Israel | Not Applicable |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
2 Holzman Street, Weizmann Science Park Rehovot, Israel | 7670402 |
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Ordinary Shares, par value NIS 0.16 per share | FOMX | The Nasdaq |
Large accelerated filer | ☐ | Accelerated filer | ☒ | ||
Non-accelerated filer | ☐ | Smaller reporting company | ☒ | ||
Emerging growth company | ☒ |
PART I | FINANCIAL INFORMATION | ||
F-2 - | |||
F-4 | |||
F-5 | |||
F-6 - | |||
F-8 - | |||
F-10 - | |||
PART II | OTHER INFORMATION | ||
Page | |
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS: | |
F-2 - F-3 | |
F-4 | |
F-5 | |
F-6 - F-7 | |
September 30 | December 31 | |||||||||||||||
March 31 | December 31 | 2019 | 2018 | |||||||||||||
2019 | 2018 | |||||||||||||||
A s s e t s | ||||||||||||||||
CURRENT ASSETS: | ||||||||||||||||
Cash and cash equivalents | $ | 18,994 | $ | 27,868 | $ | 40,534 | $ | 27,868 | ||||||||
Restricted cash | 250 | 250 | 250 | 250 | ||||||||||||
Short term bank deposits | 24,155 | 24,047 | 19,141 | 24,047 | ||||||||||||
Investment in marketable securities (Note 4) | 39,122 | 46,669 | 15,333 | 46,669 | ||||||||||||
Restricted investment in marketable securities (Note 4) | 276 | 268 | 288 | 268 | ||||||||||||
Accounts receivable: | ||||||||||||||||
Trade | 1,168 | 1,066 | - | 1,066 | ||||||||||||
Other | 1,209 | 999 | 979 | 999 | ||||||||||||
TOTAL CURRENT ASSETS | 85,174 | 101,167 | 76,525 | 101,167 | ||||||||||||
NON-CURRENT ASSETS: | ||||||||||||||||
Investment in marketable securities (Note 4) | - | 150 | - | 150 | ||||||||||||
Restricted investment in marketable securities (Note 4) | 137 | 133 | 143 | 133 | ||||||||||||
Property and equipment, net | 2,297 | 2,235 | 2,809 | 2,235 | ||||||||||||
Operating lease right of use assets (Note 6) | 1,934 | - | ||||||||||||||
Operating lease right of use assets (Note 7) | 1,947 | - | ||||||||||||||
Other | 17 | 46 | 159 | 46 | ||||||||||||
TOTAL NON-CURRENT ASSETS | 4,385 | 2,564 | 5,058 | 2,564 | ||||||||||||
TOTAL ASSETS | $ | 89,559 | $ | 103,731 | $ | 81,583 | $ | 103,731 |
September 30 | December 31 | |||||||
2019 | 2018 | |||||||
Liabilities and shareholders’ equity | ||||||||
CURRENT LIABILITIES: | ||||||||
Accounts payable and accruals: | ||||||||
Trade | $ | 7,357 | $ | 6,327 | ||||
Operating lease liabilities (Note 7) | 1,136 | - | ||||||
Other | 4,877 | 4,141 | ||||||
TOTAL CURRENT LIABILITIES | 13,370 | 10,468 | ||||||
LONG-TERM LIABILITIES: | ||||||||
Liability for employee severance benefits | 419 | 367 | ||||||
Operating lease liabilities (Note 7) | 870 | - | ||||||
Long-term debt (Note 5) | 12,939 | - | ||||||
Other liabilities | 456 | 714 | ||||||
TOTAL LONG-TERM LIABILITIES | 14,684 | 1,081 | ||||||
TOTAL LIABILITIES | 28,054 | 11,549 | ||||||
COMMITMENTS (Note 7) | ||||||||
SHAREHOLDERS' EQUITY: | ||||||||
Ordinary Shares, NIS- 0.16 par value - authorized: 135,000,000 and 90,000,000 Ordinary Shares as of September 30, 2019 and December 31, 2018, respectively; issued and outstanding: 61,121,087 and 54,351,140 Ordinary Shares as of September 30, 2019 and December 31, 2018, respectively | 2,638 | 2,331 | ||||||
Additional paid-in capital | 323,657 | 305,303 | ||||||
Accumulated deficit | (272,767 | ) | (215,409 | ) | ||||
Accumulated other comprehensive loss | 1 | (43 | ) | |||||
TOTAL SHAREHOLDERS' EQUITY | 53,529 | 92,182 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 81,583 | $ | 103,731 |
March 31 | December 31 | |||||||
2019 | 2018 | |||||||
Liabilities and shareholders’ equity | ||||||||
CURRENT LIABILITIES: | ||||||||
Accounts payable and accruals: | ||||||||
Trade | $ | 5,657 | $ | 6,327 | ||||
Operating lease liabilities (Note 6) | 914 | - | ||||||
Other | 2,859 | 4,141 | ||||||
TOTAL CURRENT LIABILITIES | 9,430 | 10,468 | ||||||
LONG-TERM LIABILITIES: | ||||||||
Liability for employee severance benefits | 397 | 367 | ||||||
Operating lease liabilities (Note 6) | 1,023 | - | ||||||
Other liabilities | 714 | 714 | ||||||
TOTAL LONG-TERM LIABILITIES | 2,134 | 1,081 | ||||||
TOTAL LIABILITIES | 11,564 | 11,549 | ||||||
COMMITMENTS (Note 6) | ||||||||
SHAREHOLDERS' EQUITY: | ||||||||
Ordinary Shares, NIS 0.16 par value - authorized: 90,000,000 Ordinary Shares as of March 31, 2019 and December 31, 2018; issued and outstanding: 54,419,323 and 54,351,140 Ordinary Shares as of March 31, 2019 and December 31, 2018, respectively | 2,334 | 2,331 | ||||||
Additional paid-in capital | 306,266 | 305,303 | ||||||
Accumulated deficit | (230,613 | ) | (215,409 | ) | ||||
Accumulated other comprehensive income (loss) | 8 | (43 | ) | |||||
TOTAL SHAREHOLDERS' EQUITY | 77,995 | 92,182 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 89,559 | $ | 103,731 |
Three months ended | ||||||||
March 31 | ||||||||
2019 | 2018 | |||||||
REVENUES (Note 7) | $ | 308 | $ | 906 | ||||
OPERATING EXPENSES: | ||||||||
Research and development | 10,848 | 22,825 | ||||||
Selling, general and administrative | 5,344 | 3,801 | ||||||
TOTAL OPERATING EXPENSES | 16,192 | 26,626 | ||||||
OPERATING LOSS | 15,884 | 25,720 | ||||||
FINANCE INCOME, net | (504 | ) | (73 | ) | ||||
LOSS BEFORE INCOME TAX | 15,380 | 25,647 | ||||||
INCOME TAX | (176 | ) | 330 | |||||
NET LOSS FOR THE PERIOD | $ | 15,204 | $ | 25,977 | ||||
LOSS PER SHARE BASIC AND DILUTED | $ | 0.28 | $ | 0.69 | ||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE IN THOUSANDS | 54,370 | 37,541 |
Nine months ended September 30 | Three months ended September 30 | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
REVENUES (Note 8) | $ | 308 | $ | 2,735 | $ | - | $ | 865 | ||||||||
OPERATING EXPENSES: | ||||||||||||||||
Research and development | 35,856 | 52,809 | 12,452 | 13,142 | ||||||||||||
Selling, general and administrative | 22,894 | 10,019 | 10,747 | 3,309 | ||||||||||||
TOTAL OPERATING EXPENSES | 58,750 | 62,828 | 23,199 | 16,451 | ||||||||||||
OPERATING LOSS | 58,442 | 60,093 | 23,199 | 15,586 | ||||||||||||
FINANCE INCOME, net | (908 | ) | (471 | ) | (38 | ) | (119 | ) | ||||||||
LOSS BEFORE INCOME TAX | 57,534 | 59,622 | 23,161 | 15,467 | ||||||||||||
INCOME TAX | (176 | ) | 463 | - | 13 | |||||||||||
NET LOSS FOR THE PERIOD | $ | 57,358 | $ | 60,085 | $ | 23,161 | $ | 15,480 | ||||||||
LOSS PER SHARE BASIC AND DILUTED | $ | 1.05 | $ | 1.50 | $ | 0.41 | $ | 0.38 | ||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE IN THOUSANDS | 54,420 | 39,932 | 55,984 | 40,873 |
Three months ended | ||||||||
March 31 | ||||||||
2019 | 2018 | |||||||
NET LOSS | $ | 15,204 | $ | 25,977 | ||||
OTHER COMPREHENSIVE LOSS (INCOME): | ||||||||
Net unrealized losses (gains) from marketable securities | (36 | ) | 15 | |||||
Losses on marketable securities reclassified into net loss | - | (1 | ) | |||||
Net unrealized losses (gains) on derivative financial instruments | (15 | ) | 14 | |||||
Gains on derivative financial instruments reclassified into net loss | - | 6 | ||||||
TOTAL OTHER COMPREHENSIVE LOSS (INCOME) | (51 | ) | 34 | |||||
TOTAL COMPREHENSIVE LOSS | $ | 15,153 | $ | 26,011 |
Nine months ended September 30 | Three months ended September 30 | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
NET LOSS | $ | 57,358 | $ | 60,085 | $ | 23,161 | $ | 15,480 | ||||||||
OTHER COMPREHENSIVE LOSS (INCOME): | ||||||||||||||||
Net unrealized gains from marketable securities | (41 | ) | (44 | ) | (1 | ) | (34 | ) | ||||||||
Losses on marketable securities reclassified into net loss | - | (5 | ) | - | (3 | ) | ||||||||||
Net unrealized losses (gains) on derivative financial instruments | (3 | ) | 68 | (1 | ) | (13 | ) | |||||||||
losses on derivative financial instruments reclassified into net loss | - | (55 | ) | - | (20 | ) | ||||||||||
TOTAL OTHER COMPREHENSIVE INCOME | (44 | ) | (36 | ) | (2 | ) | (70 | ) | ||||||||
TOTAL COMPREHENSIVE LOSS | $ | 57,314 | $ | 60,049 | $ | 23,159 | $ | 15,410 |
Ordinary shares | Additional paid-in capital | Accumulated deficit | Accumulated other comprehensive Income (loss) | Total | ||||||||||||||||||||
Number of shares | Amounts | Amounts | ||||||||||||||||||||||
BALANCE AT JANUARY 1, 2018 | 37,498,128 | $ | 1,576 | $ | 208,364 | $ | (141,281 | ) | $ | (58 | ) | $ | 68,601 | |||||||||||
Impact of initial adoption of new accounting standards, as previously reported | - | - | - | 35 | (35 | ) | - | |||||||||||||||||
CHANGES DURING THE PERIOD: | ||||||||||||||||||||||||
Comprehensive loss | - | - | - | (60,085 | ) | 36 | (60,049 | ) | ||||||||||||||||
Issuance of ordinary shares through a public offering, net of $5,175 issuance costs | 13,420,500 | 599 | 74,749 | - | - | 75,348 | ||||||||||||||||||
Issuance of ordinary shares through a securities purchase agreement, net of $39 issuance costs | 2,940,000 | 134 | 15,997 | - | - | 16,131 | ||||||||||||||||||
Exercise of warrants | 178,468 | 8 | 832 | - | - | 840 | ||||||||||||||||||
Exercise of options and restricted share units | 233,078 | 10 | 33 | - | - | 43 | ||||||||||||||||||
Share-based compensation (Note 6) | - | - | 4,144 | - | - | 4,144 | ||||||||||||||||||
BALANCE AT SEPTEMBER 30, 2018 | 54,270,174 | $ | 2,327 | $ | 304,119 | $ | (201,331 | ) | $ | (57 | ) | $ | 105,058 | |||||||||||
BALANCE AT JANUARY 1, 2019 | 54,351,140 | $ | 2,331 | $ | 305,303 | $ | (215,409 | ) | $ | (43 | ) | $ | 92,182 | |||||||||||
CHANGES DURING THE PERIOD: | ||||||||||||||||||||||||
Comprehensive loss | - | - | - | (57,358 | ) | 44 | (57,314 | ) | ||||||||||||||||
Issuance of ordinary shares and warrants, net of $359 issuance costs (Note 5 and 6) | 6,542,057 | 297 | 14,714 | - | - | 15,011 | ||||||||||||||||||
Exercise of options and restricted share units | 227,890 | 10 | 34 | - | - | 44 | ||||||||||||||||||
Share-based compensation (Note 6) | - | - | 3,606 | - | - | 3,606 | ||||||||||||||||||
BALANCE AT SEPTEMBER 30, 2019 | 61,121,087 | $ | 2,638 | $ | 323,657 | $ | (272,767 | ) | $ | 1 | $ | 53,529 |
Ordinary shares | Additional paid-in capital | Accumulated deficit | Accumulated other comprehensive Income (loss) | Total | ||||||||||||||||||||
Number of shares | Amounts | Amounts | ||||||||||||||||||||||
BALANCE AT JULY 1, 2018 | 40,693,479 | $ | 1,721 | $ | 228,154 | $ | (185,851 | ) | $ | (127 | ) | $ | 43,897 | |||||||||||
CHANGES DURING THE PERIOD: | ||||||||||||||||||||||||
Comprehensive loss | - | - | - | (15,480 | ) | 70 | (15,410 | ) | ||||||||||||||||
Issuance of ordinary shares through a public offering, net of $5,175 issuance costs | 13,420,500 | 599 | 74,749 | - | - | 75,348 | ||||||||||||||||||
Exercise of options and restricted share units | 156,195 | 7 | 26 | - | - | 33 | ||||||||||||||||||
Share-based compensation (Note 6) | - | - | 1,190 | - | - | 1,190 | ||||||||||||||||||
BALANCE AT SEPTEMBER 30, 2018 | 54,270,174 | $ | 2,327 | $ | 304,119 | $ | (201,331 | ) | $ | (57 | ) | $ | 105,058 | |||||||||||
BALANCE AT JULY 1, 2019 | 54,455,969 | $ | 2,336 | $ | 307,653 | $ | (249,606 | ) | $ | (1 | ) | $ | 60,382 | |||||||||||
CHANGES DURING THE PERIOD: | ||||||||||||||||||||||||
Comprehensive loss | - | - | - | (23,161 | ) | 2 | (23,159 | ) | ||||||||||||||||
Issuance of ordinary shares and warrants, net of $359 issuance costs (Note 5 and 6) | 6,542,057 | 297 | 14,714 | - | - | 15,011 | ||||||||||||||||||
Exercise of options and restricted share units | 123,061 | 5 | 21 | - | - | 26 | ||||||||||||||||||
Share-based compensation (Note 6) | - | - | 1,269 | - | - | 1,269 | ||||||||||||||||||
BALANCE AT SEPTEMBER 30, 2019 | 61,121,087 | $ | 2,638 | $ | 323,657 | $ | (272,767 | ) | $ | 1 | $ | 53,529 |
Ordinary shares | Additional paid-in capital | Accumulated deficit | Accumulated other comprehensive Income (loss) | Total | ||||||||||||||||||||
Number of shares | Amounts | Amounts | ||||||||||||||||||||||
BALANCE AT JANUARY 1, 2018 | 37,498,128 | $ | 1,576 | $ | 208,364 | $ | (141,281 | ) | $ | (58 | ) | $ | 68,601 | |||||||||||
Impact of initial adoption of new accounting standards, as previously reported | 35 | (35 | ) | - | ||||||||||||||||||||
CHANGES DURING THE PERIOD: | ||||||||||||||||||||||||
Comprehensive loss | - | - | - | (25,977 | ) | (34 | ) | (26,011 | ) | |||||||||||||||
Exercise of restricted share units | 53,383 | 2 | (2 | ) | - | - | - | |||||||||||||||||
Share-based compensation (Note 5) | - | - | 1,754 | - | - | 1,754 | ||||||||||||||||||
BALANCE AT MARCH 31, 2018 | 37,551,511 | 1,578 | 210,116 | (167,223 | ) | (127 | ) | 44,344 | ||||||||||||||||
BALANCE AT JANUARY 1, 2019 | 54,351,140 | $ | 2,331 | $ | 305,303 | $ | (215,409 | ) | $ | (43 | ) | $ | 92,182 | |||||||||||
CHANGES DURING THE PERIOD: | ||||||||||||||||||||||||
Comprehensive income (loss) | - | - | - | (15,204 | ) | 51 | (15,153 | ) | ||||||||||||||||
Exercise of options and restricted share units | 68,183 | 3 | 13 | - | - | 16 | ||||||||||||||||||
Share-based compensation (Note 5) | - | - | 950 | - | - | 950 | ||||||||||||||||||
BALANCE AT MARCH 31, 2019 | 54,419,323 | $ | 2,334 | $ | 306,266 | $ | (230,613 | ) | $ | 8 | $ | 77,995 |
Nine months ended September 30 | ||||||||
2019 | 2018 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net loss | $ | 57,358 | $ | 60,085 | ||||
Adjustments required to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 256 | 243 | ||||||
Loss from disposal and sale of fixed assets | 7 | 39 | ||||||
Changes in marketable securities and bank deposits, net | (269 | ) | 165 | |||||
Changes in accrued liability for employee severance benefits, net of retirement fund profit | 52 | (57 | ) | |||||
Share-based compensation | 3,606 | 4,144 | ||||||
Non-cash finance expenses, net | 85 | 20 | ||||||
Changes in operating asset and liabilities: | ||||||||
Decrease (increase) in trade and other receivables | 1,086 | (756 | ) | |||||
Increase in other non-current assets | (124 | ) | (12 | ) | ||||
Increase (decrease) in accounts payable and accruals | 1,511 | (1,467 | ) | |||||
Net cash used in operating activities | (51,148 | ) | (57,766 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Purchase of fixed assets | (861 | ) | (408 | ) | ||||
Proceeds from sale of fixed assets | 24 | 10 | ||||||
Investment in bank deposits | (34,061 | ) | (27,500 | ) | ||||
Investment in marketable securities | (13,940 | ) | (1,012 | ) | ||||
Proceeds from sale and maturity of marketable securities and bank deposits | 84,673 | 66,255 | ||||||
Net cash provided by investing activities | 35,835 | 37,345 | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Proceeds from exercise of options | 54 | 43 | ||||||
Proceeds from exercise of warrants | - | 840 | ||||||
Withholding tax from net exercise of restricted share units | (10 | ) | - | |||||
Proceeds from issuance of shares, net of issuance costs | 13,714 | 16,131 | ||||||
Proceeds from issuance of shares through public offerings, net of $5,175 issuance costs | - | 75,348 | ||||||
Proceeds from debt financing and issuance of warrants, net of $804 issuance costs | 14,196 | - | ||||||
Net cash provided by financing activities | 27,954 | 92,362 | ||||||
INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 12,641 | 71,941 | ||||||
EFFECT OF EXCHANGE RATE ON CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 25 | (20 | ) | |||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF THE PERIOD | 28,118 | 16,206 | ||||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE PERIOD | $ | 40,784 | $ | 88,127 | ||||
Cash and cash equivalents | 40,534 | 87,877 | ||||||
Restricted cash | 250 | 250 | ||||||
TOTAL CASH, CASH EQUIVALENTS AND RESTRICTED CASH SHOWN IN STATEMENT OF CASH FLOWS | $ | 40,784 | $ | 88,127 | ||||
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | ||||||||
Cashless exercise of warrants and restricted share units | $ | 7 | $ | 7 |
Three months ended | ||||||||
March 31 | ||||||||
2019 | 2018 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net Loss | $ | (15,204 | ) | $ | (25,977 | ) | ||
Adjustments required to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 76 | 86 | ||||||
Loss from disposal of fixed assets | - | 36 | ||||||
Changes in marketable securities and bank deposits, net | (264 | ) | (40 | ) | ||||
Changes in accrued liability for employee severance benefits, net of retirement fund profit | 30 | (35 | ) | |||||
Share-based compensation | 950 | 1,754 | ||||||
Non-cash finance expenses (income), net | 23 | 1 | ||||||
Changes in operating asset and liabilities: | ||||||||
Decrease (increase) in trade and other receivables | (300 | ) | 487 | |||||
Decrease in other non-current assets | (4 | ) | - | |||||
Increase (Decrease) in accounts payable and accruals | (1,949 | ) | 495 | |||||
Net cash used in operating activities | (16,642 | ) | (23,193 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Purchase of fixed assets | (138 | ) | (122 | ) | ||||
Investment in bank deposits | (8,000 | ) | (8,500 | ) | ||||
Investment in marketable securities | - | (1,012 | ) | |||||
Proceeds from sale and maturity of marketable securities and bank deposits | 15,877 | 29,642 | ||||||
Net cash provided by investing activities | 7,739 | 20,008 | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Proceeds from exercise of options | 16 | - | ||||||
Net cash provided by financing activities | 16 | - | ||||||
DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (8,887 | ) | (3,185 | ) | ||||
EFFECT OF EXCHANGE RATE ON CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 13 | (1 | ) | |||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF THE PERIOD | 28,118 | 16,206 | ||||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE PERIOD | $ | 19,244 | $ | 13,020 | ||||
Cash and cash equivalents | $ | 18,994 | $ | 12,770 | ||||
Restricted cash | 250 | 250 | ||||||
TOTAL CASH, CASH EQUIVALENTS AND RESTRICTED CASH SHOWN IN STATEMENT OF CASH FLOWS | $ | 19,244 | $ | 13,020 | ||||
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS - | ||||||||
Property and equipment purchases included in accounts payable and accruals | - | $ | 4 | |||||
Cashless exercise of RSU's | $ | 3 | $ | 2 | ||||
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | ||||||||
Interest received | $ | 307 | $ | 384 | ||||
Additions to operating lease right of use assets and liabilities | $ | 736 | - |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | ||||||||
Cash paid for taxes | $ | - | $ | 469 | ||||
Interest received | $ | 1,125 | $ | 784 | ||||
Interest paid | $ | 289 | $ | - | ||||
Additions to operating lease right of use assets | $ | 1,193 | $ | - | ||||
Additions to operating lease liabilities | $ | 1,175 | $ | - |
a. | Nature of operations |
b. | Basis of presentation |
a. | Principles of consolidation The consolidated financial statements include the accounts of Foamix and its subsidiary. Intercompany balances and transactions including profits from intercompany sales not yet realized outside the Company have been eliminated upon consolidation. |
b. | Fair value measurement Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: |
Level 1: | Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. |
Level | Observable prices that are based on inputs not quoted on active markets, but corroborated by market data or active market data of similar or identical assets or liabilities. |
Level 3: | Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. |
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. |
c. | Loss per share |
Three months ended March 31 | Nine months ended September 30 | Three months ended September 30 | ||||||||||||||||||||||
2019 | 2018 | 2019 | 2018 | 2019 | 2018 | |||||||||||||||||||
Outstanding share options and RSUs | 5,895,973 | 4,728,610 | ||||||||||||||||||||||
Outstanding share options, RSUs and shares under the ESPP | 6,055,554 | 4,680,521 | 6,380,647 | 4,874,889 | ||||||||||||||||||||
Warrants | - | 1,394,558 | 253,846 | 715,158 | 761,538 | - |
d. | Newly issued and recently adopted accounting pronouncements: |
1) | In February 2016, the The Company adopted the standard as of January 1, 2019 on a modified retrospective basis and did not restate comparative periods. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed the Company to carryforward the historical lease classification and not separate lease and non-lease components for the leases. The Company recognizes the lease payments in the consolidated statements of operations on a straight-line basis over the lease period. The adoption of the standard resulted in recognition of $1,357 of lease assets and lease liabilities as of January 1, 2019 on the Company’s consolidated balance sheets. |
2) | In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718) Improvements to Nonemployee Share-based Payments. This ASU was issued to simplify the accounting for share-based transactions by expanding the scope of Topic 718 from only being applicable to share-based payments to employees to also include share-based payment transactions for acquiring goods and services from nonemployees. As a result, nonemployee share-based transactions will be measured by estimating the fair value of the equity instruments at the grant date, taking into consideration the probability of satisfying performance conditions. This standard, adopted as of January 1, 2019, |
March 31, 2019 | September 30, 2019 | |||||||||||||||||||||||
Level 1 | Level 2 | Total | Level 1 | Level 2 | Total | |||||||||||||||||||
Marketable securities | $ | 1,001 | $ | 38,534 | $ | 39,535 | $ | 1,016 | $ | 14,748 | $ | 15,764 | ||||||||||||
Currency options designated as hedging instruments (current asset) | - | $ | 12 | $ | 12 | |||||||||||||||||||
December 31, 2018 | December 31, 2018 | |||||||||||||||||||||||
Level 1 | Level 2 | �� | Total | Level 1 | Level 2 | Total | ||||||||||||||||||
Marketable securities | $ | 991 | $ | 46,229 | $ | 47,220 | $ | 991 | $ | 46,229 | $ | 47,220 | ||||||||||||
Currency options designated as hedging instruments (current liability) | - | $ | (3 | ) | $ | (3 | ) | $ | - | $ | (3 | ) | $ | (3 | ) |
March 31 | December 31 | |||||||
2019 | 2018 | |||||||
Israeli mutual funds | $ | 1,001 | $ | 991 | ||||
Certificates of deposit | 2,086 | 2,773 | ||||||
U.S Government and agency bonds | 20,694 | 25,215 | ||||||
U.S Treasury bills | 15,754 | 18,241 | ||||||
Total | $ | 39,535 | $ | 47,220 |
September 30 | December 31 | |||||||
2019 | 2018 | |||||||
Israeli mutual funds | $ | 1,016 | $ | 991 | ||||
Certificates of deposit | 805 | 2,773 | ||||||
U.S Government bonds | 4,010 | 25,215 | ||||||
U.S Treasury bills | 9,933 | 18,241 | ||||||
Total | $ | 15,764 | $ | 47,220 |
March 31, 2019 | ||||||||||||||||
Fair value | Cost or amortized cost | Gross unrealized holding losses | Gross unrealized holding gains | |||||||||||||
Certificates of deposit | $ | 2,086 | $ | 2,092 | $ | 6 | $ | - | ||||||||
U.S Government and agency bonds | 20,694 | 20,693 | 3 | 4 | ||||||||||||
U.S Treasury bills | 15,754 | 15,753 | - | 1 | ||||||||||||
Total | $ | 38,534 | $ | 38,538 | $ | 9 | $ | 5 |
September 30, 2019 | ||||||||||||||||||||||||||||||||
December 31, 2018 | Fair | Cost or amortized cost | Gross unrealized | Gross unrealized | ||||||||||||||||||||||||||||
Fair value | Cost or amortized cost | Gross unrealized holding loss | Gross unrealized holding gains | value | holding losses | holding gains | ||||||||||||||||||||||||||
Certificates of deposit | $ | 2,773 | $ | 2,790 | $ | 17 | $ | - | $ | 805 | $ | 805 | $ | - | * | $ | - | * | ||||||||||||||
U.S Government and agency bonds | 25,215 | 25,236 | 22 | 1 | ||||||||||||||||||||||||||||
U.S Government bonds | 4,010 | 4,010 | - | * | - | * | ||||||||||||||||||||||||||
U.S Treasury bills | 18,241 | 18,243 | 3 | 1 | 9,933 | 9,932 | - | * | 1 | |||||||||||||||||||||||
Total | $ | 46,229 | $ | 46,269 | $ | 42 | $ | 2 | $ | 14,748 | $ | 14,747 | $ | - | $ | 1 | ||||||||||||||||
* Represents amounts less than $1. |
December 31, 2018 | ||||||||||||||||
Fair | Cost or amortized cost | Gross unrealized | Gross unrealized | |||||||||||||
value | holding loss | holding gains | ||||||||||||||
Certificates of deposit | $ | 2,773 | $ | 2,790 | $ | 17 | $ | - | ||||||||
U.S Government and agency Bonds | 25,215 | 25,236 | 22 | 1 | ||||||||||||
U.S Treasury bills | 18,241 | 18,243 | 3 | 1 | ||||||||||||
Total | $ | 46,229 | $ | 46,269 | $ | 42 | $ | 2 |
Market value | ||||||||
September 30, | December 31, | |||||||
2019 | 2018 | |||||||
Due within one year | $ | 14,748 | $ | 46,079 | ||||
1 to 2 years | - | 150 | ||||||
Total | $ | 14,748 | $ | 46,229 |
Market value | ||||||||
March 31 | December 31, | |||||||
2019 | 2018 | |||||||
Due within one year | $ | 38,534 | $ | 46,079 | ||||
1 to 2 years | - | 150 | ||||||
Total | $ | 38,534 | $ | 46,229 |
Nine months ended September 30, 2019 | |||||||||||||
Award amount | Exercise price range | Vesting period | Expiration | ||||||||||
Employees: | |||||||||||||
Options | 1,180,736 | $ | 2.36-$3.81 | 4 years | 10 year | ||||||||
RSUs | 284,628 | - | 4 years | - | |||||||||
Directors: | |||||||||||||
Options | 247,060 | $ | 2.66 | 1 year | 10 year | ||||||||
RSUs | 140,976 | - | 1 year | - |
Nine months ended | |||||||||||||
Award amount | Exercise price range | Vesting period | Expiration | ||||||||||
Employees: | |||||||||||||
Options | $ | 4 years | 10 years | ||||||||||
RSUs | 4 years | - |
Options | $ | 10 years | ||||||||||||
RSUs | - |
Nine months ended September 30 | ||||||||
2019 | 2018 | |||||||
Value of ordinary share | $ | 2.36-$3.83 | $ | 5.12-$5.99 | ||||
Dividend yield | 0 | % | 0 | % | ||||
Expected volatility | 59.35%-61.4 | % | 62.1%-62.6 | % | ||||
Risk-free interest rate | 1.42%-2.62 | % | 2.75%-2.84 | % | ||||
Expected term | 6 years | 6 years |
Nine months ended September 30 | Three months ended September 30 | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Research and development expenses | $ | 1,127 | $ | 1,679 | $ | 389 | $ | 376 | ||||||||
Selling, general and administrative | 2,479 | 2,465 | 880 | 814 | ||||||||||||
$ | 3,606 | $ | 4,144 | $ | 1,269 | $ | 1,190 |
Three months ended March 31 | ||||||||
2019 | 2018 | |||||||
Value of ordinary share | $ | 3.32-$3.83 | $ | 5.99 | ||||
Dividend yield | 0 | % | 0 | % | ||||
Expected volatility | 61.2%-61.4 | % | 62.1 | % | ||||
Risk-free interest rate | 2.55%-2.62 | % | 2.75 | % | ||||
Expected term | 6 years | 6 years |
Three months ended March 31 | ||||||||
2019 | 2018 | |||||||
Research and development expenses | $ | 354 | $ | 891 | ||||
Selling, general and administrative | 596 | 863 | ||||||
Total | $ | 950 | $ | 1,754 |
Nine months ended September 30 | Three months ended September 30 | |||||||
2019 | 2019 | |||||||
Office lease expenses | $ | 570 | $ | 176 | ||||
Vehicles lease expenses | $ | 63 | $ | 30 |
Nine months ended September 30 | Three months ended September 30 | |||||||
2019 | 2019 | |||||||
Office lease | $ | 595 | $ | 206 | ||||
Vehicles lease | $ | 104 | $ | 32 |
September 30 | ||||
2019 | ||||
Operating lease right-of-use assets | $ | 1,947 | ||
Operating lease liabilities | $ | 2,006 | ||
Weighted average remaining lease term | 2.13 | |||
Weighted average discount rate | 5.72 | % |
2019 | $ | 296 | ||
2020 | 1,158 | |||
2021 | 455 | |||
2022 | 229 | |||
Total lease payments | 2,138 | |||
Less imputed interest | (132 | ) | ||
Total lease liability | $ | 2,006 |
Three months ended March 31 | ||||
2019 | ||||
Office lease expenses | $ | 182 | ||
Vehicles lease expenses | $ | 25 |
Three months ended March 31 | ||||
2019 | ||||
Office lease | $ | 201 | ||
Vehicles lease | $ | 36 |
March 31 | ||||
2019 | ||||
Operating lease right-of-use assets | $ | 1,934 | ||
Operating lease liabilities | $ | 1,937 | ||
Weighted average remaining lease term | 2.4 years | |||
Weighted average discount rate | 5.54 | % |
2019 | $ | 695 | ||
2020 | 954 | |||
2021 | 279 | |||
2022 | 150 | |||
Total lease payments | $ | 2,078 | ||
Less imputed interest | $ | (141 | ) | |
Total lease liability | $ | 1,937 |
2019 | $ | 746 | ||
2020 | 682 | |||
2021 and thereafter | 21 | |||
Total | $ | 1,449 |
a. | Net revenues by geographic area were as follows: |
Nine months ended September 30 | Three months ended September 30 | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
United States | $ | - | $ | 62 | $ | - | $ | - | ||||||||
Denmark | 308 | 205 | - | 205 | ||||||||||||
Germany | - | 2,468 | - | 660 | ||||||||||||
Total revenues | $ | 308 | $ | 2,735 | $ | - | $ | 865 |
b. | Customers exceeding 10% of revenues: |
Nine months ended September 30 | Three months ended September 30 | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Customer A | $ | - | $ | 2,468 | $ | - | $ | 660 | ||||||||
Customer B | $ | 308 | $ | 205 | $ | - | $ | 205 |
c. | Net revenues by type of payment: |
Nine months ended September 30 | Three months ended September 30 | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Development service payments | $ | - | $ | 62 | $ | - | $ | - | ||||||||
Royalties | 308 | 2,673 | - | 865 | ||||||||||||
Total revenues | $ | 308 | $ | 2,735 | $ | - | $ | 865 |
Three months ended March 31 | ||||||||
2019 | 2018 | |||||||
United States | $ | - | $ | 62 | ||||
Denmark | 308 | - | ||||||
Germany | - | 844 | ||||||
Total revenues | $ | 308 | $ | 906 |
Three months ended March 31 | ||||||||
2019 | 2018 | |||||||
Development service payments | $ | - | $ | 62 | ||||
Royalties | 308 | 844 | ||||||
Total revenues | $ | 308 | $ | 906 |
(A) | If the Efficacy Determination reports that Serlopitant Significance (as defined in the Merger Agreement) was achieved in both Phase III PN Trials on or before May 31, 2020, then there will be no adjustment to the Exchange Ratio; |
(B) | If the Efficacy Determination reports that (1) Serlopitant Significance was achieved in only one Phase III PN Trial on or before May 31, 2020 and (2) Serlopitant Significance was not achieved or has not been determined in each case on or before May 31, 2020 in the other Phase III PN Trial, then the Exchange Ratio will instead be 1.2739 shares of Menlo Common Stock; and |
(C) | If the Efficacy Determination reports that Serlopitant Significance was not achieved in both Phase III PN Trials or the Efficacy Determination has not been delivered on or before May 31, 2020, then in each case the Exchange Ratio will instead be 1.8006 shares of Menlo Common Stock. |
(A) | If the Efficacy Determination reports that Serlopitant Significance (as defined in the Merger Agreement) was achieved in both Phase III PN Trials on or before May 31, 2020, then each CSR will be entitled to no shares of Menlo Common Stock; |
(B) | If the Efficacy Determination reports that (1) Serlopitant Significance was achieved in only one Phase III PN Trial on or before May 31, 2020 and (2) Serlopitant Significance was not achieved or has not been determined prior to May 31, 2020 in the other Phase III PN Trial, then each CSR will be converted into 0.6815 shares of Menlo Common Stock; and |
(C) | If the Efficacy Determination reports that Serlopitant Significance was not achieved in both Phase III PN Trials or the Efficacy Determination has not been delivered on or before May 31, 2020, then in each CSR will be converted into 1.2082 shares of Menlo common stock |
• |
costs associated with market research |
Three months ended September 30, | ||||||||
2019 | 2018 | |||||||
(in thousands of U.S. dollars) | ||||||||
Interest on bank deposits | $ | (154 | ) | $ | (51 | ) | ||
Gain from marketable securities, net | (227 | ) | (107 | ) | ||||
Total income | (381 | ) | (158 | ) | ||||
Less: | ||||||||
Other expenses | 6 | 4 | ||||||
Interest and finance expenses on long-term debt | 329 | - | ||||||
Non-cash foreign exchange loss, net | 8 | 35 | ||||||
Total expenses | 343 | 39 | ||||||
Finance income, net | $ | (38 | ) | $ | (119 | ) |
Three months ended March 31, | Nine months ended September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
(in thousands of U.S. dollars) | (in thousands of U.S. dollars) | |||||||||||||||
Interest on bank deposits | $ | (179 | ) | $ | (57 | ) | $ | (495 | ) | $ | (205 | ) | ||||
Gain from marketable securities, net | (357 | ) | (106 | ) | (890 | ) | (326 | ) | ||||||||
Total income | (536 | ) | (163 | ) | (1,385 | ) | (531 | ) | ||||||||
Less: | ||||||||||||||||
Other expenses | 4 | 3 | 15 | 13 | ||||||||||||
Foreign exchange loss, net | 28 | 87 | ||||||||||||||
Interest and finance expenses on long-term debt | 329 | - | ||||||||||||||
Non-cash foreign exchange loss, net | 133 | 47 | ||||||||||||||
Total expenses | 32 | 90 | 477 | 60 | ||||||||||||
Finance income, net | $ | (504 | ) | $ | (73 | ) | $ | (908 | ) | $ | (471 | ) |
Three months ended March 31, | Nine months ended September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
(in thousands of U.S. dollars) | (in thousands of U.S. dollars) | |||||||||||||||
Net cash (used in) / provided by: | ||||||||||||||||
Operating activities | $ | (16,642 | ) | $ | (23,193 | ) | $ | (51,148 | ) | $ | (57,766 | ) | ||||
Investing activities | 7,739 | 20,008 | 35,835 | 37,345 | ||||||||||||
Financing activities | 16 | - | $ | 27,954 | $ | 92,362 |
Proceeds from our underwritten public offerings(1) | Proceeds from our direct public offerings | Proceeds from issuance of Ordinary Shares | Payments from licensees | Total | ||||||||||||||||
Three months ended March 31, 2019 | - | - | 16,000 | 206,000 | 222,000 | |||||||||||||||
Three months ended March 31, 2018 | - | - | - | 989,000 | 989,000 |
Proceeds from our public offerings(1) | Proceeds from debt financing and issuance of warrant (1) | Proceeds from issuance of Ordinary Shares | Payments from licensees | Total | ||||||||||||||||
(in thousands of U.S. dollars) | ||||||||||||||||||||
September 30, 2019 | $ | 13,714 | $ | 14,196 | $ | 54 | $ | 1,374 | $ | 29,338 | ||||||||||
September 30, 2018 | $ | 91,479 | $ | - | $ | 883 | $ | 2,797 | $ | 95,159 |
Incorporated by Reference | ||||||||||||
Exhibit Number | Description Of Document | Form | SEC File No. | Exhibit | Filing Date | Filed Herewith | ||||||
10-Q | 001-36621 | 3.1 | May 7, 2019 | |||||||||
X | ||||||||||||
X | ||||||||||||
X | ||||||||||||
X | ||||||||||||
8-K | 001-36621 | 10.1 | July 30, 2019 | |||||||||
8-K | 001-36621 | 1.1 | August 19, 2019 | |||||||||
X | ||||||||||||
X | ||||||||||||
X | ||||||||||||
X | ||||||||||||
101.INS | XBRL Instance Document | X | ||||||||||
101.SCH | XBRL Taxonomy Extension Schema Document | X | ||||||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | X | ||||||||||
101.DEF | XBRL Taxonomy Extension Definition Document | X | ||||||||||
101.LAB | XBRL Taxonomy Extension Label Document | X | ||||||||||
101.PRE | XBRL Taxonomy Presentation Linkbase Document | X |
FOAMIX PHARMACEUTICALS LTD. | ||||
Date: | By: | /s/ David Domzalski | ||
David Domzalski | ||||
Chief Executive Officer (Principal Executive Officer) | ||||
Date: | By: | /s/ Ilan Hadar | ||
Ilan Hadar | ||||
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |