DOCUMENT AND ENTITY INFORMATION
DOCUMENT AND ENTITY INFORMATION - shares | 6 Months Ended | |
Jun. 30, 2019 | Aug. 01, 2019 | |
DOCUMENT AND ENTITY INFORMATION [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2019 | |
Entity Registrant Name | Foamix Pharmaceuticals Ltd. | |
Entity Central Index Key | 0001606645 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business Flag | true | |
Entity Emerging Growth Company | true | |
Entity Transition Period | true | |
Entity Common Stock, Shares Outstanding | 61,003,927 | |
Entity Shell Company | false | |
Entity Interactive Data Current | Yes | |
Entity Current Reporting Status | Yes |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 39,085 | $ 27,868 |
Restricted cash | 250 | 250 |
Short term bank deposits | 16,187 | 24,047 |
Investment in marketable securities (Note 4) | 14,091 | 46,669 |
Restricted investment in marketable securities (Note 4) | 282 | 268 |
Accounts receivable: | ||
Trade | 308 | 1,066 |
Other | 1,511 | 999 |
TOTAL CURRENT ASSETS | 71,714 | 101,167 |
NON-CURRENT ASSETS: | ||
Investment in marketable securities (Note 4) | 150 | |
Restricted investment in marketable securities (Note 4) | 139 | 133 |
Property and equipment, net | 2,497 | 2,235 |
Operating lease right of use assets (Note 6) | 1,858 | |
Other | 18 | 46 |
TOTAL NON-CURRENT ASSETS | 4,512 | 2,564 |
TOTAL ASSETS | 76,226 | 103,731 |
Accounts payable and accruals: | ||
Trade | 9,434 | 6,327 |
Operating lease liabilities (Note 6) | 999 | |
Other | 3,664 | 4,141 |
TOTAL CURRENT LIABILITIES | 14,097 | 10,468 |
LONG-TERM LIABILITIES: | ||
Liability for employee severance benefits | 409 | 367 |
Operating lease liabilities (Note 6) | 882 | |
Other liabilities | 456 | 714 |
TOTAL LONG-TERM LIABILITIES | 1,747 | 1,081 |
TOTAL LIABILITIES | 15,844 | 11,549 |
COMMITMENTS (Note 6) | ||
SHAREHOLDERS' EQUITY: | ||
Ordinary Shares, NIS 0.16 par value - authorized: 135,000,000 and 90,000,000 Ordinary Shares as of June 30, 2019 and December 31, 2018, respectively; issued and outstanding: 54,455,969 and 54,351,140 Ordinary Shares as of June 30, 2019 and December 31, 2018, respectively | 2,336 | 2,331 |
Additional paid-in capital | 307,653 | 305,303 |
Accumulated deficit | (249,606) | (215,409) |
Accumulated other comprehensive loss | (1) | (43) |
TOTAL SHAREHOLDERS' EQUITY | 60,382 | 92,182 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 76,226 | $ 103,731 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - ₪ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Ordinary shares, par value (in NIS per share) | ₪ 0.16 | ₪ 0.16 |
Ordinary shares, shares authorized | 135,000,000 | 90,000,000 |
Ordinary shares, shares issued | 54,455,969 | 54,351,140 |
Ordinary shares, shares outstanding | 54,455,969 | 54,351,140 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Income Statement [Abstract] | ||||
REVENUES (Note 7) | $ 964 | $ 308 | $ 1,870 | |
OPERATING EXPENSES: | ||||
Research and development | 12,556 | 16,842 | 23,404 | 39,667 |
Selling, general and administrative | 6,803 | 2,909 | 12,147 | 6,710 |
TOTAL OPERATING EXPENSES | 19,359 | 19,751 | 35,551 | 46,377 |
OPERATING LOSS | 19,359 | 18,787 | 35,243 | 44,507 |
FINANCE INCOME, net | (366) | (279) | (870) | (352) |
LOSS BEFORE INCOME TAX | 18,993 | 18,508 | 34,373 | 44,155 |
INCOME TAX | 120 | (176) | 450 | |
NET LOSS FOR THE PERIOD | $ 18,993 | $ 18,628 | $ 34,197 | $ 44,605 |
LOSS PER SHARE BASIC AND DILUTED | $ 0.35 | $ 0.46 | $ 0.63 | $ 1.15 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE IN THOUSANDS | 54,426 | 40,102 | 54,401 | 38,821 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
NET LOSS | $ 18,993 | $ 18,628 | $ 34,197 | $ 44,605 |
OTHER COMPREHENSIVE LOSS (INCOME): | ||||
Net unrealized gains from marketable securities | (4) | (25) | (40) | (10) |
Losses on marketable securities reclassified into net loss | (1) | (2) | ||
Net unrealized losses (gains) on derivative financial instruments | 13 | 67 | (2) | 81 |
losses on derivative financial instruments reclassified into net loss | (41) | (35) | ||
TOTAL OTHER COMPREHENSIVE LOSS (INCOME) | 9 | (42) | 34 | |
TOTAL COMPREHENSIVE LOSS | $ 19,002 | $ 18,628 | $ 34,155 | $ 44,639 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Ordinary shares [Member] | Additional Paid-in Capital [Member] | Accumulated deficit [Member] | Accumulated other comprehensive Income (loss) [Member] | Total |
Balance at Dec. 31, 2017 | $ 1,576 | $ 208,364 | $ (141,281) | $ (58) | $ 68,601 |
Balance (shares) at Dec. 31, 2017 | 37,498,128 | ||||
Impact of initial adoption of new accounting standards, as previously reported | 35 | (35) | |||
CHANGES DURING THE PERIOD: | |||||
Comprehensive loss | (44,605) | (34) | (44,639) | ||
Issuance of shares less offering expenses in the amount of $39K | $ 134 | 15,997 | 16,131 | ||
Issuance of shares less offering expenses in the amount of $39K (shares) | 2,940,000 | ||||
Exercise of warrants into Ordinary Shares | $ 8 | 832 | 840 | ||
Exercise of warrants into Ordinary Shares (shares) | 178,468 | ||||
Exercise of options and restricted share units | $ 3 | 7 | 10 | ||
Exercise of options and restricted share units (shares) | 76,883 | ||||
Share-based compensation (Note 5) | 2,954 | 2,954 | |||
Balance at Jun. 30, 2018 | $ 1,721 | 228,154 | (185,851) | (127) | 43,897 |
Balance (shares) at Jun. 30, 2018 | 40,693,479 | ||||
Balance at Mar. 31, 2018 | $ 1,578 | 210,116 | (167,223) | (127) | 44,344 |
Balance (shares) at Mar. 31, 2018 | 37,551,511 | ||||
CHANGES DURING THE PERIOD: | |||||
Comprehensive loss | (18,628) | (18,628) | |||
Issuance of shares less offering expenses in the amount of $39K | $ 134 | 15,997 | 16,131 | ||
Issuance of shares less offering expenses in the amount of $39K (shares) | 2,940,000 | ||||
Exercise of warrants into Ordinary Shares | $ 8 | 832 | 840 | ||
Exercise of warrants into Ordinary Shares (shares) | 178,468 | ||||
Exercise of options and restricted share units | $ 1 | 9 | 10 | ||
Exercise of options and restricted share units (shares) | 23,500 | ||||
Share-based compensation (Note 5) | 1,200 | 1,200 | |||
Balance at Jun. 30, 2018 | $ 1,721 | 228,154 | (185,851) | (127) | 43,897 |
Balance (shares) at Jun. 30, 2018 | 40,693,479 | ||||
Balance at Dec. 31, 2018 | $ 2,331 | 305,303 | (215,409) | (43) | $ 92,182 |
Balance (shares) at Dec. 31, 2018 | 54,351,140 | 54,351,140 | |||
CHANGES DURING THE PERIOD: | |||||
Comprehensive loss | (34,197) | 42 | $ (34,155) | ||
Exercise of options and restricted share units | $ 5 | 13 | 18 | ||
Exercise of options and restricted share units (shares) | 104,829 | ||||
Share-based compensation (Note 5) | 2,337 | 2,337 | |||
Balance at Jun. 30, 2019 | $ 2,336 | 307,653 | (249,606) | (1) | $ 60,382 |
Balance (shares) at Jun. 30, 2019 | 54,455,969 | 54,455,969 | |||
Balance at Mar. 31, 2019 | $ 2,334 | 306,266 | (230,613) | 8 | $ 77,995 |
Balance (shares) at Mar. 31, 2019 | 54,419,323 | ||||
CHANGES DURING THE PERIOD: | |||||
Comprehensive loss | (18,993) | (9) | (19,002) | ||
Exercise of options and restricted share units | $ 2 | 2 | |||
Exercise of options and restricted share units (shares) | 36,646 | ||||
Share-based compensation (Note 5) | 1,387 | 1,387 | |||
Balance at Jun. 30, 2019 | $ 2,336 | $ 307,653 | $ (249,606) | $ (1) | $ 60,382 |
Balance (shares) at Jun. 30, 2019 | 54,455,969 | 54,455,969 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2018 | Jun. 30, 2018 | |
Statement of Stockholders' Equity [Abstract] | ||
Issuance costs | $ 39 | $ 39 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ 34,197 | $ 44,605 |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 163 | 166 |
Loss from disposal and sale of fixed assets | 29 | 37 |
Changes in marketable securities and bank deposits, net | (358) | 133 |
Changes in accrued liability for employee severance benefits, net of retirement fund profit | 42 | (59) |
Share-based compensation | 2,337 | 2,954 |
Non-cash finance expenses, net | 3 | 24 |
Changes in operating asset and liabilities: | ||
Decrease in trade and other receivables | 246 | 278 |
Increase in accounts payable and accruals | 2,374 | 4,550 |
Net cash used in operating activities | (29,361) | (36,522) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of fixed assets | (454) | (328) |
Investment in bank deposits | (16,048) | (27,500) |
Investment in marketable securities | (1,012) | |
Proceeds from sale and maturity of marketable securities and bank deposits | 57,014 | 44,151 |
Net cash provided by investing activities | 40,512 | 15,311 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercise of options | 18 | 10 |
Proceeds from exercise of warrants | 840 | |
Proceeds from issuance of shares, net of $39 issuance costs | 16,131 | |
Net cash provided by financing activities | 18 | 16,981 |
INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 11,169 | (4,230) |
EFFECT OF EXCHANGE RATE ON CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 48 | (24) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF THE PERIOD | 28,118 | 16,206 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE PERIOD | 39,335 | 11,952 |
Cash and cash equivalents | 39,085 | 11,702 |
Restricted cash | 250 | 250 |
TOTAL CASH, CASH EQUIVALENTS AND RESTRICTED CASH SHOWN IN STATEMENT OF CASH FLOWS | 39,335 | 11,952 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | ||
Cashless exercise of warrants and restricted share units | 4 | 4 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | ||
Cash paid for taxes | 454 | |
Interest received | 666 | 505 |
Additions to operating lease right of use assets | 867 | |
Additions to operating lease liabilities | $ 850 |
CONDENSED CONSOLIDATED STATEM_6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) $ in Thousands | 6 Months Ended |
Jun. 30, 2018USD ($) | |
Securities purchase agreement [Member] | |
Stock issuance costs | $ 39 |
NATURE OF OPERATIONS AND BASIS
NATURE OF OPERATIONS AND BASIS OF PRESENTATION: | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS AND BASIS OF PRESENTATION: | NOTE 1 - NATURE OF OPERATIONS AND BASIS OF PRESENTATION: a. Nature of operations Foamix Pharmaceuticals Ltd. (hereinafter “Foamix”) is an Israeli company incorporated in 2003. Foamix’s shares are publicly traded on the Nasdaq Global Market under the symbol “FOMX”, since its initial public offering (“IPO”) in September 2014. Foamix is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing its proprietary topical drug candidates for dermatological therapy. Foamix’s lead product candidate, FMX101 (4% minocycline foam), is being developed for the treatment of moderate-to-severe acne. An additional product candidate, FMX103 (1.5% minocycline foam), is being developed for the treatment of moderate-to-severe papulopustular rosacea. Both product candidates were developed using Molecule Stabilizing Technology Foamix also licensed certain technology under development and licensing agreements to various pharmaceutical companies for development of certain products combining Foamix's foam technology with the licensee’s proprietary drugs. In May 2014, Foamix incorporated a wholly-owned subsidiary in the United States of America - Foamix Pharmaceuticals Inc. (hereinafter referred to as the "Subsidiary"). The Subsidiary was incorporated to assist Foamix with regard to marketing, regulatory affairs and business development relating to its pipeline and technology. Since incorporation through June 30, 2019, Foamix and its subsidiary (hereinafter referred to as “the Company”) incurred losses and negative cash flows from operations mainly attributable to its development efforts and has an accumulated deficit of $249,606. The Company has financed its operations mainly through the issuance of shares through private and public financing rounds, convertible loans and payments received pursuant to the terms of development and licensing agreements. The Company's cash and investments as of the issuance date of these financial statements, provide sufficient resources to fund its operations through at least the next 12 months. In order to successfully commercialize FMX101, FMX103 and any future product candidates, the Company may be required to obtain further funding through public or private offerings, debt financings, collaboration and licensing arrangements or other sources. Adequate additional funding may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise capital when needed or on attractive terms, it may be forced to delay, reduce or eliminate its research and development programs or commercialization and manufacturing efforts. b. Basis of presentation The unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America ("US GAAP") for interim financial statements. Accordingly, they do not contain all information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated interim financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2019, the consolidated results of operations, comprehensive loss and changes in shareholders’ equity for the three and six-month periods ended June 30, 2019 and 2018 and cash flows for the six-month periods ended June 30, 2019 and 2018. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s annual financial statements for the year ended December 31, 2018. The condensed consolidated balance sheet data as of December 31, 2018 was derived from the audited consolidated financial statements for the year ended December 31, 2018, included in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on February 28, 2019, but does not include all disclosures required by U.S. GAAP for annual financial statements. The results for the three and six-month periods ended June 30, 2019 are not necessarily indicative of the results expected for the full year ending December 31, 2019. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES: | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES: | NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES: a. Principles of consolidation The consolidated financial statements include the accounts of Foamix and its subsidiary. Intercompany balances and transactions including profits from intercompany sales not yet realized outside the Company have been eliminated upon consolidation. b. Fair value measurement Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data or active market data of similar or identical assets or liabilities. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. c. Loss per share Net loss per share, basic and diluted, is computed on the basis of the net loss for the period divided by the weighted average number of Ordinary Shares outstanding during the period. Diluted net loss per share is based upon the weighted average number of Ordinary Shares and of Ordinary Share equivalents outstanding when dilutive. Ordinary Share equivalents include outstanding stock options and warrants which are included under the treasury share method when dilutive. The following average share options and restricted share units (“RSUs”) were excluded from the calculation of diluted net loss per Ordinary Share because their effect would have been anti-dilutive for the periods presented (share data): Six months ended June 30 Three months ended June 30 2019 2018 2019 2018 Outstanding share options and RSUs 5,873,725 4,618,821 6,130,069 4,857,234 Warrants - 369,828 - 743,764 d. Newly issued and recently adopted accounting pronouncements Accounting pronouncements adopted in period: 1) In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2016-02, Leases (Topic 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). The new standard requires lessees to record assets and liabilities on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The Company adopted the standard as of January 1, 2019 on a modified retrospective basis and did not restate comparative periods. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed the Company to carryforward the historical lease classification and not separate lease and non-lease components for the leases. The Company recognizes the lease payments in the consolidated statements of operations on a straight-line basis over the lease period. The adoption of the standard resulted in recognition of $1,357 of lease assets and lease liabilities as of January 1, 2019 on the Company’s consolidated balance sheets. 2) In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718) Improvements to Nonemployee Share-based Payments. This ASU was issued to simplify the accounting for share-based transactions by expanding the scope of Topic 718 from only being applicable to share-based payments to employees to also include share-based payment transactions for acquiring goods and services from nonemployees. As a result, nonemployee share-based transactions will be measured by estimating the fair value of the equity instruments at the grant date, taking into consideration the probability of satisfying performance conditions. This standard, adopted as of January 1, 2019, had no material impact on the Company’s consolidated financial statements. |
FAIR VALUE PRESENTATION
FAIR VALUE PRESENTATION | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE PRESENTATION | NOTE 3 - FAIR VALUE PRESENTATION The Company’s assets and liabilities that are measured at fair value as of June 30, 2019 and December 31, 2018 are classified in the tables below in one of the three categories described in note 2b above: June 30, 2019 Level 1 Level 2 Total Marketable securities $ 1,011 $ 13,501 $ 14,512 Currency options designated as hedging instruments (current liability) $ - $ (1 ) (1 ) December 31, 2018 Level 1 Level 2 Total Marketable securities $ 991 $ 46,229 $ 47,220 Currency options designated as hedging instruments (current liability) $ - $ (3 ) $ (3 ) The Company’s debt securities are traded in markets that are not considered to be active, but are valued based on quoted market prices, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. Accordingly, these assets are categorized as Level 2. Foreign exchange risk management The Company purchases and writes non-functional currency options in order to hedge the currency exposure on the Company’s cash flow. The currency hedged items are denominated in New Israeli Shekels (“NIS”). The purchasing and writing of options is part of a comprehensive currency hedging strategy with respect to salary and rent expenses denominated in NIS. These transactions are at zero cost for periods of up to one year. The counterparties to the derivatives are major banks in Israel. As of June 30, 2019, the total hedged amount was NIS 1.8 million. The liability in the amount of $1 as of June 30, 2019 qualifies as hedge accounting. As of June 30, 2019, the Company has a lien in the amount of $282 on the Company’s marketable securities and a lien in the amount of $250 on the Company’s checking account, in respect of bank guarantees granted in order to secure the hedging transactions. |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 6 Months Ended |
Jun. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 4 - MARKETABLE SECURITIES Marketable securities as of June 30, 2019, and December 31, 2018 consisted mainly of debt and mutual funds securities. The debt securities are classified as available-for-sale and are recorded at fair value. Changes in fair value, net of taxes (if applicable), are reflected in other comprehensive loss. Realized gains and losses on sales of the securities, as well as premium or discount amortization, are included in the consolidated statement of operations as finance income or expenses. As of January 1, 2018, following the adoption of ASU No. 2016-01, Financial Instruments—Overall T June 30 December 31 2019 2018 Israeli mutual funds $ 1,011 $ 991 Certificates of deposit 1,589 2,773 U.S Government and agency bonds 11,413 25,215 U.S Treasury bills 499 18,241 Total $ 14,512 $ 47,220 As of June 30, 2019 and December 31, 2018, the fair value, cost and gross unrealized holding gains and losses of the marketable securities owned by the Company were as follows: June 30, 2019 Fair value Cost or amortized cost Gross unrealized holding losses Gross unrealized holding gains Certificates of deposit $ 1,589 $ 1,591 $ 2 $ - U.S Government and agency Bonds 11,413 11,411 - 2 U.S Treasury bills 499 499 - - Total $ 13,501 $ 13,501 $ 2 $ 2 December 31, 2018 Fair Cost or amortized cost Gross unrealized holding losses Gross unrealized holding gains Certificates of deposit $ 2,773 $ 2,790 $ 17 $ - U.S Government and agency Bonds 25,215 25,236 22 1 U.S Treasury bills 18,241 18,243 3 1 Total $ 46,229 $ 46,269 $ 42 $ 2 As of June 30, 2019, the unrealized losses attributed to the Company’s marketable securities were primarily due to credit spreads and interest rate movements. The Company has considered factors regarding other than temporary impaired securities and determined that there are no securities with impairment that is other than temporary as of June 30, 2019 and December 31, 2018. As of June 30, 2019 and December 31, 2018, the Company’s debt securities had the following maturity dates: Market value June 30, December 31, 2019 2018 Due within one year $ 13,501 $ 46,079 1 to 2 years - 150 Total $ 13,501 $ 46,229 During the six months ended June 30, 2019 and June 30, 2018 the Company received aggregate proceeds of $33,014 and $16,944, respectively, upon sale and maturity of marketable securities. $421 and $401 of the Company’s marketable securities were restricted as of June 30, 2019, and December 31, 2018, respectively, due to a lien in respect of bank guarantees granted to secure hedging transactions and the Company’s rental agreements. Refer to note 6 and note 3. |
SHARE CAPITAL_
SHARE CAPITAL: | 6 Months Ended |
Jun. 30, 2019 | |
Stockholders' Equity Note [Abstract] | |
SHARE CAPITAL | NOTE 5 - SHARE CAPITAL: Authorized shares On April 10, 2019, the Company’s shareholders approved an increase of the Company’s authorized Ordinary Shares from 90,000,000 shares previously approved to 135,000,000 shares, NIS 0.16 per share. Share based compensation Equity incentive plan: On April 10, 2019, the Company's shareholders approved a new equity incentive plan (the "Plan") replacing the previous plans approved in 2015 and 2009. The Plan included a pool of 6,027,990 Ordinary Shares for grant to Company employees, consultants, directors and other service providers. As of June 30, 2019, 5,525,416 shares remain available for grant under the Plan. Employee Share Purchase Plan: On April 10, 2019 the Company’s shareholders approved an employee share purchase plan (“ESPP”) pursuant to which qualified employees (as defined in the ESPP) may elect to purchase designated shares of the Company’s Ordinary Shares at a price equal to 85% of the lesser of the fair market value of Ordinary Shares at the beginning or end of each semi-annual share purchase period (“Purchase Period”). Employees are permitted to purchase the number of shares purchasable with up to 15% of the earnings paid (as such term is defined in the ESPP) to each of the participating employees during the Purchase Period, subject to certain limitations under Section 423 of the US Internal Revenue Code. The number of Ordinary Shares initially reserved for purchase under the ESPP was 5,400,000 Ordinary Shares. As of June 30, 2019, the Company has not issued any shares pursuant to the ESPP. In the six months ended June 30, 2019 and 2018, the Company granted options and RSUs as follows: Six months ended June 30, 2019 Award amount Exercise price range Vesting period Expiration Employees: Options 1,030,236 $2.66-$3.81 4 years 10 years RSUs 274,628 - 4 years - Directors: Options 247,060 $2.66 1 years 10 years RSUs 140,976 - 1 years - Six months ended June 30, 2018 Award amount Exercise price range Vesting period Expiration Employees: Options 571,530 $5.06-$6.40 4 years 10 years RSUs 126,844 - 4 years - Directors: Options 174,373 $5.02-$5.06 1 years 10 years RSUs 14,829 - 3 years - The fair value of options and RSUs granted to employees during the six months ended June 30, 2019, and the six months ended June 30, 2018 was $3,687 and $3,287, respectively. The fair value of RSUs granted is based on the share price on grant date. The fair value of options granted was computed, as of the grant date, using the Black-Scholes model. The underlying data used for computing the fair value of the options are as follows: Six months ended June 30 2019 2018 Value of ordinary share $ 2.66-$3.83 $ 5.12-$5.99 Dividend yield 0 % 0 % Expected volatility 60.40%-61.40 % 62.10%-62.60 % Risk-free interest rate 2.20%-2.62 % 2.75%-2.84 % Expected term 6 years 6 years The following table illustrates the effect of share-based compensation on the statements of operations: Six months ended June 30 Three months ended June 30 2019 2018 2019 2018 Research and development expenses $ 738 $ 1,303 $ 384 $ 412 Selling, general and administrative 1,599 1,651 1,004 788 $ 2,337 $ 2,954 $ 1,388 $ 1,200 |
COMMITMENTS
COMMITMENTS | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS | NOTE 6 - COMMITMENTS Operating lease agreements The Company leases office space for its headquarters and research and development facilities in Israel and the United States under several lease agreements. The lease agreement for the facilities in Israel is linked to the Israeli consumer price index (“CPI”) and due to expire in December 2020. The lease agreement in the United States was due to expire during March 2019. On March 13, 2019, the Company signed an amendment to the original lease agreement. The amendment includes an extension of the lease period of the 10,000 square feet currently leased under the original agreement (the "Current Space") and an addition of 4,639 square feet (the "Additional Space”). The Company will enter the Additional Space following a period of preparation by the lessor which is expected to be completed during August 2019 (the "Commencement Date"). On March 13, 2019, pursuant to the extension of the lease on the Current Space, the Company recognized an additional right of use asset and liability in the amount of $713. The Additional Space is considered a new lease agreement and will be recognized only on Commencement Date. As of June 30, 2019, the expected right of use asset and liability of the Additional Space to be recognized on the Commencement Date is $351. In July 2017, the Company entered into operating lease agreements in connection with the leasing of several vehicles. The lease periods are generally for three years and the payments are linked to the Israeli CPI. To secure the terms of the lease agreements, the Company has made certain prepayments to the leasing company, representing approximately three months of lease payments. These amounts have been recorded as part of the operating lease right to use assets. Operating lease costs for the three months ended June 30, 2019, are as follows: Six months ended June 30 Three months ended June 30 2019 2019 Office lease expenses $ 394 $ 212 Vehicles lease expenses $ 33 $ 8 Cash paid for amounts included in the measurement of lease liabilities are as follows: Six months ended June 30 Three months ended June 30 2019 2019 Office lease $ 389 $ 188 Vehicles lease $ 72 $ 36 Supplemental information related to leases are as follows: June 30 2019 Operating lease right-of-use assets 1,858 Operating lease liabilities 1,882 Weighted average remaining lease term 2.22 Weighted average discount rate 5.54 % Maturities of lease liabilities are as follows: 2019 511 2020 1,014 2021 326 2022 156 Total lease payments 2,007 Less imputed interest (125 ) Total lease liability 1,882 As of June 30, 2019, the Company had a lien in the amount of $139 on the Company’s marketable securities in respect of bank guarantees granted in order to secure the lease agreements. The Company elected the alternative modified transition method and included the following table previously disclosed. Future minimum lease commitments under non-cancelable operating lease agreements as of December 31, 2018 were as follows: 2019 $ 746 2020 682 2021 and thereafter 21 Total $ 1,449 |
ENTITY-WIDE DISCLOSURES_
ENTITY-WIDE DISCLOSURES: | 6 Months Ended |
Jun. 30, 2019 | |
Segment Reporting [Abstract] | |
ENTITY-WIDE DISCLOSURE: | NOTE 7 - ENTITY-WIDE DISCLOSURE: a. Net revenues by geographic area were as follows: Six months ended June 30 Three months ended June 30 2019 2018 2019 2018 United States $ - $ 62 $ - $ - Denmark 308 - - - Germany - 1,808 - 964 Total revenues $ 308 $ 1,870 $ - $ 964 b. Customers exceeding 10% of revenues: During the three and six months ended June 30, 2019 and June 30, 2018 the Company had one customer exceeding over 10% of total revenues. Revenues from the customer were $308 and $1,808 during the six months ended June 30, 2018, revenue from the customer was $964, and there was no corresponding revenue for the three months ended June 30, 2019. c. Net revenues by type of payment: Six months ended June 30 Three months ended June 30 2019 2018 2019 2018 Development service payments $ - $ 62 $ - $ - Royalties 308 1,808 - 964 Total revenues $ 308 $ 1,870 $ - $ 964 |
SUBSEQUENT EVENTS_
SUBSEQUENT EVENTS: | 6 Months Ended |
Jun. 30, 2019 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS: | NOTE 8 - SUBSEQUENT EVENTS: On July 29, 2019 (the “Closing date”) the Company secured up to $50 million in debt from two of its current shareholders (the “lenders ”) and entered into a Securities Purchase Agreement with one of the lenders for aggregate gross proceeds of approximately $14 million, before deducting offering expenses. The debt consists of term loans under a credit agreement (the “Credit Agreement”) and comprises of three trenches: (a) $15 million to be funded at closing (the “Tranche 1 Loan”), (b) up to $20 million available after the closing date but prior to February 29, 2020 (the “Tranche 2 Loan”) and (c) up to $15 million available after the closing date (the “Tranche 3 Loan”). The Company shall be permitted to borrow the Tranche 2 Loan only following (i) the FDA’s approval of the Company’s NDA for FMX101 and listing of FMX101 in the FDA’s “Orange Book,” and (ii) such time at which the Company has secured arrangements with a third party for the commercial supply and manufacture of FMX101. The Company shall be permitted to borrow the Tranche 3 Loan only following the achievement of certain revenue targets. Subject to any acceleration as provided in the Credit Agreement, including upon an event of default (as defined in the Credit Agreement), the credit facility will mature on July 29, 2024 and bear interest equal to the sum of (A) 8.25% (subject to increase in accordance with the terms of the Credit Agreement) plus (B) the greater of (x) the one-month LIBOR as of the second business day immediately preceding the first day of the calendar month or the date of borrowing (if such loan is not outstanding as of the first day of the calendar month), as applicable, and (y) 2.75%. A fee in an amount equal to 1.0% of the aggregate principal amount of all loans made on any given borrowing date shall be payable to the lenders. The Credit Agreement is secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets including intellectual property. The Credit Agreement contains certain financial covenants, including that the Company (1) at all times prior to FDA approval of FMX101 maintain a minimum aggregate cash balance of $15 million; (2) at all times on or after the date of FDA approval of FMX101 maintain a minimum aggregate cash balance of $2.5 million; and (3) as of the last day of each fiscal quarter commencing on the fiscal quarter ending September 30, 2020, receive revenue for the trailing 12-month period in amounts set forth in the Credit Agreement, which range from $10.5 million for the fiscal quarter ending September 30, 2020 to $109.5 million for the fiscal quarter ending June 30, 2024. Under the Credit Agreement, there are no required payments of principal amounts until July 2023. In connection with the Credit Agreement, on Closing date, the Company issued to the lender warrants to purchase up to an aggregate of 1,100,000 of its Ordinary Shares, at an exercise price of $2.09 per share, which represents the 5-day volume weighted average price as of the trading day immediately prior to the closing. The warrants are exercisable immediately following the closing of the Credit Agreement and are due to expire on July 29, 2026. Pu rsuant to the , the Company The Company is currently evaluating the impact of these transactions on the consolidated financial statements. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES: (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Principles of consolidation | a. Principles of consolidation The consolidated financial statements include the accounts of Foamix and its subsidiary. Intercompany balances and transactions including profits from intercompany sales not yet realized outside the Company have been eliminated upon consolidation. |
Fair value measurement | b. Fair value measurement Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data or active market data of similar or identical assets or liabilities. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. |
Loss per share | c. Loss per share Net loss per share, basic and diluted, is computed on the basis of the net loss for the period divided by the weighted average number of Ordinary Shares outstanding during the period. Diluted net loss per share is based upon the weighted average number of Ordinary Shares and of Ordinary Share equivalents outstanding when dilutive. Ordinary Share equivalents include outstanding stock options and warrants which are included under the treasury share method when dilutive. The following average share options and restricted share units (“RSUs”) were excluded from the calculation of diluted net loss per Ordinary Share because their effect would have been anti-dilutive for the periods presented (share data): Six months ended June 30 Three months ended June 30 2019 2018 2019 2018 Outstanding share options and RSUs 5,873,725 4,618,821 6,130,069 4,857,234 Warrants - 369,828 - 743,764 |
Newly issued and recently adopted accounting pronouncements: | d. Newly issued and recently adopted accounting pronouncements Accounting pronouncements adopted in period: 1) In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2016-02, Leases (Topic 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). The new standard requires lessees to record assets and liabilities on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The Company adopted the standard as of January 1, 2019 on a modified retrospective basis and did not restate comparative periods. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed the Company to carryforward the historical lease classification and not separate lease and non-lease components for the leases. The Company recognizes the lease payments in the consolidated statements of operations on a straight-line basis over the lease period. The adoption of the standard resulted in recognition of $1,357 of lease assets and lease liabilities as of January 1, 2019 on the Company’s consolidated balance sheets. 2) In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718) Improvements to Nonemployee Share-based Payments. This ASU was issued to simplify the accounting for share-based transactions by expanding the scope of Topic 718 from only being applicable to share-based payments to employees to also include share-based payment transactions for acquiring goods and services from nonemployees. As a result, nonemployee share-based transactions will be measured by estimating the fair value of the equity instruments at the grant date, taking into consideration the probability of satisfying performance conditions. This standard, adopted as of January 1, 2019, had no material impact on the Company’s consolidated financial statements. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES: (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Schedule of anti-dilutive securities | The following average share options and restricted share units (“RSUs”) were excluded from the calculation of diluted net loss per Ordinary Share because their effect would have been anti-dilutive for the periods presented (share data): Six months ended June 30 Three months ended June 30 2019 2018 2019 2018 Outstanding share options and RSUs 5,873,725 4,618,821 6,130,069 4,857,234 Warrants - 369,828 - 743,764 |
FAIR VALUE PRESENTATION (Tables
FAIR VALUE PRESENTATION (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities that are measured at fair value | The Company’s assets and liabilities that are measured at fair value as of June 30, 2019 and December 31, 2018 are classified in the tables below in one of the three categories described in note 2b above: June 30, 2019 Level 1 Level 2 Total Marketable securities $ 1,011 $ 13,501 $ 14,512 Currency options designated as hedging instruments (current liability) $ - $ (1 ) (1 ) December 31, 2018 Level 1 Level 2 Total Marketable securities $ 991 $ 46,229 $ 47,220 Currency options designated as hedging instruments (current liability) $ - $ (3 ) $ (3 ) |
MARKETABLE SECURITIES (Tables)
MARKETABLE SECURITIES (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of marketable securities | T June 30 December 31 2019 2018 Israeli mutual funds $ 1,011 $ 991 Certificates of deposit 1,589 2,773 U.S Government and agency bonds 11,413 25,215 U.S Treasury bills 499 18,241 Total $ 14,512 $ 47,220 |
Schedule of the fair value, cost and gross unrealized holding gains of the securities owned | As of June 30, 2019 and December 31, 2018, the fair value, cost and gross unrealized holding gains and losses of the marketable securities owned by the Company were as follows: June 30, 2019 Fair value Cost or amortized cost Gross unrealized holding losses Gross unrealized holding gains Certificates of deposit $ 1,589 $ 1,591 $ 2 $ - U.S Government and agency Bonds 11,413 11,411 - 2 U.S Treasury bills 499 499 - - Total $ 13,501 $ 13,501 $ 2 $ 2 December 31, 2018 Fair Cost or amortized cost Gross unrealized holding losses Gross unrealized holding gains Certificates of deposit $ 2,773 $ 2,790 $ 17 $ - U.S Government and agency Bonds 25,215 25,236 22 1 U.S Treasury bills 18,241 18,243 3 1 Total $ 46,229 $ 46,269 $ 42 $ 2 |
Schedule of maturity dates of debt securities | As of June 30, 2019 and December 31, 2018, the Company’s debt securities had the following maturity dates: Market value June 30, December 31, 2019 2018 Due within one year $ 13,501 $ 46,079 1 to 2 years - 150 Total $ 13,501 $ 46,229 |
SHARE CAPITAL_ (Tables)
SHARE CAPITAL: (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Stockholders' Equity Note [Abstract] | |
Schedule of options and RSUs granted to employees, directors and non-employees | In the six months ended June 30, 2019 and 2018, the Company granted options and RSUs as follows: Six months ended June 30, 2019 Award amount Exercise price range Vesting period Expiration Employees: Options 1,030,236 $2.66-$3.81 4 years 10 years RSUs 274,628 - 4 years - Directors: Options 247,060 $2.66 1 years 10 years RSUs 140,976 - 1 years - Six months ended June 30, 2018 Award amount Exercise price range Vesting period Expiration Employees: Options 571,530 $5.06-$6.40 4 years 10 years RSUs 126,844 - 4 years - Directors: Options 174,373 $5.02-$5.06 1 years 10 years RSUs 14,829 - 3 years - |
Schedule of underlying data used for computing the fair value of the options | The fair value of options granted was computed, as of the grant date, using the Black-Scholes model. The underlying data used for computing the fair value of the options are as follows: Six months ended June 30 2019 2018 Value of ordinary share $ 2.66-$3.83 $ 5.12-$5.99 Dividend yield 0 % 0 % Expected volatility 60.40%-61.40 % 62.10%-62.60 % Risk-free interest rate 2.20%-2.62 % 2.75%-2.84 % Expected term 6 years 6 years |
Schedule of share-based compensation | The following table illustrates the effect of share-based compensation on the statements of operations: Six months ended June 30 Three months ended June 30 2019 2018 2019 2018 Research and development expenses $ 738 $ 1,303 $ 384 $ 412 Selling, general and administrative 1,599 1,651 1,004 788 $ 2,337 $ 2,954 $ 1,388 $ 1,200 |
COMMITMENTS (Tables)
COMMITMENTS (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Operating lease expense | Operating lease costs for the three months ended June 30, 2019, are as follows: Six months ended June 30 Three months ended June 30 2019 2019 Office lease expenses $ 394 $ 212 Vehicles lease expenses $ 33 $ 8 |
Schedule of Cash Paid for Lease Liabilities | Cash paid for amounts included in the measurement of lease liabilities are as follows: Six months ended June 30 Three months ended June 30 2019 2019 Office lease $ 389 $ 188 Vehicles lease $ 72 $ 36 |
Schedule of Supplemental Information Related to Leases | Supplemental information related to leases are as follows: June 30 2019 Operating lease right-of-use assets 1,858 Operating lease liabilities 1,882 Weighted average remaining lease term 2.22 Weighted average discount rate 5.54 % |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities are as follows: 2019 511 2020 1,014 2021 326 2022 156 Total lease payments 2,007 Less imputed interest (125 ) Total lease liability 1,882 |
Schedule of Future Minimum Lease Commitments | Future minimum lease commitments under non-cancelable operating lease agreements as of December 31, 2018 were as follows: 2019 $ 746 2020 682 2021 and thereafter 21 Total $ 1,449 |
ENTITY-WIDE DISCLOSURES_ (Table
ENTITY-WIDE DISCLOSURES: (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Segment Reporting [Abstract] | |
Schedule of net revenues by geographic area | a. Net revenues by geographic area were as follows: Six months ended June 30 Three months ended June 30 2019 2018 2019 2018 United States $ - $ 62 $ - $ - Denmark 308 - - - Germany - 1,808 - 964 Total revenues $ 308 $ 1,870 $ - $ 964 |
Schedule of Net Revenues by Payment Type | c. Net revenues by type of payment: Six months ended June 30 Three months ended June 30 2019 2018 2019 2018 Development service payments $ - $ 62 $ - $ - Royalties 308 1,808 - 964 Total revenues $ 308 $ 1,870 $ - $ 964 |
NATURE OF OPERATIONS AND BASI_2
NATURE OF OPERATIONS AND BASIS OF PRESENTATION: (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ 215,409 | $ 249,606 |
Minimum period for which Company's cash and cash equivalents and available for sale securities will allow to fund its operating plan | 12 months |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES: (Schedule of Anti-Dilutive Securities) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jan. 02, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Lease assets and lease liabilities | $ 1,357 | ||||
Options and RSUs [Member] | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Average shares excluded from the computation of diluted net loss per share, because the effect of their inclusion in the computation would be anti-dilutive | 6,130,069 | 4,857,234 | 5,873,725 | 4,618,821 | |
Warrants [Member] | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Average shares excluded from the computation of diluted net loss per share, because the effect of their inclusion in the computation would be anti-dilutive | 743,764 | 369,828 |
FAIR VALUE PRESENTATION (Schedu
FAIR VALUE PRESENTATION (Schedule of Assets and Liabilities Measured at Fair Value) (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 14,512 | $ 47,220 |
Currency options designated as hedging instruments (current liabilities) | (1) | (3) |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 1,011 | 991 |
Currency options designated as hedging instruments (current liabilities) | ||
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 13,501 | 46,229 |
Currency options designated as hedging instruments (current liabilities) | $ (1) | $ (3) |
FAIR VALUE PRESENTATION (Narrat
FAIR VALUE PRESENTATION (Narrative) (Details) - 6 months ended Jun. 30, 2019 ₪ in Thousands, $ in Thousands | USD ($) | ILS (₪) |
FAIR VALUE MEASURMENTS [Abstract] | ||
Currency hedging transactions, maximum term | 1 year | |
Total hedged amount | ₪ | ₪ 1,800 | |
Derivative liability | $ 1 | |
Foreign exchange risk lien on marketable securities for bank guarantees granted to secure hedging transactions | 282 | |
Foreign exchange risk lien on checking account for bank guarantees granted to secure hedging transactions | $ 250 |
MARKETABLE SECURITIES (Schedule
MARKETABLE SECURITIES (Schedule of Marketable Securities) (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | $ 14,512 | $ 47,220 |
Israeli mutual funds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | 1,011 | 991 |
Certificates of deposit [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | 1,589 | 2,773 |
U.S. Goverment and agency bonds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | 11,413 | 25,215 |
U.S Treasury bills [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | $ 499 | $ 18,241 |
MARKETABLE SECURITIES (Schedu_2
MARKETABLE SECURITIES (Schedule of Fair Value, Cost and Gross Unrealized Holding Gains of Securities Owned) (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | $ 14,512 | $ 47,220 |
Cost or amortized cost | 13,501 | 46,269 |
Gross unrealized holding losses | 2 | 42 |
Gross unrealized holding gains | 2 | 2 |
Certificates of deposit [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | 1,589 | 2,773 |
Cost or amortized cost | 1,591 | 2,790 |
Gross unrealized holding losses | 2 | 17 |
Gross unrealized holding gains | ||
U.S. Goverment and agency bonds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | 11,413 | 25,215 |
Cost or amortized cost | 11,411 | 25,236 |
Gross unrealized holding losses | 22 | |
Gross unrealized holding gains | 2 | 1 |
U.S Treasury bills [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | 499 | 18,241 |
Cost or amortized cost | 499 | 18,243 |
Gross unrealized holding losses | 3 | |
Gross unrealized holding gains | $ 1 |
MARKETABLE SECURITIES (Schedu_3
MARKETABLE SECURITIES (Schedule of Maturity Dates of Debt Securities) (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Investments, Debt and Equity Securities [Abstract] | ||
Due within one year | $ 13,501 | $ 46,079 |
1 to 2 years | 150 | |
Total | $ 13,501 | $ 46,229 |
MARKETABLE SECURITIES (Narrativ
MARKETABLE SECURITIES (Narrative) (Details) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Secondary Offering [Member] | |||
Proceeds from sale and maturity of marketable securities | $ 33,014 | $ 16,944 | |
Marketable securities restricted | $ 421 | $ 401 | |
Adjustment in accumulated deficit | $ 35 |
SHARE CAPITAL_ (Narrative) (Det
SHARE CAPITAL: (Narrative) (Details) $ in Thousands | 6 Months Ended | ||||
Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019₪ / sharesshares | Apr. 10, 2019₪ / sharesshares | Dec. 31, 2018₪ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Ordinary shares, par value (in NIS per share) | ₪ / shares | ₪ 0.16 | ₪ 0.16 | ₪ 0.16 | ||
Ordinary shares, shares authorized | 135,000,000 | 90,000,000 | 90,000,000 | ||
Share options [Member] | Employees and directors [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Fair value of options granted | $ | $ 3,687 | $ 3,287 | |||
New equity incentive plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares available for grant | 5,525,416 | ||||
Number of shares authorized under the plan | 6,027,990 | ||||
ESPP [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares available for grant | 5,400,000 | ||||
Rate of ordinary shares for qualified employees | 85.00% | ||||
Percentage of number of shares purchasable | 15.00% | ||||
Previously approved [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Ordinary shares, par value (in NIS per share) | ₪ / shares | ₪ 0.16 | ||||
Ordinary shares, shares authorized | 135,000,000 |
SHARE CAPITAL_ (Schedule of Opt
SHARE CAPITAL: (Schedule of Options and RSUs Granted to Employees and Non-employees) (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Share options [Member] | Employee [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Award amount | 1,030,236 | 571,530 |
Exercise price range, minimum | $ 2.66 | $ 5.06 |
Exercise price range, maximum | $ 3.81 | $ 6.40 |
Vesting period | 4 years | 4 years |
Expiration period | 10 years | 10 years |
Share options [Member] | Director [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Award amount | 247,060 | 174,373 |
Exercise price range, minimum | $ 5.02 | |
Exercise price range, maximum | $ 5.06 | |
Exercise price | $ 2.66 | |
Vesting period | 1 year | 1 year |
Expiration period | 10 years | 10 years |
RSUs [Member] | Employee [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Award amount | 274,628 | 126,844 |
Vesting period | 4 years | 4 years |
RSUs [Member] | Director [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Award amount | 140,976 | 14,829 |
Vesting period | 1 year | 3 years |
SHARE CAPITAL_ (Schedule of Und
SHARE CAPITAL: (Schedule of Underlying Data Used for Computing the Fair Value of the Options) (Details) - Share options [Member] - Employees and directors [Member] - $ / shares | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility, minimum | 60.40% | 62.10% |
Expected volatility, maximum | 61.40% | 62.60% |
Risk-free interest rate, minimum | 2.20% | 2.75% |
Risk-free interest rate, maximum | 2.62% | 2.84% |
Expected term | 6 years | 6 years |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Value of ordinary share | $ 2.66 | $ 5.12 |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Value of ordinary share | $ 3.83 | $ 5.99 |
SHARE CAPITAL_ (Schedule of Sha
SHARE CAPITAL: (Schedule of Share-based Compensation) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation | $ 1,388 | $ 1,200 | $ 2,337 | $ 2,954 |
Research and development expenses [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation | 384 | 412 | 738 | 1,303 |
Selling, general and administrative [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation | $ 1,004 | $ 788 | $ 1,599 | $ 1,651 |
COMMITMENTS (Schedule of Operat
COMMITMENTS (Schedule of Operating lease expense) (Details) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019USD ($) | Jun. 30, 2019USD ($) | |
Lessee, Lease, Description [Line Items] | ||
Additional right of use asset and liability recognized on Current Space | $ 713 | |
Expected right of use asset and liability of the Additional Space to be recognized on the Commencement Date | $ 351 | 351 |
Office Building [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease cost | 212 | 394 |
Vehicle [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease cost | $ 8 | $ 33 |
COMMITMENTS (Schedule of Cash p
COMMITMENTS (Schedule of Cash paid for lease liabilities) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019 | Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Office lease | $ 188 | $ 389 |
Vehicles lease | $ 36 | $ 72 |
COMMITMENTS (Schedule of Supple
COMMITMENTS (Schedule of Supplemental Information Related to Leases) (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use assets | $ 1,858 | |
Operating lease liabilities | $ 1,882 | |
Weighted average remaining lease term | 2 years 2 months 19 days | |
Weighted average discount rate | 5.54% |
COMMITMENTS (Schedule of Maturi
COMMITMENTS (Schedule of Maturities of Lease Liabilities) (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Commitments and Contingencies Disclosure [Abstract] | ||
2019 | $ 511 | |
2020 | 1,014 | |
2021 | 326 | |
2022 | 156 | |
Total | 2,007 | |
Less imputed interest | (125) | |
Total lease liability | 1,882 | |
Restricted investments in marketable securities | $ 139 | $ 133 |
COMMITMENTS (Schedule of Future
COMMITMENTS (Schedule of Future Minimum Lease Commitments) (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2019 | $ 746 |
2020 | 682 |
2021 and thereafter | 21 |
Total | $ 1,449 |
ENTITY-WIDE DISCLOSURES_ (Sched
ENTITY-WIDE DISCLOSURES: (Schedule of Net Revenues by Geographic Area) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Total revenues | $ 964 | $ 308 | $ 1,870 | |
United States [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Total revenues | 62 | |||
Denmark [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Total revenues | 308 | |||
Germany [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Total revenues | $ 964 | $ 1,808 |
ENTITY-WIDE DISCLOSURES_ (Sch_2
ENTITY-WIDE DISCLOSURES: (Schedule of Net Revenues by Payment Type) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenue, Major Customer [Line Items] | ||||
Total revenues | $ 964 | $ 308 | $ 1,870 | |
Revenue [Member] | Development Service Payments [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Total revenues | 62 | |||
Revenue [Member] | Royalties [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Total revenues | $ 964 | $ 308 | $ 1,808 |
SUBSEQUENT EVENTS_ (Details)
SUBSEQUENT EVENTS: (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Jul. 29, 2019 | Jun. 30, 2024 | Sep. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Subsequent Event [Line Items] | |||||||
Revenue received | $ 964 | $ 308 | $ 1,870 | ||||
Shares issued during the period, value | $ 16,131 | $ 16,131 | |||||
Subsequent Event [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Debt instrument face amount | $ 50,000 | ||||||
Maturity date | Jul. 29, 2024 | ||||||
Interest rate | 8.25% | ||||||
Fee amount | 1.00% | ||||||
Revenue received | $ 109,500 | $ 10,500 | |||||
Warrants issued to purchase ordinary shares | 1,100,000 | ||||||
Exercise price | $ 2.09 | ||||||
Warrants expiration date | Jul. 29, 2026 | ||||||
Subsequent Event [Member] | Securities Purchase Agreement with one of shareholders [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Gross proceeds from Securities Purchase Agreement with lender | $ 1,400,000 | ||||||
Shares issued during the period | 6,542,057 | ||||||
Shares issued price per share | $ 2.14 | ||||||
Shares issued during the period, value | $ 14,000 | ||||||
Subsequent Event [Member] | Minimum [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Interest rate | 2.75% | ||||||
Minimum aggregate cash balance to maintain after FDA approval | $ 2,500 | ||||||
Subsequent Event [Member] | Maximum [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Minimum aggregate cash balance to maintain after FDA approval | 15,000 | ||||||
Subsequent Event [Member] | Tranche 1 Loan [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Debt instrument face amount | 15,000 | ||||||
Subsequent Event [Member] | Tranche 2 Loan [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Debt instrument face amount | 20,000 | ||||||
Subsequent Event [Member] | Tranche 3 Loan [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Debt instrument face amount | $ 15,000 |