Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | 1-May-15 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | Anthera Pharmaceuticals Inc | |
Entity Central Index Key | 1316175 | |
Document Type | 10-Q | |
Document Period End Date | 31-Mar-15 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2015 | |
Amendment Flag | FALSE | |
Current Fiscal Year End Date | -19 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 35,816,364 |
CONSOLIDATED_BALANCE_SHEETS
CONSOLIDATED BALANCE SHEETS (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $41,648 | $2,639 |
Accounts receivable | 650 | |
Prepaid expenses and other current assets | 861 | 383 |
Total current assets | 43,159 | 3,022 |
Property and equipment - net | 410 | 468 |
TOTAL | 43,569 | 3,490 |
Current liabilities: | ||
Accounts payable | 2,558 | 2,232 |
Accrued clinical expenses | 1,840 | 1,239 |
Accrued liabilities | 398 | 211 |
Accrued payroll and related costs | 1,610 | 1,069 |
Deferred revenue - current | 586 | |
Other current liabilities | 1,000 | |
Total current liabilities | 6,992 | 5,751 |
Deferred revenue - noncurrent | 1,465 | |
Total liabilities | 8,457 | 5,751 |
Commitments and Contingencies (Note 6) | ||
Stockholders' equity (deficit): | ||
Common stock, $0.001 par value, 100,000,000 shares authorized; 35,816,364 and 23,005,209 shares issued and outstanding as of March 31, 2015 and December 31, 2014, respectively | 36 | 23 |
Additional paid-in capital | 359,547 | 314,527 |
Accumulated deficit | -324,471 | -316,811 |
Total stockholders' equity (deficit) | 35,112 | -2,261 |
TOTAL | $43,569 | $3,490 |
CONSOLIDATED_BALANCE_SHEETS_Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
CONSOLIDATED BALANCE SHEETS [Abstract] | ||
Common stock, par value per share | $0.00 | $0.00 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 35,816,364 | 23,005,209 |
Common stock, shares outstanding | 35,816,364 | 23,005,209 |
CONSOLIDATED_STATEMENTS_OF_OPE
CONSOLIDATED STATEMENTS OF OPERATIONS (USD $) | 3 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
REVENUES: | ||
License fee | $49 | |
Sponsored research and development | 196 | |
Total revenues | 245 | |
OPERATING EXPENSE: | ||
Research and development | 5,995 | 5,765 |
General and administrative | 1,907 | 1,844 |
Total operating expenses | 7,902 | 7,609 |
LOSS FROM OPERATIONS | -7,657 | -7,609 |
OTHER INCOME (EXPENSE): | ||
Other income (expense) | -3 | -48 |
Interest expense | -259 | |
Total other income (expense) | -3 | -307 |
NET LOSS | ($7,660) | ($7,916) |
Net loss per share - Basic and diluted | ($0.28) | ($0.39) |
Weighted-average number of shares used in per common share calculations - basic and diluted: | 27,595,081 | 20,132,252 |
CONSOLIDATED_STATEMENTS_OF_CAS
CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
CASH FLOW FROM OPERATING ACTIVITIES: | ||
Net loss | ($7,660) | ($7,916) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 68 | 89 |
Stock-based compensation expense | 503 | 836 |
Amortization of discount and deferred interest on notes payable | 20 | |
Amortization of debt issuance costs | 22 | |
Changes in assets and liabilities: | ||
Accounts receivable | -650 | |
Prepaid expenses and other assets | -478 | -266 |
Accounts payable | 326 | 1,806 |
Accrued clinical expenses | 601 | 38 |
Accrued liabilities | 187 | -172 |
Accrued payroll and related costs | 541 | 269 |
Deferred revenue | -49 | |
Net cash used in operating activities | -6,611 | -5,274 |
INVESTING ACTIVITIES: | ||
Property and equipment purchases | -10 | |
Decrease in restricted cash | 2,400 | |
Net cash (used in) provided by investing activities | -10 | 2,400 |
FINANCING ACTIVITIES: | ||
Principal payment against note payable | -3,114 | |
Proceeds from issuance of common stock, net of offering costs | 38,534 | 3,117 |
Proceeds from issuance of common stock to collaborative partner | 7,000 | |
Proceeds from issuance of common stock pursuant to exercise of stock options | 96 | |
Net cash provided by financing activities | 45,630 | 3 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 39,009 | -2,871 |
CASH AND CASH EQUIVALENTS - Beginning of period | 2,639 | 25,946 |
CASH AND CASH EQUIVALENTS - End of period | 41,648 | 23,075 |
Non-cash financing activities: | ||
Issuance of common stock in the form of a waiver of a fee otherwise payable to Amgen under the Amgen Agreement | $1,000 |
ORGANIZATION_AND_SIGNIFICANT_A
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2015 | |
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES | 1. ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES |
Organization | |
Anthera Pharmaceuticals, Inc. (the "Company" or "Anthera") is a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs. The Company's first Phase 3 product candidate, blisibimod, targets B-cell activating factor, or BAFF, which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including systemic lupus erythematosus, or lupus, Immunoglobulin A nephropathy, or IgA nephropathy, lupus nephritis, and others. The Company's second Phase 3 product candidate, liprotamase, is a novel non-porcine investigational Pancreatic Enzyme Replacement Therapy (“PERT”) intended for the treatment of patients with Exocrine Pancreatic Insufficiency (“EPI”), often seen in patients with cystic fibrosis and other conditions. | |
Liquidity and Need for Additional Capital | |
The Company's planned principal operations are acquiring product and technology rights, raising capital and performing research and development activities. The Company is currently conducting research and development activities to treat autoimmune diseases and EPI. The Company's activities are subject to significant risks and uncertainties. Successful completion of the Company's development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to access potential markets; secure financing; develop a customer base; attract, retain and motivate qualified personnel; and develop strategic alliances. | |
Since inception in 2004, the Company has funded its operations through equity offerings, private placements of convertible debt and debt financing. On January 27, 2015, the Company received $7.0 million from its collaborative partner, Zenyaku, Kogyo Co., Ltd., or Zenyaku, pursuant to the issuance of 2,795,895 shares of its common stock to Zenyaku under the terms of a collaborative arrangement. Under the terms of the collaborative arrangement, Zenyaku has agreed to pay the Company up to another $15.0 million over the next 12 months through a combination of a forgivable loan and multiple equity purchases of the Company's common stock at a thirty-percent price premium. During the quarter ended March 31, 2015, the Company received net proceeds of $11.6 million pursuant to the sale of its common stock through an at-the-market program (“ATM”) with Cowen and Company, LLC (“Cowen”) and $26.9 million pursuant to an equity offering under the Company's universal shelf registration statement on Form S-3. As of the date of this report, the Company anticipates its existing cash, anticipated equity investment and loan proceeds from Zenyaku, partial reimbursement of global blisibimod development expense from Zenyaku, access to the capital market through an equity purchase agreement with LPC and an ATM agreement with Cowen will be sufficient to fund its near term liquidity needs for at least the next 12 months. | |
To fully execute its business plan, the Company will need to complete certain research and development activities and clinical studies. Further, the Company's product candidates will require regulatory approval prior to commercialization. These activities may span many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in completing these activities could adversely impact the Company. The Company will need substantial additional financing to conduct new trials in the development of its product candidates; such financing may not be available on terms favorable to the Company, if at all. The Company plans to meet its capital requirements primarily through issuances of equity securities, debt financing, potential partnerships and in the longer term, revenue from product sales. Failure to generate revenue or raise additional capital would adversely affect the Company's ability to achieve its intended business objectives. | |
Basis of Presentation | |
The accompanying unaudited Condensed Consolidated Financial Statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC") for Quarterly Reports on Form 10-Q and do not contain all of the information and footnotes required by U.S. generally accepted accounting principles ("U.S. GAAP") for complete financial statements. The accompanying unaudited Condensed Consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2014, filed with the SEC on March 16, 2015. In the opinion of management, the accompanying unaudited Condensed Consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary to present fairly the Company's interim consolidated financial information. The results for the three months ended March 31, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015 or for any other period. The consolidated balance sheet as of December 31, 2014 has been derived from the audited financial statements as of that date but it does not include all of the information and notes required by U.S. GAAP. | |
The Company has evaluated events and transactions subsequent to the balance sheet date and has disclosed all events or transactions that occurred subsequent to the balance sheet date but prior to filing this Quarterly Report on Form 10-Q that would require recognition or disclosure in the unaudited Condensed Consolidated Financial Statements. | |
Significant Accounting Policies | |
During the quarter ended March 31, 2015, the Company established an accounts receivable policy to account for receivable balance owed to the Company from its collaborative partner, Zenyaku. The Company's accounts receivable balance is comprised of amounts due from Zenyaku for the reimbursement of i) 100% of blisibimod development cost in Japan for IgA nephropathy; ii) 25% of global blisibimod development cost outside of Japan for IgA nephropathy; and iii) a percentage of Anthera's personnel cost at a pre-determined Full-Time Equivalent, or FTE rate. Excluding the accounts receivable policy, there have been no changes to the Company's significant accounting policies for the three months ended March 31, 2015 as compared to the significant accounting policies described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2014. | |
Use of Estimates | |
The preparation of these condensed consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses and related disclosures. On an ongoing basis, management evaluates its estimates, including critical accounting policies or estimates related to clinical trial accruals, the tax provision, stock-based compensation, allocation of consideration to various elements under multiple-element collaboration arrangement and recognition of revenue. The Company bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ significantly from these estimates. |
COLLABORATIVE_AGREEMENT
COLLABORATIVE AGREEMENT | 3 Months Ended |
Mar. 31, 2015 | |
COLLABORATIVE AGREEMENT [Abstract] | |
COLLABORATIVE AGREEMENT | 2. COLLABORATIVE AGREEMENT |
On December 11, 2014, the Company entered into an exclusive license agreement with Zenyaku (“Zenyaku Agreement”) to develop and commercialize drug candidates relating to blisibimod in Japan and potentially other countries throughout Asia, while the Company retained full development and commercialization rights of blisibimod for all other global territories including North America and the European Union. Under the terms of the Zenyaku Agreement, the Company has the right to receive an upfront and forgivable loan of $7.0 million, milestone payments of up to $22.0 million contingent upon the achievement of certain regulatory and commercial sales milestones, and up to $15.0 million in sales of the Company's common stock at a purchase price equal to 1.3 times the volume weighted average price of the Company's common stock for 20 trading days prior to the delivery of the closing notice, (the “Premium Purchase Price”). The Company exercised this right with respect to $7.0 million in shares of its common stock, and issued 2,795,895 shares at a price per share of $2.50367 to Zenyaku in exchange for $7.0 million in cash, pursuant to the terms of a subscription agreement dated January 27, 2015. Additionally, Zenyaku was granted an option to obtain licensing rights for additional countries in Asia for an incremental equity investment of $4.0 million in Anthera stock. Zenyaku is responsible for all development, marketing and commercialization costs and will reimburse Anthera for i) 100% of blisibimod development cost in Japan for IgA nephropathy; ii) 25% of global blisibimod development cost outside of Japan for IgA nephropathy; iii) a percentage of Anthera's personnel cost at a pre-determined FTE rate and iv) exclusive purchase of blisibimod clinical drug supplies at cost and blisibimod commercial drug products from the Company at a premium to the Company's manufacturing cost. Outside of Japan, the Company will be solely responsible for the development and commercialization blisibimod. The collaborative development effort between the parties will be overseen by a joint development committee. | |
The Zenyaku Agreement will continue on a country-by-country and product-by-product basis until the later of the last to expire patent covering such product containing blisibimod in such country or ten years following the commercial launch of a product containing blisibimod in such country, unless terminated earlier. Zenyaku may terminate the agreement at will or in the event that annual sales of the generic drug containing blisibimod reach 50% of annual sales of the drug resulting from this collaboration in Japan and other potential Asian countries. If the agreement is not terminated early, Zenyaku may continue to obtain clinical/commercial drug supplies from Anthera after such expiration for up to three (3) years by providing a written notice to discontinue such supplies. Either party may terminate the agreement if a party materially breaches the agreement. In addition, Anthera may terminate the agreement if Zenyaku challenges any Anthera patent. Upon expiration (but not before termination), Zenyaku may retain the licensed patent on a fully-paid and royalty free (subject to the Amgen Inc. royalty and any third party payments), irrevocable and perpetual basis. If termination is due to material breach by Anthera, Zenyaku is entitled to retain all license rights; however, is still obligated to pay the milestone payments to Anthera, the Amgen royalty and any third party payments. Upon termination due to material breach or at will by Zenyaku, then all license rights granted to Zenyaku automatically terminate. | |
The Company's deliverables under the Zenyaku Agreement include the delivery of rights to and license for blisibimod in Japan and performance of research and development activities under a joint development plan. The delivered license does not have standalone value at the inception of the arrangement due to the Company's proprietary expertise with respect to the licensed compound and related ongoing developmental participation under the collaboration agreement, which is required for Zenyaku to fully realize the value from the delivered license. Therefore, the fees received related to the license will be recorded as deferred revenue and recognized over the estimated performance period under the agreement, which is the product development period. Although the Zenyaku Agreement does not provide a contractually stated price for the rights to blisibimod, the Company determined the Premium Purchase Price to be paid by Zenyaku for its equity investment in Anthera represents consideration for the rights to blisibimod and will record deferred revenue as shares are issued to Zenyaku at the Premium Purchase Price. The Company will periodically review and, if necessary, revise the estimated periods of performance of its collaboration with Zenyaku. Fees for the performance of sponsored research and development activities and services are not refundable. Therefore, the Company will recognize all FTE reimbursement in sponsored research and development revenue as such services are rendered. Reimbursement for certain development costs will be recorded as a reduction to research and development expense in the period in which such reimbursement becomes due in accordance with ASC 808 Collaborative Arrangements, subtopic ASC 808-10-45. During the quarter ended March 31, 2015, the Company recorded total revenue of $245,000, which was comprised of $196,000 for the reimbursement of FTEs and $49,000 for the amortization of the Premium Purchase Price. In addition, during the quarter ended March 31, 2015, the Company recorded $453,000 as a reduction to research and development expenses in connection with the reimbursement of qualifying costs under the collaboration agreement. All such amounts due from Zenyaku were included in accounts receivable and were unbilled as of March 31, 2015. The Company recorded the accounts receivable at March 31, 2015 because fees earned for the performance of sponsored research and development activities and services are not refundable and Zenyaku is contractually obligated to reimburse the Company for its qualifying costs incurred under the collaboration agreement. | |
Of the remaining potential future milestones, $7.0 million are related to regulatory milestones and $15.0 million are related to commercialization milestones that may be received under the Zenyaku Agreement. Regulatory milestones include the filing and acceptance of regulatory applications for marketing approval in major markets. Commercialization milestones include the achievement of first commercial sales in a particular market or annual product sales in excess of a pre-specified threshold. At the inception of the collaboration agreement the Company assessed regulatory milestones to be substantive where there was substantive scientific and regulatory uncertainty of achievement, the amounts of payments assigned were considered to be commensurate with the enhancement, that occurred subsequent to inception of the Zenyaku Agreement, and where the value of the delivered rights and license of blisibimod and the Company's performance is necessary to the achievement of the milestone. Accordingly, the Company will recognize payments related to the achievement of such milestones, if any, when such milestone is achieved. Regulatory milestones that do not meet these conditions are considered non-substantive and payments related to the achievement of such milestones, if any, will be recorded as deferred revenue and amortized ratably over the estimated period of performance. Final determination of whether a regulatory milestone is substantive will depend upon the Company's role in achieving the milestone. The specific role and responsibilities related to the regulatory and development activities for certain of these milestones have yet to be determined and may change during the development period. Under the Zenyaku Agreement, Zenyaku will initially be responsible for commercialization activities and the Company initially may not be involved in the achievement of these commercialization milestones. These commercialization milestones would typically be achieved after the completion of the Company's regulatory and development activities. If there are no future development obligations, the Company expects to account for the commercialization milestones in the same manner as royalties, with revenue recognized upon achievement of the milestone. | |
Pursuant to the Zenyaku Agreement, the Company is entitled to enter into a loan agreement with Zenyaku for an aggregate principal amount of $7.0 million, of which $5.0 million, together with interest thereon, is forgivable upon certain achievement of the primary endpoint identified in the first Phase 3 Study for blisibimod to treat IgA nephropathy and the remaining $2.0 million, together with interest thereon, is forgivable upon the submission of the first Biologics License Application for blisibimod in the licensed territory. In exchange, Anthera will issue a Secured Promissory Note to Zenyaku (the “Promissory Note”), to be secured by certain information and materials necessary for the manufacture of blisibimod, with a maturity date of December 11, 2021 and stated interest rate of 1% per annum. The loan agreement is planned for execution in the second quarter of 2015. Proceeds from the Promissory Note and granting the license rights will be allocated in part to the Promissory Note based on its aggregate fair value at the dates of receipt. This fair value will be determined by discounting cash flows using a discount rate of market rate of borrowings that could be obtained by companies with credit risk similar to Anthera. The remainder of the proceeds will be recognized as debt issuance discount and will be allocated to the value of the license fee granted to Zenyaku and recognized over the product development period while the debt discount will be amortized over the term of the Promissory Note using the effective interest rate method. |
RESEARCH_AWARD
RESEARCH AWARD | 3 Months Ended |
Mar. 31, 2015 | |
RESEARCH AWARD [Abstract] | |
RESEARCH AWARD | 3. RESEARCH AWARD |
In March 2015, the Company received a research award from Cystic Fibrosis Foundation Therapeutics Inc. (“CFFT”) of up to $3 million to support the manufacturing and clinical development of liprotamase. The award is to be disbursed by CFFT to Anthera upon receipt of invoices from Anthera for incurred expenses. At its discretion, the Company may choose to fund a particular stage of the liprotamase development plan and related payment milestone without CFFT funds. Any CFFT funds not expended on the development program of liprotamase must be returned to CFFT and upon such return, the amounts of such returned funds will not be included as part of the research award for the purpose of calculating royalties or other amounts owed by Anthera to CFFT. To the extent CFFT provides or makes available any information, expertise, know-how or other intellectual property related to cystic fibrosis or the treatment, prevention or cure there-of (“CFFT Know-How”) to Anthera, CFFT grants to Anthera a non-exclusive, transferrable, sublicensable, worldwide rights and license under all of CFFT's rights in such CFFT Know-How to assist Anthera to research, develop, commercialize, make or have made, use, sell, have sold, offer for sale, import, export and otherwise exploit the product. | |
In consideration for CFFT's research award and any licenses of intellectual property granted by CFFT, the Company agrees to pay royalties to CFFT as follows: i) a one-time royalty in an amount equal to the royalty cap, payable in three installments between the first and second anniversaries of the first commercial sale of a product; ii) a one-time royalty in an amount equal to the actual award after net product sales reaches $100 million; and iii) in the event of a license, sale or other transfer of the product or a change of control transaction prior to the commercial sale of the product, a milestone payment equal to three times the actual award. | |
As of March 31, 2015, the Company has not drawn down on the research award. |
NET_LOSS_PER_SHARE
NET LOSS PER SHARE | 3 Months Ended | ||||||||||||
Mar. 31, 2015 | |||||||||||||
NET LOSS PER SHARE [Abstract] | |||||||||||||
NET LOSS PER SHARE | 4. NET LOSS PER SHARE | ||||||||||||
Basic net loss attributable to common stockholders per share is computed by dividing income available to common stockholders (the numerator) by the weighted-average number of common shares outstanding (the denominator) during the period. Shares issued during the period and shares reacquired during the period are weighted for the portion of the period that they were outstanding. The computation of diluted Earnings Per Share, or EPS, is similar to the computation of basic EPS except that the denominator is increased to include the number of additional common shares that would have been outstanding if the dilutive potential common shares had been issued. In addition, in computing the dilutive effect of convertible securities, the numerator is adjusted to add back any convertible preferred dividends and the after-tax amount of interest recognized in the period associated with any convertible debt. The numerator also is adjusted for any other changes in income or loss that would result from the assumed conversion of those potential common shares, such as profit-sharing expenses. Diluted EPS is identical to basic EPS since common equivalent shares are excluded from the calculation, as their effect is anti-dilutive. | |||||||||||||
The following table summarizes the Company's calculation of net loss per common share (in thousands except share and per share amounts): | |||||||||||||
Three Months Ended March 31, | |||||||||||||
2015 | 2014 | ||||||||||||
Net loss per share | |||||||||||||
Numerator | |||||||||||||
Net loss | $ | (7,660 | ) | $ | (7,916 | ) | |||||||
Denominator | |||||||||||||
Weighted-average common shares outstanding | 27,595,081 | 20,123,252 | |||||||||||
Basic and diluted net loss per share | $ | (0.28 | ) | $ | (0. 39 | ) | |||||||
As the Company incurred net losses for all of the periods presented, the following outstanding potentially dilutive securities were excluded from the computation of diluted net loss per share, as the effect of including them would have been antidilutive: | |||||||||||||
Three Months Ended March 31, | |||||||||||||
2015 | 2014 | ||||||||||||
Options to purchase common stock | 3,179,728 | 2,105,017 | |||||||||||
Warrants to purchase common stock | 556,838 | 675,006 | |||||||||||
Restricted Stock Units | 937 | 7,200 | |||||||||||
Total | 3,737,503 | 2,787,223 |
FAIR_VALUE_OF_FINANCIAL_INSTRU
FAIR VALUE OF FINANCIAL INSTRUMENTS | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
FAIR VALUE OF FINANCIAL INSTRUMENTS [Abstract] | |||||||||||||||||
FAIR VALUE OF FINANCIAL INSTRUMENTS | 5. FAIR VALUE OF FINANCIAL INSTRUMENTS | ||||||||||||||||
Pursuant to the accounting guidance for fair value measurement and its subsequent updates, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. The accounting guidance establishes a hierarchy for inputs used in measuring fair value that minimizes the use of unobservable inputs by requiring the use of observable market data when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on active market data. Unobservable inputs are inputs that reflect the assumptions market participants would use in pricing the asset or liability based on the best information available in the circumstances. | |||||||||||||||||
The fair value hierarchy is broken down into the three input levels summarized below: | |||||||||||||||||
• | Level 1 —Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by us at the reporting date. Examples of assets and liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and trading securities with quoted prices on active markets. | ||||||||||||||||
• | Level 2 —Valuations based on inputs other than the quoted prices in active markets that are observable either directly or indirectly in active markets. Examples of assets and liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds, commercial paper, certificates of deposit and over-the- counter derivatives. | ||||||||||||||||
• | Level 3 —Valuations based on unobservable inputs in which there are little or no market data, which require us to develop our own assumptions. | ||||||||||||||||
The following tables present the Company's fair value hierarchy for all its financial assets (including those in cash and cash equivalents), in thousands, by major security type measured at fair value on a recurring basis as of March 31, 2015 and December 31, 2014 (in thousands): | |||||||||||||||||
31-Mar-15 | |||||||||||||||||
Estimated | Level 1 | Level 2 | Level 3 | ||||||||||||||
Fair Value | |||||||||||||||||
Money market funds | $ | 40,676 | $ | 40,676 | $ | — | $ | — | |||||||||
31-Dec-14 | |||||||||||||||||
Estimated | Level 1 | Level 2 | Level 3 | ||||||||||||||
Fair Value | |||||||||||||||||
Money market funds | $ | 2,354 | $ | 2,354 | $ | — | $ | — | |||||||||
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2015 | |
COMMITMENTS AND CONTINGENCIES [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 6. COMMITMENTS AND CONTINGENCIES |
Leases | |
The Company leases its main operating facility in Hayward, California. The lease is for approximately 14,000 square feet. The Company recognizes rental expense on the facility on a straight line basis over the term of the lease. Differences between the straight-line net expense on rent payments are classified as deferred rent liability and included in the accrued liabilities on the balance sheet. In November 2013, the Company renewed its facility lease for an additional three years beginning October 2014 and ending September 2017. | |
Other Commitments | |
In December 2007, the Company and Amgen entered into a worldwide, exclusive license agreement (the “Amgen Agreement”) to develop and commercialize blisibimod in any indication, including for the treatment of systemic lupus erythematosus (“lupus”). Under the terms of the Amgen Agreement, the Company paid a nonrefundable, upfront license fee of $6.0 million. As there was no future alternative use for the technology, the Company expensed the license fee in research and development expenses during 2007. Under the terms of the Amgen Agreement, the Company is obligated to make additional milestone payments to Amgen of up to $33.0 million upon the achievement of certain development and regulatory milestones. The Company is also obligated to pay tiered royalties on future net sales of products, ranging from the high single digits to the low double digits, which are developed and approved as set forth in the Amgen Agreement. The Company's royalty obligations as to a particular licensed product will be payable, on a country-by-country and licensed product-by-licensed product basis, for the longer of (a) the date of expiration of the last to expire valid claim within the licensed patents that covers the manufacture, use or sale, offer to sell, or import of such licensed product by the Company or a sublicense in such country or (b) 10 years after the first commercial sale of the applicable licensed product in the applicable country. | |
In connection with the collaborative arrangement with Zenyaku pursuant to the Zenyaku Agreement, the Company amended the Amgen Agreement in November 2014 to (i) adjust certain royalty and milestone payment obligations payable to Amgen in light of the collaboration between Anthera and Zenyaku and (ii) provide that the sublicense granted by Anthera to Zenyaku shall survive the termination of the Amgen Agreement. Under this amendment, Anthera also agreed to grant Amgen the number of shares of its common stock equal to $1.0 million divided by the volume weighted average price of the Company's common stock for 20 trading days prior to issuance. The Company accrued $1.0 million of license fees as research and development expense with a corresponding current liability in the year ended December 31, 2014. The Company issued 420,751 shares of common stock to Amgen at $2.3767 per share on January 28, 2015, pursuant to a subscription agreement with Amgen, with the consideration paid by Amgen in the form of a waiver of a fee otherwise payable to Amgen under the Amgen Agreement and eliminated the accrued liability. | |
On July 11, 2014, the Company and Eli Lilly and Company (“Eli Lilly”) entered into a worldwide, exclusive license agreement (the “Lilly Agreement”), to develop and commercialize liprotamase , a Phase 3 novel investigational Pancreatic Enzyme Replacement Therapy (“PERT”), for the treatment of patients with Exocrine Pancreatic Insufficiency, or EPI, often seen in patients with cystic fibrosis and other conditions. Under the terms of the Lilly Agreement, the Company was not required to make any up-front payment but is obligated to make milestone payments of up to $33.5 million for capsule products and $9.5 million for reformulated products upon the achievement of certain regulatory and commercial sales milestones, none of which have been achieved as of March 31, 2015. In addition, after sales of the licensed products exceed an aggregate of $100.0 million in the United States, the Company is obligated to pay tiered royalties on future net sales of products, ranging from the single digits to the mid-teens, and such royalty payments are developed and approved as defined in the Lilly Agreement. The Company's royalty obligations as to a particular licensed product will be payable, on a licensed product-by-licensed product basis, for the longer of (a) the date of expiration of the last to expire valid claim within the licensed patents that covers the manufacture, use or sale, offer to sell, or import of such licensed product by the Company or a sublicense in such country, or (b) 12 years after the first commercial sale of the applicable licensed product in the applicable country. |
STOCKHOLDERS_EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2015 | |
STOCKHOLDERS' EQUITY [Abstract] | |
STOCKHOLDERS' EQUITY | 7. STOCKHOLDERS' EQUITY |
Preferred Stock | |
The Company's Fifth Amended and Restated Certificate of Incorporation designates 5,000,000 shares of the Company's capital stock as undesignated preferred stock. There were no preferred shares issued or outstanding as of March 31, 2015. | |
Warrants | |
In March 2011, in conjunction with the Hercules loan, the Company issued a seven-year warrant to purchase 40,178 shares of the Company's common stock at an exercise price of $48.00 per share. The warrant was immediately exercisable and expires in March 2018. As of March 31, 2015, the warrant remained outstanding and exercisable. | |
In September 2010, the Company closed a private placement transaction with certain accredited investors pursuant to which the Company sold an aggregate of 1,312,492 units at a purchase price of $24.00 per unit, with each unit consisting of one share of common stock and a warrant to purchase an additional 0.40 shares of common stock. Each warrant is exercisable in whole or in part at any time until September 24, 2015 at an adjusted exercise price of $23.20 per share. As of March 31, 2015, 516,660 shares of warrants remain outstanding and exercisable. | |
Common Stock | |
On April 5, 2013, the Company entered into an equity purchase agreement (the “2013 Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), pursuant to which the Company has the right, but not obligation, to sell to LPC up to an aggregate of $18.5 million in shares of common stock. On March 12, 2015, the Company terminated the 2013 Purchase Agreement, which had a remaining balance of $14.1 million as of the date of termination. Concurrent with the termination of the 2013 Purchase Agreement, the Company executed a new equity purchase agreement (the “2015 Purchase Agreement), pursuant to which the Company has the right, but not obligation, to sell to LPC up to an aggregate of $10.0 million in shares of the common stock over a period of two years in amounts as set forth in the 2015 Purchase Agreement. No sales of common stock have been made under the 2015 Purchase Agreement as of March 31, 2015. | |
On November 15, 2013, the Company entered into a Sales Agreement (the “ATM Agreement”) with Cowen to create an ATM under which the Company from time to time may offer and sell shares of its common stock, par value $0.001 per share, having an aggregate offering price of up to $25.0 million through Cowen, as agent. As of March 31, 2015, the Company had sold $21.3 million in shares of common stock, leaving a balance of $3.7 million available for future sale pursuant to the ATM Agreement. | |
In April 2013, the Company filed a universal shelf registration statement with the SEC on Form S-3 (File No. 333-187780) for the proposed offering from time to time of up to $100.0 million of its securities, including common stock, preferred stock, debt securities and/or warrants. On November 15, 2013, the Company registered $25.0 million under the registration statement for the Cowen ATM. In January 2015, the Company registered $8.0 million under the registration statement for the issuance of common stock to Zenyaku and Amgen. In February 2015, the Company registered $10.3 million under the registration statement for the 2015 Purchase Agreement with LPC. In March 2015, the Company utilized $28.7 million of this shelf registration in connection with an underwritten public offering, leaving a balance of $28.0 million available for future issuance under this shelf registration statement, which will expire in April 2016. | |
Equity Issuance | |
In January 2015, the Company issued $8.0 million in common shares under the registration statement on Form S-3 (File No. 333-187780), consisting of 2,795,895 shares and 420,751 shares of common stock to Zenyaku and Amgen, respectively. The Company received net cash proceeds of $7.0 million from Zenyaku for the shares sold to Zenyaku. The consideration paid by Amgen for its shares of the Company's common stock was in the form of a waiver of a fee otherwise payable to Amgen by the Company under an amendment to the Amgen Agreement. | |
During the three months ended March 31, 2015, the Company sold 3,125,662 shares of common stock through its ATM Agreement for net proceeds of $11.6 million. | |
In March 2015, the Company sold 6,388,889 shares of common stock at $4.50 per share in an underwritten public offering for net cash proceeds of $26.9 million. |
SHAREBASED_COMPENSATION_PLANS
SHARE-BASED COMPENSATION PLANS | 3 Months Ended | |||||||||||||
Mar. 31, 2015 | ||||||||||||||
SHARE-BASED COMPENSATION PLANS [Abstract] | ||||||||||||||
SHARE-BASED COMPENSATION PLANS | 8. SHARE-BASED COMPENSATION PLANS | |||||||||||||
2013 Plan | ||||||||||||||
On March 25, 2013, the Company's board of directors adopted the 2013 Stock Option and Incentive Plan (the “2013 Plan”), which was also approved by the Company's stockholders at its annual general meeting on May 16, 2013. The Company initially reserved 1,750,000 shares of its common stock for the issuance of awards under the 2013 Plan, plus all shares remaining available for grant under the Company's 2010 Stock Option and Incentive Plan (the “2010 Plan), plus any additional shares returned under the 2010 Plan or 2013 Plan as a result of the cancellation, forfeiture or other termination (other than by exercise) of awards issued pursuant to the 2010 Plan or 2013 Plan, subject in all cases to adjustment including reorganization, recapitalization, reclassification, stock dividend, stock split, reverse stock split or other similar change in the Company's capital stock. In June 2014, the Company's shareholders approved an additional 500,000 shares of its common stock for issuance of awards under the 2013 Plan. Of the shares of common stock reserved for issuance under the 2013 Plan, no more than 750,000 shares will be issued to any individual participant as incentive options, non-qualified options or stock appreciation rights during any calendar year. The 2013 Plan permits the granting of incentive and non-statutory stock options, restricted and unrestricted stock awards, restricted stock units, stock appreciation rights, performance share awards, cash-based awards and dividend equivalent rights to eligible employees, directors and consultants. The option exercise price of an option granted under the 2013 Plan may not be less than 100% of the fair market value of a share of the Company's common stock on the date the stock option is granted. Options granted under the 2013 Plan have a maximum term of 10 years and generally vest over four years. In addition, in the case of certain large stockholders, the minimum exercise price of incentive options must equal 110% of fair market value on the date of grant and the maximum term is limited to five years. Subject to overall Plan limitations, the maximum aggregate number of shares of common stock that may be issued in the form of incentive options shall not exceed 6,250,000 shares of common stock. The 2013 Plan does not allow the option holders to exercise their options prior to vesting. | ||||||||||||||
The terms of awards granted during the three months ended March 31, 2015 and the method for determining the grant date fair value of the awards were consistent with those described in the financial statements included in the Company's annual Report on Form 10-K for the year ended December 31, 2014. | ||||||||||||||
The following table summarizes stock option activity for the three months ended March 31, 2015 (in thousands except share and per share information): | ||||||||||||||
Number of | Weighted- | Weighted- | Aggregate | |||||||||||
Options | Average | Average | Intrinsic | |||||||||||
Exercise | Remaining | Value | ||||||||||||
Price | Contractual | |||||||||||||
Life in Years | ||||||||||||||
Balance at December 31, 2014 | 3,021,969 | $ | 3.67 | 8.92 | $ | — | ||||||||
Granted | 209,000 | $ | 1.58 | 9.76 | 604 | |||||||||
Exercised | (20,620 | ) | $ | 4.65 | 8.22 | 12 | ||||||||
Cancelled and expired | (6,250 | ) | $ | 4.56 | 8.21 | — | ||||||||
Forfeited | (24,371 | ) | 3.7 | — | 24 | |||||||||
Balance at March 31, 2015 | 3,179,728 | $ | 3.52 | 8.75 | $ | 4,150 | ||||||||
Exercisable at March 31, 2015 | 1,120,369 | $ | 4.65 | 8.08 | $ | 641 | ||||||||
The intrinsic value of stock options represents the difference between the exercise price of stock options and the market price of our stock on that day for all in-the-money options. | ||||||||||||||
The assumptions used in the Black-Scholes option-pricing model to value stock options are as follows: | ||||||||||||||
Three Months Ended March 31, | ||||||||||||||
2015 | 2014 | |||||||||||||
Expected Volatility | 92 | % | 101 | % | ||||||||||
Dividend Yield | 0 | % | 0 | % | ||||||||||
Risk-Free Interest Rate | 1.81 | % | 2.11 | % | ||||||||||
Expected Term (years) | 6.02 | 6.02 | ||||||||||||
Weighted-average fair value per option | $ | 1.19 | $ | 2.66 | ||||||||||
Restricted Stock Units | ||||||||||||||
The Company grants restricted stock unit awards (“RSUs”) under its 2013 Plan and 2010 Plan, as determined by the Company's compensation committee. The RSUs granted represent a right to receive shares of common stock at a future date determined in accordance with the participant's award agreement. An exercise price and monetary payment are not required for receipt of RSUs or the shares issued in settlement of the award. Instead, consideration is furnished in the form of the participant's services to the Company. | ||||||||||||||
Recipients of RSUs granted from the 2010 Plan are permitted to net share settle in excess of the minimum statutory withholding amount for taxes and therefore, in accordance with guidance issued by the FASB, RSUs granted from the 2010 Plan are classified as liability with the subsequent change in fair value being recorded as expense. The unsettled RSUs are re-measured at each reporting date and will continue to be re-measured until they are fully vested in approximately 0.63 years. As of March 31, 2015, the liability related to the unsettled awards was not significant. | ||||||||||||||
Recipients of RSUs granted from the 2013 Plan are not permitted to net share settle in excess of the minimum statutory withholding amount for taxes and therefore, in accordance with guidance issued by the FASB. RSUs granted from the 2013 Plan are classified as equity and the fair value of the awards are recognized on a straight-line basis over the vesting term of the awards. Substantially all of the RSUs vest over four years. | ||||||||||||||
2010 Employee Stock Purchase Plan (“ESPP”) | ||||||||||||||
Effective July 2010, under the terms of the ESPP, eligible employees of the Company may authorize the Company to deduct amounts from their compensation, which amounts are used to enable the employees to purchase shares of the Company's common stock. The Company initially reserved 12,500 shares of common stock for issuance thereunder plus on January 1, 2011 and each January 1 thereafter, the number of shares of stock reserved and available for issuance under the Plan shall be cumulatively increased by the lesser of (i) one percent (1%) of the number of shares of common stock issued and outstanding on the immediately preceding December 31 or (ii) 31,250 shares of common stock. On January 1, 2015, in accordance with the ESPP's annual increase provisions, the authorized shares in the ESPP increased by 31,250. | ||||||||||||||
The purchase price per share is 85% of the fair market value of the common stock as of the first date or the ending date of the applicable semi-annual purchase period, whichever is less (the “Look-Back Provision”). The 15% discount and the Look-Back Provision make the ESPP compensatory. The Black-Scholes option pricing model was used to value the employee stock purchase rights. | ||||||||||||||
Three Months Ended March 31, | ||||||||||||||
2015 | 2014 | |||||||||||||
Expected Volatility | 52 | % | — | |||||||||||
Dividend Yield | 0 | % | — | |||||||||||
Risk-Free Interest Rate | 0.06 | % | — | |||||||||||
Expected Term (years) | 0.5 | — | ||||||||||||
Stock-Based Compensation Expense | ||||||||||||||
Total stock-based compensation expense, including expense recorded for the ESPP, was as follows (in thousands): | ||||||||||||||
Three Months Ended March 31, | ||||||||||||||
2015 | 2014 | |||||||||||||
Research and development | $ | 202 | $ | 354 | ||||||||||
General and administrative | 301 | 482 | ||||||||||||
Total stock-based compensation | $ | 503 | $ | 836 | ||||||||||
ORGANIZATION_AND_SIGNIFICANT_A1
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2015 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Organization | Organization |
Anthera Pharmaceuticals, Inc. (the "Company" or "Anthera") is a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs. The Company's first Phase 3 product candidate, blisibimod, targets B-cell activating factor, or BAFF, which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including systemic lupus erythematosus, or lupus, Immunoglobulin A nephropathy, or IgA nephropathy, lupus nephritis, and others. The Company's second Phase 3 product candidate, liprotamase, is a novel non-porcine investigational Pancreatic Enzyme Replacement Therapy (“PERT”) intended for the treatment of patients with Exocrine Pancreatic Insufficiency (“EPI”), often seen in patients with cystic fibrosis and other conditions. | |
Liquidity and Need for Additional Capital | Liquidity and Need for Additional Capital |
The Company's planned principal operations are acquiring product and technology rights, raising capital and performing research and development activities. The Company is currently conducting research and development activities to treat autoimmune diseases and EPI. The Company's activities are subject to significant risks and uncertainties. Successful completion of the Company's development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to access potential markets; secure financing; develop a customer base; attract, retain and motivate qualified personnel; and develop strategic alliances. | |
Since inception in 2004, the Company has funded its operations through equity offerings, private placements of convertible debt and debt financing. On January 27, 2015, the Company received $7.0 million from its collaborative partner, Zenyaku, Kogyo Co., Ltd., or Zenyaku, pursuant to the issuance of 2,795,895 shares of its common stock to Zenyaku under the terms of a collaborative arrangement. Under the terms of the collaborative arrangement, Zenyaku has agreed to pay the Company up to another $15.0 million over the next 12 months through a combination of a forgivable loan and multiple equity purchases of the Company's common stock at a thirty-percent price premium. During the quarter ended March 31, 2015, the Company received net proceeds of $11.6 million pursuant to the sale of its common stock through an at-the-market program (“ATM”) with Cowen and Company, LLC (“Cowen”) and $26.9 million pursuant to an equity offering under the Company's universal shelf registration statement on Form S-3. As of the date of this report, the Company anticipates its existing cash, anticipated equity investment and loan proceeds from Zenyaku, partial reimbursement of global blisibimod development expense from Zenyaku, access to the capital market through an equity purchase agreement with LPC and an ATM agreement with Cowen will be sufficient to fund its near term liquidity needs for at least the next 12 months. | |
To fully execute its business plan, the Company will need to complete certain research and development activities and clinical studies. Further, the Company's product candidates will require regulatory approval prior to commercialization. These activities may span many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in completing these activities could adversely impact the Company. The Company will need substantial additional financing to conduct new trials in the development of its product candidates; such financing may not be available on terms favorable to the Company, if at all. The Company plans to meet its capital requirements primarily through issuances of equity securities, debt financing, potential partnerships and in the longer term, revenue from product sales. Failure to generate revenue or raise additional capital would adversely affect the Company's ability to achieve its intended business objectives. | |
Basis of Presentation | Basis of Presentation |
The accompanying unaudited Condensed Consolidated Financial Statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC") for Quarterly Reports on Form 10-Q and do not contain all of the information and footnotes required by U.S. generally accepted accounting principles ("U.S. GAAP") for complete financial statements. The accompanying unaudited Condensed Consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2014, filed with the SEC on March 16, 2015. In the opinion of management, the accompanying unaudited Condensed Consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary to present fairly the Company's interim consolidated financial information. The results for the three months ended March 31, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015 or for any other period. The consolidated balance sheet as of December 31, 2014 has been derived from the audited financial statements as of that date but it does not include all of the information and notes required by U.S. GAAP. | |
The Company has evaluated events and transactions subsequent to the balance sheet date and has disclosed all events or transactions that occurred subsequent to the balance sheet date but prior to filing this Quarterly Report on Form 10-Q that would require recognition or disclosure in the unaudited Condensed Consolidated Financial Statements. | |
Significant Accounting Policies | Significant Accounting Policies |
During the quarter ended March 31, 2015, the Company established an accounts receivable policy to account for receivable balance owed to the Company from its collaborative partner, Zenyaku. The Company's accounts receivable balance is comprised of amounts due from Zenyaku for the reimbursement of i) 100% of blisibimod development cost in Japan for IgA nephropathy; ii) 25% of global blisibimod development cost outside of Japan for IgA nephropathy; and iii) a percentage of Anthera's personnel cost at a pre-determined Full-Time Equivalent, or FTE rate. Excluding the accounts receivable policy, there have been no changes to the Company's significant accounting policies for the three months ended March 31, 2015 as compared to the significant accounting policies described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2014. | |
Use of Estimates | Use of Estimates |
The preparation of these condensed consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses and related disclosures. On an ongoing basis, management evaluates its estimates, including critical accounting policies or estimates related to clinical trial accruals, the tax provision, stock-based compensation, allocation of consideration to various elements under multiple-element collaboration arrangement and recognition of revenue. The Company bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ significantly from these estimates. |
NET_LOSS_PER_SHARE_Tables
NET LOSS PER SHARE (Tables) | 3 Months Ended | ||||||||||||
Mar. 31, 2015 | |||||||||||||
NET LOSS PER SHARE [Abstract] | |||||||||||||
Schedule of Calculation of Net Loss Per Common Share | |||||||||||||
Three Months Ended March 31, | |||||||||||||
2015 | 2014 | ||||||||||||
Net loss per share | |||||||||||||
Numerator | |||||||||||||
Net loss | $ | (7,660 | ) | $ | (7,916 | ) | |||||||
Denominator | |||||||||||||
Weighted-average common shares outstanding | 27,595,081 | 20,123,252 | |||||||||||
Basic and diluted net loss per share | $ | (0.28 | ) | $ | (0. 39 | ) | |||||||
Schedule of Antidilutive Securities | Three Months Ended March 31, | ||||||||||||
2015 | 2014 | ||||||||||||
Options to purchase common stock | 3,179,728 | 2,105,017 | |||||||||||
Warrants to purchase common stock | 556,838 | 675,006 | |||||||||||
Restricted Stock Units | 937 | 7,200 | |||||||||||
Total | 3,737,503 | 2,787,223 |
FAIR_VALUE_OF_FINANCIAL_INSTRU1
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
FAIR VALUE OF FINANCIAL INSTRUMENTS [Abstract] | |||||||||||||||||
Schedule of Financial Assets Measured at Fair Value on a Recurring Basis | |||||||||||||||||
31-Mar-15 | |||||||||||||||||
Estimated | Level 1 | Level 2 | Level 3 | ||||||||||||||
Fair Value | |||||||||||||||||
Money market funds | $ | 40,676 | $ | 40,676 | $ | — | $ | — | |||||||||
31-Dec-14 | |||||||||||||||||
Estimated | Level 1 | Level 2 | Level 3 | ||||||||||||||
Fair Value | |||||||||||||||||
Money market funds | $ | 2,354 | $ | 2,354 | $ | — | $ | — | |||||||||
SHAREBASED_COMPENSATION_PLANS_
SHARE-BASED COMPENSATION PLANS (Tables) | 3 Months Ended | |||||||||||||
Mar. 31, 2015 | ||||||||||||||
SHARE-BASED COMPENSATION PLANS [Abstract] | ||||||||||||||
Summary of Option Activity | Number of | Weighted- | Weighted- | Aggregate | ||||||||||
Options | Average | Average | Intrinsic | |||||||||||
Exercise | Remaining | Value | ||||||||||||
Price | Contractual | |||||||||||||
Life in Years | ||||||||||||||
Balance at December 31, 2014 | 3,021,969 | $ | 3.67 | 8.92 | $ | — | ||||||||
Granted | 209,000 | $ | 1.58 | 9.76 | 604 | |||||||||
Exercised | (20,620 | ) | $ | 4.65 | 8.22 | 12 | ||||||||
Cancelled and expired | (6,250 | ) | $ | 4.56 | 8.21 | — | ||||||||
Forfeited | (24,371 | ) | 3.7 | — | 24 | |||||||||
Balance at March 31, 2015 | 3,179,728 | $ | 3.52 | 8.75 | $ | 4,150 | ||||||||
Exercisable at March 31, 2015 | 1,120,369 | $ | 4.65 | 8.08 | $ | 641 | ||||||||
Schedule of Stock-Based Compensation Expense | Three Months Ended March 31, | |||||||||||||
2015 | 2014 | |||||||||||||
Research and development | $ | 202 | $ | 354 | ||||||||||
General and administrative | 301 | 482 | ||||||||||||
Total stock-based compensation | $ | 503 | $ | 836 | ||||||||||
Stock Option Plans [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Summary of Fair Value Assumptions for Stock Options and Stock Purchase Rights | Three Months Ended March 31, | |||||||||||||
2015 | 2014 | |||||||||||||
Expected Volatility | 92 | % | 101 | % | ||||||||||
Dividend Yield | 0 | % | 0 | % | ||||||||||
Risk-Free Interest Rate | 1.81 | % | 2.11 | % | ||||||||||
Expected Term (years) | 6.02 | 6.02 | ||||||||||||
Weighted-average fair value per option | $ | 1.19 | $ | 2.66 | ||||||||||
ESPP [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Summary of Fair Value Assumptions for Stock Options and Stock Purchase Rights | Three Months Ended March 31, | |||||||||||||
2015 | 2014 | |||||||||||||
Expected Volatility | 52 | % | — | |||||||||||
Dividend Yield | 0 | % | — | |||||||||||
Risk-Free Interest Rate | 0.06 | % | — | |||||||||||
Expected Term (years) | 0.5 | — | ||||||||||||
ORGANIZATION_AND_SIGNIFICANT_A2
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES (Details) (USD $) | 1 Months Ended | 3 Months Ended |
In Millions, except Share data, unless otherwise specified | Jan. 31, 2015 | Mar. 31, 2015 |
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES [Abstract] | ||
Proceeds from shares issued | $7 | |
Shares issued | 2,795,895 | |
Future expected proceeds | 15 | |
Statement [Line Items] | ||
Proceeds from issuance of stock | 7 | |
At The Market [Member] | ||
Statement [Line Items] | ||
Proceeds from issuance of stock | 11.6 | |
Shelf Registration [Member] | ||
Statement [Line Items] | ||
Proceeds from issuance of stock | $26.90 | |
Cost Inside Japan [Member] | ||
Statement [Line Items] | ||
Percentage of reimbursement cost | 100.00% | |
Cost Outside Japan [Member] | ||
Statement [Line Items] | ||
Percentage of reimbursement cost | 25.00% |
COLLABORATIVE_AGREEMENT_Detail
COLLABORATIVE AGREEMENT (Details) (USD $) | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2015 | Sep. 30, 2010 | Mar. 31, 2015 | Mar. 31, 2014 | |
COLLABORATIVE AGREEMENT [Abstract] | ||||
Maximum proceeds from common stock | $15,000,000 | $15,000,000 | ||
Purchase price ratio | 1.3 | 1.3 | ||
Proceeds from issuance of stock | 7,000,000 | |||
Issuance of common stock, shares | 6,388,889 | 1,312,492 | 2,795,895 | |
Issuance of common stock, price per share | $2.50 | $2.50 | ||
Incremental equity investment | 4,000,000 | 4,000,000 | ||
Revenue percentage threshold | 50.00% | 50.00% | ||
Total revenues | 245,000 | |||
Sponsored research and development | 196,000 | |||
License fee | 49,000 | |||
Reduction to research and development | 453,000 | |||
Statement [Line Items] | ||||
Maximum milestone payments | 22,000,000 | 22,000,000 | ||
Maximum loan amount | 7,000,000 | 7,000,000 | ||
Debt instrument, maturity date | 11-Dec-21 | |||
Interest rate | 1.00% | 1.00% | ||
Cost Inside Japan [Member] | ||||
Statement [Line Items] | ||||
Percentage of reimbursement cost | 100.00% | 100.00% | ||
Cost Outside Japan [Member] | ||||
Statement [Line Items] | ||||
Percentage of reimbursement cost | 25.00% | 25.00% | ||
Regulatory Milestones [Member] | ||||
Statement [Line Items] | ||||
Maximum milestone payments | 7,000,000 | 7,000,000 | ||
Commercialization Milestones [Member] | ||||
Statement [Line Items] | ||||
Maximum milestone payments | 15,000,000 | 15,000,000 | ||
Forgivable Upon Certain Achievements [Member] | ||||
Statement [Line Items] | ||||
Maximum loan amount | 5,000,000 | 5,000,000 | ||
Forgivable Upon Application Submission [Member] | ||||
Statement [Line Items] | ||||
Maximum loan amount | $2,000,000 | $2,000,000 |
RESEARCH_AWARD_Details
RESEARCH AWARD (Details) (USD $) | Mar. 31, 2015 |
In Millions, unless otherwise specified | |
RESEARCH AWARD [Abstract] | |
Research award amount | $3 |
Royalty threshold amount | $100 |
NET_LOSS_PER_SHARE_Schedule_of
NET LOSS PER SHARE (Schedule of Calculation of Net Loss Per Common Share) (Details) (USD $) | 3 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Numerator | ||
Net loss | ($7,660) | ($7,916) |
Denominator | ||
Denominator - Weighted-average common shares oustanding | 27,595,081 | 20,123,252 |
Basic and diluted net loss per share | ($0.28) | ($0.39) |
NET_LOSS_PER_SHARE_Schedule_of1
NET LOSS PER SHARE (Schedule of Antidilutive Securities) (Details) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents outstanding | 3,737,503 | 2,787,223 |
Options to purchase common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents outstanding | 3,179,728 | 2,105,017 |
Warrants to purchase common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents outstanding | 556,838 | 675,006 |
Restricted stock units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents outstanding | 937 | 7,200 |
FAIR_VALUE_OF_FINANCIAL_INSTRU2
FAIR VALUE OF FINANCIAL INSTRUMENTS (Details) (Money Market Funds [Member], USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Estimated Fair Value [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis | $40,676 | $2,354 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis | 40,676 | 2,354 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis | ||
Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis |
COMMITMENTS_AND_CONTINGENCIES_
COMMITMENTS AND CONTINGENCIES (Details) (USD $) | 3 Months Ended | 12 Months Ended | |
In Millions, except Share data, unless otherwise specified | Mar. 31, 2015 | Dec. 31, 2007 | Dec. 31, 2014 |
Loss Contingencies [Line Items] | |||
Square footage of operating facility, in square feet | 14,000 | ||
Amgen Inc. [Member] | |||
Loss Contingencies [Line Items] | |||
Number of shares issued under collaborative arrangement | 420,751 | ||
Share issue price | $2.38 | ||
Value of shares granted divided by weighted average price of common stock | $1 | ||
Amgen Inc. [Member] | Maximum [Member] | |||
Loss Contingencies [Line Items] | |||
Additional milestone payments upon the achievement of certain development and regulatory milestones | 33 | ||
Amgen Inc. [Member] | License Agreement [Member] | |||
Loss Contingencies [Line Items] | |||
License initiation fees | 6 | ||
Accrued license costs current | 1 | ||
Eli Lilly [Member] | Maximum [Member] | |||
Loss Contingencies [Line Items] | |||
License initiation fees | 100 | ||
Additional milestone payments upon the achievement of certain development and regulatory milestones for capsule products | 33.5 | ||
Additional milestone payments upon the achievement of certain development and regulatory milestones for reformulated products | $9.50 |
STOCKHOLDERS_EQUITY_Details
STOCKHOLDERS' EQUITY (Details) (USD $) | 1 Months Ended | 3 Months Ended | 1 Months Ended | 12 Months Ended | 1 Months Ended | ||||||
Mar. 31, 2015 | Jan. 31, 2015 | Apr. 30, 2013 | Sep. 30, 2010 | Mar. 31, 2015 | Mar. 31, 2014 | Feb. 28, 2015 | Apr. 05, 2013 | Dec. 31, 2014 | Nov. 30, 2013 | Mar. 31, 2011 | |
Class of Stock [Line Items] | |||||||||||
Issuance of common stock, shares | 6,388,889 | 1,312,492 | 2,795,895 | ||||||||
Issuance of stock, price per share | $4.50 | $24 | |||||||||
Proceeds from stock issuance | $11,600,000 | ||||||||||
Stock issued during period pursuant to purchase agreement, shares | 3,125,662 | ||||||||||
Number of shares of common stock for each warrant | 1 | ||||||||||
Exercise price of warrants | $23.20 | $48 | |||||||||
Proceeds from issuance of common stock | 26,900,000 | 38,534,000 | 3,117,000 | ||||||||
Maximum amount of shares of common stock, preferred stock, debt securities and/or warrants that may be issued under a shelf registration statement | 28,000,000 | 100,000,000 | |||||||||
Common stock, par value per share | $0.00 | $0.00 | $0.00 | ||||||||
Equity purchase agreement, authorized amount of equity authorized for sale | 8,000,000 | ||||||||||
Number of shares called by warrant(s) | 0.4 | 40,178 | |||||||||
Warrants outstanding | 516,660 | 516,660 | |||||||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | |||||||||
Lincoln Park Capital Fund [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock | 28,700,000 | ||||||||||
Maximum amount of shares of common stock, preferred stock, debt securities and/or warrants that may be issued under a shelf registration statement | 14,100,000 | ||||||||||
Equity purchase agreement, authorized amount of equity authorized for sale | 10,000,000 | 10,300,000 | 18,500,000 | ||||||||
Cowen [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock issued during period pursuant to purchase agreement | 21,300,000 | ||||||||||
Maximum amount of shares of common stock, preferred stock, debt securities and/or warrants that may be issued under a shelf registration statement | 3,700,000 | ||||||||||
Common stock, par value per share | $0.00 | ||||||||||
Equity purchase agreement, authorized amount of equity authorized for sale | 25,000,000 | ||||||||||
Amgen Inc [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Issuance of common stock, shares | 420,751 | ||||||||||
Zenyaku [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Issuance of common stock, shares | 2,795,895 | ||||||||||
Proceeds from issuance of common stock | $7,000,000 |
SHAREBASED_COMPENSATION_PLANS_1
SHARE-BASED COMPENSATION PLANS (Narrative) (Details) | 1 Months Ended | 3 Months Ended |
Jun. 30, 2014 | Mar. 31, 2015 | |
Restricted Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 4 years | |
Unrecognized compensation cost, period of recognition | 7 months 17 days | |
2013 Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Additional shares authorized | 500,000 | |
Share-based compensation, shares authorized under plan | 1,750,000 | |
Purchase price as percentage of fair market value of common stock | 100.00% | |
Maximum term for options granted under the plan | 10 years | |
Maximum shares allowed to be issued per individual | 750,000 | |
Maximum shares allowed to be issued as incentive options | 6,250,000 | |
Vesting period | 4 years | |
2013 Plan [Member] | Specific cases of certain large stockholders [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Purchase price as percentage of fair market value of common stock | 110.00% | |
Maximum term for options granted under the plan | 5 years | |
Employee Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation, shares authorized under plan | 12,500 | |
Maximum number of shares of common stock by which the number of shares of stock reserved and available for grant shall be cumulatively increased | 31,250 | |
Purchase price as percentage of fair market value of common stock | 85.00% | |
Discount percentage on issuance of stock | 15.00% | |
Percentage of the number of shares of common stock by which the number of shares available for sale shall be increased | 1.00% |
SHAREBASED_COMPENSATION_PLANS_2
SHARE-BASED COMPENSATION PLANS (Summary of Option Activity) (Details) (USD $) | 3 Months Ended | 12 Months Ended |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2015 | Dec. 31, 2014 |
Number of Options | ||
Balance at December 31, 2014 | 3,021,969 | |
Granted | 209,000 | |
Exercised | -20,620 | |
Cancelled and expired | -6,250 | |
Forfeited | -24,371 | |
Balance at March 31, 2015 | 3,179,728 | 3,021,969 |
Exercisable at March 31, 2015 | 1,120,369 | |
Weighted-Average Exercise Price | ||
Balance at December 31, 2014 | $3.67 | |
Granted | $1.58 | |
Exercised | $4.65 | |
Cancelled and expired | $4.56 | |
Forfeited | $3.70 | |
Balance at March 31, 2015 | $3.52 | $3.67 |
Exercisable at March 31, 2015 | $4.65 | |
Weighted-Average Remaining Contractual Life in Years | ||
Balance at December 31, 2014 | 8 years 9 months | 8 years 11 months 1 day |
Granted | 9 years 9 months 4 days | |
Exercised | 8 years 2 months 19 days | |
Cancelled and expired | 8 years 2 months 16 days | |
Balance at March 31, 2015 | 8 years 9 months | 8 years 11 months 1 day |
Exercisable at March 31, 2015 | 8 years 29 days | |
Aggregate Intrinsic Value | ||
Balance at December 31, 2014 | ||
Granted | 604 | |
Exercised | 12 | |
Forfeited | 24 | |
Balance at March 31, 2015 | 4,150 | |
Exercisable at March 31, 2015 | $641 |
SHAREBASED_COMPENSATION_PLANS_3
SHARE-BASED COMPENSATION PLANS (Summary of Fair Value Assumptions for Stock Options and Stock Purchase Rights) (Details) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Stock Option Plans [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected Volatility | 92.00% | 101.00% |
Dividend Yield | 0.00% | 0.00% |
Risk-Free Interest Rate | 1.81% | 2.11% |
Expected Term | 6 years 7 days | 6 years 7 days |
Weighted-average fair value per share | $1.19 | $2.66 |
ESPP [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected Volatility | 52.00% | |
Dividend Yield | 0.00% | |
Risk-Free Interest Rate | 0.06% | |
Expected Term | 6 months |
SHAREBASED_COMPENSATION_PLANS_4
SHARE-BASED COMPENSATION PLANS (Schedule of Stock-Based Compensation Expense) (Details) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $503 | $836 |
Research and Development [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | 202 | 354 |
General and Administrative [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $301 | $482 |