Document and Entity Information
Document and Entity Information | 12 Months Ended |
Dec. 31, 2018shares | |
Document And Entity Information | |
Entity Registrant Name | SOL-GEL TECHNOLOGIES LTD. |
Entity Central Index Key | 0001684693 |
Document Type | 20-F |
Document Period End Date | Dec. 31, 2018 |
Amendment Flag | false |
Current Fiscal Year End Date | --12-31 |
Is Entity a Well-known Seasoned Issuer? | No |
Is Entity a Voluntary Filer? | No |
Is Entity's Reporting Status Current? | Yes |
Entity Filer Category | Non-accelerated Filer |
Entity Shell Company | false |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | false |
Entity Common Stock, Shares Outstanding | 18,949,968 |
Document Fiscal Period Focus | FY |
Document Fiscal Year Focus | 2018 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 5,325 | $ 5,024 |
Bank deposit | 1,000 | 4,000 |
Marketable securities | 56,662 | |
Prepaid expenses and other current assets | 2,987 | 1,524 |
TOTAL CURRENT ASSETS | 65,974 | 10,548 |
NON-CURRENT ASSETS: | ||
Long term receivables | 1,653 | |
Restricted long term deposits | 462 | 120 |
Property and equipment, net | 2,604 | 2,314 |
Funds in respect of employee rights upon retirement | 642 | 680 |
TOTAL NON-CURRENT ASSETS | 3,708 | 4,767 |
TOTAL ASSETS | 69,682 | 15,315 |
CURRENT LIABILITIES: | ||
Accounts payable | 2,924 | 534 |
Other account payable | 1,971 | 1,332 |
Loans from the controlling shareholder | 65,338 | |
TOTAL CURRENT LIABILITIES | 4,895 | 67,204 |
LONG-TERM LIABILITIES - | ||
Liability for employee rights upon retirement | 878 | 810 |
TOTAL LONG-TERM LIABILITIES | 878 | 810 |
COMMITMENTS | ||
TOTAL LIABILITIES | 5,773 | 68,014 |
SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY): | ||
Ordinary shares, NIS 0.1 par value - authorized: 50,000,000 as of December 31, 2017 and 2018, respectively; issued and outstanding: 6,290,244 and 18,949,968 as of December 31, 2017 and December 31, 2018, respectively | 520 | 82 |
Additional paid-in capital | 190,853 | 42,480 |
Accumulated deficit | (127,464) | (95,261) |
TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) | 63,909 | (52,699) |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (NET OF CAPITAL DEFICIENCY) | $ 69,682 | $ 15,315 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - ₪ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Ordinary shares, par value per share | ₪ 0.1 | ₪ 0.1 |
Ordinary shares, shares authorized | 50,000,000 | 50,000,000 |
Ordinary shares, shares issued | 18,949,968 | 6,290,244 |
Ordinary shares, shares outstanding | 18,949,968 | 6,290,244 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Statement [Abstract] | |||
REVENUES | $ 129 | $ 174 | |
OPERATING EXPENSES | |||
Research and Development | 28,146 | 25,805 | 17,023 |
General and Administrative | 5,504 | 6,002 | 3,733 |
TOTAL OPERATING LOSS | 33,521 | 31,633 | 20,756 |
FINANCIAL EXPENSES (INCOME), net | (1,318) | (65) | 15 |
LOSS FOR THE YEAR | $ 32,203 | $ 31,568 | $ 20,771 |
BASIC AND DILUTED LOSS PER ORDINARY SHARE | $ 1.8 | $ 5.02 | $ 3.3 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE | 17,867,589 | 6,290,244 | 6,290,242 |
STATEMENTS OF CHANGES IN SHAREH
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) - USD ($) $ in Thousands | Ordinary shares [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total | ||
Balance at Dec. 31, 2015 | $ 82 | $ 31,322 | $ (42,922) | $ (11,518) | ||
Balance, shares at Dec. 31, 2015 | 6,290,242 | |||||
Loss for the year | (20,771) | (20,771) | ||||
Share-based compensation | 952 | 952 | ||||
Balance at Dec. 31, 2016 | $ 82 | 32,274 | (63,693) | (31,337) | ||
Balance, shares at Dec. 31, 2016 | 6,290,242 | |||||
Loss for the year | (31,568) | (31,568) | ||||
Issuance of shares due to in- process research and development acquired | [1] | 6,232 | 6,232 | |||
Issuance of shares due to in- process research and development acquired, shares | 2 | |||||
Share-based compensation | 3,974 | 3,974 | ||||
Balance at Dec. 31, 2017 | $ 82 | 42,480 | (95,261) | $ (52,699) | ||
Balance, shares at Dec. 31, 2017 | 6,290,244 | 6,290,244 | ||||
Loss for the year | (32,203) | $ (32,203) | ||||
Stock split | $ 66 | (66) | ||||
Stock split, shares | [1] | |||||
Conversion of loans from the Controlling shareholder | $ 160 | 65,178 | 65,338 | |||
Conversion of loans from the Controlling shareholder, shares | 5,444,825 | |||||
Issuance of shares through an initial public offering, net of issuance costs | $ 211 | 78,564 | 78,775 | |||
Issuance of shares through an initial public offering, net of issuance costs, shares | 7,187,500 | |||||
Exercise of options granted to employee | $ 1 | 43 | 44 | |||
Exercise of options granted to employee, shares | 27,399 | |||||
Share-based compensation | 4,654 | 4,654 | ||||
Balance at Dec. 31, 2018 | $ 520 | $ 190,853 | $ (127,464) | $ 63,909 | ||
Balance, shares at Dec. 31, 2018 | 18,949,968 | 18,949,968 | ||||
[1] | Less than 1,000. |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Loss | $ (32,203) | $ (31,568) | $ (20,771) |
Adjustments required to reconcile loss to net cash used in operating activities: | |||
Depreciation | 762 | 471 | 359 |
Changes in accrued liability for employee rights upon retirement | 106 | 30 | 68 |
Share-based compensation | 4,654 | 3,974 | 952 |
Changes in fair value of marketable securities | 29 | ||
In-process research and development acquired | 6,232 | ||
Finance expenses, net | (34) | (50) | 8 |
Changes in operating asset and liabilities: | |||
Prepaid expenses and other current assets | (1,463) | (229) | (426) |
Accounts payable, accrued expenses and other | 3,029 | (2,486) | 2,505 |
Long term receivables | 1,653 | (463) | (1,190) |
Net cash used in operating activities | (23,467) | (24,089) | (18,495) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchase of property and equipment | (1,052) | (1,925) | (385) |
Bank deposits | 3,000 | (4,000) | |
Restricted long term deposits | 8 | (13) | (15) |
Investments in marketable securities | (71,783) | ||
Proceeds from sales and maturity of marketable securities | 15,092 | ||
Amounts funded in respect of employee rights upon retirement | 9 | ||
Net cash used in investing activities | (54,735) | (5,938) | (391) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Exercise of options | 44 | ||
Initial public offering, net of issue cost | 78,775 | ||
Loans received from the controlling shareholder | 28,000 | 20,000 | |
Net cash provided by financing activities | 78,819 | 28,000 | 20,000 |
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS | 34 | 50 | (8) |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 651 | (1,977) | 1,106 |
CASH AND CASH EQUIVALENTS AT BEGINNING OF THE YEAR | 5,024 | 7,001 | 5,895 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE YEAR | 5,675 | 5,024 | 7,001 |
Cash and Cash equivalents | 5,325 | 5,024 | 7,001 |
Restricted cash | 350 | ||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH SHOWN IN STATEMENT OF CASH FLOWS | 5,675 | 5,024 | 7,001 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | |||
Purchase of property and equipment | 62 | 10 | |
Conversion of loans from the controlling shareholder | 65,338 | ||
Acquisition of in-process research and development product candidate | 6,232 | ||
SUPPLEMENTARY INFORMATION: | |||
Interest received | $ 1,477 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | NOTE 1 — NATURE OF OPERATIONS Sol-Gel Technologies Ltd. (hereafter — the Company) is an Israeli Company incorporated in 1997. The Company is a clinical stage specialty pharmaceutical company focused on developing and commercializing topical dermatological drug products. The Company’s lead product candidates are based upon its proprietary microencapsulation delivery system, consisting of microcapsules made of precipitated silica. In addition to these novel product candidates, the Company’s product pipeline includes generic product candidates. In 2007, the Company granted rights to a third party for use and commercialization of a product for skin protection. Under this agreement, the Company is entitled to royalties during the years 2016 to 2024. Based on current sales, royalties are not material. On August 4, 2014, 100% of the Company’s shares were acquired by its current controlling shareholder (the “Controlling Shareholder”). In January 2018, the Company completed an IPO on the NASDAQ Stock Market, in which it issued 6,250,000 Ordinary shares at a price per share of $12. During February 2018 the underwriters exercised their green shoe option and purchased additional 937,500 ordinary shares at the same price per share. The net proceeds received from the IPO were approximately $78,800, after deducting underwriting discounts, commissions and other offering expenses. See also note 8. Immediately prior to the closing of the IPO, the outstanding promissory note were automatically converted into 5,444,825 Ordinary shares of the Company based on the IPO price of $12 per ordinary share. See also note 7. The Company has been engaged in development activities since its incorporation. Since incorporation through December 31, 2018, the Company has an accumulated deficit of approximately $127,464 and its activities have been funded mainly by its shareholders. The Company's cash and cash equivalents, bank deposits and marketable securities as of December 31, 2018 will allow the Company to fund its operating plan through at least the next 12 months following the date of this report. However, the Company expects to continue to incur significant research and development and other costs related to its ongoing operations and in order to continue its future operations, the Company will need to obtain additional funding until becoming profitable . In September 2018, the Company established a wholly owned subsidiary in the United States. As of December 31, 2018 the subsidiary is still inactive. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 — SIGNIFICANT ACCOUNTING POLICIES a. Basis of presentation The Company’s financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). b. Use of estimates in the preparation of financial statements The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results may differ from those estimates. As applicable to these financial statements, the most significant estimates and assumptions relate to the fair value of share-based compensation. c. Functional and presentation currency The U.S. dollar (“dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted. The Company’s financing has been provided in dollars, revenues are expected to be primarily in dollars and a significant part of expenses are incurred in dollars. The financial statements are presented in dollars, which is the Company’s functional and presentation currency. Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items in the statements of operations (indicated below), the following exchange rates are used: (I) for transactions — exchange rates at transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation) — historical exchange rates. Currency transaction gains and losses are presented in financial income or expenses, as appropriate. d. Cash and cash equivalents The Company considers as cash equivalents all short-term, highly liquid investments, which include short-term bank deposits with original maturities of three months or less from the date of purchase that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash. e. Bank deposits f. Marketable securities g. Marketable securities The Company carries out transactions involving foreign currency exchange derivative financial instruments. The transactions are designed to hedge the Company’s exposure in currencies other than the U.S. dollar. The derivative does not meet the definition of a cash flow accounting hedge, therefore the changes in the fair value are included in financial expense (income), net. As of December 31, 2018, the Company has $350 on the Company’s bank account that is restricted in order to secure the hedging transactions. This amount is presented among Restricted long term deposits. h. Property and equipment: 1) Property and equipment are stated at cost, net of accumulated depreciation and amortization. 2) The Company’s property and equipment are depreciated utilizing the straight-line method on the basis of their estimated useful life. Annual rates of depreciation are as follows: % Laboratory equipment 10 – 33 (mainly 15 – 25) Office equipment and furniture 7 – 15 Computers and related equipment 33 Leasehold improvements are amortized utilizing the straight-line method over the shorter of the expected lease term or the estimated useful life of the improvements. i. Impairment of long-lived assets The Company tests long-lived assets for impairment whenever events or circumstances present an indication of impairment. If the sum of expected future cash flows (undiscounted and without interest charges) of the assets is less than the carrying amount of such assets, an impairment loss would be recognized. The assets would then be written down to their estimated fair values. For the three years ended December 31, 2018, the Company did not recognize an impairment loss for its long-lived assets. j. Share-based compensation The Company accounts for employees’ share-based payment awards classified as equity awards using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period. The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the accelerated method based on the multiple-option award approach. When options are granted as consideration for services provided by consultants and other non-employees, the grant is accounted for based on the fair value of the consideration received or the fair value of the options issued, whichever is more reliably measurable. The fair value of the options granted is measured on a final basis at the end of the related service period and is recognized over the related service period using the straight-line method. The company has elected to recognize forfeitures as they occur. k. Research and development expenses Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, lab expenses, consumable equipment and consulting fees. All costs associated with research and developments are expensed as incurred. Acquisitions of in-process research and development product candidate, which are not part of business combination, are recognized as an expense as research and development expenses as incurred. Grants received from Israel Innovation Authority (hereafter — “IIA”), formerly known as the Office of the Chief Scientist of the Ministry of Economy and Industry, or the OCS are recognized when the grant becomes receivable, provided there is reasonable assurance that the Company will comply with the conditions attached to the grant and there is reasonable assurance the grant will be received. The grant is deducted from the research and development expenses as the applicable costs are incurred. See note 6a(1). Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. The Company out sources its clinical trial activities utilizing external entities such as clinical research organizations, independent clinical investigators, and other third-party service providers to assist the Company with the execution of its clinical trials. Clinical trial costs are expensed as incurred. l. Revenue recognition On January 1, 2018 the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). According to the standard, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the performance obligation is satisfied. An entity only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer, after considering any price concession expected to be provided to the customer, when applicable. At contract inception, the entity assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The entity then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The adoption of the new standards did not change the Company’s revenue recognition as the majority of the Company’s revenues in 2018 were royalties from rights for use and commercialization of a product for skin protection granted to a third party. The Company does not have future performance obligations under the license arrangements. The revenues are recorded based on the sales that occurred during the relevant period provided by the licensee. m. Income taxes: 1) Deferred taxes 2) Uncertainty in income taxes The Company follows a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the available evidence indicates that it is more likely than not that the position will be sustained based on technical merits. If this threshold is met, the second step is to measure the tax position as the largest amount that has more than a 50% likelihood of being realized upon ultimate settlement. n. Loss per share Basic loss per share 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 loss per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents outstanding when dilutive. Ordinary share equivalents include outstanding stock options and RSUs, which are included under the treasury stock method when dilutive. The calculation of diluted loss per share does not include 349,740, 673 , o. 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. 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. The carrying amount of the cash and cash equivalents, bank deposits, restricted cash, restricted long term deposits, accrued expenses and other liabilities approximates their fair value. p. Concentration of credit risks Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash and cash equivalents, bank deposits and marketable securities and certain receivables. The Company deposits cash and cash equivalents with highly rated financial institutions (Israeli banks). In addition, all marketable securities carry a high rating or are government insured. The Company has not experienced any material credit losses in these accounts and does not believe it is exposed to significant credit risk on these instruments. q. Newly issued and recently adopted accounting pronouncements: 1) Recently adopted accounting pronouncements a. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a Consensus of the FASB Emerging Issues Task Force) (“ASU 2016-18”), which requires entities to include amounts generally described as restricted cash and restricted cash equivalents in cash and cash equivalents when reconciling beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for annual reporting periods (including interim periods within those annual reporting periods) beginning after December 15, 2017. This resulted in a decrease to net cash used in investing activities of $350 in 2018. b. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10), which addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. The amended guidance requires changes in the fair value of equity investments to be recognized through net income, rather than other comprehensive income. Adoption of the standard will be applied through a cumulative one-time adjustment to retained earnings. This standard was adopted on January 1, 2018 and its accumulative adjustment had no material impact on the Company's financial statements. In addition, in February 2018, the FASB issued ASU No. 2018-03 which includes technical corrections and improvements to clarify the guidance in ASU No. 2016-01. This standard, adopted as of January 1, 2018, had no material impact on the Company’s financial statements. 2) Newly issued accounting pronouncements: a. In February 2016, the FASB issued 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 plans to adopt the standard as of January 1, 2019 on a modified retrospective basis and will not restate comparative periods. The Company will elect the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allows the Company to carryforward the historical lease classification. The Company will make an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet. The Company will recognize those lease payments in the Statements of Operations on a straight-line basis over the lease period. The Company expects that adoption of the standard will result in recognition of approximately $1,200 of lease assets and lease liabilities as of January 1, 2019 on the Company’s balance Sheets. b. In June 2018, the FASB issued ASU 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting” that expands the scope of ASC Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of ASC Topic 718 to nonemployee awards except for certain exemptions specified in the amendment. The guidance is effective for fiscal years beginning after December 15, 2018, including interim reporting periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company does not expect to have a material impact on its financial statements. |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 12 Months Ended |
Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 3 — MARKETABLE SECURITIES The following table sets forth the Company’s marketable securities for the indicated period: December 31, 2018 Level 2 securities: U.S government and agency bonds $ 7,933 Canada government bonds 1,009 Other foreign government bonds 5,259 Corporate bonds* 42,461 Total $ 56,662 * Investments in Corporate bonds rated A or higher . 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. The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the year ended December 31, 2018: Marketable securities Balance at beginning of the year $ - Additions 71,783 Sale or maturity (15,092 ) Changes in fair value during the year (29 ) Balance at end of the period $ 56,662 As of December 31, 2018, the Company’s debt securities had the following maturity dates: Market value December 31, 2018 Due within one year 54,151 1 to 2 years 2,511 Total 56,662 |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | NOTE 4 — PROPERTY AND EQUIPMENT December 31 2017 2018 Cost: Laboratory equipment $ 2,247 $ 2,829 Office equipment and furniture 254 258 Computers and software 364 410 Leasehold improvements 1,429 1,849 4,294 5,346 Less: Accumulated depreciation and amortization (1,980 ) (2,742 ) Property and equipment, net $ 2,314 $ 2,604 Depreciation and amortization expense totaled $359, $471 and $762 for the years ended December 31, 2016, 2017 and 2018, respectively. |
EMPLOYEE SEVERANCE BENEFITS
EMPLOYEE SEVERANCE BENEFITS | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
EMPLOYEE SEVERANCE BENEFITS | NOTE 5 — EMPLOYEE SEVERANCE BENEFITS The Company is required to make severance payments upon dismissal of an employee or upon termination of employment in certain circumstances. The severance payment liability to the employees (based upon length of service and the latest monthly salary — one month’s salary for each year employed) is recorded on the Company’s balance sheet under “Liability for employee rights upon retirement.” The liability is recorded as if it were payable at each balance sheet date on an undiscounted basis. In accordance with the current employment terms starting in August 2014 with all of its employees (Section 14 of the Israeli Severance Pay Law, 1963), the Company makes regular deposits with certain insurance companies for accounts controlled by each applicable employee in order to secure the employee’s retirement benefit obligation. The Company is fully relieved from any severance pay liability with respect to each such employee after it makes the payments on behalf of the employee. The liability accrued in respect of these employees and the amounts funded, as of the respective agreement dates, are not reflected in the Company balance sheet, as the amounts funded are not under the control and management of the Company and the pension or severance pay risks have been irrevocably transferred to the applicable insurance companies (the “Contribution Plan”). With regard to the period before August 2014, the liability is funded in part from the purchase of insurance policies or by the establishment of pension funds with dedicated deposits in the funds. The amounts used to fund these liabilities are included in the balance sheets under “Funds in respect of employee rights upon retirement.” These policies are the Company’s assets. The amounts of severance payment expenses were $261, $275 and $431 for the years ended December 31, 2016, 2017 and 2018, respectively, of which $185, $257 and $292 in the years ended December, 2016, 2017 and 2018, respectively, were in respect of the Contribution Plan. The Company expects to contribute approximately $308 in the year ending December 31, 2019 to insurance companies in connection with its expected severance liabilities for that year. |
COMMITMENTS
COMMITMENTS | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS | NOTE 6 — COMMITMENTS: a. Royalty Commitments: 1) The Company is obligated to pay royalties to the IIA on proceeds from the sale of products developed from research and development activities that were funded, partially, by grants from the IIA. 2) The Company has an agreement, that was amended several times (hereafter — the agreements) with Yissum Research Development Company (hereafter — “Yissum”), the technology-licensing arm of the Hebrew University of Jerusalem. According to the agreements, the Company received from Yissum an exclusive and a non-exclusive license for the commercialization of certain Yissum patents. According to the agreements the Company shall pay Yissum: i. Royalties of 1.5% of net sales related to certain patents. ii. 1.5% – 8% of proceeds received by the Company for the sub-license or license of certain patents. According to the agreements, the Company may continue commercial use of certain Yissum’s patents in connection with the products and subject to the obligation to pay Yissum the royalties and the sub-license fees. The Company granted rights to a third party for use and commercialization of certain Yissum patents. e. Lease Agreements The Company leases office spaces and research and development facilities under several agreements. These agreements are linked to the change in the Israeli consumer price index and expire in December 2020. The annual lease expenses for the years ended December 31, 2016, 2017 and 2018 were approximately $316, $464 and $477, respectively. As of December 31, 2018, future minimum lease commitments under these operating lease agreements are as follows: Year Amount 2019 477 2020 477 Total $ 954 As security for its obligation under the lease agreements the Company deposited $112 which are classified as restricted long-term deposits. f. Vehicle Lease Agreements The Company has entered into operating lease agreements for vehicles used by its employees for a period of 3 years. The annual lease expenses for the years ended December 31, 2016, 2017 and 2018 were $156, $187 and $226, respectively. The expected annual lease payments under this agreement for the next three years are $185, $136 and $28 for the years ending December 31, 2019, 2020 and 2021, respectively. As security for its obligation under the lease agreements the Company deposited $47. g. In June 2008, the Company entered into a Master Clinical Trial Services Agreement with a third party, which was later amended in April 2016, to retain its services as a clinical research organization for certain product candidate subject to task work orders to be issued by the Company. During 2018, the Company entered into six additional task orders. As consideration for its services the Company will pay a total amount of approximately $14,343 during the term of the engagement and based on achievement of certain milestones, out of which $1,803 were recognized as an expense until December 31, 2018. h. In April 2015, the Company entered into a development, manufacturing and commercialization agreement, as amended on October 26, 2015, with a third party, to work towards the objective of obtaining all the U.S. Food and Drug Administration (hereafter- FDA) approvals necessary for the commercialization of one of its product candidates in the U.S. Under this agreement, the third party is obligated to conduct all regulatory, scientific, clinical and technical activities necessary to develop the product and prepare and file an abbreviated new drug application (hereafter- ANDA), with the FDA and gain regulatory approval. As soon as reasonably practical after FDA approval, the third party has exclusive rights and is required to use diligent efforts to commercialize this product in the U.S., including all required sales, marketing and distributing activities associated with the agreement. The Company is entitled to 50% of the third party’s gross profits related to the sale of this product, as such term is defined in the agreement, on a quarterly basis, for a period of 20 years following the first commercial sale of this product in the U.S. i. In 2016 through 2018, the Company entered into six collaboration agreements with two third parties for the development, manufacturing and commercialization of six product candidates (including an agreement assumed by the Company in August 2017, following the transfer of an in-process research and development product candidate from a related party). Under these agreements, the third parties are obligated to conduct all regulatory, scientific, clinical and technical activities necessary to develop the product and prepare and file ANDA, with the FDA and gain regulatory approval. The Company is obligated for sourcing the active pharmaceutical ingredient (API) during the development phase. Upon FDA approval, the third parties have exclusive rights and are required to use diligent efforts to commercialize this product in territories defined under the agreements, including all required sales, marketing and distributing activities associated with the agreements. The Company is entitled to 50% of the third party’s gross profits related to the sale of these products, as such term is defined in the agreements. In January 2019, one of these product candidates received final approval from the FDA. See also note 12. j. In October 2017, the Company entered into a Clinical Development Master Services Agreement with a third party, to retain it as clinical research organization for certain product candidate, subject to task work orders to be issued by the Company. As consideration for its services the Company will pay a total amount of approximately $12,927, during the term of the engagement and based on achievement of certain milestones, out of which $6,299 were recognized as an expense until December 31, 2018. k. In July 2018, the Company signed on a Master Services Agreement to receive certain clinical research services for certain product candidate subject to task work orders to be issued by the Company. As consideration for the services in the first work order the Company will pay a total amount of approximately $2,099 during the term of the engagement and based on achievement of certain milestones, $1,044 of which were recognized as an expense until December 31, 2018. |
LOANS FROM THE CONTROLLING SHAR
LOANS FROM THE CONTROLLING SHAREHOLDER | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
LOANS FROM THE CONTROLLING SHAREHOLDER | NOTE 7 — LOANS FROM THE CONTROLLING SHAREHOLDER Until December 31, 2017, the Company received loans from its Controlling Shareholder in the aggregated amount of $65,338, including loans received during the years ended December 31, 2016 and 2017 in the amounts of $20,000 and $28,000, respectively. The loans were classified as a current liability and denominated in U.S. dollars, bear no interest and were backed by a promissory note. The promissory note was unsecured note, had no repayment date and was subject to acceleration in certain events of default. In January 2018, the Company completed an IPO on the NASDAQ Stock Market Immediately prior to the closing of the IPO, the outstanding promissory note was automatically converted into 5,444,825 Ordinary shares of the Company based on the IPO price of $12 per ordinary share. See also note 8. |
SHARE CAPITAL
SHARE CAPITAL | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |
SHARE CAPITAL | NOTE 8— SHARE CAPITAL a. Ordinary shares 1) Rights of the Company’s ordinary shares 2) On October 2, 2017, the Company increased its authorized share capital to 50,000,000 shares, NIS 0.1 par value. On January 19, 2018, the Company executed a 1-for-1.8 share split of the Company’s shares by way of an issuance of bonus shares for each share. Upon the effectiveness of the share split, (i) 0.8 bonus shares were issued for each outstanding share, (ii) the number of ordinary shares into which each outstanding option to purchase ordinary shares is exercisable was proportionally increased, and (iii) the exercise price of each outstanding option to purchase ordinary shares was proportionately decreased. Unless otherwise indicated, and except for authorized capital, all of the share numbers, loss per share amounts, share prices and option exercise prices in these financial statements have been adjusted, on a retroactive basis, to reflect this 1-for-1.8 share split . In January 2018, the Company completed an IPO on the NASDAQ Stock Market, in which it issued 6,250,000 Ordinary shares at a price per share of $12. During February 2018 the underwriters exercised their green shoe option and purchased additional 937,500 ordinary shares at the same price per share. The net proceeds received from the IPO were approximately $78,800, after deducting underwriting discounts, commissions and other offering expenses in a total amount of approximately $7,450. b. Share-based compensation: 1) Option plan The awards may be exercised after vesting and in accordance with vesting schedules which will be determined by the Board of Directors for each grant. The maximum term of the awards is 10 years. The fair value of each option granted under this Plan is estimated using the Black-Scholes option pricing method. Expected volatility is based on the historical volatility of comparable peer companies. The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the options granted in dollar terms. The expected term of the options is estimated based on the simplified method. On July 13, 2017 the Company’s Board of Directors approved an increase of the ordinary shares that may be issued under the Company’s Plan by reserving an additional amount of 720,975 ordinary shares of the Company with a value of NIS 0.1 per share. 2) Options grants a. Option granted to employees and directors i. In March 2018, the board of directors approved and recommended the Company shareholders to approve a grant of 105,471 options to the Company CEO to purchase ordinary shares at an exercise price of $11.21 per share. The Company's shareholders approved the grant in May 2018. ii. In March 2018, the Company granted a total of 20,138 options to two employees to purchase ordinary shares at an exercise price of $11.21 per share. iii. In August 2018, the Company granted a total of 10,069 options to an Executive Officer to purchase ordinary shares at an exercise price of $6.78 per share. The options vest over a period of 4 years; 25% of the options vest on the first anniversary of the vesting commencement date (as described in each agreement) and the rest vest quarterly over the following three years. The options expire on the tenth anniversary of their grant date. The fair value of options granted to employees and directors in 2016, 2017 and 2018 were $986, $9,841 and $878, respectively. The underlying data used for computing the fair value of the options are as follows: 2016 2017 2018 Value of one ordinary share $ 11.99 $ 20.47-$24.37 $ 6.24-$10.40 Dividend yield 0 % 0 % 0 % Expected volatility 68.46%-79.1 % 72.91%-78.71 % 70.43 %-73.35 % Risk-free interest rate 0.95%-1.34 % 1.57%-2.23 % 2.67%-2.83 % Expected term 5-6.71 years 5-7 years 5.50-7 years The total unrecognized compensation cost of employee options at December 31, 2018 is $2,927, which is expected to be recognized over a period of 3.6 years. The following table summarizes the number of options granted to employees under the Plan for the years ended December 31, 2016, 2017 and 2018, and related information: Year ended December 31 2016 2017 2018 Number of options Weighted average exercise price Weighted average remaining contractual life Number of options Weighted average exercise price Weighted average remaining contractual life Number of options Weighted average exercise price Weighted average remaining contractual life Options outstanding at the beginning of the year 312,194 $ 1.59 402,955 $ 1.59 8.55 849,780 $ 3.45 8.63 Granted 90,761 $ 1.59 9.59 468,572 $ 4.99 9.52 135,678 $ 10.88 9.41 Exercised (27,399 ) $ 1.59 - Expired (1,350 ) $ 5.57 - Forfeited - - - (21,747 ) $ 2.25 7. (18,619 ) $ 8.62 - Options outstanding at the end of the year 402,955 $ 1.59 8.55 849,780 $ 3.45 8.63 938,090 $ 4.47 7.89 Options exercisable at the end of the year 192,338 $ 1.59 297,420 $ 1.59 7.49 519,084 $ 2.53 6.74 b. Option granted to non-employees In March 2018, the Company granted a total of 76,895 options to several consultants to purchase ordinary shares at an exercise price of $11.21 per share. The fair value of options granted to non-employees in 2017 and 2018 were $2,725 and $648, respectively. The underlying data used for computing the fair value of the options are as follows: 2017 2018 Value of one ordinary share $ 24.37 $ 10.40 Dividend yield 0 % 0 % Expected volatility 72.91 -76.63 % 79.07 % Risk-free interest rate 1.91%-2.16 % 2.86 % Expected term 10 years 10 years The total unrecognized compensation cost of non-employees options at December 31, 2018 is $358, which is expected to be recognized over a period of 3.2 . The following table summarizes the number of options granted to non-employees under the Plan for the year ended December 31, 2018, and related information: Year ended December 31 2017 2018 Number of options Weighted average exercise price Weighted average remaining contractual life Number of options Weighted average exercise price Weighted average remaining contractual life Options outstanding at the beginning of the year - - - 121,680 $ 5.12 9.54 Granted 121,680 $ 5.12 9.54 76,895 $ 11.21 9.24 Options outstanding at the end of the year 121,680 $ 5.12 9.54 198,575 $ 7.48 8.81 Options exercisable at the end of the year 7,614 $ 1.59 9.54 44,793 $ 4.59 8.54 c. The aggregate intrinsic value of the total outstanding and of total exercisable options as of December 31, 2018 is approximately $2,168 and $1,877, respectively. d. Restricted Shares granted to Directors In February 2018, the board of directors approved and recommended the Company shareholders to approve a total grant of 46,000 restricted share units (RSUs) to its independent and external directors that vest annually in equal portions over a three-year period. The fair value of the shares as of the date of grant was $495. e. The following table illustrates the effect of share-based compensation on the statements of operations: Year ended 2016 2017 2018 Research and development expenses $ 541 $ 1,932 $ 2,708 General and administrative expenses 411 2,042 $ 1,946 $ 952 $ 3,974 $ 4,654 |
TAXES ON INCOME
TAXES ON INCOME | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
TAXES ON INCOME | NOTE 9 — TAXES ON INCOME The Company is taxed under Israel tax laws: a. Tax rates The income of the Company and the Capital gains, other than income from Benefitted Enterprises (see b below), are subject to the normal corporate tax rates, 23% for 2018 b. Tax benefits under the Law for the Encouragement of Capital Investments, 1959 (the “Investment Law”) Under the Investment Law, including Amendment No. 60 to the Investment Law that was published in April 2005, by virtue of the Benefited Enterprise program for certain of its facilities; the Company may be entitled to various tax benefits. The main benefit arising from such status is the reduction in tax rates on income derived from a Benefited Enterprise. The extent of such benefits depends on the location of the enterprise. Since the Company’s facilities are not located in “national development zone A,” income derived from Benefited Enterprises will be tax exempt for a period of two years and then have a reduced tax rate for a period of up to an additional eight years. The period of tax benefits, as described above, is limited to 12 years from the beginning of the Benefited Enterprise election year (2012). As of December 31, 2018, the period of benefits has not yet commenced. In the event of distribution of cash dividends from income which was tax exempt as above, the amount distributed will be subject to the tax rate it was exempted from. The Company is entitled to claim accelerated depreciation in respect of equipment used by the approved enterprises during five tax years. Entitlement to the above benefits is conditioned upon the Company fulfilling the conditions stipulated by the Investment Law and regulations published thereunder. In the event of failure to comply with these conditions, the benefits may be canceled and the Company may be required to refund the amount of the benefits, in whole or in part, with the addition of linkage differences to the Israeli consumer price index and interest. The Investment Law was amended as part of the Economic Policy Law for the years 2011 – 2012 (the “Amendment”), which became effective on January 1, 2011. The Amendment sets alternative benefit tracks to the ones currently in place under the provisions of the Investment Law, including a reduced corporate tax rate. Tax rate for “Preferred Enterprise” income of companies not located in national development zone A, is 16% for fiscal year 2014 and thereafter. The benefits are granted to companies that qualify under criteria set forth in the Investment Law; for the most part, those criteria are similar to the criteria that have existed in the Investment Law prior to its amendment and the benefit period is unlimited in time. However, in accordance with the Amendment, the classification of licensing income as preferred income is subject to the issuance of a pre-ruling by the Israel Tax Authority. Under the transitional provisions of the Investment Law, a company is allowed to continue to enjoy the tax benefits available under the Investment Law prior to its amendment until the end of the period of benefits, as defined in the Investment Law. In each year during the period of benefits of its Benefitted Enterprise, the Company will be able to opt for application of the Amendment, thereby making available to itself the tax rate described above. The Company’s election to apply the Amendment is irrevocable. As of December 31, 2018, the Company’s management decided not to adopt the application of the Amendment. There is no assurance that future taxable income of the Company will qualify as Benefited or Preferred income or that the benefits described above will be available to the Company in the future. c. Tax assessments Tax assessments filed by the Company through the year 201 2 d. Losses for tax purposes carried forward to future years As of December 31, 2018, the Company had approximately $85.5 million of net carry forward tax losses which are available to reduce future taxable income with no limited period of use. e. Deferred income taxes: As of December, 31 2017 2018 In respect of: Net operating loss carry forward $ 16 , $ 19 , Research and development expenses 4 , 5 , Other 1,541 1,402 Less – valuation allowance (21,982 ) (26 , ) Net deferred tax assets $ — $ — f. Reconciliation of theoretical tax expenses to actual expenses The primary reconciling items between the statutory tax rate of the Company and the effective rate are the full valuation allowance of deferred tax assets and nondeductible expenses. g. Roll forward of valuation allowance Balance at January 1, 2016 $ 10,888 Additions 3,111 Balance at December 31, 2016 $ 13,999 Additions 7,983 Balance at December 31, 2017 $ 21,982 Additions 4,184 Balance at December 31, 2018 $ 26,166 h. Provision for uncertain tax positions As of December 31, 2017 and 2018, the Company does not have a provision for uncertain tax positions. |
SUPPLEMENTARY FINANCIAL STATEME
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | NOTE 10 — SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION Other accounts payables and accruals As of December, 31 2017 2018 Accrued expenses $ 910 $ 1,031 Employees payables 376 897 Other 46 43 $ 1,332 $ 1,971 |
RELATED PARTIES
RELATED PARTIES | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES | NOTE 11 — RELATED PARTIES a. Related parties include the Controlling Shareholder and companies under his control, the Board of Directors and the Executive Officers of the Company. b. As to options and restricted shares granted to directors and executive officers, see note 8. c. In July 2017, the Company granted to several Executive Officers of the Parent company 54,144 option to purchase ordinary shares at an exercise price of $5.57 per share. d e. On August 22, 2017, a related company (wholly owned by the Company’s controlling shareholder) transferred an in-process research and development product candidate (hereafter - the Product) to the Company, together with a collaboration agreement with third party to research, develop and manufacture the Product, in consideration of 2 shares. This was considered a transaction between entities under common control and thus it was recorded on historical cost basis and therefore the Company recognized an amount of $6,232 as a research and development expense in 2017. In January 2018, immediately prior to the closing of the IPO, the outstanding promissory note from the Controlling Shareholder were automatically converted into 5,444,825 Ordinary shares. See also note 7. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 12 — SUBSEQUENT EVENT In February 2019, the Company announced that a third party has received final approval from the FDA for the first generic version of a drug product. The product was developed in a collaboration between the Company and the third party in which they shared development costs and will equally share the gross profits generated from sales of the product. See also Note 6i. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of presentation | a. Basis of presentation The Company’s financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). |
Use of estimates in the preparation of financial statements | b. Use of estimates in the preparation of financial statements The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results may differ from those estimates. As applicable to these financial statements, the most significant estimates and assumptions relate to the fair value of share-based compensation. |
Functional and presentation currency | c. Functional and presentation currency The U.S. dollar (“dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted. The Company’s financing has been provided in dollars, revenues are expected to be primarily in dollars and a significant part of expenses are incurred in dollars. The financial statements are presented in dollars, which is the Company’s functional and presentation currency. Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items in the statements of operations (indicated below), the following exchange rates are used: (I) for transactions — exchange rates at transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation) — historical exchange rates. Currency transaction gains and losses are presented in financial income or expenses, as appropriate. |
Cash and cash equivalents | d. Cash and cash equivalents The Company considers as cash equivalents all short-term, highly liquid investments, which include short-term bank deposits with original maturities of three months or less from the date of purchase that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash. |
Bank deposits | e. Bank deposits Bank deposits with original maturity dates of more than three months but less than one year are included in short-term deposits. Such short-term deposits bear interest at an average annual rate of approximately 2.78% in 2018. Bank deposits with maturity of more than one year are considered long-term. |
Marketable securities | f. Marketable securities |
Derivatives and hedging | g. Derivatives and hedging The Company carries out transactions involving foreign currency exchange derivative financial instruments. The transactions are designed to hedge the Company’s exposure in currencies other than the U.S. dollar. The derivative does not meet the definition of a cash flow accounting hedge, therefore the changes in the fair value are included in financial expense (income), net. As of December 31, 2018, the Company has $350 on the Company’s bank account that is restricted in order to secure the hedging transactions. This amount is presented among Restricted long term deposits. |
Property and equipment | h. Property and equipment: 1) Property and equipment are stated at cost, net of accumulated depreciation and amortization. 2) The Company’s property and equipment are depreciated utilizing the straight-line method on the basis of their estimated useful life. Annual rates of depreciation are as follows: % Laboratory equipment 10 – 33 (mainly 15 – 25) Office equipment and furniture 7 – 15 Computers and related equipment 33 Leasehold improvements are amortized utilizing the straight-line method over the shorter of the expected lease term or the estimated useful life of the improvements. |
Impairment of long-lived assets | i. Impairment of long-lived assets The Company tests long-lived assets for impairment whenever events or circumstances present an indication of impairment. If the sum of expected future cash flows (undiscounted and without interest charges) of the assets is less than the carrying amount of such assets, an impairment loss would be recognized. The assets would then be written down to their estimated fair values. For the three years ended December 31, 2018, the Company did not recognize an impairment loss for its long-lived assets. |
Share-based compensation | j. Share-based compensation The Company accounts for employees’ share-based payment awards classified as equity awards using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period. The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the accelerated method based on the multiple-option award approach. When options are granted as consideration for services provided by consultants and other non-employees, the grant is accounted for based on the fair value of the consideration received or the fair value of the options issued, whichever is more reliably measurable. The fair value of the options granted is measured on a final basis at the end of the related service period and is recognized over the related service period using the straight-line method. The company has elected to recognize forfeitures as they occur. |
Research and development expenses | k. Research and development expenses Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, lab expenses, consumable equipment and consulting fees. All costs associated with research and developments are expensed as incurred. Acquisitions of in-process research and development product candidate, which are not part of business combination, are recognized as an expense as research and development expenses as incurred. Grants received from Israel Innovation Authority (hereafter — “IIA”), formerly known as the Office of the Chief Scientist of the Ministry of Economy and Industry, or the OCS are recognized when the grant becomes receivable, provided there is reasonable assurance that the Company will comply with the conditions attached to the grant and there is reasonable assurance the grant will be received. The grant is deducted from the research and development expenses as the applicable costs are incurred. See note 6a(1). Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. The Company out sources its clinical trial activities utilizing external entities such as clinical research organizations, independent clinical investigators, and other third-party service providers to assist the Company with the execution of its clinical trials. Clinical trial costs are expensed as incurred. |
Revenue recognition | l. Revenue recognition On January 1, 2018 the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). According to the standard, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the performance obligation is satisfied. An entity only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer, after considering any price concession expected to be provided to the customer, when applicable. At contract inception, the entity assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The entity then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The adoption of the new standards did not change the Company’s revenue recognition as the majority of the Company’s revenues in 2018 were royalties from rights for use and commercialization of a product for skin protection granted to a third party. The Company does not have future performance obligations under the license arrangements. The revenues are recorded based on the sales that occurred during the relevant period provided by the licensee. |
Income taxes | m. Income taxes: 1) Deferred taxes 2) Uncertainty in income taxes The Company follows a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the available evidence indicates that it is more likely than not that the position will be sustained based on technical merits. If this threshold is met, the second step is to measure the tax position as the largest amount that has more than a 50% likelihood of being realized upon ultimate settlement. |
Loss per share | n. Loss per share Basic loss per share 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 loss per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents outstanding when dilutive. Ordinary share equivalents include outstanding stock options and RSUs, which are included under the treasury stock method when dilutive. The calculation of diluted loss per share does not include 349,740, 673 , |
Fair value measurement | o. 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. 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. The carrying amount of the cash and cash equivalents, bank deposits, restricted cash, restricted long term deposits, accrued expenses and other liabilities approximates their fair value. |
Concentration of credit risks | p. Concentration of credit risks Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash and cash equivalents, bank deposits and marketable securities and certain receivables. The Company deposits cash and cash equivalents with highly rated financial institutions (Israeli banks). In addition, all marketable securities carry a high rating or are government insured. The Company has not experienced any material credit losses in these accounts and does not believe it is exposed to significant credit risk on these instruments. |
Newly issued and recently adopted accounting pronouncements | q. Newly issued and recently adopted accounting pronouncements: 1) Recently adopted accounting pronouncements a. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a Consensus of the FASB Emerging Issues Task Force) (“ASU 2016-18”), which requires entities to include amounts generally described as restricted cash and restricted cash equivalents in cash and cash equivalents when reconciling beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for annual reporting periods (including interim periods within those annual reporting periods) beginning after December 15, 2017. This resulted in a decrease to net cash used in investing activities of $350 in 2018. b. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10), which addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. The amended guidance requires changes in the fair value of equity investments to be recognized through net income, rather than other comprehensive income. Adoption of the standard will be applied through a cumulative one-time adjustment to retained earnings. This standard was adopted on January 1, 2018 and its accumulative adjustment had no material impact on the Company's financial statements. In addition, in February 2018, the FASB issued ASU No. 2018-03 which includes technical corrections and improvements to clarify the guidance in ASU No. 2016-01. This standard, adopted as of January 1, 2018, had no material impact on the Company’s financial statements. 2) Newly issued accounting pronouncements: a. In February 2016, the FASB issued 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 plans to adopt the standard as of January 1, 2019 on a modified retrospective basis and will not restate comparative periods. The Company will elect the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allows the Company to carryforward the historical lease classification. The Company will make an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet. The Company will recognize those lease payments in the Statements of Operations on a straight-line basis over the lease period. The Company expects that adoption of the standard will result in recognition of approximately $1,200 of lease assets and lease liabilities as of January 1, 2019 on the Company’s balance Sheets. b. In June 2018, the FASB issued ASU 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting” that expands the scope of ASC Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of ASC Topic 718 to nonemployee awards except for certain exemptions specified in the amendment. The guidance is effective for fiscal years beginning after December 15, 2018, including interim reporting periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company does not expect to have a material impact on its financial statements. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Annual Depreciation Rates | Annual rates of depreciation are as follows: % Laboratory equipment 10 – 33 (mainly 15 – 25) Office equipment and furniture 7 – 15 Computers and related equipment 33 |
MARKETABLE SECURITIES (Tables)
MARKETABLE SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Marketable Securities | The following table sets forth the Company’s marketable securities for the indicated period: December 31, 2018 Level 2 securities: U.S government and agency bonds $ 7,933 Canada government bonds 1,009 Other foreign government bonds 5,259 Corporate bonds* 42,461 Total $ 56,662 * Investments in Corporate bonds rated A or higher . |
Summary of Changes in Fair Value of Marketable Securities | The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the year ended December 31, 2018: Marketable securities Balance at beginning of the year $ - Additions 71,783 Sale or maturity (15,092 ) Changes in fair value during the year (29 ) Balance at end of the period $ 56,662 |
Schedule of Debt Securities | As of December 31, 2018, the Company’s debt securities had the following maturity dates: Market value December 31, 2018 Due within one year 54,151 1 to 2 years 2,511 Total 56,662 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | December 31 2017 2018 Cost: Laboratory equipment $ 2,247 $ 2,829 Office equipment and furniture 254 258 Computers and software 364 410 Leasehold improvements 1,429 1,849 4,294 5,346 Less: Accumulated depreciation and amortization (1,980 ) (2,742 ) Property and equipment, net $ 2,314 $ 2,604 |
COMMITMENTS (Tables)
COMMITMENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Payments Under Operating Leases | As of December 31, 2018, future minimum lease commitments under these operating lease agreements are as follows: Year Amount 2019 477 2020 477 Total $ 954 |
SHARE CAPITAL (Tables)
SHARE CAPITAL (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Effect of Share-based Compensation Statements of Operations | The following table illustrates the effect of share-based compensation on the statements of operations: Year ended 2016 2017 2018 Research and development expenses $ 541 $ 1,932 $ 2,708 General and administrative expenses 411 2,042 $ 1,946 $ 952 $ 3,974 $ 4,654 |
Employees [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Assumptions Used to Estimate Fair Value | The fair value of options granted to employees and directors in 2016, 2017 and 2018 were $986, $9,841 and $878, respectively. The underlying data used for computing the fair value of the options are as follows: 2016 2017 2018 Value of one ordinary share $ 11.99 $ 20.47-$24.37 $ 6.24-$10.40 Dividend yield 0 % 0 % 0 % Expected volatility 68.46%-79.1 % 72.91%-78.71 % 70.43 %-73.35 % Risk-free interest rate 0.95%-1.34 % 1.57%-2.23 % 2.67%-2.83 % Expected term 5-6.71 years 5-7 years 5.50-7 years |
Schedule of Stock Option Activity | The following table summarizes the number of options granted to employees under the Plan for the years ended December 31, 2016, 2017 and 2018, and related information: Year ended December 31 2016 2017 2018 Number of options Weighted average exercise price Weighted average remaining contractual life Number of options Weighted average exercise price Weighted average remaining contractual life Number of options Weighted average exercise price Weighted average remaining contractual life Options outstanding at the beginning of the year 312,194 $ 1.59 402,955 $ 1.59 8.55 849,780 $ 3.45 8.63 Granted 90,761 $ 1.59 9.59 468,572 $ 4.99 9.52 135,678 $ 10.88 9.41 Exercised (27,399 ) $ 1.59 - Expired (1,350 ) $ 5.57 - Forfeited - - - (21,747 ) $ 2.25 7. (18,619 ) $ 8.62 - Options outstanding at the end of the year 402,955 $ 1.59 8.55 849,780 $ 3.45 8.63 938,090 $ 4.47 7.89 Options exercisable at the end of the year 192,338 $ 1.59 297,420 $ 1.59 7.49 519,084 $ 2.53 6.74 |
Non Employees Member [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Assumptions Used to Estimate Fair Value | The underlying data used for computing the fair value of the options are as follows: 2017 2018 Value of one ordinary share $ 24.37 $ 10.40 Dividend yield 0 % 0 % Expected volatility 72.91 -76.63 % 79.07 % Risk-free interest rate 1.91%-2.16 % 2.86 % Expected term 10 years 10 years |
Schedule of Stock Option Activity | The following table summarizes the number of options granted to non-employees under the Plan for the year ended December 31, 2018, and related information: Year ended December 31 2017 2018 Number of options Weighted average exercise price Weighted average remaining contractual life Number of options Weighted average exercise price Weighted average remaining contractual life Options outstanding at the beginning of the year - - - 121,680 $ 5.12 9.54 Granted 121,680 $ 5.12 9.54 76,895 $ 11.21 9.24 Options outstanding at the end of the year 121,680 $ 5.12 9.54 198,575 $ 7.48 8.81 Options exercisable at the end of the year 7,614 $ 1.59 9.54 44,793 $ 4.59 8.54 |
TAXES ON INCOME (Tables)
TAXES ON INCOME (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Income Taxes | Deferred income taxes: As of December, 31 2017 2018 In respect of: Net operating loss carry forward $ 16 , $ 19 , Research and development expenses 4 , 5 , Other 1,541 1,402 Less – valuation allowance (21,982 ) (26 , ) Net deferred tax assets $ — $ — |
Roll Forward of Valuation Allowance | Roll forward of valuation allowance Balance at January 1, 2016 $ 10,888 Additions 3,111 Balance at December 31, 2016 $ 13,999 Additions 7,983 Balance at December 31, 2017 $ 21,982 Additions 4,184 Balance at December 31, 2018 $ 26,166 |
SUPPLEMENTARY FINANCIAL STATE_2
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Other Accounts Payables and Accruals | Other accounts payables and accruals As of December, 31 2017 2018 Accrued expenses $ 910 $ 1,031 Employees payables 376 897 Other 46 43 $ 1,332 $ 1,971 |
NATURE OF OPERATIONS (Details)
NATURE OF OPERATIONS (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Jan. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2007 | Aug. 04, 2014 | |
Subsidiary, Sale of Stock [Line Items] | ||||||
Per share price | $ 12 | |||||
Additional ordinary shares purchased | 937,500 | |||||
Procceds from Initial public offering, net of issuance costs | $ 78,775 | |||||
Outstanding promissory note converted into ordinary shares | 5,444,825 | 5,444,825 | ||||
Accumulated deficit | $ (127,464) | $ (95,261) | ||||
IPO [Member] | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Ordinary shares issued | 6,250,000 | |||||
Per share price | $ 12 | |||||
Procceds from Initial public offering, net of issuance costs | $ 78,800 | |||||
Controlling Shareholder [Member] | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Percentage of acquired shares | 100.00% | |||||
Minimum [Member] | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Royalties Maturity | 2016 | |||||
Maximum [Member] | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Royalties Maturity | 2024 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) ₪ in Thousands, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018USD ($)shares | Dec. 31, 2017shares | Dec. 31, 2016shares | Dec. 31, 2018ILS (₪) | |
Accounting Policies [Abstract] | ||||
Anti-dilutive shares | shares | 1,119,310 | 673,892 | 349,740 | |
Short-term deposits bear interest at an average annual rate | 2.78% | |||
Decrease in net cash used in investing activities | $ 350 | |||
Influence of adopting standard in assets and liabilities | 1,200 | |||
Total hedged amount | ₪ | ₪ 8,600 | |||
Restricted bank deposit | $ 350 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Property and Equipment Annual Depreciation Rates) (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Laboratory equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Annual rate of depreciation | 10.00% |
Laboratory equipment [Member] | Minimum [Member] | Mainly [Member] | |
Property, Plant and Equipment [Line Items] | |
Annual rate of depreciation | 15.00% |
Laboratory equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Annual rate of depreciation | 33.00% |
Laboratory equipment [Member] | Maximum [Member] | Mainly [Member] | |
Property, Plant and Equipment [Line Items] | |
Annual rate of depreciation | 25.00% |
Office equipment and furniture [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Annual rate of depreciation | 7.00% |
Office equipment and furniture [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Annual rate of depreciation | 15.00% |
Computers and software [Member] | |
Property, Plant and Equipment [Line Items] | |
Annual rate of depreciation | 33.00% |
MARKETABLE SECURITIES (Schedule
MARKETABLE SECURITIES (Schedule of Company's Marketable Securities) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | |
Level 2 securities: | |||
Marketable securities | $ 56,662 | ||
U.S government and agency bonds [Member] | |||
Level 2 securities: | |||
Marketable securities | 7,933 | ||
Canada government bonds [Member] | |||
Level 2 securities: | |||
Marketable securities | 1,009 | ||
Other foreign government bonds [Member] | |||
Level 2 securities: | |||
Marketable securities | 5,259 | ||
Corporate bonds [Member] | |||
Level 2 securities: | |||
Marketable securities | [1] | $ 42,461 | |
[1] | Investments in Corporate bonds rated A or higher. |
MARKETABLE SECURITIES (Summary
MARKETABLE SECURITIES (Summary of Changes in Fair Value of Company's Marketable Securities) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |||
Balance at beginning of the year | |||
Additions | 71,783 | ||
Sale or maturity | (15,092) | ||
Changes in fair value during the year | (29) | ||
Balance at end of the period | $ 56,662 |
MARKETABLE SECURITIES (Schedu_2
MARKETABLE SECURITIES (Schedule of Company's debt marketable securities) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Investments, Debt and Equity Securities [Abstract] | ||
Due within one year | $ 54,151 | |
1 to 2 years | 2,511 | |
Total | $ 56,662 |
PROPERTY AND EQUIPMENT (Narrati
PROPERTY AND EQUIPMENT (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation and amortization expense | $ 762 | $ 471 | $ 359 |
PROPERTY AND EQUIPMENT (Schedul
PROPERTY AND EQUIPMENT (Schedule of Property and Equipment) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 5,346 | $ 4,294 |
Accumulated depreciation and amortization | (2,742) | (1,980) |
Property and equipment, net | 2,604 | 2,314 |
Laboratory equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,829 | 2,247 |
Office furniture and equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 258 | 254 |
Computers and software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 410 | 364 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,849 | $ 1,429 |
EMPLOYEE SEVERANCE BENEFITS (De
EMPLOYEE SEVERANCE BENEFITS (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Defined Contribution Plan Disclosure [Line Items] | ||||
Amount of severance payment expenses | $ 431 | $ 275 | $ 261 | |
Contribution Plan | $ 292 | $ 257 | $ 185 | |
Subsequent Event [Member] | ||||
Defined Contribution Plan Disclosure [Line Items] | ||||
Contribution Plan | $ 308 |
COMMITMENTS (Narrative) (Detail
COMMITMENTS (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Loss Contingencies [Line Items] | |||
Lease expire | Dec. 31, 2020 | ||
Lease expense | $ 477 | $ 464 | $ 316 |
Restricted long-term deposits | 462 | 120 | |
2018 | 477 | ||
2019 | 477 | ||
Expense recognized | $ 32 | ||
Percentage of gross profits related to sale of product | 50.00% | ||
Term of commercial sale of product | 20 years | ||
Percentage of reimburse out-of-pocket expense | 40.00% | ||
Long term receivables | $ 1,562 | ||
Master Clinical Trial Services Agreement [Member] | |||
Loss Contingencies [Line Items] | |||
Consideration for services payment | 14,343 | ||
Expense recognized | 1,803 | ||
Clinical Development Master Services Agreement [Member] | Agreement One [Member] | |||
Loss Contingencies [Line Items] | |||
Consideration for services payment | 12,927 | ||
Expense recognized | 6,299 | ||
Clinical Development Master Services Agreement [Member] | Agreement Two [Member] | |||
Loss Contingencies [Line Items] | |||
Consideration for services payment | 2,099 | ||
Expense recognized | 1,044 | ||
Vehicle Lease [Member] | |||
Loss Contingencies [Line Items] | |||
Lease expense | 226 | $ 187 | $ 156 |
Operating lease agreements period | 3 years | ||
2019 | $ 185 | ||
2020 | 136 | ||
2021 | $ 28 | ||
Security deposit obligation under lease | $ 47 | ||
IIA [Member] | |||
Loss Contingencies [Line Items] | |||
Percentage of royalties payments shall not exceed aggregate rant received | 300.00% | ||
Grant received | $ 1,431 | ||
Accumulated royalty expense | $ 2,029 | ||
Yissum [Member] | |||
Loss Contingencies [Line Items] | |||
Royalties pay for net sales related to patents | 1.50% | ||
Minimum [Member] | IIA [Member] | |||
Loss Contingencies [Line Items] | |||
Royalties payable on the sale of products developed | 3.50% | ||
Minimum [Member] | Yissum [Member] | |||
Loss Contingencies [Line Items] | |||
Percentage of proceeds received for sub licence | 1.50% | ||
Maximum [Member] | IIA [Member] | |||
Loss Contingencies [Line Items] | |||
Royalties payable on the sale of products developed | 25.00% | ||
Maximum [Member] | Yissum [Member] | |||
Loss Contingencies [Line Items] | |||
Percentage of proceeds received for sub licence | 8.00% |
COMMITMENTS (Schedule of Future
COMMITMENTS (Schedule of Future Minimum Payments Under Operating Leases) (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2019 | $ 477 |
2020 | 477 |
Operating Lease Commitments | $ 954 |
LOANS FROM THE CONTROLLING SH_2
LOANS FROM THE CONTROLLING SHAREHOLDER (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Debt Disclosure [Abstract] | ||||
Loans from the controlling shareholder | $ 65,338 | |||
Loans received from the controlling shareholder | $ 28,000 | $ 20,000 | ||
Outstanding promissory note converted into ordinary shares | 5,444,825 | 5,444,825 | ||
Per share price | $ 12 |
SHARE CAPITAL (Narrative) (Deta
SHARE CAPITAL (Narrative) (Details) $ / shares in Units, $ in Thousands | Jul. 13, 2017₪ / sharesshares | Aug. 31, 2018$ / sharesshares | Mar. 31, 2018$ / sharesshares | Feb. 28, 2018USD ($)shares | Jan. 19, 2018shares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2014₪ / sharesshares | Dec. 31, 2018₪ / shares | Dec. 31, 2017₪ / sharesshares | Oct. 02, 2017₪ / sharesshares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Ordinary shares, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | |||||||||
Ordinary shares, par value per share | ₪ / shares | ₪ 0.1 | ₪ 0.1 | ₪ 0.1 | |||||||||
Share Split | 1-for-1.8 | |||||||||||
Bonus share issued for each outstanding share | 0.8 | |||||||||||
Fair value of options granted | $ | $ 878 | $ 9,841 | $ 986 | |||||||||
Per share price | $ / shares | $ 12 | |||||||||||
Additional ordinary shares purchased | 937,500 | |||||||||||
Procceds from Initial public offering, net of issuance costs | $ | $ 78,775 | |||||||||||
Restricted Stock [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Option grants | 46,000 | |||||||||||
Fair value of options granted | $ | $ 495 | |||||||||||
Employees [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Maximum term of awards | 10 years | |||||||||||
Shares available for future grant | 139,935 | |||||||||||
Option grants | 20,138 | |||||||||||
Exercise price | $ / shares | $ 11.21 | |||||||||||
Option vesting period | 4 years | |||||||||||
Percentage of option vesting | 25.00% | |||||||||||
Unrecognized compensation cost | $ | $ 2,927 | |||||||||||
Compensation costs weighted average period to be recognized | 3 years 7 months 6 days | |||||||||||
Board of Directors [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Ordinary shares, par value per share | ₪ / shares | ₪ 0.1 | ₪ 0.1 | ||||||||||
Odinary share issued under share incentive plan | 720,975 | 629,025 | ||||||||||
CEO [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Option grants | 105,471 | |||||||||||
Exercise price | $ / shares | $ 11.21 | |||||||||||
Executive Officer [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Option grants | 10,069 | |||||||||||
Exercise price | $ / shares | $ 6.78 | |||||||||||
Consultant Member [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Option grants | 76,895 | |||||||||||
Exercise price | $ / shares | $ 11.21 | |||||||||||
Non Employees Member [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Option vesting period | 4 years | |||||||||||
Percentage of option vesting | 25.00% | |||||||||||
Fair value of options granted | $ | $ 648 | $ 2,725 | ||||||||||
Unrecognized compensation cost | $ | 358 | |||||||||||
Compensation costs weighted average period to be recognized | 3 years 2 months 12 days | |||||||||||
Intrinsic value outstanding option | $ | 2,168 | |||||||||||
Intrinsic value exercisable option | $ | $ 1,877 | |||||||||||
IPO [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Ordinary shares issued | 6,250,000 | |||||||||||
Per share price | $ / shares | $ 12 | |||||||||||
Procceds from Initial public offering, net of issuance costs | $ | $ 78,800 | |||||||||||
Amount of offering expense | $ | $ 7,450 |
SHARE CAPITAL (Schedule of Assu
SHARE CAPITAL (Schedule of Assumptions Used to Estimate Fair Value) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Employees [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Value of one ordinary share | $ 11.99 | ||
Dividend yield | 0.00% | 0.00% | 0.00% |
Employees [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Value of one ordinary share | $ 6.24 | $ 20.47 | |
Expected volatility | 70.43% | 72.91% | 68.46% |
Risk-free interest rate | 2.67% | 1.57% | 0.95% |
Expected term | 5 years 6 months | 5 years | 5 years |
Employees [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Value of one ordinary share | $ 10.40 | $ 24.37 | |
Expected volatility | 73.35% | 78.71% | 79.10% |
Risk-free interest rate | 2.83% | 2.23% | 1.34% |
Expected term | 7 years | 7 years | 6 years 8 months 16 days |
Non Employees Member [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Value of one ordinary share | $ 10.40 | $ 24.37 | |
Dividend yield | 0.00% | 0.00% | |
Expected volatility | 79.07% | ||
Risk-free interest rate | 2.86% | ||
Expected term | 10 years | 10 years | |
Non Employees Member [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 72.91% | ||
Risk-free interest rate | 1.91% | ||
Non Employees Member [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 76.63% | ||
Risk-free interest rate | 2.16% |
SHARE CAPITAL (Schedule of Stoc
SHARE CAPITAL (Schedule of Stock Option Activity) (Details) - $ / shares | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Employees [Member] | ||||
Number of options | ||||
Options outstanding at beginning of year | 849,780 | 402,955 | 312,194 | |
Granted | 135,678 | 468,572 | 90,761 | |
Exercised | (27,399) | |||
Expired | (1,350) | |||
Forfeited | (18,619) | (21,747) | ||
Options outstanding at end of year | 938,090 | 849,780 | 402,955 | 312,194 |
Options exercisable at the end of the year | 519,084 | 297,420 | 192,338 | |
Weighted-average exercise price | ||||
Options outstanding at beginning of year | $ 3.45 | $ 1.59 | $ 1.59 | |
Granted | 10.88 | 4.99 | 1.59 | |
Exercised | 1.59 | |||
Expired | 5.57 | |||
Forfeited | 8.62 | 2.25 | ||
Options Outstanding at end of year | 4.47 | 3.45 | 1.59 | $ 1.59 |
Options exercisable at the end of the year | $ 2.53 | $ 1.59 | $ 1.59 | |
Weighted-average remaining contractual term | ||||
Options outstanding | 7 years 10 months 21 days | 8 years 7 months 17 days | 8 years 6 months 18 days | 9 years 2 months 30 days |
Granted | 9 years 4 months 28 days | 9 years 6 months 7 days | 9 years 7 months 2 days | |
Forfeited | 7 years 10 months 14 days | |||
Options exercisable at the end of the year | 6 years 8 months 26 days | 7 years 5 months 27 days | 9 years 7 months 2 days | |
Non Employees Member [Member] | ||||
Number of options | ||||
Options outstanding at beginning of year | 121,680 | |||
Granted | 76,895 | 121,680 | ||
Options outstanding at end of year | 198,575 | 121,680 | ||
Options exercisable at the end of the year | 44,793 | 7,614 | ||
Weighted-average exercise price | ||||
Options outstanding at beginning of year | $ 5.12 | |||
Granted | 11.21 | 5.12 | ||
Options Outstanding at end of year | 7.48 | 5.12 | ||
Options exercisable at the end of the year | $ 4.59 | $ 1.59 | ||
Weighted-average remaining contractual term | ||||
Options outstanding | 8 years 9 months 22 days | 9 years 6 months 14 days | ||
Granted | 9 years 2 months 27 days | 9 years 6 months 14 days | ||
Options exercisable at the end of the year | 8 years 6 months 14 days | 9 years 6 months 14 days |
SHARE CAPITAL (Schedule of Effe
SHARE CAPITAL (Schedule of Effect of Share-based Compensation Statements of Operations) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Share-based compensation | $ 4,654 | $ 3,974 | $ 952 |
Research and Development Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Share-based compensation | 2,708 | 1,932 | 541 |
General and Administrative Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Share-based compensation | $ 1,946 | $ 2,042 | $ 411 |
TAXES ON INCOME (Narrative) (De
TAXES ON INCOME (Narrative) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Income Tax Disclosure [Abstract] | |
Corporate tax rates | 23.00% |
Tax benefit period | 12 years |
Net carry forward tax losses | $ 85,500 |
TAXES ON INCOME (Schedule of De
TAXES ON INCOME (Schedule of Deferred Income Taxes) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
In respect of: | ||||
Net operating loss carry forward | $ 19,670 | $ 16,342 | ||
Research and development expenses | 5,094 | 4,099 | ||
Other | 1,402 | 1,541 | ||
Less - valuation allowance | (26,166) | (21,982) | $ (13,999) | $ (10,888) |
Net deferred tax assets |
TAXES ON INCOME (Roll Forward o
TAXES ON INCOME (Roll Forward of Valuation Allowance) (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Taxes On Income Roll Forward Of Valuation Allowance | ||||
Balance | $ 26,166 | $ 21,982 | $ 13,999 | $ 10,888 |
Additions | $ 4,184 | $ 7,983 | $ 3,111 |
SUPPLEMENTARY FINANCIAL STATE_3
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Schedule of Other Accounts Payables and Accruals) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Accrued expenses | $ 1,031 | $ 910 |
Employees payables | 897 | 376 |
Other | 43 | 46 |
Other accounts payables and accruals | $ 1,971 | $ 1,332 |
RELATED PARTIES (Details)
RELATED PARTIES (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Jan. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jul. 31, 2017 | |
Related Party Transactions [Abstract] | |||||
Outstanding promissory note converted into ordinary shares | 5,444,825 | 5,444,825 | |||
In-process research and development acquired | $ 6,232 | ||||
Number of shares consideration in process research and development product | 2 | ||||
Option to purchase ordinary shares | 54,144 | ||||
Exercise price | $ 5.57 |