Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Nov. 09, 2017 | |
Document And Entity Information | ||
Entity Registrant Name | VBI Vaccines Inc/BC | |
Entity Central Index Key | 764,195 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2017 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 63,804,781 | |
Trading Symbol | VBIV | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2,017 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
CURRENT ASSETS | ||
Cash | $ 10,054 | $ 32,282 |
Accounts receivable, net | 203 | 10 |
Inventory, net | 701 | 830 |
Other current assets | 1,993 | 1,236 |
Total current assets | 12,951 | 34,358 |
NON-CURRENT ASSETS | ||
Long-term deposits | 172 | 167 |
Other long term assets | 514 | 487 |
Property and equipment, net | 2,153 | 1,850 |
Intangible assets, net | 63,669 | 59,507 |
Goodwill | 9,021 | 8,385 |
Total non-current assets | 75,529 | 70,396 |
TOTAL ASSETS | 88,480 | 104,754 |
CURRENT LIABILITIES | ||
Accounts payable | 3,446 | 2,018 |
Other current liabilities | 8,138 | 5,562 |
Deferred revenues | 34 | |
Current portion of long-term debt | 1,000 | |
Total current liabilities | 12,584 | 7,614 |
NON-CURRENT LIABILITIES | ||
Long-term debt, net of debt discount of $2,460 and $3,344, as of September 30, 2017 and December 31, 2016, respectively and current portion | 11,840 | 11,956 |
Long-term deferred tax liability | 428 | |
Liabilities for severance pay | 414 | 356 |
Deferred revenues, net of current portion | 669 | 669 |
Total non-current liabilities | 12,923 | 13,409 |
COMMITMENTS AND CONTINGENCIES (NOTE 10) | ||
STOCKHOLDERS' EQUITY | ||
Common shares (unlimited authorized; no par value) (40,229,371 and 40,018,495 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively) | 134,046 | 133,312 |
Additional paid-in capital | 59,721 | 58,595 |
Accumulated other comprehensive income (loss) | 1,638 | (3,196) |
Accumulated deficit | (132,432) | (104,980) |
Total stockholders' equity | 62,973 | 83,731 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 88,480 | $ 104,754 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Statement of Financial Position [Abstract] | ||
Long-term debt, net of debt discount | $ 2,460 | $ 3,344 |
Common stock, authorized unlimited | Unlimited | Unlimited |
Common stock, no par value | ||
Common stock, shares issued | 40,229,371 | 40,018,495 |
Common stock, shares outstanding | 40,229,371 | 40,018,495 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Statement [Abstract] | ||||
Revenues | $ 193 | $ 281 | $ 664 | $ 411 |
Operating expenses: | ||||
Cost of revenue | 1,334 | 1,501 | 3,966 | 2,581 |
Research and development | 5,205 | 3,371 | 14,387 | 5,748 |
General and administration | 2,795 | 3,149 | 8,611 | 8,267 |
Total operating expenses | (9,334) | (8,021) | (26,964) | (16,596) |
Loss from operations | (9,141) | (7,740) | (26,300) | (16,185) |
Interest expense, net | 742 | 62 | 2,188 | 90 |
Foreign exchange gain | (81) | (503) | (605) | (1,481) |
Loss before incomes taxes | (9,802) | (7,299) | (27,883) | (14,794) |
Income tax benefit | 431 | |||
NET LOSS | $ (9,802) | $ (7,299) | $ (27,452) | $ (14,794) |
Net loss per share of common shares, basic and diluted | $ (0.24) | $ (0.20) | $ (0.68) | $ (0.54) |
Weighted-average number of common shares outstanding, basic and diluted | 40,229,371 | 36,150,936 | 40,115,689 | 27,592,940 |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | $ 2,818 | $ (506) | $ 4,834 | $ (816) |
COMPREHENSIVE LOSS | $ (6,984) | $ (7,805) | $ (22,618) | $ (15,610) |
Condensed Consolidated Stateme5
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - 9 months ended Sep. 30, 2017 - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Income (Loss) - Foreign Currency Translation Adjustments [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2016 | $ 133,312 | $ 58,595 | $ (3,196) | $ (104,980) | $ 83,731 |
Balance, shares at Dec. 31, 2016 | 40,018,495 | ||||
Stock-based compensation | $ 633 | 1,126 | 1,759 | ||
Stock-based compensation, shares | 179,499 | ||||
Common shares issued for services | $ 85 | 85 | |||
Common shares issued for services, shares | 25,000 | ||||
Common shares issued on exercise of stock options | $ 16 | $ 16 | |||
Common shares issued on exercise of stock options, shares | 6,377 | (6,000) | |||
Net loss | (27,452) | $ (27,452) | |||
Foreign currently translation adjustments | 4,834 | 4,834 | |||
Balance at Sep. 30, 2017 | $ 134,046 | $ 59,721 | $ 1,638 | $ (132,432) | $ 62,973 |
Balance, Shares at Sep. 30, 2017 | 40,229,371 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (27,452) | $ (14,794) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 539 | 440 |
Deferred taxes | (431) | |
Stock-based compensation | 1,844 | 1,808 |
Amortization of debt discount | 884 | 9 |
Impairment charge of intangible assets | 300 | |
Net change in operating working capital items, net of business acquisitions: | ||
(Increase) in accounts receivable | (187) | (35) |
Decrease in inventory | 198 | 272 |
(Increase) decrease in other current assets | (686) | 639 |
Decrease in other long-term assets | 26 | 15 |
Increase in trade account payable and other current liabilities | 3,169 | 1,835 |
(Decrease) in deferred revenues | (94) | (758) |
Net cash flows used in operating activities | (21,890) | (10,569) |
INVESTING ACTIVITIES | ||
Cash acquired in business combination | 2,126 | |
Changes in long-term deposits | (215) | |
Purchase of property and equipment | (526) | (311) |
Net cash flows (used in)/provided by investing activities | (526) | 1,600 |
FINANCING ACTIVITIES | ||
Proceeds from issuance of common shares for cash | 13,610 | |
Proceeds from exercise of stock options | 16 | |
Repayment of long-term debt | (375) | |
Net cash flows provided by financing activities | 16 | 13,235 |
Effect of exchange rates on cash | 172 | (27) |
CHANGE IN CASH FOR THE PERIOD | (22,228) | 4,266 |
CASH, BEGINNING OF PERIOD | 32,282 | 12,476 |
CASH, END OF PERIOD | 10,054 | 16,715 |
Supplementary disclosure of cash flow information: | ||
Cash paid during the period for interest | 1,375 | 111 |
Non-cash investing and financing activities: | ||
Common shares, options and warrants issued on acquisition of VBI | 67,494 | |
Capital expenditures included in other current liabilities | $ 145 | $ 31 |
Nature of Business and Continua
Nature of Business and Continuation of Business | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business and Continuation of Business | 1. NATURE OF BUSINESS AND CONTINUATION OF BUSINESS Corporate Overview VBI Vaccines Inc. (formerly SciVac Therapeutics, Inc.) was incorporated under the laws of British Columbia, Canada on April 9, 1965 and has the following wholly-owned subsidiaries: VBI Vaccines (Delaware) Inc., a Delaware corporation (“VBI DE”); VBI DE’s wholly-owned subsidiary, Variation Biotechnologies (US), Inc., a Delaware corporation (“VBI US”); Variation Biotechnologies, Inc. a Canadian company (“VBI Cda”) and the wholly-owned subsidiary of VBI US; SciVac Ltd. an Israeli company (“SciVac”); and SciVac USA, LLC, a Florida limited liability company (“SciVac US”) and the wholly owned subsidiary of SciVac. VBI Vaccines Inc. and its subsidiaries are collectively referred to as the “Company,” “we,” “us,” “our” or “VBI”. The Company’s principal office is located at 222 Third Street, Suite 2241, Cambridge, Massachusetts 02142. In addition, the Company has manufacturing facilities located in Rehovot, Israel and research facilities located in Ottawa, Ontario, Canada. The Company operates in one segment and therefore segment information is not presented. Principal Operations We are a commercial stage biopharmaceutical company developing next generation vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketed product is Sci-B-Vac ® ® Following our merger with VBI DE on May 6, 2016 (the “VBI-SciVac Merger”), we are also advancing our two platform technologies – our Enveloped Virus-Like Particle (“eVLP”) platform technology and our Lipid Particle Vaccine (“LPV”) technology. We are advancing a pipeline of eVLP vaccines, with lead programs in both infectious disease, with our congenital cytomegalovirus (“CMV”) vaccine, and in immuno-oncology, with our therapeutic glioblastoma multiforme (“GBM” or “glioblastoma”) vaccine candidate. Liquidity and Going Concern The Company has a limited operating history and faces a number of risks, including but not limited to, uncertainties regarding the success of its development activities, demand and market acceptance of the Company’s products and reliance on major customers. The Company anticipates that it will continue to incur significant operating costs and losses in connection with the development of its products. The Company has an accumulated deficit of $132,432 as of September 30, 2017, and cash outflows from operating activities of $21,890 for the nine months ended September 30, 2017. The Company will require significant additional funds to conduct clinical and non-clinical studies, achieve regulatory approvals, and, subject to such approvals, commercially launch its products. The Company plans to finance future operations with a combination of existing cash reserves, proceeds from the issuance of equity securities, the issuance of additional debt, and revenues from potential collaborations, if any. There is no assurance the Company will manage to obtain these sources of financing. The above conditions raise substantial doubt about the Company’s ability to continue as a going concern. The report of our independent registered public accounting firm on our consolidated financial statements for the year ended December 31, 2016 contains an explanatory paragraph regarding our ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern. On May 15, 2017, the Company entered into an equity distribution agreement (the “Distribution Agreement”) with a registered broker-dealer, as sales agent (the “Sales Agent”), pursuant to which the Company may offer and sell, from time to time, through the Sales Agent its common shares having an aggregate offering price of up to $30 million. The Company is not obligated to sell any common shares under the Distribution Agreement. Subject to the terms and conditions of the Distribution Agreement, the Sales Agent will use commercially reasonable efforts consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations, and the rules of the NASDAQ Capital Market to sell shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. The Company will pay the Sales Agent a commission of 3.0% of the aggregate gross proceeds from each sale of common shares occurring pursuant to the Distribution Agreement, if any. The Distribution Agreement may be terminated by the Sales Agent or the Company at any time upon ten days’ notice to the other party, or by the Sales Agent at any time in certain circumstances. To-date no amounts have been raised under this Distribution Agreement. See Note 13, Subsequent Events, for a description of financings completed in October 2017. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 2. SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation and Consolidation The Company’s fiscal year ends on December 31 of each calendar year. The accompanying unaudited condensed consolidated financial statements have been prepared in U.S. dollars (“USD”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”), for interim reporting. Accordingly, certain information and footnote disclosures normally included in the financial statements prepared in accordance with United States of America generally accepted accounting principles (“U.S. GAAP”), have been condensed or omitted pursuant to such rules and regulations. 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 and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from these estimates and are not necessarily indicative of the results to be expected for any future period or the entire fiscal year. The December 31, 2016 consolidated balance sheet in this document was derived from the audited consolidated financial statements and does not include all of the disclosures required by U.S. GAAP. The condensed consolidated financial statements and notes included in this quarterly report on Form 10-Q (this “Form 10-Q”) should be read in conjunction with the financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 (the “2016 10-K”), as filed with the SEC on March 20, 2017. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: SciVac, SciVac USA, and from May 6, 2016 the accounts of VBI DE, VBI US and VBI Cda. Intercompany balances and transactions between the Company and its subsidiaries are eliminated in the condensed consolidated financial statements. In the opinion of management, these condensed consolidated financial statements include all adjustments and accruals of a normal and recurring nature necessary to fairly state the financial statements for the dates and the periods presented. The results for the periods presented are not necessarily indicative of results to be expected for the full year or for any future periods. Significant Accounting Policies The significant accounting policies used in the preparation of these condensed consolidated financial statements are disclosed in the 2016 10-K, and there have been no changes to the Company’s significant accounting policies during the nine months ended September 30, 2017. Foreign currency The functional and reporting currency of the Company is the USD. Each of the Company’s subsidiaries determines its own respective functional currency, and this currency is used to separately measure each entity’s financial position and operating results. Assets and liabilities of foreign operations with a different functional currency from that of the Company are translated at the closing rate at the end of each reporting period. Profit or loss items are translated at average exchange rates for all the relevant periods. All resulting translation differences are recognized as a component of accumulated other comprehensive income (loss). Foreign exchange gains and losses arising from transactions denominated in a currency other than the functional currency of the entity involved, are included in the condensed consolidated statements of operations. Use of Estimates Preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual amounts could differ from the estimates made and changes in estimates may occur. We continually evaluate estimates used in the preparation of the condensed consolidated financial statements for reasonableness. Appropriate adjustments, if any, to the estimates used are made prospectively based upon such periodic evaluation. The significant areas of estimation include determining the deferred tax valuation allowance, the estimated lives of property and equipment and intangible assets, the inputs in determining the fair value of equity based awards and warrants issued as well as the values ascribed to assets acquired and liabilities assumed in a business combination. Actual results may differ from those estimates. Goodwill and In-Process Research and Development The Company’s intangibles including in-process research and development (“IPR&D”) and goodwill, are tested for impairment annually, or more frequently if events or circumstances indicate that the assets might be impaired. Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. Goodwill can become impaired in certain circumstances, including but not limited to: (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, or (3) an adverse action or assessment by a regulator. When evaluating goodwill for impairment, we may first perform an assessment qualitatively whether it is more likely than not that a reporting unit’s carrying amount exceeds its fair value, referred to as a “step zero” approach. The Company adopted Accounting Standards Update (“ASU”) 2017-04, “Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment” effective August 31, 2017 which has eliminated Step 2 from the goodwill impairment test. Under this update, an entity should perform its goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. The Company has established August 31 st The costs of rights to IPR&D projects acquired in an asset acquisition are expensed in the consolidated statements of operations unless the project has an alternative future use. These costs include initial payments incurred prior to regulatory approval in connection with research and development agreements that provide rights to develop, manufacture, market and/or sell pharmaceutical products. IPR&D acquired in a business combination is capitalized as an intangible asset and tested for impairment at least annually until commercialization, after which time the IPR&D is amortized over its estimated useful life. The impairment test compares the carrying amount of the IPR&D asset to its fair value. If the carrying amount exceeds the fair value of the asset, such excess is recorded as an impairment loss. The Company performed its annual impairment test on its IPR&D assets on August 31, 2017 and recorded an impairment of $300 related to certain IPR&D assets. The fair value of the IRR&D assets included in the impairment test on August 31, 2017 was determined using the income approach method. Fair value measurements of financial instruments Accounting guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The accounting guidance outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, the Company uses quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from independent sources. The fair value hierarchy is broken down into three levels based on the source of inputs as follows: Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 — Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities. Level 3 — Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement. Financial instruments recognized in the condensed consolidated balance sheet consist of cash, accounts receivable and other current assets, accounts payable and other current liabilities. The Company believes that the carrying value of the aforementioned financial instruments approximates their fair values due to the short-term nature of these instruments. The Company does not hold any derivative financial instruments. The carrying amounts of the Company’s deposits and other long-term assets approximate their respective fair values. At September 30, 2017 and December 31, 2016, the fair value of the Company’s outstanding debt is estimated to be approximately $15,512 and $15,012, respectively. In determining the fair value of the long-term debt as of September 30, 2017 and December 31, 2016 the Company used the following assumptions: September 30, 2017 December 31, 2016 Long-term debt: Interest rate 12.2 % 12.0 % Discount rate 11.0 % 13.5 % Expected time to payment in months 26 35 |
New Accounting Pronouncements
New Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
New Accounting Pronouncements | 3. NEW ACCOUNTING PRONOUNCEMENTS Recently Adopted Accounting Pronouncements Stock Compensation In March 2016, the Financial Accounting Standards Board (the “FASB”) issued ASU No. 2016-09, “Compensation - Stock Compensation (Topic 718),” which simplifies several aspects of the accounting for share-based payment award transactions, including the income tax consequences, classification of awards as either equity or liabilities, classification on the statement of cash flows and accounting for forfeitures. ASU No. 2016-09 is effective for fiscal years beginning after December 15, 2016, including periods within those fiscal years. Our adoption of this ASU in the first quarter of 2017 did not have a material impact on our condensed consolidated financial statements. Cash Flow Classification The FASB issued ASU 2016-15, an accounting standard that affects the classification of certain cash receipts and cash payments on the statement of cash flows. The standard provides guidance on eight issues: debt prepayment or extinguishment costs, settlement of zero-coupon bonds or bonds issued at a discount with insignificant cash coupon, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies, distributions received from equity method investees, beneficial interests in securitization transactions, separately identifiable cash flows and applying the predominance principle. The standard is effective for public business entities for fiscal years beginning after December 15, 2017 including periods within those fiscal years. The FASB issued ASU 2016-18, an accounting standard that requires companies to include cash and cash equivalents that have restrictions on withdrawal or use in total cash and cash equivalents on the statement of cash flows. The standard does not define restricted cash or restricted cash equivalents, but companies will need to disclose the nature of the restrictions. The standard is effective for public business entities for fiscal years beginning after December 15, 2017 including interim periods within those fiscal years. Our adoption of these ASUs in the first quarter of 2017 did not have an impact on our condensed consolidated financial statements. Recently Issued Accounting Standards, not yet Adopted Revenue from Contracts with Customers In May 2014, the FASB issued Accounting Standards Update No. 2014-09 , Leases In February 2016 the FASB issued ASU 2016-02: Leases. The ASU introduces a lessee model that results in most leases impacting the balance sheet by requiring reporting entities to recognize lease assets and lease liabilities for substantially all lease arrangements. The update is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company is currently evaluating the impact this new guidance will have on its financial statements and related disclosures. Accounting for Income Taxes on Intercompany Transfers The FASB recently issued ASU 2016-16, an accounting standard that requires the seller and buyer to recognize at the transaction date the current and deferred income tax consequences of intercompany asset transfers. The FASB expects the new standard to cause volatility in companies’ effective tax rates, particularly for those that transfer intangible assets to subsidiaries. The standard is effective for public business entities for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. While the Company continues to assess the potential impact of this standard, the adoption of this standard is not expected to have a material impact on our financial statements. Recognition and Measurement of Financial Assets and Financial Liabilities In January 2016, the FASB issued ASU 2016-01, “Financial Instruments – Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities”. This update will change the income statement impact of equity investments held by an entity; disclosures related to fair value of financial instruments and presentation of financial assets and liabilities. ASU 2016-01 is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Entities must apply the standard using a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. Except for certain early application guidance, early adoption is not permitted. The Company is currently assessing the impact that adopting this new ASU will have on our financial statements and footnote disclosures. Clarifying the Scope of Asset Derecognition Guidance and Accounting for Partial Sales of Nonfinancial Assets In February 2017, The FASB issued ASU 2017-05, “Other Income – Gains and Losses from the Derecognition of Nonfinancial Assets (Subtopic 610-12): Clarifying the Scope of Assets Derecognition Guidance and Accounting for Partial Sales of Nonfinancial Assets”. This amendment in this update clarifies the guidance on accounting for derecognition of a nonfinancial asset and an in-substance nonfinancial asset and applies only when the asset (or asset group) does not meet the definition of a business; defines in-substance nonfinancial assets; and provides guidance for partial sales of nonfinancial assets. ASU 2017-05 is effective for annual reporting periods beginning after December 15, 2017, including interim periods within those fiscal years. While the Company continues to assess the potential impact of this standard, the adoption of this standard is not expected to have a material impact on its financial statements. |
Intangibles
Intangibles | 9 Months Ended |
Sep. 30, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangibles | 4. INTANGIBLES September 30, 2017 Gross Carrying amount Accumulated Amortization Impairment Charge Cumulative Currency Translation Net Book Value Patents $ 669 $ (381 ) $ - $ 27 $ 315 IPR&D assets 61,500 - (300 ) 2,154 63,354 $ 62,169 $ (381 ) $ (300 ) $ 2,181 $ 63,669 December 31, 2016 Gross Carrying amount Accumulated Amortization Cumulative Currency Translation Net Book Value Patents $ 669 $ (334 ) $ (4 ) $ 331 IPR&D assets 61,500 - (2,324 ) 59,176 $ 62,169 $ (334 ) $ (2,328 ) $ 59,507 The Company amortizes intangible assets with finite lives on a straight-line basis over their estimated useful lives. The amortization expense for the three and nine months ended September 30, 2017 was $16 and $46, respectively compared to the three and nine months ended in 2016 of $15 and $46, respectively. The IPR&D assets relate to the May 6, 2016 VBI-SciVac Merger and will not begin amortizing until the Company commercializes its products. Future costs incurred to extend the life of the patents will be expensed. At August 31, 2017, the Company prepared its annual impairment test. As a result of that test, there was an impairment charge of $300 related to certain IPR&D assets. Such amount is included in research and development expenses in the accompanying condensed consolidated statements of operations and comprehensive loss. |
Loss Per Share of Common Shares
Loss Per Share of Common Shares | 9 Months Ended |
Sep. 30, 2017 | |
Earnings Per Share [Abstract] | |
Loss Per Share of Common Shares | 5. LOSS PER SHARE OF COMMON SHARES Basic loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, and stock options, which would result in the issuance of incremental common shares unless such effect is anti-dilutive. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as their effect would be anti-dilutive. These potentially dilutive securities are more fully described in Note 8, Stockholders’ Equity and Additional Paid-in Capital. The following potentially dilutive securities outstanding at September 30, 2017 and 2016 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: As at September 30, 2017 2016 Warrants 2,069 364 Stock options and equity awards 2,871 2,766 4,940 3,130 |
Long-term Debt
Long-term Debt | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 6. LONG-TERM DEBT As at September 30, 2017 and the December 31, 2016, the outstanding debt is as follows: September 30, 2017 December 31, 2016 Long-term debt, net of deferred financing costs and unamortized debt discount based on an imputed interest rate of 20.5% of $ 2,460 and $3,344 at September 30, 2017 and December 31, 2016, respectively $ 12,840 $ 11,956 Less: current portion 1,000 - $ 11,840 $ 11,956 As a result of the VBI-SciVac Merger, the Company through VBI DE assumed a term loan facility with Perceptive Credit Holdings, LP (the “Lender”) in the amount of $6,000 (the “Facility”), with an initial advance of $3,000 drawn down on prior to the VBI-SciVac Merger. As of the date of the VBI-SciVac Merger, the Company assumed an amount of $2,361 in the Facility. On December 6, 2016, the Company amended the Facility (the “Amended Facility”) and raised an additional $13,200 which was combined with the remaining balance from the Facility of $1,800. The total principal outstanding at September 30, 2017, including the $300 exit fee discussed below, is $15,300 before the net deferred financing costs and unamortized debt discount of $2,460. The principal on the Amended Facility accrues interest at an annual rate equal to the greater of (a) one-month LIBOR (subject to a 5.00% cap) or (b) 1.00%, plus the applicable margin. The applicable margin will be 11.00%. The first eighteen months are interest only. The interest rate as of September 30, 2017 was 12.25%. Upon the occurrence of an event of default, and during the continuance, of an event of default, the applicable margin will be increased by 4.00% per annum. The Company begins monthly principal repayments of $200 in May 2018 for 19 months upon which the remaining balance is due on maturity. The Amended Facility matures December 6, 2019 and includes both financial and non-financial covenants, including a minimum cash balance requirement of $2,500. The Company was in compliance with these covenants as of September 30, 2017. Pursuant to the Amended Facility, the Company agreed to appoint a representative of the Lender to the Board who is also a portfolio manager of the Company’s largest shareholder. The Company’s obligations under the Amended Facility are secured on a senior basis by a lien on substantially all of the assets of the Company, including the Company’s interest in its subsidiaries, and its U.S. and Canadian subsidiaries and guaranteed by the Company and its subsidiaries. The Amended Facility also contains customary events of default. In connection with the Amended Facility, on December 6, 2016, the Company issued to the Lender two tranches of warrants. The first tranche was a warrant to purchase 363,771 common shares at an exercise price of $4.13 per share and the second tranche was a warrant to purchase 1,341,282 common shares at an exercise price of $3.355 per share. The total proceeds from the Amended Facility attributed to the warrants was $2,793, based on the relative fair value of the warrants as compared to the sum of the fair values of the warrants and debt. This attribution resulted in the debt being issued at a discount. The Company incurred $360 of debt issuance costs and is required to pay an exit fee of $300 upon full repayment of the debt resulting in additional debt discount. The total debt discount of $3,453 is being charged to interest expense using the effective interest method over the term of the debt. As of September 30, 2017, the unamortized debt discount is $2,460. The Company recorded $884 of interest expense related to the amortization of the debt discount during the nine months ended September 30, 2017. The following table summarizes the future principal payments that the Company expects to make for long-term debt: Period ending September 30, Principal payments on Amended Facility and exit fee 2017 $ - 2018 1,000 2019 14,300 $ 15,300 |
Deferred Revenue and Related Pa
Deferred Revenue and Related Party Transactions | 9 Months Ended |
Sep. 30, 2017 | |
Deferred Revenue Disclosure [Abstract] | |
Deferred Revenue and Related Party Transactions | 7. DEFERRED REVENUE AND RELATED PARTY TRANSACTIONS Prior to the VBI-SciVac Merger, one of the Company’s directors was also the chairman of the board of Kevelt AS (“Kevelt”), a wholly owned subsidiary of OAO Pharmsynthez (“Pharmsynthez”), a shareholder of the Company and was also the chairman of the board of Pharmsynthez. Following the VBI-SciVac Merger, in accordance with the merger agreement, this director resigned. On April 26, 2013, SciVac entered into a Development and Manufacturing Agreement (“DMA”) with Kevelt, pursuant to which SciVac agreed to develop the manufacturing process for the production of clinical and commercial quantities of certain materials in drug substance form. On July 30, 2016, the Company received a letter of termination from Kevelt, in part containing a request for refund of $2.5 million it had previously transferred to the Company. Such amount is included in other current liabilities in the accompanying condensed consolidated financial statements. See Note 13, Subsequent Events for a description on the Kevelt settlement agreement. SciVac entered into a services agreement with OPKO Biologics Ltd. (“OPKO Bio”), a wholly-owned subsidiary of OPKO Health, Inc., a related party shareholder of the Company, dated as of March 15, 2015, as amended on January 25, 2016, pursuant to which SciVac agreed to provide certain aseptic process filling services to OPKO Bio. The terms of the services agreement are based on market rates and comparable to other non-related party service agreements. See Note 6, Long-term Debt, for the Facility from a lender that is also affiliated with the Company’s largest shareholder. Nine months ended September 30 2017 2016 Services revenues from related parties: OPKO Bio $ 4 $ 12 Subsequent to the VBI-SciVac Merger on May 6, 2016, Kevelt and Pharmsynthez are no longer considered related parties due to the common shareholder no longer having significant influence. |
Stockholders' Equity and Additi
Stockholders' Equity and Additional Paid-in Capital | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Stockholders' Equity and Additional Paid-in Capital | 8. STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL Stock option plans The Company’s stock option plans are approved by and administered by the Company’s board of directors (the “Board”) and its Compensation Committee. The Board designates, in connection with recommendations from the Compensation Committee, eligible participants to be included under the plan, and designates the number of options, exercise price and vesting period of the new options. 2006 VBI US Stock Option Plan No further options will be issued under the 2006 VBI US Stock Option Plan (the “2006 Plan”). As at September 30, 2017, there were 1,290,153 options outstanding under the 2006 Plan. 2013 Stock Incentive Plan No further options will be issued under the 2013 Equity Incentive Plan (the “2013 Plan”). As at September 30, 2017, there were 4,613 options outstanding under the 2013 Plan. 2014 Equity Incentive Plan No further options will be issued under the 2014 Equity Incentive Plan (the “2014 Plan”). As at September 30, 2017, there were 713,716 options outstanding under the 2014 Plan. 2016 VBI Equity Incentive Plan The 2016 VBI Equity Incentive Plan (the “2016 Plan”) is a rolling incentive plan that sets the number of common shares issuable under the 2016 Plan, together with any other security-based compensation arrangement of the Company, at a maximum of 10% of the aggregate common shares issued and outstanding on a non-diluted basis at the time of any grant under the 2016 Plan. The 10% maximum is inclusive of options granted under all equity incentive plans. The 2016 Plan is an omnibus equity incentive plan pursuant to which the Company may grant equity and equity-linked awards to eligible participants in order to promote the success of the Company following the VBI-SciVac Merger by providing a means to offer incentives and to attract, motivate, retain and reward persons eligible to participate in the 2016 Plan. Grants under the 2016 Plan include a grant or right consisting of one or more options, stock appreciation rights (“SARs”), restricted share units (“RSUs”), performance share units (“PSUs”), shares of restricted stock or other such award as may be permitted under the 2016 Plan. As at September 30, 2017, there were 412,250 options and 450,250 stock awards outstanding under the 2016 Plan. The aggregate number of common shares remaining available for issuance for awards under this plan was 648,702 at September 30, 2017. Activity related to stock options is as follows (in thousands, except for weighted average exercise price): Number of Stock Options Weighted Average Exercise Price Balance outstanding at December 31, 2016 2,168 $ 4.45 Granted 304 $ 3.60 Exercised (6 ) $ 2.50 Forfeited (45 ) $ 4.41 Balance outstanding at September 30, 2017 2,421 $ 4.43 Exercisable at September 30, 2017 1,634 $ 4.47 Information relating to restricted stock units is as follow (in thousands, except for weighted average fair value at grant date): Number of Stock Awards Weighted Average Fair Value at Grant Date Unvested shares outstanding at December 31, 2016 639 $ 3.88 Granted 57 $ 4.72 Vested (212) $ 4.23 Forfeited (33) $ 3.90 Unvested shares outstanding at September 30, 2017 451 $ 3.96 The fair value of the options and restricted stock units will be recognized as an expense on a straight-line basis over the vesting period. The total stock-based compensation expense recorded in the three and nine months ended September 30, 2017 and 2016 was as follows: Three months ended September 30 Nine months ended September 30 2017 2016 2017 2016 Research and development $ 166 $ 334 $ 553 $ 616 General and administrative 410 368 1,241 1,128 Cost of revenues 17 - 50 - Total stock based compensation $ 593 $ 702 $ 1,844 $ 1,744 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. INCOME TAXES The Company operates in U.S., Israel and Canadian tax jurisdictions. Its income is subject to varying rates of tax, and losses incurred in one jurisdiction cannot be used to offset income taxes payable in another. The Company’s effective tax rate on loss before tax for the three and nine months ended September 30, 2017 of 0% and 1.5%, respectively (0% - 2016) differs from the Canadian statutory rate of 26% primarily due to the recognition of a valuation allowance on the Canadian deferred tax assets as well as on the other deferred tax assets in all other jurisdictions. The Company maintains a valuation allowance on its net deferred tax assets. A valuation allowance is required when, based upon an assessment of various factors, including recent operating loss history, anticipated future earnings, and prudent and reasonable tax planning strategies, it is more likely than not that some portion of the deferred tax assets will not be realized. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. COMMITMENTS AND CONTINGENCIES Licensing (a) The Company’s manufactured and marketed product, Sci-B-Vac™, is a recombinant third generation hepatitis B vaccine whose sales and territories are governed by the Ferring License Agreement (“License Agreement”). Under the License Agreement, the Company is committed to pay Ferring royalties equal to 7% of net sales (as defined therein). Royalty payments have been de minimis for the three and nine months ended September 30, 2017 and 2016, respectively. (b) Under an Assignment and Assumption Agreement, the Company is required to pay royalties to SciGen Singapore equal to 5% of net sales of Sci-B-Vac. Royalty payments have been de minimis for the three and nine months ended September 30, 2017 and 2016. Legal Proceedings From time to time, the Company may be involved in certain claims and litigation arising out of the ordinary course of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome. The Company believes that it maintains adequate insurance coverage for any such litigation matters arising in the normal course of business. Operating Leases The Company has entered into various non-cancelable lease agreements for its office, lab and manufacturing facilities. These arrangements expire at various times through 2022. Rent expense for the three months ended September 30, 2017 and 2016 was $233 and $184, respectively and for the nine months ended September 30, 2017 and 2016 was $689 and $401, respectively. The future annual minimum payments under these leases is as follows: Year ending December 31 Remaining 2017 $ 228 2018 738 2019 685 2020 448 2021 448 Thereafter 37 Total $ 2,584 |
Revenue by Geographic Region
Revenue by Geographic Region | 9 Months Ended |
Sep. 30, 2017 | |
Revenue By Geographic Region | |
Revenue by Geographic Region | 11. REVENUE BY GEOGRAPHIC REGION Three months ended September 30 Nine months ended September 30 2017 2016 2017 2016 Israel $ 153 $ 116 $ 400 $ 206 Asia 40 - 101 4 North America - - 150 - South America - - 2 - Europe - 165 11 201 Total $ 193 $ 281 $ 664 $ 411 |
Property and Equipment, Net by
Property and Equipment, Net by Geographic Region | 9 Months Ended |
Sep. 30, 2017 | |
Property And Equipment Net By Geographic Region | |
Property and Equipment, Net by Geographic Region | 12. PROPERTY AND EQUIPMENT, NET BY GEOGRAPHIC REGION September 30, 2017 December 31, 2016 Property and equipment in Israel $ 2,015 $ 1,850 Property and equipment in North America 138 - Total $ 2,153 $ 1,850 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. SUBSEQUENT EVENTS On October 30, 2017, the Company closed an underwritten public offering and a concurrent registered direct offering of an aggregate of 23,575,410 common shares at a price of $3.05 per share. In addition, in connection with the registered direct offering, the Company issued four-year warrants to purchase 550,000 common shares at an exercise price of $3.34 per share. The aggregate estimate net proceeds from the offerings to the Company were approximately $67.4 million. On November 8, 2017, SciVac Ltd.entered into a settlement agreement with Kevelt, whereby SciVac Ltd. agreed to pay Kevelt $1,000,000 in cash by November 10, 2017, and issue 274,000 common shares of the Company by no later than December 18, 2017, to settle certain ongoing disputes arising out of SciVac Ltd.’s development and manufacturing agreement with Kevelt. As part of the settlement, the development and manufacturing agreement was terminated and Kevelt and SciVac Ltd. entered into mutual release agreements, whereby each of them released the other from all claims and liabilities arising under the development and manufacturing agreement. |
Significant Accounting Polici20
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Foreign Currency | Foreign currency The functional and reporting currency of the Company is the USD. Each of the Company’s subsidiaries determines its own respective functional currency, and this currency is used to separately measure each entity’s financial position and operating results. Assets and liabilities of foreign operations with a different functional currency from that of the Company are translated at the closing rate at the end of each reporting period. Profit or loss items are translated at average exchange rates for all the relevant periods. All resulting translation differences are recognized as a component of accumulated other comprehensive income (loss). Foreign exchange gains and losses arising from transactions denominated in a currency other than the functional currency of the entity involved, are included in the condensed consolidated statements of operations. |
Use of Estimates | Use of Estimates Preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual amounts could differ from the estimates made and changes in estimates may occur. We continually evaluate estimates used in the preparation of the condensed consolidated financial statements for reasonableness. Appropriate adjustments, if any, to the estimates used are made prospectively based upon such periodic evaluation. The significant areas of estimation include determining the deferred tax valuation allowance, the estimated lives of property and equipment and intangible assets, the inputs in determining the fair value of equity based awards and warrants issued as well as the values ascribed to assets acquired and liabilities assumed in a business combination. Actual results may differ from those estimates. |
Goodwill and In-process Research and Development | Goodwill and In-Process Research and Development The Company’s intangibles including in-process research and development (“IPR&D”) and goodwill, are tested for impairment annually, or more frequently if events or circumstances indicate that the assets might be impaired. Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. Goodwill can become impaired in certain circumstances, including but not limited to: (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, or (3) an adverse action or assessment by a regulator. When evaluating goodwill for impairment, we may first perform an assessment qualitatively whether it is more likely than not that a reporting unit’s carrying amount exceeds its fair value, referred to as a “step zero” approach. The Company adopted Accounting Standards Update (“ASU”) 2017-04, “Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment” effective August 31, 2017 which has eliminated Step 2 from the goodwill impairment test. Under this update, an entity should perform its goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. The Company has established August 31 st The costs of rights to IPR&D projects acquired in an asset acquisition are expensed in the consolidated statements of operations unless the project has an alternative future use. These costs include initial payments incurred prior to regulatory approval in connection with research and development agreements that provide rights to develop, manufacture, market and/or sell pharmaceutical products. IPR&D acquired in a business combination is capitalized as an intangible asset and tested for impairment at least annually until commercialization, after which time the IPR&D is amortized over its estimated useful life. The impairment test compares the carrying amount of the IPR&D asset to its fair value. If the carrying amount exceeds the fair value of the asset, such excess is recorded as an impairment loss. The Company recorded an impairment of $300 as a result of the impairment test on August 31, 2017 related to certain IPR&D assets. The fair value of the IRR&D assets included in the impairment test on August 31, 2017 was determined using the income approach method. |
Fair Value Measurements of Financial Instruments | Fair value measurements of financial instruments Accounting guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The accounting guidance outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, the Company uses quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from independent sources. The fair value hierarchy is broken down into three levels based on the source of inputs as follows: Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 — Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities. Level 3 — Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement. Financial instruments recognized in the condensed consolidated balance sheet consist of cash, accounts receivable and other current assets, accounts payable and other current liabilities. The Company believes that the carrying value of the aforementioned financial instruments approximates their fair values due to the short-term nature of these instruments. The Company does not hold any derivative financial instruments. The carrying amounts of the Company’s deposits and other long-term assets approximate their respective fair values. At September 30, 2017 and December 31, 2016, the fair value of the Company’s outstanding debt is estimated to be approximately $15,512 and $15,012, respectively. In determining the fair value of the long-term debt as of September 30, 2017 and December 31, 2016 the Company used the following assumptions: September 30, 2017 December 31, 2016 Long-term debt: Interest rate 12.2 % 12.0 % Discount rate 11.0 % 13.5 % Expected time to payment in months 26 35 |
Significant Accounting Polici21
Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Fair Value of Long-term Debt | In determining the fair value of the long-term debt as of September 30, 2017 and December 31, 2016 the Company used the following assumptions: September 30, 2017 December 31, 2016 Long-term debt: Interest rate 12.2 % 12.0 % Discount rate 11.0 % 13.5 % Expected time to payment in months 26 35 |
Intangibles (Tables)
Intangibles (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangibles | September 30, 2017 Gross Carrying amount Accumulated Amortization Impairment Charge Cumulative Currency Translation Net Book Value Patents $ 669 $ (381 ) $ - $ 27 $ 315 IPR&D assets 61,500 - (300 ) 2,154 63,354 $ 62,169 $ (381 ) $ (300 ) $ 2,181 $ 63,669 December 31, 2016 Gross Carrying amount Accumulated Amortization Cumulative Currency Translation Net Book Value Patents $ 669 $ (334 ) $ (4 ) $ 331 IPR&D assets 61,500 - (2,324 ) 59,176 $ 62,169 $ (334 ) $ (2,328 ) $ 59,507 |
Loss Per Share of Common Shar23
Loss Per Share of Common Shares (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Weighted Average Shares Outstanding | The following potentially dilutive securities outstanding at September 30, 2017 and 2016 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: As at September 30, 2017 2016 Warrants 2,069 364 Stock options and equity awards 2,871 2,766 4,940 3,130 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | As at September 30, 2017 and the December 31, 2016, the outstanding debt is as follows: September 30, 2017 December 31, 2016 Long-term debt, net of deferred financing costs and unamortized debt discount based on an imputed interest rate of 20.5% of $ 2,460 and $3,344 at September 30, 2017 and December 31, 2016, respectively $ 12,840 $ 11,956 Less: current portion 1,000 - $ 11,840 $ 11,956 |
Schedule of Future Payment of Long-term Debt | The following table summarizes the future principal payments that the Company expects to make for long-term debt: Period ending September 30, Principal payments on Amended Facility and exit fee 2017 $ - 2018 1,000 2019 14,300 $ 15,300 |
Deferred Revenue and Related 25
Deferred Revenue and Related Party Transactions (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Deferred Revenue Disclosure [Abstract] | |
Schedule of Revenues from Related Parties | Nine months ended September 30 2017 2016 Services revenues from related parties: OPKO Bio $ 4 $ 12 |
Stockholders' Equity and Addi26
Stockholders' Equity and Additional Paid-in Capital (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Schedule of Stock Options Activity | Activity related to stock options is as follows (in thousands, except for weighted average exercise price): Number of Stock Options Weighted Average Exercise Price Balance outstanding at December 31, 2016 2,168 $ 4.45 Granted 304 $ 3.60 Exercised (6 ) $ 2.50 Forfeited (45 ) $ 4.41 Balance outstanding at September 30, 2017 2,421 $ 4.43 Exercisable at September 30, 2017 1,634 $ 4.47 |
Schedule of Restricted Stock Units | Information relating to restricted stock units is as follow (in thousands, except for weighted average fair value at grant date): Number of Stock Awards Weighted Average Fair Value at Grant Date Unvested shares outstanding at December 31, 2016 639 $ 3.88 Granted 57 $ 4.72 Vested (212) $ 4.23 Forfeited (33) $ 3.90 Unvested shares outstanding at September 30, 2017 451 $ 3.96 |
Schedule of Stock-based Compensation Expense | The fair value of the options and restricted stock units will be recognized as an expense on a straight-line basis over the vesting period. The total stock-based compensation expense recorded in the three and nine months ended September 30, 2017 and 2016 was as follows: Three months ended September 30 Nine months ended September 30 2017 2016 2017 2016 Research and development $ 166 $ 334 $ 553 $ 616 General and administrative 410 368 1,241 1,128 Cost of revenues 17 - 50 - Total stock based compensation $ 593 $ 702 $ 1,844 $ 1,744 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Annual Minimum Lease Payments | The future annual minimum payments under these leases is as follows: Year ending December 31 Remaining 2017 $ 228 2018 738 2019 685 2020 448 2021 448 Thereafter 37 Total $ 2,584 |
Revenue by Geographic Region (T
Revenue by Geographic Region (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Revenue By Geographic Region | |
Schedule of Revenue by Geographical Region | Three months ended September 30 Nine months ended September 30 2017 2016 2017 2016 Israel $ 153 $ 116 $ 400 $ 206 Asia 40 - 101 4 North America - - 150 - South America - - 2 - Europe - 165 11 201 Total $ 193 $ 281 $ 664 $ 411 |
Property and Equipment, Net b29
Property and Equipment, Net by Geographic Region (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Property And Equipment Net By Geographic Region | |
Schedule of Property and Equipment, Net by Geographic Region | September 30, 2017 December 31, 2016 Property and equipment in Israel $ 2,015 $ 1,850 Property and equipment in North America 138 - Total $ 2,153 $ 1,850 |
Nature of Business and Contin30
Nature of Business and Continuation of Business (Details Narrative) - USD ($) $ in Thousands | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | May 15, 2017 | Dec. 31, 2016 | |
Accumulated deficit | $ 132,432 | $ 104,980 | ||
Net cash flows used in operating activities | $ (21,890) | $ (10,569) | ||
Equity Distribution Agreement [Member] | Sales Agent [Member] | ||||
Percentage of sales commission | 3.00% | |||
Equity Distribution Agreement [Member] | Sales Agent [Member] | Maximum [Member] | ||||
Available for sale of securities | $ 30,000 |
Significant Accounting Polici31
Significant Accounting Policies (Details Narrative) - USD ($) $ in Thousands | Aug. 31, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 |
Impairment charges | $ 300 | |||
Fair value of debt outstanding | $ 15,512 | $ 15,012 | ||
IPR&D assets [Member] | ||||
Impairment charges | $ 300 |
Significant Accounting Polici32
Significant Accounting Policies - Schedule of Fair Value of Long-term Debt (Details) - Fair Value, Inputs, Level 3 [Member] | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Long-term debt, Interest rate | 12.20% | 12.00% |
Long-term debt, Discount rate | 11.00% | 13.50% |
Long-term debt, Expected time to payment in months | 26 months | 35 months |
Intangibles (Details Narrative)
Intangibles (Details Narrative) - USD ($) $ in Thousands | Aug. 31, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 |
Amortization expense | $ 16 | $ 15 | $ 46 | $ 46 | |
Impairment Charge | $ 300 | ||||
IPR&D assets [Member] | |||||
Impairment Charge | $ 300 |
Intangibles - Schedule of Intan
Intangibles - Schedule of Intangibles (Details) - USD ($) $ in Thousands | Aug. 31, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 |
Intangible assets, Gross | $ 62,169 | $ 62,169 | ||
Accumulated amortization | (381) | (334) | ||
Impairment Charge | 300 | |||
Cumulative Currency Translation | 2,181 | (2,328) | ||
Intangible assets, Net | 63,669 | 59,507 | ||
Patents [Member] | ||||
Intangible assets, Gross | 669 | 669 | ||
Accumulated amortization | (381) | (334) | ||
Impairment Charge | ||||
Cumulative Currency Translation | 27 | (4) | ||
Intangible assets, Net | 315 | 331 | ||
In-Process Research and Development Assets [Member] | ||||
Intangible assets, Gross | 61,500 | 61,500 | ||
Accumulated amortization | ||||
Impairment Charge | (300) | |||
Cumulative Currency Translation | 2,154 | (2,324) | ||
Intangible assets, Net | $ 63,354 | $ 59,176 |
Loss Per Share of Common Shar35
Loss Per Share of Common Shares - Schedule of Antidilutive Weighted Average Shares Outstanding (Details) - shares | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Antidilutive weighted average shares outstanding | 4,940 | 3,130 |
Warrants [Member] | ||
Antidilutive weighted average shares outstanding | 2,069 | 364 |
Stock Options and Equity Awards [Member] | ||
Antidilutive weighted average shares outstanding | 2,871 | 2,766 |
Long-term Debt (Details Narrati
Long-term Debt (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Dec. 06, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 |
Deferred financing costs and unamortized debt discount | $ 2,460 | $ 3,344 | ||
Exit fee | $ 300 | |||
Fair value of warrants | 2,793 | |||
Debt issuance costs | 360 | |||
Debt discount | $ 3,453 | 884 | $ 9 | |
Tranche One [Member] | ||||
Number of warrants issued to purchase common stock shares | 363,771 | |||
Warrant exercise price | $ 4.13 | |||
Tranche Two [Member] | ||||
Number of warrants issued to purchase common stock shares | 1,341,282 | |||
Warrant exercise price | $ 3.355 | |||
May 2018 [Member] | ||||
Repayment of debt | 200 | |||
VBI-SciVac [Member] | ||||
Loan facility, initial advance | 3,000 | |||
Loan facility, assumed amount | 2,361 | |||
Perceptive Credit Holdings, LP [Member] | ||||
Line of credit maximum borrowing capacity | 6,000 | |||
Proceeds from line of credit | $ 13,200 | |||
Line of credit remaining balance | $ 1,800 | |||
Long term debt, gross | 15,300 | |||
Deferred financing costs and unamortized debt discount | 2,460 | |||
Exit fee | $ 300 | |||
Term loan interest rate | The principal on the Amended Facility accrues interest at an annual rate equal to the greater of (a) one-month LIBOR (subject to a 5.00% cap) or (b) 1.00%, plus the applicable margin. The applicable margin will be 11.00%. | |||
Term loan interest rate | 12.25% | |||
Term loan maturity date | Dec. 6, 2019 | |||
Minimum cash balance requirement | $ 2,500 | |||
Perceptive Credit Holdings, LP [Member] | Maximum [Member] | ||||
Term loan interest rate | 4.00% |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Debt Disclosure [Abstract] | ||
Long-term debt, net of deferred financing costs and unamortized debt discount based on an imputed interest rate of 20.5% of $2,460 and $3,344 at September 30, 2017 and December 31, 2016, respectively | $ 12,840 | $ 11,956 |
Less: current portion | 1,000 | |
Long-term debt | $ 11,840 | $ 11,956 |
Long-term Debt - Schedule of 38
Long-term Debt - Schedule of Long-term Debt (Details) (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Debt Disclosure [Abstract] | ||
Long-term debt, imputed interest rate | 20.50% | 20.50% |
Unamortized debt discount | $ 2,460 | $ 3,344 |
Long-term Debt - Schedule of Fu
Long-term Debt - Schedule of Future Payment of Long-term Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Total | $ 12,840 | $ 11,956 |
Long-term Debt [Member] | ||
2,017 | ||
2,018 | 1,000 | |
2,019 | 14,300 | |
Total | $ 15,300 |
Deferred Revenue and Related 40
Deferred Revenue and Related Party Transactions (Details Narrative) $ in Thousands | Jul. 30, 2016USD ($) |
Kevelt [Member] | |
Refund amount | $ 2,500 |
Deferred Revenue and Related 41
Deferred Revenue and Related Party Transactions - Schedule of Revenues from Related Parties (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Sep. 30, 2016 |
OPKO Bio [Member] | ||
Services revenues from related parties | $ 4 | $ 12 |
Stockholders' Equity and Addi42
Stockholders' Equity and Additional Paid-in Capital (Details Narrative) - shares | 9 Months Ended | |
Sep. 30, 2017 | Dec. 31, 2016 | |
Number of options outstanding | 2,421,000 | 2,168,000 |
Number of stock awards | 304,000 | |
2006 Plan [Member] | ||
Number of options outstanding | 1,290,153 | |
2013 Plan [Member] | ||
Number of options outstanding | 4,613 | |
2014 Plan [Member] | ||
Number of options outstanding | 713,716 | |
2016 VBI Equity Incentive Plan [Member] | ||
Percentage of common shares issued and outstanding | 10.00% | |
Number of common shares available for issuance | 648,702 | |
2016 Plan [Member] | ||
Number of options outstanding | 412,250 | |
Number of stock awards | 450,250 |
Stockholders' Equity and Addi43
Stockholders' Equity and Additional Paid-in Capital - Schedule of Stock Options Activity (Details) | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Equity [Abstract] | |
Number of Stock Options Outstanding, beginning balance | shares | 2,168,000 |
Number of Stock Options, Granted | shares | 304,000 |
Number of Stock Options, Exercised | shares | (6,000) |
Number of Stock Options, Forfeited | shares | (45,000) |
Number of Stock Options Outstanding, ending balance | shares | 2,421,000 |
Number of Stock Options, Exercisable | shares | 1,634,000 |
Weighted Average Exercise Price, beginning balance | $ / shares | $ 4.45 |
Weighted Average Exercise Price, Granted | $ / shares | 3.60 |
Weighted Average Exercise Price, Exercised | $ / shares | 2.50 |
Weighted Average Exercise Price, Forfeited | $ / shares | 4.41 |
Weighted Average Exercise Price, ending balance | $ / shares | 4.43 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 4.47 |
Stockholders' Equity and Addi44
Stockholders' Equity and Additional Paid-in Capital - Schedule of Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member] | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Number of Stock Awards, Unvested shares outstanding beginning balance | shares | 639,000 |
Number of Stock Awards, Granted | $ 57,000 |
Number of Stock Awards Vested | shares | (212,000) |
Number of Stock Awards, Forfeited | shares | (33,000) |
Number of Stock Awards, Unvested shares outstanding ending balance | shares | 451,000 |
Weighted Avg Fair Value at Grant Date, Unvested shares outstanding beginning balance | $ 3.88 |
Weighted Avg Fair Value at Grant Date, Granted | 4.72 |
Weighted Avg Fair Value at Grant Date, Vested | 4.23 |
Weighted Avg Fair Value at Grant Date, Forfeited | 3.90 |
Weighted Avg Fair Value at Grant Date, Unvested shares outstanding | $ 3.96 |
Stockholders' Equity and Addi45
Stockholders' Equity and Additional Paid-in Capital - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Total stock-based compensation | $ 593 | $ 702 | $ 1,844 | $ 1,744 |
Research and Development [Member] | ||||
Total stock-based compensation | 166 | 334 | 553 | 616 |
General and Administrative [Member] | ||||
Total stock-based compensation | 410 | 368 | 1,241 | 1,128 |
Cost of Revenues [Member] | ||||
Total stock-based compensation | $ 17 | $ 50 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | ||||
Effective tax rate percentage | 0.00% | 0.00% | 1.50% | 0.00% |
Canadian statutory income tax rate | 26.00% |
Commitments and Contingencies47
Commitments and Contingencies (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Operating leases expiration | 2,022 | |||
Operating leases, rent expense | $ 233 | $ 184 | $ 689 | $ 401 |
Ferring License Agreement [Member] | ||||
Royalty fees percentage | 7.00% | |||
Ferring License Agreement [Member] | SciGen Singapore [Member] | ||||
Royalty fees percentage | 5.00% |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Future Annual Minimum Lease Payments (Details) $ in Thousands | Sep. 30, 2017USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Remaining 2,017 | $ 228 |
2,018 | 738 |
2,019 | 685 |
2,020 | 448 |
2,021 | 448 |
Thereafter | 37 |
Total | $ 2,584 |
Revenue by Geographic Region -
Revenue by Geographic Region - Schedule of Revenue by Geographical Region (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Revenue | $ 193 | $ 281 | $ 664 | $ 411 |
Israel [Member] | ||||
Revenue | 153 | 116 | 400 | 206 |
Asia [Member] | ||||
Revenue | 40 | 101 | 4 | |
North America [Member] | ||||
Revenue | 150 | |||
South America [Member] | ||||
Revenue | 2 | |||
Europe [Member] | ||||
Revenue | $ 165 | $ 11 | $ 201 |
Property and Equipment, Net b50
Property and Equipment, Net by Geographic Region - Schedule of Property and Equipment, Net by Geographic Region (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Property and Equipment, Net by Geographic Region | $ 2,153 | $ 1,850 |
Israel [Member] | ||
Property and Equipment, Net by Geographic Region | 2,015 | 1,850 |
North America [Member] | ||
Property and Equipment, Net by Geographic Region | $ 138 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Nov. 08, 2017 | Oct. 31, 2017 | Sep. 30, 2017 | Sep. 30, 2016 |
Proceeds from issuance of stock | $ 13,610 | |||
Subsequent Event [Member] | ||||
Issuance of aggregate common shares | 23,575,410 | |||
Sale of common stock, price per share | $ 3.05 | |||
Warrant term | 4 years | |||
Warrants to purchase common stock | 550,000 | |||
Warrant exercise price per share | $ 3.34 | |||
Proceeds from issuance of stock | $ 67,400 | |||
Subsequent Event [Member] | Kevelt [Member] | Settlement Agreement [Member] | ||||
Issued shares of common stock value | $ 1,000 | |||
Number of shares of common stock issued | 274,000 |