands): | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Net operating loss carryforwards | $ | 71,472 | $ | 61,714 | ||||
Research and development tax credits | 1,384 | 1,384 | ||||||
Inventory reserve | 1,510 | 1,510 | ||||||
Total deferred tax assets | 74,366 | 64,608 | ||||||
Less — Valuation allowance | -74,366 | -64,608 | ||||||
Net deferred tax assets | $ | — | $ | — | ||||
The Company adopted FIN 48 in 2007. The Company has no unrecognized tax benefits that should be accrued under FIN 48. The Company’s policy is to record interest and penalties on income taxes as a component of the income tax provision. | ||||||||
The Company’s only taxing jurisdictions are the United States and Texas. The Company’s tax years from 1998 to the present remain open for federal examination due to the net operating loss carryforwards. Texas has a four year statute of limitations so that returns filed since 2011 remain open for state examination. | ||||||||
STOCKHOLDERS_EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Stockholders' Equity Note [Abstract] | |||||||||||
Stockholdersb Equity | 8. STOCKHOLDERS’ EQUITY: | ||||||||||
OFFERINGS | |||||||||||
On June 25, 2013, we completed a public offering of 4,312,500 shares of our common stock at a price per share of $19.00. Net proceeds to us, after deducting underwriters’ fees and offering expenses, were approximately $76.8 million. | |||||||||||
On September 7, 2012, we completed a private placement of 2,145,636 shares of our common stock at a purchase price of $11.00 per share for aggregate proceeds after expenses of approximately $23 million. The private placement shares may be resold pursuant to our shelf registration statement on Form S-3, as amended (File No. 333-184159). | |||||||||||
On February 1, 2012, we completed a direct registered offering of 2,463,537 shares of our common stock at a purchase price of $4.50 per share for aggregate proceeds after expenses of approximately $10.3 million. | |||||||||||
On February 8, 2011, we completed an underwritten public offering of 690,000 units (including the exercise of the underwriter’s over-allotment option), consisting of an aggregate of 2,760,000 shares of our common stock, Series A Warrants to purchase 2,070,000 shares of our common stock and Series B Warrants to purchase 1,690,500 shares of our common stock, at a price per unit of $17.15. Each unit consisted of four shares of our common stock, Series A Warrants exercisable for three shares of our common stock at an exercise price of $0.01 per share and Series B Warrants exercisable for 2.45 shares of our common stock at an exercise price of $2.49 per share. Net proceeds to us, after the underwriting discount and offering expenses, were approximately $10.7 million. The fair value of the Series A and Series B Warrants was determined using a Black-Scholes model with the following assumptions: risk-free interest rate of 0.18%; no dividend yield; volatility of 131.66% and an expected term of six months. This resulted in a fair value of the Series A and Series B Warrants of approximately $5.4 million and a fair value of the common stock of approximately $5.3 million, which has been recorded in Additional Paid-In Capital on our Condensed Consolidated Balance Sheet. As of December 31, 2014, 2,029,325 shares of our common stock have been issued from the exercise of the Series A Warrants at $0.01 per share and 1,108,518 shares of our common stock have been issued from the exercise of the Series B Warrants at $2.49 per share. The Series A and B Warrants have a five year term from the date of issuance. The Series B Warrants are callable by the Company in the event that the Company’s stock trades at $8.00 or more for a period of 20 trading days over any consecutive 30 trading day period. As of the date of this filing, our common stock reached this price threshold, however, we have not yet required the exercise of the Series B Warrants pursuant to this provision. The Series A and B Warrants are also exercisable on a cashless basis. In addition, in no event may the Warrants be exercised if the holder would own 20% or more of the outstanding shares of the Company’s common stock following the exercise. | |||||||||||
LOSS PER SHARE | |||||||||||
The following table presents information necessary to calculate loss per share for the three years ended December 31, 2014, 2013 and 2012 (in thousands, except per share amounts): | |||||||||||
2014 | 2013 | 2012 | |||||||||
Net loss | $ | -32,535 | $ | -28,466 | $ | -18,944 | |||||
Weighted average common shares outstanding | 23,432 | 20,808 | 15,346 | ||||||||
Basic loss per share | $ | -1.39 | $ | -1.37 | $ | -1.23 | |||||
Weighted average common and dilutive potential common shares outstanding: | |||||||||||
Weighted average common shares outstanding | 23,432 | 20,808 | 15,346 | ||||||||
Assumed exercise of stock options | — | — | — | ||||||||
23,432 | 20,808 | 15,346 | |||||||||
Diluted loss per share | $ | -1.39 | $ | -1.37 | $ | -1.23 | |||||
Net loss and basic and diluted loss per share have been revised for 2013 and 2012. For a further description of the revisions, see Note 2. “Revision of Prior Years’ Financial Statements” in the Notes to Consolidated Financial Statements. | |||||||||||
Other potential common stock of 2,910,157, 4,031,793 and 5,204,374, common shares underlying stock options and warrants for the periods ended December 31, 2014, 2013 and 2012, respectively, were excluded from the above calculation of diluted loss per share because such issuance would have been anti-dilutive. Potential common stock includes Series A Warrants issued in our February 8, 2011 public offering to purchase 39,595, 877,137 and 1,749,270 shares of our common stock at an exercise price of $0.01, for the periods ended December 31, 2014, 2013 and 2012, respectively. Additionally, potential common stock for periods ended December 31, 2014, 2013 and 2012 includes Series B Warrants issued in our February 8, 2011 public offering to purchase 429,704, 809,805 and 1,569,421 shares, respectively, of our common stock at an exercise price of $2.49. | |||||||||||
STOCK_OPTION_PLANS
STOCK OPTION PLANS | 12 Months Ended | ||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||
Share-based Arrangements with Employees and Nonemployees [Abstract] | |||||||||||||||||||||
Stock Option Plans | 9. STOCK OPTION PLANS: | ||||||||||||||||||||
As of December 31, 2014, there were 905,479 options available to grant under the 2011 Equity Incentive Plan. Typically, options are granted with an exercise price per share which is equal to the fair market value per share of common stock on the date of grant. Vesting provisions for each grant are determined by the board of directors and typically vest over a three year period. All options expire no later than the tenth anniversary of the grant date. | |||||||||||||||||||||
A summary of the status of the Company’s outstanding options at December 31, 2014, 2013, and 2012 and changes during the years then ended is presented in the tables below: | |||||||||||||||||||||
Stock | Weighted | Remaining | Aggregate | ||||||||||||||||||
Options | Average | Weighted | Intrinsic Value | ||||||||||||||||||
Exercise | Average | (In Thousands) | |||||||||||||||||||
Price | Contractual | ||||||||||||||||||||
Term | |||||||||||||||||||||
(Years) | |||||||||||||||||||||
Outstanding at December 31, 2011 | 1,960,003 | 6.79 | |||||||||||||||||||
Granted | 246,000 | 10.08 | |||||||||||||||||||
Exercised | -111,904 | 4.08 | $ | 870.8 | |||||||||||||||||
Forfeited/cancelled | -208,416 | 9.69 | |||||||||||||||||||
Outstanding at December 31, 2012 | 1,885,683 | 6.92 | |||||||||||||||||||
Granted | 505,000 | 13.37 | |||||||||||||||||||
Exercised | -14,165 | 10.31 | $ | 144.4 | |||||||||||||||||
Forfeited/cancelled | -31,667 | 11.87 | |||||||||||||||||||
Outstanding at December 31, 2013 | 2,344,851 | 8.22 | |||||||||||||||||||
Granted | 351,000 | 17.24 | |||||||||||||||||||
Exercised | -121,663 | 5.27 | $ | 1,721.10 | |||||||||||||||||
Forfeited/cancelled | -133,330 | 11.65 | |||||||||||||||||||
Outstanding at December 31, 2014 | 2,440,858 | 9.48 | 7.01 | $ | 1,202.50 | ||||||||||||||||
Exercisable at December 31, 2014 | 1,936,186 | 7.61 | 6.36 | $ | 4,204.20 | ||||||||||||||||
The following table summarizes information about stock options outstanding at December 31, 2014: | |||||||||||||||||||||
Range Of Exercise Prices | Number | Weighted | Weighted | Number | Weighted Average | ||||||||||||||||
Outstanding | Average | Average | Exercisable | Exercise | |||||||||||||||||
Remaining | Exercise | Price | |||||||||||||||||||
Life | Price | ||||||||||||||||||||
$ | 1.33 to | $ | 4 | 253,138 | 5.5 | $ | 2.32 | 253,138 | $ | 2.32 | |||||||||||
4.01 to | 5 | 762,312 | 6.2 | 4.5 | 758,980 | 4.5 | |||||||||||||||
5.01 to | 10 | 569,908 | 7 | 6.74 | 500,727 | 6.42 | |||||||||||||||
10.01 to | 20 | 749,000 | 8.6 | 15.62 | 346,923 | 15.04 | |||||||||||||||
21.00 to | 50.8 | 106,500 | 5.2 | 33.54 | 76,418 | 38.58 | |||||||||||||||
2,440,858 | 1,936,186 | ||||||||||||||||||||
Stock-based compensation is outlined in the following table (in thousands): | |||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||
R&D expense | $ | 1,924 | $ | 1,839 | $ | 880 | |||||||||||||||
G&A expense | 1,860 | 1,319 | 1,905 | ||||||||||||||||||
Total expense | $ | 3,784 | $ | 3,158 | $ | 2,785 | |||||||||||||||
At December 31, 2014, there was approximately $5.5 million of total unrecognized compensation cost related to non-vested stock options. This compensation cost is expected to be recognized over a weighted-average period of approximately 1.9 years. | |||||||||||||||||||||
Estimated fair values of stock options granted have been determined using the Black-Scholes option pricing model with the following weighted average assumptions: | |||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||
Risk-free interest rate | 2.2 | % | 1.5 | % | 0.97 | % | |||||||||||||||
Expected term | 7 years | 7 years | 6 years | ||||||||||||||||||
Volatility | 89 | % | 94 | % | 95 | % | |||||||||||||||
Dividend yield | — | — | — | ||||||||||||||||||
Fair value | $ | 13.41 | $ | 10.53 | $ | 7.75 | |||||||||||||||
Expected term represents the period that the Company’s stock-based awards are expected to be outstanding. The Company’s historical stock option exercise experience does not provide a reasonable basis upon which to estimate expected term. As such, the simplified method was used to calculate the expected term. | |||||||||||||||||||||
Due to our net operating loss position there are no anticipated windfall tax benefits upon exercise of options. | |||||||||||||||||||||
The Black-Scholes option pricing model and other existing models were developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of and are highly sensitive to subjective assumptions including the expected stock price volatility. The Company’s employee stock options have characteristics significantly different from those of traded options and changes in the subjective input assumptions can materially affect the fair value estimate. | |||||||||||||||||||||
LICENSE_RESEARCH_AND_DEVELOPME
LICENSE, RESEARCH AND DEVELOPMENT AGREEMENTS | 12 Months Ended |
Dec. 31, 2014 | |
Research and Development [Abstract] | |
License, Research And Development Agreements | 10. LICENSE, RESEARCH AND DEVELOPMENT AGREEMENTS: |
NATIONAL INSTITUTES OF HEALTH (NIH) | |
In 1999, we licensed rights to Proellex® from the National Institutes of Health (“NIH”) under an exclusive, worldwide license in the field of treatment of human endocrinologic pathologies or conditions in steroid-sensitive tissues which expires upon the expiration of the last licensed patent. Under the terms of the agreement, we are obligated to meet certain developmental milestones as outlined in a commercial development plan, which has been amended and revised from time to time as circumstances warrant. We have recently amended the agreement to provide us with rights to certain second generation compounds under certain circumstances. | |
We provide annual updates to the NIH on the progress of our development of Proellex®. The NIH has the ability to terminate the agreement for lack of payment or if we are not meeting milestones as outlined in the commercial development plan and for other reasons as outlined in the agreement. Although we believe that we have a good working relationship with the NIH, there can be no assurance that all of the objectives and conditions in the commercial development plan will be met on a timely basis or at all, or that, if we fail to meet any of such objectives, the NIH will agree to amend this agreement to our satisfaction. Failure to comply with the material terms contained in the license agreement could result in termination of such agreement, which would prohibit us from further development of Proellex® and severely harm our business prospects. The NIH retains, on behalf of the government, a nonexclusive, nontransferable, worldwide license to practice the inventions licensed under the licensed patents by or on behalf of the government. For the purpose of encouraging basic research, the NIH retains the right to grant nonexclusive research licenses to third parties. Due to the work that was done on Proellex® at the NIH prior to our license agreement, the government also has certain rights to use the product in the event of a national emergency pursuant to the Patent and Trademark Laws Amendments Act of 1980, as amended. | |
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 11. COMMITMENTS AND CONTINGENCIES: |
See footnote 5 for a discussion of our operating lease commitments. | |
Therapeutic uses of our Androxal® product candidate are covered in the United States by nine issued U.S. patents and seven pending patent applications. Foreign coverage of therapeutic uses of our Androxal® product candidate includes 71 issued foreign patents and 99 foreign pending patent applications. The issued patents and pending applications relate to methods for treating certain conditions including the treatment of testosterone deficiency in men, the treatment of diabetes mellitus Type 2, the treatment of metabolic syndrome and conditions associated therewith, and the treatment of infertility in hypogonadal men. Androxal® (the trans-isomer of clomiphene) is purified from clomiphene citrate. A third party individual holds two issued patents related to the use of anti-estrogen such as clomiphene citrate and others for use in the treatment of androgen deficiency and disorders related thereto. We requested re-examination of one of these patents by the U.S. Patent and Trademark Office (“PTO”) based on prior art. The patent holder amended the claims in the re-examination proceedings, which led the PTO to determine that the amended claims were patentable in view of those publications under consideration and a re-examination certificate was issued. We subsequently filed a second request for re-examination by the PTO in light of a number of additional publications. The request was granted and all of the claims were finally rejected by the PTO in the re-examination. The patent holder appealed the rejections to the PTO Board of Patent Appeals and Interferences (the “PTO Board”) which ultimately reversed the rejections of several dependent claims in view of those publications under consideration. The patent holder filed a Notice of Appeal to the Federal Circuit on September 28, 2010 contesting the rejections maintained by the PTO Board. A decision was rendered by the Court of Appeals for the Federal Circuit on December 12, 2011, affirming the rejection of the appealed claims. The PTO issued an Ex Parte Reexamination Certificate on April 29, 2013, canceling the rejected claims and confirming the patentability of the remaining claims. Nevertheless, we believe that our development of Androxal® does not infringe any of the remaining claims and that all of the remaining claims are invalid on various grounds including additional prior art publications. We also believe that the second of these two patents is invalid in view of published prior art not considered by the PTO. If necessary, we intend to vigorously defend any and all claims that may be brought by the holder of such patents in a court of competent jurisdiction in order to develop Androxal® further. Adverse determinations in litigation proceedings could require us to seek licenses which may not be available on commercially reasonable terms, or at all, or subject us to significant liabilities, in which case we may not be able to successfully commercialize or out-license Androxal® until such patents expire or are otherwise no longer in force. | |
On July 19, 2013, we received a letter from Dr. Harry Fisch threatening to file a lawsuit against us and two of our executive officers (Joseph S. Podolski, President and Chief Executive Officer and Ron Wiehle, Executive Vice President), seeking addition of Dr. Harry Fisch as an inventor on three of our patents, U.S. Patent Nos. 7,173,064, 7,737,185 and 7,759,360, covering therapeutic uses of Androxal®. We believe that these allegations are without merit and on August 2, 2013, we commenced a lawsuit against Dr. Fisch in the U.S. District Court for the Southern District of Texas seeking a declaratory judgment that he should not be added as inventor to any of these patents. On October 2, 2013, Dr. Fisch filed counterclaims to our complaint seeking correction of inventorship of the three patents at issue to name Dr. Fisch as a co-inventor of the applications leading these patents. Dr. Fisch subsequently stipulated that he does not claim to be a co-inventor of U.S. Patent No. 7,173,064. The court granted summary judgment in favor of the Company on separate equitable and legal grounds, and entered judgment on December 23, 2014. Our request for attorney’s fees was denied. On February 9, 2015, Dr. Fisch filed a notice of appeal of the summary judgment rulings to the United States Court of Appeals for the Federal Circuit. | |
Rights Plan | |
We are party to a rights agreement, as amended, pursuant to which a dividend consisting of one preferred stock purchase right was distributed for each share of our common stock held as of the close of business on September 13, 1999, and to each share of common stock issued thereafter until the earlier of (i) the distribution date which is defined in the rights plan, (ii) the redemption date which is defined in the rights plan or (iii) September 13, 2015. The rights plan is designed to deter coercive takeover tactics and to prevent an acquirer from gaining control of us without offering fair value to our stockholders. The rights will expire on September 13, 2015, subject to earlier redemption or exchange as provided in the rights plan. Each right entitles its holder to purchase from us one one-hundredth of a share of a new series of Series One Junior Participating Preferred Stock at a price of $20.00 per one one-hundredth of a share, subject to adjustment. The rights are generally exercisable only if a person acquires beneficial ownership of 20% or more of our outstanding common stock. | |
QUARTERLY_FINANCIAL_INFORMATIO
QUARTERLY FINANCIAL INFORMATION (UNAUDITED) | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
Quarterly Financial Information Disclosure [Abstract] | ||||||||||||||
Quarterly Financial Information (Unaudited) | 12. QUARTERLY FINANCIAL INFORMATION (UNAUDITED): | |||||||||||||
Quarterly financial information for the quarters ended March 31, June 30 and September 30, 2014 and for 2013 have been revised. For a further description of this revision, see “Note 2. Revision of Prior Years’ Financial Statements” of the Notes to Consolidated Financial Statements. | ||||||||||||||
AS REPORTED | First Quarter | Second Quarter | Third Quarter | Fourth Quarter | ||||||||||
Ended | Ended | Ended | Ended | |||||||||||
March 31, | June 30, | September 30, | December 31, | |||||||||||
2014 | 2014 | 2014 | 2014 | |||||||||||
(In thousands except per share amounts) | ||||||||||||||
Revenues and other income: | ||||||||||||||
Interest income | $ | 2 | $ | 2 | $ | 2 | $ | 3 | ||||||
Total revenues and other income | 2 | 2 | 2 | 3 | ||||||||||
Expenses: | ||||||||||||||
Research and development | 7,325 | 7,450 | 6,107 | 5,771 | ||||||||||
General and administrative | 1,226 | 1,256 | 1,277 | 1,678 | ||||||||||
Total expenses | 8,551 | 8,706 | 7,384 | 7,449 | ||||||||||
Net loss | $ | -8,549 | $ | -8,704 | $ | -7,382 | $ | -7,446 | ||||||
Net loss per share – basic and diluted | $ | -0.37 | $ | -0.38 | $ | -0.32 | $ | -0.31 | ||||||
Shares used in loss per share calculation | 23,033 | 23,102 | 23,347 | 24,234 | ||||||||||
AS REVISED | First Quarter | Second Quarter | Third Quarter | Fourth Quarter | ||||||||||
Ended | Ended | Ended | Ended | |||||||||||
March 31, | June 30, | September 30, | December 31, | |||||||||||
2014 | 2014 | 2014 | 2014 | |||||||||||
(In thousands except per share amounts) | ||||||||||||||
Revenues and other income: | ||||||||||||||
Interest income | $ | 2 | $ | 2 | $ | 2 | $ | 3 | ||||||
Total revenues and other income | 2 | 2 | 2 | 3 | ||||||||||
Expenses: | ||||||||||||||
Research and development | 7,569 | 7,491 | 6,276 | 5,771 | ||||||||||
General and administrative | 1,226 | 1,256 | 1,277 | 1,678 | ||||||||||
Total expenses | 8,795 | 8,747 | 7,553 | 7,449 | ||||||||||
Net loss | $ | -8,793 | $ | -8,745 | $ | -7,551 | $ | -7,446 | ||||||
Net loss per share – basic and diluted | $ | -0.38 | $ | -0.38 | $ | -0.32 | $ | -0.31 | ||||||
Shares used in loss per share calculation | 23,033 | 23,102 | 23,347 | 24,234 | ||||||||||
AS REPORTED | First Quarter | Second Quarter | Third Quarter | Fourth Quarter | ||||||||||
Ended | Ended | Ended | Ended | |||||||||||
March 31, | June 30, | September 30, | December 31, | |||||||||||
2013 | 2013 | 2013 | 2013 | |||||||||||
(In thousands except per share amounts) | ||||||||||||||
Revenues and other income: | ||||||||||||||
Interest income | $ | 1 | $ | 1 | $ | 3 | $ | 4 | ||||||
Total revenues and other income | 1 | 1 | 3 | 4 | ||||||||||
Expenses: | ||||||||||||||
Research and development | 6,308 | 6,037 | 4,786 | 5,781 | ||||||||||
General and administrative | 1,067 | 1,171 | 1,215 | 1,365 | ||||||||||
Total expenses | 7,375 | 7,208 | 6,001 | 7,146 | ||||||||||
Net loss | $ | -7,374 | $ | -7,207 | $ | -5,998 | $ | -7,142 | ||||||
Net loss per share – basic and diluted | $ | -0.41 | $ | -0.38 | $ | -0.26 | $ | -0.31 | ||||||
Shares used in loss per share calculation | 18,182 | 18,958 | 23,006 | 23,012 | ||||||||||
AS REVISED | First Quarter | Second Quarter | Third Quarter | Fourth Quarter | ||||||||||
Ended | Ended | Ended | Ended | |||||||||||
March 31, | June 30, | September 30, | December 31, | |||||||||||
2013 | 2013 | 2013 | 2013 | |||||||||||
(In thousands except per share amounts) | ||||||||||||||
Revenues and other income: | ||||||||||||||
Interest income | $ | 1 | $ | 1 | $ | 3 | $ | 4 | ||||||
Total revenues and other income | 1 | 1 | 3 | 4 | ||||||||||
Expenses: | ||||||||||||||
Research and development | 6,467 | 6,262 | 4,975 | 5,953 | ||||||||||
General and administrative | 1,067 | 1,171 | 1,215 | 1,365 | ||||||||||
Total expenses | 7,534 | 7,433 | 6,190 | 7,318 | ||||||||||
Net loss | $ | -7,533 | $ | -7,432 | $ | -6,187 | $ | -7,314 | ||||||
Net loss per share – basic and diluted | $ | -0.41 | $ | -0.39 | $ | -0.27 | $ | -0.32 | ||||||
Shares used in loss per share calculation | 18,182 | 18,958 | 23,006 | 23,012 | ||||||||||
SUBSEQUENT_EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2014 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. SUBSEQUENT EVENTS |
On January 6, 2015, we paid a filing fee to the FDA associated with the submission of our NDA for Androxal® in the amount of $2.3 million. | |
On January 28, 2015, the Board of Directors approved grants of a total of 189,000 stock options to certain employees. These options have an exercise price of $8.33, which was the closing price of our common stock on the date of grant, and will vest in equal annual installments on the first three year anniversaries of the date of grant. | |
On February 5, 2015, the Compensation Committee of the Board of Directors approved grants of a total of 180,000 stock options to non-employee Board Members and the Chief Financial Officer. These options have an exercise price of $8.44, which was the closing price of our common stock on the date of grant, and will vest in equal annual installments on the first three year anniversaries of the date of grant. | |
SUMMARY_OF_SIGNIFICANT_ACCOUNT1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2014 | |
Accounting Policies [Abstract] | |
Use Of Estimates | USE OF ESTIMATES |
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. | |
Certain Risks And Uncertainties | CERTAIN RISKS AND UNCERTAINTIES |
Our product candidates under development require approval from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance our product candidates will receive the necessary clearance. If we are denied clearance or clearance is delayed, it may have a material adverse impact on us. | |
Our product candidates are concentrated in rapidly changing, highly competitive markets, which are characterized by rapid technological advances, evolving regulatory requirements and industry standards. Any failure by us to anticipate or to respond adequately to technological developments in our industry, changes in regulatory requirements or industry standards, or any significant delays in the development or introduction of products or services, could have a material adverse effect on our business, operating results and future cash flows. We have no assurance of the successful development and FDA approval or the successful commercialization of our product candidates. | |
Cash And Cash Equivalents | CASH AND CASH EQUIVALENTS |
The Company considers all cash accounts and highly liquid investments having original maturities of three months or less to be cash and cash equivalents. | |
Prepaid Expenses And Other Current Assets | PREPAID EXPENSES AND OTHER CURRENT ASSETS |
Prepaid expenses and other current assets primarily consist of prepaid insurance, prepaid operating expenses and other miscellaneous assets, interest and other receivables. | |
Fixed Assets | FIXED ASSETS |
Fixed assets include lab equipment, furniture and leasehold improvements and are recorded at cost, less accumulated depreciation and amortization. Depreciation is computed on the straight-line method over an estimated useful life of three to five years or, in the case of leasehold improvements, amortized over the shorter of the useful life or the remaining term of the lease. Maintenance and repairs that do not improve or extend the life of assets are expensed as incurred. When assets are sold or retired, the cost and accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income during the period in which the transaction occurred. | |
Research And Development Expense | RESEARCH AND DEVELOPMENT EXPENSE |
Research and development (“R&D”) expenses include salaries and related employee expenses, contracted regulatory affairs activities, insurance coverage for clinical trials and prior product sales, contracted research and consulting fees, fees associated with our patent portfolio, facility costs, and internal research and development supplies. We expense R&D costs in the period they are incurred. These costs consist of direct and indirect costs associated with specific projects as well as fees paid to various entities that perform research on our behalf. | |
We estimate accrued expenses as part of our process of preparing financial statements. Examples of areas in which subjective judgments may be required include costs associated with services provided by contract organizations for clinical trials, preclinical development and manufacturing of clinical materials. We accrue for costs incurred as the services are being provided by monitoring the status of the trials or services provided and the invoices received from our external service providers. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in our trials, and we recognize this cost over the estimated term of the study based on the number of patients enrolled in the trial on an ongoing basis, beginning with patient enrollment. As actual costs become known to us, we adjust our accruals. To date, our estimates have not differed significantly from the actual costs incurred. However, subsequent changes in estimates may result in a material change in our accruals, which could also materially affect our balance sheet and results of operations. | |
Loss Per Share | LOSS PER SHARE |
Basic loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the year. Diluted loss per share is computed using the average share price for the period and applying the treasury stock method to potentially dilutive outstanding options. In applicable years all potential common stock equivalents were antidilutive and accordingly were not included in the computation. | |
Share-Based Compensation | SHARE-BASED COMPENSATION |
We had one stock-based compensation plan at December 31, 2014, the 2011 Equity Incentive Plan. Accounting for stock based compensation generally requires the recognition of the cost of employee services for share-based compensation based on the grant date fair value of the equity or liability instruments issued. We use the Black-Scholes option pricing model to estimate the fair value of our stock options. Expected volatility is determined using historical volatilities based on historical stock prices for a period equal to the expected term. The expected volatility assumption is adjusted if future volatility is expected to vary from historical experience. The expected term of options represents the period of time that options granted are expected to be outstanding and falls between the options' vesting and contractual expiration dates. The risk-free interest rate is based on the yield at the date of grant of a zero-coupon U.S. Treasury bond whose maturity period equals the option's expected term. | |
Income Taxes | INCOME TAXES |
Our net operating losses from inception to date have resulted principally from costs incurred in conducting clinical trials and in research and development activities related to efforts to develop our products and from the associated administrative costs required to support those efforts. We have recorded a deferred tax asset for our net operating losses (“NOL”); however, as the Company has incurred net operating losses since inception, and since there is no certainty of future profits, a valuation allowance has been provided in full on our deferred tax assets in the accompanying consolidated financial statements. Additionally, during 2013, the Company completed an analysis of its section 382 limit. Based on this analysis, the Company concluded that the amount of NOL carryforwards and the credits available to offset taxable income is limited under section 382. Accordingly, if the Company generates taxable income in any year in excess of its then annual limitation, the Company may be required to pay federal income taxes even though it has unexpired NOL carryforwards. Additionally, because U.S. tax laws limit the time during which NOLs and tax credit carryforwards may be applied against future taxable income and tax liabilities, the Company may not be able to take full advantage of its NOLs and tax credit carryforwards for federal income tax purposes. Future public and private stock placements may create additional limitations on the Company’s NOLs, credits and other tax attributes. | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements |
In August 2014, the FASB issued Accounting Standards Update No. 2014-15, “Presentation of Financial Statements - Going Concern.” The new standard requires management to evaluate whether there are conditions or events that raise substantial doubt about an entity's ability to continue as a going concern for both annual and interim reporting periods. This guidance is effective for us for the fiscal year beginning January 1, 2016 and interim periods thereafter. The guidance is not expected to have a material impact on our consolidated financial statements. | |
In June 2014, the FASB issued Accounting Standards Update 2014-10, “Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation.” The guidance eliminates the definition of a development stage entity thereby removing the incremental financial reporting requirements from U.S. Generally Accepted Accounting Principles for development stage entities, primarily presentation of inception to date financial information. The provisions of the amendment is effective for annual reporting periods beginning after December 15, 2015. We have elected to adopt ASU 2014-10 early and as an early adopter, we are no longer providing inception-to-date financial information in our consolidated financial statements. | |
In May 2014, the FASB issued Accounting Standards Update 2014-09, “Revenue from Contracts with Customers” (“ASU 2014-09”). ASU 2014-09 is a comprehensive new revenue recognition model requiring a company to recognize revenue to depict the transfer of goods or services to a customer at an amount reflecting the consideration it expects to receive in exchange for those goods or services. In adopting ASU 2014-09, companies may use either a full retrospective or a modified retrospective approach. Additionally, this guidance requires improved disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. ASU 2014-09 is effective for the first interim period within annual reporting periods beginning after December 15, 2016, and early adoption is not permitted. The Company is currently assessing the impact of the new standard on our consolidated financial statements. | |
REVISION_OF_PRIOR_YEARS_FINANC1
REVISION OF PRIOR YEARS' FINANCIAL STATEMENTS (Tables) | 12 Months Ended | |||||||||||||||||||
Dec. 31, 2014 | ||||||||||||||||||||
Quantifying Prior Year Misstatements Corrected in Current Year Financial Statements [Abstract] | ||||||||||||||||||||
Schedule of Quantifying Prior Year Misstatements Corrected in Current Year Financial Statements | The effect of the error corrections on the consolidated balance sheet as of December 31, 2013 are as follows (in thousands): | |||||||||||||||||||
As previously | Correction | As revised | ||||||||||||||||||
reported | ||||||||||||||||||||
Other assets, net | $ | 2,906 | $ | -2,906 | $ | 0 | ||||||||||||||
Total assets | 78,977 | -2,906 | 76,071 | |||||||||||||||||
Accumulated deficit | -237,623 | -2,906 | -240,529 | |||||||||||||||||
Total stockholders’ equity | 75,425 | -2,906 | 72,519 | |||||||||||||||||
Schedule of Error Corrections and Prior Period Adjustments | The effects of the error correction on the consolidated statements of operations for the years ended December 31, 2013 and 2012 are as follows (in thousands): | |||||||||||||||||||
Year Ended December 31, 2013 | Year Ended December 31, 2012 | |||||||||||||||||||
As previously | Correction | As | As previously | Correction | As | |||||||||||||||
reported | revised | reported | revised | |||||||||||||||||
Research and development | $ | 22,912 | $ | 745 | $ | 23,657 | $ | 13,343 | $ | 777 | $ | 14,120 | ||||||||
Total expenses | 27,730 | 745 | 28,475 | 18,170 | 777 | 18,947 | ||||||||||||||
Net loss | -27,721 | -745 | -28,466 | -18,167 | -777 | -18,944 | ||||||||||||||
Loss per share – basic and diluted | -1.33 | -0.04 | -1.37 | -1.18 | -0.05 | -1.23 | ||||||||||||||
Schedule Of Error Corrections And Prior Period Adjustments Cash flows | The effects of the error correction on the consolidated statements of cash flows for the years ended December 31, 2013 and 2012 are as follows (in thousands): | |||||||||||||||||||
Year Ended December 31, 2013 | Year Ended December 31, 2012 | |||||||||||||||||||
As previously | Correction | As | As previously | Correction | As | |||||||||||||||
reported | revised | reported | revised | |||||||||||||||||
Net cash used in operating activities | $ | -24,448 | $ | -848 | $ | -25,296 | $ | -13,495 | $ | -578 | $ | -14,073 | ||||||||
Net cash used in investing activities | -911 | 848 | -63 | -608 | 578 | -30 | ||||||||||||||
FIXED_ASSETS_Tables
FIXED ASSETS (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Property, Plant and Equipment [Abstract] | ||||||||
Property, Plant and Equipment | Fixed assets are as follows (in thousands): | |||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Laboratory equipment | $ | 20 | $ | 20 | ||||
Office equipment | 101 | 101 | ||||||
Furniture and fixtures | 18 | 18 | ||||||
Leasehold improvements | 77 | 77 | ||||||
Total fixed assets | 216 | 216 | ||||||
Less — Accumulated depreciation and amortization | 184 | 141 | ||||||
Net Fixed Assets | $ | 32 | $ | 75 | ||||
ACCRUED_EXPENSES_Tables
ACCRUED EXPENSES (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Accrued Expenses [Abstract] | ||||||||
Accrued Expenses | Accrued expenses consist of the following (in thousands): | |||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Personnel related costs | $ | 458 | $ | 196 | ||||
Research and development costs | 284 | 277 | ||||||
Other | 92 | 113 | ||||||
Total | $ | 834 | $ | 586 | ||||
FEDERAL_INCOME_TAXES_Tables
FEDERAL INCOME TAXES (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Schedule of Investments [Abstract] | ||||||||
Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences that give rise to significant portions of the deferred tax assets are as follows (in thousands): | |||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Net operating loss carryforwards | $ | 71,472 | $ | 61,714 | ||||
Research and development tax credits | 1,384 | 1,384 | ||||||
Inventory reserve | 1,510 | 1,510 | ||||||
Total deferred tax assets | 74,366 | 64,608 | ||||||
Less — Valuation allowance | -74,366 | -64,608 | ||||||
Net deferred tax assets | $ | — | $ | — | ||||
STOCKHOLDERS_EQUITY_Tables
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Stockholders' Equity Note [Abstract] | |||||||||||
Calculation of Loss Per Share | The following table presents information necessary to calculate loss per share for the three years ended December 31, 2014, 2013 and 2012 (in thousands, except per share amounts): | ||||||||||
2014 | 2013 | 2012 | |||||||||
Net loss | $ | -32,535 | $ | -28,466 | $ | -18,944 | |||||
Weighted average common shares outstanding | 23,432 | 20,808 | 15,346 | ||||||||
Basic loss per share | $ | -1.39 | $ | -1.37 | $ | -1.23 | |||||
Weighted average common and dilutive potential common shares outstanding: | |||||||||||
Weighted average common shares outstanding | 23,432 | 20,808 | 15,346 | ||||||||
Assumed exercise of stock options | — | — | — | ||||||||
23,432 | 20,808 | 15,346 | |||||||||
Diluted loss per share | $ | -1.39 | $ | -1.37 | $ | -1.23 | |||||
STOCK_OPTION_PLANS_Tables
STOCK OPTION PLANS (Tables) | 12 Months Ended | ||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||
Share-based Arrangements with Employees and Nonemployees [Abstract] | |||||||||||||||||||||
Schedule of Share-based Compensation, Stock Options, Activity | A summary of the status of the Company’s outstanding options at December 31, 2014, 2013, and 2012 and changes during the years then ended is presented in the tables below: | ||||||||||||||||||||
Stock | Weighted | Remaining | Aggregate | ||||||||||||||||||
Options | Average | Weighted | Intrinsic Value | ||||||||||||||||||
Exercise | Average | (In Thousands) | |||||||||||||||||||
Price | Contractual | ||||||||||||||||||||
Term | |||||||||||||||||||||
(Years) | |||||||||||||||||||||
Outstanding at December 31, 2011 | 1,960,003 | 6.79 | |||||||||||||||||||
Granted | 246,000 | 10.08 | |||||||||||||||||||
Exercised | -111,904 | 4.08 | $ | 870.8 | |||||||||||||||||
Forfeited/cancelled | -208,416 | 9.69 | |||||||||||||||||||
Outstanding at December 31, 2012 | 1,885,683 | 6.92 | |||||||||||||||||||
Granted | 505,000 | 13.37 | |||||||||||||||||||
Exercised | -14,165 | 10.31 | $ | 144.4 | |||||||||||||||||
Forfeited/cancelled | -31,667 | 11.87 | |||||||||||||||||||
Outstanding at December 31, 2013 | 2,344,851 | 8.22 | |||||||||||||||||||
Granted | 351,000 | 17.24 | |||||||||||||||||||
Exercised | -121,663 | 5.27 | $ | 1,721.10 | |||||||||||||||||
Forfeited/cancelled | -133,330 | 11.65 | |||||||||||||||||||
Outstanding at December 31, 2014 | 2,440,858 | 9.48 | 7.01 | $ | 1,202.50 | ||||||||||||||||
Exercisable at December 31, 2014 | 1,936,186 | 7.61 | 6.36 | $ | 4,204.20 | ||||||||||||||||
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range | The following table summarizes information about stock options outstanding at December 31, 2014: | ||||||||||||||||||||
Range Of Exercise Prices | Number | Weighted | Weighted | Number | Weighted Average | ||||||||||||||||
Outstanding | Average | Average | Exercisable | Exercise | |||||||||||||||||
Remaining | Exercise | Price | |||||||||||||||||||
Life | Price | ||||||||||||||||||||
$ | 1.33 to | $ | 4 | 253,138 | 5.5 | $ | 2.32 | 253,138 | $ | 2.32 | |||||||||||
4.01 to | 5 | 762,312 | 6.2 | 4.5 | 758,980 | 4.5 | |||||||||||||||
5.01 to | 10 | 569,908 | 7 | 6.74 | 500,727 | 6.42 | |||||||||||||||
10.01 to | 20 | 749,000 | 8.6 | 15.62 | 346,923 | 15.04 | |||||||||||||||
21.00 to | 50.8 | 106,500 | 5.2 | 33.54 | 76,418 | 38.58 | |||||||||||||||
2,440,858 | 1,936,186 | ||||||||||||||||||||
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Stock-based compensation is outlined in the following table (in thousands): | ||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||
R&D expense | $ | 1,924 | $ | 1,839 | $ | 880 | |||||||||||||||
G&A expense | 1,860 | 1,319 | 1,905 | ||||||||||||||||||
Total expense | $ | 3,784 | $ | 3,158 | $ | 2,785 | |||||||||||||||
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | Estimated fair values of stock options granted have been determined using the Black-Scholes option pricing model with the following weighted average assumptions: | ||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||
Risk-free interest rate | 2.2 | % | 1.5 | % | 0.97 | % | |||||||||||||||
Expected term | 7 years | 7 years | 6 years | ||||||||||||||||||
Volatility | 89 | % | 94 | % | 95 | % | |||||||||||||||
Dividend yield | — | — | — | ||||||||||||||||||
Fair value | $ | 13.41 | $ | 10.53 | $ | 7.75 | |||||||||||||||
QUARTERLY_FINANCIAL_INFORMATIO1
QUARTERLY FINANCIAL INFORMATION (UNAUDITED) (Tables) | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
Quarterly Financial Information Disclosure [Abstract] | ||||||||||||||
Schedule of Quarterly Financial Information | Quarterly financial information for the quarters ended March 31, June 30 and September 30, 2014 and for 2013 have been revised. For a further description of this revision, see “Note 2. Revision of Prior Years’ Financial Statements” of the Notes to Consolidated Financial Statements. | |||||||||||||
AS REPORTED | First Quarter | Second Quarter | Third Quarter | Fourth Quarter | ||||||||||
Ended | Ended | Ended | Ended | |||||||||||
March 31, | June 30, | September 30, | December 31, | |||||||||||
2014 | 2014 | 2014 | 2014 | |||||||||||
(In thousands except per share amounts) | ||||||||||||||
Revenues and other income: | ||||||||||||||
Interest income | $ | 2 | $ | 2 | $ | 2 | $ | 3 | ||||||
Total revenues and other income | 2 | 2 | 2 | 3 | ||||||||||
Expenses: | ||||||||||||||
Research and development | 7,325 | 7,450 | 6,107 | 5,771 | ||||||||||
General and administrative | 1,226 | 1,256 | 1,277 | 1,678 | ||||||||||
Total expenses | 8,551 | 8,706 | 7,384 | 7,449 | ||||||||||
Net loss | $ | -8,549 | $ | -8,704 | $ | -7,382 | $ | -7,446 | ||||||
Net loss per share – basic and diluted | $ | -0.37 | $ | -0.38 | $ | -0.32 | $ | -0.31 | ||||||
Shares used in loss per share calculation | 23,033 | 23,102 | 23,347 | 24,234 | ||||||||||
AS REVISED | First Quarter | Second Quarter | Third Quarter | Fourth Quarter | ||||||||||
Ended | Ended | Ended | Ended | |||||||||||
March 31, | June 30, | September 30, | December 31, | |||||||||||
2014 | 2014 | 2014 | 2014 | |||||||||||
(In thousands except per share amounts) | ||||||||||||||
Revenues and other income: | ||||||||||||||
Interest income | $ | 2 | $ | 2 | $ | 2 | $ | 3 | ||||||
Total revenues and other income | 2 | 2 | 2 | 3 | ||||||||||
Expenses: | ||||||||||||||
Research and development | 7,569 | 7,491 | 6,276 | 5,771 | ||||||||||
General and administrative | 1,226 | 1,256 | 1,277 | 1,678 | ||||||||||
Total expenses | 8,795 | 8,747 | 7,553 | 7,449 | ||||||||||
Net loss | $ | -8,793 | $ | -8,745 | $ | -7,551 | $ | -7,446 | ||||||
Net loss per share – basic and diluted | $ | -0.38 | $ | -0.38 | $ | -0.32 | $ | -0.31 | ||||||
Shares used in loss per share calculation | 23,033 | 23,102 | 23,347 | 24,234 | ||||||||||
AS REPORTED | First Quarter | Second Quarter | Third Quarter | Fourth Quarter | ||||||||||
Ended | Ended | Ended | Ended | |||||||||||
March 31, | June 30, | September 30, | December 31, | |||||||||||
2013 | 2013 | 2013 | 2013 | |||||||||||
(In thousands except per share amounts) | ||||||||||||||
Revenues and other income: | ||||||||||||||
Interest income | $ | 1 | $ | 1 | $ | 3 | $ | 4 | ||||||
Total revenues and other income | 1 | 1 | 3 | 4 | ||||||||||
Expenses: | ||||||||||||||
Research and development | 6,308 | 6,037 | 4,786 | 5,781 | ||||||||||
General and administrative | 1,067 | 1,171 | 1,215 | 1,365 | ||||||||||
Total expenses | 7,375 | 7,208 | 6,001 | 7,146 | ||||||||||
Net loss | $ | -7,374 | $ | -7,207 | $ | -5,998 | $ | -7,142 | ||||||
Net loss per share – basic and diluted | $ | -0.41 | $ | -0.38 | $ | -0.26 | $ | -0.31 | ||||||
Shares used in loss per share calculation | 18,182 | 18,958 | 23,006 | 23,012 | ||||||||||
AS REVISED | First Quarter | Second Quarter | Third Quarter | Fourth Quarter | ||||||||||
Ended | Ended | Ended | Ended | |||||||||||
March 31, | June 30, | September 30, | December 31, | |||||||||||
2013 | 2013 | 2013 | 2013 | |||||||||||
(In thousands except per share amounts) | ||||||||||||||
Revenues and other income: | ||||||||||||||
Interest income | $ | 1 | $ | 1 | $ | 3 | $ | 4 | ||||||
Total revenues and other income | 1 | 1 | 3 | 4 | ||||||||||
Expenses: | ||||||||||||||
Research and development | 6,467 | 6,262 | 4,975 | 5,953 | ||||||||||
General and administrative | 1,067 | 1,171 | 1,215 | 1,365 | ||||||||||
Total expenses | 7,534 | 7,433 | 6,190 | 7,318 | ||||||||||
Net loss | $ | -7,533 | $ | -7,432 | $ | -6,187 | $ | -7,314 | ||||||
Net loss per share – basic and diluted | $ | -0.41 | $ | -0.39 | $ | -0.27 | $ | -0.32 | ||||||
Shares used in loss per share calculation | 18,182 | 18,958 | 23,006 | 23,012 | ||||||||||
ORGANIZATION_AND_OPERATIONS_Ad
ORGANIZATION AND OPERATIONS (Additional Information) (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Product Information [Line Items] | ||||
Deficit accumulated during the development stage | $273,100,000 | |||
Cash and cash equivalents | 46,620,000 | 75,807,000 | 24,212,000 | 4,565,000 |
Accounts payable and accrued expenses | $2,900,000 |
REVISION_OF_PRIOR_YEARS_FINANC2
REVISION OF PRIOR YEARS' FINANCIAL STATEMENTS (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
In Thousands, unless otherwise specified | ||||
Other assets, net | $0 | |||
Total assets | 46,941 | 76,071 | ||
Accumulated deficit | -273,064 | -240,529 | -212,063 | -193,119 |
Total stockholdersb equity | 44,017 | 72,519 | 20,873 | 3,282 |
Scenario, Previously Reported [Member] | ||||
Other assets, net | 2,906 | |||
Total assets | 78,977 | |||
Accumulated deficit | -237,623 | -209,902 | -191,735 | |
Total stockholdersb equity | 75,425 | 23,034 | 4,666 | |
Restatement Adjustment [Member] | ||||
Other assets, net | -2,906 | |||
Total assets | -2,906 | |||
Accumulated deficit | -2,906 | |||
Total stockholdersb equity | ($2,906) |
REVISION_OF_PRIOR_YEARS_FINANC3
REVISION OF PRIOR YEARS' FINANCIAL STATEMENTS (Details 1) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Research and development | $5,771 | $6,276 | $7,491 | $7,569 | $5,953 | $4,975 | $6,262 | $6,467 | $27,107 | $23,657 | $14,120 |
Total expenses | 7,449 | 7,553 | 8,747 | 8,795 | 7,318 | 6,190 | 7,433 | 7,534 | 32,544 | 28,475 | 18,947 |
Net loss | -7,446 | -7,551 | -8,745 | -8,793 | -7,314 | -6,187 | -7,432 | -7,533 | -32,535 | -28,466 | -18,944 |
Loss per share - basic and diluted | ($0.31) | ($0.32) | ($0.38) | ($0.38) | ($0.32) | ($0.27) | ($0.39) | ($0.41) | ($1.39) | ($1.37) | ($1.23) |
As Previously Reported [Member] | |||||||||||
Research and development | 5,771 | 6,107 | 7,450 | 7,325 | 5,781 | 4,786 | 6,037 | 6,308 | 22,912 | 13,343 | |
Total expenses | 7,449 | 7,384 | 8,706 | 8,551 | 7,146 | 6,001 | 7,208 | 7,375 | 27,730 | 18,170 | |
Net loss | -7,446 | -7,382 | -8,704 | -8,549 | -7,142 | -5,998 | -7,207 | -7,374 | -27,721 | -18,167 | |
Loss per share - basic and diluted | ($0.31) | ($0.32) | ($0.38) | ($0.37) | ($0.31) | ($0.26) | ($0.38) | ($0.41) | ($1.33) | ($1.18) | |
Revision [Member] | |||||||||||
Research and development | 745 | 777 | |||||||||
Total expenses | 745 | 777 | |||||||||
Net loss | ($745) | ($777) | |||||||||
Loss per share - basic and diluted | ($0.04) | ($0.05) |
REVISION_OF_PRIOR_YEARS_FINANC4
REVISION OF PRIOR YEARS' FINANCIAL STATEMENTS (Details 2) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Net cash used in operating activities | ($29,334) | ($25,296) | ($14,073) |
Net cash used in investing activities | 0 | -63 | -30 |
As Previously Reported [Member] | |||
Net cash used in operating activities | -24,448 | -13,495 | |
Net cash used in investing activities | -911 | -608 | |
Revision [Member] | |||
Net cash used in operating activities | -848 | -578 | |
Net cash used in investing activities | $848 | $578 |
REVISION_OF_PRIOR_YEARS_FINANC5
REVISION OF PRIOR YEARS' FINANCIAL STATEMENTS (Additional information) (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
In Thousands, unless otherwise specified | ||||
Quantifying Misstatement in Current Year Financial Statements [Line Items] | ||||
Shareholdersb Equity | $44,017 | $72,519 | $20,873 | $3,282 |
Retained Earnings (Accumulated Deficit) | -273,064 | -240,529 | -212,063 | -193,119 |
Scenario, Previously Reported [Member] | ||||
Quantifying Misstatement in Current Year Financial Statements [Line Items] | ||||
Shareholdersb Equity | 75,425 | 23,034 | 4,666 | |
Retained Earnings (Accumulated Deficit) | ($237,623) | ($209,902) | ($191,735) |
FIXED_ASSETS_Details
FIXED ASSETS (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $216 | $216 |
Less B Accumulated depreciation and amortization | 184 | 141 |
Net Fixed Assets | 32 | 75 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 20 | 20 |
Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 101 | 101 |
Leaseholds and Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 77 | 77 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $18 | $18 |
FIXED_ASSETS_Additional_inform
FIXED ASSETS (Additional information) (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation | $43,000 | $40,000 | $17,000 |
OPERATING_LEASES_Additional_in
OPERATING LEASES (Additional information) (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Leases Operating [Line Items] | |||
Operating Leases, Rent Expense, Net | $74,000 | $79,000 | $76,000 |
Operating Leases, Future Minimum Payments Due | $27,000 |
ACCRUED_EXPENSES_Details
ACCRUED EXPENSES (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule Of Accrued Liabilities [Line Items] | ||
Personnel related costs | $458 | $196 |
Research and development costs | 284 | 277 |
Other | 92 | 113 |
Total | $834 | $586 |
FEDERAL_INCOME_TAXES_Details
FEDERAL INCOME TAXES (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Investments [Line Items] | ||
Net operating loss carryforwards | $71,472 | $61,714 |
Research and development tax credits | 1,384 | 1,384 |
Inventory reserve | 1,510 | 1,510 |
Total deferred tax assets | 74,366 | 64,608 |
Less B Valuation allowance | -74,366 | -64,608 |
Net deferred tax assets | $0 | $0 |
FEDERAL_INCOME_TAXES_Additiona
FEDERAL INCOME TAXES (Additional information) (Details) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Schedule of Investments [Line Items] | ||
Deferred Tax Assets, Operating Loss Carryforwards, Domestic | $1,400,000 | $838,000 |
Deferred Tax Assets Additional Operating Loss Carryforwards Domestic | 210,200,000 | |
Estimated Carryforwards To Offset Taxable Income Per Year | $12,200,000 |
STOCKHOLDERS_EQUITY_Details
STOCKHOLDERS' EQUITY (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Net loss | ($7,446) | ($7,551) | ($8,745) | ($8,793) | ($7,314) | ($6,187) | ($7,432) | ($7,533) | ($32,535) | ($28,466) | ($18,944) |
Weighted average common shares outstanding | 23,432 | 20,808 | 15,346 | ||||||||
Basic loss per share | ($1.39) | ($1.37) | ($1.23) | ||||||||
Weighted average common and dilutive potential common shares outstanding: | |||||||||||
Weighted average common shares outstanding | 23,432 | 20,808 | 15,346 | ||||||||
Assumed exercise of stock options | 0 | 0 | 0 | ||||||||
Weighted Average Number of Shares Outstanding, Diluted | 23,432 | 20,808 | 15,346 | ||||||||
Diluted loss per share | ($1.39) | ($1.37) | ($1.23) |
STOCKHOLDERS_EQUITY_Additional
STOCKHOLDERS' EQUITY (Additional information) (Details) (USD $) | 0 Months Ended | 12 Months Ended | 0 Months Ended | 1 Months Ended | 12 Months Ended | ||
In Millions, except Share data, unless otherwise specified | Feb. 08, 2011 | Dec. 31, 2014 | Sep. 07, 2012 | Feb. 01, 2012 | Jun. 25, 2013 | Dec. 31, 2013 | Dec. 31, 2012 |
Stockholders Equity Note [Line Items] | |||||||
Issuance of common stock, share | 2,760,000 | ||||||
Warrants price per unit | 17.15 | ||||||
Stock Issued During Period Units New Issues | 690,000 | ||||||
Gross proceeds from public offering | $10.70 | ||||||
Sale of Stock, Description of Transaction | The Series B Warrants are callable by the Company in the event that the Companys stock trades at $8.00 or more for a period of 20 trading days over any consecutive 30 trading day period | ||||||
Equity Method Investment, Ownership Percentage | 20.00% | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $0.01 | ||||||
Private Placement [Member] | |||||||
Stockholders Equity Note [Line Items] | |||||||
Issuance of common stock, share | 2,145,636 | ||||||
Sale of Stock, Price Per Share | $11 | ||||||
Proceeds from Issuance of Private Placement | 23 | ||||||
Direct Registered Offering [Member] | |||||||
Stockholders Equity Note [Line Items] | |||||||
Issuance of common stock, share | 2,463,537 | ||||||
Sale of Stock, Price Per Share | $4.50 | ||||||
Proceeds from Issuance of Private Placement | 10.3 | ||||||
Public Offering [Member] | |||||||
Stockholders Equity Note [Line Items] | |||||||
Issuance of common stock, share | 4,312,500 | ||||||
Sale of Stock, Price Per Share | $19 | ||||||
Proceeds from Issuance of Private Placement | 76.8 | ||||||
Employee Stock Option [Member] | |||||||
Stockholders Equity Note [Line Items] | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 2,910,157 | 4,031,793 | 5,204,374 | ||||
Series Warrant [Member] | |||||||
Stockholders Equity Note [Line Items] | |||||||
Stock Issued During Period Warrants New Issues | 2,070,000 | ||||||
Warrants Convertible Conversion Ratio | 3 | ||||||
Fair Value Assumptions, Expected Term | 5 years | ||||||
Stock Issued During Period Shares Exercise Of Warrants | 2,029,325 | ||||||
Series Warrant [Member] | Employee Stock Option [Member] | |||||||
Stockholders Equity Note [Line Items] | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 39,595 | 877,137 | 1,749,270 | ||||
Series B Warrant [Member] | |||||||
Stockholders Equity Note [Line Items] | |||||||
Stock Issued During Period Warrants New Issues | 1,690,500 | ||||||
Warrants Convertible Conversion Ratio | 2.45 | ||||||
Fair Value Assumptions, Expected Term | 5 years | ||||||
Stock Issued During Period Shares Exercise Of Warrants | 1,108,518 | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 429,704 | 809,805 | 1,569,421 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $2.49 | ||||||
SeriesA and B [Member] | |||||||
Stockholders Equity Note [Line Items] | |||||||
Fair Value Assumptions, Risk Free Interest Rate | 0.18% | ||||||
Fair Value Assumptions, Expected Volatility Rate | 131.66% | ||||||
Fair Value Assumptions, Expected Term | 6 years | ||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | 5.4 | ||||||
Additional Paid in Capital, Common Stock | $5.30 |
STOCK_OPTION_PLANS_Details
STOCK OPTION PLANS (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Share-Based Arrangements With Employees and Nonemployees [Line Items] | |||
Stock Options, Beginning Balance | 2,344,851 | 1,885,683 | 1,960,003 |
Stock Options, Granted | 351,000 | 505,000 | 246,000 |
Stock Options, Exercised | -121,663 | -14,165 | -111,904 |
Stock Options, Forfeited/cancelled | -133,330 | -31,667 | -208,416 |
Stock Options, Ending balance | 2,440,858 | 2,344,851 | 1,885,683 |
Stock Options, Exercisable at December 31, 2014 | 1,936,186 | ||
Weighted average exercise price, Beginning Balance | $8.22 | $6.92 | $6.79 |
Weighted average exercise price, Granted | $17.24 | $13.37 | $10.08 |
Weighted average exercise price, Exercised | $5.27 | $10.31 | $4.08 |
Weighted average exercise price, Forfeited/cancelled | $11.65 | $11.87 | $9.69 |
Weighted average exercise price, Ending Balance | $9.48 | $8.22 | $6.92 |
Weighted average exercise price, Exercisable at December 31, 2014 | $7.61 | ||
Remaining Weighted Average Contractual Term (Years) | 7 years 4 days | ||
Remaining Weighted Average Contractual Term (Years), Exercisable at December 31, 2014 | 6 years 4 months 10 days | ||
Aggregate Intrinsice Value, Exercised | $1,721,100 | $144,400 | $870,800 |
Aggregated Intrinsic Value | 1,202,500 | ||
Aggregate Intrinsice Value, Exercisable at December 31, 2014 | $4,204,200 |
STOCK_OPTION_PLANS_Details_1
STOCK OPTION PLANS (Details 1) (USD $) | 12 Months Ended | |||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |
Number Outstanding | 2,440,858 | 2,344,851 | 1,885,683 | 1,960,003 |
Weighted Average Remaining Life | 7 years 4 days | |||
Outstanding Weighted Average Exercise Price | $9.48 | $8.22 | $6.92 | $6.79 |
Number Exercisable | 1,936,186 | |||
Exercisable Weighted Average Exercise Price | $7.61 | |||
Range One [Member] | ||||
Range Of Exercise Prices, Lower Range Limit | $1.33 | |||
Range Of Exercise Prices, Upper Range Limit | $4 | |||
Number Outstanding | 253,138 | |||
Weighted Average Remaining Life | 5 years 6 months | |||
Outstanding Weighted Average Exercise Price | $2.32 | |||
Number Exercisable | 253,138 | |||
Exercisable Weighted Average Exercise Price | $2.32 | |||
Range Two [Member] | ||||
Range Of Exercise Prices, Lower Range Limit | $4.01 | |||
Range Of Exercise Prices, Upper Range Limit | $5 | |||
Number Outstanding | 762,312 | |||
Weighted Average Remaining Life | 6 years 2 months 12 days | |||
Outstanding Weighted Average Exercise Price | $4.50 | |||
Number Exercisable | 758,980 | |||
Exercisable Weighted Average Exercise Price | $4.50 | |||
Range Three [Member] | ||||
Range Of Exercise Prices, Lower Range Limit | $5.01 | |||
Range Of Exercise Prices, Upper Range Limit | $10 | |||
Number Outstanding | 569,908 | |||
Weighted Average Remaining Life | 7 years | |||
Outstanding Weighted Average Exercise Price | $6.74 | |||
Number Exercisable | 500,727 | |||
Exercisable Weighted Average Exercise Price | $6.42 | |||
Range Four [Member] | ||||
Range Of Exercise Prices, Lower Range Limit | $10.01 | |||
Range Of Exercise Prices, Upper Range Limit | $20 | |||
Number Outstanding | 749,000 | |||
Weighted Average Remaining Life | 8 years 7 months 6 days | |||
Outstanding Weighted Average Exercise Price | $15.62 | |||
Number Exercisable | 346,923 | |||
Exercisable Weighted Average Exercise Price | $15.04 | |||
Range Five [Member] | ||||
Range Of Exercise Prices, Lower Range Limit | $21 | |||
Range Of Exercise Prices, Upper Range Limit | $50.80 | |||
Number Outstanding | 106,500 | |||
Weighted Average Remaining Life | 5 years 2 months 12 days | |||
Outstanding Weighted Average Exercise Price | $33.54 | |||
Number Exercisable | 76,418 | |||
Exercisable Weighted Average Exercise Price | $38.58 |
STOCK_OPTION_PLANS_Details_2
STOCK OPTION PLANS (Details 2) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Allocated Share-based Compensation Expense | $3,784 | $3,158 | $2,785 |
Research and Development Expense [Member] | |||
Allocated Share-based Compensation Expense | 1,924 | 1,839 | 880 |
General and Administrative Expense [Member] | |||
Allocated Share-based Compensation Expense | $1,860 | $1,319 | $1,905 |
STOCK_OPTION_PLANS_Details_3
STOCK OPTION PLANS (Details 3) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Risk-free interest rate | 2.20% | 1.50% | 0.97% |
Expected term | 7 years | 7 years | 6 years |
Volatility | 89.00% | 94.00% | 95.00% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Fair value | $13.41 | $10.53 | $7.75 |
STOCK_OPTION_PLANS_Additional_
STOCK OPTION PLANS (Additional information) (Details) (USD $) | 0 Months Ended | 1 Months Ended | 12 Months Ended |
In Millions, except Share data, unless otherwise specified | Feb. 05, 2015 | Jan. 28, 2015 | Dec. 31, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 905,479 | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 10 months 24 days | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $5.50 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | 3 years | 3 years |
COMMITMENTS_AND_CONTINGENCIES_
COMMITMENTS AND CONTINGENCIES (Additional Information) (Details) (USD $) | 12 Months Ended |
Dec. 31, 2014 | |
Commitments and Contingencies [Line Items] | |
Beneficial Ownership Percentage Of Common Stock Description | The rights are generally exercisable only if a person acquires beneficial ownership of 20% or more of our outstanding common stock. |
Joseph S. Podolski | |
Commitments and Contingencies [Line Items] | |
Issued Patent Number | 7,173,064 |
Ron Wiehle | |
Commitments and Contingencies [Line Items] | |
Issued Patent Number | 7,737,185 |
Dr. Harry Fisch | |
Commitments and Contingencies [Line Items] | |
Issued Patent Number | 7,759,360 |
Foreign [Member] | |
Commitments and Contingencies [Line Items] | |
Number of patents | 71 |
Number of pending patent applications | 99 |
Junior Participating Preferred Stock [Member] | |
Commitments and Contingencies [Line Items] | |
Share Price | 20 |
Third Party [Member] | |
Commitments and Contingencies [Line Items] | |
Number of patents | 2 |
QUARTERLY_FINANCIAL_INFORMATIO2
QUARTERLY FINANCIAL INFORMATION (UNAUDITED) (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Revenues [Abstract] | |||||||||||
Interest income | $3 | $2 | $2 | $2 | $4 | $3 | $1 | $1 | $9 | $9 | $3 |
Total revenues and other income | 3 | 2 | 2 | 2 | 4 | 3 | 1 | 1 | 9 | 9 | 3 |
Expenses: | |||||||||||
Research and development | 5,771 | 6,276 | 7,491 | 7,569 | 5,953 | 4,975 | 6,262 | 6,467 | 27,107 | 23,657 | 14,120 |
General and Administrative | 1,678 | 1,277 | 1,256 | 1,226 | 1,365 | 1,215 | 1,171 | 1,067 | 5,437 | 4,818 | 4,827 |
Total expenses | 7,449 | 7,553 | 8,747 | 8,795 | 7,318 | 6,190 | 7,433 | 7,534 | 32,544 | 28,475 | 18,947 |
Net loss | -7,446 | -7,551 | -8,745 | -8,793 | -7,314 | -6,187 | -7,432 | -7,533 | -32,535 | -28,466 | -18,944 |
Net loss per share - basic and diluted | ($0.31) | ($0.32) | ($0.38) | ($0.38) | ($0.32) | ($0.27) | ($0.39) | ($0.41) | ($1.39) | ($1.37) | ($1.23) |
Shares used in loss per share calculation | 24,234 | 23,347 | 23,102 | 23,033 | 23,012 | 23,006 | 18,958 | 18,182 | |||
As Previously Reported [Member] | |||||||||||
Revenues [Abstract] | |||||||||||
Interest income | 3 | 2 | 2 | 2 | 4 | 3 | 1 | 1 | |||
Total revenues and other income | 3 | 2 | 2 | 2 | 4 | 3 | 1 | 1 | |||
Expenses: | |||||||||||
Research and development | 5,771 | 6,107 | 7,450 | 7,325 | 5,781 | 4,786 | 6,037 | 6,308 | 22,912 | 13,343 | |
General and Administrative | 1,678 | 1,277 | 1,256 | 1,226 | 1,365 | 1,215 | 1,171 | 1,067 | |||
Total expenses | 7,449 | 7,384 | 8,706 | 8,551 | 7,146 | 6,001 | 7,208 | 7,375 | 27,730 | 18,170 | |
Net loss | ($7,446) | ($7,382) | ($8,704) | ($8,549) | ($7,142) | ($5,998) | ($7,207) | ($7,374) | ($27,721) | ($18,167) | |
Net loss per share - basic and diluted | ($0.31) | ($0.32) | ($0.38) | ($0.37) | ($0.31) | ($0.26) | ($0.38) | ($0.41) | ($1.33) | ($1.18) | |
Shares used in loss per share calculation | 24,234 | 23,347 | 23,102 | 23,033 | 23,012 | 23,006 | 18,958 | 18,182 |
SUBSEQUENT_EVENTS_Additional_I
SUBSEQUENT EVENTS (Additional Information) (Details) (USD $) | 0 Months Ended | 1 Months Ended | 12 Months Ended | 0 Months Ended | ||
In Millions, except Share data, unless otherwise specified | Feb. 05, 2015 | Jan. 28, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Jan. 06, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 351,000 | 505,000 | 246,000 | |||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $17.24 | $13.37 | $10.08 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | 3 years | 3 years | |||
Subsequent Event [Member] | ||||||
Payment For Filing Fees | $2.30 | |||||
Subsequent Event [Member] | Employees [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 189,000 | |||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | 8.33 | |||||
Subsequent Event [Member] | Nonemployees [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 180,000 | |||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | 8.44 |