Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Aug. 01, 2015 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | Anthera Pharmaceuticals Inc | |
Entity Central Index Key | 1,316,175 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2,015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 39,703,998 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 35,455 | $ 2,639 |
Accounts receivable | 551 | |
Prepaid expenses and other current assets | 580 | $ 383 |
Total current assets | 36,586 | 3,022 |
Property and equipment - net | 408 | $ 468 |
Other assets | 78 | |
TOTAL | 37,072 | $ 3,490 |
Current liabilities: | ||
Accounts payable | 5,281 | 2,232 |
Accrued clinical expenses | 1,624 | 1,239 |
Accrued liabilities | 287 | 211 |
Accrued payroll and related costs | 1,060 | $ 1,069 |
Deferred revenue - current | $ 586 | |
Other current liabilities | $ 1,000 | |
Total current liabilities | $ 8,838 | $ 5,751 |
Deferred revenue - noncurrent | 1,319 | |
Total liabilities | $ 10,157 | $ 5,751 |
Commitments and Contingencies (Note 6) | ||
Stockholders' equity (deficit): | ||
Common stock, $0.001 par value, 100,000,000 shares authorized; 35,870,664 and 23,005,209 shares issued and outstanding as of June 30, 2015 and December 31, 2014, respectively | $ 36 | $ 23 |
Additional paid-in capital | 360,245 | 314,527 |
Accumulated deficit | (333,366) | (316,811) |
Total stockholders' equity (deficit) | 26,915 | (2,261) |
TOTAL | $ 37,072 | $ 3,490 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
CONSOLIDATED BALANCE SHEETS [Abstract] | ||
Common stock, par value per share | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 35,870,664 | 23,005,209 |
Common stock, shares outstanding | 35,870,664 | 23,005,209 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
REVENUES: | ||||
License fee | $ 146 | $ 195 | ||
Collaborative revenues | 143 | 339 | ||
Total revenues | 289 | 534 | ||
OPERATING EXPENSES: | ||||
Research and development | 8,539 | $ 5,279 | 14,534 | $ 11,044 |
General and administrative | 1,696 | $ 1,586 | 3,603 | $ 3,430 |
Research award | (1,100) | (1,100) | ||
Total operating expenses | 9,135 | $ 6,865 | 17,037 | $ 14,474 |
LOSS FROM OPERATIONS | (8,846) | (6,865) | (16,503) | (14,474) |
OTHER INCOME (EXPENSE): | ||||
Other income (expense) | $ (49) | (31) | $ (52) | (79) |
Interest expense | (360) | (619) | ||
Total other income (expense) | $ (49) | (391) | $ (52) | (698) |
NET LOSS | $ (8,895) | $ (7,256) | $ (16,555) | $ (15,172) |
Net loss per share - basic and diluted | $ (0.25) | $ (0.34) | $ (0.52) | $ (0.73) |
Weighted-average number of shares used in per common share calculation - basic and diluted | 35,817,794 | 21,479,386 | 31,729,152 | 20,805,162 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
CASH FLOW FROM OPERATING ACTIVITIES: | ||
Net loss | $ (16,555) | $ (15,172) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 140 | 179 |
Stock-based compensation expense | $ 1,183 | 1,292 |
Amortization of discount and deferred interest on notes payable | 39 | |
Amortization of debt issuance costs | $ 42 | |
Changes in assets and liabilities: | ||
Accounts receivable | $ (551) | |
Prepaid expenses and other assets | (275) | $ (63) |
Accounts payable | 3,049 | (519) |
Accrued clinical expenses | 385 | 460 |
Accrued liabilities | 76 | 339 |
Accrued payroll and related costs | (9) | $ 218 |
Deferred revenue | (195) | |
Net cash used in operating activities | (12,752) | $ (13,185) |
INVESTING ACTIVITIES: | ||
Property and equipment purchases | $ (80) | |
Decrease in restricted cash | $ 8,100 | |
Net cash provided by (used in) investing activities | $ (80) | 8,100 |
FINANCING ACTIVITIES: | ||
Principal payment against note payable | (9,528) | |
Proceeds from issuance of common stock, net of offering costs | $ 38,469 | $ 9,560 |
Proceeds from issuance of common stock to collaborative partner | 7,000 | |
Proceeds from issuance of common stock pursuant to exercise of stock options | 179 | $ 4 |
Net cash provided by financing activities | 45,648 | 36 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 32,816 | (5,049) |
CASH AND CASH EQUIVALENTS - Beginning of period | 2,639 | 25,946 |
CASH AND CASH EQUIVALENTS - End of period | $ 35,455 | 20,897 |
Non-cash financing activities: | ||
Interest Paid | $ 414 |
ORGANIZATION AND SIGNIFICANT AC
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 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 currently has two compounds in development, liprotamase and blisibimod. The Company licensed liprotamase from Eli Lilly & Co (Eli Lilly) in July 2014. 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. The Company licensed blisibimod from Amgen, Inc. (Amgen) in December 2007. 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 (SLE), or lupus, Immunoglobulin A nephropathy, or IgA nephropathy, lupus nephritis, and others . 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 2,795,895 Under the terms of the collaborative arrangement, Zenyaku has agreed to pay the Company up to another $ 15.0 In the first quarter of 2015, the Company received net proceeds of $ 11. 5 million pursuant to the sale of its common stock through an at-the-market program (ATM) with Cowen and Company, LLC (Cowen) . In March 2015, the Company sold 6,388,889 4.50 26. 9 million and in July 2015, the Company sold 3,833,334 7.50 26.8 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 and six months ended June 30 , 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 Beginning in 2015, the Company established a policy to account for income and related accounts receivable balances owed to the Company from its collaborative partner, Zenyaku and a research award from Cystic Fibrosis Foundation Therapeutics Inc . ( CFFT) . Our collaboration with Zenyaku provides for various types of payments to us, including development milestones, sales milestone, royalty and reimbursement for a portion of our internal and external cost. Funds received from the CFFT pursuant to a research award are recorded as an offset to Operating Expenses when payments under the award become contractually due. There have been no other changes to the Company's significant accounting policies for the six months ended June 30 , 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 | 6 Months Ended |
Jun. 30, 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 22.0 15.0 1.3 The Company exercised this right with respect to $ 7.0 2,795,895 2.50367 Additionally, Zenyaku was granted an option to obtain licensing rights for additional countries in Asia for an incremental equity investment of $ 4.0 Zenyaku is responsible for all development, marketing and commercialization costs and will reimburse Anthera for i) 100 25 at a premium to the Company's manufacturing cost. Outside of Japan, the Company will be solely responsible for the development and commercialization of 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 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 collaborative 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 three months ended June 30 , 2015, the Company recorded revenue of $ 289 ,000 , which was comprised of $ 146 ,000 for the amortization of the Premium Purchase Price and $ 14 3 ,000 for the reimbursement of FTEs , respectively . During the six months ended June 30, 2015, the Company recorded revenue of $ 534,000 19 5 , 000 for the amortization of the Premium Purchase Price and $ 33 9 ,000 for the reimbursement of FTEs, respectively. In addition, during the three and six months ended June 30 , 2015, the Company recorded and $ 409,000 and $ 862 ,000 , respectively, as reduction to research and development expenses in connection with the reimbursement of qualifying costs under the collaboration agreement. Of the remaining potential future milestones, $ 7.0 15.0 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 in Zenyaku's territory 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 2.0 (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 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. As of June 30, 2015, the Company has not executed the loan agreement with Zenyaku. |
RESEARCH AWARD
RESEARCH AWARD | 6 Months Ended |
Jun. 30, 2015 | |
RESEARCH AWARD [Abstract] | |
RESEARCH AWARD | 3. RESEARCH AWARD In March 2015, the Company received a research award of up to $ 3 CFFT for the Company 's development of liprotamase . T he Company retains the right to develop and commercialize liprotamase and will owe royalties to CFFT on net sales of any drug candidate approved and commercialized under the collaboration. The funding is to be disbursed by CFFT to the Company upon the Company's achievement of milestone specified in the award agreement. At its discretion, the Company may choose to fund a particular stage of the liprotamase development plan 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 five times the actual award , 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 For the three and six months ended June 30, 2015, the Company has received $ 1.1 1.9 |
NET LOSS PER SHARE
NET LOSS PER SHARE | 6 Months Ended |
Jun. 30, 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 June 30, Six Months Ended June 30, 2015 2014 2015 2014 Net loss per share Numerator Net loss $ (8,895 ) $ (7,256 ) $ (16,555 ) $ (15,172 ) Denominator Weighted average common shares outstanding 35,817,794 21,479,386 31,729,152 20,805,162 Basic and diluted net loss per share $ (0.25 ) $ (0.34 ) $ (0.52 ) $ (0.73 ) 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 and Six Months Ended June 30 , 2015 2014 Options to purchase common stock 3,482,848 2,155,659 Warrants to purchase common stock 556,838 675,006 Restricted Stock Units 937 2,999 Total 4,040,623 2,833,664 |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 6 Months Ended |
Jun. 30, 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 June 30 , 2015 and December 31, 2014 (in thousands): June 30 , 2015 Estimated Fair Value Level 1 Level 2 Level 3 Money market funds $ 35,190 $ 35,190 $ $ December 31, 2014 Estimated Fair Value Level 1 Level 2 Level 3 Money market funds $ 2,354 $ 2,354 $ $ There were no transfers between Level 1, Level 2 or Level 3 for the three and six months ended June 30, 201 5 and 201 4. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 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 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 33.0 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 The Company accrued $ 1.0 The Company issued 420,751 2.3767 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 9.5 June 30 , 2015. In addition, after sales of the licensed products exceed an aggregate of $ 100.0 In March 2015, the Company received a research award of up to $ 3 CFFT for the Company's development of liprotamase. The Company is obligated to pay royalties to CFFT as follows: i) a one-time royalty in an amount equal to five times the award , 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 d 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. Due to the inherent risk associated with drug development the Company ha s not accrued any obligation for the period end ed June 30, 2015. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 6 Months Ended |
Jun. 30, 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 There were no preferred shares issued or outstanding as of June 30 , 2015. Warrants In March 2011, the Company issued a seven-year warrant to purchase 40,178 48.00 June 30 , 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 24.00 0.40 23.20 June 30 , 2015, 516,660 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 On March 12, 2015, the Company terminated the 2013 Purchase Agreement, which had a remaining balance of $ 14.1 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 On July 8, 2015, the Company and LPC amended the 2015 Purchase Agreement to reduce the total amount of common shares available for purchase by LPC from $10.0 million to $ 6.0 No sales of common stock have been made under the 2015 Purchase Agreement as of June 30 , 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 25.0 As of June 30 , 2015, the Company had sold $ 21.3 3.7 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 In January 2015, the Company registered $ 8.0 February 2015, the Company registered $ 10.3 , which was reduced to $ 6.3 . In March and July 2015, the Company utilized a total of $ 57.5 million of this shelf registration in connection with two underwritten public offering s , leaving a balance of $ 3.2 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 2,795,895 420,751 The Company received net cash proceeds of $ 7.0 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. In the first quarter of 2015, the Company sold 3,125,662 11. 5 million. In March 2015, the Company sold 6,388,889 4.50 26. 9 million. In July 2015, the Company sold 3,833,334 7.50 26.8 million. |
SHARE-BASED COMPENSATION PLANS
SHARE-BASED COMPENSATION PLANS | 6 Months Ended |
Jun. 30, 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 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 and May 2015 , the Company's shareholders approved an additional 500,000 and 1,790,818 shares of its common stock for issuance of awards under the 2013 Plan , respectively . Of the shares of common stock reserved for issuance under the 2013 Plan, no more than 750,000 100 10 four 110 five 6,250,000 The terms of awards granted during the three and six months ended June 30 , 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 six months ended June 30 , 2015 (in thousands except share and per share information): Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life in Years Balance at December 31, 2014 3,021,969 $ 3.67 8.92 Granted 539,499 $ 3.52 9.74 Exercised (22,851 ) $ 4.45 8.05 Cancelled and expired (19,379 ) $ 4.69 7.95 Forfeited (36,390 ) 3.19 Balance at June 30, 2015 3,482,848 $ 3.64 8.63 Exercisable at June 30, 2015 1,295,337 $ 4.42 8.01 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. As of June 30, 2015, there was $ 5.1 million of total unrecognized compensation expense related to stock options and is expected to amortize on a straight-line basis over a weighted-average remaining period of 2. 48 years . The assumptions used in the Black-Scholes option-pricing model to value stock options are as follows: Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Expected Volatility 97 % 90 % 95 % 95 % Dividend Yield 0 % 0 % 0 % 0 % Risk-Free Interest Rate 1.52 % 0.50 % 1.63 % 1.32 % Expected Term (years) 5.59 1.97 5.76 4.03 Weighted-average fair value per option $ 4.18 $ 1.49 $ 3.02 $ 2.09 Prior to March 31, 2015, the expected volatility was determined using the volatility of a representative industry peer group. Effective April 1, 2015 , the Company determined expected volatility based on a blend of the historical volatility of its stock since becoming a public entity and the volatility of a representative industry peer group. 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. 38 years. As of June 30 , 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 values 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 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 1 31,250 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 15 For the purchase period ended June 30, 2015, the Company issued 52,069 shares pursuant to the purchase of common stock by its employees under the ESPP for gross proceeds of $ 78,000 . Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 201 4 Expected Volatility 52 % --- 52 % --- Dividend Yield 0 % --- 0 % --- Risk-Free Interest Rate 0.06 % --- 0.06 % --- Expected Term (years) 0.50 --- 0.50 --- Stock-Based Compensation Expense Total stock-based compensation expense, including expense recorded for the ESPP, was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 201 5 2014 2015 2014 Research and development $ 240 $ 187 442 $ 541 General and administrative 440 269 741 751 Total stock-based compensation $ 680 $ 456 $ 1,183 $ 1,292 |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 6 Months Ended |
Jun. 30, 2015 | |
SUBSEQUENT EVENT [Abstract] | |
SUBSEQUENT EVENT | 9. SUBSEQUENT EVENT In July 2015 , the Company completed an underwritten public offering of 3,833,334 shares of its common stock, offered at a price to the public of $ 7.50 per share. The net proceeds to the Company from the sale of shares in this offering, after deducting customary underwriting discounts and commissions and offering expense , were approximately $ 26.8 million. |
ORGANIZATION AND SIGNIFICANT 15
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 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 currently has two compounds in development, liprotamase and blisibimod. The Company licensed liprotamase from Eli Lilly & Co (Eli Lilly) in July 2014. 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. The Company licensed blisibimod from Amgen, Inc. (Amgen) in December 2007. 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 (SLE), or lupus, Immunoglobulin A nephropathy, or IgA nephropathy, lupus nephritis, and others . |
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 2,795,895 Under the terms of the collaborative arrangement, Zenyaku has agreed to pay the Company up to another $ 15.0 In the first quarter of 2015, the Company received net proceeds of $ 11. 5 million pursuant to the sale of its common stock through an at-the-market program (ATM) with Cowen and Company, LLC (Cowen) . In March 2015, the Company sold 6,388,889 4.50 26. 9 million and in July 2015, the Company sold 3,833,334 7.50 26.8 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 and six months ended June 30 , 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 Beginning in 2015, the Company established a policy to account for income and related accounts receivable balances owed to the Company from its collaborative partner, Zenyaku and a research award from Cystic Fibrosis Foundation Therapeutics Inc . ( CFFT) . Our collaboration with Zenyaku provides for various types of payments to us, including development milestones, sales milestone, royalty and reimbursement for a portion of our internal and external cost. Funds received from the CFFT pursuant to a research award are recorded as an offset to Operating Expenses when payments under the award become contractually due. There have been no other changes to the Company's significant accounting policies for the six months ended June 30 , 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) | 6 Months Ended |
Jun. 30, 2015 | |
NET LOSS PER SHARE [Abstract] | |
Schedule of Calculation of Net Loss Per Common Share | Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Net loss per share Numerator Net loss $ (8,895 ) $ (7,256 ) $ (16,555 ) $ (15,172 ) Denominator Weighted average common shares outstanding 35,817,794 21,479,386 31,729,152 20,805,162 Basic and diluted net loss per share $ (0.25 ) $ (0.34 ) $ (0.52 ) $ (0.73 ) |
Schedule of Antidilutive Securities | Three and Six Months Ended June 30 , 2015 2014 Options to purchase common stock 3,482,848 2,155,659 Warrants to purchase common stock 556,838 675,006 Restricted Stock Units 937 2,999 Total 4,040,623 2,833,664 |
FAIR VALUE OF FINANCIAL INSTR17
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS [Abstract] | |
Schedule of Financial Assets Measured at Fair Value on a Recurring Basis | June 30 , 2015 Estimated Fair Value Level 1 Level 2 Level 3 Money market funds $ 35,190 $ 35,190 $ $ December 31, 2014 Estimated Fair Value Level 1 Level 2 Level 3 Money market funds $ 2,354 $ 2,354 $ $ |
SHARE-BASED COMPENSATION PLANS
SHARE-BASED COMPENSATION PLANS (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
SHARE-BASED COMPENSATION PLANS [Abstract] | |
Summary of Option Activity | Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life in Years Balance at December 31, 2014 3,021,969 $ 3.67 8.92 Granted 539,499 $ 3.52 9.74 Exercised (22,851 ) $ 4.45 8.05 Cancelled and expired (19,379 ) $ 4.69 7.95 Forfeited (36,390 ) 3.19 Balance at June 30, 2015 3,482,848 $ 3.64 8.63 Exercisable at June 30, 2015 1,295,337 $ 4.42 8.01 |
Schedule of Stock-Based Compensation Expense | Three Months Ended June 30, Six Months Ended June 30, 201 5 2014 2015 2014 Research and development $ 240 $ 187 442 $ 541 General and administrative 440 269 741 751 Total stock-based compensation $ 680 $ 456 $ 1,183 $ 1,292 |
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 June 30, Six Months Ended June 30, 2015 2014 2015 2014 Expected Volatility 97 % 90 % 95 % 95 % Dividend Yield 0 % 0 % 0 % 0 % Risk-Free Interest Rate 1.52 % 0.50 % 1.63 % 1.32 % Expected Term (years) 5.59 1.97 5.76 4.03 Weighted-average fair value per option $ 4.18 $ 1.49 $ 3.02 $ 2.09 |
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 June 30, Six Months Ended June 30, 2015 2014 2015 201 4 Expected Volatility 52 % --- 52 % --- Dividend Yield 0 % --- 0 % --- Risk-Free Interest Rate 0.06 % --- 0.06 % --- Expected Term (years) 0.50 --- 0.50 --- |
ORGANIZATION AND SIGNIFICANT 19
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended | ||
Jul. 31, 2015 | Mar. 31, 2015 | Jan. 31, 2015 | Jun. 30, 2015 | |
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES [Abstract] | ||||
Proceeds from shares issued | $ 7 | |||
Future expected proceeds | $ 15 | |||
Proceeds from issuance of stock | $ 7 | |||
Shares issued | 2,795,895 | |||
At The Market [Member] | ||||
Proceeds from issuance of stock | $ 11.5 | |||
Shelf Registration [Member] | ||||
Proceeds from issuance of stock | $ 26.8 | $ 26.9 | ||
Shares issued | 3,833,334 | 6,388,889 | ||
Share price | $ 7.50 | $ 4.50 | ||
Cost Inside Japan [Member] | ||||
Percentage of reimbursement cost | 100.00% | |||
Cost Outside Japan [Member] | ||||
Percentage of reimbursement cost | 25.00% |
COLLABORATIVE AGREEMENT (Detail
COLLABORATIVE AGREEMENT (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jul. 31, 2015shares | Mar. 31, 2015shares | Jan. 31, 2015USD ($)$ / sharesshares | Sep. 30, 2010shares | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | |
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 | shares | 3,833,334 | 6,388,889 | 2,795,895 | 1,312,492 | ||||
Issuance of common stock, price per share | $ / shares | $ 2.50367 | |||||||
Incremental equity investment | $ 4,000,000 | |||||||
Revenue percentage threshold | 50.00% | 50.00% | ||||||
Total revenues | $ 289,000 | $ 534,000 | ||||||
License fee | 146,000 | 195,000 | ||||||
Collaborative revenues | 143,000 | 339,000 | ||||||
Reduction to research and development | 409,000 | 862,000 | ||||||
Maximum milestone payments | 22,000,000 | 22,000,000 | ||||||
Maximum loan amount | $ 7,000,000 | $ 7,000,000 | ||||||
Debt instrument, maturity date | Dec. 11, 2021 | |||||||
Interest rate | 1.00% | 1.00% | ||||||
Cost Inside Japan [Member] | ||||||||
Percentage of reimbursement cost | 100.00% | 100.00% | ||||||
Cost Outside Japan [Member] | ||||||||
Percentage of reimbursement cost | 25.00% | 25.00% | ||||||
Regulatory Milestones [Member] | ||||||||
Maximum milestone payments | $ 7,000,000 | $ 7,000,000 | ||||||
Commercialization Milestones [Member] | ||||||||
Maximum milestone payments | 15,000,000 | 15,000,000 | ||||||
Forgivable Upon Certain Achievements [Member] | ||||||||
Maximum loan amount | 5,000,000 | 5,000,000 | ||||||
Forgivable Upon Application Submission [Member] | ||||||||
Maximum loan amount | $ 2,000,000 | $ 2,000,000 |
RESEARCH AWARD (Details)
RESEARCH AWARD (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
RESEARCH AWARD [Abstract] | ||||
Research award amount | $ 3,000 | $ 3,000 | ||
Royalty threshold amount | 100,000 | 100,000 | ||
Research award | 1,100 | 1,100 | ||
Remaining research award | $ 1,900 | $ 1,900 |
NET LOSS PER SHARE (Schedule of
NET LOSS PER SHARE (Schedule of Calculation of Net Loss Per Common Share) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Numerator | ||||
Net loss | $ (8,895) | $ (7,256) | $ (16,555) | $ (15,172) |
Denominator | ||||
Weighted average common shares oustanding | 35,817,794 | 21,479,386 | 31,729,152 | 20,805,162 |
Basic and diluted net loss per share | $ (0.25) | $ (0.34) | $ (0.52) | $ (0.73) |
NET LOSS PER SHARE (Schedule 23
NET LOSS PER SHARE (Schedule of Antidilutive Securities) (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents outstanding | 4,040,623 | 2,833,664 | 4,040,623 | 2,833,664 |
Options to purchase common stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents outstanding | 3,482,848 | 2,155,659 | 3,482,848 | 2,155,659 |
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 | 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 | 2,999 | 937 | 2,999 |
FAIR VALUE OF FINANCIAL INSTR24
FAIR VALUE OF FINANCIAL INSTRUMENTS (Details) - Money Market Funds [Member] - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Estimated Fair Value [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis | $ 35,190 | $ 2,354 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis | $ 35,190 | $ 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) $ / shares in Units, $ in Millions | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2015USD ($)ft²$ / sharesshares | Dec. 31, 2007USD ($) | Dec. 31, 2014USD ($) | |
Loss Contingencies [Line Items] | |||
Square footage of operating facility, in square feet | ft² | 14,000 | ||
Research award amount | $ 3 | ||
Royalty obligation, sales amount | $ 100 | ||
Amgen Inc. [Member] | |||
Loss Contingencies [Line Items] | |||
Number of shares issued under collaborative arrangement | shares | 420,751 | ||
Share issue price | $ / shares | $ 2.3767 | ||
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 | $ 9.5 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 5 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||||
Jul. 31, 2015 | Jul. 08, 2015 | Mar. 31, 2015 | Feb. 28, 2015 | Jan. 31, 2015 | Nov. 30, 2013 | Apr. 30, 2013 | Apr. 05, 2013 | Sep. 30, 2010 | Mar. 31, 2015 | Jul. 31, 2015 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | Mar. 31, 2011 | |
Class of Stock [Line Items] | |||||||||||||||
Issuance of common stock, shares | 3,833,334 | 6,388,889 | 2,795,895 | 1,312,492 | |||||||||||
Issuance of stock, price per share | $ 7.50 | $ 4.50 | $ 24 | ||||||||||||
Proceeds from stock issuance | $ 8,000 | $ 11,500 | $ 57,500 | ||||||||||||
Stock issued during period pursuant to purchase agreement, shares | 3,125,662 | ||||||||||||||
Exercise price of warrants | $ 23.20 | $ 48 | |||||||||||||
Proceeds from issuance of common stock | $ 26,800 | $ 26,900 | $ 38,469 | $ 9,560 | |||||||||||
Maximum amount of shares of common stock, preferred stock, debt securities and/or warrants that may be issued under a shelf registration statement | 3,200 | $ 100,000 | |||||||||||||
Common stock, par value per share | $ 0.001 | $ 0.001 | |||||||||||||
Equity purchase agreement, authorized amount of equity authorized for sale | $ 8,000 | ||||||||||||||
Number of shares called by warrant(s) | 0.40 | 40,178 | |||||||||||||
Warrants outstanding | 516,660 | ||||||||||||||
Preferred stock, shares authorized | 5,000,000 | ||||||||||||||
Lincoln Park Capital Fund [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
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 | ||||||||||||||
Equity purchase agreement, authorized amount of equity authorized for sale | $ 6,300 | $ 6,000 | $ 10,300 | $ 18,500 | $ 10,000 | ||||||||||
Cowen [Member] | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued during period pursuant to purchase agreement | 21,300 | ||||||||||||||
Common stock, par value per share | $ 0.001 | ||||||||||||||
Equity purchase agreement, authorized amount of equity authorized for sale | $ 25,000 | $ 3,700 | |||||||||||||
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 |
SHARE-BASED COMPENSATION PLAN27
SHARE-BASED COMPENSATION PLANS (Narrative) (Details) - USD ($) | 1 Months Ended | 6 Months Ended | |
May. 31, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized compensation cost | $ 5,100,000 | ||
Unrecognized compensation cost, period of recognition | 2 years 5 months 23 days | ||
Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 4 years | ||
Unsettled Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 4 months 17 days | ||
2013 Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Additional shares authorized | 1,790,818 | 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% | ||
ESPP, shares issued | 52,069 | ||
ESPP, gross proceeds | $ 78,000 |
SHARE-BASED COMPENSATION PLAN28
SHARE-BASED COMPENSATION PLANS (Summary of Option Activity) (Details) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2015 | Dec. 31, 2014 | |
Number of Options | ||
Balance at December 31, 2014 | 3,021,969 | |
Granted | 539,499 | |
Exercised | (22,851) | |
Cancelled and expired | (19,379) | |
Forfeited | (36,390) | |
Balance at June 30, 2015 | 3,482,848 | 3,021,969 |
Exercisable at June 30, 2015 | 1,295,337 | |
Weighted-Average Exercise Price | ||
Balance at December 31, 2014 | $ 3.67 | |
Granted | 3.52 | |
Exercised | 4.45 | |
Cancelled and expired | 4.69 | |
Forfeited | 3.19 | |
Balance at June 30, 2015 | 3.64 | $ 3.67 |
Exercisable at June 30, 2015 | $ 4.42 | |
Weighted-Average Remaining Contractual Life in Years | ||
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2 | 8 years 7 months 17 days | 8 years 11 months 1 day |
Granted | 9 years 8 months 26 days | |
Exercised | 8 years 18 days | |
Cancelled and expired | 7 years 11 months 12 days | |
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2 | 8 years 7 months 17 days | 8 years 11 months 1 day |
Exercisable at June 30, 2015 | 8 years 4 days |
SHARE-BASED COMPENSATION PLAN29
SHARE-BASED COMPENSATION PLANS (Summary of Fair Value Assumptions for Stock Options and Stock Purchase Rights) (Details) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Stock Option Plans [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected Volatility | 97.00% | 90.00% | 95.00% | 95.00% |
Dividend Yield | 0.00% | 0.00% | 0.00% | 0.00% |
Risk-Free Interest Rate | 1.52% | 0.50% | 1.63% | 1.32% |
Expected Term | 5 years 7 months 2 days | 1 year 11 months 19 days | 5 years 9 months 4 days | 4 years 11 days |
Weighted-average fair value per option | $ 4.18 | $ 1.49 | $ 3.02 | $ 2.09 |
ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected Volatility | 52.00% | 52.00% | ||
Dividend Yield | 0.00% | 0.00% | ||
Risk-Free Interest Rate | 0.06% | 0.06% | ||
Expected Term | 6 months | 6 months |
SHARE-BASED COMPENSATION PLAN30
SHARE-BASED COMPENSATION PLANS (Schedule of Stock-Based Compensation Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 680 | $ 456 | $ 1,183 | $ 1,292 |
Research and Development [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 240 | 187 | 442 | 541 |
General and Administrative [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 440 | $ 269 | $ 741 | $ 751 |
SUBSEQUENT EVENT (Details)
SUBSEQUENT EVENT (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | ||||
Jul. 31, 2015 | Mar. 31, 2015 | Jan. 31, 2015 | Sep. 30, 2010 | Jun. 30, 2015 | Jun. 30, 2014 | |
Subsequent Event [Line Items] | ||||||
Issuance of common stock, shares | 3,833,334 | 6,388,889 | 2,795,895 | 1,312,492 | ||
Issuance of common stock, price per share | $ 2.50367 | |||||
Proceeds from issuance of common stock, net of offering costs | $ 26,800 | $ 26,900 | $ 38,469 | $ 9,560 | ||
Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Issuance of common stock, shares | 3,833,334 | |||||
Issuance of common stock, price per share | $ 7.50 | |||||
Proceeds from issuance of common stock, net of offering costs | $ 26,800 |